[Title 42 CFR ]
[Code of Federal Regulations (annual edition) - October 1, 2021 Edition]
[From the U.S. Government Publishing Office]



[[Page i]]

          
          
          Title 42

Public Health


________________________

Parts 400 to 413

                         Revised as of October 1, 2021

          Containing a codification of documents of general 
          applicability and future effect

          As of October 1, 2021
                    Published by the Office of the Federal Register 
                    National Archives and Records Administration as a 
                    Special Edition of the Federal Register

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                            Table of Contents



                                                                    Page
  Explanation.................................................       v

  Title 42:
          Chapter IV--Centers for Medicare & Medicaid 
          Services, Department of Health and Human Services          3
  Finding Aids:
      Table of CFR Titles and Chapters........................     991
      Alphabetical List of Agencies Appearing in the CFR......    1011
      List of CFR Sections Affected...........................    1021

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                     ----------------------------

                     Cite this Code: CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus, 42 CFR 400.200 
                       refers to title 42, part 
                       400, section 200.

                     ----------------------------

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                               EXPLANATION

    The Code of Federal Regulations is a codification of the general and 
permanent rules published in the Federal Register by the Executive 
departments and agencies of the Federal Government. The Code is divided 
into 50 titles which represent broad areas subject to Federal 
regulation. Each title is divided into chapters which usually bear the 
name of the issuing agency. Each chapter is further subdivided into 
parts covering specific regulatory areas.
    Each volume of the Code is revised at least once each calendar year 
and issued on a quarterly basis approximately as follows:

Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1

    The appropriate revision date is printed on the cover of each 
volume.

LEGAL STATUS

    The contents of the Federal Register are required to be judicially 
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie 
evidence of the text of the original documents (44 U.S.C. 1510).

HOW TO USE THE CODE OF FEDERAL REGULATIONS

    The Code of Federal Regulations is kept up to date by the individual 
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    To determine whether a Code volume has been amended since its 
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OMB CONTROL NUMBERS

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collection request.

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Many agencies have begun publishing numerous OMB control numbers as 
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that volume.

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    Oliver A. Potts,
    Director,
    Office of the Federal Register
    October 1, 2021







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                               THIS TITLE

    Title 42--Public Health is composed of five volumes. The parts in 
these volumes are arranged in the following order: Parts 1-399, parts 
400-413, parts 414-429, parts 430-481, and part 482 to end. The first 
volume (parts 1-399) contains current regulations issued under chapter 
I--Public Health Service (HHS). The second, third, and fourth volumes 
(parts 400-413, parts 414-429, and parts 430-481) include regulations 
issued under chapter IV--Centers for Medicare & Medicaid Services (HHS) 
and the fifth volume (part 482 to end) contains the remaining 
regulations in chapter IV and the regulations issued under chapter V by 
the Office of Inspector General-Health Care (HHS). The contents of these 
volumes represent all current regulations codified under this title of 
the CFR as of October 1, 2021.

    For this volume, Michele Bugenhagen was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of John 
Hyrum Martinez, assisted by Stephen J. Frattini.

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                         TITLE 42--PUBLIC HEALTH




                  (This book contains parts 400 to 413)

  --------------------------------------------------------------------
                                                                    Part

chapter iv--Centers for Medicare & Medicaid Services, 
  Department of Health and Human Services...................         400

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  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
                        HEALTH AND HUMAN SERVICES




  --------------------------------------------------------------------


  Editorial Note: Nomenclature changes to chapter IV appear at 62 FR 
46037, Aug. 29, 1997; 66 FR 39452, July 31, 2001; 67 FR 36540, May 24, 
2002; and 77 FR 29028, May 16, 2012

                    SUBCHAPTER A--GENERAL PROVISIONS
Part                                                                Page
400             Introduction; definitions...................           5
401             General administrative requirements.........           8
402             Civil money penalties, assessments, and 
                    exclusions..............................          38
403             Special programs and projects...............          58
404             Review of Regulations (Eff. 3-22-22)........         119
                     SUBCHAPTER B--MEDICARE PROGRAM
405             Federal health insurance for the aged and 
                    disabled................................         123
406             Hospital insurance eligibility and 
                    entitlement.............................         315
407             Supplementary medical insurance (SMI) 
                    enrollment and entitlement..............         332
408             Premiums for supplementary medical insurance         342
409             Hospital insurance benefits.................         359
410             Supplementary medical insurance (SMI) 
                    benefits................................         390
411             Exclusions from Medicare and limitations on 
                    Medicare payment........................         478
412             Prospective payment systems for inpatient 
                    hospital services.......................         581
413             Principles of reasonable cost reimbursement; 
                    payment for end-stage renal disease 
                    services; prospectively determined 
                    payment rates for skilled nursing 
                    facilities; payment for acute kidney 
                    injury dialysis.........................         803

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                     SUBCHAPTER A_GENERAL PROVISIONS





PART 400_INTRODUCTION; DEFINITIONS--Table of Contents



Subpart A [Reserved]

                          Subpart B_Definitions

Sec.
400.200 General definitions.
400.202 Definitions specific to Medicare.
400.203 Definitions specific to Medicaid.

Subpart C [Reserved]

    Authority: 42 U.S.C. 1302 and 1395hh, and 44 U.S.C. Chapter 35.

Subpart A [Reserved]



                          Subpart B_Definitions



Sec.  400.200  General definitions.

    In this chapter, unless the context indicates otherwise--
    Act means the Social Security Act, and titles referred to are titles 
of that Act.
    Administrator means the Administrator, Centers for Medicare & 
Medicaid Services (CMS), formerly the Health Care Financing 
Administration (HCFA).
    ALJ stands for administrative law judge.
    Area means the geographical area within the boundaries of a State, 
or a State or other jurisdiction, designated as constituting an area 
with respect to which a Professional Standards Review Organization or a 
Utilization and Quality Control Peer Review Organization has been or may 
be designated.
    Beneficiary means a person who is entitled to Medicare benefits and/
or has been determined to be eligible for Medicaid.
    CMP stands for competitive medical plan.
    Conditions of participation includes requirements for participation 
as the latter term is used in part 483 of this chapter.
    Condition level deficiencies includes deficiencies with respect to 
``level A requirements'' as the latter term is used in parts 442 and 483 
of this chapter.
    CORF stands for comprehensive outpatient rehabilitation facility.
    CFR stands for Code of Federal Regulations.
    CMS stands for Centers for Medicare & Medicaid Services, formerly 
the Health Care Financing Administration (HCFA).
    CY stands for calendar year.
    DAB stands for Departmental Appeals Board.
    Department means the Department of Health and Human Services (HHS), 
formerly the Department of Health, Education, and Welfare.
    ESRD stands for end-stage renal disease.
    FDA stands for the Food and Drug Administration.
    FQHC means Federally qualified health center.
    FR stands for Federal Register.
    FY stands for fiscal year.
    HCPP stands for health care prepayment plan.
    HHS stands for the Department of Health and Human Services.
    HHA stands for home health agency.
    HMO stands for health maintenance organization.
    ICF stands for intermediate care facility.
    ICF/IID stands for intermediate care facility for individuals with 
intellectual disabilities.
    Medicaid means medical assistance provided under a State plan 
approved under title XIX of the Act.
    Medicare means the health insurance program for the aged and 
disabled under title XVIII of the Act.
    NCD stands for national coverage determination.
    OASDI stands for the Old Age, Survivors, and Disability Insurance 
program under title II of the Act.
    OIG stands for the Department's Office of the Inspector General.
    Public Health Emergency (PHE) means the Public Health Emergency 
determined to exist nationwide as of January 27, 2020, by the Secretary 
pursuant to section 319 of the Public Health Service Act on January 31, 
2020, as a result of confirmed cases of COVID-19, including any 
subsequent renewals.

[[Page 6]]

    QDWI stands for Qualified Disabled and Working Individual.
    QIO stands for quality improvement organization.
    QMB stands for Qualified Medicare Beneficiary.
    Qualified Disabled and Working Individual means an individual who--
    (1) Is eligible to enroll for Medicare Part A under section 1818A of 
the Act.
    (2) Has income, as determined in accordance with SSI methodologies, 
that does not exceed 200 percent of the Federal poverty guidelines (as 
defined and revised annually by the Office of Management and Budget) for 
a family of the size of the individual's family;
    (3) Has resources, as determined in accordance with SSI 
methodologies, that do not exceed twice the relevant maximum amount 
established, for SSI eligibility, for an individual or for an individual 
and his or her spouse; and
    (4) Is not otherwise eligible for Medicaid.
    Qualified Medicare Beneficiary means an individual who--
    (1) Is entitled to Medicare Part A, with or without payment of 
premiums, but is not entitled solely because he or she is eligible to 
enroll as a QDWI;
    (2) Has resources, as determined in accordance with SSI 
methodologies, that do not exceed twice the maximum amount established 
for SSI eligibility; and
    (3) Has income, as determined in accordance with SSI methodologies, 
that does not exceed 100 percent of the Federal poverty guidelines.
    Quality improvement organization means an organization that has a 
contract with CMS, under part B of title XI of the Act, to perform 
utilization and quality control review of the health care furnished, or 
to be furnished, to Medicare beneficiaries.
    Regional Administrator means a Regional Administrator of CMS.
    Regional Office means one of the regional offices of CMS.
    RHC stands for rural health clinic.
    RRB stands for Railroad Retirement Board.
    Secretary means the Secretary of Health and Human Services.
    SNF stands for skilled nursing facility.
    Social security benefits means monthly cash benefits payable under 
section 202 or 223 of the Act.
    SSA stands for Social Security Administration.
    United States means the fifty States, the District of Columbia, the 
Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, 
and the Northern Mariana Islands.
    U.S.C. stands for United States Code.

[48 FR 12534, Mar. 25, 1983]

    Editorial Note: For Federal Register citations affecting Sec.  
400.200, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.  400.202  Definitions specific to Medicare.

    As used in connection with the Medicare program, unless the context 
indicates otherwise--
    Carrier means an entity that has a contract with CMS to determine 
and make Medicare payments for Part B benefits payable on a charge basis 
and to perform other related functions.
    Critical access hospital (CAH) means a facility designated by HFCA 
as meeting the applicable requirements of section 1820 of the Act and of 
subpart F of part 485 of this chapter.
    Departmental Appeals Board means: (1) Except as provided in 
paragraphs (2) and (3) of this definition, a Board established in the 
office of the Secretary, whose members act in panels to provide 
impartial review of disputed decisions made by operating components of 
the Department or by ALJs.
    (2) For purposes of review of ALJ decisions under part 405, subparts 
G and H; part 417, subpart Q; part 422, subpart M; and part 478, subpart 
B of this chapter, the Medicare Appeals Council designated by the Board 
Chair.
    (3) For purposes of part 426 of this chapter, a Member of the Board 
and, at the discretion of the Board Chair, any other Board staff 
appointed by the Board Chair to perform a review under that part.
    Entitled means that an individual meets all the requirements for 
Medicare benefits.
    Essential access community hospital (EACH) means a hospital 
designated by

[[Page 7]]

CMS as meeting the applicable requirements of section 1820 of the Act 
and of subpart G of part 412 of this chapter, as in effect on September 
30, 1997.
    GME stands for graduate medical education.
    Hospital insurance benefits means payments on behalf of, and in rare 
circumstances directly to, an entitled individual for services that are 
covered under Part A of title XVIII of the Act.
    Intermediary means an entity that has a contract with CMS to 
determine and make Medicare payments for Part A or Part B benefits 
payable on a cost basis and to perform other related functions.
    Local coverage determination (LCD) means a decision by a fiscal 
intermediary or a carrier under Medicare Part A or Part B, as 
applicable, whether to cover a particular service on an intermediary-
wide or carrier-wide basis in accordance with section 1862(a)(1)(A) of 
the Act. An LCD may provide that a service is not reasonable and 
necessary for certain diagnoses and/or for certain diagnosis codes. An 
LCD does not include a determination of which procedure code, if any, is 
assigned to a service or a determination with respect to the amount of 
payment to be made for the service.
    Medicare integrity program contractor means an entity that has a 
contract with CMS under section 1893 of the Act to perform exclusively 
one or more of the program integrity activities specified in that 
section.
    Medicare Part A means the hospital insurance program authorized 
under Part A of title XVIII of the Act.
    Medicare Part B means the supplementary medical insurance program 
authorized under Part B of title XVIII of the Act.
    Medicare Part C means the choice of Medicare benefits through 
Medicare Advantage plans authorized under Part C of the title XVIII of 
the Act.
    Medicare Part D means the voluntary prescription drug benefit 
program authorized under Part D of title XVIII of the Act.
    National coverage determination (NCD) means a decision that CMS 
makes regarding whether to cover a particular service nationally under 
title XVIII of the Act. An NCD does not include a determination of what 
code, if any, is assigned to a service or a determination with respect 
to the amount of payment to be made for the service.
    Nonparticipating supplier means a supplier that does not have an 
agreement with CMS to participate in Part B of Medicare in effect on the 
date of the service.
    Participating supplier means a supplier that has an agreement with 
CMS to participate in Part B of Medicare in effect on the date of the 
service.
    Payment on an assignment-related basis means payment for Part B 
services--
    (1) To a physician or other supplier that accepts assignment from 
the beneficiary, in accordance with Sec.  424.55 or Sec.  424.56 of this 
chapter;
    (2) To a physician or other supplier after the beneficiary's death, 
in accordance with Sec.  424.64(c)(1) of this chapter; or
    (3) To an entity that pays the physician or other supplier under a 
health benefit plan, in accordance with Sec.  424.66 of this chapter.
    Provider means a hospital, a CAH, a skilled nursing facility, a 
comprehensive outpatient rehabilitation facility, a home health agency, 
or a hospice that has in effect an agreement to participate in Medicare, 
or a clinic, a rehabilitation agency, or a public health agency that has 
in effect a similar agreement but only to furnish outpatient physical 
therapy or speech pathology services, or a community mental health 
center that has in effect a similar agreement but only to furnish 
partial hospitalization services.
    Railroad retirement benefits means monthly benefits payable to 
individuals under the Railroad Retirement Act of 1974 (45 U.S.C. 
beginning at section 231).
    Services means medical care or services and items, such as medical 
diagnosis and treatment, drugs and biologicals, supplies, appliances, 
and equipment, medical social services, and use of hospital, CAH, or SNF 
facilities.
    Supplementary medical insurance benefits means payment to or on 
behalf of an entitled individual for services covered under Part B of 
title XVIII of the Act.
    Supplier means a physician or other practitioner, or an entity other 
than a

[[Page 8]]

provider, that furnishes health care services under Medicare.

[48 FR 12534, Mar. 25, 1983]

    Editorial Note: For Federal Register citations affecting Sec.  
400.202, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.  400.203  Definitions specific to Medicaid.

    As used in connection with the Medicaid program, unless the context 
indicates otherwise--
    Applicant means an individual whose written application for Medicaid 
has been submitted to the agency determining Medicaid eligibility, but 
has not received final action. This includes an individual (who need not 
be alive at the time of application) whose application is submitted 
through a representative or a person acting responsibly for the 
individual.
    Federal financial participation (FFP) means the Federal Government's 
share of a State's expenditures under the Medicaid program.
    FMAP stands for the Federal medical assistance percentage, which is 
used to calculate the amount of Federal share of State expenditures for 
services.
    Intellectual disability means the condition that was previously 
referred to as mental retardation.
    Medicaid agency or agency means the single State agency 
administering or supervising the administration of a State Medicaid 
plan.
    Nursing facility (NF), effective October 1, 1990, means an SNF or an 
ICF participating in the Medicaid program.
    PCCM stands for primary care case manager.
    PCP stands for primary care physician.
    Provider means either of the following:
    (1) For the fee-for-service program, any individual or entity 
furnishing Medicaid services under an agreement with the Medicaid 
agency.
    (2) For the managed care program, any individual or entity that is 
engaged in the delivery of health care services and is legally 
authorized to do so by the State in which it delivers the services.
    Services means the types of medical assistance specified in section 
1905(a) of the Act and defined in subpart A of part 440 of this chapter.
    State means the several States, the District of Columbia, the 
Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa 
and the Northern Mariana Islands.
    State plan or the plan means a comprehensive written commitment by a 
Medicaid agency, submitted under section 1902(a) of the Act, to 
administer or supervise the administration of a Medicaid program in 
accordance with Federal requirements.

[48 FR 12534, Mar. 25, 1983, as amended at 50 FR 33029, Aug. 16, 1985; 
56 FR 8852, Mar. 1, 1991; 57 FR 29155, June 30, 1992; 67 FR 41094, June 
14, 2002; 77 FR 29028, May 16, 2012]

Subpart C [Reserved]



PART 401_GENERAL ADMINISTRATIVE REQUIREMENTS--Table of Contents



Subpart A [Reserved]

                Subpart B_Confidentiality and Disclosure

Sec.
401.101 Purpose and scope.
401.102 Definitions.
401.105 Rules for disclosure.
401.106 Publication.
401.108 CMS rulings.
401.109 Precedential Final Decisions of the Secretary.
401.110 Publications for sale.
401.112 Availability of administrative staff manuals.
401.116 Availability of records upon request.
401.118 Deletion of identifying details.
401.120 Creation of records.
401.126 Information or records that are not available.
401.128 Where requests for records may be made.
401.130 Materials available at social security district offices and 
          branch offices.
401.132 Materials in field offices of the Office of Hearings and 
          Appeals, SSA.
401.133 Availability of official reports on providers and suppliers of 
          services, State agencies, intermediaries, and carriers under 
          Medicare.
401.134 Release of Medicare information to State and Federal agencies.
401.135 Release of Medicare information to the public.
401.136 Requests for information or records.
401.140 Fees and charges.
401.144 Denial of requests.

[[Page 9]]

401.148 Administrative review.
401.152 Court review.

Subpart C [Reserved]

            Subpart D_Reporting and Returning of Overpayments

401.301 Basis and scope.
401.303 Definitions.
401.305 Requirements for reporting and returning of overpayments.

Subpart E [Reserved]

               Subpart F_Claims Collection and Compromise

401.601 Basis and scope.
401.603 Definitions.
401.605 Omissions not a defense.
401.607 Claims collection.
401.613 Compromise of claims.
401.615 Payment of compromise amount.
401.617 Suspension of collection action.
401.621 Termination of collection action.
401.623 Joint and several liability.
401.625 Effect of CMS claims collection decisions on appeals.

   Subpart G_Availability of Medicare Data for Performance Measurement

401.701 Purpose and scope.
401.703 Definitions.
401.705 Eligibility criteria for qualified entities.
401.707 Operating and governance requirements for qualified entities.
401.709 The application process and requirements.
401.711 Updates to plans submitted as part of the application process.
401.713 Ensuring the privacy and security of data.
401.715 Selection and use of performance measures.
401.716 Non-public analyses.
401.717 Provider and supplier requests for error correction.
401.718 Dissemination of data.
401.719 Monitoring and sanctioning of qualified entities.
401.721 Terminating an agreement with a qualified entity.
401.722 Qualified clinical data registries.

    Authority: Secs. 1102, 1871, and 1874(e) of the Social Security Act 
(42 U.S.C. 1302, 1395hh, and 1395w-5) and sec. 105, Pub. L. 114-10, 129 
Stat. 87.

Subpart A [Reserved]



                Subpart B_Confidentiality and Disclosure

    Source: 46 FR 55696, Nov. 12, 1981, unless otherwise noted.



Sec.  401.101  Purpose and scope.

    (a) The regulations in this subpart:
    (1) Implement section 1106(a) of the Social Security Act as it 
applies to the Centers for Medicare & Medicaid Services (CMS). The rules 
apply to information obtained by officers or employees of CMS in the 
course of administering title XVIII of the Social Security Act 
(Medicare), information obtained by Medicare intermediaries or carriers 
in the course of carrying out agreements under sections 1816 and 1842 of 
the Social Security Act, and any other information subject to section 
1106(a) of the Social Security Act;
    (2) Relate to the availability to the public, under 5 U.S.C. 552, of 
records of CMS and its components. They set out what records are 
available and how they may be obtained; and
    (3) Supplement the regulations of the Department of Health and Human 
Services relating to availability of information under 5 U.S.C. 552, 
codified in 45 CFR part 5, and do not replace or restrict them.
    (b) Except as authorized by the rules in this subpart, no 
information described in paragraph (a)(1) of this section shall be 
disclosed. The procedural rules in this subpart (Sec. Sec.  401.106 
through 401.152) shall be applied to requests for information which is 
subject to the rules for disclosure in this subpart.
    (c) Requests for information which may not be disclosed according to 
the provisions of this subpart shall be denied under authority of 
section 1106(a) of the Social Security Act and this subpart, and 
furthermore, such requests which have been made pursuant to the Freedom 
of Information Act shall be denied under authority of an appropriate 
Freedom of Information Act exemption, 5 U.S.C. 552(b).



Sec.  401.102  Definitions.

    For purposes of this subpart:
    Act means the Social Security Act.
    Freedom of Information Act rules means the substantive mandatory 
disclosure provisions of the Freedom of

[[Page 10]]

Information Act, 5 U.S.C. 552 (including the exemptions from mandatory 
disclosure, 5 U.S.C. 552(b), as implemented by the Department's public 
information regulation, 45 CFR part 5, subpart F and by Sec. Sec.  
401.106 to 401.152 of this subpart.
    Person means a person as defined in the Administrative Procedure 
Act, 5 U.S.C. 551(2). This includes State or local agencies, but does 
not include Federal agencies or State or Federal courts.
    Record has the same meaning as that provided in 45 CFR 5.5.
    Subject individual means an individual whose record is maintained by 
the Department in a system of records, as the terms ``individual,'' 
``record'', and ``system of records'' are defined in the Privacy Act of 
1974, 5 U.S.C. 552a(a).



Sec.  401.105  Rules for disclosure.

    (a) General rule. The Freedom of Information Act rules shall be 
applied to every proposed disclosure of information. If, considering the 
circumstances of the disclosure, the information would be made available 
in accordance with the Freedom of Information Act rules, then the 
information may be disclosed regardless of whether the requester or 
beneficiary of the information has a statutory right to request the 
information under the Freedom of Information Act, 5 U.S.C. 552, or 
whether a request has been made.
    (b) Application of the general rule. Pursuant to the general rule in 
paragraph (a) of this section,
    (1) Information shall be disclosed--
    (i) To a subject individual when required by the access provision of 
the Privacy Act, 5 U.S.C. 552a(d), as implemented by the Department 
Privacy Act regulation, 45 CFR part 5b; and
    (ii) To a person upon request when required by the Freedom of 
Information Act, 5 U.S.C. 552;
    (2) Unless prohibited by any other statute (e.g., the Privacy Act of 
1974, 5 U.S.C. 552a(b), the Tax Reform Act of 1976, 26 U.S.C. 6103, or 
section 1106(d) and (e) of the Social Security Act), information may be 
disclosed to any requester or beneficiary of the information, including 
another Federal agency or a State or Federal court, when the information 
would not be exempt from mandatory disclosure under Freedom of 
Information Act rules or when the information nevertheless would be made 
available under the Department's public information regulation's 
criteria for disclosures which are in the public interest and consistent 
with obligations of confidentiality and administrative necessity, 45 CFR 
part 5, subpart F, as supplemented by Sec. Sec.  401.106 to 401.152 of 
this subpart.

[42 FR 14704, Mar. 16, 1977. Redesignated at 45 FR 74913, 74914, Nov. 
13, 1980, and correctly redesignated at 46 FR 24551, May 1, 1981, as 
amended at 46 FR 55697, Nov. 12, 1981]



Sec.  401.106  Publication.

    (a) Methods of publication. Materials required to be published under 
the provisions of The Freedom of Information Act, 5 U.S.C. 552 (a)(1) 
and (2) are published in one of the following ways:
    (1) By publication in the Federal Register of CMS regulations, and 
by their subsequent inclusion in the Code of Federal Regulations;
    (2) By publication in the Federal Register of appropriate general 
notices;
    (3) By other forms of publication, when incorporated by reference in 
the Federal Register with the approval of the Director of the Federal 
Register; and
    (4) By publication of indexes of precedential orders and opinions 
issued in the adjudication of claims, statements of policy and 
interpretations which have been adopted but have not been published in 
the Federal Register, and of administrative staff manuals and 
instructions to staff that affect a member of the public.
    (b) Availability for inspection. Those materials which are published 
in the Federal Register pursuant to 5 U.S.C. 552(a)(1) shall, to the 
extent practicable and to further assist the public, be made available 
for inspection at the places specified in Sec.  401.128.

[46 FR 55696, Nov. 12, 1981, as amended at 48 FR 22924, May 23, 1983]



Sec.  401.108  CMS rulings.

    (a) After September 1981, a precedent final opinion or order or a 
statement of policy or interpretation that has not been published in the 
Federal Register as a part of a regulation or of a

[[Page 11]]

notice implementing regulations, but which has been adopted by CMS as 
having precedent, may be published in the Federal Register as a CMS 
Ruling and will be made available in the publication entitled CMS 
Rulings.
    (b) Precedent final opinions and orders and statements of policy and 
interpretation that were adopted by CMS before October, 1981, and that 
have not been published in the Federal Register are available in CMS 
Rulings.
    (c) CMS Rulings are published under the authority of the 
Administrator, CMS. They are binding on all CMS components, on all HHS 
components that adjudicate matters under the jurisdiction of CMS, and on 
the Social Security Administration to the extent that components of the 
Social Security Administration adjudicate matters under the jurisdiction 
of CMS.

[48 FR 22924, May 23, 1983, as amended at 70 FR 11472, Mar. 8, 2005; 70 
FR 37702, June 30, 2005]



Sec.  401.109  Precedential Final Decisions of the Secretary.

    (a) The Chair of the Department of Health and Human Services 
Departmental Appeals Board (DAB Chair) may designate a final decision of 
the Secretary issued by the Medicare Appeals Council in accordance with 
part 405, subpart I; part 422, subpart M; part 423, subpart U; or part 
478, subpart B, of this chapter as precedential. In determining which 
decisions should be designated as precedential, the DAB Chair may take 
into consideration decisions that address, resolve, or clarify recurring 
legal issues, rules or policies, or that may have broad application or 
impact, or involve issues of public interest.
    (b) Precedential decisions are made available to the public, with 
personally identifiable information of the beneficiary removed, and have 
precedential effect from the date they are made available to the public. 
Notice of precedential decisions is published in the Federal Register.
    (c) Medicare Appeals Council decisions designated in accordance with 
paragraph (a) of this section have precedential effect and are binding 
on all CMS components, on all HHS components that adjudicate matters 
under the jurisdiction of CMS, and on the Social Security Administration 
to the extent that components of the Social Security Administration 
adjudicate matters under the jurisdiction of CMS.
    (d) Precedential effect, as used in this section, means that the 
Medicare Appeals Council's--
    (1) Legal analysis and interpretation of a Medicare authority or 
provision is binding and must be followed in future determinations and 
appeals in which the same authority or provision applies and is still in 
effect; and
    (2) Factual findings are binding and must be applied to future 
determinations and appeals involving the same parties if the relevant 
facts are the same and evidence is presented that the underlying factual 
circumstances have not changed since the issuance of the precedential 
final decision.

[82 FR 5105, Jan. 17, 2017]



Sec.  401.110  Publications for sale.

    The following publications containing information pertaining to the 
program, organization, functions, and procedures of CMS may be purchased 
from the Superintendent of Documents, Government Printing Office, 
Washington, DC 20402.
    (a) Titles 20, 42, and 45 of the Code of Federal Regulations.
    (b) Federal Register issues.
    (c) Compilation of the Social Security Laws.
    (d) CMS Rulings.
    (e) Social Security Handbook. The information in the Handbook is not 
of precedent or interpretative force.
    (f) Medicare/Medicaid Directory of Medical Facilities.



Sec.  401.112  Availability of administrative staff manuals.

    All CMS administrative staff manuals and instructions to staff 
personnel which contain policies, procedures, or interpretations that 
affect the public are available for inspection and copying. A complete 
listing of such materials is published in CMS Rulings. These manuals are 
generally not printed in a sufficient quantity to permit sale or other 
general distribution to the public. Selected material is maintained at 
Social Security Administration district offices and field offices

[[Page 12]]

and may be inspected there. See Sec. Sec.  401.130 and 401.132 for a 
listing of this material.



Sec.  401.116  Availability of records upon request.

    (a) General. In addition to the records made available pursuant to 
Sec. Sec.  401.106, 401.108, 401.110 and 401.112, CMS will, upon request 
made in accordance with this subpart, make identified records available 
to any person, unless they are exempt from disclosure under the 
provisions of section 552(b) of title 5, United States Code (see Sec.  
401.126), or any other provision of law.
    (b) Misappropriation, alteration, or destruction of records. No 
person may remove any record made available to him for inspection or 
copying under this part, from the place where it is made available. In 
addition, no person may steal, alter, mutilate, obliterate, or destroy 
in whole or in part, such a record. See sections 641 and 2071 of title 
18 of the United States Code.



Sec.  401.118  Deletion of identifying details.

    When CMS publishes or otherwise makes available an opinion or order, 
statement of policy, or other record which relates to a private party or 
parties, the name or names or other identifying details will be deleted.



Sec.  401.120  Creation of records.

    Records will not be created by compiling selected items from the 
files, and records will not be created to provide the requester with 
such data as ratios, proportions, percentages, per capitas, frequency 
distributions, trends, correlations, and comparisons. If such data have 
been compiled and are available in the form of a record, the record 
shall be made available as provided in this subpart.



Sec.  401.126  Information or records that are not available.

    (a) Specific exemptions from disclosure. Pursuant to paragraph (b) 
of 5 U.S.C. 552, certain classes of records are exempt from disclosure. 
For some examples of the kinds of materials which are exempt, see 
subpart F of the public information regulation of the Department of 
Health and Human Services (45 CFR part 5) and the appendix to that 
regulation.
    (b) Materials exempt from disclosure by statute. Pursuant to 
paragraph (b)(3) of 5 U.S.C. 552, as amended, which exempts from the 
requirement for disclosure matters that are exempted from disclosure by 
statute, provided that such statute requires that the matters be 
withheld from the public in such a manner as to leave no discretion on 
the issue, or establishes particular criteria for withholding or refers 
to particular types of matter to be withheld:
    (1) Reports described in sections 1106 (d) and (e) of the Social 
Security Act shall not be disclosed, except in accordance with the 
provisions of sections 1106 (d) and (e). Sections 1106 (d) and (e) 
provide for public inspection of certain official reports dealing with 
the operation of the health programs established by titles XVIII and XIX 
of the Social Security Act (Medicare and Medicaid), but require that 
program validation survey reports and other formal evaluations of 
providers of services shall not identify individual patients, individual 
health care practitioners, or other individuals. Section 1106(e) further 
requires that none of the reports shall be made public until the 
contractor or provider whose performance is being evaluated has had a 
reasonable opportunity to review that report and to offer comments. See 
Sec.  401.133 (b) and (c);
    (2)(i) Except as specified in paragraph (b)(2)(ii) of this section, 
CMS may not disclose any accreditation survey or any information 
directly related to the survey (including corrective action plans) made 
by and released to it by the Joint Commission on Accreditation of 
Healthcare Organizations, the American Osteopathic Association or any 
other national accreditation organization that meets the requirements of 
Sec.  488.5 or Sec.  493.506 of this chapter. Materials that are 
confidential include accreditation letters and accompanying 
recommendations and comments prepared by an accreditation organization 
concerning the entities it surveys.
    (ii) Exceptions. (A) CMS may release the accreditation survey of any 
home health agency; and

[[Page 13]]

    (B) CMS may release the accreditation survey and other information 
directly related to the survey (including corrective action plans) to 
the extent the survey and information relate to an enforcement action 
(for example, denial of payment for new admissions, civil money 
penalties, temporary management and termination) taken by CMS; and
    (3) Tax returns and return information defined in section 6103 of 
the Internal Revenue Code, as amended by the Tax Reform Act of 1976, 
shall not be disclosed except as authorized by the Internal Revenue 
Code.
    (c) Effect of exemption. Neither 5 U.S.C. 552 nor this regulation 
directs the withholding of any record or information, except to the 
extent of the prohibitions in paragraph (b) of this section. Except for 
material required to be withheld under the statutory provisions 
incorporated in paragraph (b) of this section or under another statute 
which meets the standards in 5 U.S.C. 552(b)(3), materials exempt from 
mandatory disclosure will nevertheless be made available when this can 
be done consistently with obligations of confidentiality and 
administrative necessity. The disclosure of materials or records under 
these circumstances in response to a specific request, however, is of no 
precedent force with respect to any other request.

[46 FR 55696, Nov. 12, 1981, as amended at 58 FR 61837, Nov. 23, 1993; 
80 FR 29834, May 22, 2015]



Sec.  401.128  Where requests for records may be made.

    (a) General. Any request for any record may be made to--
    (1) Any CMS component;
    (2) Director, Office of Public Affairs, CMS 313-H, Hubert H. 
Humphrey Building, 200 Independence Avenue, Washington, DC 20201; or
    (3) Director of Public Affairs in any Regional Office of the 
Department of Health and Human Services.

The locations and service areas of these offices are as follows:

Region I--John F. Kennedy Federal Building, Boston, MA 02203. 
Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont.
Region II--26 Federal Plaza, New York, NY 10007. New York, New Jersey, 
Puerto Rico, Virgin Islands.
Region III--Gateway Building, 3535 Market Street, Philadelphia, PA 
19101. Delaware, Maryland, Pennsylvania, Virginia, West Virginia, 
District of Columbia.
Region IV--101 Marietta Street, Altanta, GA 30323. Alabama, Florida, 
Georgia, Kentucky, Mississippi, North Carolina, South Carolina, 
Tennessee.
Region V--300 South Wacker Drive, Chicago, IL 60606. Illinois, Indiana, 
Michigan, Minnesota, Ohio, Wisconsin.
Region VI--1200 Main Tower Building, Dallas, TX 75202. Arkansas, 
Louisiana, New Mexico, Oklahoma, Texas.
Region VII--601 East 12th Street, Kansas City, MO 64106. Iowa, Kansas, 
Missouri, Nebraska.
Region VIII--Federal Office Building, 19th and Stout Streets, Denver, CO 
80294. Colorado, Montana, North Dakota, South Dakota, Utah, Wyoming.
Region IX--Federal Office Building, 50 United Nations Plaza, San 
Francisco, CA 94102. Arizona, California, Hawaii, Nevada, Guam, Trust 
Territory of Pacific Islands, American Samoa.
Region X--Arcade Plaza Building, 1321 Second Avenue, Seattle, WA 98101. 
Alaska, Idaho, Oregon, Washington.

    (b) Records pertaining to individuals. CMS maintains some records 
pertaining to individuals. Disclosure of such records is generally 
prohibited by section 1106 of the Social Security Act (42 U.S.C. 1306), 
except as prescribed in Sec.  401.105 (See also Sec.  401.126(b)). 
Requests for records pertaining to individuals may be addressed to:

Director, Office of Research, Demonstrations and Statistics, CMS, 
Baltimore, Maryland 21235, when information is sought from the record of 
a person who has participated in a research survey conducted by or for 
CMS, Office of Research, Demonstrations and Statistics; or whose records 
have been included by statistical sampling techniques in research and 
statistical studies authorized by the Social Security Act in the field 
of health care financing.
    (c) Requests for materials listed in Sec.  401.130 or Sec.  401.132 
or indexed in the CMS Rulings. A request to inspect and copy materials 
listed in Sec.  401.130 or Sec.  401.132 or indexed in CMS Rulings may 
be made to any district or branch office of the Social Security 
Administration. If the specific material requested is not

[[Page 14]]

available in the office receiving the request, the material will be 
obtained and made available promptly.



Sec.  401.130  Materials available at social security district offices 
and branch offices.

    (a) Materials available for inspection. The following are available 
or will be made available for inspection at the social security district 
offices and branch offices:
    (1) Compilation of the Social Security Laws.
    (2) The Public Information Regulation of the Department of Health 
and Human Services (45 CFR part 5).
    (3) Medicare Program regulations issued by the Centers for Medicare 
& Medicaid Services. 42 CFR chapter IV .
    (4) CMS Rulings.
    (5) Social Security Handbook.
    (b) Materials available for inspection and copying. The following 
materials are available or will be made available for inspection and 
copying at the social security district offices and branch offices:
    (1) Claims Manual of the Social Security Administration.
    (2) Department Staff Manual on Organization, Department of Health 
and Human Services, Part F, CMS.
    (3) Parts 2 and 3 of the Part A

Intermediary Manual (Provider Services under Medicare CMS Pub. 13-2 and 
13-3).
    (4) Parts 2 and 3 of the Part B Intermediary Manual (Physician and 
Supplier Services).
    (5) Intermediary Letters Related to Parts 2 and 3 of the Part A and 
Part B Intermediary Manuals.
    (6) State Buy-In Handbook (State Enrollment of Eligible Individuals 
under the Supplementary Medical Insurance Program) and Letters.
    (7) Group Practice Prepayment Plan Manual (HIM-8) and Letters.
    (8) State Operations Manual (HIM-7).
    (9) CMS Letters to State Agencies on Medicare.
    (10) Skilled Nursing Facility Manual (CMS Pub. 12).
    (11) Hearing Officers Handbook (Supplementary Medical Insurance 
Program--HIM-21).
    (12) Hospital Manual (HIM-10).
    (13) Home Health Agency Manual (HIM-11).
    (14) Outpatient Physical Therapy Provider Manual (HIM-9).
    (15) Provider Reimbursement Manual (HIM-15).
    (16) Audit Program Manuals for Hospital (HIM-16), Home Health Agency 
(HIM-17), and Extended Care Facilities (HIM-18).
    (17) Statements of deficiencies based upon survey reports of health 
care institutions or facilities prepared after January 31, 1973, by a 
State agency, and such reports (including pertinent written statements 
furnished by such institution or facility on such statements of 
deficiencies), as set forth in Sec.  401.133(a). Except as otherwise 
provided for at Sec. Sec.  401.133 and 488.325 of this chapter for SNFs, 
such statements of deficiencies, reports, and pertinent written 
statements shall be available or made available only at the social 
security district office and regional office servicing the area in which 
the institution or facility is located, except that such statements of 
deficiencies and pertinent written statements shall also be available at 
the local public assistance offices servicing such area.
    (18) Indexes to the materials listed in paragraph (a) of this 
section and in this paragraph (b) and an index to the Bureau of Hearings 
and Appeals Handbook.

[46 FR 55696, Nov. 12, 1981, as amended at 59 FR 56232, Nov. 10, 1994]



Sec.  401.132  Materials in field offices of the Office of Hearings 
and Appeals, SSA.

    (a) Materials available for inspection. The following materials are 
available for inspection in the field offices of the Office of Hearings 
and Appeals, SSA.
    (1) Title 45 of the Code of Federal Regulations (including the 
public information regulation of the Department of Health and Human 
Services).
    (2) Regulations of the Social Security Administration and CMS.
    (3) Title 5, United States Code.
    (4) Compilation of the Social Security Laws.
    (5) CMS Rulings.
    (6) Social Security Handbook.
    (b) Handbook available for inspection and copying. The Office of 
Hearings and

[[Page 15]]

Appeals Handbook is available for inspection and copying in the field 
offices of the Office of Hearings and Appeals.



Sec.  401.133  Availability of official reports on providers and suppliers 
of services, State agencies, intermediaries, and carriers under Medicare.

    Except as otherwise provided for in Sec.  488.325 of this chapter 
for SNFs, the following must be made available to the public under the 
conditions specified:
    (a) Statements of deficiencies and survey reports on providers of 
services prepared by State agencies. (1) Statements of deficiencies 
based upon official survey reports prepared after January 31, 1973, by a 
State agency pursuant to its agreement entered into under section 1864 
of the Social Security Act and furnished to CMS, which relate to a State 
agency's findings on the compliance of a health care institution or 
facility with the applicable provisions in section 1861 of the Act and 
with the regulations, promulgated pursuant to those provisions, dealing 
with health and safety of patients in those institutions and facilities; 
and (2) State agency survey reports. The statement of deficiencies or 
report and any pertinent written statements furnished by the institution 
or facility on the statement of deficiencies shall be disclosed within 
90 days following the completion of the survey by the State agency, but 
not to exceed 30 days following the receipt of the report by CMS. (See 
Sec.  401.130(b)(17)) for places where statements of deficiencies, 
reports, and pertinent written statements will be available.)
    (b) CMS reports on providers of services. Upon request in writing, 
official reports and other formal evaluations (including followup 
reviews), excluding references to internal tolerance rules and practices 
contained therein, internal working papers or other informal memoranda, 
prepared and completed after January 31, 1973, which relate to the 
performance of providers of services under Medicare: Provided, That no 
information identifying individual patients, physicians, or other 
practitioners, or other individuals shall be disclosed under this 
paragraph. Those reports and other evaluations shall be disclosed within 
30 days following the final preparation thereof by CMS during which time 
the providers of services shall be afforded a reasonable opportunity to 
offer comments, and there shall be disclosed with those reports and 
evaluations any pertinent written statements furnished CMS by those 
providers on those reports and evaluations.
    (c) Contractor performance review reports. Upon request in writing, 
official contractor performance review reports and other formal 
evaluations (including followup reviews), excluding references to 
internal tolerance rules and practices contained therein, internal 
working papers or other informal memoranda, prepared and completed after 
January 31, 1973, which relate to the evaluation of the performance of 
(1) intermediaries and carriers under their agreements entered into 
pursuant to sections 1816 and 1842 of the Social Security Act and (2) 
State agencies under their agreements entered into pursuant to section 
1864 of the Act (including comparative evaluations of the performance of 
those intermediaries, carriers, and State agencies). The latest Contract 
Performance Review Report pertaining to a particular intermediary or 
carrier, prepared prior to February 1, 1973, may also be disclosed to 
any person upon request in writing. Those reports and evaluations shall 
be disclosed within 30 days following their final preparation by CMS (or 
30 days following the request therefor, in the case of the contract 
performance review report prepared prior to February 1, 1973), during 
which time those intermediaries, carriers, and State agencies, as the 
case may be, shall be afforded a reasonable opportunity to offer 
comments, and there shall be disclosed with those reports and 
evaluations any pertinent written statements furnished CMS by those 
intermediaries, carriers, on State agencies or those reports and 
evaluations.
    (d) Accreditation surveys. Upon written request, CMS will release 
the accreditation survey and related information from an accreditation 
organization meeting the requirements of Sec.  488.5 or Sec.  493.506 of 
this chapter to the extent the survey and information relate to

[[Page 16]]

an enforcement action taken (for example, denial of payment for new 
admission, civil money penalties, temporary management and termination) 
by CMS;
    (e) Upon written request, CMS will release the accreditation survey 
of any home health agency.

[46 FR 55696, Nov. 12, 1981; 46 FR 59249, Dec. 4, 1981, as amended at 58 
FR 61838, Nov. 23, 1993; 59 FR 56232, Nov. 10, 1994; 80 FR 29834, May 
22, 2015]



Sec.  401.134  Release of Medicare information to State and Federal agencies.

    (a) Except as provided in paragraph (b) of this section, the 
following information may be released to an officer or employee of an 
agency of the Federal or a State government lawfully charged with the 
administration of a program receiving grants-in-aid under title V and 
XIX of the Social Security Act for the purpose of administration of 
those titles, or to any officer or employee of the Department of Army, 
Department of Defense, solely for the administration of its Civilian 
Health and Medical Program of the Uniformed Services (CHAMPUS):
    (1) Information, including the identification number, concerning 
charges made by physicians, other practitioners, or suppliers, and 
amounts paid under Medicare for services furnished to beneficiaries by 
such physicians, other practioners, or suppliers, to enable the agency 
to determine the proper amount of benefits payable for medical services 
performed in accordance with those programs; or
    (2) Information as to physicians or other practioners that has been 
disclosed under Sec.  401.105.
    (3) Information relating to the qualifications and certification 
status of hospitals and other health care facilities obtained in the 
process of determining whether, and certifying as to whether, 
institutions or agencies meet or continue to meet the conditions of 
participation of providers of services or whether other entities meet or 
continue to meet the conditions for coverage of services they furnish.
    (b) The release of such information shall not be authorized by a 
fiscal intermediary or carrier.
    (c) The following information may be released to any officer or 
employee of an agency of the Federal or a State government lawfully 
charged with the duty of conducting an investigation or prosecution with 
respect to possible fraud or abuse against a program receiving grants-
in-aid under Medicaid, but only for the purpose of conducting such an 
investigation or prosecution, or to any officer or employee of the 
Department of the Army, Department of Defense, solely for the 
administration of its Civilian Health and Medical Program of the 
Uniformed Services (CHAMPUS), provided that the agency has filed an 
agreement with CMS that the information will be released only to the 
agency's enforcement branch and that the agency will preserve the 
confidentiality of the information received and will not disclose that 
information for other than program purposes:
    (1) The name and address of any provider of medical services, 
organization, or other person being actively investigated for possible 
fraud in connection with Medicare, and the nature of such suspected 
fraud. An active investigation exists when there is significant evidence 
supporting an initial complaint but there is need for further 
investigation.
    (2) The name and address of any provider of medical services, 
organization, or other person found, after consultation with an 
appropriate professional association or a program review team, to have 
provided unnecessary services, or of any physician or other individual 
found to have violated the assignment agreement on at least three 
occasions.
    (3) The name and address of any provider of medical services, 
organization or other person released under paragraph (c)(1) or (2) of 
this section concerning which an active investigation is concluded with 
a finding that there is no fraud or other prosecutable offense.



Sec.  401.135  Release of Medicare information to the public.

    The following shall be made available to the public under the 
conditions specified:
    (a) Information as to amounts paid to providers and other 
organizations and

[[Page 17]]

facilities for services to beneficiaries under title XVIII of the Act: 
Provided, That no information identifying any particular beneficiaries 
shall be disclosed under this paragraph.
    (b) The name of any provider of services or other person furnishing 
services to Medicare beneficiaries who--
    (1) Has been found by a Federal court to have been guilty of 
submitting false claims in connection with Medicare; or
    (2) Has been found by a carrier or intermediary, after consultation 
with a professional medical association functioning external to program 
administration or, if appropriate, the State medical authority, to have 
been engaged in a pattern of furnishing services to beneficiaries which 
are substantially in excess of their medical needs; except that the name 
of any provider or other person shall not be disclosed pursuant to a 
finding under this paragraph (b)(2) of this section, unless that 
provider or other person has first been afforded a reasonable 
opportunity to offer evidence on his behalf.
    (c) Upon request in writing, cost reports submitted by providers of 
services pursuant to section 1815 of the Act to enable the Secretary to 
determine amounts due the providers.



Sec.  401.136  Requests for information or records.

    (a) A request should reasonably identify the requested record by 
brief description. Requesters who have detailed information which would 
assist in identifying the records requested are urged to provide such 
information in order to expedite the handling of the request. Envelopes 
in which written requests are submitted should be clearly identified as 
Freedom of Information requests. The request should include the fee or 
request determination of the fee. When necessary, a written request will 
be promptly forwarded to the proper office, and the requester will be 
advised of the date of the receipt and identification and address of the 
proper office.
    (b) Determinations of whether records will be released or withheld 
will be made within 10 working days from date of receipt of the request 
in the office listed in Sec.  401.128 except where CMS extends this time 
and sends notice of such extension to the requester. Such extension may 
not exceed 10 additional working days and shall apply only where the 
following unusual circumstances exist:
    (1) The need to search for and collect the requested records from 
field facilities or other establishments that are separate from the 
office processing the requests;
    (2) The need to search for, collect, and appropriately examine a 
voluminous amount of separate and distinct records which are requested 
in a single request; or
    (3) The need for consultation, which shall be conducted with all 
practicable speed, with another agency having a substantial interest in 
the request or among two or more components of CMS having a substantial 
interest in the subject matter of the request.
    (c) If an extension is made, the requester will be notified in 
writing before the expiration of 10 working days from receipt of the 
request and will be given an explanation of why the extension was 
necessary and the date on which a determination will be made.
    (d) Authority to extend the time limit with respect to any request 
for information or records is granted to the Director, Office of Public 
Affairs, CMS and to the Director of Public Affairs in any HHS Regional 
Office. Those officers and employees of CMS who are listed in Sec.  
401.144(a) as having authority to deny requests for information from 
records maintained on individuals are granted authority to extend the 
time limit for responding to requests for information from such records.



Sec.  401.140  Fees and charges.

    (a) Statement of policy. It is CMS's policy to comply with certain 
requests for information services without charge. Except as otherwise 
determined pursuant to paragraph (c) of this section, fees will be 
charged for the following services with respect to all other requests 
for information from records which are reasonably identified by the 
requesters:
    (1) Reproduction, duplication, or copying of records;
    (2) Searches for records; and

[[Page 18]]

    (3) Certification or authentication of records.
    (b) Fee schedules. The fee schedule is as follows:
    (1) Search for records. Three dollars per hour: Provided, however, 
That no charge will be made for the first half hour.
    (2) Reproduction, duplication, or copying of records. Ten cents per 
page where such reproduction can be made by commonly available 
photocopying machines. The cost of reproducing records which cannot be 
so photocopied will be determined on an individual basis at actual cost.
    (3) Certification or authentication of records. Three dollars per 
certification or authentication.
    (4) Forwarding materials to destination. Any special arrangements 
for forwarding which are requested shall be charged at actual cost; 
however, no charge will be made for postage.
    (5) No charge will be made when the total amount does not exceed 
five dollars.
    (c) Waiver or reduction of fees. Waiver or reduction of the fees in 
paragraph (b) of this section may be made upon a determination that such 
waiver or reduction is in the public interest because furnishing the 
information can be considered as primarily benefiting the general 
public. Such determination may be made by the appropriate officer or 
employee identified in Sec.  401.144.
    (d) Sale of documents. On occasion, a previously printed document 
may be available for sale to the public; the cost of supplying the 
document is one cent per page unless the document is available for sale 
from the Superintendent of Documents, in which case the price shall be 
that determined by the Superintendent.



Sec.  401.144  Denial of requests.

    (a) General authority. Only the Director, Office of Public Affairs, 
CMS, and the Regional Directors of Public Affairs, HHS, are authorized 
to deny written requests to obtain, inspect or copy any CMS information 
or record.
    (b) Forms of denials. (1) Oral requests may be dealt with orally, 
but the requester should be advised that the oral response is not an 
official determination and that an official determination may be 
obtained only by submitting the request in writing. Appropriate 
available assistance will be offered.
    (2) Written Requests--Denials of written requests will be in writing 
and will contain the reasons for the denial including, as appropriate, a 
statement that a document requested is nonexistent or not reasonably 
described or is subject to one or more clearly described exemption(s). 
Denials will also provide the requester with appropriate information on 
how to exercise the right of appeal.



Sec.  401.148  Administrative review.

    (a) Review by the Administrator. A person whose request has been 
denied may initiate a review by filing a request for review with the 
Administrator of CMS, 700 East High Rise Building, 6401 Security 
Boulevard, Baltimore, Maryland 21235, within 30 days of receipt of the 
determination to deny or within 30 days of receipt of records which are 
in partial response to his request if a portion of a request is granted 
and a portion denied, whichever is later. Upon receipt of a timely 
request for review, the Administrator will review the decision in 
question and the findings upon which it was based. Upon the basis of the 
data considered in connection with the decision and whatever other 
evidence and written argument is submitted by the person requesting the 
review or which is otherwise obtained, the Administrator or his designee 
will affirm or revise in whole or in part the findings and decision in 
question. A decision to affirm the denial will be made only upon 
concurrence of the Assistant Secretary for Public Affairs, or his 
designee, after consultation with the General Counsel or his or her 
designee, and the appropriate program policy official. Written notice of 
the decision of the Administrator will be mailed to the person who 
requested the review. A written decision will be made within 20 working 
days from receipt of the request for review. Extension of the time limit 
may be granted under the circumstances listed in Sec.  401.136(b) to the 
extent that the maximum 10 days limit on extensions has not been 
exhausted on the initial determination. The decision will include the 
basis for it and

[[Page 19]]

will advise the requester of his right to judicial review.
    (b) Failure of the Administrator to comply with the time limits. 
Failure of the Administrator to comply with the time limits set forth in 
Sec.  401.136 and this section constitutes an exhaustion of the 
requester's administrative remedies.



Sec.  401.152  Court review.

    Where the Administrator upon review affirms the denial of a request 
for records, in whole or in part, the requester may seek court review in 
the district court of the United States pursuant to 5 U.S.C. 
552(a)(4)(B).

Subpart C [Reserved]



            Subpart D_Reporting and Returning of Overpayments

    Source: 81 FR 7683, Feb. 12, 2016, unless otherwise noted.



Sec.  401.301  Basis and scope.

    This subpart sets forth the policies and procedures for reporting 
and returning overpayments to the Medicare program for providers and 
suppliers of services under Parts A and B of title XVIII of the Act as 
required by section 1128J(d) of the Act.



Sec.  401.303  Definitions.

    For purposes of this subpart--
    Medicare contractor means a Part A/Part B Medicare Administrative 
Contractor (A/B MAC) or a Durable Medical Equipment Medicare 
Administrative Contractor (DME MAC).
    Overpayment means any funds that a person has received or retained 
under title XVIII of the Act to which the person, after applicable 
reconciliation, is not entitled under such title.
    Person means a provider (as defined in Sec.  400.202 of this 
chapter) or a supplier (as defined in Sec.  400.202 of this chapter).



Sec.  401.305  Requirements for reporting and returning of overpayments.

    (a) General. (1) A person that has received an overpayment must 
report and return the overpayment in the form and manner set forth in 
this section.
    (2) A person has identified an overpayment when the person has, or 
should have through the exercise of reasonable diligence, determined 
that the person has received an overpayment and quantified the amount of 
the overpayment. A person should have determined that the person 
received an overpayment and quantified the amount of the overpayment if 
the person fails to exercise reasonable diligence and the person in fact 
received an overpayment.
    (b) Deadline for reporting and returning overpayments. (1) A person 
who has received an overpayment must report and return the overpayment 
by the later of either of the following:
    (i) The date which is 60 days after the date on which the 
overpayment was identified.
    (ii) The date any corresponding cost report is due, if applicable.
    (2) The deadline for returning overpayments will be suspended when 
the following occurs:
    (i) OIG acknowledges receipt of a submission to the OIG Self-
Disclosure Protocol and will remain suspended until such time as a 
settlement agreement is entered, the person withdraws from the OIG Self-
Disclosure Protocol, or the person is removed from the OIG Self-
Disclosure Protocol.
    (ii) CMS acknowledges receipt of a submission to the CMS Voluntary 
Self-Referral Disclosure Protocol and will remain suspended until such 
time as a settlement agreement is entered, the person withdraws from the 
CMS Voluntary Self-Referral Disclosure Protocol, or the person is 
removed from the CMS Voluntary Self-Referral Disclosure Protocol.
    (iii) A person requests an extended repayment schedule as defined in 
Sec.  401.603 and will remain suspended until such time as CMS or one of 
its contractors rejects the extended repayment schedule request or the 
provider or supplier fails to comply with the terms of the extended 
repayment schedule.
    (c) Applicable reconciliation. (1) The applicable reconciliation 
occurs when a cost report is filed; and
    (2) In instances when the provider--
    (i) Receives more recent CMS information on the SSI ratio, the 
provider

[[Page 20]]

is not required to return any overpayment resulting from the updated 
information until the final reconciliation of the provider's cost report 
occurs; or
    (ii) Knows that an outlier reconciliation will be performed, the 
provider is not required to estimate the change in reimbursement and 
return the estimated overpayment until the final reconciliation of that 
cost report.
    (d) Reporting. (1) A person must use an applicable claims 
adjustment, credit balance, self-reported refund, or other reporting 
process set forth by the applicable Medicare contractor to report an 
overpayment, except as provided in paragraph (d)(2) of this section. If 
the person calculates the overpayment amount using a statistical 
sampling methodology, the person must describe the statistically valid 
sampling and extrapolation methodology in the report.
    (2) A person satisfies the reporting obligations of this section by 
making a disclosure under the OIG's Self-Disclosure Protocol or the CMS 
Voluntary Self-Referral Disclosure Protocol resulting in a settlement 
agreement using the process described in the respective protocol.
    (e) Enforcement. Any overpayment retained by a person after the 
deadline for reporting and returning the overpayment specified in 
paragraph (b) of this section is an obligation for purposes of 31 U.S.C. 
3729.
    (f) Lookback period. An overpayment must be reported and returned in 
accordance with this section if a person identifies the overpayment, as 
defined in paragraph (a)(2) of this section, within 6 years of the date 
the overpayment was received.

Subpart E [Reserved]



               Subpart F_Claims Collection and Compromise

    Source: 48 FR 39064, Aug. 29, 1983, unless otherwise noted.



Sec.  401.601  Basis and scope.

    (a) Basis. This subpart implements the following statutory 
provisions:
    (1) For CMS the Debt Collection Improvement Act of 1996 (Pub. L. 
104-134) (DCIA), 110 Stat. 1321, 1358 (April 26, 1996) (codified at 31 
U.S.C. 3711), and conforms to the regulations (31 CFR parts 900-904) 
issued jointly by the Department of the Treasury and the Department of 
Justice that generally prescribe claims collection standards and 
procedures under the DCIA for the Federal government.
    (2) Section 1893(f)(1) of the Act regarding the use of repayment 
plans.
    (b) Scope. Except as provided in paragraphs (c) through (f) of this 
section, the regulations in this subpart describe CMS's procedures and 
standards for the collection of claims in any amount, and the compromise 
of, or the suspension or termination of collection action on, all claims 
for money or property that do not exceed $100,000 or such higher amount 
as the Attorney General may from time to time prescribe, exclusive of 
interest, arising under any functions delegated to CMS by the Secretary.
    (c) Amount of claim. CMS refers all claims that exceed $100,000 or 
such higher amount as the Attorney General may from time to time 
prescribe, exclusive of interest, to the Department of Justice or the 
General Accounting Office for the compromise of claims, or the 
suspension or termination of collection action.
    (d) Related regulations--(1) Department regulations. DHHS 
regulations applicable to CMS that generally implement the FCCA for the 
Department are located at 45 CFR part 30. These regulations apply only 
to the extent CMS regulations do not address a situation.
    (2) CMS regulations. The following regulations govern specific debt 
management situations encountered by CMS and supplement this subpart:
    (i) Claims against Medicare beneficiaries for the recovery of 
overpayments are covered in 20 CFR 404.515.
    (ii) Adjustments in Railroad Retirement or Social Security benefits 
to recover Medicare overpayments to individuals are covered in 
Sec. Sec.  405.350-405.358 of this chapter.
    (iii) Claims against providers, physicians, or other suppliers of 
services for overpayments under Medicare and for assessment of interest 
are covered in Sec. Sec.  405.377 and 405.378 of this chapter, 
respectively.

[[Page 21]]

    (iv) Claims against beneficiaries for unpaid hospital insurance or 
supplementary medical insurance premiums under Medicare are covered in 
Sec.  408.110 of this chapter.
    (v) State repayment of Medicaid funds by installments is covered in 
Sec.  430.48 of this chapter.
    (e) Collection and compromise under other statutes and at common 
law. The regulations in this subpart do not--
    (1) Preclude disposition by CMS of claims under statutes, other than 
the FCCA, that provide for the collection or compromise of a claim, or 
suspension or termination of collection action.
    (2) Affect any rights that CMS may have under common law as a 
creditor.
    (f) Fraud. The regulations in this subpart do not apply to claims in 
which there is an indication of fraud, the presentation of a false 
claim, or misrepresentation on the part of a debtor or any other party 
having an interest in the claim. CMS forwards these claims to the 
Department of Justice for disposition under 4 CFR 105.1.
    (g) Enforced collection. CMS refers claims to the Department of 
Justice for enforced collection through litigation in those cases which 
cannot be compromised or on which collection action cannot be suspended 
or terminated in accordance with this subpart or the regulations issued 
jointly by the Attorney General and the Comptroller General.

[48 FR 39064, Aug. 29, 1983, as amended at 52 FR 48123, Dec. 18, 1987; 
57 FR 56998, Dec. 2, 1992; 61 FR 49271, Sept. 19, 1996; 61 FR 63748, 
Dec. 2, 1996; 73 FR 36447, June 27, 2008]



Sec.  401.603  Definitions.

    For purposes of this subpart--
    Claim means any debt owed to CMS.
    Debtor means any individual, partnership, corporation, estate, trust 
or other legal entity against which CMS has a claim.
    Extended repayment schedule means installment payments to pay back a 
debt.

[48 FR 39064, Aug. 29, 1983, as amended at 73 FR 36447, June 27, 2008]



Sec.  401.605  Omissions not a defense.

    The failure of CMS to comply with the regulations in this subpart, 
or with the related regulations listed in Sec.  401.601(d), is not 
available as a defense to a debtor against whom CMS has a claim for 
money or property.



Sec.  401.607  Claims collection.

    (a) General policy. CMS recovers amounts of claims due from debtors, 
including interest where appropriate, by--
    (1) Direct collections in lump sums or in installments; or
    (2) Offsets against monies owed to the debtor by the Federal 
government where possible.
    (b) Collection in lump sums. Whenever possible, CMS attempts to 
collect claims in full in one lump sum. However, if CMS determines that 
a debtor is unable to pay the claim in one lump sum, CMS may instead 
enter into an agreement to accept regular installment payments.
    (c) Collection in installments. Generally, CMS requires that all 
claims to be satisfied by installment payments must be liquidated in 
three years or less. If unusual circumstances exist, such as the 
possibility of debtor insolvency, an installment agreement that extends 
beyond three years may be approved.
    (1) Debtor request. If a debtor desires to repay a claim in 
installments, the debtor must submit--
    (i) A request to CMS; and
    (ii) Any information required by CMS to make a decision regarding 
the request.
    (2) Extended repayment schedule. (i) For purposes of this paragraph 
(c)(2), the following definitions apply:
    Extreme hardship exists when a provider or supplier qualifies as 
being in ``hardship'' as defined in this paragraph and the provider's or 
supplier's request for an extended repayment schedule (ERS) is approved 
under paragraph (c)(3) of this section.
    Hardship exists when the total amount of all outstanding outstanding 
overpayments (principal and interest and including overpayments reported 
in accordance with Sec. Sec.  401.301 through 401.305) not included in 
an approved, existing repayment schedule is 10 percent

[[Page 22]]

or greater than the total Medicare payments made for the cost reporting 
period covered by the most recently submitted cost report for a provider 
filing a cost report, or for the previous calendar year for a supplier 
or non cost-report provider.
    (ii) CMS or its contractor reviews a provider's or supplier's 
request for an ERS. For a provider or a supplier not paid by Medicare 
during the previous year or paid only during a portion of that year, the 
contractor or CMS will use the last 12 months of Medicare payments. If 
less than a 12-month payment history exists, the number of months 
available is annualized to equal an approximate yearly Medicare payment 
level for the provider or supplier.
    (iii) For a provider or supplier requesting an ERS, CMS or its 
contractor evaluates the request based on the definitions and 
information submitted under this paragraph (c)(2). For a provider or 
supplier whose situation does not meet the definitions in paragraph 
(c)(2)(i) of this section, CMS or its contractor evaluates the ERS 
request using the information in paragraph (c)(3) of this section in 
deciding to grant an ERS.
    (iv) CMS or its contractor is prohibited from granting an ERS to a 
provider or supplier if there is reason to suspect the provider or 
supplier may file for bankruptcy, cease to do business, discontinue 
participation in the Medicare program, or there is an indication of 
fraud or abuse committed against the Medicare program.
    (v) CMS or its contractor may grant a provider or a supplier an ERS 
of at least 6 months if repaying an overpayment within 30 days will 
constitute a ``hardship'' as defined in paragraph (c)(2)(i) of this 
section. If a provider or supplier is granted an ERS under this 
paragraph, missing one installment payment constitutes a default and the 
total balance of the overpayment will be recovered immediately.
    (vi) CMS or its contractor may grant a provider or a supplier an ERS 
of 36 months and up to 60 months if repaying an overpayment will 
constitute an ``extreme hardship'' as defined in paragraph (c)(2)(i) of 
this section.
    (3) CMS decision. CMS will determine the number, amount and 
frequency of installment payments based on the information submitted by 
the debtor and on other factors such as--
    (i) Total amount of the claim;
    (ii) Debtor's ability to pay; and
    (iii) Cost to CMS of administering an installment agreement.
    (d) Collection by offset. (1) CMS may offset, where possible, the 
amount of a claim against the amount of pay, compensation, benefits or 
other monies that a debtor is receiving or is due from the Federal 
government.
    (2) Under regulations at Sec.  405.350-405.358 of this chapter, CMS 
may initiate adjustments in program payments to which an individual is 
entitled under title II of the Act (Federal Old Age, Survivors, and 
Disability Insurance Benefits) or under the Railroad Retirement Act of 
1974 (45 U.S.C. 231) to recover Medicare overpayments.

[48 FR 39064, Aug. 29, 1983, as amended at 61 FR 49271, Sept. 19, 1996; 
61 FR 63748, Dec. 2, 1996; 73 FR 36447, June 27, 2008; 81 FR 7684, Feb. 
12, 2016]



Sec.  401.613  Compromise of claims.

    (a) Amount of compromise. HFCA requires that the amount to be 
recovered through a compromise of a claim must--
    (1) Bear a reasonable relation to the amount of the claim; and
    (2) Be recoverable through enforced collection procedures.
    (b) General factors. After considering the bases for a decision to 
compromise a claim under paragraph (c) of this section, CMS may further 
consider factors such as--
    (1) The age and health of the debtor if the debtor is an individual;
    (2) Present and potential income of the debtor; and
    (3) Whether assets have been concealed or improperly transferred by 
the debtor.
    (c) Basis for compromise. Bases on which CMS may compromise a claim 
include the following--
    (1) Inability to pay. CMS may compromise a claim if it determines 
that the debtor, or the estate of a deceased debtor, does not have the 
present or prospective ability to pay the full amount of the claim 
within a reasonable time.

[[Page 23]]

    (2) Litigative probabilities. CMS may compromise a claim if it 
determines that it would be difficult to prevail in a case before a 
court of law as a result of the legal issues involved or inability of 
the parties to agree to the facts of the case. The amount that CMS 
accepts in compromise under this provision will reflect--
    (i) The likelihood that CMS would have prevailed on the legal 
question(s) involved;
    (ii) Whether and to what extent CMS would have obtained a full or 
partial recovery of a judgment, depending on the availability of 
witnesses, or other evidentiary support for CMS's claim; and
    (iii) The amount of court costs that would be assessed to CMS.
    (3) Cost of collecting the claim. CMS may compromise a claim if it 
determines that the cost of collecting the claim does not justify the 
enforced collection of the full amount. In this case, CMS may adjust the 
amount it accepts as a compromise to allow an appropriate discount for 
the costs of collection it would have incurred but for the compromise.
    (d) Enforcement policy. CMS may compromise statutory penalties, 
forfeitures, or debts established as an aid to enforcement or to compel 
compliance, if it determines that its enforcement policy, in terms of 
deterrence and securing compliance both present and future, is 
adequately served by acceptance of the compromise amount.



Sec.  401.615  Payment of compromise amount.

    (a) Time and manner of compromise. Payment by the debtor of the 
amount that CMS has agreed to accept as a compromise in full settlement 
of a claim must be made within the time and in the manner prescribed by 
CMS. Accordingly, CMS will not settle a claim until the full payment of 
the compromise amount has been made.
    (b) Effect of failure to pay compromise amount. Failure of the 
debtor to make payment, as provided by the compromise agreement, 
reinstates the full amount of the claim, less any amounts paid prior to 
the default.
    (c) Prohibition against grace periods. CMS will not agree to 
inclusion of a provision in an installment agreement that would permit 
grace periods for payments that are late under the terms of the 
agreement.



Sec.  401.617  Suspension of collection action.

    (a) General conditions. CMS may temporarily suspend collection 
action on a claim if the following general conditions are met--
    (1) Amount of future recovery. CMS determines that future collection 
action may result in a recovery of an amount sufficient to justify 
periodic review and action on the claim by CMS during the period of 
suspension.
    (2) Statute of limitations. CMS determines that--
    (i) The applicable statute of limitations has been tolled, waived or 
has started running anew; or
    (ii) Future collections may be made by CMS through offset despite an 
applicable statute of limitations.
    (b) Basis for suspension. Bases on which CMS may suspend collection 
action on a particular claim include the following--
    (1) A debtor cannot be located; or
    (2) A debtor--
    (i) Owns no substantial equity in property;
    (ii) Is unable to make payment on CMS's claim or is unable to effect 
a compromise; and
    (iii) Has future prospects that justify retention of the claim.
    (c) Locating debtors. CMS will make every reasonable effort to 
locate missing debtors sufficiently in advance of the bar of an 
applicable statute of limitations to permit timely filing of a lawsuit 
to recover the amount of the claim.
    (d) Effect of suspension on liquidation of security. CMS will 
liquidate security, obtained in partial recovery of a claim, despite a 
decision under this section to suspend collection action against the 
debtor for the remainder of the claim.



Sec.  401.621  Termination of collection action.

    (a) General factors. After considering the bases for a decision to 
terminate collection action under paragraph (b) of this section, CMS may 
further consider factors such as--

[[Page 24]]

    (1) The age and health of the debtor if the debtor is an individual;
    (2) Present and potential income of the debtor; and
    (3) Whether assets have been concealed or improperly transferred by 
the debtor.
    (b) Basis for termination of collection action. Bases on which CMS 
may terminate collection action on a claim include the following--
    (1) Inability to collect a substantial amount of the claim. CMS may 
terminate collection action if it determines that it is unable to 
collect, or to enforce collection, of a significant amount of the claim. 
In making this determination, CMS will consider factors such as--
    (i) Judicial remedies available;
    (ii) The debtor's future financial prospects; and
    (iii) Exemptions available to the debtor under State or Federal law.
    (2) Inability to locate debtor. In cases involving missing debtors, 
CMS may terminate collection action if--
    (i) There is no security remaining to be liquidated;
    (ii) The applicable statute of limitations has run; or
    (iii) The prospects of collecting by offset, whether or not an 
applicable statute of limitations has run, are considered by CMS to be 
too remote to justify retention of the claim.
    (3) Cost of collection exceeds recovery. CMS may terminate 
collection action if it determines that the cost of further collection 
action will exceed the amount recoverable.
    (4) Legal insufficiency. CMS may terminate collection action if it 
determines that the claim is legally without merit.
    (5) Evidence unavailable. CMS may terminate collection action if--
    (i) Efforts to obtain voluntary payment are unsuccessful; and
    (ii) Evidence or witnesses necessary to prove the claim are 
unavailable.



Sec.  401.623  Joint and several liability.

    (a) Collection action. CMS will liquidate claims as quickly as 
possible. In cases of joint and several liability among two or more 
debtors, CMS will not allocate the burden of claims payment among the 
debtors. CMS will proceed with collection action against one debtor even 
if other liable debtors have not paid their proportionate shares.
    (b) Compromise. Compromise with one debtor does not release a claim 
against remaining debtors. Furthermore, CMS will not consider the amount 
of a compromise with one debtor to be a binding precedent concerning the 
amounts due from other debtors who are jointly and severally liable on 
the claim.



Sec.  401.625  Effect of CMS claims collection decisions on appeals.

    Any action taken under this subpart regarding the compromise of a 
claim, or suspension or termination of collection action on a claim, is 
not an initial determination for purposes of CMS appeal procedures.



   Subpart G_Availability of Medicare Data for Performance Measurement

    Source: 76 FR 76567, Dec. 7, 2011, unless otherwise noted.



Sec.  401.701  Purpose and scope.

    The regulations in this subpart implement section 1874(e) of the 
Social Security Act as it applies to Medicare data made available to 
qualified entities for the evaluation of the performance of providers 
and suppliers.



Sec.  401.703  Definitions.

    For purposes of this subpart:
    (a) Qualified entity means either a single public or private entity, 
or a lead entity and its contractors, that meets the following 
requirements:
    (1) Is qualified, as determined by the Secretary, to use claims data 
to evaluate the performance of providers and suppliers on measures of 
quality, efficiency, effectiveness, and resource use.
    (2) Agrees to meet the requirements described in this subpart at 
Sec. Sec.  401.705 through 401.721.
    (b) Provider of services (referred to as a provider) has the same 
meaning as the term ``provider'' in Sec.  400.202 of this chapter.
    (c) Supplier has the same meaning as the term ``supplier'' at Sec.  
400.202 of this chapter.

[[Page 25]]

    (d) Claim means an itemized billing statement from a provider or 
supplier that, except in the context of Part D prescription drug event 
data, requests payment for a list of services and supplies that were 
furnished to a Medicare beneficiary in the Medicare fee-for-service 
context, or to a participant in other insurance or entitlement program 
contexts. In the Medicare program, claims files are available for each 
institutional (inpatient, outpatient, skilled nursing facility, hospice, 
or home health agency) and non-institutional (physician and durable 
medical equipment providers and suppliers) claim type as well as 
Medicare Part D Prescription Drug Event (PDE) data.
    (e) Standardized data extract is a subset of Medicare claims data 
that the Secretary would make available to qualified entities under this 
subpart.
    (f) Beneficiary identifiable data is any data that contains the 
beneficiary's name, Medicare Health Insurance Claim Number (HICN), or 
any other direct identifying factors, including, but not limited to 
postal address or telephone number.
    (g) Encrypted data is any data that does not contain the 
beneficiary's name or any other direct identifying factors, but does 
include a unique CMS-assigned beneficiary identifier that allows for the 
linking of claims without divulging any direct identifier of the 
beneficiary.
    (h) Claims data from other sources means provider- or supplier-
identifiable claims data that an applicant or qualified entity has full 
data usage right to due to its own operations or disclosures from 
providers, suppliers, private payers, multi-payer databases, or other 
sources.
    (i) Clinical data is registry data, chart-abstracted data, 
laboratory results, electronic health record information, or other 
information relating to the care or services furnished to patients that 
is not included in administrative claims data, but is available in 
electronic form.
    (j) Authorized user is a third party and its contractors (including, 
where applicable, business associates as that term is defined at 45 CFR 
160.103) that need analyses or data covered by this section to carry out 
work on behalf of that third party (meaning not the qualified entity or 
the qualified entity's contractors) to whom/which the qualified entity 
provides or sells data as permitted under this subpart. Authorized user 
third parties are limited to the following entities:
    (1) A provider.
    (2) A supplier.
    (3) A medical society.
    (4) A hospital association.
    (5) An employer.
    (6) A health insurance issuer.
    (7) A healthcare provider and/or supplier association.
    (8) A state entity.
    (9) A federal agency.
    (k) Employer has the same meaning as the term ``employer'' as 
defined in section 3(5) of the Employee Retirement Insurance Security 
Act of 1974.
    (l) Health insurance issuer has the same meaning as the term 
``health insurance issuer'' as defined in section 2791 of the Public 
Health Service Act.
    (m) Medical society means a nonprofit organization or association 
that provides unified representation and advocacy for physicians at the 
national or state level and whose membership is comprised of a majority 
of physicians.
    (n) Hospital association means a nonprofit organization or 
association that provides unified representation and advocacy for 
hospitals or health systems at a national, state, or local level and 
whose membership is comprised of a majority of hospitals and health 
systems.
    (o) Healthcare Provider and/or Supplier Association means a 
nonprofit organization or association that provides unified 
representation and advocacy for providers and suppliers at the national 
or state level and whose membership is comprised of a majority of 
suppliers or providers.
    (p) State Entity means any office, department, division, bureau, 
board, commission, agency, institution, or committee within the 
executive branch of a state government.
    (q) Combined data means, at a minimum, a set of CMS claims data 
provided under this subpart combined with claims data, or a subset of 
claims data from at least one of the other claims data sources described 
in Sec.  401.707(d).

[[Page 26]]

    (r) Patient means an individual who has visited the provider or 
supplier for a face-to-face or telehealth appointment at least once in 
the past 24 months.
    (s) Marketing means the same as the term ``marketing'' at 45 CFR 
164.501 without the exception to the bar for ``consent'' based 
marketing.
    (t) Violation means a failure to comply with a requirement of a CMS 
DUA (CMS data use agreement) or QE DUA (qualified entity data use 
agreement).
    (u) Required by law means the same as the phrase ``required by law'' 
at 45 CFR 164.103.

[76 FR 76567, Dec. 7, 2011, as amended at 81 FR 44479, July 7, 2016]



Sec.  401.705  Eligibility criteria for qualified entities.

    (a) Eligibility criteria: To be eligible to apply to receive data as 
a qualified entity under this subpart, an applicant generally must 
demonstrate expertise and sustained experience, defined as 3 or more 
years, in the following three areas, as applicable and appropriate to 
the proposed use:
    (1) Organizational and governance criteria, including:
    (i) Expertise in the areas of measurement that they propose to use 
in accurately calculating quality, and efficiency, effectiveness, or 
resource use measures from claims data, including the following:
    (A) Identifying an appropriate method to attribute a particular 
patient's services to specific providers and suppliers.
    (B) Ensuring the use of approaches to ensure statistical validity 
such as a minimum number of observations or minimum denominator for each 
measure.
    (C) Using methods for risk-adjustment to account for variations in 
both case-mix and severity among providers and suppliers.
    (D) Identifying methods for handling outliers.
    (E) Correcting measurement errors and assessing measure reliability.
    (F) Identifying appropriate peer groups of providers and suppliers 
for meaningful comparisons.
    (ii) A plan for a business model that is projected to cover the 
costs of performing the required functions, including the fee for the 
data.
    (iii) Successfully combining claims data from different payers to 
calculate performance reports.
    (iv) Designing, and continuously improving the format of performance 
reports on providers and suppliers.
    (v) Preparing an understandable description of the measures used to 
evaluate the performance of providers and suppliers so that consumers, 
providers and suppliers, health plans, researchers, and other 
stakeholders can assess performance reports.
    (vi) Implementing and maintaining a process for providers and 
suppliers identified in a report to review the report prior to 
publication and providing a timely response to provider and supplier 
inquiries regarding requests for data, error correction, and appeals.
    (vii) Establishing, maintaining, and monitoring a rigorous data 
privacy and security program, including disclosing to CMS any 
inappropriate disclosures of beneficiary identifiable information, 
violations of applicable federal and State privacy and security laws and 
regulations for the preceding 10-year period (or, if the applicant has 
not been in existence for 10 years, the length of time the applicant has 
been an organization), and any corrective actions taken to address the 
issues.
    (viii) Accurately preparing performance reports on providers and 
suppliers and making performance report information available to the 
public in aggregate form, that is, at the provider or supplier level.
    (2) Expertise in combining Medicare claims data with claims data 
from other sources, including demonstrating to the Secretary's 
satisfaction that the claims data from other sources that it intends to 
combine with the Medicare data received under this subpart address the 
methodological concerns regarding sample size and reliability that have 
been expressed by stakeholders regarding the calculation of performance 
measures from a single payer source.
    (3) Expertise in establishing, documenting and implementing rigorous 
data privacy and security policies including enforcement mechanisms.

[[Page 27]]

    (b) Source of expertise and experience: An applicant may demonstrate 
expertise and experience in any or all of the areas described in 
paragraph (a) of this section through one of the following:
    (1) Activities it has conducted directly through its own staff.
    (2) Contracts with other entities if the applicant is the lead 
entity and includes documentation in its application of the contractual 
arrangements that exist between it and any other entity whose expertise 
and experience is relied upon in submitting the application.



Sec.  401.707  Operating and governance requirements for qualified entities.

    A qualified entity must meet the following operating and governance 
requirements:
    (a) Submit to CMS a list of all measures it intends to calculate and 
report, the geographic areas it intends to serve, and the methods of 
creating and disseminating reports. This list must include the following 
information, as applicable and appropriate to the proposed use:
    (1) Name of the measure, and whether it is a standard or alternative 
measure.
    (2) Name of the measure developer/owner.
    (3) If it is an alternative measure, measure specifications, 
including numerator and denominator.
    (4) The rationale for selecting each measure, including the 
relationship to existing measurement efforts and the relevancy to the 
population in the geographic area(s) the entity would serve, including 
the following:
    (i) A specific description of the geographic area or areas it 
intends to serve.
    (ii) A specific description of how each measure evaluates providers 
and suppliers on quality, efficiency, effectiveness, and/or resource 
use.
    (5) A description of the methodologies it intends to use in creating 
reports with respect to all of the following topics:
    (i) Attribution of beneficiaries to providers and/or suppliers.
    (ii) Benchmarking performance data, including the following:
    (A) Methods for creating peer groups.
    (B) Justification of any minimum sample size determinations made.
    (C) Methods for handling statistical outliers.
    (iii) Risk adjustment, where appropriate.
    (iv) Payment standardization, where appropriate.
    (b) Submit to CMS a description of the process it would establish to 
allow providers and suppliers to view reports confidentially, request 
data, and ask for the correction of errors before the reports are made 
public.
    (c) Submit to CMS a prototype report and a description of its plans 
for making the reports available to the public.
    (d) Submit to CMS information about the claims data it possesses 
from other sources, as defined at Sec.  401.703(h), and documentation of 
adequate rights to use the other claims data for the purposes of this 
subpart.
    (e) If requesting a 5 percent national sample to calculate 
benchmarks for the specific measures it is using, submit to CMS a 
justification for needing the file to calculate benchmarks.



Sec.  401.709  The application process and requirements.

    (a) Application deadline. CMS accepts qualified entity applications 
on a rolling basis after an application is made available on the CMS Web 
site. CMS reviews applications in the order in which they are received.
    (b) Selection criteria. To be approved as a qualified entity under 
this subpart, the applicant must meet one of the following:
    (1) Standard approval process: Meet the eligibility and operational 
and governance requirements, fulfill all of the application requirements 
to CMS' satisfaction, and agree to pay a fee equal to the cost of CMS 
making the data available. The applicant and each of its contractors 
that are anticipated to have access to the Medicare data must also 
execute a Data Use Agreement with CMS, that among other things, 
reaffirms the statutory ban on the use of Medicare data provided to the 
qualified entity by CMS under this subpart for purposes other than those 
referenced in this subpart.

[[Page 28]]

    (2) Conditional approval process: Meet the eligibility and 
operational and governance requirements, and fulfill all of the 
application requirements to CMS' satisfaction, with the exception of 
possession of sufficient claims data from other sources. Meeting these 
requirements will result in a conditional approval as a qualified 
entity. Entities gaining a conditional approval as a qualified entity 
must meet the eligibility requirements related to claims data from other 
sources the entity intends to combine with the Medicare data, agree to 
pay a fee equal to the cost of CMS making the data available, and 
execute a Data Use Agreement with CMS, that among other things, 
reaffirms the statutory ban on the use of Medicare data provided to the 
qualified entity by CMS under this subpart for purposes other than those 
referenced in this subpart before receiving any Medicare data. If the 
qualified entity is composed of lead entity with contractors, any 
contractors that are anticipated to have access to the Medicare data 
must also execute a Data Use Agreement with CMS.
    (c) Duration of approval. CMS permits an entity to participate as a 
qualified entity for a period of 3 years from the date of notification 
of the application approval by CMS. The qualified entity must abide by 
all CMS regulations and instructions. If the qualified entity wishes to 
continue performing the tasks after the 3-year approval period, the 
entity may re-apply for qualified entity status following the procedures 
in paragraph (f) of this section.
    (d) Reporting period. A qualified entity must produce reports on the 
performance of providers and suppliers at least annually, beginning in 
the calendar year after they are approved by CMS.
    (e) The distribution of data--(1) Initial data release. Once CMS 
fully approves a qualified entity under this subpart, the qualified 
entity must pay a fee equal to the cost of CMS making data available. 
After the qualified entity pays the fee, CMS will release the applicable 
encrypted claims data, as well as a file that crosswalks the encrypted 
beneficiary ID to the beneficiary name and the Medicare HICN. The data 
will be the most recent data available, and will be limited to the 
geographic spread of the qualified entity's other claims data, as 
determined by CMS.
    (2) Subsequent data releases. After the first quarter of 
participation, CMS will provide a qualified entity with the most recent 
additional quarter of currently available data, as well as a table that 
crosswalks the encrypted beneficiary ID to the beneficiary's name and 
the Medicare HICN. Qualified entities are required to pay CMS a fee 
equal to the cost of making data available before CMS will release the 
most recent quarter of additional data to the qualified entity.
    (f) Re-application. A qualified entity that is in good standing may 
re-apply for qualified entity status. A qualified entity is considered 
to be in good standing if it has had no violations of the requirements 
in this subpart or if the qualified entity is addressing any past 
deficiencies either on its own or through the implementation of a 
corrective action plan. To re-apply a qualified entity must submit to 
CMS documentation of any changes to what was included in its previously-
approved application. A re-applicant must submit this documentation at 
least 6 months before the end of its 3-year approval period and will be 
able to continue to serve as a qualified entity until the re-application 
is either approved or denied by CMS. If the re-application is denied, 
CMS will terminate its relationship with the qualified entity and the 
qualified entity will be subject to the requirements for return or 
destruction of data at Sec.  401.721(b).



Sec.  401.711  Updates to plans submitted as part of the application process.

    (a) If a qualified entity wishes to make changes to the following 
parts of its previously-approved application:
    (1) Its list of proposed measures--the qualified entity must send 
all the information referenced in Sec.  401.707(a) for the new measures 
to CMS at least 30 days before its intended confidential release to 
providers and suppliers.
    (2) Its proposed prototype report--the qualified entity must send 
the new prototype report to CMS at least 30 days before its intended 
confidential release to providers and suppliers.

[[Page 29]]

    (3) Its plans for sharing the reports with the public--the qualified 
entity must send the new plans to CMS at least 30 days before its 
intended confidential release to providers and suppliers.
    (b) CMS will notify the qualified entity when the entity's proposed 
changes are approved or denied for use, generally within 30 days of the 
qualified entity submitting the changes to CMS. If a CMS decision on 
approval or disapproval for a change is not forthcoming within 30 days 
and CMS does not request an additional 30 days for review, the change or 
modification shall be deemed to be approved.
    (c) If the amount of claims data from other sources available to a 
qualified entity decreases, the qualified entity must immediately inform 
CMS and submit documentation that the remaining claims data from other 
sources is sufficient to address the methodological concerns regarding 
sample size and reliability. Under no circumstances may a qualified 
entity use Medicare data to create a report, use a measure, or share a 
report after the amount of claims data from other sources available to a 
qualified entity decreases until CMS determines either that the 
remaining claims data is sufficient or that the qualified entity has 
collected adequate additional data to address any deficiencies.
    (1) If the qualified entity cannot submit the documentation required 
in paragraph (c) of this section, or if CMS determines that the 
remaining claims data is not sufficient, CMS will afford the qualified 
entity up to 120 days to obtain additional claims to address any 
deficiencies. If the qualified entity does not have access to sufficient 
new data after that time, CMS will terminate its relationship with the 
qualified entity.
    (2) If CMS determines that the remaining claims data is sufficient, 
the qualified entity may continue issuing reports, using measures, and 
sharing reports.



Sec.  401.713  Ensuring the privacy and security of data.

    (a) Data use agreement between CMS and a qualified entity. A 
qualified entity must comply with the data requirements in its data use 
agreement with CMS (hereinafter the CMS DUA). Contractors (including, 
where applicable, business associates) of qualified entities that are 
anticipated to have access to the Medicare claims data or beneficiary 
identifiable data in the context of this program are also required to 
execute and comply with the CMS DUA. The CMS DUA will require the 
qualified entity to maintain privacy and security protocols throughout 
the duration of the agreement with CMS, and will ban the use or 
disclosure of Medicare data or any derivative data for purposes other 
than those set out in this subpart. The CMS DUA will also prohibit the 
use of unsecured telecommunications to transmit such data, and will 
specify the circumstances under which such data must be stored and may 
be transmitted.
    (b) A qualified entity must inform each beneficiary whose 
beneficiary identifiable data has been (or is reasonably believed to 
have been) inappropriately accessed, acquired, or disclosed in 
accordance with the DUA.
    (c) Contractor(s) must report to the qualified entity whenever there 
is an incident where beneficiary identifiable data has been (or is 
reasonably believed to have been) inappropriately accessed, acquired, or 
disclosed.
    (d) Data use agreement between a qualified entity and an authorized 
user. In addition to meeting the other requirements of this subpart, and 
as a pre-condition of selling or disclosing any combined data or any 
Medicare claims data (or any beneficiary-identifiable derivative data of 
either kind) and as a pre-condition of selling or disclosing non-public 
analyses that include individually identifiable beneficiary data, the 
qualified entity must enter a DUA (hereinafter the QE DUA) with the 
authorized user. Among other things laid out in this subpart, such QE 
DUA must contractually bind the authorized user (including any 
contractors or business associates described in the definition of 
authorized user) to the following:
    (1)(i) The authorized user may be permitted to use such data and 
non-public analyses in a manner that a HIPAA Covered Entity could do 
under the following provisions:
    (A) Activities falling under paragraph (1) of the definition of 
``health

[[Page 30]]

care operations'' under 45 CFR 164.501: Quality improvement activities, 
including care coordination activities and efforts to track and manage 
medical costs; patient-safety activities; population-based activities 
such as those aimed at improving patient safety, quality of care, or 
population health, including the development of new models of care, the 
development of means to expand coverage and improve access to 
healthcare, the development of means of reducing healthcare disparities, 
and the development or improvement of methods of payment or coverage 
policies.
    (B) Activities falling under paragraph (2) of the definition of 
``health care operations'' under 45 CFR 164.501: Reviewing the 
competence or qualifications of health care professionals, evaluating 
practitioner and provider performance, health plan performance, 
conducting training programs in which students, trainees, or 
practitioners in areas of health care learn under supervision to 
practice or improve their skills as health care providers, training of 
non-health care professionals, accreditation, certification, licensing, 
or credentialing activities.
    (C) Activities that qualify as ``fraud and abuse detection or 
compliance activities'' under 45 CFR 164.506(c)(4)(ii).
    (D) Activities that qualify as ``treatment'' under 45 CFR 164.501.
    (ii) All other uses and disclosures of such data and/or such non-
public analyses must be forbidden except to the extent a disclosure 
qualifies as a ``required by law'' disclosure as defined at 45 CFR 
164.103.
    (2) The authorized user is prohibited from using or disclosing the 
data or non-public analyses for marketing purposes as defined at Sec.  
401.703(s).
    (3) The authorized user is required to ensure adequate privacy and 
security protection for such data and non-public analyses. At a minimum, 
regardless of whether the authorized user is a HIPAA covered entity, 
such protections of beneficiary identifiable data must be at least as 
protective as what is required of covered entities and their business 
associates regarding protected health information (PHI) under the HIPAA 
Privacy and Security Rules. In all cases, these requirements must be 
imposed for the life of such beneficiary identifiable data or non-public 
analyses and/or any derivative data, that is until all copies of such 
data or non-public analyses are returned or destroyed. Such duties must 
be written in such a manner as to survive termination of the QE DUA, 
whether for cause or not.
    (4) Except as provided for in paragraph (d)(5) of this section, the 
authorized user must be prohibited from re-disclosing or making public 
any such data or non-public analyses.
    (5)(i) At the qualified entity's discretion, it may permit an 
authorized user that is a provider as defined in Sec.  401.703(b) or a 
supplier as defined in Sec.  401.703(c), to re-disclose such data and 
non-public analyses as a covered entity will be permitted to disclose 
PHI under 45 CFR 164.506(c)(4)(i), under 45 CFR 164.506(c)(2), or under 
45 CFR 164.502(e)(1).
    (ii) All other uses and disclosures of such data and/or such non-
public analyses is forbidden except to the extent a disclosure qualifies 
as a ``required by law'' disclosure.
    (6) Authorized users who/that receive the beneficiary de-identified 
combined data or Medicare data as contemplated under Sec.  401.718 are 
contractually prohibited from linking the beneficiary de-identified data 
to any other identifiable source of information, and must be 
contractually barred from attempting any other means of re-identifying 
any individual whose data is included in such data.
    (7) The QE DUA must bind authorized user(s) to notifying the 
qualified entity of any violations of the QE DUA, and it must require 
the full cooperation of the authorized user in the qualified entity's 
efforts to mitigate any harm that may result from such violations, or to 
comply with the breach provisions governing qualified entities under 
this subpart.

[76 FR 76567, Dec. 7, 2011, as amended at 81 FR 44479, July 7, 2016]



Sec.  401.715  Selection and use of performance measures.

    (a) Standard measures. A standard measure is a measure that can be 
calculated in full or in part from claims

[[Page 31]]

data from other sources and the standardized extracts of Medicare Parts 
A and B claims, and Part D prescription drug event data and meets the 
following requirements:
    (1) Meets one of the following criteria:
    (i) Is endorsed by the entity with a contract under section 1890(a) 
of the Social Security Act.
    (ii) Is time-limited endorsed by the entity with a contract under 
section 1890(a) of the Social Security Act until such time as the full 
endorsement status is determined.
    (iii) Is developed under section 931 of the Public Health Service 
Act.
    (iv) Can be calculated from standardized extracts of Medicare Parts 
A or B claims or Part D prescription drug event data, was adopted 
through notice-and-comment rulemaking, and is currently being used in 
CMS programs that include quality measurement.
    (v) Is endorsed by a CMS-approved consensus-based entity. CMS will 
approve organizations as consensus-based entities based on review of 
documentation of the consensus-based entity's measure approval process. 
To receive approval as a consensus-based entity, an organization must 
submit information to CMS documenting its processes for stakeholder 
consultation and measures approval; an organization will only receive 
approval as a consensus-based entity if all measure specifications are 
publically available. An organization will retain CMS acceptance as a 
consensus-based entity for 3 years after the approval date, at which 
time CMS will review new documentation of the consensus-based entity's 
measure approval process for a new 3-year approval.
    (2) Is used in a manner that follows the measure specifications as 
written (or as adopted through notice-and-comment rulemaking), including 
all numerator and denominator inclusions and exclusions, measured time 
periods, and specified data sources.
    (b) Alternative measure. (1) An alternative measure is a measure 
that is not a standard measure, but that can be calculated in full, or 
in part, from claims data from other sources and the standardized 
extracts of Medicare Parts A and B claims, and Part D prescription drug 
event data, and that meets one of the following criteria:
    (i) Rulemaking process: Has been found by the Secretary, through a 
notice-and comment-rulemaking process, to be more valid, reliable, 
responsive to consumer preferences, cost-effective, or relevant to 
dimensions of quality and resource use not addressed by standard 
measures, and is used by a qualified entity in a manner that follows the 
measure specifications as adopted through notice-and-comment rulemaking, 
including all numerator and denominator inclusions and exclusions, 
measured time periods, and specified data sources.
    (ii) Stakeholder consultation approval process: Has been found by 
the Secretary, using documentation submitted by a qualified entity that 
outlines its consultation and agreement with stakeholders in its 
community, to be more valid, responsive to consumer preferences, cost-
effective, or relevant to dimensions of quality and resource use not 
addressed by standard measures, and is used by a qualified entity in a 
manner that follows the measure specifications as submitted, including 
all numerator and denominator inclusions and exclusions, measured time 
periods, and specified data sources. If a CMS decision on approval or 
disapproval of alternative measures submitted using the stakeholder 
consultation approval process is not forthcoming within 60 days of 
submission of the measure by the qualified entity, the measure will be 
deemed approved. However, CMS retains the right to disapprove a measure 
if, even after 60 days, we find it to not be ``more valid, reliable, 
responsive to consumer preferences, cost-effective, or relevant to 
dimensions of quality and resource'' than a standard measure.
    (2) An alternative measure approved under the process at paragraph 
(b)(1)(i) of this section may be used by any qualified entity. An 
alternative measure approved under the process at paragraph (b)(1)(ii) 
of this section may only be used by the qualified entity that submitted 
the measure for consideration by the Secretary. A qualified entity may 
use an alternative measure up until the point that an equivalent 
standard measure for the particular

[[Page 32]]

clinical area or condition becomes available at which point the 
qualified entity must switch to the standard measure within 6 months or 
submit additional scientific justification and receive approval, via 
either paragraphs (b)(1)(i) or (b)(1)(ii) of this section, from the 
Secretary to continue using the alternative measure.
    (3) To submit an alternative measure for consideration under the 
notice-and-comment-rulemaking process, for use in the calendar year 
following the submission, an entity must submit the following 
information by May 31st:
    (i) The name of the alternative measure.
    (ii) The name of the developer or owner of the alternative measure.
    (iii) Detailed specifications for the alternative measure.
    (iv) Evidence that use of the alternative measure would be more 
valid, reliable, responsive to consumer preferences, cost-effective, or 
relevant to dimensions of quality and resource use not addressed by 
standard measures.
    (4) To submit an alternative measure for consideration under the 
documentation of stakeholder consultation approval process described in 
paragraph (b)(1)(ii) of this section, for use once the measure is 
approved by the Secretary, an entity must submit the following 
information to CMS:
    (i) The name of the alternative measure.
    (ii) The name of the developer or owner of the alternative measure.
    (iii) Detailed specifications for the alternative measure.
    (iv) A description of the process by which the qualified entity 
notified stakeholders in the geographic region it serves of its intent 
to seek approval of an alternative measure. Stakeholders must include a 
valid cross representation of providers, suppliers, payers, employers, 
and consumers.
    (v) A list of stakeholders from whom feedback was solicited, 
including the stakeholders' names and roles in the community.
    (vi) A description of the discussion about the proposed alternative 
measure, including a summary of all pertinent arguments supporting and 
opposing the measure.
    (vii) Unless CMS has already approved the same measure for use by 
another qualified entity, no new scientific evidence on the measure is 
available, and the subsequent qualified entity wishes to rely upon the 
scientific evidence submitted by the previously approved applicant, an 
explanation backed by scientific evidence that demonstrates why the 
measure is more valid, reliable, responsive to consumer preferences, 
cost-effective, or relevant to dimensions of quality and resource use 
not addressed by a standard measure.



Sec.  401.716  Non-public analyses.

    (a) General. So long as it meets the other requirements of this 
subpart, and subject to the limits in paragraphs (b) and (c) of this 
section, the qualified entity may use the combined data to create non-
public analyses in addition to performance measures and provide or sell 
these non-public analyses to authorized users (including any contractors 
or business associates described in the definition of authorized user).
    (b) Limitations on a qualified entity. In addition to meeting the 
other requirements of this subpart, a qualified entity must comply with 
the following limitations as a pre-condition of dissemination or selling 
non-public analyses to an authorized user:
    (1) A qualified entity may only provide or sell a non-public 
analysis to a health insurance issuer as defined in Sec.  401.703(l), 
after the health insurance issuer or a business associate of that health 
insurance issuer has provided the qualified entity with claims data that 
represents a majority of the health insurance issuer's covered lives, 
using one of the four methods of calculating covered lives established 
at 26 CFR 46.4375-1(c)(2), for the time period and geographic region 
covered by the issuer-requested non-public analyses. A qualified entity 
may not provide or sell a non-public analysis to a health insurance 
issuer if the issuer does not have any covered lives in the geographic 
region covered by the issuer-requested non-public analysis.
    (2) Analyses that contain information that individually identifies 
one or

[[Page 33]]

more beneficiaries may only be disclosed to a provider or supplier (as 
defined at Sec.  401.703(b) and (c)) when both of the following 
conditions are met:
    (i) The analyses only contain identifiable information on 
beneficiaries with whom the provider or supplier have a patient 
relationship as defined at Sec.  401.703(r).
    (ii) A QE DUA as defined at Sec.  401.713(d) is executed between the 
qualified entity and the provider or supplier prior to making any 
individually identifiable beneficiary information available to the 
provider or supplier.
    (3) Except as specified under paragraph (b)(2) of this section, all 
analyses must be limited to beneficiary de-identified data. Regardless 
of the HIPAA covered entity or business associate status of the 
qualified entity and/or the authorized user, de-identification must be 
determined based on the standards for HIPAA covered entities found at 45 
CFR 164.514(b).
    (4) Analyses that contain information that individually identifies a 
provider or supplier (regardless of the level of the provider or 
supplier, that is, individual clinician, group of clinicians, or 
integrated delivery system) may not be disclosed unless one of the 
following three conditions apply:
    (i) The analysis only individually identifies the provider or 
supplier that is being supplied the analysis.
    (ii) Every provider or supplier individually identified in the 
analysis has been afforded the opportunity to appeal or correct errors 
using the process at Sec.  401.717(f).
    (iii) Every provider or supplier individually identified in the 
analysis has notified the qualified entity, in writing, that analyses 
can be disclosed to the authorized user without first going through the 
appeal and error correction process at Sec.  401.717(f).
    (c) Non-public analyses agreement between a qualified entity and an 
authorized user for beneficiary de-identified non-public analyses 
disclosures. In addition to the other requirements of this subpart, a 
qualified entity must enter a contractually binding non-public analyses 
agreement with the authorized user (including any contractors or 
business associates described in the definition of authorized user) as a 
pre-condition to providing or selling de-identified analyses. Such non-
public analyses agreement must contain the following provisions:
    (1) The authorized user may not use the analyses or derivative data 
for the following purposes:
    (i) Marketing, as defined at Sec.  401.703(s).
    (ii) Harming or seeking to harm patients or other individuals both 
within and outside the healthcare system regardless of whether their 
data are included in the analyses.
    (iii) Effectuating or seeking opportunities to effectuate fraud and/
or abuse in the healthcare system.
    (2) If the authorized user is an employer as defined in Sec.  
401.703(k), the authorized user may only use the analyses or derivative 
data for purposes of providing health insurance to employees, retirees, 
or dependents of employees or retirees of that employer.
    (3)(i) At the qualified entity's discretion, it may permit an 
authorized user that is a provider as defined in Sec.  401.703(b) or a 
supplier as defined in Sec.  401.703(c), to re-disclose the de-
identified analyses or derivative data, as a covered entity will be 
permitted under 45 CFR 164.506(c)(4)(i), or under 45 CFR 164.502(e)(1).
    (ii) All other uses and disclosures of such data and/or such non-
public analyses is forbidden except to the extent a disclosure qualifies 
as a ``required by law'' disclosure.
    (4) If the authorized user is not a provider or supplier, the 
authorized user may not re-disclose or make public any non-public 
analyses or derivative data except as required by law.
    (5) The authorized user may not link the de-identified analyses to 
any other identifiable source of information and may not in any other 
way attempt to identify any individual whose de-identified data is 
included in the analyses.
    (6) The authorized user must notify the qualified entity of any DUA 
violations, and it must fully cooperate with the qualified entity's 
efforts to mitigate any harm that may result from such violations.

[81 FR 44480, July 7, 2016]

[[Page 34]]



Sec.  401.717  Provider and supplier requests for error correction.

    (a) A qualified entity must confidentially share measures, 
measurement methodologies, and measure results with providers and 
suppliers at least 60 calendar days before making reports public. The 60 
calendar days begin on the date on which qualified entities send the 
confidential reports to providers and suppliers. A qualified entity must 
inform providers and suppliers of the date the reports will be made 
public at least 60 calendar days before making the reports public.
    (b) Before making the reports public, a qualified entity must allow 
providers and suppliers the opportunity to make a request for the data, 
or to make a request for error correction, within 60 calendar days after 
sending the confidential reports to providers or suppliers.
    (c) During the 60 calendar days between sending a confidential 
report on measure results and releasing the report to the public, the 
qualified entity must, at the request of a provider or supplier and with 
appropriate privacy and security protections, release the Medicare 
claims data and beneficiary names to the provider or supplier. Qualified 
entities may only provide the Medicare claims and/or beneficiary names 
relevant to the particular measure or measure result the provider or 
supplier is appealing.
    (d) A qualified entity must inform providers and suppliers that 
reports will be made public, including information related to the status 
of any data or error correction requests, after the date specified to 
the provider or supplier when the report is sent for review and, if 
necessary, error correction requests (at least 60 calendar days after 
the report was originally sent to the providers and suppliers), 
regardless of the status of any requests for error correction.
    (e) If a provider or supplier has a data or error correction request 
outstanding at the time the reports become public, the qualified entity 
must, if feasible, post publicly the name of the appealing provider or 
supplier and the category of the appeal request.
    (f) A qualified entity must comply with the following requirements 
before disclosing non-public analyses, as defined at Sec.  401.716, 
which contain information that individually identifies a provider or 
supplier:
    (1) A qualified entity must confidentially notify a provider or 
supplier that non-public analyses that individually identify the 
provider or supplier are going to be released to an authorized user at 
least 65 calendar days before disclosing the analyses. This confidential 
notification must include a short summary of the analyses (including the 
measures calculated), the process for the provider or supplier to 
request the analyses, the authorized users receiving the analyses, and 
the date on which the qualified entity will release the analyses to the 
authorized user.
    (2) A qualified entity must allow providers and suppliers the 
opportunity to opt-in to the review and correction process as defined in 
paragraphs (a) through (e) of this section, anytime during the 65 
calendar days. If a provider or supplier chooses to opt-in to the review 
and correction process more than 5 days into the notification period, 
the time for the review and correction process is shortened from 60 days 
to the number of days between the provider or supplier opt-in date and 
the release date specified in the confidential notification.

[76 FR 76567, Dec. 7, 2011, as amended at 81 FR 44481, July 7, 2016]



Sec.  401.718  Dissemination of data.

    (a) General. Subject to the other requirements in this subpart, the 
requirements in paragraphs (b) and (c) of this section and any other 
applicable laws or contractual agreements, a qualified entity may 
provide or sell combined data or provide Medicare data at no cost to 
authorized users defined at Sec.  401.703(b), (c), (m), and (n).
    (b) Data--(1) De-identification. Except as specified in paragraph 
(b)(2) of this section, any data provided or sold by a qualified entity 
to an authorized user must be limited to beneficiary de-identified data. 
De-identification must be determined based on the de-identification 
standards for HIPAA covered entities found at 45 CFR 164.514(b).
    (2) Exception. If such disclosure will be consistent with all 
applicable laws,

[[Page 35]]

data that individually identifies a beneficiary may only be disclosed to 
a provider or supplier (as defined at Sec.  401.703(b) and (c)) with 
whom the identifiable individuals in such data have a current patient 
relationship as defined at Sec.  401.703(r).
    (c) Data use agreement between a qualified entity and an authorized 
user. A qualified entity must contractually require an authorized user 
to comply with the requirements in Sec.  401.713(d) prior to providing 
or selling data to an authorized user under Sec.  401.718.

[81 FR 44481, July 7, 2016]



Sec.  401.719  Monitoring and sanctioning of qualified entities.

    (a) CMS will monitor and assess the performance of qualified 
entities and their contractors using the following methods:
    (1) Audits.
    (2) Submission of documentation of data sources and quantities of 
data upon the request of CMS and/or site visits.
    (3) Analysis of specific data reported to CMS by qualified entities 
through annual reports (as described in paragraph (b) of this section) 
and reports on inappropriate disclosures or uses of beneficiary 
identifiable data (as described in paragraph (c) of this section).
    (4) Analysis of complaints from beneficiaries and/or providers or 
suppliers.
    (b) A qualified entity must provide annual reports to CMS containing 
information related to the following:
    (1) General program adherence, including the following information:
    (i) The number of Medicare and private claims combined.
    (ii) The percent of the overall market share the number of claims 
represent in the qualified entity's geographic area.
    (iii) The number of measures calculated.
    (iv) The number of providers and suppliers profiled by type of 
provider and supplier.
    (v) A measure of public use of the reports.
    (2) The provider and supplier data sharing, error correction, and 
appeals process, including the following information:
    (i) The number of providers and suppliers requesting claims data.
    (ii) The number of requests for claims data fulfilled.
    (iii) The number of error corrections.
    (iv) The type(s) of problem(s) leading to the request for error 
correction.
    (v) The amount of time to acknowledge the request for data or error 
correction.
    (vi) The amount of time to respond to the request for error 
correction.
    (vii) The number of requests for error correction resolved.
    (3) Non-public analyses provided or sold to authorized users under 
this subpart, including the following information:
    (i) A summary of the analyses provided or sold, including--
    (A) The number of analyses.
    (B) The number of purchasers of such analyses.
    (C) The types of authorized users that purchased analyses.
    (D) The total amount of fees received for such analyses.
    (E) QE DUA or non-public analyses agreement violations.
    (ii) A description of the topics and purposes of such analyses.
    (iii) The number of analyses disclosed with unresolved requests for 
error correction.
    (4) Data provided or sold to authorized users under this subpart, 
including the following information:
    (i) The entities who received data.
    (ii) The basis under which each entity received such data.
    (iii) The total amount of fees received for providing, selling, or 
sharing the data.
    (iv) QE DUA violations.
    (c) A qualified entity must inform CMS of inappropriate disclosures 
or uses of beneficiary identifiable data under the DUA.
    (d) CMS may take the following actions against a qualified entity if 
CMS determines that the qualified entity violated any of the 
requirements of this subpart, regardless of how CMS learns of a 
violation:
    (1) Provide a warning notice to the qualified entity of the specific 
concern, which indicates that future deficiencies could lead to 
termination.

[[Page 36]]

    (2) Request a corrective action plan (CAP) from the qualified 
entity.
    (3) Place the qualified entity on a special monitoring plan.
    (4) Terminate the qualified entity.
    (5) In the case of a violation, as defined at Sec.  401.703(t), of 
the CMS DUA or the QE DUA, CMS will impose an assessment on a qualified 
entity in accordance with the following:
    (i) Amount of assessment. CMS will calculate the amount of the 
assessment of up to $100 per individual entitled to, or enrolled for, 
benefits under part A of title XVIII of the Social Security Act or 
enrolled for benefits under Part B of such title whose data was 
implicated in the violation based on the following:
    (A) Basic factors. In determining the amount per impacted 
individual, CMS takes into account the following:
    (1) The nature and the extent of the violation.
    (2) The nature and the extent of the harm or potential harm 
resulting from the violation.
    (3) The degree of culpability and the history of prior violations.
    (B) Criteria to be considered. In establishing the basic factors, 
CMS considers the following circumstances:
    (1) Aggravating circumstances. Aggravating circumstances include the 
following:
    (i) There were several types of violations occurring over a lengthy 
period of time.
    (ii) There were many of these violations or the nature and 
circumstances indicate a pattern of violations.
    (iii) The nature of the violation had the potential or actually 
resulted in harm to beneficiaries.
    (2) Mitigating circumstances. Mitigating circumstances include the 
following:
    (i) All of the violations subject to the imposition of an assessment 
were few in number, of the same type, and occurring within a short 
period of time.
    (ii) The violation was the result of an unintentional and 
unrecognized error and the qualified entity took corrective steps 
immediately after discovering the error.
    (C) Effects of aggravating or mitigating circumstances. In 
determining the amount of the assessment to be imposed under paragraph 
(d)(5)(i)(A) of this section:
    (1) If there are substantial or several mitigating circumstance, the 
aggregate amount of the assessment is set at an amount sufficiently 
below the maximum permitted by paragraph (d)(5)(i)(A) of this section to 
reflect the mitigating circumstances.
    (2) If there are substantial or several aggravating circumstances, 
the aggregate amount of the assessment is set at an amount at or 
sufficiently close to the maximum permitted by paragraph (d)(5)(i)(A) of 
this section to reflect the aggravating circumstances.
    (D) The standards set for the qualified entity in this paragraph are 
binding, except to the extent that--
    (1) The amount imposed is not less than the approximate amount 
required to fully compensate the United States, or any State, for its 
damages and costs, tangible and intangible, including but not limited to 
the costs attributable to the investigation, prosecution, and 
administrative review of the case.
    (2) Nothing in this section limits the authority of CMS to settle 
any issue or case as provided by part 1005 of this title or to 
compromise any assessment as provided by paragraph (d)(5)(ii)(E) of this 
section.
    (ii) Notice of determination. CMS must propose an assessment in 
accordance with this paragraph (d)(5), by notifying the qualified entity 
by certified mail, return receipt requested. Such notice must include 
the following information:
    (A) The assessment amount.
    (B) The statutory and regulatory bases for the assessment.
    (C) A description of the violations upon which the assessment was 
proposed.
    (D) Any mitigating or aggravating circumstances that CMS considered 
when it calculated the amount of the proposed assessment.
    (E) Information concerning response to the notice, including:
    (1) A specific statement of the respondent's right to a hearing in 
accordance with procedures established at Section 1128A of the Act and 
implemented in 42 CFR part 1005.

[[Page 37]]

    (2) A statement that failure to respond within 60 days renders the 
proposed determination final and permits the imposition of the proposed 
assessment.
    (3) A statement that the debt may be collected through an 
administrative offset.
    (4) In the case of a respondent that has an agreement under section 
1866 of the Act, notice that imposition of an exclusion may result in 
termination of the provider's agreement in accordance with section 
1866(b)(2)(C) of the Act.
    (F) The means by which the qualified entity may pay the amount if 
they do not intend to request a hearing.
    (iii) Failure to request a hearing. If the qualified entity does not 
request a hearing within 60 days of receipt of the notice of proposed 
determination, any assessment becomes final and CMS may impose the 
proposed assessment.
    (A) CMS notifies the qualified entity, by certified mail with return 
receipt requested, of any assessment that has been imposed and of the 
means by which the qualified entity may satisfy the judgment.
    (B) The qualified entity has no right to appeal an assessment for 
which the qualified entity has not requested a hearing.
    (iv) When an assessment is collectible. An assessment becomes 
collectible after the earliest of the following:
    (A) Sixty (60) days after the qualified entity receives CMS's notice 
of proposed determination under paragraph (d)(5)(ii) of this section, if 
the qualified entity has not requested a hearing.
    (B) Immediately after the qualified entity abandons or waives its 
appeal right at any administrative level.
    (C) Thirty (30) days after the qualified entity receives the ALJ's 
decision imposing an assessment under Sec.  1005.20(d) of this title, if 
the qualified entity has not requested a review before the DAB.
    (D) Sixty (60) days after the qualified entity receives the DAB's 
decision imposing an assessment if the qualified entity has not 
requested a stay of the decision under Sec.  1005.22(b) of this title.
    (v) Collection of an assessment. Once a determination by HHS has 
become final, CMS is responsible for the collection of any assessment.
    (A) The General Counsel may compromise an assessment imposed under 
this part, after consulting with CMS or OIG, and the Federal government 
may recover the assessment in a civil action brought in the United 
States district court for the district where the claim was presented or 
where the qualified entity resides.
    (B) The United States or a state agency may deduct the amount of an 
assessment when finally determined, or the amount agreed upon in 
compromise, from any sum then or later owing the qualified entity.
    (C) Matters that were raised or that could have been raised in a 
hearing before an ALJ or in an appeal under section 1128A(e) of the Act 
may not be raised as a defense in a civil action by the United States to 
collect an assessment.

[76 FR 76567, Dec. 7, 2011, as amended at 81 FR 44481, July 7, 2016]



Sec.  401.721  Terminating an agreement with a qualified entity.

    (a) Grounds for terminating a qualified entity agreement. CMS may 
terminate an agreement with a qualified entity if CMS determines the 
qualified entity or its contractor meets any of the following:
    (1) Engages in one or more serious violations of the requirements of 
this subpart.
    (2) Fails to completely and accurately report information to CMS or 
fails to make appropriate corrections in response to confidential 
reviews by providers and suppliers in a timely manner.
    (3) Fails to submit an approvable corrective action plan (CAP) as 
prescribed by CMS, fails to implement an approved CAP, or fails to 
demonstrate improved performance after the implementation of a CAP.
    (4) Improperly uses or discloses claims information received from 
CMS in violation of the requirements in this subpart.
    (5) Based on its re-application, no longer meets the requirements in 
this subpart.
    (6) Fails to maintain adequate data from other sources in accordance 
with Sec.  401.711(c).

[[Page 38]]

    (7) Fails to ensure authorized users comply with their QE DUAs or 
analysis use agreements.
    (b) Return or destruction of CMS data upon voluntary or involuntary 
termination from the qualified entity program:
    (1) If CMS terminates a qualified entity's agreement, the qualified 
entity and its contractors must immediately upon receipt of notification 
of the termination commence returning or destroying any and all CMS data 
(and any derivative files). In no instance can this process exceed 30 
days.
    (2) If a qualified entity voluntarily terminates participation under 
this subpart, it and its contractors must return to CMS, or destroy, any 
and all CMS data in its possession within 30 days of notifying CMS of 
its intent to end its participation.

[76 FR 76567, Dec. 7, 2011, as amended at 81 FR 44482, July 7, 2016]



Sec.  401.722  Qualified clinical data registries.

    (a) A qualified clinical data registry that agrees to meet all the 
requirements in this subpart, with the exception of Sec.  401.707(d), 
may request access to Medicare data as a quasi qualified entity in 
accordance with such qualified entity program requirements.
    (b) Notwithstanding Sec.  401.703(q) (generally defining combined 
data), for purposes of qualified clinical data registries acting as 
quasi qualified entities under the qualified entity program 
requirements, combined data means, at a minimum, a set of CMS claims 
data provided under this subpart combined with clinical data or a subset 
of clinical data.

[81 FR 44482, July 7, 2016]



PART 402_CIVIL MONEY PENALTIES, ASSESSMENTS, AND EXCLUSIONS--Table of Contents



                      Subpart A_General Provisions

Sec.
402.1 Basis and scope.
402.3 Definitions.
402.5 Right to a hearing before the final determination.
402.7 Notice of proposed determination.
402.9 Failure to request a hearing.
402.11 Notice to other agencies and other entities.
402.13 Penalty, assessment, and exclusion not exclusive.
402.15 Collateral estoppel.
402.17 Settlement.
402.19 Hearings and appeals.
402.21 Judicial review.

             Subpart B_Civil Money Penalties and Assessments

402.105 Amount of penalty.
402.107 Amount of assessment.
402.109 Statistical sampling.
402.111 Factors considered determinations regarding the amount of 
          penalties and assessments.
402.113 When a penalty and assessment are collectible.
402.115 Collection of penalty or assessment.

                          Subpart C_Exclusions

402.200 Basis and purpose.
402.205 Length of exclusion.
402.208 Factors considered in determining whether to exclude, and the 
          length of exclusion.
402.209 Scope and effect of exclusion.
402.210 Notices.
402.212 Response to notice of proposed determination to exclude.
402.214 Appeal of exclusion.
402.300 Request for reinstatement.
402.302 Basis for reinstatement.
402.304 Approval of request for reinstatement.
402.306 Denial of request for reinstatement.
402.308 Waivers of exclusions.

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 
1302 and 1395hh).

    Source: 63 FR 68690, Dec. 14, 1998, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  402.1  Basis and scope.

    (a) Basis. This part is based on the sections of the Act that are 
specified in paragraph (c) of this section.
    (b) Scope. This part--
    (1) Provides for the imposition of civil money penalties, 
assessments, and exclusions against persons that violate the provisions 
of the Act specified in paragraph (c), (d), or (e) of this section; and
    (2) Sets forth the appeal rights of persons subject to penalties, 
assessments, or exclusion and the procedures for reinstatement following 
exclusion.
    (c) Civil money penalties. CMS or OIG may impose civil money 
penalties

[[Page 39]]

against any person or other entity specified in paragraphs (c)(1) 
through (c)(34) of this section under the identified section of the Act. 
(The authorities that also permit imposition of an assessment or 
exclusion are noted in the applicable paragraphs.)
    (1) Sections 1833(h)(5)(D) and 1842(j)(2)--Any person that knowingly 
and willfully, and on a repeated basis, bills for a clinical diagnostic 
laboratory test, other than on an assignment-related basis. This 
provision includes tests performed in a physician's office but excludes 
tests performed in a rural health clinic. (This violation may also 
include an assessment and cause exclusion.)
    (2) Section 1833(i)(6)--Any person that knowingly and willfully 
presents, or causes to be presented, a bill or request for payment for 
an intraocular lens inserted during or after cataract surgery for which 
the Medicare payment rate includes the cost of acquiring the class of 
lens involved.
    (3) Section 1833(q)(2)(B)--Any entity that knowingly and willfully 
fails to provide information about a referring physician, including the 
physician's name and unique physician identification number for the 
referring physician, when seeking payment on an unassigned basis. (This 
violation, if it occurs in repeated cases, may also cause an exclusion.)
    (4) Sections 1834(a)(11)(A) and 1842(j)(2)--Any durable medical 
equipment supplier that knowingly and willfully charges for a covered 
service that is furnished on a rental basis after the rental payments 
may no longer be made (except for maintenance and servicing) as provided 
in section 1834(a)(7)(A). (This violation may also include an assessment 
and cause exclusion.)
    (5) Sections 1834(a)(18)(B) and 1842(j)(2)--Any nonparticipating 
durable medical equipment supplier that knowingly and willfully, in 
violation of section 1834(a)(18)(A), fails to make a refund to Medicare 
beneficiaries for a covered service for which payment is precluded due 
to an unsolicited telephone contact from the supplier. (This violation 
may also include an assessment and cause exclusion.)
    (6) Sections 1834(b)(5)(C) and 1842(j)(2)--Any nonparticipating 
physician or supplier that knowingly and willfully charges a Medicare 
beneficiary more than the limiting charge, as specified in section 
1834(b)(5)(B), for radiologist services. (This violation may also 
include an assessment and cause exclusion.)
    (7) Sections 1834(c)(4)(C) and 1842(j)(2)--Any nonparticipating 
physician or supplier that knowingly and willfully charges a Medicare 
beneficiary more than the limiting charge, as specified in section 
1834(c)(4)(B), for mammography screening. (This violation may also 
include an assessment and cause exclusion.)
    (8) Sections 1834(h)(3) and 1842(j)(2)--Any supplier of prosthetic 
devices, orthotics, and prosthetics that knowingly and willfully charges 
for a covered prosthetic device, orthotic, or prosthetic that is 
furnished on a rental basis after the rental payment may no longer be 
made (except for maintenance and servicing). (This violation may also 
include an assessment and cause exclusion.)
    (9) Section 1834(j)(2)(A)(iii)--Any supplier of durable medical 
equipment, including a supplier of prosthetic devices, prosthetics, 
orthotics, or supplies, that knowingly and willfully distributes a 
certificate of medical necessity in violation of section 
1834(j)(2)(A)(i) or fails to provide the information required under 
section 1834(j)(2)(A)(ii).
    (10) Sections 1834(j)(4) and 1842(j)(2)--
    (i) Any supplier of durable medical equipment, including a supplier 
of prosthetic devices, prosthetics, orthotics, or supplies, that 
knowingly and willfully fails to make refunds in a timely manner to 
Medicare beneficiaries for services billed other than on an assignment-
related basis if--
    (A) The supplier does not possess a Medicare supplier number;
    (B) The service is denied in advance under section 1834(a)(15); or
    (C) The service is determined not to be medically necessary or 
reasonable.
    (ii) These violations may also include an assessment and cause 
exclusion.
    (11) Sections 1842(b)(18)(B) and 1842(j)(2)--Any practitioner 
specified in

[[Page 40]]

section 1842(b)(18)(C) (physician assistants, nurse practitioners, 
clinical nurse specialists, certified registered nurse anesthetists, 
certified nurse-midwives, clinical social workers, and clinical 
psychologists) or other person that knowingly and willfully bills or 
collects for any services by the practitioners on other than an 
assignment-related basis. (This violation may also include an assessment 
and cause exclusion.)
    (12) Sections 1842(k) and 1842(j)(2)--Any physician who knowingly 
and willfully presents, or causes to be presented, a claim or bill for 
an assistant at cataract surgery performed on or after March 1, 1987 for 
which payment may not be made because of section 1862(a)(15). (This 
violation may also include an assessment and cause exclusion.)
    (13) Sections 1842(l)(3) and 1842(j)(2)--Any nonparticipating 
physician who does not accept payment on an assignment-related basis and 
who knowingly and willfully fails to refund on a timely basis any 
amounts collected for services that are not reasonable or medically 
necessary or are of poor quality, in accordance with section 
1842(l)(1)(A). (This violation may also include an assessment and cause 
exclusion.)
    (14) Sections 1842(m)(3) and 1842(j)(2)--(i) Any nonparticipating 
physician, who does not accept payment for an elective surgical 
procedure on an assignment-related basis and whose charge is at least 
$500, who knowingly and willfully fails to--
    (A) Disclose the information required by section 1842(m)(1) 
concerning charges and coinsurance amounts; and
    (B) Refund on a timely basis any amount collected for the procedure 
in excess of the charges recognized and approved by the Medicare 
program.
    (ii) This violation may also include an assessment and cause 
exclusion.
    (15) Sections 1842(n)(3) and 1842(j)(2)--Any physician who knowingly 
and willfully, in repeated cases, bills one or more beneficiaries, for 
purchased diagnostic tests, any amount other than the payment amount 
specified in section 1842(n)(1)(A) or section 1842(n)(1)(B). (This 
violation may also include an assessment and cause exclusion.)
    (16) Section 1842(p)(3)(A)--Any physician or practitioner who 
knowingly and willfully fails promptly to provide the appropriate 
diagnosis code or codes upon request by CMS or a carrier on any request 
for payment or bill not submitted on an assignment-related basis for any 
service furnished by the physician. (This violation, if it occurs in 
repeated cases, may also cause exclusion.)
    (17) Sections 1848(g)(1)(B) and 1842(j)(2)--
    (i) Any nonparticipating physician, supplier, or other person that 
furnishes physicians' services and does not accept payment on an 
assignment-related basis, that--
    (A) Knowingly and willfully bills or collects in excess of the 
limiting charge (as defined in section 1848(g)(2)) on a repeated basis; 
or
    (B) Fails to make an adjustment or refund on a timely basis as 
required by section 1848(g)(1)(A)(iii) or (iv).
    (ii) These violations may also include an assessment and cause 
exclusion.
    (18) Section 1848(g)(3)(B) and 1842(j)(2)--Any person that knowingly 
and willfully bills for State plan approved physicians' services, as 
defined in section 1848(j)(3), on other than an assignment-related basis 
for a Medicare beneficiary who is also eligible for Medicaid (these 
individuals include qualified Medicare beneficiaries). This provision 
applies to services furnished on or after April 1, 1990. (This violation 
may also include an assessment and cause exclusion.)
    (19) Section 1848(g)(4)(B)(ii), 1842(p)(3), and 1842(j)(2)(A)--
    (i) Any physician, supplier, or other person (except any person that 
has been excluded from the Medicare program) that, for services 
furnished after September 1, 1990, knowingly and willfully--
    (A) Fails to submit a claim on a standard claim form for services 
provided for which payment is made under Part B on a reasonable charge 
or fee schedule basis; or
    (B) Imposes a charge for completing and submitting the standard 
claims form.
    (ii) These violations, if they occur in repeated cases, may also 
cause exclusion.

[[Page 41]]

    (20) Section 1862(b)(5)(C)--Any employer (other than a Federal or 
other governmental agency) that, before October 1, 1998, willfully or 
repeatedly fails to provide timely and accurate information requested 
relating to an employee's group health insurance coverage.
    (21) Section 1862(b)(6)(B)--Any entity that knowingly, willfully, 
and repeatedly--
    (i) Fails to complete a claim form relating to the availability of 
other health benefit plans in accordance with section 1862(b)(6)(A); or
    (ii) Provides inaccurate information relating to the availability of 
other health benefit plans on the claim form.
    (22) Section 1877(g)(5)--Any person that fails to report information 
required by HHS under section 1877(f) concerning ownership, investment, 
and compensation arrangements. (This violation may also include an 
assessment and cause exclusion.)
    (23) Sections 1879(h), 1834(a)(18), and 1842(j)(2)--
    (i) Any durable medical equipment supplier, including a supplier of 
prosthetic devices, prosthetics, orthotics, or supplies, that knowingly 
and willfully fails to make refunds in a timely manner to Medicare 
beneficiaries for services billed on an assignment-related basis if--
    (A) The supplier did not possess a Medicare supplier number;
    (B) The service is denied in advance under section 1834(a)(15) of 
the Act; or
    (C) The service is determined not to be payable under section 
1834(a)(17)(b) because of unsolicited telephone contacts.
    (ii) These violations may also include an assessment and cause 
exclusion.
    (24) Section 1882(a)(2)--Any person that issues a Medicare 
supplemental policy that has not been approved by the State regulatory 
program or does not meet Federal standards on and after the effective 
date in section 1882(p)(1)(C). (This violation may also include an 
assessment and cause exclusion.)
    (25) Section 1882(p)(8)--Any person that sells or issues Medicare 
supplemental policies, on or after July 30, 1992, that fail to conform 
to the NAIC or Federal standards established under section 1882(p). 
(This violation may also include an assessment and cause exclusion.)
    (26) Section 1882(p)(9)(C)--
    (i) Any person that sells a Medicare supplemental policy and--
    (A) Fails to make available for sale the core group of basic 
benefits when selling other Medicare supplemental policies with 
additional benefits; or
    (B) Fails to provide the individual, before the sale of the policy, 
an outline of coverage describing the benefits provided by the policy.
    (ii) These violations may also include an assessment and cause 
exclusion.
    (27) Section 1882(q)(5)(C)--
    (i) Any person that fails to--
    (A) Suspend a Medicare supplemental policy at the policyholder's 
request, if the policyholder applies for and is determined eligible for 
medical assistance, and the policyholder provides notice within 90 days 
of the eligibility determination; or
    (B) Automatically reinstate the policy as of the date of termination 
of medical assistance if the policyholder loses eligibility for medical 
assistance and the policyholder provides notice within 90 days of loss 
of eligibility.
    (ii) These violations may also include an assessment and cause 
exclusion.
    (28) Section 1882(r)(6)(A)--Any person that fails to provide refunds 
or credits as required by section 1882(r)(1)(B). (This violation may 
also include an assessment and cause exclusion.)
    (29) Section 1882(s)(4)--
    (i) Any issuer of a Medicare supplemental policy that--
    (A) Does not waive any time periods applicable to preexisting 
conditions, waiting periods, elimination periods, or probationary 
periods if the time periods were already satisfied under a preceding 
Medicare supplemental policy; or
    (B) Denies a policy, conditions the issuance or effectiveness of the 
policy, or discriminates in the pricing of the policy based on health 
status or other criteria as specified in section 1882(s)(2)(A).
    (ii) These violations may also include an assessment and cause 
exclusion.
    (30) Section 1882(t)(2)--
    (i) Any issuer of a Medicare supplemental policy that--

[[Page 42]]

    (A) Fails substantially to provide medically necessary services to 
enrollees seeking the services through the issuer's network of entities;
    (B) Imposes premiums on enrollees in excess of the premiums approved 
by the State;
    (C) Acts to expel an enrollee for reasons other than nonpayment of 
premiums; or
    (D) Does not provide each enrollee at the time of enrollment with 
the specific information provided in section 1882(t)(1)(E)(i) or fails 
to obtain a written acknowledgment from the enrollee of receipt of the 
information (as required by section 1882(t)(1)(E)(ii)).
    (ii) These violations may also include an assessment and cause 
exclusion.
    (31) Sections 1834(k)(6) and 1842(j)(2)--Any person or entity who 
knowingly and willfully bills or collects for any outpatient therapy 
services or comprehensive outpatient rehabilitation services on other 
than an assignment-related basis. (This violation may also include an 
assessment and cause exclusion.)
    (32) Sections 1834(l)(6) and 1842(j)(2)--Any supplier of ambulance 
services who knowingly and willfully bills or collects for any services 
on other than an assignment-related basis. (This violation may also 
include an assessment and cause exclusion.)
    (33) Section 1806(b)(2)(B)--Any person who knowingly and willfully 
fails to furnish a beneficiary with an itemized statement of items or 
services within 30 days of the beneficiary's request.
    (34) Section 1128G (b) (1) and (2)--Any applicable manufacturer or 
applicable group purchasing organization that fails to timely, 
accurately, or completely report a payment or other transfer of value or 
an ownership or investment interest to CMS, as required under part 403, 
subpart I, of this chapter.
    (d) Assessments. CMS or OIG may impose assessments in addition to 
civil money penalties for violations of the following statutory 
sections:
    (1) Section 1833: Paragraph (h)(5)(D).
    (2) Section 1834: Paragraphs (a)(11)(A), (a)(18)(B), (b)(5)(C), 
(c)(4)(C), (h)(3), (j)(4), (k)(6), and (l)(6).
    (3) Section 1842: Paragraphs (k), (l)(3), (m)(3), and (n)(3).
    (4) Section 1848: Paragraph (g)(1)(B).
    (5) Section 1877: Paragraph (g)(5).
    (6) Section 1879: Paragraph (h).
    (7) Section 1882: Paragraphs (a)(2), (p)(8), (p)(9)(C), (q)(5)(C), 
(r)(6)(A), (s)(3), and (t)(2).
    (e) Exclusions. (1) CMS or OIG may exclude any person from 
participation in the Medicare program on the basis of any of the 
following violations of the statute:
    (i) Section 1833: Paragraphs (h)(5)(D) and, in repeated cases, 
(q)(2)(B).
    (ii) Section 1834: Paragraphs (a)(11)(A), (a)(18)(B), (b)(5)(C), 
(c)(4)(C), (h)(3), (j)(4), (k)(6), and (l)(6).
    (iii) Section 1842: Paragraphs (b)(18)(B), (k), (l)(3), (m)(3), 
(n)(3), and, in repeated cases, (p)(3)(B).
    (iv) Section 1848: Paragraphs (g)(1)(B), (g)(3)(B), and, in repeated 
cases, (g)(4)(B)(ii).
    (v) Section 1877: Paragraph (g)(5).
    (vi) Section 1879: Paragraph (h).
    (vii) Section 1882: Paragraphs (a)(2), (p)(8), (p)(9)(C), (q)(5)(C), 
(r)(6)(A), (s)(4), and (t)(2).
    (2) CMS or OIG must exclude from participation in the Medicare 
program any of the following, under the identified section of the Act:
    (i) Section 1834(a)(17)(C)--Any supplier of durable medical 
equipment and supplies that are covered under section 1834(a)(13) that 
knowingly contacts Medicare beneficiaries by telephone regarding the 
furnishing of covered services in violation of section 1834(a)(17)(A) 
and whose conduct establishes a pattern of prohibited contacts as 
described under section 1834(a)(17)(A).
    (ii) Section 1834(h)(3)--Any supplier of prosthetic devices, 
orthotics, and prosthetics that knowingly contacts Medicare 
beneficiaries by telephone regarding the furnishing of prosthetic 
devices, orthotics, or prosthetics in the same manner as in the 
violation under section 1834(a)(17)(A) and whose conduct establishes a 
pattern of prohibited contacts in the same manner as described in 
section 1834(a)(17)(C).
    (f) Responsible persons. (1) If CMS or OIG determines that more than 
one person is responsible for any of the violations described in 
paragraph (c) or paragraph (d) of this section, it may impose a civil 
money penalty or a civil

[[Page 43]]

money penalty and assessment against any one of those persons or jointly 
and severally against two or more of those persons. However, the 
aggregate amount of the assessments collected may not exceed the amount 
that could be assessed if only one person were responsible.
    (2) A principal is liable for penalties and assessments for the 
actions of his or her agent acting within the scope of the agency.
    (g) Time limits. Neither CMS nor OIG initiates an action to impose a 
civil money penalty, assessment, or proceeding to exclude a person from 
participation in the Medicare program unless it begins the action within 
6 years from the date on which the claim was presented, the request for 
payment was made, or the incident occurred.

[63 FR 68690, Dec. 14, 1998, as amended at 66 FR 49546, Sept. 28, 2001; 
78 FR 9520, Feb. 8, 2013]



Sec.  402.3  Definitions.

    For purposes of this part:
    Assessment means the amount described in Sec.  402.107 and includes 
the plural of that term.
    Assignment-related basis means that the claim submitted by a 
physician, supplier or other person is paid on the basis of an 
assignment, whereby the physician, supplier or other person agrees to 
accept the Medicare payment as payment in full for the services 
furnished to the beneficiary and is precluded from charging the 
beneficiary more than the deductible and coinsurance based upon the 
approved Medicare fee amount. Additional obligations, including 
obligations to make refunds in certain circumstances, are established at 
section 1842(b)(3) of the Act.
    Claim means an application for payment for a service for which the 
Medicare or Medicaid program may pay.
    Covered means that a service is described as reasonable and 
necessary for the diagnosis or treatment of illness or injury or to 
improve the functioning of a malformed body member. A service is not 
covered if it is specifically identified as excluded from Medicare Part 
B coverage or is not a defined Medicare Part B benefit.
    Exclusion means the temporary or permanent barring of a person or 
other entity from participation in the Medicare or State health care 
program and that services furnished or ordered by that person are not 
paid for under either program.
    General Counsel means the General Counsel of HHS or his or her 
designees.
    Initiating agency means whichever agency (CMS or the OIG) initiates 
the interaction with the person.
    Knowingly or knowingly and willfully means that a person, with 
respect to information--
    (1) Has actual knowledge of the information;
    (2) Acts in deliberate ignorance of the truth or falsity of the 
information; or
    (3) Acts in reckless disregard of the truth or falsity of the 
information; and
    (4) No proof of specific intent is required.
    Medicare supplemental policy means a policy guaranteeing that a 
health plan will pay a policyholder's coinsurance and deductible and 
will cover other limitations on payment imposed under title XVIII of the 
Act and will provide additional health plan or non-Medicare coverage for 
services up to a predefined benefit limit.
    NAIC stands for the National Association of Insurance Commissioners.
    Nonparticipating describes a physician, supplier, or other person 
(excluding any provider of services) that, at the time of furnishing the 
services to Medicare Part B beneficiaries, is not a participating 
physician or supplier.
    Participating describes a physician or supplier (excluding any 
provider of services) that, before the beginning of any given year, 
enters into an agreement with HHS that provides that the physician or 
supplier will accept payment under the Medicare program on an 
assignment-related basis for all services furnished to Medicare Part B 
beneficiaries.
    Penalty means the amount described in Sec.  402.105 and includes the 
plural of that term.
    Person means an individual, trust or estate, partnership, 
corporation, professional association or corporation, or other entity, 
public or private.
    Physicians' services means the following Medicare covered 
professional services:

[[Page 44]]

    (1) Surgery, consultation, home, office and institutional calls, and 
other professional services performed by physicians.
    (2) Services and supplies furnished ``incident to'' a physician's 
professional services.
    (3) Outpatient physical and occupational therapy services.
    (4) Diagnostic x-ray tests and other diagnostic tests (excluding 
clinical diagnostic laboratory tests).
    (5) X-ray, radium, and radioactive isotope therapy, including 
materials and services of technicians.
    (6) Antigens prepared by a physician.
    Radiologist service means radiology services performed only by, or 
under the direction of, a physician who is certified, or eligible to be 
certified, by the American Board of Radiology or for whom radiology 
services account for at least 50 percent of the total amount of charges 
made under part B of title XVIII of the Act.
    Request for payment means an application submitted by a person to 
any person for payment for a service.
    Respondent means the person upon which CMS or OIG has imposed, or 
proposes to impose, a civil money penalty, assessment, or exclusion.
    Service includes--
    (1) Any item, device, medical supply, or service claimed to have 
been furnished to a patient and listed in an itemized claim for program 
payment; or
    (2) In the case of a claim based on costs, any entry or omission in 
a cost report, books of account or other documents supporting the claim.
    State includes the District of Columbia, Puerto Rico, the Virgin 
Islands, Guam, American Samoa, the Northern Mariana Islands, and the 
Trust Territory of the Pacific Islands.
    Timely basis means that the adjustment to a bill or a refund is 
considered ``on a timely basis'' if the physician, supplier, or other 
person makes the adjustment or refund to the appropriate party no later 
than 30 days after the date the physician, supplier, or other person is 
notified by the Medicare Part B contractor of the violation and the 
requirement to refund any excess collections.

[63 FR 68690, Dec. 14, 1998, as amended at 72 FR 39752, July 20, 2007]



Sec.  402.5  Right to a hearing before the final determination.

    CMS or OIG does not make a determination adverse to any person under 
this part until the person has been given a written notice and 
opportunity for the determination to be made on the record after a 
hearing at which the person is entitled to be represented by counsel, to 
present witnesses, and to cross-examine witnesses against the person.



Sec.  402.7  Notice of proposed determination.

    (a) If CMS or OIG proposes a penalty and, as applicable, an 
assessment, or proposes to exclude a respondent from participation in 
Medicare in accordance with this part, it sends the respondent written 
notice of its intent by certified mail, return receipt requested. The 
notice includes the following information:
    (1) Reference to the statutory basis or bases for the penalty, 
assessment, exclusion, or any combination, as applicable.
    (2)(i) A description of the claims, requests for payment, or 
incidents with respect to which the penalty, assessment, and exclusion 
are proposed; or
    (ii) If CMS or OIG is relying upon statistical sampling to project 
the number and types of claims or requests for payment and the dollar 
amount, a description of the claims and requests for payment comprising 
the sample and a brief description of the statistical sampling technique 
CMS or OIG used.
    (3) The reason why the claims, requests for payment, or incidents 
are subject to a penalty and assessment.
    (4) The amount of the proposed penalty and of any proposed 
assessment.
    (5) Any mitigating or aggravating circumstances that CMS or OIG 
considered when it determined the amount of the proposed penalty and any 
applicable assessment.
    (6) Information concerning response to the notice, including--
    (i) A specific statement of the respondent's right to a hearing; and

[[Page 45]]

    (ii) A statement that failure to request a hearing within 60 days 
renders the proposed determination final and permits the imposition of 
the proposed penalty and any assessment.
    (iii) A statement that the debt may be collected through an 
administrative offset.
    (7) In the case of a respondent that has an agreement under section 
1866 of the Act, notice that imposition of an exclusion may result in 
termination of the provider's agreement in accordance with section 
1866(b)(2)(C) of the Act.



Sec.  402.9  Failure to request a hearing.

    (a) If the respondent does not request a hearing within 60 days of 
receipt of the notice of proposed determination specified in Sec.  
402.7, any civil money penalty, assessment, or exclusion becomes final 
and CMS or OIG may impose the proposed penalty, assessment, or 
exclusion, or any less severe penalty, assessment, or suspension.
    (b) CMS or OIG notifies the respondent by certified mail, return 
receipt requested, of any penalty, assessment, or exclusion that has 
been imposed and of the means by which the respondent may satisfy the 
judgment.
    (c) The respondent has no right to appeal a penalty, assessment, or 
exclusion for which he or she has not requested a hearing.



Sec.  402.11  Notice to other agencies and other entities.

    (a) Whenever a penalty, assessment, or exclusion becomes final, CMS 
or OIG notifies the following organizations and entities about the 
action and the reasons for it:
    (1) The appropriate State or local medical or professional 
association.
    (2) The appropriate quality improvement organization.
    (3) As appropriate, the State agency responsible for the 
administration of each State health care program (Medicaid, the Maternal 
and Child Health Services Block Grant Program, and the Social Services 
Block Grant Program).
    (4) The appropriate Medicare carrier or fiscal intermediary.
    (5) The appropriate State or local licensing agency or organization 
(including the Medicare and Medicaid State survey agencies).
    (6) The long-term care ombudsman.
    (b) For exclusions, CMS or OIG also notifies the public and 
specifies the effective date.



Sec.  402.13  Penalty, assessment, and exclusion not exclusive.

    Penalties, assessments, and exclusions imposed under this part are 
in addition to any other penalties prescribed by law.



Sec.  402.15  Collateral estoppel.

    (a) When a final determination that the respondent presented or 
caused to be presented a claim or request for payment falling within the 
scope of Sec.  402.1 has been rendered in any proceeding in which the 
respondent was a party and had an opportunity to be heard, the 
respondent is bound by that determination in any proceeding under this 
part.
    (b) A person who has been convicted (whether upon a verdict after 
trial or upon a plea of guilty or nolo contendere) of a Federal crime 
charging fraud or false statements is barred from denying the essential 
elements of the criminal offense if the proceedings under this part 
involve the same transactions.



Sec.  402.17  Settlement.

    CMS or OIG has exclusive authority to settle any issues or case, 
without the consent of the ALJ or the Secretary, at any time before a 
final decision by the Secretary. Thereafter, the General Counsel has the 
exclusive authority.



Sec.  402.19  Hearings and appeals.

    The hearings and appeals procedures set forth in part 1005 of 
chapter V of this title are available to any person that receives an 
adverse determination under this part. For an appeal of a civil money 
penalty, assessment, or exclusion imposed under this part, either CMS or 
OIG may represent the government in the hearing and appeals process.



Sec.  402.21  Judicial review.

    After exhausting all available administrative remedies, a respondent 
may seek judicial review of a penalty, assessment, or exclusion that has 
become final. The respondent may seek review

[[Page 46]]

only with respect to a penalty, assessment, or exclusion with respect to 
which the respondent filed an exception under Sec.  1005.21(c) of this 
title unless the court excuses the failure or neglect to urge the 
exception in accordance with section 1128A(e) of the Act because of 
extraordinary circumstances.



             Subpart B_Civil Money Penalties and Assessments



Sec.  402.105  Amount of penalty.

    (a) $2,000. Except as provided in paragraphs (b) through (h) of this 
section, CMS or OIG may impose a penalty of not more than $2,000 as 
adjusted annually under 45 CFR part 102 for each service, bill, or 
refusal to issue a timely refund that is subject to a determination 
under this part and for each incident involving the knowing, willful, 
and repeated failure of an entity furnishing a service to submit a 
properly completed claim form or to include on the claim form accurate 
information regarding the availability of other health insurance benefit 
plans (Sec.  402.1(c)(21)).
    (b) $1,000. CMS or OIG may impose a penalty of not more than $1,000 
as adjusted annually under 45 CFR part 102 for the following:
    (1) Per certificate of medical necessity knowingly and willfully 
distributed to physicians on or after December 31, 1994 that--
    (i) Contains information concerning the medical condition of the 
patient; or
    (ii) Fails to include cost information.
    (2) Per individual about whom information is requested, for willful 
or repeated failure of an employer to respond to an intermediary or 
carrier about coverage of an employee or spouse under the employer's 
group health plan (Sec.  402.1(c)(20)).
    (c) $5,000. CMS or OIG may impose a penalty of not more than $5,000 
as adjusted annually under 45 CFR part 102 for each violation resulting 
from the following:
    (1) The failure of a Medicare supplemental policy issuer, on a 
replacement policy, to waive any time periods applicable to pre-existing 
conditions, waiting periods, elimination periods, or probationary 
periods that were satisfied under a preceding policy (Sec.  
402.1(c)(29)); and
    (2) Any issuer of any Medicare supplemental policy denying a policy, 
conditioning the issuance or effectiveness of the policy, or 
discriminating in the pricing of the policy based on health status or 
other criteria as specified in section 1882(s)(2)(A). (Sec.  
402.1(c)(29)).
    (d) $10,000. (1) CMS or OIG may impose a penalty of not more than 
$10,000 as adjusted annually under 45 CFR part 102 for each day that 
reporting entity ownership arrangements is late (Sec.  402.1(c)(22)).
    (2) CMS or OIG may impose a penalty of not more than $10,000 as 
adjusted annually under 45 CFR part 102 for the following violations 
that occur on or after January 1, 1997:
    (i) Knowingly and willfully, and on a repeated basis, billing for a 
clinical diagnostic laboratory test, other than on an assignment-related 
basis (Sec.  402.1(c)(1)).
    (ii) By any durable medical equipment supplier, knowingly and 
willfully charging for a covered service that is furnished on a rental 
basis after the rental payments may no longer be made (except for 
maintenance and servicing) as provided in section 1834(a)(7)(A) (Sec.  
402.1(c)(4)).
    (iii) By any durable medical equipment supplier, knowingly and 
willfully, in violation of section 1834(a)(18)(A), failing to make a 
refund to Medicare beneficiaries for a covered service for which payment 
is precluded due to an unsolicited telephone contact from the supplier 
(Sec.  402.1(c)(5)).
    (iv) By any nonparticipating physician or supplier, knowingly and 
willfully charging a Medicare beneficiary more than the limiting charge, 
as specified in section 1834(b)(5)(B), for radiologist services (Sec.  
402.1(c)(6)).
    (v) By any nonparticipating physician or supplier, knowingly and 
willfully charging a Medicare beneficiary more than the limiting charge, 
as specified in section 1834(c)(3), for mammography screening (Sec.  
402.1(c)(7)).
    (vi) By any supplier of prosthetic devices, orthotics, and 
prosthetics, knowingly and willfully charging for a covered prosthetic 
device, orthotic, or prosthetic that is furnished on a rental basis 
after the rental payment may no

[[Page 47]]

longer be made (except for maintenance and servicing) (Sec.  
401.2(c)(8)).
    (vii) By any supplier of durable medical equipment, including a 
supplier of prosthetic devices, prosthetics, orthotics, or supplies, 
knowingly and willfully failing to make refunds in a timely manner to 
Medicare beneficiaries for services billed other than on an assigned-
related basis if--
    (A) The supplier does not possess a Medicare supplier number;
    (B) The service is denied in advance; or
    (C) The service is determined not to be medically necessary or 
reasonable (Sec.  402.1(c)(10)).
    (viii) Knowingly and willfully billing or collecting for any 
services on other than an assignment-related basis for practitioners 
specified in section 1842(b)(18)(B) (Sec.  402.1(c)(11)).
    (ix) By any physician, knowingly and willfully presenting, or 
causing to be presented, a claim or bill for an assistant at cataract 
surgery performed on or after March 1, 1987 for which payment may not be 
made because of section 1862(a)(15) (Sec.  402.1(c)(12)).
    (x) By any nonparticipating physician who does not accept payment on 
an assignment-related basis, knowingly and willfully failing to refund 
on a timely basis any amounts collected for services that are not 
reasonable or medically necessary or are of poor quality, in accordance 
with section 1842(l)(1)(A) (Sec.  402.1(c)(13)).
    (xi) By any nonparticipating physician, who does not accept payment 
for an elective surgical procedure on an assignment-related basis and 
whose charge is at least $500, knowingly and willfully failing to--
    (A) Disclose the information required by section 1842(m)(1) 
concerning charges and coinsurance amounts; and
    (B) Refund on a timely basis any amount collected for the procedure 
in excess of the charges recognized and approved by the Medicare program 
(Sec.  402.1(c)(14)).
    (xii) By any physician, in repeated cases, knowingly and willfully 
billing one or more beneficiaries, for purchased diagnostic tests, any 
amount other than the payment amount specified in section 1842(n)(1)(A) 
or section 1842(n)(1)(B) (Sec.  402.1(c)(15)).
    (xiii) By any nonparticipating physician, supplier, or other person 
that furnishes physicians' services and does not accept payment on an 
assignment-related basis--
    (A) Knowingly and willfully billing or collecting in excess of the 
limiting charge (as defined in section 1843(g)(2)) on a repeated basis; 
or
    (B) Failing to make an adjustment or refund on a timely basis as 
required by section 1848(g)(1)(A)(iii) or (iv) (Sec.  402.1(c)(17)).
    (xiv) Knowingly and willfully billing for State plan approved 
physicians' services on other than an assignment-related basis for a 
Medicare beneficiary who is also eligible for Medicaid (Sec.  
402.1(c)(18)).
    (xv) By any supplier of durable medical equipment, including a 
supplier of prosthetic devices, prosthetics, orthotics, or supplies, 
knowingly and willfully failing to make refunds in a timely manner to 
Medicare beneficiaries for services billed on an assignment-related 
basis if--
    (A) The supplier did not possess a Medicare supplier number;
    (B) The service is denied in advance; or
    (C) The service is determined not to be medically necessary or 
reasonable (Sec.  402.1(c)(23)).
    (3) CMS or OIG may impose a penalty of not more than $10,000 as 
adjusted annually under 45 CFR part 102 for each violation, if a person 
or entity knowingly and willfully bills or collects for outpatient 
therapy or comprehensive rehabilitation services other than on an 
assignment-related basis.
    (4) CMS or OIG may impose a penalty of not more than $10,000 as 
adjusted annually under 45 CFR part 102 for each violation, if a person 
or entity knowingly and willfully bills or collects for outpatient 
ambulance services other than on an assignment-related basis.
    (5) CMS or OIG may impose a penalty of not more than $10,000 as 
adjusted annually under 45 CFR part 102 for each failure of an 
applicable manufacturer or an applicable group purchasing organization 
to report timely, accurately, or completely a payment or other transfer 
of value or an ownership or investment interest (Sec.  402.1(c)(34)). 
The total penalty imposed with respect to

[[Page 48]]

failures to report in an annual submission of information will not 
exceed $150,000 as annually adjusted under 45 CFR part 102.
    (e) $15,000. CMS or OIG may impose a penalty of not more than 
$15,000 as adjusted annually under 45 CFR part 102 for if the seller of 
a Medicare supplemental policy is not the issuer, for each violation 
described in paragraphs (f)(2) and (f)(3) of this section (Sec.  402.1 
(c)(25) and (c)(26)).
    (f) $25,000. CMS or OIG may impose a penalty of not more than 
$25,000 as adjusted annually under 45 CFR part 102 for each of the 
following violations:
    (1) Issuance of a Medicare supplemental policy that has not been 
approved by an approved State regulatory program or does not meet 
Federal standards on and after the effective date in section 
1882(p)(1)(C) of the Act (Sec.  402.1(c)(23)).
    (2) Sale or issuance after July 30, 1992, of a Medicare supplemental 
policy that fails to conform with the NAIC or Federal standards 
established under section 1882(p) of the Act (Sec.  402.1(c)(25)).
    (3) Failure to make the core group of basic benefits available for 
sale when selling other Medicare supplemental plans with additional 
benefits (Sec.  402.1(c)(26)).
    (4) Failure to provide, before sale of a Medicare supplemental 
policy, an outline of coverage describing the benefits provided by the 
policy (Sec.  402.1(c)(26)).
    (5) Failure of an issuer of a policy to suspend or reinstate a 
policy, based on the policy holder's request, during entitlement to or 
upon loss of eligibility for medical assistance (Sec.  402.1(c)(27)).
    (6) Failure to provide refunds or credits for Medicare supplemental 
policies as required by section 1882(r)(1)(B) (Sec.  402.1(c)(28)).
    (7) By an issuer of a Medicare supplemental policy--
    (i) Substantial failure to provide medically necessary services to 
enrollees seeking the services through the issuer's network of entities;
    (ii) Imposition of premiums on enrollees in excess of the premiums 
approved by the State;
    (iii) Action to expel an enrollee for reasons other than nonpayment 
of premiums; or
    (iv) Failure to provide each enrollee, at the time of enrollment, 
with the specific information provided in section 1882(t)(1)(E)(i) or 
failure to obtain a written acknowledgment from the enrollee of receipt 
of the information (as required by section 1882(t)(1)(E)(ii)) (section 
1882(t)(2)).
    (g) $100. CMS or OIG may impose a penalty of not more than $100 as 
adjusted annually under 45 CFR part 102 for each violation if the person 
or entity does not furnish an itemized statement to a Medicare 
beneficiary within 30 days of the beneficiary's request.
    (h) $100,000. CMS or OIG may impose a penalty of not more than 
$10,000 as adjusted annually under 45 CFR part 102 for each knowing 
failure of an applicable manufacturer or an applicable group purchasing 
organization to report timely, accurately or completely a payment or 
other transfer of value or an ownership or investment interest (Sec.  
402.1(c)(34)). The total penalty imposed with respect to knowing 
failures to report in an annual submission of information will not 
exceed $1,000,000 as annually adjusted under 45 CFR part 102.

[63 FR 68690, Dec. 14, 1998, as amended at 66 FR 49546, Sept. 28, 2001; 
72 FR 39752, July 20, 2007; 72 FR 46175, Aug. 17, 2007; 78 FR 9520, Feb. 
8, 2013; 81 FR 61561, Sept. 6, 2016]



Sec.  402.107  Amount of assessment.

    A person subject to civil money penalties specified in Sec.  
402.1(c) may be subject, in addition, to an assessment. An assessment is 
a monetary payment in lieu of damages sustained by HHS or a State 
agency.
    (a) The assessment may not be more than twice the amount claimed for 
each service that was a basis for the civil money penalty, except for 
the violations specified in paragraph (b) of this section that occur 
before January 1, 1997.
    (b) For the violations specified in this paragraph occurring after 
January 1, 1997, the assessment may not be more than three times the 
amount claimed for each service that was the basis for a civil money 
penalty. The violations are the following:
    (1) Knowingly and willfully billing, and on a repeated basis, for a 
clinical diagnostic laboratory test, other than

[[Page 49]]

on an assignment-related basis (Sec.  402.1(c)(1)).
    (2) By any durable medical equipment supplier, knowingly and 
willfully charging for a covered service that is furnished on a rental 
basis after the rental payments may no longer be made (except for 
maintenance and servicing) as provided in section 1834(a)(7)(A) (Sec.  
402.1(c)(4)).
    (3) By any durable medical equipment supplier, knowingly and 
willfully failing, in violation of section 1834(a)(18)(A), to make a 
refund to Medicare beneficiaries for a covered service for which payment 
is precluded due to an unsolicited telephone contact from the supplier 
(Sec.  402.1(c)(5)).
    (4) By any nonparticipating physician or supplier, knowingly and 
willfully charging a Medicare beneficiary more than the limiting charge, 
as specified in section 1834(b)(5)(B), for radiologist services (Sec.  
402.1(c)(6)).
    (5) By any nonparticipating physician or supplier, knowingly and 
willfully charging a Medicare beneficiary more than the limiting charge 
as specified in section 1834(c)(3), for mammography screening (Sec.  
402.1(c)(7)).
    (6) By any supplier of prosthetic devices, orthotics, and 
prosthetics, knowingly and willfully charging for a covered prosthetic 
device, orthotic, or prosthetic that is furnished on a rental basis 
after the rental payment may no longer be made (except for maintenance 
and servicing) (Sec.  401.2(c)(8)).
    (7) By any supplier of durable medical equipment, including a 
supplier of prosthetic devices, prosthetics, orthotics, or supplies, 
knowingly and willfully failing to make refunds in a timely manner to 
Medicare beneficiaries for services billed other than on an assignment-
related basis if--
    (i) The supplier does not possess a Medicare supplier number;
    (ii) The service is denied in advance; or
    (iii) The service is determined not to be medically necessary or 
reasonable (Sec.  402.1(c)(10)).
    (8) Knowingly and willfully billing or collecting for any services 
on other than an assignment-related basis for a person or entity 
specified in sections 1834(k)(6), 1834(l)(6), or 1842(b)(18)(B) (Sec.  
402.1(c)(11), (c)(31), or (c)(32)).
    (9) By any physician, knowingly and willfully presenting, or causing 
to be presented, a claim or bill for an assistant at cataract surgery 
performed on or after March 1, 1987 for which payment may not be made 
because of section 1862(a)(15) (Sec.  402.1(c)(12)).
    (10) By any nonparticipating physician who does not accept payment 
on an assignment-related basis, knowingly and willfully failing to 
refund on a timely basis any amounts collected for services that are not 
reasonable or medically necessary or are of poor quality, in accordance 
with section 1842(l)(1)(A) (Sec.  402.1(c)(13)).
    (11) By any nonparticipating physician, who does not accept payment 
for an elective surgical procedure on an assignment-related basis and 
whose charge is at least $500, knowingly and willfully failing to--
    (i) Disclose the information required by section 1842(m)(1) 
concerning charges and coinsurance amounts; and
    (ii) Refund on a timely basis any amount collected for the procedure 
in excess of the charges recognized and approved by the Medicare program 
(Sec.  402.1(c)(14)).
    (12) By any physician, in repeated cases, knowingly and willfully 
billing one or more beneficiaries, for purchased diagnostic tests, any 
amount other than the payment amount specified in section 1842(n)(1)(A) 
or section 1842(n)(1)(B) (Sec.  402.1(c)(15)).
    (13) By any nonparticipating physician, supplier, or other person 
that furnishes physicians' services and does not accept payment on an 
assignment-related basis--
    (i) Knowingly and willfully billing or collecting in excess of the 
limiting charge (as defined in section 1843(g)(2)) on a repeated basis; 
or
    (ii) Failing to make an adjustment or refund on a timely basis as 
required by section 1848(g)(1)(A) (iii) or (iv) (Sec.  402.1(c)(17)).
    (14) Knowingly and willfully billing for State plan approved 
physicians' services on other than an assignment-related basis for a 
Medicare beneficiary who is also eligible for Medicaid (Sec.  
402.1(c)(18)).
    (15) By any supplier of durable medical equipment, including 
suppliers of prosthetic devices, prosthetics,

[[Page 50]]

orthotics, or supplies, knowingly and willfully failing to make refunds 
in a timely manner to Medicare beneficiaries for services billed on an 
assignment-related basis if--
    (i) The supplier did not possess a Medicare supplier number;
    (ii) The service is denied in advance; or
    (iii) The service is determined not to be medically necessary or 
reasonable (Sec.  402.1(c)(23)).

[63 FR 68690, Dec. 14, 1998, as amended at 66 FR 49546, Sept. 28, 2001]



Sec.  402.109  Statistical sampling.

    (a) Purpose. CMS or OIG may introduce the results of a statistical 
sampling study to show the number and amount of claims subject to 
sanction under this part that the respondent presented or caused to be 
presented.
    (b) Prima facie evidence. The results of the statistical sampling 
study, if based upon an appropriate sampling and computed by valid 
statistical methods, constitute prima facie evidence of the number and 
amount of claims or requests for payment subject to sanction under Sec.  
402.1.
    (c) Burden of proof. Once CMS or OIG has made a prima facie case, 
the burden is on the respondent to produce evidence reasonably 
calculated to rebut the findings of the statistical sampling study. CMS 
or OIG then has the opportunity to rebut this evidence.



Sec.  402.111  Factors considered in determinations regarding the amount 
of penalties and assessments.

    (a) Basic factors. In determining the amount of any penalty or 
assessment, CMS or OIG takes into account the following:
    (1) The nature of the claim, request for payment, or information 
given and the circumstances under which it was presented or given.
    (2) The degree of culpability, history of prior offenses, and 
financial condition of the person submitting the claim or request for 
payment or giving the information.
    (3) The resources available to the person submitting the claim or 
request for payment or giving the information.
    (4) Such other matters as justice may require.
    (b) Criteria to be considered. As guidelines for taking into account 
the factors listed in paragraph (a) of this section, CMS or OIG 
considers the following circumstances:
    (1) Aggravating circumstances of the incident. An aggravating 
circumstance is any of the following:
    (i) The services or incidents were of several types, occurring over 
a lengthy period of time.
    (ii) There were many of these services or incidents or the nature 
and circumstances indicate a pattern of claims or requests for payment 
for these services or a pattern of incidents.
    (iii) The amount claimed or requested for these services was 
substantial.
    (iv) Before the incident or presentation of any claim or request for 
payment subject to imposition of a civil money penalty, the respondent 
was held liable for criminal, civil, or administrative sanctions in 
connection with a program covered by this part or any other public or 
private program of payment for medical services.
    (v) There is proof that a respondent engaged in wrongful conduct, 
other than the specific conduct upon which liability is based, relating 
to government programs or in connection with the delivery of a health 
care service. (The statute of limitations governing civil money penalty 
proceedings does not apply to proof of other wrongful conduct as an 
aggravating circumstance.)
    (2) Mitigating circumstances. The following circumstances are 
mitigating circumstances:
    (i) All the services or incidents subject to a civil money penalty 
were few in number and of the same type, occurred within a short period 
of time, and the total amount claimed or requested for the services was 
less than $1,000.
    (ii) The claim or request for payment for the service was the result 
of an unintentional and unrecognized error in the process of presenting 
claims or requesting payment and the respondent took corrective steps 
promptly after discovering the error.
    (iii) Imposition of the penalty or assessment without reduction 
would

[[Page 51]]

jeopardize the ability of the respondent to continue as a health care 
provider.
    (3) Other matters as justice may require. Other circumstances of an 
aggravating or mitigating nature are taken into account if, in the 
interests of justice, they require either a reduction of the penalty or 
assessment or an increase in order to ensure the achievement of the 
purposes of this part.
    (c) Effect of aggravating or mitigating circumstances. In 
determining the amount of the penalty and assessment to be imposed for 
every service or incident subject to a determination under Sec.  
402.1(c)--
    (1) If there are substantial or several mitigating circumstances, 
the aggregate amount of the penalty and assessment is set at an amount 
sufficiently below the maximum permitted by Sec. Sec.  402.105(a) and 
402.107 to reflect that fact.
    (2) If there are substantial or several aggravating circumstances, 
the aggregate amount of the penalty and assessment is set at an amount 
at or sufficiently close to the maximum permitted by Sec. Sec.  
402.105(a) and 402.107 to reflect that fact.
    (d)(1) The standards set forth in this section are binding, except 
to the extent that their application would result in imposition of an 
amount that would exceed limits imposed by the United States 
Constitution.
    (2) The amount imposed is not less than the approximate amount 
required to fully compensate the United States, or any State, for its 
damages and costs, tangible and intangible, including but not limited to 
the costs attributable to the investigation, prosecution, and 
administrative review of the case.
    (3) Nothing in this section limits the authority of CMS or OIG to 
settle any issue or case as provided by Sec.  402.19 or to compromise 
any penalty and assessment as provided by Sec.  402.115.



Sec.  402.113  When a penalty and assessment are collectible.

    A civil money penalty and assessment become collectible after the 
earliest of the following:
    (a) Sixty days after the respondent receives CMS's or OIG's notice 
of proposed determination under Sec.  402.7, if the respondent has not 
requested a hearing before an ALJ.
    (b) Immediately after the respondent abandons or waives his or her 
appeal right at any administrative level.
    (c) Thirty days after the respondent receives the ALJ's decision 
imposing a civil money penalty or assessment under Sec.  1005.20(d) of 
this title, if the respondent has not requested a review before the DAB.
    (d) If the DAB grants an extension of the period for requesting the 
DAB's review, the day after the extension expires if the respondent has 
not requested the review.
    (e) Immediately after the ALJ's decision denying a request for a 
stay of the effective date under Sec.  1005.22(b) of this title.
    (f) If the ALJ grants a stay under Sec.  1005.22(b) of this title, 
immediately after the judicial ruling is completed.
    (g) Sixty days after the respondent receives the DAB's decision 
imposing a civil money penalty if the respondent has not requested a 
stay of the decision under Sec.  1005.22(b) of this title.



Sec.  402.115  Collection of penalty or assessment.

    (a) Once a determination by HHS has become final, CMS is responsible 
for the collection of any penalty or assessment.
    (b) The General Counsel may compromise a penalty or assessment 
imposed under this part, after consultation with CMS or OIG, and the 
Federal government may recover the penalty or assessment in a civil 
action brought in the United States district court for the district 
where the claim was presented or where the respondent resides.
    (c) The United States or a State agency may deduct the amount of a 
penalty and assessment when finally determined, or the amount agreed 
upon in compromise, from any sum then or later owing to the respondent.
    (d) Matters that were raised or that could have been raised in a 
hearing before an ALJ or in an appeal under section 1128A(e) of the Act 
may not be raised as a defense in a civil action by the United States to 
collect a penalty under this part.

[[Page 52]]



                          Subpart C_Exclusions

    Source: 72 FR 39752, July 20, 2007, unless otherwise noted.



Sec.  402.200  Basis and purpose.

    (a) Basis. This subpart is based on the sections of the Act that are 
specified in Sec.  402.1(e).
    (b) Purpose. This subpart--
    (1) Provides for the imposition of an exclusion from the Medicare 
and Medicaid programs (and, where applicable, other Federal health care 
programs) against persons that violate the provisions of the Act 
provided in Sec.  402.1(e) (and further described in Sec.  402.1(c)); 
and
    (2) Sets forth the appeal rights of persons subject to exclusion and 
the procedures for reinstatement following exclusion.



Sec.  402.205  Length of exclusion.

    The length of exclusion from participation in Medicare, Medicaid, 
and, where applicable, other Federal health care programs, is contingent 
upon the specific violation of the Medicare statute. A full description 
of the specific violations identified in the sections of the Act are 
cross-referenced in the regulatory sections listed in the table in 
paragraph (a) of this section.
    (a) In no event will the period of exclusion exceed 5 years for 
violation of the following sections of the Act:

------------------------------------------------------------------------
                                           Code of Federal Regulations
     Social Security Act paragraph                   section
------------------------------------------------------------------------
1833(h)(5)(D) in repeated cases........  Sec.   402.1(c)(1)
1833(q)(2)(B) in repeated cases........  Sec.   402.1(c)(3)
1834(a)(11)(A).........................  Sec.   402.1(c)(4)
1834(a)(18)(B).........................  Sec.   402.1(c)(5)
1834(b)(5)(C)..........................  Sec.   402.1(c)(6)
1834(c)(4)(C)..........................  Sec.   402.1(c)(7)
1834(h)(3).............................  Sec.   402.1(c)(8)
1834(j)(4).............................  Sec.   402.1(c)(10)
1834(k)(6).............................  Sec.   402.1(c)(31)
1834(l)(6).............................  Sec.   402.1(c)(32)
1842(b)(18)(B).........................  Sec.   402.1(c)(11)
1842(k)................................  Sec.   402.1(c)(12)
1842(l)(3).............................  Sec.   402.1(c)(13)
1842(m)(3).............................  Sec.   402.1(c)(14)
1842(n)(3).............................  Sec.   402.1(c)(15)
1842(p)(3)(B) in repeated cases........  Sec.   402.1(c)(16)
1848(g)(1)(B) in repeated cases........  Sec.   402.1(c)(17)
1848(g)(3)(B)..........................  Sec.   402.1(c)(18)
1848(g)(4)(B)(ii) in repeated cases....  Sec.   402.1(c)(19)
1879(h)................................  Sec.   402.1(c)(23)
------------------------------------------------------------------------

    (b) For violation of the following sections, there is no maximum 
time limit for the period of exclusion.

------------------------------------------------------------------------
                                           Code of Federal Regulations
     Social Security Act paragraph                   section
------------------------------------------------------------------------
1834(a)(17)(c) for a pattern of          Sec.   402.1(e)(2)(i)
 contacts.
1834(h)(3) for a pattern of contacts...  Sec.   402.1(e)(2)(ii)
1877(g)(5).............................  Sec.   402.1(c)(22)
1882(a)(2).............................  Sec.   402.1(c)(24)
1882(p)(8).............................  Sec.   402.1(c)(25)
1882(p)(9)(C)..........................  Sec.   402.1(c)(26)
1882(q)(5)(C)..........................  Sec.   402.1(c)(27)
1882(r)(6)(A)..........................  Sec.   402.1(c)(28)
1882(s)(4).............................  Sec.   402.1(c)(29)
1882(t)(2).............................  Sec.   402.1(c)(30)
------------------------------------------------------------------------

    (c) For a person excluded under any of the grounds specified in 
paragraph (a) of this section, notwithstanding any other requirements in 
this section, reinstatement occurs--
    (1) At the expiration of the period of exclusion, if the exclusion 
was imposed for a period of 5 years; or
    (2) At the expiration of 5 years from the effective date of the 
exclusion, if the exclusion was imposed for a period of less than 5 
years and the initiating agency did not receive the appropriate written 
request for reinstatement as specified in Sec.  402.300.



Sec.  402.208  Factors considered in determining whether to exclude, 
and the length of exclusion.

    (a) General factors. In determining whether to exclude a person and 
the length of exclusion, the initiating agency considers the following:
    (1) The nature of the claims and the circumstances under which they 
were presented.
    (2) The degree of culpability, the history of prior offenses, and 
the financial condition of the person presenting the claims.
    (3) The total number of acts in which the violation occurred.
    (4) The dollar amount at issue (Medicare Trust Fund dollars or 
beneficiary out-of-pocket expenses).
    (5) The prior history of the person insofar as its willingness or 
refusal to comply with requests to correct said violations.
    (6) Any other facts bearing on the nature and seriousness of the 
person's misconduct.
    (7) Any other matters that justice may require.
    (b) Criteria to be considered. As a guideline for taking into 
account the general factors listed in paragraph (a)

[[Page 53]]

of this section, the initiating agency may consider any one or more of 
the circumstances listed in paragraphs (b)(1) and (b)(2) of this 
section, as applicable. The respondent, in his or her written response 
to the notice of intent to exclude (that is, the proposed exclusion), 
may provide information concerning potential mitigating circumstances.
    (1) Aggravating circumstances. An aggravating circumstance may be 
any of the following:
    (i) The services or incidents were of several types and occurred 
over an extended period of time.
    (ii) There were numerous services or incidents, or the nature and 
circumstances indicate a pattern of claims or requests for payment or a 
pattern of incidents, or whether a specific segment of the population 
was targeted.
    (iii) Whether the person was held liable for criminal, civil, or 
administrative sanctions in connection with a program covered by this 
part or any other public or private program of payment for health care 
items or services at any time before the incident or whether the person 
presented any claim or made any request for payment that included an 
item or service subject to a determination under Sec.  402.1.
    (iv) There is proof that the person engaged in wrongful conduct, 
other than the specific conduct upon which liability is based, relating 
to government programs and in connection with the delivery of a health 
care item or service. The statute of limitations governing civil money 
penalty proceedings at section 1128A(c)(1) of the Act does not apply to 
proof of other wrongful conducts as an aggravating circumstance.
    (v) The wrongful conduct had an adverse impact on the financial 
integrity of the Medicare program or its beneficiaries.
    (vi) The person was the subject of an adverse action by any other 
Federal, State, or local government agency or board, and the adverse 
action is based on the same set of circumstances that serves as a basis 
for the imposition of the exclusion.
    (vii) The noncompliance resulted in a financial loss to the Medicare 
program of at least $5,000.
    (viii) The number of instances for which full, accurate, and 
complete disclosure was not made as required, or provided as requested, 
and the significance of the undisclosed information.
    (2) Mitigating circumstances. A mitigating circumstance may be any 
of the following:
    (i) All incidents of noncompliance were few in nature and of the 
same type, occurred within a short period of time, and the total amount 
claimed or requested for the items or services provided was less than 
$1,500.
    (ii) The claim(s) or request(s) for payment for the item(s) or 
service(s) provided by the person were the result of an unintentional 
and unrecognized error in the person's process for presenting claims or 
requesting payment, and the person took corrective steps promptly after 
the error was discovered.
    (iii) Previous cooperation with a law enforcement or regulatory 
entity resulted in convictions, exclusions, investigations, reports for 
weaknesses, or civil money penalties against other persons.
    (iv) Alternative sources of the type of health care items or 
services furnished by the person are not available to the Medicare 
population in the person's immediate area.
    (v) The person took corrective action promptly upon learning of the 
noncompliance from the person's employee or contractor, or by the 
Medicare contractor.
    (vi) The person had a documented mental, emotional, or physical 
condition before or during the commission of the noncompliant act(s) and 
that condition reduces the person's culpability for the acts in 
question.
    (vii) The completeness and timeliness of refunding to the Medicare 
Trust Fund or Medicare beneficiaries any inappropriate payments.
    (viii) The degree of culpability of the person in failing to provide 
timely and complete refunds.
    (3) Other matters as justice may require. Other circumstances of an 
aggravating or mitigating nature are taken into account if, in the 
interest of justice,

[[Page 54]]

those circumstances require either a reduction or increase in the 
sanction to ensure achievement for the purposes of this subpart.
    (4) Initiating agency authority. Nothing in this section limits the 
authority of the initiating agency to settle any issue or case as 
provided by Sec.  402.17, or to compromise any penalty and assessment as 
provided by Sec.  402.115.



Sec.  402.209  Scope and effect of exclusion.

    (a) Scope of exclusion. Under this title, persons may be excluded 
from the Medicare, Medicaid, and, where applicable, any other Federal 
health care programs.
    (b) Effect of exclusion on a person(s). (1) Unless and until an 
excluded person is reinstated into the Medicare program, no payment is 
made by Medicare, Medicaid, and, where applicable, any other Federal 
health care programs for any item or service furnished by the excluded 
person or at the direction or request of the excluded person when the 
person furnishing the item or service knew or had reason to know of the 
exclusion, on or after the effective date of the exclusion as specified 
in the notice of exclusion.
    (2) An excluded person may not take assignment of a Medicare 
beneficiary's claim on or after the effective date of the exclusion.
    (3) An excluded person that submits, or causes to be submitted, 
claims for items or services furnished during the exclusion period is 
subject to civil money penalty liability under section 1128A(a)(1)(D) of 
the Act, and criminal liability under section 1128B(a)(3) of the Act. In 
addition, submission of claims, or the causing of claims to be submitted 
for items or services furnished, ordered, or prescribed, by an excluded 
person may serve as the basis for denying reinstatement to the Medicare 
program.
    (c) Exceptions. (1) If a Medicare beneficiary or other person 
(including a supplier) submits an otherwise payable claim for items or 
services furnished by an excluded person, or under the medical direction 
or on the request of an excluded person after the effective date of the 
exclusion, CMS pays the first claim submitted by the beneficiary or 
other person and immediately notifies the claimant of the exclusion. CMS 
does not pay a beneficiary or other person (including a supplier) for 
items or services furnished by, or under, the medical direction of an 
excluded person more than 15 days after the date on the notice to the 
beneficiary or other person (including a supplier), or after the 
effective date of the exclusion, whichever is later.
    (2) Notwithstanding the other provisions of this section, payment 
may be made for certain emergency items or services furnished by an 
excluded person, or under the medical direction or on the request of an 
excluded person during the period of exclusion. To be payable, a claim 
for the emergency items or services must be accompanied by a sworn 
statement of the person furnishing the items or services, specifying the 
nature of the emergency and the reason that the items or services were 
not furnished by a person eligible to furnish or order the items or 
services. No claim for emergency items or services is payable if those 
items or services were provided by an excluded person that, through 
employment, contractual, or under any other arrangement, routinely 
provides emergency health care items or services.



Sec.  402.210  Notices.

    (a) Notice of proposed determination to exclude. When the initiating 
agency proposes to exclude a person from participation in a Federal 
health care program in accordance with this part, notice of the proposed 
determination to exclude must be given in writing, and delivered or sent 
by certified mail, return receipt requested. The written notice must 
include, at a minimum--
    (1) Reference to the statutory basis for the exclusion.
    (2) A description of the claims, requests for payment, or incidents 
for which the exclusion is proposed.
    (3) The reason why those claims, requests for payments, or incidents 
subject the person to an exclusion.
    (4) The length of the proposed exclusion.
    (5) A description of the circumstances that were considered when 
determining the period of exclusion.
    (6) Instructions for responding to the notice, including a specific 
statement

[[Page 55]]

of the person's right to submit documentary evidence and a written 
response concerning whether the exclusion is warranted, and any related 
issues such as potential mitigating circumstances. The notice must 
specify that--
    (i) The person has the right to request an opportunity to meet with 
an official of the initiating agency to make an oral presentation; and
    (ii) The request to make an oral presentation must be submitted 
within 30 days of the receipt of the notice of intent to exclude.
    (7) If a person fails, within the time permitted under Sec.  
402.212, to exercise the right to respond to the notice of proposed 
determination to exclude, the initiating agency may initiate actions for 
the imposition of the exclusion.
    (b) Notice of exclusion. Once the initiating agency determines that 
the exclusion is warranted, a written notice of exclusion is sent to the 
person in the same manner as described in paragraph (a) of this section. 
The exclusion is effective 20 days from the date of the notice. The 
written notice must include, at a minimum, the following:
    (1) The basis for the exclusion.
    (2) The length of the exclusion and, when applicable, the factors 
considered in setting the length.
    (3) The effect of exclusion.
    (4) The earliest date on which the initiating agency considers a 
request for reinstatement.
    (5) The requirements and procedures for reinstatement.
    (6) The appeal rights available to the excluded person under part 
1005 of this title.
    (c) Amendment to the notice of exclusion. No later than 15 days 
before the final exhibit exchanges required under Sec.  1005.8 of this 
title, the initiating agency may amend the notice of exclusion if 
information becomes available that justifies the imposition of a period 
of exclusion other than the one proposed in the original written notice.



Sec.  402.212  Response to notice of proposed determination to exclude.

    (a) A person that receives a notice of intent to exclude (that is, 
the proposed determination) as described in Sec.  402.210, may present 
to the initiating agency a written response stating whether the proposed 
exclusion is warranted, and may present additional supportive 
documentation. The person must submit this response within 60 days of 
the receipt of notice. The initiating agency reviews the materials 
presented and initiates a response to the person regarding the argument 
presented, and any changes to the determination, if appropriate.
    (b) The person is also afforded an opportunity to make an oral 
presentation to the initiating agency concerning whether the proposed 
exclusion is warranted and any related matters. The person must submit 
this request within 30 days of the receipt of notice. Within 15 days of 
receipt of the person's request, the initiating agency initiates 
communication with the person to establish a mutually agreed upon time 
and place for the oral presentation and discussion.



Sec.  402.214  Appeal of exclusion.

    (a) The procedures in part 1005 of this title apply to all appeals 
of exclusions. References to the Inspector General in that part apply to 
the initiating agency.
    (b) A person excluded under this subpart may file a request for a 
hearing before an administrative law judge (ALJ) only on the issues of 
whether--
    (1) The basis for the imposition of the exclusion exists; and
    (2) The duration of the exclusion is unreasonable.
    (c) When the initiating agency imposes an exclusion for a period of 
1 year or less, paragraph (b)(2) of this section does not apply.
    (d) The excluded person must file a request for a hearing within 60 
days from the receipt of notice of exclusion. The effective date of an 
exclusion is not delayed beyond the date stated in the notice of 
exclusion simply because a request for a hearing is timely filed (see 
paragraph (g) of this section).
    (e) A timely filed written request for a hearing must include--
    (1) A statement as to the specific issues or findings of fact and 
conclusions of law in the notice of exclusion with which the person 
disagrees.
    (2) Basis for the disagreement.

[[Page 56]]

    (3) The general basis for the defenses that the person intends to 
assert.
    (4) Reasons why the proposed length of exclusion should be modified.
    (5) Reasons, if applicable, why the health or safety of Medicare 
beneficiaries receiving items or services does not warrant the exclusion 
going into or remaining in effect before the completion of an ALJ 
proceeding in accordance with part 1005 of this title.
    (f) If the excluded person does not file a written request for a 
hearing as provided in paragraph (d) of this section, the initiating 
agency notifies the excluded person, by certified mail, return receipt 
requested, that the exclusion goes into effect or continues in 
accordance with the notice of exclusion. The excluded person has no 
right to appeal the exclusion other than as described in this section.
    (g) If the excluded person files a written request for a hearing, 
and asserts in the request that the health or safety of Medicare 
beneficiaries does not warrant the exclusion going into or remaining in 
effect before completion of an ALJ hearing, then the initiating agency 
may make a determination as to whether the exclusion goes into effect or 
continues pending the outcome of the ALJ hearing.



Sec.  402.300  Request for reinstatement.

    (a) An excluded person may submit a written request for 
reinstatement to the initiating agency no sooner than 120 days prior to 
the terminal date of exclusion as specified in the notice of exclusion. 
The written request for reinstatement must include documentation 
demonstrating that the person has met the standards set forth in Sec.  
402.302. Obtaining or reactivating a Medicare provider number (or 
equivalent) does not constitute reinstatement.
    (b) Upon receipt of a written request for reinstatement, the 
initiating agency may require the person to furnish additional, specific 
information, and authorization to obtain information from private health 
insurers, peer review organizations, and others as necessary to 
determine whether reinstatement is granted.
    (c) Failure to submit a written request for reinstatement or to 
furnish the required information or authorization results in the 
continuation of the exclusion, unless the exclusion has been in effect 
for 5 years. In this case, reinstatement is automatic.
    (d) If a period of exclusion is reduced on appeal (regardless of 
whether further appeal is pending), the excluded person may request and 
apply for reinstatement within 120 days of the expiration of the reduced 
exclusion period. A written request for the reinstatement includes the 
same standards as noted in paragraph (b) of this section.



Sec.  402.302  Basis for reinstatement.

    (a) The initiating agency authorizes reinstatement if it determines 
that--
    (1) The period of exclusion has expired;
    (2) There are reasonable assurances that the types of actions that 
formed the basis for the original exclusion did not recur and will not 
recur; and
    (3) There is no additional basis under title XVIII of the Act that 
justifies the continuation of the exclusion.
    (b) The initiating agency does not authorize reinstatement if it 
determines that submitting claims or causing claims to be submitted or 
payments to be made by the Medicare program for items or services 
furnished, ordered, or prescribed, may serve as a basis for denying 
reinstatement. This section applies regardless of whether the excluded 
person has obtained a Medicare provider number (or equivalent), either 
as an individual or as a member of a group, before being reinstated.
    (c) In making a determination regarding reinstatement, the 
initiating agency considers the following:
    (1) Conduct of the excluded person occurring before the date of the 
notice of the exclusion, if that conduct was not known to the initiating 
agency at the time of the exclusion;
    (2) Conduct of the excluded person after the date of the exclusion;
    (3) Whether all fines and all debts due and owing (including 
overpayments) to any Federal, State, or local government that relate to 
Medicare, Medicaid, or, where applicable, any Federal, State, or local 
health care program are paid in full, or satisfactory arrangements are 
made to fulfill these obligations;

[[Page 57]]

    (4) Whether the excluded person complies with, or has made 
satisfactory arrangements to fulfill, all of the applicable conditions 
of participation or conditions of coverage under the Medicare statutes 
and regulations; and
    (5) Whether the excluded person has, during the period of exclusion, 
submitted claims, or caused claims to be submitted or payment to be made 
by Medicare, Medicaid, and, where applicable, any other Federal health 
care program, for items or services furnished, ordered, or prescribed, 
and the conditions under which these actions occurred.
    (d) Reinstatement is not effective until the initiating agency 
grants the request and provides notices under Sec.  402.304. 
Reinstatement is effective as provided in the notice.
    (e) A determination for a denial of reinstatement is not appealable 
or reviewable except as provided in Sec.  402.306.
    (f) An ALJ may not require reinstatement of an excluded person in 
accordance with this chapter.



Sec.  402.304  Approval of request for reinstatement.

    (a) If the initiating agency grants a request for reinstatement, the 
initiating agency--
    (1) Gives written notice to the excluded person specifying the date 
of reinstatement; and
    (2) Notifies appropriate Federal and State agencies, and, to the 
extent possible, all others that were originally notified of the 
exclusion, that the person is reinstated into the Medicare program.
    (b) A determination by the initiating agency to reinstate an 
excluded person has no effect if Medicare, Medicaid, or, where 
applicable, any other Federal health care program has imposed a longer 
period of exclusion under its own authorities.



Sec.  402.306  Denial of request for reinstatement.

    (a) If a request for reinstatement is denied, the initiating agency 
provides written notice to the excluded person. Within 30 days of the 
date of this notice, the excluded person may submit to the initiating 
agency:
    (1) Documentary evidence and a written argument challenging the 
reinstatement denial; or
    (2) A written request to present written evidence or oral argument 
to an official of the initiating agency.
    (b) If a written request as described in paragraph (a)(2) of this 
section is received timely by the initiating agency, the initiating 
agency, within 15 days of receipt of the excluded person's request, 
initiates communication with the excluded person to establish a time and 
place for the requested meeting.
    (c) After evaluating any additional evidence submitted by the 
excluded person (or at the end of the 30-day period described in 
paragraph (a) of this section, if no documentary evidence or written 
request is submitted), the initiating agency sends written notice to the 
excluded person either confirming the denial, or approving the 
reinstatement in the manner set forth in Sec.  402.304. If the 
initiating agency elects to uphold its denial decision, the written 
notice also indicates that a subsequent request for reinstatement will 
not be considered until at least 1 year after the date of the written 
denial notice.
    (d) The decision to deny reinstatement is not subject to 
administrative review.



Sec.  402.308  Waivers of exclusions.

    (a) Basis. Section 1128(c)(3)(B) of the Act specifies that in the 
case of an exclusion from participation in the Medicare program based 
upon section 1128(a)(1), (a)(3), or (a)(4) of the Act, the individual 
may request that CMS present, on his or her behalf, a request to the OIG 
for a waiver of the exclusion.
    (b) Definitions. For purposes of this section:
    Excluded person has the same meaning as a ``person'' as defined in 
Sec.  402.3 who meets for the purposes of this subpart, the definition 
of the term ``exclusion'' in Sec.  402.3.
    Hardship for purposes of this section means something that 
negatively affects Medicare beneficiaries and results from the 
imposition of an exclusion because the excluded person is the sole 
community physician or sole source of

[[Page 58]]

essential specialized services in the Medicare community.
    Sole community physician has the same meaning as that term is 
defined Sec.  1001.2 of this title.
    Sole source of essential specialized services in the community has 
the same meaning as that term defined by the Sec.  1001.2 of this title.
    (c) General rule. If CMS determines that a hardship as defined in 
paragraph (b)(2) of this section results from exclusion of an affected 
person from the Medicare program, CMS may consider and may make a 
request to the Inspector General for waiver of the Medicare exclusion.
    (d) Submission and content of a waiver of exclusion request. An 
excluded person must submit a request for waiver of exclusion in writing 
to CMS that includes the following:
    (1) A copy of the exclusion notice from the OIG.
    (2) A statement requesting that CMS present a waiver of exclusion 
request to the OIG on his or her behalf.
    (3) A statement that he or she is the sole community physician or 
sole source of essential specialized services in the community.
    (4) Documentation to support the statement in paragraph (d)(3) of 
this section.
    (e) Processing of waiver of exclusion requests. CMS processes a 
request for a waiver of exclusion as follows:
    (1) Notifies the submitter that the waiver of exclusion request has 
been received.
    (2) Reviews and validates all submitted documents.
    (3) During its analysis, CMS may require additional, specific 
information, and authorization to obtain information from private health 
insurers, peer review organizations (including, but not limited to, 
Quality Improvement Organizations), and others as necessary to determine 
validity.
    (4) Makes a determination regarding whether or not to submit the 
waiver of exclusion request to the OIG based on review and validation of 
the submitted documents.
    (5) If CMS elects to submit the waiver of exclusion request to the 
OIG, CMS copies the excluded person on the request.
    (6) If CMS denies the request, then CMS notifies the excluded person 
of the decision and specifies the reason(s) for the decision.
    (f) Administrative or judicial review. A determination rendered 
under paragraph (e)(4) of this section is not subject to administrative 
or judicial review.



PART 403_SPECIAL PROGRAMS AND PROJECTS--Table of Contents



Subpart A [Reserved]

                Subpart B_Medicare Supplemental Policies

Sec.
403.200 Basis and scope.

                           General Provisions

403.201 State regulation of insurance policies.
403.205 Medicare supplemental policy.
403.206 General standards for Medicare supplemental policies.
403.210 NAIC model standards.
403.215 Loss ratio standards.

                        State Regulatory Programs

403.220 Supplemental Health Insurance Panel.
403.222 State with an approved regulatory program.

           Voluntary Certification Program: General Provisions

403.231 Emblem.
403.232 Requirements and procedures for obtaining certification.
403.235 Review and certification of policies.
403.239 Submittal of material to retain certification.
403.245 Loss of certification.
403.248 Administrative review of CMS determinations.

         Voluntary Certification Program: Loss Ratio Provisions

403.250 Loss ratio calculations: General provisions.
403.251 Loss ratio date and time frame provisions.
403.253 Calculation of benefits.
403.254 Calculation of premiums.
403.256 Loss ratio supporting data.
403.258 Statement of actuarial opinion.

      Subpart C_Recognition of State Reimbursement Control Systems

403.300 Basis and purpose.
403.302 Definitions.

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403.304 Minimum requirements for State systems--discretionary approval.
403.306 Additional requirements for State systems--mandatory approval.
403.308 State systems under demonstration projects--mandatory approval.
403.310 Reduction in payments.
403.312 Submittal of application.
403.314 Evaluation of State systems.
403.316 Reconsideration of certain denied applications.
403.318 Approval of State systems.
403.320 CMS review and monitoring of State systems.
403.321 State systems for hospital outpatient services.
403.322 Termination of agreements for Medicare recognition of State 
          systems.

Subparts D--F [Reserved]

   Subpart G_Religious Nonmedical Health Care Institutions_Benefits, 
                Conditions of Participation, and Payment

403.700 Basis and purpose.
403.702 Definitions and terms.
403.720 Conditions for coverage.
403.724 Valid election requirements.
403.730 Condition of participation: Patient rights.
403.732 Condition of participation: Quality assessment and performance 
          improvement.
403.734 Condition of participation: Food services.
403.736 Condition of participation: Discharge planning.
403.738 Condition of participation: Administration.
403.740 Condition of participation: Staffing.
403.742 Condition of participation: Physical environment.
403.744 Condition of participation: Life safety from fire.
403.745 Condition of participation: Building Safety.
403.746 Condition of participation: Utilization review.
403.748 Condition of participation: Emergency preparedness.
403.750 Estimate of expenditures and adjustments.
403.752 Payment provisions.
403.754 Monitoring expenditure level.
403.756 Sunset provision.
403.764 Basis and purpose of religious nonmedical health care 
          institutions providing home service.
403.766 Requirements for coverage and payment of RNHCI home services.
403.768 Excluded services.
403.770 Payments for home services.

  Subpart H_Medicare Prescription Drug Discount Card and Transitional 
                           Assistance Program

403.800 Basis and scope.
403.802 Definitions.
403.804 General rules for solicitation, application and Medicare 
          endorsement period.
403.806 Sponsor requirements for eligibility for endorsement.
403.808 Use of transitional assistance funds.
403.810 Eligibility and reconsiderations.
403.811 Enrollment, disenrollment, and associated endorsed sponsor 
          requirements.
403.812 HIPAA privacy, security, administrative data standards, and 
          national identifiers.
403.813 Marketing limitations and record retention requirements.
403.814 Special rules concerning Part C organizations and Medicare cost 
          plans and their enrollees.
403.815 Special rules concerning States.
403.816 Special rules concerning long-term care and I/T/U pharmacies.
403.817 Special rules concerning the territories.
403.820 Sanctions, penalties, and termination.
403.822 Reimbursement of transitional assistance and associated sponsor 
          requirements.

 Subpart I_Transparency Reports and Reporting of Physician Ownership or 
                          Investment Interests

403.900 Purpose and scope.
403.902 Definitions.
403.904 Reports of payments or other transfers of value.
403.906 Reports of physician ownership and investment interests.
403.908 Procedures for electronic submission of reports.
403.910 Delayed publication for payments made under product research or 
          development agreements and clinical investigations.
403.912 Penalties for failure to report.
403.914 Preemption of State laws.

 Subpart K_Access to Identifiable Data for the Center for Medicare and 
                             Medicaid Models

403.1100 Purpose and scope.
403.1105 Definitions.

[[Page 60]]

403.1110 Evaluation of models.

Subpart L_Requirements for Direct-to-Consumer Television Advertisements 
   of Drugs and Biological Products To Include the List Price of That 
                           Advertised Product

403.1200 Scope.
403.1201 Definitions.
403.1202 Pricing information.
403.1203 Specific presentation requirements.
403.1204 Compliance.

    Authority: 42 U.S.C. 1302, and 1395hh.

    Authority: 42 U.S.C. 1302 and 1395hh.

Subpart A [Reserved]



                Subpart B_Medicare Supplemental Policies

    Source: 47 FR 32400, July 26, 1982, unless otherwise noted.



Sec.  403.200  Basis and scope.

    (a) Provisions of the legislation. This subpart implements, in part, 
section 1882 of the Social Security Act. The intent of that section is 
to enable Medicare beneficiaries to identify Medicare supplemental 
policies that do not duplicate Medicare, and that provide adequate, 
fairly priced protection against expenses not covered by Medicare. The 
legislation establishes certain standards for Medicare supplemental 
policies and provides two methods for informing Medicare beneficiaries 
which policies meet those standards:
    (1) Through a State approved program, that is, a program that a 
Supplemental Health Insurance Panel determines to meet certain minimum 
requirements for the regulation of Medicare supplemental policies; and
    (2) In a State without an approved program, through certification by 
the Secretary of policies voluntarily submitted by insuring 
organizations for review against the standards.
    (b) Scope of subpart. This subpart sets forth the standards and 
procedures CMS will use to implement the voluntary certification 
program.

                           General Provisions



Sec.  403.201  State regulation of insurance policies.

    (a) The provisions of this subpart do not affect the right of a 
State to regulate policies marketed in that State.
    (b) Approval of a policy under the voluntary certification program, 
as provided for in Sec.  403.235(b), does not authorize the insuring 
organization to market a policy that does not conform to applicable 
State laws and regulations.



Sec.  403.205  Medicare supplemental policy.

    (a) Except as specified in paragraph (e) of this section, Medicare 
supplemental (or Medigap) policy means a health insurance policy or 
other health benefit plan that--
    (1) A private entity offers to a Medicare beneficiary; and
    (2) Is primarily designed, or is advertised, marketed, or otherwise 
purported to provide payment for expenses incurred for services and 
items that are not reimbursed under the Medicare program because of 
deductibles, coinsurance, or other limitations under Medicare.
    (b) The term policy includes both policy form and policy as 
specified in paragraphs (b)(1) and (b)(2) of this section.
    (1) Policy form. Policy form is the form of health insurance 
contract that is approved by and on file with the State agency for the 
regulation of insurance.
    (2) Policy. Policy is the contract--
    (i) Issued under the policy form; and
    (ii) Held by the policy holder.
    (c) If the policy otherwise meets the definition in this section, a 
Medicare supplemental policy includes-
    (1) An individual policy;
    (2) A group policy;
    (3) A rider attached to an individual or group policy; or
    (4) As of January 1, 2006, a stand-alone limited health benefit plan 
or policy that supplements Medicare benefits and is sold primarily to 
Medicare beneficiaries.
    (d) Any rider attached to a Medicare supplemental policy becomes an 
integral part of the basic policy.

[[Page 61]]

    (e) Medicare supplemental policy does not include a Medicare 
Advantage plan, a Prescription Drug Plan under Part D, or any of the 
other types of health insurance policies or health benefit plans that 
are excluded from the definition of a Medicare supplemental policy in 
section 1882(g)(1) of the Act.

[70 FR 4525, Jan. 28, 2005]



Sec.  403.206  General standards for Medicare supplemental policies.

    (a) For purposes of the voluntary certification program described in 
this subpart, a policy must meet--
    (1) The National Association of Insurance Commissioners (NAIC) model 
standards as defined in Sec.  405.210; and
    (2) The loss ratio standards specified in Sec.  403.215.
    (b) Except as specified in paragraph (c) of this section, the 
standards specified in paragraph (a) of this section must be met in a 
single policy.
    (c) In the case of a nonprofit hospital or a medical association 
where State law prohibits the inclusion of all benefits in a single 
policy, the standards specified in paragraph (a) of the section must be 
met in two or more policies issued in conjunction with one another.



Sec.  403.210  NAIC model standards.

    (a) NAIC model standards means the National Association of Insurance 
Commissioners (NAIC) ``Model Regulation to Implement the Individual 
Accident and Insurance Minimum Standards Act'' (as amended and adopted 
by the NAIC on June 6, 1979, as it applies to Medicare supplemental 
policies). Copies of the NAIC model standards can be purchased from the 
National Association of Insurance Commissioners at 350 Bishops Way, 
Brookfield, Wisconsin 53004, and from the NIARS Corporation, 318 
Franklin Avenue, Minneapolis, Minnesota 55404.
    (b) The policy must comply with the provisions of the NAIC model 
standards, except as follows--
    (1) Policy, for purposes of this paragraph, means individual and 
group policy, as specified in Sec.  403.205. The NAIC model standards 
limit ``policy'' to individual policy.
    (2) The policy must meet the loss ratio standards specified in Sec.  
403.215.

[47 FR 32400, July 26, 1982; 49 FR 44472, Nov. 7, 1984]



Sec.  403.215  Loss ratio standards.

    (a) The policy must be expected to return to the policyholders, in 
the form of aggregate benefits provided under the policy--
    (1) At least 75 percent of the aggregate amount of premiums in the 
case of group policies; and
    (2) At least 60 percent of the aggregate amount of premiums in the 
case of individual policies.
    (b) For purposes of loss ratio requirements, policies issued as a 
result of solicitation of individuals through the mail or by mass media 
advertising are considered individual policies.

                        State Regulatory Programs



Sec.  403.220  Supplemental Health Insurance Panel.

    (a) Membership. The Supplemental Health Insurance Panel (Panel) 
consists of--
    (1) The Secretary or a designee, who serves as chairperson, and
    (2) Four State Commissioners or Superintendents of Insurance 
appointed by the President. (The terms Commissioner or Superintendent of 
Insurance include persons of similar rank.)
    (b) Functions. (1) The Panel determines whether or not a State 
regulatory program for Medicare supplemental health insurance policies 
meets and continues to meet minimum requirements specified in section 
1882 of the Social Security Act.
    (2) The chairperson of the Panel informs the State Commissioners and 
Superintendents of Insurance of all determinations made under paragraph 
(b)(1) of this section.



Sec.  403.222  State with an approved regulatory program.

    (a) A State has an approved regulatory program if the Panel 
determines that the State has in effect under State law a regulatory 
program that provides for the application of standards, with respect to 
each Medicare supplemental policy issued in that State, that are equal 
to or more stringent than those

[[Page 62]]

specified in section 1882 of the Social Security Act.
    (b) Policy issued in that State means--
    (1) A group policy, if the holder of the master policy resides in 
that State; and
    (2) An individual policy, if the policy is--
    (i) Issued in that State; or
    (ii) Issued for delivery in that State.
    (c) A policy issued in a State with an approved regulatory program 
is considered to meet the NAIC model standards in Sec.  403.210 and loss 
ratio standards in Sec.  403.215.

           Voluntary Certification Program: General Provisions



Sec.  403.231  Emblem.

    (a) The emblem is a graphic symbol, approved by HHS, that indicates 
that CMS has certified a policy as meeting the requirements of the 
voluntary certification program, specified in Sec.  403.232.
    (b) Unless prohibited by the State in which the policy is marketed, 
the insuring organization may display the emblem on policies certified 
under the voluntary certification program.
    (c) The manner in which the emblem may be displayed and the 
conditions and restrictions relating to its use will be stated in the 
letter with which CMS notifies the insuring organization that a policy 
has been certified. The insuring organization must comply with these 
conditions and restrictions.
    (d) If a certified policy is issued in a State that later has an 
approved regulatory program, as provided for in Sec.  403.222, the 
insuring organization may display the emblem on the policy until the 
earliest of the following--
    (1) When prohibited by State law or regulation.
    (2) When the policy no longer meets the requirements for Medicare 
supplemental policies specified in Sec.  403.206.
    (3) The date the insuring organization would be required to submit 
material to CMS for annual review in order to retain certification, if 
the State did not have an approved program (see Sec.  403.239).



Sec.  403.232  Requirements and procedures for obtaining certification.

    (a) To be certified by CMS, a policy must meet--
    (1) The NAIC model standards specified in Sec.  403.210;
    (2) The loss ratio standards specified in Sec.  403.215; and
    (3) Any State requirements applicable to a policy--
    (i) Issued in that State; or
    (ii) Marketed in that State.
    (b) An insuring organization requesting certification of a policy 
must submit the following to CMS for review--
    (1) A copy of the policy form (including all the documents that 
would constitute the contract of insurance that is proposed to be 
marketed as a certified policy).
    (2) A copy of the application form including all attachments.
    (3) A copy of the uniform certificate issued under a group policy.
    (4) A copy of the outline of coverage, in the form prescribed by the 
NAIC model standards.
    (5) A copy of the Medicare supplement buyers' guide to be provided 
to all applicants if the buyers' guide is not the CMS/NAIC buyers' 
guide.
    (6) A statement of when and how the outline of coverage and the 
buyers' guide will be delivered and copies of applicable receipt forms.
    (7) A copy of the notice of replacement and statement as to when and 
how that notice will be delivered.
    (8) A list of States in which the policy is authorized for sale. If 
the policy was approved under a deemer provision in any State, the 
conditions involved must be specified.
    (9) A copy of the loss ratio calculations, as specified in Sec.  
403.250.
    (10) Loss ratio supporting data, as specified in Sec.  403.256.
    (11) A statement of actuarial opinion, as specified in Sec.  
403.258.
    (12) A statement that the insuring organization will notify the 
policyholders in writing, within the period of time specified in Sec.  
403.245(c), if the policy is identified as a certified policy at the 
time of sale and later loses certification.
    (13) A signed statement in which the president of the insuring 
organization, or a designee, attests that--

[[Page 63]]

    (i) The policy meets the requirements specified in paragraph (a) of 
this section; and
    (ii) The information submitted to CMS for review is accurate and 
complete and does not misrepresent any material fact.



Sec.  403.235  Review and certification of policies.

    (a) CMS will review policies that the insuring organization 
voluntarily submits, except that CMS will not review a policy issued in 
a State with an approved regulatory program under Sec.  403.222.
    (b) If the requirements specified in Sec.  403.232 are met, CMS 
will--
    (1) Certify the policy; and
    (2) Authorize the insuring organization to display the emblem on the 
policy, as provided for in Sec.  403.231.
    (c) If CMS certifies a policy, it will inform all State 
Commissioners and Superintendents of Insurance of that fact.



Sec.  403.239  Submittal of material to retain certification.

    (a) CMS certification of a policy that continues to meet the 
standards will remain in effect, if the insuring organization files the 
following material with CMS no later than the date specified in 
paragraph (b) or (c) of this section--
    (1) Any changes in the material, specified in Sec.  403.232(b), that 
was submitted for previous certification.
    (2) The loss ratio supporting data specified in Sec.  403.256(b).
    (3) A signed statement in which the president of the insuring 
organization, or a designee, attests that--
    (i) The policy continues to meet the requirements specified in Sec.  
403.232(a); and
    (ii) The information submitted to CMS for review is accurate and 
complete and does not misrepresent any material fact.
    (b) Except as specified in paragraph (c) of this section, the 
insuring organization must file the material with CMS no later than June 
30 of each year. The first time the insuring organization must file the 
material is no later than June 30 of the calendar year that follows the 
year in which CMS--
    (1) Certifies a new policy; or
    (2) Certifies a policy that lost certification as provided in Sec.  
403.245.
    (c) If the loss ratio calculation period, used to calculate the 
expected loss ratio for the last actuarial certification submitted to 
CMS, ends before the June 30 date of paragraph (b) of this section, the 
insuring organization must file the material with CMS no later then the 
last day of that rate calculation period.



Sec.  403.245  Loss of certification.

    (a) A policy loses certification if--
    (1) The insuring organization withdraws the policy from the 
voluntary certification program; or
    (2) CMS determines that--
    (i) The policy fails to meet the requirements specified in Sec.  
403.232(a); or
    (ii) The insuring organization has failed to meet the requirements 
for submittal of material specified in Sec.  403.239.
    (b) If a policy loses its certification, CMS will inform all State 
Commissioners and Superintendents of Insurance of that fact.
    (c) If a policy that displays the emblem, or that has been marketed 
as a certified policy without the emblem, loses certification, the 
insuring organization must notify each holder of the policy, or of a 
certificate issued under the policy, of that fact. The notice must be in 
writing and sent by the earlier of--
    (1) The date of the first regular premium notice after the date the 
policy loses its certification; or
    (2) 60 days after the date the policy loses its certification.



Sec.  403.248  Administrative review of CMS determinations.

    (a) This section provides for administrative review if CMS 
determines--
    (1) Not to certify a policy; or
    (2) That a policy no longer meets the standards for certification.
    (b) If CMS makes a determination specified in paragraph (a) of this 
section, it will send a notice to the insuring organization containing 
the following information:
    (1) That CMS has made such a determination.
    (2) The reasons for the determination.

[[Page 64]]

    (3) That the insuring organization has 30 days from the date of the 
notice to--
    (i) Request, in writing, an administrative review of the CMS 
determination; and
    (ii) Submit additional information to CMS for review.
    (4) That, if the insuring organization requests an administrative 
review, CMS will conduct the review, as provided for in paragraph (c) of 
this section.
    (5) That, in a case involving loss of certification, the CMS 
determination will go into effect 30 days from the date of the notice, 
unless the insuring organization requests an administrative review. If 
the insuring organization requests an administrative review, the policy 
retains its certification until CMS makes a final determination.
    (c) If the insuring organization requests an administrative review, 
CMS will conduct the review as follows--
    (1) A CMS official, not involved in the initial CMS determination, 
will initiate and complete an administrative review within 90 days of 
the date of the notice provided for in paragraph (b) of this section.
    (2) The official will consider--
    (i) The original material submitted to CMS for review, as specified 
in Sec.  403.232(b) or Sec.  403.239(a); and
    (ii) Any additional information, that the insuring organization 
submits to CMS.
    (3) Within 15 days after the administrative review is completed, CMS 
will inform the insuring organization in writing of the final decision, 
with an explanation of the final decision.
    (4) If the final decision is that a policy lose its certification, 
the loss of certification will go into effect 15 days after the date of 
CMS's notice informing the insuring organization of the final decision.

         Voluntary Certification Program: Loss Ratio Provisions



Sec.  403.250  Loss ratio calculations: General provisions.

    (a) Basic formula. The expected loss ratio is calculated by 
determining the ratio of benefits to premiums.
    (b) Calculations. The insuring organization must calculate loss 
ratios according to the provisions of Sec. Sec.  403.251, 403.253, and 
403.254.



Sec.  403.251  Loss ratio date and time frame provisions.

    (a) Initial calculation date means the first date of the period that 
the insuring organization uses to calculate the policy's expected loss 
ratio.
    (1) The initial calculation date may be before, the same as, or 
after the date the insuring organization sends the policy to CMS for 
review, except--
    (2) The initial calculation date must not be earlier than January 1 
of the calendar year in which the policy is sent to CMS.
    (b) Loss ratio calculation period means the period beginning with 
the initial calculation date and ending with the last day of the period 
for which the insuring organization calculates the policy's scale of 
premiums.
    (c) To calculate ``present values'', the insuring organization may 
ignore discounting (an actuarial procedure that provides for the impact 
of a variety of factors, such as lapse of policies) for loss ratio 
calculation periods not exceeding 12 months.



Sec.  403.253  Calculation of benefits.

    (a) General provisions. (1) Except as provided for in paragraph 
(a)(2) of this section, calculate the amount of ``benefits'' by--
    (i) Adding the present values on the initial calculation date of--
    (A) Expected incurred benefits in the loss ratio calculation period, 
to--
    (B) The total policy reserve at the last day of the loss ratio 
calculation period: and
    (ii) Subtracting the total policy reserve on the initial calculation 
date from the sum of these values.
    (2) To calculate the amount of ``benefits'' in the case of community 
or pool rated individual or group policies rerated on an annual basis, 
calculate the expected incurred benefits in the loss ratio calculation 
period.
    (b) Calculation of total policy reserve--(1) Option for calculation. 
The insuring organization must calculate ``total policy reserve'' 
according to the provisions of paragraph (b) (2) or (3) of this section.

[[Page 65]]

    (2) Total policy reserve: Federal provisions. (i) ``Total policy 
reserve'' means the sum of--
    (A) Additional reserve; and
    (B) The reserve for future contingent benefits.
    (ii) Additional reserve means the amount calculated on a net level 
reserve basis, using appropriate values to account for lapse, mortality, 
morbidity, and interest, that on the valuation date represents--
    (A) The present value of expected incurred benefits over the loss 
ratio calculation period; less--
    (B) The present value of expected net premiums over the loss ratio 
calculation period.
    (iii) Net premium means the level portion of the gross premium used 
in calculating the additional reserve. On the day the policy is issued, 
the present value of the series of those portions equals the present 
value of the expected incurred claims over the period that the gross 
premiums are computed to provide coverage.
    (iv) Reserve for future contingent benefits means the amounts, not 
elsewhere included, that provide for the extension of benefits after 
insurance coverage terminates. These benefits--
    (A) Are predicated on a health condition existing on the date 
coverage ends;
    (B) Accrue after the date coverage ends; and
    (C) Are payable after the valuation date.
    (3) Total policy reserve: State provisions. ``Total policy reserve'' 
means the total policy reserve calculated according to appropriate State 
law or regulation.



Sec.  403.254  Calculation of premiums.

    (a) General provisions. To calculate the amount of ``premiums'', 
calculate the present value on the initial calculation date of expected 
earned premiums for the loss ratio calculation period.
    (b) Specific provisions. (1) Earned premium for a given period 
means--
    (i) Written premiums for the period; plus--
    (ii) The total premium reserve at the beginning of the period; 
less--
    (iii) The total premium reserve at the end of the period.
    (2) Written premiums in a period means--
    (i) Premiums collected in that period; plus--
    (ii) Premiums due and uncollected at the end of that period; less--
    (iii) Premiums due and uncollected at the beginning of that period.
    (3) Total premium reserve means the sum of--
    (i) The unearned premium reserve;
    (ii) The advance premium reserve; and
    (iii) The reserve for rate credits.
    (4) Unearned premium reserve means the portion of gross premiums due 
that provide for days of insurance coverage after the valuation date.
    (5) Advance premium reserve means premiums received by the insuring 
organization that are due after the valuation date.
    (6) Reserve for rate credits means rate credits on a group policy 
that--
    (i) Accrue by the valuation date of the policy; and
    (ii) Are paid or credited after the valuation date.



Sec.  403.256  Loss ratio supporting data.

    (a) For purposes of requesting CMS certification under Sec.  
403.232, the insuring organization must submit the following loss ratio 
data to CMS for review--
    (1) A statement of why the policy is to be considered, for purposes 
of the loss ratio standards, an individual or a group policy.
    (2) The earliest age at which policyholders can purchase the policy.
    (3) The general marketing method and the underwriting criteria used 
for the selection of applicants to whom coverage is offered.
    (4) What policies are to be included under the one policy form, by 
the dates the policies are issued.
    (5) The loss ratio calculation period.
    (6) The scale of premiums for the loss ratio calculation period.
    (7) The expected level of earned premiums in the loss ratio 
calculation period.
    (8) The expected level of incurred claims in the loss ratio 
calculation period.

[[Page 66]]

    (9) A description of how the following assumptions were used in 
calculating the loss ratio.
    (i) Morbidity.
    (ii) Mortality.
    (iii) Lapse.
    (iv) Assumed increases in the Medicare deductible.
    (v) Impact of inflation on reimbursement per service.
    (vi) Interest.
    (vii) Expected distribution, by age and sex, of persons who will 
purchase the policy in the coming year.
    (viii) Expected impact on morbidity by policy duration of--
    (A) The process used to select insureds from among those that apply 
for a policy; and
    (B) Pre-existing condition clauses in the policy.
    (b) For purposes of requesting continued CMS certification under 
Sec.  403.239(a), the insuring organization must submit the following to 
CMS--
    (1) A description of all changes in the loss ratio data, specified 
in paragraph (a) of this section, that occurred since CMS last reviewed 
the policy.
    (2) The past loss ratio experience for the policy, including the 
experience of all riders and endorsements issued under the policy. The 
loss ratio experience data must include earned premiums, incurred 
claims, and total policy reserves that the insuring organization 
calculates--
    (i) For all years of issue combined; and
    (ii) Separately for each calendar year since CMS first certified the 
policy.



Sec.  403.258  Statement of actuarial opinion.

    (a) For purposes of certification requests submitted under Sec.  
403.232(b) and subsequent review as specified in Sec.  403.239(a), 
statement of actuarial opinion means a signed declaration in which a 
qualified actuary states that the assumptions used in calculating the 
expected loss ratio are appropriate and reasonable, taking into account 
actual policy experience, if any, and reasonable expectations.
    (b) Qualified actuary means--
    (1) A member in good standing of the American Academy of Actuaries; 
or
    (2) A person who has otherwise demonstrated his or her actuarial 
competence to the satisfaction of the Commissioner or Superintendent of 
Insurance of the domiciliary State of the insuring organization.



      Subpart C_Recognition of State Reimbursement Control Systems

    Source: 51 FR 15492, Apr. 24, 1986, unless otherwise noted.



Sec.  403.300  Basis and purpose.

    (a) Basis. This subpart implements section 1886(c) of the Act, which 
authorizes payment for Medicare inpatient hospital services in 
accordance with a State's reimbursement control system rather than under 
the Medicare reimbursement principles as described in CMS's regulations 
and instructions.
    (b) Purpose. Contained in this subpart are--
    (1) The basic requirements that a State reimbursement control system 
must meet in order to be approved by CMS;
    (2) A description of CMS's review and evaluation procedures; and
    (3) The conditions that apply if the system is approved.



Sec.  403.302  Definitions.

    For purposes of this subpart--
    Chief executive officer of a State means the Governor of the State 
or the Governor's designee.
    Existing demonstration project refers to demonstration projects 
approved by CMS under the authority of section 402(a) of the Social 
Security Amendments of 1967 (42 U.S.C. 1395b-1) or section 222(a) of the 
Social Security Amendments of 1972 (42 U.S.C. 1395b-1 (note)) and in 
effect on April 20, 1983 (the date of the enactment of Pub. L. 98-21 
(Social Security Amendments of 1983)).
    Federal hospital means a hospital that is administered by, or that 
is under exclusive contract with, the Department of Defense, the 
Veterans Administration, or the Indian Health Service.
    State system or system refers to a State reimbursement control 
system that is approved by CMS under the authority of section 1886(c) of 
the Act and

[[Page 67]]

that satisfies the requirements described in this subpart.



Sec.  403.304  Minimum requirements for State systems--discretionary approval.

    (a) Discretionary approval by CMS. CMS may approve Medicare payments 
under a State system, if CMS determines that the system meets the 
requirements in paragraphs (b) and (c) of this section and, if 
applicable paragraph (d) of this section.
    (b) Requirements for State system. (1) An application for approval 
of the system must be submitted to CMS by the Chief Executive Officer of 
the State.
    (2) The State system must apply to substantially all non-Federal 
acute care hospitals in the State.
    (3) All hospitals covered by the system must have and maintain a 
utilization and quality control review agreement with a Quality 
Improvement Organization, as required under section 1866(a)(1)(F) of the 
Act and Sec.  466.78(a) of this chapter.
    (4) Federal hospitals must be excluded from the State system.
    (5) Nonacute care or specialty hospital (such as rehabilitation, 
psychiatric, or children's hospitals) may, at the option of the State, 
be excluded from the State system.
    (6) The State system must apply to at least 75 percent of all 
revenues or expenses--
    (i) For inpatient hospital services in the State; and
    (ii) For inpatient hospital services under the State's Medicaid 
plan.
    (7) Under the system, HMOs and competitive medical plans (CMPs), as 
defined by section 1876(b) of the Act and part 417 of this chapter, must 
be allowed to negotiate payment rates with hospitals.
    (8) The system must limit hospital charges for Medicare 
beneficiaries to deductibles, coinsurance or non-covered services.
    (9) Unless a waiver is granted by CMS under Sec.  489.23 of this 
chapter, the system must prohibit payment, as required under section 
1862(a)(14) of the Act and Sec.  405.310(m) of this chapter, for 
nonphysician services provided to hospital inpatients under Part B of 
Medicare.
    (10) The system must require hospitals to submit Medicare cost 
reports or approved reports in lieu of Medicare cost reports as 
required.
    (11) The system must require--
    (i) Preparation, collection, or retention by the State of reports 
(such as financial, administrative, or statistical reports) that may be 
necessary, as determined by CMS, to review and monitor the State's 
assurances; and
    (ii) Submission of the reports to CMS upon request.
    (12) The system must provide hospitals an opportunity to appeal 
errors that they believe have been made in the determination of their 
payment rates. The system, if it is prospective may not permit providers 
to file administrative appeals that would result in a retroactive 
revision of prospectively determined payment rates.
    (c) Satisfactory assurances. The State must provide to CMS 
satisfactory assurance as to the following:
    (1) The system provides for equitable treatment of hospital patients 
and hospital employees.
    (2) The system provides for equitable treatment of all entities that 
pay hospitals for inpatient hospital services, including Federal and 
State programs. Under the requirement, the following conditions must be 
met:
    (i) Both the Medicare and Medicaid programs must participate under 
the system.
    (ii) The State must assure equitable and uniform treatment under the 
system of third-party payors of inpatient hospital services in terms of 
opportunity. Equitable opportunity must include, but need not be limited 
to, participation in the system and availability of discounts. Criteria 
under which discounts are made available must be equitably and uniformly 
applied to all payors, except for discounts negotiated by HMOs and CMPs. 
Discounts available to HMOs and CMPs as result of their statutory right 
to negotiate payment rates independently of a State system, as described 
in paragraph (b)(7) of this section, need not be available to other 
payors.
    (iii) The State must assure that all third-party payors that 
participate under the system share in the system's risks and benefits.

[[Page 68]]

    (3) The amount of Medicare payments made under the system over 36-
month periods may not exceed the amount of Medicare payment that would 
otherwise have been made under the Medicare principles of reimbursement 
for Medicare items and services had the State system not been in effect. 
States must submit the assurance and supporting data as required by 
Sec.  403.320 to document that the payment limit is not exceeded. States 
that have an existing Medicare demonstration project in effect on April 
20, 1983, and that have requested approval of a State system under 
section 1886(c)(4) of the Act, may elect to have the effectiveness of 
the State system under this paragraph judged on the basis of the State 
system's rate of increase or inflation in Medicare inpatient hospital 
payments as compared to the national rate of increase or inflation for 
such payments during the three cost reporting periods of the hospitals 
in the State beginning on or after October 1, 1983.
    (d) Additional cost-effectiveness assurance. If the assurances and 
supporting data required under paragraph (c)(3) of this section are 
insufficient to provide assurance satisfactory to CMS regarding the 
cost-effectiveness of a State system, the State may additionally submit 
one of the following assurances in order to meet the cost-effectiveness 
test:
    (1) State responsibility for excess payments. The State must agree 
that each month Medicare intermediaries will disburse to the State's 
hospital Federal funds that in the aggregate equal no more than would 
have been disbursed in the absence of the State system. Any additional 
funds necessary to pay hospitals for Medicare services required by the 
State system will be paid to the intermediaries by the State. These 
additional amounts will be refunded to the State by the intermediaries 
to the extent that, in subsequent months, the State system requires a 
smaller aggregate payment for Medicare services than would have been 
paid in the absence of the State system.
    (2) Limitations on payments. (i) The State must agree that if its 
projections exceed what Medicare would pay in any particular period, the 
State and CMS will establish and agreed upon payment schedule that will 
limit payments under the State system based on a predetermined 
percentage relationship between projected State payments and what 
payments would have been under Medicare.
    (ii) If deviation from the predetermined relationship described in 
paragraph (d)(2)(i) of this section occurs, the State must further agree 
that--
    (A) Medicare payments would be capped automatically at payment 
levels based on the rates used for the Medicare prospective payment 
system and the State would be required to pay the difference to 
individual hospitals in its system; or
    (B) The State may provide by legislation or legally binding 
regulations that any reduced payments to hospitals under the system that 
result from this cost-effectiveness assurance will constitute full and 
final payment for hospital services furnished to Medicare beneficiaries 
for the period covered by these reduced payments.



Sec.  403.306  Additional requirements for State systems--mandatory approval.

    (a) General policy--(1) Mandatory approval. HFCA will approve an 
application for Medicare reimbursement under a State system if the 
system meets all of the requirements of Sec.  403.304 and of paragraph 
(b) of this section.
    (2) Exception. CMS may approve an application if the State system 
meets all of the requirements of Sec.  403.304 but only some of the 
requirements of paragraph (b) of this section.
    (b) Additional requirements--(1) Operation of system. The system 
must--
    (i) Be operated directly by the State or by entity designated under 
State law;
    (ii) Provide for payments to hospitals using a methodology under 
which--
    (A) Prospectively determined payment rates are established; and
    (B) Exceptions, adjustments, and methods for changes in methodology 
are set forth;
    (iii) Provide that a change by the State in the system that has the 
effect of materially changing payments to hospitals can take effect only 
upon 60

[[Page 69]]

days notice to CMS and to the hospitals likely to be materially affected 
by the change and upon CMS's approval of the change.
    (2) Satisfactory assurances--(i) Admissions practice. The State must 
assure that the operation of the system will not result in any change in 
hospital admission practices that result in--
    (A) A significant reduction in the proportion of patients receiving 
hospital services covered under the system who have no third-party 
coverage and who are unable to pay for hospital services;
    (B) A significant reduction in the proportion of individuals 
admitted to hospitals for inpatient hospital services for which payment 
is less, or is likely to be less, than the anticipated charges for or 
cost of the services;
    (C) A refusal to admit patients who would be expected to require 
unusually costly or prolonged treatment for reasons other than those 
related to the appropriateness of the care available at the hospital; or
    (D) A refusal to provide emergency services to any person who is in 
need of emergency services, if the hospital provides the services.
    (ii) Consultation with local government officials. The State must 
provide documentation that it has consulted with local government 
officials concerning the impact of the system on publicly owned or 
operated hospitals.



Sec.  403.308  State systems under demonstration projects--mandatory approval.

    CMS will approve an application from a State for a State system if--
    (a) The system was in effect prior to April 20, 1983 under an 
existing demonstration project; and
    (b) The minimum requirements and assurances for approval of a State 
system are met under Sec.  403.304 (b)(1)-(10) and Sec.  403.304(c), 
and, if appropriate Sec.  403.304(d).



Sec.  403.310  Reduction in payments.

    (a) General rule. If CMS determines that the satisfactory assurances 
required of a State under Sec.  403.304(c) and, if applicable, Sec.  
403.304(d) have not been met, or will not be met, with respect to any 
36-month period, CMS will reduce Medicare payments to individual 
hospitals being reimbursed under the State's system or, if applicable, 
under the Medicare payment system, in an amount equal to the amount by 
which the Medicare payments under the system exceed the amount of 
Medicare payments to such hospitals that otherwise would have been made 
not using the State system. The amount of the recoupment will include, 
when appropriate, interest charges computed in accordance with Sec.  
405.378 of this chapter.
    (b) Recoupment procedures. The amount of the overpayment will be 
recouped on a proportionate basis from each of those hospitals that 
received payments under the State system that exceeded the payments they 
would have received under the Medicare payment system. Each hospital's 
share of the aggregate excess payment will be determined on the basis of 
a comparison of the hospital's proportionate share of the aggregate 
payment received under the State system that is in excess of what the 
aggregate payment would have been under the Medicare payment system. 
Recoupments may be accomplished by a hospital's direct payment to the 
Medicare program or by offsets to future payments made to the hospital.
    (c) Alternative recoupment procedures. As an alternative to the 
recoupment procedures described in paragraph (b) of this section and 
subject to CMS's acceptance, the State may provide, by legislation or 
legally binding regulations, procedures for the recoupment of the amount 
of payments that exceed the amount of payments that otherwise would have 
been paid by Medicare if the State system had not been in effect.
    (d) Rule for existing Medicare demonstration projects. In cases of 
existing Medicare demonstration projects where the expenditure test is 
to be applied by a rate of increase factor, the amount of the excess 
payment will be determined, for the three hospital cost reporting 
periods beginning before October 1, 1986, by a comparison of the State 
system's rate of increase to the national

[[Page 70]]

rate of increase. Recoupment of excessive payments will be assessed and 
recouped as described in this section.

[51 FR 15492, Apr. 24, 1986, as amended at 61 FR 63748, Dec. 2, 1996]



Sec.  403.312  Submittal of application.

    The Chief Executive Officer of the State is responsible for--
    (a) Submittal of the application to CMS for approval; and
    (b) Supplying the assurances and necessary documentation as required 
under Sec. Sec.  403.304 through 403.308.



Sec.  403.314  Evaluation of State systems.

    CMS will evaluate all State applications for approval of State 
systems and notify the State of its determination within 60 days.



Sec.  403.316  Reconsideration of certain denied applications.

    (a) Request for reconsideration. If CMS denies an application for a 
State system, the State may request that CMS reconsider the denial if 
the State believes that its system meets all of the requirements for 
mandatory approval under Sec. Sec.  403.304 and 403.306 or, in the case 
of a State with a system operating under an existing demonstration 
project, the applicable requirements of Sec. Sec.  403.304 and 403.308.
    (b) Time limit. (1) The State must submit its request for 
reconsideration within 60 days after the date of CMS's notice that the 
application was denied.
    (2) CMS will notify the State of the results of its reconsideration 
within 60 days after it receives the request for reconsideration.



Sec.  403.318  Approval of State systems.

    (a) Approval agreement. If CMS approves a State system, a written 
agreement will be executed between CMS and the Chief Executive Officer 
of the State. The agreement must incorporate any terms of the State's 
application for approval of the system as agreed to by the parties and, 
as a minimum, must contain provisions that require the following:
    (1) The system is operated directly by the State or an entity 
designated by State law.
    (2) For purposes of the Medicare program, the State's system applies 
only to Medicare payments for inpatient, and if applicable, outpatient 
hospital services.
    (3) The system conforms to applicable Medicare law and regulations 
other than those relating to the amount of reimbursement for inpatient 
hospital services, or for inpatient and outpatient services, whichever 
the State system covers. Applicable regulations include, for example, 
those describing Medicare benefits and entitlement requirements for 
program beneficiaries, as explained in parts 406 and 409 of this 
chapter; the requirements at part 405, subpart J of this chapter 
specifying conditions of participation for hospitals; the requirements 
at part 405, subparts A, G, and S of this chapter on Medicare program 
administration; and all applicable fraud and abuse regulations contained 
in titles 42 and 45 of the CFR.
    (4) The State must obtain CMS's approval of the State's reporting 
forms and of provider cost reporting forms or other forms that have not 
been approved by CMS but that are necessary for the collection of 
required information.
    (b) Effective date. An approved State system may not be effective 
earlier than the date of the approval agreement, which may not be 
retroactive.



Sec.  403.320  CMS review and monitoring of State systems.

    (a) General rule. The State must submit an assurance and detailed 
and quantitative studies of provider cost and financial data and 
projections to support the effectiveness of its system, as required by 
paragraphs (b) and (c) of this section.
    (b) Required information. (1) Under Sec.  403.304(c)(3) an assurance 
is required that the system will not result in greater payments over a 
36-month period than would have otherwise been made under Medicare not 
using such system. If a State that has an existing demonstration project 
in effect on April 20, 1983 elects under Sec.  403.304(c)(3) to have the 
effectiveness of its system judged on the basis of a rate of increase 
factor, the State must submit an assurance that its rate of increase or 
inflation in inpatient hospital payments does not exceed, for that 
portion of the

[[Page 71]]

36-month period that is subject to this test, the national rate of 
increase or inflation in Medicare inpatient hospital payments. The 
election of the rate of increase test applies only to the three cost 
reporting periods beginning on or after October 1, 1983. At the end of 
these cost reporting periods, the State must assure, beginning with the 
first month after the expiration of the third cost reporting period 
beginning after October 1, 1983, that payments under its system will not 
exceed over the remainder of the 36-month period what Medicare payments 
would have been.
    (2) Estimates and data are required to support the State's 
assurance, required under Sec.  403.304(c)(3), that expenditures under 
the State system will not exceed what Medicare would have paid over a 
36-month period. The estimates and projections of what Medicare would 
have otherwise paid must take into account all the Medicare 
reimbursement principles in effect at the time and, for any period in 
which payments either exceed or are less than Medicare levels, the 
values of interest the Medicare Trust Fund earned, or would have earned, 
on these amounts. Upon application for approval, the State must submit 
projections for each hospital for the first 12-month period covered by 
the assurance, in both the aggregate and on a per discharge basis, of 
Medicare inpatient expenditures under Medicare principles of 
reimbursement and parallel projections of Medicare inpatient 
expenditures under the State's system and the resulting cost or savings 
to Medicare. The State must also submit separate statewide projections 
for each year of the 36-month period, in both the aggregate and on a 
weighted average discharge basis, of inpatient expenditures under the 
State system and under the Medicare principles of reimbursement.
    (3) The projection submitted under paragraph (b)(2) of this section 
must include a detailed description of the methodology and assumptions 
used to derive the expenditure amounts under both systems. In instances 
where the assumptions are different under the projections cited in 
paragraph (b)(2) of this section, the State must provide a detailed 
explanation of the reasons for the differences. At a minimum, the 
following separate data and assumptions are to be included in the 
projections for the Medicare principles and for the State's system.
    (i) The State system base year and the Medicare allowable and 
reimbursable cost of each hospital that the State used to develop the 
projections, including the amount of estimated pass through costs.
    (ii) The categories of costs that are included in the State system 
and are reimbursed differently under the State system than under the 
Medicare system.
    (iii) The number of Medicare and total base year discharges and 
admissions for each hospital.
    (iv) The rate of change factor (and the method of application of 
this factor) used to project the base year costs over the 36-month 
period to which the assurance would apply.
    (v) Any allowance for anticipated growth in the amount of services 
from the base year (if applicable, the allowance must be presented in 
separate estimates for population increases or for increases in rates of 
admissions or both).
    (vi) Any adjustment in which the State is permitted by CMS to take 
into account previous reductions in the Medicare payment amounts that 
were the result of the effectiveness of the State's system even though 
Medicare was not a part of that system.
    (vii) Appropriate recognition and projection of the time value of 
trust fund expenditures for the period the State system expenditures 
were either less than or exceeded the Medicare system payments.
    (viii) States applying under a rate of increase effectiveness test 
under Sec.  403.304(c)(3) must also submit data projecting the parallel 
rates of increase during the requisite period.
    (4) The projections must include both the aggregate payments and the 
payments per discharge for the individual hospitals and for the State as 
a whole.
    (5) On a case-by-case basis. CMS may require additional data and 
documentation as needed to complete its review and monitoring.
    (6) For existing Medicare demonstration projects in effect on April 
20, 1983,

[[Page 72]]

the assurance and data as required by paragraphs (a) and (b) of this 
section, if appropriate, may be based on aggregate payments or payments 
per inpatient admission or discharge. CMS will judge the effectiveness 
of these systems on the basis of the rate of increase or inflation in 
Medicare inpatient hospital payments compared to the national rate of 
increase or inflation for such payments during the State's hospitals' 
three cost reporting periods beginning on or after October 1, 1983. The 
data submitted by the State for the period subject to the rate of 
increase test must include the rate of increase projection for that 
particular period of time. For the subsequent period of time, the State 
must assure that payments under its system will not exceed what Medicare 
payments would have been, as described in Sec.  403.304(c)(3).
    (7) If the amount of Medicare payments under the State system 
exceeds what would have been paid under the Medicare reimbursement 
principles in any given year, the State must also submit quantitative 
evidence that the system will result in expenditures that do not exceed 
what Medicare expenditures would have been over the 36 month period 
beginning with the first month that the State system is operating. For a 
State that has an existing demonstration project in effect on April 20, 
1983, and that elects under Sec.  403.304(c)(3) to have a rate of 
increase test apply, if the State's rate of increase or inflation 
exceeds the national rate of increase or inflation in a given year, the 
State must submit quantitative evidence that, over 36 months, its 
payments will not exceed the national rate of increase or inflation. 
Furthermore, if payments under the State's system must be compared to 
actual Medicare expenditures, at the end of the third cost reporting 
period, as described in paragraph (b)(1) of this section, and payments 
under the State's system exceed what Medicare would have paid in a given 
year, the State must submit quantitative evidence that, over 36 months, 
payments under its system will not exceed what Medicare would have paid.
    (c) Review of assurances regarding expenditures. CMS will review the 
State's assurances and data submitted under this section, as a 
prerequisite to the approval of the State's system. CMS will compare the 
State's projections of payment amounts to CMS data in order to determine 
if the State's assurance is reasonable and fully supportable. If the CMS 
data indicate that the State's system would result in payment amounts 
that would be more then that which would have been paid under the 
Medicare principles, the State's assurances would not be acceptable. For 
States applying in accordance with Sec.  403.308, if CMS data indicate 
that the State's system would result in a rate of increase or inflation 
that would be more than the national rate of increase or inflation, the 
State's assurances would not be acceptable.
    (d) Medicaid upper limit. In accordance with Sec.  447.253 of this 
chapter, the State system may not result in aggregate payments for 
Medicaid inpatient hospital services that would exceed the amount that 
would have otherwise have been paid under the Medicare principles as 
applied through the State system.
    (e) Monitoring of Medicare expenditures. CMS will monitor on a 
quarterly basis expenditures under the State's system as compared to 
what Medicare expenditures would have been if the system had not been in 
effect. If CMS determines at any time that the payments made under the 
State's system exceed the States' projections, as established by the 
satisfactory assurances required under Sec.  403.304(c) and, if 
appropriate, the predetermined percentage relationship of the payments 
as required under Sec.  403.304(d). CMS will--
    (1) Conclude that payments under the State system over a 36-month 
period will exceed what Medicare would have paid:
    (2) Terminate the waiver; and
    (3) Recoup overpayments to the affected hospitals in accordance with 
the procedures described in Sec.  403.310.



Sec.  403.321  State systems for hospital outpatient services.

    CMS may approve a State's application for approval of an outpatient 
system if the following conditions are met:

[[Page 73]]

    (a) The State's inpatient system is approved.
    (b) The State's outpatient application meets the requirements and 
assurances for an inpatient system described in Sec. Sec.  403.304 (b) 
and (c), and 403.306 (b)(1) and (b)(2)(ii).
    (c) The State submits a separate application that provides separate 
assurances and estimates and data in further support of its assurance 
submitted under paragraph (b)(1) of Sec.  403.320, as follows:
    (1) Upon application for approval, the State must submit estimates 
and data that include, but are not limited to, projections for the first 
12-month period covered by the assurance for each hospital, in both the 
aggregate and on an average cost per service and payment basis, of 
Medicare outpatient expenditures under Medicare principles of 
reimbursement; parallel projections of Medicare outpatient expenditures 
under the State system; and the resulting cost or savings to Medicare 
independent of the State system for hospital inpatient services.
    (2) The State must submit separate statewide projections for each 
year of the 36-month period of the aggregate outpatient expenditures for 
each system. The projections submitted under this paragraph must--
    (i) Comply with the requirements of paragraphs (b) (3) and (5) of 
Sec.  403.320 regarding a detailed description of the methodology used 
to derive the expenditure amounts:
    (ii) Include the data and assumptions set forth in paragraphs (b)(3) 
(i), (ii), (iii), (iv), and (v) of Sec.  403.320; and
    (iii) Include any assumption the State has adopted for establishing 
the number of Medicare and total base year outpatient services for each 
hospital.
    (3) The State must provide a detailed explanation of the reasons for 
any difference between the data or assumptions used for the separate 
projections.



Sec.  403.322  Termination of agreements for Medicare recognition 
of State systems.

    (a) Termination of agreements. (1) CMS may terminate any approved 
agreement if it finds, after the procedures described in this paragraph 
are followed that the State system does not satisfactorily meet the 
requirements of section 1886(c) of the Act or the regulations in this 
subpart. A termination must be effective on the last day of a calendar 
quarter.
    (2) CMS will give the State reasonable notice of the proposed 
termination of an agreement and of the reasons for the termination at 
least 90 days before the effective date of the termination.
    (3) CMS will give the State the opportunity to present evidence to 
refute the finding.
    (4) CMS will issue a final notice of termination upon a final review 
and determination on the State's evidence.
    (b) Termination by State. A State may voluntarily terminate a State 
system by giving CMS notice of its intent to terminate. A termination 
must be effective on the last day of a calendar quarter. The State must 
notify CMS of its intent to terminate at least 90 days before the 
effective date of the termination.

Subparts D--F [Reserved]



   Subpart G_Religious Nonmedical Health Care Institutions_Benefits, 
                Conditions of Participation, and Payment

    Source: 64 FR 67047, Nov. 30, 1999, unless otherwise noted.



Sec.  403.700  Basis and purpose.

    This subpart implements sections 1821; 1861(e), (y), and (ss); 1869; 
and 1878 of the Act regarding Medicare payment for inpatient hospital or 
posthospital extended care services furnished to eligible beneficiaries 
in religious nonmedical health care institutions.



Sec.  403.702  Definitions and terms.

    For purposes of this subpart, the following definitions and terms 
apply:
    Election means a written statement signed by the beneficiary or the 
beneficiary's legal representative indicating the beneficiary's choice 
to receive nonmedical care or treatment for religious reasons.
    Excepted medical care means medical care that is received 
involuntarily or required under Federal, State, or local laws.

[[Page 74]]

    FFY stands for Federal fiscal year.
    Medical care or treatment means health care furnished by or under 
the direction of a licensed physician that can involve diagnosing, 
treating, or preventing disease and other damage to the mind and body. 
It may involve the use of pharmaceuticals, diet, exercise, surgical 
intervention, and technical procedures.
    Nonexcepted medical care means medical care (other than excepted 
medical care) that is sought by or for a beneficiary who has elected 
religious nonmedical health care institution services.
    Religious nonmedical care or religious method of healing means 
health care furnished under established religious tenets that prohibit 
conventional or unconventional medical care for the treatment of a 
beneficiary, and the sole reliance on these religious tenets to fulfill 
a beneficiary's total health care needs.
    RNHCI stands for ``religious nonmedical health care institution,'' 
as defined in section 1861(ss)(1) of the Act.
    Religious nonmedical nursing personnel means individuals who are 
grounded in the religious beliefs of the RNHCI, trained and experienced 
in the principles of nonmedical care, and formally recognized as 
competent in the administration of care within their religious 
nonmedical health care group.



Sec.  403.720  Conditions for coverage.

    Medicare covers services furnished in an RNHCI if the following 
conditions are met:
    (a) The provider meets the definition of an RNHCI as defined in 
section 1861(ss)(1) of the Act. That is, it is an institution that:
    (1) Is described in section 501(c)(3) of the Internal Revenue Code 
of 1986 and is exempt from taxes under section 501(a).
    (2) Is lawfully operated under all applicable Federal, State, and 
local laws and regulations.
    (3) Furnishes only nonmedical nursing items and services to 
beneficiaries who choose to rely solely upon a religious method of 
healing and for whom the acceptance of medical services would be 
inconsistent with their religious beliefs.
    (4) Furnishes nonmedical items and services exclusively through 
nonmedical nursing personnel who are experienced in caring for the 
physical needs of nonmedical patients.
    (5) Furnishes nonmedical items and services to inpatients on a 24-
hour basis.
    (6) Does not furnish, on the basis of religious beliefs, through its 
personnel or otherwise medical items and services (including any medical 
screening, examination, diagnosis, prognosis, treatment, or the 
administration of drugs) for its patients.
    (7) Is not owned by, is not under common ownership with, or does not 
have an ownership interest of 5 percent or more in, a provider of 
medical treatment or services and is not affiliated with a provider of 
medical treatment or services or with an individual who has an ownership 
interest of 5 percent or more in, a provider of medical treatment or 
services. (Permissible affiliations are described at Sec.  403.738(c).)
    (8) Has in effect a utilization review plan that sets forth the 
following:
    (i) Provides for review of the admissions to the institution, the 
duration of stays, and the need for continuous extended duration of 
stays in the institution, and the items and services furnished by the 
institution.
    (ii) Requires that reviews be made by an appropriate committee of 
the institution that included the individuals responsible for overall 
administration and for supervision of nursing personnel at the 
institution.
    (iii) Provides that records be maintained of the meetings, 
decisions, and actions of the review committee.
    (iv) Meets other requirements as the Secretary finds necessary to 
establish an effective utilization review plan.
    (9) Provides information CMS may require to implement section 1821 
of the Act, including information relating to quality of care and 
coverage decisions.
    (10) Meets other requirements CMS finds necessary in the interest of 
the health and safety of the patients who receive services in the 
institution. These requirements are the conditions of participation in 
this subpart.
    (b) The provider meets the conditions of participation cited in 
Sec. Sec.  403.730

[[Page 75]]

through 403.746. (A provider may be deemed to meet conditions of 
participation in accordance with part 488 of this chapter.)
    (c) The provider has a valid provider agreement as a hospital with 
CMS in accordance with part 489 of this chapter and for payment purposes 
is classified as an extended care hospital.
    (d) The beneficiary has a condition that would make him or her 
eligible to receive services covered under Medicare Part A as an 
inpatient in a hospital or SNF.
    (e) The beneficiary has a valid election as described in Sec.  
403.724 in effect for Medicare covered services furnished in an RNHCI.



Sec.  403.724  Valid election requirements.

    (a) General requirements. An election statement must be made by the 
Medicare beneficiary or his or her legal representative.
    (1) The election must be a written statement that must include the 
following statements:
    (i) The beneficiary is conscientiously opposed to acceptance of 
nonexcepted medical treatment.
    (ii) The beneficiary acknowledges that the acceptance of nonexcepted 
medical treatment is inconsistent with his or her sincere religious 
beliefs.
    (iii) The beneficiary acknowledges that the receipt of nonexcepted 
medical treatment constitutes a revocation of the election and may limit 
further receipt of services in an RNHCI.
    (iv) The beneficiary acknowledges that the election may be revoked 
by submitting a written statement to CMS.
    (v) The beneficiary acknowledges that revocation of the election 
will not prevent or delay access to medical services available under 
Medicare Part A in facilities other than RNHCIs.
    (2) The election must be signed and dated by the beneficiary or his 
or her legal representative.
    (3) The election must be notarized.
    (4) The RNHCI must keep a copy of the election statement on file and 
submit the original to CMS with any information obtained regarding prior 
elections or revocations.
    (5) The election becomes effective on the date it is signed.
    (6) The election remains in effect until revoked.
    (b) Revocation of election. (1) A beneficiary's election is revoked 
by one of the following:
    (i) The beneficiary receives nonexcepted medical treatment for which 
Medicare payment is requested.
    (ii) The beneficiary voluntarily revokes the election and notifies 
CMS in writing.
    (2) The receipt of excepted medical treatment as defined in Sec.  
403.702 does not revoke the election made by a beneficiary.
    (c) Limitation on subsequent elections. (1) If a beneficiary's 
election has been made and revoked twice, the following limitations on 
subsequent elections apply:
    (i) The third election is not effective until 1 year after the date 
of the most recent revocation.
    (ii) Any succeeding elections are not effective until 5 years after 
the date of the most recent revocation.
    (2) CMS will not accept as the basis for payment of any claim any 
elections executed on or after January 1 of the calendar year in which 
the sunset provision described in Sec.  403.756 becomes effective.



Sec.  403.730  Condition of participation: Patient rights.

    An RNHCI must protect and promote each patient's rights.
    (a) Standard: Notice of rights. The RNHCI must do the following:
    (1) Inform each patient of his or her rights in advance of 
furnishing patient care.
    (2) Have a process for prompt resolution of grievances, including a 
specific person within the facility whom a patient may contact to file a 
grievance. In addition, the facility must provide patients with 
information about the facility's process as well as with contact 
information for appropriate State and Federal resources.
    (b) Standard: Exercise of rights. The patient has the right to:
    (1) Be informed of his or her rights and to participate in the 
development and implementation of his or her plan of care.

[[Page 76]]

    (2) Make decisions regarding his or her care, including transfer and 
discharge from the RNHCI. (See Sec.  403.736 for discharge and transfer 
requirements.)
    (3) Formulate advance directives and expect staff who furnish care 
in the RNHCI to comply with those directives, in accordance with part 
489, subpart I of this chapter. For purposes of conforming with the 
requirement in Sec.  489.102 that there be documentation in the 
patient's medical records concerning advanced directives, the patient 
care records of a beneficiary in an RNHCI are equivalent to medical 
records held by other providers.
    (c) Standard: Privacy and safety. The patient has the right to the 
following:
    (1) Personal privacy.
    (2) Care in a safe setting.
    (3) Freedom from verbal, psychological, and physical abuse, and 
misappropriation of property.
    (4) Freedom from the use of restraints.
    (5) Freedom from involuntary seclusion.
    (d) Standard: Confidentiality of patient records. For any patient 
care records or election information it maintains on patients, the RNHCI 
must establish procedures to do the following:
    (1) Safeguard the privacy of any information that identifies a 
particular patient. Information from, or copies of, records may be 
released only to authorized individuals, and the RNHCI must ensure that 
unauthorized individuals cannot gain access to or alter patient records. 
Original patient care records must be released only in accordance with 
Federal or State laws, court orders, or subpoenas.
    (2) Maintain the records and information in an accurate and timely 
manner.
    (3) Ensure timely access by patients to the records and other 
information that pertains to that patient.
    (4) Abide by all Federal and State laws regarding confidentiality 
and disclosure for patient care records and election information.



Sec.  403.732  Condition of participation: Quality assessment 
and performance improvement.

    The RNHCI must develop, implement, and maintain a quality assessment 
and performance improvement program.
    (a) Standard: Program scope. (1) The quality assessment and 
performance improvement program must include, but is not limited to, 
measures to evaluate:
    (i) Access to care.
    (ii) Patient satisfaction.
    (iii) Staff performance.
    (iv) Complaints and grievances.
    (v) Discharge planning activities.
    (vi) Safety issues, including physical environment.
    (2) In each of the areas listed in paragraph (a)(1) of this section, 
and any other areas the RNHCI includes, the RNHCI must do the following:
    (i) Define quality assessment and performance improvement measures.
    (ii) Describe and outline quality assessment and performance 
improvement activities appropriate for the services furnished by or in 
the RNHCI.
    (iii) Measure, analyze, and track performance that reflect care and 
RNHCI processes.
    (iv) Inform all patients, in writing, of the scope and 
responsibilities of the quality assessment and performance improvement 
program.
    (3) The RNHCI must set priorities for performance improvement, 
considering the prevalence of and severity of identified problems.
    (4) The RNHCI must act to make performance improvements and must 
track performance to assure that improvements are sustained.
    (b) Standard: Program responsibilities. (1) The governing body, 
administration, and staff are responsible for ensuring that the quality 
assessment and performance improvement program addresses identified 
priorities in the RNHCI and are responsible for the development, 
implementation, maintenance, and performance improvement of assessment 
actions.
    (2) The RNHCI must include all programs, departments, functions, and 
contracted services when developing, implementing, maintaining, and 
evaluating the program of quality assessment and performance 
improvement.

[[Page 77]]



Sec.  403.734  Condition of participation: Food services.

    The RNHCI must have an organized food service that is directed and 
adequately staffed by qualified personnel.
    (a) Standard: Sanitary conditions. The RNHCI must furnish food to 
the patient that is obtained, stored, prepared, distributed, and served 
under sanitary conditions.
    (b) Standard: Meals. The RNHCI must serve meals that furnish each 
patient with adequate nourishment in accordance with the recommended 
dietary allowances of the Food and Nutrition Board of the National 
Research Council, National Academy of Sciences. The RNHCI must do the 
following:
    (1) Furnish food that is palatable, attractive, and at the proper 
temperature and consistency.
    (2) Offer substitutes of similar nourishment to patients who refuse 
food served or desire alternative choices.
    (3) Furnish meals at regular times comparable to normal mealtimes in 
the community. There must be no more than 14 hours between a substantial 
evening meal and breakfast the following day.
    (4) The RNHCI must offer snacks at bedtime.



Sec.  403.736  Condition of participation: Discharge planning.

    (a) Discharge planning and instructions. The RNHCI must have in 
effect a discharge planning process that applies to all patients. The 
process must assure that appropriate post-institution services are 
obtained for each patient, as necessary. The RNHCI must assess the need 
for a discharge plan for any patient likely to suffer adverse 
consequences if there is no planning.
    (1) Discharge instructions must be provided at the time of discharge 
to the patient or the patient's caregiver as necessary.
    (2) If the patient assessment indicates a need for a discharge plan, 
the discharge plan must include instructions on post-RNHCI care to be 
used by the patient or the caregiver in the patient's home, as 
identified in the discharge plan.
    (3) If the RNHCI's patient assessment does not indicate a need for a 
discharge plan, the beneficiary or his or her legal representative may 
request a discharge plan. In this case, the RNHCI must develop a 
discharge plan for the beneficiary.
    (b) Standard: Transfer or referral. The RNHCI must transfer or refer 
patients in a timely manner to another facility (including a medical 
facility if requested by the beneficiary, or his or her legal 
representative) in accordance with Sec.  403.730(b)(2).
    (c) Standard: Reassessment. The RNHCI must reassess its discharge 
planning process on an ongoing basis. The reassessment must include a 
review of discharge plans to ensure that they are responsive to 
discharge needs.

[64 FR 67047, Nov. 30, 1999, as amended at 68 FR 66720, Nov. 28, 2003; 
84 FR 51813, Sept. 30, 2019]



Sec.  403.738  Condition of participation: Administration.

    An RNHCI must have written policies regarding its organization, 
services, and administration.
    (a) Standard: Compliance with Federal, State, and local laws. The 
RNHCI must operate in compliance with all applicable Federal, State, and 
local laws, regulations, and codes including, but not limited to, those 
pertaining to the following:
    (1) Protection against discrimination on the basis of race, color, 
national origin, age, or handicap (45 CFR parts 80, 84, and 91).
    (2) Protection of human research subjects (45 CFR part 46).
    (3) Application of all safeguards to protect against the possibility 
of fraud and abuse (42 CFR part 455).
    (4) Privacy of individually identifiable health information (45 CFR 
part 164).
    (b) Standard: Governing body. (1) The RNHCI must have a governing 
body, or a person designated to function as a governing body, that is 
legally responsible for establishing and implementing all policies 
regarding the RNHCI's management and operation.
    (2) The governing body must appoint the administrator responsible 
for the management of the RNHCI.
    (c) Standard: Affiliations and disclosure. (1) An affiliation is 
permissible if it is between one of the following:

[[Page 78]]

    (i) An individual serving as an uncompensated director, trustee, 
officer, or other member of the governing body of an RNHCI and a 
provider of medical treatment or services.
    (ii) An individual who is a director, trustee, officer, employee, or 
staff member of an RNHCI and another individual, with whom he or she has 
a family relationship, who is affiliated with (or has an ownership 
interest in) a provider of medical treatment or services.
    (iii) The RNHCI and an individual or entity furnishing goods or 
services as a vendor to both providers of medical treatment or services 
and RNHCIs.
    (2) The RNHCI complies with the disclosure requirements of 
Sec. Sec.  420.206 and 455.104 of this chapter.
    (3) The RNHCI furnishes written notice, including the identity of 
each new individual or company, to CMS at the time of a change, if a 
change occurs in any of the following:
    (i) Persons with an ownership or control interest, as defined in 
Sec. Sec.  420.201 and 455.101 of this chapter.
    (ii) The officers, directors, agents, or managing employees.
    (iii) The religious entity, corporation, association, or other 
company responsible for the management of the RNHCI.
    (iv) The RNHCI's administrator or director of nonmedical nursing 
services.

[64 FR 67047, Nov. 30, 1999, as amended at 68 FR 66720, Nov. 28, 2003]



Sec.  403.740  Condition of participation: Staffing.

    The RNHCI must be staffed with qualified experienced personnel who 
are present in sufficient numbers to meet the needs of the patients.
    (a) Standard: Personnel qualifications. The RNHCI must ensure that 
staff who supervise or furnish services to patients are qualified to do 
so and that staff allowed to practice without direct supervision have 
specific training to furnish these services.
    (b) Standard: Education, training, and performance evaluation. (1) 
The RNHCI must ensure that staff (including contractors and other 
individuals working under arrangement) have the necessary education and 
training concerning their duties so that they can furnish services 
competently. This education includes, but is not limited to, training 
related to the individual job description, performance expectations, 
applicable organizational policies and procedures, and safety 
responsibilities.
    (2) Staff must demonstrate, in practice, the skills and techniques 
necessary to perform their duties and responsibilities.
    (3) The RNHCI must evaluate the performance of staff and implement 
measures for improvement.



Sec.  403.742  Condition of participation: Physical environment.

    A RNHCI must be designed, constructed, and maintained to ensure the 
safety of the patients, staff, and the public.
    (a) Standard: Buildings. The physical plant and the overall 
environment must be maintained in a manner that ensures the safety and 
well-being of the patients. The RNHCI must have the following:
    (1) Procedures for the proper storage and disposal of trash.
    (2) Proper ventilation and temperature control and appropriate 
lighting levels to ensure a safe and secure environment.
    (3) An effective pest control program.
    (4) A preventive maintenance program to maintain essential 
mechanical, electrical, and fire protection equipment operating in an 
efficient and safe manner.
    (5) A working call system for patients to summon aid or assistance.
    (b) Standard: Patient rooms. Patient rooms must be designed and 
equipped for adequate care, comfort, and privacy of the patient.
    (1) Patient rooms must meet the following conditions:
    (i) Accommodate no more than four patients.
    (ii) Measure at least 80 square feet per patient in multiple patient 
rooms and at least 100 square feet in single patient rooms.
    (iii) Have direct access to an exit corridor.
    (iv) Be designed or equipped to assure full visual privacy for each 
patient.
    (v) Have at least one window to the outside.
    (vi) Have a floor at or above grade level.

[[Page 79]]

    (2) The RNHCI must furnish each patient with the following:
    (i) A separate bed of proper size and height for the convenience of 
the patient.
    (ii) A clean, comfortable mattress.
    (iii) Bedding appropriate to the weather and climate.
    (iv) Functional furniture appropriate to the patient's needs and 
individual closet space with clothes racks and shelves accessible to the 
patient.
    (3) CMS may permit variances in requirements specified in paragraphs 
(b)(1)(i) and (ii) of this section relating to rooms on an individual 
basis when the RNHCI adequately demonstrates in writing that the 
variances meet the following:
    (i) Are in accordance with the special needs of the patients.
    (ii) Will not adversely affect patients' health and safety.

[64 FR 67047, Nov. 30, 1999, as amended at 81 FR 64021, Sept. 16, 2016]



Sec.  403.744  Condition of participation: Life safety from fire.

    (a) General. An RNHCI must meet the following conditions:
    (1) Except as otherwise provided in this section--
    (i) The RNHCI must meet the applicable provisions and must proceed 
in accordance with the Life Safety Code (NFPA 101 and Tentative Interim 
Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4).
    (ii) Notwithstanding paragraph (a)(1)(i) of this section, corridor 
doors and doors to rooms containing flammable or combustible materials 
must be provided with positive latching hardware. Roller latches are 
prohibited on such doors.
    (2) The RNHCI must have written fire control plans that contain 
provisions for prompt reporting of fires; extinguishing fires; 
protection of patients, staff, and the public; evacuation; and 
cooperation with fire fighting authorities.
    (3) The RNHCI must maintain written evidence of regular inspection 
and approval by State or local fire control agencies.
    (4) The RNHCI may place alcohol-based hand rub dispensers in its 
facility if the dispensers are installed in a manner that adequately 
protects against inappropriate access.
    (5) When a sprinkler system is shut down for more than 10 hours the 
RHNCI must:
    (i) Evacuate the building or portion of the building affected by the 
system outage until the system is back in service, or
    (ii) Establish a fire watch until the system is back in service.
    (6) Building must have an outside window or outside door in every 
sleeping room, and for any building constructed after July 5, 2016 the 
sill height must not exceed 36 inches above the floor. Windows in atrium 
walls are considered outside windows for the purposes of this 
requirement.
    (b) Exceptions. (1) In consideration of a recommendation by the 
State survey agency or Accrediting Organization, or at the discretion of 
the Secretary, may waive, for periods deemed appropriate, specific 
provisions of the Life Safety Code, which would result in unreasonable 
hardship upon a RNHCI facility, but only if the waiver will not 
adversely affect the health and safety of the patients.
    (2) If CMS finds that the fire and safety code imposed by State law 
adequately protects patients in the institution, the provisions of the 
Life Safety Code required in paragraph (a)(1) of this section do not 
apply in that State.
    (c) The standards incorporated by reference in this section are 
approved for incorporation by reference by the Director of the Office of 
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 
51. You may inspect a copy at the CMS Information Resource Center, 7500 
Security Boulevard, Baltimore, MD or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal _regulations/ibr_ 
locations.html. If any changes in this edition of the Code are 
incorporated by reference, CMS will publish a document in the Federal 
Register to announce the changes.
    (1) National Fire Protection Association, 1 Batterymarch Park, 
Quincy, MA 02169, www.nfpa.org, 1.617.770.3000.

[[Page 80]]

    (i) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 
2011;
    (ii) TIA 12-1 to NFPA 101, issued August 11, 2011.
    (iii) TIA 12-2 to NFPA 101, issued October 30, 2012.
    (iv) TIA 12-3 to NFPA 101, issued October 22, 2013.
    (v) TIA 12-4 to NFPA 101, issued October 22, 2013.
    (2) [Reserved]

[64 FR 67047, Nov. 30, 1999, as amended at 68 FR 1385, Jan. 10, 2003; 69 
FR 18803, Apr. 9, 2004; 69 FR 49240, Aug. 11, 2004; 70 FR 15237, Mar. 
25, 2005; 70 FR 71007, Nov. 25, 2005; 71 FR 55339, Sept. 22, 2006; 81 FR 
26896, May 4, 2016]



Sec.  403.745  Condition of participation: Building safety.

    (a) Standard: Building Safety. Except as otherwise provided in this 
section the RNHCI must meet the applicable provisions and must proceed 
in accordance with the Health Care Facilities Code (NFPA 99 and 
Tentative Interim Amendments TIA 12-2, TIA 12-3, TIA 12-4, TIA 12-5 and 
TIA 12-6).
    (b) Standard: Exceptions. Chapters 7, 8, 12, and 13 of the adopted 
Health Care Facilities Code do not apply to a RNHCI.
    (c) Waiver. If application of the Health Care Facilities Code 
required under paragraph (a) of this section would result in 
unreasonable hardship for the RNHCI, CMS may waive specific provisions 
of the Health Care Facilities Code, but only if the waiver does not 
adversely affect the health and safety of individuals.
    (d) Incorporation by reference. The standards incorporated by 
reference in this section are approved for incorporation by reference by 
the Director of the Office of the Federal Register in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. You may inspect a copy at the CMS 
Information Resource Center, 7500 Security Boulevard, Baltimore, MD or 
at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html. If any changes in this 
edition of the Code are incorporated by reference, CMS will publish a 
document in the Federal Register to announce the changes.
    (1) National Fire Protection Association, 1 Batterymarch Park, 
Quincy, MA 02169, www.nfpa.org, 1.617.770.3000.
    (i) NFPA 99, Standards for Health Care Facilities Code of the 
National Fire Protection Association 99, 2012 edition, issued August 11, 
2011.
    (ii) TIA 12-2 to NFPA 99, issued August 11, 2011.
    (iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
    (iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
    (v) TIA 12-5 to NFPA 99, issued August 1, 2013.
    (vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
    (2) [Reserved]

[81 FR 26896, May 4, 2016]



Sec.  403.746  Condition of participation: Utilization review.

    The RNHCI must have in effect a written utilization review plan to 
assess the necessity of services furnished. The plan must provide that 
records be maintained of all meetings, decisions, and actions by the 
utilization review committee.
    (a) Standard: Utilization review plan. The utilization review plan 
must contain written procedures for evaluating the following:
    (1) Admissions.
    (2) Duration of care.
    (3) Continuing care of an extended duration.
    (4) Items and services furnished.
    (b) Standard: Utilization review committee. The committee is 
responsible for evaluating each admission and ensuring that the 
admission is necessary and appropriate. The utilization review plan must 
be carried out by the utilization review committee, consisting of the 
governing body, administrator or other individual responsible for the 
overall administration of the RNHCI, the supervisor of nursing staff, 
and other staff as appropriate.
    (c) Standard: Utilization review committee role in RNHCI home 
services. In addition to the requirements in paragraphs (a) and (b) of 
this section, the utilization review committee is responsible for:

[[Page 81]]

    (1) The admission, and at least every 30 days, the continued care 
review of each patient in the RHNCI home services program.
    (2) Oversight and monitoring of the home services program, including 
the purchase and utilization of designated durable medical equipment 
items for beneficiaries in the program.

[64 FR 67047, Nov. 30, 1999, as amended at 69 FR 66419, Nov. 15, 2004]



Sec.  403.748  Condition of participation: Emergency preparedness.

    The Religious Nonmedical Health Care Institution (RNHCI) must comply 
with all applicable Federal, State, and local emergency preparedness 
requirements. The RNHCI must establish and maintain an emergency 
preparedness program that meets the requirements of this section. The 
emergency preparedness program must include, but not be limited to, the 
following elements:
    (a) Emergency plan. The RNHCI must develop and maintain an emergency 
preparedness plan that must be reviewed, and updated at least every 2 
years. The plan must do all of the following:
    (1) Be based on and include a documented, facility-based and 
community-based risk assessment, utilizing an all-hazards approach.
    (2) Include strategies for addressing emergency events identified by 
the risk assessment.
    (3) Address patient population, including, but not limited to, 
persons at-risk; the type of services the RNHCI has the ability to 
provide in an emergency; and, continuity of operations, including 
delegations of authority and succession plans.
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation.
    (b) Policies and procedures. The RNHCI must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least every 2 years. At a minimum, the policies 
and procedures must address the following:
    (1) The provision of subsistence needs for staff and patients, 
whether they evacuate or shelter in place, include, but are not limited 
to the following:
    (i) Food, water, and supplies.
    (ii) Alternate sources of energy to maintain the following:
    (A) Temperatures to protect patient health and safety and for the 
safe and sanitary storage of provisions.
    (B) Emergency lighting.
    (C) Fire detection, extinguishing, and alarm systems.
    (D) Sewage and waste disposal.
    (2) A system to track the location of on-duty staff and sheltered 
patients in the RNHCI's care during an emergency. If on-duty staff and 
sheltered patients are relocated during the emergency, the RNCHI must 
document the specific name and location of the receiving facility or 
other location.
    (3) Safe evacuation from the RNHCI, which includes the following:
    (i) Consideration of care needs of evacuees.
    (ii) Staff responsibilities.
    (iii) Transportation.
    (iv) Identification of evacuation location(s).
    (v) Primary and alternate means of communication with external 
sources of assistance.
    (4) A means to shelter in place for patients, staff, and volunteers 
who remain in the facility.
    (5) A system of care documentation that does the following:
    (i) Preserves patient information.
    (ii) Protects confidentiality of patient information.
    (iii) Secures and maintains the availability of records.
    (6) The use of volunteers in an emergency and other emergency 
staffing strategies to address surge needs during an emergency.
    (7) The development of arrangements with other RNHCIs and other 
providers to receive patients in the event of limitations or cessation 
of operations to maintain the continuity of nonmedical services to RNHCI 
patients.

[[Page 82]]

    (8) The role of the RNHCI under a waiver declared by the Secretary, 
in accordance with section 1135 of Act, in the provision of care at an 
alternate care site identified by emergency management officials.
    (c) Communication plan. The RNHCI must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least every 2 
years. The communication plan must include all of the following:
    (1) Names and contact information for the following:
    (i) Staff.
    (ii) Entities providing services under arrangement.
    (iii) Next of kin, guardian or custodian.
    (iv) Other RNHCIs.
    (v) Volunteers.
    (2) Contact information for the following:
    (i) Federal, State, tribal, regional, and local emergency 
preparedness staff.
    (ii) Other sources of assistance.
    (3) Primary and alternate means for communicating with the 
following:
    (i) RNHCI's staff.
    (ii) Federal, State, tribal, regional, and local emergency 
management agencies.
    (4) A method for sharing information and care documentation for 
patients under the RNHCI's care, as necessary, with care providers to 
maintain the continuity of care, based on the written election statement 
made by the patient or his or her legal representative.
    (5) A means, in the event of an evacuation, to release patient 
information as permitted under 45 CFR 164.510(b)(1)(ii).
    (6) A means of providing information about the general condition and 
location of patients under the facility's care as permitted under 45 CFR 
164.510(b)(4).
    (7) A means of providing information about the RNHCI's occupancy, 
needs, and its ability to provide assistance, to the authority having 
jurisdiction, the Incident Command Center, or designee.
    (d) Training and testing. The RNHCI must develop and maintain an 
emergency preparedness training and testing program that is based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least every 2 years.
    (1) Training program. The RNHCI must do all of the following:
    (i) Initial training in emergency preparedness policies and 
procedures to all new and existing staff, individuals providing services 
under arrangement, and volunteers, consistent with their expected roles.
    (ii) Provide emergency preparedness training at least every 2 years.
    (iii) Maintain documentation of all emergency preparedness training.
    (iv) Demonstrate staff knowledge of emergency procedures.
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the RNHCI must conduct training on the updated 
policies and procedures.
    (2) Testing. The RNHCI must conduct exercises to test the emergency 
plan. The RNHCI must do the following:
    (i) Conduct a paper-based, tabletop exercise at least annually. A 
tabletop exercise is a group discussion led by a facilitator, using a 
narrated, clinically-relevant emergency scenario, and a set of problem 
statements, directed messages, or prepared questions designed to 
challenge an emergency plan.
    (ii) Analyze the RNHCI's response to and maintain documentation of 
all tabletop exercises, and emergency events, and revise the RNHCI's 
emergency plan, as needed.

[81 FR 64021, Sept. 16, 2016, as amended at 84 FR 51813, Sept. 30, 2019]



Sec.  403.750  Estimate of expenditures and adjustments.

    (a) Estimates. CMS estimates the level of expenditures for services 
provided under this subpart before the start of each FFY beginning with 
FFY 2000.
    (b) Adjustments to payments. When the level of estimated 
expenditures is projected to exceed the FFY trigger level as described 
in paragraph (d) of this section, for the year of the projection, 
payments to RNHCIs will be reduced by

[[Page 83]]

a proportional percentage to prevent estimated expenditures from 
exceeding the trigger level. In addition to reducing payments 
proportionally, CMS may impose alternative adjustments.
    (c) Notification of adjustments. CMS notifies participating RNHCIs 
before the start of the FFY of the type and level of expenditure 
reductions to be made and when these adjustments will apply.
    (d) Calculation of trigger level. The trigger level for FFY 1998 is 
$20,000,000. For subsequent FFYs, the trigger level is the unadjusted 
trigger level increased or decreased by the carry forward as described 
in Sec.  403.754(b). The unadjusted trigger level is the base year 
amount (the unadjusted trigger level dollar amount for the prior FFY) 
increased by the average consumer price index (the single numerical 
value published monthly by the Bureau of Labor Statistics that presents 
the relationship in United States urban areas for the current cost of 
goods and services compared to a base year, to represent the change in 
spending power) for the 12-month period ending on July 31 preceding the 
beginning of the FFY.



Sec.  403.752  Payment provisions.

    (a) Payment to RNHCIs. Payment for services may be made to an RNHCI 
that meets the conditions for coverage described in Sec.  403.720 and 
the conditions of participation described in Sec. Sec.  403.730 through 
403.746. Payment is made in accordance with Sec.  413.40 of this chapter 
to an RNHCI meeting these conditions.
    (b) Review of estimates and adjustments. There is no administrative 
or judicial review of the level of estimated expenditures or the 
adjustments in payments described in Sec.  403.750(a) and (b).
    (c) Effect on beneficiary liability. When payments are reduced in 
accordance with Sec.  403.750(b), the RNHCI may bill the beneficiary the 
amount of the Medicare reduction attributable to his or her covered 
services.
    (d) Notification of beneficiary liability. (1) The RNHCI must notify 
the beneficiary in writing at the time of admission of any proposed or 
current proportional Medicare adjustment. A beneficiary currently 
receiving care in the RNHCI must be notified in writing at least 30 days 
before the Medicare reduction is to take effect. The notification must 
inform the beneficiary that the RNHCI can bill him or her for the 
proportional Medicare adjustment.
    (2) The RNHCI must, at time of billing, provide the beneficiary with 
his or her liability for payment, based on a calculation of the Medicare 
reduction pertaining to the beneficiary's covered services permitted by 
Sec.  403.750(b).



Sec.  403.754  Monitoring expenditure level.

    (a) Tracking expenditures. Starting in FFY 1999 CMS begins 
monitoring Medicare payments to RNHCIs.
    (b) Carry forward. The difference between the trigger level and 
Medicare expenditures for a FFY results in a carry forward that either 
increases or decreases the unadjusted trigger level described in Sec.  
403.750(d). In no case may the carry forward exceed $50,000,000 for an 
FFY.



Sec.  403.756  Sunset provision.

    (a) Effective date. Beginning with FFY 2002, if the level of 
estimated expenditures for all RNHCIs exceeds the trigger level for 3 
consecutive FFYs, CMS will not accept as the basis for payment of any 
claim any election executed on or after January 1 of the following 
calendar year.
    (b) Notice of activation. A notice in the Federal Register will be 
published at least 60 days before January 1 of the calendar year that 
the sunset provision becomes effective.
    (c) Effects of sunset provision. Only those beneficiaries who have a 
valid election in effect before January 1 of the year in which the 
sunset provision becomes effective will be able to claim Medicare 
payment for care in an RNHCI, and only for RNCHI services furnished 
during that election.



Sec.  403.764  Basis and purpose of religious nonmedical health care 
institutions providing home service.

    (a) Basis. This subpart implements sections 1821, 1861, 1861(e), 
1861(m), 1861(y), 1861(ss) and 1861(aaa), 1869 and 1878 of the Act 
regarding Medicare payment for items and services provided in the home 
setting furnished to eligible

[[Page 84]]

beneficiaries by religious nonmedical health care institutions (RNHCIs).
    (b) Purpose. The home benefit provides for limited durable medical 
equipment (DME) items and RNHCI services in the home setting that are 
fiscally limited to $700,000 per calendar year, with an expiration date 
of December 31, 2006, or the date on which the 2006 spending limit is 
reached.

[69 FR 66419, Nov. 15, 2004]



Sec.  403.766  Requirements for coverage and payment of RNHCI home services.

    (a) Medicare Part A pays for RNHCI home services if the RNHCI 
provider does the following:
    (1) Submit a notice of intent to CMS to exercise the option of 
providing home service.
    (2) Provide RNHCI services to eligible beneficiaries,
    (3) Arrange with suppliers to furnish appropriate DME items as 
required to meet documented eligible beneficiary needs.
    (4) Arrange for RNHCI nurse home visits to eligible beneficiaries.
    (5) Have a utilization committee that assumes the additional 
responsibility for the oversight and monitoring of the items and RNHCI 
nursing services provided under the home benefit.
    (6) Meet all applicable requirements set forth in subpart G of this 
part.
    (b) To be an eligible beneficiary to RNHCI home services the 
beneficiary must:
    (1) Have an effective election in place.
    (2) Be confined to the home, as specified in Sec.  409.42(a) of this 
chapter.
    (3) Have a condition that makes him or her eligible to receive 
services covered under Medicare home health.
    (4) Receive home services and DME items from a RNHCI.
    (5) Be responsible for deductible and coinsurance for DME, as 
specified in Sec.  409.50 of this chapter.

[69 FR 66419, Nov. 15, 2004, as amended at 70 FR 16721, Apr. 1, 2005]



Sec.  403.768  Excluded services.

    In addition to items and services excluded in Sec.  409.49 of this 
chapter, items and services are also excluded if they are provided by:
    (a) A HHA that is not a RNHCI.
    (b) A supplier who is not providing RNHCI designated items under 
arrangement with a RNHCI.
    (c) A nurse who is not providing RNHCI home nursing services under 
arrangement with a RNHCI.

[69 FR 66419, Nov. 15, 2004]



Sec.  403.770  Payments for home services.

    (a) The RNHCI nursing visits are paid at the modified low 
utilization payment adjusted (LUPA) rate used under the home health 
prospective payment system at Sec.  484.230 of this chapter.
    (b) Appropriate DME items are paid as priced by Medicare, minus the 
deductible and coinsurance liability of the beneficiary.

[69 FR 66419, Nov. 15, 2004]



  Subpart H_Medicare Prescription Drug Discount Card and Transitional 
                           Assistance Program

    Source: 68 FR 69915, Dec. 15, 2003, unless otherwise noted.



Sec.  403.800  Basis and scope.

    (a) Basis. This subpart is based on section 1860D-31 of the Social 
Security Act (the Act).
    (b) Scope. This subpart sets forth the standards and procedures CMS 
uses to implement the Medicare Prescription Drug Discount Card and 
Transitional Assistance Program.



Sec.  403.802  Definitions.

    For purposes of this subpart, the following definitions apply:
    Affiliated organization means an organization that is a legally 
separate entity from the endorsed drug card sponsor and meets one of the 
following conditions:
    (1) The organization and the endorsed drug card sponsor are under 
common control. Common control exists if another entity has the power, 
directly or indirectly, to significantly influence or direct the actions 
or policies of the organization and the endorsed drug card sponsor.
    (2) The organization is under the control of the endorsed drug card 
sponsor

[[Page 85]]

or the organization controls the endorsed drug card sponsor. Control 
exists if an entity has the power, directly or indirectly, to 
significantly influence or direct the actions or policies of another 
entity.
    (3) The organization possesses an ownership or equity interest of 5 
percent or more in the endorsed drug card sponsor on both the date on 
which the endorsed drug card sponsor markets the organization's Part D 
plan, and the date on which the endorsed drug card sponsor signed its 
endorsement contract with CMS.
    Annual coordinated election period means the period beginning on 
November 15, 2004 and ending on December 31, 2004, during which a 
discount card enrollee may elect to disenroll from their current 
endorsed discount card program and elect enrollment in another endorsed 
discount card program effective January 1, 2005.
    Applicant means the non-governmental, single legal organization or 
entity doing business in the United States that is applying for Medicare 
endorsement of its prescription drug discount card program, as described 
in its application, to be operated by itself or in coordination with 
subcontractors.
    Application means the document submitted to CMS by an applicant that 
seeks to demonstrate the applicant's compliance with the requirements 
specified in this subpart in order to obtain Medicare endorsement of the 
applicant's prescription drug discount card program.
    Authorized representative means a person with legal authority to act 
on behalf of an individual in making decisions related to the 
individual's health care or the individual's enrollment in, 
disenrollment from, and access to negotiated prices and transitional 
assistance under the Medicare Prescription Drug Discount Card and 
Transitional Assistance Program.
    Covered discount card drug means any of the following: a drug that 
may be dispensed only upon a prescription and that is described in 
sections 1927(k)(2)(A)(i) through (iii) of the Act; a biological product 
described in sections 1927(k)(2)(B)(i) through (iii) of the Act; insulin 
described in section 1927(k)(2)(C) of the Act; the following medical 
supplies associated with the injection of insulin: syringes, needles, 
alcohol swabs, and gauze; a vaccine licensed under section 351 of the 
Public Health Service Act; or any use of a covered discount card drug 
for a medically accepted indication (as defined in section 1927(k)(6) of 
the Act). The definition of covered discount card drug excludes the 
following: agents when used for anorexia, weight loss, or weight gain; 
agents when used to promote fertility; agents when used for cosmetic 
purposes or hair growth; agents when used for the symptomatic relief of 
cough and colds; prescription vitamins and mineral products, except 
prenatal vitamins and fluoride preparations; nonprescription drugs; 
outpatient drugs for which the manufacturer seeks to require that 
associated tests or monitoring services be purchased exclusively from 
the manufacturer or its designee as a condition of sale; barbiturates; 
and benzodiazepines.
    Discount card enrollee or enrollee or card enrollee means an 
individual described in Sec.  403.810(a) who elects to enroll in a 
Medicare-endorsed prescription drug discount card program.
    Effective date means the date on which an enrollment or 
disenrollment transaction becomes effective.
    Enrollment period means the period beginning on the initial 
enrollment date and ending on December 31, 2005.
    Exclusive card program means an endorsed discount card program that 
is offered by an exclusive card sponsor.
    Exclusive card sponsor means an endorsed sponsor that also operates 
one or more Medicare managed care plans and limits enrollment in its 
endorsed discount card program to individuals described in Sec.  
403.810(a) who are enrollees in one of the Medicare managed care plans 
it offers.
    Family size means one for individuals who are single, and two for 
individuals who are married.
    Federal Employee's Health Benefits Program plan means a plan under 
chapter 89 of title 5 of the United States Code including the Retired 
Federal Employee's Health Benefits Program.
    Formulary means the list of specific drugs from among covered 
discount card drugs for which an endorsed sponsor offers negotiated 
prices to Medicare

[[Page 86]]

beneficiaries enrolled in its Medicare-endorsed prescription drug 
discount card program.
    Group enrollment means simultaneous enrollment of all or some of the 
individuals described in section 403.810(a) who are members of a 
Medicare managed care plan into the exclusive card program offered by 
the Medicare managed care organization.
    HIPAA means the Health Insurance Portability and Accountability Act 
of 1996, 42 U.S.C. 1320d and section 264 of Public Law 104-191.
    Income means the components of an individual's adjusted gross income 
(AGI), as defined under 26 U.S.C. section 62, and, to the extent not 
included in the components of AGI, retirement and disability benefits, 
or, if he or she is married, the sum of such income for the individual 
and his or her spouse.
    Initial enrollment date means the date established by the Secretary 
on which endorsed sponsors may begin accepting beneficiaries' standard 
enrollment forms.
    Initial enrollment year means the period beginning on the initial 
enrollment date and ending on December 31, 2004.
    I/T/U pharmacy means a pharmacy operated by the Indian Health 
Service, an Indian tribe or tribal organization, or an urban Indian 
organization, all of which are defined in section 4 of the Indian Health 
Care Improvement Act, 25 U.S.C. 1603.
    Long-term care facility means a skilled nursing facility, as defined 
in section 1819(a) of the Act, or nursing facility, as defined in 
section 1919(a) of the Act.
    Long-term care pharmacy means a pharmacy owned by or under contract 
with a long-term care facility to provide prescription drugs to the 
facility's residents.
    Medicare cost plan means an organization that offers enrollment 
under a reasonable cost reimbursement contract under section 1876(h) of 
the Act.
    Medicare managed care organization means a Part C organization 
offering a Part C plan described in section 1851(a)(2)(A) of the Act or 
a Medicare cost plan.
    Medicare managed care plan means a plan described in section 
1851(a)(2)(A) of the Act offered by a Part C organization or a Medicare 
cost plan.
    Medicare Prescription Drug Discount Card and Transitional Assistance 
Program or Medicare Drug Discount Card Program means the program 
established under section 1860D-31 of the Act.
    Medicare-endorsed prescription drug discount card program, or 
endorsed program, or endorsed discount card program means any 
prescription drug discount card program that has received Medicare 
endorsement and whose endorsed sponsor has entered into a contract with 
CMS.
    Medicare-endorsed prescription drug discount card sponsor, or 
endorsed sponsor, or endorsed discount card sponsor means any applicant 
that has received endorsement from Medicare and entered into a contract 
with CMS to operate an approved Medicare-endorsed discount card program.
    Negotiated price means the discounted price for a covered discount 
card drug offered by an endorsed sponsor, including any dispensing fee, 
which takes into account negotiated price concessions, such as 
discounts, direct or indirect subsidies, rebates, and direct or indirect 
remunerations.
    Network pharmacy means a licensed pharmacy that is not a mail order 
pharmacy and that is under contract with an endorsed sponsor to provide 
negotiated prices to its card enrollees and accept transitional 
assistance as payment for covered discount card drugs provided to its 
transitional assistance enrollees.
    New Medicare managed care organization means an entity applying for 
approval to enter into a new contract with CMS to offer a new, 
coordinated care plan or plans as described in section 1851(a)(2)(A) of 
the Act under Medicare Part C and an exclusive card program under the 
Medicare Drug Discount Card Program.
    Over-the-counter drug means a non-prescription drug.
    Part C organization means an organization offering a Part C plan.
    Part C plan means a plan described in section 1859(b)(1) of the Act.
    Part D plan has the meaning given the term at Sec.  423.4.

[[Page 87]]

    Pharmacy network means the group of network pharmacies under 
contract with an endorsed sponsor.
    Poverty line means the income level defined in section 673(2) of the 
Community Services Block Grant Act, 42 U.S.C. 9902(2), including any 
revision required by such section, applicable to the family size 
involved.
    Rural means a five-digit zip code in which the population density is 
less than 1000 persons per square mile.
    Second enrollment year means the period beginning on January 1, 2005 
and ending on December 31, 2005.
    Solicitation means the application materials identified in the 
notice CMS publishes in the Federal Register announcing its intention to 
accept and consider applications from applicants seeking Medicare 
endorsement for their prescription drug discount card programs.
    Special election period means the period beginning the day after the 
effective date of an individual's disenrollment from an endorsed 
discount card program for one of the reasons listed in Sec.  
403.811(b)(2). The length of any given election period will be specified 
by CMS in a form and manner that supports the goals of the Medicare Drug 
Discount Card Program.
    Special endorsed sponsor means an endorsed sponsor who has received 
special endorsement by CMS.
    Special endorsement means an endorsement granted under Sec.  403.816 
or Sec.  403.817.
    Standard enrollment form means an enrollment form or other approved 
process for enrolling individuals into an endorsed program that 
incorporates the standard elements provided by CMS.
    Subcontractor means an organization or entity doing business in the 
United States with which an applicant or endorsed sponsor enters into a 
contract or other legal arrangement in connection with the operation of 
a prescription drug discount card program.
    Suburban means a five-digit zip code in which the population density 
is between 1000 and 3000 persons per square mile.
    Transition period means the period beginning on January 1, 2006 and 
ending, for individuals enrolled for coverage under Part D, on the 
effective date of the individual's coverage, and for individuals not so 
enrolled, on the last day of the initial Part D open enrollment period.
    Transitional assistance means a subsidy that transitional assistance 
enrollees may apply toward the cost of covered discount card drugs in 
the manner described in Sec.  403.808(d).
    Transitional assistance effective date means the date on which a 
transitional assistance enrollee can access transitional assistance.
    Transitional assistance enrollee means an individual described in 
Sec.  403.810(b) who has applied for and been determined eligible for 
transitional assistance and has enrolled in a discount card program.
    Urban means a five-digit zip code in which the population density is 
greater than 3000 persons per square mile.

[68 FR 69915, Dec. 15, 2003, as amended at 70 FR 52022, Sept. 1, 2005]



Sec.  403.804  General rules for solicitation, application and Medicare 
endorsement period.

    (a) Application. (1) Except as provided in paragraph (a)(2) of this 
section, an applicant must submit an application to CMS by the deadline 
announced in the solicitation to be eligible for Medicare endorsement of 
its prescription drug discount card program. The applicant must certify 
that based on best knowledge, information, and belief, the reported 
information is accurate, complete, truthful, and supportable.
    (2) A new Medicare managed care organization may simultaneously 
apply to offer a new Part C plan or plans and an exclusive card program 
after the deadline announced in the solicitation. New Medicare managed 
care organizations seeking endorsement of their prescription drug 
discount card programs must submit an application to CMS at the time 
that they submit their Part C applications. New Medicare managed care 
organizations will be eligible for endorsement provided CMS approves 
their Part C application, the new Medicare managed care organizations 
demonstrate to CMS that they meet the criteria under paragraph (b) of 
this section, and the new Medicare managed care organizations 
demonstrate that

[[Page 88]]

they will meet the requirements of paragraph (e)(2) of this section.
    (b) Eligibility to receive endorsement. Except as specified in 
Sec. Sec.  403.814, 403.816 and 403.817, an applicant will be eligible 
for endorsement if its application demonstrates to CMS's satisfaction 
that the applicant meets the requirements of Sec.  403.806(a) and Sec.  
403.806(b)(1) and that it would operate its endorsed program in a manner 
consistent with the requirements of Sec.  403.806(b)(2) and (b)(3) 
through Sec.  403.806(m). An applicant that submits a complete 
application that meets all of the requirements of this subpart will be 
eligible to enter into a contract with CMS to operate a Medicare-
endorsed prescription drug discount card program. Following the receipt 
of its Medicare endorsement, an endorsed sponsor must comply with the 
requirements of Sec.  403.806(b)(2) and (b)(3) through Sec.  403.806(m) 
through the end of the transition period.
    (c) Ability to subcontract with other organizations and entities. 
(1) An applicant for endorsement may demonstrate that it meets the 
requirements of this subpart by combining with subcontractors.
    (2) Any subcontracts must be in final form satisfactory to CMS, 
signed by all applicable parties, and filed with CMS before an endorsed 
sponsor will be permitted to engage in any enrollment or information and 
outreach.
    (3) Once endorsed, an endorsed sponsor must ensure that its 
subcontractors comply with all applicable requirements of this subpart.
    (d) Period of endorsement. An applicant eligible to receive 
endorsement will be required to sign a contract with CMS agreeing to 
operate its approved Medicare-endorsed prescription drug discount card 
program(s) until the end of the transition period.
    (e)(1) Except as provided in paragraph (e)(2) of this section, we 
expect an endorsed sponsor to be ready by June 8, 2004, to initiate 
enrollment and fully operate its endorsed program in compliance with the 
requirements of Sec.  403.806(b)(2) and (b)(3) through Sec.  403.806(m).
    (2) A new Medicare managed care organization must be ready to 
initiate enrollment and fully operate its exclusive card program in 
compliance with the requirements of Sec. Sec.  403.806(b)(2) and (b)(3) 
through Sec.  403.806(m) upon approval of its Part C application and 
application for Medicare endorsement of its prescription drug discount 
card program.



Sec.  403.806  Sponsor requirements for eligibility for endorsement.

    Except as specified in Sec. Sec.  403.814, 403.816, and 403.817, an 
endorsed sponsor must meet the following requirements:
    (a) Applicant experience. (1) An applicant must be a non-
governmental, single legal entity doing business in the United States.
    (2) An applicant must have 3 years of private sector experience in 
the United States in pharmacy benefit management, which is defined to 
mean--
    (i) Adjudicating and processing claims for drugs at the point of 
sale;
    (ii) Negotiating with prescription drug manufacturers and others for 
discounts, rebates, and/or other price concessions on prescription 
drugs; and
    (iii) Administering and tracking individuals' subsidies or benefits 
in real time.
    (3) A single legal entity which is either the applicant or a 
subcontractor must, at the time of application for Medicare endorsement, 
operate a pharmacy benefit program, a prescription drug discount card 
program, a low-income drug assistance program, or a similar program that 
serves at least 1 million covered lives.
    (b) Financial stability and business integrity. (1) An applicant 
must demonstrate a satisfactory record of the financial stability and 
business integrity of itself, any subcontractors on whom the applicant 
relies to satisfy the 3 years experience requirement in paragraph (a)(2) 
of this section and the 1 million covered lives requirement in paragraph 
(a)(3) of this section, and any subcontractors engaged by the applicant 
to perform the following activities: develop the pharmacy network; 
negotiate with manufacturers or pharmacies for rebates, discounts, or 
other price concessions; handle eligibility for or enrollment in the 
endorsed sponsor's endorsed discount card program and/or transitional 
assistance; and administer transitional assistance.

[[Page 89]]

    (2) An endorsed sponsor and any subcontractors described in 
paragraph (b)(1) of this section must maintain a satisfactory record of 
financial stability and business integrity during the term of the 
endorsed program.
    (3) Medicare endorsement of a discount card program shall not be 
construed to express or imply any opinion that an endorsed sponsor or 
any subcontractor of an endorsed sponsor is in compliance with or not 
liable under the False Claims Act, anti-kickback statute (section 
1128B(b) of the Act), or other legal authorities for any improper 
billing, claims submission, or related conduct.
    (c) Compliance with applicable law. An endorsed sponsor must comply 
with all applicable Federal and State laws, including the Federal anti-
kickback statute (section 1128B(b) of the Act).
    (d) Prescription drug offering. An endorsed sponsor must comply with 
the following discount, rebate, and formulary requirements:
    (1) Offer all of its discount card enrollees negotiated prices on 
covered discount card drugs, which may be limited to those covered 
discount card drugs included on the endorsed sponsor's formulary.
    (2) If the endorsed sponsor uses a formulary, offer a negotiated 
price on at least one covered discount card drug in each of the lowest 
level categories for each of the therapeutic groups representing the 
drugs most commonly needed by Medicare beneficiaries as determined by 
CMS. A specific covered discount card drug may not be used to fulfill 
this requirement for more than one category.
    (3) Offer a negotiated price on a generic drug in at least 55 
percent of the lowest level categories in each of the therapeutic groups 
representing the drugs most commonly needed by Medicare beneficiaries as 
determined by CMS.
    (4) In setting negotiated prices under this section, an endorsed 
sponsor may vary its prices and the drugs included on the formulary by 
pharmacy contract and enrollee characteristics, such as transitional 
assistance eligibility status.
    (5) Synchronize changes in the list of, and negotiated prices for, 
covered discount card drugs included in the endorsed sponsor's formulary 
with formulary and negotiated prices published on a price comparison Web 
site, as described in paragraph (i)(4)(v) of this section.
    (6) Obtain rebates, discounts, or other price concessions from 
manufacturers on covered discount card drugs and pass a share of such 
concessions to enrollees through negotiated prices.
    (7) Guarantee that network and mail order pharmacies provide the 
lower of the negotiated price or usual and customary price when a 
covered discount card drug for a negotiated price is available at the 
point of sale.
    (8) Guarantee that a network pharmacy, at the point of sale, inform 
a discount card enrollee of any differential between the price of a 
prescribed drug (if it is a covered discount card drug) and the price of 
the lowest priced generic covered discount card drug that is 
therapeutically equivalent and bioequivalent and available at such 
pharmacy. Mail order pharmacies are to provide this information at the 
time of delivery of the drug.
    (9) Except during the week of November 15, 2004 (which coincides 
with the beginning of the annual coordinated election period), ensure 
that any increase in the negotiated price for a covered discount card 
drug does not exceed an amount proportionate to the change in the drug's 
average wholesale price (AWP), and/or an amount proportionate to the 
changes in the endorsed sponsor's cost structure, including material 
changes to any discounts, rebates, or other price concessions the 
endorsed sponsor receives from a pharmaceutical manufacturer or 
pharmacy.
    (e) Transitional assistance administration. An endorsed sponsor must 
administer transitional assistance funds, including any roll-over funds 
as described in Sec.  403.808(f), for transitional assistance enrollees, 
through the following procedures:
    (1) Establish accounting procedures to manage the transitional 
assistance funds for each transitional assistance enrollee.
    (2) Ensure that transitional assistance funds are applicable to, and 
only to, all covered discount card drugs

[[Page 90]]

available at the endorsed sponsors' network and mail order pharmacies, 
regardless of formulary.
    (3) Ensure that, at network and mail order pharmacies, transitional 
assistance funds are applied at the lower of negotiated price (if any) 
and the pharmacy's usual and customary price.
    (4) Ensure that network pharmacies make available to the 
transitional assistance enrollee, electronically or by telephone, at the 
point-of-sale of covered discount card drugs, the amount of transitional 
assistance remaining available to the transitional assistance enrollee. 
Mail order pharmacies are to make this information available by 
telephone.
    (5) Maintain a toll-free telephone number that discount card 
enrollees may use to determine their transitional assistance balances.
    (6) Enforce coinsurance requirements described in Sec.  403.808(e) 
and ensure that the portion of the price paid through coinsurance is not 
deducted from the total transitional assistance funds available to the 
discount card enrollee.
    (f) Service area and pharmacy access. An endorsed sponsor must meet 
the following requirements for its service area and its pharmacy 
network:
    (1) The service area must cover one or more States.
    (2) The endorsed sponsor's discount card program must be available 
to all eligible individuals residing in each State in the endorsed 
sponsor's service area and may not be offered to individuals residing 
outside of the United States.
    (3) The endorsed sponsor must have a contracted pharmacy network, 
consisting of pharmacies other than mail-order pharmacies, sufficient to 
ensure that for beneficiaries residing in the endorsed sponsor's service 
area the following requirements are satisfied:
    (i) At least 90 percent of Medicare beneficiaries, on average, in 
urban areas served by the endorsed program, live within 2 miles of a 
network pharmacy;
    (ii) At least 90 percent of Medicare beneficiaries, on average, in 
suburban areas served by the endorsed program, live within 5 miles of a 
network pharmacy; and
    (iii) At least 70 percent of Medicare beneficiaries, on average, in 
rural areas served by the endorsed program, live within 15 miles of a 
network pharmacy.
    (4) The endorsed sponsor's pharmacy network may be supplemented by 
pharmacies offering home delivery via mail-order, provided the 
requirements of paragraph (f)(3) of this section are met.
    (g) Information and outreach and customer service. (1) An endorsed 
sponsor must provide through the Internet and some other tangible medium 
(such as a mailing) to Medicare beneficiaries information and outreach 
materials describing its endorsed drug card program, including the 
following information--
    (i) The enrollment fee;
    (ii) Negotiated prices offered for covered discount card drugs;
    (iii) If offered, discounts on over-the-counter drugs;
    (iv) Any other products or services offered under the endorsement; 
and
    (v) Any other information that CMS determines is necessary for a 
full description of the endorsed discount drug card program.
    (2) An endorsed sponsor must include on a Web site the following:
    (i) Information regarding when the Web site was last updated; and
    (ii) A disclaimer that the information on the Web site may not be 
current.
    (3) An endorsed sponsor must use the following forms which 
incorporate standard elements provided by CMS:
    (i) An enrollment form (except as may be modified for an exclusive 
card sponsor as discussed in Sec.  403.814(b)(5)(iii); and
    (ii) An eligibility determination notice.
    (4) An endorsed sponsor must provide to each enrollee a card that 
complies with National Council for Prescription Drug Programs standards.
    (5) An endorsed sponsor must meet the following requirements for the 
review and approval of information and outreach materials:
    (i) Comply with the Information and Outreach Guidelines published by 
CMS except as provided in paragraph (g)(5)(vi) of this section.

[[Page 91]]

    (ii) Except as provided in paragraph (g)(5)(iii) of this section, 
not distribute any information and outreach materials until or unless 
they are approved by CMS.
    (iii) If CMS does not disapprove the initial submission of 
information and outreach materials within 30 days of receipt of these 
materials, the materials are deemed approved under paragraph (g)(5)(ii) 
of this section.
    (iv) Information and outreach materials may discuss only products or 
services inside the scope of endorsement, as described in paragraph (h) 
of this section.
    (v) Information and outreach materials include the same kinds of 
materials described in 42 CFR 422.80(b), as well as the enrollment form, 
eligibility determination form, and membership card described in 
paragraphs (g)(3) and (g)(4) of this section, Web site content, and 
information regarding discounts for over-the-counter drugs.
    (vi) All materials related to products and services that are Part D 
plans must comply with the requirements specified in Sec.  423.50 of 
this chapter.
    (6) An endorsed sponsor must maintain a toll-free customer call 
center that is open during usual business hours and that provides 
customer telephone service, including to pharmacists, in accordance with 
standard business practices. The endorsed sponsor must inform enrollees 
that the toll-free telephone number provides information on the amount 
of remaining transitional assistance, in accordance with paragraph 
(e)(5) of this section.
    (7) An endorsed sponsor must provide a system to reduce the 
likelihood of medical errors and adverse drug interactions and to 
improve medication use.
    (h) Products and services inside and outside the scope of the 
endorsement. (1) An endorsed sponsor may provide, under the endorsement, 
only those products and services inside the scope of the endorsement, 
including conducting enrollment. An endorsed sponsor must ensure that 
discount card enrollees are not charged any additional fee (other than 
the enrollment fee allowed under Sec.  403.811(c)) for products or 
services inside the scope of the endorsement.
    (2) Products and services inside the scope of the endorsement are 
limited to--
    (i) Products or services offered for no additional fee, other than 
the enrollment fee allowed under Sec.  403.811(c), that are directly 
related to a covered discount card drug; or
    (ii) A discounted price for an over-the-counter drug.
    (i) Reporting. (1) An endorsed sponsor must report to CMS on a 
periodic basis information on the major features of the endorsed 
sponsor's programs that correspond to the qualifications for 
endorsement, including, but not limited to, information concerning--
    (i) Savings from pharmacies and manufacturers obtained through 
rebates, discounts, and other price concessions;
    (ii) Savings shared with discount card enrollees by manufacturer, by 
all retail pharmacies, by all mail order pharmacies, and by all brand 
name and all generic covered discount card drugs;
    (iii) Dispensing fees;
    (iv) Certified (by the chief financial officer) financial accounting 
records on transitional assistance used by the transitional assistance 
enrollees in each month;
    (v) Participant utilization and spending statements;
    (vi) Utilization and spending for selected drugs;
    (vii) Performance on customer service metrics such as call center 
performance;
    (viii) Grievance logs; and
    (ix) Endorsed sponsor's compliance with the pharmacy network access 
standards.
    (2) An endorsed sponsor must provide notice of, and the rationale 
for, negotiated price increases, except for increases during the week of 
November 15, 2004, due to reasons other than changes in average 
wholesale price (AWP).
    (3) An endorsed sponsor must certify that based on best knowledge, 
information, and belief, the reported information is accurate, complete, 
truthful, and supportable.
    (4) Through a price comparison Web site, an endorsed sponsor must 
report the following information:
    (i) Customer service hours;

[[Page 92]]

    (ii) Customer service contact information;
    (iii) Endorsed program Web site address;
    (iv) Annual enrollment fee; and
    (v) Negotiated prices (including any applicable dispensing fee), for 
every covered discount card drug included in the discount card program's 
offering.
    (5) CMS may require endorsed sponsors to submit, in standard 
terminology, descriptions of other discount card related services they 
provide, such as pharmacist services.
    (j) Grievance process. An endorsed sponsor must establish and 
maintain a grievance process. This process must be designed to track and 
appropriately address in a timely manner enrollees' complaints about any 
aspect of their endorsed program for which the endorsed sponsor is 
responsible.
    (k) Eligibility, enrollment, and disenrollment. (1) An endorsed 
sponsor must make preliminary eligibility determinations in accordance 
with Sec.  403.810 and conduct enrollment and disenrollment in 
accordance with Sec.  403.811.
    (l) Authorized representative. An endorsed sponsor must treat an 
individual's authorized representative as the individual, if under 
applicable law, the authorized representative has the legal authority to 
act on behalf of the individual with respect to the action at issue.
    (m) Other. An endorsed sponsor must meet the requirements of 
Sec. Sec.  403.812, 403.813, and 403.822 of this subpart.

[68 FR 69915, Dec. 15, 2003, as amended at 70 FR 52023, Sept. 1, 2005]



Sec.  403.808  Use of transitional assistance funds.

    (a) Individuals determined eligible for transitional assistance in 
2004. Subject to paragraph (d) of this section, an individual who, in 
calendar year 2004, is determined eligible for transitional assistance 
under Sec.  403.810(b) is entitled to the following:
    (1) $600 in calendar year 2004; and
    (2) $600 in calendar year 2005.
    (b) Individuals determined eligible for transitional assistance in 
2005. Subject to paragraph (d) of this section, an individual who, in 
calendar year 2005, is determined eligible for transitional assistance 
under Sec.  403.810(b) is entitled to one of the following amounts for 
calendar year 2005:
    (1) If the complete application for the individual's transitional 
assistance eligibility is received on or after January 1, 2005 and 
before April 1, 2005, $600.
    (2) If the complete application for the individual's transitional 
assistance eligibility is received on or after April 1, 2005 and before 
July 1, 2005, $450.
    (3) If the complete application for the individual's transitional 
assistance eligibility is received on or after July 1, 2005 and before 
October 1, 2005, $300.
    (4) If the complete application for the individual's transitional 
assistance eligibility is received on or after October 1, 2005 and on or 
before December 31, 2005, $150.
    (c) Payment of enrollment fee. An individual found eligible for 
transitional assistance is entitled to have CMS pay the annual 
enrollment fee to the endorsed sponsor on his or her behalf.
    (d) Conditions on use of transitional assistance. A transitional 
assistance enrollee may access the transitional assistance described in 
paragraphs (a) and (b) of this section only if the following conditions 
are met:
    (1) Except as provided in Sec.  403.814(b)(3)(v), the transitional 
assistance funds are applied toward the cost of a covered discount card 
drug obtained under the Medicare Prescription Drug Discount Card and 
Transitional Assistance Program;
    (2) The individual pays a coinsurance amount in accordance with 
Sec.  403.808(e);
    (3) The individual purchases the covered discount card drug on or 
after the individual's transitional assistance effective date; and
    (4) The individual is enrolled in the Medicare Prescription Drug 
Discount Card and Transitional Assistance Program on the date the 
individual's claim for the covered discount card drug is adjudicated.
    (e) Coinsurance. If sufficient transitional assistance funds are 
available, transitional assistance funds must be expended in accordance 
with the following:
    (1) For beneficiaries with incomes at or below 100 percent of the 
poverty line, 95 percent of the price of a covered discount card drug 
must be paid from

[[Page 93]]

the available transitional assistance funds.
    (2) For beneficiaries with incomes greater than 100 percent but at 
or below 135 percent of the poverty line, 90 percent of the price of a 
covered discount card drug must be paid from the available transitional 
assistance funds.
    (f) Rollover. An individual with transitional assistance retains 
access to any balance of transitional assistance not expended in a 
calendar year during the next calendar year, up to and including the 
transition period, if the individual--
    (1) Remains in his or her current endorsed discount card program;
    (2) Elects a new endorsed program in an Annual Coordinated Election 
Period; or
    (3) Is eligible for a Special Election Period under Sec.  
403.811(b)(2) and elects a new endorsed discount card program during 
such Special Election Period.



Sec.  403.810  Eligibility and reconsiderations.

    (a) Eligibility for an endorsed discount card program. An individual 
is eligible to enroll in an endorsed discount card program only if such 
individual meets the following conditions:
    (1) The individual is entitled to benefits, or enrolled, under 
Medicare Part A or enrolled under Medicare Part B; and
    (2) The individual, at the time of applying to enroll in an endorsed 
discount card program, is not enrolled in a State medical assistance 
program under Title XIX of the Act or under a waiver pursuant to section 
1115 of the Act, under which the individual is entitled to any medical 
assistance for outpatient prescribed drugs as described in section 
1905(a)(12) of the Act, except as allowed in Sec.  403.817(d).
    (b) Eligibility for transitional assistance. An individual is 
eligible to receive transitional assistance if, at the time of applying 
for transitional assistance, the individual meets the following 
conditions:
    (1) The individual meets the conditions in paragraph (a) of this 
section;
    (2) The individual resides in one of the 50 States or the District 
of Columbia;
    (3) The individual's income is not more than 135 percent of the 
poverty line applicable to the individual's family size;
    (4) The individual does not have coverage for covered discount card 
drugs under one or more of the following sources:
    (i) A group health plan or health insurance coverage, as these terms 
are defined under section 2791 of the Public Health Service Act, other 
than a Part C plan or a group health plan consisting solely of excepted 
benefits (such as a Medigap plan) as the term is defined under section 
2791 of the Public Health Service Act;
    (ii) Coverage provided under Chapter 55 of Title 10, United States 
Code, including TRICARE; or
    (iii) A Federal Employee's Health Benefits Program plan; and
    (5) The individual (or the individual's authorized representative) 
completes a standard enrollment form and signs and dates the form in 
accordance with Sec.  403.811(a)(4). By signing the form, the individual 
(or the individual's authorized representative) certifies, under penalty 
of perjury, that, to the best of the individual's knowledge, the 
information he or she provides on the form is accurate.
    (c) Special rule for QMBs, SLMBs and QIs. An individual is deemed to 
meet the income requirements in paragraph (b)(3) of this section if the 
individual is enrolled under Title XIX of the Act as a--
    (1) Qualified Medicare Beneficiary (QMB);
    (2) Specified Low-Income Medicare Beneficiary (SLMB); or
    (3) Qualified Individual (QI).
    (d) Duration of eligibility determinations. An individual determined 
eligible for the Medicare Prescription Drug Discount Card and 
Transitional Assistance Program and, in the case of transitional 
assistance enrollees, for transitional assistance, shall remain eligible 
for the Medicare Prescription Drug Discount Card and Transitional 
Assistance Program and, in the case of transitional assistance 
enrollees, for transitional assistance for the duration of the 
individual's enrollment in the Medicare Prescription Drug Discount Card 
and Transitional Assistance Program.

[[Page 94]]

    (e) Drug card and transitional assistance benefits not treated as 
benefits under other Federal programs. Any benefits received under the 
Medicare Prescription Drug Discount Card and Transitional Assistance 
Program must not be taken into account in determining an individual's 
eligibility for, or the amount of benefits under, any other Federal 
program.
    (f) Verification of eligibility. (1) CMS will verify eligibility to 
enroll in an endorsed discount card program or to receive transitional 
assistance.
    (2) If CMS is unable to verify an individual's eligibility or 
ineligibility for transitional assistance, CMS can require the 
individual to provide additional income information in a form and manner 
specified by CMS as one condition of eligibility for transitional 
assistance.
    (g) Reconsideration. (1) If an individual is determined ineligible 
to enroll in an endorsed discount card program under paragraph (a) of 
this section or determined ineligible to receive transitional assistance 
under paragraph (b) of this section, the individual (or the individual's 
authorized representative) has a right to request that an independent 
review entity under contract with CMS reconsider the determination.
    (2) Reconsideration requests must be filed within 60 days from date 
of notice of an ineligibility determination, unless the individual (or 
the individual's authorized representative) can demonstrate good cause 
for why the 60-day time frame should be extended.
    (3) An individual (or the individual's authorized representative) 
may submit additional documentary evidence or an explanation about his 
or her eligibility in writing to the independent review entity, as part 
of the reconsideration process.
    (4) Reconsideration decisions shall be issued by the independent 
review entity in writing and contain an explanation of the reasoning of 
the decision.



Sec.  403.811  Enrollment and disenrollment and associated endorsed 
sponsor requirements.

    (a) Enrollment process. (1) An individual (or an individual's 
authorized representative) applying to enroll in an endorsed discount 
card program must complete a standard enrollment form or other method 
allowed by CMS and provide such information to the endorsed discount 
card program in which the individual wishes to enroll.
    (2) An individual electing to join an endorsed discount card program 
that charges an annual enrollment fee, and who is not applying for 
transitional assistance, must agree to pay the annual enrollment fee, if 
any, in a form and manner determined by the endorsed card sponsor.
    (3) An individual applying for transitional assistance at the time 
that they apply for enrollment in an endorsed discount card program may 
only enroll in the endorsed discount card program at that time if CMS 
determines that the individual is eligible for transitional assistance. 
Individuals not found eligible for transitional assistance may enroll in 
an endorsed discount card program without applying for transitional 
assistance after being notified of their ineligibility for transitional 
assistance.
    (4) An individual applying for transitional assistance must complete 
a standard enrollment form and sign and date the form, certifying, under 
penalty of perjury or similar sanction for false statements, as to the 
accuracy of the information provided on the standard enrollment form.
    (5) Except as provided in Sec.  403.811(b)(4), an individual who is 
not currently enrolled in an endorsed card program seeking to enroll in 
the Medicare Prescription Drug Discount Card and Transitional Assistance 
Program may do so at any time during the enrollment period.
    (6) An individual may not be enrolled in more than one endorsed 
discount card program at a time.
    (7) An individual may enroll in only one endorsed discount card 
program per year during the enrollment period. An individual enrolling 
during the initial enrollment year, with the exception of the 
circumstances under paragraph (b)(2) of this section, may change 
election for the second enrollment year during the annual coordinated 
election period. During the second enrollment year, an individual may 
enroll in only one endorsed discount card program,

[[Page 95]]

unless the individual meets the circumstances described in paragraph 
(b)(2) of this section.
    (8) An individual remains enrolled in an endorsed discount card 
program elected unless--
    (i) The individual is disenrolled under paragraph (b) of this 
section;
    (ii) The individual elects a new program during the Annual 
Coordinated Election Period; or
    (iii) The endorsed sponsor terminates its endorsed discount card 
program, or is terminated.
    (9) No new enrollment in an endorsed discount card program or 
changing election of an endorsed discount card program is allowed during 
the transition period.
    (10) Except as specified in Sec.  403.814(b)(6)(i), an individual 
may enroll in any endorsed discount card program, and only those 
endorsed discount card programs, offered in the individual's State of 
residence.
    (11) In order to access negotiated prices or transitional 
assistance, if applicable, an individual must be enrolled in an endorsed 
discount card program. Access to negotiated prices begins with the 
effective date of enrollment and ends with disenrollment. Access to 
transitional assistance begins with the transitional assistance 
effective date and ends for claims finalized on the date of 
disenrollment.
    (12) Except as provided in paragraph (b)(5) of this section, an 
individual may apply for transitional assistance at any time during the 
enrollment period.
    (b) Disenrollment process. (1) An enrollee may voluntarily disenroll 
at any time by notifying (or by having his authorized representative 
notify) the endorsed sponsor.
    (2) An enrolled individual who disenrolls during the enrollment 
period under the following circumstances is granted a Special Election 
Period in which the individual may enroll in another endorsed discount 
card program during the enrollment period:
    (i) A move of residence outside the service area of the current 
program;
    (ii) A change in residence to or from a long-term care facility;
    (iii) Enrollment in or disenrollment from a Part C plan or Medicare 
cost plan;
    (iv) An individual's current endorsed discount card program is 
terminated or terminates; or
    (v) Other exceptional circumstances, as defined by the Secretary.
    (3) Notification in order to effect a disenrollment is not required 
for an individual disenrolling from a terminating endorsed discount card 
program or enrolling in or disenrolling from a Medicare managed care 
plan offering an exclusive card program, or for individuals changing 
endorsed discount card programs during the Annual Coordinated Election 
Period.
    (4) A drug discount card enrollee who disenrolls from an endorsed 
discount card program other than for one of the reasons listed in 
paragraph (b)(2) of this section will no longer be determined eligible 
for the Medicare Prescription Drug Discount Card and Transitional 
Assistance Program and, if he or she disenrolls in 2004, must re-apply 
for the Medicare Prescription Drug Discount Card and Transitional 
Assistance Program should he or she wish to enroll in another endorsed 
discount card program for the second enrollment year.
    (5) An individual receiving transitional assistance who voluntarily 
disenrolls from an endorsed discount card program other than for one of 
the reasons listed in paragraph (b)(2) of this section will forfeit any 
transitional assistance remaining available to the individual on the 
date of disenrollment, and, if he or she disenrolls in 2004, must re-
apply for transitional assistance for 2005 in order to receive 
transitional assistance in 2005.
    (6) A discount card enrollee other than a transitional assistance 
enrollee may be involuntarily disenrolled from his or her endorsed 
discount card program for failure to pay the annual enrollment fee on a 
timely basis.
    (7) A discount drug card enrollee other than a transitional 
assistance enrollee may be charged another annual enrollment fee each 
time the individual disenrolls from one endorsed discount card program 
and enrolls in another endorsed discount card program during the 
calendar year.

[[Page 96]]

    (c) Enrollment fees. (1) An endorsed sponsor may charge an annual 
enrollment fee of no more than $30 to each individual enrolled in its 
endorsed discount card program.
    (2) An endorsed sponsor may not collect an enrollment fee from any 
individual applying for or receiving transitional assistance.
    (3) The annual enrollment fee must not be prorated for portions of 
the year.
    (4) An endorsed sponsor must charge a uniform enrollment fee to 
every discount card eligible individual, or to the Secretary in the case 
of individuals receiving transitional assistance, residing in a State.
    (5) An endorsed sponsor must refund any enrollment fee collected 
from a discount card enrollee, or any State that has paid the enrollment 
fee on behalf of the discount card enrollee, during the calendar year 
during which the individual is determined eligible to receive 
transitional assistance.
    (6) An endorsed sponsor may not charge an annual enrollment fee 
during the transition period.



Sec.  403.812  HIPAA privacy, security, administrative data standards, 
and national identifiers.

    (a) HIPAA covered entities. An endorsed sponsor is a HIPAA covered 
entity and must comply with the standards, implementation 
specifications, and requirements in 45 CFR parts 160, 162, and 164 as 
set forth in this section. Those functions of an endorsed sponsor the 
performance of which are necessary or directly related to the operations 
of the endorsed discount card program are covered functions for purposes 
of applying to endorsed sponsors the standards, implementation 
specifications, and requirements in 45 CFR parts 160, 162, and 164.
    (b) HIPAA privacy requirements. An endorsed sponsor must comply with 
the standards, implementation specifications, and requirements in the 
Standards for Privacy of Individually Identifiable Health Information, 
45 CFR parts 160 and 164, subparts A and E, in the same manner as a 
health plan, except to the extent such requirements are temporarily 
waived by the Secretary.
    (c) Security requirements--(1) Standard. An endorsed sponsor must 
comply with the applicable standards, implementation specifications, and 
requirements in the HIPAA Security Rule, 45 CFR parts 160 and 164, 
subparts A and C, in the same manner as other covered entities as of the 
compliance date of such Rule.
    (2) Attestation. An applicant in its application shall--
    (i) Attest that, as of the initial enrollment date, it will have in 
place appropriate administrative, technical, and physical safeguards to 
protect the privacy of protected health information in accordance with 
45 CFR 164.530(c); and
    (ii) Attest that its information security measures will meet the 
standards, implementation specifications, and requirements of 45 CFR 
part 164 subparts A and C as of the initial enrollment date, or, if 
unable to make this attestation, provide a plan for coming into 
compliance with these requirements by the compliance date of the 
Security Rule set forth in 45 CFR part 164, subpart C.
    (d) Administrative data standards. An endorsed sponsor must comply 
with any applicable standards, implementation specifications, and 
requirements in the Standards for Electronic Transactions under 45 CFR 
parts 160 and 162 subparts I through R.
    (e) Unique identifiers. An endorsed sponsor must comply with any 
applicable standards, implementation specifications, and requirements 
regarding standard unique identifiers under 45 CFR parts 160 and 162 as 
of the compliance date of any final rule for standard unique 
identifiers.
    (f) Applicability of other regulations. Nothing in this paragraph or 
in Sec.  403.813 shall be deemed a modification of parts 160, 162 and 
164 of title 45, Code of Federal Regulations or otherwise modify the 
applicability of such regulations to other organizations or covered 
entities independently subject to the mandates of HIPAA. If an endorsed 
sponsor is also a health plan, health care provider, or health care 
clearinghouse, nothing is this paragraph shall impair or otherwise 
affect the application of HIPAA or parts 160, 162 and 164 of title 45, 
Code of Federal Regulations to such

[[Page 97]]

entity and its performance of those functions which make such entity a 
health plan, health care provider, or health care clearinghouse.



Sec.  403.813  Marketing limitations and record retention requirements.

    (a) Marketing limitations. (1) An endorsed sponsor may only market 
the following:
    (i) Those products and services offered under the endorsed program 
that are inside the scope of endorsement defined in Sec.  403.806(h) and 
permitted under Sec.  403.812(b).
    (ii) A Part D plan offered by the endorsed sponsor or an affiliated 
organization of the endorsed sponsor.
    (2) An endorsed sponsor may not request that a drug card enrollee or 
an individual seeking to enroll in its endorsed discount card program 
authorize the endorsed sponsor to use or disclose individually 
identifiable health information for purposes of marketing any product or 
service not allowed under paragraph (a)(1) of this section.
    (3) An endorsed sponsor may not co-mingle any materials related to 
the marketing of products and services allowed under paragraph (a)(1) of 
this section with other marketing materials.
    (4) Following termination of an endorsed sponsor's endorsement under 
Sec. Sec.  403.820(c), (d) or (e) or termination of the Medicare Drug 
Discount Card and Transitional Assistance Program, a drug card 
enrollee's individually identifiable health information collected or 
maintained by an endorsed sponsor may not be used or disclosed for 
purposes of marketing any product or service.
    (b) Record retention standard. (1) An endorsed sponsor must retain 
records that it creates, collects, or maintains while participating in 
the Medicare Drug Discount Card and Transitional Assistance Program as 
part of its operations of an endorsed program for at least 6 years 
following termination of such program, or, in the event the endorsed 
sponsor's endorsement is terminated under Sec.  420.820(c), (d), or (e) 
of this chapter at least 6 years following termination of such 
endorsement. The Secretary may extend the six-year retention period if 
an endorsed sponsor's records relate to an ongoing investigation, 
litigation, or negotiation by the Secretary, the Department of Health 
and Human Services Office of Inspector General, the Department of 
Justice, or a State, or such documents otherwise relate to suspicions of 
fraud and abuse or violations of Federal or State law.
    (2) For the period during which an endorsed sponsor retains records 
as specified in paragraph (b)(1) of this section, an endorsed sponsor 
must continue to apply security and privacy protections to such records 
and the information contained therein to the same extent endorsed 
sponsors are required to do so under Sec. Sec.  403.812(b) and 
403.812(c)(1) prior to termination.

[68 FR 69915, Dec. 15, 2003, as amended at 70 FR 52023, Sept. 1, 2005]



Sec.  403.814  Special rules concerning Part C organizations and Medicare 
cost plans and their enrollees.

    (a) General requirements. (1) A Part C organization and Medicare 
cost plan may not require enrollment in an endorsed discount card 
program as a condition for enrollment in its Part C plan or Medicare 
cost plan.
    (2) A Part C organization may subsidize the enrollment fee for an 
endorsed discount card program, whether operated by the Part C 
organization or another endorsed sponsor, for individuals described in 
Sec.  403.810(a), provided that any such benefit is reflected in the 
Part C organization's Adjusted Community Rate filing.
    (b) Exclusive card sponsors. (1) A Medicare managed care 
organization may elect to become an exclusive card sponsor by limiting 
enrollment in its endorsed discount card program to individuals 
described in Sec.  403.810(a) who are enrolled in any of its Medicare 
managed care plans. The Medicare managed care organization must be the 
applicant for endorsement in order to offer an exclusive card program. 
Such an election must be made at the time of application for 
endorsement.
    (2) Except as noted in paragraphs (b)(3) and (b)(4) of this section, 
an exclusive card sponsor must comply with all requirements for endorsed 
sponsors noted in Sec. Sec.  403.804 and 403.806.

[[Page 98]]

    (3) An exclusive card sponsor is deemed to meet or is exempt from 
certain specific requirements listed in Sec.  403.806 as follows:
    (i) An exclusive card sponsor is deemed to meet the pharmacy network 
requirement in Sec.  403.806(f)(3) if its pharmacy network is not 
limited to mail-order pharmacies and is equivalent to the pharmacy 
network used in its Medicare managed care plan and such pharmacy network 
has been approved by the Secretary, or, if its Medicare managed care 
plan does not use a pharmacy network, the Secretary determines that the 
pharmacy network provides sufficient access to covered discount card 
drugs at negotiated prices for discount card enrollees under the 
standard set forth under 42 CFR 422.112 for a Part C organization 
described in section 1851(a)(2)(A) of the Act, or under 42 CFR 
417.416(e) for a Medicare cost plan.
    (ii) An exclusive card sponsor is deemed to meet the service area 
requirements in Sec.  403.806(f)(1) and (f)(2) if it operates in a 
service area equivalent to its Medicare managed care plan's service 
area.
    (iii) An exclusive card sponsor is deemed to meet the requirement 
for financial stability and business integrity in Sec.  403.806(b) 
through compliance with Sec.  422.400 of this chapter (if a Part C 
organization described in section 1851(a)(2)(A) of the Act) or 
compliance with Sec. Sec.  417.120 and 417.122 of this chapter (if a 
Medicare cost plan).
    (iv) An exclusive card sponsor is deemed to meet the covered lives 
requirement in Sec.  403.806(a)(3).
    (v) An exclusive card sponsor is deemed to meet the requirements of 
Sec.  403.806(e)(2) if it ensures that transitional assistance funds are 
applied to, and only to, the cost to transitional assistance enrollees 
of any covered discount card drugs obtained from a network or mail order 
pharmacy included in the exclusive card sponsor's pharmacy network, and 
at the option of the exclusive card sponsor, any covered discount card 
drug obtained under an outpatient prescription drug benefit offered 
under the affiliated Medicare managed care plan, including any 
deductibles, co-payments, coinsurance, and other cost-sharing amounts 
for which transitional assistance enrollees are responsible under the 
Medicare managed care plan's outpatient prescription drug benefit.
    (4) As the Secretary determines appropriate on a case-by-case basis, 
any additional requirements discussed in Sec. Sec.  403.804 and 403.806, 
except for the requirements in Sec. Sec.  403.812 and 403.813, may be 
waived or modified on behalf of an exclusive card sponsor if:
    (i) The requirements are duplicative of or conflict with the 
requirements that a Medicare managed care organization must meet either 
under Part C or under section 1876 of Title XVIII of the Act; or
    (ii) The waiver or modification is necessary to improve coordination 
between benefits under the Medicare Prescription Drug Discount Card and 
Transitional Assistance Program and the benefits either under Part C or 
under section 1876 of Title XVIII of the Act.
    (iii) The applicant seeking to become an exclusive card sponsor 
requests such waivers or modifications in writing in a manner required 
by the Secretary.
    (5) An exclusive card sponsor may conduct group enrollment according 
to the following rules:
    (i) The exclusive card sponsor must seek CMS verification that its 
Medicare managed care members are individuals described in Sec.  
403.810(a) and enroll such individuals as a group into its exclusive 
card program.
    (ii) The exclusive card sponsor must give all individuals it is 
enrolling as a group the opportunity to decline enrollment, and the 
opportunity to apply for transitional assistance.
    (iii) The exclusive card sponsor may use a modified version of the 
standard enrollment form described in Sec.  403.806(g)(3) or other CMS-
approved process for group enrollment in its endorsed discount card 
program.
    (6) An individual enrolled in a Medicare managed care plan offered 
by a Medicare managed care organization offering an exclusive card 
program to individuals enrolled in such Medicare managed care plan is 
subject to the following requirements:

[[Page 99]]

    (i) The individual may enroll only in the endorsed discount card 
program offered by his or her Medicare managed care organization.
    (ii) If the exclusive card sponsor group elects to group enroll into 
an exclusive card program members of the Medicare managed plan, the 
individual must actively decline enrollment to avoid enrollment in the 
exclusive card program.
    (c) Non-uniformity of Benefits. Implementation of the Medicare 
Prescription Drug Discount Card and Transitional Assistance Program, 
including the provision of transitional assistance and the payment or 
waiver of any enrollment fee by a Part C organization, will not be taken 
into account in applying the uniform premium and uniform benefits 
requirement in sections 1854(c) and 1854(f)(1)(D) of the Act and 42 CFR 
422.100(d)(2) and 42 CFR 422.312(b)(2).



Sec.  403.815  Special rules concerning States.

    (a) Optional State payment of enrollment fee. (1) A State may enter 
into payment arrangements with endorsed sponsors to provide payment of 
some or all of endorsed discount card programs' enrollment fees for some 
or all of the State's individuals described in Sec.  403.810(a) who are 
not transitional assistance enrollees, provided the enrollment fees are 
paid directly by the State to the endorsed sponsor.
    (2) Expenditures made by a State for enrollment fees described in 
paragraph (a)(1) of this section must not be treated as State 
expenditures for which Federal matching payments are available under 
titles XIX or XXI of the Act.
    (b) Optional State payment of coinsurance. (1) A State may enter 
into payment arrangements with pharmacies to provide payment of some or 
all of coinsurance amounts described in Sec.  403.808(e) for some or all 
of the State's transitional assistance enrollees, provided the 
coinsurance amounts are paid directly by the State to the pharmacy.
    (2) Expenditures made by a State for coinsurance described in 
paragraph (b)(1) of this section must not be treated as State 
expenditures for which Federal matching payments are available under 
titles XIX or XXI of the Act.
    (c) Coinsurance for Qualified Medicare Beneficiaries. For 
transitional assistance enrollees who are qualified Medicare 
beneficiaries, any coinsurance liability under Sec.  403.808(e) must not 
be treated as Medicare cost-sharing coinsurance, under section 
1905(p)(3)(B) of the Act, for which a State would otherwise be required 
to pay.
    (d) State data. (1) A State must provide data on a monthly basis in 
an electronic format as determined necessary by the Secretary to 
effectuate the verification of beneficiary eligibility for the Medicare 
Prescription Drug Discount Card and Transitional Assistance Program.
    (2) Expenditures made by a State in complying with the requirements 
of paragraph (d)(1) of this section will be treated as State 
expenditures for which Federal matching payments are available under 
section 1903(a)(7) of the Act.



Sec.  403.816  Special rules concerning long-term care and I/T/U pharmacies.

    (a) In general. (1) An applicant for endorsement may submit an 
application to become a special endorsed sponsor for long-term care and/
or for I/T/U pharmacies.
    (2) Of qualified applicants, the Secretary will select at least two 
of the best-qualified applicants for special endorsement for long-term 
care and at least two of the best-qualified applicants for special 
endorsement for I/T/U pharmacies.
    (3) Applicants for special endorsement for long-term care must 
demonstrate in their applications that they meet the requirements in 
paragraph (b) of this section.
    (4) Applicants for special endorsement for I/T/U pharmacies must 
demonstrate in their applications that they meet the requirements in 
paragraph (d) of this section.
    (b) Long-term care. A special endorsed sponsor for long-term care 
must--
    (1) Apply transitional assistance toward the cost of covered 
discount card drugs obtained by transitional assistance enrollees who 
reside in long-term care facilities and who receive such prescription 
drugs through long-term care pharmacies;

[[Page 100]]

    (2) Offer contractual arrangements to any long-term care pharmacy 
seeking reimbursement from transitional assistance for covered discount 
card drugs provided by such pharmacy to transitional assistance 
enrollees who reside in long-term care facilities;
    (3) Process any submitted claims from network pharmacies and out-of-
network long-term care pharmacies that supply covered discount card 
drugs to transitional assistance enrollees who reside in long-term care 
facilities, when such enrollees have unspent transitional assistance 
remaining;
    (4) Include special terms and conditions in its contracts with 
network pharmacies that are long-term care pharmacies to facilitate 
access to and the administration of transitional assistance to 
transitional assistance enrollees residing in long-term care facilities, 
including, but not limited to the following--
    (i) Waiving penalties against long-term care pharmacies for 
submitting late claims to the special endorsed sponsor due to the 
pharmacy's coordination of benefits activities; and
    (ii) Permitting a long-term care pharmacy to limit its services to 
only transitional assistance enrollees who reside in a long-term care 
facility served by the long-term care pharmacy.
    (5) Except as noted in paragraph (c) of this section, comply with 
all requirements for endorsed sponsors noted in Sec. Sec.  403.804 and 
403.806.
    (c) Waiver of requirements. (1) The following requirements will not 
apply to or will be waived for special endorsed sponsors providing 
transitional assistance to long-term care residents:
    (i) Section 403.806(d) (relating to the prescription drug offering) 
shall not apply to long-term care pharmacies in the special endorsed 
sponsor's network; and
    (ii) Section 403.806(e)(4) (requiring information about the amount 
of transitional assistance remaining) shall not apply to long-term care 
pharmacies in the special endorsed sponsor's network.
    (2)(i) As the Secretary determines appropriate on a case-by-case 
basis, any additional requirements discussed in Sec. Sec.  403.804 and 
403.806, except for the requirements in Sec. Sec.  403.812 and 403.813, 
may be waived or modified on behalf of a special endorsed sponsor for 
long-term care if the waiver or modification is--
    (A) Necessary to enable the applicant to either initiate enrollment 
activities under the special endorsement within 6 months of enactment of 
section 1860D-31 of the Act, or accommodate the unique needs of long-
term care pharmacies; or
    (B) Compliance with the requirement(s) in question would be 
impracticable or inefficient.
    (ii) Applicants to become special endorsed sponsors for long-term 
care must request such waivers or modifications in writing in a manner 
required by the Secretary.
    (d) I/T/U pharmacies. A special endorsed sponsor for I/T/U 
pharmacies must--
    (1) Apply transitional assistance toward the cost of covered 
discount card drugs obtained by transitional assistance enrollees who 
are American Indians and Alaska Natives and who receive prescription 
drugs through I/T/U pharmacies as allowed under paragraph (d)(2) of this 
section;
    (2) Offer contractual arrangements to any I/T/U pharmacy that is in 
the special endorsed sponsor's service area and seeking reimbursement 
from transitional assistance for covered discount card drugs provided by 
such pharmacy to transitional assistance enrollees who are also American 
Indians/Alaska Natives;
    (3) Include special terms and conditions in its contracts with 
network I/T/U pharmacies to facilitate access to and the administration 
of transitional assistance for transitional assistance enrollees who are 
American Indians/Alaska Natives, including, but not limited to the 
following:
    (i) Permitting an I/T/U pharmacy to limit its services to only those 
transitional assistance enrollees who are American Indians/Alaska 
Natives, and
    (ii) Allowing an I/T/U pharmacy to select which drugs to stock, 
which may be a more limited set than other retail pharmacies.
    (4) Except as noted in paragraph (e) of this section, comply with 
all requirements for endorsed sponsors noted in Sec. Sec.  403.804 and 
403.806.

[[Page 101]]

    (e) Waiver of requirements. (1) The following requirements will not 
apply to or will be waived for special endorsed sponsors providing 
transitional assistance through I/T/U pharmacies:
    (i) Section 403.806(d) (relating to the prescription drug offering) 
shall not apply to I/T/U pharmacies in the special endorsed sponsor's 
network; and
    (ii) Section 403.806(e)(4) (requiring information about the amount 
of transitional assistance remaining) shall not apply to I/T/U 
pharmacies in the special endorsed sponsor's network.
    (2)(i) As the Secretary determines appropriate on a case-by-case 
basis, any additional requirements discussed in Sec. Sec.  403.804 and 
403.806, except for the requirements in Sec. Sec.  403.812 and 403.813, 
may be waived or modified on behalf of a special endorsed sponsor for I/
T/U pharmacies if the waiver or modification is--
    (A) Necessary to enable the applicant to either initiate enrollment 
activities under the special endorsement within 6 months of enactment of 
section 1860D-31 of the Act, or accommodate the unique needs of I/T/U 
pharmacies; or
    (B) Compliance with the requirement(s) in question would be 
impracticable or inefficient.
    (ii) Applicants to become special endorsed sponsors for I/T/U 
pharmacies must request such waivers or modifications in writing in a 
manner required by the Secretary.



Sec.  403.817  Special rules concerning the territories.

    (a) In general. (1) An applicant for endorsement may submit an 
application to become a special endorsed sponsor for all of the 
territories.
    (2) Of qualified applicants, the Secretary will select at least one 
of the best-qualified applicants to receive a special endorsement for 
the territories.
    (3) Applicants for special endorsement for the territories must 
demonstrate in their applications that they meet the requirements in 
paragraph (b) of this section.
    (b) Requirements--(1) Negotiated prices. A special endorsed sponsor 
for residents of the territories must provide access to negotiated 
prices in the territories.
    (2) Transitional assistance. Any transitional assistance in the 
territories must be in accordance with paragraph (e) of this section.
    (3) Requirements, exception. Except as specified in paragraph (c) of 
this section, a special endorsed sponsor for the territories must meet 
the requirements of Sec. Sec.  403.804 and 403.806.
    (c) Waiver of requirements and alternative requirements. (1) Section 
403.806(d)(8) (requiring information about price differentials) shall 
not apply to pharmacies located in the territories and which are in the 
special endorsed sponsor's pharmacy network.
    (2) Sections 403.806(f)(2) and (f)(3) will be deemed met if the 
special endorsed sponsor makes a good faith effort to secure the 
participation of retail and mail order pharmacies throughout a 
territory.
    (3)(i) As the Secretary determines appropriate on a case-by-case 
basis, any additional requirements discussed in Sec. Sec.  403.804 and 
403.806, except for the requirements in Sec. Sec.  403.812 and 403.813, 
may be waived or modified on behalf of a special endorsed sponsor for 
the territories if--
    (A) Such waiver is necessary to enable the applicant to either 
initiate enrollment activities under the special endorsement within 6 
months of enactment of section 1860D-31 of the Act, or accommodate the 
unique needs of pharmacies in the territories; or
    (B) Compliance with the requirement(s) in question would be 
impracticable or inefficient.
    (ii) Applicants to become special endorsed sponsors for the 
territories must request such waivers or modifications in writing in a 
manner required by the Secretary.
    (d) Other exceptions. A special endorsed sponsor for the territories 
may enroll in its endorsed discount card program Medicaid enrollees with 
coverage for outpatient prescription drugs, as described in Sec.  
403.810(a)(2).
    (e) Transitional assistance provided by Territories. (1) 
Transitional assistance in the territories may be administered only 
according to a plan submitted by a territory and approved by CMS.
    (2) Territories choosing to provide transitional assistance must 
submit a

[[Page 102]]

plan to CMS within 90 days of the publication of this regulation. The 
plan must--
    (i) Describe how funds allocated to the territory are to be used to 
cover the cost of covered discount card drugs obtained by individuals 
who reside in the territory, who are entitled to benefits under Medicare 
Part A or enrolled under Medicare Part B, and who have income at or 
below 135 percent of the poverty line for the contiguous United States; 
and
    (ii) Describe how the territory will ensure that amounts received 
under the allotment are to be used only to provide covered discount card 
drugs to those individuals determined eligible for transitional 
assistance, as described in paragraph (e)(2)(i) of this section, and
    (iii) Provide such written assurance for the requirements in 
paragraph (e)(2)(ii) of this section.
    (3) CMS will review and approve plans submitted and make allotments 
to territories with approved plans.
    (4) CMS may request reports or information to substantiate that the 
territories have administered the program consistent with the 
territory's approved transitional assistance plan.



Sec.  403.820  Sanctions, penalties, and termination.

    (a) Intermediate sanctions. (1) For the violations listed in 
paragraph (a)(3) of this section, the following intermediate sanctions 
may be imposed on any endorsed sponsor:
    (i) Suspension of enrollment of Medicare beneficiaries.
    (ii) Suspension of information and outreach activities to Medicare 
beneficiaries.
    (2) Duration of sanctions. The intermediate sanctions continue in 
effect until CMS is satisfied that the deficiency on which the 
determination was based has been corrected and is not likely to recur.
    (3) Sanctionable violations. The violations for which intermediate 
sanctions may be imposed are as follows:
    (i) Substantial failure to maintain a contracted retail pharmacy 
network meeting the requirements of Sec.  403.806(f);
    (ii) Substantial failure to comply with CMS Information and Outreach 
Guidelines;
    (iii) Substantial failure to provide discount card enrollees with 
negotiated prices consistent with information reported to CMS for the 
price comparison Web site and/or reported by the endorsed sponsor;
    (iv) Except during the week of November 15, 2004 (which coincides 
with the beginning of the annual coordinated election period), 
substantial failure to ensure that the negotiated price for a covered 
discount card drug does not exceed an amount proportionate to the change 
in the drug's average wholesale price (AWP), and/or an amount 
proportionate to changes in the card sponsor's cost structure (including 
material changes to any discounts, rebates, or other price concessions 
the sponsor receives from a pharmaceutical manufacturer or pharmacy);
    (v) Charging drug card enrollees additional fees beyond a $30 
enrollment fee;
    (vi) Charging transitional assistance enrollees any enrollment fee;
    (vii) Charging a coinsurance more than 5 percent for those at or 
below 100 percent of the poverty line, or 10 percent for those above 100 
percent but at or below 135 percent of the poverty line;
    (viii) Substantial failure to administer properly the transitional 
assistance funding for transitional assistance enrollees;
    (ix) Substantial failure to provide CMS or its designees with 
requested information related to the endorsed sponsor's endorsed 
discount card operations; or
    (x) Failure to otherwise substantially comply with the requirements 
of this subpart, including failing to perform the operational 
requirements of this program or the failure to submit an acceptable plan 
of correction within the timeframe specified by CMS.
    (4) Written notice of proposed sanctions. (i) Prior to imposing 
sanctions, CMS will send a written notice to the endorsed sponsor 
stating the nature and basis of the proposed sanction.
    (ii) CMS will send a copy of the notice in paragraph (a)(4)(i) of 
this section to the Office of the Inspector General.

[[Page 103]]

    (iii) CMS will allow the endorsed sponsor 15 days from the receipt 
of notice to provide evidence that it has not committed an act or 
omission that may fairly be characterized as a basis for sanction.
    (iv) Should an endorsed sponsor present evidence described in 
paragraph (a)(4)(iii) of this section and by the time limit described in 
that paragraph, a CMS official not involved in the original sanction 
determination shall review the evidence and provide the endorsed sponsor 
a concise written decision setting forth the factual and legal basis for 
the decision that affirms or rescinds the original determination.
    (5) Effective date of sanction. (i) A sanction is effective 15 days 
after the date that the endorsed sponsor is notified of the sanction or, 
if the endorsed sponsor timely seeks reconsideration of that sanction 
decision, on the date specified in the notice of CMS's reconsideration 
determination.
    (ii) The sanction remains in effect until CMS notifies the endorsed 
sponsor that CMS is satisfied that the basis for imposing the sanction 
has been corrected and is not likely to recur.
    (b) Civil monetary penalties--(1) OIG penalties. The Office of the 
Inspector General (OIG) may impose civil monetary penalties in 
accordance with 42 CFR parts 1003 and 1005 in addition to, or in place 
of, sanctions that CMS may impose, as described in paragraph (a) of this 
section, against an endorsed sponsor whom it determines has knowingly--
    (i) Misrepresented or falsified information in information and 
outreach or comparable material provided to program enrollee or other 
persons;
    (ii) Charged a program enrollee in violation of the terms of the 
endorsement contract; or
    (iii) Used transitional assistance funds in any manner that is 
inconsistent with the purpose of the transitional assistance program.
    (2) CMS penalties. If CMS determines that an endorsed sponsor has 
engaged in conduct that it knows or should know constitutes a violation 
as described in paragraph (a)(3) of this section, where the failure to 
perform involves the operational requirements of the program, CMS may 
impose civil monetary penalties in accordance with 42 CFR parts 1003 and 
1005 in addition to, or in place of, the sanctions that CMS may impose, 
as described in paragraph (a) of this section.
    (3) CMS or the OIG may impose civil monetary penalties of no more 
than $10,000 for each violation.
    (c) Termination of endorsement by CMS. (1) CMS may terminate the 
endorsement contract at any time with notice on the following bases:
    (i) Any of the bases for the imposition of intermediate sanctions as 
stated in paragraph (a)(3) of this section; or
    (ii) The endorsed sponsor engaged in false or misleading information 
and outreach practices; or
    (iii) The endorsed sponsor fails to comply with the requirement of 
Sec.  403.804(e).
    (2) CMS shall provide the endorsed sponsor written notice of 
termination 30 days prior to the CMS-determined effective date of the 
termination at which time the endorsed sponsor must do the following:
    (i) Provide its discount card enrollees notice of the termination 
within 10 days of receiving notice from CMS;
    (ii) Continue to provide services to its discount card enrollees for 
90 days after the discount card enrollees were sent the notice of 
termination from the endorsed sponsor; and
    (iii) Suspend all information and outreach and enrollment activities 
once enrollees have received the notice of termination.
    (3) Corrective action plan. Before terminating a contract, CMS shall 
provide the endorsed sponsor with reasonable opportunity to develop and 
receive CMS approval of a corrective action plan to correct the 
deficiencies that are the basis of the proposed termination.
    (d) Termination by endorsed sponsor--(1) Cause for termination. The 
endorsed sponsor may terminate its endorsement contract if CMS fails 
substantially to carry out the terms of the contract.
    (2) Card sponsor notice. The endorsed sponsor must give advance 
notice as follows:
    (i) To CMS, at least 90 days prior to the intended date of 
termination. This notice must specify the reasons why

[[Page 104]]

the endorsed sponsor is requesting contract termination; and
    (ii) To its discount card enrollees, by mail, at least 60 days prior 
to the termination effective date. This notice must include a written 
description of alternative endorsed discount card programs that serve 
the discount card enrollee's address.
    (3) Effective date of termination. The effective date of the 
termination is determined by CMS and is at least 90 days after the date 
CMS receives the endorsed sponsor's notice of intent to terminate.
    (e) Termination by mutual consent. (1) A contract may be modified or 
terminated at any time by written mutual consent.
    (2) If the contract is terminated by mutual consent, the endorsed 
sponsor must provide notice to its discount card enrollees as provided 
in paragraph (d)(2) of this section.
    (3) If the contract is modified by mutual consent, the endorsed 
sponsor must provide notice to its discount card enrollees of any 
changes that CMS determines are appropriate for notification within 
timeframes specified by CMS.
    (f) Appeal of contract determinations--(1) Scope. This section 
establishes the procedures for reviewing the following contract 
determinations:
    (i) A determination that an applicant is not qualified to enter into 
a contract with CMS under section 1860D-31 of the Act; and
    (i) A determination to terminate a contract with an endorsed sponsor 
in accordance with paragraph (c) of this section.
    (2) Notice of determination. When CMS makes an initial contract 
determination, it gives the endorsed sponsor or applicant written notice 
specifying--
    (i) The reasons for the determination; and
    (ii) The endorsed sponsor's or applicant's right to request 
reconsideration.
    (3) Effect of contract determination. The contract determination is 
final and binding unless a timely request for a reconsideration hearing 
is filed under this section.
    (4) Right to reconsideration. An endorsed sponsor whose contract is 
terminated or an applicant denied endorsement may request a hearing for 
reconsideration of the CMS contract determination.
    (5) Method and place for filing a request. A request for a 
reconsideration hearing must be made in writing and filed with the CMS 
Central Office.
    (6) Time for filing a request. The request for a reconsideration 
hearing must be filed within 15 days from the date of the notice of the 
initial determination.
    (7) Appointment of hearing officer. CMS shall appoint a hearing 
officer to conduct the reconsideration. The hearing officer shall be a 
representative of the Administrator and not otherwise a party to the 
contract determination.
    (8) Conduct of hearing. The endorsed sponsor or applicant may be 
represented by counsel and may present evidence and examine witnesses. A 
complete recording of the proceedings will be made and transcribed.
    (9) Reconsideration determination. A reconsideration determination 
is a new determination that--
    (i) Is based on a review of the contract determination, the evidence 
and findings upon which it was based, and any other written evidence 
submitted before notice of the reconsidered determination is mailed, 
including facts relating to the status of the endorsed sponsor 
subsequent to the contract determination; and
    (ii) Affirms, reverses, or modifies the initial contract 
determination.
    (10) Notice of reconsidered determination. As soon as practicable 
after the close of the hearing, the hearing officer issues a written 
reconsideration determination that contains the following:
    (i) Findings with respect to the applicant's qualifications to enter 
into or an endorsed sponsor's qualifications to remain under a contract 
with CMS under section 1860D-31 of the Act;
    (ii) A statement of the specific reasons for the reconsidered 
determination.
    (11) Effect of reconsidered determination. A reconsidered 
determination is final and binding on the parties and is not subject to 
judicial review.
    (g) Compliance with HIPAA. Failure of an endorsed sponsor to comply 
with

[[Page 105]]

HIPAA and/or the standards, implementation specifications, and 
requirements in 45 CFR parts 160, 162, and 164, as established in Sec.  
403.812, shall be a violation of HIPAA and may be enforced under 
sections 1176 and 1177 of the Act.



Sec.  403.822  Reimbursement of transitional assistance and associated
sponsor requirements.

    (a) A Transitional Assistance Account is created within the Federal 
Supplementary Medical Insurance Trust Fund and kept separate from all 
other funds within that fund.
    (b) The Managing Trustee of the Transitional Assistance Account 
shall pay on a monthly basis from the Account the amounts certified by 
CMS as necessary to make payments for transitional assistance as allowed 
in Sec.  403.808.
    (c) Endorsed sponsors must routinely account to CMS for the 
transitional assistance provided to the transitional assistance 
enrollees for finalized (not pending, or denied) claims up to the 
allowed balance provided by CMS to the sponsor.
    (d) Payment transactions will be audited by the Secretary or his 
agent.
    (e) Federal funding in excess of the amount of the balance included 
in CMS's system is not permitted.



 Subpart I_Transparency Reports and Reporting of Physician Ownership or 
                          Investment Interests

    Source: 78 FR 9521, Feb. 8, 2013, unless otherwise noted.



Sec.  403.900  Purpose and scope.

    The regulations in this subpart implement section 1128G of the Act. 
These regulations apply to applicable manufacturers and applicable group 
purchasing organizations and describe the requirements and procedures 
for applicable manufacturers to report payments or other transfers of 
value provided to covered recipients, as well as for applicable 
manufacturers and applicable group purchasing organizations to report 
ownership or investment interests held by physicians or immediate family 
members of physicians in such entities.



Sec.  403.902  Definitions.

    For purposes of this subpart, the following definitions apply:
    Applicable group purchasing organization means an entity that:
    (1) Operates in the United States; and
    (2) Purchases, arranges for or negotiates the purchase of a covered 
drug, device, biological, or medical supply for a group of individuals 
or entities, but not solely for use by the entity itself.
    Applicable manufacturer means an entity that is operating in the 
United States and that falls within one of the following categories:
    (1) An entity that is engaged in the production, preparation, 
propagation, compounding, or conversion of a covered drug, device, 
biological, or medical supply, but not if such covered drug, device, 
biological or medical supply is solely for use by or within the entity 
itself or by the entity's own patients. This definition does not include 
distributors or wholesalers (including, but not limited to, repackagers, 
relabelers, and kit assemblers) that do not hold title to any covered 
drug, device, biological or medical supply.
    (2) An entity under common ownership with an entity in paragraph (1) 
of this definition, which provides assistance or support to such entity 
with respect to the production, preparation, propagation, compounding, 
conversion, marketing, promotion, sale, or distribution of a covered 
drug, device, biological or medical supply.
    Assistance and support means providing a service or services that 
are necessary or integral to the production, preparation, propagation, 
compounding, conversion, marketing, promotion, sale, or distribution of 
a covered drug, device, biological or medical supply.
    Certified nurse midwife means a registered nurse who has 
successfully completed a program of study and clinical experience 
meeting guidelines prescribed by the Secretary, or has been certified by 
an organization recognized by the Secretary.

[[Page 106]]

    Certified registered nurse anesthetist means a certified registered 
nurse anesthetist licensed by the State who meets such education, 
training, and other requirements relating to anesthesia services and 
related care as the Secretary may prescribe. In prescribing such 
requirements the Secretary may use the same requirements as those 
established by a national organization for the certification of nurse 
anesthetists. Such term also includes, as prescribed by the Secretary, 
an anesthesiologist assistant.
    Charitable contribution includes, but is not limited to, any payment 
or transfer of value made to an organization with tax-exempt status 
under the Internal Revenue Code of 1986, which is not provided in 
exchange for any goods, items or services.
    Charity care means services provided by a covered recipient 
specifically for a patient who is unable to pay for such services or for 
whom payment would be a significant hardship, where the covered 
recipient neither receives, nor expects to receive, payment because of 
the patient's inability to pay.
    Clinical investigation means any experiment involving one or more 
human subjects, or materials derived from human subjects, in which a 
drug, device, biological or medical supply is administered, dispensed or 
used.
    Clinical nurse specialist means, an individual who--
    (1) Is a registered nurse and is licensed to practice nursing in the 
State in which the clinical nurse specialist services are performed; and
    (2) Holds a master's degree in a defined clinical area of nursing 
from an accredited educational institution.
    Common ownership refers to circumstances where the same individual, 
individuals, entity, or entities directly or indirectly own 5 percent or 
more total ownership of two entities. This includes, but is not limited 
to, parent corporations, direct and indirect subsidiaries, and brother 
or sister corporations.
    Covered drug, device, biological, or medical supply means any drug, 
device, biological, or medical supply for which payment is available 
under Title XVIII of the Act or under a State plan under Title XIX or 
XXI of the Act (or a waiver of such plan), either separately (such as 
through a fee schedule or formulary) or as part of a bundled payment 
(for example, under the hospital inpatient prospective payment system or 
the hospital outpatient prospective payment system) and which is of the 
type that in the case of a--
    (1) Drug or biological, by law, requires a prescription to be 
dispensed; or
    (2) Device (including a medical supply that is a device), by law, 
requires premarket approval by or premarket notification to the FDA.
    Covered recipient means-- (1) Any physician, physician assistant, 
nurse practitioner, clinical nurse specialist, certified registered 
nurse anesthetist, or certified nurse-midwife who is not a bona fide 
employee of the applicable manufacturer that is reporting the payment; 
or
    (2) A teaching hospital, which is any institution that received a 
payment under 1886(d)(5)(B), 1886(h), or 1886(s) of the Act during the 
last calendar year for which such information is available.
    Device identifier is the mandatory, fixed portion of a unique device 
identifier (UDI) that identifies the specific version or model of a 
device and the labeler of that device (as described at 21 CFR 801.3 in 
paragraph (1) of the definition of ``Unique device identifier'').
    Employee means an individual who is considered to be ``employed by'' 
or an ``employee'' of an entity if the individual would be considered to 
be an employee of the entity under the usual common law rules applicable 
in determining the employer-employee relationship (as applied for 
purposes of section 3121(d)(2) of the Internal Revenue Code of 1986).
    Immediate family member means any of the following:
    (1) Spouse.
    (2) Natural or adoptive parent, child, or sibling.
    (3) Stepparent, stepchild, stepbrother, or stepsister.
    (4) Father-, mother-, daughter-, son-, brother-, or sister-in-law.
    (5) Grandparent or grandchild.
    (6) Spouse of a grandparent or grandchild.

[[Page 107]]

    Indirect payments or other transfers of value refer to payments or 
other transfers of value made by an applicable manufacturer (or an 
applicable group purchasing organization) to a covered recipient (or a 
physician owner or investor) through a third party, where the applicable 
manufacturer (or applicable group purchasing organization) requires, 
instructs, directs, or otherwise causes the third party to provide the 
payment or transfer of value, in whole or in part, to a covered 
recipient(s) (or a physician owner or investor).
    Know, knowing, or knowingly--(1) Means that a person, with respect 
to information--
    (i) Has actual knowledge of the information;
    (ii) Acts in deliberate ignorance of the truth or falsity of the 
information; or
    (iii) Acts in reckless disregard of the truth or falsity of the 
information; and
    (2) Requires no proof of a specific intent to defraud.
    Long term medical supply or device loan means the loan of supplies 
or a device for 91 days or longer.
    Non-teaching hospital covered recipient means a person who is one or 
more of the following: Physician; physician assistant; nurse 
practitioner; clinical nurse specialist; certified registered nurse 
anesthetist; or certified nurse-midwife.
    NPPES stands for the National Plan & Provider Enumeration System.
    Nurse practitioner means a nurse practitioner who performs such 
services as such individual is legally authorized to perform (in the 
State in which the individual performs such services) in accordance with 
State law (or the State regulatory mechanism provided by State law), and 
who meets such training, education, and experience requirements (or any 
combination thereof) as the Secretary may prescribe in regulations.
    Operating in the United States means that an entity--
    (1) Has a physical location within the United States or in a 
territory, possession, or commonwealth of the United States; or
    (2) Otherwise conducts activities within the United States or in a 
territory, possession, or commonwealth of the United States, either 
directly or through a legally-authorized agent.
    Ownership or investment interest--(1) Includes, but is not limited 
to the following:
    (i) Stock, stock option(s) (other than those received as 
compensation, until they are exercised).
    (ii) Partnership share(s);
    (iii) Limited liability company membership(s).
    (iv) Loans, bonds, or other financial instruments that are secured 
with an entity's property or revenue or a portion of that property or 
revenue.
    (2) May be direct or indirect and through debt, equity or other 
means.
    (3) Exceptions. The following are not ownership or investment 
interests for the purposes of this section:
    (i) An ownership or investment interest in a publicly traded 
security or mutual fund, as described in section 1877(c) of the Act.
    (ii) An interest in an applicable manufacturer or applicable group 
purchasing organization that arises from a retirement plan offered by 
the applicable manufacturer or applicable group purchasing organization 
to the physician (or a member of his or her immediate family) through 
the physician's (or immediate family member's) employment with that 
applicable manufacturer or applicable group purchasing organization.
    (iii) Stock options and convertible securities received as 
compensation, until the stock options are exercised or the convertible 
securities are converted to equity.
    (iv) An unsecured loan subordinated to a credit facility.
    (v) An ownership or investment interest if an applicable 
manufacturer or applicable group purchasing organization did not know, 
as defined in this section, about such ownership or investment interest.
    Payment or other transfer of value means a transfer of anything of 
value.
    Physician has the same meaning given that term in section 1861(r) of 
the Act.
    Physician assistant means a physician assistant who performs such 
services as such individual is legally authorized to

[[Page 108]]

perform (in the State in which the individual performs such services) in 
accordance with State law (or the State regulatory mechanism provided by 
State law), and who meets such training, education, and experience 
requirements (or any combination thereof) as the Secretary may prescribe 
in regulations.
    Related to a covered drug, device, biological, or medical supply 
means that a payment or other transfer of value is made in reference to 
or in connection with one or more covered drugs, devices, biologicals, 
or medical supplies.
    Research includes a systematic investigation designed to develop or 
contribute to generalizable knowledge relating broadly to public health, 
including behavioral and social-sciences research. This term encompasses 
basic and applied research and product development.
    Short term medical supply or device loan means the loan of a covered 
device or a device under development, or the provision of a limited 
quantity of medical supplies for a short-term trial period, not to 
exceed a loan period of 90 days or a quantity of 90 days of average 
daily use, to permit evaluation of the device or medical supply by the 
covered recipient.
    Third party means another individual or entity, regardless of 
whether such individual or entity is operating in the United States.
    Unique device identifier means an identifier that adequately 
identifies a device through its distribution and use by meeting the 
requirements of 21 CFR 801.40 and 830.3.

[78 FR 9521, Feb. 8, 2013, as amended at 79 FR 68000, Nov. 13, 2014; 84 
FR 63185, Nov. 15, 2019; 85 FR 10, Jan 2, 2020]



Sec.  403.904  Reports of payments or other transfers of value 
to covered recipients.

    (a) General rule. (1) Direct and indirect payments or other 
transfers of value provided by an applicable manufacturer to a covered 
recipient during the preceding calendar year, and direct and indirect 
payments or other transfers of value provided to a third party at the 
request of or designated by the applicable manufacturer on behalf of a 
covered recipient during the preceding calendar year, must be reported 
by the applicable manufacturer to CMS on an annual basis.
    (2) For CY 2013, only payments or other transfers of value made on 
or after August 1, 2013 must be reported to CMS.
    (b) Limitations. Certain limitations on reporting apply in the 
following circumstances:
    (1) Applicable manufacturers for whom total (gross) revenues from 
covered drugs, devices, biologicals, or medical supplies constituted 
less than 10 percent of total (gross) revenue during the fiscal year 
preceding the reporting year are only required to report payments or 
other transfers of value that are related to one or more covered drugs, 
devices, biologicals or medical supplies.
    (2) Applicable manufacturers under paragraph (2) of the definition 
in Sec.  403.902 are only required to report payments or other transfers 
of value that are related to a covered drug, device, biological, or 
medical supply for which they provided assistance or support to an 
applicable manufacturer under paragraph (1) of the definition.
    (3) Applicable manufacturers under either paragraph (1) or (2) of 
the definition in Sec.  403.902 that have separate operating divisions 
that do not manufacture any covered drugs, devices, biologicals, or 
medical supplies (for example, animal health divisions) are only 
required to report payments to covered recipients related to the 
activities of these separate divisions if those payments or other 
transfers of value are related to a covered drug, device, biological, or 
medical supply. This includes reporting of payments or other transfers 
of value that are related to covered drugs, devices, biologicals, or 
medical supplies made by applicable manufacturers to covered recipients 
through these operating divisions.
    (4) Applicable manufacturers that do not manufacture a covered drug, 
device, biological, or medical supply except when under a written 
agreement to manufacture the covered drug, device, biological, or 
medical supply for another entity, do not hold the FDA approval, 
licensure, or clearance for the covered drug, device, biological, or

[[Page 109]]

medical supply, and are not involved in the sale, marketing, or 
distribution of the product, are only required to report payments or 
other transfers of value that are related to one or more covered drugs, 
devices, biologicals, or medical supplies.
    (c) Required information to report. A report must contain all of the 
following information for each payment or other transfer of value:
    (1) Name of the covered recipient. For non-teaching hospital covered 
recipients, the name must be as listed in the National Plan & Provider 
Enumeration System (NPPES) (if applicable) and include first and last 
name, middle initial, and suffix (for all that apply).
    (2) Address of the covered recipient. Primary business address of 
the covered recipient, including all the following:
    (i) Street address.
    (ii) Suite or office number (if applicable).
    (iii) City.
    (iv) State.
    (v) ZIP code.
    (3) Identifiers for non-teaching hospital covered recipients. In the 
case of a covered recipient the following identifiers:
    (i) The specialty.
    (ii) National Provider Identifier (if applicable and as listed in 
the NPPES). If a National Provider Identifier cannot be identified for a 
non-teaching hospital covered recipient, the field may be left blank, 
indicating that the applicable manufacturer could not find one.
    (iii) State professional license number(s) (for at least one State 
where the non-teaching hospital covered recipient maintains a license), 
and the State(s) in which the license is held.
    (4) Amount of payment or other transfer of value. A payment or other 
transfer of value made to a group of covered recipients should be 
distributed appropriately among the individual covered recipients who 
requested the payment, on whose behalf the payment was made, or who are 
intended to benefit from the payment or other transfer of value.
    (5) Date of payment or transfer of value. The date of each payment 
or other transfer of value.
    (i) For payments or other transfers of value made over multiple 
dates (rather than as a lump sum), applicable manufacturers may choose 
whether to report each payment or other transfer of value as separate 
line item using the dates the payments or other transfers of value were 
each made, or as a single line item for the total payment or other 
transfer of value using the first payment date as the reported date.
    (ii) For small payments or other transfers of value reported as a 
single line item, applicable manufacturers must report the date that the 
first bundled small payment or other transfer of value was provided to 
the covered recipient.
    (6) Form of payment or transfer of value. The form of each payment 
or other transfer of value, as described in paragraph (d) of this 
section.
    (7) Nature of payment or transfer of value. The nature of each 
payment or other transfer of value, as described in paragraph (e) of 
this section.
    (8) Related covered drug, device, biological or medical supply. 
Report the marketed or brand name of the related covered drugs, devices, 
biologicals, or medical supplies, and therapeutic area or product 
category unless the payment or other transfer of value is not related to 
a particular covered drug, device, biological or medical supply.
    (i) For drugs and biologicals--
    (A) If the marketed name has not yet been selected, applicable 
manufacturers must indicate the name registered on clinicaltrials.gov.
    (B) Any regularly used identifiers must be reported, including, but 
not limited to, national drug codes.
    (ii) For devices, if the device has a unique device identifier 
(UDI), then the device identifier (DI) portions of it must be reported, 
as applicable.
    (iii) Applicable manufacturers may report the marketed name and 
therapeutic area or product category for payments or other transfers of 
value related to a non-covered drug, device, biological, or medical 
supply.
    (iv) Applicable manufacturers must indicate if the related drug, 
device, biological, or medical supply is covered or non-covered.

[[Page 110]]

    (v) Applicable manufacturers must indicate if the payment or other 
transfer of value is not related to any covered or non-covered drug, 
device, biological or medical supply.
    (9) Eligibility for delayed publication. Applicable manufacturers 
must indicate whether a payment or other transfer of value is eligible 
for delayed publication, as described in Sec.  403.910.
    (10) Payments to third parties. (i) If the payment or other transfer 
of value was provided to a third party at the request of or designated 
on behalf of a covered recipient, the payment or transfer of value must 
be reported in the name of that covered recipient.
    (ii) If the payment or other transfer of value was provided to a 
third party at the request of or designated on behalf of a covered 
recipient, the name of the entity that received the payment or other 
transfer of value (if made to an entity) or indicate ``individual'' (if 
made to an individual). If a covered recipient performed a service, but 
neither accepted the offered payment or other transfer of value nor 
requested that it be made to a third party, the applicable manufacturer 
is not required to report the offered payment or other transfer of value 
unless the applicable manufacturer nonetheless provided it to a third 
party and designated such payment or other transfer of value as having 
been provided on behalf of the covered recipient.
    (11) Payments or transfers of value to physician owners or 
investors. Must indicate whether the payment or other transfer of value 
was provided to a physician or the immediate family of the physician who 
holds an ownership or investment interest (as defined Sec.  403.902) in 
the applicable manufacturer.
    (12) Additional information or context for payment or transfer of 
value. May provide a statement with additional context for the payment 
or other transfer of value.
    (d) Reporting the form of payment or other transfer of value. An 
applicable manufacturer must report each payment or transfer of value, 
or separable part of that payment or transfer of value, as taking one of 
the following forms of payment that best describes the form of the 
payment or other transfer of value, or separable part of that payment or 
other transfer of value.
    (1) Cash or cash equivalent.
    (2) In-kind items or services.
    (3) Stock.
    (4) Stock option.
    (5) Any other ownership interest.
    (6) Dividend, profit or other return on investment.
    (e) Reporting the nature of the payment or other transfer of value. 
(1) General rule. The categories describing the nature of a payment or 
other transfer of value are mutually exclusive for the purposes of 
reporting under subpart I of this part.
    (2) Rules for categorizing natures of payment. An applicable 
manufacturer must categorize each payment or other transfer of value, or 
separable part of that payment or transfer of value, with one of the 
categories listed in paragraphs (e)(2)(i) through (xviii) of this 
section, using the designation that best describes the nature of the 
payment or other transfer of value, or separable part of that payment or 
other transfer of value. If a payment or other transfer of value could 
reasonably be considered as falling within more than one category, the 
applicable manufacturer should select one category that it deems to most 
accurately describe the nature of the payment or transfer of value.
    (i) Consulting fee.
    (ii) Compensation for services other than consulting, including 
serving as faculty or as a speaker at an event other than a continuing 
education program.
    (iii) Honoraria.
    (iv) Gift.
    (v) Entertainment.
    (vi) Food and beverage.
    (vii) Travel and lodging (including the specified destinations).
    (viii) Education.
    (ix) Research.
    (x) Charitable contribution.
    (xi) Debt forgiveness.
    (xii) Royalty or license.
    (xiii) Current or prospective ownership or investment interest.
    (xiv) Compensation for serving as faculty or as a speaker for a 
medical education program.

[[Page 111]]

    (xv) Long term medical supply or device loan.
    (xvi) Grant.
    (xvii) Space rental or facility fees (teaching hospital only).
    (xviii) Acquisitions.
    (f) Special rules for research payments. All payments or other 
transfers of value made in connection with an activity that meets the 
definition of research in this section and that are subject to a written 
agreement, a research protocol, or both, must be reported under these 
special rules.
    (1) Research-related payments or other transfers of value to covered 
recipients, including research-related payments or other transfers of 
value made indirectly to a covered recipient through a third party, must 
be reported to CMS separately from other payments or transfers of value, 
and must include the following information (in lieu of the information 
required by Sec.  403.904(c)):
    (i) Name of the research institution, individual or entity receiving 
the payment or other transfer of value.
    (A) If paid to a non-teaching hospital covered recipient, all of the 
following must be provided:
    (1) The non-teaching hospital covered recipient's name as listed in 
the NPPES (if applicable).
    (2) National Provider Identifier.
    (3) State professional license number(s) (for at least one State 
where the non-teaching hospital covered recipient maintains a license) 
and State(s) in which the license is held.
    (4) Specialty.
    (5) Primary business address of the non-teaching hospital covered 
recipient(s).
    (B) If paid to a teaching hospital covered recipient, list the name 
and primary business address of teaching hospital.
    (C) If paid to a non-covered recipient (such as a non-teaching 
hospital or clinic), list the name and primary business address of the 
entity.
    (ii) Total amount of the research payment, including all research-
related costs for activities outlined in a written agreement, research 
protocol, or both.
    (iii) Name of the research study.
    (iv) Name(s) of any related covered drugs, devices, biologicals, or 
medical supplies (subject to the requirements specified in paragraph 
(c)(8) of this section); for drugs and biologicals, the relevant 
National Drug Code(s), if any; and for devices and medical supplies, the 
relevant device identifier, if any, and the therapeutic area or product 
category if a marketed name is not available.
    (v) Information about each non-teaching hospital covered recipient 
principal investigator (if applicable) set forth in paragraph 
(f)(1)(i)(A) of this section.
    (vi) Contextual information for research (optional).
    (vii) ClinicalTrials.gov identifier (optional).
    (2) For pre-clinical studies (before any human studies have begun), 
only report the following information:
    (i) Research entity name (as required in paragraph (f)(1)(i) of this 
section).
    (ii) Total amount of payment (as required in paragraph (f)(1)(ii) of 
this section).
    (ii) Principal investigator(s) (as required in paragraph (f)(1)(v) 
of this section).
    (g) Special rules for reporting food and beverage. (1) When 
allocating the cost of food and beverage among covered recipients in a 
group setting where the cost of each individual covered recipient's meal 
is not separately identifiable, such as a platter provided to physicians 
in a group practice setting, applicable manufacturers must calculate the 
value per person by dividing the entire cost of the food or beverage by 
the total number of individuals who partook in the meal (including both 
covered recipients and non-covered recipients, such as office staff). 
The per person value of the meal must be reported as a payment or other 
transfer of value only for covered recipients who actually partook in 
the food or beverage.
    (2) Applicable manufacturers are not required to report or track 
buffet meals, snacks, soft drinks, or coffee made generally available to 
all participants of a large-scale conference or similar large-scale 
event.
    (h) Exclusions from reporting. The following are excluded from the 
reporting requirements specified in this section:

[[Page 112]]

    (1) Indirect payments or other transfers of value (as defined in 
Sec.  403.902), where the applicable manufacturer is unaware of the 
identity of the covered recipient. An applicable manufacturer is unaware 
of the identity of a covered recipient if the applicable manufacturer 
does not know (as defined in Sec.  403.902) the identity of the covered 
recipient during the reporting year or by the end of the second quarter 
of the following reporting year.
    (2)(i) For CY 2013, payments or other transfers of value less than 
$10, unless the aggregate amount transferred to, requested by, or 
designated on behalf of the covered recipient exceeds $100 in a calendar 
year.
    (ii) For CY 2014 and subsequent calendar years, to determine if 
transfers of value are excluded under this section, the dollar amounts 
specified in paragraph (h)(2)(i) of this section must be increased by 
the same percentage as the percentage increase in the consumer price 
index for all urban consumers (all items; U.S. city average) for the 12-
month period ending with June of the previous year. CMS will publish the 
values for the next reporting year 90 days before the beginning of the 
reporting year.
    (iii) Payments or other transfers of value of less than $10 in CY 
2013 (or less than the amount described in paragraph (h)(2)(i) of this 
section for CY 2014 and subsequent calendar years) provided at large-
scale conferences and similar large-scale events, as well as events open 
to the public, do not need to be reported nor included for purposes of 
the $100 aggregate threshold in CY 2013 (or the aggregate threshold 
calculated in accordance paragraph (h)(2)(i) of this section for CY 2014 
and subsequent calendar years), even if the aggregate total for a 
covered recipient exceeds the aggregate threshold for the calendar year.
    (iv) When reporting payments or other transfers of value under the 
$10 threshold for CY 2013 (or under the amount described in paragraph 
(i)(2)(ii) of this section for CY 2014 and subsequent calendar years) 
for covered recipients that exceed the aggregate threshold for the 
reporting year, applicable manufacturers may (but are not required to) 
report all small payments to a particular covered recipient that fall 
within the same nature of payment category as a single payment or other 
transfer of value.
    (3) Product samples, including coupons and vouchers that can be used 
by a patient to obtain samples, which are not intended to be sold and 
are intended for patient use.
    (4) Educational materials and items that directly benefit patients 
or are intended to be used by or with patients, including the value of 
an applicable manufacturer's services to educate patients regarding a 
covered drug, device, biological, or medical supply.
    (5) Short term medical supply or device loan.
    (6) Items or services provided under a contractual warranty 
(including service or maintenance agreements), whether or not the 
warranty period has expired, including the replacement of a covered 
device, where the terms of the warranty are set forth in the purchase or 
lease agreement for the covered device.
    (7) A transfer of anything of value to a non-teaching hospital 
covered recipient when the covered recipient is a patient, research 
subject or participant in data collection for research, and not acting 
in the professional capacity of a covered recipient.
    (8) Discounts, including rebates.
    (9) In-kind items used for the provision of charity care.
    (10) A dividend or other profit distribution from, or ownership or 
investment interest in, a publicly traded security or mutual fund.
    (11) In the case of an applicable manufacturer who offers a self-
insured plan or directly reimburses for healthcare expenses, payments 
for the provision of health care to employees and their families.
    (12) In the case of a covered recipient who is a licensed non-
medical professional, a transfer of anything of value to the covered 
recipient if the transfer is payment solely for the non-medical 
professional services of the licensed non-medical professional.
    (13) In the case of a non-teaching hospital covered recipient, a 
transfer of anything of value to the covered recipient if the transfer 
is payment solely for the services of the covered recipient

[[Page 113]]

with respect to an administrative proceeding, legal defense, 
prosecution, or settlement or judgment of a civil or criminal action and 
arbitration.
    (14) A payment or transfer of value to a covered recipient if the 
payment or transfer of value is made solely in the context of a 
personal, non-business-related relationship.

[78 FR 9521, Feb. 8, 2013, as amended at 79 FR 68000, Nov. 13, 2014; 84 
FR 63186, Nov. 15, 2019]



Sec.  403.906  Reports of physician ownership and investment interests.

    (a) General rule. (1) Each applicable manufacturer and applicable 
group purchasing organization must report to CMS on an annual basis all 
ownership and investment interests in the applicable manufacturer or 
applicable group purchasing organization that were held by a physician 
or an immediate family member of a physician during the preceding 
calendar year.
    (2) For CY 2013, only ownership or investment interests held on or 
after August 1, 2013 must be reported to CMS.
    (b) Identifying information. Reports on physician ownership and 
investment interests must include the following identifying information:
    (1) Name of the physician (as listed in the National Plan & Provider 
Enumeration System (if applicable), including first and last name, 
middle initial, and suffix (for all that apply), and an indication of 
whether the ownership or investment interest was held by the physician 
or an immediate family member of the physician.
    (2) Primary business address of the physician, including the 
following:
    (i) Street address.
    (ii) Suite or office number (if applicable).
    (iii) City.
    (iv) State.
    (v) ZIP code.
    (3) The following information for the physician (regardless of 
whether the ownership or investment interest is held by an immediate 
family member of the physician):
    (i) The specialty.
    (ii) National Provider Identifier (if applicable and as listed in 
NPPES).
    (iii) State professional license number(s) (for at least one State 
where the physician maintains a license), and the State(s) in which the 
license is held.
    (4) Dollar amount invested by each physician or immediate family 
member of the physician.
    (5) Value and terms of each ownership or investment interest.
    (6) Direct and indirect payments or other transfers of value 
provided to a physician holding an ownership or investment interest, and 
direct and indirect payments or other transfers of value provided to a 
third party at the request of or designated by the applicable 
manufacturer or applicable group purchasing organization on behalf of a 
physician owner or investor, must be reported by the applicable 
manufacturer or applicable group purchasing organization in accordance 
with the requirements for reporting payments or other transfers of value 
in Sec.  403.904(c) through (h). The terms ``applicable manufacturer and 
applicable group purchasing organization'' must be substituted for 
``applicable manufacturer,'' and ``physician owner or investor'' must be 
substituted for ``covered recipient'' in each place they appear.

[78 FR 9521, Feb. 8, 2013, as amended at 79 FR 68001, Nov. 13, 2014]



Sec.  403.908  Procedures for electronic submission of reports.

    (a) File format. Reports required under this subpart must be 
electronically submitted to CMS by March 31, 2014, and by the 90th day 
of each subsequent calendar year.
    (b) General rules. (1) If an applicable manufacturer made no 
reportable payments or transfers of value in the previous calendar year, 
nor had any reportable ownership or investment interests held by a 
physician or a physician's immediate family member (as defined in Sec.  
403.902) during the previous calendar year, the applicable manufacturer 
is not required to file a report.
    (2) If an applicable group purchasing organization had no reportable 
ownership or investment interests held by a physician or physician's 
immediate family member during the previous calendar year, the 
applicable group purchasing organization is not required to file a 
report.

[[Page 114]]

    (c) Registration. (1) Applicable manufacturers that have reportable 
payments or other transfers of value, ownership or investment interests, 
or both, are required to report under this subpart and must register 
with CMS within 90 days of the end of the calendar year for which a 
report is required.
    (2) Applicable group purchasing organizations that have reportable 
ownership or investment interests are required to report under this 
subpart and must register with CMS within 90 days of the end of the 
calendar year for which a report is required.
    (3) During registration, applicable manufacturers and applicable 
group purchasing organizations must name two points of contact with 
appropriate contact information.
    (d) Other rules. (1) Consolidated reports. (i) An applicable 
manufacturer under paragraph (1) of the definition that is under common 
ownership with separate entities that are also applicable manufacturers 
under paragraph (1) of the definition may, but is not required to, file 
a consolidated report of all the payments or other transfers of value to 
covered recipients, and physician ownership or investment interests, for 
all of the entities.
    (ii) An applicable manufacturer under paragraph (1) of the 
definition of applicable manufacturer and an entity (or entities) under 
common ownership with the applicable manufacturer under paragraph (2) of 
the definition of applicable manufacturer may, but are not required to, 
file a consolidated report of all the payments or other transfers of 
value to covered recipients, and physician ownership or investment 
interests.
    (iii) If multiple applicable manufacturers (under paragraph (1) or 
(2) of the definition or both paragraphs of the definition) submit a 
consolidated report, the report must provide the names of each 
applicable manufacturer and entity (or entities) under common ownership 
that the report covers, and the report must identify the specific entity 
that provided each payment.
    (iv) A single payment or other transfer of value reported in a 
consolidated report must only be reported once by one applicable 
manufacturer.
    (v) The applicable manufacturer submitting a consolidated report on 
behalf of itself and other applicable manufacturers under common 
ownership, as permitted under this paragraph, is liable for civil 
monetary penalties imposed on each of the applicable manufacturers whose 
reportable payments or other transfers of value were included in the 
consolidated report, up to the annual maximum amount specified in Sec.  
403.912(c) for each individual applicable manufacturer included in the 
report.
    (2) Joint ventures. If a payment or other transfer of value is 
provided in accordance with a joint venture or other cooperative 
agreement between two or more applicable manufacturers, the payment or 
other transfer of value must be reported--
    (i) In the name of the applicable manufacturer that actually 
furnished the payment or other transfer of value to the covered 
recipient, unless the terms of a written agreement between the 
applicable manufacturers specifically require otherwise, so long as the 
agreement requires that all payments or other transfers of value in 
accordance with the arrangement are reported by one of the applicable 
manufacturers; and
    (ii) Only once by one applicable manufacturer.
    (e) Attestation. Each report, including any subsequent corrections 
to a filed report, must include an attestation by the Chief Executive 
Officer, Chief Financial Officer, Chief Compliance Officer, or other 
Officer of the applicable manufacturer or applicable group purchasing 
organization that the information reported is timely, accurate, and 
complete to the best of his or her knowledge and belief. For applicable 
manufacturers choosing to submit a consolidated report in accordance 
with paragraph (d)(1) of this section, the applicable manufacturer 
submitting the consolidated report must attest on behalf of itself, in 
addition to each of the other applicable manufacturers included in the 
consolidated report.
    (f) Assumptions document. Applicable manufacturers and applicable 
group purchasing organizations may submit an assumptions document, 
explaining the reasonable assumptions made and

[[Page 115]]

methodologies used when reporting payments or other transfers of value, 
or ownership or investment interests. The assumptions documents will not 
be made available to covered recipients, physician owners or investors, 
or the public.
    (g) 45-day review period for review and error correction. (1) 
General rule. Applicable manufacturers, applicable group purchasing 
organizations, covered recipients, and physician owners or investors 
must have an opportunity to review and submit corrections to the 
information submitted for a period of not less than 45-days before CMS 
makes the information available to the public. In no case may this 45-
day period for review and submission of corrections prevent the 
information from being made available to the public.
    (2) Notification. CMS notifies the applicable manufacturers, 
applicable group purchasing organizations, covered recipients, and 
physician owners or investors when the reported information is ready for 
review.
    (i) Applicable manufacturers and applicable group purchasing 
organizations are notified through the points of contact they identified 
during registration.
    (ii) Covered recipients--
    (A) Are notified using an online posting and notifications on CMS's 
listserves.
    (B) May also register with CMS to receive notification about the 
review processes.
    (iii) The 45-day review period begins on the date specified in the 
online notification.
    (3) Process. (i) An applicable manufacturer, applicable group 
purchasing organization, covered recipient or a physician owner or 
investor may log into a secure Web site to view only the information 
reported specifically about itself.
    (ii) Covered recipients and physician owners or investors are able 
to review data submitted about them for the previous reporting year.
    (iii) If the applicable manufacturer, applicable group purchasing 
organization, covered recipient, or physician owner or investor agrees 
with the information reported, the applicable manufacturer, applicable 
group purchasing organization, covered recipient, or physician owner or 
investor may electronically certify that the information reported is 
accurate.
    (iv) If a covered recipient or physician owner or investor disagrees 
with the information reported, the covered recipient or physician owner 
or investor can initiate a dispute, which is sent to the appropriate 
applicable manufacturer or applicable group purchasing organization to 
be resolved between the parties.
    (v) Covered recipients and physician owners or investors may 
initiate disputes at any time after the 45-day period begins, but before 
the end of the calendar year, but any changes resulting from disputes 
initiated outside the 45-day period, may not be made until the next time 
the data is refreshed.
    (4) Data disputes. (i) In order to be corrected prior to the 
publication of the data, applicable manufacturers and applicable group 
purchasing organizations must notify CMS of resolved disputes and 
changes to the information submitted by no later than 15 days after the 
end of the 45-day period (that is, 60 days after the 45-day review 
period begins).
    (ii) Disputes which are not resolved by 15 days after the end of the 
review and correction period, may still be resolved, but any changes 
resulting from the disputes may be made until the next time the data is 
refreshed.
    (iii) If the dispute is not resolved by 15 days after the end of the 
45-day review and correction period, CMS publicly reports and aggregates 
the applicable manufacturer's or applicable group purchasing 
organization's version of the payment or other transfer of value, or 
ownership or investment interest data, but marks the payment or other 
transfer of value or ownership or investment interest as disputed.
    (h) Errors or omissions. (1) If an applicable manufacturer or 
applicable group purchasing organization discovers an error or omission 
in its annual report, it must submit corrected information to CMS 
immediately upon confirmation of the error or omission.
    (2) Upon receipt, CMS notifies the affected covered recipient or 
physician owner or investor that the additional

[[Page 116]]

information has been submitted and is available for review. CMS updates 
the Web site at least once annually with corrected information.

[78 FR 9521, Feb. 8, 2013, as amended at 84 FR 63187, Nov. 15, 2019]



Sec.  403.910  Delayed publication for payments made under product research 
or development agreements and clinical investigations.

    (a) General rule. Certain research payments or other transfers of 
value made to a covered recipient by an applicable manufacturer under a 
product research or development agreement may be delayed from 
publication on the Web site. Publication of a payment or other transfer 
of value is delayed when made in connection with the following 
instances:
    (1) Research on or development of a new drug, device, biological, or 
medical supply, or a new application of an existing drug, device, 
biological, or medical supply.
    (2) Clinical investigations regarding a new drug, device, 
biological, or medical supply.
    (b) Research or development agreement. The research or development 
agreement must include a written agreement, a research protocol, or both 
between the applicable manufacturer and covered recipient.
    (c) Date of publication. Payments or other transfers of value 
eligible for delayed publication must be reported to CMS (in the manner 
required in Sec.  403.904(f)) on the first reporting date following the 
year in which they occur, but CMS does not publicly post the payment 
until the first annual publication date after the earlier of the 
following:
    (1) The date of the approval, licensure or clearance of the covered 
drug, device, biological, or medical supply by FDA.
    (2) Four calendar years after the date the payment or other transfer 
of value was made.
    (d) Notification of delayed publication. (1) An applicable 
manufacturer must indicate on its research report to CMS whether a 
payment or other transfer of value is eligible for a delay in 
publication. The absence of this indication in the report will result in 
CMS posting all payments publicly in the first year of public reporting.
    (2) An applicable manufacturer must continue to indicate annually in 
its report that FDA approval, licensure, or clearance of the new drug, 
device, biological or medical supply to which the payment or other 
transfer of value is related, is pending.
    (3) An applicable manufacturer must notify CMS during subsequent 
annual submissions, if the new drug, device, biological or medical 
supply, to which the payment is related (or the new application of the 
existing drug, device, biological, or medical supply), is approved by 
the FDA.
    (4) Failure to notify CMS when FDA approval occurs may be considered 
failure to report, and the applicable manufacturer may be subject to 
civil monetary penalties.
    (5) If, after 4 years from the date of a payment first appearing in 
a report to CMS, there is an indication in a report that the payment is 
subject to delayed reporting, it is reported regardless of the 
indication.
    (e) Confidentiality. Information submitted and eligible for delayed 
publication is considered confidential and will not be subject to 
disclosure under 5 U.S.C. 552, or any similar Federal, State, or local 
law, until on or after the date on which the information made available 
to the public as required in this section.



Sec.  403.912  Penalties for failure to report.

    (a) Failure to report. (1) Any applicable manufacturer or applicable 
group purchasing organization that fails to timely, accurately or 
completely report the information required in accordance with the rules 
established under this subpart is subject to a civil monetary penalty of 
not less than $1,000, but not more than $10,000, as adjusted annually 
under 45 CFR part 102 for each payment or other transfer of value or 
ownership or investment interest not reported timely, accurately, or 
completely.
    (2) The total amount of civil monetary penalties imposed on each 
applicable manufacturer or applicable group purchasing organization 
(regardless of whether the applicable manufacturer

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was a part of a consolidated report) with respect to failures to report 
in an annual submission of information will not exceed $150,000 as 
adjusted annually under 45 CFR part 102.
    (b) Knowing failure to report. (1) Any applicable manufacturer or 
applicable group purchasing organization that knowingly fails to timely, 
accurately or completely report the information required in accordance 
with the rules established under this subpart is subject to a civil 
monetary penalty of not less than $10,000, but not more than $100,000, 
as adjusted annually under 45 CFR part 102 for each payment or other 
transfer of value or ownership or investment interest not reported 
timely, accurately, or completely.
    (2) The total amount of civil monetary penalties imposed on each 
applicable manufacturer or group purchasing organization (regardless of 
whether the applicable manufacturer was a part of a consolidated report) 
with respect to knowing failures to report in an annual submission of 
information will not exceed $1,000,000 as adjusted annually under 45 CFR 
part 102.
    (c) Total annual civil monetary penalties. The amount of civil 
monetary penalties imposed on each applicable manufacturer or applicable 
group purchasing organization under paragraphs (a)(1) and (b)(1) of this 
section are--
    (1) Aggregated separately;
    (2) Subject to separate aggregate totals under paragraphs (a)(2) and 
(b)(2) of this section, with a maximum combined annual total of 
$1,150,000 as adjusted annually under 45 CFR part 102.
    (d) Determinations regarding the amount of civil monetary penalties. 
In determining the amount of the civil monetary penalty, factors to be 
considered include, but are not limited to, the following:
    (1) The length of time the applicable manufacturer or applicable 
group purchasing organization failed to report, including the length of 
time the applicable manufacturer or applicable group purchasing 
organization knew of the payment or other transfer of value, or 
ownership or investment interest.
    (2) Amount of the payment the applicable manufacturer or applicable 
group purchasing organization failed to report.
    (3) Level of culpability.
    (4) Nature and amount of information reported in error.
    (5) Degree of diligence exercised in correcting information reported 
in error.
    (e) Record retention and audits. (1) Maintenance of records. (i) 
Applicable manufacturers and applicable group purchasing organizations 
must maintain all books, contracts, records, documents, and other 
evidence sufficient to enable the audit, evaluation, and inspection of 
the applicable manufacturer's or applicable group purchasing 
organization's compliance with the requirement to timely, accurately or 
completely submit information in accordance with the rules established 
under this subpart.
    (ii) The items described in paragraph (e)(1)(i) of this section must 
be maintained for a period of at least 5 years from the date the payment 
or other transfer of value, or ownership or investment interest is 
published publicly on the Web site.
    (2) Audit. HHS, CMS, OIG or their designees may audit, inspect, 
investigate and evaluate any books, contracts, records, documents, and 
other evidence of applicable manufacturers and applicable group 
purchasing organizations that pertain to their compliance with the 
requirement to timely, accurately or completely submit information in 
accordance with the rules established under this subpart.
    (3) The requirements in this subpart are in addition to, and do not 
limit, any other applicable requirements that may obligate applicable 
manufacturers or applicable group purchasing organizations to retain and 
allow access to records.
    (f) Use of funds. Funds collected by the Secretary as a result of 
the imposition of a civil monetary penalty under this section must be 
used to carry out the operation of this subpart.
    (g) Notice, hearings, appeals, and collection. Civil monetary 
penalties imposed under this section are subject to the provisions set 
forth in subparts A

[[Page 118]]

and B of part 402 of this chapter, including those pertaining to notice, 
opportunity for a hearing, appeals procedures, and collection of 
penalties.

[78 FR 9521, Feb. 8, 2013, as amended at 81 FR 61561, Sept. 6, 2016; 82 
FR 42749, Sept. 12, 2017]



Sec.  403.914  Preemption of State laws.

    (a) General rule. In the case of a payment or other transfer of 
value provided by an applicable manufacturer to a covered recipient, 
this subpart preempts any statute or regulation of a State or political 
subdivision of a State that requires an applicable manufacturer to 
disclose or report, in any format, the type of information regarding the 
payment or other transfer of value required to be reported under this 
subpart.
    (b) Information collected for public health purposes. (1) 
Information required to be reported to a Federal, State, or local 
governmental agency for public health surveillance, investigation, or 
other public health purposes or health oversight purposes must still be 
reported to appropriate Federal, State, or local governmental agencies, 
regardless of whether the same information is required to be reported 
under this subpart.
    (2) Governmental agencies include, but are not limited to, the 
following:
    (i) Agencies that are charged with preventing or controlling 
disease, injury, disability.
    (ii) Agencies that conduct oversight activities authorized by law, 
including audits, investigations, inspections, licensure or disciplinary 
actions, or other activities necessary for oversight of the health care 
system.



 Subpart K_Access to Identifiable Data for the Center for Medicare and 
                             Medicaid Models

    Source: 79 FR 68001, Nov. 13, 2014, unless otherwise noted.



Sec.  403.1100  Purpose and scope.

    The regulations in this subpart implement section 1115A of the Act. 
The intent of that section is to enable CMS to test innovative payment 
and service delivery models to reduce program expenditures while 
preserving and/or enhancing the quality of care furnished to individuals 
under titles XVIII, XIX, and XXI of the Act. The Secretary is also 
required to conduct an evaluation of each model tested.



Sec.  403.1105  Definitions.

    For purposes of this subpart--
    Applicable titles means Titles XVIII, XIX, or XXI of the Act.



Sec.  403.1110  Evaluation of models.

    (a) Evaluation. The Secretary conducts an evaluation of each model 
tested under section 1115A of the Act. Such evaluation must include an 
analysis of the following:
    (1) The quality of care furnished under the model, including the 
measurement of patient-level outcomes and patient-centeredness criteria 
determined appropriate by the Secretary.
    (2) The changes in spending under the applicable titles by reason of 
the model.
    (b) Information. Any State or other entity participating in the 
testing of a model under section 1115A of the Act must collect and 
report such information, including ``protected health information'' as 
that term is defined at 45 CFR 160.103, as the Secretary determines is 
necessary to monitor and evaluate such model. Such data must be produced 
to the Secretary at the time and in the form and manner specified by the 
Secretary.



Subpart L_Requirements for Direct-to-Consumer Television Advertisements 
   of Drugs and Biological Products To Include the List Price of That 
                           Advertised Product

    Source: 84 FR 20757, May 10, 2019, unless otherwise noted.



Sec.  403.1200  Scope.

    (a) Covered pharmaceuticals. Except as specified in paragraph (b) of 
this section, this subpart applies to advertisements for a prescription 
drug or biological product distributed in the United States for which 
payment is available, directly or indirectly, under titles XVIII or XIX 
of the Social Security Act.

[[Page 119]]

    (b) Excepted pharmaceuticals. An advertisement for any prescription 
drug or biological product that has a list price, as defined in Sec.  
403.1201, less than $35 per month for a 30-day supply or typical course 
of treatment shall be exempt from the requirements of this subpart.



Sec.  403.1201  Definitions.

    For the purposes of this subpart, the following definitions apply:
    (a) Biological product. Biological product means any biological 
product, as that term is defined in Public Health Service Act (``PHS 
Act'') section 351(i), that is licensed by the Food and Drug 
Administration pursuant to section 351 and is subject to the 
requirements of Federal Food, Drug, and Cosmetic Act (FDCA) section 
503(b)(1).
    (b) Prescription drug. Prescription drug means any drug, as defined 
in the FDCA section 201(g), that has been approved by the Food and Drug 
Administration pursuant to FDCA section 505 and is subject to the 
requirements of FDCA section 503(b)(1).
    (c) List price. List price means the wholesale acquisition cost, as 
defined in paragraph (d) of this section.
    (d) Wholesale acquisition cost. Wholesale acquisition cost means, 
with respect to a prescription drug or biological product, the 
manufacturer's list price for the prescription drug or biological 
product to wholesalers or direct purchasers in the United States, not 
including prompt pay or other discounts, rebates or reductions in price, 
for the most recent month for which the information is available, as 
reported in wholesale price guides or other publications of drug or 
biological product pricing data.



Sec.  403.1202  Pricing information.

    Any advertisement for any prescription drug or biological product on 
television (including broadcast, cable, streaming, or satellite) must 
contain a textual statement indicating the current list price for a 
typical 30-day regimen or for a typical course of treatment, whichever 
is most appropriate, as determined on the first day of the quarter 
during which the advertisement is being aired or otherwise broadcast, as 
follows: ``The list price for a [30-day supply of ] [typical course of 
treatment with] [name of prescription drug or biological product] is 
[insert list price]. If you have health insurance that covers drugs, 
your cost may be different.'' Where the price is related to the typical 
course of treatment and that typical course of treatment varies 
depending on the indication for which a prescription drug or biological 
product is prescribed, the list price to be used is the one for the 
typical course of treatment associated with the primary indication 
addressed in the advertisement.



Sec.  403.1203  Specific presentation requirements.

    The textual statement described in Sec.  403.1202 shall be presented 
at the end of an advertisement in a legible manner, meaning that it is 
placed appropriately and is presented against a contrasting background 
for sufficient duration and in a size and style of font that allows the 
information to be read easily.



Sec.  403.1204  Compliance.

    (a) Identification of non-compliant products. The Secretary will 
maintain a public list that will include the prescription drugs and 
biological products identified by the Secretary to be advertised in 
violation of this subpart.
    (b) State or local requirements. No State or political subdivision 
of any State may establish or continue in effect any requirement 
concerning the disclosure in a television advertisement of the pricing 
of a prescription drug or biological product which is different from, or 
in addition to, any requirement imposed by this subpart.



PART 404_REVIEW OF REGULATIONS (Eff. 3	22	22)--Table of Contents



Sec.
404.1 Retrospective Review of Existing Regulations
404.2-404.5 [Reserved]

    Authority: 5 U.S.C. 301; 5 U.S.C. 610; 31 U.S.C. 9701; 42 U.S.C. 
263a; 42 U.S.C. 273; 42 U.S.C. 300e; 42 U.S.C. 300e-5; 42 U.S.C. 300e-9; 
42 U.S.C. 405(a), 42 U.S.C. 1302; 42 U.S.C. 1306; 42 U.S.C. 1315a; 42 
U.S.C. 1320a-7; 42 U.S.C. 1320a-7j; 42 U.S.C. 1320b-8; 42 U.S.C. 1320b-
12; 42 U.S.C. 1395; 42 U.S.C. 1395aa(m); 42 U.S.C. 1395cc; 42 U.S.C. 
1395d(d); 42 U.S.C. 1395ddd; 42 U.S.C. 1395eee(f); 42 U.S.C. 1395f(b); 
42 U.S.C.

[[Page 120]]

1395ff; 42 U.S.C. 1395g; 42 U.S.C. 1395hh; 42 U.S.C. 1395i; 42 U.S.C. 
1395i-3; 42 U.S.C. 1395l(a), (i), (n), and (t); 42 U.S.C. 1395jjj; 42 
U.S.C. 1395kk; 42 U.S.C. 1395m; 42 U.S.C. 1395nn; 42 U.S.C. 1395rr; 42 
U.S.C. 1395rr(b)(l); 42 U.S.C. 1395tt; 42 U.S.C. 1395w-5; 42 U.S.C. 
1395w-101 through 1395w-152; 42 U.S.C. 1395ww; 42 U.S.C. 1395ww(k); 42 
U.S.C. 1395x; 1395x(e), the sentence following 1395x(s)(11) through 
1395x(s)(16)); 42 U.S.C. 1395x(v); 42 U.S.C. 1395y(a); 42 U.S.C. 1396r; 
42 U.S.C. 1396r-8; 42 U.S.C. 1396u-4(f); 44 U.S.C. Chapter 35; Section 
1331 of the Patient Protection and Affordable Care Act of 2010 (Pub. L. 
111-148, 124 Stat. 119), as amended by the Health Care and Education 
Reconciliation Act of 2010 (Pub. L. 111-152, 124 Stat 1029); Pub. L. 
112-202 amendments to 42 U.S.C. 263a; sec. 105, Pub. L. 114-10, 129 
Stat. 87.

    Source: 86 FR 5753, Jan. 19, 2021, unless otherwise noted.

    Effective Date Note: At 86 FR 5753, Jan. 19, 2021, part 404 was 
added, a delay published at 86 FR 15404, Mar. 23, 2021, further delaying 
the effective date until Mar. 22, 2022.



Sec.  404.1  Retrospective Review of Existing Regulations.

    (a) This section applies to and shall be deemed to amend all 
regulations issued by the Secretary or his delegates or sub-delegates in 
this chapter.
    (b) For purposes of this section,
    (1) Assess shall refer to a determination by the Department, in 
consultation with other Federal agencies as appropriate, as to whether 
the Sections issued as part of the same rulemaking (and any amendments 
or additions that may have been added thereafter) currently have a 
significant economic impact upon a substantial number of small entities.
    (2) Review shall refer to a process conducted by the Department, in 
consultation with other Federal agencies as appropriate, the purpose of 
which shall be to determine whether Sections that were issued as part of 
the same rulemaking (and any amendments or additions that may have been 
issued thereafter) should be continued without change, or should be 
amended or rescinded, consistent with the stated objectives of 
applicable statutes, to minimize any significant economic impact of the 
Sections upon a substantial number of small entities.
    (3) Section (when capitalized) shall mean a section of the Code of 
Federal Regulations. For example, 42 CFR 2.13 is a Section, and 42 CFR 
2.14 is another Section (see 1 CFR 21.11).
    (4) Year of the Section's promulgation shall mean the year the 
Section first became effective, irrespective of whether it was 
subsequently amended.
    (5) Significant economic impact upon a substantial number of small 
entities shall have the meaning of that term in section 610 of title 5 
of the United States Code.
    (c)(1) Unless a Section expires earlier or is rescinded, all 
Sections issued by the Secretary or his delegates or sub-delegates in 
this chapter shall expire at the end of:
    (i) Five calendar years after the year that this section first 
becomes effective;
    (ii) Ten calendar years after the year of the Section's 
promulgation; or
    (iii) Ten calendar years after the last year in which the Department 
assessed and (if review of the Section is required pursuant to paragraph 
(d) of this section) reviewed the Section, whichever is latest.
    (2) The last year in which the Department assessed and (if review of 
the Section is required) reviewed the Section shall be the year during 
which the findings of the assessment and (if required) the review of a 
Section are published in the Federal Register pursuant to paragraph (f) 
of this section.
    (3)(i) If, prior to the expiration of a Section under paragraph 
(c)(1) of this section, the Secretary makes a written determination that 
the public interest requires continuation of the Section in force beyond 
the date on which the Section would otherwise expire under paragraph 
(c)(1), the Secretary may continue the Section in force one time for a 
period stated in the determination, which shall not exceed one calendar 
year.
    (ii) The Department shall promptly publish in the Federal Register 
any written determination under paragraph (c)(3)(i) of this section.
    (iii) The authority of the Secretary under paragraph (c)(3)(i) of 
this section is not delegable and may be exercised only by the Secretary 
or, when the office of the Secretary is vacant or the Secretary has 
become unable to perform the functions and duties of the office of the 
Secretary, by the individual

[[Page 121]]

acting as Secretary in accordance with the law.
    (d) The Department is required to review those rulemakings (and any 
amendments or additions that may have been added thereafter) that the 
Department assesses have a significant economic impact upon a 
substantial number of small entities. In reviewing rulemakings to 
minimize any significant economic impact on a substantial number of 
small entities in a manner consistent with the stated objectives of 
applicable statutes, the Department's review shall consider the 
following factors:
    (1) The continued need for the rulemaking, consideration of which 
shall include but not be limited to the extent to which the rulemaking 
defines terms or sets standards used in or otherwise applicable to other 
Federal rules;
    (2) The nature of complaints or comments received concerning the 
rulemaking from the public;
    (3) The complexity of the rulemaking;
    (4) The extent to which the rulemaking overlaps, duplicates or 
conflicts with other Federal rules, and, to the extent feasible, with 
State and local governmental rules;
    (5) The degree to which technology, economic conditions, or other 
factors have changed in the area affected by the rulemaking since the 
rulemaking was promulgated or the last time the rulemaking was reviewed 
by the Department; and
    (6) Whether the rulemaking complies with applicable law.
    (e) If the review concludes the Section should be amended or 
rescinded, the Department shall have two years from the date that the 
findings of the review are published in the Federal Register pursuant to 
paragraph (f) of this section to amend or rescind the Section. If the 
Secretary determines that completion of the amendment or rescission is 
not feasible by the established date, he shall so certify in a statement 
published in the Federal Register and may extend the completion date by 
one year at a time, no more than three times, for a total of not more 
than five years (inclusive of the initial two-year period).
    (f) The results of all assessments and reviews conducted in a 
calendar year, including the full underlying analyses and data used to 
support the results (subject to any applicable privilege, protections 
for confidential business information, or explicit legal prohibition on 
disclosure), shall be published in a single document in the Federal 
Register during that calendar year. The document shall be organized in a 
manner that enables both the Department and the public to readily 
determine which assessments and reviews were conducted during that 
calendar year. The document shall also specify the year by which the 
next assessment (and, if required, the next review) of the Section shall 
be completed.
    (g) Paragraph (c) of this section shall not apply to:
    (1) Sections that are prescribed by Federal law, such that the 
Department exercises no discretion as to whether to promulgate the 
Section and as to what is prescribed by the Section. For Sections 
described in this paragraph (g)(1) that are adopted after the effective 
date of this section, the Federal law described in this paragraph (g)(1) 
shall be cited in the notice of adoption.
    (2) Sections whose expiration pursuant to this section would violate 
any other Federal law.
    (3) This section.
    (4) Sections that involve a military or foreign affairs function of 
the United States.
    (5) Sections addressed solely to internal agency management or 
personnel matters.
    (6) Sections related solely to Federal Government procurement.
    (7) Sections that were issued jointly with other Federal agencies, 
or that were issued in consultation with other agencies because of a 
legal requirement to consult with that other agency.
    (8) The annual Medicare payment update rules.
    (h) When the Department commences the process of performing an 
assessment or review, it shall state on a Department-managed website the 
Section(s) whose assessment or review it is commencing. It shall also 
announce once a month in the Federal Register those new assessments or 
reviews that it has commenced in the last month.

[[Page 122]]

The Department will create a docket on Regulations.gov for each 
assessment or review that the Department is conducting. The public will 
be able to submit comments to the dockets of each rulemaking being 
assessed or reviewed. Each docket shall specify the date by which 
comments must be received. There shall also be a general docket on 
Regulations.gov where the public can submit comments requesting that the 
Department assess or review a Section.
    (i) Any provision of this section held to be invalid or 
unenforceable by its terms, or as applied to any person or circumstance, 
shall be construed so as to continue to give the maximum effect to the 
provision permitted by law, unless such holding shall be one of utter 
invalidity or unenforceability, in which event the provision shall be 
severable from this section and shall not affect the remainder thereof 
or the application of the provision to persons not similarly situated or 
to dissimilar circumstances.



Sec. Sec.  404.2-404.5  [Reserved]

[[Page 123]]



                      SUBCHAPTER B_MEDICARE PROGRAM





PART 405_FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED--Table of Contents



Subpart A [Reserved]

Subpart B_Medical Services Coverage Decisions That Relate to Health Care 
                               Technology

Sec.
405.201 Scope of subpart and definitions.
405.203 FDA categorization of investigational devices.
405.205 Coverage of a non-experimental/investigational (Category B) 
          device.
405.207 Services related to a noncovered device.
405.209 Payment for a Category B (Nonexperimental/investigational) 
          device.
405.211 Coverage of items and services in FDA-approved IDE studies.
405.212 Medicare Coverage IDE study criteria.
405.213 Re-evaluation of a device categorization.
405.215 Confidential commercial and trade secret information.

Subpart C_Suspension of Payment, Recovery of Overpayments, and Repayment 
                        of Scholarships and Loans

                           General Provisions

405.301 Scope of subpart.

   Liability for Payments to Providers and Suppliers, and Handling of 
                           Incorrect Payments

405.350 Individual's liability for payments made to providers and other 
          persons for items and services furnished the individual.
405.351 Incorrect payments for which the individual is not liable.
405.352 Adjustment of title XVIII incorrect payments.
405.353 Certification of amount that will be adjusted against individual 
          title II or railroad retirement benefits.
405.354 Procedures for adjustment or recovery--title II beneficiary.
405.355 Waiver of adjustment or recovery.
405.356 Principles applied in waiver of adjustment or recovery.
405.357 Notice of right to waiver consideration.
405.358 When waiver of adjustment or recovery may be applied.
405.359 Liability of certifying or disbursing officer.

  Suspension and Recoupment of Payment to Providers and Suppliers and 
                Collection and Compromise of Overpayments

405.370 Definitions.
405.371 Suspension, offset, and recoupment of Medicare payments to 
          providers and suppliers of services.
405.372 Proceeding for suspension of payment.
405.373 Proceeding for offset or recoupment.
405.374 Opportunity for rebuttal.
405.375 Time limits for, and notification of, administrative 
          determination after receipt of rebuttal statement.
405.376 Suspension and termination of collection action and compromise 
          of claims for overpayment.
405.377 Withholding Medicare payments to recover Medicaid overpayments.
405.378 Interest charges on overpayment and underpayments to providers, 
          suppliers, and other entities.
405.379 Limitation on recoupment of provider and supplier overpayments.

                   Repayment of Scholarships and Loans

405.380 Collection of past-due amounts on scholarship and loan programs.

                       Subpart D_Private Contracts

405.400 Definitions.
405.405 General rules.
405.410 Conditions for properly opting-out of Medicare.
405.415 Requirements of the private contract.
405.420 Requirements of the opt-out affidavit.
405.425 Effects of opting-out of Medicare.
405.430 Failure to properly opt-out.
405.435 Failure to maintain opt-out.
405.440 Emergency and urgent care services.
405.445 Cancellation of opt-out and early termination of opt-out.
405.450 Appeals.
405.455 Application to Medicare Advantage contracts

          Subpart E_Criteria for Determining Reasonable Charges

405.500 Basis.
405.501 Determination of reasonable charges.
405.502 Criteria for determining reasonable charges.
405.503 Determining customary charges.
405.504 Determining prevailing charges.
405.505 Determination of locality
405.506 Charges higher than customary or prevailing charges or lowest 
          charge levels.

[[Page 124]]

405.507 Illustrations of the application of the criteria for determining 
          reasonable charges.
405.508 Determination of comparable circumstances; limitation.
405.509 Determining the inflation-indexed charge.
405.511 Reasonable charges for medical services, supplies, and 
          equipment.
405.512 Carriers' procedural terminology and coding systems.
405.515 Reimbursement for clinical laboratory services billed by 
          physicians.
405.517 Payment for drugs and biologicals that are not paid on a cost or 
          prospective payment basis.
405.520 Payment for a physician assistant's, nurse practitioner's, and 
          clinical nurse specialists' services and services furnished 
          incident to their professional services.
405.534 Limitation on payment for screening mammography services.
405.535 Special rule for nonparticipating physicians and suppliers 
          furnishing screening mammography services before January 1, 
          2002.

          Subpart F_Medicare Coverage of Innovative Technology

405.601 Medicare coverage of innovative technology.
405.603 Medical device eligibility.
405.605 Coverage of items and services.
405.607 Coverage period.

Subpart G [Reserved]

           Subpart H_Appeals Under the Medicare Part B Program

405.800 Appeals of CMS or a CMS contractor.
405.803 Appeals rights.
405.806 Impact of reversal of contractor determinations on claims 
          processing.
405.809 Reinstatement of provider or supplier billing privileges 
          following corrective action.
405.812 Effective date for DMEPOS supplier's billing privileges.
405.815 Submission of claims.
405.818 Deadline for processing provider enrollment initial 
          determinations.

   Subpart I_Determinations, Redeterminations, Reconsiderations, and 
             Appeals Under Original Medicare (Parts A and B)

405.900 Basis and scope.
405.902 Definitions.
405.904 Medicare initial determinations, redeterminations and appeals: 
          General description.
405.906 Parties to the initial determinations, redeterminations, 
          reconsiderations, hearings, and reviews.
405.908 Medicaid State agencies.
405.910 Appointed representatives.
405.912 Assignment of appeal rights.

                         Initial Determinations

405.920 Initial determinations.
405.921 Notice of initial determination.
405.922 Time frame for processing initial determinations.
405.924 Actions that are initial determinations.
405.925 Decisions of utilization review committees.
405.926 Actions that are not initial determinations.
405.927 Initial determinations subject to the reopenings process.
405.928 Effect of the initial determination.

                            Redeterminations

405.940 Right to a redetermination.
405.942 Time frame for filing a request for a redetermination.
405.944 Place and method of filing a request for a redetermination.
405.946 Evidence to be submitted with the redetermination request.
405.947 Notice to the beneficiary of applicable plan's request for a 
          redetermination.
405.948 Conduct of a redetermination.
405.950 Time frame for making a redetermination.
405.952 Withdrawal or dismissal of a request for a redetermination.
405.954 Redetermination.
405.956 Notice of a redetermination.
405.958 Effect of a redetermination.

                             Reconsideration

405.960 Right to a reconsideration.
405.962 Time frame for filing a request for a reconsideration.
405.964 Place and method of filing a request for a reconsideration.
405.966 Evidence to be submitted with the reconsideration request.
405.968 Conduct of a reconsideration.
405.970 Timeframe for making a reconsideration following a contractor 
          redetermination.
405.972 Withdrawal or dismissal of a request for reconsideration or 
          review of a contractor's dismissal of a request for 
          redetermination.
405.974 Reconsideration and review of a contractor's dismissal of a 
          request for redetermination.
405.976 Notice of a reconsideration.
405.978 Effect of a reconsideration.

[[Page 125]]

                               Reopenings

405.980 Reopening of initial determinations, redeterminations, 
          reconsiderations, decisions, and reviews.
405.982 Notice of a revised determination or decision.
405.984 Effect of a revised determination or decision.
405.986 Good cause for reopening.

                   Expedited Access to Judicial Review

405.990 Expedited access to judicial review.

                              ALJ Hearings

405.1000 Hearing before an ALJ and decision by an ALJ or attorney 
          adjudicator: General rule.
405.1002 Right to an ALJ hearing.
405.1004 Right to a review of QIC notice of dismissal.
405.1006 Amount in controversy required for an ALJ hearing and judicial 
          review.
405.1008 Parties to the proceedings on a request for an ALJ hearing.
405.1010 When CMS or its contractors may participate in the proceedings 
          on a request for an ALJ hearing.
405.1012 When CMS or its contractors may be a party to a hearing.
405.1014 Request for an ALJ hearing or a review of a QIC dismissal.
405.1016 Time frames for deciding an appeal of a QIC reconsideration or 
          escalated request for a QIC reconsideration.
405.1018 Submitting evidence.
405.1020 Time and place for a hearing before an ALJ.
405.1022 Notice of a hearing before an ALJ.
405.1024 Objections to the issues.
405.1026 Disqualification of the ALJ or attorney adjudicator.
405.1028 Review of evidence submitted by parties.
405.1030 ALJ hearing procedures.
405.1032 Issues before an ALJ or attorney adjudicator.
405.1034 Requesting information from the QIC.
405.1036 Description of an ALJ hearing process.
405.1037 Discovery.
405.1038 Deciding a case without a hearing before an ALJ.
405.1040 Prehearing and posthearing conferences.
405.1042 The administrative record.
405.1044 Consolidated proceedings.
405.1046 Notice of an ALJ or attorney adjudicator decision.
405.1048 The effect of an ALJ's or attorney adjudicator's decision.
405.1050 Removal of a hearing request from OMHA to the Council.
405.1052 Dismissal of a request for a hearing before an ALJ or request 
          for review of a QIC dismissal.
405.1054 Effect of dismissal of a request for a hearing or request for 
          review of QIC dismissal.
405.1056 Remands of requests for hearing and requests for review.
405.1058 Effect of a remand.

               Applicability of Medicare Coverage Policies

405.1060 Applicability of nation coverage determinations (NCDs).
405.1062 Applicability of local coverage determinations and other 
          policies not binding on the ALJ or attorney adjudicator and 
          Council.
405.1063 Applicability of laws, regulations, CMS Rulings, and 
          precedential decisions.

                     Medicare Appeals Council Review

405.1100 Medicare Appeals Council review: General.
405.1102 Request for Council review when ALJ or attorney adjudicator 
          issues decision or dismissal.
405.1106 Where a request for review or escalation may be filed.
405.1108 Council actions when request for review or escalation is filed.
405.1110 Council reviews on its own motion.
405.1112 Content of request for review.
405.1114 Dismissal of request for review.
405.1116 Effect of dismissal of request for Council review or request 
          for hearing.
405.1118 Obtaining evidence from the Council.
405.1120 Filling briefs with the Council.
405.1122 What evidence may be submitted to the Council.
405.1124 Oral argument.
405.1126 Case remanded by the Council.
405.1128 Action of the Council.
405.1130 Effect of the Council's decision.
405.1132 Request for escalation to Federal court.
405.1134 Extension of time to file action in Federal district court.
405.1136 Judicial review.
405.1138 Case remanded by a Federal district court.
405.1140 Council review of ALJ decision in a case remanded by a Federal 
          district court.

  Subpart J_Expedited Determinations and Reconsiderations of Provider 
 Service Terminations, and Procedures for Inpatient Hospital Discharges

405.1200 Notifying beneficiaries of provider service terminations.
405.1202 Expedited determination procedures.
405.1204 Expedited reconsiderations.
405.1205 Notifying beneficiaries of hospital discharge appeal rights.

[[Page 126]]

405.1206 Expedited determination procedures for inpatient hospital care.
405.1208 Hospital requests expedited QIO review.

Subparts K-Q [Reserved]

       Subpart R_Provider Reimbursement Determinations and Appeals

405.1801 Introduction.
405.1803 Contractor determination and notice of amount of program 
          reimbursement.
405.1804 Matters not subject to administrative or judicial review under 
          prospective payment.
405.1805 Parties to contractor determination.
405.1807 Effect of contractor determination.
405.1809 Contractor hearing procedures.
405.1811 Right to contractor hearing; contents of, and adding issues to, 
          hearing request.
405.1813 Good cause extension of time limit for requesting a contractor 
          hearing.
405.1814 Contractor hearing officer jurisdiction.
405.1815 Parties to proceedings before the contractor hearing 
          officer(s).
405.1817 Hearing officer or panel of hearing officers authorized to 
          conduct contractor hearing; disqualification of officers.
405.1819 Conduct of contractor hearing.
405.1821 Prehearing discovery and other proceedings prior to the 
          contractor hearing.
405.1823 Evidence at contractor hearing.
405.1825 Witnesses at contractor hearing.
405.1827 Record of proceedings before the contractor hearing officer(s).
405.1829 Scope of authority of contractor hearing officer(s).
405.1831 Contractor hearing decision.
405.1832 Contractor hearing officer review of compliance with the 
          substantive reimbursement requirement of an appropriate cost 
          report claim.
405.1833 Effect of contractor hearing decision.
405.1834 CMS reviewing official procedure.
405.1835 Right to Board hearing; contents of, and adding issues to, 
          hearing request.
405.1836 Good cause extension of time limit for requesting a Board 
          hearing.
405.1837 Group appeals.
405.1839 Amount in controversy.
405.1840 Board jurisdiction.
405.1842 Expedited judicial review.
405.1843 Parties to proceedings in a Board appeal.
405.1845 Composition of Board; hearings, decisions, and remands.
405.1847 Disqualification of Board members.
405.1849 Establishment of time and place of hearing by the Board.
405.1851 Conduct of Board hearing.
405.1853 Board proceedings prior to any hearing; discovery.
405.1855 Evidence at Board hearing.
405.1857 Subpoenas.
405.1859 Witnesses.
405.1861 Oral argument and written allegations.
405.1863 Administrative policy at issue.
405.1865 Record of administrative proceedings.
405.1867 Scope of Board's legal authority.
405.1868 Board actions in response to failure to follow Board rules.
405.1869 Scope of Board's authority in a hearing decision.
405.1871 Board hearing decision.
405.1873 Board review of compliance with the reimbursement requirement 
          of an appropriate cost report claim.
405.1875 Administrator review.
405.1877 Judicial review.
405.1881 Appointment of representative.
405.1883 Authority of representative.
405.1885 Reopening an intermediary determination or reviewing entity 
          decision.
405.1887 Notice of reopening; effect of reopening.
405.1889 Effect of a revision; issue-specific nature of appeals of 
          revised determinations and decisions.

Subparts S-T [Reserved]

   Subpart U_Conditions for Coverage of Suppliers of End-Stage Renal 
                         Disease (ESRD) Services

405.2100-405.2101 [Reserved]
405.2102 Definitions.
405.2110 Designation of ESRD networks.
405.2111 [Reserved]
405.2112 ESRD network organizations.
405.2113 Medical review board.
405.2114 [Reserved]
405.2131-405.2184 [Reserved]

Subparts V-W [Reserved]

  Subpart X_Rural Health Clinic and Federally Qualified Health Center 
                                Services

405.2400 Basis.
405.2401 Scope and definitions.
405.2402 Rural health clinic basic requirements.
405.2403 Rural health clinic content and terms of the agreement with the 
          Secretary.
405.2404 Termination of rural health clinic agreements.
405.2410 Application of Part B deductible and coinsurance.
405.2411 Scope of benefits.
405.2412 Physicians' services.
405.2413 Services and supplies incident to a physician's services.

[[Page 127]]

405.2414 Nurse practitioner, physician assistant, and certified nurse 
          midwife services.
405.2415 Incident to services and direct supervision.
405.2416 Visiting nurse services.
405.2417 Visiting nurse services: Determination of shortage of agencies.

               Federally Qualified Health Center Services

405.2430 Basic requirements.
405.2434 Content and terms of the agreement.
405.2436 Termination of agreement.
405.2440 Conditions for reinstatement after termination by CMS.
405.2442 Notice to the public.
405.2444 Change of ownership.
405.2446 Scope of services.
405.2448 Preventive primary services.
405.2449 Preventive services.
405.2450 Clinical psychologist and clinical social worker services.
405.2452 Services and supplies incident to clinical psychologist and 
          clinical social worker services.

 Payment for Rural Health Clinic and Federally Qualified Health Center 
                                Services

405.2460 Applicability of general payment exclusions.
405.2462 Payment for RHC and FQHC services.
405.2463 What constitutes a visit.
405.2464 Payment rate.
405.2466 Annual reconciliation.
405.2467 Requirements of the FQHC PPS.
405.2468 Allowable costs.
405.2469 FQHC supplemental payments.
405.2470 Reports and maintenance of records.
405.2472 Beneficiary appeals.

    Authority: 42 U.S.C. 263a, 405(a), 1302, 1320b-12, 1395x, 1395y(a), 
1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k).

Subpart A [Reserved]



Subpart B_Medical Services Coverage Decisions That Relate to Health Care 
                               Technology

    Authority: Secs. 1102, 1862 and 1871 of the Social Security Act as 
amended (42 U.S.C.1302, 1395y, and 1395hh).

    Source: 60 FR 48423, Sept. 19, 1995, unless otherwise noted.



Sec.  405.201  Scope of subpart and definitions.

    (a) Scope. This subpart establishes that--
    (1) CMS uses the FDA categorization of a device as a factor in 
making Medicare coverage decisions; and
    (2) CMS may consider for Medicare coverage certain devices with an 
FDA-approved investigational device exemption (IDE) that have been 
categorized as Category B (Nonexperimental/investigational) device.
    (3) CMS identifies criteria for coverage of items and services 
furnished in IDE studies.
    (b) Definitions. As used in this subpart--
    Category A (Experimental) device refers to a device for which 
``absolute risk'' of the device type has not been established (that is, 
initial questions of safety and effectiveness have not been resolved) 
and the FDA is unsure whether the device type can be safe and effective.
    Category B (Nonexperimental/investigational) device refers to a 
device for which the incremental risk is the primary risk in question 
(that is, initial questions of safety and effectiveness of that device 
type have been resolved), or it is known that the device type can be 
safe and effective because, for example, other manufacturers have 
obtained FDA premarket approval or clearance for that device type.
    ClinicalTrials.gov refers to the National Institutes of Health's 
National Library of Medicine's online registry and results database of 
publicly and privately supported clinical studies of human participants 
conducted around the world.
    Contractors refers to Medicare Administrative Contractors and other 
entities that contract with CMS to review and adjudicate claims for 
Medicare payment of items and services.
    Investigational device exemption (IDE) refers to an FDA-approved IDE 
application that permits a device, which would otherwise be subject to 
marketing approval or clearance, to be shipped lawfully for the purpose 
of conducting a clinical study in accordance with 21 U.S.C. 360j(g) and 
21 CFR part 812.

[[Page 128]]

    Routine care items and services refers to items and services that 
are otherwise generally available to Medicare beneficiaries (that is, a 
benefit category exists, it is not statutorily excluded, and there is no 
national noncoverage decision) that are furnished during a clinical 
study and that would be otherwise furnished even if the beneficiary were 
not enrolled in a clinical study.

[60 FR 48423, Sept. 19, 1995, as amended at 78 FR 74809, Dec. 10, 2013]

    Effective Date Note: At 86 FR 3009, Jan. 14, 2021, Sec.  405.201 was 
amended in paragraph (b) by adding a definition for ``Reasonable and 
necessary'' in alphabetical order, the effective date was delayed until 
May 15, 2021 at 86 FR 14542, Mar. 17, 2021 and then further delayed at 
86 FR 26849, May 18, 2021, effective Dec. 15, 2021. For the convenience 
of the user, the added text is set forth as follows:



Sec.  405.201  Scope of subpart and definitions.

                                * * * * *

    (b) * * *
    Reasonable and necessary means that an item or service is 
considered--
    (i) Safe and effective;
    (ii) Except as set forth in Sec.  411.15(o) of this chapter, not 
experimental or investigational; and
    (iii) Appropriate for Medicare patients, including the duration and 
frequency that is considered appropriate for the item or service, in 
terms of whether it meets all of the following criteria:
    (A) Furnished in accordance with accepted standards of medical 
practice for the diagnosis or treatment of the patient's condition or to 
improve the function of a malformed body member;
    (B) Furnished in a setting appropriate to the patient's medical 
needs and condition;
    (C) Ordered and furnished by qualified personnel;
    (D) Meets, but does not exceed, the patient's medical need; and
    (E) Is at least as beneficial as an existing and available medically 
appropriate alternative; or
    (F) Not later than March 15, 2022, CMS will issue draft 
subregulatory guidance on the methodology of which commercial insurers 
are relevant based on the measurement of majority of covered lives. For 
national and local coverage determinations, which have insufficient 
evidence to meet paragraphs (b)(3)(i) through (v) of this section, CMS 
will consider coverage to the extent the items or services are covered 
by a majority of commercial insurers. As part of CMS' consideration, CMS 
will include in the national or local coverage determination its 
reasoning for its decision if coverage is different than the majority of 
commercial insurers.



Sec.  405.203  FDA categorization of investigational devices.

    (a) The FDA assigns a device with an FDA-approved IDE to one of two 
categories:
    (1) Category A (Experimental) devices.
    (2) Category B (Nonexperimental/investigational) devices.
    (b) The FDA notifies CMS, when it notifies the sponsor, that the 
device is categorized by FDA as Category A (Experimental) or Category B 
(Nonexperimental).
    (c) CMS uses the categorization of the device as a factor in making 
Medicare coverage decisions.

[60 FR 48423, Sept. 19, 1995, as amended at 78 FR 74809, Dec. 10, 2013



Sec.  405.205  Coverage of a Category B 
(Nonexperimental/investigational) device.

    (a) For any device that meets the requirements of the exception at 
Sec.  411.15(o) of this chapter, the following procedures apply:
    (1) The FDA notifies CMS, when it notifies the sponsor, that the 
device is categorized by FDA as Category B (Nonexperimental/
investigational).
    (2) CMS uses the categorization of the device as a factor in making 
Medicare coverage decisions.
    (b) If the FDA becomes aware that a categorized device no longer 
meets the requirements of the exception at Sec.  411.15(o) of this 
chapter, the FDA notifies the sponsor and CMS and the procedures 
described in paragraph (a)(2) of this section apply.

[60 FR 48423, Sept. 19, 1995, as amended at 78 FR 74809, Dec. 10, 2013



Sec.  405.207  Services related to a noncovered device.

    (a) When payment is not made. Medicare payment is not made for 
medical and hospital services that are related to the use of a device 
that is not covered because CMS determines the device is not 
``reasonable'' and ``necessary'' under section 1862(a)(1)(A) of the Act 
or because it is excluded from

[[Page 129]]

coverage for other reasons. These services include all services 
furnished in preparation for the use of a noncovered device, services 
furnished contemporaneously with and necessary to the use of a 
noncovered device, and services furnished as necessary after-care that 
are incident to recovery from the use of the device or from receiving 
related noncovered services.
    (b) When payment is made. Medicare payment may be made for--
    (1) Covered services to treat a condition or complication that 
arises due to the use of a noncovered device or a noncovered device-
related service; or
    (2) Routine care items and services related to Category A 
(Experimental) devices as defined in Sec.  405.201(b), and furnished in 
conjunction with FDA-approved clinical studies that meet the coverage 
requirements in Sec.  405.211.
    (3) Routine care items and services related to Category B 
(Nonexperimental/investigational) devices as defined in Sec.  
405.201(b), and furnished in conjunction with FDA-approved clinical 
studies that meet the coverage requirements in Sec.  405.211.

[60 FR 48423, Sept. 19, 1995, as amended at 69 FR 66420, Nov. 15, 2004; 
78 FR 74809, Dec. 10, 2013]



Sec.  405.209  Payment for a Category B 
(Nonexperimental/investigational) device.

    Payment under Medicare for a Category B (Nonexperimental/
investigational) device is based on, and may not exceed, the amount that 
would have been paid for a currently used device serving the same 
medical purpose that has been approved or cleared for marketing by the 
FDA.

[78 FR 74809, Dec. 10, 2013]



Sec.  405.211  Coverage of items and services in FDA-approved IDE studies.

    (a) Coverage of routine care items and services for Category A 
(Experimental) devices. Medicare covers routine care items and services 
furnished in an FDA-approved Category A (Experimental) IDE study if CMS 
(or its designated entity) determines that the Medicare coverage IDE 
study criteria in Sec.  405.212 are met.
    (b) Coverage of Category B (Nonexperimental/investigational) IDE 
devices and routine care items and services. Medicare may make payment 
for a Category B (Nonexperimental/investigational) IDE device and 
routine care items and services furnished in an FDA-approved Category B 
(Nonexperimental/investigational) IDE study if CMS (or its designated 
entity) determines prior to the submission of the first related claim 
that the Medicare coverage IDE study criteria in Sec.  405.212 are met.
    (c) CMS (or its designated entity) must review the following to 
determine if the Medicare coverage IDE study criteria in Sec.  405.212 
are met for purposes of coverage of items and services described in 
paragraphs (a) and (b) of this section:
    (1) FDA approval letter of the IDE.
    (2) IDE study protocol.
    (3) IRB approval letter.
    (4) NCT number.
    (5) Supporting materials, as needed.
    (d) Notification. A listing of all CMS-approved Category A 
(Experimental) IDE studies and Category B (Nonexperimental/
investigational) IDE studies shall be posted on the CMS Web site and 
published in the Federal Register.

[78 FR 74809, Dec. 10, 2013]



Sec.  405.212  Medicare Coverage IDE study criteria.

    (a) For Medicare coverage of items and services described in Sec.  
405.211, a Category A (Experimental) or Category B (Nonexperimental/
investigational) IDE study must meet all of the following criteria:
    (1) The principal purpose of the study is to test whether the device 
improves health outcomes of appropriately selected patients.
    (2) The rationale for the study is well supported by available 
scientific and medical information, or it is intended to clarify or 
establish the health outcomes of interventions already in common 
clinical use.
    (3) The study results are not anticipated to unjustifiably duplicate 
existing knowledge.
    (4) The study design is methodologically appropriate and the 
anticipated number of enrolled subjects is adequate to confidently 
answer the research question(s) being asked in the study.

[[Page 130]]

    (5) The study is sponsored by an organization or individual capable 
of successfully completing the study.
    (6) The study is in compliance with all applicable Federal 
regulations concerning the protection of human subjects found at 21 CFR 
parts 50, 56, and 812 and 45 CFR part 46.
    (7) Where appropriate, the study is not designed to exclusively test 
toxicity or disease pathophysiology in healthy individuals. Studies of 
all medical technologies measuring therapeutic outcomes as one of the 
objectives may be exempt from this criterion only if the disease or 
condition being studied is life threatening and the patient has no other 
viable treatment options.
    (8) The study is registered with the National Institutes of Health's 
National Library of Medicine's ClinicalTrials.gov.
    (9) The study protocol describes the method and timing of release of 
results on all pre-specified outcomes, including release of negative 
outcomes and that the release should be hastened if the study is 
terminated early.
    (10) The study protocol must describe how Medicare beneficiaries may 
be affected by the device under investigation, and how the study results 
are or are not expected to be generalizable to the Medicare beneficiary 
population. Generalizability to populations eligible for Medicare due to 
age, disability, or other eligibility status must be explicitly 
described.
    (b) [Reserved]

[78 FR 74809, Dec. 10, 2013]



Sec.  405.213  Re-evaluation of a device categorization.

    (a) General rules. (1) Any sponsor that does not agree with an FDA 
decision that categorizes its device as Category A (experimental) may 
request re-evaluation of the categorization decision.
    (2) A sponsor may request review by CMS only after the requirements 
of paragraph (b) of this section are met.
    (3) No reviews other than those described in paragraphs (b) and (c) 
of this section are available to the sponsor.
    (4) Neither the FDA original categorization or re-evaluation 
(described in paragraph (b) of this section) nor CMS's review (described 
in paragraph (c) of this section) constitute an initial determination 
for purposes of the Medicare appeals processes under part 405, subpart G 
or subpart H, or parts 417, 473, or 498 of this chapter.
    (b) Request to FDA. A sponsor that does not agree with the FDA's 
categorization of its device may submit a written request to the FDA at 
any time requesting re-evaluation of its original categorization 
decision, together with any information and rationale that it believes 
support recategorization. The FDA notifies both CMS and the sponsor of 
its decision.
    (c) Request to CMS. If the FDA does not agree to recategorize the 
device, the sponsor may seek review from CMS. A device sponsor must 
submit its request in writing to CMS. CMS obtains copies of relevant 
portions of the application, the original categorization decision, and 
supplementary materials. CMS reviews all material submitted by the 
sponsor and the FDA's recommendation. CMS reviews only information in 
the FDA record to determine whether to change the categorization of the 
device. CMS issues a written decision and notifies the sponsor of the 
IDE and the FDA.

[60 FR 48423, Sept. 19, 1995, as amended at 78 FR 74810, Dec. 10, 2013



Sec.  405.215  Confidential commercial and trade secret information.

    To the extent that CMS relies on confidential commercial or trade 
secret information in any judicial proceeding, CMS will maintain 
confidentiality of the information in accordance with Federal law.



Subpart C_Suspension of Payment, Recovery of Overpayments, and Repayment 
                        of Scholarships and Loans

    Authority: Secs. 1102, 1815, 1833, 1842, 1862, 1866, 1870, 1871, 
1879 and 1892 of the Social Security Act (42 U.S.C. 1302, 1395g, 1395l, 
1395u, 1395y, 1395cc, 1395gg, 1395hh, 1395pp and 1395ccc) and 31 U.S.C. 
3711.

    Source: 31 FR 13534, Oct. 20, 1966, unless otherwise noted. 
Redesignated at 42 FR 52826, Sept. 30, 1977.

[[Page 131]]


    Editorial Note: Nomenclature changes to subpart C of part 405 appear 
at 76 FR 5961, Feb. 2, 2011.

                           General Provisions



Sec.  405.301  Scope of subpart.

    This subpart sets forth the policies and procedures for handling of 
incorrect payments and recovery of overpayments.

[54 FR 41733, Oct. 11, 1989]

    Liability for Payments To Providers or Suppliers and Handling of 
                           Incorrect Payments



Sec.  405.350  Individual's liability for payments made to providers 
and other persons for items and services furnished the individual.

    Any payment made under title XVIII of the Act to any provider of 
services or other person with respect to any item or service furnished 
an individual shall be regarded as a payment to the individual, and 
adjustment shall be made pursuant to Sec. Sec.  405.352 through 405.358 
where:
    (a) More than the correct amount is paid to a provider of services 
or other person and the Secretary determines that:
    (1) Within a reasonable period of time, the excess over the correct 
amount cannot be recouped from the provider of services or other person, 
or
    (2) The provider of services or other person was without fault with 
respect to the payment of such excess over the correct amount, or
    (b) A payment has been made under the provisions described in 
section 1814(e) of the Act, to a provider of services for items and 
services furnished the individual.
    (c) For purposes of paragraph (a)(2) of this section, a provider of 
services or other person must, in the absence of evidence to the 
contrary, be deemed to be without fault if the determination of the 
carrier, the intermediary, or the Centers for Medicare & Medicaid 
Services that more than the correct amount was paid was made subsequent 
to the fifth year following the year in which notice was sent to such 
individual that such amount had been paid.

[41 FR 1492, Jan. 8, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, 
as amended at 61 FR 49271, Sept. 19, 1996; 78 FR 74810, Dec. 10, 2013]



Sec.  405.351  Incorrect payments for which the individual is not liable.

    Where an incorrect payment has been made to a provider of services 
or other person, the individual is liable only to the extent that he has 
benefited from such payment.



Sec.  405.352  Adjustment of title XVIII incorrect payments.

    Where an individual is liable for an incorrect payment (i.e., a 
payment made under Sec.  405.350(a) or Sec.  405.350(b)) adjustment is 
made (to the extent of such liability) by:
    (a) Decreasing any payment under title II of the Act, or under the 
Railroad Retirement Act of 1937, to which the individual is entitled; or
    (b) In the event of the individual's death before adjustment is 
completed, by decreasing any payment under title II of the Act, or under 
the Railroad Retirement Act of 1937 payable to the estate of the 
individual or to any other person, that are based on the individual's 
earnings record (or compensation).

[31 FR 13534, Oct. 20, 1966, as amended at 41 FR 1492, Jan. 8, 1976. 
Redesignated at 42 FR 52826, Sept. 30, 1977]



Sec.  405.353  Certification of amount that will be adjusted against 
individual title II or railroad retirement benefits.

    As soon as practicable after any adjustment is determined to be 
necessary, the Secretary, for purposes of this subpart, shall certify 
the amount of the overpayment or payment (see Sec.  405.350) with 
respect to which the adjustment is to be made. If the adjustment is to 
be made by decreasing subsequent payments under the Railroad Retirement 
Act of 1937, such certification shall be made to the Railroad Retirement 
Board.



Sec.  405.354  Procedures for adjustment or recovery--title II beneficiary.

    The procedures applied in making an adjustment or recovery in the 
case of a

[[Page 132]]

title II beneficiary are the applicable procedures of 20 CFR 404.502.

[31 FR 13534, Oct. 20, 1966, as amended at 32 FR 18027, Dec. 16, 1967. 
Redesignated at 42 FR 52826, Sept. 30, 1977]



Sec.  405.355  Waiver of adjustment or recovery.

    (a) The provisions of Sec.  405.352 may not be applied and there may 
be no adjustment or recovery of an incorrect payment (i.e., a payment 
made under Sec.  405.350(a) or Sec.  405.350(b)) in any case where such 
incorrect payment has been made with respect to an individual who is 
without fault, or where such adjustment or recovery would be made by 
decreasing payments to which another person who is without fault is 
entitled as provided in section 1870(b) of the Act where such adjustment 
or recovery would defeat the purpose of title II or title XVIII of the 
Act or would be against equity and good conscience. (See 20 CFR 404.509 
and 404.512.)
    (b) Adjustment or recovery of an incorrect payment (or only such 
part of an incorrect payment as may be determined to be inconsistent 
with the purposes of Title XVIII of the Act) against an individual who 
is without fault will be deemed to be against equity and good conscience 
if the incorrect payment was made for items and services that are not 
payable under section 1862(a)(1) or (a)(9) of the Act and if the 
determination that such payment was incorrect was made subsequent to the 
fifth year following the year in which notice of such payment was sent 
to such individual.

[41 FR 1493, Jan. 8, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977; 
78 FR 74810, Dec. 10, 2013]



Sec.  405.356  Principles applied in waiver of adjustment or recovery.

    The principles applied in determining waiver of adjustment or 
recovery (Sec.  405.355) are the applicable principles of Sec.  405.358 
and 20 CFR 404.507-404.509, 404.510a, and 404.512.

[61 FR 49271, Sept. 19, 1996]



Sec.  405.357  Notice of right to waiver consideration.

    Whenever an initial determination is made that more than the correct 
amount of payment has been made, notice of the provisions of section 
1870(c) of the Act regarding waiver of adjustment or recovery shall be 
sent to the overpaid individual and to any other individual against whom 
adjustment or recovery of the overpayment is to be effected (see Sec.  
405.358).

[61 FR 49271, Sept. 19, 1996]



Sec.  405.358  When waiver of adjustment or recovery may be applied.

    Section 1870(c) of the Act provides that there shall be no 
adjustment or recovery in any case where an incorrect payment under 
title XVIII (hospital and supplementary medical insurance benefits) has 
been made (including a payment under section 1814(e) of the Act with 
respect to an individual:
    (a) Who is without fault, and
    (b) Adjustment or recovery would either:
    (1) Defeat the purposes of title II or title XVIII of the Act, or
    (2) Be against equity and good conscience.

[61 FR 49271, Sept. 19, 1996]



Sec.  405.359  Liability of certifying or disbursing officer.

    No certifying or disbursing officer shall be held liable for any 
amount certified or paid by him to any provider of services or other 
person:
    (a) Where the adjustment or recovery of such amount is waived (see 
Sec.  405.355), or
    (b) Where adjustment (see Sec.  405.352) or recovery is not 
completed prior to the death of all persons against whose benefits such 
adjustment is authorized.

  Suspension and Recoupment of Payment to Providers and Suppliers and 
                Collection and Compromise of Overpayments



Sec.  405.370  Definitions.

    (a) For purposes of this subpart, the following definitions apply:
    Credible allegation of fraud. A credible allegation of fraud is an 
allegation from any source, including but not limited to the following:
    (1) Fraud hotline tips verified by further evidence
    (2) Claims data mining.

[[Page 133]]

    (3) Patterns identified through provider audits, civil false claims 
cases, and law enforcement investigations. Allegations are considered to 
be credible when they have indicia of reliability.
    Fraud hotline tip. A complaint or other communications that are 
submitted through a fraud reporting phone number or a website intended 
for the same purpose, such as the Federal Government's HHS OIG Hotline 
or a health plan's fraud hotline.
    Medicare contractor. Unless the context otherwise requires, 
includes, but is not limited to the any of following:
    (1) A fiscal intermediary.
    (2) A carrier.
    (3) Program safeguard contractor.
    (4) Zone program integrity contractor.
    (5) Part A/Part B Medicare administrative contractor.
    Offset. The recovery by Medicare of a non-Medicare debt by reducing 
present or future Medicare payments and applying the amount withheld to 
the indebtedness. (Examples are Public Health Service debts or Medicaid 
debts recovered by CMS).
    Recoupment. The recovery by Medicare of any outstanding Medicare 
debt by reducing present or future Medicare payments and applying the 
amount withheld to the indebtedness.
    Resolution of an investigation. An investigation of credible 
allegations of fraud will be considered resolved when legal action is 
terminated by settlement, judgment, or dismissal, or when the case is 
closed or dropped because of insufficient evidence to support the 
allegations of fraud.
    Suspension of payment. The withholding of payment by a Medicare 
contractor from a provider or supplier of an approved Medicare payment 
amount before a determination of the amount of the overpayment exists, 
or until the resolution of an investigation of a credible allegation of 
fraud.
    (b) For purposes of Sec. Sec.  405.378 and 405.379, the following 
terms apply:
    Appellant means the beneficiary, assignee or other person or entity 
that has filed and pursued an appeal concerning a particular initial 
determination. Designation as an appellant does not in itself convey 
standing to appeal the determination in question.
    Fiscal intermediary means an organization that has entered into a 
contract with CMS in accordance with section 1816 of the Act and is 
authorized to make determinations and payments for Part A of title XVIII 
of the Act, and Part B provider services as specified in Sec.  421.5(c) 
of this chapter.
    Medicare Appeals Council means the council within the Departmental 
Appeals Board of the U.S. Department of Health and Human Services.
    Medicare contractor, unless the context otherwise requires, 
includes, but is not limited to, a fiscal intermediary, carrier, 
recovery audit contractor, and Medicare administrative contractor.
    Party means an individual or entity listed in Sec.  405.906 that has 
standing to appeal an initial determination and/or a subsequent 
administrative appeal determination.
    Qualified Independent Contractor (QIC) Qualified Independent 
Contractor (QIC) means an entity which contracts with the Secretary in 
accordance with section 1869 of the Act to perform reconsiderations 
under Sec.  405.960 through Sec.  405.978.
    Remand means to vacate a lower level appeal decision, or a portion 
of the decision, and return the case, or a portion of the case, to that 
level for a new decision.
    Vacate means to set aside a previous action.

[61 FR 63745, Dec. 2, 1996, as amended at 74 FR 47468, Sept. 16, 2009; 
76 FR 5961, Feb. 2, 2011; 86 FR 6093, Jan. 19, 2021]



Sec.  405.371  Suspension, offset, and recoupment of Medicare payments 
to providers and suppliers of services.

    (a) General rules--Medicare payments to providers and suppliers, as 
authorized under this subchapter (excluding payments to beneficiaries), 
may be one of the following:
    (1) Suspended, in whole or in part, by CMS or a Medicare contractor 
if CMS or the Medicare contractor possesses reliable information that an 
overpayment exists or that the payments to be made may not be correct, 
although additional information may be needed for a determination.

[[Page 134]]

    (2) In cases of suspected fraud, suspended, in whole or in part, by 
CMS or a Medicare contractor if CMS or the Medicare contractor has 
consulted with the OIG, and, as appropriate, the Department of Justice, 
and determined that a credible allegation of fraud exists against a 
provider or supplier, unless there is good cause not to suspend 
payments.
    (3) Offset or recouped, in whole or in part, by a Medicare 
contractor if the Medicare contractor or CMS has determined that the 
provider or supplier to whom payments are to be made has been overpaid.
    (4) Suspended, in whole or in part, by CMS or a Medicare contractor 
if the provider or supplier has been subject to a Medicaid payment 
suspension under Sec.  455.23(a)(1) of this chapter.
    (b) Good cause exceptions applicable to payment suspensions. (1) CMS 
may find that good cause exists not to suspend payments or not to 
continue to suspend payments to an individual or entity against which 
there are credible allegations of fraud if--
    (i) OIG or other law enforcement agency has specifically requested 
that a payment suspension not be imposed because such a payment 
suspension may compromise or jeopardize an investigation;
    (ii) It is determined that beneficiary access to items or services 
would be so jeopardized by a payment suspension in whole or part as to 
cause a danger to life or health;
    (iii) It is determined that other available remedies implemented by 
CMS or a Medicare contractor more effectively or quickly protect 
Medicare funds than would implementing a payment suspension; or
    (iv) CMS determines that a payment suspension or a continuation of a 
payment suspension is not in the best interests of the Medicare program.
    (2) Every 180 days after the initiation of a suspension of payments 
based on credible allegations of fraud, CMS will--
    (i) Evaluate whether there is good cause to not continue such 
suspension under this section; and
    (ii) Request a certification from the OIG or other law enforcement 
agency that the matter continues to be under investigation warranting 
continuation of the suspension.
    (3) Good cause not to continue to suspend payments to an individual 
or entity against which there are credible allegations of fraud must be 
deemed to exist if a payment suspension has been in effect for 18 months 
and there has not been a resolution of the investigation, except CMS may 
extend a payment suspension beyond that point if--
    (i) The case has been referred to, and is being considered by, the 
OIG for administrative action (for example, civil money penalties); or 
such administrative action is pending or
    (ii) The Department of Justice submits a written request to CMS that 
the suspension of payments be continued based on the ongoing 
investigation and anticipated filing of criminal or civil action or both 
or based on a pending criminal or civil action or both. At a minimum, 
the request must include the following:
    (A) Identification of the entity under suspension.
    (B) The amount of time needed for continued suspension in order to 
conclude the criminal or civil proceeding or both.
    (C) A statement of why or how criminal or civil action or both may 
be affected if the requested extension is not granted.
    (c) Steps necessary for suspension of payment, offset, and 
recoupment. (1) Except as provided in paragraphs (d) and (e) of this 
section, CMS or the Medicare contractor suspends payments only after it 
has complied with the procedural requirements set forth at Sec.  
405.372.
    (2) The Medicare contractor offsets or recoups payments only after 
it has complied with the procedural requirements set forth at Sec.  
405.373.
    (d) Suspension of payment in the case of unfiled cost reports. (1) 
If a provider has failed to timely file an acceptable cost report, 
payment to the provider is immediately suspended in whole or in part 
until a cost report is filed and determined by the Medicare contractor 
to be acceptable.
    (2) In the case of an unfiled cost report, the provisions of Sec.  
405.372 do not apply. (See Sec.  405.372(a)(2) concerning failure to 
furnish other information.)

[[Page 135]]

    (e) Suspension of payment in the case of unfiled hospice cap 
determination reports. (1) If a provider has failed to timely file an 
acceptable hospice cap determination report, payment to the provider is 
immediately suspended in whole or in part until a cap determination 
report is filed and determined by the Medicare contractor to be 
acceptable.
    (2) In the case of an unfiled hospice cap determination report, the 
provisions of Sec.  405.372 do not apply. (See Sec.  405.372(a)(2) 
concerning failure to furnish other information.)

[76 FR 5961, Feb. 2, 2011, as amended at 79 FR 50509, Aug. 22, 2014; 84 
FR 47852, Sept. 10, 2019]i



Sec.  405.372  Proceeding for suspension of payment.

    (a) Notice of intention to suspend--(1) General rule. Except as 
provided in paragraphs (a)(2) through (a)(4) of this section, if the 
Medicare contractor, or CMS has determined that a suspension of payments 
under Sec.  405.371(a)(1) should be put into effect, the Medicare 
contractor must notify the provider or supplier of the intention to 
suspend payments, in whole or in part, and the reasons for making the 
suspension.
    (2) Failure to furnish information. The notice requirement of 
paragraph (a)(1) of this section does not apply if the Medicare 
contractor suspends payments to a provider or supplier in accordance 
with section 1815(a) or section 1833(e) of the Act, respectively, 
because the provider or supplier has failed to submit information 
requested by the Medicare contractor that is needed to determine the 
amounts due the provider or supplier. (See Sec.  405.371(c) concerning 
failure to file timely acceptable cost reports.)
    (3) Harm to trust funds. A suspension of payment may be imposed 
without prior notice if CMS, the intermediary, or carrier determines 
that the Medicare Trust Funds would be harmed by giving prior notice. 
CMS may base its determination on an intermediary's or carrier's belief 
that giving prior notice would hinder the possibility of recovering the 
money.
    (4) Fraud. If the intended suspension of payment involves credible 
allegations of fraud under Sec.  405.371(a)(2), CMS--
    (i) In consultation with OIG and, as appropriate, the Department of 
Justice, determines whether to impose the suspension and if prior notice 
is appropriate;
    (ii) Directs the Medicare contractor as to the timing and content of 
the notification to the provider or supplier; and
    (iii) Is the real party in interest and is responsible for the 
decision.
    (b) Rebuttal--(1) If prior notice is required. If prior notice is 
required under paragraph (a) of this section, the Medicare contractor 
must give the provider or supplier an opportunity for rebuttal in 
accordance with Sec.  405.374. If a rebuttal statement is received 
within the specified time period, the suspension of payment goes into 
effect on the date stated in the notice, and the procedures and 
provisions set forth in Sec.  405.375 apply. If by the end of the period 
specified in the notice no statement has been received, the suspension 
goes into effect automatically, and the procedures set forth in 
paragraph (c) of this section are followed.
    (2) If prior notice is not required. If, under the provisions of 
paragraphs (a)(2) through (a)(4) of this section, a suspension of 
payment is put into effect without prior notice to the provider or 
supplier, the Medicare contractor must, once the suspension is in 
effect, give the provider or supplier an opportunity to submit a 
rebuttal statement as to why the suspension should be removed.
    (c) Subsequent action. (1) If a suspension of payment is put into 
effect under Sec.  405.371(a)(1), CMS or the Medicare contractor takes 
timely action after the suspension to obtain the additional information 
it may need to make a determination as to whether an overpayment exists 
or the payments may be made.
    (i) CMS or the Medicare contractor makes all reasonable efforts to 
expedite the determination.
    (ii) As soon as the determination is made, CMS or the Medicare 
contractor informs the provider or supplier and, if appropriate, the 
suspension is rescinded or any existing recoupment or offset is adjusted 
to take into account the determination.

[[Page 136]]

    (2)(i) If a suspension of payment is based upon credible allegations 
of fraud in accordance with Sec.  405.371(a)(2), subsequent action must 
be taken by CMS or the Medicare contractor to make a determination as to 
whether an overpayment exists.
    (ii) The rescission of the suspension and the issuance of a final 
overpayment determination to the provider or supplier may be delayed 
until resolution of the investigation.
    (d) Duration of suspension of payment--(1) General rule. Except as 
provided in paragraphs (d)(2) and (d)(3) of this section, a suspension 
of payment is limited to 180 days, starting with the date the suspension 
begins.
    (2) 180-day extension. (i) An intermediary, a carrier, or, in cases 
of fraud and misrepresentation, OIG or a law enforcement agency, may 
request a one-time only extension of the suspension period for up to 180 
additional days if it is unable to complete its examination of the 
information or investigation, as appropriate, within the 180-day time 
limit. The request must be submitted in writing to CMS.
    (ii) Upon receipt of a request for an extension, CMS notifies the 
provider or supplier of the requested extension. CMS then either extends 
the suspension of payment for up to an additional 180 days or determines 
that the suspended payments are to be released to the provider or 
supplier.
    (3) Exceptions to the time limits. (i) The time limits specified in 
paragraphs (d)(1) and (d)(2) of this section do not apply if the 
suspension of payments is based upon credible allegations of fraud under 
Sec.  405.371(a)(2).
    (ii) Although the time limits specified in paragraphs (d)(1) and 
(d)(2) of this section do not apply to suspensions based on credible 
allegations of fraud, all suspensions of payment in accordance with 
Sec.  405.371(a)(2) will be temporary and will not continue after the 
resolution of an investigation, unless a suspension is warranted because 
of reliable evidence of an overpayment or that the payments to be made 
may not be correct, as specified in Sec.  405.371(a)(1).
    (e) Disposition of suspended payments. Payments suspended under the 
authority of Sec.  405.371(a) are first applied to reduce or eliminate 
any overpayments determined by the Medicare contractor, or CMS, 
including any interest assessed under the provisions of Sec.  405.378, 
and then applied to reduce any other obligation to CMS or to HHS. In the 
absence of a legal requirement that the excess be paid to another 
entity, the excess is released to the provider or supplier.

[61 FR 63746, Dec. 2, 1996, as amended at 76 FR 5962, Feb. 2, 2011]



Sec.  405.373  Proceeding for offset or recoupment.

    (a) General rule. Except as specified in paragraphs (b) and (f) of 
this section, if the Medicare Administrative Contractor or CMS has 
determined that an offset or recoupment of payments under Sec.  
405.371(a)(3) should be put into effect, the Medicare Administrative 
Contractor must--
    (1) Notify the provider or supplier of its intention to offset or 
recoup payment, in whole or in part, and the reasons for making the 
offset or recoupment; and
    (2) Give the provider or supplier an opportunity for rebuttal in 
accordance with Sec.  405.374.
    (b) Exception to recouping payment. Paragraph (a) of this section 
does not apply if the Medicare Administrative Contractor, after 
furnishing a provider a written notice of the amount of program 
reimbursement in accordance with Sec.  405.1803, recoups payment under 
paragraph (c) of Sec.  405.1803. (For provider rights in this 
circumstance, see Sec. Sec.  405.1809, 405.1811, 405.1815, 405.1835, and 
405.1843.)
    (c) Actions following receipt of rebuttal statement. If a provider 
or supplier submits, in accordance with Sec.  405.374, a statement as to 
why an offset or recoupment should not be put into effect on the date 
specified in the notice, the Medicare contractor must comply with the 
time limits and notification requirements of Sec.  405.375.
    (d) No rebuttal statement received. If, by the end of the time 
period specified in the notice, no statement has been received, the 
recoupment or offset goes into effect automatically.
    (e) Duration of recoupment or offset. Except as provided in Sec.  
405.379, if a recoupment or offset is put into effect,

[[Page 137]]

it remains in effect until the earliest of the following:
    (1) The overpayment and any assessed interest are liquidated.
    (2) The Medicare contractor obtains a satisfactory agreement from 
the provider or supplier for liquidation of the overpayment.
    (3) The Medicare contractor, on the basis of subsequently acquired 
evidence or otherwise, determines that there is no overpayment.
    (f) Exception to offset or recoupment of payments for shared 
Taxpayer Identification Number. Paragraph (a) of this section does not 
apply in instances where the Medicare Administrative Contractor intends 
to offset or recoup payments to the applicable provider of services or 
supplier to satisfy an amount due from an obligated provider of services 
or supplier when the applicable and obligated provider of services or 
supplier share the same Taxpayer Identification Number.

[61 FR 63747, Dec. 2, 1996, as amended at 74 FR 47468, Sept. 16, 2009; 
81 FR 80551, Nov. 15, 2016]



Sec.  405.374  Opportunity for rebuttal.

    (a) General rule. If prior notice of the suspension of payment, 
offset, or recoupment is given under Sec.  405.372 or Sec.  405.373, the 
Medicare contractor must give the provider or supplier an opportunity, 
before the suspension, offset, or recoupment takes effect, to submit any 
statement (to include any pertinent information) as to why it should not 
be put into effect on the date specified in the notice. Except as 
provided in paragraph (b) of this section, the provider or supplier has 
at least 15 days following the date of notification to submit the 
statement.
    (b) Exception. The Medicare contractor may for cause--
    (1) Impose a shorter period for rebuttal; or
    (2) Extend the time within which the statement must be submitted.

[61 FR 63747, Dec. 2, 1996]



Sec.  405.375  Time limits for, and notification of, 
administrative determination after receipt of rebuttal statement.

    (a) Submission and disposition of evidence. If the provider or 
supplier submits a statement, under Sec.  405.374, as to why a 
suspension of payment, offset, or recoupment should not be put into 
effect, or, under Sec.  405.372(b)(2), why a suspension should be 
terminated, CMS, the intermediary, or carrier must within 15 days, from 
the date the statement is received, consider the statement (including 
any pertinent evidence submitted), together with any other material 
bearing upon the case, and determine whether the facts justify the 
suspension, offset, or recoupment or, if already initiated, justify the 
termination of the suspension, offset, or recoupment. Suspension, 
offset, or recoupment is not delayed beyond the date stated in the 
notice in order to review the statement.
    (b) Notification of determination. The Medicare contractor must send 
written notice of the determination made under paragraph (a) of this 
section to the provider or supplier. The notice must--
    (1) In the case of offset or recoupment, contain rationale for the 
determination; and
    (2) In the case of suspension of payment, contain specific findings 
on the conditions upon which the suspension is initiated, continued, or 
removed and an explanatory statement of the determination.
    (c) Determination is not appealable. A determination made under 
paragraph (a) of this section is not an initial determination and is not 
appealable.

[61 FR 63747, Dec. 2, 1996]



Sec.  405.376  Suspension and termination of collection action and compromise 
of claims for overpayment.

    (a) Basis and purpose. This section contains requirements and 
procedures for the compromise of, or suspension or termination of 
collection action on, claims for overpayments against a provider or a 
supplier under the Medicare program. It is adopted under the authority 
of the Federal Claims Collection Act (31 U.S.C. 3711). Collection and 
compromise of claims against Medicare beneficiaries are explained at 20 
CFR 404.515.
    (b) Definitions. As used in this section, debtor means a provider of 
services or a physician or other supplier of services that has been 
overpaid under

[[Page 138]]

title XVIII of the Social Security Act. It includes an individual, 
partnership, corporation, estate, trust, or other legal entity.
    (c) Basic conditions. A claim for recovery of Medicare overpayments 
against a debtor may be compromised, or collection action on it may be 
suspended or terminated, by the Centers for Medicare & Medicaid Services 
(CMS) if;
    (1) The claim does not exceed $100,000, or such higher amount as the 
Attorney General may from time to time prescribe, exclusive of interest; 
and
    (2) There is no indication of fraud, the filing of a false claim, or 
misrepresentation on the part of the debtor or any director, partner, 
manager, or other party having an interest in the claim.
    (d) Basis for compromise. A claim may be compromised for one or more 
of the following reasons:
    (1) The debtor, or the estate of a deceased debtor, does not have 
the present or prospective ability to pay the full amount within a 
reasonable time;
    (2) The debtor refuses to pay the claim in full and the United 
States is unable to collect the full amount within a reasonable time by 
legal proceedings;
    (3) There is real doubt the United States can prove its case in 
court; or
    (4) The cost of collecting the claim does not justify enforced 
collection of the full amount.
    (e) Basis for termination of collection action. Collection action 
may be terminated for one or more of the following reasons:
    (1) The United States cannot enforce collection of any significant 
sum;
    (2) The debtor cannot be located, there is no security to be 
liquidated, the statute of limitations has run, and the prospects of 
collecting by offset are too remote to justify retention of the claim;
    (3) The cost of further collection action is likely to exceed any 
recovery;
    (4) It is determined the claim is without merit; or
    (5) Evidence to substantiate the claim is no longer available.
    (f) Basis for suspension of collection action. Collection action may 
be suspended for either of the following reasons if future collection 
action is justified based on potential productivity, including 
foreseeable ability to pay, and size of claim:
    (1) The debtor cannot be located; or
    (2) The debtor is unable to make payments on the claim or to fulfill 
an acceptable compromise.
    (g) Factors considered. In determining whether a claim will be 
compromised, or collection action terminated or suspended, CMS will 
consider the following factors:
    (1) Age and health of the debtor, present and potential income, 
inheritance prospects, possible concealment or fraudulent transfer of 
assets, and the availability of assets which may be reached by enforced 
collection proceedings, for compromise under paragraph (d)(1) of this 
section, termination under paragraph (e)(1) of this section, and 
suspension under paragraph (f)(2) of this section;
    (2) Applicable exemptions available to a debtor and uncertainty 
concerning the price of the property in a forced sale, for compromise 
under paragraph (d)(2) of this section and termination under paragraph 
(e)(1) of this section; and
    (3) The probability of proving the claim in court, the probability 
of full or partial recovery, the availability of necessary evidence, and 
related pragmatic considerations, for compromise under paragraph (d)(3) 
of this section.
    (h) Amount of compromise. The amount accepted in compromise will be 
reasonable in relation to the amount that can be recovered by enforced 
collection proceedings.

Consideration shall be given to the following:
    (1) The exemptions available to the debtor under State or Federal 
law;
    (2) The time necessary to collect the overpayment;
    (3) The litigative probabilities involved; and
    (4) The administrative and litigative costs of collection where the 
cost of collecting the claim is a basis for compromise.
    (i) Payment of compromise--(1) Time and manner. Payment of the 
amount that CMS has agreed to accept as a compromise in full settlement 
of a Medicare overpayment claim must be

[[Page 139]]

made within the time and in the manner prescribed by CMS. An overpayment 
claim is not compromised or settled until the full payment of the 
compromised amount has been made within the time and in the manner 
prescribed by CMS.
    (2) Failure to pay compromised amount. Failure of the debtor or the 
estate to make payment as provided by the comprise reinstates the full 
amount of the overpayment claim, less any amounts paid prior to the 
default.
    (j) Effect of compromise, or suspension, or termination of 
collection action. Any action taken by CMS under this section regarding 
the compromise of an overpayment claim, or termination or suspension of 
collection action on an overpayment claim, is not an initial 
determination for purposes of the appeal procedures under subparts G, H, 
and R of this part.

[43 FR 59381, Dec. 20, 1978, as amended at 57 FR 56998, Dec. 2, 1992. 
Redesignated and amended at 61 FR 63745, 63747, Dec. 2, 1996]



Sec.  405.377  Withholding Medicare payments to recover Medicaid overpayments.

    (a) Basis and purpose. This section implements section 1885 of the 
Act, which provides for withholding Medicare payments to certain 
Medicaid providers that have not arranged to repay Medicaid overpayments 
as determined by the Medicaid State agency or have failed to provide 
information necessary to determine the amount (if any) of overpayments.
    (b) When withholding may be used. CMS may withhold Medicare payment 
to offset Medicaid overpayments that a Medicaid agency has been unable 
to collect if--
    (1) The Medicaid agency has followed the procedure specified in 
Sec.  447.31 of this chapter; and
    (2) The institution or person is one described in paragraph (c) of 
this section and either--
    (i) Has not made arrangements satisfactory to the Medicaid agency to 
repay the overpayment; or
    (ii) Has not provided information to the Medicaid agency necessary 
to enable the agency to determine the existence or amount of Medicaid 
overpayment.
    (c) Institutions or persons affected. Withholding under paragraph 
(b) of this section may be made with respect to any of the following 
entities that has or had in effect an agreement with a Medicaid agency 
to furnish services under an approved Medicaid State plan:
    (1) An institutional provider that has in effect an agreement under 
section 1866 of the Act. (Part 489 (Provider and Supplier Agreements) 
implements section 1866 of the Act.)
    (2) A physician or supplier that has accepted payment on the basis 
of an assignment under section 1842(b)(3)(B)(ii) of the Act. (Section 
424.55 sets forth the conditions a supplier agrees to in accepting 
assignment.)
    (d) Amount to be withheld. (1) CMS contacts the appropriate Medicare 
contractor to determine the amount of Medicare payment to which the 
institution or person is entitled.
    (2) CMS may require the Medicare contractor to withhold Medicare 
payments to the institution or person by the lesser of the following 
amounts:
    (i) The amount of the Medicare payments to which the institution or 
person would otherwise be entitled.
    (ii) The total Medicaid overpayment to the institution or person.
    (e) Notice of withholding. If CMS intends to withhold payments under 
this section, it notifies by certified mail, return receipt requested, 
the institution or person and the appropriate Medicare contractor of the 
intention to withhold Medicare payments and follows the procedure in 
Sec.  405.374. The notice includes--
    (1) Identification of the institution or person; and
    (2) The amount of Medicaid overpayment to be withheld from payments 
to which the institution or person would otherwise be entitled under 
Medicare.
    (f) Termination of withholding. CMS terminates the withholding if--
    (1) The Medicaid overpayment is completely recovered;
    (2) The institution or person enters into an agreement satisfactory 
to the Medicaid agency to repay the overpayment; or
    (3) The Medicaid agency determines that there is no overpayment 
based on newly acquired evidence or a subsequent audit.

[[Page 140]]

    (g) Disposition of funds withheld. CMS releases amounts withheld 
under this section to the Medicaid agency to be applied against the 
Medicaid overpayment made by the State agency.

[61 FR 63747, Dec. 2, 1996]



Sec.  405.378  Interest charges on overpayment and underpayments to providers, 
suppliers, and other entities.

    (a) Basis and purpose. This section, which implements sections 
1815(d), 1833(j) and 1893(f)(2)(B) of the Act and common law, and 
authority granted under the Federal Claims Collection Act, provides for 
the charging and payment of interest on overpayments and underpayments 
to Medicare providers, suppliers, HMOs, competitive medical plans 
(CMPs), and health care prepayment plans (HCPPs).
    (b) Basic rules. (1) CMS will charge interest on overpayments, and 
pay interest on underpayments, to providers and suppliers of services 
(including physicians and other practitioners), except as specified in 
paragraphs (f) and (h) of this section.
    (2) Except as provided in paragraph (j) of this section, interest 
accrues from the date of the final determination as defined in paragraph 
(c) of this section, and either is charged on the overpayment balance or 
paid on the underpayment balance for each full 30-day period that 
payment is delayed.
    (c) Definition of final determination. (1) For purposes of this 
section, any of the following constitutes a final determination:
    (i) A Notice of Amount of Program Reimbursement (NPR) is issued, as 
discussed in Sec. Sec.  405.1803, 417.576, and 417.810, and either--
    (A) A written demand for payment is made; or
    (B) A written determination of an underpayment is made by the 
intermediary after a cost report is filed.
    (ii) In cases in which an NPR is not used as a notice of 
determination (that is, primarily under part B), one of the following 
constitutes a final determination--
    (A) A written determination that an overpayment exists and a written 
demand for payment; or
    (B) A written determination of an underpayment.
    (iii) Other examples of cases in which an NPR is not used are 
carrier reasonable charge determinations under subpart E of this part, 
interim cost settlements made for HMOs, CMPs, and HCPPs under Sec. Sec.  
417.574 and 417.810(e) of this chapter, and initial retroactive 
adjustment determinations under Sec.  413.64(f)(2) of this chapter. In 
the case of interim cost settlements and initial retroactive adjustment 
determinations, if the debtor does not dispute the adjustment 
determination within the timeframe designated in the notice of the 
determination (generally at least 15 days), a final determination is 
deemed to have been made. If the provider or supplier does dispute 
portions of the determination, a final determination is deemed to have 
been made on those portions when the intermediary issues a new 
determination in response to the dispute.
    (iv) The due date of a timely-filed cost report that indicates an 
amount is due CMS, and is not accompanied by payment in full. (If an 
additional overpayment or underpayment is determined by the carrier or 
intermediary, a final determination on the additional amount is made in 
accordance with paragraphs (c)(1)(i), (c)(1)(ii), or (c)(1)(iii), of 
this section.)
    (v) With respect to a cost report that is not filed on time, the day 
following the date the cost report was due (plus a single extension of 
time not to exceed 30 days if granted for good cause), until the time as 
a cost report is filed. (When the cost report is subsequently filed, 
there is an additional determination as specified in paragraphs (c)(1) 
(i), (ii), (iii), or (iv) of this section.)
    (2) Except as required by any subsequent administrative or judicial 
reversal and specifically as provided in paragraphs (i) and (j) of this 
section, interest accrues from the date of final determination as 
specified in this section.
    (d) Rate of interest. (1) The interest rate on overpayments and 
underpayments is the higher of--
    (i) The rate as fixed by the Secretary of the Treasury after taking 
into consideration private consumer rates of interest prevailing on the 
date of final determination as defined in paragraph

[[Page 141]]

(c) of this section (this rate is published quarterly in the Federal 
Register by the Department under 45 CFR 30.13(a)); or
    (ii) The current value of funds rate (this rate is published 
annually in the Federal Register by the Secretary of the Treasury, 
subject to quarterly revisions).
    (2) [Reserved]
    (e) Accrual of interest. (1) If a cost report is filed that does not 
indicate an amount is due CMS but the intermediary makes a final 
determination that an overpayment exists, or if a carrier makes a final 
determination that an overpayment to a physician or supplier exists, 
interest will accrue beginning with the date of such final 
determination. Interest will continue to accrue during periods of 
administrative and judicial appeal and until final disposition of the 
claim.
    (2)(i) If a cost report is filed and indicates that an amount is due 
CMS, interest on the amount due will accrue from the due date of the 
cost report unless--
    (A) Full payment on the amount due accompanies the cost report; or
    (B) The provider and the intermediary agree in advance to liquidate 
the overpayment through a reduction in interim payments over the next 
30-day period.
    (ii) If the intermediary determines an additional overpayment during 
the cost settlement process, interest will accrue from the date of each 
determination.
    (iii) The interest rate on each of the final determinations of an 
overpayment will be the rate of interest in effect on the date the 
determination is made.
    (3) In the case of a cost report that is not filed on time, interest 
also will accrue on a determined overpayment from the day following the 
due date of the report (plus a single extension of time not to exceed 30 
days if granted for good cause, as specified in Sec.  413.24(f)) of this 
chapter, to the time the cost report is filed.
    (4) If an intermediary or a carrier makes a final determination that 
an underpayment exists, interest to the provider or the supplier will 
accrue from the date of notification of the underpayment.
    (f) Waiver of interest charges. (1) When an intermediary or a 
carrier makes a final determination that an overpayment or underpayment 
exists, as specified in paragraphs (e)(1), (e)(2)(ii), and (e)(4)--
    (i) Interest charges will be waived if the overpayment or 
underpayment is completely liquidated within 30 days from the date of 
the final determination.
    (ii) CMS may waive interest charges if it determines that the 
administrative cost of collecting them exceeds the interest charges.
    (2) Interest will not be waived for that period of time during which 
the cost report was due but remained unfiled for more than 30 days, as 
specified in paragraph (e)(3) of this section.
    (g) Rules applicable to partial payments. If an overpayment is 
repaid in installments or recouped by withholding from several payments 
due the provider or supplier of services--
    (1) Each payment or recoupment will be applied first to accrued 
interest and then to the principal; and
    (2) After each payment or recoupment, interest will accrue on the 
remaining unpaid balance.
    (h) Nonallowable cost. As specified in Sec. Sec.  412.113 and 
413.153 of this chapter, interest accrued on overpayments and interest 
on funds borrowed specifically to repay overpayments are not considered 
allowable costs, up to the amount of the overpayment, unless the 
provider had made a prior commitment to borrow funds for other purposes 
(for example, capital improvements).


(See Sec.  413.153(a)(2) of this chapter for exceptions based on 
administrative or judicial reversal.)
    (i) Exceptions to applicability. (1) The provisions of this section 
do not apply to the time period for which interest is payable under 
Sec.  413.64(j) of this chapter because the provider seeks judicial 
review of a decision of the Provider Reimbursement Review Board, or a 
subsequent reversal, affirmance, or modification of that decision by the 
Administrator. Prior to that time, until the provider seeks judicial 
review, interest accrues at the rate specified in this section on 
outstanding unpaid balances

[[Page 142]]

resulting from final determinations as defined in paragraph (c) of this 
section.
    (2) If an overpayment or an underpayment determination is reversed 
administratively or judicially, and the reversal is no longer subject to 
appeal, appropriate adjustments will be made with respect to the 
overpayment or underpayment and the amount of interest charged.
    (j) Special rule for provider or supplier overpayments subject to 
Sec.  405.379. If an overpayment determination subject to the limitation 
on recoupment under Sec.  405.379 is reversed in whole or in part by an 
Administrative Law Judge (ALJ) or at subsequent administrative or 
judicial levels of appeal and if funds have been recouped and retained 
by the Medicare contractor, interest will be paid to the provider or 
supplier as follows:
    (1) The applicable rate of interest is that provided in paragraph 
(d) of this section.
    (2) The interest rate in effect on the date the ALJ, the Medicare 
Appeals Council, the Federal district court or subsequent appellate 
court issues a decision reversing the overpayment determination in whole 
or in part is the rate used to calculate the interest due the provider 
or supplier.
    (3) Interest will be calculated as follows:
    (i) Interest will be paid on the principal amount recouped only.
    (ii) Interest will be calculated on a simple rather than a compound 
basis.
    (iii) Interest will be calculated in full 30-day periods and will 
not be payable on amounts recouped for any periods of less than 30 days 
in which the Medicare contractor had possession of the funds.
    (iv) In calculating the period in which the amount was recouped, 
days in which the ALJ's adjudication period to conduct a hearing are 
tolled under 42 CFR 405.1014 shall not be counted.
    (v) In calculating the period in which the amount was recouped, days 
in which the Medicare Appeals Council's adjudication period to conduct a 
review are tolled under 42 CFR 405.1106 shall not be counted.
    (4) If the decision by the ALJ, Medicare Appeals Council, Federal 
district court or a subsequent Federal reviewing court, reverses the 
overpayment determination, as modified by prior levels of administrative 
or judicial review, in part, the Medicare contractor in effectuating the 
decision may allocate recouped monies to that part of the overpayment 
determination affirmed by the decision. Interest will be paid to the 
provider or supplier on recouped amounts that remain after this 
allocation in accordance with this paragraph (j) of this section.

[47 FR 54814, Dec. 6, 1982, as amended at 49 FR 36102, Sept. 14, 1984; 
49 FR 44472, Nov. 7, 1984; 51 FR 34792, Sept. 30, 1986; 56 FR 31336, 
July 10, 1991. Redesignated at 61 FR 63745, Dec. 2, 1996; 69 FR 45607, 
July 30, 2004; 74 FR 47468, Sept. 16, 2009]



Sec.  405.379  Limitation on recoupment of provider and supplier overpayments.

    (a) Basis and purpose. This section implements section 1893(f)(2)(A) 
of the Act which limits recoupment of Medicare overpayments if a 
provider of services or supplier seeks a reconsideration until a 
decision is rendered by a Qualified Independent Contractor (QIC). This 
section also limits recoupment of Medicare overpayments when a provider 
or supplier seeks a redetermination until a redetermination decision is 
rendered.
    (b) Overpayments subject to limitation. (1) This section applies to 
overpayments that meet the following criteria:
    (i) Is one of the following types of overpayments:
    (A) Post-pay denial of claims for benefits under Medicare Part A 
which is determined and for which a written demand for payment has been 
made on or after November 24, 2003; or
    (B) Post-pay denial of claims for benefits under Medicare Part B 
which is determined and for which a written demand for payment has been 
made on or after October 29, 2003; or
    (C) Medicare Secondary Payer (MSP) recovery where the provider or 
supplier received a duplicate primary payment and for which a written 
demand for payment was issued on or after October 10, 2003; or
    (D) Medicare Secondary Payer (MSP) recovery based on the provider's 
or supplier's failure to file a proper claim with the third party payer 
plan, program, or insurer for payment and, if

[[Page 143]]

Part A, demanded on or after November 24, 2003, or, if Part B, demanded 
on or after October 29, 2003; and
    (ii) The provider or supplier can appeal the overpayment as a 
revised initial determination under the Medicare claims appeal process 
at 42 CFR parts 401 and 405 or as an initial determination for provider/
supplier MSP duplicate primary payment recoveries.
    (2) This section does not apply to all other overpayments including, 
but not limited to, the following:
    (i) All Medicare Secondary Payer recoveries except those expressly 
identified in paragraphs (b)(1)(i)(C) and (D) of this section;
    (ii) Beneficiary overpayments; and
    (iii) Overpayments that arise from a cost report determination and 
are appealed under the provider reimbursement process of 42 CFR part 405 
Subpart R--Provider Reimbursement Determinations and Appeals.
    (c) Rules of construction. (1) For purposes of this section, what 
constitutes a valid and timely request for a redetermination is to be 
determined in accordance with Sec.  405.940 through Sec.  405.958.
    (2) For purposes of this section, what constitutes a valid and 
timely request for a reconsideration is to be determined in accordance 
with Sec.  405.960 through Sec.  405.978.
    (d) General rules. (1) Medicare contractors can begin recoupment no 
earlier than 41 days from the date of the initial overpayment demand but 
shall cease recoupment of the overpayment in question, upon receipt of a 
timely and valid request for a redetermination of an overpayment. If the 
recoupment has not yet gone into effect, the contractor shall not 
initiate recoupment.
    (2) If the redetermination decision is an affirmation in whole or in 
part of the overpayment determination, recoupment may be initiated or 
resumed in accordance with paragraph (e) of this section.
    (3) Upon receipt of a timely and valid request for a reconsideration 
of an overpayment, the Medicare contractor shall cease recoupment of the 
overpayment in question. If the recoupment has not yet gone into effect, 
the contractor must not initiate recoupment.
    (4) The contractor may initiate or resume recoupment following 
action by the QIC in accordance with paragraph (f) of this section.
    (5) If the provider or supplier subsequently appeals the overpayment 
to the ALJ, the Medicare Appeals Council, or Federal court, recoupment 
remains in effect as provided in Sec.  405.373(e).
    (6) If an overpayment determination is appealed and recoupment 
stopped, the contractor may continue to recoup other overpayments owed 
by the provider or supplier in accordance with this section.
    (7) Amounts recouped prior to a reconsideration decision may be 
retained by the Medicare contractor in accordance with paragraph (g) of 
this section.
    (8) If either the redetermination or reconsideration decision is a 
full reversal of the overpayment determination or if the overpayment 
determination is reversed in whole or in part at subsequent levels of 
administrative or judicial appeal, adjustments shall be made with 
respect to the overpayment and the amount of interest charged.
    (9) Interest accrues and is payable in accordance with the 
provisions of Sec.  405.378.
    (e) Initiating or resuming recoupment after redetermination 
decision. (1) Recoupment that has been deferred or stopped may be 
initiated or resumed if the debt (remaining unpaid principal balance and 
interest) has not been satisfied in full and the provider or supplier 
has been afforded the opportunity for rebuttal in accordance with the 
requirements of Sec.  405.373 through Sec.  405.375. Recoupment may be 
resumed under any of the following circumstances:
    (i) Immediately upon receipt by the Medicare contractor of the 
provider's or supplier's request for a withdrawal of a request for a 
redetermination in accordance with Sec.  405.952(a).
    (ii) On the 60th calendar day after the date of the notice of 
redetermination issued under Sec.  405.956 if the redetermination 
decision is an affirmation in whole of the overpayment determination in 
question.
    (iii) On the 60th calendar day after the date of the written notice 
to the provider or supplier of the revised overpayment amount, if the 
redetermination decision is an affirmation in part,

[[Page 144]]

which has the effect of reducing the amount of the overpayment.
    (2) Notwithstanding paragraphs (e)(i), (ii) and (iii) of this 
section, recoupment must not be resumed, or if resumed, must cease upon 
receipt of a timely and valid request for a reconsideration by the QIC.
    (f) Initiating or resuming recoupment following action by the QIC on 
the reconsideration request. (1) Recoupment may be initiated or resumed 
upon action by the QIC subject to the following limitations:
    (i) The provider or supplier has been afforded the opportunity for 
rebuttal in accordance with the requirements of Sec.  405.373 through 
Sec.  405.375; and
    (ii) The debt (remaining unpaid principal balance and interest) has 
not been satisfied in full; and
    (iii) If the action by the QIC is the notice of the reconsideration, 
the reconsideration decision either affirms in whole or in part the 
overpayment determination, including the redetermination, in question.
    (2) For purposes of this paragraph (f), the action by the QIC on the 
reconsideration request is the earliest to occur of the following:
    (i) The QIC mails or otherwise transmits written notice of the 
dismissal of the reconsideration request in its entirety in accordance 
with Sec.  405.972; or
    (ii) The QIC receives a timely and valid request to withdraw the 
request for the reconsideration in accordance with Sec.  405.972; or
    (iii) The QIC transmits written notice of the reconsideration in 
accordance with Sec.  405.976; or
    (iv) The QIC notifies the parties in writing that the 
reconsideration is being escalated to an ALJ in accordance with Sec.  
405.970.
    (g) Disposition of funds recouped. (1) If the Medicare contractor 
recouped funds before a timely and valid request for a redetermination 
was received, the amount recouped may be retained and applied first to 
accrued interest and then to reduce or eliminate the principal balance 
of the overpayment subject to the following:
    (i) If the redetermination results in a reversal, the amount 
recouped may be applied to any other debt, including interest, owed by 
the provider or supplier before any excess is released to the provider.
    (ii) If the redetermination results in a partial reversal and the 
decision reduces the overpayment plus assessed interest below the amount 
already recouped, the excess may be applied to any other debt, including 
interest, owed by the provider or supplier before any excess is released 
to the provider or supplier.
    (iii) If the redetermination results in an affirmation and the 
provider or supplier subsequently requests a reconsideration, the 
Medicare contractor may retain the amount recouped and apply the funds 
first to accrued interest and then to outstanding principal pending 
action by the QIC on the reconsideration request.
    (2) If the Medicare contractor also recouped funds in accordance 
with paragraph (e) of this section, the amount recouped may be retained 
by the Medicare contractor and applied first to accrued interest and 
then to reduce or eliminate the outstanding principal balance pending 
action by the QIC on the reconsideration request.
    (3) If the action by the QIC is a dismissal, receipt of a 
withdrawal, a notice that the reconsideration is being escalated to an 
ALJ, or a reconsideration which affirms in whole the overpayment 
determination, including the redetermination, in question, the amount 
recouped is applied to interest first, then to reduce the outstanding 
principal balance and recoupment may be resumed as provided under 
paragraph (f) of this section.
    (4) If the action by the QIC is a reconsideration, which reverses in 
whole the overpayment determination, including the redetermination, in 
question, the amount recouped may be applied to any other debt, 
including interest, owed by the provider or supplier to CMS or to HHS 
before any excess is released to the provider or supplier.
    (5) If the action by the QIC is a reconsideration which results in a 
partial reversal and the decision reduces the overpayment plus assessed 
interest below the amount already recouped, the excess may be applied to 
any other debt, including interest, owed by the provider or supplier to 
CMS or to HHS

[[Page 145]]

before any excess is released to the provider or supplier.
    (h) Relationship to extended repayment schedules. Notwithstanding 
Sec.  401.607 (c)(2)(v) of this chapter regarding an extended repayment 
schedule (ERS), a provider or supplier will not be deemed in default if 
recoupment of an overpayment is not effectuated or stopped in accordance 
with this section, and the following conditions are met:
    (1) The provider or supplier has been granted an ERS under Sec.  
401.607(c) of this chapter.
    (2) The ERS has been granted for an overpayment that is listed in 
paragraph (b) of this section.
    (3) The provider or supplier has submitted a valid and timely 
request to the Medicare contractor for a redetermination of the 
overpayment in accordance with Sec. Sec.  405.940 through 405.958 or 
reconsideration of the overpayment in accordance with Sec. Sec.  405.960 
through 405.978.

[74 FR 47469, Sept. 16, 2009]

                   Repayment of Scholarships and Loans



Sec.  405.380  Collection of past-due amounts on scholarship and loan programs.

    (a) Basis and purpose. This section implements section 1892 of the 
Act, which authorizes the Secretary to deduct from Medicare payments for 
services amounts considered as past-due obligations under the National 
Health Service Corps Scholarship program, the Physician Shortage Area 
Scholarship program, and the Health Education Assistance Loan program.
    (b) Offsetting against Medicare payment. (1) Medicare carriers and 
intermediaries offset against Medicare payments in accordance with the 
signed repayment agreement between the Public Health Service and 
individuals who have breached their scholarship or loan obligations and 
who--
    (i) Accept Medicare assignment for services;
    (ii) Are employed by or affiliated with a provider, HMO, or 
Competitive Medical Plan (CMP) that receives Medicare payment for 
services; or
    (iii) Are members of a group practice that receives Medicare payment 
for services.
    (2) For purposes of this section, ``provider'' includes all entities 
eligible to receive Medicare payment in accordance with an agreement 
under section 1866 of the Act.
    (c) Beginning of offset. (1) The Medicare carrier offsets Medicare 
payments beginning six months after it notifies the individual or the 
group practice of the amount to be deducted and the particular 
individual to whom the deductions are attributable.
    (2) The Medicare intermediary offsets payments beginning six months 
after it notifies the provider, HMO, CMP or group practice of the amount 
to be deducted and the particular individuals to whom the deductions are 
attributable. Offset of payments is made in accordance with the terms of 
the repayment agreement. If the individual ceases to be employed by the 
provider, HMO, or CMP, or leaves the group practice, no deduction is 
made.
    (d) Refusal to offset against Medicare payment. If the individual 
refuses to enter into a repayment agreement, or breaches any provision 
of the agreement, or if Medicare payment is insufficient to maintain the 
offset collection according to the agreed upon formula, then--
    (1) The Department, within 30 days if feasible, informs the Attorney 
General; and
    (2) The Department excludes the individual from Medicare until the 
entire past due obligation has been repaid, unless the individual is a 
sole community practitioner or the sole source of essential specialized 
services in a community and the State requests that the individual not 
be excluded.

[57 FR 19092, May 4, 1992]



                       Subpart D_Private Contracts

    Authority: Secs. 1102, 1802, and 1871 of the Social Security Act (42 
U.S.C. 1302, 1395a, and 1395hh).

    Source: 63 FR 58901, Nov. 2, 1998, unless otherwise noted.

[[Page 146]]



Sec.  405.400  Definitions.

    For purposes of this subpart, the following definitions apply:
    Beneficiary means an individual who is enrolled in Part B of 
Medicare.
    Emergency care services means inpatient or outpatient hospital 
services that are necessary to prevent death or serious impairment of 
health and, because of the danger to life or health, require use of the 
most accessible hospital available and equipped to furnish those 
services.
    Legal representative means one or more individuals who, as 
determined by applicable State law, has the legal authority to enter 
into the contract with the physician or practitioner on behalf of the 
beneficiary.
    Opt-out means the status of meeting the conditions specified in 
Sec.  405.410.
    Opt-out period means, with respect to an affidavit that meets the 
requirements of Sec.  405.420, a 2-year period beginning on the date the 
affidavit is signed, as specified by Sec.  405.410(c)(1) or (2) as 
applicable, and each successive 2-year period unless the physician or 
practitioner properly cancels opt-out in accordance with Sec.  405.445.
    Participating physician means a ``physician'' as defined in this 
section who has signed an agreement to participate in Part B of 
Medicare.
    Physician means a doctor of medicine; doctor of osteopathy; doctor 
of dental surgery or of dental medicine; doctor of podiatric medicine; 
or doctor of optometry who is legally authorized to practice medicine, 
osteopathy, dental surgery, dental medicine, podiatric medicine, or 
optometry by the State in which he performs such function and who is 
acting within the scope of his license when he performs such functions.
    Practitioner means a physician assistant, nurse practitioner, 
clinical nurse specialist, certified registered nurse anesthetist, 
certified nurse midwife, clinical psychologist, clinical social worker, 
registered dietitian or nutrition professional, who is currently legally 
authorized to practice in that capacity by each State in which he or she 
furnishes services to patients or clients.
    Private contract means a document that meets the criteria specified 
in Sec.  405.415.
    Properly opt-out means to complete, without defect, the requirements 
for opt-out as specified in Sec.  405.410.
    Properly terminate opt-out means to complete, without defect, the 
requirements for terminating opt-out as specified in Sec.  405.445.
    Urgent care services means services furnished to an individual who 
requires services to be furnished within 12 hours in order to avoid the 
likely onset of an emergency medical condition.

[63 FR 58901, Nov. 2, 1998, as amended at 69 FR 1116, Jan. 7, 2004; 71 
FR 69782, Dec. 1, 2006; 79 FR 68001, Nov. 13, 2014; 80 FR 71370, Nov. 
16, 2015]



Sec.  405.405  General rules.

    (a) A physician or practitioner may enter into one or more private 
contracts with Medicare beneficiaries for the purpose of furnishing 
items or services that would otherwise be covered by Medicare, provided 
the conditions of this subpart are met.
    (b) A physician or practitioner who enters into at least one private 
contract with a Medicare beneficiary under the conditions of this 
subpart, and who submits one or more affidavits in accordance with this 
subpart, opts out of Medicare for the opt-out period described in Sec.  
405.400 unless the opt-out is terminated early according to Sec.  
405.445.
    (c) Both the private contracts described in paragraph (a) of this 
section and the physician's or practitioner's opt-out described in 
paragraph (b) of this section are null and void if the physician or 
practitioner fails to properly opt-out in accordance with the conditions 
of this subpart.
    (d) Both the private contracts described in paragraph (a) of this 
section and the physician's or practitioner's opt-out described in 
paragraph (b) of this section are null and void for the remainder of the 
opt-out period if the physician or practitioner fails to remain in 
compliance with the conditions of this subpart during the opt-out 
period.
    (e) Services furnished under private contracts meeting the 
requirements of this subpart are not covered services under Medicare, 
and no Medicare payment will be made for such services either directly 
or indirectly, except as

[[Page 147]]

permitted in accordance with Sec.  405.435(c).

[63 FR 58901, Nov. 2, 1998, as amended at 80 FR 71370, Nov. 16, 2015]



Sec.  405.410  Conditions for properly opting-out of Medicare.

    The following conditions must be met for a physician or practitioner 
to properly opt-out of Medicare:
    (a) Each private contract between a physician or a practitioner and 
a Medicare beneficiary that is entered into prior to the submission of 
the affidavit described in paragraph (b) of this section must meet the 
specifications of Sec.  405.415.
    (b) The physician or practitioner must submit an affidavit that 
meets the specifications of Sec.  405.420 to each Medicare 
Administrative Contractor with which he or she would file claims absent 
the opt-out.
    (c) A nonparticipating physician or a practitioner may opt-out of 
Medicare at any time in accordance with the following:
    (1) The initial 2-year opt-out period begins the date the affidavit 
meeting the requirements of Sec.  405.420 is signed, provided the 
affidavit is filed within 10 days after he or she signs his or her first 
private contract with a Medicare beneficiary.
    (2) If the physician or practitioner does not timely file the opt-
out affidavit(s) as specified in the previous paragraph, the initial 2-
year opt-out period begins when the last such affidavit is filed. Any 
private contract entered into before the last required affidavit is 
filed becomes effective upon the filing of the last required affidavit, 
and the furnishing of any items or services to a Medicare beneficiary 
under such contract before the last required affidavit is filed is 
subject to standard Medicare rules.
    (d) A participating physician may properly opt-out of Medicare at 
the beginning of any calendar quarter, provided that the affidavit 
described in Sec.  405.420 is submitted to the participating physician's 
Medicare Administrative Contractors at least 30 days before the 
beginning of the selected calendar quarter. A private contract entered 
into before the beginning of the selected calendar quarter becomes 
effective at the beginning of the selected calendar quarter, and the 
furnishing of any items or services to a Medicare beneficiary under such 
contract before the beginning of the selected calendar quarter is 
subject to standard Medicare rules.

[63 FR 58901, Nov. 2, 1998, as amended at 80 FR 71370, Nov. 16, 2015]



Sec.  405.415  Requirements of the private contract.

    A private contract under this subpart must:
    (a) Be in writing and in print sufficiently large to ensure that the 
beneficiary is able to read the contract.
    (b) Clearly state whether the physician or practitioner is excluded 
from Medicare under sections 1128, 1156, or 1892 or any other section of 
the Social Security Act.
    (c) State that the beneficiary or his or her legal representative 
accepts full responsibility for payment of the physician's or 
practitioner's charge for all services furnished by the physician or 
practitioner.
    (d) State that the beneficiary or his or her legal representative 
understands that Medicare limits do not apply to what the physician or 
practitioner may charge for items or services furnished by the physician 
or practitioner.
    (e) State that the beneficiary or his or her legal representative 
agrees not to submit a claim to Medicare or to ask the physician or 
practitioner to submit a claim to Medicare.
    (f) State that the beneficiary or his or her legal representative 
understands that Medicare payment will not be made for any items or 
services furnished by the physician or practitioner that would have 
otherwise been covered by Medicare if there was no private contract and 
a proper Medicare claim had been submitted.
    (g) State that the beneficiary or his or her legal representative 
enters into this contract with the knowledge that he or she has the 
right to obtain Medicare-covered items and services from physicians and 
practitioners who have not opted-out of Medicare, and that the 
beneficiary is not compelled to enter into private contracts that apply 
to

[[Page 148]]

other Medicare-covered services furnished by other physicians or 
practitioners who have not opted-out.
    (h) State the expected or known effective date and the expected or 
known expiration date of the current 2-year opt-out period.
    (i) State that the beneficiary or his or her legal representative 
understands that Medigap plans do not, and that other supplemental plans 
may elect not to, make payments for items and services not paid for by 
Medicare.
    (j) Be signed by the beneficiary or his or her legal representative 
and by the physician or practitioner.
    (k) Not be entered into by the beneficiary or by the beneficiary's 
legal representative during a time when the beneficiary requires 
emergency care services or urgent care services. (However, a physician 
or practitioner may furnish emergency or urgent care services to a 
Medicare beneficiary in accordance with Sec.  405.440.)
    (l) Be provided (a photocopy is permissible) to the beneficiary or 
to his or her legal representative before items or services are 
furnished to the beneficiary under the terms of the contract.
    (m) Be retained (original signatures of both parties required) by 
the physician or practitioner for the duration of the current 2-year 
opt-out period.
    (n) Be made available to CMS upon request.
    (o) Be entered into for each 2-year opt-out period.

[63 FR 58901, Nov. 2, 1998, as amended at 80 FR 71370, Nov. 16, 2015]



Sec.  405.420  Requirements of the opt-out affidavit.

    An affidavit under this subpart must:
    (a) Be in writing and be signed by the physician or practitioner.
    (b) Contain the physician's or practitioner's full name, address, 
telephone number, national provider identifier (NPI) or billing number, 
if one has been assigned, uniform provider identification number (UPIN) 
if one has been assigned, or, if neither an NPI nor a UPIN has been 
assigned, the physician's or practitioner's tax identification number 
(TIN).
    (c) State that, except for emergency or urgent care services (as 
specified in Sec.  405.440), during the opt-out period the physician or 
practitioner will provide services to Medicare beneficiaries only 
through private contracts that meet the criteria of paragraph Sec.  
405.415 for services that, but for their provision under a private 
contract, would have been Medicare-covered services.
    (d) State that the physician or practitioner will not submit a claim 
to Medicare for any service furnished to a Medicare beneficiary during 
the opt-out period, nor will the physician or practitioner permit any 
entity acting on his or her behalf to submit a claim to Medicare for 
services furnished to a Medicare beneficiary, except as specified in 
Sec.  405.440.
    (e) State that, during the opt-out period, the physician or 
practitioner understands that he or she may receive no direct or 
indirect Medicare payment for services that he or she furnishes to 
Medicare beneficiaries with whom he or she has privately contracted, 
whether as an individual, an employee of an organization, a partner in a 
partnership, under a reassignment of benefits, or as payment for a 
service furnished to a Medicare beneficiary under a Medicare Advantage 
plan.
    (f) State that a physician or practitioner who opts-out of Medicare 
acknowledges that, during the opt-out period, his or her services are 
not covered under Medicare and that no Medicare payment may be made to 
any entity for his or her services, directly or on a capitated basis.
    (g) State a promise by the physician or practitioner to the effect 
that, during the opt-out period, the physician or practitioner agrees to 
be bound by the terms of both the affidavit and the private contracts 
that he or she has entered into.
    (h) Acknowledge that the physician or practitioner recognizes that 
the terms of the affidavit apply to all Medicare-covered items and 
services furnished to Medicare beneficiaries by the physician or 
practitioner during the opt-out period (except for emergency or urgent 
care services furnished to the beneficiaries with whom he or she has not 
previously privately contracted) without regard to any payment 
arrangements the physician or practitioner may make.

[[Page 149]]

    (i) With respect to a physician who has signed a Part B 
participation agreement, acknowledge that such agreement terminates on 
the effective date of the affidavit.
    (j) Acknowledge that the physician or practitioner understands that 
a beneficiary who has not entered into a private contract and who 
requires emergency or urgent care services may not be asked to enter 
into a private contract with respect to receiving such services and that 
the rules of Sec.  405.440 apply if the physician furnishes such 
services.

[63 FR 58901, Nov. 2, 1998, as amended at 79 FR 68001, Nov. 13, 2014]



Sec.  405.425  Effects of opting-out of Medicare.

    If a physician or practitioner opts-out of Medicare in accordance 
with this subpart, the following results obtain during the opt-out 
period:
    (a) Except as provided in Sec.  405.440, no payment may be made 
directly by Medicare or by any Medicare Advantage plan to the physician 
or practitioner or to any entity to which the physician or practitioner 
reassigns his right to receive payment for services.
    (b) The physician or practitioner may not furnish any item or 
service that would otherwise be covered by Medicare (except for 
emergency or urgent care services) to any Medicare beneficiary except 
through a private contract that meets the requirements of this subpart.
    (c) The physician or practitioner is not subject to the requirement 
to submit a claim for items or services furnished to a Medicare 
beneficiary, as specified in Sec.  424.5(a)(6) of this chapter, except 
as provided in Sec.  405.440.
    (d) The physician or practitioner is prohibited from submitting a 
claim to Medicare for items or services furnished to a Medicare 
beneficiary except as provided in Sec.  405.440.
    (e) In the case of a physician, he or she is not subject to the 
limiting charge provisions of Sec.  414.48 of this chapter, except for 
services provided under Sec.  405.440.
    (f) The physician or practitioner is not subject to the prohibition-
on-reassignment provisions of Sec.  414.80 of this chapter, except for 
services provided under Sec.  405.440.
    (g) In the case of a practitioner, he or she is not prohibited from 
billing or collecting amounts from beneficiaries (as provided in 42 
U.S.C. 1395u(b)(18)(B)).
    (h) The death of a beneficiary who has entered into a private 
contract (or whose legal representative has done so) does not invoke 
Sec.  424.62 or Sec.  424.64 of this chapter with respect to the 
physician or practitioner with whom the beneficiary (or legal 
representative) has privately contracted.
    (i) The physician or practitioner who has not been excluded under 
sections 1128, 1156 or 1892 of the Act and whose Medicare enrollment is 
not revoked under Sec.  424.535 of this chapter may order, certify the 
need for, prescribe, or refer a beneficiary for Medicare-covered items, 
services, and drugs, provided the physician or practitioner is not paid, 
directly or indirectly, for such services (except as provided in Sec.  
405.440).
    (j) The physician or practitioner who is excluded under sections 
1128, 1156 or 1892 of the Act or whose Medicare enrollment is revoked 
under Sec.  424.535 of this chapter may not order, prescribe or certify 
the need for Medicare-covered items, services, and drugs except, with 
respect to exclusions, as provided in Sec.  1001.1901 of this title, and 
must otherwise comply with the terms of any exclusion in accordance with 
Sec.  1001.1901 of this title effective with the date of the exclusion.

[63 FR 58901, Nov. 2, 1998, as amended at 79 FR 68001, Nov. 13, 2014; 80 
FR 71370, Nov. 16, 2015; 84 FR 47852, Sept. 10, 2019]



Sec.  405.430  Failure to properly opt-out.

    (a) A physician or practitioner fails to properly opt-out if--
    (1) Any private contract between the physician or practitioner and a 
Medicare beneficiary, that was entered into before the affidavit 
described in Sec.  405.420 was filed, does not meet the specifications 
of Sec.  405.415; or
    (2) He or she fails to submit the affidavit(s) in accordance with 
Sec.  405.420.
    (b) If a physician or practitioner fails to properly opt-out in 
accordance with paragraph (a) of this section, the following results 
obtain:

[[Page 150]]

    (1) The physician's or practitioner's attempt to opt-out of Medicare 
is nullified, and all of the private contracts between the physician or 
practitioner and Medicare beneficiaries for the two-year period covered 
by the attempted opt-out are deemed null and void.
    (2) The physician or practitioner must submit claims to Medicare for 
all Medicare-covered items and services furnished to Medicare 
beneficiaries, including the items and services furnished under the 
nullified contracts. A nonparticipating physician is subject to the 
limiting charge provisions of Sec.  414.48 of this chapter. A 
participating physician is subject to the limitations on charges of the 
participation agreement he or she signed.
    (3) The practitioner may not reassign any claim except as provided 
in Sec.  424.80 of this chapter.
    (4) The practitioner may neither bill nor collect an amount from the 
beneficiary except for applicable deductible and coinsurance amounts.
    (5) The physician or practitioner may make another attempt to 
properly opt-out at any time.



Sec.  405.435  Failure to maintain opt-out.

    (a) A physician or practitioner fails to maintain opt-out under this 
subpart if, during the opt-out period--
    (1) He or she knowingly and willfully--
    (i) Submits a claim for Medicare payment (except as provided in 
Sec.  405.440); or
    (ii) Receives Medicare payment directly or indirectly for Medicare-
covered services furnished to a Medicare beneficiary (except as provided 
in Sec.  405.440).
    (2) He or she fails to enter into private contracts with Medicare 
beneficiaries for the purpose of furnishing items and services that 
would otherwise be covered by Medicare, or enters into contracts that 
fail to meet the specifications of Sec.  405.415; or
    (3) He or she fails to comply with the provisions of Sec.  405.440 
regarding billing for emergency care services or urgent care services; 
or
    (4) He or she fails to retain a copy of each private contract that 
he or she has entered into for the duration of the current 2-year period 
for which the contracts are applicable or fails to permit CMS to inspect 
them upon request.
    (b) If a physician or practitioner fails to maintain opt-out in 
accordance with paragraph (a) of this section, then, for the remainder 
of the opt-out period, except as provided by paragraph (d) of this 
section--
    (1) All of the private contracts between the physician or 
practitioner and Medicare beneficiaries are deemed null and void.
    (2) The physician's or practitioner's opt-out of Medicare is 
nullified.
    (3) The physician or practitioner must submit claims to Medicare for 
all Medicare-covered items and services furnished to Medicare 
beneficiaries.
    (4) The physician or practitioner or beneficiary will not receive 
Medicare payment on Medicare claims for the remainder of the opt-out 
period, except as provided in paragraph (c) of this section.
    (5) The physician is subject to the limiting charge provisions of 
Sec.  414.48 of this chapter.
    (6) The practitioner may not reassign any claim except as provided 
in Sec.  424.80 of this chapter.
    (7) The practitioner may neither bill nor collect any amount from 
the beneficiary except for applicable deductible and coinsurance 
amounts.
    (8) The physician or practitioner may not attempt to once more meet 
the criteria for properly opting-out until the current 2-year period 
expires.
    (c) Medicare payment may be made for the claims submitted by a 
beneficiary for the services of an opt-out physician or practitioner 
when the physician or practitioner did not privately contract with the 
beneficiary for services that were not emergency care services or urgent 
care services and that were furnished no later than 15 days after the 
date of a notice by the carrier that the physician or practitioner has 
opted-out of Medicare.
    (d) If a physician or practitioner demonstrates that he or she has 
taken good faith efforts to maintain opt-out (including by refunding 
amounts in excess of the charge limits to beneficiaries with whom he or 
she did not sign a private contract) within 45 days of a notice from the 
Medicare Administrative Contractor of a violation of

[[Page 151]]

paragraph (a) of this section, then the requirements of paragraphs 
(b)(1) through (8) of this section are not applicable. In situations 
where a violation of paragraph (a) of this section is not discovered by 
the Medicare Administrative Contractor during the current 2-year period 
when the violation actually occurred, then the requirements of 
paragraphs (b)(1) through (8) of this section are applicable from the 
date that the first violation of paragraph (a) of this section occurred 
until the end of the 2-year period during which the violation occurred 
unless the physician or practitioner takes good faith efforts, within 45 
days of any notice from the Medicare Administrative Contractor that the 
physician or practitioner failed to maintain opt-out, or within 45 days 
of the physician's or practitioner's discovery of the failure to 
maintain opt-out, whichever is earlier, to correct his or her violations 
of paragraph (a) of this section. Good faith efforts include, but are 
not limited to, refunding any amounts collected in excess of the charge 
limits to beneficiaries with whom he or she did not sign a private 
contract.

[63 FR 58901, Nov. 2, 1998, as amended at 70 FR 70329, Nov. 21, 2005; 80 
FR 71370, Nov. 16, 2015]



Sec.  405.440  Emergency and urgent care services.

    (a) A physician or practitioner who has opted-out of Medicare under 
this subpart need not enter into a private contract to furnish emergency 
care services or urgent care services to a Medicare beneficiary. 
Accordingly, a physician or practitioner will not be determined to have 
failed to maintain opt-out if he or she furnishes emergency care 
services or urgent care services to a Medicare beneficiary with whom the 
physician or practitioner has not previously entered into a private 
contract, provided the physician or practitioner complies with the 
billing requirements specified in paragraph (b) of this section.
    (b) When a physician or practitioner who has not been excluded under 
sections 1128, 1156, or 1892 of the Social Security Act furnishes 
emergency care services or urgent care services to a Medicare 
beneficiary with whom the physician or practitioner has not previously 
entered into a private contract, he or she:
    (1) Must submit a claim to Medicare in accordance with both 42 CFR 
part 424 and Medicare instructions (including but not limited to 
complying with proper coding of emergency or urgent care services 
furnished by physicians and practitioners who have opted-out of 
Medicare).
    (2) May collect no more than--
    (i) The Medicare limiting charge, in the case of a physician; or
    (ii) The deductible and coinsurance, in the case of a practitioner.
    (c) Emergency care services or urgent care services furnished to a 
Medicare beneficiary with whom the physician or practitioner has 
previously entered into a private contract (that is, entered into before 
the onset of the emergency medical condition or urgent medical 
condition), are furnished under the terms of the private contract.
    (d) Medicare may make payment for emergency care services or urgent 
care services furnished by a physician or practitioner who has properly 
opted-out when the services are furnished and the claim for services is 
made in accordance with this section. A physician or practitioner who 
has been excluded must comply with the regulations at Sec.  1001.1901 
(Scope and effect of exclusion) of this title when he or she furnishes 
emergency services to beneficiaries and may not bill and be paid for 
urgent care services.



Sec.  405.445  Cancellation of opt-out and early termination of opt-out.

    (a) A physician or practitioner may cancel opt-out by submitting a 
written notice to each Medicare Administrative Contractor to which he or 
she would file claims absent the opt-out, not later than 30 days before 
the end of the current 2-year opt-out period, indicating that the 
physician or practitioner does not want to extend the application of the 
opt-out affidavit for a subsequent 2-year period.
    (b) To properly terminate opt-out a physician or practitioner must:
    (1) Not have previously opted out of Medicare.
    (2) Notify all Medicare Administrative Contractors, with which he or 
she

[[Page 152]]

filed an affidavit, of the termination of the opt-out no later than 90 
days after the effective date of the initial 2-year period.
    (3) Refund to each beneficiary with whom he or she has privately 
contracted all payment collected in excess of:
    (i) The Medicare limiting charge (in the case of physicians); or
    (ii) The deductible and coinsurance (in the case of practitioners).
    (4) Notify all beneficiaries with whom the physician or practitioner 
entered into private contracts of the physician's or practitioner's 
decision to terminate opt-out and of the beneficiaries' right to have 
claims filed on their behalf with Medicare for the services furnished 
during the period between the effective date of the opt-out and the 
effective date of the termination of the opt-out period.
    (c) When the physician or practitioner properly terminates opt-out 
in accordance with paragraph (b), he or she will be reinstated in 
Medicare as if there had been no opt-out, and the provision of Sec.  
405.425 shall not apply unless the physician or practitioner 
subsequently properly opts out.
    (d) A physician or practitioner who has completed opt-out on or 
before January 1, 1999 may terminate opt-out during the 90 days 
following January 1, 1999 if he or she notifies all carriers to whom he 
or she would otherwise submit claims of the intent to terminate opt-out 
and complies with paragraphs (b)(3) and (4) of this section. Paragraph 
(c) of this section applies in these cases.

[63 FR 58901, Nov. 2, 1998, as amended at 80 FR 71371, Nov. 16, 2015]



Sec.  405.450  Appeals.

    (a) A determination by CMS that a physician or practitioner has 
failed to properly opt out, failed to maintain opt-out, failed to timely 
renew opt-out, failed to privately contract, failed to properly 
terminate opt-out, or failed to properly cancel opt-out is an initial 
determination for purposes of Sec.  498.3(b) of this chapter.
    (b) A determination by CMS that no payment can be made to a 
beneficiary for the services of a physician who has opted-out is an 
initial determination for purposes of Sec.  405.924.

[63 FR 58901, Nov. 2, 1998, as amended at 79 FR 68001, Nov. 13, 2014; 80 
FR 71371, Nov. 16, 2015]



Sec.  405.455  Application to Medicare Advantage contracts.

    An organization that has a contract with CMS to provide one or more 
Medicare Advantage (M + C) plans to beneficiaries (part 422 of this 
chapter):
    (a) Must acquire and maintain information from Medicare carriers on 
physicians and practitioners who have opted-out of Medicare.
    (b) Must make no payment directly or indirectly for Medicare covered 
services furnished to a Medicare beneficiary by a physician or 
practitioner who has opted-out of Medicare.
    (c) May make payment to a physician or practitioner who furnishes 
emergency or urgent care services to a beneficiary who has not 
previously entered into a private contract with the physician or 
practitioner in accordance with Sec.  405.440.

[63 FR 58901, Nov. 2, 1998, as amended at 79 FR 68001, Nov. 13, 2014]



          Subpart E_Criteria for Determining Reasonable Charges

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 
1302 and 1395hh).

    Source: 32 FR 12599, Aug. 31, 1967, unless otherwise noted. 
Redesignated at 42 FR 52826, Sept. 30, 1977.



Sec.  405.500  Basis.

    Subpart E is based on the provisions of the following sections of 
the Act: Section 1814(b) provides for Part A payment on the basis of the 
lesser of a provider's reasonable costs or customary charges. Section 
1832 establishes the scope of benefits provided under the Part B 
supplementary medical insurance program. Section 1833(a) sets forth the 
amounts of payment for supplementary medical insurance services on the 
basis of the lesser of a provider's reasonable costs or customary 
charges. Section 1834(a) specifies how payments are made for the 
purchase or rental of

[[Page 153]]

new and used durable medical equipment for Medicare beneficiaries. 
Section 1834(b) provides for payment for radiologist services on a fee 
schedule basis. Section 1834(c) provides for payments and standards for 
screening mammography. Section 1842(b) sets forth the provisions for a 
carrier to enter into a contract with the Secretary and to make 
determinations with respect to Part B claims. Section 1842(h) sets forth 
the requirements for a physician or supplier to voluntarily enter into 
an agreement with the Secretary to become a participating physician or 
supplier. Section 1842(i) sets forth the provisions for the payment of 
Part B claims. Section 1848 establishes a fee schedule for payment of 
physician services. Section 1861(b) sets forth the inpatient hospital 
services covered by the Medicare program. Section 1861(s) sets forth 
medical and other health services covered by the Medicare program. 
Section 1861(v) sets forth the general authority under which CMS may 
establish limits on provider costs recognized as reasonable in 
determining Medicare program payments. Section 1861(aa) sets forth the 
rural health clinic services and Federally qualified health center 
services covered by the Medicare program. Section 1861(jj) defines the 
term ``covered osteoporosis drug.'' Section 1862(a)(14) lists services 
that are excluded from coverage. Section 1866(a) specifies the terms for 
provider agreements. Section 1881 authorizes special rules for the 
coverage of and payment for services furnished to patients with end-
stage renal disease. Section 1886 sets forth the requirements for 
payment to hospitals for inpatient hospital services. Section 1887 sets 
forth requirements for payment of provider-based physicians and payment 
under certain percentage arrangements. Section 1889 provides for 
Medicare and Medigap information by telephone.

[60 FR 63175, Dec. 8, 1995]



Sec.  405.501  Determination of reasonable charges.

    (a) Except as specified in paragraphs (b), (c), and (d) of this 
section, Medicare pays no more for Part B medical and other health 
services than the ``reasonable charge'' for such service. The reasonable 
charge is determined by the carriers (subject to any deductible and 
coinsurance amounts as specified in Sec. Sec.  410.152 and 410.160 of 
this chapter).
    (b) Part B of Medicare pays on the basis of ``reasonable cost'' (see 
part 413 of this chapter) for certain institutional services, certain 
services furnished under arrangements with institutions, and services 
furnished by entities that elect to be paid on a cost basis (including 
health maintenance organizations, rural health clinics, FQHCs that are 
authorized to bill under a reasonable cost system, and end-stage renal 
disease facilities).
    (c) Carriers will determine the reasonable charge on the basis of 
the criteria specified in Sec.  405.502, and the customary and 
prevailing charge screens in effect when the service was furnished. 
(Also see Sec. Sec.  415.55 through 415.70 and Sec. Sec.  415.100 
through 415.130 of this chapter, which pertain to the determination of 
reimbursement for services performed by hospital-based physicians.) 
However, when services are furnished more than 12 months before the 
beginning of the fee screen year (January 1 through December 30) in 
which a request for payment is made, payment is based on the customary 
and prevailing charge screens in effect for the fee screen year that 
ends immediately preceding the fee screen year in which the claim or 
request for payment is made.
    (d) Payment under Medicare Part B for durable medical equipment and 
prosthetic and orthotic devices is determined in accordance with the 
provisions of subpart D of part 414 of this chapter.

[47 FR 63274, Dec. 31, 1981, as amended at 51 FR 34978, Oct. 1, 1986; 51 
FR 37911, Oct. 27, 1986; 54 FR 9003, Mar. 2, 1989; 57 FR 24975, June 12, 
1992; 57 FR 33896, July 31, 1992; 57 FR 57688, Dec. 7, 1992; 60 FR 
63176, Dec. 8, 1995; 79 FR 25473, May 2, 2014]



Sec.  405.502  Criteria for determining reasonable charges.

    (a) Criteria. The law allows for flexibility in the determination of 
reasonable charges to accommodate reimbursement to the various ways in 
which health services are furnished and

[[Page 154]]

charged for. The criteria for determining what charges are reasonable 
include:
    (1) The customary charges for similar services generally made by the 
physician or other person furnishing such services.
    (2) The prevailing charges in the locality for similar services.
    (3) In the case of physicians' services, the prevailing charges 
adjusted to reflect economic changes as provided under Sec.  405.504 of 
this subpart.
    (4) In the case of medical services, supplies, and equipment that 
are reimbursed on a reasonable charge basis (excluding physicians' 
services), the inflation-indexed charge as determined under Sec.  
405.509.
    (5) [Reserved]
    (6) In the case of medical services, supplies, and equipment 
(including equipment servicing) that the Secretary judges do not 
generally vary significantly in quality from one supplier to another, 
the lowest charge levels at which such services, supplies, and equipment 
are widely and consistently available in a locality.
    (7) Other factors that may be found necessary and appropriate with 
respect to a category of service to use in judging whether the charge is 
inherently reasonable. This includes special reasonable charge limits 
(which may be either upper or lower limits) established by CMS or a 
carrier if it determines that the standard rules for calculating 
reasonable charges set forth in this subpart result in the grossly 
deficient or excessive charges. The determination of these limits is 
described in paragraphs (g) and (h) of this section.
    (8) In the case of laboratory services billed by a physician but 
performed by an outside laboratory, the payment levels established in 
accordance with the criteria stated in Sec.  405.515.
    (9) Except as provided in paragraph (a)(10) of this section, in the 
case of services of assistants-at-surgery as defined in Sec.  405.580 in 
teaching and non-teaching settings, charges that are not more than 16 
percent of the prevailing charge in the locality, adjusted by the 
economic index, for the surgical procedure performed by the primary 
surgeon. Payment is prohibited for the services of an assistant-at-
surgery in surgical procedures for which CMS has determined that 
assistants-at-surgery on average are used in less than 5 percent of such 
procedures nationally.
    (10) In the case of services of assistants at surgery that meet the 
exception under Sec.  415.190(c)(2) or (c)(3) of this chapter because 
the physician is performing a unique, necessary, specialized medical 
service in the total care of a patient during surgery, reasonable 
charges consistent with prevailing practice in the carrier's service 
area rather than the special assistant at surgery rate.
    (b) Comparable services limitation. The law also specifies that the 
reasonable charge cannot be higher than the charge applicable for a 
comparable service under comparable circumstances to the carriers' own 
policyholders and subscribers.
    (c) Application of criteria. In applying these criteria, the 
carriers are to exercise judgment based on factual data on the charges 
made by physicians to patients generally and by other persons to the 
public in general and on special factors that may exist in individual 
cases so that determinations of reasonable charge are realistic and 
equitable.
    (d) Responsibility of Administration and carriers. Determinations by 
carriers of reasonable charge are not reviewed on a case-by-case basis 
by the Centers for Medicare & Medicaid Services, although the general 
procedures and performance of functions by carriers are evaluated. In 
making determinations, carriers apply the provisions of the law under 
broad principles issued by the Centers for Medicare & Medicaid Services. 
These principles are intended to assure overall consistency among 
carriers in their determinations of reasonable charge. The principles in 
Sec. Sec.  405.503 through 405.507 establish the criteria for making 
such determinations in accordance with the statutory provisions.
    (e) Determination of reasonable charges under the End-Stage Renal 
Disease (ESRD) Program--(1) General. Reasonable charges for renal-
related items and services (furnished in connection with transplantation 
or dialysis) must be related to costs and allowances that are reasonable 
when the treatments are furnished in an effective and economical manner.

[[Page 155]]

    (2) Nonprovider (independent) dialysis facilities. Reasonable 
charges for renal-related items and services furnished before August 1, 
1983 must be determined related to costs and charges prior to July, 
1973, in accordance with the regulations at Sec.  405.541. Items and 
services related to outpatient maintenance dialysis that are furnished 
after that date are paid for in accordance with Sec. Sec.  405.544 and 
413.170 of this chapter.
    (3) Provider services and (hospital-based) dialysis facilities. 
Renal-related items and services furnished by providers, or by ESRD 
facilities based in hospitals, before August 1, 1983 are paid for under 
the provider reimbursement provisions found generally in part 413 of 
this chapter. Items and services related to outpatient maintenance 
dialysis that are furnished after that date are paid for in accordance 
with Sec. Sec.  405.544 and 413.170 of this chapter.
    (4) Physicians' services. Reasonable charges for renal-related 
physicians' services must be determined considering charges made for 
other services involving comparable physicians' time and skill 
requirements, in accordance with regulations at Sec. Sec.  405.542 and 
405.543.
    (5) Health maintenance organizations (HMOs). For special rules 
concerning the reimbursement of ESRD services furnished by risk-basis 
HMOs, or by facilities owned or operated by or related to such HMOs by 
common ownership or control, see Sec. Sec.  405.2042(b)(14) and 
405.2050(c).
    (f) Determining payments for certain physician services furnished in 
outpatient hospital settings--(1) General rule. If physician services of 
the type routinely furnished in physicians' offices are furnished in 
outpatient hospital settings before January 1, 1992, carriers determine 
the reasonable charge for those services by applying the limits 
described in paragraph (f)(5) of this section.
    (2) Definition. As used in this paragraph (f), outpatient settings 
means--
    (i) Hospital outpatient departments, including clinics and emergency 
rooms; and
    (ii) Comprehensive outpatient rehabilitation facilities.
    (3) Services covered by limits. The carrier establishes a list of 
services routinely furnished in physicians' offices in the area. The 
carrier has the discretion to determine which professional services are 
routinely furnished in physicians' offices, based on current medical 
practice in the area. Listed below are some examples of routine services 
furnished by office-based physicians.

                                Examples

    Review of recent history, determination of blood pressure, 
ausculation of heart and lungs, and adjustment of medication.
    Brief history and examination, and initiation of diagnostic and 
treatment programs.
    Treatment of an acute respiratory infection.

    (4) Services excluded from limits. The limits established under this 
paragraph do not apply to the following:
    (i) Rural health clinic services.
    (ii) Surgical services included on the ambulatory surgical center 
list of procedures published under Sec.  416.65(c) of this chapter.
    (iii) Services furnished in a hospital emergency room after the 
sudden onset of a medical condition manifesting itself by acute symptoms 
of sufficient severity (including severe pain) such that the absence of 
immediate medical attention could reasonably be expected to result in--
    (A) Placing the patient's health in serious jeopardy;
    (B) Serious impairment to bodily functions; or
    (C) Serious dysfunction of any bodily organ or part.
    (iv) Anesthesiology services and diagnostic and therapeutic 
radiology services.
    (v) Federally qualified health center services paid under the rules 
in part 405 subpart X.
    (5) Methodology for developing limits--(i) Development of a charge 
base. The carrier establishes a charge base for each service identified 
as a routine office-based physician service. The charge base consists of 
the prevailing charge in the locality for each such service adjusted by 
the economic index. The carrier uses the prevailing

[[Page 156]]

charges that apply to services by nonspecialists in office practices in 
the locality in which the outpatient setting is located.
    (ii) Calculation of the outpatient limits. The carrier calculates 
the charge limit for each service by multiplying the charge base amount 
for each service by .60.
    (6) Application of limits. The reasonable charge for physician 
services of the type described in paragraph (f)(3) of this section that 
are furnished in an outpatient setting is the lowest of the actual 
charges, the customary charges in accordance with Sec.  405.503, the 
prevailing charges applicable to these services in accordance with Sec.  
405.504, or the charge limits calculated in paragraph (f)(5)(ii) of this 
section.
    (g) Determination of payment amounts in special circumstances--(1) 
General. (i) For purposes of this paragraph (g), a ``category of items 
or services'' may consist of a single item or service or any number of 
items or services.
    (ii) CMS or a carrier may determine that the standard rules for 
calculating payment amounts set forth in this subpart for a category of 
items or services identified in section 1861(s) of the Act (other than 
physicians' services paid under section 1848 of the Act and those items 
and services for which payment is made under a prospective payment 
system, such as outpatient hospital services or home health services) 
will result in grossly deficient or excessive amounts. A payment amount 
will not be considered grossly excessive or deficient if it is 
determined that an overall payment adjustment of less than 15 percent is 
necessary to produce a realistic and equitable payment amount. For CMS-
initiated adjustments, CMS will publish in the Federal Register an 
analysis of payment adjustments that exceed $100 million per year in 
compliance with Executive Order 12866. If CMS makes adjustments that 
have a significant effect on a substantial number of small entities, it 
will publish an analysis in compliance with the Regulatory Flexibility 
Act.
    (iii) If CMS or the carrier determines that the standard rules for 
calculating payment amounts for a category of items or services will 
result in grossly deficient or excessive amounts, CMS, or the carrier, 
may establish special payment limits that are realistic and equitable 
for a category of items or services. If CMS makes a determination, it is 
considered a national determination. A carrier determination is one made 
by a carrier or intermediary or groups of carriers or intermediaries 
even if the determination applies to payment in all States.
    (iv) The limit on the payment amount is either an upper limit to 
correct a grossly excessive payment amount or a lower limit to correct a 
grossly deficient payment amount.
    (v) The limit is either a specific dollar amount or is based on a 
special method to be used in determining the payment amount.
    (vi) Except as provided in paragraph (h) of this section, a payment 
limit for a given year may not vary by more than 15 percent from the 
payment amount established for the preceding year.
    (vii) Examples of excessive or deficient payment amounts. Examples 
of the factors that may result in grossly deficient or excessive payment 
amounts include, but are not limited to, the following:
    (A) The marketplace is not competitive. This includes circumstances 
in which the marketplace for a category of items or services is not 
truly competitive because a limited number of suppliers furnish the item 
or service.
    (B) Medicare and Medicaid are the sole or primary sources of payment 
for a category of items or services.
    (C) The payment amounts for a category of items or services do not 
reflect changing technology, increased facility with that technology, or 
changes in acquisition, production, or supplier costs.
    (D) The payment amounts for a category of items or services in a 
particular locality are grossly higher or lower than payment amounts in 
other comparable localities for the category of items or services, 
taking into account the relative costs of furnishing the category of 
items or services in the different localities.
    (E) Payment amounts for a category of items or services are grossly 
higher or lower than acquisition or production

[[Page 157]]

costs for the category of items or services.
    (F) There have been increases in payment amounts for a category of 
items or services that cannot be explained by inflation or technology.
    (G) The payment amounts for a category of items or services are 
grossly higher or lower than the payments made for the same category of 
items or services by other purchasers in the same locality.
    (H) A new technology exists which is not reflected in the existing 
payment allowances.
    (2) Establishing a limit. In establishing a payment limit for a 
category of items or services, CMS or a carrier considers the available 
information that is relevant to the category of items or services and 
establishes a payment amount that is realistic and equitable. The 
factors CMS or a carrier considers in establishing a specific dollar 
amount or special payment method for a category of items or services may 
include, but are not limited to, the following:
    (i) Price markup. Price markup is the relationship between the 
retail and wholesale prices or manufacturer's costs of a category of 
items or services. If information on a particular category of items or 
services is not available, CMS or a carrier may consider the price 
markup on a similar category of items or services and information on 
general industry pricing trends.
    (ii) Differences in charges. CMS or a carrier may consider the 
differences in charges for a category of items or services made to non-
Medicare and Medicare patients or to institutions and other large volume 
purchasers.
    (iii) Costs. CMS or a carrier may consider resources (for example, 
overhead, time, acquisition costs, production costs, and complexity) 
required to produce a category of items or services.
    (iv) Use. CMS or a carrier may impute a reasonable rate of use for a 
category of items or services and consider unit costs based on efficient 
use.
    (v) Payment amounts in other localities. CMS or a carrier may 
consider payment amounts for a category of items or services furnished 
in another locality.
    (3) Notification of limits--(i) National limits. CMS publishes in 
the Federal Register proposed and final notices announcing a special 
payment limit described in paragraph (g) of this section before it 
adopts the limit. The notices set forth the criteria and circumstances, 
if any, under which a carrier may grant an exception to a payment limit 
for a category of items or services.
    (ii) Carrier-level limits. (A) A carrier proposing to establish a 
special payment limit for a category of items or services must inform 
the affected suppliers and Medicaid agencies of the proposed payment 
amounts and the factors it considered in proposing the particular limit, 
as described in paragraphs (g)(1) through (g)(4) of this section and 
must solicit comments. The notice must also consider the following:
    (1) The effects on the Medicare program, including costs, savings, 
assignment rates, beneficiary liability, and quality of care.
    (2) What entities would be affected, such as classes of providers or 
suppliers and beneficiaries.
    (3) How significantly would these entities be affected.
    (4) How would the adjustment affect beneficiary access to items or 
services.
    (B) Before publication of a final notice, the carrier must--
    (1) Evaluate the comments it receives on the proposed notice.
    (2) Notify CMS in writing of any final limits it plans to establish. 
CMS will acknowledge in writing to the carrier that it received the 
carrier's notification.
    (3) After receipt of CMS' acknowledgement, inform the affected 
suppliers and State Medicaid agencies of any final limits it 
establishes.
    (C) The effective date for a final payment limit may apply to 
services furnished at least 60 days after the date that the carrier 
notifies affected suppliers and State Medicaid agencies of the final 
limit.
    (4) Use of valid and reliable data. In determining whether a payment 
amount is grossly excessive or deficient and in establishing an 
appropriate payment amount, valid and reliable data are used. To ensure 
the use of valid and reliable data, CMS or the carrier must

[[Page 158]]

meet the following criteria to the extent applicable:
    (i) Develop written guidelines for data collection and analysis.
    (ii) Ensure consistency in any survey to collect and analyze pricing 
data.
    (iii) Develop a consistent set of survey questions to use when 
requesting retail prices.
    (iv) Ensure that sampled prices fully represent the range of prices 
nationally.
    (v) Consider the geographic distribution of Medicare beneficiaries.
    (vi) Consider relative prices in the various localities to ensure 
that an appropriate mix of areas with high, medium, and low consumer 
prices was included.
    (vii) Consider criteria to define populous State, less populous 
State, urban area, and rural area.
    (viii) Consider a consistent approach in selecting retail outlets 
within selected cities.
    (ix) Consider whether the distribution of sampled prices from 
localities surveyed is fully representative of the distribution of the 
U.S. population.
    (x) Consider the products generally used by beneficiaries and 
collect prices of these products.
    (xi) When using wholesale costs, consider the cost of the services 
necessary to furnish a product to beneficiaries.
    (5) Review of market prices. If CMS or a carrier makes a payment 
adjustment of more than 15 percent under this paragraph (g), CMS or the 
carrier will review market prices in the years subsequent to the year 
that the initial reduction is effective in order to ensure that further 
reductions continue to be appropriate.
    (h) Special payment limit adjustments greater than 15 percent of the 
payment amount. In addition to applying the general rules under 
paragraphs (g)(1) through (g)(5) of this section, CMS applies the 
following rules in establishing a payment adjustment greater than 15 
percent of the payment amount for a category of items or services within 
a year:
    (1) Potential impact of special limit. CMS considers the potential 
impact on quality, access, beneficiary liability, assignment rates, and 
participation of suppliers.
    (2) Supplier consultation. Before making a determination that a 
payment amount for a category of items or services is not inherently 
reasonable by reason of its grossly excessive or deficient amount, CMS 
consults with representatives of the supplier industry likely to be 
affected by the change in the payment amount.
    (3) Publication of national limits. If CMS determines under this 
paragraph (h) to establish a special payment limit for a category of 
items or services, it publishes in the Federal Register the proposed and 
final notices of a special payment limit before it adopts the limit. The 
notices set forth the criteria and circumstances, if any, under which a 
carrier may grant an exception to the limit for the category of items or 
services.
    (i) Proposed notice. The proposed notice--
    (A) Explains the factors and data that CMS considered in determining 
that the payment amount for a category of items or services is grossly 
excessive or deficient;
    (B) Specifies the proposed payment amount or methodology to be 
established for a category of items or services;
    (C) Explains the factors and data that CMS considered in determining 
the payment amount or methodology, including the economic justification 
for a uniform fee or payment limit if it is proposed;
    (D) Explains the potential impacts of a limit on a category of items 
or services as described in paragraph (h)(1) of this section; and
    (E) Allows no less than 60 days for public comment on the proposed 
payment limit for the category of items or services.
    (ii) Final notice. The final notice--
    (A) Explains the factors and data that CMS considered, including the 
economic justification for any uniform fee or payment limit established; 
and
    (B) Responds to the public comments.
    (i) Proposed notice. The proposed notice--
    (A) Explains the factors and data that CMS considered in determining 
that the payment amount for a category of items or services is grossly 
excessive or deficient;

[[Page 159]]

    (B) Specifies the proposed payment amount or methodology to be 
established for a category of items or services;
    (C) Explains the factors and data that CMS considered in determining 
the payment amount or methodology, including the economic justification 
for a uniform fee or payment limit if it is proposed;
    (D) Explains the potential impacts of a limit on a category of items 
or services as described in paragraph (h)(1) of this section; and
    (E) Allows no less than 60 days for public comment on the proposed 
payment limit for the category of items or services.
    (ii) Final notice. The final notice--
    (A) Explains the factors and data that CMS considered, including the 
economic justification for any uniform fee or payment limit established; 
and
    (B) Responds to the public comments.
    (i) Paramedic intercept ambulance services. (1) CMS establishes its 
payment allowance on a carrier-wide basis by using the median allowance 
from all localities within an individual carrier's jurisdiction.
    (2) CMS's payment allowance is equal to the advanced life support 
rate minus 40 percent of the basic life support rate.
    (3) CMS bases payment on the lower of the actual charge or the 
amount described in paragraph (i)(1) and (i)(2) of this section.

(Secs. 1102, 1814(b), 1833(a), 1842(b), and (h), and 1871, 1903(i)(1) of 
the Social Security Act; 49 Stat. 647, as amended, 79 Stat. 296, 302, 
310, 331; 86 Stat. 1395, 1454; 42 U.S.C. 1302, 1395u(b), 1395hh, 
1396b(i)(1).

[32 FR 12599, Aug. 31, 1967]

    Editorial Note: For Federal Register citations affecting Sec.  
405.502, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.  405.503  Determining customary charges.

    (a) Customary charge defined. The term ``customary charges'' will 
refer to the uniform amount which the individual physician or other 
person charges in the majority of cases for a specific medical procedure 
or service. In determining such uniform amount, token charges for 
charity patients and substandard charges for welfare and other low 
income patients are to be excluded. The reasonable charge cannot, except 
as provided in Sec.  405.506, be higher than the individual physician's 
or other person's customary charge. The customary charge for different 
physicians or other persons may, of course, vary. Payment for covered 
services would be based on the actual charge for the service when, in a 
given instance, that charge is less than the amount which the carrier 
would otherwise have found to be within the limits of acceptable charges 
for the particular service. Moreover, the income of the individual 
beneficiary is not to be taken into account by the carrier in 
determining the amount which is considered to be a reasonable charge for 
a service rendered to him. There is no provision in the law for a 
carrier to evaluate the reasonableness of charges in light of an 
individual beneficiary's economic status.
    (b) Variation of charges. If the individual physician or other 
person varies his charges for a specific medical procedure or service, 
so that no one amount is charged in the majority of cases, it will be 
necessary for the carrier to exercise judgment in the establishment of a 
``customary charge'' for such physician or other person. In making this 
judgment, an important guide, to be utilized when a sufficient volume of 
data on the physician's or other person's charges is available, would be 
the median or midpoint of his charges, excluding token and substandard 
charges as well as exceptional charges on the high side. A significant 
clustering of charges in the vicinity of the median amount might 
indicate that a point of such clustering should be taken as the 
physician's or other person's ``customary'' charge. Use of relative 
value scales will help in arriving at a decision in such instances.
    (c) Use of relative value scales. If, for a particular medical 
procedure or service, the carrier is unable to determine the customary 
charge on the basis of reliable statistical data (for example, because 
the carrier does not yet have sufficient data or because the performance 
of the particular medical procedure or service by the physician or other 
person is infrequent), the carrier may use appropriate relative value

[[Page 160]]

scales to determine the customary charge for such procedure or service 
in relation to customary charges of the same physician or person for 
other medical procedures and services.
    (d) Revision of customary charge. A physician's or other person's 
customary charge is not necessarily a static amount. Where a physician 
or other person alters his charges, a revised pattern of charges for his 
services may develop. Where on the basis of adequate evidence, the 
carrier finds that the physician or other person furnishing services has 
changed his charge for a service to the public in general, the customary 
charge resulting from the revised charge for the service should be 
recognized as the customary charge in making determinations of 
reasonable charges for such service when rendered thereafter to 
supplementary insurance beneficiaries. If the new customary charge is 
not above the top of the range of prevailing charges (see Sec.  
405.504(a)), it should be deemed to be reasonable by the carrier, 
subject to the provisions of Sec.  405.508.



Sec.  405.504  Determining prevailing charges.

    (a) Ranges of charges. (1) In the case of physicians' services 
furnished beginning January 1, 1987, the prevailing charges for a 
nonparticipating physician as defined in this paragraph will be no 
higher than the same level that was set for services furnished during 
the previous calendar year for a physician who was a participating 
physician during that year. A nonparticipating physician is a physician 
who has not entered into an agreement with the Medicare program to 
accept payment on an assignment-related basis (in accordance with Sec.  
424.55 of this chapter) for all items and services furnished to 
individuals enrolled under Part B of Medicare during a given calendar 
year.
    (2) No charge for Part B medical or other health services may be 
considered to be reasonable if it exceeds the higher of:
    (i) The prevailing charge for similar services in the same locality 
in effect on December 31, 1970, provided such prevailing charge had been 
found acceptable by CMS; or
    (ii) The prevailing charge that, on the basis of statistical data 
and methodology acceptable to CMS, would cover:
    (A) 75 percent of the customary charges made for similar services in 
the same locality during the 12-month period of July 1 through June 30 
preceding the fee screen year (January 1 through December 31) in which 
the service was furnished; or
    (B) In the case of services furnished more than 12 months before the 
beginning of the fee screen year (January 1 through December 31) in 
which the claim or request for payment is submitted, 75 percent of the 
customary charges made for similar services in the same locality during 
the 12 month period of July 1 through June 30 preceding the fee screen 
year that ends immediately preceding the fee screen year in which the 
claim or request for payment is submitted.
    (3)(i) In the case of physicians' services, furnished before January 
1, 1992, each prevailing charge in each locality may not exceed the 
prevailing charge determined for the FY ending June 30, 1973 (without 
reference to the adjustments made in accordance with the economic 
stabilization program then in effect), except on the basis of 
appropriate economic index data that demonstrate the higher prevailing 
charge level is justified by:
    (A) Changes in general earnings levels of workers that are 
attributable to factors other than increases in their productivity; and
    (B) changes in expenses of the kind incurred by physicians in office 
practice. The office-expense component and the earnings component of 
such index shall be given the relative weights shown in data on self-
employed physicians' gross incomes.

    Example. The available data indicate the office-expense and earnings 
components of the index should be given relative weights of 40 percent 
and 60 percent, respectively, and it is calculated that the aggregate 
increase in expenses of practice for a particular July through June 
period was 112 percent over the expenses of practice for calendar year 
1971 and the increase in earnings (less increases in workers' 
productivity was 110 percent over the earnings for calendar year 1971. 
The allowable increase in any prevailing charge that could be recognized 
during the next fee

[[Page 161]]

screen year would be 110.8 percent ((.40 x 112) + (.60) x 110) = 110.8) 
above the prevailing charge recognized for fiscal year 1973.

    (ii)(A) If the increase in the prevailing charge in a locality for a 
particular physician service resulting from an aggregate increase in 
customary charges for that service does not exceed the index determined 
under paragraph (a)(3)(i) of this section, the increase is permitted and 
any portion of the allowable increase not used is carried forward and is 
a basis for justifying increases in that prevailing charge in the 
future. However, if the increase in the prevailing charge exceeds the 
allowable increase, the increase will be reduced to the allowable 
amount. Further increases will be justified only to the degree that they 
do not exceed further rises in the economic index. The prevailing charge 
for physicians' services furnished during the 15-month period beginning 
July 1, 1984 may not exceed the prevailing charge for physicians' 
services in effect for the 12-month period beginning July 1, 1983. The 
increase in prevailing charges for physicians' services for subsequent 
fee screen years similarly may not reflect the rise in the economic 
index that would have otherwise been provided for the period beginning 
July 1, 1984, and must be treated as having fully provided for the rise 
in the economic index which would have been otherwise taken into 
account.
    (B) Notwithstanding the provisions of paragraphs (a)(3)(i) and 
(ii)(A) of this section, the prevailing charge in the case of a 
physician service in a particular locality determined pursuant to 
paragraphs (a)(2) and (3)(i) of this section for the fiscal year 
beginning July 1, 1975, and for any subsequent fee screen years, if 
lower than the prevailing charge for the fiscal year ending June 30, 
1975, by reason of the application of economic index data, must be 
raised to such prevailing charge which was in effect for the fiscal year 
ending June 30, 1975. (If the amount paid on any claim processed by a 
carrier after the original reasonable charge update for the fiscal year 
beginning July 1, 1975, and prior to the adjustments required by the 
preceding sentence, was at least $1 less than the amount due pursuant to 
the preceding sentence, the difference between the amount previously 
paid and the amount due shall be paid within 6 months after December 31, 
1975; however, no payment shall be made on any claim where the 
difference between the amount previously and the amount due shall be 
paid within 6 months after December 31, 1975; however, no payment shall 
be made on any claim where the difference between the amount previously 
paid and the amount due is less than $1.)
    (iii) If, for any reason, a prevailing charge for a service in a 
locality has no precise counterpart in the carrier's charge data for 
calendar year 1971 (the data on which the prevailing charge calculations 
for fiscal year 1973 were based), the limit on the prevailing charge 
will be estimated, on the basis of data and methodology acceptable to 
CMS, to seek to produce the effect intended by the economic index 
criterion. The allowance or reduction of an increase in a prevailing 
charge for any individual medical item or service may affect the 
allowance or reduction of an increase in the prevailing charges for 
other items or services if, for example, the limit on the prevailing 
charge is estimated, or if the prevailing charges for more than one item 
or service are established through the use of a relative value schedule 
and dollar conversion factors.
    (b) Variation in range of prevailing charges. The range of 
prevailing charges in a locality may be different for physicians or 
other persons who engage in a specialty practice or service than for 
others. Existing differentials in the level of charges between different 
kinds of practice or service could, in some localities, lead to the 
development of more than one range of prevailing charges for application 
by the carrier in its determinations of reasonable charges. Carrier 
decisions in this respect should be responsive to the existing patterns 
of charges by physicians and other persons who render covered services, 
and should establish differentials in the levels of charges between 
different kinds of practice or service only where in accord with such 
patterns.
    (c) Re-evaluation and adjustment of prevailing charges. 
Determinations of

[[Page 162]]

prevailing charges by the carrier are to be re-evaluated and adjusted 
from time to time on the basis of factual information about the charges 
made by physicians and other persons to the public in general. This 
information should be obtained from all possible sources including a 
carrier's experience with its own programs as well as with the 
supplementary medical insurance program.
    (d) Computation and issuance of the MEI after CY 1992--(1) For 
update years after CY 1992, the MEI is a physician input price index, in 
which the annual percent changes for the direct-labor price components 
are adjusted by an annual percent change in a 10-year moving average 
index of labor productivity in the nonfarm business sector.
    (2) The MEI is constructed, using as a base year, CY 1989 weights 
and annual percent changes in the economic price proxies as shown on the 
following chart:

   Medicare Economic Index Expenditure Categories, Weights, and Price
                                 Proxies
------------------------------------------------------------------------
                                  1989 weights
        Expense category              \1 2\          Price proxy \3\
                                    (percent)
------------------------------------------------------------------------
    Total......................           100.0
1. Physician's Own Time (net               54.2
 income, general earnings).
    a. Wages and Salaries......            45.3  Average hourly
                                                  earnings, total
                                                  private non-farm. \4\
    b. Fringe Benefits.........             8.8  Employment Cost Index,
                                                  fringe benefits,
                                                  private non-farm. \4\
2. Physician Practice Expense..            45.8
    a. Non-physician Employee              16.3
     Compensation.
        (1) Wages and Salaries.            13.8  Employment Cost Index,
                                                  wages and salaries
                                                  weighted for
                                                  occupational mix of
                                                  non-physician
                                                  employees. \4\
        (2) Fringe Benefits....             2.5  Employment Cost Index,
                                                  fringe benefits, white
                                                  collar. \4\
    b. Office Expense..........            10.3  CPI-U, housing.
    c. Medical Materials and                5.2  PPI, ethical drugs;
     Supplies.                                    PPI, surgical
                                                  appliances and
                                                  supplies; and CPI-U
                                                  medical equipment and
                                                  supplies (equally
                                                  weighted).
    d. Professional Liability               4.8  CMS survey of change in
     Insurance.                                   average liability
                                                  premiums for $100,000/
                                                  $300,000 liability
                                                  coverage among 9 major
                                                  insurers.
    e. Medical Equipment.......             2.3  PPI, medical
                                                  instruments and
                                                  equipment.
    f. Other Professional                   6.9
     Expense.
        (1) Professional Car...             1.4  CPI-U, private
                                                  transportation.
        (2) Other..............             5.5  CPI-U, all items less
                                                  food and energy.
------------------------------------------------------------------------
\1\ Sources: Martin L. Gonzalez, ed.: Physician Marketplace Statistics,
  Fall, 1990. Center for Health Policy Research, Chicago, American
  Medical Association, 1990; Mark Holoweiko, ``Practice Expenses Take
  the Leap of the Decade,'' Medical Economics, November 12, 1990; and
  CMS, OACT special study.
\2\ Due to rounding, weights may not sum to 100.0%
\3\ All price proxies are for annual percent changes for the 12 months
  ending June 30th.
\4\ Annual percent change values for Physicians' Own Time and Non-
  physician Employee Compensation are net of the change in the 10-year
  moving average of output per man-hour to exclude changes in non-farm
  business sector labor productivity.

    (3) If there is no methodological change, CMS publishes a notice in 
the Federal Register to announce the annual increase in the MEI before 
the beginning of the update year to which it applies. If there are 
changes in the base year weights or price proxies, or if there are any 
other MEI methodological changes, they are published in the Federal 
Register with an opportunity for public comment.

[32 FR 12600, Aug. 31, 1967, as amended at 40 FR 25447, June 16, 1975; 
42 FR 18275, Apr. 6, 1977. Redesignated at 42 FR 52826, Sept. 30, 1977, 
as amended at 43 FR 4430, Feb. 2, 1978; 47 FR 63274, Dec. 31, 1982; 51 
FR 34978, Oct. 1, 1986; 53 FR 6648, Mar. 2, 1988; 57 FR 55912, Nov. 25, 
1992]



Sec.  405.505  Determination of locality.

    ``Locality'' is the geographical area for which the carrier is to 
derive the reasonable charges or fee schedule amounts for services or 
items. Usually, a locality may be a State (including the District of 
Columbia, a territory, or a Commonwealth), a political or economic 
subdivision of a State, or a group of States. It should include a cross 
section of the population with respect to economic and other 
characteristics. Where people tend to gravitate toward certain 
population centers to

[[Page 163]]

obtain medical care or service, localities may be recognized on a basis 
constituting medical services areas (interstate or otherwise), 
comparable in concept to ``trade areas.'' Localities may differ in 
population density, economic level, and other major factors affecting 
charges for services. Carriers therefore shall delineate localities on 
the basis of their knowledge of local conditions. However, distinctions 
between localities are not to be so finely made that a locality includes 
only a very limited geographic area whose population has distinctly 
similar income characteristics (e.g., a very rich or very poor 
neighborhood within a city).

[57 FR 27305, June 18, 1992]



Sec.  405.506  Charges higher than customary or prevailing charges 
or lowest charge levels.

    A charge which exceeds the customary charge of the physician or 
other person who rendered the medical or other health service, or the 
prevailing charge in the locality, or an applicable lowest charge level 
may be found to be reasonable, but only where there are unusual 
circumstances, or medical complications requiring additional time, 
effort or expense which support an additional charge, and only if it is 
acceptable medical or medical service practice in the locality to make 
an extra charge in such cases. The mere fact that the physician's or 
other person's customary charge is higher than prevailing would not 
justify a determination that it is reasonable.

(Secs. 1102, 1842(b) and 1871, 1903(i)(1) of the Social Security Act; 49 
Stat. 647, 79 Stat. 302, 310, 331; 86 Stat. 1395, 1454; (42 U.S.C. 1302, 
1395u(b), 1395hh, 1396b(i)(1)))

[43 FR 32300, July 26, 1978]



Sec.  405.507  Illustrations of the application of the criteria 
for determining reasonable charges.

    The following examples illustrate how the general criteria on 
customary charges and prevailing charges might be applied in determining 
reasonable charges under the supplementary medical insurance program. 
Basically, these examples demonstrate that, except where the actual 
charge is less, reasonable charges will reflect current customary 
charges of the particular physician or other person within the ranges of 
the current prevailing charges in the locality for that type and level 
of service:

    The prevailing charge for a specific medical procedure ranges from 
$80 to $100 in a certain locality.
    Doctor A's bill is for $75 although he customarily charges $80 for 
the procedure.
    Doctor B's bill is his customary charge of $85
    Doctor C's bill is his customary charge of $125
    Doctor D's bill is for $100, although he customarily charges $80, 
and there are no special circumstances in the case.
    The reasonable charge for Doctor A would be limited to $75 since 
under the law the reasonable charge cannot exceed the actual charge, 
even if it is lower than his customary charge and below the prevailing 
charges for the locality.
    The reasonable charge for Doctor B would be $85, because it is his 
customary charge and it falls within the range of prevailing charges for 
that locality.
    The reasonable charge for Doctor C could not be more than $100, the 
top of the range of prevailing charges.
    The reasonable charge for Doctor D would be $80, because that is his 
customary charge. Even though his actual charge of $100 falls within the 
range of prevailing charges, the reasonable charge cannot exceed his 
customary charge in the absence of special circumstances.



Sec.  405.508  Determination of comparable circumstances; limitation.

    (a) Application of limitation. The carrier may not in any case make 
a determination of reasonable charge which would be higher than the 
charge upon which it would base payment to its own policyholders for a 
comparable service in comparable circumstances. The charge upon which it 
would base payment, however, does not necessarily mean the amount the 
carrier would be obligated to pay. Under certain circumstances, some 
carriers pay amounts on behalf of individuals who are their 
policyholders, which are below the customary charges of physicians or 
other persons to other individuals. Payment under the supplementary 
medical insurance program would not be limited to these lower amounts.
    (b) When comparability exists. ``Comparable circumstances,'' as used 
in the

[[Page 164]]

Act and this subpart, refers to the circumstances under which services 
are rendered to individuals and the nature of the carrier's health 
insurance programs and the method it uses to determine the amounts of 
payments under these programs. Generally, comparability would exist 
where:
    (1) The carrier bases payment under its program on the customary 
charges, as presently constituted, of physicians or other persons and on 
current prevailing charges in a locality, and
    (2) The determination does not preclude recognition of factors such 
as speciality status and unusual circumstances which affect the amount 
charged for a service.
    (c) Responsibility for determining comparability. Responsibility for 
determining whether or not a carrier's program has comparability will in 
the first instance fall upon the carrier in reporting pertinent 
information about its programs to the Centers for Medicare & Medicaid 
Services. When the pertinent information has been reported, the Centers 
for Medicare & Medicaid Services will advise the carrier whether any of 
its programs have comparability.



Sec.  405.509  Determining the inflation-indexed charge.

    (a) Definition. For purposes of this section, inflation-indexed 
charge means the lowest of the fee screens used to determine reasonable 
charges (as determined in Sec.  405.503 for the customary charge, Sec.  
405.504 for the prevailing charge, this section for the inflation-
indexed charge, and Sec.  405.511 for the lowest charge level) for 
services, supplies, and equipment reimbursed on a reasonable charge 
basis (excluding physicians' services), that is in effect on December 31 
of the previous fee screen year, updated by the inflation adjustment 
factor, as described in paragraph (b) of this section.
    (b) Application of inflation adjustment factor to determine 
inflation-indexed charge. (1) For fee screen years beginning on or after 
January 1, 1987, the inflation-indexed charge is determined by updating 
the fee screen used to determine the reasonable charges in effect on 
December 31 of the previous fee screen year by application of an 
inflation adjustment factor, that is, the annual change in the level of 
the consumer price index for all urban consumers, as compiled by the 
Bureau of Labor Statistics, for the 12-month period ending on June 30 of 
each year.
    (2) For services, supplies, and equipment furnished from October 1, 
1985 through December 31, 1986 the inflation adjustment factor is zero.
    (c) The inflation-indexed charge does not apply to any services, 
supplies, or equipment furnished after December 31, 1991, that are 
covered under or limited by the fee schedule for physicians' services 
established under section 1848 of the Act and part 415 of this chapter. 
These services are subject to the Medicare Economic Index described in 
Sec.  415.30 of this chapter.

[51 FR 34979, Oct. 1, 1986; 51 FR 37911, Oct. 27, 1986, as amended at 56 
FR 59621, Nov. 25, 1991]



Sec.  405.511  Reasonable charges for medical services, supplies, 
and equipment.

    (a) General rule. (1) A charge for any medical service, supply, or 
equipment (including equipment servicing) that in the judgment of CMS 
generally does not vary significantly in quality from one supplier to 
another (and that is identified by a notice published in the Federal 
Register) may not be considered reasonable if it exceeds:
    (i) The customary charge of the supplier (see Sec.  405.503);
    (ii) The prevailing charge in the locality (see Sec.  405.504);
    (iii) The charge applicable for a comparable service and under 
comparable circumstances to the policyholders or subscribers of the 
carrier (see Sec.  405.508);
    (iv) The lowest charge level at which the item or service is widely 
and consistently available in the locality (see paragraph (c) of this 
section); or
    (v) The inflation-indexed charge, as determined under Sec.  405.509, 
in the case of medical services, supplies, and equipment that are 
reimbursed on a reasonable charge basis (excluding physicians' 
services).
    (2) In the case of laboratory services, paragraph (a)(1) of this 
section is applicable to services furnished by physicians in their 
offices, by independent laboratories (see Sec.  405.1310(a)) and to

[[Page 165]]

services furnished by a hospital laboratory for individuals who are 
neither inpatients nor outpatients of a hospital. Allowance of 
additional charges exceeding the lowest charge level can be approved by 
the carrier on the basis of unusual circumstances or medical 
complications in accordance with Sec.  405.506.
    (b) Public notice of items and services subject to the lowest charge 
level rule. Before the Secretary determines that lowest charge levels 
should be established for an item or service, notice of the proposed 
determination will be published with an opportunity for public comment. 
The descriptions or specifications of items or services in the notice 
will be in sufficient detail to permit a determination that items or 
services conforming to the descriptions will not vary significantly in 
quality.
    (c) Calculating the lowest charge level. The lowest charge level at 
which an item or service is widely and consistently available in a 
locality is calculated by the carrier in accordance with instructions 
from CMS as follows:
    (1) For items or services furnished on or before December 31, 1986. 
(i) A lowest charge level is calculated for each identified item or 
service in January and July of each year.
    (ii) The lowest charge level for each identified item or service is 
set at the 25th percentile of the charges (incurred or submitted on 
claims processed by the carrier) for that item or service, in the 
locality designated by the carrier for this purpose, during the second 
calendar quarter preceding the determination date. Accordingly, the 
January calculations will be based on charges for the July through 
September quarter of the previous calendar year, and the July 
calculations will be based on charges for the January through March 
quarter of the same calendar year.
    (2) For items or services furnished on or after January 1, 1987. (i) 
A lowest charge level is calculated for each identified item or service 
in January of each year.
    (ii) The lowest charge level for each identified item or service is 
set at the 25th percentile of the charges (incurred or submitted on 
claims processed by the carrier) for that item or service, in the 
locality designated by the carrier for this purpose, during the 3-month 
period of July 1 through September 30 preceding the fee screen year 
(January 1 through December 31) for which the item or service was 
furnished.
    (3) Lowest charge levels for laboratory services. In setting lowest 
charge levels for laboratory services, the carrier will consider only 
charges made for laboratory services performed by physicians in their 
offices, by independent laboratories which meet coverage requirements, 
and for services furnished by a hospital laboratory for individuals who 
are neither inpatients nor outpatients of a hospital.
    (d) Locality. Subject to the approval of the Secretary, the carrier 
may designate its entire service area as the locality for purposes of 
this section, or may otherwise modify the localities used for 
calculating prevailing charges. (The modified locality for an item or 
service will also be used for calculating the prevailing charge for that 
item or service.)

(Secs. 1102, 1842(b) and 1871, 1903(i)(1) of the Social Security Act; 49 
Stat. 647, 79 Stat. 302, 310, 331, 86 Stat. 1395, 1454 (42 U.S.C. 1302, 
1395u(b), 1395hh, 1396b(i)(1)))

[43 FR 32300, July 26, 1978, as amended at 50 FR 40174, Oct. 1, 1985; 51 
FR 34979, Oct. 1, 1986]



Sec.  405.512  Carriers' procedural terminology and coding systems.

    (a) General. Procedural terminology and coding systems are designed 
to provide physicians and third party payers with a common language that 
accurately describes the kinds and levels of services provided and that 
can serve as a basis for coverage and payment determinations.
    (b) Modification of terminology and/or coding systems. A carrier 
that wishes to modify its system of procedural terminology and coding 
shall submit its request to the Centers for Medicare & Medicaid Services 
with all pertinent data and information for approval before the revision 
is implemented. The Centers for Medicare & Medicaid Services will 
evaluate the proposal in the light of the guidelines specified in 
paragraph (c) of this section and such other considerations as may be 
pertinent, and consult with the Assistant Secretary for Health. The 
Centers for Medicare & Medicaid Services will approve such a revision if 
it determines

[[Page 166]]

that the potential advantages of the proposed new system, outweigh the 
disadvantages.
    (c) Guidelines. The following considerations and guidelines are 
taken into account in evaluating a carrier's proposal to change its 
system of procedural terminology and coding:
    (1) The rationale for converting to the new terminology and coding;
    (2) The estimated short-run and long-run impact on the cost of the 
health insurance program, other medical care costs, administrative 
expenses, and the reliability of the estimates;
    (3) The degree to which the conversion to the proposed new 
terminology and coding can be accomplished in a way that permits full 
implementation of the reasonable charge criteria in accordance with the 
provisions of this subpart;
    (4) The degree to which the proposed new terminology and coding are 
accepted by physicians in the carrier's area (physician acceptance is 
assumed only if a majority of the Medicare and non-Medicare bills and 
claims completed by physicians in the area and submitted to the carrier 
can reasonably be expected to utilize the proposed new terminology and 
coding);
    (5) The extent to which the proposed new terminology and coding 
system is used by the carrier in its non-Medicare business;
    (6) The clarity with which the proposed system defines its 
terminology and whether the system lends itself to:
    (i) Accurate determinations of coverage;
    (ii) Proper assessment of the appropriate level of payment; and
    (iii) Meeting the carrier's or Professional Standards Review 
Organizations' review needs and such other review needs as may be 
appropriate;
    (7) Compatibility of the new terminology and coding system with 
other systems that the carrier and other carriers may utilize in the 
administration of the Medicare program--e.g., its compatibility with 
systems and statistical requirements and with the historical data in the 
carrier's processing system; and
    (8) Compatibility of the proposed system with the carriers methods 
for determining payment under the fee schedule for physicians' services 
for services which are identified by a single element of terminology but 
which may vary in content.

[40 FR 7639, Feb. 21, 1975. Redesignated at 42 FR 52826, Sept. 30, 1977, 
as amended at 59 FR 10298, Mar. 4, 1994]



Sec.  405.515  Reimbursement for clinical laboratory services billed 
by physicians.

    This section implements section 1842(h) of the Social Security Act, 
which places a limitation on reimbursement for markups on clinical 
laboratory services billed by physicians. If a physician's bill, or a 
request for payment for a physician's services, includes a charge for a 
laboratory test for which payment may be made under this part, the 
amount payable with respect to the test shall be determined as follows 
(subject to the coinsurance and deductible provisions at Sec. Sec.  
410.152 and 410.160 of this chapter):
    (a) If the bill or request for payment indicates that the test was 
personally performed or supervised either by the physician who submitted 
the bill (or for whose services the request for payment was made), or by 
another physician with whom that physician shares his or her practice, 
the payment will be based on the physician's reasonable charge for the 
test (as determined in accordance with Sec.  405.502).
    (b) If the bill or request for payment indicates that the test was 
performed by an outside laboratory, and identifies both the laboratory 
and the amount the laboratory charged, payment for the test will be 
based on the lower of--
    (1) The laboratory's reasonable charge for the service (as 
determined in accordance with Sec.  405.502), or
    (2) The amount that the laboratory charged the physician for the 
service.
    (c) If the bill or request for payment does not indicate that the 
conditions specified in paragraph (a) of this section were met, and does 
not identify both the laboratory and the amount the laboratory charged, 
payment will be based on the lowest charge at which the carrier 
estimates the test could have been secured from a laboratory serving the 
physician's locality. The carrier will estimate this lowest amount twice 
a year by (i) obtaining

[[Page 167]]

lists of charges laboratories make to physicians from as many commercial 
laboratories serving the carrier's area as possible (including 
laboratories in other States from which tests may be obtained by 
physicians in the carrier's service area) and (ii) establishing a 
schedule of lowest prices based on this information. The carrier will 
take into consideration specific circumstances, such as a need for 
emergency services that may be costlier than routine services, in making 
the estimate in a particular case. However, in no case may this estimate 
be higher than the lowest customary charge for commercial laboratories, 
or when applicable to the laboratory service, the lowest charge level 
determined in accordance with Sec.  405.511, in the carrier's service 
area.
    (d) When a physician bills, in accordance with paragraph (b) or (c) 
of this section, for a laboratory test and indicates that it was 
performed by an independent laboratory, a nominal payment will also be 
made to the physician for collecting, handling, and shipping the 
specimen to the laboratory, if the physician bills for such a service.

[46 FR 42672, Aug. 24, 1981, as amended at 51 FR 41351, Nov. 14, 1986]



Sec.  405.517  Payment for drugs and biologicals that are not paid on a cost 
or prospective payment basis.

    (a) Applicability--(1) Payment for drugs and biologicals before 
January 1, 2004. Payment for a drug or biological that is not paid on a 
cost or prospective payment basis is determined by the standard 
methodology described in paragraph (b) of this section. Examples of when 
this procedure applies include a drug or biological furnished incident 
to a physician's service, a drug or biological furnished by an 
independent dialysis facility that is not included in the ESRD composite 
rate set forth in Sec.  413.170(c) of this chapter, and a drug or 
biological furnished as part of the durable medical equipment benefit.
    (2) Payment for drugs and biologicals on or after January 1, 2004. 
Effective January 1, 2004, payment for drugs and biologicals that are 
not paid on a cost or prospective payment basis are paid in accordance 
with part 414, subpart I of this chapter.
    (3) Payment for drugs and biologicals on or after January 1, 2005. 
Effective January 1, 2005, payment for drugs and biologicals that are 
not paid on a cost or prospective payment basis are paid in accordance 
with part 414, subpart K of this chapter.
    (b) Methodology. Payment for a drug or biological described in 
paragraph (a) of this section is based on the lower of the actual charge 
on the Medicare claim for benefits or 95 percent of the national average 
wholesale price of the drug or biological.
    (c) Multiple-source drugs. For multiple-source drugs and 
biologicals, for purposes of this regulation, the average wholesale 
price is defined as the lesser of the median average wholesale price for 
all sources of the generic forms of the drug or biological or the lowest 
average wholesale price of the brand name forms of the drug or 
biological.

[63 FR 58905, Nov. 2, 1998, as amended at 69 FR 1116, Jan. 7, 2004; 69 
FR 66420, Nov. 15, 2004]



Sec.  405.520  Payment for a physician assistant's, nurse practitioner's, 
and clinical nurse specialists' services and services furnished incident 
to their professional services.

    (a) General rule. A physician assistant's, nurse practitioner's, and 
clinical nurse specialists' services, and services and supplies 
furnished incident to their professional services, are paid in 
accordance with the physician fee schedule. The payment for a physician 
assistants' services may not exceed the limits at Sec.  414.52 of this 
chapter. The payment for a nurse practitioners' and clinical nurse 
specialists' services may not exceed the limits at Sec.  414.56 of this 
chapter.
    (b) Requirements. Medicare payment is made only if all claims for 
payment are made on an assignment-related basis in accordance with Sec.  
424.55 of this chapter, that sets forth, respectively, the conditions 
for coverage of physician assistants' services, nurse practitioners' 
services and clinical nurse specialists' services, and services and 
supplies furnished incident to their professional services.
    (c) Civil money penalties. Any person or entity who knowingly and 
willingly bills a Medicare beneficiary amounts in

[[Page 168]]

excess of the appropriate coinsurance and deductible is subject to a 
civil money penalty as described in Sec. Sec.  402.1(c)(11), 
402.105(d)(2)(viii), and 402.107(b)(8) of this chapter.

[63 FR 58905, Nov. 2, 1998, as amended at 66 FR 49547, Sept. 28, 2001]



Sec.  405.534  Limitation on payment for screening mammography services.

    The provisions in paragraphs (a), (b), and (c) of this section apply 
for services provided from January 1, 1991 until December 31, 2001. 
Screening mammography services provided after December 31, 2001 are paid 
under the physician fee schedule in accordance with Sec.  414.2 of this 
chapter.
    (a) Basis and scope. This section implements section 1834(c) of the 
Act by establishing a limit on payment for screening mammography 
examinations. There are three categories of billing for screening 
mammography services. Those categories and the payment limitations on 
each are set forth in paragraphs (b) through (d) of this section.
    (b) Global or complete service billing representing both the 
professional and technical components of the procedure. If a fee is 
billed for a global service, the amount of payment subject to the 
deductible is equal to 80 percent of the least of the following:
    (1) The actual charge for the service.
    (2) The amount established for the global procedure for a diagnostic 
bilateral mammogram under the fee schedule for physicians' services set 
forth at part 414, subpart A.
    (3) The payment limit for the procedure. For screening mammography 
services furnished in CY 1994, the payment limit is $59.63. On January 1 
of each subsequent year, the payment limit is updated by the percentage 
increase in the Medicare Economic Index (MEI) and reflects the 
relationship between the relative value units for the professional and 
technical components of a diagnostic bilateral mammogram under the fee 
schedule for physicians' services.
    (c) Professional component billing representing only the physician's 
interpretation for the procedure. If the professional component of 
screening mammography services is billed separately, the amount of 
payment for that professional component, subject to the deductible, is 
equal to 80 percent of the least of the following:
    (1) The actual charge for the professional component of the service.
    (2) The amount established for the professional component of a 
diagnostic bilateral mammogram under the fee schedule for physicians' 
services.
    (3) The professional component of the payment limit for screening 
mammography services described in paragraph (b)(3) of this section.
    (d) Technical component billing representing other resources 
involved in furnishing the procedure. If the technical component of 
screening mammography services is billed separately, the amount of 
payment, subject to the deductible, is equal to 80 percent of the least 
of the following:
    (1) The actual charge for the technical component of the service.
    (2) The amount established for the technical component of a 
diagnostic bilateral mammogram under the fee schedule for physicians' 
services.
    (3) The technical component of the payment limit for screening 
mammography services described in paragraph (b)(3) of this section.

[55 FR 53521, Dec. 31, 1990, as amended at 59 FR 49833, Sept. 30, 1994; 
66 FR 55328, Nov. 1, 2001]



Sec.  405.535  Special rule for nonparticipating physicians and suppliers 
furnishing screening mammography services before January 1, 2002.

    The provisions in this section apply for screening mammography 
services provided from January 1, 1991 until December 31, 2001. 
Screening mammography services provided after December 31, 2001 are 
physician services pursuant to Sec.  414.2 of this chapter paid under 
the physician fee schedule. If screening mammography services are 
furnished to a beneficiary by a nonparticipating physician or supplier 
that does not accept assignment, a limiting charge applies to the 
charges billed to the beneficiary. The limiting charge is the lesser of 
the following:
    (a) 115 percent of the payment limit set forth in Sec.  
405.534(b)(3), (c)(3), and

[[Page 169]]

(d)(3) (limitations on the global service, professional component, and 
technical component of screening mammography services, respectively).
    (b) The limiting charge for the global service, professional 
component, and technical component of a diagnostic bilateral mammogram 
under the fee schedule for physicians' services set forth at Sec.  
414.48(b) of this chapter.

[59 FR 49833, Sept. 30, 1994, as amended at 62 FR 59098, Oct. 31, 1997; 
66 FR 55328, Nov. 1, 2001]



          Subpart F_Medicare Coverage of Innovative Technology

    Source: 86 FR 3009, Jan. 14, 2021, unless otherwise noted.

    Effective Date Note: At 86 FR 3009, Jan. 14, 2021, subpart F was 
added, the effective date was delayed until May 15, 2021 at 86 FR 14542, 
Mar. 17, 2021, then further delayed at 86 FR 26848, May 18, 2021, 
effective Dec. 15, 2021.



Sec.  405.601  Medicare coverage of innovative technology.

    (a) Basis and scope. Medicare coverage of innovative technology 
(MCIT) is a program that provides national, time-limited coverage under 
section 1862(a)(1)(A) of the Act for certain breakthrough medical 
devices. Manufacturer participation in the pathway for breakthrough 
device coverage is voluntary.
    (b) Definitions. For the purposes of this subpart, the following 
definitions are applicable:
    Breakthrough device means a device that receives such designation by 
the Food and Drug Administration (FDA) (section 515B(d)(1) of the FD&C 
Act (21 U.S.C. 360e-3(d)(1)).
    MCIT stands for Medicare coverage of innovative technology.



Sec.  405.603  Medical device eligibility.

    The MCIT pathway is available only to medical devices that meet all 
of the following:
    (a) That are FDA-designated breakthrough devices.
    (b) That were FDA market authorized on [Enter date 2 years prior to 
effective date of final rule] and thereafter.
    (c) That are used according to their FDA approved or cleared 
indication for use.
    (d) That are within a Medicare benefit category.
    (e) That are not the subject of a Medicare national coverage 
determination.
    (f) That are not otherwise excluded from coverage through law or 
regulation.



Sec.  405.605  Coverage of items and services.

    Covered items and services furnished within the MCIT pathway may 
include any of the following, if not otherwise excluded from coverage 
and according to existing coverage and/or payment policies as 
applicable:
    (a) The breakthrough device.
    (b) Any reasonable and necessary procedures to implant and/or use 
the breakthrough device.
    (c) Reasonable and necessary items and services to maintain the 
breakthrough device.
    (d) Related care and services for the breakthrough device.
    (e) Reasonable and necessary services to treat complications arising 
from use of the breakthrough device.



Sec.  405.607  Coverage period.

    (a) Start of the period. The MCIT pathway begins on the date 
requested by the manufacturer in an email to CMS at any time opting in 
to the MCIT pathway provided the requested start date is no earlier 
than--
    (1) The date the breakthrough device receives FDA market 
authorization; or
    (2) The date requested by the manufacturer, provided that such a 
date is not later than 2 years after the date described in paragraph 
(a)(1) of this section.
    (b) End of the period. The MCIT pathway for a breakthrough device 
ends as follows:
    (1) No later than 4 years from the date the breakthrough device 
received FDA market authorization.
    (2) Prior to 4 years if a manufacturer withdraws the breakthrough 
device from the MCIT pathway.
    (3) Prior to 4 years if the breakthrough device becomes the subject 
of a national coverage determination or

[[Page 170]]

otherwise becomes noncovered through law, regulation, or at the 
discretion of the Secretary subsequent to an FDA medical device safety 
communication or Warning Letter.
    (4) Prior to 4 years if the FDA removes authorization of a device, 
the breakthrough device is removed from the MCIT pathway.

Subpart G [Reserved]



           Subpart H_Appeals Under the Medicare Part B Program

    Authority: Secs. 1102, 1866(j), and 1871 of the Social Security Act 
(42 U.S.C. 1302, 1395cc(j), and 1395hh).

    Source: 77 FR 29028, May 16, 2012, unless otherwise noted.



Sec.  405.800  Appeals of CMS or a CMS contractor.

    A CMS contractor's (that is, a carrier, Fiscal Intermediary or 
Medicare Administrative Contractor (MAC)) determination that a provider 
or supplier fails to meet the requirements for Medicare billing 
privileges.
    (a) Denial of a provider or supplier enrollment application. If CMS 
or a CMS contractor denies a provider's or supplier's enrollment 
application, CMS or the CMS contractor notifies the provider or supplier 
by certified mail. The notice includes the following:
    (1) The reason for the denial in sufficient detail to allow the 
provider or supplier to understand the nature of its deficiencies.
    (2) The right to appeal in accordance with part 498 of this chapter.
    (3) The address to which the written appeal must be mailed.
    (b) Revocation of Medicare billing privileges--(1) Notice of 
revocation. If CMS or a CMS contractor revokes a provider's or 
supplier's Medicare billing privileges, CMS or a CMS contractor notifies 
the supplier by certified mail. The notice must include the following:
    (i) The reason for the revocation in sufficient detail for the 
provider or supplier to understand the nature of its deficiencies.
    (ii) The right to appeal in accordance with part 498 of this 
chapter.
    (iii) The address to which the written appeal must be mailed.
    (2) Effective date of revocation. The revocation of a provider's or 
supplier's billing privileges is effective 30 days after CMS or the CMS 
contractor mails notice of its determination to the provider or 
supplier, except if the revocation is based on a Federal exclusion or 
debarment, felony conviction, license suspension or revocation, or the 
practice location is determined by CMS or its contractor not to be 
operational. When a revocation is based on a Federal exclusion or 
debarment, felony conviction, license suspension or revocation, or the 
practice location is determined by CMS or its contractor not to be 
operational, the revocation is effective with the date of exclusion or 
debarment, felony conviction, license suspension or revocation or the 
date that CMS or its contractor determined that the provider or supplier 
was no longer operational.
    (3) Payment after revocation. Medicare does not pay, and the CMS 
contractor rejects, claims for services submitted with a service date on 
or after the effective date of a provider's or supplier's revocation.
    (c) Additional years applied to a reenrollment bar. (1) If, under 
Sec.  424.535(c)(2)(i) of this chapter, CMS or a CMS contractor applies 
additional years to a provider's or supplier's existing reenrollment 
bar, CMS or the CMS contractor notifies the provider or supplier by 
certified mail. The notice includes the following:
    (i) The reason for the application of additional years in sufficient 
detail to allow the provider or supplier to understand the nature of the 
action.
    (ii) The right to appeal in accordance with part 498 of this 
chapter.
    (iii) The address to which the written appeal must be mailed.
    (2) Paragraph (c)(1) of this section applies only to the years added 
to the existing reenrollment bar under Sec.  424.535(c)(2)(i) of this 
chapter and not to the original length of the reenrollment bar, which is 
not subject to appeal.

[77 FR 29028, May 16, 2012, as amended at 84 FR 47852, Sept. 10, 2019]

[[Page 171]]



Sec.  405.803  Appeals rights.

    (a) A provider or supplier may appeal the initial determination to 
deny a provider or supplier's enrollment application, or if applicable, 
to revoke current billing privileges by following the procedures 
specified in part 498 of this chapter.
    (b) The reconsideration of a determination to deny or revoke a 
provider or supplier's Medicare billing privileges is handled by a CMS 
Regional Office or a contractor hearing officer not involved in the 
initial determination.
    (c) Providers and suppliers have the opportunity to submit evidence 
related to the enrollment action. Providers and suppliers must, at the 
time of their request, submit all evidence that they want to be 
considered.
    (d) If supporting evidence is not submitted with the appeal request, 
the contractor contacts the provider or supplier to try to obtain the 
evidence.
    (e) If the provider or supplier fails to submit the evidence before 
the contractor issues its decision, the provider or supplier is 
precluded from introducing new evidence at higher levels of the appeals 
process.



Sec.  405.806  Impact of reversal of contractor determinations 
on claims processing.

    (a) Claims for services furnished to Medicare beneficiaries during a 
period in which the supplier billing privileges were not effective are 
rejected.
    (b) If a supplier is determined not to have qualified for billing 
privileges in one period but qualified in another, Medicare contractors 
process claims for services furnished to beneficiaries during the period 
for which the supplier was Medicare-qualified. Subpart C of this part 
sets forth the requirements for the recovery of overpayments.
    (c) If a revocation of a supplier's billing privileges is reversed 
upon appeal, the supplier's billing privileges are reinstated back to 
the date that the revocation became effective.
    (d) If the denial of a supplier's billing privileges is reversed 
upon appeal and becomes binding, then the appeal decision establishes 
the date that the supplier's billing privileges become effective.



Sec.  405.809  Reinstatement of provider or supplier billing privileges 
following corrective action.

    (a) General rule. A provider or supplier--
    (1) May only submit a corrective action plan for a revocation for 
noncompliance under Sec.  424.535(a)(1) of this chapter; and
    (2) Subject to paragraph (a)(1) of this section, has only one 
opportunity to correct all deficiencies that served as the basis of its 
revocation through a corrective action plan.
    (b) Review of a corrective action plan. Subject to paragraph (a)(1) 
of this section, CMS or its contractor reviews a submitted corrective 
action plan and does either of the following:
    (1) Reinstates the provider or supplier's billing privileges if the 
provider or supplier provides sufficient evidence to CMS or its 
contractor that it has complied fully with the Medicare requirements, in 
which case--
    (i) The effective date of the reinstatement is based on the date the 
provider or supplier is in compliance with all Medicare requirements; 
and
    (ii) CMS or its contractor may pay for services furnished on or 
after the effective date of the reinstatement.
    (2) Refuses to reinstate a provider or supplier's billing 
privileges. The refusal of CMS or its contractor to reinstate a provider 
or supplier's billing privileges based on a corrective action plan is 
not an initial determination under part 498 of this chapter.

[79 FR 72530, Dec. 5, 2014]



Sec.  405.812  Effective date for DMEPOS supplier's billing privileges.

    If a CMS contractor, contractor hearing officer, or ALJ determines 
that a DMEPOS supplier's denied enrollment application meets the 
standards in Sec.  424.57 of this chapter and any other requirements 
that may apply, the determination establishes the effective date of the 
billing privileges as not earlier than the date the carrier made the 
determination to deny the DMEPOS supplier's enrollment application. 
Claims are rejected for services furnished before that effective date.

[[Page 172]]



Sec.  405.815  Submission of claims.

    A provider or supplier succeeding in having its enrollment 
application denial or billing privileges revocation reversed in a 
binding decision, or in having its billing privileges reinstated, may 
submit claims to the CMS contractor for services furnished during 
periods of Medicare qualification, subject to the limitations in Sec.  
424.44 of this chapter, regarding the timely filing of claims. If the 
claims previously were filed timely but were rejected, they are 
considered filed timely upon resubmission. Previously denied claims for 
items or services furnished during a period of denial or revocation may 
be resubmitted to CMS within 1 year after the date of reinstatement or 
reversal.



Sec.  405.818  Deadline for processing provider enrollment 
initial determinations.

    Contractors approve or deny complete provider or supplier enrollment 
applications to approval or denial within the following timeframes:
    (a) Initial enrollments. Contractors process new enrollment 
applications within 180 days of receipt.
    (b) Revalidation of existing enrollments. Contractors process 
revalidations within 180 days of receipt.
    (c) Change-of-information and reassignment of payment request. 
Contractors process change-of-information and reassignment of payment 
requests within 90 days of receipt.



   Subpart I_Determinations, Redeterminations, Reconsiderations, and 
           Appeals Under Original Medicare (Part A and Part B)

    Source: 70 FR 11472, Mar. 8, 2005, unless otherwise noted.



Sec.  405.900  Basis and scope.

    (a) Statutory basis. This subpart is based on the following 
provisions of the Act:
    (1) Section 1869(a) through (e) and (g) of the Act.
    (2) Section 1862(b)(2)(B)(viii) of the Act.
    (b) Scope. This subpart establishes the requirements for appeals of 
initial determinations for benefits under Part A or Part B of Medicare, 
including the following:
    (1) The initial determination of whether an individual is entitled 
to benefits under Part A or Part B. (Regulations governing 
reconsiderations of these initial determinations are at 20 CFR, part 
404, subpart J).
    (2) The initial determination of the amount of benefits available to 
an individual under Part A or Part B.
    (3) Any other initial determination relating to a claim for benefits 
under Part A or Part B, including an initial determination made by a 
quality improvement organization under section 1154(a)(2) of the Act or 
by an entity under contract with the Secretary (other than a contract 
under section 1852 of the Act) to administer provisions of titles XVIII 
or XI of the Act.

[70 FR 11472, Mar. 8, 2005, as amended at 80 FR 10617, Feb. 27, 2015]



Sec.  405.902  Definitions.

    For the purposes of this subpart, the term--
    ALJ means an Administrative Law Judge of the Department of Health 
and Human Services.
    Appellant means the beneficiary, assignee or other person or entity 
that has filed and pursued an appeal concerning a particular initial 
determination. Designation as an appellant does not in itself convey 
standing to appeal the determination in question.
    Applicable plan means liability insurance (including self-
insurance), no-fault insurance, or a workers' compensation law or plan.
    Appointed representative means an individual appointed by a party to 
represent the party in a Medicare claim or claim appeal.
    Assignee means:
    (1) A supplier that furnishes items or services to a beneficiary and 
has accepted a valid assignment of a claim or
    (2) A provider or supplier that furnishes items or services to a 
beneficiary, who is not already a party, and has accepted a valid 
assignment of the right to appeal a claim executed by the beneficiary.
    Assignment of a claim means the transfer by a beneficiary of his or 
her claim for payment to the supplier in

[[Page 173]]

return for the latter's promise not to charge more for his or her 
services than what the carrier finds to be the Medicare-approved amount, 
as provided in Sec. Sec.  424.55 and 424.56 of this chapter.
    Assignment of appeal rights means the transfer by a beneficiary of 
his or her right to appeal under this subpart to a provider or supplier 
who is not already a party, as provided in section 1869(b)(1)(C) of the 
Act.
    Assignor means a beneficiary whose provider of services or supplier 
has taken assignment of a claim or an appeal of a claim.
    Attorney Adjudicator means a licensed attorney employed by OMHA with 
knowledge of Medicare coverage and payment laws and guidance, and 
authorized to take the actions provided for in this subpart on requests 
for ALJ hearing and requests for reviews of QIC dismissals.
    Authorized representative means an individual authorized under State 
or other applicable law to act on behalf of a beneficiary or other party 
involved in the appeal. The authorized representative will have all of 
the rights and responsibilities of a beneficiary or party, as 
applicable, throughout the appeals process.
    Beneficiary means an individual who is enrolled to receive benefits 
under Medicare Part A or Part B.
    Carrier means an organization that has entered into a contract with 
the Secretary in accordance to section 1842 of the Act and is authorized 
to make determinations for Part B of title XVIII of the Act.
    Clean claim means a claim that has no defect or impropriety 
(including any lack of required substantiating documentation) or 
particular circumstance requiring special treatment that prevents timely 
payment from being made on the claim under title XVIII within the time 
periods specified in sections 1816(c) and 1842(c) of the Act.
    Contractor means an entity that contracts with the Federal 
government to review and/or adjudicate claims, determinations and/or 
decisions.
    Council stands for the Medicare Appeals Council within the 
Departmental Appeals Board of the U.S. Department of Health and Human 
Services.
    Family member means for purposes of the QIC reconsideration panel 
under Sec.  405.968 the following persons as they relate to the 
physician or healthcare provider.
    (1) The spouse (other than a spouse who is legally separated from 
the physician or health care professional under a decree of divorce or 
separate maintenance);
    (2) Children (including stepchildren and legally adopted children);
    (3) Grandchildren;
    (4) Parents; and
    (5) Grandparents.
    Fiscal Intermediary means an organization that has entered into a 
contract with CMS in accordance with section 1816 of the Act and is 
authorized to make determinations and payments for Part A of title XVIII 
of the Act, and Part B provider services as specified in Sec.  421.5(c) 
of this chapter.
    OMHA stands for the Office of Medicare Hearings and Appeals within 
the U.S. Department of Health and Human Services, which administers the 
ALJ hearing process in accordance with section 1869(b)(1) of the Act.
    Party means an individual or entity listed in Sec.  405.906 that has 
standing to appeal an initial determination and/or a subsequent 
administrative appeal determination.
    Provider means a hospital, critical access hospital, skilled nursing 
facility, comprehensive outpatient rehabilitation facility, home health 
agency, or hospice that has in effect an agreement to participate in 
Medicare, or clinic, rehabilitation agency, or public health agency that 
has in effect a similar agreement, but only to furnish outpatient 
physical therapy or speech pathology services, or a community mental 
health center that has in effect a similar agreement but only to furnish 
partial hospitalization services.
    Qualified Independent Contractor (QIC) means an entity which 
contracts with the Secretary in accordance with section 1869 of the Act 
to perform reconsiderations under Sec.  405.960 through Sec.  405.978.
    Quality Improvement Organization (QIO) means an entity that 
contracts with the Secretary in accordance with sections 1152 and 1153 
of the Act and 42

[[Page 174]]

CFR subchapter F, to perform the functions described in section 1154 of 
the Act and 42 CFR subchapter F, including expedited determinations as 
described in Sec.  405.1200 through Sec.  405.1208.
    Reliable evidence means evidence that is relevant, credible, and 
material.
    Remand means to vacate a lower level appeal decision, or a portion 
of the decision, and return the case, or a portion of the case, to that 
level for a new decision.
    Similar fault means to obtain, retain, convert, seek, or receive 
Medicare funds to which a person knows or should reasonably be expected 
to know that he or she or another for whose benefit Medicare funds are 
obtained, retained, converted, sought, or received is not legally 
entitled. This includes, but is not limited to, a failure to demonstrate 
that he or she filed a proper claim as defined in part 411 of this 
chapter.
    Supplier means, unless the context otherwise requires, a physician 
or other practitioner, a facility, or other entity (other than a 
provider of services) that furnishes items or services under Medicare.
    Vacate means to set aside a previous action.

[70 FR 11472, Mar. 8, 2005, as amended at 74 FR 65333, Dec. 9, 2009; 80 
FR 10617, Feb. 27, 2015; 82 FR 5106, Jan. 17, 2017]



Sec.  405.904  Medicare initial determinations, redeterminations and appeals: 
General description.

    (a) General overview--(1) Entitlement appeals. The SSA makes an 
initial determination on an application for Medicare benefits and/or 
entitlement of an individual to receive Medicare benefits. A beneficiary 
who is dissatisfied with the initial determination may request, and SSA 
will perform, a reconsideration in accordance with 20 CFR part 404, 
subpart J if the requirements for obtaining a reconsideration are met. 
Following the reconsideration, the beneficiary may request a hearing 
before an ALJ under this subpart (42 CFR part 405, subpart I). If the 
beneficiary obtains a hearing before an ALJ and is dissatisfied with the 
decision of the ALJ, or if the beneficiary requests a hearing and no 
hearing is conducted, and the beneficiary is dissatisfied with the 
decision of an ALJ or an attorney adjudicator, he or she may request the 
Council to review the case. Following the action of the Council, the 
beneficiary may be entitled to file suit in Federal district court.
    (2) Claim appeals. The Medicare contractor makes an initial 
determination when a claim for Medicare benefits under Part A or Part B 
is submitted. A beneficiary who is dissatisfied with the initial 
determination may request that the contractor perform a redetermination 
of the claim if the requirements for obtaining a redetermination are 
met. Following the contractor's redetermination, the beneficiary may 
request, and the Qualified Independent Contractor (QIC) will perform, a 
reconsideration of the claim if the requirements for obtaining a 
reconsideration are met. Following the reconsideration, the beneficiary 
may request a hearing before an ALJ. If the beneficiary obtains a 
hearing before the ALJ and is dissatisfied with the decision of the ALJ, 
or if the beneficiary requests a hearing and no hearing is conducted, 
and the beneficiary is dissatisfied with the decision of an ALJ or 
attorney adjudicator, he or she may request the Council to review the 
case. If the Council reviews the case and issues a decision, and the 
beneficiary is dissatisfied with the decision, the beneficiary may file 
suit in Federal district court if the amount remaining in controversy 
and the other requirements for judicial review are met.
    (b) Non-beneficiary appellants. In general, the procedures described 
in paragraph (a) of this section are also available to parties other 
than beneficiaries either directly or through a representative acting on 
a party's behalf, consistent with the requirements of this subpart I. A 
provider generally has the right to judicial review only as provided 
under section 1879(d) of the Act; that is, when a determination involves 
a finding that services are not covered because--
    (1) They were custodial care (see Sec.  411.15(g) of this chapter); 
they were not reasonable and necessary (see Sec.  411.15(k) of this 
chapter); they did not qualify as covered home health services because 
the beneficiary was not confined to the home or did not need

[[Page 175]]

skilled nursing care on an intermittent basis (see Sec.  409.42(a) and 
(c)(1) of this chapter); or they were hospice services provided to a 
non-terminally ill individual (see Sec.  418.22 of this chapter); and
    (2) Either the provider or the beneficiary, or both, knew or could 
reasonably be expected to know that those services were not covered 
under Medicare.

[70 FR 11472, Mar. 8, 2005, as amended at 82 FR 5106, Jan. 17, 2017]



Sec.  405.906  Parties to the initial determinations, redeterminations, 
reconsiderations, hearings, and reviews.

    (a) Parties to the initial determination. The parties to the initial 
determination are the following individuals and entities:
    (1) A beneficiary who files a claim for payment under Medicare Part 
A or Part B or has had a claim for payment filed on his or her behalf, 
or in the case of a deceased beneficiary, when there is no estate, any 
person obligated to make or entitled to receive payment in accordance 
with part 424, subpart E of this chapter. Payment by a third party payer 
does not entitle that entity to party status.
    (2) A supplier who has accepted assignment for items or services 
furnished to a beneficiary that are at issue in the claim.
    (3) A provider of services who files a claim for items or services 
furnished to a beneficiary.
    (4) An applicable plan for an initial determination under Sec.  
405.924(b)(16) where Medicare is pursuing recovery directly from the 
applicable plan. The applicable plan is the sole party to an initial 
determination under Sec.  405.924(b)(16) (that is, where Medicare is 
pursuing recovery directly from the applicable plan).
    (b) Parties to the redetermination, reconsideration, proceedings on 
a request for hearing, and Council review. The parties to the 
redetermination, reconsideration, proceedings on a request for hearing, 
and Council review are--
    (1) The parties to the initial determination in accordance with 
paragraph (a) of this section, except under paragraph (a)(1) of this 
section where a beneficiary has assigned appeal rights under Sec.  
405.912;
    (2) A State agency in accordance with Sec.  405.908;
    (3) A provider or supplier that has accepted an assignment of appeal 
rights from the beneficiary according to Sec.  405.912;
    (4) A non-participating physician not billing on an assigned basis 
who, in accordance with section 1842(l) of the Act, may be liable to 
refund monies collected for services furnished to the beneficiary 
because those services were denied on the basis of section 1862(a)(1) of 
the Act; and
    (5) A non-participating supplier not billing on an assigned basis 
who, in accordance with sections 1834(a)(18) and 1834(j)(4) of the Act, 
may be liable to refund monies collected for items furnished to the 
beneficiary.
    (c) Appeals by providers and suppliers when there is no other party 
available. If a provider or supplier is not already a party to the 
proceeding in accordance with paragraphs (a) and (b) of this section, a 
provider of services or supplier may appeal an initial determination 
relating to services it rendered to a beneficiary who subsequently dies 
if there is no other party available to appeal the determination. This 
paragraph (c) does not apply to an initial determination with respect to 
an applicable plan under Sec.  405.924(b)(16).

[70 FR 11472, Mar. 8, 2005, as amended at 80 FR 10617, Feb. 27, 2015; 82 
FR 5106, Jan. 17, 2017]



Sec.  405.908  Medicaid State agencies.

    When a beneficiary is enrolled to receive benefits under both 
Medicare and Medicaid, the Medicaid State agency may file a request for 
an appeal with respect to a claim for items or services furnished to a 
dually eligible beneficiary only for services for which the Medicaid 
State agency has made payment, or for which it may be liable. A Medicaid 
State agency is considered a party only when it files a timely 
redetermination request with respect to a claim for items or services 
furnished to a beneficiary in accordance with 42 CFR parts 940 through 
958. If a State agency files a request for redetermination, it may 
retain party status at the

[[Page 176]]

QIC, OMHA, Council, and judicial review levels.

[70 FR 11472, Mar. 8, 2005, as amended at 82 FR 5106, Jan. 17, 2017]



Sec.  405.910  Appointed representatives.

    (a) Scope of representation. An appointed representative may act on 
behalf of an individual or entity in exercising his or her right to an 
initial determination or appeal. Appointed representatives do not have 
party status and may take action only on behalf of the individual or 
entity that they represent.
    (b) Persons not qualified. A party may not name as an appointed 
representative, an individual who is disqualified, suspended, or 
otherwise prohibited by law from acting as a representative in any 
proceedings before DHHS, or in entitlement appeals, before SSA.
    (c) Completing a valid appointment. For purposes of this subpart, an 
appointment of representation must:
    (1) Be in writing and signed and dated by both the party and 
individual agreeing to be the representative;
    (2) Provide a statement appointing the representative to act on 
behalf of the party, and in the case of a beneficiary, authorizing the 
adjudicator to release identifiable health information to the appointed 
representative.
    (3) Include a written explanation of the purpose and scope of the 
representation;
    (4) Contain both the party's and appointed representative's name, 
phone number, and address;
    (5) Identify the beneficiary's Medicare number when the beneficiary 
is the party appointing a representative, or identify the Medicare 
National Provider Identifier number of the provider or supplier that 
furnished the item or service when the provider or supplier is the party 
appointing a representative;
    (6) Include the appointed representative's professional status or 
relationship to the party;
    (7) Be filed with the entity processing the party's initial 
determination or appeal.
    (d) Curing a defective appointment of representative. (1) If any one 
of the seven elements named in paragraph (c) of this section is missing 
from the appointment, the adjudicator should contact the party and 
provide a description of the missing documentation or information.
    (2) Unless the defect is cured, the prospective appointed 
representative lacks the authority to act on behalf of the party, and is 
not entitled to obtain or receive any information related to the appeal, 
including the appeal decision.
    (3) If an adjudication time frame applies, the time from the later 
of the date that a defective appointment of representative was filed or 
the current appeal request was filed by the prospective appointed 
representative, to the date when the defect was cured or the party 
notifies the adjudicator that he or she will proceed with the appeal 
without a representative does not count towards the adjudication time 
frame.
    (e) Duration of appointment. (1) Unless revoked, an appointment is 
considered valid for 1 year from the date that the Appointment of 
Representative (AOR) form or other conforming written instrument 
contains the signatures of both the party and the appointed 
representative.
    (2) To initiate an appeal within the 1-year time frame, the 
representative must file a copy of the AOR form, or other conforming 
written instrument, with the appeal request. Unless revoked, the 
representation is valid for the duration of an individual's appeal of an 
initial determination.
    (3) For an initial determination of a Medicare Secondary Payer 
recovery claim, an appointment signed in connection with the party's 
efforts to make a claim for third party payment is valid from the date 
that appointment is signed for the duration of any subsequent appeal, 
unless the appointment is specifically revoked.
    (4) For an initial determination of a Medicare Secondary Payer 
recovery claim, an appointment signed by an applicable plan which has 
party status in accordance with Sec.  405.906(a)(4) is valid from the 
date that appointment is signed for the duration of any subsequent 
appeal, unless the appointment is specifically revoked.
    (f) Appointed representative fees--(1) General rule. An appointed 
representative for a beneficiary who wishes to charge a fee for services 
rendered in

[[Page 177]]

connection with an appeal before the Secretary must obtain approval of 
the fee from the Secretary. Services rendered below the OMHA level are 
not considered proceedings before the Secretary.
    (2) No fees or costs against trust funds. No award of attorney or 
any other representative's fees or any costs in connection with an 
appeal may be made against the Medicare trust funds.
    (3) Special rules for providers and suppliers. A provider or 
supplier that furnished the items or services to a beneficiary that are 
the subject of the appeal may represent that beneficiary in an appeal 
under this subpart, but the provider or supplier may not charge the 
beneficiary any fee associated with the representation. If a provider or 
supplier furnishes services or items to a beneficiary, the provider or 
supplier may not represent the beneficiary on the issues described in 
section 1879(a)(2) of the Act, unless the provider or supplier waives 
the right to payment from the beneficiary for the services or items 
involved in the appeal.
    (4) Special rules for purposes of third party payment. The Secretary 
does not review fee arrangements made by a beneficiary for purposes of 
making a claim for third party payment (as defined in 42 CFR 411.21) 
even though the representation may ultimately include representation for 
a Medicare Secondary Payer recovery claim.
    (5) Reasonableness of representative fees. In determining the 
reasonableness of a representative's fee, the Secretary will not apply 
the test specified in sections 206(a)(2) and (a)(3) of the Act.
    (g) Responsibilities of an appointed representative. (1) An 
appointed representative has an affirmative duty to--
    (i) Inform the party of the scope and responsibilities of the 
representation;
    (ii) Inform the party of the status of the appeal and the results of 
actions taken on behalf of the party, including, but not limited to, 
notification of appeal determinations, decisions, and further appeal 
rights;
    (iii) Disclose to a beneficiary any financial risk and liability of 
a non-assigned claim that the beneficiary may have;
    (iv) Not act contrary to the interest of the party; and
    (v) Comply with all laws and CMS regulations, CMS Rulings, and 
instructions.
    (2) An appeal request filed by a provider or supplier described in 
paragraph (f)(3) of this section must also include a statement signed by 
the provider or supplier stating that no financial liability is imposed 
on the beneficiary in connection with that representation. If 
applicable, the appeal request must also include a signed statement that 
the provider or supplier waives the right to payment from the 
beneficiary for services or items regarding issues described in section 
1879(a)(2) of the Act.
    (h) Authority of an appointed representative. An appointed 
representative may, on behalf of the party--
    (1) Obtain appeals information about the claim to the same extent as 
the party;
    (2) Submit evidence;
    (3) Make statements about facts and law; and
    (4) Make any request, or give, or receive, any notice about the 
appeal proceedings.
    (i) Notice or request to an appointed representative--(1) Initial 
determinations. When a contractor takes an action or issues an initial 
determination, it sends the action or notice to the party.
    (2) Appeals. When a contractor, QIC, ALJ or attorney adjudicator, or 
the Council takes an action or issues a redetermination, 
reconsideration, or appeal decision, in connection with an initial 
determination, it sends notice of the action to the appointed 
representative.
    (3) The contractor, QIC, ALJ or attorney adjudicator, or Council 
sends any requests for information or evidence regarding a claim that is 
appealed to the appointed representative. The contractor sends any 
requests for information or evidence regarding an initial determination 
to the party.
    (4) For initial determinations and appeals involving Medicare 
Secondary Payer recovery claims where the beneficiary is a party, the 
adjudicator sends notices and requests to both the beneficiary and the 
beneficiary's representative, if the beneficiary has a representative.

[[Page 178]]

    (j) Effect of notice or request to an appointed representative. A 
notice or request sent to the appointed representative has the same 
force and effect as if was sent to the party.
    (k) Information available to the appointed representative. An 
appointed representative may obtain any and all appeals information 
applicable to the claim at issue that is available to the party.
    (l) Delegation of appointment by appointed representative. (1) An 
appointed representative may not designate another individual to act as 
the appointed representative of the party unless--
    (i) The appointed representative provides written notice to the 
party of the appointed representative's intent to delegate to another 
individual, which contains the name of the designee and the designee's 
acceptance to be obligated by and comply with the requirements of 
representation under this subpart; and
    (ii) The party accepts the designation as evidenced by a written 
statement signed by the party. The written statement signed by the party 
is not required when the appointed representative and designee are 
attorneys in the same law firm or organization and the notice described 
in paragraph (l)(1)(i) of this section so indicates.
    (2) A delegation is not effective until the adjudicator receives a 
copy of the acceptance described in paragraph (l)(1)(ii) of this 
section, unless the appointed representative and designee are attorneys 
in the same law firm or organization, in which case the notice described 
in paragraph (l)(1)(i) of this section may be submitted even though the 
acceptance described in paragraph (l)(1)(ii) of this section is not 
required.
    (3) A party's or representative's failure to notify the adjudicator 
that an appointment of representative has been delegated is not good 
cause for missing a deadline or not appearing at a hearing.
    (m) Revoking the appointment of representative. (1) A party may 
revoke an appointment of representative without cause at any time.
    (2) Revocation. Revocation is not effective until the adjudicator 
receives a signed, written statement from the party.
    (3) Death of the party. (i) The death of a party terminates the 
authority of the appointed representative, except as specified in 
paragraph (m)(3)(ii) of this section.
    (ii) A party's death does not terminate an appeal that is in 
progress if another individual or entity may be entitled to receive or 
obligated to make payment for the items or services that are the subject 
of the appeal. The appointment of representative remains in effect for 
the duration of the appeal except for MSP recovery claims.
    (4) A party's or representative's failure to notify the adjudicator 
that an appointment of representative has been revoked is not good cause 
for missing a deadline or not appearing at a hearing.

[70 FR 11472, Mar. 8, 2005, as amended at 80 FR 10617, Feb. 27, 2015; 82 
FR 5106, Jan. 17, 2017; 84 FR 19869, May 7, 2019]



Sec.  405.912  Assignment of appeal rights.

    (a) Who may be an assignee. Only a provider, or supplier that--
    (1) Is not a party to the initial determination as defined in Sec.  
405.906; and
    (2) Furnished an item or service to the beneficiary may seek 
assignment of appeal rights from the beneficiary for that item or 
service.
    (b) Who may not be an assignee. An individual or entity who is not a 
provider or supplier may not be an assignee. A provider or supplier that 
furnishes an item or service to a beneficiary may not seek assignment 
for that item or service when considered a party to the initial 
determination as defined in Sec.  405.906.
    (c) Requirements for a valid assignment of appeal right. The 
assignment of appeal rights must--
    (1) Be executed using a CMS standard form;
    (2) Be in writing and signed by both the beneficiary assigning his 
or her appeal rights and by the assignee;
    (3) Indicate the item or service for which the assignment of appeal 
rights is authorized;
    (4) Contain a waiver of the assignee's right to collect payment from 
the assignor for the specific item or service

[[Page 179]]

that are the subject of the appeal except as set forth in paragraph 
(d)(2) of this section; and
    (5) Be submitted at the same time the request for redetermination or 
other appeal is filed.
    (d) Waiver of right to collect payment. (1) Except as specified in 
paragraph (d)(2) of this section, the assignee must waive the right to 
collect payment for the item or service for which the assignment of 
appeal rights is made. If the assignment is revoked under paragraph 
(g)(2) or (g)(3) of this section, the waiver of the right to collect 
payment nevertheless remains valid. A waiver of the right to collect 
payment remains in effect regardless of the outcome of the appeal 
decision.
    (2) The assignee is not prohibited from recovering payment 
associated with coinsurance or deductibles or when an advance 
beneficiary notice is properly executed.
    (e) Duration of a valid assignment of appeal rights. Unless revoked, 
the assignment of appeal rights is valid for all administrative and 
judicial review associated with the item or service as indicated on the 
standard CMS form, even in the event of the death of the assignor.
    (f) Rights of the assignee. When a valid assignment of appeal rights 
is executed, the assignor transfers all appeal rights involving the 
particular item or service to the assignee. These include, but are not 
limited to--
    (1) Obtaining information about the claim to the same extent as the 
assignor;
    (2) Submitting evidence;
    (3) Making statements about facts or law; and
    (4) Making any request, or giving, or receiving any notice about 
appeal proceedings.
    (g) Revocation of assignment. When an assignment of appeal rights is 
revoked, the rights to appeal revert to the assignor. An assignment of 
appeal rights may be revoked in any of the following ways:
    (1) In writing by the assignor. The revocation of assignment must be 
delivered to the adjudicator and the assignee, and is effective on the 
date of receipt by the adjudicator.
    (2) By abandonment if the assignee does not file an appeal of an 
unfavorable decision.
    (3) By act or omission by the assignee that is determined by an 
adjudicator to be contrary to the financial interests of the assignor.
    (h) Responsibilities of the assignee. Once the assignee files an 
appeal, the assignee becomes a party to the appeal. The assignee must 
meet all requirements for appeals that apply to any other party.

[70 FR 11472, Mar. 8, 2005, as amended at 70 FR 37702, June 30, 2005]

                         Initial Determinations



Sec.  405.920  Initial determinations.

    After a claim is filed with the appropriate contractor in the manner 
and form described in subpart C of part 424 of this chapter, the 
contractor must--
    (a) Determine if the items and services furnished are covered or 
otherwise reimbursable under title XVIII of the Act;
    (b) Determine any amounts payable and make payment accordingly; and
    (c) Notify the parties to the initial determination of the 
determination in accordance with Sec.  405.921.



Sec.  405.921  Notice of initial determination.

    (a) Notice of initial determination sent to the beneficiary. (1) The 
notice must be written in a manner calculated to be understood by the 
beneficiary, and sent to the last known address of the beneficiary.
    (2) Content of the notice. The notice of initial determination must 
contain all of the following:
    (i) The reasons for the determination, including whether a local 
medical review policy, a local coverage determination, or national 
coverage determination was applied.
    (ii) The procedures for obtaining additional information concerning 
the contractor's determination, such as a specific provision of the 
policy, manual, law or regulation used in making the determination.

[[Page 180]]

    (iii) Information on the right to a redetermination if the 
beneficiary is dissatisfied with the outcome of the initial 
determination and instructions on how to request a redetermination.
    (iv) Any other requirements specified by CMS.
    (b) Notice of initial determination sent to providers and suppliers. 
(1) An electronic or paper remittance advice (RA) notice is the notice 
of initial determination sent to providers and suppliers that accept 
assignment.
    (i) The electronic RA must comply with the format and content 
requirements of the standard adopted for national use by covered 
entities under the Health Insurance Portability and Accountability Act 
(HIPAA) and related CMS manual instructions.
    (ii) When a paper RA is mailed, it must comply with CMS manual 
instructions that parallel the HIPAA data content and coding 
requirements.
    (2) The notice of initial determination must contain all of the 
following:
    (i) The basis for any full or partial denial determination of 
services or items on the claim.
    (ii) Information on the right to a redetermination if the provider 
or supplier is dissatisfied with the outcome of the initial 
determination.
    (iii) All applicable claim adjustment reason and remark codes to 
explain the determination.
    (iv) The source of the RA and who may be contacted if the provider 
or supplier requires further information.
    (v) All content requirements of the standard adopted for national 
use by covered entities under HIPAA.
    (vi) Any other requirements specified by CMS.
    (c) Notice of initial determination sent to an applicable plan--(1) 
Content of the notice. The notice of initial determination under Sec.  
405.924(b)(16) must contain all of the following:
    (i) The reasons for the determination.
    (ii) The procedures for obtaining additional information concerning 
the contractor's determination, such as a specific provision of the 
policy, manual, law or regulation used in making the determination.
    (iii) Information on the right to a redetermination if the liability 
insurance (including self-insurance), no-fault insurance, or workers' 
compensation law or plan is dissatisfied with the outcome of the initial 
determination and instructions on how to request a redetermination.
    (iv) Any other requirements specified by CMS.
    (2) [Reserved]

[70 FR 11472, Mar. 8, 2005, as amended at 80 FR 10617, Feb. 27, 2015]



Sec.  405.922  Time frame for processing initial determinations.

    The contractor issues initial determinations on clean claims within 
30 calendar days of receipt if they are submitted by or on behalf of the 
beneficiary who received the items and/or services; otherwise, interest 
must be paid at the rate specified at 31 U.S.C. 3902(a) for the period 
beginning on the day after the required payment date and ending on the 
date payment is made.

[70 FR 11472, Mar. 8, 2005, as amended at 74 FR 65333, Dec. 9, 2009]



Sec.  405.924  Actions that are initial determinations.

    (a) Applications and entitlement of individuals. SSA makes initial 
determinations and processes reconsiderations with respect to an 
individual on the following:
    (1) A determination with respect to entitlement to hospital 
insurance or supplementary medical insurance under Medicare.
    (2) A disallowance of an individual's application for entitlement to 
hospital or supplementary medical insurance, if the individual fails to 
submit evidence requested by SSA to support the application. (SSA 
specifies in the initial determination the conditions of entitlement 
that the applicant failed to establish by not submitting the requested 
evidence).
    (3) A denial of a request for withdrawal of an application for 
hospital or supplementary medical insurance, or a denial of a request 
for cancellation of a request for withdrawal.
    (4) A determination as to whether an individual, previously 
determined as entitled to hospital or supplementary

[[Page 181]]

medical insurance, is no longer entitled to those benefits, including a 
determination based on nonpayment of premiums.
    (5) An adjustment of premium for hospital or supplementary medical 
insurance as outlined in Sec. Sec.  406.32(d), 408.20(e), and 408.22 of 
this chapter, and 20 CFR 418.1301.
    (b) Claims made by or on behalf of beneficiaries. The Medicare 
contractor makes initial determinations regarding claims for benefits 
under Medicare Part A and Part B. A finding that a request for payment 
or other submission does not meet the requirements for a Medicare claim 
as defined in Sec.  424.32 of this chapter, is not considered an initial 
determination. An initial determination for purposes of this subpart 
includes, but is not limited to, determinations with respect to any of 
the following:
    (1) If the items and/or services furnished are covered under title 
XVIII.
    (2) In the case of determinations on the basis of section 1879(b) or 
(c) of the Act, if the beneficiary, or supplier who accepts assignment 
under Sec.  424.55 of this chapter knew, or could reasonably have 
expected to know at the time the items or services were furnished, that 
the items or services were not covered.
    (3) In the case of determinations on the basis of section 1842(l)(1) 
of the Act, if the beneficiary or physician knew, or could reasonably 
have expected to know at the time the services were furnished, that the 
services were not covered.
    (4) Whether the deductible is met.
    (5) The computation of the coinsurance amount.
    (6) The number of days used for inpatient hospital, psychiatric 
hospital, or post-hospital extended care.
    (7) Periods of hospice care used.
    (8) Requirements for certification and plan of treatment for 
physician services, durable medical equipment, therapies, inpatient 
hospitalization, skilled nursing care, home health, hospice, and partial 
hospitalization services.
    (9) The beginning and ending of a spell of illness, including a 
determination made under the presumptions established under Sec.  
409.60(c)(2) of this chapter, and as specified in Sec.  409.60(c)(4) of 
this chapter.
    (10) The medical necessity of services, or the reasonableness or 
appropriateness of placement of an individual at an acute level of 
patient care made by the Quality Improvement Organization (QIO) on 
behalf of the contractor in accordance with Sec.  476.86(c)(1) of this 
chapter.
    (11) Any other issues having a present or potential effect on the 
amount of benefits to be paid under Part A or Part B of Medicare, 
including a determination as to whether there was an underpayment of 
benefits paid under Part A or Part B, and if so, the amount thereof.
    (12) If a waiver of adjustment or recovery under sections 1870(b) 
and (c) of the Act is appropriate--
    (i) When an overpayment of hospital insurance benefits or 
supplementary medical insurance benefits (including a payment under 
section 1814(e) of the Act) was made for an individual; or
    (ii) For a Medicare Secondary Payer recovery claim against a 
beneficiary or against a provider or supplier.
    (13) If a particular claim is not payable by Medicare based upon the 
application of the Medicare Secondary Payer provisions of section 
1862(b) of the Act.
    (14) Under the Medicare Secondary Payer provisions of sections 
1862(b) of the Act that Medicare has a recovery claim against a 
provider, supplier, or beneficiary for services or items that were 
already paid by the Medicare program, except when the Medicare Secondary 
Payer recovery claim against the provider or supplier is based upon 
failure to file a proper claim as defined in part 411 of this chapter 
because this action is a reopening.
    (15) A claim not payable to a beneficiary for the services of a 
physician who has opted-out.
    (16) Under the Medicare Secondary Payer provisions of section 
1862(b) of the Act that Medicare has a recovery claim if Medicare is 
pursuing recovery directly from an applicable plan. That is, there is an 
initial determination with respect to the amount and existence of the 
recovery claim.

[[Page 182]]

    (c) Determinations by QIOs. An initial determination for purposes of 
this subpart also includes a determination made by a QIO that:
    (1) A provider can terminate services provided to an individual when 
a physician certified that failure to continue the provision of those 
services is likely to place the individual's health at significant risk; 
or
    (2) A provider can discharge an individual from the provider of 
services.

[70 FR 11472, Mar. 8, 2005, as amended at 74 FR 65333, Dec. 9, 2009; 79 
FR 68001, Nov. 13, 2014; 80 FR 10618, Feb. 27, 2015; 83 FR 16721, Apr. 
16, 2018]



Sec.  405.925  Decisions of utilization review committees.

    (a) General rule. A decision of a utilization review committee is a 
medical determination by a staff committee of the provider or a group 
similarly composed and does not constitute a determination by the 
Secretary within the meaning of section 1869 of the Act. The decision of 
a utilization review committee may be considered by CMS along with other 
pertinent medical evidence in determining whether or not an individual 
has the right to have payment made under Part A of title XVIII.
    (b) Applicability under the prospective payment system. CMS may 
consider utilization review committee decisions related to inpatient 
hospital services paid for under the prospective payment system (see 
part 412 of this chapter) only as those decisions concern:
    (1) The appropriateness of admissions resulting in payments under 
subparts D, E and G of part 412 of this chapter.
    (2) The covered days of care involved in determinations of outlier 
payments under Sec.  412.80(a)(1)(i) of this chapter; and
    (3) The necessity of professional services furnished in high cost 
outliers under Sec.  412.80(a)(1)(ii) of this chapter.

[48 FR 39831, Sept. 1, 1983. Redesignated at 77 FR 29028, May 16, 2012]



Sec.  405.926  Actions that are not initial determinations.

    Actions that are not initial determinations and are not appealable 
under this subpart include, but are not limited to the following:
    (a) Any determination for which CMS has sole responsibility, for 
example one of the following:
    (1) If an entity meets the conditions for participation in the 
program.
    (2) If an independent laboratory meets the conditions for coverage 
of services.
    (3) Determination under the Medicare Secondary Payer provisions of 
section 1862(b) of the Act of the debtor for a particular recovery 
claim.
    (b) The coinsurance amounts prescribed by regulation for outpatient 
services under the prospective payment system.
    (c) Any issue regarding the computation of the payment amount of 
program reimbursement of general applicability for which CMS or a 
carrier has sole responsibility under Part B such as the establishment 
of a fee schedule set forth in part 414 of this chapter, or an inherent 
reasonableness adjustment pursuant to Sec.  405.502(g), and any issue 
regarding the cost report settlement process under Part A.
    (d) Whether an individual's appeal meets the qualifications for 
expedited access to judicial review provided in Sec.  405.990.
    (e) Any determination regarding whether a Medicare overpayment claim 
must be compromised, or collection action terminated or suspended under 
the Federal Claims Collection Act of 1966, as amended.
    (f) Determinations regarding the transfer or discharge of residents 
of skilled nursing facilities in accordance with Sec.  483.5 definition 
of `transfer and discharge' and Sec.  483.15 of this chapter.
    (g) Determinations regarding the readmission screening and annual 
resident review processes required by subparts C and E of part 483 of 
this chapter.
    (h) Determinations for a waiver of Medicare Secondary Payer recovery 
under section 1862(b) of the Act.
    (i) Determinations for a waiver of interest.
    (j) Determinations for a finding regarding the general applicability 
of the Medicare Secondary Payer provisions (as opposed to the 
application of these provisions to a particular claim or claims for 
Medicare payment for benefits).

[[Page 183]]

    (k) Except as specified in Sec.  405.924(b)(16), determinations 
under the Medicare Secondary Payer provisions of section 1862(b) of the 
Act that Medicare has a recovery against an entity that was or is 
required or responsible (directly, as an insurer or self-insurer; as a 
third party administrator; as an employer that sponsors, contributes to 
or facilitates a group health plan or a large group health plan; or 
otherwise) to make payment for services or items that were already 
reimbursed by the Medicare program.
    (l) A contractor's, QIC's, ALJ's or attorney adjudicator's, or 
Council's determination or decision to reopen or not to reopen an 
initial determination, redetermination, reconsideration, decision, or 
review decision.
    (m) Determinations that CMS or its contractors may participate in 
the proceedings on a request for an ALJ hearing or act as parties in an 
ALJ hearing or Council review.
    (n) Determinations that a provider or supplier failed to submit a 
claim timely or failed to submit a timely claim despite being requested 
to do so by the beneficiary or the beneficiary's subrogee.
    (o) Determinations with respect to whether an entity qualifies for 
an exception to the electronic claims submission requirement under part 
424 of this chapter.
    (p) Determinations by the Secretary of sustained or high levels of 
payment errors in accordance with section 1893(f)(3)(A) of the Act.
    (q) A contractor's prior determination related to coverage of 
physicians' services.
    (r) Requests for anticipated payment under the home health 
prospective payment system under Sec.  409.43(c)(ii)(2) of this chapter.
    (s) Claim submissions on forms or formats that are incomplete, 
invalid, or do not meet the requirements for a Medicare claim and 
returned or rejected to the provider or supplier.
    (t) A contractor's prior authorization determination with regard 
to--
    (1) Durable medical equipment, prosthetics, orthotics, and supplies 
(DMEPOS)); and
    (2) Hospital outpatient department (OPD) services.
    (u) Issuance of notice to an individual entitled to Medicare 
benefits under Title XVIII of the Act when such individual received 
observation services as an outpatient for more than 24 hours, as 
specified under Sec.  489.20(y) of this chapter.

[70 FR 11472, Mar. 8, 2005, as amended at 70 FR 37702, June 30, 2005; 80 
FR 10618, Feb. 27, 2015; 80 FR 81706, Dec. 30, 2015; 81 FR 57267, Aug. 
22, 2016; 81 FR 68847, Oct. 4, 2016; 82 FR 5107, Jan. 17, 2017; 84 FR 
19869, May 7, 2019; 84 FR 61490, Nov. 12, 2019]



Sec.  405.927  Initial determinations subject to the reopenings process.

    Minor errors or omissions in an initial determination must be 
corrected only through the contractor's reopenings process under Sec.  
405.980(a)(3).



Sec.  405.928  Effect of the initial determination.

    (a) An initial determination described in Sec.  405.924(a) is 
binding unless it is revised or reconsidered in accordance with 20 CFR 
404.907, or revised as a result of a reopening in accordance with 20 CFR 
404.988.
    (b) An initial determination described in Sec.  405.924(b) is 
binding upon all parties to the initial determination unless--
    (1) A redetermination is completed in accordance with Sec.  405.940 
through Sec.  405.958; or
    (2) The initial determination is revised as a result of a reopening 
in accordance with Sec.  405.980.
    (c) An initial determination listed in Sec.  405.924(b) where a 
party submits a timely, valid request for redetermination under Sec.  
405.942 through Sec.  405.944 must be processed as a redetermination 
under Sec.  405.948 through Sec.  405.958 unless the initial 
determination involves a clerical error or other minor error or 
omission.

                            Redeterminations



Sec.  405.940  Right to a redetermination.

    A person or entity that may be a party to a redetermination in 
accordance with Sec.  405.906(b) and that is dissatisfied with an 
initial determination may request a redetermination by a contractor in 
accordance with Sec.  405.940

[[Page 184]]

through Sec.  405.958, regardless of the amount in controversy.



Sec.  405.942  Time frame for filing a request for a redetermination.

    (a) Time frame for filing a request. Except as provided in paragraph 
(b) of this section, any request for redetermination must be filed 
within 120 calendar days from the date a party receives the notice of 
the initial determination.
    (1) For purposes of this section, the date of receipt of the initial 
determination will be presumed to be 5 calendar days after the date of 
the notice of initial determination, unless there is evidence to the 
contrary.
    (2) The request is considered as filed on the date it is received by 
the contractor.
    (b) Extending the time frame for filing a request. General rule. If 
the 120 calendar day period in which to file a request for a 
redetermination has expired and a party shows good cause, the contractor 
may extend the time frame for filing a request for redetermination.
    (1) How to request an extension. A party may file a request for an 
extension of time for filing a request for a redetermination with the 
contractor. The party should include any evidence supporting the request 
for extension. The request for redetermination extension must--
    (i) Be in writing;
    (ii) State why the request for redetermination was not filed within 
the required time frame; and
    (iii) Meet the requirements of Sec.  405.944.
    (2) How the contractor determines if good cause exists. In 
determining if a party has good cause for missing a deadline to request 
a redetermination, the contractor considers--
    (i) The circumstances that kept the party from making the request on 
time;
    (ii) If the contractor's action(s) misled the party; and
    (iii) If the party had or has any physical, mental, educational, or 
linguistic limitations, including any lack of facility with the English 
language, that prevented the party from filing a timely request or from 
understanding or knowing about the need to file a timely request.
    (3) Examples of good cause. Examples of circumstances when good 
cause may be found to exist include, but are not limited to, the 
following situations:
    (i) The party was prevented by serious illness from contacting the 
contractor in person, in writing, or through a friend, relative, or 
other person; or
    (ii) The party had a death or serious illness in his or her 
immediate family; or
    (iii) Important records of the party were destroyed or damaged by 
fire or other accidental cause; or
    (iv) The contractor gave the party incorrect or incomplete 
information about when and how to request a redetermination; or
    (v) The party did not receive notice of the determination or 
decision; or
    (vi) The party sent the request to a Government agency in good faith 
within the time limit, and the request did not reach the appropriate 
contractor until after the time period to file a request expired.

[70 FR 11472, Mar. 8, 2005, as amended at 74 FR 65333, Dec. 9, 2009]



Sec.  405.944  Place and method of filing a request for a redetermination.

    (a) Filing location. The request for redetermination must be filed 
with the contractor indicated on the notice of initial determination.
    (b) Content of redetermination request. The request for 
redetermination must be in writing and should be made on a standard CMS 
form. A written request that is not made on a standard CMS form is 
accepted if it contains the same required elements as follows:
    (1) The beneficiary's name;
    (2) The Medicare number;
    (3) Specific service(s) and/or item(s) for which the redetermination 
is being requested and the specific date(s) of the service;
    (4) The name of the party or the representative of the party.
    (c) Requests for redetermination by more than one party. If more 
than one party timely files a request for redetermination on the same 
claim before a redetermination is made on the first timely filed 
request, the contractor

[[Page 185]]

must consolidate the separate requests into one proceeding and issue one 
redetermination.

[70 FR 11472, Mar. 8, 2005, as amended at 84 FR 19869, May 7, 2019]



Sec.  405.946  Evidence to be submitted with the redetermination request.

    (a) Evidence submitted with the request. When filing the request for 
redetermination, a party must explain why it disagrees with the 
contractor's determination and should include any evidence that the 
party believes should be considered by the contractor in making its 
redetermination.
    (b) Evidence submitted after the request. When a party submits 
additional evidence after filing the request for redetermination, the 
contractor's 60 calendar day decision-making time frame is automatically 
extended for up to 14 calendar days for each submission.

[70 FR 11472, Mar. 8, 2005, as amended at 70 FR 37702, June 30, 2005; 74 
FR 65333, Dec. 9, 2009]



Sec.  405.947  Notice to the beneficiary of applicable plan's request for 
a redetermination.

    (a) A CMS contractor must send notice of the applicable plan's 
appeal to the beneficiary.
    (b) Issuance and content of the notice must comply with CMS 
instructions.

[80 FR 10618, Feb. 27, 2015]



Sec.  405.948  Conduct of a redetermination.

    A redetermination consists of an independent review of an initial 
determination. In conducting a redetermination, the contractor reviews 
the evidence and findings upon which the initial determination was 
based, and any additional evidence the parties submit or the contractor 
obtains on its own. An individual who was not involved in making the 
initial determination must make a redetermination. The contractor may 
raise and develop new issues that are relevant to the claims in the 
particular case.



Sec.  405.950  Time frame for making a redetermination.

    (a) General rule. The contractor mails, or otherwise transmits, 
written notice of the redetermination or dismissal to the parties to the 
redetermination at their last known addresses within 60 calendar days of 
the date the contractor receives a timely filed request for 
redetermination.
    (b) Exceptions. (1) If a contractor grants an appellant's request 
for an extension of the 120 calendar day filing deadline made in 
accordance with Sec.  405.942(b), the 60 calendar day decision-making 
time frame begins on the date the contractor receives the late-filed 
request for redetermination, or when the request for an extension is 
granted, whichever is later.
    (2) If a contractor receives from multiple parties timely requests 
for redetermination of a claim determination, consistent with Sec.  
405.944(c), the contractor must issue a redetermination or dismissal 
within 60 calendar days of the latest filed request.
    (3) If a party submits additional evidence after the request for 
redetermination is filed, the contractor's 60 calendar day decision-
making time frame is extended for up to 14 calendar days for each 
submission, consistent with Sec.  405.946(b).

[70 FR 11472, Mar. 8, 2005, as amended at 70 FR 37702, June 30, 2005; 74 
FR 65333, Dec. 9, 2009]



Sec.  405.952  Withdrawal or dismissal of a request for a redetermination.

    (a) Withdrawing a request. A party that files a request for 
redetermination may withdraw its request by filing a written and signed 
request for withdrawal. The request for withdrawal must contain a clear 
statement that the appellant is withdrawing the request for a 
redetermination and does not intend to proceed further with the appeal. 
The request must be received in the contractor's mailroom before a 
redetermination is issued. The appeal will proceed with respect to any 
other parties that have filed a timely request for redetermination.
    (b) Dismissing a request. A contractor dismisses a redetermination 
request, either entirely or as to any stated issue, under any of the 
following circumstances:
    (1) When the person or entity requesting a redetermination is not a 
proper party under Sec.  405.906(b) or does

[[Page 186]]

not otherwise have a right to a redetermination under section 1869(a) of 
the Act;
    (2) When the contractor determines the party failed to make out a 
valid request for redetermination that substantially complies with Sec.  
405.944;
    (3) When the party fails to file the redetermination request within 
the proper filing time frame in accordance with Sec.  405.942;
    (4) When a beneficiary or the beneficiary's representative files a 
request for redetermination, but the beneficiary dies while the request 
is pending, and all of the following criteria apply:
    (i) The beneficiary's surviving spouse or estate has no remaining 
financial interest in the case. In deciding this issue, the contractor 
considers if the surviving spouse or estate remains liable for the 
services for which payment was denied or a Medicare contractor held the 
beneficiary liable for subsequent similar services under the limitation 
on liability provisions based on the denial of payment for services at 
issue;
    (ii) No other individual or entity with a financial interest in the 
case wishes to pursue the appeal; and
    (iii) No other party filed a valid and timely redetermination 
request under Sec. Sec.  405.942 and 405.944;
    (5) When a party filing the redetermination request submits a timely 
written request for withdrawal with the contractor; or
    (6) When the contractor has not issued an initial determination on 
the claim or the matter for which a redetermination is sought.
    (c) Notice of dismissal. A contractor mails or otherwise transmits a 
written notice of the dismissal of the redetermination request to the 
parties at their last known addresses. The notice states that there is a 
right to request that the contractor vacate the dismissal action.
    (d) Vacating a dismissal. If good and sufficient cause is 
established, a contractor may vacate its dismissal of a request for 
redetermination within 180 calendar days from the date of the notice of 
dismissal.
    (e) Effect of dismissal. The dismissal of a request for 
redetermination is binding unless it is modified or reversed by a QIC 
under Sec.  405.974(b) or vacated under paragraph (d) of this section.

[70 FR 11472, Mar. 8, 2005, as amended at 74 FR 65333, Dec. 9, 2009; 84 
FR 19870, May 7, 2019]



Sec.  405.954  Redetermination.

    Upon the basis of the evidence of record, the contractor adjudicates 
the claim(s), and renders a redetermination affirming or reversing, in 
whole or in part, the initial determination in question.



Sec.  405.956  Notice of a redetermination.

    (a) Notification to parties--(1) General rule. Written notice of a 
redetermination affirming, in whole or in part, the initial 
determination must be mailed or otherwise transmitted to all parties at 
their last known addresses in accordance with the time frames 
established in Sec.  405.950. Written notice of a redetermination fully 
reversing the initial determination must be mailed or otherwise 
transmitted to the appellant in accordance with the time frames 
established in Sec.  405.950. If the redetermination results in issuance 
of supplemental payment to a provider or supplier, the Medicare 
contractor must also issue an electronic or paper RA notice to the 
provider or supplier.
    (2) Overpayment cases involving multiple beneficiaries who have no 
liability. In an overpayment case involving multiple beneficiaries who 
have no liability, the contractor may issue a written notice only to the 
appellant.
    (b) Content of the notice for affirmations, in whole or in part. For 
decisions that are affirmations, in whole or in part, of the initial 
determination, the redetermination must be written in a manner 
calculated to be understood by a beneficiary, and contain--
    (1) A clear statement indicating the extent to which the 
redetermination is favorable or unfavorable;
    (2) A summary of the facts, including, as appropriate, a summary of 
the clinical or scientific evidence used in making the redetermination;
    (3) An explanation of how pertinent laws, regulations, coverage 
rules, and CMS policies apply to the facts of the case;

[[Page 187]]

    (4) A summary of the rationale for the redetermination in clear, 
understandable language;
    (5) Notification to the parties of their right to a reconsideration 
and a description of the procedures that a party must follow in order to 
request a reconsideration, including the time frame within which a 
reconsideration must be requested;
    (6) A statement of any specific missing documentation that must be 
submitted with a request for a reconsideration, if applicable;
    (7) A statement that all evidence the appellant wishes to introduce 
during the claim appeals process should be submitted with the request 
for a reconsideration;
    (8) Notification that evidence not submitted to the QIC as indicated 
in paragraph (b)(6) of this section, is not considered at the OMHA level 
or further appeal, unless the appellant demonstrates good cause as to 
why that evidence was not provided previously; and
    (9) The procedures for obtaining additional information concerning 
the redetermination, such as specific provisions of the policy, manual, 
or regulation used in making the redetermination.
    (10) Any other requirements specified by CMS.
    (c) Content of the notice for a full reversal. For decisions that 
are full reversals of the initial determination, the redetermination 
must be in writing and contain--
    (1) A clear statement indicating that the redetermination is wholly 
favorable;
    (2) Any other requirements specified by CMS.
    (d) Exception for beneficiary appeal requests. (1) The notice must 
inform beneficiary appellants that the requirements of paragraph (b)(8) 
of this section are not applicable for purposes of beneficiary appeals.
    (2) This exception does not apply for appeal requests from 
beneficiaries who are represented by providers or suppliers.

[70 FR 11472, Mar. 8, 2005, as amended at 82 FR 5107, Jan. 17, 2017]



Sec.  405.958  Effect of a redetermination.

    In accordance with section 1869(a)(3)(D) of the Act, once a 
redetermination is issued, it becomes part of the initial determination. 
The redetermination is binding upon all parties unless--
    (a) A reconsideration is completed in accordance with Sec.  405.960 
through Sec.  405.978; or
    (b) The redetermination is revised as a result of a reopening in 
accordance with Sec.  405.980.

[70 FR 11472, Mar. 8, 2005, as amended at 74 FR 65333, Dec. 9, 2009]

                             Reconsideration



Sec.  405.960  Right to a reconsideration.

    A person or entity that is a party to a redetermination made by a 
contractor as described under Sec.  405.940 through Sec.  405.958, and 
is dissatisfied with that determination, may request a reconsideration 
by a QIC in accordance with Sec.  405.962 through Sec.  405.966, 
regardless of the amount in controversy.



Sec.  405.962  Timeframe for filing a request for a reconsideration.

    (a) Timeframe for filing a request. Except as provided in paragraph 
(b) of this section and in Sec.  405.974(b)(1), regarding a request for 
QIC reconsideration of a contractor's dismissal of a redetermination 
request, any request for a reconsideration must be filed within 180 
calendar days from the date the party receives the notice of the 
redetermination.
    (1) For purposes of this section, the date of receipt of the 
redetermination will be presumed to be 5 calendar days after the date of 
the notice of redetermination, unless there is evidence to the contrary.
    (2) For purposes of meeting the 180 calendar day filing deadline, 
the request is considered as filed on the date it is received by the 
QIC.
    (b) Extending the time for filing a request--(1) General rule. A QIC 
may extend the 180 calendar day timeframe for filing a request for 
reconsideration for good cause.
    (2) How to request an extension. A party to the redetermination must 
file its request for an extension of the time for filing the 
reconsideration request

[[Page 188]]

with its request for reconsideration. A party should include evidence to 
support the request for extension. The request for reconsideration and 
request for extension must--
    (i) Be in writing;
    (ii) State why the request for reconsideration was not filed within 
the required timeframe; and
    (iii) Meet the requirements of Sec.  405.964.
    (3) How the QIC determines whether good cause exists. In determining 
whether a party has good cause for missing a deadline to request 
reconsideration, the QIC applies the good cause provisions contained in 
Sec.  405.942(b)(2) and (b)(3).

[70 FR 11472, Mar. 8, 2005, as amended at 74 FR 65334, Dec. 9, 2009]



Sec.  405.964  Place and method of filing a request for a reconsideration.

    (a) Filing location. The request for reconsideration must be filed 
with the QIC indicated on the notice of redetermination.
    (b) Content of reconsideration request. The request for 
reconsideration must be in writing and should be made on a standard CMS 
form. A written request that is not made on a standard CMS form is 
accepted if it contains the same required elements, as follows:
    (1) The beneficiary's name;
    (2) Medicare number;
    (3) Specific service(s) and item(s) for which the reconsideration is 
requested and the specific date(s) of service;
    (4) The name of the party or the representative of the party; and
    (5) The name of the contractor that made the redetermination.
    (c) Requests for reconsideration by more than one party. If more 
than one party timely files a request for reconsideration on the same 
claim before a reconsideration is made on the first timely filed 
request, the QIC must consolidate the separate requests into one 
proceeding and issue one reconsideration.

[70 FR 11472, Mar. 8, 2005, as amended at 84 FR 19870, May 7, 2019]



Sec.  405.966  Evidence to be submitted with the reconsideration request.

    (a) Evidence submitted with the request. When filing a request for 
reconsideration, a party should present evidence and allegations of fact 
or law related to the issue in dispute and explain why it disagrees with 
the initial determination, including the redetermination.
    (1) This evidence must include any missing documentation identified 
in the notice of redetermination, consistent with Sec.  405.956(b)(6).
    (2) Absent good cause, failure to submit all evidence, including 
documentation requested in the notice of redetermination prior to the 
issuance of the notice of reconsideration precludes subsequent 
consideration of that evidence.
    (b) Evidence submitted after the request. Each time a party submits 
additional evidence after filing the request for reconsideration, the 
QIC's 60 calendar day decisionmaking timeframe is automatically extended 
by up to 14 calendar days for each submission. This extension does not 
apply to timely submissions of documentation specifically requested by a 
QIC, unless the documentation was originally requested in the notice of 
redetermination.
    (c) Exception for beneficiaries and State Medicaid Agencies that 
file reconsideration requests. (1) Beneficiaries and State Medicaid 
Agencies that file requests for reconsideration are not required to 
comply with the requirements of paragraph (a) of this section. However, 
the automatic 14 calendar day extension described in paragraph (b) of 
this section applies to each evidence submission made after the request 
for reconsideration is filed.
    (2) Beneficiaries who are represented by providers or suppliers must 
comply with the requirements of paragraph (a) of this section.

[70 FR 11472, Mar. 8, 2005, as amended at 74 FR 65334, Dec. 9, 2009]



Sec.  405.968  Conduct of a reconsideration.

    (a) General rules. (1) A reconsideration consists of an independent, 
on-the-record review of an initial determination, including the 
redetermination and all issues related to payment of the claim. In 
conducting a reconsideration, the QIC reviews the evidence and findings 
upon which the initial determination, including the redetermination, was 
based, and any additional evidence the parties submit or that the QIC 
obtains on its own. If the

[[Page 189]]

initial determination involves a finding on whether an item or service 
is reasonable and necessary for the diagnosis or treatment of illness or 
injury (under section 1862(a)(1)(A) of the Act), a QIC's reconsideration 
must involve consideration by a panel of physicians or other appropriate 
health care professionals, and be based on clinical experience, the 
patient's medical records, and medical, technical, and scientific 
evidence of record to the extent applicable.
    (b) Authority of the QIC. (1) National coverage determinations 
(NCDs), CMS Rulings, Council decisions designated by the Chair of the 
Departmental Appeals Board as having precedential effect under Sec.  
401.109 of this chapter, and applicable laws and regulations are binding 
on the QIC.
    (2) QICs are not bound by LCDs, LMRPs, or CMS program guidance, such 
as program memoranda and manual instructions, but give substantial 
deference to these policies if they are applicable to a particular case. 
A QIC may decline to follow a policy, if the QIC determines, either at a 
party's request or at its own discretion, that the policy does not apply 
to the facts of the particular case.
    (3) If a QIC declines to follow a policy in a particular case, the 
QIC's reconsideration explains the reasons why the policy was not 
followed.
    (4) A QIC's decision to decline to follow a policy under this 
section applies only to the specific claim being reconsidered and does 
not have precedential effect.
    (5) A QIC may raise and develop new issues that are relevant to the 
claims in a particular case provided that the contractor rendered a 
redetermination with respect to the claims.
    (c) Qualifications of the QIC's panel members. (1) Members of a 
QIC's panel who conduct reconsiderations must have sufficient medical, 
legal, and other expertise, including knowledge of the Medicare program.
    (2) When a redetermination is made with respect to whether an item 
or service is reasonable and necessary (section 1862(a)(1)(A) of the 
Act), the QIC designates a panel of physicians or other appropriate 
health care professionals to consider the facts and circumstances of the 
redetermination.
    (3) Where a claim pertains to the furnishing of treatment by a 
physician, or the provision of items or services by a physician, a 
reviewing professional must be a physician.
    (d) Disqualification of a QIC panel member. No physician or health 
care professional employed by or otherwise working for a QIC may review 
determinations regarding--
    (1) Health care services furnished to a patient if that physician or 
health care professional was directly responsible for furnishing those 
services; or
    (2) Health care services provided in or by an institution, 
organization, or agency, if that physician or health care professional 
or any member of the physician's family or health care professional's 
family has, directly or indirectly, a significant financial interest in 
that institution, organization, or agency (see the term family member as 
defined in Sec.  405.902).

[70 FR 11472, Mar. 8, 2005, as amended at 82 FR 5107, Jan. 17, 2017]



Sec.  405.970  Timeframe for making a reconsideration following a contract
or redetermination.

    (a) General rule. Within 60 calendar days of the date the QIC 
receives a timely filed request for reconsideration following a 
contractor redetermination or any additional time provided by paragraph 
(b) of this section, the QIC mails, or otherwise transmits to the 
parties at their last known addresses, written notice of--
    (1) The reconsideration;
    (2) Its inability to complete its review within 60 calendar days in 
accordance with paragraphs (c) through (e) of this section; or
    (3) Dismissal.
    (b) Exceptions. (1) If a QIC grants an appellant's request for an 
extension of the 180 calendar day filing deadline made in accordance 
with Sec.  405.962(b), the QIC's 60 calendar day decision-making 
timeframe begins on the date the QIC receives the late filed request for 
reconsideration following a contractor redetermination, or when the 
request for an extension that meets the requirements of Sec.  405.962(b) 
is granted, whichever is later.

[[Page 190]]

    (2) If a QIC receives timely requests for reconsideration following 
a contractor redetermination from multiple parties, consistent with 
Sec.  405.964(c), the QIC must issue a reconsideration, notice that it 
cannot complete its review, or dismissal within 60 calendar days for 
each submission of the latest filed request.
    (3) Each time a party submits additional evidence after the request 
for reconsideration following a contractor redetermination is filed, the 
QIC's 60 calendar day decisionmaking timeframe is extended by up to 14 
calendar days for each submission, consistent with Sec.  405.966(b).
    (c) Responsibilities of the QIC. Within 60 calendar days of 
receiving a request for a reconsideration following a contractor 
redetermination, or any additional time provided for under paragraph (b) 
of this section, a QIC must take one of the following actions:
    (1) Notify all parties of its reconsideration, consistent with Sec.  
405.976.
    (2) Notify the parties that it cannot complete the reconsideration 
by the deadline specified in paragraph (b) of this section and offer the 
appellant the opportunity to escalate the appeal to OMHA. The QIC 
continues to process the reconsideration unless it receives a written 
request from the appellant to escalate the case to OMHA after the 
adjudication period has expired.
    (d) Responsibilities of the appellant. If an appellant wishes to 
exercise the option of escalating the case to OMHA, the appellant must 
notify the QIC in writing.
    (e) Actions following appellant's notice. (1) If the appellant fails 
to notify the QIC, or notifies the QIC that the appellant does not 
choose to escalate the case, the QIC completes its reconsideration 
following a contractor redetermination and notifies the appellant of its 
action consistent with Sec.  405.972 or Sec.  405.976.
    (2) If the appellant notifies the QIC that the appellant wishes to 
escalate the case, the QIC must take one of the following actions within 
5 calendar days of receipt of the notice or 5 calendar days from the end 
of the applicable adjudication period under paragraph (a) or (b) of this 
section:
    (i) Complete its reconsideration following a contractor 
redetermination and notify all parties of its decision consistent with 
Sec.  405.972 or Sec.  405.976.
    (ii) Acknowledge the escalation notice in writing and forward the 
case file to OMHA.

[70 FR 11472, Mar. 8, 2005, as amended at 70 FR 37702, June 30, 2005; 74 
FR 65334, Dec. 9, 2009; 82 FR 5107, Jan. 17, 2017; 84 FR 19870, May 7, 
2019]



Sec.  405.972  Withdrawal or dismissal of a request for reconsideration 
or review of a contractor's dismissal of a request for redetermination.

    (a) Withdrawing a request. An appellant that files a request for 
reconsideration may withdraw its request by filing a written and signed 
request for withdrawal. The request for withdrawal must--
    (1) Contain a clear statement that the appellant is withdrawing the 
request for reconsideration and does not intend to proceed further with 
the appeal.
    (2) Be received in the QIC's mailroom before the reconsideration is 
issued.
    (b) Dismissing a request. A QIC dismisses a reconsideration request, 
either entirely or as to any stated issue, under any of the following 
circumstances:
    (1) When the person or entity requesting reconsideration is not a 
proper party under Sec.  405.906(b) or does not otherwise have a right 
to a reconsideration under section 1869(b) of the Act;
    (2) When the QIC determines that the party failed to make out a 
valid request for reconsideration that substantially complies with Sec.  
405.964(a) and (b);
    (3) When the party fails to file the reconsideration request in 
accordance with the timeframes established in Sec.  405.962, or fails to 
file the request for review of a contractor's dismissal of a 
redetermination request in accordance with the timeframes established in 
Sec.  405.974(b)(1);
    (4) When a beneficiary or the beneficiary's representative files a 
request for reconsideration, but the beneficiary dies while the request 
is pending, and all of the following criteria apply:
    (i) The beneficiary's surviving spouse or estate has no remaining 
financial interest in the case. In deciding this

[[Page 191]]

issue, the QIC considers if the surviving spouse or estate remains 
liable for the services for which payment was denied or a Medicare 
contractor held the beneficiary liable for subsequent similar services 
under the limitation on liability provisions based on the denial of 
payment for services at issue;
    (ii) No other individual or entity with a financial interest in the 
case wishes to pursue the appeal; and
    (iii) No other party to the redetermination filed a valid and timely 
request for reconsideration under Sec. Sec.  405.962 and 405.964.
    (5) When a party filing for the reconsideration submits a written 
request of withdrawal to the QIC and satisfies the criteria set forth in 
paragraph (a) of this section before the reconsideration has been 
issued; or
    (6) When the contractor has not issued a redetermination on the 
initial determination for which a reconsideration is sought.
    (c) Notice of dismissal. A QIC mails or otherwise transmits written 
notice of the dismissal of the reconsideration request to the parties at 
their last known addresses. The notice states that there is a right to 
request that the contractor vacate the dismissal action. The appeal will 
proceed with respect to any other parties that have filed a timely 
request for reconsideration.
    (d) Vacating a dismissal. If good and sufficient cause is 
established, a QIC may vacate its dismissal of a request for 
reconsideration within 180 calendar days of the date of the notice of 
dismissal.
    (e) Effect of dismissal. The dismissal of a request for 
reconsideration is binding unless it is modified or reversed by an ALJ 
or attorney adjudicator under Sec.  405.1004 or vacated under paragraph 
(d) of this section. The dismissal of a request for review of a 
contractor's dismissal of a redetermination request is binding and not 
subject to further review unless vacated under paragraph (d) of this 
section.

[70 FR 11472, Mar. 8, 2005, as amended at 74 FR 65334, Dec. 9, 2009; 82 
FR 5107, Jan. 17, 2017; 84 FR 19870, May 7, 2019]



Sec.  405.974  Reconsideration and review of a contractor's dismissal 
of a request for redetermination.

    (a) Reconsideration of a contractor determination. Except as 
provided in Sec.  405.972, upon the basis of the evidence of record, the 
QIC must issue a reconsideration affirming or reversing, in whole or in 
part, the initial determination, including the redetermination, in 
question.
    (b) Review of a contractor's dismissal of a redetermination request. 
(1) A party to a contractor's dismissal of a request for redetermination 
has a right to have the dismissal reviewed by a QIC, if the party files 
a written request for review of the dismissal with the QIC within 60 
calendar days after receipt of the contractor's notice of dismissal.
    (i) For purposes of this section, the date of receipt of the 
contractor's notice of dismissal is presumed to be 5 calendar days after 
the date of the notice of dismissal, unless there is evidence to the 
contrary.
    (ii) For purposes of meeting the 60 calendar day filing deadline, 
the request is considered as filed on the date it is received by the QIC 
indicated on the notice of dismissal.
    (2) If the QIC determines that the contractor's dismissal was in 
error, it vacates the dismissal and remands the case to the contractor 
for a redetermination.
    (3) A QIC's review of a contractor's dismissal of a redetermination 
request is binding and not subject to further review.

[70 FR 11472, Mar. 8, 2005, as amended at 70 FR 37703, June 30, 2005; 74 
FR 65334, Dec. 9, 2009; 82 FR 5108, Jan. 17, 2017]



Sec.  405.976  Notice of a reconsideration.

    (a) Notification to parties--(1) General rules. (i) Written notice 
of the reconsideration must be mailed or otherwise transmitted to all 
parties at their last known addresses, in accordance with the timeframes 
established in Sec.  405.970(a) or (b).
    (ii) The notice must be written in a manner reasonably calculated to 
be understood by a beneficiary.
    (iii) The QIC must promptly notify the entity responsible for 
payment of claims under Part A or Part B of its reconsideration. If the 
reconsideration

[[Page 192]]

results in issuance of supplemental payment to a provider or supplier, 
the Medicare contractor must also issue an electronic or paper RA notice 
to the provider or supplier.
    (2) Overpayment cases involving multiple beneficiaries who have no 
liability. In an overpayment case involving multiple beneficiaries who 
have no liability, the QIC may issue a written notice only to the 
appellant.
    (b) Content of the notice. The reconsideration must be in writing 
and contain--
    (1) A clear statement indicating whether the reconsideration is 
favorable or unfavorable;
    (2) A summary of the facts, including as appropriate, a summary of 
the clinical or scientific evidence used in making the reconsideration;
    (3) An explanation of how pertinent laws, regulations, coverage 
rules, and CMS policies, apply to the facts of the case, including, 
where applicable, the rationale for declining to follow an LCD, LMRP, or 
CMS program guidance;
    (4) In the case of a determination on whether an item or service is 
reasonable or necessary under section 1862(a)(1)(A) of the Act, an 
explanation of the medical and scientific rationale for the decision;
    (5) A summary of the rationale for the reconsideration.
    (i) If the notice of redetermination indicated that specific 
documentation should be submitted with the reconsideration request, and 
the documentation was not submitted with the request for 
reconsideration, the summary must indicate how the missing documentation 
affected the reconsideration; and
    (ii) The summary must also specify that, consistent with Sec. Sec.  
405.956(b)(8) and 405.966(b), all evidence, including evidence requested 
in the notice of redetermination, that is not submitted prior to the 
issuance of the reconsideration will not be considered at the OMHA 
level, unless the appellant demonstrates good cause as to why the 
evidence was not provided prior to the issuance of the QIC's 
reconsideration. This requirement does not apply to beneficiaries, 
unless the beneficiary is represented by a provider or supplier or to 
State Medicaid Agencies;
    (6) Information concerning to the parties' right to an ALJ hearing, 
including the applicable amount in controversy requirement and 
aggregation provisions;
    (7) A statement of whether the amount in controversy is estimated to 
meet or not meet the amount required for an ALJ hearing, if--
    (i) The request for reconsideration was filed by a beneficiary who 
is not represented by a provider, supplier, or Medicaid State agency; 
and
    (ii) The reconsideration decision is partially or fully unfavorable.
    (8) A description of the procedures that a party must follow in 
order to obtain an ALJ hearing of an expedited reconsideration, 
including the time frame under which a request for an ALJ hearing must 
be filed;
    (9) If appropriate, advice as to the requirements for use of the 
expedited access to judicial review process set forth in Sec.  405.990;
    (10) The procedures for obtaining additional information concerning 
the reconsideration, such as specific provisions of the policy, manual, 
or regulation used in making the reconsideration; and
    (11) Any other requirements specified by CMS.

[70 FR 11472, Mar. 8, 2005, as amended at 82 FR 5108, Jan. 17, 2017]



Sec.  405.978  Effect of a reconsideration.

    A reconsideration is binding on all parties, unless--
    (a) An ALJ or attorney adjudicator decision is issued in accordance 
to a request for an ALJ hearing made in accordance with Sec.  405.1014;
    (b) A review entity issues a decision in accordance to a request for 
expedited access to judicial review under Sec.  405.990; or
    (c) The reconsideration is revised as a result of a reopening in 
accordance with Sec.  405.980.

[70 FR 11472, Mar. 8, 2005, as amended at 74 FR 65334, Dec. 9, 2009; 82 
FR 5108, Jan. 17, 2017]

[[Page 193]]

                               Reopenings



Sec.  405.980  Reopening of initial determinations, redeterminations, 
reconsiderations, decisions, and reviews.

    (a) General rules. (1) A reopening is a remedial action taken to 
change a binding determination or decision that resulted in either an 
overpayment or underpayment, even though the binding determination or 
decision may have been correct at the time it was made based on the 
evidence of record. That action may be taken by--
    (i) A contractor to revise the initial determination or 
redetermination;
    (ii) A QIC to revise the reconsideration;
    (iii) An ALJ or attorney adjudicator to revise his or her decision; 
or
    (iv) The Council to revise the ALJ or attorney adjudicator decision, 
or its review decision.
    (2) If a contractor issues a denial of a claim because it did not 
receive requested documentation during medical review and the party 
subsequently requests a redetermination, the contractor must process the 
request as a reopening.
    (3) Notwithstanding paragraph (a)(4) of this section, a contractor 
must process clerical errors (which includes minor errors and omissions) 
as reopenings, instead of as redeterminations as specified in Sec.  
405.940. If the contractor receives a request for reopening and 
disagrees that the issue is a clerical error, the contractor must 
dismiss the reopening request and advise the party of any appeal rights, 
provided the timeframe to request an appeal on the original denial has 
not expired. For purposes of this section, clerical error includes human 
or mechanical errors on the part of the party or the contractor such 
as--
    (i) Mathematical or computational mistakes;
    (ii) Inaccurate data entry; or
    (iii) Denials of claims as duplicates.
    (4) When a party has filed a valid request for an appeal of an 
initial determination, redetermination, reconsideration, ALJ or attorney 
adjudicator decision, or Council review, no adjudicator has jurisdiction 
to reopen an issue on a claim that is under appeal until all appeal 
rights for that issue are exhausted. Once the appeal rights for the 
issue have been exhausted, the contractor, QIC, ALJ or attorney 
adjudicator, or Council may reopen as set forth in this section.
    (5) The contractor's, QIC's, ALJ's or attorney adjudicator's, or 
Council's decision on whether to reopen is binding and not subject to 
appeal.
    (6) A determination under the Medicare secondary payer provisions of 
section 1862(b) of the Act that Medicare has an MSP recovery claim for 
services or items that were already reimbursed by the Medicare program 
is not a reopening, except where the recovery claim is based upon a 
provider's or supplier's failure to demonstrate that it filed a proper 
claim as defined in part 411 of this chapter.
    (b) Time frames and requirements for reopening initial 
determinations and redeterminations initiated by a contractor. A 
contractor may reopen an initial determination or redetermination on its 
own motion--
    (1) Within 1 year from the date of the initial determination or 
redetermination for any reason.
    (2) Within 4 years from the date of the initial determination or 
redetermination for good cause as defined in Sec.  405.986.
    (3) At any time if there exists reliable evidence as defined in 
Sec.  405.902 that the initial determination was procured by fraud or 
similar fault as defined in Sec.  405.902.
    (4) At anytime if the initial determination is unfavorable, in whole 
or in part, to the party thereto, but only for the purpose of correcting 
a clerical error on which that determination was based.
    (5) At any time to effectuate a decision issued under the coverage 
appeals process.
    (c) Time frame and requirements for reopening initial determinations 
and redeterminations requested by a party. (1) A party may request that 
a contractor reopen its initial determination or redetermination within 
1 year from the date of the initial determination or redetermination for 
any reason.
    (2) A party may request that a contractor reopen its initial 
determination or redetermination within 4 years from the date of the 
initial determination or

[[Page 194]]

redetermination for good cause in accordance with Sec.  405.986.
    (3) A party may request that a contractor reopen its initial 
determination at any time if the initial determination is unfavorable, 
in whole or in part, to the party thereto, but only for the purpose of 
correcting a clerical error on which that determination was based. Third 
party payer error does not constitute clerical error. See Sec.  
405.986(c).
    (4) A party may request that a contractor reopen an initial 
determination for the purpose of reporting and returning an overpayment 
under Sec.  401.305 of this chapter.
    (d) Time frame and requirements for reopening reconsiderations, 
decisions and reviews initiated by a QIC, ALJ or attorney adjudicator, 
or the Council. (1) A QIC may reopen its reconsideration on its own 
motion within 180 calendar days from the date of the reconsideration for 
good cause in accordance with Sec.  405.986. If the QIC's 
reconsideration was procured by fraud or similar fault, then the QIC may 
reopen at any time.
    (2) An ALJ or attorney adjudicator may reopen his or her decision, 
or the Council may reopen an ALJ or attorney adjudicator decision on its 
own motion within 180 calendar days from the date of the decision for 
good cause in accordance with Sec.  405.986. If the decision was 
procured by fraud or similar fault, then the ALJ or attorney adjudicator 
may reopen his or her decision, or the Council may reopen an ALJ or 
attorney adjudicator decision, at any time.
    (3) The Council may reopen its review decision on its own motion 
within 180 calendar days from the date of the review decision for good 
cause in accordance with Sec.  405.986. If the Council's decision was 
procured by fraud or similar fault, then the Council may reopen at any 
time.
    (e) Time frames and requirements for reopening reconsiderations, 
decisions, and reviews requested by a party. (1) A party to a 
reconsideration may request that a QIC reopen its reconsideration within 
180 calendar days from the date of the reconsideration for good cause in 
accordance with Sec.  405.986.
    (2) A party to an ALJ or attorney adjudicator decision may request 
that an ALJ or attorney adjudicator reopen his or her decision, or the 
Council reopen an ALJ or attorney adjudicator decision, within 180 
calendar days from the date of the decision for good cause in accordance 
with Sec.  405.986.
    (3) A party to a Council review may request that the Council reopen 
its decision within 180 calendar days from the date of the review 
decision for good cause in accordance with Sec.  405.986.

[70 FR 11472, Mar. 8, 2005, as amended at 70 FR 37703, June 30, 2005; 74 
FR 65334, Dec. 9, 2009; 81 FR 7684, Feb. 12, 2016; 82 FR 5108, Jan. 17, 
2017]



Sec.  405.982  Notice of a revised determination or decision.

    (a) When adjudicators initiate reopenings. When any determination or 
decision is reopened and revised as provided in Sec.  405.980, the 
contractor, QIC, ALJ or attorney adjudicator, or the Council must mail 
its revised determination or decision to the parties to that 
determination or decision at their last known address. In the case of a 
full or partial reversal resulting in issuance of a payment to a 
provider or supplier, a revised electronic or paper remittance advice 
notice must be issued by the Medicare contractor. An adverse revised 
determination or decision must state the rationale and basis for the 
reopening and revision and any right to appeal.
    (b) Reopenings initiated at the request of a party. The contractor, 
QIC, ALJ or attorney adjudicator, or the Council must mail its revised 
determination or decision to the parties to that determination or 
decision at their last known address. In the case of a full or partial 
reversal resulting in issuance of a payment to a provider or supplier, a 
revised electronic or paper remittance advice notice must be issued by 
the Medicare contractor. An adverse revised determination or decision 
must state the rationale and basis for the reopening and revision and 
any right to appeal.

[70 FR 11472, Mar. 8, 2005, as amended at 82 FR 5108, Jan. 17, 2017]



Sec.  405.984  Effect of a revised determination or decision.

    (a) Initial determinations. The revision of an initial determination 
is binding upon all parties unless a party files a

[[Page 195]]

written request for a redetermination that is accepted and processed in 
accordance with Sec.  405.940 through Sec.  405.958.
    (b) Redeterminations. The revision of a redetermination is binding 
upon all parties unless a party files a written request for a QIC 
reconsideration that is accepted and processed in accordance with Sec.  
405.960 through Sec.  405.978.
    (c) Reconsiderations. The revision of a reconsideration is binding 
upon all parties unless a party files a written request for an ALJ 
hearing that is accepted and processed in accordance with Sec.  405.1000 
through Sec.  405.1063.
    (d) ALJ or attorney adjudicator decisions. The revision of an ALJ or 
attorney adjudicator decision is binding upon all parties unless a party 
files a written request for a Council review that is accepted and 
processed in accordance with Sec.  405.1100 through Sec.  405.1130.
    (e) Council review. The revision of a Council review is binding upon 
all parties unless a party files a civil action in which a Federal 
district court accepts jurisdiction and issues a decision.
    (f) Appeal of only the portion of the determination or decision 
revised by the reopening. Only the portion of the initial determination, 
redetermination, reconsideration, or hearing decision revised by the 
reopening may be subsequently appealed.
    (g) Effect of a revised determination or decision. A revised 
determination or decision is binding unless it is appealed or otherwise 
reopened.

[70 FR 11472, Mar. 8, 2005, as amended at 82 FR 5108, Jan. 17, 2017]



Sec.  405.986  Good cause for reopening.

    (a) Establishing good cause. Good cause may be established when--
    (1) There is new and material evidence that--
    (i) Was not available or known at the time of the determination or 
decision; and
    (ii) May result in a different conclusion; or
    (2) The evidence that was considered in making the determination or 
decision clearly shows on its face that an obvious error was made at the 
time of the determination or decision.
    (b) Change in substantive law or interpretative policy. A change of 
legal interpretation or policy by CMS in a regulation, CMS ruling, or 
CMS general instruction, or a change in legal interpretation or policy 
by SSA in a regulation, SSA ruling, or SSA general instruction in 
entitlement appeals, whether made in response to judicial precedent or 
otherwise, is not a basis for reopening a determination or hearing 
decision under this section. This provision does not preclude 
contractors from conducting reopenings to effectuate coverage decisions 
issued under the authority granted by section 1869(f) of the Act.
    (c) Third party payer error. A request to reopen a claim based upon 
a third party payer's error in making a primary payment determination 
when Medicare processed the claim in accordance with the information in 
its system of records or on the claim form does not constitute good 
cause for reopening.

[70 FR 11472, Mar. 8, 2005, as amended at 70 FR 37703, June 30, 2005]

                   Expedited Access to Judicial Review



Sec.  405.990  Expedited access to judicial review.

    (a) Process for expedited access to judicial review. (1) For 
purposes of this section, a ``review entity'' means an entity of up to 
three reviewers who are ALJs or members of the Departmental Appeals 
Board (DAB), as determined by the Secretary.
    (2) In order to obtain expedited access to judicial review (EAJR), a 
review entity must certify that the Council does not have the authority 
to decide the question of law or regulation relevant to the matters in 
dispute and that there is no material issue of fact in dispute.
    (3) A party may make a request for EAJR only once with respect to a 
question of law or regulation for a specific matter in dispute in an 
appeal.
    (b) Conditions for making the expedited appeals request. (1) A party 
may request EAJR in place of an ALJ hearing or Council review if the 
following conditions are met:
    (i) A QIC has made a reconsideration determination and the party has 
filed a request for--

[[Page 196]]

    (A) An ALJ hearing in accordance with Sec.  405.1002 and a decision, 
dismissal order, or remand order of the ALJ or attorney adjudicator has 
not been issued;
    (B) Council review in accordance with Sec.  405.1102 and a final 
decision, dismissal order, or remand order of the Council has not been 
issued; or
    (ii) The appeal has been escalated from the QIC to OMHA for an ALJ 
hearing after the period described in Sec.  405.970(a) and Sec.  
405.970(b) has expired, and the QIC does not issue a decision or 
dismissal order within the timeframe described in Sec.  405.970(e).
    (2) The requestor is a party, as defined in paragraph (e) of this 
section.
    (3) The amount remaining in controversy meets the requirements of 
Sec.  405.1006(b) or (c).
    (4) If there is more than one party to the reconsideration, hearing, 
or Council review, each party concurs, in writing, with the request for 
the EAJR.
    (5) There are no material issues of fact in dispute.
    (c) Content of the request for EAJR. The request for EAJR must--
    (1) Allege that there are no material issues of fact in dispute and 
identify the facts that the requestor considers material and that are 
not disputed; and
    (2) Assert that the only factor precluding a decision favorable to 
the requestor is--
    (i) A statutory provision that is unconstitutional, or a provision 
of a regulation or national coverage determination and specify the 
statutory provision that the requestor considers unconstitutional or the 
provision of a regulation or a national coverage determination that the 
requestor considers invalid, or
    (ii) A CMS Ruling that the requester considers invalid;
    (3) Include a copy of any QIC reconsideration and of any ALJ or 
attorney adjudicator decision that the requester has received;
    (4) If any QIC reconsideration or ALJ or attorney adjudicator 
decision was based on facts that the requestor is disputing, state why 
the requestor considers those facts to be immaterial; and
    (5) If any QIC reconsideration or ALJ or attorney adjudicator 
decision was based on a provision of a law, regulation, national 
coverage determination or CMS Ruling in addition to the one the 
requestor considers unconstitutional or invalid, a statement as to why 
further administrative review of how that provision applies to the facts 
is not necessary.
    (d) Place and time for an EAJR request--(1) Method and place for 
filing request. The requestor may--
    (i) If a request for ALJ hearing or Council review is not pending, 
file a written EAJR request with the HHS Departmental Appeals Board with 
his or her request for an ALJ hearing or Council review; or
    (ii) If an appeal is already pending for an ALJ hearing or otherwise 
before OMHA, or the Council, file a written EAJR request with the HHS 
Departmental Appeals Board.
    (2) Time of filing request. The party may file a request for the 
EAJR--
    (i) If the party has requested a hearing, at any time before receipt 
of the notice of the ALJ's or attorney adjudicator's decision; or
    (ii) If the party has requested Council review, at any time before 
receipt of notice of the Council's decision.
    (e) Parties to the EAJR. The parties to the EAJR are the persons or 
entities who were parties to the QIC's reconsideration determination 
and, if applicable, to the ALJ hearing.
    (f) Determination on EAJR request. (1) The review entity described 
in paragraph (a) of this section will determine whether the request for 
EAJR meets all of the requirements of paragraphs (b), (c), and (d) of 
this section.
    (2) Within 60 calendar days after the date the review entity 
receives a request and accompanying documents and materials meeting the 
conditions in paragraphs (b), (c), and (d) of this section, the review 
entity will issue either a certification in accordance to paragraph (g) 
of this section or a denial of the request.
    (3) A determination by the review entity either certifying that the 
requirements for EAJR are met pursuant to paragraph (g) of this section 
or denying the request is not subject to review by the Secretary.
    (4) If the review entity fails to make a determination within the 
time frame

[[Page 197]]

specified in paragraph (f)(2) of this section, then the requestor may 
bring a civil action in Federal district court within 60 calendar days 
of the end of the time frame.
    (g) Certification by the review entity. If a party meets the 
requirements for the EAJR, the review entity certifies in writing that--
    (1) The material facts involved in the claim are not in dispute;
    (2) Except as indicated in paragraph (g)(3) of this section, the 
Secretary's interpretation of the law is not in dispute;
    (3) The sole issue(s) in dispute is the constitutionality of a 
statutory provision, or the validity of a provision of a regulation, CMS 
Ruling, or national coverage determination;
    (4) But for the provision challenged, the requestor would receive a 
favorable decision on the ultimate issue (such as whether a claim should 
be paid); and
    (5) The certification by the review entity is the Secretary's final 
action for purposes of seeking expedited judicial review.
    (h) Effect of certification by the review entity. If an EAJR request 
results in a certification described in paragraph (g) of this section--
    (1) The party that requested the EAJR is considered to have waived 
any right to completion of the remaining steps of the administrative 
appeals process regarding the matter certified.
    (2) The requestor has 60 calendar days, beginning on the date of the 
review entity's certification within which to bring a civil action in 
Federal district court.
    (3) The requestor must satisfy the requirements for venue under 
section 1869(b)(2)(C)(iii) of the Act, as well as the requirements for 
filing a civil action in a Federal district court under Sec.  
405.1136(a) and Sec.  405.1136(c) through Sec.  405.1136(f).
    (i) Rejection of EAJR. (1) If a request for EAJR does not meet all 
the conditions set out in paragraphs (b), (c) and (d) of this section, 
or if the review entity does not certify a request for EAJR, the review 
entity advises in writing all parties that the request has been denied, 
and forwards the request to OMHA or the Council, which will treat it as 
a request for hearing or for Council review, as appropriate.
    (2) Whenever a review entity forwards a rejected EAJR request to 
OMHA or the Council, the appeal is considered timely filed, and if an 
adjudication time frame applies to the appeal, the adjudication time 
frame begins on the day the request is received by OMHA or the Council 
from the review entity.
    (j) Interest on any amounts in controversy. (1) If a provider or 
supplier is granted judicial review in accordance with this section, the 
amount in controversy, if any, is subject to annual interest beginning 
on the first day of the first month beginning after the 60 calendar day 
period as determined in accordance with paragraphs (f)(4) or (h)(2) of 
this section, as applicable.
    (2) The interest is awarded by the reviewing court and payable to a 
prevailing party.
    (3) The rate of interest is equal to the rate of interest applicable 
to obligations issued for purchase by the Federal Supplementary Medical 
Insurance Trust Fund for the month in which the civil action authorized 
under this subpart is commenced.
    (4) No interest awarded in accordance with this paragraph shall be 
income or cost for purposes of determining reimbursement due to 
providers or suppliers under Medicare.

[70 FR 11472, Mar. 8, 2005, as amended at 70 FR 37703, June 30, 2005; 74 
FR 65334, Dec. 9, 2009; 82 FR 5108, Jan. 17, 2017]

                              ALJ Hearings



Sec.  405.1000  Hearing before an ALJ and decision by an ALJ 
or attorney adjudicator: General rule.

    (a) If a party is dissatisfied with a QIC's reconsideration, or if 
the adjudication period specified in Sec.  405.970 for the QIC to 
complete its reconsideration has elapsed, the party may request a 
hearing before an ALJ.
    (b) A hearing before an ALJ may be conducted in-person, by video-
teleconference (VTC), or by telephone. At the hearing, the parties may 
submit evidence (subject to the restrictions in Sec.  405.1018 and Sec.  
405.1028), examine the

[[Page 198]]

evidence used in making the determination under review, and present and/
or question witnesses.
    (c) In some circumstances, CMS or its contractor may participate in 
the proceedings under Sec.  405.1010, or join the hearing before an ALJ 
as a party under Sec.  405.1012.
    (d) The ALJ or attorney adjudicator conducts a de novo review and 
issues a decision based on the administrative record, including, for an 
ALJ, any hearing record.
    (e) If all parties who are due a notice of hearing in accordance 
with Sec.  405.1020(c) waive their right to appear at the hearing in 
person or by telephone or video-teleconference, the ALJ or an attorney 
adjudicator may make a decision based on the evidence that is in the 
file and any new evidence that is submitted for consideration.
    (f) The ALJ may require the parties to participate in a hearing if 
it is necessary to decide the case. If the ALJ determines that it is 
necessary to obtain testimony from a non-party, he or she may hold a 
hearing to obtain that testimony, even if all of the parties who are 
entitled to a notice of hearing in accordance with Sec.  405.1020(c) 
have waived the right to appear. In that event, however, the ALJ will 
give the parties the opportunity to appear when the testimony is given, 
but may hold the hearing even if none of the parties decide to appear.
    (g) An ALJ or attorney adjudicator may also issue a decision on the 
record on his or her own initiative if the evidence in the 
administrative record supports a fully favorable finding for the 
appellant, and no other party to the appeal is liable for the claims at 
issue, unless CMS or a contractor has elected to be a party to the 
hearing in accordance with Sec.  405.1012.
    (h) If more than one party timely files a request for hearing on the 
same claim before a decision is made on the first timely filed request, 
the requests are consolidated into one proceeding and record, and one 
decision, dismissal, or remand is issued.

[82 FR 5109, Jan. 17, 2017]



Sec.  405.1002  Right to an ALJ hearing.

    (a) A party to a QIC reconsideration has a right to a hearing before 
an ALJ if--
    (1) The party files a written request for an ALJ hearing within 60 
calendar days after receipt of the notice of the QIC's reconsideration.
    (2) The party meets the amount in controversy requirements of Sec.  
405.1006.
    (3) For purposes of this section, the date of receipt of the 
reconsideration is presumed to be 5 calendar days after the date of the 
reconsideration, unless there is evidence to the contrary.
    (4) For purposes of meeting the 60 calendar day filing deadline, the 
request is considered as filed on the date it is received by the office 
specified in the QIC's reconsideration.
    (b) A party who files a timely appeal before a QIC and whose appeal 
continues to be pending before a QIC at the end of the period described 
in Sec.  405.970 has a right to a hearing before an ALJ if--
    (1) The party files a written request with the QIC to escalate the 
appeal for a hearing before an ALJ after the period described in Sec.  
405.970(a) and (b) has expired and the party files the request in 
accordance with Sec.  405.970(d);
    (2) The QIC does not issue a decision or dismissal order within 5 
calendar days of receiving the request for escalation in accordance with 
Sec.  405.970(e)(2); and
    (3) The party has an amount remaining in controversy specified in 
Sec.  405.1006.

[70 FR 11472, Mar. 8, 2005, as amended at 70 FR 37703, June 30, 2005; 74 
FR 65335, Dec. 9, 2009; 82 FR 5109, Jan. 17, 2017]



Sec.  405.1004  Right to a review of QIC notice of dismissal.

    (a) A party to a QIC's dismissal of a request for reconsideration 
has a right to have the dismissal reviewed by an ALJ or attorney 
adjudicator if--
    (1) The party files a written request for review within 60 calendar 
days after receipt of the notice of the QIC's dismissal.
    (2) The party meets the amount in controversy requirements of Sec.  
405.1006.
    (3) For purposes of this section, the date of receipt of the QIC's 
dismissal is presumed to be 5 calendar days after

[[Page 199]]

the date of the dismissal notice, unless there is evidence to the 
contrary.
    (4) For purposes of meeting the 60 calendar day filing deadline, the 
request is considered as filed on the date it is received by the office 
specified in the QIC's dismissal.
    (b) If the ALJ or attorney adjudicator determines that the QIC's 
dismissal was in error, he or she vacates the dismissal and remands the 
case to the QIC for a reconsideration in accordance with Sec.  405.1056.
    (c) If the ALJ or attorney adjudicator affirms the QIC's dismissal 
of a reconsideration request, he or she issues a notice of decision 
affirming the QIC dismissal in accordance with Sec.  405.1046(b).
    (d) The ALJ or attorney adjudicator may dismiss the request for 
review of a QIC's dismissal in accordance with Sec.  405.1052(b).

[70 FR 11472, Mar. 8, 2005, as amended at 70 FR 37703, June 30, 2005; 74 
FR 65335, Dec. 9, 2009; 82 FR 5109, Jan. 17, 2017]



Sec.  405.1006  Amount in controversy required for an ALJ hearing 
and judicial review.

    (a) Definitions. For the purposes of aggregating claims to meet the 
amount in controversy requirement for an ALJ hearing or judicial review:
    (1) ``Common issues of law and fact'' means the claims sought to be 
aggregated are denied, or payment is reduced, for similar reasons and 
arise from a similar fact pattern material to the reason the claims are 
denied or payment is reduced.
    (2) ``Delivery of similar or related services'' means like or 
coordinated services or items provided to one or more beneficiaries.
    (b) ALJ review. To be entitled to a hearing before an ALJ, the party 
must meet the amount in controversy requirements of this section.
    (1) For ALJ hearing requests, the required amount remaining in 
controversy must be $100 increased by the percentage increase in the 
medical care component of the consumer price index for all urban 
consumers (U.S. city average) as measured from July 2003 to the July 
preceding the current year involved.
    (2) If the figure in paragraph (b)(1) of this section is not a 
multiple of $10, then it is rounded to the nearest multiple of $10. The 
Secretary will publish changes to the amount in controversy requirement 
in the Federal Register when necessary.
    (c) Judicial review. To be entitled to judicial review, a party must 
meet the amount in controversy requirements of this subpart at the time 
it requests judicial review.
    (1) For review requests, the required amount remaining in 
controversy must be $1,000 or more, adjusted as specified in paragraphs 
(b)(1) and (b)(2) of this section.
    (2) [Reserved]
    (d) Calculating the amount remaining in controversy--(1) In general. 
The amount remaining in controversy is computed as the actual amount 
charged the individual for the items and services in the disputed claim, 
reduced by--
    (i) Any Medicare payments already made or awarded for the items or 
services; and
    (ii) Any deductible and/or coinsurance amounts that may be collected 
for the items or services.
    (2) Limitation on liability. Notwithstanding paragraph (d)(1) of 
this section, when payment is made for items or services under section 
1879 of the Act or Sec.  411.400 of this chapter, or the liability of 
the beneficiary for those services is limited under Sec.  411.402 of 
this chapter, the amount in controversy is computed as the amount the 
beneficiary would have been charged for the items or services in 
question if those expenses were not paid under Sec.  411.400 of this 
chapter or if that liability was not limited under Sec.  411.402 of this 
chapter, reduced by any deductible and/or coinsurance amounts that may 
be collected for the items or services.
    (3) Item or service terminations. When a matter involves a provider 
or supplier termination of Medicare-covered items or services that is 
disputed by a beneficiary, and the beneficiary did not elect to continue 
receiving the items or services, the amount in controversy is calculated 
in accordance with paragraph (d)(1) of this section, except that the 
amount charged to the individual and any deductible and coinsurance

[[Page 200]]

that may be collected for the items or services are calculated using the 
amount the beneficiary would have been charged if the beneficiary had 
received the items or services the beneficiary asserts should have been 
covered based on the beneficiary's current condition, and Medicare 
payment were not made for the items or services.
    (4) Overpayments. Notwithstanding paragraph (d)(1) of this section, 
when an appeal involves an identified overpayment, the amount in 
controversy is the amount of the overpayment specified in the demand 
letter, or the amount of the revised overpayment if the amount 
originally demanded changes as a result of a subsequent determination or 
appeal, for the items or services in the disputed claim. When an appeal 
involves an estimated overpayment amount determined through the use of 
statistical sampling and extrapolation, the amount in controversy is the 
total amount of the estimated overpayment determined through 
extrapolation, as specified in the demand letter, or as subsequently 
revised.
    (5) Coinsurance and deductible challenges. Notwithstanding paragraph 
(d)(1) of this section, for appeals filed by beneficiaries challenging 
only the computation of a coinsurance amount or the amount of a 
remaining deductible, the amount in controversy is the difference 
between the amount of the coinsurance or remaining deductible, as 
determined by the contractor, and the amount of the coinsurance or 
remaining deductible the beneficiary believes is correct.
    (6) Fee schedule or contractor price challenges. Notwithstanding 
paragraph (d)(1) of this section, for appeals of claims where the 
allowable amount has been paid in full and the appellant is challenging 
only the validity of the allowable amount, as reflected on the published 
fee schedule or in the published contractor-priced amount applicable to 
the items or services in the disputed claim, the amount in controversy 
is the difference between the amount the appellant argues should have 
been the allowable amount for the items or services in the disputed 
claim in the applicable jurisdiction and place of service, and the 
published allowable amount for the items or services.
    (e) Aggregating claims to meet the amount in controversy--(1) 
Aggregating claims in appeals of QIC reconsiderations for an ALJ 
hearing. Either an individual appellant or multiple appellants may 
aggregate two or more claims to meet the amount in controversy for an 
ALJ hearing if--
    (i) The claims were previously reconsidered by a QIC;
    (ii) The appellant(s) requests aggregation of claims appealed in the 
same request for ALJ hearing, or in multiple requests for an ALJ hearing 
filed with the same request for aggregation, and the request is filed 
within 60 calendar days after receipt of all of the reconsiderations 
being appealed; and
    (iii) The claims that a single appellant seeks to aggregate involve 
the delivery of similar or related services, or the claims that multiple 
appellants seek to aggregate involve common issues of law and fact, as 
determined by an ALJ or attorney adjudicator. Only an ALJ may determine 
the claims that a single appellant seeks to aggregate do not involve the 
delivery of similar or related services, or the claims that multiple 
appellants seek to aggregate do not involve common issues of law and 
fact. Part A and Part B claims may be combined to meet the amount in 
controversy requirements.
    (2) Aggregating claims that are escalated from the QIC level for an 
ALJ hearing. Either an individual appellant or multiple appellants may 
aggregate two or more claims to meet the amount in controversy for an 
ALJ hearing if--
    (i) The claims were pending before the QIC in conjunction with the 
same request for reconsideration;
    (ii) The appellant(s) requests aggregation of the claims for an ALJ 
hearing in the same request for escalation; and
    (iii) The claims that a single appellant seeks to aggregate involve 
the delivery of similar or related services, or the claims that multiple 
appellants seek to aggregate involve common issues of law and fact, as 
determined by an ALJ or attorney adjudicator. Only an ALJ may determine 
the claims that a single appellant seeks to aggregate do not involve the 
delivery of similar or related services, or the claims that multiple 
appellants seek to aggregate

[[Page 201]]

do not involve common issues of law and fact. Part A and Part B claims 
may be combined to meet the amount in controversy requirements.
    (f) Content of request for aggregation. When an appellant(s) seeks 
to aggregate claims in a request for an ALJ hearing, the appellant(s) 
must--
    (1) Specify all of the claims the appellant(s) seeks to aggregate; 
and
    (2) State why the appellant(s) believes that the claims involve 
common issues of law and fact or delivery of similar or related 
services.

[70 FR 11472, Mar. 8, 2005, as amended at 74 FR 65335, Dec. 9, 2009; 82 
FR 5109, Jan. 17, 2017; 84 FR 19870, May 7, 2019]



Sec.  405.1008  Parties to the proceedings on a request for an ALJ hearing.

    The party who filed the request for hearing and all other parties to 
the reconsideration are parties to the proceedings on a request for an 
ALJ hearing. In addition, a representative of CMS or its contractor may 
be a party under the circumstances described in Sec.  405.1012.

[82 FR 5110, Jan. 17, 2017]



Sec.  405.1010  When CMS or its contractors may participate in the proceedings 
on a request for an ALJ hearing.

    (a) When CMS or a contractor can participate. (1) CMS or its 
contractors may elect to participate in the proceedings on a request for 
an ALJ hearing upon filing a notice of intent to participate in 
accordance with paragraph (b) of this section.
    (2) An ALJ may request, but may not require, CMS and/or one or more 
of its contractors to participate in any proceedings before the ALJ, 
including the oral hearing, if any. The ALJ cannot draw any adverse 
inferences if CMS or the contractor decides not to participate in any 
proceedings before the ALJ, including the hearing.
    (b) How an election is made-- (1) No notice of hearing. If CMS or a 
contractor elects to participate before receipt of a notice of hearing, 
or when a notice of hearing is not required, it must send written notice 
of its intent to participate to--
    (i) The assigned ALJ or attorney adjudicator, or a designee of the 
Chief ALJ if the request for hearing is not yet assigned to an ALJ or 
attorney adjudicator; and
    (ii) The parties who were sent a copy of the notice of 
reconsideration or, for escalated requests for reconsideration, any 
party that filed a request for reconsideration or was found liable for 
the services at issue subsequent to the initial determination.
    (2) Notice of hearing. If CMS or a contractor elects to participate 
after receipt of a notice of hearing, it must send written notice of its 
intent to participate to the ALJ and the parties who were sent a copy of 
the notice of hearing.
    (3) Timing of election. CMS or a contractor must send its notice of 
intent to participate--
    (i) If no hearing is scheduled, no later than 30 calendar days after 
notification that a request for hearing was filed; or
    (ii) If a hearing is scheduled, no later than 10 calendar days after 
receipt of the notice of hearing by the QIC or another contractor 
designated by CMS to receive the notice of hearing.
    (c) Roles and responsibilities of CMS or a contractor as a 
participant. (1) Subject to paragraphs (d)(1) through (3) of this 
section, participation may include filing position papers and/or 
providing testimony to clarify factual or policy issues in a case, but 
it does not include calling witnesses or cross-examining the witnesses 
of a party to the hearing.
    (2) When CMS or its contractor participates in an ALJ hearing, CMS 
or its contractor may not be called as a witness during the hearing and 
is not subject to examination or cross-examination by the parties, 
except as provided in paragraph (d)(3) of this section. However, the 
parties may provide testimony to rebut factual or policy statements made 
by a participant and the ALJ may question the participant about its 
testimony.
    (3) CMS or contractor position papers and written testimony are 
subject to the following:
    (i) Unless the ALJ or attorney adjudicator grants additional time to 
submit the position paper or written testimony, a position paper or 
written testimony must be submitted within 14 calendar days of an 
election to participate if no hearing has been scheduled,

[[Page 202]]

or no later than 5 calendar days prior to the hearing if a hearing is 
scheduled.
    (ii) A copy of any position paper or written testimony it submits to 
OMHA must be sent within the same time frame specified in paragraph 
(c)(3)(i) of this section to--
    (A) The parties that are required to be sent a copy of the notice of 
intent to participate in accordance with paragraph (b)(1) of this 
section, if the position paper or written testimony is being submitted 
before receipt of a notice of hearing for the appeal; or
    (B) The parties who were sent a copy of the notice of hearing, if 
the position paper or written testimony is being submitted after receipt 
of a notice of hearing for the appeal.
    (iii) If CMS or a contractor fails to send a copy of its position 
paper or written testimony to the parties or fails to submit its 
position paper or written testimony within the time frames described in 
this paragraph, the position paper or written testimony will not be 
considered in deciding the appeal.
    (d) Limitation on participating in a hearing. (1) If CMS or a 
contractor has been made a party to a hearing in accordance with Sec.  
405.1012, no entity that elected to be a participant in the proceedings 
in accordance with this section (or that elected to be a party to the 
hearing but was made a participant in accordance with Sec.  
405.1012(d)(1)) may participate in the oral hearing, but such entity may 
file a position paper and/or written testimony to clarify factual or 
policy issues in the case.
    (2) If CMS or a contractor did not elect to be a party to a hearing 
in accordance with Sec.  405.1012 and more than one entity elected to be 
a participant in the proceedings in accordance with this section, only 
the first entity to file a response to the notice of hearing as provided 
under Sec.  405.1020(c) may participate in the oral hearing. Entities 
that filed a subsequent response to the notice of hearing may not 
participate in the oral hearing, but may file a position paper and/or 
written testimony to clarify factual or policy issues in the case.
    (3) If CMS or a contractor is precluded from participating in the 
oral hearing under paragraph (d)(1) or (2) of this section, the ALJ may 
grant leave to the precluded entity to participate in the oral hearing 
if the ALJ determines that the entity's participation is necessary for a 
full examination of the matters at issue. If the ALJ does not grant 
leave to the precluded entity to participate in the oral hearing, the 
precluded entity may still be called as a witness by CMS or a contractor 
that is a party to the hearing in accordance with Sec.  405.1012.
    (e) Invalid election. (1) An ALJ or attorney adjudicator may 
determine that a CMS or contractor election is invalid under this 
section if the election was not timely filed or the election was not 
sent to the correct parties.
    (2) If an election is determined to be invalid, a written notice 
must be sent to the entity that submitted the election and the parties 
who are entitled to receive notice of the election in accordance with 
this section.
    (i) If no hearing is scheduled or the election was submitted after 
the hearing occurred, the written notice of invalid election must be 
sent no later than the date the notice of decision, dismissal, or remand 
is mailed.
    (ii) If a hearing is scheduled, the written notice of invalid 
election must be sent prior to the hearing. If the notice would be sent 
fewer than 5 calendar days before the hearing is scheduled to occur, 
oral notice must be provided to the entity that submitted the election, 
and the written notice must be sent as soon as possible after the oral 
notice is provided.

[82 FR 5110, Jan. 17, 2017, as amended at 84 FR 19870, May 7, 2019]



Sec.  405.1012  When CMS or its contractors may be a party to a hearing.

    (a) When CMS or a contractor can elect to be a party to a hearing. 
(1) Unless the request for hearing is filed by an unrepresented 
beneficiary, and unless otherwise provided in this section, CMS or one 
of its contractors may elect to be a party to the hearing upon filing a 
notice of intent to be a party to the hearing in accordance with 
paragraph (b) of this section no later than 10 calendar days after 
receipt of the notice of hearing by the QIC or another contractor 
designated by CMS to receive the notice of hearing.

[[Page 203]]

    (2) Unless the request for hearing is filed by an unrepresented 
beneficiary, an ALJ may request, but may not require, CMS and/or one or 
more of its contractors to be a party to the hearing. The ALJ cannot 
draw any adverse inferences if CMS or the contractor decides not to be a 
party to the hearing.
    (b) How an election is made. If CMS or a contractor elects to be a 
party to the hearing, it must send written notice to the ALJ and the 
parties who were sent a copy of the notice of hearing of its intent to 
be a party to the hearing.
    (c) Roles and responsibilities of CMS or a contractor as a party. 
(1) As a party, CMS or a contractor may file position papers, submit 
evidence, provide testimony to clarify factual or policy issues, call 
witnesses or cross-examine the witnesses of other parties.
    (2) CMS or contractor position papers, written testimony, and 
evidentiary submissions are subject to the following:
    (i) Any position paper, written testimony, and/or evidence must be 
submitted no later than 5 calendar days prior to the hearing unless the 
ALJ grants additional time to submit the position paper, written 
testimony, and/or evidence.
    (ii) A copy of any position paper, written testimony, and/or 
evidence it submits to OMHA must be sent within the same time frame 
specified in paragraph (c)(2)(i) of this section to the parties who were 
sent a copy of the notice of hearing.
    (iii) If CMS or a contractor fails to send a copy of its position 
paper, written testimony, and/or evidence to the parties or fails to 
submit its position paper, written testimony, and/or evidence within the 
time frames described in this section, the position paper, written 
testimony, and/or evidence will not be considered in deciding the 
appeal.
    (d) Limitation on participating in a hearing. (1) If CMS and one or 
more contractors, or multiple contractors, file an election to be a 
party to the hearing, the first entity to file its election after the 
notice of hearing is issued is made a party to the hearing and the other 
entities are made participants in the proceedings under Sec.  405.1010, 
subject to Sec.  405.1010(d)(1) and (3), unless the ALJ grants leave to 
an entity to also be a party to the hearing in accordance with paragraph 
(d)(2) of this section.
    (2) If CMS or a contractor filed an election to be a party in 
accordance with this section but is precluded from being made a party 
under paragraph (d)(1) of this section, the ALJ may grant leave to be a 
party to the hearing if the ALJ determines that the entity's 
participation as a party is necessary for a full examination of the 
matters at issue.
    (e) Invalid election. (1) An ALJ may determine that a CMS or 
contractor election is invalid under this section if the request for 
hearing was filed by an unrepresented beneficiary, the election was not 
timely, the election was not sent to the correct parties, or CMS or a 
contractor had already filed an election to be a party to the hearing 
and the ALJ did not determine that the entity's participation as a party 
is necessary for a full examination of the matters at issue.
    (2) If an election is determined to be invalid, a written notice 
must be sent to the entity that submitted the election and the parties 
who were sent the notice of hearing.
    (i) If the election was submitted after the hearing occurred, the 
written notice of invalid election must be sent no later than the date 
the decision, dismissal, or remand notice is mailed.
    (ii) If the election was submitted before the hearing occurs, the 
written notice of invalid election must be sent prior to the hearing. If 
the notice would be sent fewer than 5 calendar days before the hearing 
is scheduled to occur, oral notice must be provided to the entity that 
submitted the election, and the written notice to the entity and the 
parties who were sent the notice of hearing must be sent as soon as 
possible after the oral notice is provided.

[82 FR 5111, Jan. 17, 2017, as amended at 84 FR 19870, May 7, 2019]



Sec.  405.1014  Request for an ALJ hearing or a review of a QIC dismissal.

    (a) Content of the request. (1) The request for an ALJ hearing or a 
review of

[[Page 204]]

a QIC dismissal must be made in writing. The request must include all of 
the following--
    (i) The name, address, and Medicare health number of the beneficiary 
whose claim is being appealed, and the beneficiary's telephone number if 
the beneficiary is the appealing party and not represented.
    (ii) The name, address, and telephone number, of the appellant, when 
the appellant is not the beneficiary.
    (iii) The name, address, and telephone number, of the designated 
representative, if any.
    (iv) The Medicare appeal number or document control number, if any, 
assigned to the QIC reconsideration or dismissal notice being appealed.
    (v) The dates of service of the claim(s) being appealed, if 
applicable.
    (vi) The reasons the appellant disagrees with the QIC's 
reconsideration or other determination being appealed.
    (2) The appellant must submit a statement of any additional evidence 
to be submitted and the date it will be submitted.
    (3) Special rule for appealing statistical sample and/or 
extrapolation. If the appellant disagrees with how a statistical sample 
and/or extrapolation was conducted, the appellant must--
    (i) Include the information in paragraphs (a)(1) and (2) of this 
section for each sample claim that the appellant wishes to appeal;
    (ii) File the request for hearing for all sampled claims that the 
appellant wishes to appeal within 60 calendar days of the date the party 
receives the last reconsideration for the sample claims, if they were 
not all addressed in a single reconsideration; and
    (iii) Assert the reasons the appellant disagrees with how the 
statistical sample and/or extrapolation was conducted in the request for 
hearing.
    (b) Complete request required. (1) A request must contain the 
information in paragraph (a)(1) of this section to the extent the 
information is applicable, to be considered complete. If a request is 
not complete, the appellant will be provided with an opportunity to 
complete the request, and if an adjudication time frame applies, it does 
not begin until the request is complete. If the appellant fails to 
provide the information necessary to complete the request within the 
time frame provided, the appellant's request for hearing or review will 
be dismissed.
    (2) If supporting materials submitted with a request clearly provide 
information required for a complete request, the materials will be 
considered in determining whether the request is complete.
    (c) When and where to file. The request for an ALJ hearing or 
request for review of a QIC dismissal must be filed--
    (1) Within 60 calendar days from the date the party receives notice 
of the QIC's reconsideration or dismissal, except as provided in 
paragraph (a)(3)(ii) of this section for appeals of extrapolations;
    (2) With the office specified in the QIC's reconsideration or 
dismissal. If the request for hearing is timely filed with an office 
other than the office specified in the QIC's reconsideration, the 
request is not treated as untimely, and any applicable time frame 
specified in Sec.  405.1016 for deciding the appeal begins on the date 
the office specified in the QIC's reconsideration or dismissal receives 
the request for hearing. If the request for hearing is filed with an 
office, other than the office specified in the QIC's reconsideration or 
dismissal, OMHA must notify the appellant of the date the request was 
received in the correct office and the commencement of any applicable 
adjudication time frame.
    (d) Copy requirement. (1) The appellant must send a copy of the 
request for hearing or request for review of a QIC dismissal to the 
other parties who were sent a copy of the QIC's reconsideration or 
dismissal. If additional materials submitted with the request are 
necessary to provide the information required for a complete request in 
accordance with paragraph (b) of this section, copies of the materials 
must be sent to the parties as well (subject to authorities that apply 
to disclosing the personal information of other parties). If additional 
evidence is submitted with the request for hearing, the appellant may 
send a copy of the evidence, or briefly describe the evidence pertinent 
to the party and offer to provide copies of the evidence to the party at

[[Page 205]]

the party's request (subject to authorities that apply to disclosing the 
evidence).
    (2) Evidence that a copy of the request for hearing or request for 
review of a QIC dismissal, or a copy of submitted evidence or a summary 
thereof, was sent in accordance with paragraph (d)(1) of this section 
includes--
    (i) Certification on the standard form for requesting an ALJ hearing 
or requesting a review of a QIC dismissal that a copy of the request is 
being sent to the other parties;
    (ii) An indication, such as a copy or ``cc'' line, on a request for 
hearing or request for review of a QIC dismissal that a copy of the 
request and any applicable attachments or enclosures are being sent to 
the other parties, including the name and address of the recipient;
    (iii) An affidavit or certificate of service that identifies the 
name and address of the recipient, and what was sent to the recipient; 
or
    (iv) A mailing or shipping receipt that identifies the name and 
address of the recipient, and what was sent to the recipient.
    (3) If the appellant, other than an unrepresented beneficiary, fails 
to send a copy of the request for hearing or request for review of a QIC 
dismissal, any additional materials, or a copy of submitted evidence or 
a summary thereof, as described in paragraph (d)(1) of this section, the 
appellant will be provided with an additional opportunity to send the 
request, materials, and/or evidence or summary thereof, and if an 
adjudication time frame applies, it begins upon receipt of evidence that 
the request, materials, and/or evidence or summary thereof were sent. If 
the appellant, other than an unrepresented beneficiary, again fails to 
provide evidence that the request, materials, and/or evidence or summary 
thereof were sent within the additional time frame provided to send the 
request, materials, and/or evidence or summary thereof, the appellant's 
request for hearing or request for review of a QIC dismissal will be 
dismissed.
    (e) Extension of time to request a hearing or review. (1) If the 
request for hearing or review of a QIC dismissal is not filed within 60 
calendar days of receipt of the QIC's reconsideration or dismissal, an 
appellant may request an extension for good cause (See Sec.  
405.942(b)(2) and (3)).
    (2) Any request for an extension of time must be in writing, give 
the reasons why the request for a hearing or review was not filed within 
the stated time period, and must be filed with the request for hearing 
or request for review of a QIC dismissal, or upon notice that the 
request may be dismissed because it was not timely filed, with the 
office specified in the notice of reconsideration or dismissal.
    (3) An ALJ or attorney adjudicator may find there is good cause for 
missing the deadline to file a request for an ALJ hearing or request for 
review of a QIC dismissal, or there is no good cause for missing the 
deadline to file a request for a review of a QIC dismissal, but only an 
ALJ may find there is no good cause for missing the deadline to file a 
request for an ALJ hearing. If good cause is found for missing the 
deadline, the time period for filing the request for hearing or request 
for review of a QIC dismissal will be extended. To determine whether 
good cause for late filing exists, the ALJ or attorney adjudicator uses 
the standards set forth in Sec.  405.942(b)(2) and (3).
    (4) If a request for hearing is not timely filed, any applicable 
adjudication period in Sec.  405.1016 begins the date the ALJ or 
attorney adjudicator grants the request to extend the filing deadline.
    (5) A determination granting a request to extend the filing deadline 
is not subject to further review.

[82 FR 5112, Jan. 17, 2017, as amended at 84 FR 19870, May 7, 2019]



Sec.  405.1016  Time frames for deciding an appeal of a QIC reconsideration 
or escalated request for a QIC reconsideration.

    (a) Adjudication period for appeals of QIC reconsiderations. When a 
request for an ALJ hearing is filed after a QIC has issued a 
reconsideration, an ALJ or attorney adjudicator issues a decision, 
dismissal order, or remand to the QIC, as appropriate, no later than the 
end of the 90 calendar day period beginning on the date the request for 
hearing is received by the office specified in the

[[Page 206]]

QIC's notice of reconsideration, unless the 90 calendar day period has 
been extended as provided in this subpart.
    (b) When the adjudication period begins. (1) Unless otherwise 
specified in this subpart, the adjudication period specified in 
paragraph (a) of this section begins on the date that a timely filed 
request for hearing is received by the office specified in the QIC's 
reconsideration, or, if it is not timely filed, the date that the ALJ or 
attorney adjudicator grants any extension to the filing deadline.
    (2) If the Council remands a case and the case was subject to an 
adjudication time frame under paragraph (a) or (c) of this section, the 
remanded appeal will be subject to the adjudication time frame of 
paragraph (a) of this section beginning on the date that OMHA receives 
the Council remand.
    (c) Adjudication period for escalated requests for QIC 
reconsiderations. When an appeal is escalated to OMHA because the QIC 
has not issued a reconsideration determination within the period 
specified in Sec.  405.970, an ALJ or attorney adjudicator issues a 
decision, dismissal order, or remand to the QIC, as appropriate, no 
later than the end of the 180 calendar day period beginning on the date 
that the request for escalation is received by OMHA in accordance with 
Sec.  405.970, unless the 180 calendar day period is extended as 
provided in this subpart.
    (d) Waivers and extensions of adjudication period. (1) At any time 
during the adjudication process, the appellant may waive the 
adjudication period specified in paragraphs (a) and (c) of this section. 
The waiver may be for a specific period of time agreed upon by the ALJ 
or attorney adjudicator and the appellant.
    (2) The adjudication periods specified in paragraphs (a) and (c) of 
this section are extended as otherwise specified in this subpart, and 
for the following events--
    (i) The duration of a stay of action on adjudicating the claims or 
matters at issue ordered by a court or tribunal of competent 
jurisdiction; or
    (ii) The duration of a stay of proceedings granted by an ALJ or 
attorney adjudicator on a motion by an appellant, provided no other 
party also filed a request for hearing on the same claim at issue.
    (e) Effect of exceeding adjudication period. If an ALJ or attorney 
adjudicator fails to issue a decision, dismissal order, or remand to the 
QIC within an adjudication period specified in this section, subject to 
paragraphs (b) and (d) of this section, the party that filed the request 
for hearing may escalate the appeal in accordance with paragraph (f) of 
this section. If the party that filed the request for hearing does not 
elect to escalate the appeal, the appeal remains pending with OMHA for a 
decision, dismissal order, or remand.
    (f) Requesting escalation--(1) When and how to request escalation. 
An appellant who files a timely request for hearing before an ALJ and 
whose appeal continues to be pending with OMHA at the end of the 
applicable adjudication period under paragraph (a) or (c) of this 
section, subject to paragraphs (b) and (d) of this section, may exercise 
the option of escalating the appeal to the Council by filing a written 
request with OMHA to escalate the appeal to the Council and sending a 
copy of the request to escalate to the other parties who were sent a 
copy of the QIC reconsideration.
    (2) Escalation. If the request for escalation meets the requirements 
of paragraph (f)(1) of this section and an ALJ or attorney adjudicator 
is not able to issue a decision, dismissal order, or remand order within 
the later of 5 calendar days of receiving the request for escalation, or 
5 calendar days from the end of the applicable adjudication period set 
forth in paragraph (a) or (c) of this section, subject to paragraphs (b) 
and (d) of this section, OMHA will take the following actions--
    (i) Send a notice to the appellant stating that an ALJ or attorney 
adjudicator is not able to issue a decision, dismissal order, or remand 
order within the adjudication period set forth in paragraph (a) or (c) 
of this section, the QIC reconsideration will be the decision that is 
subject to Council review consistent with Sec.  405.1102(a), and the 
appeal will be escalated to the Council for a review in accordance with 
Sec.  405.1108; and
    (ii) Forward the case file to the Council.

[[Page 207]]

    (3) Invalid escalation request. If an ALJ or attorney adjudicator 
determines the request for escalation does not meet the requirements of 
paragraph (f)(1) of this section, OMHA will send a notice to the 
appellant explaining why the request is invalid within 5 calendar days 
of receiving the request for escalation.

[82 FR 5113, Jan. 17, 2017]



Sec.  405.1018  Submitting evidence.

    (a) When evidence may be submitted. Except as provided in this 
section, parties must submit all written or other evidence they wish to 
have considered with the request for hearing, by the date specified in 
the request for hearing in accordance with Sec.  405.1014(a)(2), or if a 
hearing is scheduled, within 10 calendar days of receiving the notice of 
hearing.
    (b) Effect on adjudication period. If a party submits written or 
other evidence later than 10 calendar days after receiving the notice of 
hearing, any applicable adjudication period specified in Sec.  405.1016 
is extended by the number of calendar days in the period between 10 
calendar days after receipt of the notice of hearing and the day the 
evidence is received.
    (c) New evidence. (1) Any evidence submitted by a provider, 
supplier, or beneficiary represented by a provider or supplier that is 
not submitted prior to the issuance of the QIC's reconsideration 
determination must be accompanied by a statement explaining why the 
evidence was not previously submitted to the QIC, or a prior decision-
maker (see Sec.  405.1028).
    (2) If a statement explaining why the evidence was not previously 
submitted to the QIC or a prior decision-maker is not included with the 
evidence, the evidence will not be considered.
    (d) When this section does not apply. (1) The requirements in 
paragraphs (a) and (b) of this section do not apply to oral testimony 
given at a hearing, or to evidence submitted by an unrepresented 
beneficiary.
    (2) The requirements in paragraph (c) of this section do not apply 
to oral testimony given at a hearing, or to evidence submitted by an 
unrepresented beneficiary, CMS or any of its contractors, a Medicaid 
State agency, an applicable plan, or a beneficiary represented by 
someone other than a provider or supplier.

[82 FR 5113, Jan. 17, 2017]



Sec.  405.1020  Time and place for a hearing before an ALJ.

    (a) General. The ALJ sets the time and place for the hearing, and 
may change the time and place, if necessary.
    (b) Determining how appearances are made--(1) Appearances by 
unrepresented beneficiaries. The ALJ will direct that the appearance of 
an unrepresented beneficiary who filed a request for hearing be 
conducted by video-teleconferencing (VTC) if the ALJ finds that VTC 
technology is available to conduct the appearance, unless the ALJ find 
good cause for an in-person appearance.
    (i) The ALJ may also offer to conduct a hearing by telephone if the 
request for hearing or administrative record suggests that a telephone 
hearing may be more convenient for the unrepresented beneficiary.
    (ii) The ALJ, with the concurrence of the Chief ALJ or designee, may 
find good cause that an in-person hearing should be conducted if--
    (A) VTC or telephone technology is not available; or
    (B) Special or extraordinary circumstances exist.
    (2) Appearances by individuals other than unrepresented 
beneficiaries. The ALJ will direct that the appearance of an individual, 
other than an unrepresented beneficiary who filed a request for hearing, 
be conducted by telephone, unless the ALJ finds good cause for an 
appearance by other means.
    (i) The ALJ may find good cause for an appearance by VTC if he or 
she determines that VTC is necessary to examine the facts or issues 
involved in the appeal.
    (ii) The ALJ, with the concurrence of the Chief ALJ or designee, 
also may find good cause that an in-person hearing should be conducted 
if--
    (A) VTC and telephone technology are not available; or
    (B) Special or extraordinary circumstances exist.
    (c) Notice of hearing. (1) A notice of hearing is sent to all 
parties that filed

[[Page 208]]

an appeal or participated in the reconsideration; any party who was 
found liable for the services at issue subsequent to the initial 
determination or may be found liable based on a review of the record; 
the QIC that issued the reconsideration or from which the request for 
reconsideration was escalated, or another contractor designated to 
receive the notice of hearing by CMS; and CMS or a contractor that 
elected to participate in the proceedings in accordance with Sec.  
405.1010(b) or that the ALJ believes would be beneficial to the hearing, 
advising them of the proposed time and place of the hearing.
    (2) The notice of hearing will require all parties to the ALJ 
hearing to reply to the notice by:
    (i) Acknowledging whether they plan to attend the hearing at the 
time and place proposed in the notice of hearing, or whether they object 
to the proposed time and/or place of the hearing;
    (ii) If the party or representative is an entity or organization, 
specifying who from the entity or organization plans to attend the 
hearing, if anyone, and in what capacity, in addition to the individual 
who filed the request for hearing; and
    (iii) Listing the witnesses who will be providing testimony at the 
hearing.
    (3) The notice of hearing will require CMS or a contractor that 
wishes to attend the hearing as a participant to reply to the notice by:
    (i) Acknowledging whether it plans to attend the hearing at the time 
and place proposed in the notice of hearing; and
    (ii) Specifying who from the entity plans to attend the hearing.
    (d) A party's right to waive a hearing. A party may also waive the 
right to a hearing and request a decision based on the written evidence 
in the record in accordance with Sec.  405.1038(b). As provided in Sec.  
405.1000, an ALJ may require the parties to attend a hearing if it is 
necessary to decide the case. If an ALJ determines that it is necessary 
to obtain testimony from a non-party, he or she may still hold a hearing 
to obtain that testimony, even if all of the parties have waived the 
right to appear. In those cases, the ALJ will give the parties the 
opportunity to appear when the testimony is given but may hold the 
hearing even if none of the parties decide to appear.
    (e) A party's objection to time and place of hearing. (1) If a party 
objects to the time and place of the hearing, the party must notify the 
ALJ at the earliest possible opportunity before the time set for the 
hearing.
    (2) The party must state the reason for the objection and state the 
time and place he or she wants the hearing to be held.
    (3) The request must be in writing, except that a party may orally 
request that a hearing be rescheduled in an emergency circumstance the 
day prior to or day of the hearing. The ALJ must document all oral 
requests for a rescheduled hearing in writing and maintain the 
documentation in the administrative record.
    (4) The ALJ may change the time or place of the hearing if the party 
has good cause.
    (5) If the party's objection to the place of the hearing includes a 
request for an in-person or VTC hearing, the objection and request are 
considered in paragraph (i) of this section.
    (f) Good cause for changing the time or place. The ALJ can find good 
cause for changing the time or place of the scheduled hearing and 
reschedule the hearing if the information available to the ALJ supports 
the party's contention that--
    (1) The party or his or her representative is unable to attend or to 
travel to the scheduled hearing because of a serious physical or mental 
condition, incapacitating injury, or death in the family; or
    (2) Severe weather conditions make it impossible to travel to the 
hearing; or
    (3) Good cause exists as set forth in paragraph (g) of this section.
    (g) Good cause in other circumstances. (1) In determining whether 
good cause exists in circumstances other than those set forth in 
paragraph (f) of this section, the ALJ considers the party's reason for 
requesting the change, the facts supporting the request, and the impact 
of the proposed change on the efficient administration of the hearing 
process.

[[Page 209]]

    (2) Factors evaluated to determine the impact of the change include, 
but are not limited to, the effect on processing other scheduled 
hearings, potential delays in rescheduling the hearing, and whether any 
prior changes were granted the party.
    (3) Examples of other circumstances a party might give for 
requesting a change in the time or place of the hearing include, but are 
not limited to, the following:
    (i) The party has attempted to obtain a representative but needs 
additional time.
    (ii) The party's representative was appointed within 10 calendar 
days of the scheduled hearing and needs additional time to prepare for 
the hearing.
    (iii) The party's representative has a prior commitment to be in 
court or at another administrative hearing on the date scheduled for the 
hearing.
    (iv) A witness who will testify to facts material to a party's case 
is unavailable to attend the scheduled hearing and the evidence cannot 
be otherwise obtained.
    (v) Transportation is not readily available for a party to travel to 
the hearing.
    (vi) The party is unrepresented, and is unable to respond to the 
notice of hearing because of any physical, mental, educational, or 
linguistic limitations (including any lack of facility with the English 
language) that he or she has.
    (vii) The party or representative has a prior commitment that cannot 
be changed without significant expense.
    (viii) The party or representative asserts that he or she did not 
receive the notice of hearing and is unable to appear at the scheduled 
time and place.
    (h) Effect of rescheduling hearing. If a hearing is postponed at the 
request of the appellant for any of the above reasons, the time between 
the originally scheduled hearing date and the new hearing date is not 
counted toward the adjudication period specified in Sec.  405.1016.
    (i) A party's request for an in-person or VTC hearing. (1) If an 
unrepresented beneficiary who filed the request for hearing objects to a 
VTC hearing or to the ALJ's offer to conduct a hearing by telephone, or 
if a party other than an unrepresented beneficiary who filed the request 
for hearing objects to a telephone or VTC hearing, the party must notify 
the ALJ at the earliest possible opportunity before the time set for the 
hearing and request a VTC or an in-person hearing.
    (2) The party must state the reason for the objection and state the 
time and/or place he or she wants an in-person or VTC hearing to be 
held.
    (3) The request must be in writing.
    (4) When a party's request for an in-person or VTC hearing as 
specified under paragraph (i)(1) of this section is granted and an 
adjudication time frame applies in accordance with Sec.  405.1016, the 
ALJ issues a decision, dismissal, or remand to the QIC within the 
adjudication time frame specified in Sec.  405.1016 (including any 
applicable extensions provided in this subpart) unless the party 
requesting the hearing agrees to waive such adjudication time frame in 
writing.
    (5) The ALJ may grant the request, with the concurrence of the Chief 
ALJ or designee if the request was for an in-person hearing, upon a 
finding of good cause and will reschedule the hearing for a time and 
place when the party may appear in person or by VTC before the ALJ. Good 
cause is not required for a request for VTC hearing made by an 
unrepresented beneficiary who filed the request for hearing and objects 
to an ALJ's offer to conduct a hearing by telephone.
    (j) Amended notice of hearing. If the ALJ changes or will change the 
time and/or place of the hearing, an amended notice of hearing must be 
sent to all of the parties who were sent a copy of the notice of hearing 
and CMS or its contractors that elected to be a participant or party to 
the hearing in accordance with Sec.  405.1022(a).

[70 FR 11472, Mar. 8, 2005, as amended at 70 FR 37704, June 30, 2005; 74 
FR 65335, Dec. 9, 2009; 82 FR 5114, Jan. 17, 2017; 84 FR 19870, May 7, 
2019]



Sec.  405.1022  Notice of a hearing before an ALJ.

    (a) Issuing the notice. After the ALJ sets the time and place of the 
hearing, notice of the hearing will be mailed or otherwise transmitted 
in accordance with OMHA procedures to the parties

[[Page 210]]

and other potential participants, as provided in Sec.  405.1020(c) at 
their last known address, or given by personal service, except to a 
party or potential participant who indicates in writing that it does not 
wish to receive this notice. The notice is mailed, transmitted, or 
served at least 20 calendar days before the hearing unless the recipient 
agrees in writing to the notice being mailed, transmitted, or served 
fewer than 20 calendar days before the hearing.
    (b) Notice information. (1) The notice of hearing contains--
    (i) A statement that the issues before the ALJ include all of the 
issues brought out in the initial determination, redetermination, or 
reconsideration that were not decided entirely in a party's favor, for 
the claims specified in the request for hearing; and
    (ii) A statement of any specific new issues the ALJ will consider in 
accordance with Sec.  405.1032.
    (2) The notice will inform the parties that they may designate a 
person to represent them during the proceedings.
    (3) The notice must include an explanation of the procedures for 
requesting a change in the time or place of the hearing, a reminder that 
the ALJ may dismiss the hearing request if the appellant fails to appear 
at the scheduled hearing without good cause, and other information about 
the scheduling and conduct of the hearing.
    (4) The appellant will also be told if his or her appearance or that 
of any other party or witness is scheduled by VTC, telephone, or in 
person. If the ALJ has scheduled the appellant or other party to appear 
at the hearing by VTC, the notice of hearing will advise that the 
scheduled place for the hearing is a VTC site and explain what it means 
to appear at the hearing by VTC.
    (5) The notice advises the appellant or other parties that if they 
object to appearing by VTC or telephone, and wish instead to have their 
hearing at a time and place where they may appear in person before the 
ALJ, they must follow the procedures set forth at Sec.  405.1020(i) for 
notifying the ALJ of their objections and for requesting an in-person 
hearing.
    (c) Acknowledging the notice of hearing. (1) If the appellant, any 
other party to the reconsideration to whom the notice of hearing was 
sent, or their representative does not acknowledge receipt of the notice 
of hearing, OMHA attempts to contact the party for an explanation.
    (2) If the party states that he or she did not receive the notice of 
hearing, a copy of the notice is sent to him or her by certified mail or 
other means requested by the party and in accordance with OMHA 
procedures.
    (3) The party may request that the ALJ reschedule the hearing in 
accordance with Sec.  405.1020(e).

[82 FR 5115, Jan. 17, 2017]



Sec.  405.1024  Objections to the issues.

    (a) If a party objects to the issues described in the notice of 
hearing, he or she must notify the ALJ in writing at the earliest 
possible opportunity before the time set for the hearing, and no later 
than 5 calendar days before the hearing.
    (b) The party must state the reasons for his or her objections and 
send a copy of the objections to all other parties who were sent a copy 
of the notice of hearing, and CMS or a contractor that elected to be a 
party to the hearing.
    (c) The ALJ makes a decision on the objections either in writing, at 
a prehearing conference, or at the hearing.

[70 FR 11472, Mar. 8, 2005, as amended at 74 FR 65335, Dec. 9, 2009; 82 
FR 5115, Jan. 17, 2017]



Sec.  405.1026  Disqualification of the ALJ or attorney adjudicator.

    (a) An ALJ or attorney adjudicator cannot adjudicate an appeal if he 
or she is prejudiced or partial to any party or has any interest in the 
matter pending for decision.
    (b) If a party objects to the ALJ or attorney adjudicator assigned 
to adjudicate the appeal, the party must notify the ALJ within 10 
calendar days of the date of the notice of hearing if a hearing is 
scheduled, or the ALJ or attorney adjudicator at any time before a 
decision, dismissal order, or remand order is issued if no hearing is 
scheduled. The ALJ or attorney adjudicator

[[Page 211]]

considers the party's objections and decides whether to proceed with the 
appeal or withdraw.
    (c) If the ALJ or attorney adjudicator withdraws, another ALJ or 
attorney adjudicator will be assigned to adjudicate the appeal. If the 
ALJ or attorney adjudicator does not withdraw, the party may, after the 
ALJ or attorney adjudicator has issued an action in the case, present 
his or her objections to the Council in accordance with Sec.  405.1100 
through Sec.  405.1130. The Council will then consider whether the 
decision or dismissal should be revised or if applicable, a new hearing 
held before another ALJ. If the case is escalated to the Council after a 
hearing is held but before the ALJ issues a decision, the Council 
considers the reasons the party objected to the ALJ during its review of 
the case and, if the Council deems it necessary, may remand the case to 
another ALJ for a hearing and decision.
    (d) If the party objects to the ALJ or attorney adjudicator and the 
ALJ or attorney adjudicator subsequently withdraws from the appeal, any 
adjudication time frame that applies to the appeal in accordance with 
Sec.  405.1016 is extended by 14 calendar days.

[82 FR 5115, Jan. 17, 2017]



Sec.  405.1028  Review of evidence submitted by parties.

    (a) New evidence--(1) Examination of any new evidence. After a 
hearing is requested but before a hearing is held by an ALJ or a 
decision is issued if no hearing is held, the ALJ or attorney 
adjudicator will examine any new evidence submitted in accordance with 
Sec.  405.1018, by a provider, supplier, or beneficiary represented by a 
provider or supplier to determine whether the provider, supplier, or 
beneficiary represented by a provider or supplier had good cause for 
submitting the evidence for the first time at the OMHA level.
    (2) Determining if good cause exists. An ALJ or attorney adjudicator 
finds good cause when--
    (i) The new evidence is, in the opinion of the ALJ or attorney 
adjudicator, material to an issue addressed in the QIC's reconsideration 
and that issue was not identified as a material issue prior to the QIC's 
reconsideration;
    (ii) The new evidence is, in the opinion of the ALJ, material to a 
new issue identified in accordance with Sec.  405.1032(b)(1);
    (iii) The party was unable to obtain the evidence before the QIC 
issued its reconsideration and submits evidence that, in the opinion of 
the ALJ or attorney adjudicator, demonstrates the party made reasonable 
attempts to obtain the evidence before the QIC issued its 
reconsideration;
    (iv) The party asserts that the evidence was submitted to the QIC or 
another contractor and submits evidence that, in the opinion of the ALJ 
or attorney adjudicator, demonstrates the new evidence was submitted to 
the QIC or another contractor before the QIC issued the reconsideration; 
or
    (v) In circumstances not addressed in paragraphs (a)(2)(i) through 
(iv) of this section, the ALJ or attorney adjudicator determines that 
the party has demonstrated that it could not have obtained the evidence 
before the QIC issued its reconsideration.
    (3) If good cause does not exist. If the ALJ or attorney adjudicator 
determines that there was not good cause for submitting the evidence for 
the first time at the OMHA level, the ALJ or attorney adjudicator must 
exclude the evidence from the proceeding and may not consider it in 
reaching a decision.
    (4) Notification to parties. If a hearing is conducted, as soon as 
possible, but no later than the start of the hearing, the ALJ must 
notify all parties and participants who responded to the notice of 
hearing whether the evidence will be considered or is excluded from 
consideration.
    (b) Duplicative evidence. The ALJ or attorney adjudicator may 
exclude from consideration any evidence submitted by a party at the OMHA 
level that is duplicative of evidence already in the record forwarded to 
OMHA.

[82 FR 5115, Jan. 17, 2017]



Sec.  405.1030  ALJ hearing procedures.

    (a) General rule. A hearing is open to the parties and to other 
persons the ALJ considers necessary and proper.
    (b) At the hearing. (1) At the hearing, the ALJ fully examines the 
issues,

[[Page 212]]

questions the parties and other witnesses, and may accept evidence that 
is material to the issues consistent with Sec. Sec.  405.1018 and 
405.1028.
    (2) The ALJ may limit testimony and/or argument at the hearing that 
are not relevant to an issue before the ALJ, that are repetitive of 
evidence or testimony already in the record, or that relate to an issue 
that has been sufficiently developed or on which the ALJ has already 
ruled. The ALJ may, but is not required to, provide the party or 
representative with an opportunity to submit additional written 
statements and affidavits on the matter, in lieu of testimony and/or 
argument at the hearing. The written statements and affidavits must be 
submitted within the time frame designated by the ALJ.
    (3) If the ALJ determines that a party or party's representative is 
uncooperative, disruptive to the hearing, or abusive during the course 
of the hearing after the ALJ has warned the party or representative to 
stop such behavior, the ALJ may excuse the party or representative from 
the hearing and continue with the hearing to provide the other parties 
and participants with an opportunity to offer testimony and/or argument. 
If a party or representative was excused from the hearing, the ALJ will 
provide the party or representative with an opportunity to submit 
written statements and affidavits in lieu of testimony and/or argument 
at the hearing, and the party or representative may request a recording 
of the hearing in accordance with Sec.  405.1042 and respond in writing 
to any statements made by other parties or participants and/or testimony 
of the witnesses at the hearing. The written statements and affidavits 
must be submitted within the time frame designated by the ALJ.
    (c) Missing evidence. The ALJ may also stop the hearing temporarily 
and continue it at a later date if he or she believes that there is 
material evidence missing at the hearing. If the missing evidence is in 
the possession of the appellant, and the appellant is a provider, 
supplier, or a beneficiary represented by a provider or supplier, the 
ALJ must determine if the appellant had good cause in accordance with 
Sec.  405.1028 for not producing the evidence earlier.
    (d) Effect of new evidence on adjudication period. If an appellant, 
other than an unrepresented beneficiary, submits evidence pursuant to 
paragraph (b) or (c) of this section, and an adjudication period applies 
to the appeal, the adjudication period specified in Sec.  405.1016 is 
extended in accordance with Sec.  405.1018(b).
    (e) Continued hearing. (1) A hearing may be continued to a later 
date. Notice of the continued hearing must be sent in accordance with 
Sec.  405.1022, except that a waiver of notice of the hearing may be 
made in writing or on the record, and the notice is sent to the parties 
and participants who attended the hearing, and any additional parties or 
potential parties or participants the ALJ determines are appropriate.
    (2) If the appellant requests the continuance and an adjudication 
period applies to the appeal in accordance with Sec.  405.1016, the 
adjudication period is extended by the period between the initial 
hearing date and the continued hearing date.
    (f) Supplemental hearing. (1) The ALJ may conduct a supplemental 
hearing at any time before he or she mails a notice of the decision in 
order to receive new and material evidence, obtain additional testimony, 
or address a procedural matter. The ALJ determines whether a 
supplemental hearing is necessary and if one is held, the scope of the 
hearing, including when evidence is presented and what issues are 
discussed. Notice of the supplemental hearing must be sent in accordance 
with Sec.  405.1022, except that the notice is sent to the parties and 
participants who attended the hearing, and any additional parties or 
potential parties or participants the ALJ determines are appropriate.
    (2) If the appellant requests the supplemental hearing and an 
adjudication period applies to the appeal in accordance with Sec.  
405.1016, the adjudication period is extended by the period between the 
initial hearing date and the supplemental hearing date.

[82 FR 5116, Jan. 17, 2017]

[[Page 213]]



Sec.  405.1032  Issues before an ALJ or attorney adjudicator.

    (a) General rule. The issues before the ALJ or attorney adjudicator 
include all the issues for the claims or appealed matter specified in 
the request for hearing that were brought out in the initial 
determination, redetermination, or reconsideration that were not decided 
entirely in a party's favor. (For purposes of this provision, the term 
``party'' does not include a representative of CMS or one of its 
contractors that may be participating in the hearing.)
    (b) New issues--(1) When a new issue may be considered. A new issue 
may include issues resulting from the participation of CMS or its 
contractor at the OMHA level of adjudication and from any evidence and 
position papers submitted by CMS or its contractor for the first time to 
the ALJ. The ALJ or any party may raise a new issue relating to a claim 
or appealed matter specified in the request for hearing; however, the 
ALJ may only consider a new issue, including a favorable portion of a 
determination on a claim or appealed matter specified in the request for 
hearing, if its resolution could have a material impact on the claim or 
appealed matter and--
    (i) There is new and material evidence that was not available or 
known at the time of the determination and that may result in a 
different conclusion; or
    (ii) The evidence that was considered in making the determination 
clearly shows on its face that an obvious error was made at the time of 
the determination.
    (2) Notice of the new issue. The ALJ may consider a new issue at the 
hearing if he or she notifies the parties that were or will be sent the 
notice of hearing about the new issue before the start of the hearing.
    (3) Opportunity to submit evidence. If notice of the new issue is 
sent after the notice of hearing, the parties will have at least 10 
calendar days after receiving notice of the new issue to submit evidence 
regarding the issue, and without affecting any applicable adjudication 
period. If a hearing is conducted before the time to submit evidence 
regarding the issue expires, the record will remain open until the 
opportunity to submit evidence expires.
    (c) Adding claims to a pending appeal. (1) Claims that were not 
specified in a request for hearing may only be added to a pending appeal 
if the claims were adjudicated in the same reconsideration that is 
appealed, and the period to request an ALJ hearing for that 
reconsideration has not expired, or an ALJ or attorney adjudicator 
extends the time to request an ALJ hearing on those claims in accordance 
with Sec.  405.1014(e).
    (2) Before a claim may be added to a pending appeal, the appellant 
must submit evidence that demonstrates the information that constitutes 
a complete request for hearing in accordance with Sec.  405.1014(b) and 
other materials related to the claim that the appellant seeks to add to 
the pending appeal were sent to the other parties to the claim in 
accordance with Sec.  405.1014(d).
    (d) Appeals involving statistical sampling and extrapolations--(1) 
Generally. If the appellant does not assert the reasons the appellant 
disagrees with how a statistical sample and/or extrapolation was 
conducted in the request for hearing, in accordance with Sec.  
405.1014(a)(3)(iii), issues related to how the statistical sample and 
extrapolation were conducted shall not be considered or decided.
    (2) Consideration of sample claims. If a party asserts a 
disagreement with how a statistical sample and/or extrapolation was 
conducted in the request for hearing, in accordance with Sec.  
405.1014(a)(3)(iii), paragraphs (a) through (c) of this section apply to 
the adjudication of the sample claims but, in deciding issues related to 
how a statistical sample and/or extrapolation was conducted the ALJ or 
attorney adjudicator must base his or her decision on a review of the 
entire sample to the extent appropriate to decide the issue.

[82 FR 5116, Jan. 17, 2017]



Sec.  405.1034  Requesting information from the QIC.

    (a) If an ALJ or attorney adjudicator believes that the written 
record is missing information that is essential to resolving the issues 
on appeal and that information can be provided only

[[Page 214]]

by CMS or its contractors, the information may be requested from the QIC 
that conducted the reconsideration or its successor.
    (1) Official copies of redeterminations and reconsiderations that 
were conducted on the appealed claims, and official copies of dismissals 
of a request for redetermination or reconsideration, can be provided 
only by CMS or its contractors. Prior to issuing a request for 
information to the QIC, OMHA will confirm whether an electronic copy of 
the redetermination, reconsideration, or dismissal is available in the 
official system of record, and if so will accept the electronic copy as 
an official copy.
    (2) ``Can be provided only by CMS or its contractors'' means the 
information is not publicly available, is not in the possession of, and 
cannot be requested and obtained by one of the parties. Information that 
is publicly available is information that is available to the general 
public via the Internet or in a printed publication. Information that is 
publicly available includes, but is not limited to, information 
available on a CMS or contractor Web site or information in an official 
CMS or DHHS publication (including, but not limited to, provisions of 
NCDs or LCDs, procedure code or modifier descriptions, fee schedule 
data, and contractor operating manual instructions).
    (b) The ALJ or attorney adjudicator retains jurisdiction of the 
case, and the case remains pending at OMHA.
    (c) The QIC has 15 calendar days after receiving the request for 
information to furnish the information or otherwise respond to the 
information request directly or through CMS or another contractor.
    (d) If an adjudication period applies to the appeal in accordance 
with Sec.  405.1016, the adjudication period is extended by the period 
between the date of the request for information and the date the QIC 
responds to the request or 20 calendar days after the date of the 
request, whichever occurs first.

[82 FR 5117, Jan. 17, 2017, as amended at 84 FR 19870, May 7, 2019]



Sec.  405.1036  Description of an ALJ hearing process.

    (a) The right to appear and present evidence. (1) Any party to a 
hearing has the right to appear before the ALJ to present evidence and 
to state his or her position. A party may appear by video-
teleconferencing (VTC), telephone, or in person as determined under 
Sec.  405.1020.
    (2) A party may also make his or her appearance by means of a 
representative, who may make the appearance by VTC, telephone, or in 
person, as determined under Sec.  405.1020.
    (3) Witness testimony may be given and CMS participation may also be 
accomplished by VTC, telephone, or in person, as determined under Sec.  
405.1020.
    (b) Waiver of the right to appear. (1) A party may submit to OMHA a 
written statement indicating that he or she does not wish to appear at 
the hearing.
    (2) The appellant may subsequently withdraw his or her waiver at any 
time before the notice of the hearing decision is issued; however, by 
withdrawing the waiver the appellant agrees to an extension of the 
adjudication period as specified in Sec.  405.1016 that may be necessary 
to schedule and hold the hearing.
    (3) Other parties may withdraw their waiver up to the date of the 
scheduled hearing, if any. Even if all of the parties waive their right 
to appear at a hearing, the ALJ may require them to attend an oral 
hearing if he or she believes that a personal appearance and testimony 
by the appellant or any other party is necessary to decide the case.
    (c) Presenting written statements and oral arguments. A party or a 
person designated to act as a party's representative may appear before 
the ALJ to state the party's case, to present a written summary of the 
case, or to enter written statements about the facts and law material to 
the case in the record. A copy of any written statements must be 
provided to the other parties to a hearing, if any, at the same time 
they are submitted to the ALJ.
    (d) Witnesses at a hearing. Witnesses may appear at a hearing. They 
testify under oath or affirmation, unless the ALJ finds an important 
reason to excuse them from taking an oath or affirmation. The ALJ may 
ask the witnesses any questions relevant to the

[[Page 215]]

issues and allows the parties or their designated representatives to do 
so.
    (e) What evidence is admissible at a hearing. The ALJ may receive 
evidence at the hearing even though the evidence is not admissible in 
court under the rules of evidence used by the court.
    (f) Subpoenas. (1) Except as provided in this section, when it is 
reasonably necessary for the full presentation of a case, an ALJ may, on 
his or her own initiative or at the request of a party, issue subpoenas 
for the appearance and testimony of witnesses and for a party to make 
books, records, correspondence, papers, or other documents that are 
material to an issue at the hearing available for inspection and 
copying. An ALJ may not issue a subpoena to CMS or its contractors, on 
his or her own initiative or at the request of a party, to compel an 
appearance, testimony, or the production of evidence.
    (2) A party's written request for a subpoena must--
    (i) Give the names of the witnesses or documents to be produced;
    (ii) Describe the address or location of the witnesses or documents 
with sufficient detail to find them;
    (iii) State the important facts that the witness or document is 
expected to prove; and
    (iv) Indicate why these facts cannot be proven without issuing a 
subpoena.
    (3) Parties to a hearing who wish to subpoena documents or witnesses 
must file a written request for the issuance of a subpoena with the 
requirements set forth in paragraph (f)(2) of this section with the ALJ 
no later than the end of the discovery period established by the ALJ 
under Sec.  405.1037(c).
    (4) Where a party has requested a subpoena, a subpoena will be 
issued only where a party--
    (i) Has sought discovery;
    (ii) Has filed a motion to compel;
    (iii) Has had that motion granted by the ALJ; and
    (iv) Nevertheless, has not received the requested discovery.
    (5) Reviewability of subpoena rulings--
    (i) General rule. An ALJ ruling on a subpoena request is not subject 
to immediate review by the Council. The ruling may be reviewed solely 
during the course of the Council's review specified in Sec.  405.1016(e) 
and (f), Sec.  405.1102, or Sec.  405.1110, as applicable. Exception. To 
the extent a subpoena compels disclosure of a matter for which an 
objection based on privilege, or other protection from disclosure such 
as case preparation, confidentiality, or undue burden, was made before 
an ALJ, the Council may review immediately the subpoena or that portion 
of the subpoena as applicable.
    (ii) Where CMS objects to a subpoena ruling, the Council must take 
review and the subpoena ruling at issue is automatically stayed pending 
the Council's order.
    (iii) Upon notice to the ALJ that a party or non-party, as 
applicable, intends to seek Council review of the subpoena, the ALJ must 
stay all proceedings affected by the subpoena.
    (iv) The ALJ determines the length of the stay under the 
circumstances of a given case, but in no event is the stay less than 15 
calendar days beginning after the day on which the ALJ received notice 
of the party or non-party's intent to seek Council review.
    (v) If the Council grants a request for review of the subpoena, the 
subpoena or portion of the subpoena, as applicable, is stayed until the 
Council issues a written decision that affirms, reverses, or modifies 
the ALJ's action on the subpoena.
    (vi) If the Council does not grant review or take own motion review 
within the time allotted for the stay, the stay is lifted and the ALJ's 
action stands.
    (6) Enforcement. (i) If the ALJ determines, whether on his or her 
own motion or at the request of a party, that a party or non-party 
subject to a subpoena issued under this section has refused to comply 
with the subpoena, the ALJ may request the Secretary to seek enforcement 
of the subpoena in accordance with section 205(e) of the Act, 42 U.S.C. 
405(e).
    (ii) Any enforcement request by an ALJ must consist of a written 
notice to the Secretary describing in detail the ALJ's findings of 
noncompliance and his or her specific request for enforcement, and 
providing a copy of the subpoena and evidence of its receipt by 
certified mail by the party or nonparty subject to the subpoena.

[[Page 216]]

    (iii) The ALJ must promptly mail a copy of the notice and related 
documents to the party subject to the subpoena, and to any other party 
and affected non-party to the appeal.

[70 FR 11472, Mar. 8, 2005, as amended at 74 FR 65336, Dec. 9, 2009; 82 
FR 5117, Jan. 17, 2017]



Sec.  405.1037  Discovery.

    (a) General rules. (1) Discovery is permissible only when CMS or its 
contractor elects to be a party to an ALJ hearing, in accordance with 
Sec.  405.1012.
    (2) The ALJ may permit discovery of a matter that is relevant to the 
specific subject matter of the ALJ hearing, provided the matter is not 
privileged or otherwise protected from disclosure and the ALJ determines 
that the discovery request is not unreasonable, unduly burdensome or 
expensive, or otherwise inappropriate.
    (3) Any discovery initiated by a party must comply with all 
requirements and limitations of this section, along with any further 
requirements or limitations ordered by the ALJ.
    (b) Limitations on discovery. Any discovery before the ALJ is 
limited.
    (1) A party may request of another party the reasonable production 
of documents for inspection and copying.
    (2) A party may not take the deposition, upon oral or written 
examination, of another party unless the proposed deponent agrees to the 
deposition or the ALJ finds that the proposed deposition is necessary 
and appropriate in order to secure the deponent's testimony for an ALJ 
hearing.
    (3) A party may not request admissions or send interrogatories or 
take any other form of discovery not permitted under this section.
    (c) Time limits. (1) A party's discovery request is timely if the 
date of receipt of a request by another party is no later than the date 
specified by the ALJ.
    (2) A party may not conduct discovery any later than the date 
specified by the ALJ.
    (3) Before ruling on a request to extend the time for requesting 
discovery or for conducting discovery, the ALJ must give the other 
parties to the appeal a reasonable period to respond to the extension 
request.
    (4) The ALJ may extend the time in which to request discovery or 
conduct discovery only if the requesting party establishes that it was 
not dilatory or otherwise at fault in not meeting the original discovery 
deadline.
    (5) If the ALJ grants the extension request, it must impose a new 
discovery deadline and, if necessary, reschedule the hearing date so 
that all discoveries end no later than 45 calendar days before the 
hearing.
    (d) Motions to compel or for protective order. (1) Each party is 
required to make a good faith effort to resolve or narrow any discovery 
dispute.
    (2) A party may submit to the ALJ a motion to compel discovery that 
is permitted under this section or any ALJ order, and a party may submit 
a motion for a protective order regarding any discovery request to the 
ALJ.
    (3) Any motion to compel or for protective order must include a 
self-sworn declaration describing the movant's efforts to resolve or 
narrow the discovery dispute. The declaration must also be included with 
any response to a motion to compel or for protective order.
    (4) The ALJ must decide any motion in accordance with this section 
and any prior discovery ruling in the appeal.
    (5) The ALJ must issue and mail to each party a discovery ruling 
that grants or denies the motion to compel or for protective order in 
whole or in part; if applicable, the discovery ruling must specifically 
identify any part of the disputed discovery request upheld and any part 
rejected, and impose any limits on discovery the ALJ finds necessary and 
appropriate.
    (e) Reviewability of discovery and disclosure rulings--(1) General 
rule. An ALJ discovery ruling, or an ALJ disclosure ruling such as one 
issued at a hearing is not subject to immediate review by the Council. 
The ruling may be reviewed solely during the course of the Council's 
review specified in Sec.  405.1016(e) and (f), Sec.  405.1100, Sec.  
405.1102, or Sec.  405.1110, as applicable.
    (2) Exception. To the extent a ruling authorizes discovery or 
disclosure of a matter for which an objection based on privilege, or 
other protection from disclosure such as case preparation, 
confidentiality, or undue burden, was

[[Page 217]]

made before the ALJ, the Council may review that portion of the 
discovery or disclosure ruling immediately.
    (i) Where CMS objects to a discovery ruling, the Council must take 
review and the discovery ruling at issue is automatically stayed pending 
the Council's order.
    (ii) Upon notice to the ALJ that a party intends to seek Council 
review of the ruling, the ALJ must stay all proceedings affected by the 
ruling.
    (iii) The ALJ determines the length of the stay under the 
circumstances of a given case, but in no event must the length of the 
stay be less than 15 calendar days beginning after the day on which the 
ALJ received notice of the party or non-party's intent to seek Council 
review.
    (iv) Where CMS requests the Council to take review of a discovery 
ruling or where the Council grants a request, made by a party other than 
CMS, to review a discovery ruling, the ruling is stayed until the time 
the Council issues a written decision that affirms, reverses, modifies, 
or remands the ALJ's ruling.
    (v) With respect to a request from a party, other than CMS, for 
review of a discovery ruling, if the Council does not grant review or 
take own motion review within the time allotted for the stay, the stay 
is lifted and the ruling stands.
    (f) Adjudication period. If an adjudication period applies to the 
appeal in accordance with Sec.  405.1016, and a party requests discovery 
from another party to the hearing, the adjudication period is extended 
for the duration of discovery, from the date a discovery request is 
granted until the date specified for ending discovery.

[70 FR 11472, Mar. 8, 2005, as amended at 70 FR 37704, June 30, 2005; 74 
FR 65336, Dec. 9, 2009; 82 FR 5117, Jan. 17, 2017]



Sec.  405.1038  Deciding a case without a hearing before an ALJ.

    (a) Decision fully favorable. If the evidence in the administrative 
record supports a finding fully in favor of the appellant(s) on every 
issue and no other party to the appeal is liable for claims at issue, an 
ALJ or attorney adjudicator may issue a decision without giving the 
parties prior notice and without an ALJ conducting a hearing, unless CMS 
or a contractor has elected to be a party to the hearing in accordance 
with Sec.  405.1012. The notice of the decision informs the parties that 
they have the right to a hearing and a right to examine the evidence on 
which the decision is based.
    (b) Parties do not wish to appear. (1) An ALJ or attorney 
adjudicator may decide a case on the record and without an ALJ 
conducting a hearing if--
    (i) All the parties who would be sent a notice of hearing in 
accordance with Sec.  405.1020(c) indicate in writing that they do not 
wish to appear before an ALJ at a hearing, including a hearing conducted 
by telephone or video-teleconferencing, if available; or
    (ii) The appellant lives outside the United States and does not 
inform OMHA that he or she wants to appear at a hearing before an ALJ, 
and there are no other parties who would be sent a notice of hearing in 
accordance with Sec.  405.1020(c) and who wish to appear.
    (2) When a hearing is not held, the decision of the ALJ or attorney 
adjudicator must refer to the evidence in the record on which the 
decision was based.
    (c) Stipulated decision. If CMS or one of its contractors submits a 
written statement or makes an oral statement at a hearing indicating the 
item or service should be covered or payment may be made, and the 
written or oral statement agrees to the amount of payment the parties 
believe should be made if the amount of payment is an issue before the 
ALJ or attorney adjudicator, an ALJ or attorney adjudicator may issue a 
stipulated decision finding in favor of the appellant or other liable 
parties on the basis of the statement, and without making findings of 
fact, conclusions of law, or further explaining the reasons for the 
decision.

[82 FR 5117, Jan. 17, 2017]



Sec.  405.1040  Prehearing and posthearing conferences.

    (a) The ALJ may decide on his or her own, or at the request of any 
party to the hearing, to hold a prehearing or posthearing conference to 
facilitate the hearing or the hearing decision.
    (b) The ALJ informs the parties who will be or were sent a notice of 
hearing

[[Page 218]]

in accordance with Sec.  405.1020(c), and CMS or a contractor that has 
elected to be a participant in the proceedings or party to the hearing 
at the time the notice of conference is sent, of the time, place, and 
purpose of the conference at least 7 calendar days before the conference 
date, unless a party indicates in writing that it does not wish to 
receive a written notice of the conference.
    (c) At the conference--
    (1) The ALJ or an OMHA attorney designated by the ALJ conducts the 
conference, but only the ALJ conducting a conference may consider 
matters in addition to those stated in the conference notice if the 
parties consent to consideration of the additional matters in writing.
    (2) An audio recording of the conference is made.
    (d) The ALJ issues an order to all parties and participants who 
attended the conference stating all agreements and actions resulting 
from the conference. If a party does not object within 10 calendar days 
of receiving the order, or any additional time granted by the ALJ, the 
agreements and actions become part of the administrative record and are 
binding on all parties.

[82 FR 5118, Jan. 17, 2017]



Sec.  405.1042  The administrative record.

    (a) Creating the record. (1) OMHA makes a complete record of the 
evidence and administrative proceedings on the appealed matter, 
including any prehearing and posthearing conferences, and hearing 
proceedings that were conducted.
    (2) The record will include marked as exhibits, the appealed 
determinations, and documents and other evidence used in making the 
appealed determinations and the ALJ's or attorney adjudicator's 
decision, including, but not limited to, claims, medical records, 
written statements, certificates, reports, affidavits, and any other 
evidence the ALJ or attorney adjudicator admits. The record will also 
include any evidence excluded or not considered by the ALJ or attorney 
adjudicator, including, but not limited to, new evidence submitted by a 
provider or supplier, or beneficiary represented by a provider or 
supplier, for which no good cause was established, and duplicative 
evidence submitted by a party.
    (3) A party may request and review a copy of the record prior to or 
at the hearing, or, if a hearing is not held, at any time before the 
notice of decision is issued.
    (4) If a request for review is filed or the case is escalated to the 
Council, the complete record, including any prehearing and posthearing 
conference and hearing recordings, is forwarded to the Council.
    (5) A typed transcription of the hearing is prepared if a party 
seeks judicial review of the case in a Federal district court within the 
stated time period and all other jurisdictional criteria are met, 
unless, upon the Secretary's motion prior to the filing of an answer, 
the court remands the case.
    (b) Requesting and receiving copies of the record. (1) While an 
appeal is pending at OMHA, a party may request and receive a copy of all 
or part of the record from OMHA, including any index of the 
administrative record, documentary evidence, and a copy of the audio 
recording of the oral proceedings. The party may be asked to pay the 
costs of providing these items.
    (2) If a party requests a copy of all or part of the record from 
OMHA or the ALJ or attorney adjudicator and an opportunity to comment on 
the record, any adjudication period that applies in accordance with 
Sec.  405.1016 is extended by the time beginning with the receipt of the 
request through the expiration of the time granted for the party's 
response.
    (3) If a party requests a copy of all or part of the record and the 
record, including any audio recordings, contains information pertaining 
to an individual that the requesting party is not entitled to receive, 
such as personally identifiable information or protected health 
information, such portions of the record will not be furnished unless 
the requesting party obtains consent from the individual.

[82 FR 5118, Jan. 17, 2017]



Sec.  405.1044  Consolidated proceedings.

    (a) Consolidated hearing. (1) A consolidated hearing may be held if 
one or more of the issues to be considered at

[[Page 219]]

the hearing are the same issues that are involved in one or more other 
appeals pending before the same ALJ.
    (2) It is within the discretion of the ALJ to grant or deny an 
appellant's request for consolidation. In considering an appellant's 
request, the ALJ may consider factors such as whether the claims at 
issue may be more efficiently decided if the appeals are consolidated 
for hearing. In considering the appellant's request for consolidation, 
the ALJ must take into account any adjudication deadlines for each 
appeal and may require an appellant to waive the adjudication deadline 
associated with one or more appeals if consolidation otherwise prevents 
the ALJ from deciding all of the appeals at issue within their 
respective deadlines.
    (3) The ALJ may also propose on his or her own motion to consolidate 
two or more appeals in one hearing for administrative efficiency, but 
may not require an appellant to waive the adjudication deadline for any 
of the consolidated cases.
    (4) Notice of a consolidated hearing must be included in the notice 
of hearing issued in accordance with Sec. Sec.  405.1020 and 405.1022.
    (b) Consolidated or separate decision and record. (1) If the ALJ 
decides to hold a consolidated hearing, he or she may make either--
    (i) A consolidated decision and record; or
    (ii) A separate decision and record on each appeal.
    (2) If a separate decision and record on each appeal is made, the 
ALJ is responsible for making sure that any evidence that is common to 
all appeals and material to the common issue to be decided, and audio 
recordings of any conferences that were conducted and the consolidated 
hearing are included in each individual administrative record, as 
applicable.
    (3) If a hearing will not be conducted for multiple appeals that are 
before the same ALJ or attorney adjudicator, and the appeals involve one 
or more of the same issues, the ALJ or attorney adjudicator may make a 
consolidated decision and record at the request of the appellant or on 
the ALJ's or attorney adjudicator's own motion.
    (c) Limitation on consolidated proceedings. Consolidated proceedings 
may only be conducted for appeals filed by the same appellant, unless 
multiple appellants aggregated claims to meet the amount in controversy 
requirement in accordance with Sec.  405.1006 and the beneficiaries 
whose claims are at issue have all authorized disclosure of their 
protected information to the other parties and any participants.

[82 FR 5118, Jan. 17, 2017]



Sec.  405.1046  Notice of an ALJ or attorney adjudicator decision.

    (a) Decisions on requests for hearing--(1) General rule. Unless the 
ALJ or attorney adjudicator dismisses or remands the request for 
hearing, the ALJ or attorney adjudicator will issue a written decision 
that gives the findings of fact, conclusions of law, and the reasons for 
the decision. The decision must be based on evidence offered at the 
hearing or otherwise admitted into the record, and shall include 
independent findings and conclusions. OMHA mails or otherwise transmits 
a copy of the decision to all the parties at their last known address 
and the QIC that issued the reconsideration or from which the appeal was 
escalated. For overpayment cases involving multiple beneficiaries, where 
there is no beneficiary liability, the ALJ or attorney adjudicator may 
choose to send written notice only to the appellant. In the event a 
payment will be made to a provider or supplier in conjunction with the 
ALJ's or attorney adjudicator's decision, the contractor must also issue 
a revised electronic or paper remittance advice to that provider or 
supplier.
    (2) Content of the notice. The decision must be written in a manner 
calculated to be understood by a beneficiary and must include--
    (i) The specific reasons for the determination, including, to the 
extent appropriate, a summary of any clinical or scientific evidence 
used in making the determination;
    (ii) For any new evidence that was submitted for the first time at 
the OMHA level and subject to a good cause determination pursuant to

[[Page 220]]

Sec.  405.1028, a discussion of the new evidence and the good cause 
determination that was made;
    (iii) The procedures for obtaining additional information concerning 
the decision; and
    (iv) Notification of the right to appeal the decision to the 
Council, including instructions on how to initiate an appeal under this 
section.
    (3) Limitation on decision. When the amount of payment for an item 
or service is an issue before the ALJ or attorney adjudicator, the ALJ 
or attorney adjudicator may make a finding as to the amount of payment 
due. If the ALJ or attorney adjudicator makes a finding concerning 
payment when the amount of payment was not an issue before the ALJ or 
attorney adjudicator, the contractor may independently determine the 
payment amount. In either of the aforementioned situations, an ALJ's or 
attorney adjudicator's decision is not binding on the contractor for 
purposes of determining the amount of payment due. The amount of payment 
determined by the contractor in effectuating the ALJ's or attorney 
adjudicator's decision is a new initial determination under Sec.  
405.924.
    (b) Decisions on requests for review of a QIC dismissal--(1) General 
rule. Unless the ALJ or attorney adjudicator dismisses the request for 
review of a QIC dismissal, or the QIC's dismissal is vacated and 
remanded, the ALJ or attorney adjudicator will issue a written decision 
affirming the QIC's dismissal. OMHA mails or otherwise transmits a copy 
of the decision to all the parties that received a copy of the QIC's 
dismissal.
    (2) Content of the notice. The decision must be written in a manner 
calculated to be understood by a beneficiary and must include--
    (i) The specific reasons for the determination, including a summary 
of the evidence considered and applicable authorities;
    (ii) The procedures for obtaining additional information concerning 
the decision; and
    (iii) Notification that the decision is binding and is not subject 
to further review, unless reopened and revised by the ALJ or attorney 
adjudicator.
    (c) Recommended decision. An ALJ or attorney adjudicator issues a 
recommended decision if he or she is directed to do so in the Council's 
remand order. An ALJ or attorney adjudicator may not issue a recommended 
decision on his or her own motion. The ALJ or attorney adjudicator mails 
a copy of the recommended decision to all the parties at their last 
known address.

[82 FR 5119, Jan. 17, 2017, as amended at 84 FR 19871, May 7, 2019]



Sec.  405.1048  The effect of an ALJ's or attorney adjudicator's decision.

    (a) The decision of the ALJ or attorney adjudicator on a request for 
hearing is binding on all parties unless--
    (1) A party requests a review of the decision by the Council within 
the stated time period or the Council reviews the decision issued by an 
ALJ or attorney adjudicator under the procedures set forth in Sec.  
405.1110, and the Council issues a final decision or remand order or the 
appeal is escalated to Federal district court under the provisions at 
Sec.  405.1132 and the Federal district court issues a decision.
    (2) The decision is reopened and revised by an ALJ or attorney 
adjudicator or the Council under the procedures explained in Sec.  
405.980;
    (3) The expedited access to judicial review process at Sec.  405.990 
is used;
    (4) The ALJ's or attorney adjudicator's decision is a recommended 
decision directed to the Council and the Council issues a decision; or
    (5) In a case remanded by a Federal district court, the Council 
assumes jurisdiction under the procedures in Sec.  405.1138 and the 
Council issues a decision.
    (b) The decision of the ALJ or attorney adjudicator on a request for 
review of a QIC dismissal is binding on all parties unless the decision 
is reopened and revised by the ALJ or attorney adjudicator under the 
procedures in Sec.  405.980.

[82 FR 5119, Jan. 17, 2017]



Sec.  405.1050  Removal of a hearing request from OMHA to the Council.

    If a request for hearing is pending before OMHA, the Council may 
assume responsibility for holding a hearing by

[[Page 221]]

requesting that OMHA send the hearing request to it. If the Council 
holds a hearing, it conducts the hearing according to the rules for 
hearings before an ALJ. Notice is mailed to all parties at their last 
known address informing them that the Council has assumed responsibility 
for the case.

[70 FR 11472, Mar. 8, 2005, as amended at 82 FR 5118, Jan. 17, 2017]



Sec.  405.1052  Dismissal of a request for a hearing before an ALJ 
or request for review of a QIC dismissal.

    (a) Dismissal of request for hearing. An ALJ dismisses a request for 
a hearing under any of the following conditions:
    (1) Neither the party that requested the hearing nor the party's 
representative appears at the time and place set for the hearing, if--
    (i) The party was notified before the time set for the hearing that 
the request for hearing might be dismissed for failure to appear, the 
record contains documentation that the party acknowledged the notice of 
hearing, and the party does not contact the ALJ within 10 calendar days 
after the hearing, or does contact the ALJ but the ALJ determines the 
party did not demonstrate good cause for not appearing; or
    (ii) The record does not contain documentation that the party 
acknowledged the notice of hearing, the ALJ sends a notice to the party 
at the last known address asking why the party did not appear, and the 
party does not respond to the ALJ's notice within 10 calendar days after 
receiving the notice or does contact the ALJ but the ALJ determines the 
party did not demonstrate good cause for not appearing.
    (iii) In determining whether good cause exists under paragraphs 
(a)(1)(i) and (ii) of this section, the ALJ considers any physical, 
mental, educational, or linguistic limitations (including any lack of 
facility with the English language), that the party may have.
    (2) The person or entity requesting a hearing has no right to it 
under Sec.  405.1002.
    (3) The party did not request a hearing within the stated time 
period and the ALJ has not found good cause for extending the deadline, 
as provided in Sec.  405.1014(e).
    (4) The beneficiary whose claim is being appealed died while the 
request for hearing is pending and all of the following criteria apply:
    (i) The request for hearing was filed by the beneficiary or the 
beneficiary's representative, and the beneficiary's surviving spouse or 
estate has no remaining financial interest in the case. In deciding this 
issue, the ALJ considers if the surviving spouse or estate remains 
liable for the services that were denied or a Medicare contractor held 
the beneficiary liable for subsequent similar services under the 
limitation on liability provisions based on the denial of the services 
at issue.
    (ii) No other individuals or entities that have a financial interest 
in the case wish to pursue an appeal under Sec.  405.1002.
    (iii) No other individual or entity filed a valid and timely request 
for an ALJ hearing in accordance to Sec.  405.1014.
    (5) The ALJ dismisses a hearing request entirely or refuses to 
consider any one or more of the issues because a QIC, an ALJ or attorney 
adjudicator, or the Council has made a previous determination or 
decision under this subpart about the appellant's rights on the same 
facts and on the same issue(s) or claim(s), and this previous 
determination or decision has become binding by either administrative or 
judicial action.
    (6) The appellant abandons the request for hearing. An ALJ may 
conclude that an appellant has abandoned a request for hearing when OMHA 
attempts to schedule a hearing and is unable to contact the appellant 
after making reasonable efforts to do so.
    (7) The appellant's request is not complete in accordance with Sec.  
405.1014(a)(1) or the appellant, other than an unrepresented 
beneficiary, did not send a copy of its request to the other parties in 
accordance with Sec.  405.1014(d), after the appellant is provided with 
an opportunity to complete the request and/or send a copy of the request 
to the other parties.
    (b) Dismissal of request for review of a QIC dismissal. An ALJ or 
attorney adjudicator dismisses a request for review

[[Page 222]]

of a QIC dismissal under any of the following conditions:
    (1) The person or entity requesting a review of a dismissal has no 
right to it under Sec.  405.1004.
    (2) The party did not request a review within the stated time period 
and the ALJ or attorney adjudicator has not found good cause for 
extending the deadline, as provided in Sec.  405.1014(e).
    (3) The beneficiary whose claim is being appealed died while the 
request for review is pending and all of the following criteria apply:
    (i) The request for review was filed by the beneficiary or the 
beneficiary's representative, and the beneficiary's surviving spouse or 
estate has no remaining financial interest in the case. In deciding this 
issue, the ALJ or attorney adjudicator considers if the surviving spouse 
or estate remains liable for the services that were denied or a Medicare 
contractor held the beneficiary liable for subsequent similar services 
under the limitation on liability provisions based on the denial of the 
services at issue.
    (ii) No other individuals or entities that have a financial interest 
in the case wish to pursue an appeal under Sec.  405.1004.
    (iii) No other individual or entity filed a valid and timely request 
for a review of the QIC dismissal in accordance to Sec.  405.1014.
    (4) The appellant's request is not complete in accordance with Sec.  
405.1014(a)(1) or the appellant, other than an unrepresented 
beneficiary, did not send a copy of its request to the other parties in 
accordance with Sec.  405.1014(d), after the appellant is provided with 
an opportunity to complete the request and/or send a copy of the request 
to the other parties.
    (c) Withdrawal of request. At any time before notice of the 
decision, dismissal, or remand is mailed, if only one party requested 
the hearing or review of the QIC dismissal and that party asks to 
withdraw the request, an ALJ or attorney adjudicator may dismiss the 
request for hearing or request for review of a QIC dismissal. This 
request for withdrawal may be submitted in writing, or a request to 
withdraw a request for hearing may be made orally at a hearing before 
the ALJ. The request for withdrawal must include a clear statement that 
the appellant is withdrawing the request for hearing or review of the 
QIC dismissal and does not intend to further proceed with the appeal. If 
an attorney or other legal professional on behalf of a beneficiary or 
other appellant files the request for withdrawal, the ALJ or attorney 
adjudicator may presume that the representative has advised the 
appellant of the consequences of the withdrawal and dismissal.
    (d) Notice of dismissal. OMHA mails or otherwise transmits a written 
notice of the dismissal of the hearing or review request to the 
appellant, all parties who were sent a copy of the request for hearing 
or review at their last known address, and to CMS or a CMS contractor 
that is a party to the proceedings on a request for hearing. The notice 
states that there is a right to request that the ALJ or attorney 
adjudicator vacate the dismissal action. The appeal will proceed with 
respect to any other parties who filed a valid request for hearing or 
review regarding the same claim or disputed matter.
    (e) Vacating a dismissal. If good and sufficient cause is 
established, the ALJ or attorney adjudicator may vacate his or her 
dismissal of a request for hearing or review within 180 calendar days of 
the date of the notice of dismissal.

[82 FR 5119, Jan. 17, 2017, as amended at 84 FR 19871, May 7, 2019]



Sec.  405.1054  Effect of dismissal of a request for a hearing or request 
for review of QIC dismissal.

    (a) The dismissal of a request for a hearing is binding, unless it 
is vacated by the Council under Sec.  405.1108(b), or vacated by the ALJ 
or attorney adjudicator under Sec.  405.1052(e).
    (b) The dismissal of a request for review of a QIC dismissal of a 
request for reconsideration is binding and not subject to further review 
unless it is vacated by the ALJ or attorney adjudicator under Sec.  
405.1052(e).

[82 FR 5120, Jan. 17, 2017]



Sec.  405.1056  Remands of requests for hearing and requests for review.

    (a) Missing appeal determination or case record. (1) If an ALJ or 
attorney adjudicator requests an official copy of

[[Page 223]]

a missing redetermination or reconsideration for an appealed claim in 
accordance with Sec.  405.1034, and the QIC or another contractor does 
not furnish the copy within the time frame specified in Sec.  405.1034, 
the ALJ or attorney adjudicator may issue a remand directing the QIC or 
other contractor to reconstruct the record or, if it is not able to do 
so, initiate a new appeal adjudication.
    (2) If the QIC does not furnish the case file for an appealed 
reconsideration, an ALJ or attorney adjudicator may issue a remand 
directing the QIC to reconstruct the record or, if it is not able to do 
so, initiate a new appeal adjudication.
    (3) If the QIC or another contractor is able to reconstruct the 
record for a remanded case and returns the case to OMHA, the case is no 
longer remanded and the reconsideration is no longer vacated, and any 
adjudication period that applies to the appeal in accordance with Sec.  
405.1016 is extended by the period between the date of the remand and 
the date that case is returned to OMHA.
    (b) No redetermination. If an ALJ or attorney adjudicator finds that 
the QIC issued a reconsideration that addressed coverage or payment 
issues related to the appealed claim and no redetermination of the claim 
was made (if a redetermination was required under this subpart) or the 
request for redetermination was dismissed, the reconsideration will be 
remanded to the QIC, or its successor to re-adjudicate the request for 
reconsideration.
    (c) Requested remand--(1) Request contents and timing. At any time 
prior to an ALJ or attorney adjudicator issuing a decision or dismissal, 
the appellant and CMS or one of its contractors may jointly request a 
remand of the appeal to the entity that conducted the reconsideration. 
The request must include the reasons why the appeal should be remanded 
and indicate whether remanding the case will likely resolve the matter 
in dispute.
    (2) Granting the request. An ALJ or attorney adjudicator may grant 
the request and issue a remand if he or she determines that remanding 
the case will likely resolve the matter in dispute.
    (d) Remanding a QIC's dismissal of a request for reconsideration. 
(1) Consistent with Sec.  405.1004(b), an ALJ or attorney adjudicator 
will remand a case to the appropriate QIC if the ALJ or attorney 
adjudicator determines that a QIC's dismissal of a request for 
reconsideration was in error.
    (2) If an official copy of the notice of dismissal or case file 
cannot be obtained from the QIC, an ALJ or attorney adjudicator may also 
remand a request for review of a dismissal in accordance with the 
procedures in paragraph (a) of this section.
    (e) Relationship to local and national coverage determination 
appeals process. (1) An ALJ or attorney adjudicator remands an appeal to 
the QIC that made the reconsideration if the appellant is entitled to 
relief pursuant to Sec.  426.460(b)(1), Sec.  426.488(b), or Sec.  
426.560(b)(1) of this chapter.
    (2) Unless the appellant is entitled to relief pursuant to Sec.  
426.460(b)(1), Sec.  426.488(b), or Sec.  426.560(b)(1) of this chapter, 
the ALJ or attorney adjudicator applies the LCD or NCD in place on the 
date the item or service was provided.
    (f) Notice of remand. OMHA mails or otherwise transmits a written 
notice of the remand of the request for hearing or request for review to 
the appellant, all of the parties who were sent a copy of the request at 
their last known address, and CMS or a contractor that elected to be a 
participant in the proceedings or party to the hearing. The notice 
states that there is a right to request that the Chief ALJ or a designee 
review the remand, unless the remand was issued under paragraph (d)(1) 
of this section.
    (g) Review of remand. Upon a request by a party or CMS or one of its 
contractors filed within 30 calendar days of receiving a notice of 
remand, the Chief ALJ or designee will review the remand, and if the 
remand is not authorized by this section, vacate the remand order. The 
determination on a request to review a remand order is binding and not 
subject to further review. The review of remand procedures provided for 
in this paragraph are not

[[Page 224]]

available for and do not apply to remands that are issued under 
paragraph (d)(1) of this section.

[82 FR 5121, Jan. 17, 2017, as amended at 84 FR 19871, May 7, 2019]



Sec.  405.1058  Effect of a remand.

    A remand of a request for hearing or request for review is binding 
unless vacated by the Chief ALJ or a designee in accordance with Sec.  
405.1056(g).

[82 FR 5121, Jan. 17, 2017]

               Applicability of Medicare Coverage Policies



Sec.  405.1060  Applicability of national coverage determinations (NCDs).

    (a) General rule. (1) An NCD is a determination by the Secretary of 
whether a particular item or service is covered nationally under 
Medicare.
    (2) An NCD does not include a determination of what code, if any, is 
assigned to a particular item or service covered under Medicare or a 
determination of the amount of payment made for a particular item or 
service.
    (3) NCDs are made under section 1862(a)(1) of the Act as well as 
under other applicable provisions of the Act.
    (4) An NCD is binding on fiscal intermediaries, carriers, QIOs, 
QICs, ALJs and attorney adjudicators, and the Council.
    (b) Review by an ALJ or attorney adjudicator. (1) An ALJ or attorney 
adjudicator may not disregard, set aside, or otherwise review an NCD.
    (2) An ALJ or attorney adjudicator may review the facts of a 
particular case to determine whether an NCD applies to a specific claim 
for benefits and, if so, whether the NCD was applied correctly to the 
claim.
    (c) Review by the Council. (1) The Council may not disregard, set 
aside, or otherwise review an NCD for purposes of a section 1869 claim 
appeal, except that the DAB may review NCDs as provided under part 426 
of this title.
    (2) The Council may review the facts of a particular case to 
determine whether an NCD applies to a specific claim for benefits and, 
if so, whether the NCD was applied correctly to the claim.

[70 FR 11472, Mar. 8, 2005, as amended at 70 FR 37704, June 30, 2005; 82 
FR 5121, Jan. 17, 2017]



Sec.  405.1062  Applicability of local coverage determinations 
and other policies not binding on the ALJ or attorney adjudicator and Council.

    (a) ALJs and attorney adjudicators and the Council are not bound by 
LCDs, LMRPs, or CMS program guidance, such as program memoranda and 
manual instructions, but will give substantial deference to these 
policies if they are applicable to a particular case.
    (b) If an ALJ or attorney adjudicator or Council declines to follow 
a policy in a particular case, the ALJ or attorney adjudicator or 
Council decision must explain the reasons why the policy was not 
followed. An ALJ or attorney adjudicator or Council decision to 
disregard such policy applies only to the specific claim being 
considered and does not have precedential effect.
    (c) An ALJ or attorney adjudicator or the Council may not set aside 
or review the validity of an LMRP or LCD for purposes of a claim appeal. 
An ALJ or the DAB may review or set aside an LCD (or any part of an LMRP 
that constitutes an LCD) in accordance with part 426 of this title.

[70 FR 11472, Mar. 8, 2005, as amended at 82 FR 5121, Jan. 17, 2017]



Sec.  405.1063  Applicability of laws, regulations, CMS Rulings, 
and precedential decisions.

    (a) All laws and regulations pertaining to the Medicare and Medicaid 
programs, including, but not limited to Titles XI, XVIII, and XIX of the 
Social Security Act and applicable implementing regulations, are binding 
on ALJs and attorney adjudicators, and the Council.
    (b) CMS Rulings are published under the authority of the 
Administrator, CMS. Consistent with Sec.  401.108 of this chapter, 
rulings are binding on all CMS components, on all HHS components that 
adjudicate matters under the jurisdiction of CMS, and on the Social 
Security Administration to the extent that components of the Social 
Security

[[Page 225]]

Administration adjudicate matters under the jurisdiction of CMS.
    (c) Precedential decisions designated by the Chair of the 
Departmental Appeals Board in accordance with Sec.  401.109 of this 
chapter, are binding on all CMS components, all HHS components that 
adjudicate matters under the jurisdiction of CMS, and on the Social 
Security Administration to the extent that components of the Social 
Security Administration adjudicate matters under the jurisdiction of 
CMS.

[82 FR 5121, Jan. 17, 2017]

                     Medicare Appeals Council Review



Sec.  405.1100  Medicare Appeals Council review: General.

    (a) The appellant or any other party to an ALJ's or attorney 
adjudicator's decision or dismissal may request that the Council review 
the ALJ's or attorney adjudicator's decision or dismissal.
    (b) Under circumstances set forth in Sec. Sec.  405.1016 and 
405.1108, the appellant may request that a case be escalated to the 
Council for a decision even if the ALJ or attorney adjudicator has not 
issued a decision, dismissal, or remand in his or her case.
    (c) When the Council reviews an ALJ's or attorney adjudicator's 
decision, it undertakes a de novo review. The Council issues a final 
decision or dismissal order or remands a case to the ALJ or attorney 
adjudicator within 90 calendar days of receipt of the appellant's 
request for review, unless the 90 calendar day period is extended as 
provided in this subpart.
    (d) When deciding an appeal that was escalated from the OMHA level 
to the Council, the Council will issue a final decision or dismissal 
order or remand the case to the OMHA Chief ALJ within 180 calendar days 
of receipt of the appellant's request for escalation, unless the 180 
calendar day period is extended as provided in this subpart.

[82 FR 5122, Jan. 17, 2017]



Sec.  405.1102  Request for Council review when ALJ or attorney adjudicator 
issues decision or dismissal.

    (a)(1) A party to a decision or dismissal issued by an ALJ or 
attorney adjudicator may request a Council review if the party files a 
written request for a Council review within 60 calendar days after 
receipt of the ALJ's or attorney adjudicator's decision or dismissal.
    (2) For purposes of this section, the date of receipt of the ALJ's 
or attorney adjudicator's decision or dismissal is presumed to be 5 
calendar days after the date of the notice of the decision or dismissal, 
unless there is evidence to the contrary.
    (3) The request is considered as filed on the date it is received by 
the entity specified in the notice of the ALJ's or attorney 
adjudicator's action.
    (b) A party requesting a review may ask that the time for filing a 
request for Council review be extended if--
    (1) The request for an extension of time is in writing;
    (2) It is filed with the Council; and
    (3) It explains why the request for review was not filed within the 
stated time period. If the Council finds that there is good cause for 
missing the deadline, the time period will be extended. To determine 
whether good cause exists, the Council uses the standards outlined at 
Sec.  405.942(b)(2) and (3).
    (c) A party does not have the right to seek Council review of an 
ALJ's or attorney adjudicator's remand to a QIC, affirmation of a QIC's 
dismissal of a request for reconsideration, or dismissal of a request 
for review of a QIC dismissal.
    (d) For purposes of requesting Council review (Sec. Sec.  405.1100 
through 405.1140), unless specifically excepted, the term ``party'', 
includes CMS where CMS has entered into a case as a party according to 
Sec.  405.1012. The term, ``appellant,'' does not include CMS, where CMS 
has entered into a case as a party according to Sec.  405.1012.

[82 FR 5122, Jan. 17, 2017]



Sec.  405.1106  Where a request for review or escalation may be filed.

    (a) When a request for a Council review is filed after an ALJ or 
attorney adjudicator has issued a decision or dismissal, the request for 
review must be filed with the entity specified in the notice of the 
ALJ's or attorney adjudicator's action. The appellant must also send a 
copy of the request for review to the other parties to the ALJ or

[[Page 226]]

attorney adjudicator decision or dismissal who received notice of the 
decision or dismissal. Failure to copy the other parties tolls the 
Council's adjudication deadline set forth in Sec.  405.1100 until all 
parties to the ALJ or attorney adjudicator decision or dismissal receive 
notice of the request for Council review. If the request for review is 
timely filed with an entity other than the entity specified in the 
notice of the ALJ's or attorney adjudicator's action, the Council's 
adjudication period to conduct a review begins on the date the request 
for review is received by the entity specified in the notice of the 
ALJ's or attorney adjudicator's action. Upon receipt of a request for 
review from an entity other than the entity specified in the notice of 
the ALJ's or attorney adjudicator's action, the Council sends written 
notice to the appellant of the date of receipt of the request and 
commencement of the adjudication timeframe.
    (b) If an appellant files a request to escalate an appeal to the 
Council level because the ALJ or attorney adjudicator has not completed 
his or her action on the request for hearing within an applicable 
adjudication period under Sec.  405.1016, the request for escalation 
must be filed with OMHA and the appellant must also send a copy of the 
request for escalation to the other parties who were sent a copy of the 
QIC reconsideration. Failure to copy the other parties tolls the 
Council's adjudication deadline set forth in Sec.  405.1100 until all 
parties who were sent a copy of the QIC reconsideration receive notice 
of the request for escalation. In a case that has been escalated from 
OMHA, the Council's 180 calendar day period to issue a final decision, 
dismissal order, or remand order begins on the date the request for 
escalation is received by the Council.

[82 FR 5122, Jan. 17, 2017]



Sec.  405.1108  Council actions when request for review or escalation is filed.

    (a) Except as specified in paragraphs (c) and (d) of this section, 
when a party requests that the Council review an ALJ's or attorney 
adjudicator's decision, the Council will review the ALJ's or attorney 
adjudicator's decision de novo. The party requesting review does not 
have a right to a hearing before the Council. The Council will consider 
all of the evidence in the administrative record. Upon completion of its 
review, the Council may adopt, modify, or reverse the ALJ's or attorney 
adjudicator's decision or remand the case to an ALJ or attorney 
adjudicator for further proceedings.
    (b) When a party requests that the Council review an ALJ's or 
attorney adjudicator's dismissal of a request for a hearing, the Council 
may deny review or vacate the dismissal and remand the case to the ALJ 
or attorney adjudicator for further proceedings.
    (c) The Council will dismiss a request for review when the party 
requesting review does not have a right to a review by the Council, or 
will dismiss the request for a hearing for any reason that the ALJ or 
attorney adjudicator could have dismissed the request for hearing.
    (d) When an appellant requests escalation of a case from the OMHA 
level to the Council, the Council may take any of the following actions:
    (1) Issue a decision based on the record constructed at the QIC and 
any additional evidence, including oral testimony, entered in the record 
by the ALJ or attorney adjudicator before the case was escalated.
    (2) Conduct any additional proceedings, including a hearing, that 
the Council determines are necessary to issue a decision.
    (3) Remand the case to OMHA for further proceedings, including a 
hearing.
    (4) Dismiss the request for Council review because the appellant 
does not have the right to escalate the appeal.
    (5) Dismiss the request for a hearing for any reason that the ALJ or 
attorney adjudicator could have dismissed the request.

[70 FR 11472, Mar. 8, 2005, as amended at 82 FR 5122, Jan. 17, 2017]



Sec.  405.1110  Council reviews on its own motion.

    (a) General rule. The Council may decide on its own motion to review 
a decision or dismissal issued by an ALJ or attorney adjudicator. CMS or 
any of its contractors may refer a case to the Council for it to 
consider reviewing

[[Page 227]]

under this authority anytime within 60 calendar days of receipt of an 
ALJ's or attorney adjudicator's decision or dismissal.
    (b) Referral of cases. (1) CMS or any of its contractors may refer a 
case to the Council if, in their view, the decision or dismissal 
contains an error of law material to the outcome of the claim or 
presents a broad policy or procedural issue that may affect the public 
interest. CMS may also request that the Council take own motion review 
of a case if--
    (i) CMS or its contractor participated in the appeal at the OMHA 
level; and
    (ii) In CMS' view, the ALJ's or attorney adjudicator's decision or 
dismissal is not supported by the preponderance of evidence in the 
record or the ALJ or attorney adjudicator abused his or her discretion.
    (2) CMS' referral to the Council is made in writing and must be 
filed with the Council no later than 60 calendar days after the ALJ's or 
attorney adjudicator's decision or dismissal is received. The written 
referral will state the reasons why CMS believes the Council must review 
the case on its own motion. CMS will send a copy of its referral to all 
parties to the ALJ's or attorney adjudicator's action who received a 
copy of the decision under Sec.  405.1046(a) or the notice of dismissal 
under Sec.  405.1052(d), and to the OMHA Chief ALJ. Parties to the ALJ's 
or attorney adjudicator's action may file exceptions to the referral by 
submitting written comments to the Council within 20 calendar days of 
the referral notice. A party submitting comments to the Council must 
send such comments to CMS and all other parties to the ALJ's or attorney 
adjudicator's action who received a copy of the decision under Sec.  
405.1046(a) or the notice of dismissal under Sec.  405.1052(d).
    (c) Standard of review--(1) Referral by CMS after participation at 
the OMHA level. If CMS or its contractor participated in an appeal at 
the OMHA level, the Council exercises its own motion authority if there 
is an error of law material to the outcome of the case, an abuse of 
discretion by the ALJ or attorney adjudicator, the decision is not 
consistent with the preponderance of the evidence of record, or there is 
a broad policy or procedural issue that may affect the general public 
interest. In deciding whether to accept review under this standard, the 
Council will limit its consideration of the ALJ's or attorney 
adjudicator's action to those exceptions raised by CMS.
    (2) Referral by CMS when CMS did not participate in the OMHA 
proceedings or appear as a party. The Council will accept review if the 
decision or dismissal contains an error of law material to the outcome 
of the case or presents a broad policy or procedural issue that may 
affect the general public interest. In deciding whether to accept 
review, the Council will limit its consideration of the ALJ's or 
attorney adjudicator's action to those exceptions raised by CMS.
    (d) Council's action. If the Council decides to review a decision or 
dismissal on its own motion, it will mail the results of its action to 
all the parties to the hearing and to CMS if it is not already a party 
to the hearing. The Council may adopt, modify, or reverse the decision 
or dismissal, may remand the case to an ALJ or attorney adjudicator for 
further proceedings or may dismiss a hearing request. The Council must 
issue its action no later than 90 calendar days after receipt of the CMS 
referral, unless the 90 calendar day period has been extended as 
provided in this subpart. The Council may not, however, issue its action 
before the 20 calendar day comment period has expired, unless it 
determines that the agency's referral does not provide a basis for 
reviewing the case. If the Council does not act within the applicable 
adjudication deadline, the ALJ's or attorney adjudicator's decision or 
dismissal is binding on the parties to the ALJ's or attorney 
adjudicator's action.
    (e) Referral timeframe. For purposes of this section, the date of 
receipt of the ALJ's or attorney adjudicator's decision or dismissal is 
presumed to be 5 calendar days after the date of the notice of the 
decision or dismissal, unless there is evidence to the contrary.

[82 FR 5122, Jan. 17, 2017, as amended at 84 FR 19871, May 7, 2019]

[[Page 228]]



Sec.  405.1112  Content of request for review.

    (a) The request for Council review must be filed with the entity 
specified in the notice of the ALJ's or attorney adjudicator's action. 
The request for review must be in writing and may be made on a standard 
form. A written request that is not made on a standard form is accepted 
if it contains the beneficiary's name; Medicare number; the specific 
service(s) or item(s) for which the review is requested; the specific 
date(s) of service; the date of the ALJ's or attorney adjudicator's 
decision or dismissal order, if any; and the name of the party or the 
representative of the party; and any other information CMS may decide.
    (b) The request for review must identify the parts of the ALJ's or 
attorney adjudicator's action with which the party requesting review 
disagrees and explain why he or she disagrees with the ALJ's or attorney 
adjudicator's decision, dismissal, or other determination being 
appealed. For example, if the party requesting review believes that the 
ALJ's or attorney adjudicator's action is inconsistent with a statute, 
regulation, CMS Ruling, or other authority, the request for review 
should explain why the appellant believes the action is inconsistent 
with that authority.
    (c) The Council will limit its review of an ALJ's or attorney 
adjudicator's actions to those exceptions raised by the party in the 
request for review, unless the appellant is an unrepresented 
beneficiary. For purposes of this section only, we define a 
representative as anyone who has accepted an appointment as the 
beneficiary's representative, except a member of the beneficiary's 
family, a legal guardian, or an individual who routinely acts on behalf 
of the beneficiary, such as a family member or friend who has a power of 
attorney.

[82 FR 5123, Jan. 17, 2017, as amended at 84 FR 19871, May 7, 2019]



Sec.  405.1114  Dismissal of request for review.

    The Council dismisses a request for review if the party requesting 
review did not file the request within the stated period of time and the 
time for filing has not been extended. The Council also dismisses the 
request for review if--
    (a) The party asks to withdraw the request for review;
    (b) The party does not have a right to request Council review; or
    (c) The beneficiary whose claim is being appealed died while the 
request for review is pending and all of the following criteria apply:
    (1) The request for review was filed by the beneficiary or the 
beneficiary's representative, and the beneficiary's surviving spouse or 
estate has no remaining financial interest in the case. In deciding this 
issue, the Council considers whether the surviving spouse or estate 
remains liable for the services that were denied or a Medicare 
contractor held the beneficiary liable for subsequent similar services 
under the limitation on liability provisions based on the denial of the 
services at issue;
    (2) No other individual or entity with a financial interest in the 
case wishes to pursue an appeal under Sec.  405.1102;
    (3) No other party to the ALJ's or attorney adjudicator's action 
filed a valid and timely review request under Sec. Sec.  405.1102 and 
405.1112.

[70 FR 11472, Mar. 8, 2005, as amended at 82 FR 5123, Jan. 17, 2017; 84 
FR 19871, May 7, 2019]



Sec.  405.1116  Effect of dismissal of request for Council review 
or request for hearing.

    The dismissal of a request for Council review or denial of a request 
for review of a dismissal issued by an ALJ or attorney adjudicator is 
binding and not subject to further review unless reopened and vacated by 
the Council. The Council's dismissal of a request for hearing is also 
binding and not subject to judicial review.

[70 FR 11472, Mar. 8, 2005, as amended at 82 FR 5123, Jan. 17, 2017]



Sec.  405.1118  Obtaining evidence from the Council.

    A party may request and receive a copy of all or part of the record 
of the ALJ's or attorney adjudicator's action, including any index of 
the administrative record, documentary evidence, and a copy of the audio 
recording of the oral proceedings. However, the party

[[Page 229]]

may be asked to pay the costs of providing these items. If a party 
requests evidence from the Council and an opportunity to comment on that 
evidence, the time beginning with the Council's receipt of the request 
for evidence through the expiration of the time granted for the party's 
response will not be counted toward the 90 calendar day adjudication 
deadline.

[70 FR 11472, Mar. 8, 2005, as amended at 74 FR 65337, Dec. 9, 2009; 82 
FR 5123, Jan. 17, 2017]



Sec.  405.1120  Filing briefs with the Council.

    Upon request, the Council will give the party requesting review, as 
well as all other parties, a reasonable opportunity to file briefs or 
other written statements about the facts and law relevant to the case. 
Any party who submits a brief or statement must send a copy to all of 
the other parties. Unless the party requesting review files the brief or 
other statement with the request for review, the time beginning with the 
date of receipt of the request to submit the brief and ending with the 
date the brief is received by the Council will not be counted toward the 
adjudication timeframe set forth in Sec.  405.1100. The Council may also 
request, but not require, CMS or its contractor to file a brief or 
position paper if the Council determines that it is necessary to resolve 
the issues in the case. The Council will not draw any adverse inference 
if CMS or a contractor either participates, or decides not to 
participate in Council review.

[70 FR 11472, Mar. 8, 2005, as amended at 82 FR 5123, Jan. 17, 2017]



Sec.  405.1122  What evidence may be submitted to the Council.

    (a) Appeal before the Council on request for review of ALJ's or 
attorney adjudicator's decision. (1) If the Council is reviewing an 
ALJ's or attorney adjudicator's decision, the Council limits its review 
of the evidence to the evidence contained in the record of the 
proceedings before the ALJ or attorney adjudicator. However, if the 
ALJ's or attorney adjudicator's decision decides a new issue that the 
parties were not afforded an opportunity to address at the OMHA level, 
the Council considers any evidence related to that issue that is 
submitted with the request for review.
    (2) If the Council determines that additional evidence is needed to 
resolve the issues in the case and the administrative record indicates 
that the previous decision-makers have not attempted to obtain the 
evidence, the Council may remand the case to an ALJ or attorney 
adjudicator to obtain the evidence and issue a new decision.
    (b) Appeal before Council as a result of appellant's request for 
escalation. (1) If the Council is reviewing a case that is escalated 
from the OMHA level to the Council, the Council will decide the case 
based on the record constructed at the QIC and any additional evidence, 
including oral testimony, entered in the record by the ALJ or attorney 
adjudicator before the case was escalated.
    (2) If the Council receives additional evidence with the request for 
escalation that is material to the question to be decided, or determines 
that additional evidence is needed to resolve the issues in the case, 
and the record provided to the Council indicates that the previous 
decision-makers did not attempt to obtain the evidence before 
escalation, the Council may remand the case to an ALJ or attorney 
adjudicator to consider or obtain the evidence and issue a new decision.
    (c) Evidence related to issues previously considered by the QIC. (1) 
If new evidence related to issues previously considered by the QIC is 
submitted to the Council by a provider, supplier, or a beneficiary 
represented by a provider or supplier, the Council must determine if the 
provider, supplier, or the beneficiary represented by a provider or 
supplier had good cause for submitting it for the first time at the 
Council level.
    (2) If the Council determines that good cause does not exist, the 
Council must exclude the evidence from the proceeding, may not consider 
it in reaching a decision, and may not remand the issue to an ALJ or 
attorney adjudicator.
    (3) The Council must notify all parties if it excludes the evidence. 
The Council may remand to an ALJ or attorney adjudicator if--

[[Page 230]]

    (i) The ALJ or attorney adjudicator did not consider the new 
evidence submitted by the provider, supplier, or beneficiary represented 
by a provider or supplier because good cause did not exist; and
    (ii) The Council finds that good cause existed under Sec.  405.1028 
and the ALJ or attorney adjudicator should have reviewed the evidence.
    (iii) The new evidence is submitted by a party that is not a 
provider, supplier, or a beneficiary represented by a provider or 
supplier.
    (d) Subpoenas. (1) Except as provided in this section, when it is 
reasonably necessary for the full presentation of a case, the Council 
may, on its own initiative or at the request of a party, issue subpoenas 
requiring a party to make books, records, correspondence, papers, or 
other documents that are material to an issue at the hearing available 
for inspection and copying. The Council may not issue a subpoena to CMS 
or its contractors, on its own initiative or at the request of a party, 
to compel the production of evidence.
    (2) A party's request for a subpoena must--
    (i) Give a sufficient description of the documents to be produced;
    (ii) State the important facts that the documents are expected to 
prove; and
    (iii) Indicate why these facts could not be proven without issuing a 
subpoena.
    (3) A party to the Council review on escalation that wishes to 
subpoena documents must file a written request that complies with the 
requirements set out in paragraph (d)(2) of this section within 10 
calendar days of the request for escalation.
    (4) A subpoena will issue only where a party--
    (i) Has sought discovery;
    (ii) Has filed a motion to compel;
    (iii) Has had that motion granted; and
    (iv) Nevertheless, has still not received the requested discovery.
    (e) Reviewability of subpoena rulings--
    (1) General rule. A Council ruling on a subpoena request is not 
subject to immediate review by the Secretary.
    (2) Exception. To the extent a subpoena compels disclosure of a 
matter for which an objection based on privilege, or other protection 
from disclosure such as case preparation, confidentiality, or undue 
burden, was made before the Council, the Secretary may review 
immediately that subpoena or portion of the subpoena.
    (3) Upon notice to the Council that a party or non-party, as 
applicable, intends to seek Secretary review of the subpoena, the 
Council must stay all proceedings affected by the subpoena.
    (4) The Council determines the length of the stay under the 
circumstances of a given case, but in no event is less than 15 calendar 
days after the day on which the Council received notice of the party or 
non-party's intent to seek Secretary review.
    (5) If the Secretary grants a request for review, the subpoena or 
portion of the subpoena, as applicable, is stayed until the Secretary 
issues a written decision that affirms, reverses, modifies, or remands 
the Council's action for the subpoena.
    (6) If the Secretary does not grant review or take own motion review 
within the time allotted for the stay, the stay is lifted and the 
Council's action stands.
    (f) Enforcement. (1) If the Council determines, whether on its own 
motion or at the request of a party, that a party or non-party subject 
to a subpoena issued under this section has refused to comply with the 
subpoena, the Council may request the Secretary to seek enforcement of 
the subpoena in accordance with section 205(e) of the Act, 42 U.S.C. 
405(e).
    (2) Any enforcement request by the Council must consist of a written 
notice to the Secretary describing in detail the Council's findings of 
noncompliance and its specific request for enforcement, and providing a 
copy of the subpoena and evidence of its receipt by certified mail by 
the party or nonparty subject to the subpoena.
    (3) The Council must promptly mail a copy of the notice and related 
documents to the party or non-party subject to the subpoena, and to any 
other party and affected non-party to the appeal.

[[Page 231]]

    (4) If the Secretary does not grant review or take own motion review 
within the time allotted for the stay, the stay is lifted and the 
subpoena stands.

[70 FR 11472, Mar. 8, 2005, as amended at 74 FR 65337, Dec. 9, 2009; 82 
FR 5123, Jan. 17, 2017]



Sec.  405.1124  Oral argument.

    A party may request to appear before the Council to present oral 
argument.
    (a) The Council grants a request for oral argument if it decides 
that the case raises an important question of law, policy, or fact that 
cannot be readily decided based on written submissions alone.
    (b) The Council may decide on its own that oral argument is 
necessary to decide the issues in the case. If the Council decides to 
hear oral argument, it tells the parties of the time and place of the 
oral argument at least 10 calendar days before the scheduled date.
    (c) In case of a previously unrepresented beneficiary, a newly hired 
representative may request an extension of time for preparation of the 
oral argument and the Council must consider whether the extension is 
reasonable.
    (d) The Council may also request, but not require, CMS or its 
contractor to appear before it if the Council determines that it may be 
helpful in resolving the issues in the case.
    (e) The Council will not draw any inference if CMS or a contractor 
decides not to participate in the oral argument.

[70 FR 11472, Mar. 8, 2005, as amended at 74 FR 65338, Dec. 9, 2009; 82 
FR 5124, Jan. 17, 2017]



Sec.  405.1126  Case remanded by the Council.

    (a) When the Council may remand a case. Except as specified in Sec.  
405.1122(c), the Council may remand a case in which additional evidence 
is needed or additional action by the ALJ or attorney adjudicator is 
required. The Council will designate in its remand order whether the ALJ 
or attorney adjudicator will issue a decision or a recommended decision 
on remand.
    (b) Action by ALJ on remand. The ALJ or attorney adjudicator will 
take any action that is ordered by the Council and may take any 
additional action that is not inconsistent with the Council's remand 
order.
    (c) Notice when case is returned with a recommended decision. When 
the ALJ or attorney adjudicator sends a case to the Council with a 
recommended decision, a notice is mailed to the parties at their last 
known address. The notice tells them that the case was sent to the 
Council, explains the rules for filing briefs or other written 
statements with the Council, and includes a copy of the recommended 
decision.
    (d) Filing briefs with the Council when ALJ or attorney adjudicator 
issues recommended decision. (1) Any party to the recommended decision 
may file with the Council briefs or other written statements about the 
facts and law relevant to the case within 20 calendar days of the date 
on the recommended decision. Any party may ask the Council for 
additional time to file briefs or statements. The Council will extend 
this period, as appropriate, if the party shows that it has good cause 
for requesting the extension.
    (2) All other rules for filing briefs with and obtaining evidence 
from the Council follow the procedures explained in this subpart.
    (e) Procedures before the Council. (1) The Council, after receiving 
a recommended decision, will conduct proceedings and issue its decision 
or dismissal according to the procedures explained in this subpart.
    (2) If the Council determines that more evidence is required, it may 
again remand the case to an ALJ or attorney adjudicator for further 
inquiry into the issues, rehearing if applicable, receipt of evidence, 
and another decision or recommended decision. However, if the Council 
decides that it can get the additional evidence more quickly, it will 
take appropriate action.

[70 FR 11472, Mar. 8, 2005, as amended at 74 FR 65338, Dec. 9, 2009; 82 
FR 5124, Jan. 17, 2017]



Sec.  405.1128  Action of the Council.

    (a) After it has reviewed all the evidence in the administrative 
record and any additional evidence received, subject to the limitations 
on Council consideration of additional evidence in

[[Page 232]]

Sec.  405.1122, the Council will make a decision or remand the case to 
an ALJ or attorney adjudicator.
    (b) The Council may adopt, modify, or reverse the ALJ's or attorney 
adjudicator's decisionor recommended decision.
    (c) The Council mails a copy of its decision to all the parties at 
their last known addresses. For overpayment cases involving multiple 
beneficiaries where there is no beneficiary liability the Council may 
choose to send written notice only to the appellant. In the event the 
decision will result in a payment to a provider or supplier, the 
Medicare contractor must issue any electronic or paper remittance advice 
notice to that provider or supplier.

[70 FR 11472, Mar. 8, 2005, as amended at 82 FR 5124, Jan. 17, 2017]



Sec.  405.1130  Effect of the Council's decision.

    The Council's decision is final and binding on all parties unless a 
Federal district court issues a decision modifying the Council's 
decision or the decision is revised as the result of a reopening in 
accordance with Sec.  405.980. A party may file an action in a Federal 
district court within 60 calendar days after the date it receives notice 
of the Council's decision.

[74 FR 65338, Dec. 9, 2009, as amended at 82 FR 5124, Jan. 17, 2017]



Sec.  405.1132  Request for escalation to Federal court.

    (a) If the Council does not issue a decision or dismissal or remand 
the case to an ALJ or attorney adjudicator within the adjudication 
period specified in Sec.  405.1100, or as extended as provided in this 
subpart, the appellant may request that the appeal, other than an appeal 
of an ALJ or attorney adjudicator dismissal, be escalated to Federal 
district court. Upon receipt of a request for escalation, the Council 
may--
    (1) Issue a decision or dismissal or remand the case to an ALJ or 
attorney adjudicator, if that action is issued within the latter of 5 
calendar days of receipt of the request for escalation or 5 calendar 
days from the end of the applicable adjudication time period set forth 
in Sec.  405.1100; or
    (2) If the Council is not able to issue a decision or dismissal or 
remand as set forth in paragraph (a)(1) of this section, it will send a 
notice to the appellant acknowledging receipt of the request for 
escalation and confirming that it is not able to issue a decision, 
dismissal or remand order within the statutory time frame.
    (b) A party may file an action in a Federal district court within 60 
calendar days after the date it receives the Council's notice that the 
Council is not able to issue a final decision, dismissal order, or 
remand order unless the party is appealing an ALJ or attorney 
adjudicator dismissal.

[70 FR 11472, Mar. 8, 2005, as amended at 74 FR 65338, Dec. 9, 2009; 82 
FR 5124, Jan. 17, 2017]



Sec.  405.1134  Extension of time to file action in Federal district court.

    (a) Any party to the Council's decision or to a request for EAJR 
that has been certified by the review entity other than CMS may request 
that the time for filing an action in a Federal district court be 
extended.
    (b) The request must--
    (1) Be in writing.
    (2) Give the reasons why the action was not filed within the stated 
time period.
    (3) Be filed with the Council.
    (c) If the party shows that he or she had good cause for missing the 
deadline, the time period will be extended. To determine whether good 
cause exists, the Council uses the standards specified in Sec.  
405.942(b)(2) or (b)(3).

[70 FR 11472, Mar. 8, 2005, as amended at 82 FR 5124, Jan. 17, 2017]



Sec.  405.1136  Judicial review.

    (a) General rules. (1) To the extent authorized by sections 1869, 
1876(c)(5)(B), and 1879(d) of the Act, a party to a Council decision, or 
an appellant who requests escalation to Federal district court if the 
Council does not complete its review of the ALJ's or attorney 
adjudicator's decision within the applicable adjudication period, may 
obtain a court review if the amount remaining in controversy satisfies 
the requirements of Sec.  405.1006(c).
    (2) If the Council's adjudication period set forth in Sec.  405.1100 
expires and

[[Page 233]]

the appellant does not request escalation to Federal district court, the 
case remains with the Council until a final decision, dismissal order, 
or remand order is issued.
    (b) Court in which to file civil action. (1) Any civil action 
described in paragraph (a) of this section must be filed in the district 
court of the United States for the judicial district in which the party 
resides or where such individual, institution, or agency has its 
principal place of business.
    (2) If the party does not reside within any judicial district, or if 
the individual, institution, or agency does not have its principal place 
of business within any such judicial district, the civil action must be 
filed in the District Court of the United States for the District of 
Columbia.
    (c) Time for filing civil action. (1) Any civil action described in 
paragraph (a) of this section must be filed within the time periods 
specified in Sec.  405.1130, Sec.  405.1132, or Sec.  405.1134, as 
applicable.
    (2) For purposes of this section, the date of receipt of the notice 
of the Council's decision or the Council's notice that it is not able to 
issue a decision within the statutory timeframe shall be presumed to be 
5 calendar days after the date of the notice, unless there is a 
reasonable showing to the contrary.
    (3) Where a case is certified for judicial review in accordance with 
the expedited access to judicial review process in Sec.  405.990, the 
civil action must be filed within 60 calendar days after receipt of the 
review entity's certification, except where the time is extended by the 
ALJ or attorney adjudicator or Council, as applicable, upon a showing of 
good cause.
    (d) Proper defendant. (1) In any civil action described in paragraph 
(a) of this section, the Secretary of HHS, in his or her official 
capacity, is the proper defendant. Any civil action properly filed shall 
survive notwithstanding any change of the person holding the Office of 
the Secretary of HHS or any vacancy in such office.
    (2) If the complaint is erroneously filed against the United States 
or against any agency, officer, or employee of the United States other 
than the Secretary, the plaintiff will be notified that he or she has 
named an incorrect defendant and is granted 60 calendar days from the 
date of receipt of the notice in which to commence the action against 
the correct defendant, the Secretary.
    (e) Prohibition against judicial review of certain Part B 
regulations or instructions. Under section 1869(e)(1) of the Act, a 
court may not review a regulation or instruction that relates to a 
method of payment under Medicare Part B if the regulation was published, 
or the instructions issued, before January 1, 1991.
    (f) Standard of review. (1) Under section 205(g) of the Act, the 
findings of the Secretary of HHS as to any fact, if supported by 
substantial evidence, are conclusive.
    (2) When the Secretary's decision is adverse to a party due to a 
party's failure to submit proof in conformity with a regulation 
prescribed under section 205(a) of the Act pertaining to the type of 
proof a party must offer to establish entitlement to payment, the court 
will review only whether the proof conforms with the regulation and the 
validity of the regulation.

[70 FR 11472, Mar. 8, 2005, as amended at 70 FR 37705, June 30, 2005; 74 
FR 65338, Dec. 9, 2009; 82 FR 5124, Jan. 17, 2017]



Sec.  405.1138  Case remanded by a Federal district court.

    When a Federal district court remands a case to the Secretary for 
further consideration, unless the court order specifies otherwise, the 
Council, acting on behalf of the Secretary, may make a decision, or it 
may remand the case to an ALJ or attorney adjudicator with instructions 
to take action and either issue a decision, take other action, or return 
the case to the Council with a recommended decision. If the Council 
remands a case, the procedures specified in Sec.  405.1140 will be 
followed.

[70 FR 11472, Mar. 8, 2005, as amended at 82 FR 5124, Jan. 17, 2017]



Sec.  405.1140  Council review of ALJ decision in a case remanded 
by a Federal district court.

    (a) General rules. (1) In accordance with Sec.  405.1138, when a 
case is remanded by a Federal district court for further consideration 
and the Council remands

[[Page 234]]

the case to an ALJ or attorney adjudicator, a decision subsequently 
issued by the ALJ becomes the final decision of the Secretary unless the 
Council assumes jurisdiction.
    (2) The Council may assume jurisdiction based on written exceptions 
to the decision of the ALJ or attorney adjudicator that a party files 
with the Council or based on its authority under paragraph (c) of this 
section.
    (3) The Council either makes a new, independent decision based on 
the entire record that will be the final decision of the Secretary after 
remand, or remands the case to an ALJ or attorney adjudicator for 
further proceedings.
    (b) A party files exceptions disagreeing with the decision of the 
ALJ or attorney adjudicator. (1) If a party disagrees with an ALJ or 
attorney adjudicator decision described in paragraph (a) of this 
section, in whole or in part, he or she may file exceptions to the 
decision with the Council. Exceptions may be filed by submitting a 
written statement to the Council setting forth the reasons for 
disagreeing with the decision of the ALJ or attorney adjudicator. The 
party must file exceptions within 30 calendar days of the date the party 
receives the decision of the ALJ or attorney adjudicator or submit a 
written request for an extension within the 30 calendar day period. The 
Council will grant a timely request for a 30 calendar day extension. A 
request for an extension of more than 30 calendar days must include a 
statement of reasons as to why the party needs the additional time and 
may be granted if the Council finds good cause under the standard 
established in Sec.  405.942(b)(2) or (b)(3).
    (2) If written exceptions are timely filed, the Council considers 
the party's reasons for disagreeing with the decision of the ALJ or 
attorney adjudicator. If the Council concludes that there is no reason 
to change the decision of the ALJ or attorney adjudicator, it will issue 
a notice addressing the exceptions and explaining why no change in the 
decision of the ALJ or attorney adjudicator is warranted. In this 
instance, the decision of the ALJ or attorney adjudicator is the final 
decision of the Secretary after remand.
    (3) When a party files written exceptions to the decision of the 
ALJ, the Council may assume jurisdiction at any time. If the Council 
assumes jurisdiction, it makes a new, independent decision based on its 
consideration of the entire record adopting, modifying, or reversing the 
decision of the ALJ or attorney adjudicator or remanding the case to an 
ALJ or attorney adjudicator for further proceedings, including a new 
decision. The new decision of the Council is the final decision of the 
Secretary after remand.
    (c)  Council assumes jurisdiction without exceptions being filed. 
(1) Any time within 60 calendar days after the date of the decision of 
the ALJ or attorney adjudicator, the Council may decide to assume 
jurisdiction of the case even though no written exceptions have been 
filed.
    (2) Notice of this action is mailed to all parties at their last 
known address.
    (3) The parties will be provided with the opportunity to file briefs 
or other written statements with the Council about the facts and law 
relevant to the case.
    (4) After the briefs or other written statements are received or the 
time allowed (usually 30 calendar days) for submitting them has expired, 
the Council will either issue a final decision of the Secretary 
affirming, modifying, or reversing the decision of the ALJ, or remand 
the case to an ALJ or attorney adjudicator for further proceedings, 
including a new decision.
    (d) Exceptions are not filed and the Council does not otherwise 
assume jurisdiction. If no exceptions are filed and the Council does not 
assume jurisdiction of the cases within 60 calendar days after the date 
of the ALJ's or attorney adjudicator's decision, the decision of the ALJ 
or attorney adjudicator becomes the final decision of the Secretary 
after remand.

[70 FR 11472, Mar. 8, 2005, as amended at 74 FR 65338, Dec. 9, 2009; 82 
FR 5124, Jan. 17, 2017]

[[Page 235]]



  Subpart J_Expedited Determinations and Reconsiderations of Provider 
 Service Terminations, and Procedures for Inpatient Hospital Discharges

    Source: 69 FR 69624, Nov. 26, 2004, unless otherwise noted.



Sec.  405.1200  Notifying beneficiaries of provider service terminations.

    (a) Applicability and scope. (1) For purposes of Sec. Sec.  405.1200 
through 405.1204, the term, provider, is defined as a home health agency 
(HHA), skilled nursing facility (SNF), comprehensive outpatient 
rehabilitation facility (CORF), or hospice.
    (2) For purposes of Sec. Sec.  405.1200 through 405.1204, a 
termination of Medicare-covered service is a discharge of a beneficiary 
from a residential provider of services, or a complete cessation of 
coverage at the end of a course of treatment prescribed in a discrete 
increment, regardless of whether the beneficiary agrees that the 
services should end. A termination does not include a reduction in 
services. A termination also does not include the termination of one 
type of service by the provider if the beneficiary continues to receive 
other Medicare-covered services from the provider.
    (b) Advance written notice of service terminations. Before any 
termination of services, the provider of the service must deliver valid 
written notice to the beneficiary of the provider's decision to 
terminate services. The provider must use a standardized notice, as 
specified by CMS, in accordance with the following procedures:
    (1) Timing of notice. A provider must notify the beneficiary of the 
decision to terminate covered services no later than 2 days before the 
proposed end of the services. If the beneficiary's services are expected 
to be fewer than 2 days in duration, the provider must notify the 
beneficiary at the time of admission to the provider. If, in a non-
residential setting, the span of time between services exceeds 2 days, 
the notice must be given no later than the next to last time services 
are furnished.
    (2) Content of the notice. The standardized termination notice must 
include the following information:
    (i) The date that coverage of services ends;
    (ii) The date that the beneficiary's financial liability for 
continued services begins;
    (iii) A description of the beneficiary's right to an expedited 
determination under Sec.  405.1202, including information about how to 
request an expedited determination and about a beneficiary's right to 
submit evidence showing that services must continue;
    (iv) A beneficiary's right to receive the detailed information 
specified under Sec.  405.1202(f); and
    (v) Any other information required by CMS.
    (3) When delivery of the notice is valid. Delivery of the 
termination notice is valid if--
    (i) The beneficiary (or the beneficiary's authorized representative) 
has signed and dated the notice to indicate that he or she has received 
the notice and can comprehend its contents; and
    (ii) The notice is delivered in accordance with paragraph (b)(1) of 
this section and contains all the elements described in paragraph (b)(2) 
of this section.
    (4) If a beneficiary refuses to sign the notice. The provider may 
annotate its notice to indicate the refusal, and the date of refusal is 
considered the date of receipt of the notice.
    (5) Financial liability for failure to deliver valid notice. A 
provider is financially liable for continued services until 2 days after 
the beneficiary receives valid notice as specified under paragraph 
(b)(3) of this section, or until the service termination date specified 
on the notice, whichever is later. A beneficiary may waive continuation 
of services if he or she agrees with being discharged sooner than the 
planned service termination date.



Sec.  405.1202  Expedited determination procedures.

    (a) Beneficiary's right to an expedited determination by the QIO. A 
beneficiary has a right to an expedited determination by a QIO under the 
following circumstances:

[[Page 236]]

    (1) For services furnished by a non-residential provider, the 
beneficiary disagrees with the provider of those services that services 
should be terminated, and a physician certifies that failure to continue 
the provision of the service(s) may place the beneficiary's health at 
significant risk.
    (2) For services furnished by a residential provider or a hospice, 
the beneficiary disagrees with the provider's decision to discharge the 
beneficiary.
    (b) Requesting an expedited determination. (1) A beneficiary who 
wishes to exercise the right to an expedited determination must submit a 
request for a determination to the QIO in the State in which the 
beneficiary is receiving those provider services, in writing or by 
telephone, by no later than noon of the calendar day following receipt 
of the provider's notice of termination. If the QIO is unable to accept 
the beneficiary's request, the beneficiary must submit the request by 
noon of the next day the QIO is available to accept a request.
    (2) The beneficiary, or his or her representative, must be available 
to answer questions or to supply information that the QIO may request to 
conduct its review.
    (3) The beneficiary may, but is not required to, submit evidence to 
be considered by a QIO in making its decision.
    (4) If a beneficiary makes an untimely request for an expedited 
determination by a QIO, the QIO will accept the request and make a 
determination as soon as possible, but the 72-hour time frame under 
paragraph (e)(6) and the financial liability protection under paragraph 
(g) of this section do not apply.
    (c) Coverage of provider services. Coverage of provider services 
continues until the date and time designated on the termination notice, 
unless the QIO reverses the provider's service termination decision. If 
the QIO's decision is delayed because the provider did not timely supply 
necessary information or records, the provider may be liable for the 
costs of any additional coverage, as determined by the QIO in accordance 
with paragraph (e)(7) of this section. If the QIO finds that the 
beneficiary did not receive valid notice, coverage of provider services 
continues until at least 2 days after valid notice has been received. 
Continuation of coverage is not required if the QIO determines that 
coverage could pose a threat to the beneficiary's health or safety.
    (d) Burden of proof. When a beneficiary requests an expedited 
determination by a QIO, the burden of proof rests with the provider to 
demonstrate that termination of coverage is the correct decision, either 
on the basis of medical necessity, or based on other Medicare coverage 
policies.
    (1) In order for the QIO to determine whether the provider has met 
the burden of proof, the provider should supply any and all information 
that a QIO requires to sustain the provider's termination decision, 
consistent with paragraph (f) of this section.
    (2) The beneficiary may submit evidence to be considered by a QIO in 
making its decision.
    (e) Procedures the QIO must follow. (1) On the day the QIO receives 
the request for an expedited determination under paragraph (b) of this 
section, it must immediately notify the provider of those services that 
a request for an expedited determination has been made.
    (2) The QIO determines whether the provider delivered valid notice 
of the termination decision consistent with Sec.  405.1200(b) and 
paragraph (f) of this section.
    (3) The QIO examines the medical and other records that pertain to 
the services in dispute. If applicable, the QIO determines whether a 
physician has certified that failure to continue the provision of 
services may place the beneficiary's health at significant risk.
    (4) The QIO must solicit the views of the beneficiary who requested 
the expedited determination.
    (5) The QIO must provide an opportunity for the provider/
practitioner to explain why the termination or discharge is appropriate.
    (6) No later than 72 hours after receipt of the request for an 
expedited determination, the QIO must notify the beneficiary, 
beneficiary's physician, and the provider of services of its 
determination whether termination of

[[Page 237]]

Medicare coverage is the correct decision, either on the basis of 
medical necessity or based on other Medicare coverage policies.
    (7) If the QIO does not receive the information needed to sustain a 
provider's decision to terminate services, it may make its determination 
based on the evidence at hand, or it may defer a decision until it 
receives the necessary information. If this delay results in extended 
Medicare coverage of an individual's provider services, the provider may 
be held financially liable for these services, as determined by the QIO.
    (8) The QIO's initial notification may be by telephone, followed by 
a written notice including the following information:
    (i) The rationale for the determination;
    (ii) An explanation of the Medicare payment consequences of the 
determination and the date a beneficiary becomes fully liable for the 
services; and
    (iii) Information about the beneficiary's right to a reconsideration 
of the QIO's determination, including how to request a reconsideration 
and the time period for doing so.
    (f) Responsibilities of providers. (1) When a QIO notifies a 
provider that a beneficiary has requested an expedited determination, 
the provider must send a detailed notice to the beneficiary by close of 
business of the day of the QIO's notification. The detailed termination 
notice must include the following information:
    (i) A specific and detailed explanation why services are either no 
longer reasonable and necessary or are no longer covered;
    (ii) A description of any applicable Medicare coverage rule, 
instruction, or other Medicare policy, including citations to the 
applicable Medicare policy rules or information about how the 
beneficiary may obtain a copy of the Medicare policy;
    (iii) Facts specific to the beneficiary and relevant to the coverage 
determination that are sufficient to advise the beneficiary of the 
applicability of the coverage rule or policy to the beneficiary's case; 
and
    (iv) Any other information required by CMS.
    (2) Upon notification by the QIO of the request for an expedited 
determination, the provider must supply all information that the QIO 
needs to make its expedited determination, including a copy of the 
notices required under Sec.  405.1200(b) and under paragraph (f)(1) of 
this section. The provider must furnish this information as soon as 
possible, but no later than by close of business of the day the QIO 
notifies the provider of the request for an expedited determination. At 
the discretion of the QIO, the provider may make the information 
available by phone or in writing (with a written record of any 
information not transmitted initially in writing).
    (3) At a beneficiary's request, the provider must furnish the 
beneficiary with a copy of, or access to, any documentation that it 
sends to the QIO including records of any information provided by 
telephone. The provider may charge the beneficiary a reasonable amount 
to cover the costs of duplicating the documentation and/or delivering it 
to the beneficiary. The provider must accommodate such a request by no 
later than close of business of the first day after the material is 
requested.
    (g) Coverage during QIO review. When a beneficiary requests an 
expedited determination in accordance with the procedures required by 
this section, the provider may not bill the beneficiary for any disputed 
services until the expedited determination process (and reconsideration 
process, if applicable) has been completed.



Sec.  405.1204  Expedited reconsiderations.

    (a) Beneficiary's right to an expedited reconsideration. A 
beneficiary who is dissatisfied with a QIO's expedited determination may 
request an expedited reconsideration by the appropriate QIC.
    (b) Requesting an expedited reconsideration. (1) A beneficiary who 
wishes to obtain an expedited reconsideration must submit a request for 
the reconsideration to the appropriate QIC, in writing or by telephone, 
by no later than noon of the calendar day following initial notification 
(whether by telephone

[[Page 238]]

or in writing) receipt of the QIO's determination. If the QIC is unable 
to accept the beneficiary's request, the beneficiary must submit the 
request by noon of the next day the QIC is available to accept a 
request.
    (2) The beneficiary, or his or her representative, must be available 
to answer questions or supply information that the QIC may request to 
conduct its reconsideration.
    (3) The beneficiary may, but is not required to, submit evidence to 
be considered by a QIC in making its decision.
    (4) A beneficiary who does not file a timely request for an 
expedited QIC reconsideration subsequently may request a reconsideration 
under the standard claims appeal process, but the coverage protections 
described in paragraph (f) of this section would not extend through this 
reconsideration, nor would the timeframes or the escalation process 
described in paragraphs (c)(3) and (c)(5) of this section, respectively.
    (c) Procedures the QIC must follow. (1) On the day the QIC receives 
the request for an expedited determination under paragraph (b) of this 
section, the QIC must immediately notify the QIO that made the expedited 
determination and the provider of services of the request for an 
expedited reconsideration.
    (2) The QIC must offer the beneficiary and the provider an 
opportunity to provide further information.
    (3) Unless the beneficiary requests an extension in accordance with 
paragraph (c)(6) of this section, no later than 72 hours after receipt 
of the request for an expedited reconsideration, and any medical or 
other records needed for such reconsideration, the QIC must notify the 
QIO, the beneficiary, the beneficiary's physician, and the provider of 
services, of its decision on the reconsideration request.
    (4) The QIC's initial notification may be done by telephone, 
followed by a written notice including:
    (i) The rationale for the reconsideration decision;
    (ii) An explanation of the Medicare payment consequences of the 
determination and the beneficiary's date of liability; and
    (iii) Information about the beneficiary's right to appeal the QIC's 
reconsideration decision to OMHA for an ALJ hearing in accordance with 
subpart I of this part, including how to request an appeal and the time 
period for doing so.
    (5) Unless the beneficiary requests an extension in accordance with 
paragraph (c)(6) of this section, if the QIC does not issue a decision 
within 72 hours of receipt of the request, the QIC must notify the 
beneficiary of his or her right to have the case escalated to OMHA for 
an ALJ hearing in accordance with subpart I of this part, if the amount 
remaining in controversy after the QIO determination meets the 
requirements for an ALJ hearing under Sec.  405.1006.
    (6) A beneficiary requesting an expedited reconsideration under this 
section may request (either in writing or orally) that the QIC grant 
such additional time as the beneficiary specifies (not to exceed 14 
days) for the reconsideration. If an extension is granted, the deadlines 
in paragraph (c)(3) of this section do not apply.
    (d) Responsibilities of the QIO. (1) When a QIC notifies a QIO that 
a beneficiary has requested an expedited reconsideration, the QIO must 
supply all information that the QIC needs to make its expedited 
reconsideration as soon as possible, but no later than by close of 
business of the day that the QIC notifies the QIO of the request for an 
expedited reconsideration.
    (2) At a beneficiary's request, the QIO must furnish the beneficiary 
with a copy of, or access to, any documentation that it sends to the 
QIC. The QIO may charge the beneficiary a reasonable amount to cover the 
costs of duplicating the documentation and/or delivering it to the 
beneficiary. The QIO must accommodate the request by no later than close 
of business of the first day after the material is requested.
    (e) Responsibilities of the provider. A provider may, but is not 
required to, submit evidence to be considered by a QIC in making its 
decision. If a provider fails to comply with a QIC's request for 
additional information beyond that furnished to the QIO for purposes of 
the expedited determination, the QIC makes its reconsideration decision 
based on the information available.

[[Page 239]]

    (f) Coverage during QIC reconsideration process. When a beneficiary 
requests an expedited reconsideration in accordance with the deadline 
specified in (b)(1) of this section, the provider may not bill the 
beneficiary for any disputed services until the QIC makes its 
determination.

[69 FR 69624, Nov. 26, 2004, as amended at 82 FR 5124, Jan. 17, 2017]



Sec.  405.1205  Notifying beneficiaries of hospital discharge appeal rights.

    (a) Applicability and scope. (1) For purposes of Sec. Sec.  
405.1204, 405.1205, 405.1206, and 405.1208, the term ``hospital'' is 
defined as any facility providing care at the inpatient hospital level, 
whether that care is short term or long term, acute or non acute, paid 
through a prospective payment system or other reimbursement basis, 
limited to specialty care or providing a broader spectrum of services. 
This definition includes critical access hospitals.
    (2) For purposes of Sec. Sec.  405.1204, 405.1205, 405.1206, and 
405.1208, a discharge is a formal release of a beneficiary from an 
inpatient hospital.
    (b) Advance written notice of hospital discharge rights. For all 
Medicare beneficiaries, hospitals must deliver valid, written notice of 
a beneficiary's rights as a hospital inpatient, including discharge 
appeal rights. The hospital must use a standardized notice, as specified 
by CMS, in accordance with the following procedures:
    (1) Timing of notice. The hospital must provide the notice at or 
near admission, but no later than 2 calendar days following the 
beneficiary's admission to the hospital.
    (2) Content of the notice. The notice must include the following 
information:
    (i) The beneficiary's rights as a hospital inpatient including the 
right to benefits for inpatient services and for post-hospital services 
in accordance with 1866(a)(1)(M) of the Act.
    (ii) The beneficiary's right to request an expedited determination 
of the discharge decision including a description of the process under 
Sec.  405.1206, and the availability of other appeals processes if the 
beneficiary fails to meet the deadline for an expedited determination.
    (iii) The circumstances under which a beneficiary will or will not 
be liable for charges for continued stay in the hospital in accordance 
with 1866(a)(1)(M) of the Act.
    (iv) A beneficiary's right to receive additional detailed 
information in accordance with Sec.  405.1206(e).
    (v) Any other information required by CMS.
    (3) When delivery of the notice is valid. Delivery of the written 
notice of rights described in this section is valid if--
    (i) The beneficiary (or the beneficiary's representative) has signed 
and dated the notice to indicate that he or she has received the notice 
and can comprehend its contents, except as provided in paragraph (b)(4) 
of this section; and
    (ii) The notice is delivered in accordance with paragraph (b)(1) of 
this section and contains all the elements described in paragraph (b)(2) 
of this section.
    (4) If a beneficiary refuses to sign the notice. The hospital may 
annotate its notice to indicate the refusal, and the date of refusal is 
considered the date of receipt of the notice.
    (c) Follow up notification. (1) The hospital must present a copy of 
the signed notice described in paragraph (b)(2) of this section to the 
beneficiary (or beneficiary's representative) prior to discharge. The 
notice should be given as far in advance of discharge as possible, but 
not more than 2 calendar days before discharge.
    (2) Follow up notification is not required if the notice required 
under Sec.  405.1205(b) is delivered within 2 calendar days of 
discharge.

[71 FR 68720, Nov. 27, 2006]



Sec.  405.1206  Expedited determination procedures for inpatient hospital care.

    (a) Beneficiary's right to an expedited determination by the QIO. A 
beneficiary has a right to request an expedited determination by the QIO 
when a hospital (acting directly or through its utilization review 
committee), with physician concurrence, determines that inpatient care 
is no longer necessary.

[[Page 240]]

    (b) Requesting an expedited determination. (1) A beneficiary who 
wishes to exercise the right to an expedited determination must submit a 
request to the QIO that has an agreement with the hospital as specified 
in Sec.  476.78 of this chapter. The request must be made no later than 
the day of discharge and may be in writing or by telephone.
    (2) The beneficiary, or his or her representative, upon request by 
the QIO, must be available to discuss the case.
    (3) The beneficiary may, but is not required to, submit written 
evidence to be considered by a QIO in making its decision.
    (4) A beneficiary who makes a timely request for an expedited QIO 
review in accordance with paragraph (b)(1) of this section is subject to 
the financial liability protections under paragraphs (f)(1) and (f)(2) 
of this section, as applicable.
    (5) A beneficiary who fails to make a timely request for an 
expedited determination by a QIO, as described in paragraph (b)(1) of 
this section, and remains in the hospital without coverage, still may 
request an expedited QIO determination at any time during the 
hospitalization. The QIO will issue a decision in accordance with 
paragraph (d)(6)(ii) of this section, however, the financial liability 
protection under paragraphs (f)(1) and (f)(2) of this section does not 
apply.
    (6) A beneficiary who fails to make a timely request for an 
expedited determination in accordance with paragraph (b)(1) of this 
section, and who is no longer an inpatient in the hospital, may request 
QIO review within 30 calendar days after the date of discharge, or at 
any time for good cause. The QIO will issue a decision in accordance 
with paragraph (d)(6)(iii) of this section; however, the financial 
liability protection under paragraphs (f)(1) and (f)(2) of this section 
does not apply.
    (c) Burden of proof. When a beneficiary (or his or her 
representative, if applicable) requests an expedited determination by a 
QIO, the burden of proof rests with the hospital to demonstrate that 
discharge is the correct decision, either on the basis of medical 
necessity, or based on other Medicare coverage policies. Consistent with 
paragraph (e)(2) of this section, the hospital should supply any and all 
information that a QIO requires to sustain the hospital's discharge 
determination.
    (d) Procedures the QIO must follow. (1) When the QIO receives the 
request for an expedited determination under paragraph (b)(1) of this 
section, it must immediately notify the hospital that a request for an 
expedited determination has been made.
    (2) The QIO determines whether the hospital delivered valid notice 
consistent with Sec.  405.1205(b)(3).
    (3) The QIO examines the medical and other records that pertain to 
the services in dispute.
    (4) The QIO must solicit the views of the beneficiary (or the 
beneficiary's representative) who requested the expedited determination.
    (5) The QIO must provide an opportunity for the hospital to explain 
why the discharge is appropriate.
    (6)(i) When the beneficiary requests an expedited determination in 
accordance with paragraph (b)(1) of this section, the QIO must make a 
determination and notify the beneficiary, the hospital, and physician of 
its determination within one calendar day after it receives all 
requested pertinent information.
    (ii) When the beneficiary makes an untimely request for an expedited 
determination, and remains in the hospital, consistent with paragraph 
(b)(5) of this section, the QIO will make a determination and notify the 
beneficiary, the hospital, and the physician of its determination within 
2 calendar days following receipt of the request and pertinent 
information.
    (iii) When the beneficiary makes an untimely request for an 
expedited determination, and is no longer an inpatient in the hospital, 
consistent with paragraph (b)(6) of this section, the QIO will make a 
determination and notify the beneficiary, the hospital, and physician of 
its determination within 30 calendar days after receipt of the request 
and pertinent information.
    (7) If the QIO does not receive the information needed to sustain a 
hospital's decision to discharge, it may make its determination based on 
the evidence at hand, or it may defer a decision until it receives the 
necessary

[[Page 241]]

information. If this delay results in extended Medicare coverage of an 
individual's hospital services, the hospital may be held financially 
liable for these services, as determined by the QIO.
    (8) When the QIO issues an expedited determination, the QIO must 
notify the beneficiary, the physician, and hospital of its decision by 
telephone, followed by a written notice that must include the following 
information:
    (i) The basis for the determination.
    (ii) A detailed rationale for the determination.
    (iii) An explanation of the Medicare payment consequences of the 
determination and the date a beneficiary becomes fully liable for the 
services.
    (iv) Information about the beneficiary's right to a reconsideration 
of the QIO's determination as set forth in Sec.  405.1204, including how 
to request a reconsideration and the time period for doing so.
    (e) Responsibilities of hospitals. (1) When a QIO notifies a 
hospital that a beneficiary has requested an expedited determination, 
the hospital must deliver a detailed notice to the beneficiary as soon 
as possible but no later than noon of the day after the QIO's 
notification. The detailed notice must include the following 
information:
    (i) A detailed explanation why services are either no longer 
reasonable and necessary or are otherwise no longer covered.
    (ii) A description of any applicable Medicare coverage rule, 
instruction, or other Medicare policy, including information about how 
the beneficiary may obtain a copy of the Medicare policy.
    (iii) Facts specific to the beneficiary and relevant to the coverage 
determination that are sufficient to advise the beneficiary of the 
applicability of the coverage rule or policy to the beneficiary's case.
    (iv) Any other information required by CMS.
    (2) Upon notification by the QIO of the request for an expedited 
determination, the hospital must supply all information that the QIO 
needs to make its expedited determination, including a copy of the 
notices required as specified in Sec.  405.1205 (b) and (c) and 
paragraph (e)(1) of this section. The hospital must furnish this 
information as soon as possible, but no later than by noon of the day 
after the QIO notifies the hospital of the request for an expedited 
determination. At the discretion of the QIO, the hospital must make the 
information available by phone or in writing (with a written record of 
any information not transmitted initially in writing).
    (3) At a beneficiary's (or representative's) request, the hospital 
must furnish the beneficiary with a copy of, or access to, any 
documentation that it sends to the QIO, including written records of any 
information provided by telephone. The hospital may charge the 
beneficiary a reasonable amount to cover the costs of duplicating the 
documentation and/or delivering it to the beneficiary. The hospital must 
accommodate such a request by no later than close of business of the 
first day after the material is requested.
    (f) Coverage during QIO expedited review--(1) General rule and 
liability while QIO review is pending. If the beneficiary remains in the 
hospital past midnight of the discharge date ordered by the physician, 
and the hospital, the physician who concurred with the discharge 
determination, or the QIO subsequently finds that the beneficiary 
requires inpatient hospital care, the beneficiary is not financially 
responsible for continued care (other than applicable coinsurance and 
deductible) until the hospital once again determines that the 
beneficiary no longer requires inpatient care, secures concurrence from 
the physician responsible for the beneficiary's care or the QIO, and 
notifies the beneficiary with a notice consistent with 405.1205 (c).
    (2) Timely filing and limitation on liability. If a beneficiary 
files a request for an expedited determination by the QIO in accordance 
with paragraph (b)(1) of this section, the beneficiary is not 
financially responsible for inpatient hospital services (other than 
applicable coinsurance and deductible) furnished before noon of the 
calendar day after the date the beneficiary (or his or her 
representative) receives notification (either orally or in writing) of 
the expedited determination by the QIO.
    (3) Untimely request and liability. When a beneficiary does not file 
a request for

[[Page 242]]

an expedited determination by the QIO in accordance with paragraph (b) 
of this section, but remains in the hospital past the discharge date, 
that beneficiary may be held responsible for charges incurred after the 
date of discharge or as otherwise stated by the QIO.
    (4) Hospital requests an expedited review. When the hospital 
requests a review in accordance with Sec.  405.1208, and the QIO concurs 
with the hospital's discharge determination, a hospital may not charge 
the beneficiary until the date specified by the QIO.
    (g) Effect of an expedited QIO determination. The QIO determination 
is binding upon the beneficiary, physician, and hospital, except in the 
following circumstances:
    (1) Right to request a reconsideration. If the beneficiary is still 
an inpatient in the hospital and is dissatisfied with the determination, 
he or she may request a reconsideration according to the procedures 
described in Sec.  405.1204.
    (2) Right to pursue the general claims appeal process. If the 
beneficiary is no longer an inpatient in the hospital and is 
dissatisfied with this determination, the determination is subject to 
the general claims appeal process.

[71 FR 68721, Nov. 27, 2006]



Sec.  405.1208  Hospital requests expedited QIO review.

    (a) General rule. (1) If the hospital (acting directly or through 
its utilization review committee) believes that the beneficiary does not 
require further inpatient hospital care but is unable to obtain the 
agreement of the physician, it may request an expedited determination by 
the QIO.
    (2) When the hospital requests review, and the QIO concurs with the 
hospital's discharge determination, a hospital may not charge a 
beneficiary until the date specified by the QIO in accordance with 
405.1206(f)(4).
    (b) Procedures hospital must follow. (1) The hospital must (acting 
directly or through its utilization review committee) notify the 
beneficiary (or his or her representative) that it has requested that 
review.
    (2) The hospital must supply any pertinent information the QIO 
requires to conduct its review and must make it available by phone or in 
writing, by close of business of the first full working day immediately 
following the day the hospital submits the request for review.
    (c) Procedures the QIO must follow. (1) The QIO must notify the 
hospital that it has received the request for review and must notify the 
hospital if it has not received all pertinent records.
    (2) The QIO must examine the pertinent records pertaining to the 
services.
    (3) The QIO must solicit the views of the beneficiary in question.
    (4) The QIO must make a determination and notify the beneficiary, 
the hospital, and physician within 2 working days of the hospital's 
request and receipt of any pertinent information submitted by the 
hospital.
    (d) Notice of an expedited determination. (1) When a QIO issues an 
expedited determination as stated in paragraph (c)(4) of this section, 
it must notify the beneficiary, physician, and hospital of its decision, 
by telephone and subsequently in writing.
    (2) A written notice of the expedited initial determination must 
contain the following:
    (i) The basis for the determination;.
    (ii) A detailed rationale for the determination;
    (iii) A statement explaining the Medicare payment consequences of 
the expedited determination and date of liability, if any; and
    (iv) A statement informing the beneficiary of his or her appeal 
rights and the timeframe for requesting an appeal.
    (e) Effect of an expedited determination. The expedited 
determination under this section is binding upon the beneficiary, 
physician, and hospital, except in the following circumstances:
    (1) When a beneficiary remains in the hospital. If the beneficiary 
is still an inpatient in the hospital and is dissatisfied with this 
determination, he or she may request a reconsideration according to the 
procedures described in Sec.  405.1204. The procedures described in 
Sec.  405.1204 will apply to reconsiderations requested under this 
section. If the beneficiary does not make a request in accordance with 
Sec.  405.1204(b)(1), the timeframes described in Sec.  405.1204(c)(3), 
the escalation procedures described in

[[Page 243]]

Sec.  405.1204(c)(5), and the coverage rule described in Sec.  
405.1204(f) will not apply.
    (2) When a beneficiary is no longer an inpatient in the hospital. If 
the beneficiary is no longer an inpatient in the hospital and is 
dissatisfied with this determination, this determination is subject to 
the general claims appeal process.

[69 FR 69624, Nov. 26, 2004, as amended at 71 FR 68722, Nov. 27, 2006]

Subparts K-Q [Reserved]



       Subpart R_Provider Reimbursement Determinations and Appeals

    Authority: Secs. 205, 1102, 1814(b), 1815(a), 1833, 1861(v), 1871, 
1872, 1878, and 1886 of the Social Security Act (42 U.S.C. 405, 1302, 
1395f(b), 1395g(a), 1395l, 1395x(v), 1395hh, 1395ii, 1395oo, and 
1395ww).

    Source: 39 FR 34515, Sept. 26, 1974, unless otherwise noted. 
Redesignated at 42 FR 52826, Sept. 30, 1977.

    Editorial Note: Nomenclature changes to subpart R of part 405 appear 
at 79 FR 55031, Aug. 22, 2014.



Sec.  405.1801  Introduction.

    (a) Definitions. As used in this subpart:
    Administrator means the Administrator or Deputy Administrator of 
CMS.
    Administrator review means that review provided for in section 
1878(f) of the Act (42 U.S.C. 1395oo(f)) and Sec.  405.1875.
    Board means the Provider Reimbursement Review Board established in 
accordance with section 1878 of the Act (42 U.S.C. 1395oo) and Sec.  
405.1845.
    Board hearing means that hearing provided for in section 1878(a) of 
the Act (42 U.S.C. 1395oo(a)), and Sec.  405.1835.
    CMS reviewing official means the reviewing official provided for in 
Sec.  405.1834.
    CMS reviewing official procedure means the review provided for in 
Sec.  405.1834.
    Contractor determination means the following:
    (1) With respect to a provider of services that has filed a cost 
report under Sec. Sec.  413.20 and 413.24 of this chapter, the term 
means a final determination of the amount of total reimbursement due the 
provider, pursuant to Sec.  405.1803 following the close of the 
provider's cost reporting period, for items and services furnished to 
beneficiaries for which reimbursement may be made on a reasonable cost 
basis under Medicare for the period covered by the cost report.
    (2) With respect to a hospital that receives payments for inpatient 
hospital services under the prospective payment system (part 412 of this 
chapter), the term means a final determination of the total amount of 
payment due the hospital, pursuant to Sec.  405.1803 following the close 
of the hospital's cost reporting period, under that system for the 
period covered by the final determination.
    (3) For purposes of appeal to the Provider Reimbursement Review 
Board, the term is synonymous with the phrases ``intermediary's final 
determination,'' ``final determination of the organization serving as 
its fiscal intermediary,'' ``Secretary's final determination'' and 
``final determination of the Secretary,'' as those phrases are used in 
section 1878(a) of the Act, and with the phrases ``final contractor 
determination'' and ``final Secretary determination'' as those phrases 
are used in this subpart.
    (4) For purposes of Sec.  405.376 concerning claims collection 
activities, the term does not include an action by CMS with respect to a 
compromise of a Medicare overpayment claim, or termination or suspension 
of collection action on an overpayment claim, against a provider or 
physician or other supplier.
    Contractor hearing means that hearing provided for in Sec.  
405.1809.
    Contractor hearing officer(s) means the hearing officer or panel of 
hearing officers provided for in Sec.  405.1817.
    Date of receipt means the date a document or other material is 
received by either of the following:
    (1) A party or an affected nonparty. A party or an affected 
nonparty, such as CMS, involved in proceedings before a reviewing 
entity.
    (i) As applied to a party or an affected nonparty, the phrase ``date 
of receipt'' in this definition is synonymous with the term ``notice,'' 
as that term is

[[Page 244]]

used in section 1878 of the Act and in this subpart.
    (ii) For purposes of a contractor hearing, if no contractor hearing 
officer is appointed (or none is currently presiding), the date of 
receipt of materials sent to the contractor hearing officer (as 
permitted under paragraph (d) of this section) is presumed to be, as 
applicable, the date that the contractor stamps ``Received'' on the 
materials, or the date of electronic delivery.
    (iii) The date of receipt by a party or affected nonparty of 
documents involved in proceedings before a reviewing entity is presumed 
to be 5 days after the date of issuance of a contractor notice or a 
reviewing entity document. This presumption, which is otherwise 
conclusive, may be overcome if it is established by a preponderance of 
the evidence that such materials were actually received on a later date.
    (2) A reviewing entity. For purposes of this definition, a reviewing 
entity is deemed to include the Office of the Attorney Advisor. The 
determination as to the date of receipt by the reviewing entity to which 
the document or other material was submitted (as permitted under 
paragraph (d) of this section) is final and binding as to all parties to 
the appeal. The date of receipt of documents by a reviewing entity is 
presumed to be, as applicable, one of the following dates:
    (i) Of delivery where the document or material is transmitted by a 
nationally-recognized next-day courier (such as the United States Postal 
Service's Express Mail, Federal Express, UPS, DHL, etc.).
    (ii) Stamped ``Received'' by the reviewing entity on the document or 
other submitted material (where a nationally-recognized next-day courier 
is not employed). This presumption, which is otherwise conclusive, may 
be overcome if it is established by clear and convincing evidence that 
the document or other material was actually received on a different 
date.
    (iii) Of electronic delivery. In writing or written means a hard 
copy or electronic submission (subject to the restrictions in paragraph 
(d) of this section), as applicable throughout this subpart.
    Reviewing entity means the contractor hearing officer(s), a CMS 
reviewing official, the Board, or the Administrator.
    (b) General rules--(1) Providers. In order to be paid for covered 
services furnished to Medicare beneficiaries, a provider must file a 
cost report with its contractor as specified in Sec.  413.24 of this 
chapter. For purposes of this subpart, the term ``provider'' includes a 
hospital (as described in part 482 of this chapter), hospice program (as 
described in Sec.  418.3 of this chapter), critical access hospital 
(CAH), comprehensive outpatient rehabilitation facility (CORF), renal 
dialysis facility, Federally qualified health center (FQHC), home health 
agency (HHA), rural health clinic (RHC), skilled nursing facility (SNF), 
and any other entity included under the Act. (FQHCs and RHCs are 
providers, for purposes of this subpart, effective with cost reporting 
periods beginning on or after October 1, 1991).
    (2) Other nonprovider entities participating in Medicare Part A. (i) 
Providers of services, as well as, other entities (including, but not 
limited to health maintenance organizations (HMOs) and competitive 
medical plans (CMPs) (as described in Sec.  400.200 of this chapter)) 
may participate in the Medicare program, but do not qualify as providers 
under the Act or this subpart.
    (ii) Some of these nonprovider entities are required to file 
periodic cost reports and are paid on the basis of information furnished 
in these reports. Except as provided at Sec.  413.200(g), these 
nonprovider entities may not obtain a contractor hearing or a Board 
hearing under section 1878 of the Act or this subpart.
    (iii) Some other hearing will be available to these nonprovider 
entities, if the amount in controversy is at least $1,000.
    (iv) For any nonprovider hearing, the procedural rules for a Board 
hearing set forth in this subpart are applicable to the maximum extent 
possible.
    (c) Effective dates. (1) Except as provided in paragraphs (c)(2) and 
(c)(3) of this section or in Sec.  405.1885(e), this subpart applies to 
all cost reporting periods ending on or after December 31,

[[Page 245]]

1971, for which reimbursement may be made on a reasonable cost basis.
    (2) Sections 405.1835 to 405.1877 apply only to cost reporting 
periods ending on or after June 30, 1973, for which reimbursement may be 
made on a reasonable cost basis.
    (3) With respect to hospitals under the prospective payment system 
(see part 412 of this chapter), the appeals procedures in Sec. Sec.  
405.1811 to 405.1877 that apply become applicable with the hospital's 
first cost reporting period beginning on or after October 1, 1983.
    (d) Method for submissions and calculating time periods and 
deadlines. Except for subpoena requests being sent to a nonparty under 
Sec.  405.1857(c), the reviewing entity may prescribe the method(s) by 
which a party must make a submission, including the requirement to use 
an electronic filing system for submission of documents. Such methods or 
instructions apply to any period of time or deadline prescribed or 
allowed under this subpart (for example, requests for appeal under 
Sec. Sec.  405.1811(b), 405.1835(b), and 405.1837(c) and (e)) or 
authorized by a reviewing entity. In computing any period of time or 
deadline prescribed or allowed under this subpart or authorized by a 
reviewing entity the following principles are applicable:
    (1) The day of the act, event, or default from which the designated 
time period begins to run is not included.
    (2) Each succeeding calendar day, including the last day, is 
included in the designated time period, except that, in calculating a 
designated period of time for an act by a reviewing entity, a day is not 
included where the reviewing entity is unable to conduct business in the 
usual manner due to extraordinary circumstances beyond its control such 
as natural or other catastrophe, weather conditions, fire, or furlough. 
In that case, the designated time period resumes when the reviewing 
entity is again able to conduct business in the usual manner.
    (3) If the last day of the designated time period is a Saturday, a 
Sunday, a Federal legal holiday (as enumerated in Rule 6(a) of the 
Federal Rules of Civil Procedure), or a day on which the reviewing 
entity is unable to conduct business in the usual manner, the deadline 
becomes the next day that is not one of the aforementioned days.
    (4) For purposes of paragraph (d) of this section, the reviewing 
entity is deemed to also include--
    (i) The contractor, if the contractor hearing officer(s) is not yet 
appointed (or none is currently presiding); and
    (ii) The Office of the Attorney Advisor.

[39 FR 34515, Sept. 26, 1974. Redesignated at 42 FR 52826, Sept. 30, 
1977, as amended at 48 FR 39834, Sept. 1, 1983; 48 FR 45773, Oct. 7, 
1983; 49 FR 322, Jan. 3, 1984; 49 FR 23013, June 1, 1984; 51 FR 34793, 
Sept. 30, 1986; 61 FR 63749, Dec. 2, 1996; 73 FR 30243, May 23, 2008; 73 
FR 49356, Aug. 21, 2008; 80 FR 70597, Nov. 13, 2015; 85 FR 59018, Sept. 
18, 2020]



Sec.  405.1803  Contractor determination and notice of amount 
of program reimbursement.

    (a) General requirement. Upon receipt of a provider's cost report, 
or amended cost report where permitted or required, the contractor must 
within a reasonable period of time (as specified in Sec.  
405.1835(c)(1)), furnish the provider and other parties as appropriate 
(see Sec.  405.1805) a written notice reflecting the contractor's final 
determination of the total amount of reimbursement due the provider. The 
contractor must include the following information in the notice, as 
appropriate:
    (1) Reasonable cost. The notice must--
    (i) Explain the contractor's determination of total program 
reimbursement due the provider on the basis of reasonable cost for the 
reporting period covered by the cost report or amended cost report; and
    (ii) Relate this determination to the provider's claimed total 
program reimbursement due the provider for this period.
    (2) Prospective payment. With respect to a hospital that receives 
payments for inpatient hospital services under the prospective payment 
system (see part 412 of this chapter), the contractor must include in 
the notice its determination of the total amount of the payments due the 
hospital under that system for the cost reporting period covered by the 
notice. The notice must explain (with appropriate use of the applicable 
money amounts) any difference in the amount determined to be due, and 
the amounts received by the

[[Page 246]]

hospital during the cost reporting period covered by the notice.
    (3) Hospice caps. With respect to a hospice, the reporting period 
for the cap calculation is the cap year; and the contractors' 
determination of program reimbursement letter, which provides the 
results of the inpatient and aggregate cap calculations, shall serve as 
a notice of program reimbursement. The time period for filing cap 
appeals begins with receipt of the determination of program 
reimbursement letter.
    (b) Requirements for contractor notices. The contractor must include 
in each notice appropriate references to law, regulations, CMS Rulings, 
or program instructions to explain why the contractor's determination of 
the amount of program reimbursement for the period differs from the 
amount the provider claimed. The notice must also inform the provider of 
its right to contractor or Board hearing (see Sec. Sec.  405.1809, 
405.1811, 405.1815, 405.1835, and 405.1843) and that the provider must 
request the hearing within 180 days after the date of receipt of the 
notice.
    (c) Use of notice as basis for recoupment of overpayments. The 
contractor's determination contained in its notice is the basis for 
making the retroactive adjustment (required by Sec.  413.64(f) of this 
chapter) to any program payments made to the provider during the period 
to which the determination applies, including recoupment under Sec.  
405.373 from ongoing payments to the provider of any overpayments to the 
provider identified in the determination. Recoupment is made 
notwithstanding any request for hearing on the determination the 
provider may make under Sec.  405.1811 or Sec.  405.1835.
    (d) Effect of certain final agency decisions and final court 
judgments; audits of self-disallowed and other items. (1) This paragraph 
applies to the following administrative decisions and court judgments:
    (i) A final hearing decision by the contractor (as described in 
Sec.  405.1833 of this subpart) or the Board (as described in Sec.  
405.1871(b) of this subpart).
    (ii) A final decision by a CMS reviewing official (as described in 
Sec.  405.1834(f)(1) of this subpart) or the Administrator (as described 
in Sec.  405.1875(e)(4) of this subpart) following review of a hearing 
decision by the contractor or the Board, respectively.
    (iii) A final, non-appealable judgment by a court on a Medicare 
reimbursement issue that the court rendered in accordance with 
jurisdiction under section 1878 of the Act (as described in Sec. Sec.  
405.1842 and 405.1877 of this subpart).
    (2) For any final agency decision or final court judgment specified 
in paragraph (d)(1) of this section, the contractor must promptly, upon 
notification from CMS--
    (i) Determine the effect of the final decision or judgment on the 
contractor determination for the cost reporting period at issue in the 
decision or judgment; and
    (ii) Issue any revised contractor determination, and make any 
additional program payment, or recoup or offset any program payment (as 
described in Sec.  405.371 of this subpart), for the period that may be 
necessary to implement the final decision or judgment on the specific 
matters at issue in the decision or judgment.
    (3) CMS may require the contractor to audit any item, including any 
self-disallowed item, at issue in an appeal or a civil action, before 
any revised contractor determination or additional Medicare payment, 
recoupment, or offset may be determined for an item under paragraph 
(d)(2) of this section.
    (4) For any final settlement agreement, whether for an appeal to the 
contractor hearing officer(s) or the Board or for a civil action before 
a court, the contractor must implement the settlement agreement in 
accordance with paragraphs (d)(2) and (d)(3) of this section, unless a 
particular administrative or judicial settlement agreement provides 
otherwise.

[48 FR 39834, Sept. 1, 1983, as amended at 49 FR 322, Jan. 3, 1984; 51 
FR 34793, Sept. 30, 1986; 61 FR 63748, Dec. 2, 1996; 73 FR 30244, May 
23, 2008; 74 FR 39412, Aug. 6, 2009; 80 FR 70597, Nov. 13, 2015]



Sec.  405.1804  Matters not subject to administrative and judicial review 
under prospective payment.

    Neither administrative nor judicial review is available for 
controversies about the following matters:
    (a) The determination of the requirement, or the proportional 
amount, of

[[Page 247]]

the budget neutrality adjustment in the prospective payment rates 
required under section 1886(e)(1) of the Social Security Act.
    (b) The establishment of--
    (1) Diagnosis related groups (DRGs);
    (2) The methodology for the classification of inpatient discharges 
within the DRGs; or
    (3) Appropriate weighting factors that reflect the relative hospital 
resources used with respect to discharge within each DRG.

[49 FR 322, Jan. 1, 1984, as amended at 78 FR 75195, Dec. 10, 2013]



Sec.  405.1805  Parties to contractor determination.

    The parties to the contractor's determination are the provider and 
any other entity found by the contractor to be a related organization of 
the provider under Sec.  413.17 of this chapter.

[48 FR 39835, Sept. 1, 1983, as amended at 51 FR 34793, Sept. 30, 1986]



Sec.  405.1807  Effect of contractor determination.

    The determination shall be final and binding on the party or parties 
to such determination unless:
    (a) A contractor hearing is requested in accordance with Sec.  
405.1811 and a contractor hearing decision rendered in accordance with 
Sec.  405.1831; or
    (b) The contractor determination is revised in accordance with Sec.  
405.1885; or
    (c) A Board hearing is requested in accordance with Sec.  405.1835 
and a hearing decision rendered pursuant thereto.



Sec.  405.1809  Contractor hearing procedures.

    (a) Hearings. Each contractor must establish and maintain written 
procedures for contractor hearings, in accordance with the regulations 
in this subpart, for resolving issues that may arise between the 
contractor and a provider concerning the amount of reasonable cost 
reimbursement, or prospective payment due the provider (except as 
provided in Sec.  405.1804) under the Medicare program. The procedures 
must provide for a hearing on the contractor determination contained in 
the notice of program reimbursement (Sec.  405.1803), if the provider 
files a timely request for a hearing.
    (b) Amount in controversy. In order for a contractor to grant a 
hearing, the following dates and amounts in controversy apply:
    (1) For cost reporting periods ending prior to June 30, 1973, the 
amount of program reimbursement in controversy must be at least $1000.
    (2) For cost reporting periods ending on or after June 30, 1973, the 
amount of program reimbursement in controversy must be at least $1000 
but less than $10,000.

[48 FR 39835, Sept. 1, 1983, as amended at 49 FR 323, Jan. 1, 1984]



Sec.  405.1811  Right to contractor hearing; contents of, 
and adding issues to, hearing request.

    (a) Right to hearing on final contractor determination. A provider 
(but no other individual, entity, or party) has a right to a contractor 
hearing, as a single provider appeal, with respect to a final contractor 
or Secretary determination for the provider's cost reporting period, 
if--
    (1) The provider is dissatisfied with the contractor's final 
determination of the total amount of reimbursement due the provider, as 
set forth in the contractor's written notice pursuant to Sec.  405.1803. 
Exception: If a final contractor determination is reopened under Sec.  
405.1885, any review by the contractor hearing officer must be limited 
solely to those matters that are specifically revised in the 
contractor's revised final determination (Sec. Sec.  405.1887(d), 
405.1889(b), and the ``Exception'' in Sec.  405.1832(c)(2)(i)).
    (2) The amount in controversy (as determined in accordance with 
Sec.  405.1839) must be at least $1,000 but less than $10,000.
    (3) Unless the provider qualifies for a good cause extension under 
Sec.  405.1813, the date of receipt by the contractor of the provider's 
hearing request must be no later than 180 days after the date of receipt 
by the provider of the final contractor or Secretary determination.
    (b) Contents of request for a contractor hearing on final contractor 
determination. The provider's request for a contractor hearing under 
paragraph (a) of this section must be submitted in writing to the 
contractor, and the request must

[[Page 248]]

include the elements described in paragraphs (b)(1) through (b)(3) of 
this section. If the provider submits a hearing request that does not 
meet the requirements of paragraph (b)(1), (b)(2), or (b)(3) of this 
section, the contractor hearing officer may dismiss with prejudice the 
appeal or take any other remedial action he or she considers 
appropriate.
    (1) A demonstration that the provider satisfies the requirements for 
a contractor hearing as specified in paragraph (a) of this section, 
including a specific identification of the final contractor or Secretary 
determination under appeal.
    (2) For each specific item under appeal, a separate explanation of 
why, and a description of how, the provider is dissatisfied with the 
specific aspects of the final contractor or Secretary determination 
under appeal, including an account of all of the following:
    (i) Why the provider believes Medicare payment is incorrect for each 
disputed item (or, where applicable, why the provider is unable to 
determine whether Medicare payment is correct because it allegedly does 
not have access to underlying information concerning the calculation of 
its payment); and
    (ii) How and why the provider believes Medicare payment should be 
determined differently for each disputed item.
    (iii) If the provider self-disallows a specific item (as specified 
in Sec.  413.24(j) of this chapter), an explanation of the nature and 
amount of each self-disallowed item, the reimbursement sought for the 
item, and why the provider self-disallowed the item instead of claiming 
reimbursement for the item.
    (3) A copy of the final contractor or Secretary determination under 
appeal and any other documentary evidence the provider considers 
necessary to satisfy the hearing request requirements of paragraphs 
(b)(1) and (b)(2) of this section.
    (c) Right to hearing based on untimely contractor determination. 
Notwithstanding the provisions of paragraph (a) of this section, a 
provider (but no other individual, entity, or party) has a right to a 
contractor hearing, as a single provider appeal, for specific items for 
a cost reporting period if--
    (1) A final contractor determination for the provider's cost 
reporting period is not issued (through no fault of the provider) within 
12 months after the date of receipt by the contractor of the provider's 
perfected cost report or amended cost report (as specified in Sec.  
413.24(f) of this chapter). The date of receipt by the contractor of the 
provider's perfected cost report or amended cost report is presumed to 
be the date of electronic delivery, or the date the contractor stamped 
``Received'' on such cost report unless it is shown by a preponderance 
of the evidence that the contractor received the cost report on an 
earlier date.
    (2) Unless the provider qualifies for a good cause extension under 
Sec.  405.1813, the date of receipt by the contractor of the provider's 
hearing request is no later than 180 days after the expiration of the 12 
month period for issuance of the final contractor determination (as 
determined in accordance with paragraph (c)(1) of this section); and
    (3) The amount in controversy (as determined in accordance with 
Sec.  405.1839) is at least $1,000 but less than $10,000.
    (d) Contents of request for a contractor hearing based on untimely 
contractor determination. The provider's request for a contractor 
hearing under paragraph (c) of this section must be submitted in writing 
to the contractor, and the request must include the elements described 
in paragraphs (d)(1) through (d)(3) of this section. If the provider 
submits a hearing request that does not meet the requirements of 
paragraph (d)(1), (d)(2), or (d)(3) of this section, the contractor 
hearing officer may dismiss with prejudice the appeal or take any other 
remedial action he or she considers appropriate.
    (1) A demonstration that the provider satisfies the requirements for 
a contractor hearing as specified in paragraph (c) of this section.
    (2) An explanation (for each specific item at issue) of the 
following:
    (i) Why the provider believes Medicare payment is incorrect for each 
disputed item (or, where applicable, why the provider is unable to 
determine whether Medicare payment is correct

[[Page 249]]

because it does not have access to underlying information concerning the 
calculation of Medicare payment).
    (ii) How and why the provider believes Medicare payment must be 
determined differently for each disputed item.
    (iii) If the provider self-disallows a specific item, a description 
of the nature and amount of each self-disallowed item and the 
reimbursement or payment sought for the item.
    (3) A copy of any documentary evidence the provider considers 
necessary to satisfy the hearing request requirements of paragraphs 
(d)(1) and (d)(2) of this section.
    (e) Adding issues to the hearing request. After filing a hearing 
request in accordance with paragraphs (a) and (b), or paragraphs (c) and 
(d), of this section, a provider may add specific Medicare payment 
issues to the original hearing request by submitting a written request 
to the contractor hearing officer, only if--
    (1) The request to add issues complies with the requirements of 
paragraphs (a) and (b), or paragraphs (c) and (d), of this section as to 
each new specific item at issue.
    (2) The specific items raised in the initial hearing request and the 
specific items identified in subsequent requests to add issues, when 
combined, satisfy the amount in controversy requirements of paragraph 
(a)(2) or paragraph (c)(3) of this section.
    (3) The contractor hearing officer receives the provider's request 
to add issues no later than 60 days after the expiration of the 
applicable 180-day period prescribed in paragraph (a)(3) or paragraph 
(c)(2) of this section.

[73 FR 30244, May 23, 2008, as amended at 79 FR 50349, Aug. 22, 2014; 79 
FR 59680, Oct. 3, 2014; 80 FR 70597, Nov. 13, 2015; 85 FR 59018, Sept. 
18, 2020]



Sec.  405.1813  Good cause extension of time limit for requesting 
a contractor hearing.

    (a) A request for a contractor hearing that is received by the 
contractor after the applicable 180-day time limit prescribed in Sec.  
405.1811(a)(3) or Sec.  405.1811(c)(2) must be dismissed by the 
contractor hearing officer(s), except that the hearing officer(s) may 
extend the time limit upon a good cause showing by the provider.
    (b) The contractor hearing officer(s) may find good cause to extend 
the time limit only if the provider demonstrates in writing it could not 
reasonably have been expected to file timely due to extraordinary 
circumstances beyond its control (such as a natural or other 
catastrophe, fire, or strike), and the provider's written request for an 
extension is received by the contractor hearing officer(s) within a 
reasonable time (as determined by the contractor hearing officer(s) 
under the circumstances) after the expiration of the applicable 180-day 
limit prescribed in Sec.  405.1811(a)(3) or Sec.  405.1811(c)(2).
    (c) The contractor hearing officer(s) may not grant a request for an 
extension under this section if--
    (1) The provider relies on a change in the law, regulations, CMS 
Rulings, or general CMS instructions (whether based on a court decision 
or otherwise) or a CMS administrative ruling or policy as the basis for 
the extension request; or
    (2) The date of receipt by the contractor of the provider's 
extension request is later than 3 years after the date of the contractor 
or other determination that the provider seeks to appeal.
    (d) If an extension request is granted or denied under this section, 
the contractor hearing officer(s) must send prompt written notice to the 
provider, and send a copy to each party to the appeal. The notice must 
include an explanation of the reasons for the decision by the hearing 
officer(s) and the facts underlying the decision.
    (e)(1) A decision denying an extension request under this section 
and dismissing the appeal is final and binding on the provider, unless 
the dismissal decision is reviewed by a CMS reviewing official in 
accordance with Sec.  405.1834(b)(2)(i) of this subpart or reopened and 
revised by the contractor hearing officer(s) in accordance with Sec.  
405.1885 through Sec.  405.1889 of this subpart. The contractor hearing 
officer(s) promptly sends the decision to the appropriate component of 
CMS (currently the Center for Medicare Management) (as specified in 
Sec.  405.1834(b)(4) of this subpart).

[[Page 250]]

    (2) A decision granting an extension request under this section is 
not subject to immediate review by a CMS reviewing official (as 
described in Sec.  405.1834(b)(3) of this subpart). Any decision may be 
examined during the course of CMS review of a final jurisdictional 
dismissal decision or a final hearing decision by the contractor hearing 
officer(s) (as described in Sec. Sec.  405.1834(b)(2)(i) and 
405.1834(b)(2)(ii) of this subpart).

[73 FR 30245, May 23, 2008, as amended at 80 FR 70598, Nov. 13, 2015; 85 
FR 59019, Sept. 18, 2020]



Sec.  405.1814  Contractor hearing officer jurisdiction.

    (a) General rules. (1) After a request for a contractor hearing is 
filed under Sec.  405.1811 of this subpart, the contractor hearing 
officer(s) must do the following:
    (i) Determine in accordance with paragraph (b) of this section 
whether or not it has jurisdiction to grant a hearing on each of the 
specific matters at issue in the hearing request.
    (ii) Make a preliminary determination of the scope of its 
jurisdiction (that is, whether the request for hearing was timely, and 
whether the amount in controversy requirement has been met), if any, 
over the matters at issue in the appeal before conducting any of the 
following proceedings:
    (A) Determining its authority to decide a legal question relevant to 
a matter at issue (as described in Sec.  405.1829 of this subpart);
    (B) Permitting discovery (as specified in Sec.  405.1821 of this 
subpart); or
    (C) Conducting a hearing (as specified in Sec.  405.1819 of this 
subpart);
    (2) The hearing officer(s) may revise a preliminary jurisdictional 
determination at any subsequent stage of the proceedings in an appeal, 
and it must promptly notify the parties of any revised determination.
    (3) Under paragraph (c)(1) of this section, each contractor hearing 
decision (as described in Sec.  405.1831 of this subpart) must include a 
final jurisdictional finding for each specific matter at issue in the 
appeal.
    (4) If the hearing officer(s) finally determines it lacks 
jurisdiction over every specific matter at issue in the appeal, it 
issues a jurisdictional dismissal decision under paragraph (c)(2) of 
this section.
    (5) Final jurisdictional findings and jurisdictional dismissal 
decisions by the hearing officer(s) are subject to the CMS reviewing 
official procedure in accordance with paragraph (d) of this section and 
Sec.  405.1834(b)(2)(i) and (b)(2)(ii) of this subpart.
    (b) Criteria. Except for the amount in controversy requirement, the 
jurisdiction of the contractor hearing officer(s) to grant a hearing is 
determined separately for each specific matter at issue in the 
contractor or Secretary determination for the cost reporting period 
under appeal. The hearing officer(s) has jurisdiction to grant a hearing 
over a specific matter at issue in an appeal only if the provider has a 
right to a contractor hearing under Sec.  405.1811. Certain matters at 
issue are removed from the jurisdiction of the contractor hearing 
officer(s); these matters include, but are not limited to, the 
following:
    (1) A finding in a contractor determination that expenses incurred 
for certain items or services furnished by a provider to an individual 
are not payable under title XVIII of the Act because those items and 
services are excluded from coverage under section 1862 of the Act and 
part 411 of the regulations. Review of these findings is limited to the 
applicable provisions of sections 1155, 1869, and 1879(d) of the Act, 
and of subpart I of part 405 and subpart B of part 478, as applicable.
    (2) Certain matters affecting payments to hospitals under the 
prospective payment system, as provided in section 1886(d)(7) of the Act 
and Sec.  405.1804 of this subpart.
    (c) Final jurisdictional findings, and jurisdictional dismissal 
decisions by contractor hearing officer(s). (1) In issuing a hearing 
decision under Sec.  405.1831 of this subpart, the contractor hearing 
officer(s) must make a final determination of its jurisdiction, or lack 
thereof, for each specific matter at issue in the hearing decision. Each 
contractor hearing decision must include specific findings of fact and 
conclusions of law as

[[Page 251]]

to the jurisdiction of the hearing officer(s), or lack thereof, to grant 
a hearing on each matter at issue in the appeal.
    (2) If the hearing officer(s) finally determines it lacks 
jurisdiction to grant a hearing for every specific matter at issue in an 
appeal, it must issue a jurisdictional dismissal decision. Each 
jurisdictional dismissal decision by the hearing officer(s) must include 
specific findings of fact and conclusions of law explaining the 
determination that there is no jurisdiction to grant a hearing on each 
matter at issue in the appeal. A copy of the jurisdictional dismissal 
decision must be sent promptly to each party to the appeal.
    (3) A jurisdictional dismissal decision by the contractor hearing 
officer(s) under paragraph (c)(2) of this section is final and binding 
on the parties, unless the decision is reviewed by a CMS reviewing 
official in accordance with Sec.  405.1834 of this subpart or reopened 
and revised by the contractor hearing officer(s) in accordance with 
Sec.  405.1885 through Sec.  405.1889 of this subpart.
    (d) CMS reviewing official review. Any finding by the contractor 
hearing officer as to whether it has jurisdiction to grant a hearing on 
a specific matter at issue in an appeal is not subject to further 
administrative review, except as provided in this paragraph. The 
contractor hearing officer's jurisdictional findings as to specific 
matters at issue in an appeal may be reviewed solely during the course 
of CMS reviewing official review of one of the contractor hearing 
officer decisions specified in Sec.  405.1834(b)(2) of this subpart.

[73 FR 30245, May 23, 2008, as amended at 80 FR 70598, Nov. 13, 2015; 85 
FR 59019, Sept. 18, 2020]



Sec.  405.1815  Parties to proceedings before the contractor 
hearing officer(s).

    When a provider files a request for a contractor hearing in 
accordance with Sec.  405.1811 of this subpart, the parties to all 
proceedings before the contractor hearing officer(s) are the provider 
and, if applicable, any other entity found by the contractor hearing 
officer(s) to be a related organization of the provider under the 
principles enunciated in Sec.  413.17 of this chapter. The parties must 
be given reasonable notice of the time, date, and place of any 
contractor hearing. Neither the contractor nor CMS may be made a party 
to proceedings before the contractor hearing officer(s).

[73 FR 30246, May 23, 2008]



Sec.  405.1817  Hearing officer or panel of hearing officers authorized 
to conduct contractor hearing; disqualification of officers.

    The contractor hearing provided for in Sec.  405.1809 shall be 
conducted by a hearing officer or panel of hearing officers designated 
by the contractor. Such hearing officer or officers shall be persons 
knowledgeable in the field of health care reimbursement. The hearing 
officer or officers shall not have had any direct responsibility for the 
program reimbursement determination with respect to which a request for 
hearing is filed; no hearing officer (or officers) shall conduct a 
hearing in a case in which he is prejudiced or partial with respect to 
any party, or where he has any interest in the matter pending for 
determination before him. Notice of any objection which a party may have 
with respect to a hearing officer shall be presented in writing to such 
officer by the objecting party at the party's earliest opportunity. The 
hearing officer shall consider the objection and shall, at his 
discretion, either proceed in the conduct of the hearing or withdraw. If 
the hearing officer does not withdraw, the objecting party may, after 
the hearing, present his objections to an executive official of the 
contractor, who shall rule promptly on the objection.



Sec.  405.1819  Conduct of contractor hearing.

    The hearing shall be open to all parties thereto (see Sec.  
405.1815) and to representatives of the contractor and of the Centers 
for Medicare & Medicaid Services (see Sec.  405.1815). The hearing 
officer(s) shall inquire fully into all of the matters at issue and 
shall receive into evidence the testimony and any documents which are 
relevant and material to such matters. If the hearing officer(s) 
believes that there is relevant and material evidence available which 
has not been presented at the hearing,

[[Page 252]]

he (they) may, at any time prior to the sending of notice of the 
decision, reopen the hearing record for the receipt of such evidence. 
The order in which the evidence and the allegations shall be presented 
and the conduct of the hearing shall be at the discretion of the hearing 
officer(s).

[39 FR 34515, Sept. 26, 1974, as amended at 85 FR 59019, Sept. 18, 2020]



Sec.  405.1821  Prehearing discovery and other proceedings prior to 
the contractor hearing.

    (a) Discovery rule: Time limits. (1) Limited prehearing discovery 
may be permitted by the contractor hearing officer(s) upon request of a 
party, provided the request is timely and the hearing officer(s) makes a 
preliminary finding of its jurisdiction over the matters at issue in 
accordance with Sec.  405.1814(a) of this subpart.
    (2) A prehearing discovery request is timely if the request by a 
party is served no later than 120 days before the initially scheduled 
starting date of the contractor hearing, unless the contractor hearing 
officer(s) extends the time for requesting discovery.
    (3) In the absence of a specific schedule for responses set by the 
contractor hearing officer(s), responses to interrogatories and requests 
for production of documents are due according to the schedule agreed 
upon by the party serving discovery and the party to which the discovery 
is directed. Responses by a party to interrogatories or requests for 
production of documents must be served no later than 45 days before the 
initially scheduled start of the contractor hearing, unless the 
contractor hearing officer(s) orders otherwise. Responses by a nonparty 
to requests for production of documents must be served no later than 75 
days after the date the requests were served on the nonparty, unless the 
party requesting the documents and the nonparty to which the requests 
are directed agree on a different time for responding, or unless the 
contractor hearing officer(s) extends the time for responding.
    (4) Before ruling on a request to extend the time for requesting 
discovery or for responding to discovery, the hearing officer(s) must 
give the other parties to the appeal and any nonparty subject to a 
discovery request a reasonable period to respond to the extension 
request.
    (5) If the extension request is granted, the hearing officer(s) sets 
a new deadline and has the discretion to reschedule the hearing date.
    (b) Discovery criteria--(1) General rule. The contractor hearing 
officer(s) may permit discovery of a matter that is relevant to the 
specific subject matter of the contractor hearing, provided the matter 
is not privileged or otherwise protected from disclosure and the 
discovery request is not unreasonable, unduly burdensome or expensive, 
or otherwise inappropriate. In determining whether to permit discovery, 
and in fixing the scope and limits of any discovery, the hearing 
officer(s) uses the Federal Rules of Civil Procedure and Rules 401 and 
501 of the Federal Rules of Evidence for guidance.
    (2) Limitations on discovery. Any discovery before the contractor 
hearing officer(s) is limited as follows:
    (i) A party may request of another party, or of a nonparty other 
than CMS, HHS or any Federal agency, the reasonable production of 
documents for inspection and copying.
    (ii) A party may request another party to respond to a reasonable 
number of written interrogatories.
    (iii) A party may not request admissions, take oral or written 
depositions, or take any other form of discovery not permitted under 
this section.
    (c) Discovery procedures. Rights of nonparties: Motions to compel or 
for protective order. (1) A party may request discovery of another party 
to the proceedings before the contractor hearing officer(s) or of a 
nonparty other than CMS, HHS or other Federal agency. Any discovery 
request filed with the contractor hearing officer(s) must be sent 
promptly to the party or nonparty from which the discovery is requested, 
and to any other party to the contractor hearing (as described in Sec.  
405.1815 of this subpart).
    (2) If a discovery request is made of a nonparty to the contractor 
hearing, the nonparty has the rights any party has in responding to a 
discovery request. The rights of the nonparty include, but are not 
limited to, the right

[[Page 253]]

to select and use any attorney or other representative, and to submit 
discovery responses, objections, or motions to the hearing officer(s).
    (3) Each party and nonparty is required to make a good faith effort 
to resolve or narrow any discovery dispute, regardless of whether the 
dispute is with another party or a nonparty.
    (i) A party may submit to the contractor hearing officer(s) a motion 
to compel discovery that is permitted under this section, and a motion 
for a protective order regarding any discovery request may be submitted 
to the hearing officer(s) by a party or nonparty.
    (ii) Any motion to compel or for protective order must include a 
self-sworn declaration describing the movant's efforts to resolve or 
narrow the discovery dispute. A self-sworn declaration describing 
efforts to resolve or narrow a discovery dispute also must be included 
with any response to a motion to compel or for a protective order.
    (iii) The hearing officer(s) must--
    (A) Decide the motion in accordance with this section and any prior 
discovery ruling; and
    (B) Issue and send to each party and any affected nonparty a 
discovery ruling that grants or denies the motion to compel or for 
protective order in whole or in part; if applicable the discovery ruling 
must specifically identify any part of the disputed discovery request 
upheld and any part rejected, and impose any limits on discovery the 
hearing officer(s) finds necessary and appropriate. Nothing in this 
section authorizes the contractor hearing officer to compel any action 
from the Secretary or CMS.
    (d) Reviewability of discovery or disclosure rulings--(1) General 
rule. A discovery ruling issued in accordance with paragraph (c)(3) of 
this section, or a disclosure ruling (such as one issued at a hearing), 
is not subject to immediate review by a CMS official (as described in 
Sec.  405.1834(b)(3) of this subpart). A discovery ruling may be 
examined solely during the course of CMS review under Sec.  405.1834 of 
this subpart of a jurisdictional dismissal decision (as described in 
Sec.  405.1814(c)(2) of this subpart) or a hearing decision (as 
described in Sec.  405.1831 of this subpart) by the contractor hearing 
officer(s).
    (2) Exception. To the extent a ruling authorizes discovery or 
disclosure of a matter for which an objection based on privilege or 
other protection from disclosure such as case preparation, 
confidentiality, or undue burden, was made before the contractor hearing 
officer(s), that portion of the discovery or disclosure ruling may 
immediately be reviewed by a CMS reviewing official in accordance with 
Sec.  405.1834(b)(3).
    (i) Upon notice to the contractor hearing officer that the provider 
intends to seek immediate review of a ruling, or that the contractor or 
other affected nonparty intends to suggest that the Administrator 
through the CMS reviewing official, take own motion review of the 
ruling, the contractor hearing officer stays all proceedings affected by 
the ruling.
    (ii) The contractor hearing officer must determine, under the 
circumstances of a given case, the length of any stay, but in no event 
may the stay be less than 15 days.
    (iii) If the Administrator through the CMS reviewing official--
    (A) Grants a request for review, or takes own motion review, of a 
ruling, the ruling is stayed until such time as the CMS reviewing 
official issues a written decision that affirms, reverses, modifies, or 
remands the contractor hearing officer's ruling.
    (B) Does not grant review or take own motion review within the time 
allotted for the stay, the stay is lifted and the ruling is not subject 
to immediate review.
    (e) Prehearing conference. The contractor hearing officer(s) has 
discretion to schedule a prehearing conference. A prehearing conference 
may be conducted in person or telephonically, at the discretion of the 
contractor hearing officer(s). When a panel of contractor hearing 
officers is designated, the panel may appoint one or more hearing 
officers to act for the panel for any prehearing conference or any 
matter addressed at the conference.

[73 FR 30246, May 23, 2008; 73 FR 49356, Aug. 21, 2008; 85 FR 59019, 
Sept. 18, 2020]

[[Page 254]]



Sec.  405.1823  Evidence at contractor hearing.

    Evidence may be received at the contractor hearing even though 
inadmissible under the rules of evidence applicable to court procedure. 
The hearing officer(s) shall give the parties opportunity for submission 
and consideration of facts and arguments, and during the course of the 
hearing, should in ruling upon admissibility of evidence, exclude 
irrelevant, immaterial, or unduly repetitious evidence. The hearing 
officer(s) shall render a final ruling on the admissibility of evidence.



Sec.  405.1825  Witnesses at contractor hearing.

    The hearing officer(s) may examine the witnesses and shall allow the 
parties and their representatives to do so. Parties to the proceedings 
may also cross-examine witnesses.



Sec.  405.1827  Record of proceedings before the contractor hearing officer(s).

    (a) The contractor hearing officer(s) must maintain a complete 
record of all proceedings in an appeal.
    (b) The record consists of all documents and any other tangible 
materials timely submitted to the hearing officer(s) by the parties to 
the appeal and by any nonparty (as described in Sec.  405.1821(c) of 
this subpart), along with all correspondence, rulings, orders, and 
decisions (including the final decision) issued by the hearing 
officer(s).
    (c) The record must include a complete transcription of the 
proceedings at any contractor hearing.
    (d) A copy of the transcription must be made available to any party 
upon request.

[73 FR 30247, May 23, 2008]



Sec.  405.1829  Scope of authority of contractor hearing officer(s).

    (a) The hearing officer(s) in exercising his authority must comply 
with all the provisions of title XVIII of the Act and regulations issued 
thereunder, as well as with CMS Rulings issued under the authority of 
the Administrator of the Centers for Medicare & Medicaid Services (as 
described in Sec.  401.108 of this chapter), and with the general 
instructions issued by the Centers for Medicare & Medicaid Services in 
accordance with the Secretary's agreement with the contractor.
    (b)(1) If the contractor hearing officer(s) has jurisdiction to 
conduct a hearing on the specific matters at issue under Sec.  405.1811, 
and the legal authority to fully resolve the matters in a hearing 
decision (as described in Sec.  405.1831 of this subpart), the hearing 
officer(s) must affirm, modify, or reverse the contractor's findings on 
each specific matter at issue in the contractor or Secretary 
determination for the cost year under appeal.
    (2) The contractor hearing officer(s) also may make additional 
revisions on specific matters regardless of whether the contractor 
considered the matters in issuing the contractor determination for the 
cost year, provided the hearing officer(s) does not consider or decide 
any specific matter for which it lacks jurisdiction (as described in 
Sec.  405.1814(b) of this subpart) or which was not timely raised in the 
provider's hearing request.
    (3) The authority of the contractor hearing officer(s) under this 
paragraph to make the additional revisions is limited to those revisions 
necessary to fully resolve a specific matter at issue if--
    (i) The hearing officer(s) has jurisdiction to grant a hearing on 
the specific matter under Sec. Sec.  405.1811 and 405.1814 of this 
subpart; and
    (ii) The specific matter was timely raised in an initial request for 
a contractor hearing filed in accordance with Sec.  405.1811(b) of this 
subpart or in a timely request to add issues to an appeal submitted in 
accordance with Sec.  405.1811(c) of this subpart.

[39 FR 34515, Sept. 26, 1974. Redesignated at 42 FR 52826, Sept. 30, 
1977, as amended at 73 FR 30247, May 23, 2008]



Sec.  405.1831  Contractor hearing decision.

    (a) If the contractor hearing officer(s) finds jurisdiction (as 
described in Sec.  405.1814(a) of this subpart) and conducts a hearing, 
the contractor hearing officer(s) must promptly issue a written hearing 
decision.
    (b) The contractor hearing decision must be based on the evidence 
from the contractor hearing (as described in

[[Page 255]]

Sec.  405.1823 of this subpart) and other evidence as may be included in 
the record (as described in Sec.  405.1827 of this subpart).
    (c) The decision must include findings of fact and conclusions of 
law on jurisdictional issues (as described in Sec.  405.1814(c)(1) of 
this subpart) and on the merits of the provider's reimbursement claims, 
and include appropriate citations to the record evidence and to the 
applicable law, regulations, CMS Rulings, and other interpretive rules, 
general statements of policy, and rules of agency organization, 
procedure, or practice established by CMS.
    (d) A copy of the decision must be sent promptly to the contractor, 
to each party and to the appropriate component of CMS (which currently 
is the Center for Medicare Management).
    (e) When the contractor's denial of the relief that the provider 
seeks before the contractor hearing officer(s) was based on procedural 
grounds (for example, the alleged failure of the provider to satisfy a 
time limit), or was based on the alleged failure to supply adequate 
documentation to support the provider's claim, and the contractor 
hearing officer(s) rule(s) that the basis of the contractor's denial is 
invalid, the contractor hearing officer(s) remands to the contractor for 
the contractor to make a determination on the merits of the provider's 
claim.

[73 FR 30248, May 23, 2008; 73 FR 49356, Aug. 21, 2008; 85 FR 59019, 
Sept. 18, 2020]



Sec.  405.1832  Contractor hearing officer review of compliance with 
the substantive reimbursement requirement of an appropriate cost report claim.

    (a) General. In order to receive or potentially qualify for 
reimbursement for a specific item, the provider must include in its cost 
report an appropriate claim for the specific item (as prescribed in 
Sec.  413.24(j) of this chapter). If the provider files an appeal to the 
contractor seeking reimbursement for a specific item and any party to 
such appeal questions whether the provider's cost report included an 
appropriate claim for the specific item, the contractor hearing 
officer(s) must address such questions in accordance with the procedures 
set forth in this section.
    (b) Summary of procedures--(1) Preliminary steps. The contractor 
hearing officer(s) must give each party to the appeal an adequate 
opportunity to submit factual evidence and legal argument regarding the 
question of whether the provider's cost report included an appropriate 
claim for the specific item under appeal. Upon receipt of timely 
submitted factual evidence and legal argument (if any), the contractor 
hearing officer(s) must review such evidence and argument, and prepare 
written specific findings of fact and conclusions of law on the question 
of whether the provider's cost report complied with, for the specific 
item under appeal, the cost report claim requirements prescribed in 
Sec.  413.24(j) of this chapter. In reaching such specific factual 
findings and legal conclusions, the contractor hearing officer(s) must 
follow the procedures set forth in Sec.  413.24(j)(3) of this chapter 
for determining whether the provider's cost report included an 
appropriate claim for the specific item under appeal. The contractor 
hearing officer(s) must promptly give a copy of such written specific 
factual findings and legal conclusions to each party to the appeal, and 
such factual findings and legal conclusions must be included in the 
record of administrative proceedings for the appeal (as prescribed in 
Sec.  405.1827).
    (2) Limits on contractor hearing officer(s) actions. The contractor 
hearing officer(s)'s specific findings of fact and conclusions of law 
(in accordance with paragraph (b)(1) of this section) must not be 
invoked or relied on by the contractor hearing officer(s) as a basis to 
deny, or decline to exercise, jurisdiction over a specific item or take 
any other of the actions specified in paragraph (c) of this section. 
Upon giving the parties to the appeal the contractor hearing 
officer(s)'s written specific factual findings and legal conclusions 
(pursuant to paragraph (b)(1) of this section) on the question of 
whether the provider's cost report included an appropriate cost report 
claim for the specific item under appeal, the contractor hearing 
officer(s) must proceed to issue one of the two types of overall 
decisions specified in paragraphs (d) and (e) of this section with 
respect to the specific item. If the contractor

[[Page 256]]

hearing officer(s) issues an overall contractor hearing decision (as 
specified in paragraph (d) of this section) regarding the specific item 
under appeal, the contractor hearing officer(s)'s written specific 
factual findings and legal conclusions (in accordance with paragraph 
(b)(1) of this section) must be included in such overall contractor 
hearing decision regarding the specific item, along with the other 
matters that are required by the regulations for an overall contractor 
hearing decision. However, if the contractor hearing officer(s) issues 
an overall jurisdictional dismissal decision (as specified in paragraph 
(e) of this section) regarding the specific item under appeal, the 
contractor hearing officer(s)'s written specific factual findings and 
legal conclusions (in accordance with paragraph (b)(1) of this section) 
must not be included in the overall jurisdictional dismissal decision 
regarding the specific item. The contractor hearing officer(s) may 
permit reimbursement for the specific item under appeal, as part of an 
overall contractor hearing decision, but such reimbursement may be 
permitted only to the extent authorized by paragraph (f) of this 
section.
    (c) Prohibition of certain types of decisions, orders, and other 
actions. (1) If the contractor hearing officer(s) determines, in its 
findings of fact and conclusions of law (as prescribed by paragraph 
(b)(1) of this section), that the provider's cost report did not include 
an appropriate claim for the specific item under appeal, the contractor 
hearing officer(s) may not--
    (i) Deny jurisdiction over the specific item under appeal, based on 
(in whole or in part) the contractor hearing officer(s)'s factual 
findings and legal conclusions (reached under paragraph (b)(1) of this 
section);
    (ii) Decline to exercise jurisdiction over the specific item under 
appeal, based on (in whole or in part) the contractor hearing 
officer(s)'s factual findings and legal conclusions (reached under 
paragraph (b)(1) of this section); or
    (iii) Impose any sanction or take any other action against the 
interests of any party to the appeal except as provided in paragraph (f) 
of this section, based on (in whole or in part) the contractor hearing 
officer(s)'s factual findings and legal conclusions (in accordance with 
paragraph (b)(1) of this section).
    (2) Regardless of whether the contractor hearing officer(s) 
determines, in its findings of fact and conclusions of law (as 
prescribed by paragraph (b)(1) of this section), that the provider's 
cost report did or did not include an appropriate claim for the specific 
item under appeal, the contractor hearing officer(s) may not--
    (i) Deny jurisdiction over the specific item under appeal, based on 
(in whole or in part) the absence, in the final contractor or Secretary 
determination under appeal, of an adjustment, revision, correction, or 
other change to the specific item under appeal, or the lack of a 
particular determination by the contractor or the Secretary regarding 
the specific item. Exception: If the provider's appeal of the specific 
item is based on a reopening of such item (pursuant to Sec.  405.1885) 
where the specific item is not revised, adjusted, corrected, or 
otherwise changed in a revised final contractor or Secretary 
determination, the contractor must deny jurisdiction over the specific 
item under appeal (as prescribed in Sec. Sec.  405.1887(d) and 
405.1889(b));
    (ii) Decline to exercise jurisdiction over the specific item under 
appeal, based on (in whole or in part) the absence, in the final 
contractor or Secretary determination under appeal, of an adjustment, 
revision, correction, or other change to the specific item under appeal, 
or the lack of a particular determination by the contractor or the 
Secretary regarding the specific item; or
    (iii) Impose any sanction or take any other action against the 
interests of any party to the appeal except as provided in paragraph (f) 
of this section, based on (in whole or in part) the absence, in the 
final contractor or Secretary determination under appeal, of an 
adjustment, revision, correction, or other change to the specific item 
under appeal, or the lack of a particular determination by the 
contractor or the Secretary regarding the specific item.
    (d) Contractor hearing decision must include any factual findings 
and legal conclusions under paragraph (b)(1) of this

[[Page 257]]

section. If the contractor hearing officer(s) issues a hearing decision 
regarding the specific item under appeal (pursuant to Sec.  405.1831), 
any specific findings of fact and conclusions of law by the contractor 
hearing officer(s) (reached under paragraph (b)(1) of this section), on 
the question of whether the provider's cost report included an 
appropriate claim for the specific item, must be included in such 
hearing decision along with the other matters prescribed by Sec.  
405.1831. The contractor hearing officer(s)'s factual findings and legal 
conclusions (in accordance with paragraph (b)(1) of this section) about 
whether there was an appropriate cost report claim for the specific item 
under appeal are subject to the provisions of Sec.  405.1833 just as 
those provisions apply to the other parts of the contractor hearing 
decision. If the contractor hearing officer(s) determines that the 
provider's cost report--
    (1) Included an appropriate claim for the specific item under appeal 
(as prescribed in Sec.  413.24(j) of this chapter), the contractor 
hearing decision also must address whether the other substantive 
reimbursement requirements for the specific item are also satisfied; or
    (2) Did not include an appropriate claim for the specific item under 
appeal, the contractor hearing officer(s) has discretion whether or not 
to address in the contractor hearing decision whether the other 
substantive reimbursement requirements for the specific item are also 
satisfied.
    (e) Contractor jurisdictional dismissal decision must not include 
factual findings and legal conclusions under paragraph (b)(1) of this 
section. If the contractor hearing officer(s) issues a jurisdictional 
dismissal decision regarding the specific item under appeal (in 
accordance with Sec.  405.1814(c)), the contractor hearing officer(s)'s 
specific findings of fact and conclusions of law (in accordance with 
paragraph (b)(1) of this section) on the question of whether the 
provider's cost report included an appropriate claim for the specific 
item must not be included in such jurisdictional dismissal decision.
    (f) Effects of the contractor hearing officer(s)'s factual findings 
and legal conclusions under paragraph (b)(1) of this section when part 
of a final contractor hearing decision. If the contractor hearing 
officer(s) determines, as part of a final and binding contractor hearing 
decision (pursuant to Sec.  405.1833 and paragraphs (b)(1) and (d) of 
this section), that the provider's cost report--
    (1) Included an appropriate claim for the specific item under appeal 
(as prescribed in Sec.  413.24(j) of this chapter), the specific item is 
reimbursable in accordance with Medicare policy, but only if the 
contractor hearing officer(s) further determines in such final 
contractor hearing decision that all the other substantive reimbursement 
requirements for the specific item are also satisfied; or
    (2) Did not include an appropriate cost report claim for the 
specific item under appeal, the specific item is not reimbursable, 
regardless of whether the contractor hearing officer(s) further 
determines in such final contractor hearing decision that the other 
substantive reimbursement requirements for the specific item are or are 
not satisfied.

[80 FR 70598, Nov. 13, 2015]



Sec.  405.1833  Effect of contractor hearing decision.

    A contractor hearing decision issued in accordance with Sec.  
405.1831 of this subpart is final and binding on all parties to the 
contractor hearing and on the contractor, unless the hearing decision is 
reviewed by a CMS reviewing official in accordance with Sec.  405.1834 
of this subpart or reopened and revised by the contractor hearing 
officer(s) in accordance with Sec.  405.1885 through Sec.  405.1889 of 
this subpart. Final contractor hearing decisions are subject to the 
provisions of Sec.  405.1803(d) of this subpart.

[73 FR 30248, May 23, 2008; 73 FR 49356, Aug. 21, 2008]



Sec.  405.1834  CMS reviewing official procedure.

    (a) Scope. A provider that is a party to, and dissatisfied with, a 
final decision by the contractor hearing officer(s), upon submitting a 
request that meets the requirements of paragraph (c) of this section, is 
entitled to further administrative review of the decision,

[[Page 258]]

or the decision may be reviewed at the discretion of the Administrator. 
No other individual, entity, or party has the right to the review. The 
review is conducted on behalf of the Administrator by a designated CMS 
reviewing official who considers whether the decision of the contractor 
hearing officer(s) is consistent with the controlling legal authority 
(as described in Sec.  405.1834(e)(1) of this subpart) and the evidence 
in the record. Based on the review, the CMS reviewing official issues a 
decision on behalf of the Administrator.
    (b) General rules. (1) A CMS reviewing official may immediately 
review any final decision of the contractor hearing officer(s) as 
specified in paragraph (b)(2) of this section.
    (i) Nonfinal decisions and other nonfinal actions by the contractor 
hearing officer(s) are not immediately reviewable, except as provided in 
paragraph (b)(3) of this section.
    (ii) The CMS reviewing official exercises this review authority in 
response to a request from a provider party to the appeal that meets the 
requirements of paragraph (c) of this section or may exercise his or her 
discretion to take own motion review.
    (2) A CMS reviewing official may immediately review the following:
    (i) Any final jurisdictional dismissal decision by the contractor 
hearing officer(s), including any finding that the provider failed to 
demonstrate good cause for extending the time in which to request a 
hearing (as described in Sec. Sec.  405.1813(e)(1) and 405.1814(c)(3) of 
this subpart).
    (ii) Any final contractor hearing decision (as described in Sec.  
405.1831 of this subpart).
    (iii) If the CMS reviewing official reviews a contractor hearing 
decision regarding a specific item, then the CMS reviewing official's 
review of such a contractor hearing decision will include, and any 
decision issued by the CMS reviewing official (under paragraph (e) of 
this section) will address, the contractor hearing officer(s)'s specific 
findings of fact and conclusions of law in such contractor hearing 
decision (as specified in Sec.  405.1832(b)(1) and (d)) on the question 
of whether the provider's cost report included an appropriate claim for 
the specific item under appeal (as specified in Sec.  413.24(j) of this 
chapter).
    (3) Nonfinal decisions and other nonfinal actions by the contractor 
hearing officer(s) are not subject to the CMS reviewing official 
procedure until the contractor hearing officer(s) issues a final 
decision as specified in paragraph (b)(2) of this section (as described 
in Sec. Sec.  405.1813(e)(2), 405.1814(c) and (d), and 405.1821(d)(1) of 
this subpart), except that the CMS reviewing official may immediately 
review a ruling, authorizing discovery or disclosure of a matter, where 
there is a claim of privilege or other protection from disclosure such 
as case preparation, confidentiality, or undue burden.
    (4) In order to facilitate the Administrator's exercise of this 
review authority, the contractor hearing officer(s) must promptly send 
copies of any decision specified in paragraph (b)(2) of this section or 
in Sec.  405.1821(d)(2) of this subpart to the appropriate component of 
CMS (currently the Center for Medicare Management).
    (i) All requests for review by a CMS reviewing official and all 
written submissions to a CMS reviewing official under paragraphs (c) and 
(d) of this section also must be sent to the appropriate component of 
CMS.
    (ii) The appropriate CMS component examines each contractor hearing 
officer decision that is reviewable under paragraph (b)(2) of this 
section or Sec.  405.1821(d)(2) of this subpart, along with any review 
requests and any other submissions made by a party in accordance with 
the provisions of this section, in order to assist the Administrator's 
exercise of this review authority.
    (c) Request for review. (1) A provider's request for review by a CMS 
reviewing official is granted if--
    (i) The date of receipt by the appropriate CMS component of the 
review request is no later than 60 days after the date of receipt by the 
provider of the contractor hearing officer decision; or
    (ii) The request seeks review of a decision listed in paragraph 
(b)(2) of this section, and the provider complies with the requirements 
of paragraph (c)(2) of this section.

[[Page 259]]

    (2) The provider must submit its request for review in writing, 
attach a copy of the contractor decision for which it seeks review and 
include a brief description of all of the following:
    (i) Those aspects of the contractor hearing officer decision with 
which the provider is dissatisfied.
    (ii) The reasons for the provider's dissatisfaction.
    (iii) Any argument or record evidence the provider believes supports 
its position.
    (iv) Any additional, extra-record evidence relied on by the 
provider, along with a demonstration that such evidence was improperly 
excluded from the contractor hearing (as described in Sec.  405.1823 of 
this subpart).
    (3) A provider request for immediate review of a contractor hearing 
officer ruling authorizing discovery or disclosure in accordance with 
paragraph (b)(3) of this section must--
    (i) Be made as soon as practicable after the ruling is made, but in 
no event later than 5 business days after the date it received notice of 
the ruling; and
    (ii) State the reason(s) why the ruling is in error and the 
potential harm that may be caused if immediate review is not granted.
    (d) Own motion review. (1) The Administrator has discretion to take 
own motion review of a contractor hearing officer decision (regardless 
of whether the decision was favorable or unfavorable to the provider) or 
other reviewable action.
    (2) In order to exercise this authority, the CMS reviewing official 
must, no later than 60 days after the date of the contractor hearing 
officer's decision, notify the parties and the contractor that he or she 
intends to review the contractor hearing officer decision or other 
reviewable action.
    (3) In the notice, the CMS reviewing official identifies with 
particularity the issues that are to be reviewed, and gives each party 
(as described in Sec.  405.1815 of this subpart) and affected nonparty a 
reasonable period to comment on the issues through a written submission 
complying with paragraph (c)(2) of this section.
    (e) Review procedure. (1) In reviewing a contractor hearing officer 
decision specified in paragraph (b)(2) of this section, the CMS 
reviewing official must--
    (i) Comply with all applicable law, regulations, and CMS Rulings (as 
described in Sec.  401.108 of this chapter), and afford great weight to 
other interpretive rules, general statements of policy, and rules of 
agency organization, procedure, or practice established by CMS;
    (ii) Subject to paragraph (e)(1)(iii) of this section, limit the 
review to the record of the proceedings before the contractor hearing 
officer(s) (as described in Sec.  405.1827 of this subpart) and any 
written submissions by the parties under paragraphs (c)(2) or (d) of 
this section; and
    (iii) Consider additional, extra-record evidence only if he or she 
determines that the evidence was improperly excluded from the contractor 
hearing (as described in Sec.  405.1823 of this subpart).
    (2) Review of a contractor decision specified in paragraph (b)(2) of 
this section is limited to a hearing on the written record in accordance 
with paragraph (e)(1)(ii) of this section, unless the CMS reviewing 
official determines that--
    (i) Additional, extra-record evidence may be considered in 
accordance with paragraph (e)(1)(iii) of this section;
    (ii) An oral hearing is necessary for consideration of the extra-
record evidence; and
    (iii) It is not necessary or appropriate to remand the matter to the 
contractor hearing officer(s).
    (3) Upon completion of the review of a contractor hearing decision 
specified in paragraph (b)(2) of this section, the CMS reviewing 
official issues a written decision that affirms, reverses, modifies, or 
remands the contractor hearing decision. A copy of the decision must be 
sent promptly to each party, to the contractor, and to the appropriate 
component of CMS (currently the Center for Medicare Management).
    (f) Effect of a decision: Remand. (1) A decision of affirmation, 
reversal, or modification by the CMS reviewing official is final and 
binding on each party and the contractor. No further review or appeal of 
a decision is available, but the decision may be reopened and revised by 
a CMS reviewing official in accordance with Sec.  405.1885 through

[[Page 260]]

Sec.  405.1889 of this subpart. Decisions of a CMS reviewing official 
are subject to the provisions of Sec.  405.1803(d) of this subpart. A 
decision by a CMS reviewing official remanding an appeal to the 
contractor hearing officer(s) for further proceedings under paragraph 
(f)(2) of this section is not a final decision.
    (2) A remand to the contractor hearing officer(s) by the CMS 
reviewing official must--
    (i) Vacate the contractor hearing officer decision;
    (ii) Be governed by the same criteria that apply to remands by the 
Administrator to the Board under Sec.  405.1875(f)(2) of this subpart, 
and require the contractor hearing officer(s) to take specific actions 
on remand; and
    (iii) Result in the contractor hearing officer(s) taking the actions 
required on remand and issuing a new contractor hearing decision in 
accordance with Sec. Sec.  405.1831 and 405.1833 of this subpart.

[73 FR 30248, May 23, 2008; 73 FR 49356 Aug. 21, 2008, as amended at 80 
FR 70599, Nov. 13, 2015; 85 FR 59019, Sept. 18, 2020]



Sec.  405.1835  Right to Board hearing; contents of, and adding issues to, 
hearing request.

    (a) Right to hearing on final contractor determination. A provider 
(but no other individual, entity, or party) has a right to a Board 
hearing, as a single provider appeal, with respect to a final contractor 
or Secretary determination for the provider's cost reporting period, 
if--
    (1) The provider is dissatisfied with the contractor's final 
determination of the total amount of reimbursement due the provider, as 
set forth in the contractor's written notice specified under Sec.  
405.1803. Exception: If a final contractor determination is reopened 
under Sec.  405.1885, any review by the Board must be limited solely to 
those matters that are specifically revised in the contractor's revised 
final determination (Sec. Sec.  405.1887(d), 405.1889(b), and the 
``Exception'' in Sec.  405.1873(c)(2)(i)).
    (2) The amount in controversy (as determined in accordance with 
Sec.  405.1839) must be $10,000 or more.
    (3) Unless the provider qualifies for a good cause extension under 
Sec.  405.1836, the date of receipt by the Board of the provider's 
hearing request must be no later than 180 days after the date of receipt 
by the provider of the final contractor or Secretary determination.
    (b) Contents of request for a Board hearing on final contractor 
determination. The provider's request for a Board hearing under 
paragraph (a) of this section must be submitted in writing in the manner 
prescribed by the Board, and the request must include the elements 
described in paragraphs (b)(1) through (4) of this section. If the 
provider submits a hearing request that does not meet the requirements 
of paragraph (b)(1), (2), or (3) of this section, the Board may dismiss 
with prejudice the appeal or take any other remedial action it considers 
appropriate.
    (1) A demonstration that the provider satisfies the requirements for 
a Board hearing as specified in paragraph (a) of this section, including 
a specific identification of the final contractor or Secretary 
determination under appeal.
    (2) For each specific item under appeal, a separate explanation of 
why, and a description of how, the provider is dissatisfied with the 
specific aspects of the final contractor or Secretary determination 
under appeal, including an account of all of the following:
    (i) Why the provider believes Medicare payment is incorrect for each 
disputed item (or, where applicable, why the provider is unable to 
determine whether Medicare payment is correct because it does not have 
access to underlying information concerning the calculation of its 
payment).
    (ii) How and why the provider believes Medicare payment must be 
determined differently for each disputed item.
    (iii) If the provider self-disallows a specific item (as specified 
in Sec.  413.24(j) of this chapter), an explanation of the nature and 
amount of each self-disallowed item, the reimbursement sought for the 
item, and why the provider self-disallowed the item instead of claiming 
reimbursement for the item.
    (3) A copy of the final contractor or Secretary determination under 
appeal and any other documentary evidence the provider considers 
necessary to satisfy the hearing request requirements

[[Page 261]]

of paragraphs (b)(1) and (b)(2) of this section.
    (4) With respect to a provider under common ownership or control, 
the name and address of its parent corporation, and a statement that--
    (i) To the best of the provider's knowledge, no other provider to 
which it is related by common ownership or control, has pending a 
request for a Board hearing pursuant to this section or pursuant to 
Sec.  405.1837(b)(1) on any of the same issues contained in the 
provider's hearing request for a cost reporting period that ends within 
the same calendar year as the calendar year covered by the provider's 
hearing request; or
    (ii) Such a pending appeal(s) exist(s), and the provider name(s), 
provider number(s), and the case number(s) (if assigned), for such 
appeal(s).
    (c) Right to hearing based on untimely contractor determination. 
Notwithstanding the provisions of paragraph (a) of this section, a 
provider (but no other individual, entity, or party) has a right to a 
Board hearing, as a single provider appeal, for specific items for a 
cost reporting period if--
    (1) A final contractor determination for the provider's cost 
reporting period is not issued (through no fault of the provider) within 
12 months after the date of receipt by the contractor of the provider's 
perfected cost report or amended cost report (as specified in Sec.  
413.24(f) of this chapter). The date of receipt by the contractor of the 
provider's perfected cost report or amended cost report is presumed to 
be the date the contractor stamped ``Received'' on such cost report 
unless it is shown by a preponderance of the evidence that the 
contractor received the cost report on an earlier date.
    (2) Unless the provider qualifies for a good cause extension under 
Sec.  405.1836, the date of receipt by the Board of the provider's 
hearing request is no later than 180 days after the expiration of the 12 
month period for issuance of the final contractor determination (as 
determined in accordance with paragraph (c)(1) of this section); and
    (3) The amount in controversy (as determined in accordance with 
Sec.  405.1839) is $10,000 or more.
    (d) Contents of request for a Board hearing based on untimely 
contractor determination. The provider's request for a Board hearing 
under paragraph (c) of this section must be submitted in writing in the 
manner prescribed by the Board, and the request must include the 
elements described in paragraphs (d)(1) through (4) of this section. If 
the provider submits a hearing request that does not meet the 
requirements of paragraph (d)(1), (2), or (3) of this section, the Board 
may dismiss with prejudice the appeal or take any other remedial action 
it considers appropriate.
    (1) A demonstration that the provider satisfies the requirements for 
a Board hearing as specified in paragraph (c) of this section.
    (2) An explanation (for each specific item at issue) of the 
following:
    (i) Why the provider believes Medicare payment is incorrect for each 
disputed item (or, where applicable, why the provider is unable to 
determine whether Medicare payment is correct because it does not have 
access to underlying information concerning the calculation of Medicare 
payment).
    (ii) How and why the provider believes Medicare payment must be 
determined differently for each disputed item.
    (iii) If the provider self-disallows a specific item, a description 
of the nature and amount of each self-disallowed item and the 
reimbursement or payment sought for the item.
    (3) A copy of any documentary evidence the provider considers 
necessary to satisfy the hearing request requirements of paragraphs 
(d)(1) and (d)(2) of this section.
    (4) With respect to a provider under common ownership or control, 
the name and address of its parent corporation, and a statement that 
meets all of the requirements of paragraphs (b)(4)(i) and (b)(4)(ii) of 
this section.
    (e) Adding issues to the hearing request. After filing a hearing 
request in accordance with paragraphs (a) and (b), or paragraphs (c) and 
(d), of this section, a provider may add specific Medicare payment 
issues to the original hearing request by submitting a written request 
to the Board only if--
    (1) The request to add issues complies with the requirements of 
paragraphs

[[Page 262]]

(a) and (b), or paragraphs (c) and (d), of this section as to each new 
specific item at issue.
    (2) The specific items raised in the initial hearing request and the 
specific items identified in subsequent requests to add issues, when 
combined, satisfy the amount in controversy requirements of paragraph 
(a)(2) or paragraph (c)(3) of this section.
    (3) The Board receives the provider's request to add issues no later 
than 60 days after the expiration of the applicable 180-day period 
prescribed in paragraph (a)(3) or paragraph (c)(2), of this section.

[73 FR 30249, May 23, 2008; 73 FR 49356, Aug. 21, 2008, as amended at 79 
FR 50350, Aug. 22, 2014; 79 FR 59680, Oct. 3, 2014; 80 FR 70599, Nov. 
13, 2015; 85 FR 59019, Sept. 18, 2020]



Sec.  405.1836  Good cause extension of time limit for requesting 
a Board hearing.

    (a) A request for a Board hearing that the Board receives after the 
applicable 180-day time limit prescribed in Sec.  405.1835(a)(3) or 
Sec.  405.1835(c)(2) must be dismissed by the Board, except that the 
Board may extend the time limit upon a good cause showing by the 
provider.
    (b) The Board may find good cause to extend the time limit only if 
the provider demonstrates in writing it could not reasonably be expected 
to file timely due to extraordinary circumstances beyond its control 
(such as a natural or other catastrophe, fire, or strike), and the 
provider's written request for an extension is received by the Board 
within a reasonable time (as determined by the Board under the 
circumstances) after the expiration of the applicable 180-day limit 
specified in Sec.  405.1835(a)(3) or Sec.  405.1835(c)(2).
    (c) The Board may not grant a request for an extension under this 
section if--
    (1) The provider relies on a change in the law, regulations, CMS 
Rulings, or general CMS instructions (whether based on a court decision 
or otherwise) or a CMS administrative ruling or policy as the basis for 
the extension request; or
    (2) The date of receipt by the Board of the provider's extension 
request is later than 3 years after the date of the contractor or other 
determination that the provider seeks to appeal.
    (d) If an extension request is granted or denied under this section, 
the Board must give prompt written notice to the provider, and send a 
copy of the notice to each party to the appeal. The notice must include 
a detailed explanation of the reasons for the decision by the Board and 
the facts underlying the decision.
    (e)(1) If the Board denies an extension request and determines it 
lacks jurisdiction to grant a hearing for every specific matter at issue 
in an appeal, it must issue a Board dismissal decision dismissing the 
appeal for lack of Board jurisdiction. This decision by the Board must 
be in writing and include the explanation of the extension request 
denial required under paragraph (d) of this section, in addition to 
specific findings of fact and conclusions of law explaining the Board's 
determination that it lacks jurisdiction to grant a hearing on each 
matter at issue in the appeal (as described in Sec.  405.1840(c) ). A 
copy of the Board's dismissal decision must be sent promptly to each 
party to the appeal (as described in Sec.  405.1843).
    (2) A Board dismissal decision under paragraph (e)(1) of this 
section is final and binding on the parties, unless the decision is 
reversed, affirmed, modified, or remanded by the Administrator under 
Sec. Sec.  405.1875(a)(2)(ii) and 405.1875(e) or Sec.  405.1875(f) of 
this subpart, no later than 60 days after the date of receipt by the 
provider of the Board's decision.
    (i) This Board decision is inoperative during the 60-day period for 
review of the decision by the Administrator, or in the event the 
Administrator reverses, affirms, modifies, or remands that decision, 
within the period.
    (ii) A Board decision under paragraph (e)(1) of this section that is 
otherwise final and binding may be reopened and revised by the Board in 
accordance with Sec. Sec.  405.1885 through 405.1889 of this subpart.
    (3) The Administrator may review a Board decision granting an 
extension request solely during the course of an Administrator review of 
one of the Board decisions specified as final, or deemed final by the 
Administrator, under Sec.  405.1875(a)(2) of this subpart.

[[Page 263]]

    (4) A finding by the Board or the Administrator that the provider 
did or did not demonstrate good cause for extending the time for 
requesting a Board hearing is not subject to judicial review.

[73 FR 30250, May 23, 2008; 73 FR 49356, Aug. 21, 2008, as amended at 80 
FR 70600, Nov. 13, 2015; 85 FR 59019, Sept. 18, 2020]



Sec.  405.1837  Group appeals.

    (a)  Right to Board hearing as part of a group appeal: Criteria. A 
provider (but no other individual, entity, or party) has a right to a 
Board hearing, as part of a group appeal with other providers, with 
respect to a final contractor or Secretary determination for the 
provider's cost reporting period, only if--
    (1) The provider satisfies individually the requirements for a Board 
hearing under Sec.  405.1835(a) or Sec.  405.1835(c), except for the 
$10,000 amount in controversy requirement in Sec.  405.1835(a)(2) or 
Sec.  405.1835(c)(3).
    (2) The matter at issue in the group appeal involves a single 
question of fact or interpretation of law, regulations, or CMS Rulings 
that is common to each provider in the group; and
    (3) The amount in controversy is, in the aggregate, $50,000 or more, 
as determined in accordance with Sec.  405.1839 of this subpart.
    (b) Usage and filing of group appeals--(1) Mandatory use of group 
appeals. (i) Two or more providers under common ownership or control 
that wish to appeal to the Board a specific matter at issue that 
involves a question of fact or interpretation of law, regulations, or 
CMS Rulings that is common to the providers, and that arises in cost 
reporting periods that end in the same calendar year, and for which the 
amount in controversy is $50,000 or more in the aggregate, must bring 
the appeal as a group appeal.
    (ii) One or more of the providers under common ownership or control 
may appeal more than one cost reporting period with respect to the issue 
that is the subject of the group appeal for purposes of meeting the 
$50,000 amount in controversy requirement, and, subject to the Board's 
discretion, may appeal more than one cost reporting period with respect 
to the issue that is the subject of the group appeal for other purposes, 
such as convenience.
    (iii) A group appeal involving two or more providers under common 
ownership or control must consist entirely of providers under common (to 
all) ownership or control.
    (iv)(A) Example 1: A, B, C and D are commonly owned providers that 
wish to appeal issue X. This issue was adjusted on A, B and C's CY 2004 
cost reports, and on D's CY 2005 cost report. The amount in controversy 
is more than $50,000 in the aggregate for providers A, B and C, and more 
than $10,000 for provider D. Providers A, B and C must appeal issue X as 
a group appeal. Provider D may pursue an individual appeal to the Board 
under the procedures set forth in Sec.  405.1835 of this subpart, or if 
the Board agrees, Provider D may join the group appeal. (If Provider D 
joins the group appeal, the calendar years in the group appeal would 
then be 2004 and 2005, and any provider related to Providers A through D 
by common ownership or control would be required to appeal issue X for 
its cost reporting period ending in 2004 or 2005 through the group 
appeal.)
    (B) Example 2: A, B and C are commonly owned providers that wish to 
appeal issue X. This issue was adjusted on A, B and C's CY 2004 cost 
reports. The amount in controversy is less than $50,000 in the aggregate 
for providers A, B and C ($10,000 for A, $10,000 for B and $7,000 for 
C). Providers A, B and C cannot appeal issue X as a group appeal. 
Provider A, if it wishes, and provider B, if it wishes, may pursue an 
individual appeal to the Board under the procedures set forth in Sec.  
405.1835 of this subpart. Provider C may not pursue an individual appeal 
to the Board, because the amount in controversy is less than $10,000; 
however, it may pursue an appeal to the contractor under the procedures 
set forth in Sec.  405.1811 of this subpart.
    (2) Optional group appeals. (i) Two or more providers not under 
common ownership or control may bring a group appeal before the Board 
under this section, if the providers wish to appeal to the Board a 
specific matter at issue that involves a question of fact or 
interpretation of law, regulations,

[[Page 264]]

or CMS Rulings that is common to the providers. Alternatively, any 
provider may appeal to the Board any issues in a single provider appeal 
brought under Sec.  405.1835 of this subpart.
    (ii) One or more of the providers bringing a group appeal under this 
paragraph may appeal more than one cost reporting period with respect to 
the issue that is the subject of the group appeal for purposes of 
meeting the $50,000 amount in controversy requirement, and, subject to 
the Board's discretion, may appeal more than one cost reporting period 
with respect to the issue that is the subject of the group appeal for 
other purposes, such as convenience.
    (3) Initiating a group appeal. With respect to group appeals brought 
under paragraph (b)(1) of this section, one or more commonly owned or 
operated providers must make a written request for a Board hearing as a 
group appeal in accordance with paragraph (c) of this section. Any group 
appeal filed by a single provider must be joined by related providers on 
common issues in accordance with paragraphs (b)(1) and (e) of this 
section. With respect to group appeals brought under paragraph (b)(2) of 
this section, two or more providers may submit--
    (i) A written request for a Board hearing as a group appeal in 
accordance with paragraph (c) of this section; or
    (ii) A request to the Board in accordance with paragraph (e)(4) of 
this section that a specific matter at issue in a single provider 
appeal, filed previously under Sec.  405.1835 of this subpart, be 
transferred from the single appeal to a group appeal.
    (c) Contents of request for a group appeal. The request for a Board 
hearing as a group appeal must be submitted in writing to the Board, and 
the request must include all of the following:
    (1) A demonstration that the request satisfies the requirements for 
a Board hearing as a group appeal, as specified in paragraph (a) of this 
section.
    (2) An explanation (for each specific item at issue) of each 
provider's dissatisfaction with the final contractor or Secretary 
determination under appeal, including an account of--
    (i) Why the provider believes Medicare payment is incorrect for each 
disputed item;
    (ii) How and why the provider believes Medicare payment must be 
determined differently for each disputed item; and
    (iii) If the provider self-disallows a specific item (as specified 
in Sec.  413.24(j) of this chapter), an explanation of the nature and 
amount of each self-disallowed item, the reimbursement sought for the 
item, and why the provider self-disallowed the item instead of claiming 
reimbursement for the item.
    (3) A copy of each final contractor or Secretary determination under 
appeal, and any other documentary evidence the providers consider to 
satisfy the hearing request requirements of paragraphs (c)(1) and (c)(2) 
of this section, and a precise description of the one question of fact 
or interpretation of law, regulations, or CMS Rulings that is common to 
the particular matter at issue in the group appeal.
    (4) A statement that--
    (i) The providers believe they have satisfied all of the 
requirements for a group appeal hearing request under paragraph (a) of 
this section and requesting the Board to proceed to make jurisdictional 
findings in accordance with Sec.  405.1840; or
    (ii) The Board is requested to defer making jurisdictional findings 
until the providers request the findings in accordance with paragraph 
(e)(2) of this section.
    (d) Board's preliminary response to group appeal hearing requests. 
(1) Upon receipt of a group appeal hearing request, the Board must take 
any necessary ministerial steps.
    (2) The steps, include, for example--
    (i) Acknowledging the request;
    (ii) Assigning a case number to the appeal; or
    (iii) If applicable, transferring a specific matter at issue from a 
single provider appeal filed under Sec.  405.1835 of this subpart to a 
group appeal filed under this section.
    (e) Group appeal procedures pending full formation of the group and 
issuance of a Board decision. (1) A provider (or providers) may file a 
group appeal hearing request with the Board under

[[Page 265]]

this section before each provider member of the group identifies or 
complies with paragraphs (a)(1) and (a)(2) of this section, or before 
the group satisfies the $50,000 amount in controversy requirement under 
paragraph (a)(3) of this section. Proceedings before the Board in any 
partially formed group appeal are subject to the provisions of 
paragraphs (e)(2), (e)(3), and (e)(4) of this section. The Board will 
determine that a group appeal brought under paragraph (b)(1) of this 
section is fully formed upon a notice in writing from the group that it 
is fully formed. Absent such a notice from the group, the Board may 
issue an order, requiring the group to demonstrate (within a period of 
not less than 15 days) that at least one commonly owned or controlled 
provider has preserved the issue for appeal by claiming the relevant 
item on its cost report or by self-disallowing the item, but has not yet 
received its final determination with respect to the item for a cost 
year that is within the same calendar year as that covered by the group 
appeal (or that it has received its final determination with respect to 
the item for that period, and is still within the time to request a 
hearing on the issue). The Board determines that a group appeal brought 
under paragraph (b)(2) of this section is fully formed upon a notice in 
writing from the group that it is fully formed, or following an order 
from the Board that in its judgment, that the group is fully formed, or 
through general instructions that set forth a schedule for the closing 
of group appeals brought under paragraph (b)(2) of this section. When 
the Board has determined that a group appeal brought under paragraph 
(b)(1) of this section is fully formed, absent an order from the Board 
modifying its determination, no other provider under common ownership or 
control may appeal to the Board the issue that is the subject of the 
group appeal with respect to a cost reporting period that falls within 
the calendar year(s) covered by the group appeal.
    (2) The Board may make jurisdictional findings under Sec.  405.1840 
at any time, including, but not limited to, following a request by the 
providers for the jurisdictional findings. The providers may request 
jurisdictional findings by notifying the Board in writing that the group 
appeal is fully formed, or that the providers believe they have 
satisfied all of the requirements for a group appeal hearing request, 
and the Board may proceed to make jurisdictional findings. The providers 
must include with the notice any additional information or documentary 
evidence that is required for group appeal hearing requests. The Board 
does not dismiss a group appeal hearing request for failure to meet the 
$50,000 amount in controversy requirement until the Board has 
determined, in accordance with paragraph (e)(1) of this section, that 
the group is fully formed.
    (3) If the Board makes a preliminary determination of jurisdiction 
to conduct a hearing as a group appeal under this section, the Board 
then takes any further actions in the appeal it finds to be appropriate 
under this subpart (as described in Sec.  405.1840(a) of this subpart). 
The Board may take further actions, even though the providers in the 
appeal may wish to add other providers to the group in accordance with 
paragraph (e)(4) of this section. The Board must make separate 
jurisdictional findings for each cost reporting period added 
subsequently to the group appeal (as described in Sec. Sec.  405.1837(a) 
and 405.1839(b) of this subpart).
    (4) A provider may submit a request to the Board to join a group 
appeal any time before the Board issues one of the decisions specified 
in Sec.  405.1875(a)(2). By submitting a request, the provider agrees 
that, if the request is granted, the provider is bound by the Board's 
actions and decision in the appeal. If the Board denies a request, the 
Board's action is without prejudice to any separate appeal the provider 
may bring in accordance with Sec.  405.1811, Sec.  405.1835, or this 
section. For purposes of determining timeliness for the filing of any 
separate appeal and for the adding of issues to such appeal, the date of 
receipt of the provider's request to form or join the group appeal is 
considered the date of receipt for purposes of meeting the applicable 
180-day period prescribed in Sec.  405.1835(a)(3) or Sec.  
405.1835(c)(2).
    (5)(i) Except as specified in paragraph (ii) of this paragraph, when 
a provider

[[Page 266]]

has appealed an issue through electing to form, or joining, a group 
appeal under the procedures set forth in this section, it may not 
subsequently request that the Board transfer that issue to a single 
provider appeal brought in accordance with Sec.  405.1811 or Sec.  
405.1835 of this subpart.
    (ii) Exception. When the Board determines that the requirements for 
a group appeal are not met (that is, when there has been a failure to 
meet the amount in controversy or the common issue requirement), it 
transfers the issue that was the subject of the group appeal to a single 
provider appeal (or appeals) for the provider (or providers) that meets 
(or meet) the requirements for a single provider appeal.
    (f) Limitations on group appeals. (1) After the date of receipt by 
the Board of a group appeal hearing request under paragraph (c) of this 
section, a provider may not add other questions of fact or law to the 
appeal, regardless of whether the question is common to other members of 
the appeal (as described in Sec.  405.1837(a)(2) and (g) of this 
subpart).
    (2) The Board may not consider, in one group appeal, more than one 
question of fact, interpretation of law, regulations, or CMS Rulings 
that is common to each provider in the appeal. If the Board finds 
jurisdiction over a group appeal hearing request under Sec.  405.1840 of 
this subpart--
    (i) The Board must determine whether the appeal involves specific 
matters at issue that raise more than one factual or legal question 
common to each provider; and
    (ii) When the appeal is found to involve more than one factual or 
legal question common to each provider, the Board must assign a separate 
case number to the appeal of each common factual or legal question and 
conduct further proceedings in the various appeals separately for each 
case.
    (g) Issues not common to the group appeal. A provider involved in a 
group appeal that also wishes to appeal a specific matter that does not 
raise a factual or legal question common to each of the other providers 
in the group must file a separate request for a single provider hearing 
in accordance with Sec.  405.1811 or Sec.  405.1835 of this subpart, or 
file a separate request for a hearing as part of a different group 
appeal under this section, as applicable.

[73 FR 30250, May 23, 2008, as amended at 80 FR 70600, Nov. 13, 2015]



Sec.  405.1839  Amount in controversy.

    (a) Single provider appeals. (1) In order to satisfy the amount in 
controversy requirement under Sec.  405.1811(a)(2) or Sec.  
405.1811(c)(3) for a contractor hearing or the amount in controversy 
requirement under Sec.  405.1835(a)(2) or Sec.  405.1835(c)(3) for a 
Board hearing for a single provider, the provider must demonstrate that 
if its appeal were successful, the provider's total program 
reimbursement for each cost reporting period under appeal would increase 
by at least $1,000 but by less than $10,000 for a contractor hearing, or 
by at least $10,000 for a Board hearing, as applicable.
    (2) Aggregation of claims. For purposes of satisfying the applicable 
amount in controversy requirement for a single provider appeal to the 
contractor or the Board, the provider may aggregate claims for 
additional program payment for more than one specific matter at issue, 
provided each specific claim and issue is for the same cost reporting 
period. Aggregation of claims from more than one cost reporting period 
to meet the applicable amount in controversy requirement is prohibited, 
even if a specific claim or issue in the appeal recurs for multiple cost 
years.
    (b) Group appeals. (1) In order to satisfy the amount in controversy 
requirement under Sec.  405.1837(a)(3) of this subpart for a Board 
hearing as a group appeal, the group must demonstrate that if its appeal 
were successful, the total program reimbursement for the cost reporting 
periods under appeal would increase, in the aggregate, by at least 
$50,000.
    (2) Aggregation of claims. (i) For purposes of satisfying the amount 
in controversy requirement, group members are not allowed to aggregate 
claims involving different issues.
    (A) A group appeal must involve a single question of fact or 
interpretation of law, regulations, or CMS Ruling that is common to each 
provider (as described in Sec.  405.1837(a)(2) of this subpart).

[[Page 267]]

    (B) The single issue that is common to each provider may exist over 
different cost reporting periods.
    (ii) For purposes of satisfying the amount in controversy 
requirement, a provider may appeal multiple cost reporting periods and 
different providers in the group may appeal different cost reporting 
periods.
    (c) Limitations on change in Medicare reimbursement. (1) In order to 
satisfy the applicable amount in controversy requirement for a single 
provider appeal or a group appeal, an appeal favorable to the 
provider(s) on all specific matters at issue in the appeal increases 
program reimbursement for the provider(s) in the cost reporting 
period(s) at issue by an amount that equals or exceeds the applicable 
amount in controversy threshold.
    (2) The applicable amount in controversy requirement is not 
satisfied if the result of a favorable appeal decreases program 
reimbursement for the provider(s) in the cost reporting year(s) at issue 
in the appeal.
    (3) Any effects that a favorable appeal might have on program 
reimbursement for the provider(s) in cost reporting period(s) not at 
issue in the appeal have no bearing on whether the amount in controversy 
requirement is satisfied for the cost year(s) at issue in the appeal.
    (4) When a provider (or group of providers) has requested a hearing 
before a contractor under Sec.  405.1811 of this subpart, and the amount 
in controversy is subsequently determined to be at least $10,000 (for 
example, due to a reassessment of the amount in controversy by the 
contractor hearing office or due to adding an issue), the appeal is 
transferred to the Board. The Board is not bound by any jurisdictional 
finding of the contractor hearing officer(s).
    (5) When a provider or group of providers has requested a hearing 
before the Board under Sec.  405.1835 or Sec.  405.1837 of this subpart, 
and the amount in controversy changes to an amount less than the minimum 
for a Board appeal due to--
    (A) The settlement or partial settlement of an issue, transfer of an 
issue to a group appeal, or the abandonment of an issue in an individual 
appeal, the change in the amount in controversy does not deprive the 
Board of jurisdiction.
    (B) A more accurate assessment of the amount in controversy, the 
Board does not retain jurisdiction.

[73 FR 30252, May 23, 2008; 73 FR 49356, Aug. 21, 2008, as amended at 80 
FR 70600, Nov. 13, 2015]



Sec.  405.1840  Board jurisdiction.

    (a) General rules. (1) After a request for a Board hearing is filed 
under Sec.  405.1835 or Sec.  405.1837 of this part, the Board must 
determine in accordance with paragraph (b) of this section, whether or 
not it has jurisdiction to grant a hearing on each of the specific 
matters at issue in the hearing request.
    (2) The Board must make a preliminary determination of the scope of 
its jurisdiction (that is, whether the request for hearing was timely, 
and whether the amount in controversy requirement has been met), if any, 
over the matters at issue in the appeal before conducting any of the 
following proceedings:
    (i) Determining its authority to decide a legal question relevant to 
a matter at issue (as described in Sec.  405.1842 of this subpart).
    (ii) Permitting discovery (as described in Sec.  405.1853 of this 
subpart).
    (iii) Issuing a subpoena (as described in Sec.  405.1857 of this 
subpart).
    (iv) Conducting a hearing (as described in Sec.  405.1845 of this 
subpart).
    (3) The Board may revise a preliminary determination of jurisdiction 
at any subsequent stage of the proceedings in a Board appeal, and must 
promptly notify the parties of any revised determination. Under 
paragraph (c)(1) of this section, each expedited judicial review (EJR) 
decision (as described in Sec.  405.1842 of this subpart) and hearing 
decision (as described in Sec.  405.1871 of this subpart) by the Board 
must include a jurisdictional finding for each specific matter at issue 
in the appeal.
    (4) If the Board finally determines it lacks jurisdiction over every 
specific matter at issue in the appeal, the Board must issue a dismissal 
decision under paragraph (c)(2) of this section.
    (5) Final jurisdictional findings and dismissal decisions by the 
Board under

[[Page 268]]

paragraphs (c)(1) and (c)(2) of this section are subject to 
Administrator and judicial review in accordance with paragraph (d) of 
this section.
    (b) Criteria. Except with respect to the amount in controversy 
requirement, the jurisdiction of the Board to grant a hearing must be 
determined separately for each specific matter at issue in each 
contractor or Secretary determination for each cost reporting period 
under appeal. The Board has jurisdiction to grant a hearing over a 
specific matter at issue in an appeal only if the provider has a right 
to a Board hearing as a single provider appeal under Sec.  405.1835 of 
this subpart or as part of a group appeal under Sec.  405.1837 of this 
subpart, as applicable. Certain matters at issue are removed from 
jurisdiction of the Board. These matters include, but are not 
necessarily limited to, the following:
    (1) A finding in a contractor determination that expenses incurred 
for certain items or services furnished by a provider to an individual 
are not payable under title XVIII of the Act because those items or 
services are excluded from coverage under section 1862 of the Act and 
part 411 of the regulations. Review of these findings is limited to the 
applicable provisions of sections 1155, 1869, and 1879(d) of the Act and 
of subpart I of part 405 and subpart B of part 478 of the regulations, 
as applicable.
    (2) Certain matters affecting payments to hospitals under the 
prospective payment system, as provided in section 1886(d)(7) of the Act 
and Sec.  405.1804 of this subpart.
    (c) Board's jurisdictional findings and jurisdictional dismissal 
decisions. (1) In issuing an EJR decision under Sec.  405.1842 of this 
subpart or a hearing decision under Sec.  405.1871 of this subpart, as 
applicable, the Board must make a separate determination of whether it 
has jurisdiction for each specific matter at issue in each contractor or 
Secretary determination under appeal. A decision by the Board must 
include specific findings of fact and conclusions of law as to whether 
the Board has jurisdiction to grant a hearing on each matter at issue in 
the appeal.
    (2) Except as provided in Sec. Sec.  405.1836(e)(1) and 
405.1842(f)(2)(i), where the Board determines it lacks jurisdiction to 
grant a hearing for every specific matter at issue in an appeal, it must 
issue a dismissal decision dismissing the appeal for lack of Board 
jurisdiction. The decision by the Board must include specific findings 
of fact and conclusions of law explaining the Board's determination that 
it lacks jurisdiction to grant a hearing on each matter at issue in the 
appeal. A copy of the Board's decision must be sent promptly to each 
party to the appeal (as described in Sec.  405.1843).
    (3) A dismissal decision by the Board under paragraph (c)(2) of this 
section is final and binding on the parties unless the decision is 
reversed, affirmed, modified or remanded by the Administrator under 
Sec.  405.1875(a)(2)(ii) and Sec.  405.1875(e) or Sec.  405.1875(f) of 
this subpart, no later than 60 days after the date of receipt by the 
provider of the Board's decision. The Board decision is inoperative 
during the 60-day period for review of the decision by the 
Administrator, or in the event the Administrator reverses, affirms, 
modifies or remands that decision within that period. A final Board 
decision under paragraphs (c)(2) and (c)(3) of this section may be 
reopened and revised by the Board in accordance with Sec. Sec.  405.1885 
through 405.1889 of this subpart.
    (d) Administrator and judicial review. Any finding by the Board as 
to whether it has jurisdiction to grant a hearing on a specific matter 
at issue in an appeal is not subject to further administrative and 
judicial review, except as provided in this paragraph. The Board's 
jurisdictional findings as to specific matters at issue in an appeal may 
be reviewed solely during the course of Administrator review of one of 
the Board decisions specified as final, or deemed to be final by the 
Administrator, under Sec.  405.1875(a)(2) of this subpart, or during the 
course of judicial review of a final agency decision as described in 
Sec.  405.1877(a) of this subpart, as applicable.

[73 FR 30253, May 23, 2008, as amended at 80 FR 70600, Nov. 13, 2015; 85 
FR 59019, Sept. 18, 2020]



Sec.  405.1842  Expedited judicial review.

    (a) Basis and scope. (1) This section implements provisions in 
section

[[Page 269]]

1878(f)(1) of the Act that give a provider the right to seek EJR of a 
legal question relevant to a specific matter at issue in a Board appeal 
if there is Board jurisdiction to conduct a hearing on the matter (as 
described in Sec.  405.1840 of this subpart), and the Board determines 
it lacks the authority to decide the legal question (as described in 
Sec.  405.1867 of this subpart, which explains the scope of the Board's 
legal authority).
    (2) A provider may request a Board decision that the provider is 
entitled to seek EJR or the Board may consider issuing a decision on its 
own motion. Each EJR decision by the Board must include a specific 
jurisdictional finding on the matter(s) at issue, and, where the Board 
determines that it does have jurisdiction on the matter(s) at issue, a 
separate determination of the Board's authority to decide the legal 
question(s).
    (3) The Administrator may review the Board's jurisdictional finding, 
but not the Board's authority determination.
    (4) The provider has a right to seek EJR of the legal question under 
section 1878(f)(1) of the Act only if--
    (i) The final EJR decision of the Board or the Administrator, as 
applicable, includes a finding of Board jurisdiction over the specific 
matter at issue and a determination by the Board that it has no 
authority to decide the relevant legal question; or
    (ii) The Board fails to make a determination of its authority to 
decide the legal question no later than 30 days after finding 
jurisdiction over the matter at issue and notifying the provider that 
the provider's EJR request is complete.
    (b) General--(1) Prerequisite of Board jurisdiction. The Board (or 
the Administrator) must find that the Board has jurisdiction over the 
specific matter at issue before the Board may determine its authority to 
decide the legal question.
    (2) Initiating EJR procedures. A provider or group of providers may 
request the Board to grant EJR of a specific matter or matters under 
appeal, or the Board on its own motion may consider whether to grant EJR 
of a specific matter or matters under appeal. Under paragraph (c) of 
this section, the Board may initiate own motion consideration of its 
authority to decide a legal question only if the Board makes a 
preliminary finding that it has jurisdiction over the specific matter at 
issue to which the legal question is relevant. Under paragraphs (d) and 
(e) of this section, a provider may request a determination of the 
Board's authority to decide a legal question, but the 30-day period for 
the Board to make a determination under section 1878(f)(1) of the Act 
does not begin to run until the Board finds jurisdiction to conduct a 
hearing on the specific matter at issue in the EJR request and notifies 
the provider that the provider's request is complete.
    (c) Board's own motion consideration. (1) If the Board makes a 
finding that it has jurisdiction to conduct a hearing on a specific 
matter at issue in accordance with Sec.  405.1840(a) of this part, it 
may then consider on its own motion whether it lacks the authority to 
decide a legal question relevant to the matter at issue.
    (2) The Board must initiate its own motion consideration by issuing 
a written notice to each of the parties to the appeal (as described in 
Sec.  405.1843 of this subpart). The notice must--
    (i) Identify each specific matter at issue for which the Board has 
made a finding that it has jurisdiction under Sec.  405.1840(a) of this 
part, and for each specific matter, identify each relevant statutory 
provision, regulation, or CMS Ruling; and
    (ii) Specify a reasonable period of time for the parties to respond 
in writing.
    (3) After considering any written responses made by the parties to 
its notice of own motion consideration, the Board must determine whether 
it has sufficient information to issue an EJR decision for each specific 
matter and legal question included in the notice. If necessary, the 
Board may request additional information regarding its jurisdiction or 
authority from a party (or parties), and the Board must give any other 
party a reasonable opportunity to comment on any additional submission. 
Once the Board determines it needs no further information from the 
parties (or that any information has

[[Page 270]]

not been rendered timely), it must issue an EJR decision in accordance 
with paragraph (f) of this section.
    (d) Provider requests. A provider (or, in the case of a group 
appeal, a group of providers) may request a determination by the Board 
that it lacks the authority to decide a legal question relevant to a 
specific matter at issue in an appeal. A provider must submit a request 
in writing to the Board and to each party to the appeal (as described in 
Sec.  405.1843 of this subpart), and the request must include--
    (1) For each specific matter and question included in the request, 
an explanation of why the provider believes the Board has jurisdiction 
under Sec.  405.1840 of this subpart over each matter at issue and no 
authority to decide each relevant legal question; and
    (2) Any documentary evidence the provider believes supports the 
request.
    (e) Board action on provider requests. (1) If the Board makes a 
finding that it has jurisdiction to conduct a hearing on a specific 
matter at issue in accordance with Sec.  405.1840(a) of this part, then 
(and only then) it must consider whether it lacks the authority to 
decide a legal question relevant to the matter at issue. The Board is 
required to make a determination of its authority to decide the legal 
question raised in a review request under paragraph (d)(1) of this 
section by issuing an EJR decision no later than 30 days after receiving 
a complete provider request as defined in paragraph (e)(2) of this 
section.
    (2) Requirements of a complete provider request. A complete provider 
request for EJR consists of the following:
    (i) A request for an EJR decision by the provider(s).
    (ii) All of the information and documents found necessary by the 
Board for issuing a decision in accordance with paragraph (f) of this 
section.
    (3) Board's response to provider requests. After receiving a 
provider request for an EJR decision, the Board must review the request, 
along with any responses to the request submitted by other parties to 
the appeal (as described in Sec.  405.1843 of this subpart). The Board 
must respond to the provider(s) as follows:
    (i) Upon receiving a complete provider request, issue an EJR 
decision in accordance with paragraph (f) of this section no later than 
30 days after receipt of the complete provider request. If the Board 
does not issue a decision within that 30-day period, the provider has a 
right to file a complaint in Federal district court in order to obtain 
EJR over the specific matter(s) at issue.
    (ii) If the provider has not submitted a complete request, issue no 
later than 30 days after receipt of the incomplete request a written 
notice to the provider describing in detail the further information that 
the provider must submit in order to complete the request.
    (f) Board's decision on EJR: Criteria for granting EJR. Subject to 
paragraph (h)(3) of this section, the Board is required to issue an EJR 
decision following either the completion of the Board's own motion 
consideration under paragraph (c) of this section, or a notice issued by 
the Board in accordance with paragraph (e)(3)(i) of this section.
    (1) The Board's decision must grant EJR for a legal question 
relevant to a specific matter at issue in a Board appeal if the Board 
determines the following conditions are satisfied:
    (i) The Board has jurisdiction to conduct a hearing on the specific 
matter at issue in accordance with Sec.  405.1840 of this subpart.
    (ii) The Board lacks the authority to decide a specific legal 
question relevant to the specific matter at issue because the legal 
question is a challenge either to the constitutionality of a provision 
of a statute, or to the substantive or procedural validity of a 
regulation or CMS Ruling.
    (2) The Board's decision must deny EJR for a legal question relevant 
to a specific matter at issue in a Board appeal if any of the following 
conditions are satisfied:
    (i) The Board determines that it does not have jurisdiction to 
conduct a hearing on the specific matter at issue in accordance with 
Sec.  405.1840 of this subpart.
    (ii) The Board determines it has the authority to decide a specific 
legal

[[Page 271]]

question relevant to the specific matter at issue because the legal 
question is neither a challenge to the constitutionality of a provision 
of a statute, nor a challenge to the substantive or procedural validity 
of a regulation or CMS Ruling.
    (iii) The Board does not have sufficient information to determine 
whether the criteria specified in paragraph (f)(1)(i) or (f)(1)(ii) of 
this section are met.
    (3) A copy of the Board's decision must be sent promptly to--
    (i) Each party to the Board appeal (as described in Sec.  405.1843 
of this subpart) and
    (ii) The Office of the Attorney Advisor.
    (g) Further review after the Board issues an EJR decision--(1) 
General rules. (i) Under Sec.  405.1875(a)(2)(iii) of this subpart, the 
Administrator may review, on his or her own motion, or at the request of 
a party, the jurisdictional component only of the Board's EJR decision.
    (ii) Any review by the Administrator is limited to the question of 
whether there is Board jurisdiction over the specific matter at issue; 
the Administrator may not review the Board's determination of its 
authority to decide the legal question.
    (iii) An EJR decision by the Board becomes final and binding on the 
parties unless the decision is reversed, affirmed, modified, or remanded 
by the Administrator under Sec. Sec.  405.1875(a)(2)(iii), 405.1875(e), 
and 405.1875(f) of this subpart no later than 60 days after the date of 
receipt by the provider of the Board's decision.
    (iv) A Board decision is inoperative during the 60-day period for 
review by the Administrator, or in the event the Administrator reverses, 
affirms, modifies, or remands that decision within that period.
    (v) Any right of the provider to obtain EJR from a Federal district 
court is specified at paragraphs (g)(2) and (g)(3) of this section (when 
the Board issues a timely EJR decision) and paragraph (g)(4) of this 
section (in the absence of a timely Board decision).
    (vi) A final Board decision under paragraph (f) of this section, and 
a final Administrator decision made upon review of a final Board 
decision (as described in Sec.  405.1875(a)(2) and (e) of this subpart) 
may be reopened and revised in accordance with Sec. Sec.  405.1885 
through 405.1889 of this subpart.
    (2) Board grants EJR. If the Board grants EJR, the provider may file 
a complaint in a Federal district court in order to obtain EJR of the 
legal question. If the Administrator renders, no later than 60 days 
after the date of receipt by the provider of the Board's decision 
granting EJR, a decision finding that the Board has no jurisdiction over 
the matter at issue, the Board's decision is nonfinal and the provider 
has no right to obtain judicial review based on the Board's decision (as 
described in Sec.  405.1877(a)(3) and (b)(3) of this subpart).
    (3) Board denies EJR. If the Board's decision denies EJR because the 
Board finds that it has the authority to decide the legal question 
relevant to the matter at issue, the Administrator may not review the 
Board's authority determination, and the provider has no right to obtain 
EJR. If the Board denies EJR based on a finding that it lacks 
jurisdiction over the specific matter, the provider has no right to 
obtain EJR unless--
    (i) The Administrator renders timely a final decision reversing the 
Board, finding the Board has jurisdiction over the matter at issue, and 
remanding to the Board; or
    (ii) A court reverses the Board's or Administrator's decision as to 
jurisdiction, the Administrator remands to the Board, and the Board 
subsequently issues on remand from the Administrator an EJR decision 
granting EJR on the basis that it lacks the authority to decide the 
legal question.
    (4) No timely EJR decision. The Board must issue an EJR decision no 
later than 30 days after the date of a written notice under paragraph 
(e)(3)(i) of this section, when the provider submits a complete request 
for EJR. If the Board does not issue an EJR decision within a 30-day 
period, the provider(s) has a right to seek EJR under section 1878(f)(1) 
of the Act.
    (h) Effect of final EJR decisions and lawsuits on further Board 
proceedings--(1) Final decisions granting EJR. If the

[[Page 272]]

final decision of the Board or the Administrator, as applicable (as 
described in Sec. Sec.  405.1842(g)(1) and 405.1875(e)(4) of this 
subpart), grants EJR, the Board may not conduct any further proceedings 
on the legal question. The Board must dismiss--
    (i) The specific matter at issue from the appeal.
    (ii) The entire appeal if there are no other matters at issue that 
are within the Board's jurisdiction and can be fully decided by the 
Board.
    (2) Final decisions denying EJR. If the final decision:
    (i) Of the Board denies EJR solely on the basis that the Board 
determines it has the authority to decide the legal question relevant to 
the specific matter at issue, the Board must conduct further proceedings 
on the legal question and issue a decision on the matter at issue in 
accordance with this subpart.
    Exception: If the provider(s) file(s) a lawsuit pertaining to the 
legal question, and for a period that is covered by the Board's decision 
denying EJR, the Board may not conduct any further proceedings under 
this subpart on the legal question or the matter at issue before the 
lawsuit is finally resolved.
    (ii) Of the Board (or the Administrator) denies EJR on the basis 
that the Board lacks jurisdiction over the specific matter at issue, the 
Board (or the Administrator) must, as applicable, dismiss the specific 
matter at issue from the appeal, or dismiss the appeal entirely if there 
are no other matters at issue that are within the Board's jurisdiction 
and can be fully decided by the Board. If only the specific matter(s) is 
dismissed from the appeal, judicial review may be had only after a final 
decision on the appeal is made by the Board or Administrator, as 
applicable (as described in Sec. Sec.  405.1840(d) and 405.1877(a) of 
this subpart). If the Board or the Administrator, as applicable, 
dismisses the appeal entirely, the decision is subject to judicial 
review under Sec.  405.1877(a) of this subpart.
    (3) Provider lawsuits. (i) If the provider files a lawsuit seeking 
judicial review (whether on the basis of the EJR provisions of section 
1878(f)(1) of the Act or on some other basis) pertaining to a legal 
question that is allegedly relevant to a specific matter at issue in a 
Board appeal to which the provider is a party and that is allegedly not 
within the Board's authority to decide, the Office of the Attorney 
Advisor must promptly provide the Board with written notice of the 
lawsuit and a copy of the complaint.
    (ii) If the lawsuit is filed after a final EJR decision by the Board 
or the Administrator, as applicable (as described in Sec. Sec.  
405.1842(g)(1) and 405.1875(e)(4) of this subpart), on the legal 
question, the Board must carry out the applicable provisions of 
paragraphs (h)(1) and (h)(2) of this section in any pending Board appeal 
on the specific matter at issue.
    (iii) If the lawsuit is filed before a final EJR decision is issued 
on the legal question, the Board may not conduct any further proceedings 
on the legal question or the matter at issue until the lawsuit is 
resolved.

[73 FR 30254, May 23, 2008; 73 FR 49356, Aug. 21, 2008]



Sec.  405.1843  Parties to proceedings in a Board appeal.

    (a)(1) When a provider files a request for a hearing before the 
Board in accordance with Sec.  405.1835 or Sec.  405.1837, the parties 
to all proceedings in the Board appeal include the provider, a 
contractor, and, where applicable, any other entity found by the Board 
to be a related organization of the provider under the principles 
enunciated in Sec.  413.17 of this chapter.
    (2) All parties to a Board appeal are to familiarize themselves with 
the instructions for handling a Provider Reimbursement Review Board 
(PRRB) appeal, including any and all requirements related to the 
electronic/online filing of documents.
    (b) Neither the Secretary nor CMS may be made a party to proceedings 
in a Board appeal.
    (1) The Board may call as a witness any employee or officer of the 
Department of Health and Human Services or CMS having personal knowledge 
of the facts and the issues in controversy in an appeal.
    (2) The regulations at 45 CFR Part 2 (Testimony by employees and 
production of documents in proceedings where the United States is not a 
party) apply

[[Page 273]]

as to whether such employee or officer will appear.
    (c) A contractor may designate a representative from the Secretary 
or CMS, who may be an attorney, to represent the contractor in 
proceedings before the Board.
    (d) Although CMS is not a party to proceedings in a Board appeal, 
there may be instances where CMS determines that the administrative 
policy implications of a case are substantial enough to warrant comment 
from CMS (as described in Sec.  405.1863 of this subpart). CMS--
    (1) May file amicus curiae (friend of the court) briefing papers 
with the Board in accordance with a schedule to be determined by the 
Board.
    (2) Must promptly send copies of any documents filed with the Board 
to each party to the appeal.
    (e) A nonparty other than CMS may seek leave from the Board to file 
amicus curiae briefing papers with the Board.
    (f) The Board may exclude from the record all or part of an amicus 
curiae briefing paper. When the Board excludes from the record all or 
part of an amicus curiae briefing paper submitted by CMS, it states for 
the record its reason(s) in writing.

[73 FR 30256, May 23, 2008, as amended at 85 FR 59019, Sept. 18, 2020]



Sec.  405.1845  Composition of Board; hearings, decisions, and remands.

    (a) The Board will consist of five members appointed by the 
Secretary. All shall be knowledgeable in the field of cost 
reimbursement. At least one shall be a certified public accountant. Two 
Board members shall be representative of providers of services.
    (b) The term of office for Board members shall be 3 years, except 
that initial appointments may be for such shorter terms as the Secretary 
may designate to permit staggered terms of office. No member shall serve 
more than two consecutive 3-year terms of office. The Secretary shall 
have the authority to terminate a Board member's term of office for good 
cause.
    (c) Composition of the Board. The Secretary designates one member of 
the Board as Chairperson. The Chairperson coordinates and directs the 
administrative activities of the Board and the conduct of proceedings 
before the Board. CMS provides administrative support for the Board. 
Under the direction of the Chairperson, the Board is solely responsible 
for the content of its decisions.
    (d) Quorum. (1) The Board must have a quorum in order to issue one 
of the decisions specified as final, or deemed final by the 
Administrator, under Sec.  405.1875(a)(2)(i), (a)(2)(iii), and 
(a)(2)(iv), but a quorum is not required for other Board actions.
    (2) Three Board members, at least one of whom is representative of 
providers, are required in order to constitute a quorum.
    (3) The opinion of the majority of those Board members issuing a 
decision specified as final, or deemed as final by the Administrator, 
under Sec.  405.1875(a)(2), constitutes the Board's decision.
    (e) Hearings. The Board may conduct a hearing and issue a hearing 
decision (as described in Sec.  405.1871 of this subpart) on a specific 
matter at issue in an appeal, provided it finds jurisdiction over the 
matter at issue in accordance with Sec.  405.1840 of this part and 
determines it has the legal authority to fully resolve the issue (as 
described in Sec.  405.1867 of this subpart).
    (f) Oral hearings. (1) In accordance with paragraph (d) of this 
section, the Board does not need a quorum in order to hold an oral 
hearing (as described in Sec.  405.1851 of this subpart). The 
Chairperson of the Board may designate one or more Board members to 
conduct an oral hearing (where less than a quorum conducts the hearing). 
Because the presence of all Board members is not required at an oral 
hearing, the Board, at its discretion, may hold more than one oral 
hearing at a time.
    (2) Waiver of oral hearings. With the contractor's agreement and the 
Board's approval, the provider (or, in the case of group appeals, the 
group of providers) and any related organizations (as described in Sec.  
405.1843(a) of this subpart) may waive any right to an oral hearing and 
stipulate that the Board may issue a hearing decision on the written 
record. An on-the-written-

[[Page 274]]

record hearing consists of all the evidence and written argument or 
comments submitted to the Board and included in the record (as described 
in Sec.  405.1865 of this subpart).
    (g) Hearing decisions. The Board's hearing decision must be based on 
the transcript of any oral hearing before the Board, any matter admitted 
into evidence at a hearing or deemed admissible evidence for the record 
(as described in Sec.  405.1855 of this subpart), and any written 
argument or comments timely submitted to the Board (as described in 
Sec.  405.1865 of this subpart).
    (h) Remands. (1) Except as provided in paragraph (h)(3) of this 
section, a Board remand order may be reviewed solely during the course 
of Administrator review of one of the Board decisions specified in Sec.  
405.1875(a)(2) of this subpart), or of judicial review of a final agency 
decision as described in Sec.  405.1877(a) and (c)(3) of this part, as 
applicable.
    (2) The Board may order a remand requiring specific actions of a 
party to the appeal. In ordering a remand, the Board must--
    (i) Specify any actions required of the party and explain the 
factual and legal basis for ordering a remand;
    (ii) Issue the remand order in writing; and
    (iii) Send the remand order promptly to the parties and any affected 
nonparty, such as CMS, to the appeal.
    (3) A Board remand order is not subject to immediate Administrator 
review unless the Administrator determines that the remand order might 
otherwise evade his or her review (as described in Sec.  
405.1875(a)(2)(iv) of this subpart).

[39 FR 34515, Sept. 26, 1974, as amended at 41 FR 52051, Nov. 26, 1976. 
Redesignated at 42 FR 52826, Sept. 30, 1977, as amended at 73 FR 30256, 
May 23, 2008; 85 FR 59019, Sept. 18, 2020]



Sec.  405.1847  Disqualification of Board members.

    No Board member shall join in the conduct of a hearing in a case in 
which he is prejudiced or partial with respect to any party or in which 
he has any interest in the matter pending for decision before him. 
Notice of any objection which a party may have with respect to a Board 
member shall be presented in writing to such Board member by the 
objecting party at its earliest opportunity. The Board member shall 
consider the objection and shall, in his discretion, either proceed to 
join in the conduct of the hearing or withdraw. If he does not withdraw, 
the objecting party may petition the Board, presenting its objection and 
reasons therefor, and be entitled to a ruling thereon before the hearing 
can proceed.



Sec.  405.1849  Establishment of time and place of hearing by the Board.

    The Board shall fix the time and place for the hearing and shall 
send notice thereof to the parties' contact information on file, not 
less than 30 days prior to the scheduled time. Either on its own motion 
or for good cause shown by a party, the Board may, as appropriate, 
reschedule, adjourn, postpone, or reopen the hearing, provided that 
reasonable written notice is given to the parties.

[39 FR 34515, Sept. 26, 1974, as amended at 85 FR 59019, Sept. 18, 2020]



Sec.  405.1851  Conduct of Board hearing.

    The Board hearing shall be open to the parties, to representatives 
of the Centers for Medicare & Medicaid Services, and to such other 
persons as the Board deems necessary and proper. The Board shall inquire 
fully into all of the matters at issue and shall receive into evidence 
the testimony of witnesses and any documents which are relevant and 
material to such matters. If the Board believes that there is relevant 
and material evidence available which has not been presented at the 
hearing, it may at any time prior to the issuing of the notice of the 
decision, reconvene the hearing for the receipt of such evidence. The 
order in which the evidence and the allegations shall be presented and 
the conduct of the hearing shall be at the discretion of the Board.

[39 FR 34515, Sept. 26, 1974, as amended at 85 FR 59019, Sept. 18, 2020]



Sec.  405.1853  Board proceedings prior to any hearing; discovery.

    (a) Preliminary narrowing of the issues. Upon receiving notification 
that a request for a Board hearing is submitted, the contractor must--

[[Page 275]]

    (1) Promptly review both the materials submitted with the provider 
hearing request, and the information underlying each contractor or 
Secretary determination for each cost reporting period under appeal.
    (2) Expeditiously attempt to join with the provider in resolving 
specific factual or legal issues and submitting to the Board written 
stipulations setting forth the specific issues that remain for Board 
resolution based on the review; and
    (3) Ensure that the evidence it considered in making its 
determination, or, where applicable, the evidence the Secretary 
considered in making his or her determination, is included in the 
record.
    (b) Position papers. (1) After any preliminary narrowing of the 
issues, the parties must file position papers in order to narrow the 
issues further. In each case, and as appropriate, the Board establishes 
the deadlines as to when the provider(s) and the contractor must submit 
position papers to the Board.
    (2) The Board has the discretion to extend the deadline for 
submitting a position paper. Each position paper must set forth the 
relevant facts and arguments regarding the Board's jurisdiction over 
each remaining matter at issue in the appeal (as described in Sec.  
405.1840 of this subpart), and the merits of the provider's Medicare 
payment claims for each remaining issue.
    (3) In the absence of a Board order or general instructions to the 
contrary, any supporting exhibits regarding Board jurisdiction must 
accompany the position paper. Exhibits regarding the merits of the 
provider's Medicare payment claims may be submitted in a timeframe to be 
decided by the Board through a schedule applicable to a specific case or 
through general instructions.
    (c) Initial status conference. (1) Upon review of the parties' 
position papers, one or more members of the Board may conduct an initial 
status conference. An initial status conference may be conducted in 
person or telephone, at the discretion of the Board.
    (2) The Board may use the status conference to discuss any of the 
following:
    (i) Simplification of the issues.
    (ii) The necessity or desirability of amendments to the pleadings, 
including the need for a more definite statement.
    (iii) Stipulations and admissions of fact or as to the content and 
authenticity of documents.
    (iv) Whether the parties can agree to submission of the case on a 
stipulated record.
    (v) Whether a party may waive appearance at an oral hearing and 
submit only documentary evidence (the admissibility of which is subject 
to objection from other parties) and written argument.
    (vi) Limitation of the number of witnesses.
    (vii) Scheduling dates for the exchange of witness lists and of 
proposed exhibits.
    (viii) Discovery as permitted under this section.
    (ix) The time and place for the hearing.
    (x) Potential settlement of some or all of the issues.
    (xi) Other matters that the Board deems necessary and appropriate. 
The Board may issue any orders at the conference found necessary and 
appropriate to narrow the issues further and expedite further 
proceedings in the appeal.
    (3) After the status conference, the Board may--
    (i) Issue in writing a report and order specifying what transpired 
and formalizing any orders issued at the conference; and
    (ii) Require the parties to submit (jointly or otherwise) a proposed 
report and order, in order to facilitate issuance of a final report and 
order.
    (d) Further status conferences. Upon a party's request, or on its 
own motion, the Board may conduct further status conferences where it 
finds the proceedings necessary and appropriate.
    (e) Discovery--(1) General rules. (i) Discovery is limited in Board 
proceedings.
    (ii) The Board may permit discovery of a matter that is relevant to 
the specific subject matter of the Board hearing, provided the matter is 
not privileged or otherwise protected from disclosure and the discovery 
request is not unreasonable, unduly burdensome

[[Page 276]]

or expensive, or otherwise inappropriate.
    (iii) Any discovery initiated by a party must comply with all 
requirements and limitations of this section, and with any further 
requirements or limitations ordered by the Board.
    (iv) The applicable provisions of the Federal Rules of Civil 
Procedure and Rules 401 and 501 of the Federal Rules of Evidence serve 
as guidance for any discovery that is permitted under this section or by 
Board order.
    (2) Limitations on discovery. Any discovery before the Board is 
limited as follows:
    (i) A party may request of another party, or of a nonparty other 
than CMS, the Secretary or any Federal agency, the reasonable production 
of documents for inspection and copying.
    (ii) A party may also request another party to respond to a 
reasonable number of written interrogatories.
    (iii)(A) A party may not take the deposition, upon oral or written 
examination, of another party or a nonparty, unless the proposed 
deponent agrees to the deposition or the Board finds that the proposed 
deposition is necessary and appropriate under the criteria set forth in 
Federal Rules of Civil Procedure 26 and 32(a)(3) in order to secure the 
deponent's testimony for a Board hearing.
    (B) The regulations at 45 CFR Part 2 (Testimony by employees and 
production of documents in proceedings where the United States is not a 
party) apply as to whether an employee or officer of CMS or HHS will 
appear for a deposition.
    (iv) A party may not request admissions or take any other form of 
discovery not authorized under this section.
    (3) Time limits. (i) A party's discovery request is timely if the 
date the request is served on another party or nonparty, as applicable, 
is no later than 120 days before the initially scheduled starting date 
of the Board hearing, unless the Board extends the time for the request.
    (ii)(A) Depositions. (1) In the absence of an order or instruction 
by the Board setting a schedule for the holding of a deposition, a party 
desiring to take a deposition must give reasonable notice in writing to 
the deponent of a scheduled deposition.
    (2) A deposition may not be held any later than 45 days before the 
initially scheduled starting of the Board hearing, unless the Board 
orders otherwise.
    (B) Responses. (1) In the absence of a Board order or general 
instructions of the Board setting a schedule for responses, responses to 
interrogatories and requests for production of documents are due 
according to the schedule agreed upon by the party serving discovery and 
the party to which the discovery is directed, or within the time 
allotted by the Federal Rules of Civil Procedure.
    (2) Responses by a party to interrogatories, and responses by a 
party or nonparty to requests for production of documents, must be 
served no later than 45 days before the initially scheduled starting 
date of the Board hearing, unless the Board orders otherwise.
    (iii) Before ruling on a request to extend the time for requesting 
discovery or for conducting or responding to discovery, the Board must 
give the other parties to the appeal, and any nonparty subject to a 
discovery request, a reasonable period to respond to the extension 
request.
    (iv) The Board has the discretion to extend the time in which to 
request discovery or conduct or respond to discovery.
    (v) If the Board grants the extension request, it sets a new 
discovery deadline and has the discretion to reschedule the hearing 
date.
    (4) Rights of nonparties. If a discovery request is made of a 
nonparty to the Board appeal, the nonparty has the rights any party has 
in responding to a discovery request. The rights of the nonparty 
include, but are not limited to, the right to select and use any 
attorney or other representative, and to submit discovery responses, 
objections, or motions to the Board.
    (5) Motions to compel or for protective order. (i) Each party is 
required to make a good faith effort to resolve or narrow any discovery 
dispute, regardless of whether the dispute is with another party or a 
nonparty.
    (ii) A party may submit to the Board a motion to compel discovery 
that is permitted under this section or any

[[Page 277]]

Board order, and a party or nonparty may submit a motion for a 
protective order regarding any discovery request to the Board.
    (iii) Any motion to compel or for protective order must include a 
self-sworn declaration describing the movant's efforts to resolve or 
narrow the discovery dispute.
    (iv) A self-sworn declaration describing the movant's efforts to 
resolve or narrow the discovery dispute must be included with any 
response to a motion to compel or for protective order.
    (v) The Board must decide any motion in accordance with this section 
and any prior discovery ruling.
    (vi)(A) The Board must issue and send to each party and any affected 
nonparty a discovery ruling that grants or denies, in whole or in part, 
the motion to compel or the motion for a protective order, if 
applicable.
    (B) The discovery ruling must--
    (1) Specifically identify any part of the disputed discovery request 
upheld and any part rejected, and
    (2) Impose any limits on discovery the Board finds necessary and 
appropriate.
    (vii) Nothing in this section authorizes the Board to compel any 
action from the Secretary or CMS.
    (6) Reviewability of discovery and disclosure rulings--(i) General 
rule. A Board discovery ruling, or a Board disclosure ruling, such as 
one issued at a hearing, is not subject to immediate review by the 
Administrator (as described in Sec.  405.1875(a)(3) of this subpart). 
The ruling may be reviewed solely during the course of Administrator 
review of one of the Board decisions specified as final or deemed to be 
final, by the Administrator, under Sec.  405.1875(a)(2)of this subpart, 
or of judicial review of a final agency decision as described in Sec.  
405.1877(a) and (c)(3) of this subpart, as applicable.
    (ii) Exception. To the extent a ruling authorizes discovery or 
disclosure of a matter for which an objection based on privilege, or 
other protection from disclosure such as case preparation, 
confidentiality, or undue burden, was made before the Board, that 
portion of the discovery or disclosure ruling may be reviewed 
immediately by the Administrator in accordance with Sec.  
405.1875(a)(3)(i) of this subpart. Upon notice to the Board that a party 
or nonparty, as applicable, intends to seek Administrator review of the 
ruling,--
    (A)(1) The Board must stay all proceedings affected by the ruling.
    (2) The Board determines the length of the stay under the 
circumstances of a given case, but in no event may the length of the 
stay be less than 15 days after the day on which the Board received 
notice of the party or nonparty's intent to seek Administrator review.
    (B) If the Administrator--
    (1) Grants a request for review, or takes own motion review, of a 
ruling, the ruling is stayed until the time the Administrator issues a 
written decision that affirms, reverses, modifies, or remands the 
Board's ruling.
    (2) Does not grant a request or take own motion review within the 
time allotted for the stay, the stay is lifted and the ruling is not 
subject to immediate review.

[73 FR 30257, May 23, 2008; 73 FR 49356, Aug. 21, 2008; 85 FR 59019, 
Sept. 18, 2020]



Sec.  405.1855  Evidence at Board hearing.

    Evidence may be received at the Board hearing even though 
inadmissible under the rules of evidence applicable to court procedure. 
The Board shall give the parties opportunity for submission and 
consideration of facts and arguments and during the course of the 
hearing should, in ruling upon admissibility of evidence, exclude 
irrelevant, immaterial, or unduly repetitious evidence. The Board shall 
render a final ruling on the admissibility of evidence.



Sec.  405.1857  Subpoenas.

    (a) Time limits. (1) The Board may issue a subpoena--
    (i) To a party to a Board appeal or to a nonparty other than CMS or 
the Secretary or any Federal agency, requiring the attendance and 
testimony of witnesses or the production of documents for inspection and 
copying, provided the Board makes a preliminary finding of its 
jurisdiction over the matters at issue in accordance with Sec.  
405.1840(a) of this subpart.

[[Page 278]]

    (ii) At the request of a party for purposes of discovery (as 
described in Sec.  405.1853 of this subpart) or an oral hearing (as 
described in Sec.  405.1845 of this subpart); and
    (iii) On its own motion solely for purposes of a hearing.
    (2) The date of receipt by the Board of a party's subpoena request 
may not be any later than for subpoenas requested for purposes of--
    (i) Discovery, 120 days before the initially scheduled starting date 
of the Board hearing; and
    (ii) An oral hearing, 45 days before the scheduled starting date of 
the Board hearing.
    (3) Subject to paragraph (4) of this section, the Board may not 
issue a subpoena any later than for purposes of--
    (i) Discovery, 90 days before the initially scheduled starting date 
of the Board hearing; and
    (ii) An oral hearing, whether issued at a party's request or on the 
Board's own motion, 30 days before the scheduled starting date of the 
Board hearing.
    (4) The Board may extend the deadlines specified in paragraphs 
(a)(2) and (a)(3) of this section provided the Board gives each party to 
the appeal and any nonparty subject to the subpoena request or subpoena 
a reasonable period of time to comment on any proposed extension. If the 
Board extends a deadline, it retains the discretion to reschedule the 
hearing date.
    (b) Criteria--(1) Discovery subpoenas. The Board may issue a 
subpoena for purposes of discovery if all of the following are 
applicable:
    (i) The subpoena was requested in accordance with the requirements 
of paragraph (c)(1) of this section.
    (ii) The party's discovery request complies with the applicable 
provisions of Sec.  405.1853(e) of this part.
    (iii) A subpoena is necessary and appropriate to compel a response 
to the discovery request.
    (2) Hearing subpoenas. The Board may issue a subpoena for purposes 
of an oral hearing if--
    (i) The party's subpoena request meets the requirements of paragraph 
(c)(1) of this section;
    (ii) A subpoena is necessary and appropriate to compel the 
attendance and testimony of witnesses or the production of documents for 
inspection or copying, provided the testimony or documents are relevant 
and material to a matter at issue in the appeal but not unduly 
repetitious (as described in Sec.  405.1855 of this subpart); and
    (iii) The subpoena does not compel the disclosure of matter that is 
privileged or otherwise protected from disclosure for reasons such as 
case preparation, confidentiality, or undue burden.
    (iv) The subpoena does not impose undue burden or expense on the 
party or nonparty subject to the subpoena, and is not otherwise 
unreasonable or inappropriate.
    (3) Guiding principles. In determining whether to issue, quash, or 
modify a subpoena under this section, the Board uses the applicable 
provisions of the Federal Rules of Civil Procedure and Rules 401 and 501 
of the Federal Rules of Evidence for guidance.
    (c) Procedures-- (1) Subpoena requests. The requesting party must 
send any subpoena request submitted to the Board promptly to the party 
or nonparty subject to the subpoena, and to any other party to the Board 
appeal. If the subpoena request is being sent to a nonparty subject to 
the subpoena, then the subpoena request must be sent by certified mail. 
The request must--
    (i) Identify with particularity any witnesses (and their addresses, 
if known) or any documents (and their location, if known) sought by the 
subpoena, and the means, time, or location for securing any witness 
testimony or documents;
    (ii) Describe specifically, in the case of a hearing subpoena, the 
facts any witnesses, documents, or tangible materials are expected to 
establish, and why those facts cannot be established without a subpoena; 
and
    (iii) Explain why a subpoena is appropriate under the criteria 
prescribed in paragraph (b) of this section.
    (2) Contents of subpoenas. A subpoena issued by the Board, whether 
on its own motion or at the request of a party, must be in writing and 
either sent promptly by the Board to the party or nonparty subject to 
the subpoena by certified mail or overnight delivery (and to any other 
party and

[[Page 279]]

affected nonparty to the appeal by regular mail), or hand-delivered. 
Each subpoena must--
    (i) Be issued in the name of the Board, and include the case number 
and name of the appeal;
    (ii) Provide notice that--
    (A) The subpoena is issued in accordance with section 1878(e) of the 
Act and Sec.  405.1857 of this subpart; and
    (B) CMS must pay the fees and the mileage of any witnesses, as 
provided in section 205(d) of the Act.
    (iii) If applicable, require named witnesses to attend a particular 
proceeding at a certain time and location and to testify on specific 
subjects; and
    (iv) If applicable, require the production of specific documents for 
inspection or copying at a certain time and location.
    (3) Rights of nonparties. If a nonparty to the Board appeal is 
subject to the subpoena or subpoena request, the nonparty has the rights 
any party has in responding to a subpoena or subpoena request. The 
rights of the nonparty include, but are not limited to, the right to 
select and use any attorney or other representative, and to submit 
responses, objections, motions, or any other pertinent materials to the 
Board regarding the subpoena or subpoena request.
    (4) Board action on subpoena requests and motions. After issuing a 
subpoena or receiving a subpoena request, the Board must do the 
following:
    (i) Give the party or nonparty subject to the subpoena or subpoena 
request a reasonable period of time for the submission of any responses, 
objections, or motions.
    (ii) Consider the subpoena or subpoena request, and any responses, 
objections, or motions related thereto, under the criteria specified in 
paragraph (b) of this section.
    (iii)(A) Issue in writing and send promptly to each party and any 
affected nonparty an order granting or denying any motion to quash or 
modify a subpoena, or granting or denying any subpoena request in whole 
or in part; and
    (B) Issue, if applicable, an original or modified subpoena in 
accordance with paragraph (c)(2) of this section.
    (d) Reviewability--(1) General rules. (i) If the Board issues, 
quashes, or modifies, or refuses to issue, quash, or modify, a subpoena 
under paragraphs (c)(2) or (c)(4) of this section, the Board's action is 
not subject to immediate review by the Administrator (as described in 
Sec.  405.1875(a)(3) of this subpart).
    (ii) Any Board action on a subpoena may be reviewed solely during 
the course of Administrator review of one of the Board decisions 
specified in Sec.  405.1875(a)(2) of this subpart, or of judicial review 
of a final agency decision as described in Sec.  405.1877(a) and (c)(3) 
of this subpart, as applicable.
    (2) Exception. (i) To the extent a subpoena compels disclosure of a 
matter for which an objection based on privilege, or other protection 
from disclosure such as case preparation, confidentiality, or undue 
burden, was made before the Board, the Administrator may review 
immediately that portion of the subpoena in accordance with Sec.  
405.1875(a)(3)(ii) of this subpart.
    (ii) Upon notice to the Board that a party or nonparty, as 
applicable, intends to seek Administrator review of the subpoena, the 
Board must stay all proceedings affected by the subpoena.
    (iii) The Board determines the length of the stay under the 
circumstances of a given case, but in no event may the stay be less than 
15 days after the day on which the Board received notice of the party or 
nonparty's intent to seek Administrator review.
    (iv) If the Administrator grants a request for review, or takes own 
motion review, of the subpoena, the subpoena or portion of the subpoena, 
as applicable, is stayed until such time as the Administrator issues a 
written decision that affirms, reverses, modifies, or remands the 
Board's action on the subpoena.
    (v) If the Administrator does not grant review or take own motion 
review within the time allotted for the stay, the stay is lifted and the 
Board's action is not immediately reviewable.
    (e) Enforcement. (i) If the Board determines, whether on its own 
motion or at the request of a party, that a party or nonparty subject to 
a subpoena issued under this section has refused to comply with the 
subpoena, the Board may

[[Page 280]]

request the Administrator to seek enforcement of the subpoena in 
accordance with section 205(e) of the Act.
    (ii) Any enforcement request by the Board must consist of a written 
notice to the Administrator describing in detail the Board's findings of 
noncompliance and its specific request for enforcement, and providing a 
copy of the subpoena and evidence of its receipt by certified mail by 
the party or nonparty subject to the subpoena.
    (iii) The Board must promptly mail a copy of the notice and related 
documents to the party or nonparty subject to the subpoena, and to any 
other party and affected nonparty to the appeal.

[73 FR 30258, May 23, 2008; 73 FR 49356, Aug. 21, 2008; 85 FR 59019, 
Sept. 18, 2020]



Sec.  405.1859  Witnesses.

    Witnesses at the hearing shall testify under oath or affirmation, 
unless excused by the Board for cause. The Board may examine the 
witnesses and shall allow the parties or their representatives to do so. 
Parties to the proceeding may also cross-examine witnesses.



Sec.  405.1861  Oral argument and written allegations.

    The parties, upon their request, shall be allowed a reasonable time 
for the presentation of oral argument or for the filing of briefs or 
other written statements of allegations as to facts or law. Copies of 
any brief or other written statement shall be filed in sufficient number 
that they may be made available to all parties and to the Centers for 
Medicare & Medicaid Services.



Sec.  405.1863  Administrative policy at issue.

    Where a party to the Board hearing puts into issue an administrative 
policy which is interpretative of the law or regulations, the Board will 
promptly notify to the Centers for Medicare & Medicaid Services.



Sec.  405.1865  Record of administrative proceedings.

    (a)(1) The Board and, if applicable, the Administrator must maintain 
a complete record of all proceedings in each appeal.
    (2) For proceedings before the Board, the administrative record 
consists of all evidence, documents and any other tangible materials 
submitted by the parties to the appeal and by any nonparty (as described 
in Sec. Sec.  405.1853(e)(4) and 405.1857(c)(3) of this subpart), along 
with all Board correspondence, rulings, subpoenas, orders, and 
decisions.
    (3) The term ``record'' is intended to encompass both the unappended 
record and any appendix to the record (as described in Sec.  405.1865(b) 
of this subpart).
    (4) The record includes a complete transcription of the proceedings 
at any oral hearing before the Board.
    (5) A copy of any transcription must be made available to any party 
upon written request.
    (b) Any evidence ruled inadmissible by the Board (as described in 
Sec.  405.1855 of this subpart) and any other submitted matter that the 
Board declines to consider (whether as untimely or otherwise) must be, 
to the extent practicable, clearly identified and segregated in an 
appendix to the record for purposes of any further review (as described 
in Sec. Sec.  405.1875 and 405.1877 of this subpart).
    (c) To the extent applicable, the administrative record also 
includes all documents (including written submissions) and any other 
tangible materials submitted to the Administrator by the parties to the 
appeal or by any nonparty (as described in Sec. Sec.  405.1853(e)(4) and 
405.1857(c)(3) of this subpart), in addition to all correspondence from 
the Administrator or the Office of the Attorney Advisor, and all 
rulings, orders, and decisions by the Administrator. The provisions of 
paragraph (b) of this section also pertain to any proceedings before the 
Administrator, to the extent the Administrator finds evidence 
inadmissible or declines to consider a specific matter (whether as 
untimely or otherwise).

[73 FR 30260, May 23, 2008; 73 FR 49356, Aug. 21, 2008]



Sec.  405.1867  Scope of Board's legal authority.

    In exercising its authority to conduct proceedings under this 
subpart, the

[[Page 281]]

Board must comply with all the provisions of Title XVIII of the Act and 
regulations issued thereunder, as well as CMS Rulings issued under the 
authority of the Administrator as described in Sec.  401.108 of this 
subchapter. The Board shall afford great weight to interpretive rules, 
general statements of policy, and rules of agency organization, 
procedure, or practice established by CMS.

[48 FR 22925, May 23, 1983, as amended at 73 FR 30260, May 23, 2008; 73 
FR 49356, Aug. 21, 2008]



Sec.  405.1868  Board actions in response to failure to follow Board rules.

    (a) The Board has full power and authority to make rules and 
establish procedures, not inconsistent with the law, regulations, and 
CMS Rulings, that are necessary or appropriate to carry out the 
provisions of section 1878 of the Act and of the regulations in this 
subpart. The Board's powers include the authority to take appropriate 
actions in response to the failure of a party to a Board appeal to 
comply with Board rules and orders or for inappropriate conduct during 
proceedings in the appeal.
    (b) If a provider fails to meet a filing deadline or other 
requirement established by the Board in a rule or order, the Board may--
    (1) Dismiss the appeal with prejudice;
    (2) Issue an order requiring the provider to show cause why the 
Board should not dismiss the appeal; or
    (3) Take any other remedial action it considers appropriate.
    (c) If a contractor fails to meet a filing deadline or other 
requirement established by the Board, the Board may--
    (1) Take other actions that it considers appropriate, such as--
    (i) Issuing a decision based on the written record submitted to that 
point; or
    (ii) Issuing a written notice to CMS describing the contractor's 
actions and requesting that CMS take appropriate action, such as review 
of the contractor's compliance with the contractual requirements of 
Sec. Sec.  421.120, 421.122, and 421.124 of this chapter; and
    (2) Not use its authority to take an action such as, a sanction, 
reversing or modifying the contractor's or Secretary's determination for 
the cost reporting period under appeal, or ruling against the contractor 
on a disputed issue of law or fact in the appeal.
    (d)(1) If the Board dismisses the appeal with prejudice under this 
section, it must issue a dismissal decision dismissing the appeal. The 
decision by the Board must be in writing and include an explanation of 
the reason for the dismissal. A copy of the Board's dismissal decision 
must be sent promptly to each party to the appeal (as described in Sec.  
405.1843 of this subpart).
    (2) A dismissal decision by the Board is final and binding on the 
parties unless the decision is reversed, affirmed, modified, or remanded 
by the Administrator under Sec.  405.1875(a)(2)(ii), and Sec.  
405.1875(e) or Sec.  405.1875(f) of this part, no later than 60 days 
after the date of receipt by the provider of the Board's decision.
    (i) The Board decision is inoperative during the 60-day period for 
review by the Administrator, or in the event the Administrator reverses, 
affirms, modifies, or remands the decision within the period.
    (ii) The Board may reopen and revise a final Board decision in 
accordance with Sec. Sec.  405.1885 through 405.1889 of this subpart.
    (e)(1) Any action taken by the Board under this section other than 
dismissal of the appeal is not subject to immediate Administrator review 
(as described in Sec.  405.1875(a)(3) of this subpart) or judicial 
review (as described in Sec.  405.1877(a)(3) of this subpart).
    (2) A Board action other than dismissal of the appeal may be 
reviewed solely during the course of Administrator review of one of the 
Board decisions specified as final, or deemed to be final by the 
Administrator, under Sec.  405.1875(a)(2) of this subpart, or of 
judicial review of a final agency decision as described in Sec.  
405.1877(a) of this subpart, as applicable.
    (f) Ex parte communications with Board staff concerning procedural 
matters are not prohibited.
    (g) Upon receipt of a credible allegation that a party's 
representative has divulged to that party, or to the Board, information 
that was obtained during

[[Page 282]]

the course of the representative's relationship (such as legal counsel 
or employee) with an opposing party and that was intended by that party 
to be kept confidential, the Board--
    (1) Investigates the allegation; and
    (2) May take remedial action when it determines that it is 
appropriate to do so, against the party or the representative (such as 
prohibiting the representative from appearing before it, excluding such 
information from the record, or if the overall fairness of the hearing 
has been compromised, dismissing the case).

[73 FR 30260, May 23, 2008; 73 FR 49356, Aug. 21, 2008; 85 FR 59019, 
Sept. 18, 2020]



Sec.  405.1869  Scope of Board's authority in a hearing decision.

    (a) If the Board has jurisdiction to conduct a hearing on a specific 
matter at issue under section 1878(a) or (b) of the Act and Sec.  
405.1840 of this subpart, and the legal authority to fully resolve the 
matter in a hearing decision (as described in Sec. Sec.  405.1842(f), 
405.1867, and 405.1871 of this subpart), section 1878 of the Act, and 
paragraph (a) of this section give the Board the power to affirm, 
modify, or reverse the contractor's findings on each specific matter at 
issue in the contractor determination for the cost reporting period 
under appeal, and to make additional revisions on specific matters 
regardless of whether the contractor considered the matters in issuing 
the contractor determination. The Board's power to make additional 
revisions in a hearing decision does not authorize the Board to consider 
or decide a specific matter at issue for which it lacks jurisdiction (as 
described in Sec.  405.1840(b) of this subpart) or which was not timely 
raised in the provider's hearing request. The Board's power under 
section 1878(d) of the Act and paragraph (a) of this section to make 
additional revisions is limited to those revisions necessary to resolve 
fully a specific matter at issue if--
    (1) The Board has jurisdiction to grant a hearing on the specific 
matter at issue under section 1878(a) or (b) of the Act and Sec.  
405.1840 of this subpart; and
    (2) The specific matter at issue was timely raised in an initial 
request for a Board hearing filed in accordance with Sec.  405.1835 or 
Sec.  405.1837 of this subpart, as applicable, or in a timely request to 
add issues to a single provider appeal submitted in accordance with 
Sec.  405.1835(c) of this subpart.
    (b)(1) If the Board has jurisdiction to conduct a hearing on a 
specific matter at issue solely under Sec. Sec.  405.1840 and 405.1835 
or Sec.  405.1837 of this subpart, as applicable, and the legal 
authority to fully resolve the matter in a hearing decision (as 
described in Sec. Sec.  405.1842(f), 405.1867, and 405.1871 of this 
subpart), the Board is authorized to do the following:
    (i) Affirm, modify, or reverse the contractor's or Secretary's 
findings on each specific matter at issue in the contractor or Secretary 
determination under appeal.
    (ii) Make additional revisions on each specific matter at issue 
regardless of whether the contractor considered these revisions in 
issuing the contractor determination under appeal, provided the Board 
does not consider or decide a specific matter for which it lacks 
jurisdiction (as described in Sec.  405.1840(b) of this subpart) or that 
was not timely raised in the provider's hearing request.
    (2) The Board's authority under this section to make the additional 
revisions is limited to those revisions necessary to resolve a specific 
matter at issue.

[73 FR 30261, May 23, 2008]



Sec.  405.1871  Board hearing decision.

    (a)(1) If the Board finds jurisdiction over a specific matter at 
issue and conducts a hearing on the matter (as described in Sec. Sec.  
405.1840(a) and 405.1845(e) of this subpart), the Board must issue a 
hearing decision deciding the merits of the specific matter at issue.
    (2) A Board hearing decision must be in writing and based on the 
admissible evidence from the Board hearing and other admissible evidence 
and written argument or comments as may be included in the record and 
accepted by the Board (as described in Sec. Sec.  405.1845(g) and 
405.1865 of this subpart).
    (3) The decision must include findings of fact and conclusions of 
law regarding the Board's jurisdiction over each specific matter at 
issue (see

[[Page 283]]

Sec.  405.1840(c)(1)), and whether the provider carried its burden of 
production of evidence and burden of proof by establishing, by a 
preponderance of the evidence, that the provider is entitled to relief 
on the merits of the matter at issue.
    (4) The decision must include appropriate citations to the record 
evidence and to the applicable law, regulations, CMS Rulings, and other 
interpretive rules, general statements of policy, and rules of agency 
organization, procedure, or practice established by CMS. Where the 
Board's decision reverses or modifies a contractor determination on an 
issue for which the policy expressed in an interpretive rule (other than 
a regulation or a CMS Ruling), general statement of policy or rule of 
agency organization, procedure or practice established by CMS would be 
dispositive of that issue (if followed by the Board), the Board decision 
must explain how it gave great weight to such interpretive rule or other 
such instruction but did not uphold the contractor's determination on 
the issue.
    (5) A copy of the decision must be sent promptly to each party to 
the appeal.
    (b)(1) A Board hearing decision issued in accordance with paragraph 
(a) of this section is final and binding on the parties to the Board 
appeal unless the hearing decision is reversed, affirmed, modified, or 
remanded by the Administrator under Sec. Sec.  405.1875(a)(2)(i), 
405.1875(e), and 405.1875(f) of this subpart, no later than 60 days 
after the date of receipt by the provider of the Board's decision.
    (2) A Board hearing decision is inoperative during the 60-day period 
for review of the decision by the Administrator, or in the event the 
Administrator reverses, affirms, modifies, or remands that decision 
within the period.
    (3) A Board hearing decision that is final under paragraph (b)(1) of 
this section is subject to the provisions of Sec.  405.1803(d) of this 
subpart, unless the decision is the subject of judicial review (as 
described in Sec.  405.1877 of this subpart).
    (4) A final Board decision under paragraph (a) and (b) of this 
section may be reopened and revised by the Board in accordance with 
Sec. Sec.  405.1885 through 405.1889 of this subpart.
    (5) When the contractor's denial of the relief that the provider 
seeks before the Board is based on procedural grounds (for example, the 
alleged failure of the provider to satisfy a time limit) or is based on 
the alleged failure to supply adequate documentation to support the 
provider's claim, and the Board rules that the basis of the contractor's 
denial is invalid, the Board remands to the contractor for the 
contractor to make a determination on the merits of the provider's 
claim.

[73 FR 30261, May 23, 2008, as amended at 85 FR 59019, Sept. 18, 2020]



Sec.  405.1873  Board review of compliance with the reimbursement requirement 
of an appropriate cost report claim.

    (a) General. In order to receive or potentially receive 
reimbursement for a specific item, the provider must include in its cost 
report an appropriate claim for the specific item (as prescribed in 
Sec.  413.24(j) of this chapter). If the provider files an appeal to the 
Board seeking reimbursement for the specific item and any party to such 
appeal questions whether the provider's cost report included an 
appropriate claim for the specific item, the Board must address such 
question in accordance with the procedures set forth in this section.
    (b) Summary of procedures--(1) Preliminary steps. The Board must 
give the parties an adequate opportunity to submit factual evidence and 
legal argument regarding the question of whether the provider's cost 
report included an appropriate claim for the specific item under appeal. 
Upon receipt of timely submitted factual evidence or legal argument (if 
any), the Board must review such evidence and argument and prepare 
written specific findings of fact and conclusions of law on the question 
of whether the provider's cost report complied with, for the specific 
item under appeal, the cost report claim requirements prescribed in 
Sec.  413.24(j) of this chapter. In reaching such specific factual 
findings and legal conclusions, the Board must follow the procedures set 
forth in Sec.  413.24(j)(3) of this chapter for determining whether

[[Page 284]]

the provider's cost report included an appropriate claim for the 
specific item under appeal. The Board must promptly give a copy of such 
written specific factual findings and legal conclusions to each party to 
the appeal, and such factual findings and legal conclusions must be 
included in the record of administrative proceedings for the appeal (as 
prescribed in Sec.  405.1865).
    (2) Limits on Board actions. The Board's specific findings of fact 
and conclusions of law (pursuant to paragraph (b)(1) of this section) 
must not be invoked or relied on by the Board as a basis to deny, or 
decline to exercise, jurisdiction over a specific item or take any other 
of the actions specified in paragraph (c) of this section. Upon giving 
the parties to the appeal the Board's written specific factual findings 
and legal conclusions (pursuant to paragraph (b)(1) of this section) on 
the question of whether the provider's cost report included an 
appropriate cost report claim for the specific item under appeal, the 
Board must proceed to issue one of the four types of overall decisions 
specified in paragraphs (d) and (e) of this section with respect to the 
specific item. If the Board issues either of two types of overall Board 
decisions (as specified in paragraph (d) of this section) regarding the 
specific item under appeal, the Board's written specific factual 
findings and legal conclusions (pursuant to paragraph (b)(1) of this 
section) must be included in such overall Board decision regarding the 
specific item, along with the other matters that are required by the 
regulations for the pertinent type of overall Board decision. However, 
if the Board issues either of two other types of overall Board decisions 
(as specified in paragraph (e) of this section) regarding the specific 
item under appeal, the Board's written specific factual findings and 
legal conclusions (pursuant to paragraph (b)(1) of this section) must 
not be included in the overall Board decision regarding the specific 
item. The Board may permit reimbursement for the specific item under 
appeal, as part of one of the two types of overall Board decisions that 
are specified in paragraph (d) of this section, but such reimbursement 
may be permitted only to the extent authorized by paragraph (f) of this 
section.
    (c) Prohibition of certain types of decisions, orders, and other 
actions. (1) If the Board determines, in its findings of fact and 
conclusions of law (as prescribed by paragraph (b)(1) of this section), 
that the provider's cost report did not include an appropriate claim for 
the specific item under appeal, the Board may not--
    (i) Deny jurisdiction over the specific item under appeal, based on 
(in whole or in part) the Board's factual findings and legal conclusions 
(reached under paragraph (b)(1) of this section);
    (ii) Decline to exercise jurisdiction over the specific item under 
appeal, based on (in whole or in part) the Board's factual findings and 
legal conclusions (reached under paragraph (b)(1) of this section); or
    (iii) Take any of the actions set forth in Sec.  405.1868(b), (c), 
or (d), impose any sanction, or take any other action against the 
interests of any party to the appeal, except as provided in paragraph 
(f) of this section, based on (in whole or in part) the Board's factual 
findings and legal conclusions (reached under paragraph (b)(1) of this 
section).
    (2) Regardless of whether the Board determines, in its findings of 
fact and conclusions of law (as prescribed by paragraph (b)(1) of this 
section), that the provider's cost report did or did not include an 
appropriate claim for the specific item under appeal, the Board may 
not--
    (i) Deny jurisdiction over the specific item under appeal, based on 
(in whole or in part) the absence, in the final contractor determination 
or Secretary determination under appeal, of an adjustment, revision, 
correction, or other change to the specific item under appeal, or the 
lack of a particular determination by the contractor or the Secretary 
regarding the specific item. Exception: If the provider's appeal of the 
specific item is based on a reopening of such item (pursuant to Sec.  
405.1885) where the specific item is not revised, adjusted, corrected, 
or otherwise changed in a revised final contractor or Secretary 
determination, the Board must deny jurisdiction over the specific item 
under appeal (as prescribed in Sec. Sec.  405.1887(d) and 405.1889(b));

[[Page 285]]

    (ii) Decline to exercise jurisdiction over the specific item under 
appeal, based on (in whole or in part) the absence, in the final 
contractor determination or Secretary determination under appeal, of an 
adjustment, revision, correction, or other change to the specific item 
under appeal, or the lack of a particular determination by the 
contractor or the Secretary regarding the specific item; or
    (iii) Take any of the actions set forth in Sec.  405.1868(b), (c), 
or (d), impose any sanction, or take any other action against the 
interests of any party to the appeal, except as provided in paragraph 
(f) of this section, based on (in whole or in part) the absence, in the 
final contractor determination or Secretary determination under appeal, 
of an adjustment, revision, correction, or other change to the specific 
item under appeal, or the lack of a particular determination by the 
contractor or the Secretary regarding the specific item.
    (d) Two types of Board decisions that must include any factual 
findings and legal conclusions under paragraph (b)(1) of this section--
(1) Board hearing decision. If the Board issues a hearing decision 
regarding the specific item under appeal (pursuant to Sec.  405.1871), 
any specific findings of fact and conclusions of law by the Board (in 
accordance with paragraph (b)(1) of this section), on the question of 
whether the provider's cost report included an appropriate claim for the 
specific item, must be included in such hearing decision along with the 
other matters prescribed by Sec.  405.1871(a). The Board's factual 
findings and legal conclusions (reached under paragraph (b)(1) of this 
section), about whether there was an appropriate cost report claim for 
the specific item under appeal, are subject to the provisions of Sec.  
405.1871(b) just as those provisions apply to the other parts of the 
Board's hearing decision. If the Board determines that the provider's 
cost report--
    (i) Included an appropriate claim for the specific item under appeal 
(as prescribed in Sec.  413.24(j) of this chapter), the Board's hearing 
decision must also address whether the other substantive reimbursement 
requirements for the specific item are also satisfied; or
    (ii) Did not include an appropriate claim for the specific item 
under appeal, the Board has discretion whether or not to address in the 
Board's hearing decision whether the other substantive reimbursement 
requirements for the specific item are also satisfied.
    (2) Board expedited judicial review (EJR) decision, where EJR is 
granted. If the Board issues an EJR decision where EJR is granted 
regarding a legal question that is relevant to the specific item under 
appeal (in accordance with Sec.  405.1842(f)(1)), the Board's specific 
findings of fact and conclusions of law (reached under paragraph (b)(1) 
of this section), on the question of whether the provider's cost report 
included an appropriate claim for the specific item, must be included in 
such EJR decision along with the other matters prescribed by Sec.  
405.1842(f)(1). The Board's factual findings and legal conclusions (in 
accordance with paragraph (b)(1) of this section) about whether there 
was an appropriate cost report claim for the specific item under appeal 
are subject to the provisions of Sec.  405.1842(g)(1), (g)(2), (h)(1), 
and (h)(3) in the same manner as those provisions apply to the other 
parts of the Board's EJR decision.
    (e) Two other types of Board decisions that must not include the 
Board's factual findings and legal conclusions under paragraph (b)(1) of 
this section--(1) Board jurisdictional dismissal decision. If the Board 
issues a jurisdictional dismissal decision regarding the specific item 
under appeal (pursuant to Sec.  405.1840(c)), the Board's specific 
findings of fact and conclusions of law (in accordance with paragraph 
(b)(1) of this section), on the question of whether the provider's cost 
report included an appropriate claim for the specific item, must not be 
included in such jurisdictional dismissal decision.
    (2) Board expedited judicial review (EJR) decision, where EJR is 
denied. If the Board issues an EJR decision where EJR is denied 
regarding a legal question that is relevant to the specific item under 
appeal (in accordance with Sec.  405.1842(f)(2)), the Board's specific 
findings of fact and conclusions of law (in accordance with paragraph 
(b)(1) of this section), on the question of whether the provider's cost 
report included

[[Page 286]]

an appropriate claim for the same item, must not be included in such EJR 
decision. If the Board conducts further proceedings and issues another 
decision (as specified in Sec.  405.1842(h)(2)(i)), the Board's specific 
findings of fact and conclusions of law (in accordance with paragraph 
(b)(1) of this section)--
    (i) Must be included in any further hearing decision or EJR decision 
where EJR is granted regarding the specific item under appeal (as 
specified in paragraph (d) of this section); but
    (ii) Must not be included in any further jurisdictional dismissal 
decision or EJR decision where EJR is denied regarding the specific item 
under appeal (as prescribed in paragraph (e) of this section).
    (f) Effects of the Board's factual findings and legal conclusions 
under paragraph (b)(1) of this section in two types of final decisions--
(1) When part of a final hearing decision. If the Board determines, or 
the Administrator of CMS determines (pursuant to Sec.  
405.1875(a)(2)(v)), as applicable, in a final and binding hearing 
decision (in accordance with Sec.  405.1871(b) and paragraphs (b)(1) and 
(d)(1) of this section), that the provider's cost report--
    (i) Included an appropriate claim for the specific item under appeal 
(as prescribed in Sec.  413.24(j) of this chapter), the specific item is 
reimbursable in accordance with Medicare policy, but only if the Board 
further determines in such final hearing decision that all the other 
substantive reimbursement requirements for the specific item are also 
satisfied; or
    (ii) Did not include an appropriate cost report claim for the 
specific item under appeal, the specific item is not reimbursable, 
regardless of whether the Board further determines in such final hearing 
decision that the other substantive reimbursement requirements for the 
specific item are or are not satisfied.
    (2) When part of a final EJR decision that grants EJR. If the Board 
determines or the Administrator of CMS determines (pursuant to Sec.  
405.1875(a)(2)(v)), as applicable, in a final and binding EJR decision 
that grants EJR regarding a legal question that is relevant to the 
specific item under appeal (in accordance with Sec.  405.1842(g)(1) and 
paragraphs (b)(1) and (d)(2) of this section), that the provider's cost 
report--
    (i) Included an appropriate claim for the specific item under appeal 
(as prescribed in Sec.  413.24(j) of this chapter), the specific item is 
reimbursable in accordance with Medicare policy, but only to the extent 
permitted by the final decision of a Federal court pursuant to the EJR 
provisions of section 1878(f)(1) of the Act (refer also to Sec. Sec.  
405.1842 and 405.1877); or
    (ii) Did not include an appropriate claim for the specific item 
under appeal, the specific item is not reimbursable, unless--
    (A) The specific factual findings and legal conclusions (in 
accordance with paragraph (b)(1) of this section) of the Board or the 
Administrator, as applicable, on the question of whether the provider's 
cost report included an appropriate claim for the specific item under 
appeal, are reversed or modified by the final decision of a Federal 
court (in accordance with section 1878(f)(1) of the Act and Sec.  
405.1877); and
    (B) Only to the extent otherwise permitted by the final decision of 
a Federal court pursuant to the EJR provisions of section 1878(f)(1) of 
the Act (refer also to Sec. Sec.  405.1842 and 405.1877) and by Medicare 
policy.

[80 FR 70600, Nov. 13, 2015]



Sec.  405.1875  Administrator review.

    (a) Basic rule: Time limit for rendering Administrator decisions, 
Board decisions, and action subject to immediate review. The 
Administrator, at his or her discretion, may immediately review any 
decision of the Board specified in paragraph (a)(2) of this section. 
Nonfinal decisions or actions by the Board are not immediately 
reviewable, except as provided in paragraph (a)(3) of this section. The 
Administrator may exercise this discretionary review authority on his or 
her own motion, or in response to a request from: a party to the Board 
appeal; CMS; or, in the case of a matter specified in paragraph 
(a)(3)(i) or (a)(3)(ii) of this section, another affected nonparty to a 
Board appeal. All requests for Administrator review and any other 
submissions to the Administrator under paragraph (c) of this section 
must be sent to the Office of the

[[Page 287]]

Attorney Advisor. The Office of the Attorney Advisor must examine each 
Board decision specified in paragraph (a)(2) of this section, and each 
matter described in Sec.  405.1845(h)(3), Sec.  405.1853(e)(6)(ii), or 
Sec.  405.1857(d)(2) of this subpart, of which it becomes aware, 
together with any review requests or any other submission made in 
accordance with the provisions of this section, in order to assist the 
Administrator's exercise of this discretionary review authority. The 
Board is required to send to the Office of the Attorney Advisor a copy 
of each decision specified in paragraphs (a)(2)(i), (ii), and (iii) of 
this section upon issuance of the decision.
    (1) The date of rendering any decision after the review by the 
Administrator must be no later than 60 days after the date of receipt by 
the provider of a reviewable Board decision or action. For purposes of 
this section, the date of rendering is the date the Administrator signs 
the decision, and not the date the decision is mailed or otherwise 
transmitted to the parties.
    (2) The Administrator may immediately review:
    (i) A Board hearing decision (as described in Sec.  405.1871 of this 
subpart).
    (ii) A Board dismissal decision (as described in Sec. Sec.  
405.1836(e)(1) and (e)(2), 405.1840(c)(2) and (c)(3), 405.1868(d)(1) and 
(d)(2) of this subpart).
    (iii) A Board EJR decision, but only the question of whether there 
is Board jurisdiction over a specific matter at issue in the decision; 
the Administrator may not review the Board's determination in a decision 
of its authority to decide a legal question relevant to the matter at 
issue (as described in Sec.  405.1842(h) of this subpart).
    (iv) Any other Board decision or action deemed to be final by the 
Administrator.
    (v) If the Administrator reviews a Board hearing decision regarding 
a specific item, or for a Board EJR decision the question of whether 
there is Board jurisdiction over a specific item, the Administrator's 
review of such a hearing decision or EJR decision, as applicable, will 
include, and any decision issued by the Administrator (under paragraph 
(e) of this section) will address, the Board's specific findings of fact 
and conclusions of law in such hearing decision or EJR decision (as 
prescribed in Sec.  405.1873(b)(1) and (d)) on the question of whether 
the provider's cost report included an appropriate claim for the 
specific item under appeal (as prescribed in Sec.  413.24(j) of this 
chapter).
    (3) Any decision or action by the Board not specified in paragraph 
(a)(2)(i) through (a)(2)(iii) of this section, or not deemed to be final 
by the Administrator under paragraph (a)(2)(iv) of this section, is 
nonfinal and not subject to Administrator review until the Board issues 
one of the decisions specified in paragraph (a)(2) of this section, 
except the Administrator may review immediately the following matters:
    (i) A Board ruling authorizing discovery or disclosure of a matter 
for which an objection was made based on privilege or other protection 
from disclosure such as case preparation, confidentiality, or undue 
burden (as described in Sec.  405.1853(e)(6)(ii) of this subpart).
    (ii) A Board subpoena compelling disclosure of a matter for which an 
objection was made based on privilege or other protection from 
disclosure such as case preparation, confidentiality, or undue burden 
(as described in Sec.  405.1857(d)(2) of this subpart).
    (b) Illustrative list of criteria for deciding whether to review. In 
deciding whether to review a Board decision or other matter specified in 
paragraphs (a)(2) and (a)(3) of this section, either on his or her own 
motion or in response to a request for review, the Administrator 
considers criteria such as whether it appears that--
    (1) The Board made an erroneous interpretation of law, regulation, 
CMS Ruling, or other interpretive rules, general statements of policy, 
or rules of agency organization, procedure, or practice established by 
CMS.
    (2) A Board hearing decision meets the requirements of Sec.  
405.1871(a) of this subpart.
    (3) The Board erred in refusing to admit certain evidence or in not 
considering other submitted matter (as described in Sec. Sec.  405.1855 
and 405.1865(b) of this subpart), or in admitting certain evidence.

[[Page 288]]

    (4) The case presents a significant policy issue having a basis in 
law and regulations, and review is likely to lead to the issuance of a 
CMS Ruling or other directive needed to clarify a statutory or 
regulatory provision.
    (5) The Board has incorrectly found, assumed, or denied jurisdiction 
over a specific matter at issue or extended its authority in a manner 
not provided for by statute, regulation, CMS Ruling, or other 
interpretive rules, general statements of policy, and rules of agency 
organization, procedure, or practice established by CMS.
    (6) The decision or other action of the Board requires 
clarification, amplification, or an alternative legal basis.
    (7) A remand to the Board may be necessary or appropriate under the 
criteria prescribed in paragraph (f) of this section.
    (c) Procedures--(1) Review requests. (i)(A) A party to a Board 
appeal or CMS may request Administrator review of a Board decision 
specified in paragraph (a)(2) of this section or a matter described in 
paragraph (a)(3) of this section.
    (B) A nonparty other than CMS may request Administrator review 
solely of a matter described in paragraph (a)(3)(i) or (a)(3)(ii) of 
this section.
    (ii) The date of receipt by the Office of Attorney Advisor of any 
review request must be no later than 15 days after the date the party 
making the request received the Board's decision or other reviewable 
action.
    (iii) A request for review (or a response to a request) must be 
submitted in writing, identify the specific issues for which review is 
requested, and explain why review is or is not appropriate, under the 
criteria specified in paragraph (b) of this section or for some other 
reason.
    (iv) A copy of any review request (or response to a request) must be 
sent promptly to each party to the appeal, the Office of the Attorney 
Advisor, and, as applicable, CMS, and any other affected nonparty.
    (2) Exception to time for requesting review. If a party, or 
nonparty, as applicable, seeks immediate review of a matter described in 
Sec.  405.1875(a)(3)(i) or (a)(3)(ii) of this subpart, the request for 
review must be made as soon as practicable, but in no event later than 5 
business days after the day the party or nonparty seeking review 
received notice of the ruling or subpoena. The request must state the 
reason(s) why the ruling was in error and the potential harm that may be 
caused if immediate review is not granted.
    (3) Notice of review. (i) When the Administrator decides to review a 
Board decision or other matter specified in paragraphs (a)(2) or (a)(3) 
of this section, respectively, whether on his or her own motion or upon 
request, the Administrator must send a written notice to the parties, 
CMS, and any other affected nonparty stating that the Board's decision 
is under review, and indicating the specific issues that are being 
considered.
    (ii) The Administrator may decline to review a Board decision or 
other matter, or any issue in a decision or matter, even if a request 
for review is submitted in accordance with paragraph (c)(1) or (c)(2) of 
this section.
    (4) Written submissions on review. If the Administrator accepts 
review of the Board's decision or other reviewable action, a party, CMS, 
or, another affected nonparty that requested review solely of a matter 
described in paragraph (a)(3)(i) or (a) (3)(ii) of this section, may 
tender written submissions regarding the review.
    (i) The date of receipt by the Office of the Attorney Advisor of any 
material must be no later than 15 days after the date the party, CMS or 
other affected nonparty submitting comments received the Administrator's 
notice under paragraph (c)(3) of this section, taking review of the 
Board decision or other reviewable matter.
    (ii) Any submission must be limited to the issues accepted for 
Administrator review (as identified in the notice) and be confined to 
the record of Board proceedings (as described in Sec.  405.1865 of this 
subpart). The submission may include--
    (A) Argument and analysis supporting or taking exception to the 
Board's decision or other reviewable action;
    (B) Supporting reasons, including legal citations and excerpts of 
record

[[Page 289]]

evidence, for any argument and analysis submitted under paragraph 
(c)(4)(ii)(A) of this section;
    (C) Proposed findings of fact and conclusions of law;
    (D) Rebuttal to any written submission filed previously with the 
Administrator in accordance with paragraph (c)(4) of this section; or
    (E) A request, with supporting reasons, that the decision or other 
reviewable action be remanded to the Board.
    (d) Ex parte communications prohibited. The Administrator does not 
consider any communication that does not meet the following requirements 
or is not submitted within the required time limits. All communications 
from any party, CMS, or other affected nonparty, concerning a Board 
decision (or other reviewable action) that is being reviewed or may be 
reviewed by the Administrator must--
    (1) Be in writing.
    (2) Contain a certification that copies were served on all other 
parties, CMS, and any other affected nonparty, as applicable.
    (3) Include, but are not limited to--
    (i) Requests for review and responses to requests for review 
submitted under paragraph (c)(1) or (c)(2) of this section; and
    (ii) Written submissions regarding review submitted under paragraph 
(c)(4) of this section.
    (e) Administrator's decision. (1) Upon completion of any review, the 
Administrator may render a written decision that--
    (i) For purposes of review of a Board decision specified in 
paragraph (a)(2) of this section, affirms, reverses, or modifies the 
Board's decision, or vacates that decision and remands the case to the 
Board for further proceedings in accordance with paragraph (f)(1)(i) of 
this section; or
    (ii) For purposes of review of a matter described in paragraph 
(a)(3) of this section, affirms, reverses, modifies, or remands the 
Board's discovery or disclosure ruling, or subpoena, as applicable, and 
remands the case to the Board for further proceedings in accordance with 
paragraph (f)(1)(ii) of this section.
    (2) The date of rendering of any decision by the Administrator must 
be no later than 60 days after the date of receipt by the provider of 
the Board's decision or other reviewable action. The Administrator must 
promptly send a copy of his or her decision to the Board, to each party 
to the appeal, to CMS, and, if applicable, to any other affected 
nonparty.
    (3) Any decision by the Administrator may rely on--
    (i) Applicable provisions of the law, regulations, CMS Rulings, and 
other interpretive rules, general statements of policy, and rules of 
agency organization, procedure, or practice established by CMS.
    (ii) Prior decisions of the Board, the Administrator, and the 
courts, and any other law that the Administrator finds applicable, 
whether or not cited in materials submitted to the Administrator.
    (iii) The administrative record for the case (as described in Sec.  
405.1865 of this subpart).
    (iv) Generally known facts that are not subject to reasonable 
dispute.
    (4) A timely decision by the Administrator that affirms, reverses, 
or modifies one of the Board decisions specified in paragraph (a)(2) of 
this section is final and binding on each party to the Board appeal (as 
described in Sec.  405.1877(a)(4) of this subpart).
    (i) If the final Administrator decision follows review of a Board 
hearing decision, the Administrator's decision is subject to the 
provisions of Sec.  405.1803(d) of this subpart, unless that final 
decision is the subject of judicial review (as described in Sec.  
405.1877 of this subpart).
    (ii) The Administrator, in accordance with Sec. Sec.  405.1885 
through 405.1889 of this subpart, may reopen and revise a final 
Administrator decision.
    (iii) A decision by the Administrator remanding a matter to the 
Board for further proceedings in accordance with paragraph (f) of this 
section is not a final decision for purposes of judicial review (as 
described in Sec.  405.1877(a)(4) of this subpart) or the provisions of 
Sec.  405.1803(d).
    (f) Remand. (1) A remand to the Board by the Administrator has the 
effect for purposes of review--
    (i) With respect to a Board decision specified in paragraph (a)(2) 
of this section, vacating the Board's decision and

[[Page 290]]

requiring further proceedings in accordance with the Administrator's 
decision and this subpart; or
    (ii) With respect to a matter described in paragraph (a)(3) of this 
section, affirming, reversing, modifying, or remanding the Board's 
remand order, discovery ruling, or subpoena, as applicable, and 
returning the case to the Board for further proceedings in accordance 
with the Administrator's decision and this subpart.
    (2) The Administrator may direct the Board to take further action 
for the development of additional facts or new issues, or to consider 
the applicability of laws or regulations other than those considered by 
the Board. The following are not acceptable bases for remand:
    (i) Presentation of evidence existing at the time of the Board 
hearing that was known or reasonably may be known.
    (ii) Introduction of a favorable court ruling, regardless of whether 
the ruling was made or was available at the time of the Board hearing or 
at the time the Board issued its decision.
    (iii) Change in a party's representation, regardless when made.
    (iv) Presentation of an alternative legal basis concerning an issue 
in dispute.
    (v) Attempted retraction of a waiver of a right, regardless when 
made.
    (3) After remand, the Board must take the actions required in the 
Administrator's remand order and issue a new decision in accordance with 
paragraph (f)(1)(i) of this section, or issue under paragraph (f)(1)(ii) 
of this section an initial decision or a further remand order, discovery 
ruling, or subpoena ruling, as applicable.
    (4) Administrator review of any decision or other action by the 
Board after remand is, to the extent applicable, subject to the 
provisions of paragraphs (a)(2) or (a)(3) of this section.
    (5) In addition to ordering a remand to the Board, the Administrator 
may order a remand to any component of HHS or CMS or to a contractor 
under appropriate circumstances, including, but not limited to, for the 
purpose of effectuating a court order (as described in Sec.  
405.1877(g)(2) of this subpart). When the contractor's denial of the 
relief, that the provider sought before the Board and that is under 
review by the Administrator, was based on procedural grounds (such as 
the alleged failure of the provider to satisfy a time limit) or was 
based on the alleged failure to supply adequate documentation to support 
the provider's claim, and the Administrator rules that the basis of the 
contractor's denial is invalid, the Administrator remands to the 
contractor for the contractor to make a determination on the merits of 
the provider's claim.

[73 FR 30262, May 23, 2008; 73 FR 49356, 49357, Aug. 21, 2008, as 
amended at 80 FR 70602, Nov. 13, 2015; 85 FR 59019, Sept. 18, 2020]



Sec.  405.1877  Judicial review.

    (a) Basis and scope. (1) Notwithstanding the provisions of 5 U.S.C. 
704 or any other provision of law, sections 205(h) and 1872 of the Act 
provide that a decision or other action by a reviewing entity is subject 
to judicial review solely to the extent authorized by section 1878(f)(1) 
of the Act. This section, along with the EJR provisions of Sec.  
405.1842 of this subpart, implements section 1878(f)(1) of the Act.
    (2) Section 1878(f)(1) of the Act provides that a provider has a 
right to obtain judicial review of a final decision of the Board, or of 
a timely reversal, affirmation, or modification by the Administrator of 
a final Board decision, by filing a civil action in accordance with the 
Federal Rules of Civil Procedure in a Federal district court with venue 
no later than 60 days after the date of receipt by the provider of a 
final Board decision or a reversal, affirmation, or modification by the 
Administrator. The Secretary (and not the Administrator or CMS itself, 
or the contractor) is the only proper defendant in a civil action 
brought under section 1878(f)(1) of the Act.
    (3) A Board decision is final and subject to judicial review under 
section 1878(f)(1) of the Act only if the decision--
    (i) Is one of the Board decisions specified in Sec.  
405.1875(a)(2)(i) through (a)(2)(iii) of this subpart or, in a 
particular case, is deemed to be final by the Administrator under Sec.  
405.1875(a)(2)(iv) of this subpart; and
    (ii) Is not reversed, affirmed, modified, or remanded by the 
Administrator

[[Page 291]]

under Sec. Sec.  405.1875(e) and 405.1875(f) of this subpart within 60 
days of the date of receipt by the provider of the Board's decision. A 
provider is not required to seek Administrator review under Sec.  
405.1875(c) first in order to seek judicial review of a Board decision 
that is final and subject to judicial review under section 1878(f)(1) of 
the Act.
    (4) If the Administrator timely reverses, affirms, or modifies one 
of the Board decisions specified in Sec.  405.1875(a)(2)(i) through 
(a)(2)(iii) of this subpart or deemed to be final by the Administrator 
in a particular case under Sec.  405.1875(a)(2)(iv) of this subpart, the 
Administrator's reversal, affirmation, or modification is the only 
decision subject to judicial review under section 1878(f)(1) of the Act. 
A remand of a Board decision by the Administrator to the Board vacates 
the decision. Neither the Board's decision nor the Administrator's 
remand is a final decision subject to judicial review under section 
1878(f)(1) of the Act (as described in Sec.  405.1875(e)(4), Sec.  
405.1875(f)(1), and Sec.  405.1875(f)(4) of this subpart).
    (b) Determining when a civil action may be filed--(1) General rule. 
Under section 1878(f)(1) of the Act, the 60-day periods for 
Administrator review of a decision by the Board, and for judicial review 
of any final Board decision, respectively, both begin to run on the same 
day. Paragraphs (b)(2), (b)(3) and (b)(4) of this section identify how 
various actions or inaction by the Administrator within the 60-day 
review period determine the scope and timing of any right a provider may 
have to judicial review under section 1878(f)(1) of the Act.
    (2) Administrator declines review. If the Administrator declines any 
review of a Board decision specified in Sec.  405.1875(a)(2) of this 
subpart, whether through inaction or in a written notice issued under 
Sec.  405.1875(c)(3) of this subpart, the provider must file any civil 
action seeking judicial review of the Board's final decision under 
section 1878(f)(1) of the Act no later than 60 days after the date of 
receipt by the provider of the Board's decision.
    (3) Administrator accepts review and renders timely decision. When 
the Administrator decides to review, in a notice under Sec.  
405.1875(c)(3) of this subpart, any issue in a Board decision specified 
as final, or deemed as final by the Administrator, under Sec.  
405.1875(a)(2) of this subpart, and he or she subsequently renders a 
decision within the 60-day review period (as described in Sec.  
405.1875(a)(1) of this subpart), the provider has no right to obtain 
judicial review of the Board's decision under section 1878(f)(1) of the 
Act.
    (i) If the Administrator timely reverses, affirms, or modifies the 
Board's decision, the provider's only right under section 1878(f)(1) of 
the Act is to request judicial review of the Administrator's decision by 
filing a civil action no later than 60 days after the date of receipt by 
the provider of the Administrator's decision (as described in Sec.  
405.1877(a)(3) of this subpart).
    (ii) If the Administrator timely vacates the Board's decision and 
remands for further proceedings (as described in Sec.  405.1875(f)(1)(i) 
of this subpart), a provider has no right to judicial review under 
section 1878(f)(1) of the Act of the Board's decision or of the 
Administrator's remand (as described in Sec.  405.1877(a)(3) of this 
subpart).
    (4) Administrator accepts review and timely decision is not 
rendered. If the Administrator decides to review, in a notice under 
Sec.  405.1875(c)(3) of this subpart, any issue in a Board decision 
specified as final, or deemed to be final by the Administrator, under 
Sec.  405.1875(a)(2), but he or she does not render a decision within 
the 60-day review period, this subsequent inaction constitutes an 
affirmation of the Board's decision by the Administrator, for purposes 
of the time in which to seek judicial review. In this case, the provider 
must file any civil action requesting judicial review of the 
Administrator's final decision under section 1878(f)(1) of the Act no 
later than 60 days after the expiration of the 60-day period for a 
decision by the Administrator under Sec.  405.1875(a)(1) and Sec.  
405.1875(e)(2) of this subpart.
    (c) Statutory limitations on and preclusion of judicial review. The 
Act limits or precludes judicial review of certain matters at issue. 
Limitations on and preclusions of judicial review include the following:
    (1) A finding in a contractor determination that expenses incurred 
for

[[Page 292]]

items and services furnished by a provider to an individual are not 
payable under title XVIII of the Act because those items or services are 
excluded from coverage under section 1862 of the Act, and the 
regulations at 42 CFR part 411, is not reviewable by the Board (as 
described in Sec.  405.1840(b)(1) of this subpart) and is not subject to 
judicial review under section 1878(f)(1) of the Act; the finding is 
subject to judicial review solely in accordance with the applicable 
provisions of sections 1155, 1869, and 1879(d) of the Act, and of 
subpart I of part 405 and subpart B of part 478, as applicable.
    (2) Certain matters affecting payments to hospitals under the 
prospective payment system are completely removed from administrative 
and judicial review, as provided in section 1886(d)(7) of the Act, and 
Sec. Sec.  405.1804 and 405.1840(b)(2) of this subpart.
    (3) Any Board remand order, or discovery or disclosure ruling or 
subpoena specified in Sec.  405.1875(a)(3)(i) through (a)(3)(ii) of this 
subpart, or a decision by the Administrator following immediate review 
of a Board remand order, discovery ruling, or subpoena, is not subject 
to immediate judicial review under section 1878(f)(1) of the Act. 
Judicial review of all nonfinal Board actions, including any such Board 
remand order, discovery or disclosure ruling, or subpoena (except as 
provided in Sec.  405.1857(e) of this subpart), is limited to review of 
a final agency decision as described in Sec.  405.1877(a) of this 
subpart.
    (d) Group appeals. If a final decision is issued by the Board or 
rendered by the Administrator, as applicable, in any group appeal 
brought under Sec.  405.1837, those providers in the group appeal that 
seek judicial review of the final decision under section 1878(f)(1) of 
the Act must file a civil action as a group (as described in Sec.  
405.1877(e)(2) of this subpart) for the specific matter at issue and 
common factual or legal question that was addressed in the final agency 
decision in the group appeal.
    (e) Venue for civil actions--(1) Single provider appeals. A civil 
action under section 1878(f)(1) of the Act requesting judicial review of 
a final decision of the Board or the Administrator, as applicable, in a 
single provider appeal under Sec.  405.1835 of this subpart must be 
brought in the District Court of the United States for the judicial 
district in which the provider is located or in the United States 
District Court for the District of Columbia.
    (2) Group appeals. A civil action under section 1878(f)(1) of the 
Act seeking judicial review of a final decision of the Board or the 
Administrator, as applicable, in a group appeal under Sec.  405.1837 of 
this subpart must be brought in the District Court of the United States 
for the judicial district in which the greatest number of providers 
participating in both the group appeal and the civil action are located 
or in the United States District Court for the District of Columbia.
    (f) Service of process. Process must be served as described under 45 
CFR part 4.
    (g) Remand by a court--(1) General rule. Under section 1874 of the 
Act, and Sec.  421.5(b) of this chapter, the Secretary is the real party 
in interest in a civil action seeking relief under title XVIII of the 
Act. The Secretary has delegated to the Administrator the authority 
under section 1878(f)(1) of the Act to review decisions of the Board 
and, as applicable, render a final agency decision. If a court, in a 
civil action brought by a provider against the Secretary as the real 
party in interest regarding a matter pertaining to Medicare payment to 
the provider, orders a remand for further action by the Secretary, any 
component of HHS or CMS, or the contractor, the remand order must be 
deemed, except as provided in paragraph (g)(3) of this section, to be 
directed to the Administrator in the first instance, regardless of 
whether the court's remand order refers to the Secretary, the 
Administrator, the Board, any other component of HHS or CMS, or the 
contractor.
    (2) Procedures. (i) Upon receiving notification of a court remand 
order, the Administrator must prepare an appropriate remand order and, 
if applicable, file the order in any Board appeal at issue in the civil 
action.
    (ii) The Administrator's remand order must--
    (A) Describe the specific requirements of the court's remand order;

[[Page 293]]

    (B) Require compliance with those requirements by the pertinent 
component of HHS or CMS or by the contractor, as applicable; and
    (C) Remand the matter to the appropriate entity for further action.
    (iii) After the entity named in the Administrator's remand order 
completes its response to that order, the entity's response after remand 
is subject to further proceedings before the Board or the Administrator, 
as applicable, in accordance with this subpart. For example--
    (A) If the contractor issues a revised contractor determination 
after remand, the provider may request a Board hearing on the revised 
determination (as described in Sec. Sec.  405.1803(d) and 405.1889 of 
this subpart); or,
    (B) If the contractor hearing officer(s) or the Board issues a new 
decision after remand, a decision may be reviewed by a CMS reviewing 
official or the Administrator, respectively (as described in Sec. Sec.  
405.1834 and 405.1875(f)(4) of this subpart).
    (3) Exception. The provisions of paragraphs (g)(1) and (g)(2) of 
this section do not apply to the extent they may be inconsistent with 
the court's remand order or any other order of the court regarding the 
civil action.
    (h) Implementation of final court judgment. (1) When a final, non-
appealable court judgment is issued in a civil action brought by a 
provider against the Secretary as the real party in interest regarding a 
matter affecting Medicare payment, a court judgment is subject to the 
provisions of Sec.  405.1803(d) of this subpart.
    (2) The provisions of paragraph (h)(1) of this section do not apply 
to the extent they may be inconsistent with the court's final judgment 
or any other order of a court regarding the civil action.

[73 FR 30264, May 23, 2008]



Sec.  405.1881  Appointment of representative.

    A provider or other party may be represented by legal counsel or any 
other person it appoints to act as its representative at the 
proceedings, conducted in accordance with Sec. Sec.  405.1819 and 
405.1851.



Sec.  405.1883  Authority of representative.

    A representative appointed by a provider or other party may accept 
or give on behalf of the provider or other party any request or notice 
relative to any proceeding before a hearing officer or the Board. A 
representative shall be entitled to present evidence and allegations as 
to facts and law in any proceeding affecting the party he represents and 
to obtain information with respect to a request for a contractor hearing 
or a Board hearing made in accordance with Sec.  405.1811, Sec.  
405.1835, or Sec.  405.1837 to the same extent as the party he 
represents. Notice to a provider or other party of any action, 
determination, or decision, or a request for the production of evidence 
by a hearing officer or the Board sent to the representative of the 
provider or other party shall have the same force and effect as if it 
had been sent to the provider or other party.



Sec.  405.1885  Reopening a contractor determination 
or reviewing entity decision.

    (a) General. (1) A Secretary determination, a contractor 
determination, or a decision by a reviewing entity (as described in 
Sec.  405.1801(a)) may be reopened, with respect to specific findings on 
matters at issue in a determination or decision, by CMS (with respect to 
Secretary determinations), by the contractor (with respect to contractor 
determinations), or by the reviewing entity that made the decision (as 
described in paragraph (c) of this section).
    (i) A specific finding on a matter at issue may be legal or factual 
in nature or a mixed matter of both law and fact.
    (ii) A specific finding on a matter at issue may include a factual 
matter that arose in or was determined for the same cost reporting 
period as the period at issue in an appeal filed, or a reopening 
requested by a provider or initiated by a contractor, under this 
subpart.
    (iii) A specific finding on a matter at issue may include a 
predicate fact, which is a finding of fact based on a factual matter 
that first arose in or was first determined for a cost reporting period 
that predates the period at issue (in an appeal filed, or a reopening

[[Page 294]]

requested by a provider or initiated by a contractor, under this 
subpart), and once determined, was used to determine an aspect of the 
provider's reimbursement for one or more later cost reporting periods.
    (iv) Except as provided for by this section, Sec.  405.1887, and 
Sec.  405.1889, a specific finding on a matter at issue may not be 
reopened and, if reopened, revised.
    (2) A determination or decision may be reopened either through own 
motion of CMS (for Secretary determinations), the contractor or 
reviewing entity, by notifying the parties to the determination or 
decision (as specified in Sec.  405.1887), or by granting the request of 
the provider affected by the determination or decision.
    (3) A contractor's discretion to reopen or not reopen a matter is 
subject to a contrary directive from CMS to reopen or not reopen that 
matter.
    (4) If CMS directs a contractor to reopen a matter, reopening is 
considered an own motion reopening by the contractor. A reopening may 
result in a revision of any matter at issue in the determination or 
decision.
    (5) If a matter is reopened and a revised determination or decision 
is made, a revised determination or decision is appealable to the extent 
provided in Sec.  405.1889 of this subpart.
    (6) A determination or decision to reopen or not to reopen a 
determination or decision is not a final determination or decision 
within the meaning of this subpart and is not subject to further 
administrative review or judicial review.
    (b) Time limits--(1) Own motion reopening of a determination not 
procured by fraud or similar fault. An own motion reopening is timely 
only if the notice of intent to reopen (as described in Sec.  405.1887) 
is sent no later than 3 years after the date of the determination or 
decision that is the subject of the reopening. The date the notice is 
sent is presumed to be the date indicated on the notice unless it is 
shown by a preponderance of the evidence that the notice was sent on a 
later date.
    (2) Request for reopening of a determination not based on fraud or 
similar fault. (i) A reopening made upon request is timely only if the 
request to reopen is received by CMS, the contractor, or reviewing 
entity, as appropriate, no later than 3 years after the date of the 
determination or decision that is the subject of the requested 
reopening. The date of receipt by CMS, the contractor, or the reviewing 
entity of the request to reopen is determined by applying the date of 
receipt presumption criteria for reviewing entities defined in Sec.  
405.1801(a), unless it is shown by clear and convincing evidence that 
CMS, the contractor, or the reviewing entity received the request on an 
earlier date.
    (ii) A request to reopen does not toll the time in which to appeal 
an otherwise appealable determination or decision.
    (iii) A request to reopen that is received within the 3-year period 
described in this paragraph is timely, notwithstanding that the notice 
of reopening required under Sec.  405.1887 of this subpart is issued 
after such 3-year period.
    (iv) The 3-year period described in paragraphs (b)(2)(i) through 
(b)(2)(iii) of this section applies to, and is calculated separately 
for, each specific finding on a matter at issue (as described in 
paragraphs (a)(1)(i) through (a)(1)(iv) of this section, but not to such 
findings when made as part of a determination of reasonable cost under 
section 1861(v)(1)(A) of the Act.
    (3) Reopening of a determination procured by fraud or similar fault. 
A Secretary or contractor determination or decision by the reviewing 
entity may be reopened and revised at any time if it is established that 
the determination or decision was procured by fraud or similar fault of 
any party to the determination or decision.
    (c) Jurisdiction for reopening. Jurisdiction for reopening a 
contractor determination or contractor hearing decision rests 
exclusively with the contractor or contractor hearing officer(s) that 
rendered the determination or decision (or, when applicable, with the 
successor contractor), subject to a directive from CMS to reopen or not 
reopen the determination or decision. Jurisdiction for reopening a 
Secretary determination, CMS reviewing official decision, a Board 
decision, or an Administrator decision rests exclusively

[[Page 295]]

with CMS, the CMS reviewing official, Board or Administrator, 
respectively.
    (1) CMS-directed reopenings. CMS may direct a contractor or 
contractor hearing officer(s) to reopen and revise any matter, subject 
to the time limits specified in paragraph (b) of this section, and 
subject to the limitation expressed in paragraph (c)(2) of this section, 
by providing explicit direction to the contractor or contractor hearing 
officer(s) to reopen and revise.
    (i) Examples. A contractor determination or contractor hearing 
decision must be reopened and revised if CMS provides explicit notice to 
the contractor that the contractor determination or the contractor 
hearing decision is inconsistent with the applicable law, regulations, 
CMS ruling, or other interpretive rules, general statements of policy, 
and rules of agency organization, procedure, or practice established by 
CMS in effect, and as CMS understood those legal provisions, at the time 
the determination or decision was rendered by the contractor. CMS may 
also direct the contractor to reopen a particular contractor 
determination or decision in order to implement a final agency decision 
(as described in Sec. Sec.  405.1833, 405.1871(b) and 405.1875 of this 
subpart), a final, non-appealable court judgment Sec.  405.1877, or an 
agreement to settle an administrative appeal or a lawsuit, regarding the 
same determination or decision.
    (ii) [Reserved]
    (2) Prohibited reopenings. A change of legal interpretation or 
policy by CMS in a regulation, CMS ruling, or other interpretive rules, 
general statements of policy, and rules of agency organization, 
procedure, or practice established by CMS, whether made in response to 
judicial precedent or otherwise, is not a basis for reopening a CMS or 
contractor determination, a contractor hearing decision, a CMS reviewing 
official decision, a Board decision, or an Administrator decision, under 
this section.
    (3) Reopening by CMS or contractor of determination currently on 
appeal to the Board or Administrator. CMS or a contractor may reopen, on 
its own motion or on request of the provider(s), a Secretary or 
contractor determination that is currently pending on appeal before the 
Board or Administrator.
    (i) The scope of the reopening may include any matter covered by the 
determination, including those specific matters that are appealed to the 
Board or the Administrator.
    (ii) The contractor must send a copy of the notice required under 
Sec.  405.1887(a) to the Board or to the Administrator, through the 
Office of the Attorney Advisor, specifically informing that the 
matter(s) to be addressed by the reopening is currently under appeal to 
the Board or to the Administrator or is covered by the same 
determination that is under appeal.
    (4) Reopening of determination within the time for appealing that 
determination to the Board. CMS or a contractor may reopen, on its own 
motion or on request of the provider(s), a Secretary or contractor 
determination for which no appeal was taken to the Board, but for which 
the time to appeal to the Board has not yet expired, by sending the 
notice specified in Sec.  405.1887(a) of this subpart.

[73 FR 30265, May 23, 2008, as amended at 78 FR 75195, Dec. 10, 2013; 85 
FR 59019, Sept. 18, 2020]



Sec.  405.1887  Notice of reopening; effect of reopening.

    (a) In exercising its reopening authority under Sec.  405.1885, CMS 
(for Secretary determinations), the contractor or the reviewing entity, 
as applicable, must provide written notice to all parties to the 
determination or decision that is the subject of the reopening. Notices 
of--
    (1) Reopening by a CMS reviewing official or the Board must be sent 
promptly to the Administrator.
    (2) Contractor reopenings of determinations that are currently 
pending before the Board or the Administrator must meet the requirements 
specified in Sec.  405.1885(c)(3) and (c)(4) of this subpart.
    (b) Upon receipt of the notice required under Sec.  405.1887(a) of 
this subpart, the parties to the prior Secretary or contractor 
determination or decision by a reviewing entity, as applicable, must be 
allowed a reasonable period of time in which to present any

[[Page 296]]

additional evidence or argument in support of their positions.
    (c) Upon concluding its reopening, CMS, the contractor or the 
reviewing entity, as applicable, must provide written notice promptly to 
all parties to the determination or decision that is the subject of the 
reopening, informing the parties as to what matter(s), if any, is 
revised, with a complete explanation of the basis for any revision.
    (d) A reopening by itself does not extend appeal rights. Any matter 
that is reconsidered during the course of a reopening, but is not 
revised, is not within the proper scope of an appeal of a revised 
determination or decision (as described in Sec.  405.1889 of this 
subpart).

[73 FR 30266, May 23, 2008]



Sec.  405.1889  Effect of a revision; issue-specific nature of appeals 
of revised determinations and decisions.

    (a) If a revision is made in a Secretary or contractor determination 
or a decision by a reviewing entity after the determination or decision 
is reopened as provided in Sec.  405.1885 of this subpart, the revision 
must be considered a separate and distinct determination or decision to 
which the provisions of Sec. Sec.  405.1811, 405.1834, 405.1835, 
405.1837, 405.1875, 405.1877 and 405.1885 of this subpart are 
applicable.
    (b)(1) Only those matters that are specifically revised in a revised 
determination or decision are within the scope of any appeal of the 
revised determination or decision.
    (2) Any matter that is not specifically revised (including any 
matter that was reopened but not revised) may not be considered in any 
appeal of the revised determination or decision.

[73 FR 30266, May 23, 2008]

Subparts S-T [Reserved]



   Subpart U_Conditions for Coverage of Suppliers of End-Stage Renal 
                         Disease (ESRD) Services

    Authority: Secs. 1102, 1861, 1862(a), 1871, 1874, and 1881 of the 
Social Security Act (42 U.S.C. 1302, 1320b-8, 1395x, 1395y(a), 1395hh, 
1395kk, and 1395rr), unless otherwise noted.

    Source: 41 FR 22511, June 3, 1976, unless otherwise noted. 
Redesignated at 42 FR 52826, Sept. 30, 1977.



Sec. Sec.  405.2100-405.2101  [Reserved]



Sec.  405.2102  Definitions.

    As used in this subpart, the following definitions apply:
    Network, ESRD. All Medicare-approved ESRD facilities in a designated 
geographic area specified by CMS.
    Network organization. The administrative governing body to the 
network and liaison to the Federal government.

[41 FR 22511, June 3, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, 
as amended at 43 FR 48950, Oct. 19, 1978; 51 FR 30361, Aug. 26, 1986; 53 
FR 6547, Mar. 1, 1988; 55 FR 9575, Mar. 14, 1990; 72 FR 15273, Mar. 30, 
2007; 73 FR 20473, Apr. 15, 2008; 79 FR 66261, Nov. 6, 2014]



Sec.  405.2110  Designation of ESRD networks.

    CMS designated ESRD networks in which the approved ESRD facilities 
collectively provide the necessary care for ESRD patients.
    (a) Effect on patient choice of facility. The designation of 
networks does not require an ESRD patient to seek care only through the 
facilities in the designated network where the patient resides, nor does 
the designation of networks limit patient choice of physicians or 
facilities, or preclude patient referral by physicians to a facility in 
another designated network.
    (b) Redesignation of networks. CMS will redesignate networks, as 
needed, to ensure that the designations are consistent with ESRD program 
experience, consistent with ESRD program objectives specified in Sec.  
405.2101, and compatible with efficient program administration.

[51 FR 30361, Aug. 26, 1986]



Sec.  405.2111  [Reserved]



Sec.  405.2112  ESRD network organizations.

    CMS will designate an administrative governing body (network 
organization) for each network. The functions of a network organization 
include but are not limited to the following:
    (a) Developing network goals for placing patients in settings for 
self-care and transplantation.

[[Page 297]]

    (b) Encouraging the use of medically appropriate treatment settings 
most compatible with patient rehabilitation and the participation of 
patients, providers of services, and renal disease facilities in 
vocational rehabilitation programs.
    (c) Developing criteria and standards relating to the quality and 
appropriateness of patient care and, with respect to working with 
patients, facilities, and providers of services, for encouraging 
participation in vocational rehabilitation programs.
    (d) Evaluating the procedures used by facilities in the network in 
assessing patients for placement in appropriate treatment modalities.
    (e) Making recommendations to member facilities as needed to achieve 
network goals.
    (f) On or before July 1 of each year, submitting to CMS an annual 
report that contains the following information:
    (1) A statement of the network goals.
    (2) The comparative performance of facilities regarding the 
placement of patients in appropriate settings for--
    (i) Self-care;
    (ii) Transplants; and
    (iii) Vocational rehabilitation programs.
    (3) Identification of those facilities that consistently fail to 
cooperate with the goals specified under paragraph (f)(1) of this 
section or to follow the recommendations of the medical review board.
    (4) Identification of facilities and providers that are not 
providing appropriate medical care.
    (5) Recommendations with respect to the need for additional or 
alternative services in the network including self-dialysis training, 
transplantation and organ procurement.
    (g) Evaluating and resolving patient grievances.
    (h) Appointing a network council and a medical review board (each 
including at least one patient representative) and supporting and 
coordinating the activities of each.
    (i) Conducting on-site reviews of facilities and providers as 
necessary, as determined by the medical review board or CMS, using 
standards of care as specified under paragraph (c) of this section.
    (j) Collecting, validating, and analyzing such data as necessary to 
prepare the reports required under paragraph (f) of this section and the 
Secretary's report to Congress on the ESRD program and to assure the 
maintenance of the registry established under section 1881(c)(7) of the 
Act.

[53 FR 1620, Jan. 21, 1988]



Sec.  405.2113  Medical review board.

    (a) General. The medical review board must be composed of 
physicians, nurses, and social workers engaged in treatment relating to 
ESRD and qualified to evaluate the quality and appropriateness of care 
delivered to ESRD patients, and at least one patient representative.
    (b) Restrictions on medical review board members. (1) A medical 
review board member must not review or provide advice with respect to 
any case in which he or she has, or had, any professional involvement, 
received reimbursement or supplied goods.
    (2) A medical review board member must not review the ESRD services 
of a facility in which he or she has a direct or indirect financial 
interest (as described in section 1126(a)(1) of the Act).

[51 FR 30361, Aug. 26, 1986, as amended at 53 FR 1620, Jan. 21, 1988]



Sec.  405.2114  [Reserved]



Sec. Sec.  405.2131-405.2184  [Reserved]

Subparts V-W [Reserved]



  Subpart X_Rural Health Clinic and Federally Qualified Health Center 
                                Services

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 
1302 and 1395hh).

    Source: 43 FR 8261, Mar. 1, 1978, unless otherwise noted.



Sec.  405.2400  Basis.

    Subpart X is based on the provisions of the following sections of 
the Act:
    (a) Section 1833--Amounts of payment for supplementary medical 
insurance services.

[[Page 298]]

    (b) Section 1861(aa)--Rural health clinic services and Federally 
qualified health center services covered by the Medicare program.
    (c) Section 1834(o)--Federally qualified health center prospective 
payment system beginning October 1, 2014.

[79 FR 25473, May 2, 2014]



Sec.  405.2401  Scope and definitions.

    (a) Scope. This subpart establishes the requirements for coverage 
and reimbursement of rural health clinic and Federally qualified health 
center services under Medicare.
    (b) Definitions. As used in this subpart, unless the context 
indicates otherwise:
    Allowable costs means costs that are incurred by a RHC or FQHC that 
is authorized to bill based on reasonable costs and are reasonable in 
amount and proper and necessary for the efficient delivery of RHC and 
FQHC services.
    Beneficiary means an individual enrolled in the Supplementary 
Medical Insurance program for the Aged and Disabled (part of title XVIII 
of the Act).
    Certified nurse midwife (CNM) means an individual who meets the 
applicable education, training, and other requirements of Sec.  
410.77(a) of this chapter.
    Clinical psychologist (CP) means an individual who meets the 
applicable education, training, and other requirements of Sec.  
410.71(d) of this chapter.
    Clinical social worker (CSW) means an individual who meets the 
applicable education, training, and other requirements of Sec.  
410.73(a) of this chapter.
    CMS stands for Centers for Medicare & Medicaid Services.
    Coinsurance means that portion of the RHC's charge for covered 
services or that portion of the FQHC's charge or PPS rate for covered 
services for which the beneficiary is liable (in addition to the 
deductible, where applicable).
    Covered services means items or services for which the beneficiary 
is entitled to have payment made on his or her behalf under this 
subpart.
    Deductible means the amount incurred by the beneficiary during a 
calendar year as specified in Sec.  410.160 and Sec.  410.161 of this 
chapter.
    Employee means any individual who, under the common law rules that 
apply in determining the employer-employee relationship (as applied for 
purposes of section 3121(d)(2) of the Internal Revenue Code of 1986), is 
considered to be employed by, or an employee of, an entity. (Application 
of these common law rules is discussed in 20 CFR 404.1007 and 26 CFR 
31.3121(d)-1(c).)
    Federally qualified health center (FQHC) means an entity that has 
entered into an agreement with CMS to meet Medicare program requirements 
under Sec.  405.2434 and--
    (1) Is receiving a grant under section 330 of the Public Health 
Service (PHS) Act, or is receiving funding from such a grant under a 
contract with the recipient of such a grant and meets the requirements 
to receive a grant under section 330 of the PHS Act;
    (2) Is determined by the HRSA to meet the requirements for receiving 
such a grant;
    (3) Was treated by CMS, for purposes of Medicare Part B, as a 
comprehensive federally funded health center as of January 1, 1990; or
    (4) Is an outpatient health program or facility operated by a tribe 
or tribal organizations under the Indian Self-Determination Act or by an 
Urban Indian organization receiving funds under title V of the Indian 
Health Care Improvement Act.
    HRSA means the Health Resources and Services Administration.
    Medicare Administrative Contractor (MAC) means an organization that 
has a contract with the Secretary to administer the benefits covered by 
this subpart as described in Sec.  421.404 of this chapter.
    Nurse practitioner (NP) means individuals who meet the applicable 
education, training, and other requirements of Sec.  410.75(b) of this 
chapter.
    Physician assistant (PA) means an individual who meet the applicable 
education, training, and other requirements of Sec.  410.74(c) of this 
chapter.
    Prospective payment system (PPS) means a method of payment in which 
Medicare payment is made based on a predetermined, fixed amount.
    Reporting period generally means a period of 12 consecutive months 
specified by the MAC as the period for which a RHC or FQHC must report 
required costs and utilization information. The

[[Page 299]]

first and last reporting periods may be less than 12 months.
    Rural health clinic (RHC) means a facility that has--
    (1) Been determined by the Secretary to meet the requirements of 
section 1861(aa)(2) of the Act and part 491 of this chapter concerning 
RHC services and conditions for approval; and
    (2) Filed an agreement with CMS that meets the requirements in Sec.  
405.2402 to provide RHC services under Medicare.
    Secretary means the Secretary of Health and Human Services or his or 
her delegate.
    Visiting nurse services means part-time or intermittent nursing care 
and related medical supplies (other than drugs or biologicals) furnished 
by a registered professional nurse or licensed practical nurse to a 
homebound patient.

(Secs. 1102, 1833, 1861(aa), 1871, 1902(a)(13), Social Security Act; 49 
Stat. 647, 79 Stat. 302, 322, and 331, 91 Stat. 1485 (42 U.S.C. 1302, 
1395l, 1395hh, 1395x(aa), and 1396(a)(13))

[43 FR 8261, Mar. 1, 1978, as amended at 43 FR 30526, July 14, 1978; 47 
FR 21049, May 17, 1982; 47 FR 23448, May 28, 1982; 51 FR 41351, Nov. 14, 
1986; 57 FR 24975, June 12, 1992; 59 FR 26958, May 25, 1994; 60 FR 
63176, Dec. 8, 1995; 61 FR 14657, Apr. 3, 1996; 69 FR 74815, Dec. 24, 
2003; 71 FR 55345, Sept. 22, 2006; 79 FR 25473, May 2, 2014; 83 FR 
60072, Nov. 23, 2018]



Sec.  405.2402  Rural health clinic basic requirements.

    (a) Certification by the State survey agency. The rural health 
clinic must be certified in accordance with part 491 of this chapter.
    (b) Acceptance of the clinic as qualified to furnish RHC services. 
If the Secretary, after reviewing the survey agency or accrediting 
organization recommendation, as applicable, and other evidence relating 
to the qualifications of the clinic, determines that the clinic meets 
the requirements of this subpart and of part 491 of this chapter, the 
clinic is provided with--
    (1) Written notice of the determination; and
    (2) Two copies of the agreement to be filed as required by section 
1861(aa)(1) of the Act.
    (c) Filing of agreement by the clinic. If the clinic wishes to 
participate in the program, it must--
    (1) Have both copies of the agreement signed by an authorized 
representative; and
    (2) File them with the Secretary.
    (d) Acceptance by the Secretary. If the Secretary accepts the 
agreement filed by the clinic, the Secretary returns to the clinic one 
copy of the agreement with a notice of acceptance specifying the 
effective date.
    (e) Appeal rights. If CMS declines to enter into an agreement or if 
CMS terminates an agreement, the clinic is entitled to a hearing in 
accordance with Sec.  498.3(b)(5) and (6) of this chapter.

[43 FR 8261, Mar. 1, 1978, as amended at 52 FR 22454, June 12, 1987; 79 
FR 25474, May 2, 2014]



Sec.  405.2403  Rural health clinic content and terms of the agreement 
with the Secretary.

    (a) Under the agreement, the RHC agrees to the following:
    (1) Maintaining compliance with conditions. The RHC agrees to 
maintain compliance with the conditions set forth in part 491 of this 
chapter and to report promptly to CMS any failure to do so.
    (2) Charges to beneficiaries. The RHC agrees not to charge the 
beneficiary or any other person for items and services for which the 
beneficiary is entitled to have payment made under the provisions of 
this part (or for which the beneficiary would have been entitled if the 
RHC had filed a request for payment in accordance with Sec.  410.165 of 
this chapter), except for any deductible or coinsurance amounts for 
which the beneficiary is liable under Sec.  405.2410.
    (3) Refunds to beneficiaries. (i) The RHC agrees to refund as 
promptly as possible any money incorrectly collected from beneficiaries 
or from someone on their behalf.
    (ii) As used in this section, money incorrectly collected means sums 
collected in excess of the amount for which the beneficiary was liable 
under Sec.  405.2410. It includes amounts collected at a time when the 
beneficiary was believed not to be entitled to Medicare benefits but:
    (A) The beneficiary is later determined to have been entitled to 
Medicare benefits; and
    (B) The beneficiary's entitlement period falls within the time the 
RHC's

[[Page 300]]

agreement with the Secretary is in effect.
    (4) Beneficiary treatment. (i) The RHC agrees to accept 
beneficiaries for care and treatment; and
    (ii) The RHC agrees not to impose any limitations on the acceptance 
of beneficiaries for care and treatment that it does not impose on all 
other persons.
    (b) Additional provisions. The agreement may contain any additional 
provisions that the Secretary finds necessary or desirable for the 
efficient and effective administration of the Medicare program.

[43 FR 8261, Mar. 1, 1978, as amended at 51 FR 41351, Nov. 14, 1986; 79 
FR 25474, May 2, 2014]



Sec.  405.2404  Termination of rural health clinic agreements.

    (a) Termination by RHC--(1) Notice to Secretary. If the RHC wishes 
to terminate its agreement it shall file with the Secretary a written 
notice stating the intended effective date of termination.
    (2) Action by the Secretary. (i) The Secretary may approve the date 
proposed by the RHC, or set a different date no later than 6 months 
after the date of the RHC's notice.
    (ii) The Secretary may approve a date which is less than 6 months 
after the date of notice if the Secretary determines that termination on 
that date would not:
    (A) Unduly disrupt the furnishing of services to the community 
serviced by the RHC; or
    (B) Otherwise interfere with the effective and efficient 
administration of the Medicare program.
    (3) Cessation of business. If a RHC ceases to furnish services to 
the community, the Secretary deems it to be a voluntary termination of 
the agreement by the RHC, effective on the last day of business.
    (b) Termination by the Secretary--(1) Cause for termination. The 
Secretary may terminate an agreement if he or she determines that the 
RHC:
    (i) No longer meets the conditions for certification under part 491 
of this chapter;
    (ii) Is not in substantial compliance with the provisions of the 
agreement, the requirements of this subpart, any other applicable 
regulations of this part, or any applicable provisions of title XVIII of 
the Act; or
    (iii) Has undergone a change of ownership.
    (2) Notice of termination. The Secretary gives notice of termination 
to the RHC at least 15 days before the effective date stated in the 
notice.
    (3) Appeal by the RHC. A RHC may appeal the termination of its 
agreement in accordance with the provisions set forth in part 498 of 
this chapter.
    (c) Effect of termination. Payment will not be available for RHC 
services furnished on or after the effective date of termination.
    (d) Notice to the public. Prompt notice of the date and effect of 
termination must be given to the public by either of the following:
    (1) The RHC, after the Secretary has approved or set a termination 
date.
    (2) The Secretary, when he or she has terminated the agreement.
    (e) Conditions for reinstatement after termination of agreement by 
the Secretary. When an agreement with a RHC is terminated by the 
Secretary, the RHC may not file another agreement to participate in the 
Medicare program unless the Secretary:
    (1) Finds that the reason for the termination of the prior agreement 
has been removed; and
    (2) Is assured that the reason for the termination will not recur.

[43 FR 8261, Mar. 1, 1978, as amended at 52 FR 22454, June 12, 1987; 79 
FR 25474, May 2, 2014; 82 FR 38509, Aug. 14, 2017]



Sec.  405.2410  Application of Part B deductible and coinsurance.

    (a) Application of deductible. (1) Medicare payment for RHC services 
begins only after the beneficiary has incurred the deductible.
    (2) Medicare payment for services covered under the FQHC benefit is 
not subject to the usual Part B deductible.
    (b) Application of coinsurance. Except for preventive services for 
which Medicare pays 100 percent under Sec.  410.152(l) of this chapter, 
a beneficiary's responsibility is either of the following:
    (1) For RHCs that are authorized to bill on the basis of the 
reasonable cost system--

[[Page 301]]

    (i) A coinsurance amount that does not exceed 20 percent of the 
RHC's reasonable customary charge for the covered service; and
    (ii)(A) The beneficiary's deductible and coinsurance amount for any 
one item or service furnished by the RHC may not exceed a reasonable 
amount customarily charged by the RHC for that particular item or 
service; or
    (B) For any one item or service furnished by a FQHC, a coinsurance 
amount that does not exceed 20 percent of a reasonable customary charge 
by the FQHC for that particular item or service.
    (2) For FQHCs authorized to bill under the PPS, a coinsurance amount 
which is 20 percent of the lesser of--
    (i) The FQHC's actual charge; or
    (ii) The FQHC PPS rate for the covered service.

[71 FR 55345, Sept. 22, 2006, as amended at 79 FR 25474, May 2, 2014; 80 
FR 71371, Nov. 16, 2015]



Sec.  405.2411  Scope of benefits.

    (a) The following RHC and FQHC services are reimbursable under this 
subpart:
    (1) The physicians' services specified in Sec.  405.2412.
    (2) Services and supplies furnished as an incident to a physician's 
professional service.
    (3) The nurse practitioner or physician assistant services specified 
in Sec.  405.2414.
    (4) Services and supplies furnished as incident to a nurse 
practitioner, physician assistant, certified nurse midwife, clinical 
psychologist, or clinical social worker service.
    (5) Visiting nurse services when provided in accordance with 
1861(aa)(1) of the Act and Sec.  405.2416.
    (6) Clinical psychologist and clinical social worker services as 
specified in Sec.  405.2450.
    (b) RHC and FQHC services are--
    (1) Covered when furnished in a RHC, FQHC, or other outpatient 
setting, including a patient's place of residence;
    (2) Covered when furnished during a Part A stay in a skilled nursing 
facility only when provided by a physician, nurse practitioner, 
physician assistant, certified nurse midwife or clinical psychologist 
employed or under contract with the RHC or FQHC at the time the services 
are furnished; and
    (3) Not covered in a--
    (i) Hospital as defined in section 1861(e) of the Act; or
    (ii) Critical access hospital as defined in section 1861(mm)(1) of 
the Act.

[43 FR 8261, Mar. 1, 1978, as amended at 79 FR 25475, May 2, 2014]



Sec.  405.2412  Physicians' services.

    Physicians' services are professional services that are furnished by 
either of the following:
    (a) By a physician at the RHC or FQHC.
    (b) Outside of the RHC or FQHC by a physician whose agreement with 
the RHC or FQHC provides that he or she will be paid by the RHC or FQHC 
for such services and certification and cost reporting requirements are 
met.

[79 FR 25475, May 2, 2014]



Sec.  405.2413  Services and supplies incident to a physician's services.

    (a) Services and supplies incident to a physician's professional 
service are reimbursable under this subpart if the service or supply is:
    (1) Of a type commonly furnished in physicians' offices;
    (2) Of a type commonly rendered either without charge or included in 
the RHC's or FQHC's bill;
    (3) Furnished as an incidental, although integral, part of a 
physician's professional services;
    (4) Services and supplies must be furnished in accordance with 
applicable State law; and
    (5) Furnished under the direct supervision of a physician, except 
that services and supplies furnished incident to Transitional Care 
Management, General Care Management, and the Psychiatric Collaborative 
Care Model can be furnished under general supervision of a physician 
when these services or supplies are furnished by auxiliary personnel, as 
defined in Sec.  410.26(a)(1) of this chapter.

[[Page 302]]

    (b) Only drugs and biologicals which cannot be self-administered are 
included within the scope of this benefit.

[43 FR 8261, Mar. 1, 1978, as amended at 78 FR 74810, Dec. 10, 2013; 79 
FR 25475, May 2, 2014; 79 FR 68001, Nov. 13, 2014; 81 FR 80552, Nov. 15, 
2016; 82 FR 53358, Nov. 15, 2017]



Sec.  405.2414  Nurse practitioner, physician assistant, 
and certified nurse midwife services.

    (a) Professional services are payable under this subpart if the 
services meet all of the following:
    (1) Furnished by a nurse practitioner, physician assistant, or 
certified nurse midwife who is employed by, or receives compensation 
from, the RHC or FQHC.
    (2) Furnished under the medical supervision of a physician.
    (3) Furnished in accordance with any medical orders for the care and 
treatment of a patient prepared by a physician.
    (4) Are of a type which the nurse practitioner, physician assistant 
or certified nurse midwife who furnished the service is legally 
permitted to perform by the State in which the service is rendered.
    (5) The services would be covered if furnished by a physician.
    (b) The physician supervision requirement is met if the conditions 
specified in Sec.  491.8(b) of this chapter and any pertinent 
requirements of State law are satisfied.
    (c) The services of nurse practitioners, physician assistants or 
certified nurse midwives are not covered if State law or regulations 
require that the services be performed under a physician's order and no 
such order was prepared.

[43 FR 8261, Mar. 1, 1978, as amended at 79 FR 25475, May 2, 2014]



Sec.  405.2415  Incident to services and direct supervision.

    (a) Services and supplies incident to a nurse practitioner, 
physician assistant, certified nurse midwife, clinical psychologist, or 
clinical social worker service are payable under this subpart if the 
service or supply is all of the following:
    (1) Of a type commonly furnished in physicians' offices.
    (2) Of a type commonly rendered either without charge or included in 
the RHC's or FQHC's bill.
    (3) Furnished as an incidental, although integral part of 
professional services furnished by a nurse practitioner, physician 
assistant, certified nurse-midwife, clinical psychologist, or clinical 
social worker.
    (4) Furnished in accordance with applicable State law.
    (5) Furnished under the direct supervision of a nurse practitioner, 
physician assistant, or certified nurse-midwife, except that services 
and supplies furnished incident to Transitional Care Management, General 
Care Management, and the Psychiatric Collaborative Care model can be 
furnished under general supervision of a nurse practitioner, physician 
assistant, or certified nurse-midwife, when these services or supplies 
are furnished by auxiliary personnel, as defined in Sec.  410.26(a)(1) 
of this chapter.
    (b) The direct supervision requirement is met in the case of any of 
the following persons only if the person is permitted to supervise these 
services under the written policies governing the RHC or FQHC:
    (1) Nurse practitioner.
    (2) Physician assistant.
    (3) Certified nurse-midwife.
    (4) Clinical psychologist.
    (5) Clinical social worker.
    (c) Only drugs and biologicals which cannot be self-administered are 
included within the scope of this benefit.

[79 FR 25475, May 2, 2014, as amended at 79 FR 68001, Nov. 13, 2014; 81 
FR 80552, Nov. 15, 2016; 82 FR 53358, Nov. 15, 2017]



Sec.  405.2416  Visiting nurse services.

    (a) Visiting nurse services are covered if the services meet all of 
the following:
    (1) The RHC or FQHC is located in an area in which the Secretary has 
determined that there is a shortage of home health agencies.
    (2) The services are rendered to a homebound individual.
    (3) The services are furnished by a registered professional nurse or 
licensed practical nurse that is employed by, or receives compensation 
for the services from the RHC or FQHC.

[[Page 303]]

    (4) The services are furnished under a written plan of treatment 
that is both of the following:
    (i)(A) Established and reviewed at least every 60 days by a 
supervising physician of the RHC or FQHC; or
    (B)(1) Established by a nurse practitioner, physician assistant or 
certified nurse midwife; and
    (2) Reviewed at least every 60 days by a supervising physician.
    (ii) Signed by the supervising physician, nurse practitioner, 
physician assistant or certified nurse midwife of the RHC or FQHC.
    (5) During a PHE, as defined in Sec.  400.200 of this chapter, an 
area typically served by the RHC, and an area that is included in the 
FQHC's service area plan, is determined to have a shortage of home 
health agencies, and no request for this determination is required.
    (b) The nursing care covered by this section includes the following:
    (1) Services that must be performed by a registered professional 
nurse or licensed practical nurse if the safety of the patient is to be 
assured and the medically desired results achieved.
    (2) Personal care services, to the extent covered under Medicare as 
home health services. These services include helping the patient to 
bathe, to get in and out of bed, to exercise and to take medications.
    (c) This benefit does not cover household and housekeeping services 
or other services that would constitute custodial care.
    (d) For purposes of this section, homebound means an individual who 
is permanently or temporarily confined to his or her place of residence 
because of a medical or health condition. The individual may be 
considered homebound if he or she leaves the place of residence 
infrequently. For this purpose, ``place of residence'' does not include 
a hospital or long term care facility.

[43 FR 8261, Mar. 1, 1978, as amended at 79 FR 25475, May 2, 2014; 85 FR 
19285, Apr. 6, 2020]



Sec.  405.2417  Visiting nurse services: Determination of shortage of agencies.

    A shortage of home health agencies exists if the Secretary 
determines that the RHC or FQHC:
    (a) Is located in a county, parish, or similar geographic area in 
which there is no participating home health agency or adequate home 
health services are not available to patients of the RHC or FQHC.
    (b) Has (or expects to have) patients whose permanent residences are 
not within the area serviced by a participating home health agency.
    (c) Has (or expects to have) patients whose permanent residences are 
not within a reasonable traveling distance, based on climate and 
terrain, of a participating home health agency.

[43 FR 8261, Mar. 1, 1978, as amended at 79 FR 25476, May 2, 2014]

               Federally Qualified Health Center Services

    Source: 57 FR 24978, June 12, 1992, unless otherwise noted.



Sec.  405.2430  Basic requirements.

    (a) Filing procedures. (1) In response to a request from an entity 
that wishes to participate in the Medicare program, CMS enters into an 
agreement with an entity when all of the following occur:
    (i) HRSA approves the entity as meeting the requirements of section 
330 of the PHS Act.
    (ii) The entity assures CMS that it meets the requirements specified 
in this subpart and part 491 of this chapter, as described in Sec.  
405.2434(a).
    (iii) The FQHC terminates other provider agreements, unless the FQHC 
assures CMS that it is not using the same space, staff and resources 
simultaneously as a physician's office or another type of provider or 
supplier. A corporate entity may own other provider types as long as the 
provider types are distinct from the FQHC.
    (2) CMS sends the entity a written notice of the disposition of the 
request.
    (3) When the requirement of paragraph (a)(1) of this section is 
satisfied, CMS sends the entity two copies of the agreement. The entity 
must sign and return both copies of the agreement to CMS.
    (4) If CMS accepts the agreement filed by the FQHC, CMS returns to 
the center one copy of the agreement with the notice of acceptance 
specifying the

[[Page 304]]

effective date (see Sec.  489.11), as determined under Sec.  405.2434.
    (b) Prior HRSA FQHC determination. An entity applying to become a 
FQHC must do the following:
    (1) Be determined by HRSA as meeting the applicable requirements of 
the PHS Act, as specified in Sec.  405.2401(b).
    (2) Receive approval by HRSA as a FQHC under section 330 of the PHS 
Act (42 U.S.C. 254b).
    (c) Appeals. An entity is entitled to a hearing in accordance with 
part 498 of this chapter when CMS fails to enter into an agreement with 
the entity.

[57 FR 24978, June 12, 1992, as amended at 61 FR 14657, Apr. 3, 1996; 79 
FR 25476, May 2, 2014]



Sec.  405.2434  Content and terms of the agreement.

    Under the agreement, the FQHC must agree to the following:
    (a) Maintain compliance with the requirements. (1) The FQHC must 
agree to maintain compliance with the FQHC requirements set forth in 
this subpart and part 491, except that the provisions of Sec.  491.3 do 
not apply.
    (2) FQHCs must promptly report to CMS any changes that result in 
noncompliance with any of these requirements.
    (b) Effective date of agreement. The effective date of the agreement 
is determined in accordance with the provisions of Sec.  489.13 of this 
chapter.
    (c) Charges to beneficiaries. (1) For non-FQHC services that are 
billed to Part B, the beneficiary is responsible for payment of a 
coinsurance amount which is 20 percent of the amount of Part B payment 
made to the FQHC for the covered services.
    (2) The beneficiary is responsible for blood deductible expenses, as 
specified in Sec.  410.161.
    (3) The FQHC agrees not to charge the beneficiary (or any other 
person acting on behalf of a beneficiary) for any FQHC services for 
which the beneficiary is entitled to have payment made on his or her 
behalf by the Medicare program (or for which the beneficiary would have 
been entitled if the FQHC had filed a request for payment in accordance 
with Sec.  410.165 of this chapter), except for coinsurance amounts.
    (4) The FQHC may charge the beneficiary for items and services that 
are not FQHC services. If the item or service is covered under Medicare 
Part B, the FQHC may not charge the beneficiary more than 20 percent of 
the Part B payment amount.
    (d) Refunds to beneficiaries. (1) The FQHC must agree to refund as 
promptly as possible any money incorrectly collected from Medicare 
beneficiaries or from someone on their behalf.
    (2) As used in this section, ``money incorrectly collected'' means 
any amount for covered services that is greater than the amount for 
which the beneficiary was liable because of the coinsurance requirements 
specified in part 410, subpart E.
    (3) Amounts also are considered incorrectly collected if the FQHC 
believed the beneficiary was not entitled to Medicare benefits but--
    (i) The beneficiary was later determined to have been so entitled;
    (ii) The beneficiary's entitlement period fell within the time the 
FQHC's agreement with CMS was in effect; and
    (iii) The amounts exceed the beneficiary's coinsurance liability.
    (e) Treatment of beneficiaries. (1) The FQHC must agree to accept 
Medicare beneficiaries for care and treatment.
    (2) The FQHC may not impose any limitations with respect to care and 
treatment of Medicare beneficiaries that it does not also impose upon 
all other persons seeking care and treatment from the FQHC. Failure to 
comply with this requirement is a cause for termination of the FQHC's 
agreement with CMS in accordance with Sec.  405.2436(d).
    (3) If the FQHC does not furnish treatment for certain illnesses and 
conditions to patients who are not Medicare beneficiaries, it need not 
furnish such treatment to Medicare beneficiaries.

[57 FR 24978, June 12, 1992, as amended at 79 FR 25476, May 2, 2014]



Sec.  405.2436  Termination of agreement.

    (a) Termination by FQHC. The FQHC may terminate its agreement by--
    (1) Filing with CMS a written notice stating its intention to 
terminate the agreement; and

[[Page 305]]

    (2) Notifying CMS of the date on which the FQHC requests that the 
termination take effect.
    (b) Effective date. (1) Upon receiving a FQHC's notice of intention 
to terminate the agreement, CMS will set a date upon which the 
termination takes effect. This effective date may be--
    (i) The date proposed by the FQHC in its notice of intention to 
terminate, if that date is acceptable to CMS; or
    (ii) Except as specified in paragraph (2) of this section, a date 
set by CMS, which is no later than 6 months after the date CMS receives 
the FQHC's notice of intention to terminate.
    (2) The effective date of termination may be less than 6 months 
following CMS's receipt of the FQHC's notice of intention to terminate 
if CMS determines that termination on such a date would not--
    (i) Unduly disrupt the furnishing of FQHC services to the community; 
or
    (ii) Otherwise interfere with the effective and efficient 
administration of the Medicare program.
    (3) The termination is effective at the end of the last day of 
business as a FQHC.
    (c) Termination by CMS. (1) CMS may terminate an agreement with a 
FQHC if it finds that the FQHC--
    (i) No longer meets the requirements specified in this subpart; or
    (ii) Is not in substantial compliance with--
    (A) The provisions of the agreement; or
    (B) The requirements of this subpart, any other applicable 
regulations of this part, or any applicable provisions of title XVIII of 
the Act.
    (2) Notice by CMS. CMS will notify the FQHC in writing of its 
intention to terminate an agreement at least 15 days before the 
effective date stated in the written notice.
    (3) Appeal. A FQHC may appeal CMS's decision to terminate the 
agreement in accordance with part 498 of this chapter.
    (d) Effect of termination. When a FQHC's agreement is terminated 
whether by the FQHC or CMS, payment will not be available for FQHC 
services furnished on or after the effective date of termination.

[57 FR 24978, June 12, 1992, as amended at 79 FR 25476, May 2, 2014]



Sec.  405.2440  Conditions for reinstatement after termination by CMS.

    When CMS has terminated an agreement with a FQHC, CMS does not enter 
into another agreement with the FQHC to participate in the Medicare 
program unless CMS--
    (a) Finds that the reason for the termination no longer exists; and
    (b) Is assured that the reason for the termination of the prior 
agreement will not recur.

[57 FR 24978, June 12, 1992, as amended at 79 FR 25476, May 2, 2014]



Sec.  405.2442  Notice to the public.

    (a) When the FQHC voluntarily terminates the agreement and an 
effective date is set for the termination, the FQHC must notify the 
public in the area serviced by the FQHC prior to a prospective effective 
date or on the actual day that business ceases, if no prospective date 
of termination has been set. The notice must include--
    (1) Effective date of termination of the provision of services; and
    (2) Effect of termination of the agreement.
    (b) When CMS terminates the agreement, CMS will notify the public in 
the area serviced by the FQHC.

[57 FR 24978, June 12, 1992, as amended at 79 FR 25476, May 2, 2014; 82 
FR 38509, Aug. 14, 2017]



Sec.  405.2444  Change of ownership.

    (a) What constitutes change of ownership--(1) Incorporation. The 
incorporation of an unincorporated FQHC constitutes change of ownership.
    (2) Merger. The merger of the FQHC corporation into another 
corporation, or the consolidation of two or more corporations, one of 
which is the FQHC corporation, resulting in the creation of a new 
corporation, constitutes a change of ownership. (The merger of another 
corporation into the FQHC corporation does not constitute change of 
ownership.)

[[Page 306]]

    (3) Leasing. The lease of all or part of an entity constitutes a 
change of ownership of the leased portion.
    (b) Notice to CMS. A FQHC which is contemplating or negotiating 
change of ownership must notify CMS.
    (c) Assignment of agreement. When there is a change of ownership as 
specified in paragraph (a) of this section, the agreement with the 
existing FQHC is automatically assigned to the new owner if it continues 
to meet the conditions to be a FQHC.
    (d) Conditions that apply to assigned agreements. An assigned 
agreement is subject to all applicable statutes and regulations and to 
the terms and conditions under which it was originally issued including, 
but not limited to, the following:
    (1) Compliance with applicable health and safety standards.
    (2) Compliance with the ownership and financial interest disclosure 
requirements of part 420, subpart C of this subchapter.

[57 FR 24978, June 12, 1992, as amended at 79 FR 25476, May 2, 2014]



Sec.  405.2446  Scope of services.

    (a) For purposes of this section, the terms rural health clinic and 
RHC when they appear in the cross references in paragraph (b) of this 
section also mean Federally qualified health centers and FQHCs.
    (b) FQHC services that are paid for under this subpart are 
outpatient services that include the following:
    (1) Physician services specified in Sec.  405.2412.
    (2) Services and supplies furnished as incident to a physician's 
professional service, as specified in Sec.  405.2413.
    (3) Nurse practitioner, physician assistant or certified nurse 
midwife services as specified in Sec.  405.2414.
    (4) Services and supplies furnished as incident to a nurse 
practitioner, physician assistant, or certified nurse midwife service, 
as specified in Sec.  405.2415.
    (5) Clinical psychologist and clinical social worker services 
specified in Sec.  405.2450.
    (6) Services and supplies furnished as incident to a clinical 
psychologist or clinical social worker service, as specified in Sec.  
405.2452.
    (7) Visiting nurse services specified in Sec.  405.2416.
    (8) Preventive primary services specified in Sec.  405.2448 of this 
subpart.
    (9) Medical nutrition therapy services as specified in part 410, 
subpart G of this chapter, and diabetes outpatient self-management 
training services as specified in part 410, subpart H of this chapter.
    (c) FQHC services are covered when provided in outpatient settings 
only, including a patient's place of residence, which may be a skilled 
nursing facility or a nursing facility or other institution used as a 
patient's home.
    (d) FQHC services are not covered in a hospital, as defined in 
section 1861(e)(1) of the Act.

[57 FR 24979, June 12, 1992, as amended at 61 FR 14657, Apr. 3, 1996; 71 
FR 69782, Dec. 1, 2006; 79 FR 25476, May 2, 2014]



Sec.  405.2448  Preventive primary services.

    (a) Preventive primary services are those health services that--
    (1) A FQHC is required to provide as preventive primary health 
services under section 330 of the PHS Act; and
    (2) Are furnished by a or under the direct supervision of a 
physician, nurse practitioner, physician assistant, certified nurse 
midwife, clinical psychologist or clinical social worker employed by or 
under contract with the FQHC.
    (i) By a or under the direct supervision of a physician, nurse 
practitioner, physician assistant, certified nurse midwife, clinical 
psychologist or clinical social worker; or
    (ii) By a member of the FQHC's health care staff who is an employee 
of the FQHC or by a physician under arrangements with the FQHC.
    (3) Except as specifically provided in section 1861(s) of the Act, 
include only drugs and biologicals that cannot be self-administered.
    (b) Preventive primary services which may be paid for when provided 
by FQHCs are the following:
    (1) Medical social services.
    (2) Nutritional assessment and referral.
    (3) Preventive health education.
    (4) Children's eye and ear examinations.
    (5) Prenatal and post-partum care.

[[Page 307]]

    (6) Perinatal services.
    (7) Well child care, including periodic screening.
    (8) Immunizations, including tetanus-diptheria booster and influenza 
vaccine.
    (9) Voluntary family planning services.
    (10) Taking patient history.
    (11) Blood pressure measurement.
    (12) Weight.
    (13) Physical examination targeted to risk.
    (14) Visual acuity screening.
    (15) Hearing screening.
    (16) Cholesterol screening.
    (17) Stool testing for occult blood.
    (18) Dipstick urinalysis.
    (19) Risk assessment and initial counseling regarding risks.
    (20) Tuberculosis testing for high risk patients.
    (21) For women only.
    (i) Clinical breast exam.
    (ii) Referral for mammography; and
    (iii) Thyroid function test.
    (c) Preventive primary services do not include group or mass 
information programs, health education classes, or group education 
activities, including media productions and publications.
    (d) Screening mammography is not considered a FQHC service, but may 
be provided at a FQHC if the FQHC if the center meets the requirements 
applicable to that service specified in Sec.  410.34 of this subchapter. 
Payment is made under applicable Medicare requirements.
    (e) Preventive primary services do not include eyeglasses, hearing 
aids, or preventive dental services.

[57 FR 24980, June 12, 1992, as amended at 61 FR 14657, Apr. 3, 1996; 79 
FR 25477, May 2, 2014; 80 FR 71371, Nov. 16, 2015]



Sec.  405.2449  Preventive services.

    For services furnished on or after January 1, 2011, preventive 
services covered under the Medicare FQHC benefit are those preventive 
services defined in section 1861(ddd)(3) of the Act, and Sec.  410.2 of 
this chapter. Specifically, these include the following:
    (a) The specific services currently listed in section 1861(ww)(2) of 
the Act, with the explicit exclusion of electrocardiograms.
    (b) The Initial Preventive Physical Examination (IPPE) (as specified 
by section 1861(ww)(1) of the Act as added by section 611 of the 
Medicare Prescription Drug, Improvement and Modernization Act of 2003 
(Pub. L. 108-173) and Sec.  410.16 of this chapter).
    (c) The Personalized Prevention Plan Services (PPPS), also known as 
the ``Annual Wellness Visit'' (as specified by section 1861(hhh) of the 
Act as added by section 4103 of the Affordable Care Act (Pub. L. 111-
148) and Sec.  410.15 of this chapter).

[75 FR 73613, Nov. 29, 2010, as amended at 79 FR 25477, May 2, 2014]



Sec.  405.2450  Clinical psychologist and clinical social worker services.

    (a) For clinical psychologist or clinical social worker professional 
services to be payable under this subpart, the services must be--
    (1) Furnished by an individual who owns, is employed by, or 
furnishes services under contract to the FQHC;
    (2) Of a type that the clinical psychologist or clinical social 
worker who furnishes the services is legally permitted to perform by the 
State in which the service is furnished;
    (3) Performed by a clinical social worker or clinical psychologist 
who is legally authorized to perform such services under State law or 
the State regulatory mechanism provided by the law of the State in which 
such services are performed; and
    (4) Covered if furnished by a physician.
    (b) If State law prescribes a physician supervision requirement, it 
is met if the conditions specified in Sec.  491.8(b) of this chapter and 
any pertinent requirements of State law are satisfied.
    (c) The services of clinical psychologists or clinical social 
workers are not covered if State law or regulations require that the 
services be performed under a physician's order and no such order was 
prepared.

[57 FR 24980, June 12, 1992, as amended at 61 FR 14657, Apr. 3, 1996]

[[Page 308]]



Sec.  405.2452  Services and supplies incident to clinical psychologist 
and clinical social worker services.

    (a) Services and supplies incident to a clinical psychologist's or 
clinical social worker's services are reimbursable under this subpart if 
the service or supply is--
    (1) Of a type commonly furnished in a physician's office;
    (2) Of a type commonly furnished either without charge or included 
in the FQHC's bill;
    (3) Furnished as an incidental, although integral part of 
professional services furnished by a clinical psychologist or clinical 
social worker;
    (4) Services and supplies must be furnished in accordance with 
applicable State law; and
    (5) Furnished under the direct supervision of a clinical 
psychologist or clinical social worker.
    (b) The direct supervision requirement in paragraph (a)(5) of this 
section is met only if the clinical psychologist or clinical social 
worker is permitted to supervise such services under the written 
policies governing the FQHC.

[43 FR 8261, Mar. 1, 1978, as amended at 78 FR 74810, Dec. 10, 2013; 79 
FR 25477, May 2, 2014; 79 FR 68001, Nov. 13, 2014]

 Payment for Rural Health Clinic and Federally Qualified Health Center 
                                Services

    Source: 57 FR 24976, 24977, June 12, 1992, unless otherwise noted.



Sec.  405.2460  Applicability of general payment exclusions.

    The payment conditions, limitations, and exclusions set out in 
subpart C of this part, part 410 and part 411 of this chapter are 
applicable to payment for services provided by RHCs and FQHCs, except 
that preventive primary services, as defined in Sec.  405.2448, are 
statutorily authorized for FQHCs and not excluded by the provisions of 
section 1862(a) of the Act.

[79 FR 25477, May 2, 2014]



Sec.  405.2462  Payment for RHC and FQHC services.

    (a) Payment to provider-based RHCs that are authorized to bill under 
the reasonable cost system. A RHC that is authorized to bill under the 
reasonable cost system is paid in accordance with parts 405 and 413 of 
this subchapter, as applicable, if the RHC is--
    (1) An integral and subordinate part of a hospital, skilled nursing 
facility or home health agency participating in Medicare (that is, a 
provider of services); and
    (2) Operated with other departments of the provider under common 
licensure, governance and professional supervision.
    (b) Payment to independent RHCs that are authorized to bill under 
the reasonable cost system. (1) RHCs that are authorized to bill under 
the reasonable cost system are paid on the basis of an all-inclusive 
rate for each beneficiary visit for covered services. This rate is 
determined by the MAC, in accordance with this subpart and general 
instructions issued by CMS.
    (2) The amount payable by the MAC for a visit is determined in 
accordance with paragraphs (f)(1) and (2) of this section.
    (c) Payment to FQHCs that are authorized to bill under the PPS. A 
FQHC that is authorized to bill under the PPS is paid a single, per diem 
rate based on the prospectively set rate for each beneficiary visit for 
covered services. Except as noted in paragraph (d) of this section, this 
rate is adjusted for the following:
    (1) Geographic differences in cost based on the Geographic Practice 
Cost Indices (GPCIs) in accordance with section 1848(e) of the Act and 
42 CFR 414.2 and 414.26 are used to adjust payment under the physician 
fee schedule during the same period, limited to only the work and 
practice expense GPCIs.
    (2) Furnishing of care to a beneficiary that is a new patient with 
respect to the FQHC, including all sites that are part of the FQHC. A 
new patient is one that has not been treated by the FQHC's organization 
within the previous 3 years.
    (3) Furnishing of care to a beneficiary receiving a comprehensive 
initial Medicare visit (that is an initial preventive physical 
examination or an initial annual wellness visit) or a subsequent annual 
wellness visit.

[[Page 309]]

    (d) Payment to grandfathered tribal FQHCs. (1) A ``grandfathered 
tribal FQHC'' is a FQHC that:
    (i) Is operated by a tribe or tribal organization under the Indian 
Self-Determination Education and Assistance Act (ISDEAA);
    (ii) Was billing as if it were provider-based to an IHS hospital on 
or before April 7, 2000; and
    (iii) Is not operating as a provider-based department of an IHS 
hospital.
    (2) A grandfathered tribal FQHC is paid at the Medicare outpatient 
per visit rate as set annually by the IHS.
    (3) The payment rate is not adjusted:
    (i) By the FQHC Geographic Adjustment Factor;
    (ii) For new patients, annual wellness visits, or initial preventive 
physical examinations; or
    (iii) Annually by the Medicare Economic Index or a FQHC PPS market 
basket.
    (4) The payment rate is adjusted annually by the IHS under the 
authority of sections 321(a) and 322(b) of the Public Health Service Act 
(42 U.S.C. 248 and 249(b)), Pub. L. 83-568 (42 U.S.C. 2001(a)), and the 
Indian Health Care Improvement Act (25 U.S.C. 1601 et seq.).
    (e)(1) Except for preventive services for which Medicare pays 100 
percent under Sec.  410.152(l) of this chapter, Medicare pays--
    (i) Eighty (80) percent of the lesser of the FQHC's actual charge or 
the PPS encounter rate for FQHCs authorized to bill under the PPS; or
    (ii) Eighty (80) percent of the lesser of a grandfathered tribal 
FQHC's actual charge, or the outpatient rate for Medicare as set 
annually by the IHS for grandfathered tribal FQHCs that are authorized 
to bill at this rate.
    (2) No deductible is applicable to FQHC services.
    (f) For RHCs visits, payment is made in accordance with one of the 
following:
    (1) If the deductible has been fully met by the beneficiary prior to 
the RHC visit, Medicare pays 80 percent of the all-inclusive rate.
    (2) If the deductible has not been fully met by the beneficiary 
before the visit, and the amount of the RHC's reasonable customary 
charge for the services that is applied to the deductible is less than 
the all-inclusive rate, the amount applied to the deductible is 
subtracted from the all-inclusive rate and 80 percent of the remainder, 
if any, is paid to the RHC.
    (3) If the deductible has not been fully met by the beneficiary 
before the visit, and the amount of the RHC's reasonable customary 
charge for the services that is applied to the deductible is equal to or 
exceeds the all-inclusive rate, no payment is made to the RHC.
    (g) To receive payment, the RHC or FQHC must do all of the 
following:
    (1) Furnish services in accordance with the requirements of subpart 
X of part 405 of this chapter and subpart A of part 491 of this chapter.
    (2) File a request for payment on the form and manner prescribed by 
CMS.
    (3) HCPCS coding. FQHCs and RHCs are required to submit HCPCS and 
other codes as required in reporting services furnished.

[79 FR 25477, May 2, 2014, as amended at 80 FR 71371, Nov. 16, 2015; 83 
FR 60073, Nov. 23, 2018]



Sec.  405.2463  What constitutes a visit.

    (a) Visit--General. (1) For RHCs, a visit is either of the 
following:
    (i) Face-to-face encounter between a RHC patient and one of the 
following:
    (A) Physician.
    (B) Physician assistant.
    (C) Nurse practitioner.
    (D) Certified nurse midwife.
    (E) Visiting registered professional or licensed practical nurse.
    (G) Clinical psychologist.
    (H) Clinical social worker.
    (ii) Qualified transitional care management service.
    (2) For FQHCs, a visit is either of the following:
    (i) A visit as described in paragraph (a)(1)(i) or (ii) of this 
section.
    (ii) A face-to-face encounter between a patient and either of the 
following:
    (A) A qualified provider of medical nutrition therapy services as 
defined in part 410, subpart G, of this chapter.
    (B) A qualified provider of outpatient diabetes self-management 
training services as defined in part 410, subpart H, of this chapter.
    (b) Visit--Medical. (1) A medical visit is a face-to-face encounter 
between a

[[Page 310]]

RHC or FQHC patient and one of the following:
    (i) Physician.
    (ii) Physician assistant.
    (iii) Nurse practitioner.
    (iv) Certified nurse midwife.
    (v) Visiting registered professional or licensed practical nurse.
    (2) A medical visit for a FQHC patient may be either of the 
following:
    (i) Medical nutrition therapy visit.
    (ii) Diabetes outpatient self-management training visit.
    (3) Visit--Mental health. A mental health visit is a face-to-face 
encounter between a RHC or FQHC patient and one of the following:
    (i) Clinical psychologist.
    (ii) Clinical social worker.
    (iii) Other RHC or FQHC practitioner, in accordance with paragraph 
(b)(1) of this section, for mental health services.
    (c) Visit--Multiple. (1) For RHCs and FQHCs that are authorized to 
bill under the reasonable cost system, encounters with more than one 
health professional and multiple encounters with the same health 
professional that take place on the same day and at a single location 
constitute a single visit, except when the patient--
    (i) Suffers an illness or injury subsequent to the first visit that 
requires additional diagnosis or treatment on the same day;
    (ii) Has a medical visit and a mental health visit on the same day; 
or
    (iii) Has an initial preventive physical exam visit and a separate 
medical or mental health visit on the same day.
    (2) For RHCs and FQHCs that are authorized to bill under the 
reasonable cost system, Medicare pays RHCs and FQHCs for more than 1 
visit per day when the conditions in paragraph (c)(1) of this section 
are met.
    (3) For FQHCs that are authorized to bill under the reasonable cost 
system, Medicare pays for more than 1 visit per day when a DSMT or MNT 
visit is furnished on the same day as a visit described in paragraph 
(c)(1) of this section are met.
    (4) For FQHCs billing under the PPS, and grandfathered tribal FQHCs 
that are authorized to bill as a FQHC at the outpatient per visit rate 
for Medicare as set annually by the Indian Health Service--
    (i) Suffers an illness or injury subsequent to the first visit that 
requires additional diagnosis or treatment on the same day; or
    (ii) Has a medical visit and a mental health visit on the same day.

[79 FR 68001, Nov. 13, 2014, as amended at 80 FR 71372, Nov. 16, 2015]



Sec.  405.2464  Payment rate.

    (a) Payment rate for RHCs that are authorized to bill under the 
reasonable cost system.
    (1) Except as specified in paragraphs (d) and (e) of this section, 
an RHC that is authorized to bill under the reasonable cost system is 
paid an all-inclusive rate that is determined by the MAC at the 
beginning of the cost reporting period.
    (2) The rate is determined by dividing the estimated total allowable 
costs by estimated total visits for RHC services.
    (3) The rate determination is subject to any tests of reasonableness 
that may be established in accordance with this subpart.
    (4) The MAC, during each reporting period, periodically reviews the 
rate to assure that payments approximate actual allowable costs and 
visits and adjusts the rate if:
    (i) There is a significant change in the utilization of services;
    (ii) Actual allowable costs vary materially from allowable costs; or
    (iii) Other circumstances arise which warrant an adjustment.
    (5) The RHC may request the MAC to review the rate to determine 
whether adjustment is required.
    (b) Payment rate for FQHCs that are authorized to bill under the 
prospective payment system. (1) Except as specified in paragraphs (d) 
and (e) of this section, a per diem rate is calculated by CMS by 
dividing total FQHC costs by total FQHC daily encounters to establish an 
average per diem cost.
    (2) The per diem rate is adjusted as follows:
    (i) For geographic differences in the cost of inputs according to 
Sec.  405.2462(c)(1).
    (ii) When the FQHC furnishes services to a new patient, as defined 
in Sec.  405.2462(c)(2).

[[Page 311]]

    (iii) When a beneficiary receives either of the following:
    (A) A comprehensive initial Medicare visit (that is, an initial 
preventive physical examination or an initial annual wellness visit).
    (B) A subsequent annual wellness visit.
    (c) Payment for care management services. For chronic care 
management services furnished between January 1, 2016 and December 31, 
2017, payment to RHCs and FQHCs is at the physician fee schedule 
national non-facility payment rate. For care management services 
furnished on or after January 1, 2018, payment to RHCs and FQHCs is at 
the rate set for each of the RHC and FQHC payment codes for care 
management services.
    (d) Payment for FQHCs that are authorized to bill as grandfathered 
tribal FQHCs. Grandfathered tribal FQHCs are paid at the outpatient per 
visit rate for Medicare as set annually by the Indian Health Service for 
each beneficiary visit for covered services. There are no adjustments to 
this rate.
    (e) Payment for communication technology-based and remote evaluation 
services. For communication technology-based and remote evaluation 
services furnished on or after January 1, 2019, payment to RHCs and 
FQHCs is at the rate set for each of the RHC and FQHC payment codes for 
communication technology-based and remote evaluation services.

[79 FR 25478, May 2, 2014, as amended at 80 FR 71372, Nov. 16, 2015; 83 
FR 60073, Nov. 23, 2018]



Sec.  405.2466  Annual reconciliation.

    (a) General. Payments made to RHCs or FQHCs that are authorized to 
bill under the reasonable cost system during a reporting period are 
subject to annual reconciliation to assure that those payments do not 
exceed or fall short of the allowable costs attributable to covered 
services furnished to Medicare beneficiaries during that period.
    (b) Calculation of reconciliation for RHCs or FQHCs that are 
authorized to bill under the reasonable cost system. (1) The total 
reimbursement amount due the RHC or FQHC for covered services furnished 
to Medicare beneficiaries is based on the report specified in Sec.  
405.2470(c)(2) and is calculated by the MAC as follows:
    (i) The average cost per visit is calculated by dividing the total 
allowable cost incurred for the reporting period by total visits for RHC 
or FQHC services furnished during the period. The average cost per visit 
is subject to tests of reasonableness which may be established in 
accordance with this subpart.
    (ii) The total cost of RHC or FQHC services furnished to Medicare 
beneficiaries is calculated by multiplying the average cost per visit by 
the number of visits for covered RHC or FQHC services by beneficiaries.
    (iii) The total payment due the RHC is 80 percent of the amount 
calculated by subtracting the amount of deductible incurred by 
beneficiaries that is attributable to RHC services from the cost of 
these services. FQHC services are not subject to a deductible and the 
payment computation for FQHCs does not include a reduction related to 
the deductible.
    (iv) For RHCs and FQHCs, payment for pneumococcal and influenza 
vaccine and their administration is 100 percent of Medicare reasonable 
cost.
    (2) The total reimbursement amount due is compared with total 
payments made to the RHC or FQHC for the reporting period, and the 
difference constitutes the amount of the reconciliation.
    (c) Notice of program reimbursement. The MAC notifies the RHC or 
FQHC that is authorized to bill under the reasonable-cost system:
    (1) Setting forth its determination of the total reimbursement 
amount due the RHC or FQHC for the reporting period and the amount, if 
any, of the reconciliation; and
    (2) Informing the RHC or FQHC of its right to have the determination 
reviewed at a hearing under the procedures set forth in subpart R of 
this part.
    (d) Payment of reconciliation amount--(1) Underpayments. If the 
total reimbursement due the RHC or FQHC that is authorized to bill under 
the reasonable cost system exceeds the payments made for the reporting 
period, the MAC makes a lump-sum payment to the

[[Page 312]]

RHC or FQHC to bring total payments into agreement with total 
reimbursement due the RHC or FQHC.
    (2) Overpayments. If the total payments made to a RHC or FQHC for 
the reporting period exceed the total reimbursement due the RHC or FQHC 
for the period, the MAC arranges with the RHC or FQHC for repayment 
through a lump-sum refund, or, if that poses a hardship for the RHC or 
FQHC, through offset against subsequent payments or a combination of 
offset and refund. The repayment must be completed as quickly as 
possible, generally within 12 months from the date of the notice of 
program reimbursement. A longer repayment period may be agreed to by the 
MAC if the MAC is satisfied that unusual circumstances exist which 
warrant a longer period.

[57 FR 24976, June 12, 1992, as amended at 61 FR 14657, Apr. 3, 1996; 79 
FR 25478, May 2, 2014]



Sec.  405.2467  Requirements of the FQHC PPS.

    (a) Cost reporting. For cost reporting periods beginning on or after 
October 1, 2014, FQHCs are paid the lesser of their actual charges or 
the FQHC PPS rate that does all of the following:
    (1) Includes a process for appropriately describing the services 
furnished by FQHCs.
    (2) Establishes payment rates for specific payment codes based on 
such appropriate descriptions of services.
    (3) Takes into account the type, intensity and duration of services 
furnished by FQHCs.
    (4) May include adjustments (such as geographic adjustments) 
determined by the Secretary.
    (b) Initial payments. (1) Beginning October 1, 2014, for the first 
15 months of the PPS, the estimated aggregate amount of PPS rates is 
equal to 100 percent of the estimated amount of reasonable costs that 
would have occurred for that period if the PPS had not been implemented.
    (2) Payment rate is calculated based on the reasonable cost system, 
prior to productivity adjustments and any payment limitations.
    (c) Payments in subsequent years. (1) Beginning January 1, 2016, PPS 
payment rates will be increased by the percentage increase in the 
Medicare economic index.
    (2) Beginning January 1, 2017, PPS rates will be increased by the 
percentage increase in a market basket of FQHC goods and services as 
established through regulations, or, if not available, the Medicare 
economic index.

[79 FR 25479, May 2, 2014, as amended at 80 FR 71372, Nov. 16, 2015]



Sec.  405.2468  Allowable costs.

    (a) Applicability of general Medicare principles. In determining 
whether and to what extent a specific type or item of cost is allowable, 
such as interest, depreciation, bad debts and owner compensation, the 
MAC applies the principles for reimbursement of provider costs, as set 
forth in part 413 of this subchapter.
    (b) Typical RHC and FQHC costs. The following types and items of 
cost are included in allowable costs to the extent that they are covered 
and reasonable:
    (1) Compensation for the services of a physician, physician 
assistant, nurse practitioner, certified nurse-midwife, visiting 
registered professional or licensed practical nurse, clinical 
psychologist, and clinical social worker who owns, is employed by, or 
furnishes services under contract to a FQHC or RHC.
    (2) Compensation for the duties that a supervising physician is 
required to perform under the agreement specified in Sec.  491.8 of this 
chapter.
    (3) Costs of services and supplies incident to the services of a 
physician, physician assistant, nurse practitioner, nurse-midwife, 
qualified clinical psychologist, or clinical social worker.
    (4) Overhead costs, including RHC or FQHC administration, costs 
applicable to use and maintenance of the entity, and depreciation costs.
    (5) Costs of services purchased by the RHC or FQHC.
    (c) Tests of reasonableness of cost and utilization. Tests of 
reasonableness authorized by sections 1833(a) and 1861(v)(1)(A) of the 
Act may be established by CMS or the MAC with respect to direct or 
indirect overall costs, costs of specific items and services, or costs 
of groups of items and services. For RHCs and FQHCs that are authorized

[[Page 313]]

to bill under the reasonable cost system, these tests include, but are 
not limited to, screening guidelines and payment limits.
    (d) Screening guidelines. (1) Costs in excess of amounts established 
by the guidelines are not included unless the RHC or FQHC that is 
authorized to bill under the reasonable cost system provides reasonable 
justification satisfactory to the MAC.
    (2) Screening guidelines are used to assess the costs of services, 
including the following:
    (i) Compensation for the professional and supervisory services of 
physicians and for the services of physician assistants, nurse 
practitioners, and nurse-midwives.
    (ii) Services of physicians, physician assistants, nurse 
practitioners, nurse-midwives, visiting nurses, qualified clinical 
psychologists, and clinical social workers.
    (iii) The level of administrative and general expenses.
    (iv) Staffing (for example, the ratio of other RHC or FQHC personnel 
to physicians, physician assistants, and nurse practitioners).
    (v) The reasonableness of payments for services purchased by the RHC 
or FQHC, subject to the limitation that the costs of physician services 
purchased by the RHC or FQHC may not exceed amounts determined under the 
applicable provisions of subpart E of part 405 or part 415 of this 
chapter.
    (e) Payment limitations. Limits on payments may be set by CMS, on 
the basis of costs estimated to be reasonable for the provision of such 
services.
    (f) Graduate medical education. (1) Effective for portions of cost 
reporting periods occurring on or after January 1, 1999, if an RHC or an 
FQHC incurs ``all or substantially all'' of the costs for the training 
program in the nonhospital setting as defined in Sec.  413.75(b) of this 
chapter, the RHC or FQHC may receive direct graduate medical education 
payment for those residents. However, in connection with cost reporting 
periods for which ``all or substantially all of the costs for the 
training program in the nonhospital setting'' is not defined in Sec.  
413.75(b) of this chapter, if an RHC or an FQHC incurs the salaries and 
fringe benefits (including travel and lodging where applicable) of 
residents training at the RHC or FQHC, the RHC or FQHC may receive 
direct graduate medical education payments for those residents.
    (2) Direct graduate medical education costs are not included as 
allowable cost under Sec.  405.2466(b)(1)(i); and therefore, are not 
subject to the limit on the all-inclusive rate for allowable costs.
    (3) Allowable graduate medical education costs must be reported on 
the RHC's or the FQHC's cost report under a separate cost center.
    (4) Allowable graduate medical education costs are non-reimbursable 
if payment for these costs are received from a hospital or a Medicare 
Advantage organization.
    (5) Allowable direct graduate medical education costs under 
paragraphs (f)(6) and (f)(7)(i) of this section, are subject to 
reasonable cost principles under part 413 and the reasonable 
compensation equivalency limits in Sec. Sec.  415.60 and 415.70 of this 
chapter.
    (6) The allowable direct graduate medical education costs are those 
costs incurred by the nonhospital site for the educational activities 
associated with patient care services of an approved program, subject to 
the redistribution and community support principles in Sec.  413.85(c).
    (i) The following costs are allowable direct graduate medical 
education costs to the extent that they are reasonable--
    (A) The costs of the residents' salaries and fringe benefits 
(including travel and lodging expenses where applicable).
    (B) The portion of teaching physicians' salaries and fringe benefits 
that are related to the time spent teaching and supervising residents.
    (C) Facility overhead costs that are allocated to direct graduate 
medical education.
    (ii) The following costs are not allowable graduate medical 
education costs--
    (A) Costs associated with training, but not related to patient care 
services.
    (B) Normal operating and capital-related costs.

[[Page 314]]

    (C) The marginal increase in patient care costs that the RHC or FQHC 
experiences as a result of having an approved program.
    (D) The costs associated with activities described in Sec.  
413.85(h) of this chapter.
    (7) Payment is equal to the product of--
    (i) The RHC's or the FQHC's allowable direct graduate medical 
education costs; and
    (ii) Medicare's share, which is equal to the ratio of Medicare 
visits to the total number of visits (as defined in Sec.  405.2463).
    (8) Direct graduate medical education payments to RHCs and FQHCs 
made under this section are made from the Federal Supplementary Medical 
Insurance Trust Fund.

[43 FR 8261, Mar. 1, 1978. Redesignated and amended at 57 FR 24977, June 
12, 1992; 60 FR 63176, Dec. 8, 1995; 61 FR 14658, Apr. 3, 1996; 63 FR 
41002, July 31, 1998; 66 FR 39932, Aug. 1, 2001; 70 FR 47484, Aug. 12, 
2005; 79 FR 25479, May 2, 2014; 79 FR 50351, Aug. 22, 2014]



Sec.  405.2469  FQHC supplemental payments.

    (a) Eligibility for supplemental payments. FQHCs under contract 
(directly or indirectly) with MA organizations are eligible for 
supplemental payments for FQHC services furnished to enrollees in MA 
plans offered by the MA organization to cover the difference, if any, 
between their payments from the MA plan and what they would receive 
under one of the following:
    (1) The PPS rate if the FQHC is authorized to bill under the PPS; or
    (2) The Medicare outpatient per visit rate as set annually by the 
Indian Health Service for grandfathered tribal FQHCs.
    (b) Calculation of supplemental payment. The supplemental payment 
for FQHC covered services provided to Medicare patients enrolled in MA 
plans is based on the difference between--
    (1) Payments received by the FQHC from the MA plan as determined on 
a per visit basis and the FQHCs all-inclusive cost-based per visit rate 
as set forth in this subpart, less any amount the FQHC may charge as 
described in section 1857(e)(3)(B) of the Act; or
    (2) Payments received by the FQHC from the MA plan as determined on 
a per visit basis and the FQHC PPS rate as set forth in this subpart, 
less any amount the FQHC may charge as described in section 
1857(e)(3)(B) of the Act; or
    (3) Payments received by the FQHC from the MA plan as determined on 
a per visit basis and the FQHC outpatient rate as set forth in this 
section under paragraph (a)(2) of this section, less any amount the FQHC 
may charge as described in section 1857(e)(3)(B) of the Act.
    (c) Financial incentives. Any financial incentives provided to FQHCs 
under their MA contracts, such as risk pool payments, bonuses, or 
withholds, are prohibited from being included in the calculation of 
supplemental payments due to the FQHC.
    (d) Per visit supplemental payment. A supplemental payment required 
under this section is made to the FQHC when a covered face-to-face 
encounter occurs between a MA enrollee and a practitioner as set forth 
in Sec.  405.2463.

[79 FR 25479, May 2, 2014, as amended at 80 FR 71372, Nov. 16, 2015]



Sec.  405.2470  Reports and maintenance of records.

    (a) Maintenance and availability of records. The RHC or FQHC must:
    (1) Maintain adequate financial and statistical records, in the form 
and containing the data required by CMS, to allow the MAC to determine 
payment for covered services furnished to Medicare beneficiaries in 
accordance with this subpart;
    (2) Make the records available for verification and audit by HHS or 
the General Accounting Office;
    (3) Maintain financial data on an accrual basis, unless it is part 
of a governmental institution that uses a cash basis of accounting. In 
the latter case, appropriate depreciation on capital assets is allowable 
rather than the expenditure for the capital asset.
    (b) Adequacy of records. (1) The MAC may suspend reimbursement if it 
determines that the RHC or FQHC does not maintain records that provide 
an adequate basis to determine payments under Medicare.

[[Page 315]]

    (2) The suspension continues until the RHC or FQHC demonstrates to 
the MAC's satisfaction that it does, and will continue to, maintain 
adequate records.
    (c) Reporting requirements--(1) Initial report. At the beginning of 
its initial reporting period, the RHC or FQHC must submit an estimate of 
budgeted costs and visits for RHC or FQHC services for the reporting 
period, in the form and detail required by CMS, and such other 
information as CMS may require to establish the payment rate.
    (2) Annual reports. Within 90 days after the end of its reporting 
period, the RHC or FQHC must submit, in such form and detail as may be 
required by CMS, a report of:
    (i) Its operations, including the allowable costs actually incurred 
for the period and the actual number of visits for RHC or FQHC services 
furnished during the period; and
    (ii) The estimated costs and visits for RHC services or FQHC 
services for the succeeding reporting period and such other information 
as CMS may require to establish the payment rate.
    (3) Late reports. If the RHC or FQHCdoes not submit an adequate 
annual report on time, the MAC may reduce or suspend payments to 
preclude excess payment to the RHC or FQHC.
    (4) Inadequate reports. If the RHC or FQHC does not furnish a report 
or furnishes a report that is inadequate for the MAC to make a 
determination of program payment, CMS may deem all payments for the 
reporting period to be overpayments.
    (5) Postponement of due date. For good cause shown by the RHC or 
FQHC, the MAC may, with CMS's approval, grant a 30-day postponement of 
the due date for the annual report.
    (6) Reports following termination of agreement or change of 
ownership. The report from a RHC or FQHC which voluntarily or 
involuntarily ceases to participate in the Medicare program or 
experiences a change in ownership (see Sec. Sec.  405.2436-405.2438) is 
due no later than 45 days following the effective date of the 
termination of agreement or change of ownership.
    (d) Collection of additional claims data. Beginning January 1, 2011, 
a Medicare FQHC must report on its Medicare claims such information as 
the Secretary determines is needed to develop and implement a 
prospective payment system for FQHCs including, but not limited to all 
pertinent HCPCS (Healthcare Common Procedure Coding System) code(s) 
corresponding to the service(s) provided for each Medicare FQHC visit 
(as defined in Sec.  405.2463).

[43 FR 8261, Mar. 1, 1978, as amended at 75 FR 73613, Nov. 29, 2010; 79 
FR 25479, May 2, 2014]



Sec.  405.2472  Beneficiary appeals.

    A beneficiary may request a hearing by an intermediary (subject to 
the limitations and conditions set forth in subpart H of this part) if:
    (a) The beneficiary is dissatisfied with a MAC's determination 
denying a request for payment made on his or her behalf by a RHC or 
FQHC;
    (b) The beneficiary is dissatisfied with the amount of payment; or
    (c) The beneficiary believes the request for payment is not being 
acted upon with reasonable promptness.

[43 FR 8261, Mar. 1, 1978. Redesignated and amended at 57 FR 24978, June 
12, 1992; 79 FR 25480, May 2, 2014]



PART 406_HOSPITAL INSURANCE ELIGIBILITY AND ENTITLEMENT--Table of Contents



                      Subpart A_General Provisions

Sec.
406.1 Statutory basis.
406.2 Scope.
406.3 Definitions.
406.5 Basis of eligibility and entitlement.
406.6 Application or enrollment for hospital insurance.
406.7 Forms to apply for entitlement under Medicare Part A.

          Subpart B_Hospital Insurance Without Monthly Premiums

406.10 Individual age 65 or over who is entitled to social security or 
          railroad retirement benefits, or who is eligible for social 
          security benefits.
406.11 Individual age 65 or over who is not eligible as a social 
          security or railroad retirement benefits beneficiary, or on 
          the basis of government employment.
406.12 Individual under age 65 who is entitled to social security or 
          railroad retirement disability benefits.
406.13 Individual who has end-stage renal disease.

[[Page 316]]

406.15 Special provisions applicable to Medicare qualified government 
          employment.

                  Subpart C_Premium Hospital Insurance

406.20 Basic requirements.
406.21 Individual enrollment.
406.22 Effect of month of enrollment on entitlement.
406.24 Special enrollment period related to coverage under group health 
          plans.
406.25 Special enrollment period for volunteers outside the United 
          States.
406.26 Enrollment under State buy-in.
406.28 End of entitlement.
406.32 Monthly premiums.
406.33 Determination of months to be counted for premium increase: 
          Enrollment.
406.34 Determination of months to be counted for premium increase: 
          Reenrollment.
406.38 Prejudice to enrollment rights because of Federal Government 
          error.

  Subpart D_Special Circumstances That Affect Entitlement to Hospital 
                                Insurance

406.50 Nonpayment of benefits on behalf of certain aliens.
406.52 Conviction of certain offenses.

    Authority: 42 U.S.C 1302 and 1395hh.

    Source: 48 FR 12536, Mar. 25, 1983, unless otherwise noted. 
Redesignated at 51 FR 41338, Nov. 14, 1986.



                      Subpart A_General Provisions



Sec.  406.1  Statutory basis.

    Sections 226, 226A, 1818 and 1818A of the Social Security Act and 
section 103 of Public Law 89-97 establish the conditions for entitlement 
to hospital insurance benefits. Sections 202 (t) and (u) of the Act 
specify limitations that apply to certain aliens and to persons 
convicted of certain offenses.

[48 FR 12536, Mar. 25, 1983. Redesignated at 51 FR 41338, Nov. 14, 1986, 
as amended at 56 FR 38078, Aug. 12, 1991]



Sec.  406.2  Scope.

    Subparts A through D of this part specify the conditions of 
eligibility for hospital insurance and set forth certain specific 
conditions that affect entitlement to benefits. Hospital insurance is 
authorized under Part A of title XVIII and is also referred to as 
Medicare Part A. It includes inpatient hospital care, posthospital SNF 
care, home health services, and hospice care.

[48 FR 56026, Dec. 16, 1983, as amended at 50 FR 33033, Aug. 16, 1985. 
Redesignated and amended at 51 FR 41338, Nov. 14, 1986]



Sec.  406.3  Definitions.

    First month of eligibility means the first month in which an 
individual meets all the requirements for entitlement to hospital 
insurance except application or enrollment if that is required.
    First month of entitlement means the first month for which the 
individual meets all the requirements for entitlement to Part A 
benefits.
    Insured individual means an individual who has the number of 
quarters of coverage required for monthly social security benefits.
    Quarter of coverage means a calendar quarter that is counted toward 
the number of covered quarters required to make the individual eligible 
for monthly social security benefits. A quarter is counted if during 
that quarter (or that calendar year) the individual earned a required 
minimum amount of money. (For details, see 20 CFR part 404, subpart B.)



Sec.  406.5  Basis of eligibility and entitlement.

    (a) Hospital insurance without premiums. Hospital insurance is 
available to most individuals without payment of a premium if they:
    (1) Are age 65 or over, or
    (2) Have received social security or railroad retirement disability 
benefits for 25 months; or
    (3) Have end-stage renal disease. Subpart B of this part explains 
the requirements such individuals must meet to obtain hospital insurance 
without premiums.
    (b) Premium hospital insurance. Many individuals who are age 65 or 
over, but do not meet the requirements set forth in subpart B of this 
part, and certain individuals under age 65, may obtain the benefits by 
paying a premium. Section 406.20 of this part explains the requirements 
individuals must meet to obtain premium hospital insurance.

[48 FR 12536, Mar. 25, 1983, as amended at 50 FR 33033, Aug. 16, 1985; 
56 FR 38078, Aug. 12, 1991]

[[Page 317]]



Sec.  406.6  Application or enrollment for hospital insurance.

    (a) Basic provision. In most cases, eligibility for Medicare Part A 
is a result of entitlement to monthly social security or railroad 
retirement cash benefits or eligibility for monthly social security cash 
benefits. This section specifies the individuals who need not file an 
application to become entitled to hospital insurance, those who must 
file an application, and those who must enroll.
    (b) Individuals who need not file an application for hospital 
insurance. An individual who meets any of the following conditions need 
not file an application for hospital insurance:
    (1) Is under age 65 and has been entitled, for more than 24 months, 
to monthly social security or railroad retirement benefits based on 
disability.
    (2) At the time of attainment of age 65, is entitled to monthly 
social security or railroad retirement benefits.
    (3) Establishes entitlement to monthly social security or railroad 
retirement benefits at any time after attaining age 65.
    (c) Individuals who must file an application for hospital insurance. 
An individual must file an application for hospital insurance if he or 
she seeks entitlement to hospital insurance on the basis of--
    (1) The transitional provisions set forth in Sec.  406.11;
    (2) Deemed entitlement to disabled widow's or widower's benefit 
under certain circumstances as provided in Sec.  406.12;
    (3) A diagnosis of end-stage renal disease, as specified in Sec.  
406.13;
    (4) Effective January 1, 1981, eligibility for social security cash 
benefits, as specified in Sec.  406.10(a)(3), if the individual has 
attained age 65 without applying for those benefits; or
    (5) The special provisions applicable to government employment as 
set forth in Sec.  406.15.
    (d) When application is deemed to be filed. (1) An application based 
on the transitional provisions or on ESRD is deemed to be filed in the 
first month of eligibility if it is filed not more than 3 months before 
the first month, and is retroactive to that month if filed within 12 
months after the first month. An application filed more than 12 months 
after the first month of eligibility is retroactive to the 12th month 
before the month it is filed.
    (2) An application for deemed entitlement to disabled widow's or 
widower's benefits, that is filed before the first month in which the 
individual meets all conditions of entitlement for this benefit, will be 
deemed a valid application if those conditions are met before an initial 
determination, reconsideration, or hearing decision is made on the 
application. If the conditions are met after the date of any hearing 
decision, a new application will have to be filed. An application 
validly filed within 12 months after the first month of eligibility is 
retroactive to that first month. If filed more than 12 months after that 
first month, it is retroactive to the 12th month before the month of 
filing.
    (3) Effective June 8, 1980, an application based on eligibility for 
social security benefits at or after age 65, that is filed before the 
first month in which the individual meets all eligibility conditions for 
this benefit, will be deemed a valid application if those conditions are 
met before an initial determination, reconsideration, or hearing 
decision is made on the application. If the conditions are met after the 
date of any hearing decision, a new application will have to be filed.
    (4) Effective March 1, 1981, an application under Sec.  406.10 that 
is validly filed within 6 months after the first month of eligibility is 
retroactive to that first month. If filed more than 6 months after that 
first month, it is retroactive to the 6th month before the month of 
filing.
    (e) Individuals who must enroll for hospital insurance. An 
individual who must pay a monthly premium for hospital insurance must 
enroll in accordance with the procedures set forth in Sec.  406.21.

[48 FR 12536, Mar. 25, 1983, as amended at 50 FR 33033, Aug. 16, 1985; 
53 FR 47202, Nov. 22, 1988; 61 FR 40345, Aug. 2, 1996]



Sec.  406.7  Forms to apply for entitlement under Medicare Part A.

    The following forms, available free of charge by mail from CMS or at 
any Social Security branch or district office,

[[Page 318]]

are used to apply for Medicare entitlement under the circumstances 
indicated:

    CMS-18-F-5--Application for Hospital Insurance Entitlement. (For use 
by individuals who are not eligible for retirement benefits under Title 
II of the Social Security Act or under the Railroad Retirement Act. This 
form may also be used for enrollment in the supplementary medical 
insurance program.)
    CMS-43--Application for Health Insurance Benefits under Medicare for 
Individuals with End Stage Renal Disease (ESRD). (An initial application 
for entitlement by individuals with ESRD).


As an alternative, an individual may use the application for monthly 
social benefits to apply also for Medicare entitlement if he or she is 
eligible for hospital insurance at that time.

[53 FR 6633, Mar. 2, 1988]



          Subpart B_Hospital Insurance Without Monthly Premiums



Sec.  406.10  Individual age 65 or over who is entitled to social security 
or railroad retirement benefits, or who is eligible 
for social security benefits.

    (a) Requirements. An individual is entitled to hospital insurance 
benefits under section 226 of the Act if he or she has attained aged 65 
and is:
    (1) Entitled to monthly social security benefits under section 202 
of the Social Security Act;
    (2) A qualified railroad retirement beneficiary who has been 
certified as such to the Social Security Administration by the Railroad 
Retirement Board in accordance with section 7(d) of the Railroad 
Retirement Act of 1974; or
    (3) Effective January 1, 1981, eligible for monthly social security 
benefits under section 202 of the Act and has filed an application for 
hospital insurance.
    (b) Beginning and end of entitlement. (1) Entitlement begins with 
the first day of the first month in which the individual meets the 
requirements of paragraph (a) of this section.
    (2) Entitlement continues until the individual dies or no longer 
meets the requirements of paragraph (a) of this section. An individual 
is not entitled to railroad retirement benefits and is neither entitled 
to, nor eligible for, monthly social security benefits in the month in 
which he or she dies. However, an individual who meets all other 
requirements for hospital insurance entitlement is entitled to hospital 
insurance in the month in which he or she dies if he or she--
    (i) Would have been entitled to monthly railroad retirement benefits 
or social security benefits in that month if he or she had not died; or
    (ii) Has filed an application for hospital insurance and would have 
been eligible for monthly social security benefits in that month if he 
or she had not died.



Sec.  406.11  Individual age 65 or over who is not eligible as 
a social security or railroad retirement benefits beneficiary, 
or on the basis of government employment.

    (a) Basis. Section 103 of the law that established the Medicare 
program in 1965 (Pub. L. 89-97) provided for eligibility for certain 
individuals who were age 65 or would soon attain age 65 but would not be 
able to qualify for social security or railroad retirement benefits.
    (b) Requirements. Unless he or she is excluded under paragraph (c) 
of this section, an individual age 65 or over who does not meet the 
requirements of Sec.  406.10 or Sec.  406.15 (and who would not meet 
those requirements if he or she filed an application), is entitled to 
Medicare Part A benefits if he or she meets the following requirements:
    (1) Age and quarters of coverage. (i) He or she attained age 65 
before 1968; or
    (ii) If he or she attained age 65 in 1968 or later, he or she must 
have at least 3 quarters of coverage for each year that elapsed after 
1966 and before the year in which he or she attained age 65. (The 
quarters of coverage may have been acquired at any time, not necessarily 
during the elapsed years.)
    (2) Residence and citizenship. He or she is a resident of the United 
States and--
    (i) A citizen of the United States; or
    (ii) An alien lawfully admitted for permanent residence who has 
continuously resided in the United States for 5 years immediately 
preceding the first month in which he or she meets all other 
requirements for entitlement to hospital insurance.

[[Page 319]]

    (3) Application. He or she has filed an application for Medicare 
Part A no earlier than the third month before the first month of 
eligibility.
    (c) Bases for exclusion. An individual who meets the requirements of 
paragraph (b) of this section is excluded from Medicare Part A if he or 
she--
    (1) Has been convicted of spying, sabotage, or treason, sedition, 
and subversive action under chapter 37, 105, or 115 of title 18 of the 
United States Code;
    (2) Has been convicted of conspiracy to establish a dictatorship 
under section 4 of the Internal Security Act of 1950;
    (3) On February 16, 1965, was or could have been covered under the 
Federal Employees Health Benefits Act (FEHBA) of 1959; or
    (4) In his or her first month of eligibility;
    (i) Is covered by an enrollment under the FEHBA; or
    (ii) Could have been covered by an enrollment under that Act if he 
or she (or any other person who could provide him or her with coverage) 
was a Federal employee at any time after February 15, 1965, and had 
enrolled and retained coverage under that Act.
    (d) End of exclusion. An individual excluded under paragraph (c)(3) 
or (4) of this section can become entitled beginning with the first 
month in which he or she loses the right to FEHBA coverage solely 
because he or she or the other person leaves Federal employment.
    (e) Beginning and end of entitlement. (1) Entitlement begins--
    (i) In the first month of eligibility if the application is filed no 
later than 12 months after the first month of eligibility:
    (ii) In the 12th month before the month of application if the 
application is filed more than 12 months after the first month of 
eligibility.
    (2) Entitlement continues until death or until the month before the 
month in which the individual becomes entitled under Sec.  406.10 or 
Sec.  406.15.

[48 FR 12536, Mar. 25, 1983, as amended at 50 FR 33033, Aug. 16, 1985; 
53 FR 47202, Nov. 22, 1988]



Sec.  406.12  Individual under age 65 who is entitled to social security 
or railroad retirement disability benefits.

    (a) Basic requirements. An individual under age 65 is entitled to 
hospital insurance benefits if, for 25 months, he or she has been--
    (1) Entitled or deemed entitled to social security disability 
benefits as an insured individual, child, widow, or widower who is 
``under a disability'' or
    (2) A disabled qualified beneficiary certified under Section 7(d) of 
the Railroad Retirement Act.
    (b) Previous periods of disability benefits entitlement. Months of a 
previous period of entitlement or deemed entitlement to disability 
benefits count toward the 25-month requirement if any of the following 
conditions is met:
    (1) Entitlement was as an insured individual or a disabled qualified 
railroad retirement beneficiary, and the previous period ended within 
the 60 months preceding the month in which the current disability began.
    (2) Entitlement was as a disabled child, widow, or widower, and the 
previous period ended within the 84 months preceding the month in which 
the current disability began.
    (3) The previous period ended on or after March 1, 1988 and the 
current impairment is the same as, or directly related to, the 
impairment on which the previous period of entitlement was based.
    (c) Deemed entitlement to disabled widow's or widower's monthly 
benefits--(1) Purpose. The provisions of paragraphs (c) (2), (3), and 
(4) of this section are intended to enable individuals--
    (i) To meet the 25-month requirement of paragraph (a) of this 
section; or
    (ii) To retain hospital insurance entitlement when they are no 
longer entitled to monthly disability benefits.
    (2) Deemed entitlement for certain individuals entitled to old-age 
insurance benefits. An individual who becomes entitled to monthly old-
age insurance benefits before age 65, is, by law, precluded from 
establishing or retaining entitlement to disabled widow's or widower's 
monthly benefits. However, for purposes of meeting the 25-month 
requirement, a widow or widower who meets all other requirements for 
disability benefits and is excluded solely because

[[Page 320]]

of entitlement to old-age insurance benefits, shall be deemed to be (or 
to continue to be) entitled to disability benefits. A widow or widower 
who is not entitled to disability benefits for the month before 
attaining age 60 must file two applications, one for old-age insurance 
benefits and one for hospital insurance.
    (3) Deemed entitlement for certain individuals entitled to mother's 
benefits. An individual entitled to mother's insurance benefits under 
section 202(g) of the Social Security Act cannot at the same time be 
entitled to disabled widow's benefits. However, if she applies for 
hospital insurance, she will be deemed to be entitled to disabled 
widow's monthly benefits in the first month (of the 12 months before 
application) in which she would have been entitled to those benefits if 
she had filed an application for them.
    (4) Deemed entitlement for certain individuals entitled to father's 
benefits. An individual who is entitled to father's insurance benefits 
under section 202(g) of the Act cannot at the same time be entitled to 
disabled widower's benefits. However, if he applies for hospital 
insurance benefits, he will be deemed to be entitled to disabled 
widower's monthly benefits as follows:
    (i) If he applied for hospital insurance benefits before May 1984, 
he was deemed entitled to disabled widower's benefits for any month 
after April 1981 for which he would have been entitled to those benefits 
if he had filed an application for them.
    (ii) If he applies for hospital insurance benefits in or after May 
1984, he is deemed entitled to disabled widower's benefits for any 
month, up to 12 months before the month of application, for which he 
would have been entitled to those benefits if he had filed an 
application for them.
    (iii) Hospital insurance entitlement under this paragraph (c)(4) 
could not begin before May 1983.
    (5) Deemed retroactive entitlement for certain disabled widows and 
widowers. In some cases, disabled widows or widowers cannot become 
entitled to monthly cash benefits before the month in which they file 
application. However, for purposes of meeting the 25-month requirement, 
disability benefit entitlement will be deemed to have begun with the 
earliest month (of the 12 months before the application for cash 
benefits) in which the individual met all the requirements except the 
filing of an application. (This provision is effective for applications 
filed on or after January 1, 1978.)
    (d) When entitlement begins and ends. (1) Entitlement to hospital 
insurance begins with the 25th month of an individual's entitlement or 
deemed entitlement to disability benefits. Although an individual is not 
entitled to disability benefits for the month in which he or she dies, 
for purposes of this paragraph the individual will be deemed to be 
entitled for the month of death.
    (2) Except as provided in paragraph (e) of this section, entitlement 
to hospital insurance ends with the earliest of the following:
    (i) The last day of the last month in which he or she was entitled 
or deemed entitled to disability benefits or was qualified as a disabled 
railroad retirement beneficiary, if he or she was notified of the 
termination of entitlement before that month.
    (ii) The last day of the month following the month in which he or 
she is mailed a notice that his or her entitlement or deemed entitlement 
to disability benefits, or his or her status as a qualified disabled 
railroad retirement beneficiary, has ended.
    (iii) The last day of the month before the month he or she attains 
age 65. (An individual who is entitled to social security or railroad 
retirement cash benefits for the month of attainment of age 65 is 
automatically entitled to hospital insurance under Sec.  406.10.)
    (iv) The day of death.
    (e) Continuation of Medicare entitlement when disability benefit 
entitlement ends because of substantial gainful activity (SGA)--(1) 
Definitions. As used in this section--
    Trial work period means the 9-month period provided under title II 
of the Act and as defined 20 CFR 404.1592, during which the individual 
may test his or her ability to work and still receive disability cash 
benefits; and
    Reentitlement period means a period as defined in 20 CFR 404.1592a 
that begins with the first month after the trial

[[Page 321]]

work period and ends with the 36th month after the trial work period or, 
if earlier, with the first month in which the impairment no longer 
exists or is no longer disabling. (During the reentitlement period, 
benefits may be discontinued because of SGA. However, if SGA is later 
discontinued, benefits may be reinstated without a new application and a 
new disability determination.)
    (2) Duration of continued Medicare entitlement. If an individual's 
entitlement to disability benefits or status as a qualified disabled 
railroad retirement beneficiary ends because he or she engaged in, or 
demonstrated the ability to engage in, substantial gainful activity 
after the 36 months following the end of the trial work period, Medicare 
entitlement continues until the earlier of the following:
    (i) The last day of the 78th month following the first month of 
substantial gainful activity occurring after the 15th month of the 
individual's reentitlement period or, if later, the end of the month 
following the month the individual's disability benefit entitlement 
ends.
    (ii) The last day of the month following the month in which notice 
is mailed to the individual indicating that he or she is no longer 
entitled to hospital insurance because of an event or circumstance (for 
example, there has been medical improvement, or the disabled widow has 
remarried) that would terminate disability benefit entitlement if it had 
not already been terminated because of substantial gainful activity.

[48 FR 12536, Mar. 25, 1983. Redesignated at 51 FR 41338, Nov. 14, 1986, 
as amended at 53 FR 47202, Nov. 22, 1988; 56 FR 38078, Aug. 12, 1991; 56 
FR 50058, Oct. 3, 1991; 61 FR 40345, Aug. 2, 1996; 69 FR 57225, Sept. 
24, 2004]



Sec.  406.13  Individual who has end-stage renal disease.

    (a) Statutory basis and applicability. This section explains the 
conditions of entitlement to hospital insurance benefits on the basis of 
end-stage renal disease, and specifies the beginning and end of the 
period of entitlement. It implements section 226A of the Social Security 
Act.
    (b) Definitions. As used in this section:
    End-stage renal disease (ESRD) means that stage of kidney impairment 
that appears irreversible and permanent and requires a regular course of 
dialysis or kidney transplantation to maintain life.
    Child or spouse means a child or spouse whose relationship to the 
parent or spouse meets the relationship requirements for entitlement to 
child's monthly social security benefits or to wife's, husband's, 
widow's, widower's, mother's or father's monthly benefits, as set forth 
in 20 CFR part 404. However, the duration of relationship requirements 
apply only to divorced spouses. (See 20 CFR 404.331.)
    Dependent child means a person who, on the first day he or she has 
end-stage renal disease, is unmarried and meets the dependency 
requirements for entitlement to child's social security benefits on the 
basis of a parent's earnings (see 20 CFR 404.350-404.365) and who--
    (1) Is under age 22;
    (2) Is under a disability that began before age 22; or
    (3) Is under age 26, is receiving at least one-half support from 
that parent, and has continuously received at least one-half support 
from that parent since the day before attaining age 22.
    One-half support means regular contributions, in cash or in kind, 
that equals or exceeds one-half of the child's total support.
    (c) Requirements. An individual is entitled to hospital insurance 
benefits if--
    (1) He or she is medically determined to have ESRD;
    (2) He or she is:
    (i) Fully or currently insured under the social security program 
(title II of the Act) or would be fully or currently insured if his or 
her employment (after 1936) as defined under the Railroad Retirement Act 
were considered ``employment'' under the Social Security Act;
    (ii) Entitled to monthly social security or railroad retirement 
benefits; or
    (iii) The spouse or dependent child of a person who meets the 
requirements of paragraph (c)(2)(i) or (c)(2)(ii) of this section;

[[Page 322]]

    (3) He or she has filed an application for Medicare Part A; and
    (4) He or she has satisfied the waiting period explained in 
paragraph (e) of this section.
    (d) Filing an application. (1) An individual may obtain an 
application form, and help in completing it, from any social security 
office.
    (2) An application is not valid if it is filed earlier than the 
third month before the month in which the individual meets the 
conditions of paragraphs (c)(1), (c)(2), and (c)(4) of this section.
    (3) If an individual who has ESRD dies before he or she has filed an 
application, or is unable to file because of physical or mental 
condition, a relative or other person responsible for his or her affairs 
may file in his or her behalf. If a responsible person is not available, 
the hospital or dialysis facility that furnished treatment may file the 
application.
    (e) Beginning of entitlement--(1) Basic limitations. Entitlement can 
begin no earlier than the first month in which the individual meets the 
conditions specified in paragraph (c) of this section, or the 12th month 
before the month of application, whichever is later.
    (2) Waiting period. Entitlement begins on the first day of the third 
month after the month in which the individual initiates a regular course 
of renal dialysis, if the course is maintained throughout the waiting 
period, unless entitlement would begin earlier under paragraph (e) (3) 
or (4) of this section. This means that if dialysis began in January, 
entitlement would begin April 1.
    (3) Exceptions: Early kidney transplant. If the individual receives 
a transplant, entitlement begins with the first day of the month in 
which the transplant was performed. However, if the individual is 
admitted as an inpatient to a hospital that is an approved renal 
transplantation center or renal dialysis center (see Sec.  405.2102) for 
procedures preliminary to transplant surgery, entitlement begins--
    (i) On the first day of the month in which he or she initially 
enters the hospital, if the transplant is performed in that month or in 
either of the next 2 months; or
    (ii) On the first day of the second month before the month of kidney 
transplantation, if the transplant is delayed more than 2 months after 
the month of initial hospital stay.

For example, if an individual enters the hospital in January, and the 
transplant is performed in January, February, or March, entitlement 
would begin January 1. However, if the transplant is performed in April, 
entitlement would begin February 1.
    (4) Exceptions: Self-dialysis training. Entitlement begins on the 
first day of the month in which a regular course of renal dialysis began 
if:
    (i) Before the end of the waiting period, the individual 
participates in a self-dialysis training program offered by a 
participating Medicare facility that is approved to provide such 
training;
    (ii) The patient's physician has certified that it is reasonable to 
expect the individual will complete the training program and will self-
dialyze on a regular basis; and
    (iii) The regular course of dialysis is maintained throughout the 
time that would otherwise be the waiting period (unless it is terminated 
earlier because the individual dies).
    (f) End of entitlement. Entitlement ends with--
    (1) The end of the 12th month after the month in which a regular 
course of dialysis ends; or
    (2) The end of the 36th month after the month in which the 
individual has received a kidney transplant.
    (g) Resumption of entitlement. Entitlement is resumed under the 
following conditions:
    (1) An individual who initiates a regular course of renal dialysis 
or has a kidney transplant during the 12-month period after the previous 
course of dialysis ended is entitled to Part A benefits and eligible to 
enroll in Part B with the month the regular course of dialysis is 
resumed or the month the kidney is transplanted.
    (2) An individual who initiates a regular course of renal dialysis 
or has a kidney transplant during the 36-month period after an earlier 
kidney transplant is entitled to Part A benefits and eligible to enroll 
in Part B with the month the regular course of dialysis

[[Page 323]]

begins or with the month the subsequent kidney transplant occurs.
    (3) An individual who initiates a regular course of renal dialysis 
more than 12 months after the previous course of regular dialysis ended 
or more than 36 months after the month of a kidney transplant is 
eligible to enroll in Part A and Part B with the month in which the 
regular course of dialysis is resumed. If he or she is otherwise 
entitled under the conditions specified in paragraph (c) of this 
section, including the filing of an application, entitlement begins with 
the month in which dialysis is initiated or resumed, without a waiting 
period, subject to the limitations of paragraph (e)(1) of this section.

[48 FR 12536, Mar. 25, 1983, as amended at 60 FR 22535, May 8, 1995]



Sec.  406.15  Special provisions applicable to Medicare qualified 
government employment.

    (a) Definition. As used in this section, Medicare-qualified 
government employment means Federal, State, or local government 
employment that is subject only to the hospital insurance portion of the 
tax imposed by the Federal Insurance Contributions Act (F.I.C.A.). This 
includes--
    (1) Wages paid for Federal employment after December 1982.
    (2) Wages paid to State and local government employees hired after 
March 31, 1986.
    (3) Wages paid to State and local government employees hired before 
April 1, 1986 but whose employment after March 31, 1986 is covered, for 
Medicare purposes only, under an agreement under section 218 of the Act.
    (b) Crediting of wages that are taxable only for Medicare purposes. 
Medicare qualified government employment is credited in the same way and 
in the same amount as social security covered employment is credited for 
monthly social security cash benefit purposes. However, since only the 
Medicare portion (not the social security portion) of the F.I.C.A. tax 
is imposed, Medicare qualified government employment does not help 
qualify the individual for monthly Social Security cash benefits.
    (c) Required quarters of coverage. (1) To qualify for hospital 
insurance on the basis of Medicare qualified government employment, an 
individual must have the number of quarters of coverage necessary to 
qualify for hospital insurance under Sec.  406.10, Sec.  406.12, or 
Sec.  406.13.
    (2) An individual who has worked in Medicare qualified government 
employment may qualify for hospital insurance on the basis of Medicare 
qualified government employment exclusively, or a combination of 
Medicare qualified government employment and social security covered 
employment.
    (d) Transitional provision for Federal employment. Any individual 
who was a Federal employee at any time both during and before January 
1983 will receive credit for quarters of Federal employment before 
January 1983 without paying tax. This transitional provision applies 
even if the Federal employee did not receive Federal wages for January 
1983, for instance, because he or she was on approved leave without pay 
or on loan to a State or foreign agency.
    (e) Conditions of entitlement. An individual who has worked in 
Medicare qualified government employment (or any related individual who 
would be entitled to social security cash benefits on the employee's 
record if Medicare qualified government employment qualified for those 
benefits) is entitled to hospital insurance benefits if he or she--
    (1) Would meet the requirements of Sec.  406.10, Sec.  406.12, or 
Sec.  406.13 if Medicare qualified government employment were social 
security covered employment; and
    (2) Has filed an application for hospital insurance.

For purposes of this section not more than 12 months before the month of 
application may be counted towards the 25-month qualifying period 
specified in Sec.  406.12(a).
    (f) Beginning and end of entitlement--(1) Basic rule. Subject to the 
limitations specified in paragraph (f)(2) and (f)(3) of this section, 
entitlement begins and ends as specified in Sec.  406.10, Sec.  406.12 
or Sec.  406.13, whichever is used to establish hospital insurance 
entitlement for the Federal, State, or local government employee or 
related individual.

[[Page 324]]

    (2) Limitations: Federal government employment. (i) Hospital 
insurance entitlement based on Federal employment could not begin before 
January 1983.
    (ii) No months before January 1983 may be used to satisfy the 
qualifying period required for entitlement based on disability.
    (3) Limitations: State and local government employment. (i) Hospital 
insurance entitlement based on State or local government employment 
cannot begin before April 1986.
    (ii) No months before April 1986 may be used to satisfy the 
qualifying period required for entitlement based on disability.

[53 FR 47202, Nov. 22, 1988]



                  Subpart C_Premium Hospital Insurance



Sec.  406.20  Basic requirements.

    (a) General provisions. Hospital insurance benefits are available to 
most individuals age 65 or over and to certain individuals under age 65 
who do not qualify for those benefits under subpart B of this part and 
are willing to pay a monthly premium. This is called premium hospital 
insurance.
    (b) Eligibility of individuals age 65 or over to enroll for premium 
hospital insurance. Any individual is eligible to enroll for Medicare 
Part A if he or she--
    (1) Has attained age 65;
    (2) Is a resident of the United States and is either--
    (i) A citizen of the United States; or
    (ii) An alien lawfully admitted for permanent residence who has 
resided in the United States continuously for the 5-year period 
immediately preceding the month in which he or she meets all other 
requirements;
    (3) Is not eligible for Part A benefits under subpart B of this 
part; and
    (4) Is entitled to supplementary medical insurance (Part B of 
Medicare) or is eligible and has enrolled for it during an enrollment 
period.
    (c) Eligibility of individuals under age 65 to enroll for premium 
hospital insurance. An individual who has not attained age 65 is 
eligible to enroll for Medicare Part A if he or she meets the following 
conditions:
    (1) Has been entitled to Medicare Part A (under Sec.  406.12 or 
Sec.  406.15) on the basis of entitlement or deemed entitlement to 
social security disability benefits, as provided under section 226(b) of 
the Act.
    (2) Continues to have a disabling physical or mental impairment.
    (3) Loses entitlement to disability benefits (and therefore also 
loses entitlement to Medicare Part A under Sec.  406.12) solely because 
his or her earnings exceed the amount allowed under the social security 
regulations pertaining to ``substantial gainful activity'' (20 CFR 
404.1571-404.1574); and
    (4) Is not otherwise entitled to Medicare Part A.

[56 FR 38078, Aug. 12, 1991; 56 FR 50058, Oct. 3, 1991]



Sec.  406.21  Individual enrollment.

    (a) Basic provision. An individual who meets the requirements of 
Sec.  406.20 (b) or (c) may enroll for premium hospital insurance only 
during his or her ``initial enrollment period'', a ``general enrollment 
period'', a ``special enrollment period'', or, for HMO/CMP enrollees, a 
``transfer enrollment period'', as set forth in paragraphs (b) through 
(f) of this section.
    (b) Initial enrollment periods--(1) Initial enrollment period for 
individual age 65 or over. The initial enrollment period extends for 7 
months, from the third month before the month the individual first meets 
the requirements of Sec.  406.20 (b)(1) through (b)(3) through the third 
month after that first month of eligibility.
    (2) Initial enrollment period of individual under age 65. The 
initial enrollment period begins with the month in which the individual 
receives notice that entitlement to Medicare Part A will end because he 
or she has lost entitlement to disability benefits solely because of 
earnings in excess of the amounts allowed under the social security 
regulations on substantial gainful activity (20 CFR 404.1571-404.1574). 
It continues for 7 full months after that month.
    (c) General enrollment period. (1) Except as specified in paragraph 
(c)(4) of this section, the general enrollment period extends from 
January 1 to March 31 of each calendar year.

[[Page 325]]

    (2) General enrollment periods are for individuals who do not enroll 
during the special enrollment period, who failed to enroll during the 
initial enrollment period, or whose previous period of entitlement had 
terminated.
    (3) If the individual enrolls or reenrolls during a general 
enrollment period, his or her entitlement begins on July 1 of the 
calendar year.
    (4) During the period April 1 through September 30, 1981, the 
general enrollment period was any time after the end of the individual's 
initial enrollment period. Any eligible individual whose initial 
enrollment period has ended, or whose previous period of entitlement had 
terminated, could enroll or reenroll during that 6-month period.
    (d) ``Deemed'' initial enrollment period for individual age 65 or 
over. (1) If an individual who has attained age 65 fails to enroll 
during the initial enrollment period because of reliance on incorrect 
documentary information which led him or her to believe that he or she 
was not yet age 65, an initial enrollment period may be established for 
him or her as though he or she had attained age 65 on the date indicated 
by the incorrect documentary information.
    (2) The deemed initial enrollment period will be used to determine 
the individual's premium and right to enroll in a general enrollment 
period if such use is advantageous to the individual.
    (e) [Reserved]
    (f) Transfer enrollment period for HMO/CMP enrollees--(1) 
Terminology. HMO or CMP means an eligible organization as defined in 
Sec.  417.401 which has a contract with CMS under part 417, subpart L of 
this chapter.
    (2) Basic rule. Effective February 1, 1991, individuals enrolled in 
an HMO or CMP under part 417, subpart K of this chapter who meet the 
requirements of Sec.  406.20(b) may enroll in premium hospital insurance 
during a transfer enrollment period. This transfer enrollment period 
begins with any month or any part of a month in which the individual is 
enrolled in an HMO or CMP and ends with the last day of the 8th 
consecutive month in which the individual is no longer enrolled in the 
HMO or CMP.
    (3) Effective date of coverage. (i) If the individual enrolls in 
premium hospital insurance while still enrolled in an HMO or CMP, or 
during the first month that he or she is no longer enrolled in the HMO 
or CMP, part A coverage will begin on the first day of the month of part 
A enrollment, or, at the option of the individual, on the first day of 
any of the following 3 months.
    (ii) If the individual enrolls in premium hospital insurance during 
any of the last 7 months of the transfer enrollment period, coverage 
will begin on the first day of the month after the month of enrollment.

[48 FR 12536, Mar. 25, 1983. Redesignated at 51 FR 41338, Nov. 14, 1986, 
as amended at 53 FR 47203, Nov. 22, 1988; 56 FR 38079, Aug. 12, 1991; 57 
FR 36014, Aug. 12, 1992; 61 FR 40345, Aug. 2, 1996]



Sec.  406.22  Effect of month of enrollment on entitlement.

    (a) Individual age 65 or over. For an individual who has attained 
age 65, the following rules apply:
    (1) If the individual enrolls during the 3 months before the first 
month of eligibility, entitlement begins with the first month of 
eligibility.
    (2) If the individual enrolls in the first month of eligibility, 
entitlement begins with the following month.
    (3) If the individual enrolls during the month after the first month 
of eligibility, entitlement begins with the second month after the month 
of enrollment.
    (4) If the individual enrolls in either of the last 2 months of the 
enrollment period, entitlement begins with the third month after the 
month of enrollment.
    (b) Individual under age 65. For an individual who has not attained 
age 65, the following rules apply:
    (1) If the individual enrolls before the month in which he or she 
meets the requirements of Sec.  406.20(c), entitlement begins with the 
month in which the individual meets those requirements.
    (2) If the individual enrolls in the month in which he or she first 
meets the requirements of Sec.  406.20(c), entitlement begins with the 
following month.
    (3) If the individual enrolls in the month following the month in 
which he or she meets the requirements of

[[Page 326]]

Sec.  406.20(c), entitlement begins with the second month after the 
month of enrollment.
    (4) If the individual enrolls more than one month after the month in 
which he or she first meets the requirements of Sec.  406.20(c), 
entitlement begins with the third month after the month of enrollment.

[56 FR 38079, Aug. 12, 1991]



Sec.  406.24  Special enrollment period related to coverage 
under group health plans.

    (a) Terminology. As used in this subpart, the following terms have 
the indicated meanings.
    (1) Current employment status has the meaning given this term in 
Sec.  411.104 of this chapter.
    (2) Family member has the meaning given this term in Sec.  411.201 
of this chapter.
    (3) Group health plan (GHP) and large group health plan (LGHP) have 
the meanings given those terms in Sec.  411.101 of this chapter, except 
that the ``former employee'' language of those definitions does not 
apply with respect to SEPs because--
    (i) Section 1837(i)(1)(A) of the Act explicitly requires that GHP 
coverage of an individual age 65 or older, be by reason of the 
individual's (or the individual's spouse's) current employment status; 
and
    (ii) The sentence following section 1837(i)(1)(B), of the Act refers 
to ``large group health plan''. Under section 1862(b)(1)(B)(i), as 
amended by OBRA '93, LGHP coverage of a disabled individual must be ``by 
virtue of the individual's or a family member's current employment 
status with an employer''.
    (4) Special enrollment period (SEP) is a period provided by statute 
to enable certain individuals to enroll in Medicare without having to 
wait for the general enrollment period.
    (b) Duration of SEP.\2\ (1) The SEP includes any month during any 
part of which--
---------------------------------------------------------------------------

    \2\ Before March 1995, SEPs began on the first day of the first 
month the individual was no longer covered under a GHP or LGHP by reason 
of current employment status.
---------------------------------------------------------------------------

    (i) An individual over age 65 is enrolled in a GHP by reason of the 
current employment status of the individual or the individual's spouse; 
or
    (ii) An individual under age 65 and disabled--
    (A) Is enrolled in a GHP by reason of the current employment status 
of the individual or the individual's spouse; or
    (B) Is enrolled in an LGHP by reason of the current employment 
status of the individual or a member of the individual's family.
    (2) The SEP ends on the last day of the eighth consecutive month 
during which the individual is at no time enrolled in a GHP or an LGHP 
by reason of current employment status.
    (c) Conditions for use of a SEP.\3\ In order to use a SEP, the 
individual must meet the following conditions:
---------------------------------------------------------------------------

    \3\ Before August 10, 1993, an individual under age 65 could qualify 
for a SEP only if he or she had LGHP coverage as an ``active 
individual'', which the statute defined as ``an employee, employer, 
self-employed individual (such as the employer), individual associated 
with the employer in a business relationship, or as a member of the 
family of any of those persons''.
---------------------------------------------------------------------------

    (1) When first eligible to enroll for premium hospital insurance 
under Sec.  406.20(b) or (c), the individual was--
    (i) Age 65 or over and covered under a GHP by reason of the current 
employment status of the individual or the individual's spouse;
    (ii) Under age 65 and covered under an LGHP by reason of the current 
employment status of the individual or a member of the individual's 
family ; or
    (iii) Under age 65 and covered under a GHP by reason of the current 
employment status of the individual or the individual's spouse.
    (2) For all the months thereafter, the individual has maintained 
coverage either under hospital insurance or a GHP or LGHP.
    (d) Special rule: Additional SEPs. (1) Generally, if an individual 
fails to enroll during any available SEP, he or she is not entitled to 
any additional SEPs.
    (2) However, if an individual fails to enroll during a SEP, because 
coverage under the same or a different GHP or LGHP was restored before 
the end of that particular SEP, that failure to enroll does not preclude 
additional SEPs.

[[Page 327]]

    (e) Effective date of coverage. (1) If the individual enrolls in a 
month during any part of which he or she is covered under a GHP or LGHP 
on the basis of current employment status, or in the first full month 
when no longer so covered, coverage begins on the first day of the month 
of enrollment or, at the individual's option, on the first day of any of 
the three following months.
    (2) If the individual enrolls in any month of the SEP other than the 
months specified in paragraph (e)(1) of this section, coverage begins on 
the first day of the month following the month of enrollment.

[61 FR 40346, Aug. 2, 1996]



Sec.  406.25  Special enrollment period for volunteers 
outside the United States.

    (a) General rule. A SEP, as defined in Sec.  406.24(a)(4) of this 
subchapter, is provided for an individual that meets the following 
requirements:
    (1) The individual is serving as a volunteer outside of the United 
States in a program that covers at least a 12-month period.
    (2) The individual is in a program that is sponsored by an 
organization described in section 501(c)(3) of the Internal Revenue Code 
of 1986 and is exempt from taxation under section 501(a) of Internal 
Revenue Code of 1986.
    (3) The individual can demonstrate that he or she has health 
insurance that covers medical services that the individual receives 
outside the United States while serving in the program.
    (4) The individual--
    (i) At the time he or she first met the requirements of Sec.  406.10 
through 406.15 or Sec.  406.20(b), elected not to enroll in premium 
hospital insurance during the individual's initial enrollment period; or
    (ii) Terminated enrollment in premium hospital insurance during a 
month in which the individual met the requirements of this section for a 
SEP.
    (b) Duration of SEP. The SEP is the 6-month period beginning on the 
first day of the month that includes the date that the individual no 
longer meets the requirements of paragraph (a) of this section.
    (c) Effective date of coverage. Coverage under a SEP authorized by 
this section begins on the first day of the month following the month in 
which the individual enrolls.

[73 FR 36468, June 27, 2008]



Sec.  406.26  Enrollment under State buy-in.

    (a) Enrollment of QMBs under a State buy-in agreement--(1) Effective 
date. Beginning with calendar year 1990, a State may request and be 
granted a modification of its buy-in agreement to include enrollment and 
payment of Part A premiums for QMBs (as defined in section 1905(p)(1) of 
the Act) who can become entitled to Medicare Part A only by paying a 
premium.
    (i) Any State that has a buy-in agreement in effect must participate 
in daily exchanges of enrollment data with CMS.
    (ii) [Reserved]
    (2) Amount of premium. Premiums paid under State buy-in are not 
subject to increase because of late enrollment or reenrollment.
    (b) Beginning of coverage under buy-in. The coverage period begins 
with the latest of the following:
    (1) The third month following the month in which the agreement 
modification covering QMBs is effectuated.
    (2) The first month in which the individual is entitled to premium 
hospital insurance under Sec.  406.20(b) and has QMB status.
    (3) The date specified in the agreement modification.
    (c) End of coverage under buy-in. Buy-in coverage ends with the 
earlier of the following:
    (1) Death. Coverage ends on the last day of the month in which the 
QMB dies.
    (2) Loss of QMB status. If the individual loses eligibility for QMB 
status, coverage ends on the last day of the month in which CMS receives 
the State's notice of ineligibility.
    (3) Termination of buy-in agreement. If the State's buy-in agreement 
is terminated, coverage ends on the last day of the last month for which 
the agreement is in effect.
    (4) Entitlement to premium-free Part A. If the individual becomes 
entitled to premium-free Part A, buy-in coverage ends on the last day of 
entitlement to premium Part A.

[[Page 328]]

    (d) Continuation of coverage: Individual enrollment following 
termination of buy-in coverage--(1) Deemed enrollment. If coverage under 
a buy-in agreement ends because the agreement is terminated or the 
individual loses QMB status, the individual--
    (i) Is considered to have enrolled during his or her initial 
enrollment period; and
    (ii) Is entitled to Part A benefits and liable for Part A premiums 
beginning with the first month for which he or she is no longer covered 
under the buy-in agreement.
    (2) Voluntary termination. (i) An individual may voluntarily 
terminate entitlement acquired under paragraph (d)(1) of this section by 
filing, with SSA or CMS, a request for disenrollment.
    (ii) Voluntary disenrollment is effective as follows:
    (A) If the individual files a request within 30 days after the date 
of CMS's notice that buy-in coverage has ended, the individual's 
entitlement ends on the last day of the last month for which the State 
paid the premium.
    (B) If the individual files the request more than 30 days but not 
more than 6 months after buy-in coverage ends, entitlement ends on the 
last day of the month in which the request is filed.
    (C) If the individual files the request later than the 6th month 
after buy-in coverage ends, entitlement ends at the end of the month 
after the month in which request is filed.

[56 FR 38080, Aug. 12, 1991, as amended at 85 FR 25632, May 1, 2020]



Sec.  406.28  End of entitlement.

    Any of the following actions or events ends entitlement to premium 
hospital insurance:
    (a) Filing of request for termination. The beneficiary may at any 
time give CMS or the Social Security Administration written notice that 
he or she no longer wishes to participate in the premium hospital 
insurance program.
    (1) If he or she files the notice before entitlement begins, he or 
she will be deemed not to have enrolled.
    (2) If he or she files the notice after entitlement begins, that 
entitlement will end at the close of the month following the month in 
which he or she filed the notice.
    (b) Eligibility for hospital insurance without premiums. (1) If an 
individual meets the eligibility requirements for hospital insurance 
specified in Sec.  406.10, Sec.  406.11, Sec.  406.13 or Sec.  406.15, 
entitlement to premium hospital insurance ends with the month before the 
month in which he or she meets those requirements.
    (2) If an individual meets the requirements of Sec.  406.10, Sec.  
406.11, Sec.  406.13, or Sec.  406.15, he or she will be deemed to have 
filed the required application for hospital insurance benefits in his or 
her first month of eligibility under that section.
    (c) End of entitlement to supplementary medical insurance (SMI) for 
individual who has attained age 65. In the case of an individual 
enrolled on the basis of Sec.  406.20(b), entitlement to premium 
hospital insurance ends on the same date that entitlement to SMI ends.
    (d) Nonpayment of premium. (1) If an individual fails to pay the 
premium bill, entitlement will end on the last day of the third month 
after the billing month.
    (2) CMS may reinstate entitlement if the individual shows good cause 
for failure to pay on time, and pays all overdue premiums within 3 
calendar months after the date specified in paragraph (d)(1) of this 
section.
    (e) Death. Entitlement ends with the day of death. (A premium is due 
for the month of death.)
    (f) End of disabling impairment for individual under age 65. In the 
case of an individual enrolled on the basis of Sec.  406.20(c), 
entitlement to premium hospital insurance ends on the last day of the 
month after the month in which the individual is notified that he or she 
no longer has a disabling impairment.

[48 FR 12536, Mar. 25, 1983. Redesignated at 51 FR 41338, Nov. 14, 1986, 
as amended at 53 FR 47204, Nov. 22, 1988. Redesignated and amended at 56 
FR 38080, Aug. 12, 1991]



Sec.  406.32  Monthly premiums.

    (a) Promulgation and effective date. Beginning with 1984, premiums 
are promulgated each September, effective for the succeeding calendar 
year.

[[Page 329]]

    (b) Monthly premiums: Determination of dollar amount. (1) Effective 
for calendar years beginning January 1989, the dollar amount is 
determined based on an estimate of one-twelfth of the average per capita 
costs for benefits and administrative costs that will be payable with 
respect to individuals age 65 or over from the Federal Hospital 
Insurance Trust Fund during the succeeding calendar year.
    (2) Before 1989, the dollar amount was determined by multiplying $33 
by the ratio of the next year's inpatient deductible to $76, which was 
the inpatient deductible determined for 1973. (Because of cost controls, 
the deductible actually charged for that year was $72.)
    (3) Effective for months beginning January 1994, if an individual 
meets the requirements in paragraph (c) of this section, the monthly 
premium determined under paragraph (b)(1) of this section is reduced in 
each month in which the individual meets the requirements by 25 percent 
in 1994, 30 percent in 1995, 35 percent in 1996, 40 percent in 1997 and 
45 percent in 1998 and thereafter.
    (4) The amount determined under paragraphs (b) (1), (2), or (3) of 
this section is rounded to the next nearest multiple of $1. (Fifty cents 
is rounded to the next higher dollar.)
    (c) Qualifying for a reduction in monthly premium. An individual who 
qualifies for the reduction described in paragraph (b)(3) of this 
section must be an individual who--
    (1) Has 30 or more quarters of coverage (QCs) as defined in 20 CFR 
404.140 through 404.146;
    (2) Has been married for at least the previous one year period to a 
worker who has 30 or more QCs;
    (3) Had been married to a worker who had 30 or more QCs for a period 
of at least one year before the death of the worker;
    (4) Is divorced from, after at least 10 years of marriage to, a 
worker who had 30 or more QCs at the time the divorce became final; or
    (5) Is divorced from, after at least 10 years of marriage to, a 
worker who subsequently died and who had 30 or more QCs at the time the 
divorce became final.
    (d) Monthly premiums: Increase for late enrollment and for 
reenrollment. For an individual who enrolls after the close of the 
initial enrollment period or reenrolls, the amount of the monthly 
premium, as determined under paragraph (b) of this section, is increased 
by 10 percent for each full 12 months in the periods described in 
Sec. Sec.  406.33 and 406.34. Effective beginning with premiums due for 
July 1986, the premium increase is limited to 10 percent and is payable 
for twice the number of full 12-month periods determined under those 
sections.
    (e) Collection of monthly premiums. (1) CMS will bill the enrollee 
on a monthly basis and include an addressed return envelope with the 
bill.
    (2) The enrollee must pay by check or money order that is payable to 
``CMS Medicare Insurance,'' and shows his or her name and the claim 
number that appears on his or her Medicare card. He or she must return 
the bill with the check or money order.
    (f) Months for which payment is due. (1) A premium payment is due 
for each month beginning with the first month of coverage and continuing 
through the month of death or if earlier, the month in which coverage 
ends.
    (2) A premium is due for the month of death if coverage is still in 
effect, even if the individual dies on the first day of the month.
    (g) Option for group payments. A public or private organization may 
pay the premiums on behalf of one or more enrollees under a contract or 
other arrangement with CMS if CMS determines that this method of payment 
is administratively feasible. (The rules set forth in subpart E of part 
408 of this chapter, for SMI premiums, also apply to group payment of 
Part A premiums.)

[48 FR 12536, Mar. 25, 1983. Redesignated at 51 FR 41338, Nov. 14, 1986, 
as amended at 53 FR 47203, Nov. 22, 1988; 56 FR 8839, Mar. 1, 1991. 
Redesignated and amended at 56 FR 38079, 38080, Aug. 12, 1991; 57 FR 
36014, Aug. 12, 1992; 57 FR 58717, Dec. 11, 1992; 59 FR 26959, May 25, 
1994]



Sec.  406.33  Determination of months to be counted for premium increase: 
Enrollment.

    (a) Enrollment before April 1, 1981, or after September 30, 1981. 
The months to be counted for premium increase are

[[Page 330]]

the months from the end of the initial enrollment period through the end 
of the general enrollment period, the special enrollment period, or the 
transfer enrollment period in which the individual enrolls, excluding 
the following:
    (1) Any months before September 1973.
    (2) For premiums due for months after May 1986, any months beginning 
with January 1983 during which the individual was enrolled in an 
employer group health plan based on the current employment of the 
individual or the individual's spouse.
    (3) Any months during the SEP under Sec.  406.24 of this subpart, 
during which premium hospital insurance coverage is in effect.
    (4) Any months that the individual was enrolled in an HMO or CMP 
under part 417, subpart K of this chapter as described in Sec.  
406.21(f).
    (5) For premiums due for months after December 2006, any months 
during which the individual met the requirements for a SEP under Sec.  
406.25(a) of this subpart.
    (6) Any months during the 6-month SEP described in Sec.  406.25(b) 
of this subpart during which premium hospital insurance coverage is in 
effect.
    (b) Enrollment during the period April 1 through September 30, 1981. 
The months to be counted for premium increase are the months from the 
end of the initial enrollment period through the month in which the 
individual enrolled, excluding any months before September 1973.
    (c) Examples. (1) John F's initial enrollment period ended July 1979 
but he did not enroll until January 1980. The months to be counted are 
August 1979 through March 1980. Since only 8 months elapsed, there is no 
premium increase.
    (2) Mary T's initial enrollment period ended in April 1980 but she 
did not enroll until May 1981. The months to be counted are May 1980 
through May 1981. Since 13 months has elapsed, the premium would be 
increased by 10 percent.
    (3) Effective with July 1986, Mary T, in Example 2, would no longer 
have to pay an increased premium because she had paid it for twice the 
number of full 12-month periods during which she could have been, but 
was not, enrolled in the program.
    (4) Vincent C's initial enrollment period ended August 31, 1986. He 
was covered under his wife's employer group health plan until she 
retired on May 31, 1989. He enrolled during June 1989, the first month 
of the special enrollment period under Sec.  406.21(e). No months are 
countable for premium increase purposes because the exclusions of 
paragraph (a) of this section apply to all months.
    (5) Terry P enrolled in the 1987 general enrollment period, with 
coverage effective July 1987. There were 28 months after the end of his 
initial enrollment period through the end of the 1987 general enrollment 
period. His premium is increased by 10 percent. The increase will be 
eliminated after he has paid the additional 10 percent for 48 months.

[48 FR 12536, Mar. 25, 1983. Redesignated at 51 FR 41338, Nov. 14, 1986, 
as amended at 53 FR 47203, Nov. 22, 1988. Further redesignated and 
amended at 57 FR 36014, Aug. 12, 1992; 73 FR 36468, June 27, 2008]



Sec.  406.34  Determination of months to be counted for premium increase: 
Reenrollment.

    (a) First reenrollment before April 1, 1981 or after September 30, 
1981. The months to be counted for premium increase are:
    (1) The months specified in Sec.  406.33(a) or (b); plus
    (2) The months from the end of the first period of entitlement 
through the end of the general enrollment period in which the individual 
reenrolled.
    (b) First reenrollment during the period April 1, 1981 through 
September 30, 1981. The months to be counted for premium increase are--
    (1) The months specified in Sec.  406.33(a); plus
    (2) The months from the end of the first period of entitlement 
through the month in which the individual reenrolled.
    (c) Subsequent reenrollment during the period April 1, 1981 through 
September 30, 1981. The months to be counted for premium increase are--
    (1) The months specified in paragraph (a) of this section; plus

[[Page 331]]

    (2) The months from April 1981 through the month in which the 
individual reenrolled for the second time. (Since only one reenrollment 
was permitted before April 1981, any months from the end of the 
individual's first enrollment period of entitlement through March 1981 
are not counted.)
    (d) Subsequent reenrollment after September 30, 1981. The months to 
be counted for premium increase are--
    (1) The months specified in paragraph (a) or (b) of this section, 
for the first and second periods of coverage; plus
    (2) The months from the end of each subsequent period of entitlement 
through the end of the general enrollment period in which the individual 
reenrolled, excluding any months before April 1981.
    (e) Example. Peter M enrolled during his initial enrollment period, 
terminated his first coverage period in August 1979 and reenrolled for 
the first time in January 1980. The 7 months to be counted (September 
1979 through March, 1980) were not enough to require any increase in the 
premium. Peter terminated his second period of coverage in February 1981 
and reenrolled for the second time in July 1981. Since the 4 months 
(April through July 1981), when added to the previous 7 months, bring 
the total to only 11 months, no premium increase is required.

[48 FR 12536, Mar. 25, 1983. Redesignated at 51 FR 41338, Nov. 14, 1986. 
Further redesignated and amended at 57 FR 58717, Dec. 11, 1992]



Sec.  406.38  Prejudice to enrollment rights because of 
Federal Government error.

    (a) If an individual's enrollment or nonenrollment for premium 
hospital insurance is unintentional, inadvertent, or erroneous because 
of the error, misrepresentation, or inaction of a Federal employee, or 
any person authorized by the Federal Government to act on its behalf, 
the Social Security Administration or CMS may take whatever action it 
determines is necessary to provide appropriate relief.
    (b) The action may include--
    (1) Designation of a special initial or general enrollment period;
    (2) Designation of an entitlement period;
    (3) Adjustment of premiums;
    (4) Any combination of the actions specified in paragraph (b) (1) 
through (3) of this section; or
    (5) Any other remedial action which may be necessary to correct or 
eliminate the effects of such error, misrepresentation, or inaction.

[48 FR 12536, Mar. 25, 1983. Redesignated at 51 FR 41338, Nov. 14, 1986. 
Further redesignated at 56 FR 38080, Aug. 12, 1991]



  Subpart D_Special Circumstances That Affect Entitlement to Hospital 
                                Insurance



Sec.  406.50  Nonpayment of benefits on behalf of certain aliens.

    (a) Hospital insurance benefit payments may not be made for services 
furnished to an alien in any month in which his or her monthly social 
security benefits are suspended (or would be suspended if he or she were 
entitled to those benefits) because the alien remains outside the United 
States for more than 6 months.
    (b) Benefits will be payable beginning with services furnished in 
the first full calendar month the alien is back in the United States.

[48 FR 12536, Mar. 25, 1983. Redesignated at 51 FR 41338, Nov. 14, 1986. 
Further redesignated at 57 FR 58717, Dec. 11, 1992]



Sec.  406.52  Conviction of certain offenses.

    (a) Penalty that affects entitlement. (1) If an individual is 
convicted of any of the crimes listed in Sec.  406.11(c) (1) and (2), 
the court may impose, in addition to all other penalties, a penalty that 
affects entitlement to hospital insurance, beginning with the month of 
conviction.
    (2) The additional penalty is that the individual's income (or the 
income of the insured individual on whose earnings record he or she 
became or seeks to become entitled) for the year of conviction and any 
previous year may not be counted in determining the insured status 
necessary for entitlement to hospital insurance.
    (b) Effect of pardon. If the President of the United States pardons 
the convicted individual, that individual regains (or may again seek) 
entitlement

[[Page 332]]

effective with the month following the month in which the pardon is 
granted.

[48 FR 12536, Mar. 25, 1983. Redesignated at 51 FR 41338, Nov. 14, 1986. 
Further redesignated at 57 FR 58717, Dec. 11, 1992]



PART 407_SUPPLEMENTARY MEDICAL INSURANCE (SMI) ENROLLMENT AND ENTITLEMENT--
Table of Contents



                      Subpart A_General Provisions

Sec.
407.1 Basis and scope.
407.2 General description of program.
407.4 Basic requirements for entitlement.

         Subpart B_Individual Enrollment and Entitlement for SMI

407.10 Eligibility to enroll.
407.11 Forms used to apply for enrollment under Medicare Part B.
407.12 General enrollment provisions.
407.14 Initial enrollment period.
407.15 General enrollment period.
407.17 Automatic enrollment.
407.18 Determining month of automatic enrollment.
407.20 Special enrollment period related to coverage under group health 
          plans.
407.21 Special enrollment period for volunteers outside the United 
          States.
407.22 Request for individual enrollment.
407.25 Beginning of entitlement: Individual enrollment.
407.27 Termination of entitlement: Individual enrollment.
407.30 Limitations on enrollment.
407.32 Prejudice to enrollment rights because of Federal Government 
          misrepresentation, inaction, or error.

                    Subpart C_State Buy-in Agreements

407.40 Enrollment under a State buy-in agreement.
407.42 Buy-in groups available to the 50 States, the District of 
          Columbia, and the Northern Mariana Islands.
407.43 Buy-in groups available to Puerto Rico, Guam, the Virgin Islands, 
          and American Samoa.
407.45 Termination of State buy-in agreements.
407.47 Beginning of coverage under a State buy-in agreement.
407.48 Termination of coverage under a State buy-in agreement.
407.50 Continuation of coverage: Individual enrollment following end of 
          coverage under a State buy-in agreement.

    Authority: 42 U.S.C 1302 and 1395hh.

    Source: 53 FR 47204, Nov. 22, 1988, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  407.1  Basis and scope.

    (a) Statutory basis. The supplementary medical insurance (SMI) 
program is authorized by Part B of title XVIII of the Social Security 
Act.
    (1) Section 1831 of the Act establishes the program.
    (2) Sections 1836 and 1837 set forth the eligibility and enrollment 
requirements.
    (3) Section 1838 specifies the entitlement periods, which vary 
depending on the time and method of enrollment and on the basis for 
termination.
    (4) Section 1843 sets forth the requirements for State buy-in 
agreements under which States may enroll, and pay the SMI premiums for, 
eligible individuals who are also eligible for cash assistance or 
Medicaid.
    (5) Section 104(b) of the Social Security Amendments of 1965 (Pub. 
L. 89-87) specifies the limitations that apply to certain aliens and 
persons convicted of subversive activities.
    (b) Scope. This part sets forth the eligibility, enrollment, and 
entitlement requirements and procedures for supplementary medical 
insurance. (The rules about premiums are in part 408 of this chapter.)



Sec.  407.2  General description of program.

    Part B of Title XVIII of the Act provides for voluntary 
``supplementary medical insurance'' available to most individuals age 65 
or over and to disabled individuals who are under age 65 and entitled to 
hospital insurance. The SMI program is financed by premiums paid by (or 
for) each individual enrolled in the program, plus contributions from 
Federal funds. It covers certain physicians' services, outpatient 
services, home health services, services furnished by rural health 
clinics (RHCs), Federally qualified health centers (FQHCS), ambulatory 
surgical centers (ASCs), and comprehensive outpatient rehabilitation 
facilities (CORFs), and other medical and other health services.

[57 FR 24980, June 12, 1992]

[[Page 333]]



Sec.  407.4  Basic requirements for entitlement.

    (a) An individual must meet the following requirements to be 
entitled to SMI:
    (1) Eligibility. The individual must meet the eligibility 
requirements specified in Sec.  407.10(a).
    (2) Enrollment. The individual must enroll for SMI, or must be 
enrolled by a State under a buy-in agreement as specified in Sec.  
407.40.
    (b) SMI pays only for covered expenses incurred during an 
individual's period of entitlement.



         Subpart B_Individual Enrollment and Entitlement for SMI



Sec.  407.10  Eligibility to enroll.

    (a) Basic rule. Except as specified in paragraph (b) of this 
section, an individual is eligible to enroll for SMI if he or she--
    (1) Is entitled to hospital insurance under any of the rules set 
forth in Sec. Sec.  406.10 through 406.15 of this chapter; or
    (2) Meets the following requirements:
    (i) Has attained age 65. (An individual is considered to have 
attained age 65 on the day before the 65th anniversary of his or her 
birth.)
    (ii) Is a resident of the United States.
    (iii) Is a citizen of the United States, or an alien lawfully 
admitted for permanent residence who has resided continuously in the 
United States during the 5 years preceding the month in which he or she 
applies for enrollment.
    (b) Exception. An individual is not eligible to enroll for SMI if he 
or she has been convicted of--
    (1) Spying, sabotage, treason, or subversive activities under 
chapter 37, 105, or 115 of title 18 of the United States Code; or
    (2) Conspiracy to establish dictatorship under section 4 of the 
Internal Security Act of 1950.



Sec.  407.11  Forms used to apply for enrollment under Medicare Part B.

    The following forms, available free of charge by mail from CMS, or 
at any Social Security branch or district office, are used to apply for 
enrollment under the supplementary medical insurance program.

CMS-4040--Application for Enrollment in the Supplementary Medical 
Insurance Program. (This form is used for enrollment by individuals who 
are not eligible for monthly benefits or for hospital insurance.)
CMS-40-B--Application for Medical Insurance. (For general use by the SSA 
District Office in requesting medical insurance protection during the 
general enrollment period or during the initial enrollment period if the 
enrollee is not subject to automatic enrollment is SMI.)
CMS-40-D--Application for Enrollment in the Supplementary Medical 
Insurance Program. (This form is mailed to individuals who do not have 
current supplementary medical insurance because of prior refusals, 
voluntary withdrawal, or premium default from prior coverage. It is used 
during the annual general enrollment period.)
CMS-40-F--Application for Medical Insurance. (For use by beneficiaries 
residing outside the United States.)
CMS-18-F-5--Application for Hospital Insurance Entitlement. (For use by 
individuals who are not eligible for retirement benefits under Title II 
of the Social Security Act or under the Railroad Retirement Act. This 
form may also be used for enrollment in the supplementary medical 
insurance program.)


As an alternative, the individual may request enrollment by answering 
the Part B enrollment questions on an application for monthly Social 
Security benefits, or by signing a simple statement of request, if he or 
she is eligible to enroll at that time.



Sec.  407.12  General enrollment provisions.

    (a) Opportunity to enroll. (1) An individual who is eligible to 
enroll for SMI may do so during an initial enrollment period or a 
general enrollment period as specified in Sec. Sec.  407.14, and 407.15. 
An individual who meets the conditions specified in Sec.  407.20 may 
enroll during a special enrollment period, as provided in that section.
    (2) An individual who fails to enroll during his or her initial 
enrollment period or whose enrollment has been terminated may enroll or 
reenroll during a general enrollment period, or, if he or she meets the 
specified conditions, during a special enrollment period.
    (b) Enrollment periods ending on a nonworkday. (1) If an enrollment 
period ends on a Federal nonworkday, that period is automatically 
extended to the next succeeding workday.

[[Page 334]]

    (2) A Federal nonworkday is any Saturday, Sunday, or Federal legal 
holiday or a day that is declared by statute or executive order to be a 
day on which Federal employees are not required to work.



Sec.  407.14  Initial enrollment period.

    (a) Duration. (1) The initial enrollment period is the 7-month 
period that begins 3 months before the month an individual first meets 
the eligibility requirements of Sec.  407.10 and ends 3 months after 
that first month of eligibility.
    (2) In determining the initial enrollment period of an individual 
who is age 65 or over and eligible for enrollment solely because of 
entitlement to hospital insurance, the individual is considered as first 
meeting the eligibility requirements for SMI n the first day he or she 
becomes entitled to hospital insurance or would have been entitled if he 
or she filed an application for that program.
    (b) Deemed initial enrollment period. (1) SSA or CMS will establish 
a deemed initial enrollment period for an individual who fails to enroll 
during the initial enrollment period because of a belief, based on 
erroneous documentary evidence, that he or she had not yet attained age 
65. The period will be established as though the individual had attained 
age 65 on the date indicated by the incorrect information.
    (2) A deemed initial enrollment period established under paragraph 
(b)(1) of this section is used to determine the individual's premium and 
right to enroll in a general enrollment period if that is advantageous 
to the individual.



Sec.  407.15  General enrollment period.

    (a) Except as specified in paragraph (b) of this section, the 
general enrollment period is January through March of each calendar 
year.
    (b) An unlimited general enrollment period existed between April 1 
and September 30, 1981. Any eligible individual whose initial enrollment 
period had ended, or whose previous period of entitlement had 
terminated, could have enrolled or reenrolled during any month of that 
6-month period.



Sec.  407.17  Automatic enrollment.

    (a) Who is automatically enrolled. An individual is automatically 
enrolled for SMI if he or she:
    (1) Resides in the United States, except in Puerto Rico;
    (2) Becomes entitled to hospital insurance under any of the 
provisions set forth in Sec. Sec.  406.10 through 406.15 of this 
chapter; and
    (3) Does not decline SMI enrollment.
    (b) Opportunity to decline automatic enrollment. (1) SSA will notify 
an individual that he or she is automatically enrolled under paragraph 
(a) of this section and grant the individual a specified period (at 
least 2 months after the month the notice is mailed) to decline 
enrollment.
    (2) The individual may decline enrollment by submitting to SSA or 
CMS a signed statement that he or she does not wish SMI.
    (3) The statement must be submitted before entitlement begins, or if 
later, within the time limits set in the notice of enrollment.



Sec.  407.18  Determining month of automatic enrollment.

    (a) An individual who is automatically enrolled in SMI under Sec.  
407.17 will have the month of enrollment determined in accordance with 
paragraphs (b) through (f) of this section. The month of enrollment 
determines the month of entitlement.
    (b) An individual is automatically enrolled in the third month of 
the initial enrollment period if he or she--
    (1) Is entitled to social security benefits under section 202 of the 
Act on the first day of the initial enrollment period;
    (2) Is entitled to hospital insurance based on end-stage renal 
disease; on entitlement to disability benefits as a social security or 
railroad retirement beneficiary; or on deemed entitlement to disability 
benefits on the basis of Medicare-qualified government employment; or
    (3) Establishes entitlement to hospital insurance by filing an 
application and meeting all other requirements (as set forth in subpart 
B of part 406 of this chapter) during the first 3 months of the initial 
enrollment period.

[[Page 335]]

    (c) If an individual establishes entitlement to hospital insurance 
on the basis of an application filed in the last 4 months of the SMI 
initial enrollment period, he or she is automatically enrolled for SMI 
in the month in which the application is filed.
    (d) If an individual establishes entitlement to hospital insurance 
on the basis of an application filed after the SMI initial enrollment 
period but not during a general enrollment period in effect before April 
1, 1981, or after September 30, 1981, he or she is automatically 
enrolled for SMI on the first day of the next general enrollment period.
    (e) If the individual establishes entitlement to hospital insurance 
on the basis of an application filed during a SMI general enrollment 
period in effect before April 1, 1981 or after September 30, 1981, he or 
she is automatically enrolled on the first day of that period.
    (f) If an individual established entitlement to hospital insurance 
on the basis of an application filed during the general enrollment 
period of April 1, 1981, through September 30, 1981, he or she was 
automatically enrolled for SMI on the first day of the month in which 
the application was filed.



Sec.  407.20  Special enrollment period related to coverage 
under group health plans.

    (a) Terminology--(1) Group health plan (GHP) and large group health 
plan (LGHP). These terms have the meanings given them in Sec.  411.101 
of this chapter except that the ``former employee'' language of those 
definitions does not apply with respect to SEPs for the reasons 
specified in Sec.  406.24(a)(3) of this chapter.
    (2) Special enrollment period (SEP). This term has the meaning set 
forth in Sec.  406.24(a)(4) of this chapter. In order to use a SEP, an 
individual must meet the conditions of paragraph (b) and of paragraph 
(c) or (d) of this section, as appropriate.
    (b) General rule. All individuals must meet the following 
conditions:
    (1) They are eligible to enroll for SMI on the basis of age or 
disability, but not on the basis of end-stage renal disease.
    (2) When first eligible for SMI coverage (4th month of their initial 
enrollment period), they were covered under a GHP or LGHP on the basis 
of current employment status or, if not so covered, they enrolled in SMI 
during their initial enrollment period; and
    (3) For all months thereafter, they maintained coverage under either 
SMI or a GHP or LGHP. (Generally, if an individual fails to enroll in 
SMI during any available SEP, he or she is not entitled to any 
additional SEPs. However, if an individual fails to enroll during a SEP 
because coverage under the same or a different GHP or LGHP was restored 
before the end of that particular SEP, that failure to enroll does not 
preclude additional SEPs.)
    (c) Special rule: Individual age 65 or over. For an individual who 
is or was covered under a GHP, coverage must be by reason of the current 
employment status of the individual or the individual's spouse.
    (d) Special rules: Disabled individual.\4\ Individuals entitled on 
the basis of disability (but not on the basis of end-stage renal 
disease) must meet conditions that vary depending on whether they were 
covered under a GHP or an LGHP.
---------------------------------------------------------------------------

    \4\ Under the current statute, the SEP provision applicable to 
disabled individuals covered under an LGHP expires on September 1998. 
Unless Congress changes that date, the last SEP available under those 
provisions will begin with June 1998.
---------------------------------------------------------------------------

    (1) For a disabled individual who is or was covered under a GHP, 
coverage must be on the basis of the current employment status of the 
individual or the individual's spouse.
    (2) For a disabled individual who is or was covered under an LGHP, 
coverage must be as follows:
    (i) Before August 10, 1993, as an ``active individual'', that is, as 
an employee, employer, self-employed individual (such as the employer), 
individual associated with the employer in a business relationship, or 
as a member of the family of any of those persons.
    (ii) On or after August 10, 1993, by reason of current employment 
status of the individual or a member of the individual's family.

[[Page 336]]

    (e) Effective date of coverage. The rule set forth in Sec.  
406.24(d) for Medicare Part A applies equally to Medicare Part B.

[61 FR 40346, Aug. 2, 1996]



Sec.  407.21  Special enrollment period for volunteers 
outside the United States.

    (a) General rule. A SEP, as defined in Sec.  406.24(a)(4) of this 
subchapter, is provided for an individual who does not elect to enroll 
or to be deemed enrolled in SMI when first eligible, or who terminates 
SMI enrollment, if the individual meets the following requirements:
    (1) The individual is serving as a volunteer outside of the United 
States in a program that covers at least a 12-month period.
    (2) The individual is in a program that is sponsored by an 
organization described in section 501(c)(3) of the Internal Revenue Code 
of 1986 and is exempt from taxation under section 501(a) of the Internal 
Revenue Code of 1986.
    (3) The individual demonstrates that he or she has health insurance 
that covers medical services that the individual receives outside of the 
United States while serving in the program.
    (b) Duration of SEP. The SEP is the 6-month period beginning on the 
first day of the month that includes the date that the individual no 
longer satisfies the provisions of paragraph (a) of this section.
    (c) Effective date of coverage. Coverage under a SEP authorized by 
this section, begins on the first day of the month following the month 
in which the individual enrolls.

[73 FR 36468, June 27, 2008]



Sec.  407.22  Request for individual enrollment.

    (a) A request for enrollment is required of an individual who meets 
the eligibility requirements of Sec.  407.10 and desires SMI, if the 
individual--
    (1) Is not entitled to hospital insurance;
    (2) Has previously declined enrollment in SMI;
    (3) Has had a previous period of SMI entitlement which terminated;
    (4) Resides in Puerto Rico or outside the United States; or
    (5) Is enrolling or reenrolling during a special enrollment period 
under Sec.  407.20.
    (b) A request for enrollment under paragraph (a) of this section 
must:
    (1) Be signed by the individual or someone acting in his or her 
behalf; and
    (2) Be filed with SSA or CMS during the initial enrollment period, a 
general enrollment period, or a special enrollment period as provided in 
Sec.  407.20.



Sec.  407.25  Beginning of entitlement: Individual enrollment.

    The following apply whether an individual is self-enrolled or 
automatically enrolled in SMI:
    (a) Enrollment during initial enrollment period. (1) If an 
individual enrolls during the first three months of the initial 
enrollment period, entitlement begins with the first month of 
eligibility.
    (2) If an individual enrolls during the fourth month of the initial 
enrollment period, entitlement begins with the following month.
    (3) If an individual enrolls during the fifth month of the initial 
enrollment period, entitlement begins with the second month after the 
month of enrollment.
    (4) If an individual enrolls in either of the last two months of the 
initial enrollment period, entitlement begins with the third month after 
the month of enrollment.
    (5) Example. An individual first meets the eligibility requirements 
for enrollment in April. The initial enrollment period is January 
through July. The month in which the individual enrolls determines the 
month that begins the period of entitlement, as follows:

------------------------------------------------------------------------
 Enrolls in initial enrollment period        Entitlement begins on--
------------------------------------------------------------------------
January...............................  April 1 (month eligibility
                                         requirements first met).
February..............................  April 1.
March.................................  April 1.
April.................................  May 1 (month following month of
                                         enrollment).
May...................................  July 1 (second month after month
                                         of enrollment).
June..................................  September 1 (third month after
                                         month of enrollment).
July..................................  October 1 (third month after
                                         month of enrollment).
------------------------------------------------------------------------


[[Page 337]]

    (b) Enrollment on reenrollment during general enrollment period. (1) 
if an individual enrolls or reenrolls during a general enrollment period 
before April 1, 1981 or after September 30, 1981, entitlement begins on 
July 1 of that calendar year.
    (2) If an individual enrolled or reenrolled during the general 
enrollment period between April 1, 1981 and September 20, 1981, 
entitlement began with the third month after the month in which the 
enrollment request was filed.
    (c) Enrollment or reenrollment during a SEP. The rules set forth in 
Sec.  406.24(d) of this chapter apply.

[53 FR 47204, Nov. 22, 1988, as amended at 61 FR 40347, Aug. 2, 1996]



Sec.  407.27  Termination of entitlement: Individual enrollment.

    An individual's entitlement will terminate for any of the following 
reasons:
    (a) Death. Entitlement to SMI ends on the last day of the month in 
which the individual dies.
    (b) Termination of hospital insurance benefits. If an individual's 
entitlement to hospital insurance ends before the month in which he or 
she attains age 65, entitlement to SMI will end on the same day unless 
it has been previously terminated in accordance with paragraph (c) or 
(d) of this section.
    (c) Request by individual. An individual may at any time give CMS or 
SSA written notice that he or she no longer wishes to participate in 
SMI, and request disenrollment.
    (1) Before July 1987, entitlement ended at the end of the calendar 
quarter after the quarter in which the individual filed the 
disenrollment request.
    (2) For disenrollment requests filed in or after July 1987, 
entitlement ends at the end of the month after the month in which the 
individual files the disenrollment request.
    (d) Nonpayment of premiums. If an individual fails to pay the 
premiums, entitlement will end as provided in the rules for SMI 
premiums, set forth in part 408 of this chapter.



Sec.  407.30  Limitations on enrollment.

    (a) Initial enrollment periods--(1) Individual under age 65. An 
individual who has not attained age 65 may have one or more periods of 
entitlement to hospital insurance, based on disability. Since each 
period of disability entitlement entitles the individual to hospital 
insurance and since entitlement to hospital insurance makes the 
individual eligible for SMI enrollment, an individual may have an SMI 
initial enrollment period for each continous period of entitlement to 
hospital insurance.
    (2) Individuals who have attained age 65. An individual who has 
attained age 65 may not have more than one initial enrollment period on 
the basis of age. However, if the individual develops ESRD after age 65, 
he or she may have another initial enrollment period based on meeting 
the requirements of Sec.  406.13 of this chapter.
    (b) Number of enrollments. There is no limitation on the number of 
enrollments.
    (c) Coverage under buy-in agreements. For purposes of paragraph (a) 
of this section, the continued enrollment of an individual following the 
end of coverage under a State buy-in agreement in considered an initial 
enrollment.



Sec.  407.32  Prejudice to enrollment rights because of Federal Government 
misrepresentation, inaction, or error.

    If an individual's enrollment or nonenrollment in SMI is 
unintentional, inadvertent, or erroneous because of the error, 
misrepresentation, on inaction of a Federal employee or any person 
authorized by the Federal Government to act in its behalf, the Social 
Security Administration or CMS may take whatever action it determines is 
necessary to provide appropriate relief. The action may include:
    (a) Designation of a special initial or general enrollment period;
    (b) Designation of an entitlement period based on that enrollment 
period;
    (c) Adjustment of premiums;
    (d) Any combination of actions under paragraphs (a) through (c) of 
this section; or
    (e) Any other remedial action that may be necessary to correct or 
eliminate the effects of the error, misrepresentation, or inaction.

[[Page 338]]



                    Subpart C_State Buy-In Agreements



Sec.  407.40  Enrollment under a State buy-in agreement.

    (a) Statutory basis. (1) Section 1843 of the Act, as amended through 
1969, permitted a State to enter into an agreement with the Secretary to 
enroll in the SMI program certain individuals who are eligible for SMI 
and who are members of the buy-in group specified in the agreement. A 
buy-in group could include certain individuals receiving Federally-aided 
State cash assistance (with the option of excluding individuals also 
entitled to social security benefits or railroad retirement benefits) or 
could include all individuals eligible for Medicaid. Before 1981, 
December 31, 1969 was the last day on which a State could request a buy-
in agreement or a modification to include a coverage group broader than 
the one originally selected.
    (2) Section 945(e) of the Omnibus Reconciliation Act of 1980 (Pub. 
L. 96-499) further amended section 1843 to provide that, during calendar 
year 1981, a State could request a buy-in agreement if it did not 
already have one, or request a broader coverage group for an existing 
agreement.
    (3) Several laws enacted during 1980-1987 had the effect of 
requiring that the buy-in groups available under section 1843 of the Act 
be expanded to include certain individuals who lose eligibility for cash 
assistance payments but are treated as if they were cash assistance 
beneficiaries for Medicaid eligibility purposes.
    (4) Section 301(e)(1) of the Medicare Catastrophic Coverage Act of 
1988 (Pub. L. 100-360) amends section 1843 of the Act to restore the 
1981 provisions on a permanent basis, effective ``after 1988.''
    (5) The same section 301, as amended by section 608(d)(14)(H) of the 
Family Support Act of 1988 (Pub. L. 100-485), further amended section 
1843 of the Act, beginning January 1, 1989, to establish a new buy-in 
category consisting of Qualified Medicare Beneficiaries and to provide 
that a State may request a buy-in agreement if it does not already have 
one, or request a broader buy-in group for the existing agreement.
    (b) Definitions. As used in this section, unless the context 
indicates otherwise--
    Cash assistance means any of the following kinds of monthly cash 
benefits, authorized by specified titles of the Act and, for 
convenience, represented by initials, as follows:
    AABD stands for aid to the aged, blind or disabled under the first 
title XVI of the Act in effect until December 31, 1973.
    AB stands for aid to the blind under title X of the Act.
    AFDC stands for aid to families with dependent children under Part A 
of title IV of the Act.
    APTD stands for aid to the permanently and totally disabled under 
title XIV of the Act.
    OAA stands for old-age assistance under title I of the Act.
    SSI stands for supplemental security income for the aged, blind, and 
disabled under the second title XVI of the Act, effective January 1, 
1974.
    SSP stands for State supplementary payments, whether mandatory or 
optional, to an aged, blind, or disabled individual under the second 
title XVI or the Act.
    Qualified Medicare Beneficiary or QMB means an individual who meets 
the definition in Sec.  400.200 of this chapter and, therefore, is 
eligible to have the State Medicaid agency pay Medicare cost sharing 
amounts on his or her behalf.
    Railroad retirement beneficiary means an individual entitled to 
receive an annuity under the Railroad Retirement Act of 1974.
    State means one of the 50 States, the District of Columbia, Guam, 
Puerto Rico, the Virgin Islands, American Samoa, or the Northern Mariana 
Islands, except when reference is made to ``the 50 States''.
    State buy-in agreement or buy-in agreement means an agreement 
authorized by section 1843 of the Act, under which a State secures SMI 
or premium HI coverage for individuals who are members of the buy-in 
group specified in the agreement, by enrolling them and paying the 
premiums on their behalf.
    (c) Basic rules. (1) A State that has a buy-in agreement in effect 
must enroll any individual who is eligible to enroll in SMI under Sec.  
407.10.

[[Page 339]]

    (2) Any State that does not have a buy-in agreement in effect may 
request buy-in for any one of the groups specified in Sec. Sec.  407.42 
and 407.43.
    (3) Any State that does have an agreement may request a modification 
to cover a broader buy-in group or cancel its current agreement and 
request a new agreement to cover a narrower group.
    (4) Any State that has a buy-in agreement in effect must participate 
in daily exchanges of enrollment data with CMS.

[56 FR 38080, Aug. 12, 1991; 56 FR 50058, Oct. 3, 1991; 85 FR 25632, May 
1, 2020]



Sec.  407.42  Buy-in groups available to the 50 States, 
the District of Columbia, and the Northern Mariana Islands.

    (a) Categories included in the buy-in groups. The buy-in groups that 
are available to the 50 States, the District of Columbia, and the 
Northern Mariana Islands are specified in paragraph (b) of this section 
in terms of the following categories:
    (1) Category A: Individuals who--
    (i) Receive SSI or SSP or both; and
    (ii) Are covered under the State's Medicaid plan as categorically 
needy.
    (2) Category B: Individuals who--
    (i) Under the Act or any other provision of Federal law are treated, 
for Medicaid eligibility purposes, as though they were receiving SSI or 
SSP; and
    (ii) Are covered under the State's Medicaid plan as categorically 
needy.
    (3) Category C: Individuals who are receiving AFDC.
    (4) Category D: Individuals who, under the Act or any other 
provision of Federal law, are treated, for Medicaid eligibility 
purposes, as though they were receiving AFDC.
    (5) Category E: Individuals who, in accordance with Sec.  435.134 of 
this chapter, are covered under the State's Medicaid plan despite the 
increase in social security benefits provided by Public Law 92-336.
    (6) Category F: Individuals who are Qualified Medicare 
Beneficiaries. \1\
---------------------------------------------------------------------------

    \1\ Rules for buy-in for premium hospital insurance for QMBs are set 
forth in Sec.  406.26 of this chapter.
---------------------------------------------------------------------------

    (7) Category G: All other individuals who are eligible for Medicaid.
    (b) Buy-in groups available. Any of the 50 States, the District of 
Columbia, and the Northern Mariana Islands may buy-in for one of the 
following groups:
    (1) Group 1: Categories A through G.
    (2) Group 2: Categories A through F.
    (3) Group 3: Categories A through E.
    (4) Group 4: Categories A, B, and F, individuals in categories C and 
D who are not social security or railroad retirement beneficiaries, and 
individuals in category E who are included in that category (in 
accordance with Sec.  435.134 of this chapter) because they received 
OAA, AB, APTD, or AABD in August 1972 or would have been eligible to 
receive such cash assistance for that month if they had applied or had 
not been institutionalized.
    (5) Group 5: Categories A and B, individuals in categories C and D 
who are not social security or railroad retirement beneficiaries, and 
individuals in category E who are included in that category (in 
accordance with Sec.  435.134 of this chapter) because they received 
OAA, AB, APTD, or AABD in August 1972 or would have been eligible to 
receive such cash assistance for that month if they had applied or had 
not been institutionalized.
    (6) Group 6: Categories A, B, and F, and individuals in category E 
who are included in that category (in accordance with Sec.  435.134 of 
this chapter) because they received AABD in August 1972 or would have 
been eligible to receive AABD for that month if they had applied or had 
not been institutionalized. This option is available only to those 
States that had an AABD program as of December 31, 1973.
    (7) Group 7: Categories A and B, and individuals in category E who 
are included in that category (in accordance with Sec.  435.134 of this 
chapter) because they received AABD in August 1972 or would have been 
eligible to receive AABD for that month if they had applied or had not 
been institutionalized. This option is available only to those States 
that had an AABD program as of December 31, 1973.

[56 FR 38081, Aug. 12, 1991, as amended at 81 FR 86447, Nov. 30, 2016]

[[Page 340]]



Sec.  407.43  Buy-in groups available to Puerto Rico, Guam, 
the Virgin Islands, and American Samoa.

    (a) Categories included in buy-in groups. The buy-in groups that are 
available to Puerto Rico, Guam, the Virgin Islands, and American Samoa, 
which are not covered by the SSI program, are described in paragraph (b) 
of this section in terms of the following categories:
    (1) Category A: Individuals receiving OAA, AB, APTD, or AFDC.
    (2) Category B: Individuals who, under the Act or any other 
provision of Federal law, are treated, for Medicaid eligibility 
purposes, as though they were receiving AFDC.
    (3) Category C: Individuals who, in accordance with Sec.  436.112 of 
this chapter, are covered under the State's Medicaid plan despite the 
increase in social security benefits provided by Public Law 92-336.
    (4) Category D: Individuals who are Qualified Medicare 
Beneficiaries. \1\
---------------------------------------------------------------------------

    \1\ Rules for buy-in for premium hospital insurance for QMBs are set 
forth in Sec.  406.26 of this chapter.
---------------------------------------------------------------------------

    (5) Category E: All other individuals who are eligible for Medicaid.
    (b) Buy-in groups available. Puerto Rico, Guam, the Virgin Islands, 
and American Samoa may choose any of the following coverage groups:
    (1) Group 1: Categories A through E.
    (2) Group 2: Categories A through D.
    (3) Group 3: Categories A through C.
    (4) Group 4: Individuals in category D, and individuals in 
categories A and B who are not social security or railroad retirement 
beneficiaries.
    (5) Group 5: Individuals in categories A and B who are not social 
security or railroad retirement beneficiaries.
    (6) Group 6: Individuals in category D, individuals in category A 
who are receiving OAA, and individuals in category C who are included in 
that category (in accordance with Sec.  436.112 of this chapter) because 
they received OAA for August 1972 or would have been eligible to receive 
OAA for that month if they had applied or had not been 
institutionalized.
    (7) Group 7: Individuals in category A who are receiving OAA, and 
individuals in category C who are included in that category (in 
accordance with Sec.  436.112 of this chapter) because they received OAA 
for August 1972 or would have been eligible to receive OAA for that 
month if they had applied or had not been institutionalized.
    (8) Group 8: Individuals in category D and individuals in category A 
who are receiving OAA and are not social security or railroad retirement 
beneficiaries.
    (9) Group 9: Individuals in category A who are receiving OAA and are 
not social security or railroad retirement beneficiaries.

[56 FR 38082, Aug. 12, 1991]



Sec.  407.45  Termination of State buy-in agreements.

    (a) Termination by the State--(1) Termination after advance notice. 
A State may terminate its buy-in agreement after giving CMS 3 months, 
advance notice.
    (2) Termination without advance notice. A State may terminate its 
buy-in agreement without advance notice if--
    (i) The State gives CMS written certification to the effect that it 
is no longer legally able to comply with one or more of the provisions 
of the agreement; and
    (ii) Submits a supporting opinion from the appropriate State legal 
officer, if CMS requests such an opinion.
    (b) Termination by CMS. If CMS, after giving the State notice and 
opportunity for hearing, finds that the State has failed to comply 
substantially with one or more of the provisions of the agreement, other 
than the requirement for timely payment of premiums, CMS will give the 
State written notice to the effect that the agreement will terminate on 
the date indicated in the notice unless, before that date, CMS finds 
that there is no longer that failure to comply. (Rules for collection of 
overdue premiums, including assessment of interest and offset against 
FFP due the State, are those set forth in the Notice published on 
September 30, 1985 at 50 FR 39784.)



Sec.  407.47  Beginning of coverage under a State buy-in agreement.

    (a) General rule. The beginning of an individual's coverage period 
depends on two factors:

[[Page 341]]

    (1) The individual's meeting the SMI eligibility requirements and 
the requirements for being a member of the buy-in group; and
    (2) The effective date of the buy-in agreement or agreement 
modification that covers the group to which the individual belongs, and 
which may not be earlier than the third month after the month in which 
the agreement or modification is executed.
    (b) Application of general rule: Medicaid eligibles who are, or are 
treated as, cash assistance beneficiaries. For Medicaid eligibles who 
are, or are treated as, cash assistance beneficiaries (that is, are 
members of categories A through E of Sec.  407.42(a) or categories A 
through C of Sec.  407.43(a)), coverage begins with the later of the 
following:
    (1) The first month in which the individual--
    (i) Meets the SMI eligibility requirements specified in Sec.  
407.10; and
    (ii) Is a member of one of those categories.
    (2) The month in which the buy-in agreement is effective.
    (c) Application of general rule: Qualified Medicare Beneficiaries. 
For individuals who are QMBs (that is, are members of category F of 
Sec.  407.42 or category D of Sec.  407.43(a)), coverage begins with the 
later of the following:
    (1) The first month in which the individual meets the SMI 
eligibility requirements specified in Sec.  407.10, and has QMB status.
    (2) The month in which the buy-in agreement or agreement 
modification covering QMBs is effective.
    (d) Application of general rule: Other individuals eligible for 
Medicaid. For individuals who are members of category G of Sec.  
407.42(a) or category E of Sec.  407.43(a), coverage begins with the 
later of the following:
    (1) The second month after the month in which the individual--
    (i) Meets the SMI eligibility requirements specified in Sec.  
407.10; and
    (ii) Is determined to be eligible for Medicaid.
    (2) The month in which the buy-in agreement or agreement 
modification is effective.
    (e) Coverage based on erroneous report. If the State erroneously 
reports to SSA that an individual is a member of its coverage group, the 
rules of paragraphs (a) through (d) of this section apply, and coverage 
begins as though the individual were in fact a member of the group. 
Coverage will end only as provided in Sec.  407.48.

[56 FR 38082, Aug. 12, 1991]



Sec.  407.48  Termination of coverage under a State buy-in agreement.

    An individual's coverage under a buy-in agreement terminates with 
the earliest of the following events:
    (a) Death. Coverage ends on the last day of the month in which the 
individual dies.
    (b) Loss of entitlement to hospital insurance benefits before age 
65. If an individual loses entitlement to hospital insurance benefits 
before attaining age 65, coverage ends on the last day of the last month 
for which he or she is entitled to hospital insurance.
    (c) Loss of eligibility for the buy-in group. If an individual loses 
eligibility for inclusion in the buy-in group, buy-in coverage ends as 
follows:
    (1) On the last day of the last month for which he or she is 
eligible for inclusion in the group, if CMS determines ineligibility or 
receives a State ineligibility notice by the 25th day of the second 
month after the month in which the individual becomes ineligible for 
inclusion in the group.
    (2) On the last day of the second month before the month in which 
CMS receives a State ineligibility notice later than the time specified 
in paragraph (c)(1) of this section. A notice received by CMS after the 
25th day of the month is considered to have been received in the 
following month.
    (d) Termination or modification of buy-in agreement. If the State's 
buy-in agreement is terminated, or modified to substitute a narrower 
buy-in group, coverage ends on the last day of the last month for which 
the agreement was in effect, or covered the broader buy-in group.

[53 FR 47204, Nov. 22, 1988, as amended at 56 FR 38082, Aug. 12, 1991]

[[Page 342]]



Sec.  407.50  Continuation of coverage: Individual enrollment following end 
of coverage under a State buy-in agreement.

    (a) Deemed enrollment. When coverage under a buy-in agreement ends 
because the agreement terminates, or is modified to substitute a 
narrower buy-in group, or because the individual is no longer eligible 
for inclusion in the buy-in group, the individual--
    (1) Is considered to have enrolled during his or her initial 
enrollment period; and
    (2) Will be entitled to SMI on this basis and liable for SMI 
premiums beginning with the first month for which he or she is no longer 
covered under the buy-in agreement.
    (b) Voluntary termination. (1) An individual may voluntarily 
terminate entitlement acquired under paragraph (a) of this section by 
filing, with SSA or CMS, a request for disenrollment.
    (2) Voluntary disenrollment is effective as follows:
    (i) If the individual files a request within 30 days after the date 
of CMS's notice that buy-in coverage has ended, the individual's 
entitlement ends on the last day of the last month for which the State 
paid the premium.
    (ii) If the individual files the request more than 30 days but not 
more than 6 months after buy-in coverage ends, entitlement ends on the 
last day of the month in which the request is filed.
    (iii) If the individual files the request later than the 6th month 
after buy-in coverage ends, entitlement ends at the end of the month 
after the month in which request is filed. \1\
---------------------------------------------------------------------------

    \1\ For requests filed before July 1987, entitlement ended on the 
last day of the calendar quarter after the quarter in which the 
disenrollment request was filed.

[53 FR 47204, Nov. 22, 1988, as amended at 56 FR 38082, Aug. 12, 1991]



PART 408_PREMIUMS FOR SUPPLEMENTARY MEDICAL INSURANCE--Table of Contents



                      Subpart A_General Provisions

Sec.
408.1 Statutory basis.
408.2 Scope and purpose.
408.3 Definitions.
408.4 Payment obligations.
408.6 Methods and priorities for payment.
408.8 Grace period and termination date.
408.10 Claim for monthly benefits pending concurrently with request for 
          SMI enrollment.

                   Subpart B_Amount of Monthly Premium

408.20 Monthly premiums.
408.21 Reduction in Medicare Part B premium as an additional benefit 
          under Medicare + Choice plans.
408.22 Increased premiums for late enrollment and for reenrollment.
408.24 Individuals who enrolled or reenrolled before April 1, 1981 or 
          after September 30, 1981.
408.25 Individuals who enrolled or reenrolled between April 1 and 
          September 30, 1981.
408.26 Examples.
408.27 Rounding the monthly premium.
408.28 Increased premiums due to the income-related monthly adjustment 
          amount (IRMAA).

                Subpart C_Deduction From Monthly Benefits

408.40 Deduction from monthly benefits: Basic rules.
408.42 Deduction from railroad retirement benefits.
408.43 Deduction from social security benefits.
408.44 Deduction from civil service annuities.
408.45 Deduction from age 72 special payments.
408.46 Effect of suspension of social security benefits.
408.47 [Reserved]
408.50 When premiums are considered paid.
408.52 Change from direct remittance to deduction.
408.53 Change from partial direct remittance to full deduction.

             Subpart D_Direct Remittance: Individual Payment

408.60 Direct remittance: Basic rules.
408.62 Initial and subsequent billings.
408.63 Billing procedures when monthly benefits are less than monthly 
          premiums.
408.65 Payment options.
408.68 When premiums are considered paid.
408.70 Change from quarterly to monthly payments.
408.71 Change from deduction or State payment to direct remittance.

               Subpart E_Direct Remittance: Group Payment

408.80 Basic rules.
408.82 Conditions for group billing.
408.84 Billing and payment procedures.

[[Page 343]]

408.86 Responsibilities under group billing arrangement.
408.88 Refund of group payments.
408.90 Termination of group billing arrangement.
408.92 Change from group payment to deduction or individual payment.

           Subpart F_Termination and Reinstatement of Coverage

408.100 Termination of coverage for nonpayment of premiums.
408.102 Reconsideration of termination.
408.104 Reinstatement procedures.

Subpart G_Collection of Unpaid Premiums; Refund of Excess Premiums After 
                        the Death of the Enrollee

408.110 Collection of unpaid premiums.
408.112 Refund of excess premiums after the enrollee dies.

 Subpart H_Supplementary Medical Insurance Premium Surcharge Agreements

408.200 Statutory basis.
408.201 Definitions.
408.202 Conditions for participation.
408.205 Application procedures.
408.207 Billing and payment procedures.
408.210 Termination of SMI premium surcharge agreement.

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 
1302 and 1395hh).

    Source: 52 FR 48115, Dec. 18, 1987, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  408.1  Statutory basis.

    (a) This part implements certain provisions of sections 1837 through 
1840 and 1881(d) of the Social Security Act (the Act) and conforms to 
other regulations that implement section 1843 of the Act. Section 
1838(b) requires regulations to establish when an individual's coverage 
ends because of nonpayment of premiums. It also specifies that those 
regulations may provide a grace period for payment of overdue premiums 
without loss of coverage. Section 1839 sets forth the specific 
procedures for determining the amount of the monthly premium and section 
1840 establishes the rules for payment of premiums. Section 1843 
provides that a State may enter into a buy-in agreement to secure SMI 
coverage for certain individuals by enrolling them in the SMI program 
and paying the premiums on their behalf. Section 1881(d) provides that 
Medicare payment, for the reasonable charges incurred in connection with 
a kidney donation, shall be made (without regard to deductible, premium, 
or coinsurance provisions of title XVIII) as prescribed in regulations.
    (b) The Federal Claims Collection Act (31 U.S.C. 3711), as 
implemented by 4 CFR parts 101-105, provides the basic authority for 
recovery of debts owed the United States government and specifies the 
conditions for the suspension or termination of collection action. 
Departmental regulations at 45 CFR part 30, updated by a final rule 
published on January 5, 1987 (52 FR 260) set forth procedures for the 
exercise of the Department's authority to collect and dispose of debts 
and were intended to complement rules applicable to particular programs. 
CMS rules are set forth at 42 CFR part 401, subpart F.

[52 FR 48115, Dec. 18, 1987; 53 FR 4158, Feb. 12, 1988, as amended at 56 
FR 48112, Sept. 24, 1991]



Sec.  408.2  Scope and purpose.

    (a) This part sets forth the policies and procedures for determining 
the amount of monthly supplementary medical insurance (SMI) premiums, 
for the payment, collection, or refund of premiums, for termination of 
coverage because of nonpayment of premiums, and for reinstatement of 
coverage if certain conditions are met. It conforms to subpart C of part 
407 of this chapter, which sets forth the requirements for State buy-in 
agreements. These policies are intended to protect enrollee coverage to 
the maximum degree compatible with maintaining the integrity of the SMI 
program.
    (b) Policies that apply to premiums that certain individuals must 
pay in order to become entitled to Medicare Part A hospital insurance 
benefits, are set forth in part 406 of this chapter.

[52 FR 48115, Dec. 18, 1987; 53 FR 4159, Feb. 12, 1988]



Sec.  408.3  Definitions.

    As used in this part, unless the context indicates otherwise--

[[Page 344]]

    Enrollee means an individual who is enrolled in the SMI program 
under Medicare Part B.
    Taxable year means the 12-month period (calendar or fiscal year) for 
which the individual files his or her income tax return.



Sec.  408.4  Payment obligations.

    (a) Month for which payment is due. (1) A payment is due for each 
month, beginning with the first month of SMI coverage and continuing 
through the month of death or, if earlier, the month in which coverage 
terminates.
    (2) A premium is due for the month of death, if SMI coverage is 
still in effect, even though the individual dies on the first day of the 
month.
    (b) Overdue premiums. (1) Overdue premiums constitute an obligation 
enforceable against the enrollee or the enrollee's estate.
    (2) Overdue premiums are collected--
    (i) By deduction from social security or railroad retirement 
benefits or Federal civil service annuities;
    (ii) Directly from the enrollee or the enrollee's estate; or
    (iii) By offset against any SMI payments payable to the enrollee or 
the enrollee's estate.
    (3) Interest is not charged on overdue premiums, except under a 
State buy-in agreement, as provided in Sec.  408.6(c)(4).
    (c) Premiums not required for certain kidney donors. (1) No premiums 
are required for SMI benefits related to the donation of a kidney if the 
donor is not an enrollee.
    (2) A kidney donor who is an enrollee is not relieved of the 
obligation for premiums.

[52 FR 48115, Dec. 18, 1987; 53 FR 4159, Feb. 12, 1988]



Sec.  408.6  Methods and priorities for payment.

    (a) Methods of payment--(1) General rules. Premiums are paid by one 
of the following four methods:
    (i) Payment by a State under a buy-in agreement.
    (ii) Deduction from monthly railroad retirement of social security 
cash benefits or Federal civil service annuities.
    (iii) Direct remittance on an individual basis, by or on behalf of 
the enrollee.
    (iv) Direct remittance on a group basis, by an employer, union, 
lodge or other organization, or by an entity of State or local 
government.
    (2) Special situations. (i) If the monthly social security benefit 
or age 72 special benefit is less than the monthly premium, the benefit 
is withheld and the enrollee is required to pay the balance through 
direct remittance. (This situation may arise if the individual first 
becomes eligible for social security benefits after December 31, 1981, 
and is, therefore, not eligible for the fixed minimum, or receives age 
72 special benefits that are reduced because the individual receives a 
government pension.)
    (ii) If the monthly railroad retirement benefit or civil service 
annuity payment is less than the premium, the monthly payment is not 
withheld and the enrollee is required to pay the total premium by direct 
remittance.
    (b) Priorities for payment. (1) If an enrollee is enrolled under a 
State buy-in agreement--
    (i) SMI premiums may not be deducted from monthly cash benefits or 
annuities; and
    (ii) The enrollee may not be required to pay by direct remittance.
    (2) If an enrollee is not covered under a State buy-in agreement, 
but is receiving a monthly benefit or an annuity specified in paragraph 
(a)(1)(ii) of this section--
    (i) The premiums are deducted from that benefit or annuity; or
    (ii) If the monthly benefit or payment is less than the monthly 
premium, the rules of paragraph (a)(2) of this section apply.
    (3) If an enrollee is neither covered under a State buy-in 
agreement, nor receiving monthly benefits or annuity payments, the 
premiums must be paid totally by direct remittance.
    (c) Payment by a State under a buy-in agreement. (1) A buy-in 
agreement is an agreement under which a State, through enrollment and 
payment of SMI premiums, secures SMI benefits for individuals who are 
eligible for that program and also eligible for certain other cash or 
medical benefits. (Policies on enrollment under State buy-in agreements 
are contained in subpart C of part 407 of this chapter.)

[[Page 345]]

    (2) The State pays the premiums for each month for which an 
individual is covered under the agreement.
    (3) If an individual's coverage under a State buy-in agreement 
terminates, his coverage continues on an individual enrollment basis. 
The premiums are then deducted from benefits, as set forth in subpart C 
of this part, or paid by direct remittance in accordance with subpart D 
or subpart E of this part.
    (4) Policy on collection of premiums from buy-in States is set forth 
in a Federal Register notice published on September 30, 1985 at 50 FR 
39784.



Sec.  408.8  Grace period and termination date.

    (a) Grace period. (1) For all initial premium payments (monthly or 
quarterly), and subsequent monthly or quarterly payments, the grace 
period ends with the last day of the third month after the billing 
month.
    (2) For payments required because the monthly benefit is less than 
the monthly premium, the grace period ends on April 30 of the year 
following the calendar year which the premiums are due.
    (b) Extension of grace period: Last day is nonwork day. If the last 
day of the grace period is a Saturday, Sunday, legal holiday, or a day 
that, by statute or executive order, is a nonwork day for Federal 
employees, the grace period is extended to the next succeeding work day.
    (c) Termination date. The end of the grace period is the termination 
date for SMI coverage if overdue premiums have not been paid by that 
date in accordance with Sec.  408.68.
    (d) Extension of grace period for good cause. (1) CMS may reinstate 
entitlement, without interruption of coverage, if the individual shows 
good cause for failure to pay within the initial grace period, and pays 
all overdue premiums within three calendar months after the termination 
date.
    (2) Good cause will be found if the individual establishes, by a 
credible statement, that failure to pay premiums within the initial 
grace period was due to conditions over which he or she had no control, 
or which he or she could not reasonably have been expected to foresee.

[52 FR 48115, Dec. 18, 1987, as amended at 56 FR 48112, Sept. 24, 1991]



Sec.  408.10  Claim for monthly benefits pending concurrently with request 
for SMI enrollment.

    (a) If it is clear that an individual who applies for social 
security or railroad retirement benefits and for SMI will be entitled to 
monthly benefits, the application for monthly benefits is processed 
simultaneously with the request for SMI enrollment.
    (1) If monthly benefits are paid, the SMI premiums are deducted from 
those benefits.
    (2) If monthly benefits are suspended (for instance, because the 
individual's earnings exceed the maximum allowed by law), the enrollee 
is billed for direct remittance.
    (b) If it is clear that an individual will be entitled to SMI, but 
there is substantial question as to eligibility for monthly benefits, 
the request for SMI enrollment is processed separately.
    (1) When SMI enrollment is approved, the enrollee is billed for 
direct remittance.
    (2) When the application for monthly benefits is adjudicated, the 
following rules apply:
    (i) If monthly benefits are paid, the SMI premiums are deducted from 
those benefits, with appropriate adjustments for any premiums already 
paid by direct remittance.
    (ii) If the application for monthly benefits is approved but the 
benefits are suspended, the grace period is as set forth in Sec.  
408.8(a).
    (iii) If the application for monthly benefits is denied, the grace 
period is as set forth in Sec.  408.8(a)(1).

[52 FR 48115, Dec. 18, 1987, as amended at 56 FR 48112, Sept. 24, 1991]



                  Subpart B_Amount of Monthly Premiums



Sec.  408.20  Monthly premiums.

    (a) Statutory provisions. (1) The law established a monthly premium 
of $3 for the initial period of the program. It also set forth criteria 
and procedures

[[Page 346]]

for the Secretary to follow each December, beginning with December 1968, 
to determine and promulgate the standard monthly premium for the 12-
month period beginning with July of the following year.
    (2) The law was amended in 1983 to require that the Secretary 
promulgate the standard monthly premium in September of that year, and 
each year thereafter, to be effective for the 12 months beginning with 
the following January.
    (3) The standard monthly premium applies to individuals who enroll 
during their initial enrollment periods. In other situations, that 
premium may be increased or decreased as specified in this subpart.
    (4) The law was further amended in 1984 to include a temporary 
``hold harmless'' provision (set forth in paragraph (e) of this 
section), that was subsequently extended and finally made permanent in 
1988.
    (5) The law was further amended in 2003 to ensure that amounts 
payable from the Transitional Assistance Account described in Sec.  
403.822 of this chapter shall not be taken into account in computing 
actuarrial rates or premium amounts.
    (b) Criteria and procedures for the period from July 1976 through 
December 1983, the period from January 1991 through December 1995, and 
for periods after December 1998. (1) For periods from July 1976 through 
December 1983 and after December 1998, the Secretary determines and 
promulgates as the standard monthly premium (for disabled as well as 
aged enrollees) the lower of the following:
    (i) The actuarial rate for the aged.
    (ii) The monthly premium promulgated the previous December for the 
year beginning July 1, increased by a percentage that is the same as the 
latest cost-of-living increase in old age insurance benefits that 
occurred before the current promulgation. (Because of the change in the 
effective dates of the premium amount (under paragraph (a)(2) of this 
section), there was no increase in the standard monthly premium for the 
period July 1983 through December 1983.)
    (2) For periods after December 1998, the Secretary determines the 
standard monthly premium in the manner specified in paragraph (b)(1) of 
this section, but promulgates it in September for the following calendar 
year.
    (3) The premiums for calendar years 1991 through 1995 are those 
amounts as specified by section 1839(e)(1)(B) of the Act as follows:
    (i) In 1991, $29.90;
    (ii) In 1992, $31.80;
    (iii) In 1993, $36.60;
    (iv) In 1994, $41.10; and
    (v) In 1995, $46.10.
    (4) In no case shall payment made for transitional assistance costs 
under part 403, subpart H of this chapter be included in the formula 
used to calculate actuarial rates or standard monthly premiums.
    (c) Premiums for calendar years 1984 through 1990 and 1996 through 
1998. For calendar years 1984 through 1990 and 1996 through 1998, the 
standard monthly premium for all enrollees--
    (1) Is equal to 50 percent of the actuarial rate for enrollees age 
65 or over, that is, is calculated on the basis of 25 percent of program 
costs without regard to any cost-of-living increase in old age insurance 
benefits; and
    (2) Is promulgated in the preceding September.
    (d) Limitation on increase of standard premium: 1987 and 1988. If 
there is no cost-of-living increase in old age or disability benefits 
for December 1985 or December 1986, the standard monthly premiums for 
1987 and 1988 (promulgated in September 1986 and September 1987, 
respectively) may not be increased.
    (e) Nonstandard premiums for certain cases--(1) Basic rule. A 
nonstandard premium may be established in individual cases only if the 
individual is entitled to old age or disability benefits for the months 
of November and December, and actually receives the corresponding 
benefit checks in December and January.
    (2) Special rules: Calendar years 1987 and 1988. For calendar years 
1987 and 1988, the following rules apply:
    (i) A nonstandard premium may be established if there is a cost-of-
living increase in old age or disability benefits but, because the 
increase in the standard premium is greater than the cost-of-living 
increase, the beneficiary

[[Page 347]]

would receive a lower cash benefit in January than he or she received in 
December.
    (ii) A nonstandard premium may not be established if the reduction 
in the individual's benefit would result, in whole or in part, from any 
circumstance other than the circumstance described in paragraph 
(e)(2)(i) of this section.
    (3) Special rule: Calendar years after 1988. (i) Beginning with 
calendar year 1989, a premium increase greater than the cost-of-living 
increase is still a prerequisite for a nonstandard premium.
    (ii) However, a nonstandard premium is not precluded solely because 
the cash benefit is further reduced as a result of government pension 
offset or workers' compensation payment.
    (iii) Beginning with CY 2007, a nonstandard premium may not be 
applied to individuals who are required to pay an income-related monthly 
adjustment amount described in Sec.  408.28 of this part.
    (4) Amount of nonstandard premium. The nonstandard premium is the 
greater of the following:
    (i) The premium paid for December.
    (ii) The standard premium promulgated for January, reduced as 
necessary to compensate for--
    (A) The fact that the cost-of-living increase was less than the 
increase in the standard premium; or
    (B) The further reduction in benefit because of government pension 
offset or workers' compensation payments.
    (5) Effective dates of nonstandard premium. A nonstandard premium 
established under this paragraph (e) continues in effect for the rest of 
the calendar year even if later there are retroactive adjustments in 
benefit payments. (The nonstandard premium could be affected by a 
determination that the individual had not established, or had lost, 
entitlement to monthly benefits for November or December, or both.)
    (6) Effect of late enrollment or reenrollment. A nonstandard premium 
is subject to increase for late enrollment or reenrollment as required 
under other sections of this subpart. The increase is computed on the 
basis of the standard premium and added to the nonstandard premium.

[56 FR 8839, Mar. 1, 1991, as amended at 59 FR 26959, May 25, 1994; 68 
FR 69927, Dec. 15, 2003; 73 FR 36468, June 27, 2008]



Sec.  408.21  Reduction in Medicare Part B premium as an additional benefit 
under Medicare + Choice plans.

    (a) Basis for reduction in Part B premium. Beginning January 1, 2003 
an M + C organization may elect to receive a reduction in its payments 
under Sec.  422.250(a)(1) of this chapter if--
    (1) 80 percent of the payment reduction is applied to reduce the 
standard Medicare Part B premiums of its Medicare enrollees.
    (2) The Medicare Part B premium is reduced monthly and is offered to 
all Medicare enrollees in a specific plan benefit package.
    (b) Administrative requirements for the Part B premium reduction. 
(1) The Medicare Part B premium reduction cannot be greater than the 
standard premium amount determined for the year, under section 
1839(a)(3) of the Act. However, it may be less.
    (2) The Medicare Part B premium reduction must be a multiple of 10 
cents.
    (3) The Medicare Part B premium reduction is applied regardless of 
who pays or collects the Part B premium on behalf of the beneficiary.
    (4) The Medicare Part B premium can never be less than zero and will 
never result in a payment to a beneficiary for a specific month.
    (c) Beneficiary eligibility. In order for a beneficiary to be 
eligible for the Medicare Part B premium reduction, the beneficiary must 
be enrolled in an M + C plan that offers the Medicare Part B premium 
reduction as an additional benefit.
    (d) Notifications. After determining the Medicare Part B premium 
reduction amount for each eligible beneficiary, CMS will--
    (1) Transmit this information to the Social Security Administration, 
Railroad Retirement Board, or the Office of Personnel Management, as 
appropriate, which will adjust the benefit check amounts as appropriate 
and notify the beneficiaries of their new benefit amount.

[[Page 348]]

    (2) Notify states and formal groups and direct billed beneficiaries 
of their reduced premium amounts in the regular monthly billing process.

[68 FR 66723, Nov. 28, 2003]



Sec.  408.22  Increased premiums for late enrollment and for reenrollment.

    For an individual who enrolls after expiration of his or her initial 
enrollment period or reenrolls after termination of a coverage period, 
the standard monthly premium determined under Sec.  408.20 is increased 
by ten percent for each full twelve months in the periods specified in 
Sec. Sec.  408.24 and 408.25.



Sec.  408.24  Individuals who enrolled or reenrolled before April 1, 1981 
or after September 30, 1981.

    (a) Enrollment. For an individual who first enrolled before April 1, 
1981 or after September 30, 1981, the period includes the number of 
months elapsed between the close of the individual's initial enrollment 
period and the close of the enrollment period in which he or she first 
enrolled, and excludes the following:
    (1) The three months of January through March 1968, if the 
individual first enrolled before April 1968.
    (2) Any months before January 1973 during which the individual was 
precluded from enrolling or reenrolling by the 3-year limitation on 
enrollment or reenrollment that was in effect before October 30, 1972.
    (3) Any months in or before a period of coverage under a State buy-
in agreement.
    (4) For an individual under age 65, any month before his or her 
current continuous period of entitlement to hospital insurance.
    (5) For an individual age 65 or older, any month before the month he 
or she attained age 65.
    (6) For premiums due for months beginning with September 1984 and 
ending with May 1986, the following:
    (i) Any months after December 1982 during which the individual was--
    (A) Age 65 to 69;
    (B) Entitled to hospital insurance (Medicare Part A); and
    (C) Covered under a group health plan (GHP) by reason of current 
employment status.
    (ii) Any months of SMI coverage for which the individual enrolled 
during a special enrollment period as provided in Sec.  407.20 of this 
chapter.
    (7) For premiums due for months beginning with June 1986, the 
following:
    (i) Any months after December 1982 during which the individual was:
    (A) Age 65 or over; and
    (B) Covered under a GHP by reason of current employment status.
    (ii) Any months of SMI coverage for which the individual enrolled 
during a special enrollment period as provided in Sec.  407.20 of this 
chapter.
    (8) For premiums due for months beginning with January 1987, the 
following:
    (i) Any months after December 1986 and before October 1998 during 
which the individual was:
    (A) A disabled Medicare beneficiary under age 65;
    (B) Not eligible for Medicare on the basis of end stage renal 
disease, under Sec.  406.13 of this chapter; and
    (C) Covered under an LGHP as described in Sec.  407.20 of this 
chapter.
    (ii) Any months of SMI coverage for which the individual enrolled 
during a special enrollment period as provided in Sec.  407.20 of this 
chapter.
    (9) For premiums due for months beginning with July 1990, the 
following:
    (i) Any months after December 1986 during which the individual met 
the conditions of paragraphs (a)(8)(i)(A) and (a)(8)(i)(B) of this 
section, and was covered under a GHP by reason of the current employment 
status of the individual or the individual's spouse.
    (ii) Any months of SMI coverage for which the individual enrolled 
during a special enrollment period as provided in Sec.  407.20 of this 
chapter.
    (10) For premiums due for months beginning with January 1, 2007, the 
following:
    (i) Any months after December 2006 during which the individual met 
the conditions under Sec.  407.21(a) of this chapter.
    (ii) Any months of Part B (SMI) coverage for which the individual 
enrolled during a special enrollment period as provided in Sec.  
407.21(b) of this chapter.
    (b) Reenrollment. For an individual who reenrolled before April 1, 
1981 or after September 30, 1981, the period:

[[Page 349]]

    (1) Includes the following:
    (i) The number of months elapsed between the close of the 
individual's initial enrollment period and the close of the enrollment 
period in which he or she first enrolled; plus
    (ii) The number of months elapsed between the individual's initial 
period of coverage and the close of the enrollment period in which he or 
she reenrolled; plus
    (iii) The number of months elapsed between each subsequent period of 
coverage and the close of the enrollment period in which he or she 
reenrolled.
    (2) Excludes the following:
    (i) Any of the periods specified in paragraph (a) of this section; 
and
    (ii) Any month before April 1981 during which the individual was 
precluded from reenrolling by the two-enrollment limitation in effect 
before that date.

[52 FR 48118, Dec. 18, 1987, as amended at 53 FR 6648, Mar. 2, 1988; 61 
FR 40347, Aug. 2, 1996; 73 FR 36468, June 27, 2008]



Sec.  408.25  Individuals who enrolled or reenrolled between April 1 
and September 30, 1981.

    (a) Basic rules. Except as specified in paragraph (b) of this 
section, the rules set forth in Sec.  408.24 apply to an individual who 
enrolled or reenrolled between April 1 and September 30, 1981.
    (b) Exception. For an individual who enrolled or reenrolled between 
April 1 and September 30, 1981, the months to be counted ran through the 
month in which he or she reenrolled. (During those 6 months, continuous 
open enrollment was in effect and there was no 3-month ``general 
enrollment period''.)



Sec.  408.26  Examples.

    Example 1. Mr. J, who became age 65 and otherwise eligible for 
enrollment in November 1965, first enrolls in March 1968. The months to 
be included in determining the amount of the increase in Mr. J's 
premiums begin with June 1966 (the first month after the close of his 
initial enrollment period) and extend through December 1967 (the period 
January through March of 1968 is excluded in determining the total 
months) for a total of 19 months. Since there is only one full 12-month 
period in 19 months, Mr. J's premiums will be 10 percent greater than if 
he had enrolled in his initial enrollment period.
    Example 2. Mr. V, who enrolled in December 1965, voluntarily 
terminates his enrollment effective midnight December 31, 1967. He 
enrolls for a second time in January 1969. The months to be included in 
determining the amount of the increase in Mr. V's premiums are January 
1968 through March 1969, a total of 15 months. Since this totals one 
full 12-month period. Mr. V's monthly premium, will be increased by 10 
percent.
    Example 3. Ms. N becomes age 65 in July 1965 and first enrolls in 
December 1967. She pays premiums increased by 10 percent above the 
regular rate, beginning July 1968, the first month of her SMI coverage. 
Ms. N fails to pay the premiums for the calendar quarter ending June 30, 
1970, and her coverage is terminated on that date, the end of her grace 
period. Ms. N enrolls for a second time in January 1971. The months to 
be included in determining the amount of the increase in Ms. N's 
premiums are June 1966 through December 1967, a total of 19 months, and 
July 1970 through March 1971, a total of 9 months, for a grand total of 
28 months. Since this totals two full 12-month periods, Ms. N's monthly 
premium will be increased by 20 percent.
    Example 4. Mr. X attained age 65 in August 1966 and enrolled during 
his initial enrollment period. His coverage was terminated effective 
June 30, 1968, for nonpayment of premiums. He reenrolls in March 1973. 
For purposes of computing any applicable premium increase, he will not 
be charged any months between March 1971 (the end of the last general 
enrollment period during which he was eligible to reenroll under the law 
in effect before October 30, 1972) and January 1973. Therefore, he will 
be charged 36 months (July 1968-March 1971 plus January 1973-March 1973) 
and his premiums for his second period of coverage will be increased 30 
percent.
    Example 5. Ms. C, who attained age 65 in August 1973, had two 
periods of supplementary medical insurance coverage, both of which were 
terminated because of nonpayment of premiums: August 1973 through April 
1975 and July 1977 through August 1978. She reenrolls in July 1981. The 
months to be included in determining the amount of premium increase are 
May 1975 through March 1977 (23 months) and April 1981 through July 1981 
(4 months) for a total of 27 months. The 31 months from September 1978 
through March 1981 may not be counted because Ms. C was prevented from 
reenrolling by the two-enrollment limitation in effect before April 1, 
1981. For Ms. C, the standard monthly premium would be increased by 20 
percent.

[52 FR 48115, Dec. 18, 1987; 53 FR 4159, Feb. 12, 1988]



Sec.  408.27  Rounding the monthly premium.

    Any monthly premium that is not a multiple of 10 cents is rounded to 
the

[[Page 350]]

nearest multiple of 10 cents, and any odd mulitple of 5 cents is rounded 
to the next higher multiple of 10 cents.

[52 FR 48115, Dec. 18, 1987; 53 FR 4159, Feb. 12, 1988]



Sec.  408.28  Increased premiums due to the income-related monthly 
adjustment amount (IRMAA).

    Beginning January 1, 2007, Medicare beneficiaries must pay an 
income-related monthly adjustment amount in addition to the Part B (SMI) 
standard monthly premium, plus any applicable increase for late 
enrollment or reenrollment, if the beneficiary's modified adjusted gross 
income exceeds the threshold amounts specified in 20 CFR 418.1115.

[73 FR 36469, June 27, 2008]



                Subpart C_Deduction From Monthly Benefits



Sec.  408.40  Deduction from monthly benefits: Basic rules.

    (a) Deduction from monthly benefits. (1) Enrollees who are receiving 
monthly benefits do not have the option of paying by direct remittance 
to avoid deduction.
    (2) If the enrollee is entitled to more than one type of monthly 
benefit, the order of priority for deduction is as follows:
    (i) Railroad retirement benefits.
    (ii) Social security benefits.
    (iii) Civil service annuities.
    (b) Deduction from initial or reinstated benefits. When an enrollee 
receives a monthly benefit check after an initial award or after a 
period of suspension, that check is, if administratively feasible, 
reduced or increased to deduct unpaid premiums or refund premiums paid 
in advance by direct remittance.
    (c) Ongoing deductions. The premium for each month is deducted from 
the cash benefit for the preceding month, e.g., the premium for March is 
deducted from the benefit for February, which is paid at the beginning 
of March.



Sec.  408.42  Deduction from railroad retirement benefits.

    (a) Responsibility for deductions. If an enrollee is entitled to 
railroad retirement benefits, his or her SMI premiums are deducted from 
those benefits by the Railroad Retirement Board (RRB) even though he or 
she is also entitled to social security benefits or a civil service 
annuity, or both.
    (b) Action when benefits are suspended. If the railroad retirement 
benefits are suspended, the RRB sends premium notices requesting direct 
remittance, to be made in accordance with the rules set forth in Subpart 
D of this part.



Sec.  408.43  Deduction from social security benefits.

    SSA, acting as CMS's agent, deducts the premiums from the monthly 
social security benefits if the enrollee is not entitled to railroad 
retirement benefits. (If the benefit is less than the monthly premium, 
the benefit is withheld and the enrollee is required to pay the balance 
through direct remittance.)



Sec.  408.44  Deduction from civil service annuities.

    (a) Responsibility for deductions. If an enrollee is not entitled to 
railroad retirement benefits or social security benefits, and is 
receiving a civil service annuity, the premiums are deducted from that 
annuity by the Office of Personnel Management (OPM) on the basis of a 
notice from SSA indicating that the annuitant is entitled to SMI.
    (b) Deduction of spouse's premiums. If the annuitant's spouse is 
also enrolled for SMI and is not entitled to a civil service annuity or 
to social security or railroad retirement benefits, and the annuitant 
gives written consent, OPM also deducts the spouse's premium from the 
annuitant's monthly check.
    (c) Withdrawal of annuitant's consent. (1) If an annuitant wishes to 
withdraw consent for deduction of the spouse's premium, he or she must 
send written notice of withdrawal to OPM.
    (2) The withdrawal notice is effective with the third month after 
the month in which it is received, or with the month specified in the 
notice, whichever is later.



Sec.  408.45  Deduction from age 72 special payments.

    (a) Deduction of premiums. SMI premiums are deducted from age 72 
special

[[Page 351]]

payments made under section 228 of the Act or the payments are withheld 
under procedures that correspond to the rules set forth in Sec. Sec.  
408.40 and 408.43.
    (b) Collection of premiums while age 72 special payments are 
suspended. If the age 72 special payments are suspended, CMS or its 
agent notifies the enrollee to pay premiums by direct remittance, in 
accordance with the rules set forth in Sec.  408.60.
    (c) Grace period. The grace period ends with the last day of the 
third month after the billing month.
    (d) Resumption of age 72 special payments. (1) If age 72 special 
payments are resumed before the end of the grace period and all premium 
arrears can be deducted from those special payments, SMI coverage 
continues and the enrollee need not pay by direct remittance.
    (2) Subsequent special payments are reduced by the amount of the 
premium for as long as the enrollee receives special payments.



Sec.  408.46  Effect of suspension of social security benefits.

    (a) Benefit payments to be resumed during the taxable year. (1) If 
social security benefit payments are scheduled to be resumed during the 
enrollee's current taxable year, the enrollee is not billed.
    (2) The enrollee may, if he or she wishes, pay the premiums during 
suspension of benefits.
    (b) Benefit payments not to be resumed during the enrollee's current 
taxable year. (1) If social security benefits are suspended for a period 
that will not permit collection of all premiums due from monthly 
benefits payable in the enrollee's current taxable year, CMS or its 
agents bill the enrollee and require direct remittance in accordance 
with subpart D of this part.
    (2) The first billing is for whatever premiums are necessary to 
place the enrollee in a quarterly cycle.
    (3) Thereafter, the billing is on a quarterly basis. (Quarters for 
different enrollees are staggered throughout the year.)
    (4) The enrollee has the option of paying premiums for more than one 
quarter at the same time.



Sec.  408.47  [Reserved]



Sec.  408.50  When premiums are considered paid.

    (a) Actual deduction. A premium is considered paid if it is actually 
deducted from a monthly benefit check. Therefore--
    (1) The premium is ``paid'' even if SSA later finds that the benefit 
was paid in error; but
    (2) A finding that a monthly benefit was erroneously withheld does 
not constitute payment of the premium for that month. Since there was no 
payment, there was no deduction. The enrollee is billed and continuance 
of coverage depends on payment of premiums before the end of the grace 
period or extended grace period.
    (b) Payment within the grace period. Overdue premiums are considered 
paid within the grace period in the following situations:
    (1) Benefits are resumed during the grace period. (i) Monthly cash 
benefit payments are payable for the last month of the initial grace 
period or for earlier months on the basis of a notice filed by the 
enrollee before the initial grace period ends; and
    (ii) Those payments are sufficient to permit deduction of all 
overdue premiums.
    (2) Annual earnings report or other report submitted during the 
grace period shows a benefit is due. (i) Before the end of the grace 
period, the enrollee submits a report clearly showing that monthly cash 
benefits, previously withheld, are payable; and
    (ii) Those benefits are sufficient to permit deduction of the full 
amount of the overdue premiums.
    (3) Premium arrears are paid by direct remittance. The enrollee 
makes a direct remittance payment of all overdue premiums before the end 
of the grace period.

[52 FR 48115, Dec. 18, 1987; 53 FR 4159, Feb. 12, 1988; 56 FR 48112, 
Sept. 24, 1991]



Sec.  408.52  Change from direct remittance to deduction.

    If a direct remittance enrollee becomes entitled to monthly 
benefits--
    (a) The SMI premiums are deducted from those benefits; and

[[Page 352]]

    (b) The enrollee is notified of the deduction and of any adjustment 
of the initial benefit check that is required to collect overdue 
premiums or refund premiums paid in advance.



Sec.  408.53  Change from partial direct remittance to full deduction.

    If a benefit that was less than the premium (and therefore required 
direct remittance of the difference) is increased to an amount equal to, 
or greater than, the premium--
    (a) The full premium is paid from the benefit; and
    (b) Any amounts the enrollee had paid toward premiums not yet due 
are refunded.



             Subpart D_Direct Remittance: Individual Payment



Sec.  408.60  Direct remittance: Basic rules.

    (a) Premiums not deducted from monthly benefits under Subpart C of 
this part or paid by a State buy-in agreement must be paid by direct 
remittance to CMS or its agents, by or on behalf of the enrollee.
    (b) Quarterly payment is preferred as more cost-effective, but 
monthly payment is accepted if the enrollee is unwilling or unable to 
make quarterly payments or is also paying hospital insurance premiums, 
which must be paid every month.
    (c) CMS, directly or through its agents, sends quarterly or monthly 
premium bills and includes an addressed return envelope with the bill.
    (d) The individual must--
    (1) Send a check or money order that is drawn payable to ``CMS 
Medicare Insurance'' and show the enrollee's name and claim number as it 
appears on the Medicare card; and
    (2) Return the bill with the check or money order in the 
preaddressed envelope.



Sec.  408.62  Initial and subsequent billings.

    (a) Monthly billing. (1) The first premium bill is for the period 
from the first month of coverage (or the first month of change from 
deduction or State buy-in payment) through the end of the first month 
after the month of billing.
    (2) Subsequent billings are for periods of one month.
    (b) Quarterly billing. (1) The first premium bill is for the period 
from the first month of coverage (or of change from deduction or State 
buy-in payment) through the third month after the month of billing.
    (2) Subsequent billings are for periods of three months.



Sec.  408.63  Billing procedures when monthly benefits are less than 
monthly premiums.

    If monthly benefits are less than monthly premiums, the following 
procedures apply:
    (a) Notice of amount due. At the beginning of SMI entitlement, and 
at the beginning of each succeeding calendar year, SSA--
    (1) Notifies the enrollee of the amount of benefits payable for the 
rest of the year and the total premiums due for those same months; and
    (2) Bills the enrollee for the difference.
    (b) Notice of amount overdue. At the beginning of each succeeding 
calendar year, SSA--
    (1) Notifies the enrollee of any amounts overdue for premiums for 
the preceding calendar year; and
    (2) Indicates that if the amount still overdue on April 30 is equal 
to or greater than the premium for 3 months, SMI coverage will terminate 
on that date.



Sec.  408.65  Payment options.

    (a) The enrollee is not asked to pay premiums at the time of 
enrollment but is instructed to pay them upon receipt of a premium bill 
from CMS or its agents.
    (b) However, if the enrollee wishes, he or she may pay from one to 
12 months or from one to four quarters at the time of enrollment.



Sec.  408.68  When premiums are considered paid.

    (a) Payment by check. The premium is considered paid if the check is 
paid by the bank the first or second time it is presented for payment.
    (b) Payment within the grace period. (1) A premium is considered 
paid within

[[Page 353]]

the grace period if it is delivered personally, or mailed on or before 
the last day of that period.
    (2) A premium payment is considered to have been mailed 7 days 
before it is received by CMS.



Sec.  408.70  Change from quarterly to monthly payments.

    If an enrollee requests change from quarterly to monthly payment--
    (a) If the enrollee is paid up under the quarterly cycle, the first 
monthly bill is for one month.
    (b) If the enrollee is not paid up under the quarter system, the 
first bill includes all premiums due.



Sec.  408.71  Change from deduction or State payment to direct remittance.

    (a) Basis for change. An SMI enrollee is required to pay by direct 
remittance in any of the following circumstances:
    (1) The enrollee's entitlement to social security or railroad 
retirement benefits ends for any reason other than death.
    (2) The premiums can no longer be deducted from the civil service 
annuity of the enrollee or the enrollee's spouse.
    (3) The enrollee no longer qualifies for coverage under a State buy-
in agreement, and is not entitled to social security or railroad 
retirement monthly benefits.
    (b) Billing. When any of the events specified in paragraph (a) of 
this section occurs (or as soon thereafter as possible), CMS or its 
agents bill the enrollee for direct remittance, in accordance with this 
subpart.



               Subpart E_Direct Remittance: Group Payment



Sec.  408.80  Basic rules.

    (a) Sources of group payment. An employer, a lodge, union, or other 
organization may pay SMI premiums on behalf of one or more enrollees.
    (b) Informal arrangement. Enrollees may turn over their premium 
notices to their employer, union, lodge, or other organization and that 
organization may send a single payment (with the premium notices 
attached so that the payments can readily be identified with the 
appropriate enrollees) to the CMS Premium Collection Center. Prompt 
payment is essential since SMI coverage terminates if premiums are not 
paid by the end of the grace period.
    (c) Group billing arrangement. CMS may send a single notice for the 
premiums due from a group of enrollees if the following conditions are 
met:
    (1) The group payer--
    (i) Uses funds other than the enrollees' to pay all or a substantial 
part of the premiums; or
    (ii) Deducts the premiums from periodic payments it makes to the 
enrollees in the group.
    (2) The enrollee's rights are protected and enrollees are not 
required to pay the costs of having their premiums paid on a group 
basis.



Sec.  408.82  Conditions for group billing.

    CMS agrees to a group billing arrangement only if the following 
conditions are met:
    (a) Conditions the group payer must meet. The group payer submits a 
written request for group billing--
    (1) Showing that all or part of the payments are made from the 
payer's funds or from funds due the enrollees and in the payer's 
possession; and
    (2) Agreeing not to charge the enrollees for the service of paying 
the premiums or for the administrative costs such as recordkeeping and 
postage.
    (b) Enrollees eligible for group payment. (1) Group payment may be 
made only on behalf of individuals who are already enrolled and are 
being billed for direct remittance.
    (2) Group payment may not be made for enrollees whose premiums are 
being deducted from monthly benefits in accordance with Subpart C of 
this part or being paid by the State under a buy-in agreement.
    (c) Protection of enrollee's rights. The use of group billing must 
not jeopardize the enrollees' right--
    (1) To confidentiality of personal information;
    (2) To terminate enrollment;
    (3) To resume individual payment of premiums if he or she wishes; 
and
    (4) To receive notice of any action that affects the SMI benefits.
    (d) Authorization by the enrollee. (1) To ensure maximum feasible 
protection of the rights specified in paragraph (c) of this section, 
each enrollee must give

[[Page 354]]

written authorization as specified in Sec.  408.84(a)(2).
    (2) A group payer that is not an entity of State or local government 
must submit all enrollee authorizations to CMS.
    (3) A group payer that is an entity of State or local government may 
retain the authorizations and certify to CMS that it has on file an 
authorization for each enrollee included in the group.
    (4) It is on the basis of the enrollee's authorization that CMS 
sends the group payer information about each enrollee, as necessary to 
carry out the group payment function.
    (e) Size of group. The number of enrollees must be at least 20, 
which is the minimum size sufficient to make group billing efficient. 
(Smaller groups may use the informal procedure described in Sec.  
408.80(b).)



Sec.  408.84  Billing and payment procedures.

    (a) Initial premium notice. (1) CMS or its agent always sends the 
initial premium notice to the enrollee.
    (2) An enrollee who wishes to have the premiums paid on a group 
basis must give the notice to the group payer, along with written 
authorization for sending subsequent notices to the group payer and for 
release of the information required for the group payment process.
    (b) Monthly billings. Group premiums are billed on a monthly basis. 
However, the group payer may pay up to 12 months in advance.
    (c) Group payers must make their payments within 30 days after 
billing, to avoid infringing on the 90-day grace period during which the 
premiums may be paid by the enrollee if he or she is dropped from the 
group.
    (d) Effect of group payment. Payment by a group payer is considered 
payment by the enrollee.



Sec.  408.86  Responsibilities under group billing arrangement.

    (a) Enrollee responsibilities. (1) The enrollee is still responsible 
for premium payments; the group payer simply acts as his agent. If the 
agent fails to pay, or identifies the payment incorrectly, SSA notifies 
both the agent and the enrollee that the enrollee's account is 
delinquent. If an enrollee fails to take action on that notice, 
entitlement is terminated for nonpayment of premiums.
    (2) The enrollee must promptly notify both SSA and the group payer 
of any change of address.
    (b) Group payer's responsibilities. The group payer must--
    (1) Make premium payments promptly upon receipt of notices;
    (2) Promptly notify both CMS and the enrollee when it drops an 
enrollee from the group;
    (3) Make payments in a way that facilitates efficient and economical 
processing; and
    (4) Maintain the confidentiality of the personal information 
obtained from CMS for the group payment process.
    (c) CMS responsibilities. CMS--
    (1) Sends the bill to the group payer upon authorization from the 
enrollee;
    (2) Notifies both the payer and the enrollee if the payer fails to 
make timely payments; and
    (3) Refunds excess premiums in accordance with Sec.  408.88.



Sec.  408.88  Refund of group payments.

    (a) Basis for refund. Group payments are refunded only in the 
following circumstances:
    (1) The premium was for a month after the month in which the 
enrollee's SMI coverage terminated or the enrollee died.
    (2) The premium was for a month after the month in which the group 
payer gave notice (before the 26th day of that month) that the enrollee 
was no longer eligible for group payment and was being dropped from the 
group.
    (b) Example. F is the wife of J who is a retiree of Corporation X. 
That corporation pays premiums on behalf of all of its retirees and 
their dependents. F obtains a divorce from J on October 20 and thus 
disqualifies herself for further premium payments by the corporation. 
The corporation gives notice on November 10 that a refund is due because 
F has been dropped from the list of persons for whom it has agreed to 
pay premiums. The premium paid for December would be refunded to the 
group payer.
    (c) To whom refund is made. (1) CMS ordinarily refunds to the group 
payer

[[Page 355]]

the premiums specified in paragraph (a) of this section.
    (2) However, if CMS has information that clearly shows those 
premiums were paid from the enrollee's funds, it sends the refund to the 
enrollee.



Sec.  408.90  Termination of group billing arrangement.

    (a) A group billing arrangement may be terminated either by the 
group payer or by CMS upon 30 days' notice.
    (b) CMS may terminate the arrangement if it finds that the group 
payer is not acting in the best interest of the enrollees or that, for 
any other reason, the arrangement has proved inconvenient for CMS.



Sec.  408.92  Change from group payment to deduction or individual payment.

    (a) Enrollee excluded from group payment arrangement because of 
entitlement to monthly benefits. (1) When an enrollee becomes entitled 
to monthly benefits from which premiums can be deducted as specified in 
subpart C of this part, CMS notifies the group payer to discontinue 
payment for that enrollee.
    (2) In order to maintain confidentiality, CMS does not explain to 
the group payer the reason for excluding the enrollee from the group 
payment arrangement.
    (3) The enrollee's premiums are thereafter deducted from the monthly 
benefits, in accordance with subpart C of this part.
    (b) Enrollee no longer eligible for the group. (1) When an enrollee 
is no longer eligible to be included in the group (for instance because 
he or she is no longer employed by the group payer or has terminated 
union or lodge membership), the group payer must promptly notify CMS and 
the enrollee.
    (2) CMS or its agents resume sending individual bills to the 
enrollee, for direct remittance subject to the grace period and 
termination dates specified in Sec.  408.8.



           Subpart F_Termination and Reinstatement of Coverage



Sec.  408.100  Termination of coverage for nonpayment of premiums.

    (a) Effective date of termination. Termination is effective on the 
last day of the grace period. The determination is not made until 15 
days after that day to allow for processing of remittances mailed late 
in the grace period, as provided in Sec.  408.68.
    (b) Notice of termination. (1) SSA sends the enrollee notice of 
termination between 15 and 30 days after the end of the grace period and 
includes information regarding the enrollee's right of appeal.
    (2) CMS notifies any intermediary or carrier that had previously 
been informed that the enrollee had met the SMI deductible for the year 
in which the termination is effective.



Sec.  408.102  Reconsideration of termination.

    (a) Basic rules. Coverage may be reinstated without interruption of 
benefits if the following conditions are met:
    (1) The enrollee appeals the termination by the end of the month 
following the month in which SSA sent the notice of termination.
    (2) The enrollee alleges and it is found that the enrollee did not 
receive timely and adequate notice that the premiums were overdue.
    (3) The enrollee pays, within 30 days after SSA's subsequent request 
for payment, all premiums due through the month in which he or she 
appealed the termination.
    (b) Basis for reinstating coverage. Coverage may be reinstated if 
the evidence establishes one of the following:
    (1) The enrollee acted diligently to pay the premiums or to request 
relief upon receiving a premium notice very late in the grace period or 
shortly after its end, and the delayed notice was not the enrollee's 
fault. (For example, if the billing notice was misaddressed or lost in 
the mail, it would not be the enrollee's fault; if the enrollee had 
moved and not notified SSA of the new address, he or she would be 
responsible for the delay.)
    (2) On the basis of information given by SSA, the enrollee could 
reasonably have believed that the premiums were being paid by deduction 
from benefits or by some other means. (An example would be a notice 
indicating that premiums would be paid by a State Medicaid agency or a 
group payer or would

[[Page 356]]

be deducted from the spouse's civil service annuity.)
    (c) No basis for reinstating coverage. Coverage may not be 
reinstated if the enrollee--
    (1) Received timely and adequate notice but failed to pay within the 
grace period, for example because of insufficient income or resources; 
or
    (2) Appealed the termination more than one month after the month in 
which SSA sent the termination notice.



Sec.  408.104  Reinstatement procedures.

    (a) Request for payment. If the conditions of Sec.  408.102(a) (1) 
and (2) are met, SSA sends written notice requesting the enrollee to 
pay, within 30 days, all premiums due through the month in which the 
enrollee appealed the termination.
    (b) Reinstatement of coverage. If SSA receives the requested payment 
within 30 days, it sets aside the termination and reinstates the 
enrollee's coverage without interruption.



Subpart G_Collection of Unpaid Premiums; Refund of Excess Premiums After 
                        the Death of the Enrollee



Sec.  408.110  Collection of unpaid premiums.

    (a) Basis and scope--(1) Basis. Under the Federal Claims Collection 
Act of 1966 (31 U.S.C. 3711), CMS is required to collect any debts due 
it but is authorized to suspend or terminate collection action on debts 
of less than $20,000 when certain conditions are met. (See 4 CFR, parts 
101-105 for general rules implementing the Federal Claims Collection 
Act.) As indicated in Sec.  408.4, unpaid premiums are debts owed the 
Federal government by the enrollee or the enrollee's estate.
    (2) Scope. This section sets forth the methods of collection used by 
CMS and the circumstances under which CMS terminates or renews 
collection action. The regulations in this section apply to hospital 
insurance premiums as well as SMI premiums.
    (b) Collection of unpaid premiums. Generally, CMS will attempt to 
collect unpaid premiums by one of the following methods:
    (1) By billing enrollees who pay the premiums directly to CMS or to 
a designated agent in accordance with Sec.  408.60.
    (2) By deduction from any benefits payable to the enrollee or the 
estate of a deceased enrollee under Title II or XVIII of the Social 
Security Act, the Railroad Retirement Act or any act administered by the 
Office of Personnel Management in accordance with Sec.  408.4(b) and 
Subpart C of this part (Deduction from Monthly Benefits); or
    (3) By billing the estate of a deceased enrollee.
    (c) Termination of collection action. CMS terminates collection 
action on unpaid premiums under either of the following circumstances, 
if the cost of collection exceeds the amount of overdue premiums:
    (1) The individual is not entitled to benefits under the Acts listed 
in paragraph (b)(2) of this section, is not currently enrolled for SMI 
or premium hospital insurance, and demonstrates, to CMS's satisfaction, 
that he or she is unable to pay the debt within a reasonable time.
    (2) The individual has been dead more than 27 months (the maximum 
time allowed for claiming SMI benefits), and the legal representative of 
his or her estate demonstrates, to CMS's satisfaction, that the estate 
is unable to pay the debt within a reasonable time.
    (d) Renewal of collection efforts. CMS renews collection efforts in 
either of the following circumstances, if the cost of collection does 
not exceed the amount of the overdue premiums:
    (1) The individual enrolls again for premium hospital insurance or 
SMI. (Payment of overdue premiums is not a prerequisite for 
reenrollment.)
    (2) The individual becomes entitled or reentitled to social security 
or railroad retirement benefits or a Federal civil service annuity.



Sec.  408.112  Refund of excess premiums after the enrollee dies.

    If CMS has received premiums for months after the enrollee's death, 
CMS refunds those premiums as follows:
    (a) To the person or persons who paid the premiums or, if the 
premiums were paid by the enrollee, to the representative of the 
enrollee's estate, if any.

[[Page 357]]

    (b) If refund cannot be made under paragraph (a) of this section, 
CMS refunds the premiums to the enrollee's survivors in the following 
order of priority:
    (1) The surviving spouse, if he or she was either living in the same 
household with the deceased at the time of death, or was, for the month 
of death, entitled to monthly social security or railroad retirement 
benefits on the basis of the same earnings record as the deceased 
beneficiary;
    (2) The child or children who were, for the month of death, entitled 
to monthly social security or railroad retirement benefits on the basis 
of the same earnings record as the deceased (and, if there is more than 
one child, in equal parts to each child);
    (3) The parent or parents who were, for the month of death, entitled 
to monthly social security or railroad retirement benefits on the basis 
of the same earnings record as the deceased (and, if there is more than 
one parent, in equal parts to each parent);
    (4) The surviving spouse who was not living in the same household 
with the deceased at the time of death and was not, for the month of 
death, entitled to monthly social security or railroad retirement 
benefits on the basis of the same earnings record as the deceased 
beneficiary;
    (5) The child or children who were not entitled to monthly social 
security or railroad retirement benefits on the basis of the same 
earnings record as the deceased (and, if there is more than one child, 
in equal parts to each child);
    (6) The parent or parents who were not entitled to monthly social 
security or railroad retirement benefits on the basis of the same 
earnings record as the deceased (and, if there is more than one parent, 
in equal parts to each parent).

If none of the listed relatives survives, no refund can be made.



 Subpart H_Supplementary Medical Insurance Premium Surcharge Agreements

    Source: 67 FR 60996, Sept. 27, 2002, unless otherwise noted.



Sec.  408.200  Statutory basis.

    This subpart implements provisions of section 1839(e) of the Social 
Security Act that allow State or local government agencies to enter into 
an agreement with the Secretary to pay, on a quarterly or other periodic 
basis, a lump sum for the total of the SMI premium late enrollment 
surcharge amounts due for a group of eligible enrollees.



Sec.  408.201  Definitions.

    For purposes of this subpart, the following definitions apply:
    SMI premium surcharge means the amount that the standard monthly SMI 
premium is increased for late enrollment or for reenrollment as 
specified in Sec. Sec.  408.22 through 408.25.
    SMI premium surcharge agreement means a written arrangement between 
the Secretary and a State or local government agency to pay, on a 
quarterly, monthly, or other periodic basis, a lump sum for the SMI 
premium surcharge amounts due for a designated group of eligible 
enrollees.



Sec.  408.202  Conditions for participation.

    (a) A State or local government agency may apply to CMS to enter 
into an SMI premium surcharge agreement if the following conditions are 
met:
    (1) Each individual designated for coverage under the premium 
surcharge agreement must be enrolled in Medicare Part B at the time the 
individual is added to the premium surcharge account.
    (2) Each enrollee designated for coverage under the agreement must, 
at the time the individual is added to the premium surcharge account, be 
responsible for paying the base premium and surcharge through direct 
remittance or benefit withholding from Social Security or Railroad 
Retirement benefits or a Civil Service annuity.
    (3) Each enrollee designated for coverage under the agreement must, 
at the time the individual is added to the premium surcharge account, 
not have premiums paid by a State Welfare Agency under a State buy-in 
agreement as described in Sec.  407.40 of this chapter or under a group 
billing arrangement as described in Sec.  408.80.

[[Page 358]]

    (b) The State or local government agency must secure from each 
enrollee a signed, written statement authorizing CMS to send billing 
notices directly to the State or local government agency, and to release 
to the State or local government agency information required under the 
SMI premium surcharge agreement.
    (c) The authorization statement for each enrollee must be retained 
in the State or local government agency files for as long as the 
enrollee is covered by the agreement. These authorization statements 
need not be forwarded to CMS.
    (d) The State or local government agency must certify to CMS, in 
writing, that an authorization statement is on file for each enrollee 
covered under the SMI premium surcharge agreement. Only one 
certification is necessary for the entire group of covered enrollees.
    (e) A State or local government agency must establish an automated 
data exchange with CMS using the Third Party Premium Collection System, 
in order to transmit electronically an input file that will be used to 
add or remove enrollees from the billing system.



Sec.  408.205  Application procedures.

    (a) A State or local government agency must contact its CMS regional 
office (RO) to request application materials.
    (b) If interested in entering into an agreement, the State or local 
government agency must return to the RO two copies of the completed 
application materials.
    (c) CMS reviews the application materials, and, when they are 
approved, notifies the State or local government agency, and the RO.



Sec.  408.207  Billing and payment procedures.

    (a) Adding and removing enrollees. The State or local government 
agency must transmit an input file containing addition and removal 
records electronically to CMS as follows:
    (1) Input files must be transmitted at least once each calendar 
month, but may be transmitted as often as once a day.
    (2) CMS will not add or remove enrollees retroactively, except for 
removals upon the death of an enrollee.
    (3) The State or local government agency must pay the SMI premium 
surcharge for each eligible enrollee who is included in the agreement 
for the time period beginning with the month the enrollee is added and 
continuing through the month the State or local government agency 
informs CMS that the enrollee is to be removed, the month the enrollee's 
Part B coverage terminates, or the month of the enrollee's death, 
whichever comes first.
    (b) Payment and grace period. Payment must be made to CMS as 
follows:
    (1) Payment to CMS must be received by CMS by the first day of each 
month.
    (2) There is a 10-day grace period for receipt of payment.
    (3) Payment must be made to CMS via electronic funds transfer.
    (c) Late payment penalties. CMS may assess interest for any payment 
it does not receive by the first day of the month as follows:
    (1) Interest will be assessed at the SMI trust fund rate as computed 
for new investments in accordance with section 1841(c) of the Act.
    (2) Interest will be waived if the full payment is received by the 
10th day of the month in which it is due.
    (3) Interest will be calculated and assessed in 30-day increments.
    (4) Interest will be assessed on the balance of the amount billed 
that remains unpaid at the expiration of the grace period and unpaid 
balances from prior periods.
    (5) Interest will continue to accrue on unpaid amounts until the 
balance is paid in full.
    (d) Disagreement over billing amounts or interest. If the State or 
local government agency disagrees with the amount assessed in a billing 
statement or interest charge, it must notify CMS as follows:
    (1) The State or local government agency must provide evidence 
suitable to CMS to substantiate its claim.
    (2) The State or local government agency must continue to make full 
payment while CMS evaluates the evidence provided.
    (3) Credit for payment amounts or interest that CMS determines to be 
due

[[Page 359]]

to the State or local government agency will be reflected as an 
adjustment in subsequent bills, effective on the date the corrected 
amount would have been due.



Sec.  408.210  Termination of SMI premium surcharge agreement.

    (a) Termination by the State or local government agency. The State 
or local government agency may voluntarily terminate its agreement with 
CMS as follows:
    (1) The State or local government agency must notify CMS, in 
writing, at least 30 days before the effective date of the termination.
    (2) The State or local government agency must pay any unpaid premium 
surcharge amounts and interest due within 30 days after the effective 
date of the termination.
    (3) Interest will continue to accrue until all amounts due are paid 
in full.
    (b) Termination by CMS. CMS may terminate the agreement with a State 
or local government agency as follows:
    (1) If a State or local government agency's payments are delinquent 
30 days or more, CMS may terminate the agreement with 30 days advance 
notice.
    (2) If the State or local government agency fails to comply with the 
terms of the agreement or procedures promulgated by CMS, CMS may 
terminate the agreement with 30 days advance notice.
    (3) If CMS finds that the State or local government agency is not 
acting in the best interest of the enrollees, or CMS, or for any reason 
other than those in paragraphs (b)(1) and (b)(2) of this section, CMS 
may terminate the agreement at any time.
    (4) The State or local government agency must pay all outstanding 
premium surcharge and any interest amounts due within 30 days after the 
effective date of the termination.
    (5) Interest will continue to accrue until all amounts due are paid 
in full.
    (6) After the agreement is terminated, CMS will resume collection of 
the premium surcharge from the enrollees covered under the terminated 
agreement.
    (7) If an agreement is terminated by CMS, the State or local 
government agency must wait 3 years from the effective date of the 
termination before it can request to enter into another SMI premium 
surcharge agreement.



PART 409_HOSPITAL INSURANCE BENEFITS--Table of Contents



        Subpart A_Hospital Insurance Benefits: General Provisions

Sec.
409.1 Statutory basis.
409.2 Scope.
409.3 Definitions.
409.5 General description of benefits.

  Subpart B_Inpatient Hospital Services and Inpatient Critical Access 
                            Hospital Services

409.10 Included services.
409.11 Bed and board.
409.12 Nursing and related services; medical social services; use of 
          hospital or CAH facilities.
409.13 Drugs and biologicals.
409.14 Supplies, appliances, and equipment.
409.15 Services furnished by an intern or a resident-in-training.
409.16 Other diagnostic or therapeutic services.
409.17 Physical therapy, occupational therapy, and speech-language 
          pathology services.
409.18 Services related to kidney transplantations.

                     Subpart C_Posthospital SNF Care

409.20 Coverage of services.
409.21 Nursing care.
409.22 Bed and board.
409.23 Physical therapy, occupational therapy, and speech-language 
          pathology services.
409.24 Medical social services.
409.25 Drugs, biologicals, supplies, appliances, and equipment.
409.26 Transfer agreement hospital services.
409.27 Other services generally provided by (or under arrangements made 
          by) SNFs.

      Subpart D_Requirements for Coverage of Posthospital SNF Care

409.30 Basic requirements.
409.31 Level of care requirement.
409.32 Criteria for skilled services and the need for skilled services.
409.33 Examples of skilled nursing and rehabilitation services.
409.34 Criteria for ``daily basis''.
409.35 Criteria for ``practical matter''.
409.36 Effect of discharge from posthospital SNF care.

[[Page 360]]

         Subpart E_Home Health Services Under Hospital Insurance

409.40 Basis, purpose, and scope.
409.41 Requirement for payment.
409.42 Beneficiary qualifications for coverage of services.
409.43 Plan of care requirements.
409.44 Skilled services requirements.
409.45 Dependent services requirements.
409.46 Allowable administrative costs.
409.47 Place of service requirements.
409.48 Visits.
409.49 Excluded services.
409.50 Coinsurance for durable medical equipment (DME) and applicable 
          disposable devices furnished as a home health service.

             Subpart F_Scope of Hospital Insurance Benefits

409.60 Benefit periods.
409.61 General limitations on amounts of benefits.
409.62 Lifetime maximum on inpatient psychiatric care.
409.63 Reduction of inpatient psychiatric benefit days available in the 
          initial benefit period.
409.64 Services that are counted toward allowable amounts.
409.65 Lifetime reserve days.
409.66 Revocation of election not to use lifetime reserve days.
409.68 Guarantee of payment for inpatient hospital or inpatient CAH 
          services furnished before notification of exhaustion of 
          benefits.

        Subpart G_Hospital Insurance Deductibles and Coinsurance

409.80 Inpatient deductible and coinsurance: General provisions
409.82 Inpatient hospital deductible.
409.83 Inpatient hospital coinsurance.
409.85 Skilled nursing facility (SNF) care coinsurance.
409.87 Blood deductible.
409.89 Exemption of kidney donors from deductible and coinsurance 
          requirements.

            Subpart H_Payments of Hospital Insurance Benefits

409.100 To whom payment is made.
409.102 Amounts of payment.

    Authority: 42 U.S.C. 1302 and 1395hh.

    Source: 48 FR 12541, Mar. 25, 1983, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 409 appear at 62 FR 
46037, Aug. 29, 1997.



        Subpart A_Hospital Insurance Benefits: General Provisions



Sec.  409.1  Statutory basis.

    This part is based on the identified provisions of the following 
sections of the Social Security Act:
    (a) Sections 1812 and 1813 establish the scope of benefits of the 
hospital insurance program under Medicare Part A and set forth 
deductible and coinsurance requirements.
    (b) Sections 1814 and 1815 establish conditions for, and limitations 
on, payment for services furnished by providers.
    (c) Section 1820 establishes the critical access hospital program.
    (d) Section 1861 describes the services covered under Medicare Part 
A, and benefit periods.
    (e) Section 1862(a) specifies exclusions from coverage.
    (f) Section 1881 sets forth the rules for individuals who have end-
stage renal disease (ESRD), for organ donors, and for dialysis, 
transplantation, and other services furnished to ESRD patients.

[60 FR 50441, Sept. 29, 1995, as amended at 65 FR 62646, Oct. 19, 2000]



Sec.  409.2  Scope.

    Subparts A through G of this part describe the benefits available 
under Medicare Part A and set forth the limitations on those benefits, 
including certain amounts of payment for which beneficiaries are 
responsible.

[48 FR 12541, Mar. 25, 1983, as amended at 50 FR 33033, Aug. 16, 1985]



Sec.  409.3  Definitions.

    As used in this part, unless the context indicates otherwise--
    Arrangements means arrangements which provide that Medicare payment 
made to the provider that arranged for the services discharges the 
liability of the beneficiary or any other person to pay for those 
services.
    Covered refers to services for which the law and the regulations 
authorize Medicare payment.
    Nominal charge provider means a provider that furnishes services 
free of charge or at a nominal charge and is either a public provider, 
or another

[[Page 361]]

provider that (1) demonstrates to CMS's satisfaction that a significant 
portion of its patients are low-income, and (2) requests that payment 
for its services be determined accordingly.
    Participating refers to a hospital or other facility that meets the 
conditions of participation and has in effect a Medicare provider 
agreement.
    Qualified hospital means a facility that--
    (a) Is primarily engaged in providing, by or under the supervision 
of doctors of medicine or osteopathy, inpatient services for the 
diagnosis, treatment, and care or rehabilitation of persons who are 
sick, injured, or disabled;
    (b) Is not primarily engaged in providing skilled nursing care and 
related services for inpatients who require medical or nursing care;
    (c) Provides 24-hour nursing service in accordance with Sec. 
1861(e)(5) of the Act;
    (d) If it is a U.S. hospital, is licensed, or approved as meeting 
the standards for licensing, by the State or local licensing agency; and
    (e) If it is a foreign hospital, is licensed, or approved as meeting 
the standard for licensing, by the appropriate foreign licensing agency, 
and for purposes of furnishing nonemergency services to U.S. residents, 
is accredited by the Joint Commission on Accreditation of Healthcare 
Organizations (JCAHO), or by a foreign program under standards that CMS 
finds to be equivalent to those of JCAHO.

[48 FR 12541, Mar. 25, 1983, as amended at 50 FR 33033, Aug. 16, 1985; 
51 FR 41338, Nov. 14, 1986; 71 FR 48135, Aug. 18, 2006]



Sec.  409.5  General description of benefits.

    Hospital insurance (Part A of Medicare) helps pay for inpatient 
hospital or inpatient CAH services and posthospital SNF care. It also 
pays for home health services and hospice care. There are limitations on 
the number of days of care that Medicare can pay for and there are 
deductible and coinsurance amounts for which the beneficiary is 
responsible. For each type of service, certain conditions must be met as 
specified in the pertinent sections of this subpart and in part 418 of 
this chapter regarding hospice care. Conditions for payment of emergency 
inpatient services furnished by a nonparticipating U.S. hospital and for 
services furnished in a foreign country are set forth in subparts G and 
H of part 424 of this chapter.

[71 FR 48135, Aug. 18, 2006]



  Subpart B_Inpatient Hospital Services and Inpatient Critical Access 
                            Hospital Services



Sec.  409.10  Included services.

    (a) Subject to the conditions, limitations, and exceptions set forth 
in this subpart, the term ``inpatient hospital or inpatient CAH 
services'' means the following services furnished to an inpatient of a 
participating hospital or of a participating CAH or, in the case of 
emergency services or services in foreign hospitals, to an inpatient of 
a qualified hospital:
    (1) Bed and board.
    (2) Nursing services and other related services.
    (3) Use of hospital or CAH facilities.
    (4) Medical social services.
    (5) Drugs, biologicals, supplies, appliances, and equipment.
    (6) Certain other diagnostic or therapeutic services.
    (7) Medical or surgical services provided by certain interns or 
residents-in-training.
    (8) Transportation services, including transport by ambulance.
    (b) Inpatient hospital services does not include the following types 
of services:
    (1) Posthospital SNF care, as described in Sec.  409.20, furnished 
by a hospital or a critical access hospital that has a swing-bed 
approval.
    (2) Nursing facility services, described in Sec.  440.155 of this 
chapter, that may be furnished as a Medicaid service under title XIX of 
the Act in a swing-bed hospital that has an approval to furnish nursing 
facility services.
    (3) Physician services that meet the requirements of Sec.  
415.102(a) of this chapter for payment on a fee schedule basis.
    (4) Physician assistant services, as defined in section 
1861(s)(2)(K)(i) of the Act.
    (5) Nurse practitioner and clinical nurse specialist services, as 
defined in section 1861(s)(2)(K)(ii) of the Act.

[[Page 362]]

    (6) Certified nurse mid-wife services, as defined in section 
1861(gg) of the Act.
    (7) Qualified psychologist services, as defined in section 1861(ii) 
of the Act.
    (8) Services of an anesthetist, as defined in Sec.  410.69

[48 FR 12541, Mar. 25, 1983, as amended at 50 FR 33033, Aug. 16, 1985; 
58 FR 30666, May 26, 1993; 64 FR 3648, Jan. 25, 1999; 65 FR 18535, Apr. 
7, 2000]



Sec.  409.11  Bed and board.

    (a) Semiprivate and ward accommodations. Except for applicable 
deductible and coinsurance amounts, Medicare Part A pays in full for bed 
and board and semiprivate (2 to 4 beds), or ward (5 or more beds) 
accommodations.
    (b) Private accommodations--(1) Conditions for payment in full. 
Except for applicable deductible and coinsurance amounts, Medicare Part 
A pays in full for a private room if--
    (i) The patient's condition requires him or her to be isolated;
    (ii) The hospital or CAH has no semiprivate or ward accommodations; 
or
    (iii) The hospital's or CAH's semiprivate and ward accommodations 
are fully occupied by other patients, were so occupied at the time the 
patient was admitted to the hospital or CAH, respectively, for treatment 
of a condition that required immediate inpatient hospital or inpatient 
CAH care, and have been so occupied during the interval.
    (2) Period of payment. In the situations specified in paragraph 
(b)(1) (i) and (iii) of this section, Medicare pays for a private room 
until the patient's condition no longer requires isolation or until 
semiprivate or ward accommodations are available.
    (3) Conditions for patient's liability. The hospital or CAH may 
charge the patient the difference between its customary charge for the 
private room and its most prevalent charge for a semiprivate room if--
    (i) None of the conditions of paragraph (b)(1) of this section is 
met; and
    (ii) The private room was requested by the patient or a member of 
the family, who, at the time of the request, was informed what the 
hospital's or CAH's charge would be.

[48 FR 12541, Mar. 25, 1983, as amended at 58 FR 30666, May 26, 1993]



Sec.  409.12  Nursing and related services, medical social services; 
use of hospital or CAH facilities.

    (a) Except as provided in paragraph (b) of this section, Medicare 
pays for nursing and related services, use of hospital or CAH 
facilities, and medical social services as inpatient hospital or 
inpatient CAH services only if those services are ordinarily furnished 
by the hospital or CAH, respectively, for the care and treatment of 
inpatients.
    (b) Exception. Medicare does not pay for the services of a private 
duty nurse or attendant. An individual is not considered to be a private 
duty nurse or attendant if he or she is a hospital or CAH employee at 
the time the services are furnished.

[48 FR 12541, Mar. 25, 1983, as amended at 50 FR 33033, Aug. 16, 1985; 
58 FR 30666, 30667, May 26, 1993]



Sec.  409.13  Drugs and biologicals.

    (a) Except as specified in paragraph (b) of this section, Medicare 
pays for drugs and biologicals as inpatient hospital or inpatient CAH 
services only if--
    (1) They represent a cost to the hospital or CAH;
    (2) They are ordinarily furnished by the hospital or CAH for the 
care and treatment of inpatients; and
    (3) They are furnished to an inpatient for use in the hospital or 
CAH.
    (b) Exception. Medicare pays for a limited supply of drugs for use 
outside the hospital or CAH if it is medically necessary to facilitate 
the beneficiary's departure from the hospital and required until he or 
she can obtain a continuing supply.

[48 FR 12541, Mar. 25, 1983, as amended at 58 FR 30666, May 26, 1993]



Sec.  409.14  Supplies, appliances, and equipment.

    (a) Except as specified in paragraph (b) of this section, Medicare 
pays for supplies, appliances, and equipment as inpatient hospital or 
inpatient CAH services only if--
    (1) They are ordinarily furnished by the hospital or CAH to 
inpatients; and
    (2) They are furnished to inpatients for use in the hospital or CAH.

[[Page 363]]

    (b) Exceptions. Medicare pays for items to be used beyond the 
hospital or CAH stay if--
    (1) The item is one that the beneficiary must continue to use after 
he or she leaves the hospital or CAH, for example, heart valves or a 
heart pacemaker, or
    (2) The item is medically necessary to permit or facilitate the 
beneficiary's departure from the hospital or CAH and is required until 
the beneficiary can obtain a continuing supply. Tracheostomy or draining 
tubes are examples.

[48 FR 12541, Mar. 25, 1983, as amended at 58 FR 30666, May 26, 1993]



Sec.  409.15  Services furnished by an intern or a resident-in-training.

    Medical or surgical services provided by an intern or a resident-in-
training are included as ``inpatient hospital or inpatient CAH 
services'' if they are provided--
    (a) By an intern or a resident-in-training under a teaching program 
approved by the Council on Medical Education of the American Medical 
Association, or the Bureau of Professional Education of the American 
Osteopathic Association;
    (b) By an intern or a resident-in-training in the field of dentistry 
under a teaching program approved by the Council on Dental Education of 
the American Dental Association; or
    (c) By an intern or a resident-in-training in the field of podiatry 
under a teaching program approved by the Council on Podiatry Education 
of the American Podiatry Association.

[48 FR 12541, Mar. 25, 1983, as amended at 58 FR 30666, May 26, 1993]



Sec.  409.16  Other diagnostic or therapeutic services.

    Diagnostic or therapeutic services other than those provided for in 
Sec. Sec.  409.12, 409.13, and 409.14 are considered as inpatient 
hospital or inpatient CAH services if--
    (a) They are furnished by the hospital or CAH, or by others under 
arrangements made by the hospital or CAH;
    (b) Billing for those services is through the hospital or CAH; and
    (c) The services are of a kind ordinarily furnished to inpatients 
either by the hospital or CAH or under arrangements made by the hospital 
or CAH.

[48 FR 12541, Mar. 25, 1983, as amended at 58 FR 30666, May 26, 1993]



Sec.  409.17  Physical therapy, occupational therapy, and speech-language 
pathology services.

    (a) General rules. (1) Except as specified in this section, physical 
therapy, occupational therapy, or speech-language pathology services 
must be furnished by qualified physical therapists, physical therapist 
assistants, occupational therapists, occupational therapy assistants, or 
speech-language pathologists who meet the requirements specified in part 
484 of this chapter.
    (2) Physical therapy, occupational therapy or speech-language 
pathology services must be furnished under a plan that meets the 
requirements of paragraphs (b) through (d) of this section, or plan 
requirements specific to the payment policy under which the services are 
rendered, if applicable.
    (b) Establishment of the plan. The plan must be established before 
treatment begins by one of the following:
    (1) A physician.
    (2) A nurse practitioner, a clinical nurse specialist or a physician 
assistant.
    (3) The physical therapist furnishing the physical therapy services.
    (4) A speech-language pathologist furnishing the speech-language 
pathology services.
    (5) An occupational therapist furnishing the occupational therapy 
services.
    (c) Content of the plan. The plan:
    (1) Prescribes the type, amount, frequency, and duration of the 
physical therapy, occupational therapy, or speech-language pathology 
services to be furnished to the individual; and
    (2) Indicates the diagnosis and anticipated goals.
    (d) Changes in the plan. Any changes in the plan are implemented in 
accordance with the provider's policies and procedures.

[72 FR 66397, Nov. 27, 2007, as amended at 73 FR 69932, Nov. 19, 2008; 
75 FR 73613, Nov. 29, 2010]

[[Page 364]]



Sec.  409.18  Services related to kidney transplantations.

    (a) Kidney transplants. Medicare pays for kidney transplantation 
surgery only if performed in a renal transplantation center approved 
under subpart U of part 405 of this chapter.
    (b) Services in connection with kidney donations. Medicare pays for 
services related to the evaluation or preparation of a potential or 
actual donor, to the donation of the kidney, or to postoperative 
recovery services directly related to the kidney donation--
    (1) If the kidney is intended for an individual who has ESRD and is 
entitled to Medicare benefits or can be expected to become so entitled 
within a reasonable time; and
    (2) Regardless of whether the donor is entitled to Medicare.



                     Subpart C_Posthospital SNF Care



Sec.  409.20  Coverage of services.

    (a) Included services. Subject to the conditions and limitations set 
forth in this subpart and subpart D of this part, ``posthospital SNF 
care'' means the following services furnished to an inpatient of a 
participating SNF, or of a participating hospital or critical access 
hospital (CAH) that has a swing-bed approval:
    (1) Nursing care provided by or under the supervision of a 
registered professional nurse.
    (2) Bed and board in connection with the furnishing of that nursing 
care.
    (3) Physical therapy, occupational therapy, and speech-language 
pathology services.
    (4) Medical social services.
    (5) Drugs, biologicals, supplies, appliances, and equipment.
    (6) Services furnished by a hospital with which the SNF has a 
transfer agreement in effect under Sec.  483.70(j) of this chapter.
    (7) Other services that are generally provided by (or under 
arrangements made by) SNFs.
    (b) Excluded services--(1) Services that are not considered 
inpatient hospital services. No service is included as posthospital SNF 
care if it would not be included as an inpatient hospital service under 
Sec. Sec.  409.11 through 409.18.
    (2) Services not generally provided by (or under arrangements made 
by) SNFs. Except as specifically listed in Sec. Sec.  409.21 through 
409.27, only those services generally provided by (or under arrangements 
made by) SNFs are considered as posthospital SNF care. For example, a 
type of medical or surgical procedure that is ordinarily performed only 
on an inpatient basis in a hospital is not included as ``posthospital 
SNF care,'' because such procedures are not generally provided by (or 
under arrangements made by) SNFs.
    (c) Terminology. In Sec.  409.21 through Sec.  409.36--.
    (1) The terms SNF and swing-bed hospital are used when the context 
applies to the particular facility.
    (2) The term facility is used to mean both SNFs and swing-bed 
hospitals.
    (3) The term swing-bed hospital includes a CAH with swing-bed 
approval under subpart F of part 485 of this chapter.
    (4) The term post-hospital SNF care includes SNF care that does not 
follow a hospital stay when the beneficiary is enrolled in a plan, as 
defined in Sec.  422.4 of this chapter, offered by a Medicare + Choice 
(M + C) organization, that includes the benefits described in Sec.  
422.101(c) of this chapter.

[48 FR 12541, Mar. 25, 1983, as amended at 50 FR 33033, Aug. 16, 1985; 
58 FR 30667, May 26, 1993; 63 FR 26306, May 12, 1998; 64 FR 3648, Jan. 
25, 1999; 64 FR 41681, July 30, 1999; 68 FR 46070, Aug. 4, 2003; 68 FR 
50854, Aug. 22, 2003; 69 FR 35529, June 25, 2004; 75 FR 73613, Nov. 29, 
2010; 82 FR 32258, July 13, 2017]



Sec.  409.21  Nursing care.

    (a) Basic rule. Medicare pays for nursing care as posthospital SNF 
care when provided by or under the supervision of a registered 
professional nurse.
    (b) Exception. Medicare does not pay for the services of a private 
duty nurse or attendant. An individual is not considered to be a private 
duty nurse or attendant if he or she is an SNF employee at the time the 
services are furnished.

[63 FR 26306, May 12, 1998]



Sec.  409.22  Bed and board.

    (a) Semiprivate and ward accommodations. Except for applicable 
deductible and coinsurance amounts Medicare

[[Page 365]]

Part A pays in full for semiprivate (2 to 4 beds), or ward (5 or more 
beds) accommodations.
    (b) Private accommodations--(1) Conditions for payment in full. 
Except for applicable coinsurance amounts, Medicare pays in full for a 
private room if--
    (i) The patient's condition requires him to be isolated;
    (ii) The SNF has no semiprivate or ward accommodations; or
    (iii) The SNF semiprivate and ward accommodations are fully occupied 
by other patients, were so occupied at the time the patient was admitted 
to the SNF for treatment of a condition that required immediate 
inpatient SNF care, and have been so occupied during the interval.
    (2) Period of payment. In the situations specified in paragraph 
(b)(1) (i) and (iii) of this section. Medicare pays for a private room 
until the patient's condition no longer requires isolation or until 
semiprivate or ward accommodations are available.
    (3) Conditions for patient's liability. The facility may charge the 
patient the difference between its customary charge for the private room 
furnished and its most prevalent charge for a semiprivate room if:
    (i) None of the conditions of paragraph (b)(1) of this section is 
met, and
    (ii) The private room was requested by the patient or a member of 
the family who, at the time of request was informed what the charge 
would be.



Sec.  409.23  Physical therapy, occupational therapy, and speech-language 
pathology services.

    Medicare pays for physical therapy, occupational therapy, or speech-
language pathology services as posthospital SNF care if they are 
furnished--
    (a) By (or under arrangements made by) the facility and billed by 
(or through) the facility;
    (b) By qualified physical therapists, physical therapist assistants, 
occupational therapists, occupational therapy assistants, or speech-
language pathologists as defined in part 484 of this chapter; and
    (c) In accordance with a plan that meets the requirements of Sec.  
409.17(b) through (d) of this part.

[75 FR 73613, Nov. 29, 2010]



Sec.  409.24  Medical social services.

    Medicare pays for medical social services as posthospital SNF care, 
including--
    (a) Assessment of the social and emotional factors related to the 
beneficiary's illness, need for care, response to treatment, and 
adjustment to care in the facility;
    (b) Case work services to assist in resolving social or emotional 
problems that may have an adverse effect on the beneficiary's ability to 
respond to treatment; and
    (c) Assessment of the relationship of the beneficiary's medical and 
nursing requirements to his or her home situation, financial resources, 
and the community resources available upon discharge from facility care.

[63 FR 26306, May 12, 1998]



Sec.  409.25  Drugs, biologicals, supplies, appliances, and equipment.

    (a) Drugs and biologicals. Except as specified in paragraph (b) of 
this section, Medicare pays for drugs and biologicals as posthospital 
SNF care only if--
    (1) They represent a cost to the facility;
    (2) They are ordinarily furnished by the facility for the care and 
treatment of inpatients; and
    (3) They are furnished to an inpatient for use in the facility.
    (b) Exception. Medicare pays for a limited supply of drugs for use 
outside the facility if it is medically necessary to facilitate the 
beneficiary's departure from the facility and required until he or she 
can obtain a continuing supply.
    (c) Supplies, appliances, and equipment. Except as specified in 
paragraph (d) of this section, Medicare pays for supplies, appliances, 
and equipment as posthospital SNF care only if they are--
    (1) Ordinarily furnished by the facility to inpatients; and
    (2) Furnished to inpatients for use in the facility.

[[Page 366]]

    (d) Exception. Medicare pays for items to be used after the 
individual leaves the facility if--
    (1) The item is one that the beneficiary must continue to use after 
leaving, such as a leg brace; or
    (2) The item is necessary to permit or facilitate the beneficiary's 
departure from the facility and is required until he or she can obtain a 
continuing supply, for example, sterile dressings.

[63 FR 26307, May 12, 1998]



Sec.  409.26  Transfer agreement hospital services.

    (a) Services furnished by an intern or a resident-in-training. 
Medicare pays for medical services that are furnished by an intern or a 
resident-in-training (under a hospital teaching program approved in 
accordance with the provisions of Sec.  409.15) as posthospital SNF 
care, if the intern or resident is in--
    (1) A participating hospital with which the SNF has in effect an 
agreement under Sec.  483.70(j) of this chapter for the transfer of 
patients and exchange of medical records; or
    (2) A hospital that has a swing-bed approval, and is furnishing 
services to an SNF-level inpatient of that hospital.
    (b) Other diagnostic or therapeutic services. Medicare pays for 
other diagnostic or therapeutic services as posthospital SNF care if 
they are provided--
    (1) By a participating hospital with which the SNF has in effect a 
transfer agreement as described in paragraph (a)(1) of this section; or
    (2) By a hospital or a CAH that has a swing-bed approval, to its own 
SNF-level inpatient.

[63 FR 26307, May 12, 1998; 82 FR 32258, July 13, 2017]



Sec.  409.27  Other services generally provided by 
(or under arrangements made by) SNFs.

    In addition to those services specified in Sec. Sec.  409.21 through 
409.26, Medicare pays as posthospital SNF care for such other diagnostic 
and therapeutic services as are generally provided by (or under 
arrangements made by) SNFs, including--
    (a) Medical and other health services as described in subpart B of 
part 410 of this chapter, subject to any applicable limitations or 
exclusions contained in that subpart or in Sec.  409.20(b);
    (b) Respiratory therapy services prescribed by a physician for the 
assessment, diagnostic evaluation, treatment, management, and monitoring 
of patients with deficiencies and abnormalities of cardiopulmonary 
function; and
    (c) Transportation by ambulance that meets the general medical 
necessity requirements set forth in Sec.  410.40(e)(1) of this chapter.

[63 FR 26307, May 12, 1998, as amended at 64 FR 41681, July 30, 1999; 84 
FR 63187, Nov. 15, 2019]



      Subpart D_Requirements for Coverage of Posthospital SNF Care



Sec.  409.30  Basic requirements.

    Posthospital SNF care, including SNF-type care furnished in a 
hospital or CAH that has a swing-bed approval, is covered only if the 
beneficiary meets the requirements of this section and only for days 
when he or she needs and receives care of the level described in Sec.  
409.31. A beneficiary in an SNF is also considered to meet the level of 
care requirements of Sec.  409.31 up to and including the assessment 
reference date for the initial Medicare assessment prescribed in Sec.  
413.343(b) of this chapter, when correctly assigned one of the case-mix 
classifiers that CMS designates for this purpose as representing the 
required level of care. For the purposes of this section, the assessment 
reference date is defined in accordance with Sec.  483.315(d) of this 
chapter, and must be set for no later than the eighth day of 
posthospital SNF care.
    (a) Pre-admission requirements. The beneficiary must--
    (1) Have been hospitalized in a participating or qualified hospital 
or participating CAH, for medically necessary inpatient hospital or 
inpatient CAH care, for at least 3 consecutive calendar days, not 
counting the date of discharge; and
    (2) Have been discharged from the hospital or CAH in or after the 
month he or she attained age 65, or in a month for which he or she was 
entitled to hospital insurance benefits on the basis of

[[Page 367]]

disability or end-stage renal disease, in accordance with part 406 of 
this chapter.
    (b) Date of admission requirements. \1\ (1) Except as specified in 
paragraph (b)(2) of this section, the beneficiary must be in need of 
posthospital SNF care, be admitted to the facility, and receive the 
needed care within 30 calendar days after the date of discharge from a 
hospital or CAH.
---------------------------------------------------------------------------

    \1\ Before December 5, 1980, the law required that admission and 
receipt of care be within 14 days after discharge from the hospital or 
CAH and permitted admission up to 28 days after discharge if a SNF bed 
was not available in the geographic area in which the patient lived, or 
at the time it would be medically appropriate to begin an active course 
of treatment, if SNF care would not be medically appropriate within 14 
days after discharge.
---------------------------------------------------------------------------

    (2) The following exceptions apply--
    (i) A beneficiary for whom posthospital SNF care would not be 
medically appropriate within 30 days after discharge from the hospital 
or CAH, or a beneficiary enrolled in a Medicare + Choice (M + C) plan, 
may be admitted at the time it would be medically appropriate to begin 
an active course of treatment.
    (ii) If, upon admission to the SNF, the beneficiary was enrolled in 
an M + C plan, as defined in Sec.  422.4 of this chapter, offering the 
benefits described in Sec.  422.101(c) of this chapter, the beneficiary 
will be considered to have met the requirements described in paragraphs 
(a) and (b) of this section, and also in Sec.  409.31(b)(2), for the 
duration of the SNF stay.

[48 FR 12541, Mar. 25, 1983, as amended at 51 FR 41338, Nov. 14, 1986; 
58 FR 30666, 30667, May 26, 1993; 62 FR 46025, Aug. 29, 1997; 63 FR 
26307, May 12, 1998; 64 FR 41681, July 30, 1999; 68 FR 50584, Aug. 22, 
2003; 72 FR 43436, Aug. 3, 2007; 82 FR 36633, Aug. 4, 2017; 84 FR 38832, 
Aug. 7, 2019]



Sec.  409.31  Level of care requirement.

    (a) Definition. As used in this section, skilled nursing and skilled 
rehabilitation services means services that:
    (1) Are ordered by a physician;
    (2) Require the skills of technical or professional personnel such 
as registered nurses, licensed practical (vocational) nurses, physical 
therapists, occupational therapists, and speech pathologists or 
audiologists; and
    (3) Are furnished directly by, or under the supervision of, such 
personnel.
    (b) Specific conditions for meeting level of care requirements. (1) 
The beneficiary must require skilled nursing or skilled rehabilitation 
services, or both, on a daily basis.
    (2) Those services must be furnished for a condition--
    (i) For which the beneficiary received inpatient hospital or 
inpatient CAH services; or
    (ii) Which arose while the beneficiary was receiving care in a SNF 
or swing-bed hospital for a condition for which he or she received 
inpatient hospital or inpatient CAH services; or
    (iii) For which, for an M + C enrollee described in Sec.  
409.20(c)(4), a physician has determined that a direct admission to a 
SNF without an inpatient hospital or inpatient CAH stay would be 
medically appropriate.
    (3) The daily skilled services must be ones that, as a practical 
matter, can only be provided in a SNF, on an inpatient basis.

[48 FR 12541, Mar. 25, 1983, as amended at 58 FR 30666, May 26, 1993; 68 
FR 50854, Aug. 22, 2003; 70 FR 45055, Aug. 4, 2005]



Sec.  409.32  Criteria for skilled services and the need for skilled services.

    (a) To be considered a skilled service, the service must be so 
inherently complex that it can be safely and effectively performed only 
by, or under the supervision of, professional or technical personnel.
    (b) A condition that does not ordinarily require skilled services 
may require them because of special medical complications. Under those 
circumstances, a service that is usually nonskilled (such as those 
listed in Sec.  409.33(d)) may be considered skilled because it must be 
performed or supervised by skilled nursing or rehabilitation personnel. 
For example, a plaster cast on a leg does not usually require skilled 
care. However, if the patient has a preexisting acute skin condition or 
needs traction, skilled personnel may be needed to adjust traction or 
watch for complications. In situations of this type, the complications, 
and the

[[Page 368]]

skilled services they require, must be documented by physicians' orders 
and nursing or therapy notes.
    (c) The restoration potential of a patient is not the deciding 
factor in determining whether skilled services are needed. Even if full 
recovery or medical improvement is not possible, a patient may need 
skilled services to prevent further deterioration or preserve current 
capabilities. For example, a terminal cancer patient may need some of 
the skilled services described in Sec.  409.33.

[48 FR 12541, Mar. 25, 1983, as amended at 59 FR 65493, Dec. 20, 1994]



Sec.  409.33  Examples of skilled nursing and rehabilitation services.

    (a) Services that could qualify as either skilled nursing or skilled 
rehabilitation services--(1) Overall management and evaluation of care 
plan. (i) When overall management and evaluation of care plan constitute 
skilled services. The development, management, and evaluation of a 
patient care plan based on the physician's orders constitute skilled 
services when, because of the patient's physical or mental condition, 
those activities require the involvement of technical or professional 
personnel in order to meet the patient's needs, promote recovery, and 
ensure medical safety. Those activities include the management of a plan 
involving a variety of personal care services only when, in light of the 
patient's condition, the aggregate of those services requires the 
involvement of technical or professional personnel.
    (ii) Example. An aged patient with a history of diabetes mellitus 
and angina pectoris who is recovering from an open reduction of a 
fracture of the neck of the femur requires, among other services, 
careful skin care, appropriate oral medications, a diabetic diet, an 
exercise program to preserve muscle tone and body condition, and 
observation to detect signs of deterioration in his or her condition or 
complications resulting from restricted, but increasing, mobility. 
Although any of the required services could be performed by a properly 
instructed person, such a person would not have the ability to 
understand the relationship between the services and evaluate the 
ultimate effect of one service on the other. Since the nature of the 
patient's condition, age, and immobility create a high potential for 
serious complications, such an understanding is essential to ensure the 
patient's recovery and safety. Under these circumstances, the management 
of the plan of care would require the skills of a nurse even though the 
individual services are not skilled. Skilled planning and management 
activities are not always specifically identified in the patient's 
clinical record. Therefore, if the patient's overall condition supports 
a finding that recovery and safety can be ensured only if the total care 
is planned, managed, and evaluated by technical or professional 
personnel, it is appropriate to infer that skilled services are being 
provided.
    (2) Observation and assessment of the patient's changing condition--
(i) When observation and assessment constitute skilled services. 
Observation and assessment constitute skilled services when the skills 
of a technical or professional person are required to identify and 
evaluate the patient's need for modification of treatment or for 
additional medical procedures until his or her condition is stabilized.
    (ii) Examples. A patient with congestive heart failure may require 
continuous close observation to detect signs of decompensation, abnormal 
fluid balance, or adverse effects resulting from prescribed 
medication(s) that serve as indicators for adjusting therapeutic 
measures. Similarly, surgical patients transferred from a hospital to an 
SNF while in the complicated, unstabilized postoperative period, for 
example, after hip prosthesis or cataract surgery, may need continued 
close skilled monitoring for postoperative complications and adverse 
reaction. Patients who, in addition to their physical problems, exhibit 
acute psychological symptoms such as depression, anxiety, or agitation, 
may also require skilled observation and assessment by technical or 
professional personnel to ensure their safety or the safety of others, 
that is, to observe for indications of suicidal or hostile behavior. The 
need for services of this type must be documented by physicians' orders 
or nursing or therapy notes.

[[Page 369]]

    (3) Patient education services--(i) When patient education services 
constitute skilled services. Patient education services are skilled 
services if the use of technical or professional personnel is necessary 
to teach a patient self-maintenance.
    (ii) Examples. A patient who has had a recent leg amputation needs 
skilled rehabilitation services provided by technical or professional 
personnel to provide gait training and to teach prosthesis care. 
Similarly, a patient newly diagnosed with diabetes requires instruction 
from technical or professional personnel to learn the self-
administration of insulin or foot-care precautions.
    (b) Services that qualify as skilled nursing services. (1) 
Intravenous or intramuscular injections and intravenous feeding.
    (2) Enteral feeding that comprises at least 26 per cent of daily 
calorie requirements and provides at least 501 milliliters of fluid per 
day.
    (3) Nasopharyngeal and tracheostomy aspiration;
    (4) Insertion and sterile irrigation and replacement of suprapubic 
catheters;
    (5) Application of dressings involving prescription medications and 
aseptic techniques;
    (6) Treatment of extensive decubitus ulcers or other widespread skin 
disorder;
    (7) Heat treatments which have been specifically ordered by a 
physician as part of active treatment and which require observation by 
nurses to adequately evaluate the patient's progress;
    (8) Initial phases of a regimen involving administration of medical 
gases;
    (9) Rehabilitation nursing procedures, including the related 
teaching and adaptive aspects of nursing, that are part of active 
treatment, e.g., the institution and supervision of bowel and bladder 
training programs.
    (c) Services which would qualify as skilled rehabilitation services. 
(1) Ongoing assessment of rehabilitation needs and potential: Services 
concurrent with the management of a patient care plan, including tests 
and measurements of range of motion, strength, balance, coordination, 
endurance, functional ability, activities of daily living, perceptual 
deficits, speech and language or hearing disorders;
    (2) Therapeutic exercises or activities: Therapeutic exercises or 
activities which, because of the type of exercises employed or the 
condition of the patient, must be performed by or under the supervision 
of a qualified physical therapist or occupational therapist to ensure 
the safety of the patient and the effectiveness of the treatment;
    (3) Gait evaluation and training: Gait evaluation and training 
furnished to restore function in a patient whose ability to walk has 
been impaired by neurological, muscular, or skeletal abnormality;
    (4) Range of motion exercises: Range of motion exercises which are 
part of the active treatment of a specific disease state which has 
resulted in a loss of, or restriction of, mobility (as evidenced by a 
therapist's notes showing the degree of motion lost and the degree to be 
restored);
    (5) Maintenance therapy; Maintenance therapy, when the specialized 
knowledge and judgment of a qualified therapist is required to design 
and establish a maintenance program based on an initial evaluation and 
periodic reassessment of the patient's needs, and consistent with the 
patient's capacity and tolerance. For example, a patient with 
Parkinson's disease who has not been under a rehabilitation regimen may 
require the services of a qualified therapist to determine what type of 
exercises will contribute the most to the maintenance of his present 
level of functioning.
    (6) Ultrasound, short-wave, and microwave therapy treatment by a 
qualified physical therapist;
    (7) Hot pack, hydrocollator, infrared treatments, paraffin baths, 
and whirlpool; Hot pack hydrocollator, infrared treatments, paraffin 
baths, and whirlpool in particular cases where the patient's condition 
is complicated by circulatory deficiency, areas of desensitization, open 
wounds, fractures, or other complications, and the skills, knowledge, 
and judgment of a qualified physical therapist are required; and

[[Page 370]]

    (8) Services of a speech pathologist or audiologist when necessary 
for the restoration of function in speech or hearing.
    (d) Personal care services. Personal care services which do not 
require the skills of qualified technical or professional personnel are 
not skilled services except under the circumstances specified in Sec.  
409.32(b). Personal care services include, but are not limited to, the 
following:
    (1) Administration of routine oral medications, eye drops, and 
ointments;
    (2) General maintenance care of colostomy and ileostomy;
    (3) Routine services to maintain satisfactory functioning of 
indwelling bladder catheters;
    (4) Changes of dressings for noninfected postoperative or chronic 
conditions;
    (5) Prophylactic and palliative skin care, including bathing and 
application of creams, or treatment of minor skin problems;
    (6) Routine care of the incontinent patient, including use of 
diapers and protective sheets;
    (7) General maintenance care in connection with a plaster cast;
    (8) Routine care in connection with braces and similar devices;
    (9) Use of heat as a palliative and comfort measure, such as 
whirlpool and hydrocollator;
    (10) Routine administration of medical gases after a regimen of 
therapy has been established;
    (11) Assistance in dressing, eating, and going to the toilet;
    (12) Periodic turning and positioning in bed; and
    (13) General supervision of exercises which have been taught to the 
patient; including the actual carrying out of maintenance programs, 
i.e., the performance of the repetitive exercises required to maintain 
function do not require the skills of a therapist and would not 
constitute skilled rehabilitation services (see paragraph (c) of this 
section). Similarly, repetitious exercises to improve gait, maintain 
strength, or endurance; passive exercises to maintain range of motion in 
paralyzed extremities, which are not related to a specific loss of 
function; and assistive walking do not constitute skilled rehabilitation 
services.

[48 FR 12541, Mar. 25, 1983, as amended at 63 FR 26307, May 12, 1998; 64 
FR 41681, July 30, 1999]



Sec.  409.34  Criteria for ``daily basis''.

    (a) To meet the daily basis requirement specified in Sec.  
409.31(b)(1), the following frequency is required:
    (1) Skilled nursing services or skilled rehabilitation services must 
be needed and provided 7 days a week; or
    (2) As an exception, if skilled rehabilitation services are not 
available 7 days a week those services must be needed and provided at 
least 5 days a week.
    (b) A break of one or two days in the furnishing of rehabilitation 
services will not preclude coverage if discharge would not be practical 
for the one or two days during which, for instance, the physician has 
suspended the therapy sessions because the patient exhibited extreme 
fatigue.



Sec.  409.35  Criteria for ``practical matter''.

    (a) General considerations. In making a ``practical matter'' 
determination, as required by Sec.  409.31(b)(3), consideration must be 
given to the patient's condition and to the availability and feasibility 
of using more economical alternative facilities and services. However, 
in making that determination, the availability of Medicare payment for 
those services may not be a factor. For example, if a beneficiary can 
obtain daily physical therapy services on an outpatient basis, the 
unavailability of Medicare payment for those alternative services due to 
the beneficiary's non-enrollment in Part B may not be a basis for 
finding that the needed care can only be provided in a SNF.
    (b) Examples of circumstances that meet practical matter criteria--
(1) Beneficiary's condition. Inpatient care would be required ``as a 
practical matter'' if transporting the beneficiary to and from the 
nearest facility that furnishes the required daily skilled services 
would be an excessive physical hardship.
    (2) Economy and efficiency. Even if the beneficiary's condition does 
not preclude transportation, inpatient care might be more efficient and 
less costly

[[Page 371]]

if, for instance, the only alternative is daily transportation by 
ambulance.

[48 FR 12541, Mar. 25, 1983, as amended at 50 FR 33033, Aug. 16, 1985; 
85 FR 47632, Aug. 5, 2020]



Sec.  409.36  Effect of discharge from posthospital SNF care.

    If a beneficiary is discharged from a facility after receiving 
posthospital SNF care, he or she is not entitled to additional services 
of this kind in the same benefit period unless--
    (a) He or she is readmitted to the same or another facility within 
30 calendar days following the day of discharge (or, before December 5, 
1980, within 14 calendar days after discharge); or
    (b) He or she is again hospitalized for at least 3 consecutive 
calendar days.



         Subpart E_Home Health Services Under Hospital Insurance



Sec.  409.40  Basis, purpose, and scope.

    This subpart implements sections 1814(a)(2)(C), 1835(a)(2)(A), and 
1861(m) of the Act with respect to the requirements that must be met for 
Medicare payment to be made for home health services furnished to 
eligible beneficiaries.

[59 FR 65493, Dec. 20, 1994]



Sec.  409.41  Requirement for payment.

    In order for home health services to qualify for payment under the 
Medicare program the following requirements must be met:
    (a) The services must be furnished to an eligible beneficiary by, or 
under arrangements with, an HHA that--
    (1) Meets the conditions of participation for HHAs at part 484 of 
this chapter; and
    (2) Has in effect a Medicare provider agreement as described in part 
489, subparts A, B, C, D, and E of this chapter.
    (b) The certification and recertification requirements for home 
health services described in Sec.  424.22.
    (c) All requirements contained in Sec. Sec.  409.42 through 409.47.

[59 FR 65494, Dec. 20, 1994, as amended at 85 FR 27619, May 8, 2020]



Sec.  409.42  Beneficiary qualifications for coverage of services.

    To qualify for Medicare coverage of home health services, a 
beneficiary must meet each of the following requirements:
    (a) Confined to the home. The beneficiary must be confined to the 
home or in an institution that is not a hospital, SNF or nursing 
facility as defined in section 1861(e)(1), 1819(a)(1) or 1919(a)(1) of 
the Act, respectively.
    (b) Under the care of a physician or allowed practitioner, as 
defined at Sec.  484.2 of this chapter. The beneficiary must be under 
the care of a physician or allowed practitioner, as defined at Sec.  
484.2 of this chapter who establishes the plan of care. A doctor of 
podiatric medicine may establish a plan of care only if that is 
consistent with the functions he or she is authorized to perform under 
State law.
    (c) In need of skilled services. The beneficiary must need at least 
one of the following skilled services as certified by a physician or 
allowed practitioner, as defined at Sec.  484.2 of this chapter in 
accordance with the certification and recertification requirements for 
home health services under Sec.  424.22 of this chapter.
    (1) Intermittent skilled nursing services that meet the criteria for 
skilled services and the need for skilled services found in Sec.  
409.32. (Also see Sec.  409.33(a) and (b) for a description of examples 
of skilled nursing and rehabilitation services.) These criteria are 
subject to the following limitations in the home health setting:
    (i) In the home health setting, management and evaluation of a 
patient care plan is considered a reasonable and necessary skilled 
service when underlying conditions or complications are such that only a 
registered nurse can ensure that essential non-skilled care is achieving 
its purpose. To be considered a skilled service, the complexity of the 
necessary unskilled services that are a necessary part of the medical 
treatment must require the involvement of licensed nurses to promote the 
patient's recovery and medical safety in view of the overall condition. 
Where nursing visits are not needed to observe and assess the effects of 
the non-skilled services being provided

[[Page 372]]

to treat the illness or injury, skilled nursing care would not be 
considered reasonable and necessary, and the management and evaluation 
of the care plan would not be considered a skilled service. In some 
cases, the condition of the patient may cause a service that would 
originally be considered unskilled to be considered a skilled nursing 
service. This would occur when the patient's underlying condition or 
complication requires that only a registered nurse can ensure that 
essential non-skilled care is achieving its purpose. The registered 
nurse is ensuring that service is safely and effectively performed. 
However, a service is not considered a skilled nursing service merely 
because it is performed by or under the supervision of a licensed nurse. 
Where a service can be safely and effectively performed (or self 
administered) by non-licensed staff without the direct supervision of a 
nurse, the service cannot be regarded as a skilled service even if a 
nurse actually provides the service.
    (ii) In the home health setting, skilled education services are no 
longer needed if it becomes apparent, after a reasonable period of time, 
that the patient, family, or caregiver could not or would not be 
trained. Further teaching and training would cease to be reasonable and 
necessary in this case, and would cease to be considered a skilled 
service. Notwithstanding that the teaching or training was unsuccessful, 
the services for teaching and training would be considered to be 
reasonable and necessary prior to the point that it became apparent that 
the teaching or training was unsuccessful, as long as such services were 
appropriate to the patient's illness, functional loss, or injury.
    (2) Physical therapy services that meet the requirements of Sec.  
409.44(c).
    (3) Speech-language pathology services that meet the requirements of 
Sec.  409.44(c).
    (4) Occupational therapy services in the current and subsequent 
certification periods (subsequent adjacent episodes) that meet the 
requirements of Sec.  409.44(c) initially qualify for home health 
coverage as a dependent service as defined in Sec.  409.45(d) if the 
beneficiary's eligibility for home health services has been established 
by virtue of a prior need for intermittent skilled nursing care, speech-
language pathology services, or physical therapy in the current or prior 
certification period. Subsequent to an initial covered occupational 
therapy service, continuing occupational therapy services which meet the 
requirements of Sec.  409.44(c) are considered to be qualifying 
services.
    (d) Under a plan of care. The beneficiary must be under a plan of 
care that meets the requirements for plans of care specified in Sec.  
409.43.
    (e) By whom the services must be furnished. The home health services 
must be furnished by, or under arrangements made by, a participating 
HHA.

[59 FR 65494, Dec. 20, 1994; 60 FR 39122, Aug. 1, 1995, as amended at 74 
FR 58133, Nov. 10, 2009; 76 FR 68606, Nov. 4, 2011; 85 FR 27619, May 8, 
2020]



Sec.  409.43  Plan of care requirements.

    (a) Contents. An individualized plan of care must be established and 
periodically reviewed by the certifying physician or allowed 
practitioner.
    (1) The HHA must be acting upon a plan of care that meets the 
requirements of this section for HHA services to be covered.
    (2) For HHA services to be covered, the individualized plan of care 
must specify the services necessary to meet the patient-specific needs 
identified in the comprehensive assessment.
    (3)(i) The plan of care must include all of the following:
    (A) The identification of the responsible discipline(s) and the 
frequency and duration of all visits as well as those items listed in 
Sec.  484.60(a) of this chapter that establish the need for such 
services.
    (B) Any provision of remote patient monitoring or other services 
furnished via telecommunications technology (as defined in Sec.  
409.46(e)) or audio-only technology. Such services must be tied to the 
patient-specific needs as identified in the comprehensive assessment, 
cannot substitute for a home visit ordered as part of the plan of care, 
and cannot be considered a home visit for the purposes of patient 
eligibility or payment.
    (ii) All care provided must be in accordance with the plan of care.

[[Page 373]]

    (b) Physician's orders. The physician or allowed practitioner's 
orders for services in the plan of care must specify the medical 
treatments to be furnished as well as the type of home health discipline 
that will furnish the ordered services and at what frequency the 
services will be furnished. Orders for services to be provided ``as 
needed'' or ``PRN'' must be accompanied by a description of the 
beneficiary's medical signs and symptoms that would occasion the visit 
and a specific limit on the number of those visits to be made under the 
order before an additional physician or allowed practitioner order would 
have to be obtained. Orders for care may indicate a specific range in 
frequency of visits to ensure that the most appropriate level of 
services is furnished. If a range of visits is ordered, the upper limit 
of the range is considered the specific frequency.
    (c) Physician or allowed practitioner signature--(1) Request for 
Anticipated payment signature requirements. If the physician or allowed 
practitioner signed plan of care is not available at the time the HHA 
requests an anticipated payment of the initial percentage prospective 
payment in accordance with Sec.  484.205, the request for the 
anticipated payment must be based on--
    (i) A physician or allowed practitioner's orders that--
    (A) Is recorded in the plan of care;
    (B) Includes a description of the patient's condition and the 
services to be provided by the home health agency;
    (C) Includes an attestation (relating to the physician's orders and 
the date received) signed and dated by the registered nurse or qualified 
therapist (as defined in 42 CFR 484.115) responsible for furnishing or 
supervising the ordered service in the plan of care; and
    (D) Is copied into the plan of care and the plan of care is 
immediately submitted to the physician; or
    (ii) A referral prescribing detailed orders for the services to be 
rendered that is signed and dated by a physician.
    (2) Final percentage payment signature requirements. The plan of 
care must be signed and dated--
    (i) By a physician as described who meets the certification and 
recertification requirements of Sec.  424.22 of this chapter; and
    (ii) Before the claim for each episode (for episodes beginning on or 
before December 31, 2019) or 30-day period (for periods beginning on or 
after January 1, 2020) is submitted.
    (3) Changes to the plan of care signature requirements. Any changes 
in the plan must be signed and dated by a physician.
    (d) Oral (verbal) orders. If any services are provided based on a 
physician's oral orders, the orders must be put in writing and be signed 
and dated with the date of receipt by the registered nurse or qualified 
therapist (as defined in Sec.  484.115 of this chapter) responsible for 
furnishing or supervising the ordered services. Oral orders may only be 
accepted by personnel authorized to do so by applicable State and 
Federal laws and regulations as well as by the HHA's internal policies. 
The oral orders must also be countersigned and dated by the physician or 
allowed practitioner before the HHA bills for the care.
    (e) Frequency of review. (1) The plan of care must be reviewed by 
the physician or allowed practitioner (as specified in Sec.  409.42(b)) 
in consultation with agency professional personnel at least every 60 
days or more frequently when there is a--
    (i) Beneficiary elected transfer;
    (ii) Significant change in condition; or
    (iii) Discharge with goals met and/or no expectation of a return to 
home health care and the patient returns to home health care within 60 
days.
    (2) Each review of a beneficiary's plan of care must contain the 
signature of the physician or allowed practitioner who reviewed it and 
the date of review.
    (f) Termination of the plan of care. The plan of care is considered 
to be terminated if the beneficiary does not receive at least one 
covered skilled nursing, physical therapy, speech-language pathology 
services, or occupational therapy visit in a 60-day period unless the 
physician or allowed practitioner documents that the interval without

[[Page 374]]

such care is appropriate to the treatment of the beneficiary's illness 
or injury.

[59 FR 65494, Dec. 20, 1994, as amended at 65 FR 41210, July 3, 2000; 74 
FR 58133, Nov. 10, 2009; 80 FR 68717, Nov. 5, 2015; 82 FR 4578, Jan. 13, 
2017; 83 FR 56627, Nov. 13, 2018; 84 FR 60642, Nov. 8, 2019; 85 FR 
19285, Apr. 6, 2020; 85 FR 27619, May 8, 2020; 85 FR 70354, Nov. 4, 
2020]



Sec.  409.44  Skilled services requirements.

    (a) General. The Medicare Administrative Contractor's decision on 
whether care is reasonable and necessary is based on information 
provided on the forms and in the medical record concerning the unique 
medical condition of the individual beneficiary. A coverage denial is 
not made solely on the basis of the reviewer's general inferences about 
patients with similar diagnoses or on data related to utilization 
generally but is based upon objective clinical evidence regarding the 
beneficiary's individual need for care.
    (b) Skilled nursing care. (1) Skilled nursing care consists of those 
services that must, under State law, be performed by a registered nurse, 
or practical (vocational) nurse, as defined in Sec.  484.115 of this 
chapter, meet the criteria for skilled nursing services specified in 
Sec.  409.32, and meet the qualifications for coverage of skilled 
services specified in Sec.  409.42(c). See Sec.  409.33(a) and (b) for a 
description of skilled nursing services and examples of them.
    (i) In determining whether a service requires the skill of a 
licensed nurse, consideration must be given to the inherent complexity 
of the service, the condition of the beneficiary, and accepted standards 
of medical and nursing practice.
    (ii) If the nature of a service is such that it can safely and 
effectively be performed by the average nonmedical person without direct 
supervision of a licensed nurse, the service cannot be regarded as a 
skilled nursing service.
    (iii) The fact that a skilled nursing service can be or is taught to 
the beneficiary or to the beneficiary's family or friends does not 
negate the skilled aspect of the service when performed by the nurse.
    (iv) If the service could be performed by the average nonmedical 
person, the absence of a competent person to perform it does not cause 
it to be a skilled nursing service.
    (2) The skilled nursing care must be provided on a part-time or 
intermittent basis.
    (3) The skilled nursing services must be reasonable and necessary 
for the treatment of the illness or injury.
    (i) To be considered reasonable and necessary, the services must be 
consistent with the nature and severity of the beneficiary's illness or 
injury, his or her particular medical needs, and accepted standards of 
medical and nursing practice.
    (ii) The skilled nursing care provided to the beneficiary must be 
reasonable within the context of the beneficiary's condition.
    (iii) The determination of whether skilled nursing care is 
reasonable and necessary must be based solely upon the beneficiary's 
unique condition and individual needs, without regard to whether the 
illness or injury is acute, chronic, terminal, or expected to last a 
long time.
    (c) Physical therapy, speech-language pathology services, and 
occupational therapy. To be covered, physical therapy, speech-language 
pathology services, and occupational therapy must satisfy the criteria 
in paragraphs (c)(1) and (2) of this section.
    (1) Speech-language pathology services and physical or occupational 
therapy services must relate directly and specifically to a treatment 
regimen (established by the physician or allowed practitioner) after any 
needed consultation with the qualified therapist, that is designed to 
treat the beneficiary's illness or injury. Services related to 
activities for the general physical welfare of beneficiaries (for 
example, exercises to promote overall fitness) do not constitute 
physical therapy, occupational therapy, or speech-language pathology 
services for Medicare purposes. To be covered by Medicare, all of the 
requirements apply as follows:
    (i) The patient's plan of care must describe a course of therapy 
treatment and therapy goals which are consistent with the evaluation of 
the patient's function, and both must be included in the clinical 
record. The therapy goals

[[Page 375]]

must be established by a qualified therapist in conjunction with the 
physician or allowed practitioner.
    (ii) The patient's clinical record must include documentation 
describing how the course of therapy treatment for the patient's illness 
or injury is in accordance with accepted professional standards of 
clinical practice.
    (iii) Therapy treatment goals described in the plan of care must be 
measurable, and must pertain directly to the patient's illness or 
injury, and the patient's resultant impairments.
    (iv) The patient's clinical record must demonstrate that the method 
used to assess a patient's function included objective measurements of 
function in accordance with accepted professional standards of clinical 
practice enabling comparison of successive measurements to determine the 
effectiveness of therapy goals. Such objective measurements would be 
made by the qualified therapist using measurements which assess 
activities of daily living that may include but are not limited to 
eating, swallowing, bathing, dressing, toileting, walking, climbing 
stairs, or using assistive devices, and mental and cognitive factors.
    (2) Physical and occupational therapy and speech-language pathology 
services must be reasonable and necessary. To be considered reasonable 
and necessary, the following conditions must be met:
    (i) The services must be considered under accepted standards of 
professional clinical practice, to be a specific, safe, and effective 
treatment for the beneficiary's condition. Each of the following 
requirements must also be met:
    (A) The patient's function must be initially assessed and 
periodically reassessed by a qualified therapist, of the corresponding 
discipline for the type of therapy being provided, using a method which 
would include objective measurement as described in Sec.  
409.44(c)(1)(iv). If more than one discipline of therapy is being 
provided, a qualified therapist from each of the disciplines must 
perform the assessment and periodic reassessments. The measurement 
results and corresponding effectiveness of the therapy, or lack thereof, 
must be documented in the clinical record.
    (B) At least every 30 calendar days a qualified therapist (instead 
of an assistant) must provide the needed therapy service and 
functionally reassess the patient in accordance with Sec.  
409.44(c)(2)(i)(A). Where more than one discipline of therapy is being 
provided, a qualified therapist from each of the disciplines must 
provide the needed therapy service and functionally reassess the patient 
in accordance with Sec.  409.44(c)(2)(i)(A) at least every 30 calendar 
days.
    (C) As specified in paragraphs (c)(2)(i)(A) and (B) of this section, 
therapy visits for the therapy discipline(s) not in compliance with 
these policies will not be covered until the following conditions are 
met:
    (1) The qualified therapist has completed the reassessment and 
objective measurement of the effectiveness of the therapy as it relates 
to the therapy goals. As long as paragraphs (c)(2)(i)(C)(2) and 
(c)(2)(i)(C)(3) of this section are met, therapy coverage resumes with 
the completed reassessment therapy visit.
    (2) The qualified therapist has determined if goals have been 
achieved or require updating.
    (3) The qualified therapist has documented measurement results and 
corresponding therapy effectiveness in the clinical record in accordance 
with paragraph (c)(2)(i)(F) of this section.
    (D) If the criteria for maintenance therapy, described at Sec.  
409.44(c)(2)(iii)(B) and (C) of this section are not met, the following 
criteria must also be met for subsequent therapy visits to be covered:
    (1) If the objective measurements of the reassessment do not reveal 
progress toward goals, the qualified therapist together with the 
physician or allowed practitioner must determine whether the therapy is 
still effective or should be discontinued.
    (2) If therapy is to be continued in accordance with Sec.  
409.44(c)(2)(iv)(B)(1) of this section, the clinical record must 
document with a clinically supportable statement why there is an 
expectation that the goals are attainable in a reasonable and generally 
predictable period of time.

[[Page 376]]

    (E) Clinical notes written by therapy assistants may supplement the 
clinical record, and if included, must include the date written, the 
signature, professional designation, and objective measurements or 
description of changes in status (if any) relative to each goal being 
addressed by treatment. Assistants may not make clinical judgments about 
why progress was or was not made, but must report the progress or the 
effectiveness of the therapy (or lack thereof) objectively.
    (F) Documentation by a qualified therapist must include the 
following:
    (1) The therapist's assessment of the effectiveness of the therapy 
as it relates to the therapy goals;
    (2) Plans for continuing or discontinuing treatment with reference 
to evaluation results and or treatment plan revisions;
    (3) Changes to therapy goals or an updated plan of care that is sent 
to the physician or allowed practitioner for signature or discharge;
    (4) Documentation of objective evidence or a clinically supportable 
statement of expectation that the patient can continue to progress 
toward the treatment goals and is responding to therapy in a reasonable 
and generally predictable period of time; or in the case of maintenance 
therapy, the patient is responding to therapy and can meet the goals in 
a predictable period of time.
    (ii) The services must be of such a level of complexity and 
sophistication or the condition of the beneficiary must be such that the 
services required can safely and effectively be performed only by a 
qualified physical therapist or by a qualified physical therapy 
assistant under the supervision of a qualified physical therapist, by a 
qualified speech-language pathologist, or by a qualified occupational 
therapist or a qualified occupational therapy assistant under the 
supervision of a qualified occupational therapist (as defined in Sec.  
484.115 of this chapter). Services that do not require the performance 
or supervision of a physical therapist or an occupational therapist are 
not considered reasonable or necessary physical therapy or occupational 
therapy services, even if they are performed by or supervised by a 
physical therapist or occupational therapist. Services that do not 
require the skills of a speech-language pathologist are not considered 
to be reasonable and necessary speech-language pathology services even 
if they are performed by or supervised by a speech-language pathologist.
    (iii) For therapy services to be covered in the home health setting, 
one of the following three criteria must be met:
    (A) There must be an expectation that the beneficiary's condition 
will improve materially in a reasonable (and generally predictable) 
period of time based on the physician's or allowed practitioner's 
assessment of the beneficiary's restoration potential and unique medical 
condition.
    (1) Material improvement requires that the clinical record 
demonstrate that the patient is making improvement towards goals when 
measured against his or her condition at the start of treatment.
    (2) If an individual's expected restorative potential would be 
insignificant in relation to the extent and duration of therapy services 
required to achieve such potential, therapy would not be considered 
reasonable and necessary, and thus would not be covered.
    (3) When a patient suffers a transient and easily reversible loss or 
reduction of function which could reasonably be expected to improve 
spontaneously as the patient gradually resumes normal activities, 
because the services do not require the performance or supervision of a 
qualified therapist, those services are not to be considered reasonable 
and necessary covered therapy services.
    (B) The unique clinical condition of a patient may require the 
specialized skills, knowledge, and judgment of a qualified therapist to 
design or establish a safe and effective maintenance program required in 
connection with the patient's specific illness or injury.
    (1) If the services are for the establishment of a maintenance 
program, they must include the design of the program, the instruction of 
the beneficiary, family, or home health aides, and the necessary 
periodic reevaluations of the beneficiary and the program to the degree 
that the specialized knowledge and judgment of a physical

[[Page 377]]

therapist, speech-language pathologist, or occupational therapist is 
required.
    (2) The maintenance program must be established by a qualified 
therapist (and not an assistant).
    (C) The unique clinical condition of a patient may require the 
specialized skills of a qualified therapist or therapist assistant to 
perform a safe and effective maintenance program required in connection 
with the patient's specific illness or injury. Where the clinical 
condition of the patient is such that the complexity of the therapy 
services required--
    (1) Involve the use of complex and sophisticated therapy procedures 
to be delivered by the therapist or the therapist assistant in order to 
maintain function or to prevent or slow further deterioration of 
function; or
    (2) To maintain function or to prevent or slow further deterioration 
of function must be delivered by the therapist or the therapist 
assistant in order to ensure the patient's safety and to provide an 
effective maintenance program, then those reasonable and necessary 
services must be covered.
    (iv) The amount, frequency, and duration of the services must be 
reasonable and necessary, as determined by a qualified therapist and/or 
physician or allowed practitioner, using accepted standards of clinical 
practice.
    (A) Where factors exist that would influence the amount, frequency 
or duration of therapy services, such as factors that may result in 
providing more services than are typical for the patient's condition, 
those factors must be documented in the plan of care and/or functional 
assessment.
    (B) Clinical records must include documentation using objective 
measures that the patient continues to progress towards goals. If 
progress cannot be measured, and continued progress towards goals cannot 
be expected, therapy services cease to be covered except when--
    (1) Therapy progress regresses or plateaus, and the reasons for lack 
of progress are documented to include justification that continued 
therapy treatment will lead to resumption of progress toward goals; or
    (2) Maintenance therapy as described in Sec.  409.44(c)(2)(iii)(B) 
or (C) is needed.

[59 FR 65494, Dec. 20, 1994, as amended at 74 FR 58133, Nov. 10, 2009; 
75 FR 70461, Nov. 17, 2010; 76 FR 68606, Nov. 4, 2011; 77 FR 67162, Nov. 
8, 2012; 79 FR 66116, Nov. 6, 2014; 82 FR 4578, Jan. 13, 2017; 84 FR 
60642, Nov. 8, 2019; 85 FR 27619, May 8, 2020]



Sec.  409.45  Dependent services requirements.

    (a) General. Services discussed in paragraphs (b) through (g) of 
this section may be covered only if the beneficiary needs skilled 
nursing care on an intermittent basis, as described in Sec.  409.44(b); 
physical therapy or speech-language pathology services as described in 
Sec.  409.44(c); or has a continuing need for occupational therapy 
services as described in Sec.  409.44(c) if the beneficiary's 
eligibility for home health services has been established by virtue of a 
prior need for intermittent skilled nursing care, speech-language 
pathology services, or physical therapy in the current or prior 
certification period; and otherwise meets the qualifying criteria 
(confined to the home, under the care of a physician or allowed 
practitioner, in need of skilled services, and under a plan of care) 
specified in Sec.  409.42. Home health coverage is not available for 
services furnished to a beneficiary who is no longer in need of one of 
the qualifying skilled services specified in this paragraph. Therefore, 
dependent services furnished after the final qualifying skilled service 
are not covered, except when the dependent service was not followed by a 
qualifying skilled service as a result of the unexpected inpatient 
admission or death of the beneficiary, or due to some other 
unanticipated event.
    (b) Home health aide services. To be covered, home health aide 
services must meet each of the following requirements:
    (1) The reason for the visits by the home health aide must be to 
provide hands-on personal care to the beneficiary or services that are 
needed to maintain the beneficiary's health or to facilitate treatment 
of the beneficiary's illness or injury. The physician or allowed 
practitioner's orders must indicate the frequency of the home health 
aide services required by

[[Page 378]]

the beneficiary. These services may include but are not limited to:
    (i) Personal care services such as bathing, dressing, grooming, 
caring for hair, nail and oral hygiene that are needed to facilitate 
treatment or to prevent deterioration of the beneficiary's health, 
changing the bed linens of an incontinent beneficiary, shaving, 
deodorant application, skin care with lotions and/or powder, foot care, 
ear care, feeding, assistance with elimination (including enemas unless 
the skills of a licensed nurse are required due to the beneficiary's 
condition, routine catheter care, and routine colostomy care), 
assistance with ambulation, changing position in bed, and assistance 
with transfers.
    (ii) Simple dressing changes that do not require the skills of a 
licensed nurse.
    (iii) Assistance with medications that are ordinarily self-
administered and that do not require the skills of a licensed nurse to 
be provided safely and effectively.
    (iv) Assistance with activities that are directly supportive of 
skilled therapy services but do not require the skills of a therapist to 
be safely and effectively performed, such as routine maintenance 
exercises and repetitive practice of functional communication skills to 
support speech-language pathology services.
    (v) Routine care of prosthetic and orthotic devices.
    (2) The services to be provided by the home health aide must be--
    (i) Ordered by a physician or allowed practitioner in the plan of 
care; and
    (ii) Provided by the home health aide on a part-time or intermittent 
basis.
    (3) The services provided by the home health aide must be reasonable 
and necessary. To be considered reasonable and necessary, the services 
must--
    (i) Meet the requirement for home health aide services in paragraph 
(b)(1) of this section;
    (ii) Be of a type the beneficiary cannot perform for himself or 
herself; and
    (iii) Be of a type that there is no able or willing caregiver to 
provide, or, if there is a potential caregiver, the beneficiary is 
unwilling to use the services of that individual.
    (4) The home health aide also may perform services incidental to a 
visit that was for the provision of care as described in paragraphs 
(b)(3)(i) through (iii) of this section. For example, these incidental 
services may include changing bed linens, personal laundry, or preparing 
a light meal.
    (c) Medical social services. Medical social services may be covered 
if the following requirements are met:
    (1) The services are ordered by a physician or allowed practitioner 
and included in the plan of care.
    (2)(i) The services are necessary to resolve social or emotional 
problems that are expected to be an impediment to the effective 
treatment of the beneficiary's medical condition or to his or her rate 
of recovery.
    (ii) If these services are furnished to a beneficiary's family 
member or caregiver, they are furnished on a short-term basis and it can 
be demonstrated that the service is necessary to resolve a clear and 
direct impediment to the effective treatment of the beneficiary's 
medical condition or to his or her rate of recovery.
    (3) The frequency and nature of the medical social services are 
reasonable and necessary to the treatment of the beneficiary's 
condition.
    (4) The medical social services are furnished by a qualified social 
worker or qualified social work assistant under the supervision of a 
social worker as defined in Sec.  484.115 of this chapter.
    (5) The services needed to resolve the problems that are impeding 
the beneficiary's recovery require the skills of a social worker or a 
social work assistant under the supervision of a social worker to be 
performed safely and effectively.
    (d) Occupational therapy. Occupational therapy services that are not 
qualifying services under Sec.  409.44(c) are nevertheless covered as 
dependent services if the requirements of Sec.  409.44(c)(2)(i) through 
(iv), as to reasonableness and necessity, are met.
    (e) Durable medical equipment. Durable medical equipment in 
accordance with Sec.  410.38 of this chapter, which describes the scope 
and conditions of payment for durable medical equipment under Part B, 
may be covered under the home health benefit as either a Part A or

[[Page 379]]

Part B service. Durable medical equipment furnished by an HHA as a home 
health service is always covered by Part A if the beneficiary is 
entitled to Part A.
    (f) Medical supplies. Medical supplies (including catheters, 
catheter supplies, ostomy bags, and supplies relating to ostomy care but 
excluding drugs and biologicals) may be covered as a home health 
benefit. For medical supplies to be covered as a Medicare home health 
benefit, the medical supplies must be needed to treat the beneficiary's 
illness or injury that occasioned the home health care.
    (g) Intern and resident services. The medical services of interns 
and residents in training under an approved hospital teaching program 
are covered if the services are ordered by the physician or allowed 
practitioner who is responsible for the plan of care and the HHA is 
affiliated with or under the common control of the hospital furnishing 
the medical services.

Approved means--
    (1) Approved by the Accreditation Council for Graduate Medical 
Education;
    (2) In the case of an osteopathic hospital, approved by the 
Committee on Hospitals of the Bureau of Professional Education of the 
American Osteopathic Association;
    (3) In the case of an intern or resident-in-training in the field of 
dentistry, approved by the Council on Dental Education of the American 
Dental Association; or
    (4) In the case of an intern or resident-in-training in the field of 
podiatry, approved by the Council on Podiatric Medical Education of the 
American Podiatric Medical Association.

[59 FR 65495, Dec. 20, 1994; 60 FR 39122, 39123, Aug. 1, 1995, as 
amended at 82 FR 4578, Jan. 13, 2017; 85 FR 27620, May 8, 2020]



Sec.  409.46  Allowable administrative costs.

    Services that are allowable as administrative costs but are not 
separately billable include, but are not limited to, the following:
    (a) Registered nurse initial evaluation visits. Initial evaluation 
visits by a registered nurse for the purpose of assessing a 
beneficiary's health needs, determining if the agency can meet those 
health needs, and formulating a plan of care for the beneficiary are 
allowable administrative costs. If a physician or allowed practitioner 
specifically orders that a particular skilled service be furnished 
during the evaluation in which the agency accepts the beneficiary for 
treatment and all other coverage criteria are met, the visit is billable 
as a skilled nursing visit. Otherwise it is considered to be an 
administrative cost.
    (b) Visits by registered nurses or qualified professionals for the 
supervision of home health aides. Visits by registered nurses or 
qualified professionals for the purpose of supervising home health aides 
as required at Sec.  484.80(h) of this chapter are allowable 
administrative costs. Only if the registered nurse or qualified 
professional visits the beneficiary for the purpose of furnishing care 
that meets the coverage criteria at Sec.  409.44, and the supervisory 
visit occurs simultaneously with the provision of covered care, is the 
visit billable as a skilled nursing or therapist's visit.
    (c) Respiratory care services. If a respiratory therapist is used to 
furnish overall training or consultative advice to an HHA's staff and 
incidentally provides respiratory therapy services to beneficiaries in 
their homes, the costs of the respiratory therapist's services are 
allowable as administrative costs. Visits by a respiratory therapist to 
a beneficiary's home are not separately billable. However, respiratory 
therapy services that are furnished as part of a plan of care by a 
skilled nurse or physical therapist and that constitute skilled care may 
be separately billed as skilled visits.
    (d) Dietary and nutrition personnel. If dieticians or nutritionists 
are used to provide overall training or consultative advice to HHA staff 
and incidentally provide dietetic or nutritional services to 
beneficiaries in their homes, the costs of these professional services 
are allowable as administrative costs. Visits by a dietician or 
nutritionist to a beneficiary's home are not separately billable.

[[Page 380]]

    (e) Telecommunications technology. Telecommunications technology, as 
indicated on the plan of care, can include: remote patient monitoring, 
defined as the collection of physiologic data (for example, ECG, blood 
pressure, glucose monitoring) digitally stored and/or transmitted by the 
patient or caregiver or both to the home health agency; teletypewriter 
(TTY); and 2-way audio-video telecommunications technology that allows 
for real-time interaction between the patient and clinician. The costs 
of any equipment, set-up, and service related to the technology are 
allowable only as administrative costs. Visits to a beneficiary's home 
for the sole purpose of supplying, connecting, or training the patient 
on the technology, without the provision of a skilled service, are not 
separately billable.

[59 FR 65496, Dec. 20, 1994, as amended at 82 FR 4578, Jan. 13, 2017; 83 
FR 56627, Nov. 13, 2018; 85 FR 27620, May 8, 2020; 85 FR 70354, Nov. 4, 
2020]



Sec.  409.47  Place of service requirements.

    To be covered, home health services must be furnished in either the 
beneficiary's home or an outpatient setting as defined in this section.
    (a) Beneficiary's home. A beneficiary's home is any place in which a 
beneficiary resides that is not a hospital, SNF, or nursing facility as 
defined in sections 1861(e)(1), 1819(a)(1), of 1919(a)(1) of the Act, 
respectively.
    (b) Outpatient setting. For purposes of coverage of home health 
services, an outpatient setting may include a hospital, SNF or a 
rehabilitation center with which the HHA has an arrangement in 
accordance with the requirements of Sec.  484.105(e) of this chapter and 
that is used by the HHA to provide services that either--
    (1) Require equipment that cannot be made available at the 
beneficiary's home; or
    (2) Are furnished while the beneficiary is at the facility to 
receive services requiring equipment described in paragraph (b)(1) of 
this section.

[59 FR 65496, Dec. 20, 1994, as amended at 82 FR 4578, Jan. 13, 2017]



Sec.  409.48  Visits.

    (a) Number of allowable visits under Part A. To the extent that all 
coverage requirements specified in this subpart are met, payment may be 
made on behalf of eligible beneficiaries under Part A for an unlimited 
number of covered home health visits. All Medicare home health services 
are covered under hospital insurance unless there is no Part A 
entitlement.
    (b) Number of visits under Part B. To the extent that all coverage 
requirements specified in this subpart are met, payment may be made on 
behalf of eligible beneficiaries under Part B for an unlimited number of 
covered home health visits. Medicare home health services are covered 
under Part B only when the beneficiary is not entitled to coverage under 
Part A.
    (c) Definition of visit. A visit is an episode of personal contact 
with the beneficiary by staff of the HHA or others under arrangements 
with the HHA, for the purpose of providing a covered service.
    (1) Generally, one visit may be covered each time an HHA employee or 
someone providing home health services under arrangements enters the 
beneficiary's home and provides a covered service to a beneficiary who 
meets the criteria of Sec.  409.42 (confined to the home, under the care 
of a physician or allowed practitioner, in need of skilled services, and 
under a plan of care).
    (2) If the HHA furnishes services in an outpatient facility under 
arrangements with the facility, one visit may be covered for each type 
of service provided.
    (3) If two individuals are needed to provide a service, two visits 
may be covered. If two individuals are present, but only one is needed 
to provide the care, only one visit may be covered.
    (4) A visit is initiated with the delivery of covered home health 
services and ends at the conclusion of delivery of covered home health 
services. In those circumstances in which all reasonable and necessary 
home health services cannot be provided in the course of a single visit, 
HHA staff or others providing services under arrangements with the HHA 
may remain at the beneficiary's residence between

[[Page 381]]

visits (for example, to provide non-covered services). However, if all 
covered services could be provided in the course of one visit, only one 
visit may be covered.

[59 FR 65497, Dec. 20, 1994, as amended at 85 FR 27620, May 8, 2020]



Sec.  409.49  Excluded services.

    (a) Drugs and biologicals. Drugs and biologicals are excluded from 
payment under the Medicare home health benefit.
    (1) A drug is any chemical compound that may be used on or 
administered to humans or animals as an aid in the diagnosis, treatment 
or prevention of disease or other condition or for the relief of pain or 
suffering or to control or improve any physiological pathologic 
condition.
    (2) A biological is any medicinal preparation made from living 
organisms and their products including, but not limited to, serums, 
vaccines, antigens, and antitoxins.
    (b) Transportation. The transportation of beneficiaries, whether to 
receive covered care or for other purposes, is excluded from home health 
coverage. Costs of transportation of equipment, materials, supplies, or 
staff may be allowable as administrative costs, but no separate payment 
is made for them.
    (c) Services that would not be covered as inpatient services. 
Services that would not be covered if furnished as inpatient hospital 
services are excluded from home health coverage.
    (d) Housekeeping services. Services whose sole purpose is to enable 
the beneficiary to continue residing in his or her home (for example, 
cooking, shopping, Meals on Wheels, cleaning, laundry) are excluded from 
home health coverage.
    (e) Services covered under the End Stage Renal Disease (ESRD) 
program. Services that are covered under the ESRD program and are 
contained in the composite rate reimbursement methodology, including any 
service furnished to a Medicare ESRD beneficiary that is directly 
related to that individual's dialysis, are excluded from coverage under 
the Medicare home health benefit.
    (f) Prosthetic devices. Items that meet the requirements of Sec.  
410.36(a)(2) of this chapter for prosthetic devices covered under Part B 
are excluded from home health coverage. Catheters, catheter supplies, 
ostomy bags, and supplies relating to ostomy care are not considered 
prosthetic devices if furnished under a home health plan of care and are 
not subject to this exclusion from coverage.
    (g) Medical social services provided to family members. Except as 
provided in Sec.  409.45(c)(2), medical social services provided solely 
to members of the beneficiary's family and that are not incidental to 
covered medical social services being provided to the beneficiary are 
not covered.
    (h) Services covered under the home infusion therapy benefit. 
Services that are covered under the home infusion therapy benefit as 
outlined at Sec.  486.525 of this chapter, including any home infusion 
therapy services furnished to a Medicare beneficiary that is under a 
home health plan of care, are excluded from coverage under the Medicare 
home health benefit. Excluded home infusion therapy services pertain to 
the items and services for the provision of home infusion drugs, as 
defined at Sec.  486.505 of this chapter. Services for the provision of 
drugs and biologicals not covered under this definition may continue to 
be provided under the Medicare home health benefit.

[59 FR 65497, Dec. 20, 1994; 60 FR 39123, Aug. 1, 1995; 85 FR 70354, 
Nov. 4, 2020]



Sec.  409.50  Coinsurance for durable medical equipment (DME) and applicable 
disposable devices furnished as a home health service.

    The coinsurance liability of the beneficiary or other person for the 
following home health services is:
    (a) DME--20 percent of the customary (insofar as reasonable) charge.
    (b) An applicable disposable device (as defined in section 
1834(s)(2) of the Act)--20 percent of the payment amount for furnishing 
Negative Pressure Wound Therapy (NPWT) using a disposable device (as 
that term is defined in Sec.  484.202 of this chapter).

[81 FR 76796, Nov. 3, 2016]

[[Page 382]]



             Subpart F_Scope of Hospital Insurance Benefits



Sec.  409.60  Benefit periods.

    (a) When benefit periods begin. The initial benefit period begins on 
the day the beneficiary receives inpatient hospital, inpatient CAH, or 
SNF services for the first time after becoming entitled to hospital 
insurance. Thereafter, a new benefit period begins whenever the 
beneficiary receives inpatient hospital, inpatient CAH, or SNF services 
after he or she has ended a benefit period as described in paragraph (b) 
of this section.
    (b) When benefit periods end--(1) A benefit period ends when a 
beneficiary has, for at least 60 consecutive days not been an inpatient 
in any of the following:
    (i) A hospital that meets the requirements of section 1861(e)(1) of 
the Act.
    (ii) A CAH that meets the requirements of section 1820 of the Act.
    (iii) A SNF that meets the requirements of sections 1819(a)(1) or 
1861(y) of the Act.
    (2) For purposes of ending a benefit period, a beneficiary was an 
inpatient of a SNF if his or her care in the SNF met the skilled level 
of care requirements specified in Sec.  409.31(b) (1) and (3).
    (c) Presumptions. (1) For purposes of determining whether a 
beneficiary was an inpatient of a SNF under paragraph (b)(2) of this 
section--
    (i) A beneficiary's care met the skilled level of care requirements 
if inpatient SNF claims were paid for those services under Medicare or 
Medicaid, unless:
    (A) Such payments were made under Sec.  411.400 or Medicaid 
administratively necessary days provisions which result in payment for 
care not meeting the skilled level of care requirements, or
    (B) A Medicare denial and a Medicaid payment are made for the same 
period, in which case the presumption in paragraph (c)(2)(ii) of this 
section applies;
    (ii) A beneficiary's care met the skilled level of care requirements 
if a SNF claim was paid under section 1879(e) of the Social Security 
Act;
    (iii) A beneficiary's care did not meet the skilled level of care 
requirements if a SNF claim was paid for the services under Sec.  
411.400;
    (iv) A beneficiary's care did not meet the skilled level of care 
requirements if a Medicaid SNF claim was denied on the grounds that the 
services were not at the skilled level of care (even if paid under 
applicable Medicaid administratively necessary days provisions which 
result in payment for care not meeting the skilled level of care 
requirements);
    (2) For purposes of determining whether a beneficiary was an 
inpatient of a SNF under paragraph (b)(2) of this section a 
beneficiary's care in a SNF is presumed--
    (i) To have met the skilled level of care requirements during any 
period for which the beneficiary was assigned to one of the Resource 
Utilization Groups designated as representing the required level of 
care, as provided in Sec.  409.30.
    (ii) To have met the skilled level of care requirements if a 
Medicaid or Medicare claim was denied on grounds other than that the 
services were not at the skilled level of care;
    (iii) Not to have met the skilled level of care requirements if a 
Medicare SNF claim was denied on the grounds that the services were not 
at the skilled level of care and payment was not made under Sec.  
411.400; or
    (iv) Not to have met the skilled level of care requirements if no 
Medicare or Medicaid claim was submitted by the SNF.
    (3) If information upon which to base a presumption is not readily 
available, the intermediary may, at its discretion review the 
beneficiary's medical records to determine whether he or she was an 
inpatient of a SNF as set forth under paragraph (b)(2) of this section.
    (4) When the intermediary makes a benefit period determination based 
upon paragraph (c)(1) of this section, the beneficiary may seek to 
reverse the benefit period determination by timely appealing the prior 
Medicare SNF claim determination under part 405, subpart G of this 
chapter, or the prior Medicaid SNF claim under part 431, subpart E of 
this chapter.
    (5) When the intermediary makes a benefit period determination under 
paragraph (c)(2) of this section, the beneficiary will be notified of 
the basis for the determination, and of his or her right to present 
evidence to rebut the

[[Page 383]]

determination that the skilled level of care requirements specified in 
Sec.  409.31 (b)(1) and (b)(3) were or were not met on reconsideration 
and appeal under 42 CFR, part 405, subpart G of this chapter.
    (d) Limitation on benefit period determinations. When the 
intermediary considers the same prior SNF stay of a particular 
beneficiary in making benefit period determinations for more than one 
inpatient Medicare claim--
    (1) Medicare will recognize only the initial level of care 
characterization for that prior SNF stay (or if appealed under 42 CFR 
part 405, subpart G of this chapter, the level of care determined under 
appeal); or
    (2) If part of a prior SNF stay has one level of care 
characterization and another part has another level of care 
characterization, Medicare will recognize only the initial level of care 
characterization for a particular part of a prior SNF stay (or if 
appealed under 42 CFR part 405, subpart G of this chapter, the level of 
care determined under appeal).
    (e) Relation of benefit period to benefit limitations. The 
limitations specified in Sec. Sec.  409.61 and 409.64, and the 
deductible and coinsurance requirements set forth in subpart G of this 
part apply for each benefit period. The limitations of Sec.  409.63 
apply only to the initial benefit period.

[52 FR 22645, June 15, 1987; 52 FR 28824, Aug. 4, 1987, as amended at 58 
FR 30667, May 26, 1993; 63 FR 26307, May 12, 1998; 70 FR 45055, Aug. 4, 
2005]



Sec.  409.61  General limitations on amount of benefits.

    (a) Inpatient hospital or inpatient CAH services--(1) Regular 
benefit days. Up to 90 days are available in each benefit period, 
subject to the limitations on days for psychiatric hospital services set 
forth in Sec. Sec.  409.62 and 409.63.
    (i) For the first 60 days (referred to in this subpart as full 
benefit days), Medicare pays the hospital or CAH for all covered 
services furnished the beneficiary, except for a deductible which is the 
beneficiary's responsibility. (Section 409.82 specifies the requirements 
for the inpatient hospital deductible.)
    (ii) For the next 30 days (referred to in this subpart as 
coinsurance days), Medicare pays for all covered services except for a 
daily coinsurance amount, which is the beneficiary's responsibility. 
(Section 409.83 specifies the inpatient hospital coinsurance amounts.)
    (2) Lifetime reserve days. Each beneficiary has a non-renewable 
lifetime reserve of 60 days of inpatient hospital or inpatient CAH 
services that he may draw upon whenever he is hospitalized for more than 
90 days in a benefit period. Upon exhaustion of the regular benefit 
days, the reserve days will be used unless the beneficiary elects not to 
use them, as provided in Sec.  409.65. For lifetime reserve days, 
Medicare pays for all covered services except for a daily coinsurance 
amount that is the beneficiary's responsibility. (See Sec.  409.83.)
    (3) Order of payment for inpatient hospital or inpatient CAH 
services. Medicare pays for inpatient hospital services in the following 
order.
    (i) The 60 full benefit days;
    (ii) The 30 coinsurance days;
    (iii) The remaining lifetime reserve days.
    (b) Posthospital SNF care furnished by a SNF, or by a hospital or a 
CAH with a swing-bed approval. Up to 100 days are available in each 
benefit period after discharge from a hospital or CAH. For the first 20 
days, Medicare pays for all covered services. For the 21st through 100th 
day, Medicare pays for all covered services except for a daily 
coinsurance amount that is the beneficiary's responsibility.
    (c) Renewal of inpatient benefits. The beneficiary's full 
entitlement to the 90 inpatient hospital or inpatient CAH regular 
benefit days, and the 100 SNF benefit days, is renewed each time he or 
she begins a benefit period. However, once lifetime reserve days are 
used, they can never be renewed.
    (d) Home health services. Medicare Part A pays for all covered home 
health services \1\ with no deductible, and subject to the following 
limitations on payment for durable medical equipment (DME):
---------------------------------------------------------------------------

    \1\ Before July 1, 1981, Medicare Part A paid for not more than 100 
home health visits during one year following the beneficiary's most 
recent discharge from a hospital or a SNF.
---------------------------------------------------------------------------

    (1) For DME furnished by an HHA that is a nominal charge provider,

[[Page 384]]

Medicare Part A pays 80 percent of fair compensation.
    (2) For DME furnished by an HHA that is not a nominal charge 
provider, Medicare Part A pays the lesser of the following:
    (i) 80 percent of the reasonable cost of the service.
    (ii) The reasonable cost of, or the customary charge for, the 
service, whichever is less, minus 20 percent of the customary (insofar 
as reasonable) charge for the service.

[48 FR 12541, Mar. 25, 1983, as amended at 51 FR 41339, Nov. 14, 1986; 
54 FR 4027, Jan. 27, 1989; 58 FR 30666, 30667, May 26, 1993]



Sec.  409.62  Lifetime maximum on inpatient psychiatric care.

    There is a lifetime maximum of 190 days on inpatient psychiatric 
hospital services available to any beneficiary. Therefore, once an 
individual receives benefits for 190 days of care in a psychiatric 
hospital, no further benefits of that type are available to that 
individual.



Sec.  409.63  Reduction of inpatient psychiatric benefit days available 
in the initial benefit period.

    (a) Reduction rule. (1) If the individual was an inpatient in a 
psychiatric hospital on the first day of Medicare entitlement and for 
any of the 150 days immediately before that first day of entitlement, 
those days are subtracted from the 150 days (90 regular days plus 60 
lifetime reserve days) which would otherwise be available in the initial 
benefit period for inpatient psychiatric services in a psychiatric or 
general hospital.
    (2) Reduction is required only if the hospital was participating in 
Medicare as a psychiatric hospital on the individual's first day of 
entitlement.
    (3) The reduction applies only to the beneficiary's first benefit 
period. For subsequent benefit periods, the 90 benefit days, plus any 
remaining lifetime reserve days, subject to the 190 day lifetime limit 
on psychiatric hospital care, are available.
    (b) Application to general hospital days. (1) Days spent in a 
general hospital before entitlement are not subtracted under paragraph 
(a) of this section even if the stay was for diagnosis or treatment of 
mental illness.
    (2) After entitlement, all psychiatric care days, whether in a 
general or a psychiatric hospital, are counted toward the number of days 
available in the initial benefit period.
    (c) Examples: (1) The individual was an inpatient of a participating 
psychiatric hospital for 20 days before the first day of entitlement and 
remained there for another 6 months. Therefore, 130 days of benefits 
(150 minus 20) are payable. Payment could be made for: 60 full benefit 
days, 30 coinsurance days, and 40 lifetime reserve days.
    (2) During the 150-day period preceding Medicare entitlement, an 
individual had been a patient of a general hospital for 60 days of 
inpatient psychiatric care and had spent 90 days in a psychiatric 
hospital, ending with the first day of entitlement. During the initial 
benefit period, the beneficiary spent 90 days in a general hospital and 
received psychiatric care there. The 60 days spent in the general 
hospital for psychiatric treatment before entitlement do not reduce the 
benefits available in the first benefit period. Only the 90 days spent 
in the psychiatric hospital before entitlement reduce such benefits, 
leaving a total of 60 available psychiatric days. However, after 
entitlement, the reduction applies not only to days spent in a 
psychiatric hospital, but also to days of psychiatric treatment in a 
general hospital. Thus, Medicare payment could be made only for 60 of 
the 90 days spent in the general hospital.
    (3) An individual was admitted to a general hospital for a mental 
condition and, after 10 days, transferred to a participating psychiatric 
hospital. The individual remained in the psychiatric hospital for 78 
days before becoming entitled to hospital insurance benefits and for 130 
days after entitlement. The beneficiary was then transferred to a 
general hospital and received treatment of a medical condition for 20 
days. The 10 days spent in the general hospital during the 150-day pre-
entitlement period have no effect on the inpatient hospital benefit days 
available to the individual for psychiatric care in the first benefit 
period, even though the general hospital stay was for a

[[Page 385]]

mental condition. Only the 78 days spent in the psychiatric hospital 
during the pre-entitlement period are subtracted from the 150 benefit 
days. Accordingly, the individual has 72 days of psychiatric care (150 
days less 78 days) available in the first benefit period. Benefits could 
be paid for the individual's hospitalization during the first benefit 
period in the following manner. For the 130-day psychiatric hospital 
stay, 72 days (60 full benefit days and 12 coinsurance days), and for 
the general hospital stay, 20 days (18 coinsurance and 2 lifetime 
reserve days).



Sec.  409.64  Services that are counted toward allowable amounts.

    (a) Except as provided in paragraph (b) of this section for lifetime 
reserve days, all covered inpatient days and home health visits are 
counted toward the allowable amounts specified in Sec. Sec.  409.61 
through 409.63 if--
    (1) They are paid for by Medicare; or
    (2) They would be paid for by Medicare if the following requirements 
had been met:
    (i) A proper and timely request for payment had been filed; and
    (ii) The hospital, CAH, SNF, or home health agency had submitted all 
necessary evidence, including physician or allowed practitioner 
certification of need for services when such certification was required;
    (3) They could not be paid for because the total payment due was 
equal to, or less than, the applicable deductible and coinsurance 
amounts.
    (b) Exception. Even though the requirements of paragraph (a)(2) of 
this section are met, lifetime reserve days are not counted toward the 
allowable amounts if the beneficiary elected or is deemed to have 
elected not to use them as set forth in Sec.  409.65.

[48 FR 12541, Mar. 25, 1983, as amended at 58 FR 30667, May 26, 1993; 85 
FR 70354, Nov. 4, 2020]



Sec.  409.65  Lifetime reserve days.

    (a) Election not to use lifetime reserve days. (1) Whenever a 
beneficiary has exhausted the 90 regular benefit days, the hospital or 
CAH may bill Medicare for lifetime reserve days unless the beneficiary 
elects not to use them or, in accordance with paragraph (b) of this 
section, is deemed to have elected not to use them.
    (2) It may be advantageous to elect not to use lifetime reserve days 
if the beneficiary has private insurance coverage that begins after the 
first 90 inpatient days in a benefit period, or if the daily charge is 
only slightly higher than the lifetime reserve days coinsurance amount. 
In such cases, the beneficiary may want to save the lifetime reserve 
days for future care that may be more expensive.
    (3) If the beneficiary elects not to use lifetime reserve days for a 
particular hospital or CAH stay, they are still available for a later 
stay. However, once the beneficiary uses lifetime reserve days, they can 
never be renewed.
    (4) If the beneficiary elects not to use lifetime reserve days, the 
hospital or CAH may require him or her to pay for any services furnished 
after the regular days are exhausted.
    (b) Deemed election. A beneficiary will be deemed to have elected 
not to use lifetime reserve days if the average daily charges for such 
days is equal to or less than the applicable coinsurance amount 
specified in Sec.  409.83. A beneficiary would get no benefit from using 
the days under those circumstances.
    (c) Who may file an election. An election not to use reserve days 
may be filed by--
    (1) The beneficiary; or
    (2) If the beneficiary is physically or mentally unable to act, by 
the beneficiary's legal representative. In addition, if some other 
payment source is available, such as private insurance, any person 
authorized under Sec.  405.1664 of this chapter to execute a request for 
payment for the beneficiary may file the election.
    (d) Filing the election. (1) The beneficiary's election not to use 
lifetime reserve days must be filed in writing with the hospital or CAH.
    (2) The election may be filed at the time of admission to the 
hospital or CAH or at any time thereafter up to 90 days after the 
beneficiary's discharge.
    (3) A retroactive election (that is, one made after lifetime reserve 
days have been used because the regular days were exhausted), is not 
acceptable unless it is approved by the hospital or CAH.

[[Page 386]]

    (e) Period covered by election--(1) General rule. Except as provided 
in paragraph (e)(2) of this section, an election not to use lifetime 
reserve days may apply to an entire hospital or CAH stay or to a single 
period of consecutive days in a stay, but cannot apply to selected days 
in a stay. For example, a beneficiary may restrict the election to the 
period covered by private insurance but cannot use individual lifetime 
reserve days within that period. If an election not to use reserve days 
is effective after the first day on which reserve days are available, it 
must remain in effect until the end of the stay, unless it is revoked in 
accordance with Sec.  409.66.
    (2) Exception. A beneficiary election not to use lifetime reserve 
days for an inpatient hospital or inpatient CAH stay for which payment 
may be made under the prospective payment system (part 412 of this 
chapter) is subject to the following rules:
    (i) If the beneficiary has one or more regular benefit days (see 
Sec.  409.61(a)(1) of this chapter) remaining in the benefit period upon 
entering the hospital or CAH, an election not to use lifetime reserve 
days will apply automatically to all days that are not outlier days. The 
beneficiary may also elect not to use lifetime reserve days for outlier 
days but this election must apply to all outlier days.
    (ii) If the beneficiary has no regular benefit days (see Sec.  
409.61(a)(1) of this chapter) remaining in the benefit period upon 
entering the hospital or CAH, an election not to use lifetime reserve 
days must apply to the entire hospital or CAH stay.

[48 FR 12541, Mar. 25, 1983, as amended at 48 FR 39837, Sept. 1, 1983; 
49 FR 323, Jan. 3, 1984; 58 FR 30666, 30667, May 26, 1993]



Sec.  409.66  Revocation of election not to use lifetime reserve days.

    (a) Except as provided in paragraph (c) of this section, a 
beneficiary (or anyone authorized to execute a request for payment, if 
the beneficiary is incapacitated) may revoke an election not to use 
lifetime reserve days during hospitalization or within 90 days after 
discharge.
    (b) The revocation must be submitted to the hospital or CAH in 
writing and identify the stay or stays to which it applies.
    (c) Exceptions. A revocation of an election not to use lifetime 
reserve days may not be filed--
    (1) After the beneficiary dies; or
    (2) After the hospital or CAH has filed a claim under the 
supplementary medical insurance program (Medicare Part B), for medical 
and other health services furnished to the beneficiary on the days in 
question.

[48 FR 12541, Mar. 25, 1983, as amended at 58 FR 30666, May 26, 1993]



Sec.  409.68  Guarantee of payment for inpatient hospital or inpatient 
CAH services furnished before notification of exhaustion of benefits.

    (a) Conditions for payment. Payment may be made for inpatient 
hospital or inpatient CAH services furnished a beneficiary after he or 
she has exhausted the available benefit days if the following conditions 
are met:
    (1) The services were furnished before CMS or the intermediary 
notified the hospital or CAH that the beneficiary had exhausted the 
available benefit days and was not entitled to have payment made for 
those services.
    (2) At the time the hospital or CAH furnished the services, it was 
unaware that the beneficiary had exhausted the available benefit days 
and could reasonably have assumed that he or she was entitled to have 
payment made for these services.
    (3) Payment would be precluded solely because the beneficiary has no 
benefit days available for the particular hospital or CAH stay.
    (4) The hospital or CAH claims reimbursement for the services and 
refunds any payments made for those services by the beneficiary or by 
another person on his or her behalf.
    (b) Limitations on payment. (1) If all of the conditions in 
paragraph (a) of this section are met, Medicare payment may be made for 
the day of admission, and up to 6 weekdays thereafter, plus any 
intervening Saturdays, Sundays, and Federal holidays.
    (2) Payment may not be made under this section for any day after the 
hospital or CAH is notified that the beneficiary has exhausted the 
available benefit days.

[[Page 387]]

    (c) Recovery from the beneficiary. Any payment made to a hospital or 
CAH under this section is considered an overpayment to the beneficiary 
and may be recovered from him or her under the provisions set forth 
elsewhere in this chapter.

[48 FR 12541, Mar. 25, 1983, as amended at 50 FR 33033, Aug. 16, 1985; 
58 FR 30666, May 26, 1993]



        Subpart G_Hospital Insurance Deductibles and Coinsurance



Sec.  409.80  Inpatient deductible and coinsurance: General provisions.

    (a) What they are. (1) The inpatient deductible and coinsurance 
amounts are portions of the cost of covered hospital or CAH or SNF 
services that Medicare does not pay.
    (2) The hospital or CAH or SNF may charge these amounts to the 
beneficiary or someone on his or her behalf.
    (b) Changes in the inpatient deductible and coinsurance amounts. (1) 
The law requires the Secretary to adjust the inpatient hospital 
deductible each year to reflect changes in the average cost of hospital 
care. In adjusting the deductible, the Secretary must use a formula 
specified in section 1813(b)(2) of the Act. Under that formula, the 
inpatient hospital deductible is increased each year by about the same 
percentage as the increase in the average Medicare daily hospital costs. 
The result of the deductible increase is that the beneficiary continues 
to pay about the same proportion of the hospital bill.
    (2) Since the coinsurance amounts are, by statute, specific 
fractions of the deductible, they change when the deductible changes.

[48 FR 12541, Mar. 25, 1983, as amended at 58 FR 30666, May 26, 1993]



Sec.  409.82  Inpatient hospital deductible.

    (a) General provisions--(1) The inpatient hospital deductible is a 
fixed amount chargeable to the beneficiary when he or she receives 
covered services in a hospital or a CAH for the first time in a benefit 
period.
    (2) Although the beneficiary may be hospitalized several times 
during a benefit period, the deductible is charged only once during that 
period. If the beneficiary begins more than one benefit period in the 
same year, a deductible is charged for each of those periods.
    (3) For services furnished before January 1, 1982, the applicable 
deductible is the one in effect when the benefit period began.
    (4) For services furnished after December 31, 1981, the applicable 
deductible is the one in effect during the calendar year in which the 
services were furnished.
    (b) Specific deductible amounts. The specific deductible amounts for 
each calendar year are published in the Federal Register no later than 
October 1 of the preceding year.
    (c) Exception to published amounts. If the total hospital or CAH 
charge is less than the deductible amount applicable for the calendar 
year in which the services were furnished, the amount of the charge is 
the deductible for the year.

[48 FR 12541, Mar. 25, 1983, as amended at 54 FR 4026, Jan. 27, 1989; 58 
FR 30666, 30667, May 26, 1993]



Sec.  409.83  Inpatient hospital coinsurance.

    (a) General provisions--(1) Inpatient hospital coinsurance is the 
amount chargeable to a beneficiary for each day after the first 60 days 
of inpatient hospital care or inpatient CAH care or both in a benefit 
period.
    (2) For each day from the 61st to the 90th day, the coinsurance 
amount is \1/4\ of the applicable deductible.
    (3) For each day from the 91st to the 150th day (lifetime reserve 
days), the coinsurance amount is \1/2\ of the applicable deductible.
    (4) For coinsurance days before January 1, 1982, the coinsurance 
amount is based on the deductible applicable for the calendar year in 
which the benefit period began. The coinsurance amounts do not change 
during a beneficiary's benefit period even though the coinsurance days 
may fall in a subsequent year for which a higher deductible amount has 
been determined.
    (5) For coinsurance days after December 31, 1981, the coinsurance 
amount is based on the deductible applicable for the calendar year in 
which

[[Page 388]]

the services were furnished. For example, if an individual starts a 
benefit period by being admitted to a hospital in 1981 and remains in 
the hospital long enough to use coinsurance days in 1982, the 
coinsurance amount charged for those days is based on the 1982 inpatient 
hospital deductible.
    (b) Specific coinsurance amounts. The specific coinsurance amounts 
for each calendar year are published in the Federal Register no later 
than October 1 of the preceding year.
    (c) Exceptions to published amounts. (1) If the actual charge to the 
patient for the 61st through the 90th day of inpatient hospital or 
inpatient CAH services is less than the coinsurance amount applicable 
for the calendar year in which the services were furnished, the actual 
charge per day is the daily coinsurance amount.
    (2) If the actual charge to the patient for the 91st through the 
150th day (lifetime reserve days) is less than the coinsurance amount 
applicable for the calendar year in which the services were furnished, 
the beneficiary is deemed to have elected not to use the days because he 
or she would not benefit from using them.

[48 FR 12541, Mar. 25, 1983, as amended at 54 FR 4026, Jan. 27, 1989; 58 
FR 30666, 30667, May 26, 1993]



Sec.  409.85  Skilled nursing facility (SNF) care coinsurance.

    (a) General provisions. (1) SNF care coinsurance is the amount 
chargeable to a beneficiary after the first 20 days of SNF care in a 
benefit period.
    (2) For each day from the 21st through the 100th day, the 
coinsurance is \1/8\ of the applicable inpatient hospital deductible.
    (3) For coinsurance days before January 1, 1982, the coinsurance 
amount is based on the deductible applicable for the year in which the 
benefit period began. The coinsurance amounts do not change during a 
beneficiary's benefit period even though the coinsurance days may fall 
in a subsequent year for which a higher deductible amount has been 
determined.
    (4) For coinsurance days after December 31, 1981, the coinsurance 
amount is based on the deductible applicable for the calendar year in 
which the services were furnished.
    (b) Specific coinsurance amounts. The specific SNF coinsurance 
amounts for each calendar year are published in the Federal Register no 
later than October 1 of the preceding year.
    (c) Exception to published amounts. If the actual charge to the 
patient is less than the coinsurance amount applicable for the calendar 
year in which the services were furnished, the actual charge per day is 
the daily coinsurance.

[48 FR 12541, Mar. 25, 1983, as amended at 54 FR 4026, Jan. 27, 1989]



Sec.  409.87  Blood deductible.

    (a) General provisions. (1) As used in this section, packed red 
cells means the red blood cells that remain after plasma is separated 
from whole blood.
    (2) A unit of packed red cells is treated as the equivalent of a 
unit of whole blood.
    (3) Medicare does not pay for the first 3 units of whole blood or 
units of packed red cells that a beneficiary receives, during a calendar 
year, as an inpatient of a hospital or CAH or SNF, or on an outpatient 
basis under Medicare Part B.
    (4) The deductible does not apply to other blood components such as 
platelets, fibrinogen, plasma, gamma globulin, and serum albumin, or to 
the cost of processing, storing, and administering blood.
    (5) The blood deductible is in addition to the inpatient hospital 
deductible and daily coinsurance.
    (6) The Part A blood deductible is reduced to the extent that the 
Part B blood deductible has been applied. For example, if a beneficiary 
had received one unit under Medicare Part B, and later in the same 
benefit period received three units under Medicare Part A, Medicare Part 
A would pay for the third of the latter units. (As specified in Sec.  
410.161 of this chapter, the Part B blood deductible is reduced to the 
extent a blood deductible has been applied under Medicare Part A.)
    (b) Beneficiary's responsibility for the first 3 units of whole 
blood or packed red cells--(1) Basic rule. Except as specified in 
paragraph (b)(2) of this section, the beneficiary is responsible for the 
first 3

[[Page 389]]

units of whole blood or packed red cells. He or she has the option of 
paying the hospital's or CAH's charges for the blood or packed red cells 
or arranging for it to be replaced.
    (2) Exception. The beneficiary is not responsible for the first 3 
units of whole blood or packed red cells if the provider obtained that 
blood or red cells at no charge other than a processing or service 
charge. In that case, the blood or red cells is deemed to have been 
replaced.
    (c) Provider's right to charge for the first 3 units of whole blood 
or packed red cells--(1) Basic rule. Except as specified in paragraph 
(c)(2) of this section, a provider may charge a beneficiary its 
customary charge for any of the first 3 units of whole blood or packed 
red cells.
    (2) Exception. A provider may not charge the beneficiary for the 
first 3 units of whole blood or packed red cells in any of the following 
circumstances:
    (i) The blood or packed red cells has been replaced.
    (ii) The provider (or its blood supplier) receives, from an 
individual or a blood bank, a replacement offer that meets the criteria 
specified in paragraph (d) of this section. The provider is precluded 
from charging even if it or its blood supplier rejects the replacement 
offer.
    (iii) The provider obtained the blood or packed red cells at no 
charge other than a processing or service charge and it is therefore 
deemed to have been replaced.
    (d) Criteria for replacement of blood. A blood replacement offer 
made by a beneficiary, or an individual or a blood bank on behalf of a 
beneficiary, discharges the beneficiary's obligation to pay for 
deductible blood or packed red cells if the replacement blood meets the 
applicable criteria specified in Food and Drug Administration 
regulations under 21 CFR part 640, i.e.--
    (1) The replacement blood would not endanger the health of a 
beneficiary; and
    (2) The prospective donor's health would not be endangered by making 
a blood donation.

[48 FR 12541, Mar. 25, 1983, as amended at 56 FR 8840, Mar. 1, 1991; 57 
FR 36014, Aug. 12, 1992; 58 FR 30666, 30667, May 26, 1993]



Sec.  409.89  Exemption of kidney donors from deductible 
and coinsurance requirements.

    The deductible and coinsurance requirements set forth in this 
subpart do not apply to any services furnished to an individual in 
connection with the donation of a kidney for transplant surgery.



            Subpart H_Payment of Hospital Insurance Benefits

    Source: 53 FR 6633, Mar. 2, 1988, unless otherwise noted.



Sec.  409.100  To whom payment is made.

    (a) Basic rule. Except as provided in paragraph (b) of this 
section--
    (1) Medicare pays hospital insurance benefits only to a 
participating provider.
    (2) For home health services (including medical supplies described 
in section 1861(m)(5) of the Act, but excluding durable medical 
equipment to the extent provided for in such section) furnished to an 
individual who at the time the item or service is furnished is under a 
plan of care of an HHA, payment is made to the HHA (without regard to 
whether the item or service is furnished by the HHA directly, under 
arrangement with the HHA, or under any other contracting or consulting 
arrangement).
    (b) Exceptions. Medicare may pay hospital insurance benefits as 
follows:
    (1) For emergency services furnished by a nonparticipating hospital, 
to the hospital or to the beneficiary, under the conditions prescribed 
in subpart G of part 424 of this chapter.
    (2) For services furnished by a Canadian or Mexican hospital, to the 
hospital or to the beneficiary, under the conditions prescribed in 
subpart H of part 424 of this chapter.

[53 FR 6633, Mar. 2, 1988, as amended at 65 FR 41211, July 3, 2000]



Sec.  409.102  Amounts of payment.

    (a) The amounts Medicare pays for hospital insurance benefits are 
generally determined in accordance with part 412 or part 413 of this 
chapter.
    (b) Except as provided in Sec. Sec.  409.61(d) and 409.89, hospital 
insurance benefits

[[Page 390]]

are subject to the deductible and coinsurance requirements set forth in 
subpart G of this part.



PART 410_SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS--Table of Contents



                      Subpart A_General Provisions

Sec.
410.1 Basis and scope.
410.2 Definitions.
410.3 Scope of benefits.
410.5 Other applicable rules.

               Subpart B_Medical and Other Health Services

410.10 Medical and other health services: Included services.
410.12 Medical and other health services: Basic conditions and 
          limitations.
410.14 Special requirements for services furnished outside the United 
          States.
410.15 Annual wellness visits providing Personalized Prevention Plan 
          Services: Conditions for and limitations on coverage.
410.16 Initial preventive physical examination: Conditions for and 
          limitations on coverage.
410.17 Cardiovascular disease screening tests.
410.18 Diabetes screening tests.
410.19 Ultrasound screening for abdominal aortic aneurysms: Condition 
          for and limitation on coverage.
410.20 Physicians' services.
410.21 Limitations on services of a chiropractor.
410.22 Limitations on services of an optometrist.
410.23 Screening for glaucoma: Conditions for and limitations on 
          coverage
410.24 Limitations on services of a doctor of dental surgery or dental 
          medicine.
410.25 Limitations on services of a podiatrist.
410.26 Services and supplies incident to a physician's professional 
          services: Conditions.
410.27 Therapeutic outpatient hospital or CAH services and supplies 
          incident to a physician's or nonphysician practitioner's 
          service: Conditions.
410.28 Hospital or CAH diagnostic services furnished to outpatients: 
          Conditions.
410.29 Limitations on drugs and biologicals.
410.30 Prescription drugs used in immunosuppressive therapy.
410.31 Bone mass measurement: Conditions for coverage and frequency 
          standards.
410.32 Diagnostic X-ray tests, diagnostic laboratory tests, and other 
          diagnostic tests: Conditions.
410.33 Independent diagnostic testing facility.
410.34 Mammography services: Conditions for and limitations on coverage.
410.35 X-ray therapy and other radiation therapy services: Scope.
410.36 Medical supplies, appliances, and devices: Scope.
410.37 Colorectal cancer screening tests: Conditions for and limitations 
          on coverage.
410.38 Durable medical equipment, prosthetics, orthotics and supplies 
          (DMEPOS): Scope and conditions.
410.39 Prostate cancer screening tests: Conditions for and limitations 
          on coverage.
410.40 Coverage of ambulance services.
410.41 Requirements for ambulance providers and suppliers.
410.42 Limitations on coverage of certain services furnished to hospital 
          outpatients.
410.43 Partial hospitalization services: Conditions and exclusions.
410.45 Rural health clinic services: Scope and conditions.
410.46 Physician and other practitioner services furnished in or at the 
          direction of an IHS or Indian tribal hospital or clinic: Scope 
          and conditions.
410.47 Pulmonary rehabilitation program: Conditions for coverage.
410.48 Kidney disease education services.
410.49 Cardiac rehabilitation program and intensive cardiac 
          rehabilitation program: Conditions of coverage.
410.50 Institutional dialysis services and supplies: Scope and 
          conditions.
410.52 Home dialysis services, supplies, and equipment: Scope and 
          conditions.
410.55 Services related to kidney donations: Conditions.
410.56 Screening pelvic examinations.
410.57 Pneumococcal vaccine and flu vaccine.
410.58 Additional services to HMO and CMP enrollees.
410.59 Outpatient occupational therapy services: Conditions.
410.60 Outpatient physical therapy services: Conditions.
410.61 Plan of treatment requirements for outpatient rehabilitation 
          services.
410.62 Outpatient speech-language pathology services: Conditions and 
          exclusions.
410.63 Hepatitis B vaccine and blood clotting factors: Conditions.
410.64 Additional preventive services.
410.66 Emergency outpatient services furnished by a nonparticipating 
          hospital and services furnished in a foreign country.
410.67 Medicare coverage and payment of Opioid use disorder treatment 
          services furnished by Opioid treatment programs.
410.68 Antigens: Scope and conditions.

[[Page 391]]

410.69 Services of a certified registered nurse anesthetist or an 
          anesthesiologist's assistant: Basic rule and definitions.
410.71 Clinical psychologist services and services and supplies incident 
          to clinical psychologist services.
410.73 Clinical social worker services.
410.74 Physician assistants' services.
410.75 Nurse practitioners' services.
410.76 Clinical nurse specialists' services.
410.77 Certified nurse-midwives' services: Qualifications and 
          conditions.
410.78 Telehealth services.
410.79 Medicare Diabetes Prevention Program expanded model: Conditions 
          of coverage.

                Subpart C_Home Health Services Under SMI

410.80 Applicable rules.

   Subpart D_Comprehensive Outpatient Rehabilitation Facility (CORF) 
                                Services

410.100 Included services.
410.102 Excluded services.
410.105 Requirements for coverage of CORF services.

  Subpart E_Community Mental Health Centers (CMHCs) Providing Partial 
                        Hospitalization Services

410.110 Requirements for coverage of partial hospitalization services by 
          CMHCs.

Subpart F [Reserved]

                   Subpart G_Medical Nutrition Therapy

410.130 Definitions.
410.132 Medical nutrition therapy.
410.134 Provider qualifications.

  Subpart H_Outpatient Diabetes Self-Management Training and Diabetes 
                          Outcome Measurements

410.140 Definitions.
410.141 Outpatient diabetes self-management training.
410.142 CMS process for approving national accreditation organizations.
410.143 Requirements for approved accreditation organizations.
410.144 Quality standards for deemed entities.
410.145 Requirements for entities.
410.146 Diabetes outcome measurements.

                    Subpart I_Payment of SMI Benefits

410.150 To whom payment is made.
410.152 Amounts of payment.
410.155 Outpatient mental health treatment limitation.
410.160 Part B annual deductible.
410.161 Part B blood deductible.
410.163 Payment for services furnished to kidney donors.
410.165 Payment for rural health clinic services and ambulatory surgical 
          center services: Conditions.
410.170 Payment for home health services, for medical and other health 
          services furnished by a provider or an approved ESRD facility, 
          and for comprehensive outpatient rehabilitation facility 
          (CORF) services: Conditions.
410.172 Payment for partial hospitalization services in CMHCs: 
          Conditions.
410.175 Alien absent from the United States.

    Authority: 42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd.

    Source: 51 FR 41339, Nov. 14, 1986, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 410 appear at 62 FR 
46037, Aug. 29, 1997.



                      Subpart A_General Provisions



Sec.  410.1  Basis and scope.

    (a) Statutory basis. This part is based on the indicated provisions 
of the following sections of the Act:
    (1) Section 1832--Scope of benefits furnished under the Medicare 
Part B supplementary medical insurance (SMI) program.
    (2) Section 1833 through 1835 and 1862--Amounts of payment for SMI 
services, the conditions for payment, and the exclusions from coverage.
    (3) Section 1861(qq)--Definition of the kinds of services that may 
be covered.
    (4) Section 1865(b)--Permission for CMS to approve and recognize a 
national accreditation organization for the purpose of deeming entities 
accredited by the organization to meet program requirements.
    (5) Section 1881--Medicare coverage for end-stage renal disease 
beneficiaries.
    (6) Section 1842(o)--Payment for drugs and biologicals not paid on a 
cost or prospective payment basis.
    (b) Scope of part. This part sets forth the benefits available under 
Medicare Part B, the conditions for payment and the limitations on 
services, the percentage of incurred expenses that Medicare Part B pays, 
and the deductible and copayment amounts for which the beneficiary is 
responsible. (Exclusions applicable to these services are

[[Page 392]]

set forth in subpart C of part 405 of this chapter. General conditions 
for Medicare payment are set forth in part 424 of this chapter.)

[51 FR 41339, Nov. 14, 1986, as amended at 53 FR 6648, Mar. 2, 1988; 55 
FR 53521, Dec. 31, 1990; 59 FR 63462, Dec. 8, 1994; 63 FR 58905, Nov. 2, 
1998; 65 FR 83148, Dec. 29, 2000; 69 FR 66420, Nov. 15, 2004]



Sec.  410.2  Definitions.

    As used in this part--
    Community mental health center (CMHC) means an entity that--
    (1) Provides outpatient services, including specialized outpatient 
services for children, the elderly, individuals who are chronically 
mentally ill, and residents of its mental health service area who have 
been discharged from inpatient treatment at a mental health facility;
    (2) Provides 24-hour-a-day emergency care services;
    (3) Provides day treatment or other partial hospitalization 
services, or psychosocial rehabilitation services;
    (4) Provides screening for patients being considered for admission 
to State mental health facilities to determine the appropriateness of 
this admission;
    (5) Meets applicable licensing or certification requirements for 
CMHCs in the State in which it is located; and
    (6) Provides at least 40 percent of its services to individuals who 
are not eligible for benefits under title XVIII of the Social Security 
Act.
    Encounter means a direct personal contact between a patient and a 
physician, or other person who is authorized by State licensure law and, 
if applicable, by hospital or CAH staff bylaws, to order or furnish 
hospital services for diagnosis or treatment of the patient.
    Nominal charge provider means a provider that furnishes services 
free of charge or at a nominal charge, and is either a public provider 
or another provider that (1) demonstrates to CMS's satisfaction that a 
significant portion of its patients are low-income; and (2) requests 
that payment for its services be determined accordingly.
    Outpatient means a person who has not been admitted as an inpatient 
but who is registered on the hospital or CAH records as an outpatient 
and receives services (rather than supplies alone) directly from the 
hospital or CAH.
    Partial hospitalization services means a distinct and organized 
intensive ambulatory treatment program that offers less than 24-hour 
daily care other than in an individual's home or in an inpatient or 
residential setting and furnishes the services as described in Sec.  
410.43.
    Participating refers to a hospital, CAH, SNF, HHA, CORF, or hospice 
that has in effect an agreement to participate in Medicare; or a clinic, 
rehabilitation agency, or public health agency that has a provider 
agreement to participate in Medicare but only for purposes of providing 
outpatient physical therapy, occupational therapy, or speech pathology 
services; or a CMHC that has in effect a similar agreement but only for 
purposes of providing partial hospitalization services, and 
nonparticipating refers to a hospital, CAH, SNF, HHA, CORF, hospice, 
clinic, rehabilitation agency, public health agency, or CMHC that does 
not have in effect a provider agreement to participate in Medicare.
    Preventive services means all of the following:
    (1) The specific services listed in section 1861(ww)(2) of the Act, 
with the explicit exclusion of electrocardiograms;
    (2) The Initial Preventive Physical Examination (IPPE) (as specified 
by section 1861(ww)(1) of the Act); and
    (3) Annual Wellness Visit (AWV), providing Personalized Prevention 
Plan Services (PPPS) (as specified by section 1861(hhh)(1) of the Act).

[59 FR 6577, Feb. 11, 1994, as amended at 62 FR 46025, Aug. 29, 1997; 65 
FR 18536, Apr. 7, 2000; 75 FR 72259, Nov. 24, 2010; 75 FR 73613, Nov. 
29, 2010]



Sec.  410.3  Scope of benefits.

    (a) Covered services. The SMI program helps pay for the following:
    (1) Medical and other health services such as physicians' services, 
outpatient services furnished by a hospital or a CAH, diagnostic tests, 
outpatient physical therapy and speech pathology services, rural health 
clinic services, Federally qualified health center services, IHS, Indian 
tribe, or tribal organization facility services, and outpatient renal 
dialysis services.

[[Page 393]]

    (2) Services furnished by ambulatory surgical centers (ASCs), home 
health agencies (HHAs), comprehensive outpatient rehabilitation 
facilities (CORFs), and partial hospitalization services provided by 
community mental health centers (CMHCs).
    (3) Other medicial services, equipment, and supplies that are not 
covered under Medicare Part A hospital insurance.
    (b) Limitations on amount of payment. (1) Medicare Part B does not 
pay the full reasonable costs or charges for all covered services. The 
beneficiary is responsible for an annual deductible and a blood 
deductible and, after the annual deductible has been satisfied, for 
coinsurance amounts specified for most of the services.
    (2) Specific rules on payment are set forth in subpart I of this 
part.

[51 FR 41339, Nov. 14, 1986, as amended at 57 FR 24981, June 12, 1992; 
58 FR 30668, May 26, 1993; 59 FR 6577, Feb. 11, 1994; 66 FR 55328, Nov. 
1, 2001; 75 FR 73613, Nov. 29, 2010]



Sec.  410.5  Other applicable rules.

    The following other rules of this chapter set forth additional 
policies and procedures applicable to four of the kinds of services 
covered under the SMI program:
    (a) Part 494: End-Stage Renal Disease Facilities.
    (b) Part 405, Subpart X: Rural Health Clinic and Federally Qualified 
Health Center services.
    (c) Part 416: Ambulatory Surgical Center services.
    (d) Part 493: Laboratory Services.

[51 FR 41339, Nov. 14, 1986, as amended at 57 FR 7134, Feb. 28, 1992; 57 
FR 24981, June 12, 1992; 73 FR 20474, Apr. 15, 2008]



               Subpart B_Medical and Other Health Services



Sec.  410.10  Medical and other health services: Included services.

    Subject to the conditions and limitations specified in this subpart, 
``medical and other health services'' includes the following services:
    (a) Physicians' services.
    (b) Services and supplies furnished incident to a physician's 
professional services, of kinds that are commonly furnished in 
physicians' offices and are commonly either furnished without charge or 
included in the physicians' bills.
    (c) Services and supplies, including partial hospitalization 
services, that are incident to physician services and are furnished to 
outpatients by or under arrangements made by a hospital or a CAH.
    (d) Diagnostic services furnished to outpatients by or under 
arrangements made by a hospital or a CAH if the services are services 
that the hospital or CAH ordinarily furnishes to its outpatients for 
diagnostic study.
    (e) Diagnostic laboratory and X-ray tests (including diagnostic 
mammography that meets the conditions for coverage specified in Sec.  
410.34(b) of this subpart) and other diagnostic tests.
    (f) X-ray therapy and other radiation therapy services.
    (g) Medical supplies, appliances, and devices.
    (h) Durable medical equipment.
    (i) Ambulance services.
    (j) Rural health clinic services.
    (k) Home dialysis supplies and equipment; on or after July 1, 1991, 
epoetin (EPO) for home dialysis patients, and, on or after January 1, 
1994, for dialysis patients, competent to use the drug; self-care home 
dialysis support services; and institutional dialysis services and 
supplies.
    (l) Pneumococcal vaccinations.
    (m) Outpatient physical therapy and speech pathology services.
    (n) Cardiac pacemakers and pacemaker leads.
    (o) Additional services furnished to enrollees of HMOs or CMPs, as 
described in Sec.  410.58.
    (p) Hepatitis B vaccine.
    (q) Blood clotting factors for hemophilia patients competent to use 
these factors without medical or other supervision.
    (r) Screening mammography services.
    (s) Federally qualified health center services.
    (t) Services of a certified registered nurse anesthetist or an 
anesthesiologist's assistant.
    (u) Prescription drugs used in immunosuppressive therapy.
    (v) Clinical psychologist services and services and supplies 
furnished as an

[[Page 394]]

incident to the services of a clinical psychologist, as provided in 
Sec.  410.71.
    (w) Clinical social worker services, as provided in Sec.  410.73.
    (x) Services of physicians and other practitioners furnished in or 
at the direction of an IHS or Indian tribal hospital or clinic.
    (y) Intravenous immune globulin administered in the home for the 
treatment of primary immune deficiency diseases.

[51 FR 41339, Nov. 14, 1986, as amended at 52 FR 27765, July 23, 1987; 
55 FR 22790, June 4, 1990; 55 FR 53522, Dec. 31, 1990; 56 FR 8841, Mar. 
1, 1991; 56 FR 43709, Sept. 4, 1991; 57 FR 24981, June 12, 1992; 57 FR 
33896, July 31, 1992; 58 FR 30668, May 26, 1993; 59 FR 26959, May 25, 
1994; 59 FR 49833, Sept. 30, 1994; 60 FR 8955, Feb. 16, 1995; 63 FR 
20128, Apr. 23, 1998; 66 FR 55328, Nov. 1, 2001; 69 FR 66420, Nov. 15, 
2004]



Sec.  410.12  Medical and other health services: 
Basic conditions and limitations.

    (a) Basic conditions. The medical and other health services 
specified in Sec.  410.10 are covered by Medicare Part B only if they 
are not excluded under subpart A of part 411 of this chapter, and if 
they meet the following conditions:
    (1) When the services must be furnished. The services must be 
furnished while the individual is in a period of entitlement. (The rules 
on entitlement are set forth in part 406 of this chapter.)
    (2) By whom the services must be furnished. The services must be 
furnished by a facility or other entity as specified in Sec. Sec.  
410.14 through 410.69.
    (3) Physician certification and recertification requirements. If the 
services are subject to physician certification requirements, they must 
be certified as being medically necessary, and as meeting other 
applicable requirements, in accordance with subpart B of part 424 of 
this chapter.
    (b) Limitations on payment. Payment for medical and other health 
services is subject to limitations on the amounts of payment as 
specified in Sec. Sec.  410.152 and 410.155 and to the annual and blood 
deductibles as set forth in Sec. Sec.  410.160 and 410.161.

[51 FR 41339, Nov. 14, 1986, as amended at 53 FR 6648, Mar. 2, 1988; 57 
FR 33896, July 31, 1992]



Sec.  410.14  Special requirements for services furnished 
outside the United States.

    Medicare part B pays for physicians' services and ambulance services 
furnished outside the United States if the services meet the applicable 
conditions of Sec.  410.12 and are furnished in connection with covered 
inpatient hospital services that meet the specific requirements and 
conditions set forth in subpart H of part 424 of this chapter.

[51 FR 41339, Nov. 14, 1986, as amended at 53 FR 6648, Mar. 2, 1988]



Sec.  410.15  Annual wellness visits providing Personalized Prevention 
Plan Services: Conditions for and limitations on coverage.

    (a) Definitions. For purposes of this section--
    A review of any current opioid prescriptions means, with respect to 
the individual determined to have a current prescription for opioids, 
all of the following:
    (i) A review of the potential risk factors to the individual for 
opioid use disorder;
    (ii) An evaluation of the individual's severity of pain and current 
treatment plan;
    (iii) The provision of information on non-opioid treatment options; 
and
    (iv) A referral to a specialist, as appropriate.
    Detection of any cognitive impairment means assessment of an 
individual's cognitive function by direct observation, with due 
consideration of information obtained by way of patient report, concerns 
raised by family members, friends, caretakers or others.
    Eligible beneficiary means an individual who is no longer within 12 
months after the effective date of his or her first Medicare Part B 
coverage period and who has not received either an initial preventive 
physical examination or an annual wellness visit providing a 
personalized prevention plan within the past 12 months.
    Establishment of, or an update to the individual's medical and 
family history means, at minimum, the collection and documentation of 
the following:
    (i) Past medical and surgical history, including experiences with 
illnesses,

[[Page 395]]

hospital stays, operations, allergies, injuries and treatments.
    (ii) Use or exposure to medications and supplements, including 
calcium and vitamins.
    (iii) Medical events in the beneficiary's parents and any siblings 
and children, including diseases that may be hereditary or place the 
individual at increased risk.
    First annual wellness visit providing personalized prevention plan 
services means the following services furnished to an eligible 
beneficiary by a health professional that include, and take into account 
the results of, a health risk assessment, as those terms are defined in 
this section:
    (i) Review (and administration if needed) of a health risk 
assessment (as defined in this section).
    (ii) Establishment of an individual's medical and family history.
    (iii) Establishment of a list of current providers and suppliers 
that are regularly involved in providing medical care to the individual.
    (iv) Measurement of an individual's height, weight, body-mass index 
(or waist circumference, if appropriate), blood pressure, and other 
routine measurements as deemed appropriate, based on the beneficiary's 
medical and family history.
    (v) Detection of any cognitive impairment that the individual may 
have, as that term is defined in this section.
    (vi) Review of the individual's potential (risk factors) for 
depression, including current or past experiences with depression or 
other mood disorders, based on the use of an appropriate screening 
instrument for persons without a current diagnosis of depression, which 
the health professional may select from various available standardized 
screening tests designed for this purpose and recognized by national 
medical professional organizations.
    (vii) Review of the individual's functional ability and level of 
safety, based on direct observation or the use of appropriate screening 
questions or a screening questionnaire, which the health professional as 
defined in this section may select from various available screening 
questions or standardized questionnaires designed for this purpose and 
recognized by national professional medical organizations.
    (viii) Establishment of the following:
    (A) A written screening schedule for the individual such as a 
checklist for the next 5 to 10 years, as appropriate, based on 
recommendations of the United States Preventive Services Task Force and 
the Advisory Committee on Immunization Practices, and the individual's 
health risk assessment (as that term is defined in this section), health 
status, screening history, and age-appropriate preventive services 
covered by Medicare.
    (B) A list of risk factors and conditions for which primary, 
secondary or tertiary interventions are recommended or are underway for 
the individual, including any mental health conditions or any such risk 
factors or conditions that have been identified through an initial 
preventive physical examination (as described under Sec.  410.16 of this 
subpart), and a list of treatment options and their associated risks and 
benefits.
    (ix) Furnishing of personalized health advice to the individual and 
a referral, as appropriate, to health education or preventive counseling 
services or programs aimed at reducing identified risk factors and 
improving self management, or community-based lifestyle interventions to 
reduce health risks and promote self-management and wellness, including 
weight loss, physical activity, smoking cessation, fall prevention, and 
nutrition.
    (x) At the discretion of the beneficiary, furnish advance care 
planning services to include discussion about future care decisions that 
may need to be made, how the beneficiary can let others know about care 
preferences, and explanation of advance directives which may involve the 
completion of standard forms.
    (xi) Furnishing of a review of any current opioid prescriptions as 
that term is defined in this section.
    (xii) Screening for potential substance use disorders including a 
review of the individual's potential risk factors for substance use 
disorder and referral for treatment as appropriate.
    (xiii) Any other element determined appropriate through the national 
coverage determination process.

[[Page 396]]

    Health professional means--
    (i) A physician who is a doctor of medicine or osteopathy (as 
defined in section 1861(r)(1) of the Act); or
    (ii) A physician assistant, nurse practitioner, or clinical nurse 
specialist (as defined in section 1861(aa)(5) of the Act); or
    (iii) A medical professional (including a health educator, a 
registered dietitian, or nutrition professional, or other licensed 
practitioner) or a team of such medical professionals, working under the 
direct supervision (as defined in Sec.  410.32(b)(3)(ii)) of a physician 
as defined in paragraph (i) of this definition.
    Health risk assessment means, for the purposes of this section, an 
evaluation tool that meets the following criteria:
    (i) Collects self-reported information about the beneficiary.
    (ii) Can be administered independently by the beneficiary or 
administered by a health professional prior to or as part of the AWV 
encounter.
    (iii) Is appropriately tailored to and takes into account the 
communication needs of underserved populations, persons with limited 
English proficiency, and persons with health literacy needs.
    (iv) Takes no more than 20 minutes to complete.
    (v) Addresses, at a minimum, the following topics:
    (A) Demographic data, including but not limited to age, gender, 
race, and ethnicity.
    (B) Self assessment of health status, frailty, and physical 
functioning.
    (C) Psychosocial risks, including but not limited to, depression/
life satisfaction, stress, anger, loneliness/social isolation, pain, and 
fatigue.
    (D) Behavioral risks, including but not limited to, tobacco use, 
physical activity, nutrition and oral health, alcohol consumption, 
sexual health, motor vehicle safety (seat belt use), and home safety.
    (E) Activities of daily living (ADLs), including but not limited to, 
dressing, feeding, toileting, grooming, physical ambulation (including 
balance/risk of falls), and bathing.
    (F) Instrumental activities of daily living (IADLs), including but 
not limited to, shopping, food preparation, using the telephone, 
housekeeping, laundry, mode of transportation, responsibility for own 
medications, and ability to handle finances.
    Review of the individual's functional ability and level of safety 
means, at minimum, assessment of the following topics:
    (i) Hearing impairment.
    (ii) Ability to successfully perform activities of daily living.
    (iii) Fall risk.
    (iv) Home safety.
    Subsequent annual wellness visit providing personalized prevention 
plan services means the following services furnished to an eligible 
beneficiary by a health professional that include, and take into account 
the results of an updated health risk assessment, as those terms are 
defined in this section:
    (i) Review (and administration, if needed) of an updated health risk 
assessment (as defined in this section).
    (ii) An update of the individual's medical and family history.
    (iii) An update of the list of current providers and suppliers that 
are regularly involved in providing medical care to the individual as 
that list was developed for the first annual wellness visit providing 
personalized prevention plan services or the previous subsequent annual 
wellness visit providing personalized prevention plan services.
    (iv) Measurement of an individual's weight (or waist circumference), 
blood pressure and other routine measurements as deemed appropriate, 
based on the individual's medical and family history.
    (v) Detection of any cognitive impairment that the individual may 
have, as that term is defined in this section.
    (vi) An update to the following:
    (A) The written screening schedule for the individual as that 
schedule is defined in paragraph (a) of this section for the first 
annual wellness visit providing personalized prevention plan services.
    (B) The list of risk factors and conditions for which primary, 
secondary or tertiary interventions are recommended or are underway for 
the individual as that list was developed at the first annual wellness 
visit providing personalized prevention plan services or the previous 
subsequent annual wellness visit providing personalized prevention plan 
services.

[[Page 397]]

    (vii) Furnishing of personalized health advice to the individual and 
a referral, as appropriate, to health education or preventive counseling 
services or programs as that advice and related services are defined in 
paragraph (a) of this section.
    (viii) At the discretion of the beneficiary, furnish advance care 
planning services to include discussion about future care decisions that 
may need to be made, how the beneficiary can let others know about care 
preferences, and explanation of advance directives which may involve the 
completion of standard forms.
    (ix) Furnishing of a review of any current opioid prescriptions as 
that term is defined in this section.
    (x) Screening for potential substance use disorders including a 
review of the individual's potential risk factors for substance use 
disorder and referral for treatment as appropriate.
    (xi) Any other element determined appropriate through the national 
coverage determination process.
    (b) Conditions for coverage of annual wellness visits providing 
personalized prevention plan services. Medicare Part B pays for first 
and subsequent annual wellness visits providing personalized prevention 
plan services that are furnished to an eligible beneficiary, as 
described in this section, if they are furnished by a health 
professional, as defined in this section.
    (c) Limitations on coverage of an annual wellness visit providing 
personalized prevention plan services. Payment may not be made for 
either a first or a subsequent annual wellness visit providing 
personalized prevention plan services that is performed for an 
individual who is--
    (1) Not an eligible beneficiary as described in this section.
    (2) An eligible beneficiary as described in this section and who has 
had either an initial preventive physical examination as specified in 
Sec.  410.16 of this subpart or either a first or a subsequent annual 
wellness visit providing personalized prevention plan services performed 
within the past 12 months.
    (d) Effective date. Coverage for an annual wellness visit providing 
personalized prevention plan services is effective for services 
furnished on or after January 1, 2011.

[75 FR 73613, Nov. 29, 2010, as amended at 76 FR 1367, Jan. 10, 2011; 76 
FR 73470, Nov. 28, 2011; 80 FR 71372, Nov. 16, 2015; 85 FR 85025, Dec. 
28, 2020]



Sec.  410.16  Initial preventive physical examination: 
Conditions for and limitations on coverage.

    (a) Definitions. As used in this section, the following definitions 
apply:
    A review of any current opioid prescriptions means, with respect to 
the individual determined to have a current prescription for opioids, 
all of the following:
    (i) A review of the potential risk factors to the individual for 
opioid use disorder;
    (ii) An evaluation of the individual's severity of pain and current 
treatment plan;
    (iii) The provision of information on non-opioid treatment options; 
and
    (iv) A referral to a specialist, as appropriate.
    Eligible beneficiary means, for the purposes of this section, an 
individual who receives his or her initial preventive examination not 
more than 1 year after the effective date of his or her first Medicare 
Part B coverage period.
    End-of-life planning means, for purposes of this section, verbal or 
written information regarding the following areas:
    (1) An individual's ability to prepare an advance directive in the 
case where an injury or illness causes the individual to be unable to 
make health care decisions.
    (2) Whether or not the physician is willing to follow the 
individual's wishes as expressed in an advance directive.
    Initial preventive physical examination means all of the following 
services furnished to an eligible beneficiary by a physician or other 
qualified nonphysician practitioner with the goal of health promotion 
and disease detection:
    (1) Review of the beneficiary's medical and social history with 
attention to modifiable risk factors for disease, as those terms are 
defined in this section.

[[Page 398]]

    (2) Review of the beneficiary's potential (risk factors) for 
depression, including current or past experiences with depression or 
other mood disorders, based on the use of an appropriate screening 
instrument for persons without a current diagnosis of depression, which 
the physician or other qualified nonphysician practitioner may select 
from various available standardized screening tests designed for this 
purpose and recognized by national professional medical organizations.
    (3) Review of the beneficiary's functional ability, and level of 
safety as those terms are defined in this section, as described in 
paragraph (4) of this definition, based on the use of appropriate 
screening questions or a screening questionnaire, which the physician or 
other qualified nonphysician practitioner may select from various 
available screening questions or standardized questionnaires designed 
for this purpose and recognized by national professional medical 
organizations.
    (4) An examination to include measurement of the beneficiary's 
height, weight, body mass index, blood pressure, a visual acuity screen, 
and other factors as deemed appropriate, based on the beneficiary's 
medical and social history, and current clinical standards.
    (5) End-of-life planning as that term is defined in this section 
upon agreement with the individual.
    (6) A review of any current opioid prescriptions as defined in this 
section.
    (7) Screening for potential substance use disorders to include a 
review of the individual's potential risk factors for substance use 
disorder and referral for treatment as appropriate.
    (8) Education, counseling, and referral, as deemed appropriate by 
the physician or qualified nonphysician practitioner, based on the 
results of the review and evaluation services described in this section.
    (9) Education, counseling, and referral, including a brief written 
plan such as a checklist provided to the individual for obtaining an 
electrocardiogram, as appropriate, and the appropriate screening and 
other preventive services that are covered as separate Medicare Part B 
benefits as described in sections 1861(s)(10), (jj), (nn), (oo), (pp), 
(qq)(1), (rr), (uu), (vv), (xx)(1), (yy), (bbb), and (ddd) of the Act.
    Medical history is defined to include, at a minimum, the following:
    (1) Past medical and surgical history, including experiences with 
illnesses, hospital stays, operations, allergies, injuries, and 
treatments.
    (2) Current medications and supplements, including calcium and 
vitamins.
    (3) Family history, including a review of medical events in the 
beneficiary's family, including diseases that may be hereditary or place 
the individual at risk.
    A physician for purposes of this section means a doctor of medicine 
or osteopathy (as defined in section 1861(r)(1) of the Act).
    A qualified nonphysician practitioner for purposes of this section 
means a physician assistant, nurse practitioner, or clinical nurse 
specialist (as authorized under section 1861(s)(2)(K)(i) and section 
1861(s)(2)(K)(ii) of the Act and defined in section 1861(aa)(5) of the 
Act, or in Sec. Sec.  410.74, 410.75, and 410.76).
    Review of the beneficiary's functional ability and level of safety 
must include, at a minimum, a review of the following areas:
    (1) Hearing impairment.
    (2) Activities of daily living.
    (3) Falls risk.
    (4) Home safety
    Social history is defined to include, at a minimum, the following:
    (1) History of alcohol, tobacco, and illicit drug use.
    (2) Diet.
    (3) Physical activities.
    (b) Condition for coverage of an initial preventive physical 
examination. Medicare Part B pays for an initial preventive physical 
examination provided to an eligible beneficiary, as described in this 
section, if it is furnished by a physician or other qualified 
nonphysician practitioner, as defined in this section.
    (c) Limitations on coverage of initial preventive physical 
examinations. Payment may not be made for an initial

[[Page 399]]

preventive physical preventive examination that is performed for an 
individual who is not an eligible beneficiary as described in this 
section.

[69 FR 66420, Nov. 15, 2004, as amended at 71 FR 69783, Dec. 1, 2006; 73 
FR 69932, Nov. 19, 2008; 85 FR 85025, Dec. 28, 2020]



Sec.  410.17  Cardiovascular disease screening tests.

    (a) Definition. For purposes of this subpart, the following 
definition apply:
    Cardiovascular screening blood test means:
    (1) A lipid panel consisting of a total cholesterol, HDL 
cholesterol, and triglyceride. The test is performed after a 12-hour 
fasting period.
    (2) Other blood tests, previously recommended by the U.S. Preventive 
Services Task Force (USPSTF), as determined by the Secretary through a 
national coverage determination process.
    (3) Other non-invasive tests, for indications that have a blood test 
recommended by the USPSTF, as determined by the Secretary through a 
national coverage determination process.
    (b) General conditions of coverage. Medicare Part B covers 
cardiovascular disease screening tests when ordered by the physician who 
is treating the beneficiary (see Sec.  410.32(a)) for the purpose of 
early detection of cardiovascular disease in individuals without 
apparent signs or symptoms of cardiovascular disease.
    (c) Limitation on coverage of cardiovascular screening tests. 
Payment may be made for cardiovascular screening tests performed for an 
asymptomatic individual only if the individual has not had the screening 
tests paid for by Medicare during the preceding 59 months following the 
month in which the last cardiovascular screening tests were performed.

[69 FR 66421, Nov. 15, 2004]



Sec.  410.18  Diabetes screening tests.

    (a) Definitions. For purposes of this section, the following 
definitions apply:
    Diabetes means diabetes mellitus, a condition of abnormal glucose 
metabolism diagnosed using the following criteria: a fasting blood sugar 
greater than or equal to 126 mg/dL on two different occasions; a 2-hour 
post-glucose challenge greater than or equal to 200 mg/dL on two 
different occasions; or a random glucose test over 200 mg/dL for a 
person with symptoms of uncontrolled diabetes.
    Pre-diabetes means a condition of abnormal glucose metabolism 
diagnosed using the following criteria: a fasting glucose level of 100-
125 mg/dL, or a 2-hour post-glucose challenge of 140-199 mg/dL. The term 
pre-diabetes includes the following conditions:
    (1) Impaired fasting glucose.
    (2) Impaired glucose tolerance.
    (b) General conditions of coverage. Medicare Part B covers diabetes 
screening tests after a referral from a physician or qualified 
nonphysician practitioner to an individual at risk for diabetes for the 
purpose of early detection of diabetes.
    (c) Types of tests covered. The following tests are covered if all 
other conditions of this subpart are met:
    (1) Fasting blood glucose test.
    (2) Post-glucose challenges including, but not limited to, an oral 
glucose tolerance test with a glucose challenge of 75 grams of glucose 
for non-pregnant adults, a 2-hour post glucose challenge test alone.
    (3) Other tests as determined by the Secretary through a national 
coverage determination.
    (d) Amount of testing covered. Medicare covers the following for 
individuals:
    (1) Diagnosed with pre-diabetes, two screening tests per calendar 
year.
    (2) Previously tested who were not diagnosed with pre-diabetes, or 
who were never tested before, one screening test per year.
    (e) Eligible risk factors. Individuals with the following risk 
factors are eligible to receive the benefit:
    (1) Hypertension.
    (2) Dyslipidemia.
    (3) Obesity, defined as a body mass index greater than or equal to 
30 kg/m\2\.
    (4) Prior identification of impaired fasting glucose or glucose 
intolerance.
    (5) Any two of the following characteristics:
    (i) Overweight, defined as body mass index greater than 25, but less 
than 30 kg/m\2\.

[[Page 400]]

    (ii) A family history of diabetes.
    (iii) 65 years of age or older.
    (iv) A history of gestational diabetes mellitus or delivery of a 
baby weighing more than 9 pounds.

[69 FR 66421, Nov. 15, 2004]



Sec.  410.19  Ultrasound screening for abdominal aortic aneurysms: 
Condition for and limitation on coverage.

    (a) Definitions: As used in this section, the following definitions 
apply:
    Eligible beneficiary means an individual who--
    (1) Has not been previously furnished an ultrasound screening for an 
abdominal aortic aneurysm under Medicare program; and
    (2) Is included in at least one of the following risk categories:
    (i) Has a family history of an abdominal aortic aneurysm.
    (ii) Is a man age 65 to 75 who has smoked at least 100 cigarettes in 
his lifetime.
    (iii) Is an individual who manifests other risk factors in a 
beneficiary category recommended for screening by the United States 
Preventive Services Task Force regarding abdominal aortic aneurysms, as 
specified by the Secretary through a national coverage determination 
process.
    Ultrasound screening for abdominal aortic aneurysms means the 
following services furnished to an asymptomatic individual for the early 
detection of an abdominal aortic aneurysm:
    (1) A procedure using soundwaves (or other procedures using 
alternative technologies of commensurate accuracy and cost, as specified 
by the Secretary through a national coverage determination process) 
provided for the early detection of abdominal aortic aneurysms.
    (2) Includes a physician's interpretation of the results of the 
procedure.
    (b) Conditions for coverage of an ultrasound screening for abdominal 
aortic aneurysms. Medicare Part B pays for one ultrasound screening for 
an abdominal aortic aneurysm provided to eligible beneficiaries, as 
described in this section, after a referral from a physician or a 
qualified nonphysician practitioner as defined in Sec.  410.16(a), when 
the test is performed by a provider or supplier that is authorized to 
provide covered ultrasound diagnostic services.
    (c) Limitation on coverage of ultrasound screening for abdominal 
aortic aneurysms. Payment may not be made for an ultrasound screening 
for an abdominal aortic aneurysm that is performed for an individual 
that does not meet the definition of ``eligible beneficiary'' specified 
in this section.

[71 FR 69783, Dec. 1, 2006, as amended at 78 FR 74810, Dec. 10, 2013]



Sec.  410.20  Physicians' services.

    (a) Included services. Medicare Part B pays for physicians' 
services, including diagnosis, therapy, surgery, consultations, and 
home, office, and institutional calls.
    (b) By whom services must be furnished. Medicare Part B pays for the 
services specified in paragraph (a) of this section if they are 
furnished by one of the following professionals who is legally 
authorized to practice by the State in which he or she performs the 
functions or actions, and who is acting within the scope of his or her 
license.
    (1) A doctor of medicine or osteopathy, including an osteopathic 
practitioner recognized in section 1101(a)(7) of the Act.
    (2) A doctor of dental surgery or dental medicine.
    (3) A doctor of podiatric medicine.
    (4) A doctor of optometry.
    (5) A chiropractor who meets the qualifications specified in Sec.  
410.22
    (c) Limitations on services. The Services specified in paragraph (a) 
of this section may be covered under Medicare Part B if they are 
furnished within the limitations specified in Sec. Sec.  410.22 through 
410.25.
    (d) Prior determination of medical necessity for physicians' 
services--(1) Definitions. (i) A ``Prior Determination of Medical 
Necessity'' means an individual decision by a Medicare contractor, 
before a physician's service is furnished, as to whether or not the 
physician's service is covered consistent with the requirements of 
section 1862(a)(1)(A) of the Act relating to medical necessity.
    (ii) An ``eligible requester'' includes the following:
    (A) A participating physician (or a physician that accepts 
assignment),

[[Page 401]]

but only with respect to physicians' services to be furnished to an 
individual who is entitled to receive benefits under this part and who 
has consented to the physician making the request under this section for 
those physicians' services.
    (B) An individual entitled to benefits under this part, but only 
with respect to physicians' services for which the individual receives, 
from a physician, an advance beneficiary notice under section 1879(a) of 
the Act.
    (2) General rule. Each Medicare contractor will, through the 
procedures established in CMS manual instructions, allow requests for 
prior determinations of medical necessity from eligible requesters under 
its respective jurisdiction for those services identified by CMS 
(updated annually in conjunction with the update to the MPFS and posted 
on that specific Medicare contractor's Web site by the Healthcare Common 
Procedure Coding System procedure code and code description). Only those 
services listed on that Medicare contractor's Web site on the date the 
request for a prior determination is made are subject to prior 
determination. Each contractor's list will consist of the following:
    (i) The national list, provided by CMS, of the most expensive 
physicians' services (as defined in section 1848(j)(3) of the Act) 
included in the MPFS which are performed at least 50 times annually.
    (ii) The national list, provided by CMS, of plastic and dental 
surgeries that may be covered by Medicare and that have an amount of at 
least $1,000 on the MPFS (not including the adjustment for location by 
the GPCI).
    (3) Services with local coverage determinations (LCDs) or national 
coverage determinations (NCDs). In instances where an LCD or an NCD 
exists that has sufficiently specific reasonable and necessary criteria 
addressing the particular clinical indication for the procedure for 
which the prior determination is requested, the contractor will send a 
copy of the LCD or NCD to the requestor along with an explanation that 
the LCD or NCD serves as the prior determination and that no further 
determination will be made.
    (4) Identification of eligible services. CMS will identify the 
number of services that are eligible for a prior determination through 
manual instructions consistent with the criteria established in the 
regulation.
    (5) Statutory procedures. Under sections 1869(h)(3) through (h)(6) 
of the Act, the following procedures apply:
    (i) Request for prior determination--(A) In general. An eligible 
requester may submit to the contractor a request for a determination, 
before the furnishing of a physician's service, as to whether the 
physician's service is covered under this title consistent with the 
applicable requirements of section 1862(a)(1)(A) of the Act (relating to 
medical necessity).
    (B) Accompanying documentation. CMS may require that the request be 
accompanied by a description of the physician's service, supporting 
documentation relating to the medical necessity of the physician's 
service, and other appropriate documentation. In the case of a request 
submitted by an eligible requester who is described in section 
1869(h)(1)(B)(ii) of the Act, the Secretary may require that the request 
also be accompanied by a copy of the advance beneficiary notice 
involved.
    (ii) Response to request--(A) General rule. The contractor will 
provide the eligible requester with written notice of a determination as 
to whether--
    (1) The physician's service is covered (the physician's service is 
covered consistent with the requirements of section 1862(a)(1)(A) of the 
Act relating to medical necessity); or
    (2) The physician's service is not covered (the physician's service 
is not covered consistent with the requirements of section 1862(a)(1)(A) 
of the Act relating to medical necessity); or
    (3) The contractor lacks sufficient information to make a coverage 
determination with respect to the physician's service.
    (B) Contents of notice for certain determinations--(1) Coverage. If 
the contractor makes the determination described in paragraph 
(d)(5)(ii)(A)(1) of this section, the contractor will indicate in the 
prior determination notice that the physician service is covered 
consistent with the requirements of

[[Page 402]]

section 1862(a)(1)(A) of the Act relating to medical necessity.
    (2) Noncoverage. If the contractor makes the determination described 
in paragraph (d)(5)(ii)(A)(2) of this section, the contractor will 
include in the notice a brief explanation of the basis for the 
determination, including on what national or local coverage or 
noncoverage determination (if any) the determination is based, and a 
description of any applicable rights under section 1869(a) of the Act.
    (3) Insufficient information. If the contractor makes the 
determination described in paragraph (d)(5)(ii)(A)(3) of this section, 
the contractor will include in the notice a description of the 
additional information required to make the coverage determination.
    (C) Deadline to respond. The notice described in paragraphs 
(d)(5)(ii)(A)(1) through (d)(5)(ii)(A)(3) of this section will be 
provided by the contractor within 45 days of the date the request for a 
prior determination is received by the contractor.
    (D) Informing beneficiary in case of physician request. In the case 
of a request by a participating physician or a physician accepting 
assignment, the process will provide that the individual to whom the 
physician's service is to be furnished will be informed of any 
determination described in paragraph (d)(5)(ii)(A)(2) of this section 
(relating to a determination of non-coverage). The beneficiary will also 
be notified that, notwithstanding the determination of non-coverage, the 
beneficiary has the right to obtain the physician's service in question 
and have a claim submitted for the physician's service.
    (iii) Binding nature of positive determination. If the contractor 
makes the determination described in paragraph (d)(5)(ii)(A)(1) of this 
section, that determination will be binding on the contractor in the 
absence of fraud or evidence of misrepresentation of facts presented to 
the contractor.
    (iv) Limitation on further review--(A) General rule. Contractor 
determinations described in paragraph (d)(5)(ii)(A)(2) of this section 
or paragraph (d)(5)(ii)(A)(3) of this section (relating to pre-service 
claims) are not subject to administrative appeal or judicial review.
    (B) Decision not to seek prior determination or negative 
determination does not impact the right to obtain services, seek 
reimbursement, or appeal rights. Nothing in this paragraph will be 
construed as affecting the right of an individual who--
    (1) Decides not to seek a prior determination under this paragraph 
with respect to physicians' services; or
    (2) Seeks such a determination and has received a determination 
described in paragraph (d)(5)(ii)(A)(2) of this section, from receiving 
(and submitting a claim for) those physicians' services and from 
obtaining administrative or judicial review respecting that claim under 
the other applicable provisions of this part 405 subpart I of this 
chapter. Failure to seek a prior determination under this paragraph with 
respect to physicians' services will not be taken into account in that 
administrative or judicial review.
    (C) No prior determination after receipt of services. Once an 
individual is provided physicians' services, there will be no prior 
determination under this paragraph with respect to those physicians' 
services.
    (e) Medical record documentation. The physician may review and 
verify (sign/date), rather than re-document, notes in a patient's 
medical record made by physicians; residents; nurses; medical, physician 
assistant, and advanced practice registered nurse students; or other 
members of the medical team including, as applicable, notes documenting 
the physician's presence and participation in the services.

[51 FR 41339, Nov. 14, 1986, as amended at 73 FR 9678, Feb. 22, 2008; 84 
FR 63187, Nov. 15, 2019]



Sec.  410.21  Limitations on services of a chiropractor.

    (a) Qualifications for chiropractors. (1) A chiropractor licensed or 
authorized to practice before July 1, 1974, and an individual who began 
studies in a chiropractic college before that date, must have--
    (i) Had preliminary education equal to the requirements for 
graduation from an accredited high school or other secondary school;
    (ii) Graduated from a college of chiropractic approved by the 
State's

[[Page 403]]

chiropractic examiners after completing a course of study covering a 
period of not less than 3 school years of 6 months each year in actual 
continuous attendance and covering adequate courses of study in the 
subjects of anatomy, physiology, symptomatology and diagnosis, hygiene 
and sanitation, chemistry, histology, pathology, and principles and 
practice of chiropractic, including clinical instruction in vertebral 
palpation, nerve tracing and adjusting; and
    (iii) Passed an examination prescribed by the State's chiropractic 
examiners covering the subjects specified in paragraph (a)(1)(ii) of 
this section.
    (2) A chiropractor first licensed or authorized to practice after 
June 30, 1974, and an individual who begins studies in a chiropractic 
college after that date, must have--
    (i) Had preliminary education equal to the requirements for 
graduation from an accredited high school or other secondary school;
    (ii) Satisfactorily completed 2 years of pre-chiropractic study at 
the college level;
    (iii) Satisfactorily completed a 4-year course of 8 months each year 
offered by a college or school of chiropractic approved by the State's 
chiropractic examiners and including at least 4,000 hours in courses in 
anatomy, physiology, symptomatology and diagnosis, hygiene and 
sanitation, chemistry, histology, pathology, principles and practice of 
chiropractic, and clinical instruction in vertebral palpation, nerve 
tracing and adjusting, plus courses in the use and effect of X-ray and 
chiropractic analysis;
    (iv) Passed an examination prescribed by the State's chiropractic 
examiners covering the subjects specified in paragraph (a)(2)(iii) of 
this section; and
    (v) Attained 21 years of age.
    (b) Limitations on services. (1) Medicare Part B pays only for a 
chiropractor's manual manipulation of the spine to correct a subluxation 
if the subluxation has resulted in a neuromusculoskeletal condition for 
which manual manipulation is appropriate treatment.
    (2) Medicare Part B does not pay for X-rays or other diagnostic or 
therapeutic services furnished or ordered by a chiropractor.

[51 FR 41339, Nov. 14, 1986, as amended at 64 FR 59439, Nov. 2, 1999. 
Redesignated at 66 FR 55328, Nov. 1, 2001]



Sec.  410.22  Limitations on services of an optometrist.

    Medicare Part B pays for the services of a doctor of optometry, 
which he or she is legally authorized to perform in the State in which 
he or she performs them, if the services are among those described in 
section 1861(s) of the Act and Sec.  410.10 of this part.

[64 FR 59439, Nov. 2, 1999. Redesignated at 66 FR 55328, Nov. 1, 2001]



Sec.  410.23  Screening for glaucoma: Conditions for and limitations 
on coverage.

    (a) Definitions: As used in this section, the following definitions 
apply:
    (1) Direct supervision in the office setting means the optometrist 
or the ophthalmologist must be present in the office suite and be 
immediately available to furnish assistance and direction throughout the 
performance of the procedure. It does not mean the physician must be 
present in the room when the procedure is performed.
    (2) Eligible beneficiary means individuals in the following high 
risk categories:
    (i) Individual with diabetes mellitus.
    (ii) Individual with a family history of glaucoma.
    (iii) African-Americans age 50 and over.
    (iv) Hispanic-Americans age 65 and over.
    (3) Screening for glaucoma means the following procedures furnished 
to an individual for the early detection of glaucoma:
    (i) A dilated eye examination with an intraocular pressure 
measurement.
    (ii) A direct ophthalmoscopy examination, or a slit-lamp 
biomicroscopic examination.
    (b) Condition for coverage of screening for glaucoma. Medicare Part 
B pays for glaucoma screening examinations provided to eligible 
beneficiaries as described in paragraph (a)(2) of this section if they 
are furnished by or under

[[Page 404]]

the direct supervision in the office setting of an optometrist or 
ophthalmologist who is legally authorized to perform these services 
under State law (or the State regulatory mechanism provided by State 
law) of the State in which the services are furnished, as would 
otherwise be covered if furnished by a physician or incident to a 
physician's professional service.
    (c) Limitations on coverage of glaucoma screening examinations. (1) 
Payment may not be made for a glaucoma screening examination that is 
performed for an individual who is not an eligible beneficiary as 
described in paragraph (a)(2) of this section.
    (2) Payment may be made for a glaucoma screening examination that is 
performed on an individual who is an eligible beneficiary as described 
in paragraph (a)(2) of this section, after at least 11 months have 
passed following the month in which the last glaucoma screening 
examination was performed.

[66 FR 55328, Nov. 1, 2001, as amended at 70 FR 70330, Nov. 21, 2005]



Sec.  410.24  Limitations on services of a doctor of dental surgery 
or dental medicine.

    Medicare Part B pays for services furnished by a doctor of dental 
surgery or dental medicine within the scope of his or her license, if 
the services would be covered as physicians' services when performed by 
a doctor of medicine or osteopathy. \1\
---------------------------------------------------------------------------

    \1\ For services furnished before July 1, 1981, Medicare Part B paid 
only for the following services of a doctor of dental surgery or dental 
medicine;
    Surgery on the jaw or any adjoining structure; and
    Reduction of a fracture of the jaw or other facial bone.

[51 FR 41339, Nov. 14, 1986, as amended at 56 FR 8852, Mar. 1, 1991]



Sec.  410.25  Limitations on services of a podiatrist.

    Medicare Part B pays for the services of a doctor of podiatric 
medicine, acting within the scope of his or her license, if the services 
would be covered as physicians' services when performed by a doctor of 
medicine or osteopathy.



Sec.  410.26  Services and supplies incident to a physician's 
professional services: Conditions.

    (a) Definitions. For purposes of this section, the following 
definitions apply:
    (1) Auxiliary personnel means any individual who is acting under the 
supervision of a physician (or other practitioner), regardless of 
whether the individual is an employee, leased employee, or independent 
contractor of the physician (or other practitioner) or of the same 
entity that employs or contracts with the physician (or other 
practitioner), has not been excluded from the Medicare, Medicaid and all 
other federally funded health care programs by the Office of Inspector 
General or had his or her Medicare enrollment revoked, and meets any 
applicable requirements to provide incident to services, including 
licensure, imposed by the State in which the services are being 
furnished.
    (2) Direct supervision means the level of supervision by the 
physician (or other practitioner) of auxiliary personnel as defined in 
Sec.  410.32(b)(3)(ii).
    (3)  General supervision means the service is furnished under the 
physician's (or other practitioner's) overall direction and control, but 
the physician's (or other practitioner's) presence is not required 
during the performance of the service.
    (4) Independent contractor means an individual (or an entity that 
has hired such an individual) who performs part-time or full-time work 
for which the individual (or the entity that has hired such an 
individual) receives an IRS-1099 form.
    (5) Leased employment means an employment relationship that is 
recognized by applicable State law and that is established by two 
employers by a contract such that one employer hires the services of an 
employee of the other employer.
    (6) Noninstitutional setting means all settings other than a 
hospital or skilled nursing facility.
    (7) Practitioner means a non-physician practitioner who is 
authorized by the Act to receive payment for services incident to his or 
her own services.
    (8) Services and supplies means any services or supplies (including 
drugs or

[[Page 405]]

biologicals that are not usually self-administered) that are included in 
section 1861(s)(2)(A) of the Act and are not specifically listed in the 
Act as a separate benefit included in the Medicare program.
    (b) Medicare Part B pays for services and supplies incident to the 
service of a physician (or other practitioner).
    (1) Services and supplies must be furnished in a noninstitutional 
setting to noninstitutional patients.
    (2) Services and supplies must be an integral, though incidental, 
part of the service of a physician (or other practitioner) in the course 
of diagnosis or treatment of an injury or illness.
    (3) Services and supplies must be commonly furnished without charge 
or included in the bill of a physician (or other practitioner).
    (4) Services and supplies must be of a type that are commonly 
furnished in the office or clinic of a physician (or other 
practitioner).
    (5) In general, services and supplies must be furnished under the 
direct supervision of the physician (or other practitioner). Designated 
care management services can be furnished under general supervision of 
the physician (or other practitioner) when these services or supplies 
are provided incident to the services of a physician (or other 
practitioner). The physician (or other practitioner) supervising the 
auxiliary personnel need not be the same physician (or other 
practitioner) who is treating the patient more broadly. However, only 
the supervising physician (or other practitioner) may bill Medicare for 
incident to services.
    (6) Services and supplies must be furnished by the physician, 
practitioner with an incident to benefit, or auxiliary personnel.
    (7) Services and supplies must be furnished in accordance with 
applicable State law.
    (8) A physician (or other practitioner) may be an employee or an 
independent contractor.
    (9) Claims for drugs payable administered by a physician as defined 
in section 1861(r) of the Social Security Act to refill an implanted 
item of DME may only be paid under Part B to the physician as a drug 
incident to a physician's service under section 1861(s)(2)(A). These 
drugs are not payable to a pharmacy/supplier as DME under section 
1861(s)(6) of the Act.
    (c) Limitations. (1) Drugs and biologicals are also subject to the 
limitations specified in Sec.  410.29.
    (2) Physical therapy, occupational therapy and speech-language 
pathology services provided incident to a physician's professional 
services are subject to the provisions established in Sec. Sec.  
410.59(a)(3)(iii), 410.60(a)(3)(iii), and 410.62(a)(3)(ii).

[51 FR 41339, Nov. 14, 1986, as amended at 66 FR 55328, Nov. 1, 2001; 67 
FR 20684, Apr. 26, 2002; 69 FR 66421, Nov. 15, 2004; 77 FR 69361, Nov. 
16, 2012; 78 FR 74811, Dec. 10, 2013; 79 FR 68002, Nov. 13, 2014; 80 FR 
14870, Mar. 20, 2015; 80 FR 71372, Nov. 16, 2015; 81 FR 80552, Nov. 15, 
2016]



Sec.  410.27  Therapeutic outpatient hospital or CAH services and supplies 
incident to a physician's or nonphysician practitioner's service: Conditions.

    (a) Medicare Part B pays for therapeutic hospital or CAH services 
and supplies furnished incident to a physician's or nonphysician 
practitioner's service, which are defined as all services and supplies 
furnished to hospital or CAH outpatients that are not diagnostic 
services and that aid the physician or nonphysician practitioner in the 
treatment of the patient, including drugs and biologicals which are not 
usually self-administered, if--
    (1) They are furnished--
    (i) By or under arrangements made by the participating hospital or 
CAH, except in the case of a SNF resident as provided in Sec.  411.15(p) 
of this subchapter;
    (ii) As an integral although incidental part of a physician's or 
nonphysician practitioner's services;
    (iii) In the hospital or CAH or in a department of the hospital or 
CAH, as defined in Sec.  413.65 of this subchapter;
    (iv) Under the general supervision (or other level of supervision as 
specified by CMS for the particular service) of a physician or a 
nonphysician practitioner as specified in paragraph (g) of this section, 
subject to the following requirements:
    (A) For services furnished in the hospital or CAH, or in an 
outpatient department of the hospital or CAH, both

[[Page 406]]

on and off-campus, as defined in Sec.  413.65 of this chapter, general 
supervision means the definition specified at Sec.  410.32(b)(3)(i).
    (B) Certain therapeutic services and supplies may be assigned either 
direct supervision or personal supervision. For purposes of this 
section, direct supervision means that the physician or nonphysician 
practitioner must be immediately available to furnish assistance and 
direction throughout the performance of the procedure. It does not mean 
that the physician or nonphysician practitioner must be present in the 
room when the procedure is performed. Personal supervision means the 
definition specified at Sec.  410.32(b)(3)(iii);
    (C) Nonphysician practitioners may provide the required supervision 
of services that they may personally furnish in accordance with State 
law and all additional requirements, including those specified in 
Sec. Sec.  410.71, 410.73, 410.74, 410.75, 410.76, and 410.77; and
    (D) For purposes of this section, direct supervision means that the 
physician or nonphysician practitioner must be immediately available to 
furnish assistance and direction throughout the performance of the 
procedure. It does not mean that the physician or nonphysician 
practitioner must be present in the room when the procedure is 
performed. For pulmonary rehabilitation, cardiac rehabilitation, and 
intensive cardiac rehabilitation services, direct supervision must be 
furnished by a doctor of medicine or a doctor of osteopathy, as 
specified in Sec. Sec.  410.47 and 410.49, respectively. Until the later 
of the end of the calendar year in which the PHE as defined in Sec.  
400.200 of this chapter ends or December 31, 2021, the presence of the 
physician includes virtual presence through audio/video real-time 
communications technology (excluding audio-only); and
    (v) In accordance with applicable State law.
    (2) In the case of partial hospitalization services, also meet the 
conditions of paragraph (e) of this section.
    (b) Drugs and biologicals are also subject to the limitations 
specified in Sec.  410.129.
    (c) Rules on emergency services furnished to outpatients by 
nonparticipating hospitals are specified in subpart G of Part 424 of 
this chapter.
    (d) Rules on emergency services furnished to outpatients in a 
foreign country are specified in subpart H of Part 424 of this chapter.
    (e) Medicare Part B pays for partial hospitalization services if 
they are--
    (1) Prescribed by a physician who certifies and recertifies the need 
for the services in accordance with subpart B of part 424 of this 
chapter; and
    (2) Furnished under a plan of treatment as required under subpart B 
of part 424 of this chapter.
    (f) Services furnished by an entity other than the hospital are 
subject to the limitations specified in Sec.  410.42(a).
    (g) For purposes of this section, ``nonphysician practitioner''' 
means a clinical psychologist, licensed clinical social worker, 
physician assistant, nurse practitioner, clinical nurse specialist, or 
certified nurse-midwife.

[76 FR 74580, Nov. 30, 2011, as amended at 78 FR 75196, Dec. 10, 2013; 
84 FR 61490, Nov. 12, 2019; 85 FR 8476, Feb. 14, 2020; 85 FR 19285, Apr. 
6, 2020; 85 FR 86299, Dec. 29, 2020]



Sec.  410.28  Hospital or CAH diagnostic services furnished to outpatients: 
Conditions.

    (a) Medicare Part B pays for hospital or CAH diagnostic services 
furnished to outpatients, including drugs and biologicals required in 
the performance of the services (even if those drugs or biologicals are 
self-administered), if those services meet the following conditions:
    (1) They are furnished by or under arrangements made by a 
participating hospital or participating CAH, except in the case of an 
SNF resident as provided in Sec.  411.15(p) of this chapter.
    (2) They are ordinarily furnished by, or under arrangements made by, 
the hospital or CAH to its outpatients for the purpose of diagnostic 
study.
    (3) They would be covered as inpatient hospital services if 
furnished to an inpatient.
    (b) Drugs and biologicals are also subject to the limitations 
specified in Sec.  410.29(b) and (c).
    (c) Diagnostic services furnished by an entity other than the 
hospital or CAH are subject to the limitations specified in Sec.  
410.42(a).

[[Page 407]]

    (d) Rules on emergency services furnished to outpatients by 
nonparticipating hospitals are set forth in subpart G of part 424 of 
this chapter.
    (e) Medicare Part B makes payment under section 1833(t) of the Act 
for diagnostic services furnished by or under arrangements made by the 
participating hospital only when the diagnostic services are furnished 
under the appropriate level of physician supervision specified by CMS in 
accordance with the definitions in this paragraph and in Sec.  
410.32(b)(3)(i), (b)(3)(ii), and (b)(3)(iii). Under general supervision 
at a facility accorded provider-based status, the training of the 
nonphysician personnel who actually perform the diagnostic procedure and 
the maintenance of the necessary equipment and supplies are the 
continuing responsibility of the facility. In addition--
    (1) For services furnished directly or under arrangement in the 
hospital or in an on-campus or off-campus outpatient department of the 
hospital, as defined in Sec.  413.65 of this chapter, ``direct 
supervision'' means that the physician must be immediately available to 
furnish assistance and direction throughout the performance of the 
procedure. It does not mean that the physician must be present in the 
room where the procedure is performed. During a Public Health Emergency, 
as defined in Sec.  400.200 of this chapter, the presence of the 
physician includes virtual presence through audio/video real-time 
communications technology when use of such technology is indicated to 
reduce exposure risks for the beneficiary or health care provider.
    (2) For services furnished under arrangement in nonhospital 
locations, ``direct supervision'' means the definition specified in 
Sec.  410.32(b)(3)(ii).
    (f) The rules for clinical diagnostic laboratory tests set forth in 
Sec. Sec.  410.32(a) and (d)(2) through (d)(4) of this subpart are 
applicable to those tests when furnished in hospitals and CAHs.

[51 FR 41339, Nov. 14, 1986, as amended at 58 FR 30668, May 26, 1993; 63 
FR 26307, May 12, 1998; 65 FR 18536, Apr. 7, 2000; 66 FR 58809, Nov. 23, 
2001; 74 FR 60680, Nov. 20, 2009; 75 FR 72259, Nov. 24, 2010; 85 FR 
19286, Apr. 6, 2020]



Sec.  410.29  Limitations on drugs and biologicals.

    Medicare part B does not pay for the following:
    (a) Except as provided in Sec.  410.28(a) for outpatient diagnostic 
services and Sec.  410.63(b) for blood clotting factors, and except for 
EPO, any drug or biological which is usually self-administered by the 
patient.
    (b) Any drug product that meets all of the following conditions:
    (1) The drug product was approved by the Food and Drug 
Administration (FDA) before October 10, 1962.
    (2) The drug product is available only through prescription.
    (3) The drug product is the subject of a notice of opportunity for 
hearing issued under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act and published in the Federal Register on a proposed order 
of FDA to withdraw its approval for the drug product because it has 
determined that the product is less than effective for all its labeled 
indications.
    (4) The drug product is presently not subject to a determination by 
FDA, made under its efficacy review program, that there is a compelling 
justification of the drug product's medical need. (21 CFR 310.6 contains 
an explanation of the efficacy review program.)
    (c) Any drug product that is identical, related, or similar, as 
defined in 21 CFR 310.6, to a drug product that meets the conditions of 
paragraph (b) of this section.

[51 FR 41339, Nov. 14, 1986, as amended at 55 FR 22790, June 4, 1990; 56 
FR 43709, Sept. 4, 1991; 80 FR 70602, Nov. 13, 2015]



Sec.  410.30  Prescription drugs used in immunosuppressive therapy.

    (a) Scope. Payment may be made for prescription drugs used in 
immunosuppressive therapy that have been approved for marketing by the 
FDA and that meet one of the following conditions:
    (1) The approved labeling includes the indication for preventing or 
treating the rejection of a transplanted organ or tissue.
    (2) The approved labeling includes the indication for use in 
conjunction

[[Page 408]]

with immunosuppressive drugs to prevent or treat rejection of a 
transplanted organ or tissue.
    (3) Have been determined by a carrier (in accordance with part 421, 
subpart C of this chapter), in processing a Medicare claim, to be 
reasonable and necessary for the specific purpose of preventing or 
treating the rejection of a patient's transplanted organ or tissue, or 
for use in conjunction with immunosuppressive drugs for the purpose of 
preventing or treating the rejection of a patient's transplanted organ 
or tissue. (In making these determinations, the carriers may consider 
factors such as authoritative drug compendia, current medical 
literature, recognized standards of medical practice, and professional 
medical publications.)
    (b) Eligibility. For drugs furnished on or after December 21, 2000, 
coverage is available only for prescription drugs used in 
immunosuppressive therapy, furnished to an individual who received an 
organ or tissue transplant for which Medicare payment is made, provided 
the individual is eligible to receive Medicare Part B benefits.
    (c) Coverage. Drugs are covered under this provision irrespective of 
whether they can be self-administered.

[60 FR 8955, Feb. 16, 1995. Redesignated at 63 FR 34327, June 24, 1998; 
74 FR 62002, Nov. 25, 2009]



Sec.  410.31  Bone mass measurement: Conditions for coverage 
and frequency standards.

    (a) Definition. As used in this section unless specified otherwise, 
the following definition applies:
    Bone mass measurement means a radiologic, radioisotopic, or other 
procedure that meets the following conditions:
    (1) Is performed for the purpose of identifying bone mass, detecting 
bone loss, or determining bone quality.
    (2) Is performed with either a bone densitometer (other than single-
photon or dual-photon absorptiometry) or with a bone sonometer system 
that has been cleared for marketing for this use by the FDA under 21 CFR 
part 807, or approved for marketing by the FDA for this use under 21 CFR 
part 814.
    (3) Includes a physician's interpretation of the results of the 
procedure.
    (b) Conditions for coverage. (1) Medicare covers a medically 
necessary bone mass measurement if the following conditions are met:
    (i) Following an evaluation of the beneficiary's need for the 
measurement, including a determination as to the medically appropriate 
procedure to be used for the beneficiary, it is ordered by the physician 
or a qualified nonphysician practitioner (as these terms are defined in 
Sec.  410.32(a)) treating the beneficiary.
    (ii) It is performed under the appropriate level of supervision of a 
physician (as set forth in Sec.  410.32(b)).
    (iii) It is reasonable and necessary for diagnosing and treating the 
Condition of a beneficiary who meets the conditions described in 
paragraph (d) of this section.
    (2) Medicare covers a medically necessary bone mass measurement for 
an individual defined under paragraph (d)(5) of this section if the 
conditions under paragraph (b)(1) of this section are met and the 
monitoring is performed by the use of a dual energy x-ray absorptiometry 
system (axial skeleton).
    (3) Medicare covers a medically necessary confirmatory baseline bone 
mass measurement for an individual defined under paragraph (d) of this 
section, if the conditions under paragraph (b)(1) of this section are 
met and the confirmatory baseline bone mass measurement is performed by 
a dual energy x-ray absorptiometry system (axial skeleton) and the 
initial measurement was not performed by a dual energy x-ray 
absorptiometry system (axial skeleton).
    (c) Standards on frequency of coverage--(1) General rule. Except as 
allowed under paragraph (c)(2) of this section, Medicare may cover a 
bone mass measurement for a beneficiary if at least 23 months have 
passed since the month the last bone mass measurement was performed.
    (2) Exception. If medically necessary, Medicare may cover a bone 
mass measurement for a beneficiary more frequently than allowed under 
paragraph (c)(1) of this section. Examples of situations where more 
frequent bone mass measurement procedures may be medically necessary 
include, but are not

[[Page 409]]

limited to the following medical circumstances:
    (i) Monitoring beneficiaries on long-term glucocorticoid (steroid) 
therapy of more than 3 months.
    (ii) Allowing for a confirmatory baseline measurement to permit 
monitoring of beneficiaries in the future if the requirements of 
paragraph (b)(3) of this section are met.
    (d) Beneficiaries who may be covered. The following categories of 
beneficiaries may receive Medicare coverage for a medically necessary 
bone mass measurement:
    (1) A woman who has been determined by the physician (or a qualified 
nonphysician practitioner) treating her to be estrogen-deficient and at 
clinical risk for osteoporosis, based on her medical history and other 
findings.
    (2) An individual with vertebral abnormalities as demonstrated by an 
x-ray to be indicative of osteoporosis, osteopenia, or vertebral 
fracture.
    (3) An individual receiving (or expecting to receive) glucocorticoid 
(steroid) therapy equivalent to an average of 5.0 mg of prednisone, or 
greater, per day for more than 3 months.
    (4) An individual with primary hyperparathyroidism.
    (5) An individual being monitored to assess the response to or 
efficacy of an FDA-approved osteoporosis drug therapy.
    (e) Denial as not reasonable and necessary. If CMS determines that a 
bone mass measurement does not meet the conditions for coverage in 
paragraphs (b) or (d) of this section, or the standards on frequency of 
coverage in paragraph (c) of this section, it is excluded from Medicare 
coverage as not ``reasonable'' and ``necessary'' under section 
1862(a)(1)(A) of the Act and Sec.  411.15(k) of this chapter.
    (f) Use of the National Coverage Determination Process. For the 
purposes of paragraphs (b)(2) and (b)(3) of this section, CMS may 
determine through the National Coverage Determination process that 
additional bone mass measurement systems are reasonable and necessary 
under section 1862(a)(1) of the Act for monitoring and confirming 
baseline bone mass measurements.

[71 FR 69783, Dec. 1, 2006]



Sec.  410.32  Diagnostic x-ray tests, diagnostic laboratory tests, 
and other diagnostic tests: Conditions.

    (a) Ordering diagnostic tests. Except as otherwise provided in this 
section, all diagnostic x-ray tests, diagnostic laboratory tests, and 
other diagnostic tests must be ordered by the physician who is treating 
the beneficiary, that is, the physician who furnishes a consultation or 
treats a beneficiary for a specific medical problem and who uses the 
results in the management of the beneficiary's specific medical problem. 
Tests not ordered by the physician who is treating the beneficiary are 
not reasonable and necessary (see Sec.  411.15(k)(1) of this chapter).
    (1) Mammography exception. A physician who meets the qualification 
requirements for an interpreting physician under section 354 of the 
Public Health Service Act as provided in Sec.  410.34(a)(7) may order a 
diagnostic mammogram based on the findings of a screening mammogram even 
though the physician does not treat the beneficiary.
    (2) Application to nonphysician practitioners. Nonphysician 
practitioners (that is, clinical nurse specialists, clinical 
psychologists, clinical social workers, nurse-midwives, nurse 
practitioners, and physician assistants) who furnish services that would 
be physician services if furnished by a physician, and who are operating 
within the scope of their authority under State law and within the scope 
of their Medicare statutory benefit, may be treated the same as 
physicians treating beneficiaries for the purpose of this paragraph.
    (3) Public Health Emergency exceptions. During the Public Health 
Emergency for COVID-19, as defined in Sec.  400.200 of this chapter, the 
order of a physician or other applicable practitioner is not required 
for one otherwise covered diagnostic laboratory test for COVID-19 and 
for one otherwise covered diagnostic laboratory test each for influenza 
virus or similar respiratory condition needed to obtain a final COVID-19 
diagnosis when performed in conjunction with COVID-19 diagnostic 
laboratory test in order to rule-out influenza virus or related 
diagnosis. Subsequent

[[Page 410]]

otherwise covered COVID-19 and related tests described in the previous 
sentence are reasonable and necessary when ordered by a physician or 
nonphysician practitioner in accordance with this paragraph (a), or when 
ordered by a pharmacist or other healthcare professional who is 
authorized under applicable state law to order diagnostic laboratory 
tests. FDA-authorized COVID-19 serology tests are included as covered 
tests subject to the same order requirements during the Public Health 
Emergency for COVID-19, as defined in Sec.  400.20 of this chapter, as 
they are reasonable and necessary under section 1862(a)(1)(A) of the Act 
for beneficiaries with known current or known prior COVID-19 infection 
or suspected current or suspected prior COVID-19 infection.
    (b) Diagnostic x-ray and other diagnostic tests-- (1) Basic rule. 
Except as indicated in paragraph (b)(2) of this section, all diagnostic 
x-ray and other diagnostic tests covered under section 1861(s)(3) of the 
Act and payable under the physician fee schedule must be furnished under 
the appropriate level of supervision by a physician as defined in 
section 1861(r) of the Act or, to the extent that they are authorized to 
do so under their scope of practice and applicable State law, by a nurse 
practitioner, clinical nurse specialist, physician assistant, certified 
registered nurse anesthetist, or a certified nurse-midwife. Services 
furnished without the required level of supervision are not reasonable 
and necessary (see Sec.  411.15(k)(1) of this chapter).
    (2) Exceptions. The following diagnostic tests payable under the 
physician fee schedule are excluded from the basic rule set forth in 
paragraph (b)(1) of this section:
    (i) Diagnostic mammography procedures, which are regulated by the 
Food and Drug Administration.
    (ii) Diagnostic tests personally furnished by a qualified 
audiologist as defined in section 1861(ll)(3) of the Act.
    (iii) Diagnostic psychological and neuropsychological testing 
services when--
    (A) Personally furnished by a clinical psychologist or an 
independently practicing psychologist as defined in program 
instructions; or
    (B) Furnished under the general supervision of a physician or 
clinical psychologist; or under the general supervision of a nurse 
practitioner, clinical nurse specialist, physician assistant, certified 
registered nurse anesthetist or certified nurse-midwife, to the extent 
they are authorized to perform the tests under their scope of practice 
and applicable State laws.
    (iv) Diagnostic tests (as established through program instructions) 
personally performed by a physical therapist who is certified by the 
American Board of Physical Therapy Specialties as a qualified 
electrophysiologic clinical specialist and permitted to provide the 
service under State law.
    (v) Diagnostic tests performed by a nurse practitioner or clinical 
nurse specialist authorized to perform the tests under applicable State 
laws.
    (vi) Pathology and laboratory procedures listed in the 80000 series 
of the Current Procedural Terminology published by the American Medical 
Association.
    (vii) Diagnostic tests performed by a certified nurse-midwife 
authorized to perform the tests under applicable State laws.
    (viii) During the COVID-19 Public Health Emergency as defined in 
Sec.  400.200 of this chapter, diagnostic tests performed by a physician 
assistant authorized to perform the tests under applicable State law.
    (ix) Diagnostic tests performed by a physician assistant authorized 
to perform the tests under their scope of practice and applicable State 
laws.
    (3) Levels of supervision. Except where otherwise indicated, all 
diagnostic x-ray and other diagnostic tests subject to this provision 
and payable under the physician fee schedule must be furnished under at 
least a general level of supervision as defined in paragraph (b)(3)(i) 
of this section. In addition, some of these tests also require either 
direct or personal supervision as defined in paragraph (b)(3)(ii) or 
(iii) of this section, respectively. When direct or personal supervision 
is required, supervision at the specified level is required throughout 
the performance of the test.

[[Page 411]]

    (i) General supervision means the procedure is furnished under the 
physician's overall direction and control, but the physician's presence 
is not required during the performance of the procedure. Under general 
supervision, the training of the nonphysician personnel who actually 
perform the diagnostic procedure and the maintenance of the necessary 
equipment and supplies are the continuing responsibility of the 
physician.
    (ii) Direct supervision in the office setting means the physician 
(or other supervising practitioner) must be present in the office suite 
and immediately available to furnish assistance and direction throughout 
the performance of the procedure. It does not mean that the physician 
(or other supervising practitioner) must be present in the room when the 
procedure is performed. Until the later of the end of the calendar year 
in which the PHE as defined in Sec.  400.200 of this chapter ends or, 
December 31, 2021, the presence of the physician (or other practitioner) 
includes virtual presence through audio/video real-time communications 
technology (excluding audio-only).
    (iii) Personal supervision means a physician must be in attendance 
in the room during the performance of the procedure.
    (4) Supervision requirement for RRA or RPA. Diagnostic tests that 
are performed by a registered radiologist assistant (RRA) who is 
certified and registered by the American Registry of Radiologic 
Technologists or a radiology practitioner assistant (RPA) who is 
certified by the Certification Board for Radiology Practitioner 
Assistants, and that would otherwise require a personal level of 
supervision as specified in paragraph (b)(3) of this section, may be 
furnished under a direct level of physician supervision to the extent 
permitted by state law and state scope of practice regulations.
    (c) Portable x-ray services. Portable x-ray services furnished in a 
place of residence used as the patient's home are covered if the 
following conditions are met:
    (1) These services are furnished under the general supervision of a 
physician, as defined in paragraph (b)(3)(i) of this section.
    (2) These services are ordered by a physician as provided in 
paragraph (a) or by a nonphysician practitioner as provided in paragraph 
(a)(2) of this section.
    (3) The supplier of these services meets the requirements set forth 
in part 486, subpart C of this chapter, concerning conditions for 
coverage for portable x-ray services.
    (4) The procedures are limited to--
    (i) Skeletal films involving the extremities, pelvis, vertebral 
column, or skull;
    (ii) Chest or abdominal films that do not involve the use of 
contrast media; and
    (iii) Diagnostic mammograms if the approved portable x-ray supplier, 
as defined in subpart C of part 486 of this chapter, meets the 
certification requirements of section 354 of the Public Health Service 
Act, as implemented by 21 CFR part 900, subpart B.
    (d) Diagnostic laboratory tests--(1) Who may furnish services. 
Medicare Part B pays for covered diagnostic laboratory tests that are 
furnished by any of the following:
    (i) A participating hospital or participating RPCH.
    (ii) A nonparticipating hospital that meets the requirements for 
emergency outpatient services specified in subpart G of part 424 of this 
chapter and the laboratory requirements specified in part 493 of this 
chapter.
    (iii) The office of the patient's attending or consulting physician 
if that physician is a doctor of medicine, osteopathy, podiatric 
medicine, dental surgery, or dental medicine.
    (iv) An RHC.
    (v) A laboratory, if it meets the applicable requirements for 
laboratories of part 493 of this chapter, including the laboratory of a 
nonparticipating hospital that does not meet the requirements for 
emergency outpatient services in subpart G of part 424 of this chapter.
    (vi) An FQHC.
    (vii) An SNF to its resident under Sec.  411.15(p) of this chapter, 
either directly (in accordance with Sec.  483.75(k)(1)(i) of this 
chapter) or under an arrangement (as defined in Sec.  409.3 of this 
chapter) with another entity described in this paragraph.

[[Page 412]]

    (2) Documentation and recordkeeping requirements--
    (i) Ordering the service. Except for tests described in paragraph 
(a)(3) of this section, the physician (or qualified nonphysician 
practitioner, as defined in paragraph (a)(2) of this section), who 
orders the service must maintain documentation of medical necessity in 
the beneficiary's medical record.
    (ii) Submitting the claim. Except for tests described in paragraph 
(a)(3) of this section, the entity submitting the claim must maintain 
the following documentation:
    (A) The documentation that it receives from the ordering physician 
or nonphysician practitioner.
    (B) The documentation that the information that it submitted with 
the claim accurately reflects the information it received from the 
ordering physician or nonphysician practitioner.
    (iii) Requesting additional information. The entity submitting the 
claim may request additional diagnostic and other medical information to 
document that the services it bills are reasonable and necessary. If the 
entity requests additional documentation, it must request material 
relevant to the medical necessity of the specific test(s), taking into 
consideration current rules and regulations on patient confidentiality.
    (3) Claims review.
    (i) Documentation requirements. Except for tests described in 
paragraph (a)(3) introductory text, upon request by CMS, the entity 
submitting the claim must provide the following information:
    (A) Documentation of the order for the service billed (including 
information sufficient to enable CMS to identify and contact the 
ordering physician or nonphysician practitioner).
    (B) Documentation showing accurate processing of the order and 
submission of the claim.
    (C) Diagnostic or other medical information supplied to the 
laboratory by the ordering physician or nonphysician practitioner, 
including any ICD-9-CM code or narrative description supplied.
    (ii) Services that are not reasonable and necessary. If the 
documentation provided under paragraph (d)(3)(i) of this section does 
not demonstrate that the service is reasonable and necessary, CMS takes 
the following actions:
    (A) Provides the ordering physician or nonphysician practitioner 
information sufficient to identify the claim being reviewed.
    (B) Requests from the ordering physician or nonphysician 
practitioner those parts of a beneficiary's medical record that are 
relevant to the specific claim(s) being reviewed.
    (C) If the ordering physician or nonphysician practitioner does not 
supply the documentation requested, informs the entity submitting the 
claim(s) that the documentation has not been supplied and denies the 
claim.
    (iii) Medical necessity. The entity submitting the claim may request 
additional diagnostic and other medical information from the ordering 
physician or nonphysician practitioner to document that the services it 
bills are reasonable and necessary. If the entity requests additional 
documentation, it must request material relevant to the medical 
necessity of the specific test(s), taking into consideration current 
rules and regulations on patient confidentiality.
    (4) Automatic denial and manual review. (i) General rule. Except as 
provided in paragraph (d)(4)(ii) of this section, CMS does not deny a 
claim for services that exceed utilization parameters without reviewing 
all relevant documentation that is submitted with the claim (for 
example, justifications prepared by providers, primary and secondary 
diagnoses, and copies of medical records).
    (ii) Exceptions. CMS may automatically deny a claim without manual 
review if a national coverage decision or LMRP specifies the 
circumstances under which the service is denied, or the service is 
specifically excluded from Medicare coverage by law.
    (e) Diagnostic laboratory tests furnished in hospitals and CAHs. The 
provisions of paragraphs (a) and (d)(2) through (d)(4) of this section, 
inclusive, of this section apply to all diagnostic

[[Page 413]]

laboratory test furnished by hospitals and CAHs to outpatients.

[62 FR 59098, Oct. 31, 1997, as amended at 63 FR 26308, May 12, 1998; 63 
FR 53307, Oct. 5, 1998; 63 FR 58906, Nov. 2, 1998; 64 FR 59440, Nov. 2, 
1999; 66 FR 58809, Nov. 23, 2001; 69 FR 66421, Nov. 15, 2004; 72 FR 
66398, Nov. 27, 2007; 75 FR 73615, Nov. 29, 2010; 77 FR 69361, Nov. 16, 
2012; 83 FR 60073, Nov. 23, 2018; 85 FR 19286, Apr. 6, 2020; 85 FR 
27620, May 8, 2020; 85 FR 54871, Sept. 2, 2020; 85 FR 85026, Dec. 28, 
2020]



Sec.  410.33  Independent diagnostic testing facility.

    (a) General rule. (1) Effective for diagnostic procedures performed 
on or after March 15, 1999, carriers will pay for diagnostic procedures 
under the physician fee schedule only when performed by a physician, a 
group practice of physicians, an approved supplier of portable x-ray 
services, a nurse practitioner, or a clinical nurse specialist when he 
or she performs a test he or she is authorized by the State to perform, 
or an independent diagnostic testing facility (IDTF). An IDTF may be a 
fixed location, a mobile entity, or an individual nonphysician 
practitioner. It is independent of a physician's office or hospital; 
however, these rules apply when an IDTF furnishes diagnostic procedures 
in a physician's office.
    (2) Exceptions. The following diagnostic tests that are payable 
under the physician fee schedule and furnished by a nonhospital testing 
entity are not required to be furnished in accordance with the criteria 
set forth in paragraphs (b) through (e) and (g) and (h) of this section.
    (i) Diagnostic mammography procedures, which are regulated by the 
Food and Drug Administration.
    (ii) Diagnostic tests personally furnished by a qualified 
audiologist as defined in section 1861(ll)(3) of the Act.
    (iii) Diagnostic psychological testing services personally furnished 
by a clinical psychologist or a qualified independent psychologist as 
defined in program instructions.
    (iv) Diagnostic tests (as established through program instructions) 
personally performed by a physical therapist who is certified by the 
American Board of Physical Therapy Specialties as a qualified 
electrophysiologic clinical specialist and permitted to provide the 
service under State law.
    (b) Supervising physician. (1) Each supervising physician must be 
limited to providing general supervision to no more than three IDTF 
sites. This applies to both fixed sites and mobile units where three 
concurrent operations are capable of performing tests.
    (2) The supervising physician must evidence proficiency in the 
performance and interpretation of each type of diagnostic procedure 
performed by the IDTF. The proficiency may be documented by 
certification in specific medical specialties or subspecialties or by 
criteria established by the carrier for the service area in which the 
IDTF is located. In the case of a procedure requiring the direct or 
personal supervision of a physician as set forth in Sec.  
410.32(b)(3)(ii) or (b)(3)(iii), the IDTF's supervising physician must 
personally furnish this level of supervision whether the procedure is 
performed in the IDTF or, in the case of mobile services, at the remote 
location. The IDTF must maintain documentation of sufficient physician 
resources during all hours of operations to assure that the required 
physician supervision is furnished. In the case of procedures requiring 
direct supervision, the supervising physician may oversee concurrent 
procedures.
    (c) Nonphysician personnel. Any nonphysician personnel used by the 
IDTF to perform tests must demonstrate the basic qualifications to 
perform the tests in question and have training and proficiency as 
evidenced by licensure or certification by the appropriate State health 
or education department. In the absence of a State licensing board, the 
technician must be certified by an appropriate national credentialing 
body. The IDTF must maintain documentation available for review that 
these requirements are met.
    (d) Ordering of tests. All procedures performed by the IDTF must be 
specifically ordered in writing by the physician who is treating the 
beneficiary, that is, the physician who is furnishing a consultation or 
treating a beneficiary for a specific medical problem and who uses the 
results in the management of the beneficiary's specific medical problem. 
(Nonphysician practitioners may

[[Page 414]]

order tests as set forth in Sec.  410.32(a)(3).) The order must specify 
the diagnosis or other basis for the testing. The supervising physician 
for the IDTF may not order tests to be performed by the IDTF, unless the 
IDTF's supervising physician is in fact the beneficiary's treating 
physician. That is, the physician in question had a relationship with 
the beneficiary prior to the performance of the testing and is treating 
the beneficiary for a specific medical problem. The IDTF may not add any 
procedures based on internal protocols without a written order from the 
treating physician.
    (e) Multi-State entities. (1) An IDTF that operates across State 
boundaries must--
    (i) Maintain documentation that its supervising physicians and 
technicians are licensed and certified in each of the States in which it 
operates; and
    (ii) Operate in compliance with all applicable Federal, State, and 
local licensure and regulatory requirements with regard to the health 
and safety of patients.
    (2) The point of the actual delivery of service means the place of 
service on the claim form. When the IDTF performs or administers an 
entire diagnostic test at the beneficiary's location, the beneficiary's 
location is the place of service. When one or more aspects of the 
diagnostic testing are performed at the IDTF, the IDTF is the place of 
service.
    (f) Applicability of State law. An IDTF must comply with the 
applicable laws of any State in which it operates.
    (g) Application certification standards. The IDTF must certify in 
its enrollment application that it meets the following standards and 
related requirements:
    (1) Operates its business in compliance with all applicable Federal 
and State licensure and regulatory requirements for the health and 
safety of patients.
    (2) Provides complete and accurate information on its enrollment 
application. Changes in ownership, changes of location, changes in 
general supervision, and adverse legal actions must be reported to the 
Medicare fee-for-service contractor on the Medicare enrollment 
application within 30 calendar days of the change. All other changes to 
the enrollment application must be reported within 90 days.
    (3) Maintain a physical facility on an appropriate site. For the 
purposes of this standard, a post office box, commercial mailbox, hotel, 
or motel is not considered an appropriate site.
    (i) The physical facility, including mobile units, must contain 
space for equipment appropriate to the services designated on the 
enrollment application, facilities for hand washing, adequate patient 
privacy accommodations, and the storage of both business records and 
current medical records within the office setting of the IDTF, or IDTF 
home office, not within the actual mobile unit.
    (ii) IDTF suppliers that provide services remotely and do not see 
beneficiaries at their practice location are exempt from providing hand 
washing and adequate patient privacy accommodations.
    (4) Has all applicable diagnostic testing equipment available at the 
physical site excluding portable diagnostic testing equipment. The IDTF 
must--
    (i) Maintain a catalog of portable diagnostic equipment, including 
diagnostic testing equipment serial numbers at the physical site;
    (ii) Make portable diagnostic testing equipment available for 
inspection within 2 business days of a CMS inspection request.
    (iii) Maintain a current inventory of the diagnostic testing 
equipment, including serial and registration numbers and provide this 
information to the designated fee-for-service contractor upon request, 
and notify the contractor of any changes in equipment within 90 days.
    (5) Maintain a primary business phone under the name of the 
designated business. The IDTF must have its--
    (i) Primary business phone located at the designated site of the 
business or within the home office of the mobile IDTF units.
    (ii) Telephone or toll free telephone numbers available in a local 
directory and through directory assistance.
    (6) Have a comprehensive liability insurance policy of at least 
$300,000 per location that covers both the place of

[[Page 415]]

business and all customers and employees of the IDTF. The policy must be 
carried by a nonrelative-owned company. Failure to maintain required 
insurance at all times will result in revocation of the IDTF's billing 
privileges retroactive to the date the insurance lapsed. IDTF suppliers 
are responsible for providing the contact information for the issuing 
insurance agent and the underwriter. In addition, the IDTF must--
    (i) Ensure that the insurance policy must remain in force at all 
times and provide coverage of at least $300,000 per incident; and
    (ii) Notify the CMS designated contractor in writing of any policy 
changes or cancellations.
    (7) Agree not to directly solicit patients, which include, but is 
not limited to, a prohibition on telephone, computer, or in-person 
contacts. The IDTF must accept only those patients referred for 
diagnostic testing by an attending physician, who is furnishing a 
consultation or treating a beneficiary for a specific medical problem 
and who uses the results in the management of the beneficiary's specific 
medical problem. Nonphysician practitioners may order tests as set forth 
in Sec.  410.32(a)(3).
    (8) Answer, document, and maintain documentation of a beneficiary's 
written clinical complaint at the physical site of the IDTF (For mobile 
IDTFs, this documentation would be stored at their home office.) This 
includes, but is not limited to, the following:
    (i) The name, address, telephone number, and health insurance claim 
number of the beneficiary.
    (ii) The date the complaint was received; the name of the person 
receiving the complaint; and a summary of actions taken to resolve the 
complaint.
    (iii) If an investigation was not conducted, the name of the person 
making the decision and the reason for the decision.
    (9) Openly post these standards for review by patients and the 
public.
    (10) Disclose to the government any person having ownership, 
financial, or control interest or any other legal interest in the 
supplier at the time of enrollment or within 30 days of a change.
    (11) Have its testing equipment calibrated and maintained per 
equipment instructions and in compliance with applicable manufacturers 
suggested maintenance and calibration standards.
    (12) Have technical staff on duty with the appropriate credentials 
to perform tests. The IDTF must be able to produce the applicable 
Federal or State licenses or certifications of the individuals 
performing these services.
    (13) Have proper medical record storage and be able to retrieve 
medical records upon request from CMS or its fee-for-service contractor 
within 2 business days.
    (14) Permit CMS, including its agents, or its designated fee-for-
service contractors, to conduct unannounced, on-site inspections to 
confirm the IDTF's compliance with these standards. The IDTF must--
    (i) Be accessible during regular business hours to CMS and 
beneficiaries; and
    (ii) Maintain a visible sign posting its normal business hours.
    (15) With the exception of hospital-based and mobile IDTFs, a fixed-
base IDTF is prohibited from the following:
    (i) Sharing a practice location with another Medicare-enrolled 
individual or organization;
    (ii) Leasing or subleasing its operations or its practice location 
to another Medicare-enrolled individual or organization; or
    (iii) Sharing diagnostic testing equipment used in the initial 
diagnostic test with another Medicare-enrolled individual or 
organization.
    (16) Enrolls for any diagnostic testing services that it furnishes 
to a Medicare beneficiary, regardless of whether the service is 
furnished in a mobile or fixed base location.
    (17) Bills for all mobile diagnostic services that are furnished to 
a Medicare beneficiary, unless the mobile diagnostic service is part of 
a service provided under arrangement as described in section 1861(w)(1) 
of the Act.
    (h) Failure to meet standards. If an IDTF fails to meet one or more 
of the standards in paragraph (g) of this section at the time of 
enrollment, its enrollment will be denied. CMS will revoke a supplier's 
billing privileges if and IDTF is found not to meet the

[[Page 416]]

standards in paragraph (g) or (b)(1) of this section.
    (i) Effective date of billing privileges. The filing date of the 
Medicare enrollment application is the date that the Medicare contractor 
receives a signed provider enrollment application that it is able to 
process to approval. The effective date of billing privileges for a 
newly enrolled IDTF is the later of the following:
    (1) The filing date of the Medicare enrollment application that was 
subsequently approved by a Medicare fee-for-service contractor; or
    (2) The date the IDTF first started furnishing services at its new 
practice location.

[62 FR 59099, Oct. 31, 1997, as amended at 64 FR 59440, Nov. 2, 1999; 71 
FR 69784, Dec. 1, 2006; 72 FR 18914, Apr. 16, 2007; 72 FR 66398, Nov. 
27, 2007; 73 FR 2432, Jan. 15, 2008; 73 FR 69933, Nov. 19, 2008; 73 FR 
80304, Dec. 31, 2008]



Sec.  410.34  Mammography services: Conditions for and limitations on coverage.

    (a) Definitions. As used in this section, the following definitions 
apply:
    (1) Diagnostic mammography means a radiologic procedure furnished to 
a man or woman with signs or symptoms of breast disease, or a personal 
history of breast cancer, or a personal history of biopsy-proven benign 
breast disease, and includes a physician's interpretation of the results 
of the procedure.
    (2) Screening mammography means a radiologic procedure furnished to 
a woman without signs or symptoms of breast disease, for the purpose of 
early detection of breast cancer, and includes a physician's 
interpretation of the results of the procedure.
    (3) Supplier of diagnostic mammography means a facility that is 
certified and responsible for ensuring that all diagnostic mammography 
services furnished to Medicare beneficiaries meet the conditions for 
coverage of diagnostic mammography services as specified in paragraph 
(b) of this section.
    (4) Supplier of screening mammography means a facility that is 
certified and responsible for ensuring that all screening mammography 
services furnished to Medicare beneficiaries meet the conditions and 
limitations for coverage of screening mammography services as specified 
in paragraphs (c) and (d) of this section.
    (5) Certificate means the certificate described in 21 CFR 900.2(b) 
that may be issued to, or renewed for, a facility that meets the 
requirements for conducting an examination or procedure involving 
mammography.
    (6) Provisional certificate means the provisional certificate 
described in 21 CFR 900.2(m) that may be issued to a facility to enable 
the facility to qualify to meet the requirements for conducting an 
examination or procedure involving mammography.
    (7) The term meets the certification requirements of section 354 of 
the Public Health Service (PHS) Act means that in order to qualify for 
coverage of its services under the Medicare program, a supplier of 
diagnostic or screening mammography services must meet the following 
requirements:
    (i) Must have a valid provisional certificate, or a valid 
certificate, that has been issued by FDA indicating that the supplier 
meets the certification requirements of section 354 of the PHS Act, as 
implemented by 21 CFR part 900, subpart B.
    (ii) Has not been issued a written notification by FDA that states 
that the supplier must cease conducting mammography examinations because 
the supplier is not in compliance with certain critical certification 
requirements of section 354 of the PHS Act, implemented by 21 CFR part 
900, subpart B.
    (iii) Must not employ for provision of the professional component of 
mammography services a physician or physicians for whom the facility has 
received written notification by FDA that the physician (or physicians) 
is (or are) in violation of the certification requirements set forth in 
section 354 of the PHS Act, as implemented by 21 CFR 900.12(a)(1)(i).
    (b) Conditions for coverage of diagnostic mammography services. 
Medicare Part B pays for diagnostic mammography services if they meet 
the following conditions:
    (1) They are ordered by a doctor of medicine or osteopathy (as 
defined in section 1861(r)(1) of the Act).
    (2) They are furnished by a supplier of diagnostic mammography 
services

[[Page 417]]

that meets the certification requirements of section 354 of the PHS Act, 
as implemented by 21 CFR part 900, subpart B.
    (c) Conditions for coverage of screening mammography services. 
Medicare Part B pays for screening mammography services if they are 
furnished by a supplier of screening mammography services that meets the 
certification requirements of section 354 of the PHS Act, as implemented 
by 21 CFR part 900, subpart B.
    (d) Limitations on coverage of screening mammography services. The 
following limitations apply to coverage of screening mammography 
services as described in paragraphs (c) and (d) of this section:
    (1) The service must be, at a minimum a two-view exposure (that is, 
a cranio-caudal and a medial lateral oblique view) of each breast.
    (2) Payment may not be made for screening mammography performed on a 
woman under age 35.
    (3) Payment may be made for only 1 screening mammography performed 
on a woman over age 34, but under age 40.
    (4) For an asymptomatic woman over 39 years of age, payment may be 
made for a screening mammography performed after at least 11 months have 
passed following the month in which the last screening mammography was 
performed.

[59 FR 49833, Sept. 30, 1994, as amended at 60 FR 14224, Mar. 16, 1995; 
60 FR 63176, Dec. 8, 1995; 62 FR 59100, Oct. 31, 1997; 63 FR 4596, Jan. 
30, 1998]



Sec.  410.35  X-ray therapy and other radiation therapy services: Scope.

    Medicare Part B pays for X-ray therapy and other radiation therapy 
services, including radium therapy and radioactive isotope therapy, and 
materials and the services of technicians administering the treatment.

[51 FR 41339, Nov. 14, 1986. Redesignated at 55 FR 53522, Dec. 31, 1990]



Sec.  410.36  Medical supplies, appliances, and devices: Scope.

    (a) Medicare Part B pays for the following medical supplies, 
appliances and devices:
    (1) Surgical dressings, and splints, casts, and other devices used 
for reduction of fractures and dislocations.
    (2) Prosthetic devices, other than dental, that replace all or part 
of an internal body organ, including colostomy bags and supplies 
directly related to colostomy care, including--
    (i) Replacement of prosthetic devices; and
    (ii) One pair of conventional eyeglasses or conventional contact 
lenses furnished after each cataract surgery during which an intraocular 
lens is inserted.
    (3) Leg, arm, back, and neck braces and artificial legs, arms, and 
eyes, including replacements if required because of a change in the 
individual's physical condition.
    (b) The conditions of payment described in Sec.  410.38(d) also 
apply to medical supplies, appliances, and devices.

[51 FR 41339, Nov. 14, 1986, as amended at 57 FR 36014, Aug. 12, 1992; 
57 FR 57688, Dec. 7, 1992; 84 FR 60801, Nov. 8, 2019]



Sec.  410.37  Colorectal cancer screening tests: Conditions for 
and limitations on coverage.

    (a) Definitions. As used in this section, the following definitions 
apply:
    (1) Colorectal cancer screening tests means any of the following 
procedures furnished to an individual for the purpose of early detection 
of colorectal cancer:
    (i) Screening fecal-occult blood tests.
    (ii) Screening flexible sigmoidoscopies.
    (iii) Screening colonoscopies, including anesthesia furnished in 
conjunction with the service.
    (iv) Screening barium enemas.
    (v) Other tests or procedures established by a national coverage 
determination, and modifications to tests under this paragraph, with 
such frequency and payment limits as CMS determines appropriate, in 
consultation with appropriate organizations
    (2) Screening fecal-occult blood test means--
    (i) A guaiac-based test for peroxidase activity, testing two samples 
from each of three consecutive stools, or,
    (ii) Other tests as determined by the Secretary through a national 
coverage determination.

[[Page 418]]

    (3) An individual at high risk for colorectal cancer means an 
individual with--
    (i) A close relative (sibling, parent, or child) who has had 
colorectal cancer or an adenomatous polyp;
    (ii) A family history of familial adenomatous polyposis;
    (iii) A family history of hereditary nonpolyposis colorectal cancer;
    (iv) A personal history of adenomatous polyps; or
    (v) A personal history of colorectal cancer; or
    (vi) Inflammatory bowel disease, including Crohn's Disease, and 
ulcerative colitis.
    (4) Screening barium enema means--
    (i) A screening double contrast barium enema of the entire 
colorectum (including a physician's interpretation of the results of the 
procedure); or
    (ii) In the case of an individual whose attending physician decides 
that he or she cannot tolerate a screening double contrast barium enema, 
a screening single contrast barium enema of the entire colorectum 
(including a physician's interpretation of the results of the 
procedure).
    (5) An attending physician for purposes of this provision is a 
doctor of medicine or osteopathy (as defined in section 1861(r)(1) of 
the Act) who is fully knowledgeable about the beneficiary's medical 
condition, and who would be responsible using the results of any 
examination performed in the overall management of the beneficiary's 
specific medical problem.
    (b) Condition for coverage of screening fecal-occult blood tests. 
Medicare Part B pays for a screening fecal-occult blood test if it is 
ordered in writing by the beneficiary's attending physician, physician 
assistant, nurse practitioner, or clinical nurse specialist.
    (c) Limitations on coverage of screening fecal-occult blood tests. 
(1) Payment may not be made for a screening fecal-occult blood test 
performed for an individual under age 50.
    (2) For an individual 50 years of age or over, payment may be made 
for a screening fecal-occult blood test performed after at least 11 
months have passed following the month in which the last screening 
fecal-occult blood test was performed.
    (d) Condition for coverage of flexible sigmoidoscopy screening. 
Medicare Part B pays for a flexible sigmoidoscopy screening service if 
it is performed by a doctor of medicine or osteopathy (as defined in 
section 1861(r)(1) of the Act), or by a physician assistant, nurse 
practitioner, or clinical nurse specialist (as defined in section 
1861(aa)(5) of the Act and Sec. Sec.  410.74, 410.75, and 410.76) who is 
authorized under State law to perform the examination.
    (e) Limitations on coverage of screening flexible sigmoidoscopies. 
(1) Payment may not be made for a screening flexible sigmoidoscopy 
performed for an individual under age 50.
    (2) For an individual 50 years of age or over, except as described 
in paragraph (e)(3) of this section, payment may be made for screening 
flexible sigmoidoscopy after at least 47 months have passed following 
the month in which the last screening flexible sigmoidoscopy or, as 
provided in paragraphs (h) and (i) of this section, the last screening 
barium enema was performed.
    (3) In the case of an individual who is not at high risk for 
colorectal cancer as described in paragraph (a)(3) of this section but 
who has had a screening colonoscopy performed, payment may be made for a 
screening flexible sigmoidosocopy only after at least 119 months have 
passed following the month in which the last screening colonoscopy was 
performed.
    (f) Condition for coverage of screening colonoscopies. Medicare Part 
B pays for a screening colonoscopy if it is performed by a doctor of 
medicine or osteopathy (as defined in section 1861(r)(1) of the Act).
    (g) Limitations on coverage of screening colonoscopies. (1) 
Effective for services furnished on or after July 1, 2001, except as 
described in paragraph (g)(3) of this section, payment may be made for a 
screening colonoscopy performed for an individual who is not at high 
risk for colorectal cancer as described in paragraph (a)(3) of this 
section, after at least 119 months have passed following the month in 
which the last screening colonoscopy was performed.
    (2) Payment may be made for a screening colonoscopy performed for an 
individual who is at high risk for

[[Page 419]]

colorectal cancer as described in paragraph (a)(3) of this section, 
after at least 23 months have passed following the month in which the 
last screening colonoscopy was performed, or, as provided in paragraphs 
(h) and (i) of this section, the last screening barium enema was 
performed.
    (3) In the case of an individual who is not at high risk for 
colorectal cancer as described in paragraph (a)(3) of this section but 
who has had a screening flexible sigmoidoscopy performed, payment may be 
made for a screening colonoscopy only after at least 47 months have 
passed following the month in which the last screening flexible 
sigmoidoscopy was performed.
    (h) Conditions for coverage of screening barium enemas. Medicare 
Part B pays for a screening barium enema if it is ordered in writing by 
the beneficiary's attending physician.
    (i) Limitations on coverage of screening barium enemas. (1) In the 
case of an individual age 50 or over who is not at high risk of 
colorectal cancer, payment may be made for a screening barium enema 
examination performed after at least 47 months have passed following the 
month in which the last screening barium enema or screening flexible 
sigmoidoscopy was performed.
    (2) In the case of an individual who is at high risk for colorectal 
cancer, payment may be made for a screening barium enema examination 
performed after at least 23 months have passed following the month in 
which the last screening barium enema or the last screening colonoscopy 
was performed.

[62 FR 59100, Oct. 31, 1997, as amended at 66 FR 55329, Nov. 1, 2001; 67 
FR 80040, Dec. 31, 2002; 77 FR 69362, Nov. 16, 2012; 78 FR 74811, Dec. 
10, 2013; 79 FR 68002, Nov. 13, 2014]



Sec.  410.38  Durable medical equipment, prosthetics, orthotics 
and supplies (DMEPOS): Scope and conditions.

    (a) General scope. Medicare Part B pays for durable medical 
equipment, including ventilators, oxygen equipment, hospital beds, and 
wheelchairs, if the equipment is used in the patient's home or in an 
institution that is used as a home.
    (b) Institutions that may not qualify as the patient's home. An 
institution that is used as a home may not be a hospital or a CAH or a 
SNF as defined in sections 1861(e)(1), 1861(mm)(1) and 1819(a)(1) of the 
Act, respectively.
    (c) Definitions. As used in this section:
    (1) Physician has the same meaning as in section 1861(r)(1) of the 
Act.
    (2) Treating practitioner means physician as defined in section 
1861(r)(1) of the Act, or physician assistant, nurse practitioner, or 
clinical nurse specialist, as those terms are defined in section 
1861(aa)(5) of the Act.
    (3) DMEPOS supplier means an entity with a valid Medicare supplier 
number, including an entity that furnishes items through the mail.
    (4) Written Order/Prescription is a written communication from a 
treating practitioner that documents the need for a beneficiary to be 
provided an item of DMEPOS.
    (5) Face-to-face encounter is an in-person or telehealth encounter 
between the treating practitioner and the beneficiary.
    (6) Power mobility device (PMD) means a covered item of durable 
medical equipment that is in a class of wheelchairs that includes a 
power wheelchair (a four-wheeled motorized vehicle whose steering is 
operated by an electronic device or a joystick to control direction and 
turning) or a power-operated vehicle (a three or four-wheeled motorized 
scooter that is operated by a tiller) that a beneficiary uses in the 
home.
    (7) Master List of DMEPOS items Potentially Subject to Face-To-Face 
Encounter and Written Orders Prior to Delivery and/or Prior 
Authorization Requirements, also referred to as ``Master List,'' are 
items of DMEPOS that CMS has identified in accordance with sections 
1834(a)(11)(B) and 1834(a)(15) of the Act. The criteria for this list 
are specified in Sec.  414.234 of this chapter. The Master List shall 
serve as a library of DMEPOS items from which items may be selected for 
inclusion on Required Face-to-Face Encounter and Written Order Prior to 
Delivery List and/or the Required Prior Authorization List.
    (8) Required Face-to-Face Encounter and Written Order Prior to 
Delivery List is a list of DMEPOS items selected from the Master List 
and subject to the

[[Page 420]]

requirements of a Face-to-Face Encounter and Written Order Prior to 
Delivery. The list of items is published in the Federal Register and 
posted on the CMS website. The list is effective no less than 60 days 
following its publication. When selecting items from the Master List, 
CMS may consider factors such as operational limitations, item 
utilization, cost-benefit analysis, emerging trends, vulnerabilities 
identified in official agency reports, or other analysis.
    (d) Conditions of Payment. The requirements described in this 
paragraph (d) are conditions of payment applicable to DMEPOS items.
    (1) Written Order/Prescription. All DMEPOS items require a written 
order/prescription for Medicare payment. Medicare Contractors shall 
consider the totality of the medical records when reviewing for 
compliance with standardized written order/prescription elements.
    (i) Elements. A written order/prescription must include the 
following elements:
    (A) Beneficiary Name or Medicare Beneficiary Identifier (MBI).
    (B) General Description of the item.
    (C) Quantity to be dispensed, if applicable.
    (D) Order Date.
    (E) Treating Practitioner Name or National Provider Identifier 
(NPI).
    (F) Treating Practitioner Signature.
    (ii) Timing of the Written Order/Prescription.
    (A) For PMDs and other DMEPOS items selected for inclusion on the 
Required Face-to-Face Encounter and Written Order Prior to Delivery 
List, the written order/prescription must be communicated to the 
supplier prior to delivery.
    (B) For all other DMEPOS, the written order/prescription must be 
communicated to the supplier prior to claim submission.
    (2) Items Requiring a Face-to-Face Encounter. For PMDs and other 
DMEPOS items selected for inclusion on the Required Face-to-Face 
Encounter and Written Order Prior to Delivery List, the treating 
practitioner must document and communicate to the DMEPOS supplier that 
the treating practitioner has had a face-to-face encounter with the 
beneficiary within the 6 months preceding the date of the written order/
prescription.
    (i) The encounter must be used for the purpose of gathering 
subjective and objective information associated with diagnosing, 
treating, or managing a clinical condition for which the DMEPOS is 
ordered.
    (ii) If it is a telehealth encounter, the requirements of Sec. Sec.  
410.78 and 414.65 of this chapter must be met.
    (3) Documentation: A supplier must maintain the written order/
prescription and the supporting documentation provided by the treating 
practitioner and make them available to CMS and its agents upon request.
    (i) Upon request by CMS or its agents, a supplier must submit 
additional documentation to CMS or its agents to support and/or 
substantiate the medical necessity for the DMEPOS item.
    (ii) The face-to-face encounter must be documented in the pertinent 
portion of the medical record (for example, history, physical 
examination, diagnostic tests, summary of findings, progress notes, 
treatment plans or other sources of information that may be 
appropriate). The supporting documentation must include subjective and 
objective beneficiary specific information used for diagnosing, 
treating, or managing a clinical condition for which the DMEPOS is 
ordered.
    (e) Suspension of face-to-face encounter and written order prior to 
delivery requirements. CMS may suspend face-to-face encounter and 
written order prior to delivery requirements generally or for a 
particular item or items at any time and without undertaking rulemaking, 
except those items for which inclusion on the Master List was 
statutorily imposed.

[51 FR 41339, Nov. 14, 1986, as amended at 57 FR 57688, Dec. 7, 1992; 58 
FR 30668, May 26, 1993; 70 FR 50946, Aug. 26, 2005; 71 FR 17030, Apr. 5, 
2006; 77 FR 69362, Nov. 16, 2012; 84 FR 60802, Nov. 8, 2019]



Sec.  410.39  Prostate cancer screening tests: Conditions for 
and limitations on coverage.

    (a) Definitions. As used in this section, the following definitions 
apply:

[[Page 421]]

    (1) Prostate cancer screening tests means any of the following 
procedures furnished to an individual for the purpose of early detection 
of prostate cancer:
    (i) A screening digital rectal examination.
    (ii) A screening prostate-specific antigen blood test.
    (iii) For years beginning after 2002, other procedures CMS finds 
appropriate for the purpose of early detection of prostate cancer, 
taking into account changes in technology and standards of medical 
practice, availability, effectiveness, costs, and other factors CMS 
considers appropriate.
    (2) A screening digital rectal examination means a clinical 
examination of an individual's prostate for nodules or other 
abnormalities of the prostate.
    (3) A screening prostate-specific antigen blood test means a test 
that measures the level of prostate-specific antigen in an individual's 
blood.
    (4) A physician for purposes of this provision means a doctor of 
medicine or osteopathy (as defined in section 1861(r)(1) of the Act) who 
is fully knowledgeable about the beneficiary, and who would be 
responsible for explaining the results of the screening examination or 
test.
    (5) A physician assistant, nurse practitioner, clinical nurse 
specialist, or certified nurse midwife for purposes of this provision 
means a physician assistant, nurse practitioner, clinical nurse 
specialist, or certified nurse midwife (as defined in sections 1861(aa) 
and 1861(gg) of the Act) who is fully knowledgeable about the 
beneficiary, and who would be responsible for explaining the results of 
the screening examination or test.
    (b) Condition for coverage of screening digital rectal examinations. 
Medicare Part B pays for a screening digital rectal examination if it is 
performed by the beneficiary's physician, or by the beneficiary's 
physician assistant, nurse practitioner, clinical nurse specialist, or 
certified nurse midwife as defined in paragraphs (a)(4) or (a)(5) of 
this section who is authorized to perform this service under State law.
    (c) Limitation on coverage of screening digital rectal examinations. 
(1) Payment may not be made for a screening digital rectal examination 
performed for a man age 50 or younger.
    (2) For an individual over 50 years of age, payment may be made for 
a screening digital rectal examination only if the man has not had such 
an examination paid for by Medicare during the preceding 11 months 
following the month in which his last Medicare-covered screening digital 
rectal examination was performed.
    (d) Condition for coverage of screening prostate-specific antigen 
blood tests. Medicare Part B pays for a screening prostate-specific 
antigen blood test if it is ordered by the beneficiary's physician, or 
by the beneficiary's physician assistant, nurse practitioner, clinical 
nurse specialist, or certified nurse midwife as defined in paragraphs 
(a)(4) or (a)(5) of this section who is authorized to order this test 
under State law.
    (e) Limitation on coverage of screening prostate-specific antigen 
blood test. (1) Payment may not be made for a screening prostate-
specific antigen blood test performed for a man age 50 or younger.
    (2) For an individual over 50 years of age, payment may be made for 
a screening prostate-specific antigen blood test only if the man has not 
had such an examination paid for by Medicare during the preceding 11 
months following the month in which his last Medicare-covered screening 
prostate-specific antigen blood test was performed.

[64 FR 59440, Nov. 2, 1999, as amended at 65 FR 19331, Apr. 11, 2000]



Sec.  410.40  Coverage of ambulance services.

    (a) Definitions. As used in this section, the following definitions 
apply:
    Non-physician certification statement means a statement signed and 
dated by an individual which certifies that the medical necessity 
provisions of paragraph (e)(1) of this section are met and who meets all 
of the criteria in paragraphs (i) through (iii) of this definition. The 
statement need not be a stand-alone document and no specific format or 
title is required.
    (i) Has personal knowledge of the beneficiary's condition at the 
time the ambulance transport is ordered or the service is furnished;

[[Page 422]]

    (ii) Who must be employed:
    (A) By the beneficiary's attending physician; or
    (B) By the hospital or facility where the beneficiary is being 
treated and from which the beneficiary is transported;
    (iii) Is among the following individuals, with respect to whom all 
Medicare regulations and all applicable State licensure laws apply:
    (A) Physician assistant (PA).
    (B) Nurse practitioner (NP).
    (C) Clinical nurse specialist (CNS).
    (D) Registered nurse (RN).
    (E) Licensed practical nurse (LPN).
    (F) Social worker.
    (G) Case manager.
    (H) Discharge planner.
    Physician certification statement means a statement signed and dated 
by the beneficiary's attending physician which certifies that the 
medical necessity provisions of paragraph (e)(1) of this section are 
met. The statement need not be a stand-alone document and no specific 
format or title is required.
    (b) Basic rules. Medicare Part B covers ambulance services if the 
following conditions are met:
    (1) The supplier meets the applicable vehicle, staff, and billing 
and reporting requirements of Sec.  410.41 and the service meets the 
medical necessity and origin and destination requirements of paragraphs 
(e) and (f) of this section.
    (2) Medicare Part A payment is not made directly or indirectly for 
the services.
    (c) Levels of service. Medicare covers the following levels of 
ambulance service, which are defined in Sec.  414.605 of this chapter:
    (1) Basic life support (BLS) (emergency and nonemergency).
    (2) Advanced life support, level 1 (ALS1) (emergency and 
nonemergency).
    (3) Advanced life support, level 2 (ALS2).
    (4) Paramedic ALS intercept (PI).
    (5) Specialty care transport (SCT).
    (6) Fixed wing transport (FW).
    (7) Rotary wing transport (RW).
    (d) Paramedic ALS intercept services. Paramedic ALS intercept 
services must meet the following requirements:
    (1) Be furnished in an area that is designated as a rural area by 
any law or regulation of the State or that is located in a rural census 
tract of a metropolitan statistical area (as determined under the most 
recent Goldsmith Modification). (The Goldsmith Modification is a 
methodology to identify small towns and rural areas within large 
metropolitan counties that are isolated from central areas by distance 
or other features.)
    (2) Be furnished under contract with one or more volunteer ambulance 
services that meet the following conditions:
    (i) Are certified to furnish ambulance services as required under 
Sec.  410.41.
    (ii) Furnish services only at the BLS level.
    (iii) Be prohibited by State law from billing for any service.
    (3) Be furnished by a paramedic ALS intercept supplier that meets 
the following conditions:
    (i) Is certified to furnish ALS services as required in Sec.  
410.41(b)(2).
    (ii) Bills all the beneficiaries who receive ALS intercept services 
from the entity, regardless of whether or not those beneficiaries are 
Medicare beneficiaries.
    (e) Medical necessity requirements--(1) General rule. Medicare 
covers ambulance services, including fixed wing and rotary wing 
ambulance services, only if they are furnished to a beneficiary whose 
medical condition is such that other means of transportation are 
contraindicated. The beneficiary's condition must require both the 
ambulance transportation itself and the level of service provided in 
order for the billed service to be considered medically necessary. 
Nonemergency transportation by ambulance is appropriate if either: the 
beneficiary is bed-confined, and it is documented that the beneficiary's 
condition is such that other methods of transportation are 
contraindicated; or, if his or her medical condition, regardless of bed 
confinement, is such that transportation by ambulance is medically 
required. Thus, bed confinement is not the sole criterion in determining 
the medical necessity of ambulance transportation. It is one factor that 
is

[[Page 423]]

considered in medical necessity determinations. For a beneficiary to be 
considered bed-confined, the following criteria must be met:
    (i) The beneficiary is unable to get up from bed without assistance.
    (ii) The beneficiary is unable to ambulate.
    (iii) The beneficiary is unable to sit in a chair or wheelchair.
    (2) Special rule for nonemergency, scheduled, repetitive ambulance 
services. (i) Medicare covers medically necessary nonemergency, 
scheduled, repetitive ambulance services if the ambulance provider or 
supplier, before furnishing the service to the beneficiary, obtains a 
physician certification statement dated no earlier than 60 days before 
the date the service is furnished.
    (ii) In all cases, the provider or supplier must keep appropriate 
documentation on file and, upon request, present it to the contractor. 
The presence of the signed physician certification statement does not 
alone demonstrate that the ambulance transport was medically necessary. 
All other program criteria must be met in order for payment to be made.
    (3) Special rule for nonemergency ambulance services that are either 
unscheduled or that are scheduled on a nonrepetitive basis. Medicare 
covers medically necessary nonemergency ambulance services that are 
either unscheduled or that are scheduled on a nonrepetitive basis under 
one of the following circumstances:
    (i) For a resident of a facility who is under the care of a 
physician if the ambulance provider or supplier obtains a physician 
certification statement within 48 hours after the transport.
    (ii) For a beneficiary residing at home or in a facility who is not 
under the direct care of a physician. A physician certification is not 
required.
    (iii) If the ambulance provider or supplier is unable to obtain a 
signed physician certification statement from the beneficiary's 
attending physician, a non-physician certification statement must be 
obtained.
    (iv) If the ambulance provider or supplier is unable to obtain the 
required physician or non-physician certification statement within 21 
calendar days following the date of the service, the ambulance provider 
or supplier must document its attempts to obtain the requested 
certification and may then submit the claim. Acceptable documentation 
includes a signed return receipt from the U.S. Postal Service or other 
similar service that evidences that the ambulance supplier attempted to 
obtain the required signature from the beneficiary's attending physician 
or other individual named in paragraph (e)(3)(iii) of this section.
    (v) In all cases, the provider or supplier must keep appropriate 
documentation on file and, upon request, present it to the contractor. 
The presence of the physician or non-physician certification statement 
or signed return receipt does not alone demonstrate that the ambulance 
transport was medically necessary. All other program criteria must be 
met in order for payment to be made.
    (f) Origin and destination requirements. Medicare covers the 
following ambulance transportation:
    (1) From any point of origin to the nearest hospital, CAH, or SNF 
that is capable of furnishing the required level and type of care for 
the beneficiary's illness or injury. The hospital or CAH must have 
available the type of physician or physician specialist needed to treat 
the beneficiary's condition.
    (2) From a hospital, CAH, or SNF to the beneficiary's home.
    (3) From a SNF to the nearest supplier of medically necessary 
services not available at the SNF where the beneficiary is a resident, 
including the return trip.
    (4) For a beneficiary who is receiving renal dialysis for treatment 
of ESRD, from the beneficiary's home to the nearest facility that 
furnishes renal dialysis, including the return trip.
    (5) During a Public Health Emergency, as defined in Sec.  400.200 of 
this chapter, a ground ambulance transport from any point of origin to a 
destination that is equipped to treat the condition of the patient 
consistent with any applicable state or local Emergency Medical Services 
protocol that governs the destination location. Such destinations 
include, but are not limited to, alternative sites determined to be part 
of a hospital, critical access hospital or skilled nursing facility,

[[Page 424]]

community mental health centers, federally qualified health centers, 
rural health clinics, physician offices, urgent care facilities, 
ambulatory surgical centers, any location furnishing dialysis services 
outside of an ESRD facility when an ESRD facility is not available, and 
the beneficiary's home.
    (g) Specific limits on coverage of ambulance services outside the 
United States. If services are furnished outside the United States, 
Medicare Part B covers ambulance transportation to a foreign hospital 
only in conjunction with the beneficiary's admission for medically 
necessary inpatient services as specified in subpart H of part 424 of 
this chapter.

[64 FR 3648, Jan. 25, 1999, as amended at 65 FR 13914, Mar. 15, 2000; 67 
FR 9132, Feb. 27, 2002; 77 FR 69362, Nov. 16, 2012; 84 FR 63187, Nov. 
15, 2019; 85 FR 19286, Apr. 6, 2020]



Sec.  410.41  Requirements for ambulance providers and suppliers.

    (a) Vehicle. A vehicle used as an ambulance must meet the following 
requirements:
    (1) Be specially designed to respond to medical emergencies or 
provide acute medical care to transport the sick and injured and comply 
with all State and local laws governing an emergency transportation 
vehicle.
    (2) Be equipped with emergency warning lights and sirens, as 
required by State or local laws.
    (3) Be equipped with telecommunications equipment as required by 
State or local law to include, at a minimum, one two-way voice radio or 
wireless telephone.
    (4) Be equipped with a stretcher, linens, emergency medical 
supplies, oxygen equipment, and other lifesaving emergency medical 
equipment as required by State or local laws.
    (b) Vehicle staff. A vehicle furnishing ambulance services must be 
staffed by at least two people who meet the requirements of state and 
local laws where the services are being furnished, and at least one of 
the staff members must, for:
    (1) BLS vehicles. (i) Be certified at a minimum as an emergency 
medical technician-basic by the State or local authority where the 
services are furnished; and
    (ii) Be legally authorized to operate all lifesaving and life-
sustaining equipment on board the vehicle;
    (2) ALS vehicles. (i) Meet the requirements of paragraph (b)(1) of 
this section; and
    (ii) Be certified as a paramedic or an emergency medical technician, 
by the State or local authority where the services are being furnished, 
to perform one or more ALS services.
    (c) Billing and reporting requirements. An ambulance supplier must 
comply with the following requirements:
    (1) Bill for ambulance services using CMS-designated procedure codes 
to describe origin and destination and indicate on claims form that the 
physician certification statement or non-physician certification 
statement is on file, if required.
    (2) Upon a carrier's request, complete and return the ambulance 
supplier form designated by CMS and provide the Medicare carrier with 
documentation of compliance with emergency vehicle and staff licensure 
and certification requirements in accordance with State and local laws.
    (3) Upon a carrier's request, provide additional information and 
documentation as required.

[64 FR 3648, Jan. 25, 1999, as amended at 80 FR 71373, Nov. 16, 2015; 84 
FR 63188, Nov. 15, 2019]



Sec.  410.42  Limitations on coverage of certain services furnished 
to hospital outpatients.

    (a) General rule. Except as provided in paragraph (b) of this 
section, Medicare Part B does not pay for any item or service that is 
furnished to a hospital outpatient (as defined in Sec.  410.2) during an 
encounter (as defined in Sec.  410.2) by an entity other than the 
hospital unless the hospital has an arrangement (as defined in Sec.  
409.3 of this chapter) with that entity to furnish that particular 
service to its patients. As used in this paragraph, the term 
``hospital'' includes a CAH.
    (b) Exception. The limitations stated in paragraph (a) of this 
section do not apply to the following services:
    (1) Physician services that meet the requirements of Sec.  
415.102(a) of this chapter for payment on a fee schedule basis.

[[Page 425]]

    (2) Physician assistant services, as defined in section 
1861(s)(2)(K)(i) of the Act.
    (3) Nurse practitioner and clinical nurse specialist services, as 
defined in section 1861(s)(2)(K)(ii) of the Act.
    (4) Certified nurse mid-wife services, as defined in section 
1861(gg) of the Act.
    (5) Qualified psychologist services, as defined in section 1861(ii) 
of the Act.
    (6) Services of an anesthetist, as defined in Sec.  410.69.
    (7) Services furnished to SNF residents as defined in Sec.  
411.15(p) of this chapter.

[65 FR 18536, Apr. 7, 2000]



Sec.  410.43  Partial hospitalization services: Conditions and exclusions.

    (a) Partial hospitalization services are services that--
    (1) Are reasonable and necessary for the diagnosis or active 
treatment of the individual's condition;
    (2) Are reasonably expected to improve or maintain the individual's 
condition and functional level and to prevent relapse or 
hospitalization;
    (3) Are furnished in accordance with a physician certification and 
plan of care as specified under Sec.  424.24(e) of this chapter; and
    (4) Include any of the following:
    (i) Individual and group therapy with physicians or psychologists or 
other mental health professionals to the extent authorized under State 
law.
    (ii) Occupational therapy requiring the skills of a qualified 
occupational therapist, provided by an occupational therapist, or under 
appropriate supervision of a qualified occupational therapist by an 
occupational therapy assistant as specified in part 484 of this chapter.
    (iii) Services of social workers, trained psychiatric nurses, and 
other staff trained to work with psychiatric patients.
    (iv) Drugs and biologicals furnished for therapeutic purposes, 
subject to the limitations specified in Sec.  410.29.
    (v) Individualized activity therapies that are not primarily 
recreational or diversionary.
    (vi) Family counseling, the primary purpose of which is treatment of 
the individual's condition.
    (vii) Patient training and education, to the extent the training and 
educational activities are closely and clearly related to the 
individual's care and treatment.
    (viii) Diagnostic services.
    (b) The following services are separately covered and not paid as 
partial hospitalization services:
    (1) Physician services that meet the requirements of Sec.  
415.102(a) of this chapter for payment on a fee schedule basis.
    (2) Physician assistant services, as defined in section 
1861(s)(2)(K)(i) of the Act.
    (3) Nurse practitioner and clinical nurse specialist services, as 
defined in section 1861(s)(2)(K)(ii) of the Act.
    (4) Qualified psychologist services, as defined in section 1861(ii) 
of the Act.
    (5) Services furnished to SNF residents as defined in Sec.  
411.15(p) of this chapter.
    (c) Partial hospitalization programs are intended for patients who--
    (1) Require a minimum of 20 hours per week of therapeutic services 
as evidenced in their plan of care;
    (2) Are likely to benefit from a coordinated program of services and 
require more than isolated sessions of outpatient treatment;
    (3) Do not require 24-hour care;
    (4) Have an adequate support system while not actively engaged in 
the program;
    (5) Have a mental health diagnosis;
    (6) Are not judged to be dangerous to self or others; and
    (7) Have the cognitive and emotional ability to participate in the 
active treatment process and can tolerate the intensity of the partial 
hospitalization program.

[59 FR 6577, Feb. 11, 1994, as amended at 65 FR 18536, Apr. 7, 2000; 72 
FR 66399, Nov. 27, 2007; 73 FR 68811, Nov. 18, 2008]



Sec.  410.45  Rural health clinic services: Scope and conditions.

    (a) Medicare Part B pays for the following rural health clinic 
services, if they are furnished in accordance with the requirements and 
conditions specified in part 405, subpart X, and part 491 of this 
chapter:
    (1) Physicians' services.

[[Page 426]]

    (2) Services and supplies furnished as an incident to physicians' 
professional services.
    (3) Nurse practitioner and physician assistant services.
    (4) Services and supplies furnished as an incident to nurse 
practitioners' or physician assistants' services.
    (5) Visiting nurse services.
    (b) Medicare pays for rural health clinic services when they are 
furnished at the clinic, at a hospital or other medical facility, or at 
the beneficiary's place of residence.



Sec.  410.46  Physician and other practitioner services furnished in 
or at the direction of an IHS or Indian tribal hospital or clinic: 
Scope and conditions.

    (a) Medicare Part B pays, in accordance with the physician fee 
schedule, for services furnished in or at the direction of a hospital or 
outpatient clinic (provider-based or free-standing) that is operated by 
the Indian Health Service (IHS) or by an Indian tribe or tribal 
organization (as those terms are defined in section 4 of the Indian 
Health Care Improvement Act). These services are subject to the same 
situations, terms, and conditions that would apply if the services were 
furnished in or at the direction of a hospital or clinic that is not 
operated by IHS or by an Indian tribe or tribal organization. Payments 
include health professional shortage areas incentive payments when the 
requirements for these incentive payments in Sec.  414.42 of this 
chapter are met.
    (b) Payment is not made under this section to the extent that 
Medicare otherwise pays for the same services under other provisions.
    (c) Payment is made under these provisions for the following 
services:
    (1) Services for which payment is made under the physician fee 
schedule in accordance with part 414 of this chapter.
    (2) Services furnished by non-physician practitioners for which 
payment under Part B is made under the physician fee schedule.
    (3) Services furnished by a physical therapist or occupational 
therapist, for which payment under Part B is made under the physician 
fee schedule.
    (d) Payments under these provisions will be paid to the IHS or 
tribal hospital or clinic.

[66 FR 55329, Nov. 1, 2001]



Sec.  410.47  Pulmonary rehabilitation program: Conditions for coverage.

    (a) Definitions. As used in this section:
    Individualized treatment plan means a written plan established, 
reviewed, and signed by a physician every 30 days, that describes all of 
the following:
    (i) The individual's diagnosis.
    (ii) The type, amount, frequency, and duration of the items and 
services under the plan.
    (iii) The goals set for the individual under the plan.
    Medical director means the physician who oversees or supervises the 
PR program.
    Outcomes assessment means a written evaluation of the patient's 
progress as it relates to the individual's rehabilitation which includes 
the following:
    (i) Beginning and end evaluations, based on patient-centered 
outcomes, which are conducted by the physician at the start and end of 
the program.
    (ii) Objective clinical measures of effectiveness of the PR program 
for the individual patient, including exercise performance and self-
reported measures of shortness of breath and behavior.
    Physician means a doctor of medicine or osteopathy as defined in 
section 1861(r)(1) of the Act.
    Physician-prescribed exercise means physical activity, including 
aerobic exercise, prescribed and supervised by a physician that improves 
or maintains an individual's pulmonary functional level.
    Psychosocial assessment means a written evaluation of an 
individual's mental and emotional functioning as it relates to the 
individual's rehabilitation or respiratory condition.
    Pulmonary rehabilitation means a physician-supervised program for 
COPD and certain other chronic respiratory diseases designed to optimize 
physical and social performance and autonomy.
    Supervising physician means a physician that is immediately 
available and accessible for medical consultations and medical 
emergencies at all times

[[Page 427]]

items and services are being furnished under the PR program.
    (b) Beneficiaries who may be covered. (1) Medicare covers pulmonary 
rehabilitation for beneficiaries with moderate to very severe COPD 
(defined as GOLD classification II, III and IV), when referred by the 
physician treating the chronic respiratory disease.
    (2) Additional medical indications for coverage for pulmonary 
rehabilitation program services may be established through a national 
coverage determination (NCD).
    (c) Components. Pulmonary rehabilitation includes all of the 
following components:
    (1) Physician-prescribed exercise. This physical activity includes 
techniques such as exercise conditioning, breathing retraining, step, 
and strengthening exercises. Some aerobic exercise must be included in 
each pulmonary rehabilitation session.
    (2) Education or training. (i) Education or training closely and 
clearly related to the individual's care and treatment which is tailored 
to the individual's needs.
    (ii) Education includes information on respiratory problem 
management and, if appropriate, brief smoking cessation counseling.
    (iii) Any education or training prescribed must assist in 
achievement of individual goals towards independence in activities of 
daily living, adaptation to limitations and improved quality of life.
    (3) Psychosocial assessment. The psychosocial assessment must meet 
the criteria as defined in paragraph (a) of this section and includes:
    (i) An assessment of those aspects of an individual's family and 
home situation that affects the individual's rehabilitation treatment.
    (ii) A psychosocial evaluation of the individual's response to and 
rate of progress under the treatment plan.
    (4) Outcomes assessment. The outcomes assessment must meet the 
criteria as defined in paragraph (a) of this section.
    (5) Individualized treatment plan. The individualized treatment plan 
must be established, reviewed, and signed by a physician, who is 
involved in the patient's care and has knowledge related to his or her 
condition, every 30 days.
    (d) Settings. (1) Medicare Part B pays for a pulmonary 
rehabilitation in the following settings:
    (i) Physician's offices.
    (ii) Hospital outpatient settings.
    (2) All settings must have the following available for immediate use 
and accessible at all times:
    (i) The necessary cardio-pulmonary, emergency, diagnostic, and 
therapeutic life-saving equipment accepted by the medical community as 
medically necessary (for example, oxygen, cardiopulmonary resuscitation 
equipment, and defibrillator) to treat chronic respiratory disease.
    (ii) A physician must be immediately available and accessible for 
medical consultations and emergencies at all times when services are 
being provided under the program. This provision is satisfied if the 
physician meets the requirements for direct supervision for physician 
office services at Sec.  410.26 of this subpart and for hospital 
outpatient services at Sec.  410.27 of this subpart.
    (e) Physician standards. Medicare Part B pays for pulmonary 
rehabilitation services for PR programs supervised by a physician who 
meets the following requirements--
    (1) Is responsible and accountable for the pulmonary rehabilitation 
program, including oversight of the PR staff.
    (2) Is involved substantially, in consultation with staff, in 
directing the progress of the individual in the program including direct 
patient contact related to the periodic review of his or her treatment 
plan.
    (3) Has expertise in the management of individuals with respiratory 
pathophysiology, and cardiopulmonary training and/or certification 
including basic life support.
    (4) Is licensed to practice medicine in the State in which the 
pulmonary rehabilitation program is offered.
    (f) Limitations on coverage: Sessions. Medicare Part B pays for 
services provided in connection with a pulmonary rehabilitation exercise 
program for up to 36 sessions, no more than two sessions per day. Up to 
an additional 36

[[Page 428]]

sessions may be approved by the Medicare contractor, based on medical 
necessity in accordance with section 1862(a)(1)(A) of the Act.
    (g) Effective date. Coverage for pulmonary rehabilitation program 
services is effective January 1, 2010.

[74 FR 62002, Nov. 25, 2009]



Sec.  410.48  Kidney disease education services.

    (a) Definitions. As used in this section:
    Kidney disease patient education services means face-to-face 
educational services provided to patients with Stage IV chronic kidney 
disease.
    Physician means a physician as defined in section 1861(r)(1) of the 
Act.
    Qualified person means either of the following healthcare entities 
that meets the qualifications and requirements specified in this section 
to provide kidney disease patient education services--
    (i) One of the following healthcare professionals who furnishes 
services for which payment may be made under the physician fee schedule:
    (A) Physician (as defined in section 1861(r)(1) of the Act).
    (B) Physician assistant as defined in section 1861(aa)(5) of the Act 
and Sec.  410.74 of this subpart).
    (C) Nurse practitioner as defined in section 1861(aa)(5) of the Act 
and Sec.  410.75 of this subpart).
    (D) Clinical nurse specialist (as defined in section 1861(aa)(5) of 
the Act and Sec.  410.76 of this subpart),
    (ii)(A) A hospital, critical access hospital, skilled nursing 
facility, comprehensive outpatient rehabilitation facility, home health 
agency, or hospice that is located in a rural area as defined in Sec.  
412.64(b)(ii)(C) of this chapter; or
    (B) A hospital or critical access hospital that is treated as being 
rural under Sec.  412.103 of this chapter.
    Renal dialysis facility means a unit, which is approved to furnish 
dialysis service(s) directly to end-stage renal disease (ESRD) patients, 
as defined in Sec.  405.2102 of this chapter.
    Stage IV chronic kidney disease means kidney damage with a severe 
decrease in glomerular filtration rate (GFR) quantitatively defined by a 
GFR value of 15-29 ml/min/1.73m\2\, using the Modification of Diet in 
Renal Disease (MDRD) Study formula.
    (b) Covered beneficiaries. Medicare Part B covers outpatient kidney 
disease patient education services if the beneficiary meets all of the 
conditions and requirements of this subpart, including all of the 
following:
    (1) Is diagnosed with Stage IV chronic kidney disease.
    (2) Obtains a referral from the physician (as defined in section 
1861(r)(1) of the Act) managing the beneficiary's kidney condition.
    (c) Qualified person. (1) Medicare Part B covers outpatient kidney 
disease patient education services provided by a qualified person as 
defined in paragraph (a) of this section and must be able to properly 
receive Medicare payment under part 424 of this chapter.
    (2) A qualified person does not include either of the following:
    (i) A hospital, critical access hospital, skilled nursing facility, 
comprehensive outpatient rehabilitation facility, home health agency or 
hospice if kidney disease patient education services are provided 
outside of a rural area as defined in Sec.  412.64(b)(ii)(C) of this 
chapter unless the services are furnished in a hospital or critical 
access hospital that is treated as being in a rural area under Sec.  
412.103 of this chapter.
    (ii) A renal dialysis facility, as defined in Sec.  405.2102 of this 
chapter.
    (d) Standards for content of kidney disease patient education 
services. The content of the kidney disease patient education services 
includes the following:
    (1) The management of comorbidities including for the purpose of 
delaying the need for dialysis which includes, but not limited to, the 
following topics:
    (i) Prevention and treatment of cardiovascular disease.
    (ii) Prevention and treatment of diabetes.
    (iii) Hypertension management.
    (iv) Anemia management.
    (v) Bone disease and disorders of calcium and phosphorus metabolism 
management.
    (vi) Symptomatic neuropathy management.

[[Page 429]]

    (vii) Impairments in functioning and well-being.
    (2) The prevention of uremic complications which includes, but not 
limited to, the following topics:
    (i) Information on how the kidneys work and what happens when the 
kidneys fail.
    (ii) Understanding if remaining kidney function can be protected, 
preventing disease progression, and realistic chances of survival.
    (iii) Diet and fluid restrictions.
    (iv) Medication review, including how each medication works, 
possible side effects and minimization of side effects, the importance 
of compliance, and informed decision-making if the patient decides not 
to take a specific drug.
    (3) Therapeutic options, treatment modalities, and settings, 
including a discussion of the advantages and disadvantages of each 
treatment option and how the treatments replace the kidney, which 
includes, but not limited to, the following topics:
    (i) Hemodialysis, both at home and in-facility.
    (ii) Peritoneal dialysis (PD), including intermittent PD, continuous 
ambulatory PD, and continuous cycling PD, both at home and in-facility.
    (iii) All dialysis access options for hemodialysis and peritoneal 
dialysis.
    (iv) Transplantation.
    (4) Opportunities for beneficiaries to actively participate in the 
choice of therapy and be tailored to meet the needs of the individual 
beneficiary involved which includes, but not limited to, the following 
topics:
    (i) Physical symptoms.
    (ii) Impact on family and social life.
    (iii) Exercise.
    (iv) The right to refuse treatment.
    (v) Impact on work and finances.
    (vi) The meaning of test results.
    (vii) Psychological impact.
    (5) Qualified persons must develop outcomes assessments designed to 
measure beneficiary knowledge about chronic kidney disease and its 
treatment.
    (i) The outcomes assessments serve to assess program effectiveness 
of preparing the beneficiary to make informed decisions about their 
healthcare options related to chronic kidney disease.
    (ii) The outcomes assessments serve to assess the program's 
effectiveness in meeting the communication needs of underserved 
populations, including persons with disabilities, persons with limited 
English proficiency, and persons with health literacy needs.
    (iii) The assessment must be administered to the beneficiary during 
a kidney disease education session.
    (iv) The outcomes assessments must be made available to CMS upon 
request.
    (e) Limitations for coverage of kidney disease education services. 
(1) Medicare Part B makes payment for up to 6 sessions of kidney disease 
patient education services.
    (2) A session is 1 hour long and may be provided individually or in 
group settings of 2 to 20 individuals who need not all be Medicare 
beneficiaries.
    (f) Effective date. Medicare Part B covers kidney disease patient 
education services for dates of service on or after January 1, 2010.

[74 FR 62003, Nov. 25, 2009]



Sec.  410.49  Cardiac rehabilitation program and intensive 
cardiac rehabilitation program: Conditions of coverage.

    (a) Definitions. As used in this section:
    Cardiac rehabilitation (CR) means a physician-supervised program 
that furnishes physician prescribed exercise, cardiac risk factor 
modification, psychosocial assessment, and outcomes assessment.
    Individualized treatment plan means a written plan tailored to each 
individual patient that includes all of the following:
    (i) A description of the individual's diagnosis.
    (ii) The type, amount, frequency, and duration of the items and 
services furnished under the plan.
    (iii) The goals set for the individual under the plan.
    Intensive cardiac rehabilitation (ICR) program means a physician-
supervised program that furnishes cardiac rehabilitation and has shown, 
in peer-reviewed published research, that it improves patients' 
cardiovascular disease

[[Page 430]]

through specific outcome measurements described in paragraph (c) of this 
section.
    Intensive cardiac rehabilitation site means a hospital outpatient 
setting or physician's office that is providing intensive cardiac 
rehabilitation utilizing an approved ICR program.
    Medical director means a physician that oversees or supervises the 
cardiac rehabilitation or intensive cardiac rehabilitation program at a 
particular site.
    Outcomes assessment means an evaluation of progress as it relates to 
the individual's rehabilitation which includes all of the following:
    (i) Minimally, assessments from the commencement and conclusion of 
cardiac rehabilitation and intensive cardiac rehabilitation, based on 
patient-centered outcomes which must be measured by the physician 
immediately at the beginning of the program and at the end of the 
program.
    (ii) Objective clinical measures of exercise performance and self-
reported measures of exertion and behavior.
    Physician means a doctor of medicine or osteopathy as defined in 
section 1861(r)(1) of the Act.
    Physician-prescribed exercise means aerobic exercise combined with 
other types of exercise (that is, strengthening, stretching) as 
determined to be appropriate for individual patients by a physician.
    Psychosocial assessment means an evaluation of an individual's 
mental and emotional functioning as it relates to the individual's 
rehabilitation which includes an assessment of those aspects of an 
individual's family and home situation that affects the individual's 
rehabilitation treatment, and psychosocial evaluation of the 
individual's response to and rate of progress under the treatment plan.
    Supervising physician means a physician that is immediately 
available and accessible for medical consultations and medical 
emergencies at all times items and services are being furnished to 
individuals under cardiac rehabilitation and intensive cardiac 
rehabilitation programs.
    (b) General rule--(1) Covered beneficiary rehabilitation services. 
Medicare part B covers cardiac rehabilitation and intensive cardiac 
rehabilitation program services for beneficiaries who have experienced 
one or more of the following:
    (i) An acute myocardial infarction within the preceding 12 months;
    (ii) A coronary artery bypass surgery;
    (iii) Current stable angina pectoris;
    (iv) Heart valve repair or replacement;
    (v) Percutaneous transluminal coronary angioplasty (PTCA) or 
coronary stenting;
    (vi) A heart or heart-lung transplant.
    (vii) Stable, chronic heart failure defined as patients with left 
ventricular ejection fraction of 35 percent or less and New York Heart 
Association (NYHA) class II to IV symptoms despite being on optimal 
heart failure therapy for at least 6 weeks, on or after February 18, 
2014 for cardiac rehabilitation and on or after February 9, 2018 for 
intensive cardiac rehabilitation; or
    (viii) Other cardiac conditions as specified through a national 
coverage determination (NCD). The NCD process may also be used to 
specify non-coverage of a cardiac condition for ICR if coverage is not 
supported by clinical evidence.
    (2) Components of a cardiac rehabilitation program and an intensive 
cardiac rehabilitation program. Cardiac rehabilitation programs and 
intensive cardiac rehabilitation programs must include all of the 
following:
    (i) Physician-prescribed exercise each day cardiac rehabilitation 
items and services are furnished.
    (ii) Cardiac risk factor modification, including education, 
counseling, and behavioral intervention, tailored to the patients' 
individual needs.
    (iii) Psychosocial assessment.
    (iv) Outcomes assessment.
    (v) An individualized treatment plan detailing how components are 
utilized for each patient. The individualized treatment plan must be 
established, reviewed, and signed by a physician every 30 days.
    (3) Settings. (i) Medicare Part B pays for cardiac rehabilitation 
and intensive cardiac rehabilitation in one of the following settings:
    (A) A physician's office.
    (B) A hospital outpatient setting.

[[Page 431]]

    (ii) All settings must have a physician immediately available and 
accessible for medical consultations and emergencies at all times when 
items and services are being furnished under the program. This provision 
is satisfied if the physician meets the requirements for direct 
supervision for physician office services, at Sec.  410.26 of this 
subpart; and for hospital outpatient services at Sec.  410.27 of this 
subpart.
    (c) Standards for an intensive cardiac rehabilitation program. (1) 
To be approved as an intensive cardiac rehabilitation program, a program 
must demonstrate through peer-reviewed, published research that it has 
accomplished one or more of the following for its patients:
    (i) Positively affected the progression of coronary heart disease.
    (ii) Reduced the need for coronary bypass surgery.
    (iii) Reduced the need for percutaneous coronary interventions;
    (2) An intensive cardiac rehabilitation program must also 
demonstrate through peer-reviewed published research that it 
accomplished a statistically significant reduction in 5 or more of the 
following measures for patients from their levels before cardiac 
rehabilitation services to after cardiac rehabilitation services:
    (i) Low density lipoprotein.
    (ii) Triglycerides.
    (iii) Body mass index.
    (iv) Systolic blood pressure.
    (v) Diastolic blood pressure.
    (vi) The need for cholesterol, blood pressure, and diabetes 
medications.
    (3) A list of approved intensive cardiac rehabilitation programs, 
identified through the national coverage determination process, will be 
posted to the CMS Web site and listed in the Federal Register.
    (4) All prospective intensive cardiac rehabilitation sites must 
apply to enroll as an intensive cardiac rehabilitation program site 
using the designated forms as specified at Sec.  424.510 of this 
chapter. For purposes of appealing an adverse determination concerning 
site approval, an intensive cardiac rehabilitation site is considered a 
supplier (or prospective supplier) as defined in Sec.  498.2 of this 
chapter.
    (d) Standards for the physician responsible for cardiac 
rehabilitation program. A physician responsible for a cardiac 
rehabilitation program or intensive cardiac rehabilitation programs is 
identified as the medical directors. The medical director, in 
consultation with staff, are involved in directing the progress of 
individuals in the program, must possess all of the following:
    (1) Expertise in the management of individuals with cardiac 
pathophysiology.
    (2) Cardiopulmonary training in basic life support or advanced 
cardiac life support.
    (3) Be licensed to practice medicine in the State in which the 
cardiac rehabilitation program is offered.
    (e) Standards for supervising-physicians. Physicians acting as the 
supervising-physician must possess all of the following:
    (1) Expertise in the management of individuals with cardiac 
pathophysiology.
    (2) Cardiopulmonary training in basic life support or advanced 
cardiac life support.
    (3) Be licensed to practice medicine in the State in which the 
cardiac rehabilitation program is offered.
    (f) Limitations for coverage of cardiac rehabilitation programs. (1) 
Cardiac Rehabilitation: The number of cardiac rehabilitation program 
sessions are limited to a maximum of 2 1-hour sessions per day for up to 
36 sessions over up to 36 weeks with the option for an additional 36 
sessions over an extended period of time if approved by the Medicare 
contractor under section 1862(a)(1)(A) of the Act.
    (2) Intensive Cardiac Rehabilitation: Intensive cardiac 
rehabilitation program sessions are limited to 72 1-hour sessions (as 
defined in section 1848(b)(5) of the Act), up to 6 sessions per day, 
over a period of up to 18 weeks.

[74 FR 62003, Nov. 25, 2009, as amended at 84 FR 63188, Nov. 15, 2019]



Sec.  410.50  Institutional dialysis services and supplies: 
Scope and conditions.

    Medicare Part B pays for the following institutional dialysis 
services and supplies if they are furnished in approved ESRD facilities:

[[Page 432]]

    (a) All services, items, supplies, and equipment necessary to 
perform dialysis and drugs medically necessary and the treatment of the 
patient for ESRD and, as of January 1, 2011, renal dialysis services as 
defined in Sec.  413.171 of this chapter.
    (b) Routine dialysis monitoring tests (i.e., hematocrit and clotting 
time) used by the facility to monitor the patients' fluids incident to 
each dialysis treatment, when performed by qualified staff of the 
facility under the direction of a physician, as provided in Sec.  
494.130 of this chapter, even if the facility does not meet the 
conditions for coverage of services of independent laboratories in part 
494 of this chapter.
    (c) Routine diagnostic tests.
    (d) Epoetin (EPO) and its administration.

[51 FR 41339, Nov. 14, 1986, as amended at 56 FR 43709, Sept. 4, 1991; 
59 FR 1285, Jan. 10, 1994; 73 FR 20474, Apr. 15, 2008; 75 FR 49197, Aug. 
12, 2010]



Sec.  410.52  Home dialysis services, supplies, and equipment: 
Scope and conditions.

    (a) Medicare Part B pays for the following services, supplies, and 
equipment furnished to an ESRD patient in his or her home:
    (1) Purchase or rental, installation, and maintenance of all 
dialysis equipment necessary for home dialysis, and reconditioning of 
this equipment. Dialysis equipment includes, but is not limited to, 
artificial kidney and automated peritoneal dialysis machines, and 
support equipment such as blood pumps, bubble detectors, and other alarm 
systems.
    (2) Items and supplies required for dialysis, including (but not 
limited to) dialyzers, syringes and needles, forceps, scissors, scales, 
sphygmomanometer with cuff and stethoscope, alcohol wipes, sterile 
drapes, and rubber gloves.
    (3) Home dialysis support services furnished by an approved ESRD 
facility, including periodic monitoring of the patient's home 
adaptation, emergency visits by qualified provider or facility 
personnel, any of the tests specified in paragraphs (b) through (d) of 
Sec.  410.50, personnel costs associated with the installation and 
maintenance of dialysis equipment, testing and appropriate treatment of 
water, and ordering of supplies on an ongoing basis.
    (4) On or after July 1, 1991, erythropoeisis-stimulating agents for 
use at home by a home dialysis patient and, on or after January 1, 1994, 
by a dialysis patient, if it has been determined, in accordance with 
Sec.  494.90(a)(4) of this chapter, that the patient is competent to use 
the drug safely and effectively.
    (b) Home dialysis support services specified in paragraph (a)(3) of 
this section must be furnished in accordance with a written treatment 
plan that is prepared and reviewed by a team consisting of the 
individual's physician and other qualified professionals. (Section 
494.90 of this chapter contains details on patient plans of care).

[51 FR 41339, Nov. 14, 1986, as amended at 56 FR 43709, Sept. 4, 1991; 
59 FR 26959, May 25, 1994; 73 FR 20474, Apr. 15, 2008]



Sec.  410.55  Services related to kidney donations: Conditions.

    Medicare Part B pays for medical and other health services covered 
under this subpart that are furnished in connection with a kidney 
donation--
    (a) If the kidney is intended for an individual who has end-stage 
renal disease and is entitled to Medicare benefits; and
    (b) Regardless of whether the donor is entitled to Medicare.



Sec.  410.56  Screening pelvic examinations.

    (a) Conditions for screening pelvic examinations. Medicare Part B 
pays for a screening pelvic examination (including a clinical breast 
examination) if it is performed by a doctor of medicine or osteopathy 
(as defined in section 1861(r)(1) of the Act), or by a certified nurse 
midwife (as defined in section 1861(gg) of the Act), or a physician 
assistant, nurse practitioner, or clinic nurse specialist (as defined in 
section 1861(aa) of the Act) who is authorized under State law to 
perform the examination.
    (b) Limits on coverage of screening pelvic examinations. The 
following limitations apply to coverage of screening pelvic examination 
services:

[[Page 433]]

    (1) General rule. Except as specified in paragraphs (b)(2) and 
(b)(3) of this section, payment may be made for a pelvic examination 
performed on an asymptomatic woman only if the individual has not had a 
pelvic examination paid for by Medicare during the preceding 23 months 
following the month in which her last Medicare-covered screening pelvic 
examination was performed.
    (2) More frequent screening based on high-risk factors. Subject to 
the limitation as specified in paragraph (b)(4) of this section, payment 
may be made for a screening pelvic examination performed more frequently 
than once every 24 months if the test is performed by a physician or 
other practitioner specified in paragraph (a) of this section, and there 
is evidence that the woman is at high risk (on the basis of her medical 
history or other findings) of developing cervical cancer or vaginal 
cancer, as determined in accordance with the following risk factors:
    (i) High risk factors for cervical cancer:
    (A) Early onset of sexual activity (under 16 years of age).
    (B) Multiple sexual partners (five or more in a lifetime).
    (C) History of a sexually transmitted disease (including HIV 
infection).
    (D) Absence of three negative or any Pap smears within the previous 
7 years.
    (ii) High risk factor for vaginal cancer: DES (diethylstilbestrol)-
exposed daughters of women who took DES during pregnancy.
    (3) More frequent screening for women of childbearing age. Subject 
to the limitation as specified in paragraph (b)(4) of this section, 
payment may be made for a screening pelvic examination performed more 
frequently than once every 24 months if the test is performed by a 
physician or other practitioner as specified in paragraph (a) of this 
section for a woman of childbearing age who has had an examination that 
indicated the presence of cervical or vaginal cancer or other 
abnormality during any of the preceding 3 years. The term ``woman of 
childbearing age'' means a woman who is premenopausal, and has been 
determined by a physician, or a qualified practitioner, as specified in 
paragraph (a) of this section, to be of childbearing age, based on her 
medical history or other findings.
    (4) Limitation applicable to women at high risk and those of 
childbearing age. Payment is not made for a screening pelvic examination 
for women considered to be at high risk (under any of the criteria 
described in paragraph (b)(2) of this section), or who qualify for 
coverage under the childbearing provision (under the criteria described 
in paragraph (b)(3) of this section) more frequently than once every 11 
months after the month that the last screening pelvic examination 
covered by Medicare was performed.

[62 FR 59101, Oct. 31, 1997; 63 FR 4596, Jan. 30, 1998, as amended at 66 
FR 55329, Nov. 1, 2001]



Sec.  410.57  Pneumococcal vaccine and flu vaccine.

    (a) Medicare Part B pays for pneumococcal vaccine and its 
administration when reasonable and necessary for the prevention of 
disease, if the vaccine is ordered by a doctor of medicine or 
osteopathy.
    (b) Medicare Part B pays for the influenza virus vaccine and its 
administration.
    (c) Medicare Part B pays for the COVID-19 vaccine and its 
administration.

[63 FR 35066, June 26, 1998, as amended at 85 FR 71197, Nov. 6, 2020]



Sec.  410.58  Additional services to HMO and CMP enrollees.

    Services not usually covered under Medicare Part B may be covered as 
medical and other health services if they are furnished to an enrollee 
of an HMO or a CMP and the following conditions are met:
    (a) The services are--
    (1) Furnished by a physician assistant or nurse practitioner as 
defined in Sec.  491.2 of this chapter, or are incident to services 
furnished by such a practitioner; or
    (2) Furnished by a clinical psychologist as defined in Sec.  417.416 
of this chapter to an enrollee of an HMO or CMP that participates in 
Medicare under a risk-sharing contract, or are incident to those 
services.
    (b) The services are services that would be covered under Medicare 
Part

[[Page 434]]

B if they were furnished by a physician or as incident to a physician's 
professional services.



Sec.  410.59  Outpatient occupational therapy services: Conditions.

    (a) Basic rule. Except as specified in paragraph (a)(3)(iii) of this 
section, Medicare Part B pays for outpatient occupational therapy 
services only if they are furnished by an individual meeting the 
qualifications in part 484 of this chapter for an occupational therapist 
or an appropriately supervised occupational therapy assistant but only 
under the following conditions:
    (1) They are furnished to a beneficiary while he or she is under the 
care of a physician who is a doctor of medicine, osteopathy, or 
podiatric medicine.
    (2) They are furnished under a written plan of treatment that meets 
the requirements of Sec.  410.61.
    (3) They are furnished--
    (i) By a provider as defined in Sec.  489.2 of this chapter, or by 
others under arrangements with, and under the supervision of, a 
provider; or
    (ii) By, or under the direct supervision of, an occupational 
therapist in private practice as described in paragraph (c) of this 
section; or
    (iii) By, or incident to the service of, a physician, physician 
assistant, clinical nurse specialist, or nurse practitioner when those 
professionals may perform occupational therapy services within the scope 
of State law. When an occupational therapy service is provided incident 
to the service of a physician, physician assistant, clinical nurse 
specialist, or nurse practitioner, by anyone other than a physician, 
physician assistant, clinical nurse specialist, or nurse practitioner, 
the service and the person who furnishes the service must meet the 
standards and conditions that apply to occupational therapy and 
occupational therapists, except that a license to practice occupational 
therapy in the State is not required.
    (4) Effective for dates of service on and after January 1, 2020, for 
occupational therapy services described in paragraph (a)(3)(i) or (ii) 
of this section, as applicable--
    (i) Claims for services furnished in whole or in part by an 
occupational therapy assistant must include the prescribed modifier; and
    (ii) Effective for dates of service on or after January 1, 2022, 
claims for such services that include the modifier and for which payment 
is made under sections 1848 or 1834(k) of the Act are paid an amount 
equal to 85 percent of the amount of payment otherwise applicable for 
the service.
    (iii) For purposes of this paragraph, ``furnished in whole or in 
part'' means when the occupational therapy assistant either:
    (A) Furnishes all the minutes of a service exclusive of the 
occupational therapist; or
    (B) Furnishes a portion of a service separately from the part 
furnished by the occupational therapist such that the minutes for that 
portion of a service furnished by the occupational therapy assistant 
exceed 10 percent of the total minutes for that service.
    (b) Conditions for coverage of outpatient therapy services furnished 
to certain inpatients of a hospital or a CAH or SNF. Medicare Part B 
pays for outpatient occupational therapy services furnished to an 
inpatient of a hospital, CAH, or SNF who requires them but who has 
exhausted or is otherwise ineligible for benefit days under Medicare 
Part A.
    (c) Special provisions for services furnished by occupational 
therapists in private practice--(1) Basic qualifications. In order to 
qualify under Medicare as a supplier of outpatient occupational therapy 
services, each individual occupational therapist in private practice 
must meet the following requirements:
    (i) Be legally authorized (if applicable, licensed, certified, or 
registered) to engage in the private practice of occupational therapy by 
the State in which he or she practices, and practice only within the 
scope of his or her license, certification, or registration.
    (ii) Engage in the private practice of occupational therapy on a 
regular basis as an individual, in one of the following practice types: 
a solo practice, partnership, or group practice; or as an employee of 
one of these.
    (iii) Bill Medicare only for services furnished in his or her 
private practice

[[Page 435]]

office space, or in the patient's home. A therapist's private practice 
office space refers to the location(s) where the practice is operated, 
in the State(s) where the therapist (and practice, if applicable) is 
legally authorized to furnish services, during the hours that the 
therapist engages in practice at that location. When services are 
furnished in private practice office space, that space must be owned, 
leased, or rented by the practice and used for the exclusive purpose of 
operating the practice. A patient's home does not include any 
institution that is a hospital, an CAH, or a SNF.
    (iv) Treat individuals who are patients of the practice and for whom 
the practice collects fees for the services furnished.
    (2) Supervision of occupational therapy services. Occupational 
therapy services are performed by, or under the direct supervision of, 
an occupational therapist in private practice. All services not 
performed personally by the therapist must be performed by employees of 
the practice, directly supervised by the therapist, and included in the 
fee for the therapist's services.
    (d) Excluded services. No service is included as an outpatient 
occupational therapy service if it would not be included as an inpatient 
hospital service if furnished to a hospital or CAH inpatient.
    (e) Annual limitation on incurred expenses. (1) Amount of 
limitation. (i) In 1999, 2000, and 2001, no more than $1,500 of 
allowable charges incurred in a calendar year for outpatient 
occupational therapy services are recognized incurred expenses.
    (ii) In 2002 and thereafter, the limitation is determined by 
increasing the limitation in effect in the previous calendar year by the 
increase in the Medicare Economic Index for the current year.
    (iii) The limitation is not applied for services furnished from 
December 8, 2003 through December 31, 2005.
    (iv) Outpatient occupational therapy services furnished by a CAH 
directly or under arrangements must be counted towards the annual 
limitation on incurred expenses as if such services were paid under 
section 1834(k)(1)(b) of the Act.
    (v) Beginning in 2018 and for each successive calendar year, the 
amount described in paragraph (e)(1)(ii) of this section is no longer 
applied as a limitation on incurred expenses for outpatient occupational 
therapy services, but, is instead applied as a threshold above which 
claims for occupational therapy services must include the KX modifier 
(the KX modifier threshold) to indicate that the service is medically 
necessary and justified by appropriate documentation in the medical 
record and claims for services above the KX modifier threshold that do 
not include the KX modifier are denied.
    (2) For purposes of applying the KX modifier threshold, outpatient 
occupational therapy includes:
    (i) Outpatient occupational therapy services furnished under this 
section;
    (ii) Outpatient occupational therapy services furnished by a 
comprehensive outpatient rehabilitation facility;
    (iii) Outpatient occupational therapy services furnished by a 
physician or incident to a physician's service;
    (iv) Outpatient occupational therapy services furnished by a nurse 
practitioner, clinical nurse specialist, or physician assistant or 
incident to their services; and
    (v) Outpatient occupational therapy services furnished by a CAH 
directly or under arrangements, included in the amount of annual 
incurred expenses as if such services were furnished under section 
1834(k)(1)(B) of the Act.
    (3) A process for medical review of claims for outpatient 
occupational therapy services applies as follows:
    (i) For 2012 through 2017, medical review applies to claims for 
services at or in excess of $3,700 of recognized incurred expenses as 
described in paragraph (e)(1)(i) of this section.
    (A) For 2012, 2013, and 2014 all claims at and above the $3,700 
medical review threshold are subject to medical review; and
    (B) For 2015, 2016, and 2017 claims at and above the $3,700 medical 
review threshold are subject to a targeted medical review process.
    (ii) For 2018 and subsequent years, a targeted medical review 
process applies when the accrued annual incurred expenses reach the 
following medical review threshold amounts:

[[Page 436]]

    (A) Beginning with 2018 and before 2028, $3,000;
    (B) For 2028 and each year thereafter, the applicable medical review 
threshold is determined by increasing the medical review threshold in 
effect for the previous year (starting with $3,000 in 2027) by the 
increase in the Medicare Economic Index for the current year.

[63 FR 58906, Nov. 2, 1998, as amended at 67 FR 80040, Dec. 31, 2002; 69 
FR 66421, Nov. 15, 2004; 72 FR 66399, Nov. 27, 2007; 77 FR 69363, Nov. 
16, 2012; 78 FR 74811, Dec. 10, 2013; 79 FR 68002, Nov. 13, 2014; 83 FR 
60073, Nov. 23, 2018; 84 FR 63188, Nov. 15, 2019]



Sec.  410.60  Outpatient physical therapy services: Conditions.

    (a) Basic rule. Except as specified in paragraph (a)(3)(iii) of this 
section, Medicare Part B pays for outpatient physical therapy services 
only if they are furnished by an individual meeting the qualifications 
in part 484 of this chapter for a physical therapist or an appropriately 
supervised physical therapist assistant but only under the following 
conditions:
    (1) They are furnished to a beneficiary while he or she is under the 
care of a physician who is a doctor of medicine, osteopathy, or 
podiatric medicine.
    (2) They are furnished under a written plan of treatment that meets 
the requirements of Sec.  410.61.
    (3) They are furnished--
    (i) By a provider as defined in Sec.  489.2 of this chapter, or by 
others under arrangements with, and under the supervision of, a 
provider; or
    (ii) By, or under the direct supervision of a physical therapist in 
private practice as described in paragraph (c) of this section; or
    (iii) By, or incident to the service of, a physician, physician 
assistant, clinical nurse specialist, or nurse practitioner when those 
professionals may perform physical therapy services under State law. 
When a physical therapy service is provided incident to the service of a 
physician, physician's assistant, clinical nurse specialist, or nurse 
practitioner, by anyone other than a physician, physician assistant, 
clinical nurse specialist, or nurse practitioner, the service and the 
person who furnishes the service must meet the standards and conditions 
that apply to physical therapy and physical therapists, except that a 
license to practice physical therapy in the State is not required.
    (4) Effective for dates of service on and after January 1, 2020, for 
physical therapy services described in paragraphs (a)(3)(i) or (ii) of 
this section, as applicable--
    (i) Claims for services furnished in whole or in part by a physical 
therapist assistant must include the prescribed modifier; and
    (ii) Effective for dates of service on or after January 1, 2022, 
claims for such services that include the modifier and for which payment 
is made under sections 1848 or 1834(k) of the Act are paid an amount 
equal to 85 percent of the amount of payment otherwise applicable for 
the service.
    (iii) For purposes of this paragraph, ``furnished in whole or in 
part'' means when the physical therapist assistant either:
    (A) Furnishes all the minutes of a service exclusive of the physical 
therapist; or
    (B) Furnishes a portion of a service separately from the part 
furnished by the physical therapist such that the minutes for that 
portion of a service furnished by the physical therapist assistant 
exceed 10 percent of the total minutes for that service.
    (b) Condition for coverage of outpatient physical therapy services 
furnished to certain inpatients of a hospital or a CAH or SNF. Medicare 
Part B pays for outpatient physical therapy services furnished to an 
inpatient of a hospital, CAH, or SNF who requires them but who has 
exhausted or is otherwise + ineligible for benefit days under Medicare 
Part A.
    (c) Special provisions for services furnished by physical therapists 
in private practice--(1) Basic qualifications. In order to qualify under 
Medicare as a supplier of outpatient physical therapy services, each 
individual physical therapist in private practice must meet the 
following requirements:
    (i) Be legally authorized (if applicable, licensed, certified, or 
registered) to engage in the private practice of physical therapy by the 
State in which he or she practices, and practice only

[[Page 437]]

within the scope of his or her license, certification, or registration.
    (ii) Engage in the private practice of physical therapy on a regular 
basis as an individual, in one of the following practice types: a solo 
practice, partnership, or group practice; or as an employee of one of 
these.
    (iii) Bill Medicare only for services furnished in his or her 
private practice office space, or in the patient's home. A therapist's 
private practice office space refers to the location(s) where the 
practice is operated, in the State(s) where the therapist (and practice, 
if applicable) is legally authorized to furnish services, during the 
hours that the therapist engages in practice at that location. When 
services are furnished in private practice office space, that space must 
be owned, leased, or rented by the practice and used for the exclusive 
purpose of operating the practice. A patient's home does not include any 
institution that is a hospital, a CAH, or a SNF.
    (iv) Treat individuals who are patients of the practice and for whom 
the practice collects fees for the services furnished.
    (2) Supervision of physical therapy services. Physical therapy 
services are performed by, or under the direct supervision of, a 
physical therapist in private practice. All services not performed 
personally by the therapist must be performed by employees of the 
practice, directly supervised by the therapist, and included in the fee 
for the therapist's services.
    (d) Excluded services. No service is included as an outpatient 
physical therapy service if it would not be included as an inpatient 
hospital service if furnished to a hospital or CAH inpatient.
    (e) Annual limitation on incurred expenses--(1) Amount of 
limitation. (i) In 1999, 2000, and 2001, no more than $1,500 of 
allowable charges incurred in a calendar year for outpatient physical 
therapy services are recognized incurred expenses.
    (ii) In 2002 and thereafter, the limitation shall be determined by 
increasing the limitation in effect in the previous calendar year by the 
increase in the Medicare Economic Index for the current year.
    (iii) The limitation is not applied for services furnished from 
December 8, 2003 through December 31, 2005.
    (iv) Outpatient physical therapy and speech-language pathology 
services furnished by a CAH directly or under arrangements must be 
counted towards the annual limitation on incurred expenses as if such 
services were paid under section 1834(k)(1)(b) of the Act.
    (v) Beginning in 2018 and for each successive calendar year, the 
amount described in paragraph (e)(1)(ii) of this section is not applied 
as a limitation on incurred expenses for outpatient physical therapy and 
outpatient speech-language pathology services, but is instead applied as 
a threshold above which claims for physical therapy and speech-language 
pathology services must include the KX modifier (the KX modifier 
threshold) to indicate that the service is medically necessary and 
justified by appropriate documentation in the medical record; and claims 
for services above the KX modifier threshold that do not include the KX 
modifier are denied.
    (2) For purposes of applying the KX modifier threshold, outpatient 
physical therapy includes:
    (i) Outpatient physical therapy services furnished under this 
section;
    (ii) Outpatient speech-language pathology services furnished under 
Sec.  410.62;
    (iii) Outpatient physical therapy and speech-language pathology 
services furnished by a comprehensive outpatient rehabilitation 
facility;
    (iv) Outpatient physical therapy and speech-language pathology 
services furnished by a physician or incident to a physician's service;
    (v) Outpatient physical therapy and speech-language pathology 
services furnished by a nurse practitioner, clinical nurse specialist, 
or physician assistant or incident to their services; and
    (vi) Outpatient physical therapy and speech-language pathology 
services furnished by a CAH directly or under arrangements, included in 
the amount of annual incurred expenses as if such services were 
furnished and paid under section 1834(k)(1)(B) of the Act.
    (3) A process for medical review of claims for physical therapy and 
speech-

[[Page 438]]

language pathology services applies as follows:
    (i) For 2012 through 2017, medical review applies to claims for 
services at or in excess of $3,700 of recognized incurred expenses as 
described in paragraph (e)(1)(i) of this section.
    (A) For 2012, 2013, and 2014 all claims at and above the $3,700 
medical review threshold are subject to medical review; and
    (B) For 2015, 2016, and 2017 claims at and above the $3,700 medical 
review threshold are subject to a targeted medical review process.
    (ii) For 2018 and subsequent years, a targeted medical review 
process when the accrued annual incurred expenses reach the following 
medical review threshold amounts:
    (A) Beginning with 2018 and before 2028, $3,000;
    (B) For 2028 and each year thereafter, the applicable medical review 
threshold is determined by increasing the medical review threshold in 
effect for the previous year (starting with $3,000 for 2017) by the 
increase in the Medicare Economic Index for the current year.

[63 FR 58906, Nov. 2, 1998, as amended at 67 FR 80041, Dec. 31, 2002; 69 
FR 66422, Nov. 15, 2004; 72 FR 66399, Nov. 27, 2007; 77 FR 69363, Nov. 
16, 2012; 78 FR 74811, Dec. 10, 2013; 79 FR 68002, Nov. 13, 2014; 83 FR 
60073, Nov. 23, 2018; 84 FR 63188, Nov. 15, 2019]



Sec.  410.61  Plan of treatment requirements for outpatient 
rehabilitation services.

    (a) Basic requirement. Outpatient rehabilitation services (including 
services furnished by a qualified physical or occupational therapist in 
private practice), must be furnished under a written plan of treatment 
that meets the requirements of paragraphs (b) through (e) of this 
section.
    (b) Establishment of the plan. The plan is established before 
treatment is begun by one of the following:
    (1) A physician.
    (2) A physical therapist who furnishes the physical therapy 
services.
    (3) A speech-language pathologist who furnishes the speech-language 
pathology services.
    (4) An occupational therapist who furnishes the occupational therapy 
services.
    (5) A nurse practitioner, a clinical nurse specialist, or a 
physician assistant.
    (c) Content of the plan. The plan prescribes the type, amount, 
frequency, and duration of the physical therapy, occupational therapy, 
or speech-language pathology services to be furnished to the individual, 
and indicates the diagnosis and anticipated goals.
    (d) Changes in the plan. Any changes in the plan--
    (1) Are made in writing and signed by one of the following:
    (i) The physician.
    (ii) The physical therapist who furnishes the physical therapy 
services.
    (iii) The occupational therapist that furnishes the occupational 
therapy services.
    (iv) The speech-language pathologist who furnishes the speech-
language pathology services.
    (v) A registered professional nurse or a staff physician, in 
accordance with oral orders from the physician, physical therapist, 
occupational therapist, or speech-language pathologist who furnishes the 
services.
    (vi) A nurse practitioner, a clinical nurse specialist, or a 
physician assistant.
    (2) The changes are incorporated in the plan immediately.

[53 FR 6638, Mar. 2, 1988; 53 FR 12945, Apr. 20, 1988, as amended at 54 
FR 38680, Sept. 20, 1989; 54 FR 46614, Nov. 6, 1989. Redesignated at 56 
FR 8854, Mar. 1, 1991; 56 FR 23022, May 20, 1991; 63 FR 58907, Nov. 2, 
1998; 67 FR 80040, Dec. 31, 2002; 72 FR 66399, Nov. 27, 2007; 77 FR 
69363, Nov. 16, 2012; 83 FR 60073, Nov. 23, 2018]



Sec.  410.62  Outpatient speech-language pathology services: 
Conditions and exclusions.

    (a) Basic rule. Except as specified in paragraph (a)(3)(ii) of this 
section, Medicare Part B pays for outpatient speech-language pathology 
services only if they are furnished by an individual who meets the 
qualifications for a speech-language pathologist in Sec.  484.115 of 
this chapter and only under the following conditions:
    (1) They are furnished to a beneficiary while he or she is under the 
care of a physician who is a doctor of medicine or osteopathy.

[[Page 439]]

    (2) They are furnished under a written plan of treatment that meets 
the requirements of Sec.  410.61.
    (3) They are furnished by one of the following:
    (i) A provider as defined in Sec.  489.2 of this chapter, or by 
others under arrangements with, and under the supervision of, a 
provider.
    (ii) A speech-language pathologist in private practice as described 
in paragraph (c) of this section.
    (iii) Incident to the service of, a physician, physician assistant, 
clinical nurse specialist, or nurse practitioner when those 
professionals may perform speech-language pathology services under State 
law. When a speech-language pathology service is provided incident to 
the services of a physician, physician assistant, clinical nurse 
specialist, or nurse practitioner, by anyone other than a physician, 
physician assistant, clinical nurse specialist, or nurse practitioner, 
the service and the person who furnishes the service must meet the 
standards and conditions that apply to speech-language pathology and 
speech-language pathologists, except that a license to practice speech-
language pathology services in the State is not required.
    (b) Condition for coverage of outpatient speech-language pathology 
services furnished to certain inpatients of a hospital or a CAH or SNF. 
Medicare Part B pays for outpatient speech-language pathology services 
furnished to an inpatient of a hospital, CAH, or SNF who requires the 
services but has exhausted or is otherwise ineligible for benefit days 
under Medicare Part A.
    (c) Special provisions for services furnished by speech-language 
pathologists in private practice--(1) Basic qualifications. In order to 
qualify under Medicare as a supplier of outpatient speech-language 
pathology services, each individual speech-language pathologist in 
private practice must meet the following requirements:
    (i) Be legally authorized (if applicable, licensed, certified, or 
registered) to engage in the private practice of speech-language 
pathology by the State in which he or she practices, and practice only 
within the scope of his or her license and/or certification.
    (ii) Engage in the private practice of speech-language pathology on 
a regular basis as an individual, in one of the following practice 
types: a solo practice, partnership, or group practice; or as an 
employee of one of these.
    (iii) Bill Medicare only for services furnished in one of the 
following:
    (A) A speech-language pathologist's private practice office space 
that meets all of the following:
    (1) The location(s) where the practice is operated, in the State(s) 
where the therapist (and practice, if applicable) is legally authorized 
to furnish services and during the hours that the therapist engages in 
practice at that location.
    (2) The space must be owned, leased, or rented by the practice, and 
used for the exclusive purpose of operating the practice.
    (B) A patient's home not including any institution that is a 
hospital, a CAH, or a SNF.
    (iv) Treat individuals who are patients of the practice and for whom 
the practice collects fees for the services furnished.
    (d) Excluded services. No service is included as an outpatient 
speech-language pathology service if it is not included as an inpatient 
hospital service if furnished to a hospital or CAH inpatient.

[51 FR 41339, Nov. 14, 1986, as amended at 53 FR 6648, Mar. 2, 1988; 56 
FR 8852, Mar. 1, 1991; 56 FR 23022, May 20, 1991; 58 FR 30668, May 26, 
1993; 63 FR 58907, Nov. 2, 1998; 69 FR 66422, Nov. 15, 2004; 73 FR 
69933, Nov. 19, 2008; 76 FR 73470, Nov. 28, 2011; 77 FR 69363, Nov. 16, 
2012; 79 FR 68002, Nov. 13, 2014; 82 FR 4578, Jan. 13, 2017; 83 FR 
60073, Nov. 23, 2018]



Sec.  410.63  Hepatitis B vaccine and blood clotting factors: Conditions.

    Notwithstanding the exclusion from coverage of vaccines (see Sec.  
405.310 of this chapter) and self-administered drugs (see Sec.  410.29), 
the following services are included as medical and other health services 
covered under Sec.  410.10, subject to the specified conditions:
    (a) Hepatitis B vaccine: Conditions. Effective September 1, 1984, 
hepatitis B vaccinations that are reasonable and necessary for the 
prevention of illness for those individuals who are at high or 
intermediate risk of contracting hepatitis B as listed below:

[[Page 440]]

    (1) High risk groups. (i) End-Stage Renal Disease (ESRD) patients;
    (ii) Hemophiliacs who receive Factor VIII or IX concentrates;
    (iii) Clients of institutions for individuals with intellectual 
disabilities;
    (iv) Persons who live in the same household as a hepatitis B 
carrier;
    (v) Homosexual men;
    (vi) Illicit injectable drug abusers;
    (vii) Pacific Islanders (that is, those Medicare beneficiaries who 
reside on Pacific islands under U.S. jurisdiction, other than residents 
of Hawaii); and
    (viii) Persons diagnosed with diabetes mellitus.
    (2) Intermediate risk groups. (i) Staff in institutions for 
individuals with intellectual disabilities and classroom employees who 
work with individuals with intellectual disabilities;
    (ii) Workers in health care professions who have frequent contact 
with blood or blood-derived body fluids during routine work (including 
workers who work outside of a hospital and have frequent contact with 
blood or other infectious secretions); and
    (iii) Heterosexually active persons with multiple sexual partners 
(that is, those Medicare beneficiaries who have had at least two 
documented episodes of sexually transmitted diseases within the 
preceding 5 years).
    (3) Exception. Individuals described in paragraphs (a) (1) and (2) 
of this section are not considered at high or intermediate risk of 
contracting hepatitis B if they have undergone a prevaccination 
screening and have been found to be currently positive for antibodies to 
hepatitis B.
    (b) Blood clotting factors: Conditions. Effective July 18, 1984, 
blood clotting factors to control bleeding for hemophilia patients 
competent to use these factors without medical or other supervision, and 
items related to the administration of those factors. The amount of 
clotting factors covered under this provision is determined by the 
carrier based on the historical utilization pattern or profile developed 
by the carrier for each patient, and based on consideration of the need 
for a reasonable reserve supply to be kept in the home in the event of 
emergency or unforeseen circumstance.
    (c) Blood clotting factors: Furnishing Fee. (1) Effective January 1, 
2005, a furnishing fee of $0.14 per unit of clotting factor is paid to 
entities that furnish blood clotting factors unless the costs associated 
with furnishing the clotting factor are paid through another payment 
system, for example, hospitals that furnish clotting factor to patients 
during a Part A covered inpatient hospital stay.
    (2) The furnishing fee for blood clotting factors furnished in 2006 
or a subsequent year is be equal to the furnishing fee paid the previous 
year increased by the percentage increase in the consumer price index 
for medical care for the 12-month period ending with June of the 
previous year.

[55 FR 22790, June 4, 1990; 55 FR 31186, Aug. 1, 1990, as amended at 69 
FR 66422, Nov. 15, 2004; 77 FR 69363, Nov. 16, 2012]



Sec.  410.64  Additional preventive services.

    (a) Medicare Part B pays for additional preventive services not 
described in paragraph (1) or (3) of the definition of ``preventive 
services'' under Sec.  410.2, that identify medical conditions or risk 
factors for individuals if the Secretary determines through the national 
coverage determination process (as defined in section 1869(f)(1)(B) of 
the Act) that these services are all of the following:
    (1) Reasonable and necessary for the prevention or early detection 
of illness or disability.
    (2) Recommended with a grade of A or B by the United States 
Preventive Services Task Force.
    (3) Appropriate for individuals entitled to benefits under part A or 
enrolled under Part B.
    (b) In making determinations under paragraph (a) of this section 
regarding the coverage of a new preventive service, the Secretary may 
conduct an assessment of the relation between predicted outcomes and the 
expenditures for such services and may take into account the results of 
such an assessment in making such national coverage determinations.

[73 FR 69933, Nov. 19, 2008, as amended at 75 FR 73615, Nov. 29, 2010]

[[Page 441]]



Sec.  410.66  Emergency outpatient services furnished by a nonparticipating 
hospital and services furnished in a foreign country.

    Conditions for payment of emergency inpatient services furnished by 
a nonparticipating U.S. hospital and for services furnished in a foreign 
country are set forth in subparts G and H of part 424 of this chapter.

[71 FR 48136, Aug. 18, 2006]



Sec.  410.67  Medicare coverage and payment of Opioid use disorder 
treatment services furnished by Opioid treatment programs.

    (a) Basis and scope-- (1) Basis. This section implements sections 
1861(jjj), 1861(s)(2)(HH), 1833(a)(1)(CC) and 1834(w) of the Act which 
provide for coverage of opioid use disorder treatment services furnished 
by an opioid treatment program and the payment of a bundled payment 
under Part B to an opioid treatment program for opioid use disorder 
treatment services that are furnished to a beneficiary during an episode 
of care beginning on or after January 1, 2020.
    (2) Scope. This section sets forth the criteria for an opioid 
treatment program, the scope of opioid use disorder treatment services, 
and the methodology for determining the bundled payments to opioid 
treatment programs for furnishing opioid use disorder treatment 
services.
    (b) Definitions. For purposes of this section, the following 
definitions apply:
    Episode of care means a one-week (contiguous 7-day) period.
    Opioid treatment program means an entity that is an opioid treatment 
program (as defined in Sec.  8.2 of this title, or any successor 
regulation) that meets the requirements described in paragraph (c) of 
this section.
    Opioid use disorder treatment service means one of the following 
items or services for the treatment of opioid use disorder that is 
furnished by an opioid treatment program that meets the requirements 
described in paragraph (c) of this section.
    (1) Opioid agonist and antagonist treatment medications (including 
oral, injected, or implanted versions) that are approved by the Food and 
Drug Administration under section 505 of the Federal, Food, Drug, and 
Cosmetic Act for use in treatment of opioid use disorder.
    (2) Dispensing and administration of opioid agonist and antagonist 
treatment medications, if applicable.
    (3) Substance use counseling by a professional to the extent 
authorized under State law to furnish such services including services 
furnished via two-way interactive audio-video communication technology, 
as clinically appropriate, and in compliance with all applicable 
requirements. During a Public Health Emergency, as defined in Sec.  
400.200 of this chapter, where audio/video communication technology is 
not available to the beneficiary, the counseling services may be 
furnished using audio-only telephone calls if all other applicable 
requirements are met.
    (4) Individual and group therapy with a physician or psychologist 
(or other mental health professional to the extent authorized under 
State law), including services furnished via two-way interactive audio-
video communication technology, as clinically appropriate, and in 
compliance with all applicable requirements. During a Public Health 
Emergency, as defined in Sec.  400.200 of this chapter, where audio/
video communication technology is not available to the beneficiary, the 
therapy services may be furnished using audio-only telephone calls if 
all other applicable requirements are met.
    (5) Toxicology testing.
    (6) Intake activities, including initial medical examination 
services required under Sec.  8.12(f)(2) of this title and initial 
assessment services required under Sec.  8.12(f)(4) of this title.
    (7) Periodic assessment services required under Sec.  8.12(f)(4) of 
this title, that are furnished during a face-to-face encounter, 
including services furnished via two-way interactive audio-video 
communication technology, as clinically appropriate, and in compliance 
with all applicable requirements. During the Public Health Emergency, as 
defined in Sec.  400.200 of this chapter, in cases where a beneficiary 
does not have access to two-way audio-video communications technology, 
periodic assessments can be furnished using audio-

[[Page 442]]

only telephone calls if all other applicable requirements are met.
    (8) Opioid antagonist medications that are approved by the Food and 
Drug Administration under section 505 of the Federal Food, Drug, and 
Cosmetic Act for the emergency treatment of known or suspected opioid 
overdose and overdose education furnished in conjunction with opioid 
antagonist medication.
    (c) Requirements for opioid treatment programs. To participate in 
the Medicare program and receive payment, an opioid treatment program 
must meet all of the following:
    (1) Be enrolled in the Medicare program.
    (2) Have in effect a certification by the Substance Abuse and Mental 
Health Services Administration (SAMHSA) for the opioid treatment 
program.
    (3) Be accredited by an accrediting body approved by the SAMHSA.
    (4) Have in effect a provider agreement under part 489 of this 
title.
    (d) Bundled payments for opioid use disorder treatment services 
furnished by opioid treatment programs. (1) CMS will establish 
categories of bundled payments for opioid treatment programs for an 
episode of care as follows:
    (i) Categories for each type of opioid agonist and antagonist 
treatment medication;
    (ii) A category for medication not otherwise specified, which will 
be used for new FDA-approved opioid agonist or antagonist treatment 
medications for which CMS has not established a category; and
    (iii) A category for episodes of care in which no medication is 
provided.
    (2) The bundled payment for episodes of care in which a medication 
is provided consists of payment for a drug component, reflecting payment 
for the applicable FDA-approved opioid agonist or antagonist medication 
in the patient's treatment plan, and a non-drug component, reflecting 
payment for all other opioid use disorder treatment services reflected 
in the patient's treatment plan (including dispensing/administration of 
the medication, if applicable). The payments for the drug component and 
non-drug component are added together to create the bundled payment 
amount. The bundled payment for episodes of care in which no medication 
is provided consists of a single payment amount for all opioid use 
disorder treatment services reflected in the patient's treatment plan 
(excluding medication and dispensing/administration of medication).
    (i) Drug component. The payment for the drug component for an 
episode of care will be determined as follows, using the most recent 
data available at time of ratesetting for the applicable calendar year:
    (A) Implantable and injectable medications. For implantable and 
injectable medications, the payment is determined using the methodology 
set forth in section 1847A of the Act, except that the payment amount 
must be 100 percent of the ASP, if ASP is used; and the payment must be 
100 percent of the wholesale acquisition cost (WAC), if WAC is used.
    (B) For oral medications, if ASP data are available, the payment 
amount is 100 percent of ASP, which will be determined based on ASP data 
that have been calculated consistent with the provisions in part 414, 
subpart 800 of this chapter and voluntarily submitted by drug 
manufacturers. If ASP data are not available, the payment amount for 
methadone will be based on the TRICARE rate and for buprenorphine will 
be calculated using the National Average Drug Acquisition Cost.
    (C) Exception. For the drug component of bundled payments in the 
medication not otherwise specified category under paragraph (d)(1)(iii) 
of this section, the payment amount is be based on the applicable 
methodology under paragraphs (d)(2)(i)(A) and (B) of this section 
(applying the most recent available data for such new medication), or 
invoice pricing until the necessary data become available.
    (ii) Non-drug component. The payment for CY 2020 for the non-drug 
component of the bundled payment for an episode of care is the sum of:
    (A) The CY 2019 Medicare physician fee schedule non-facility rates 
for the following items and services:
    (1) Psychotherapy, 30 minutes with patient
    (2) Group psychotherapy

[[Page 443]]

    (3) Alcohol and/or substance (other than tobacco) abuse structured 
assessment and brief intervention at the non-physician practitioner 
rate.
    (4) For administration of an injectable medication, if applicable, 
drug administration (Therapeutic, prophylactic).
    (5) For the insertion, removal, or insertion and removal of the 
implantable medication, if applicable, the applicable rate.
    (B) For dispensing oral medication, if applicable, an approximation 
of the average dispensing fees under state Medicaid programs.
    (C) One fourth of the sum of the CY 2019 Clinical Laboratory Fee 
Schedule rate for two drug tests, presumptive, capable of being read by 
direct optical observation only and for a drug test, definitive, 1-7 
drug classes.
    (iii) No medication provided episodes of care. The bundled payment 
amount for CY 2020 for an episode of care in which no medication is 
provided is based on the non-drug component rate for an episode of care 
in which a drug is dispensed or administered, not including any amounts 
reflecting the cost of dispensing or administration of a drug.
    (3) At least one OUD treatment service described in paragraphs 
(b)(1) through (5) of this section must be furnished to bill for the 
bundled payment for an episode of care.
    (4) Adjustments will be made to the bundled payment for the 
following:
    (i) If the opioid treatment program furnishes:
    (A) Counseling or therapy services in excess of the amount specified 
in the beneficiary's treatment plan and for which medical necessity is 
documented in the medical record, an adjustment will be made for each 
additional 30 minutes of counseling or individual therapy furnished 
during the episode of care.
    (B) Intake activities described in paragraph (b)(6) of this section, 
an adjustment will be made when intake activities are furnished.
    (C) Periodic assessments described in paragraph (b)(7) of this 
section, an adjustment will be made when this service is furnished.
    (D) Additional take home supply of oral drugs of up to 21 days, in 
increments of 7 days, an adjustment will be made when oral medications 
are dispensed.
    (E) Take-home supply of opioid antagonist medications that are 
approved by the Food and Drug Administration under section 505 of the 
Federal, Food, Drug and Cosmetic Act for the emergency treatment of 
known or suspected opioid overdose and overdose education furnished in 
conjunction with opioid antagonist medication, an adjustment will be 
made when these medications are dispensed. This adjustment will be 
limited to once every 30 days, except when a further take home supply of 
these medications is medically reasonable and necessary. The opioid 
treatment program must document in the medical record the reason(s) for 
the exception. The amount of the drug component of the adjustment will 
be determined using the methodology in paragraph (d)(2)(i) of this 
section. The amount of the non-drug component of the adjustment will be 
determined based on the CY 2020 Medicare payment rate for CPT code 
96161.
    (ii) The payment amounts for the non-drug component of the bundled 
payment for an episode of care, and the adjustments for counseling or 
therapy, intake activities and periodic assessments will be 
geographically adjusted using the Geographic Adjustment Factor described 
in Sec.  414.26 of this chapter.
    (iii) The payment amounts for the non-drug component of the bundled 
payment for an episode of care, and the adjustments for counseling or 
therapy, intake activities and periodic assessments will be updated 
annually using the Medicare Economic Index described in Sec.  405.504(d) 
of this chapter.
    (5) Payment for medications delivered, administered or dispensed to 
a beneficiary as part of the bundled payment is considered a duplicative 
payment if a claim for delivery, administration or dispensing of the 
same medications for the same beneficiary on the same date of service 
was also separately paid under Medicare Part B or Part D. CMS will 
recoup the duplicative payment made to the opioid treatment program.

[[Page 444]]

    (e) Beneficiary cost-sharing. A beneficiary copayment amount of zero 
will apply.

[84 FR 63189, Nov. 15, 2019, as amended at 85 FR 19286, Apr. 6, 2020; 85 
FR 27620, May 8, 2020; 85 FR 85026, Dec. 28, 2020]



Sec.  410.68  Antigens: Scope and conditions.

    Medicare Part B pays for--
    (a) Antigens that are furnished as services incident to a 
physician's professional services; or
    (b) A supply of antigen sufficient for not more than 12 months that 
is--
    (1) Prepared for a patient by a doctor of medicine or osteopathy who 
has examined the patient and developed a plan of treatment including 
dosage levels; and
    (2) Administered--
    (i) In accord with the plan of treatment developed by the doctor of 
medicine or osteopathy who prepared the antigen; and
    (ii) By a doctor of medicine or osteopathy or by a properly 
instructed person under the supervision of a doctor of medicine or 
osteopathy.

[54 FR 4026, Jan. 27, 1989, as amended at 65 FR 65440, Nov. 1, 2000]



Sec.  410.69  Services of a certified registered nurse anesthetist 
or an anesthesiologist's assistant: Basic rule and definitions.

    (a) Basic rule. Medicare Part B pays for anesthesia services and 
related care furnished by a certified registered nurse anesthetist or an 
anesthesiologist's assistant who is legally authorized to perform the 
services by the State in which the services are furnished.
    (b) Definitions. For purposes of this part--
    Anesthesia and related care means those services that a certified 
registered nurse anesthetist is legally authorized to perform in the 
state in which the services are furnished.
    Anesthesiologist's assistant means a person who--
    (1) Works under the direction of an anesthesiologist;
    (2) Is in compliance with all applicable requirements of State law, 
including any licensure requirements the State imposes on nonphysician 
anesthetists; and
    (3) Is a graduate of a medical school-based anesthesiologist's 
assistant educational program that--
    (A) Is accredited by the Committee on Allied Health Education and 
Accreditation; and
    (B) Includes approximately two years of specialized basic science 
and clinical education in anesthesia at a level that builds on a 
premedical undergraduate science background.
    Anesthetist includes both an anesthesiologist's assistant and a 
certified registered nurse anesthetist.
    Certified registered nurse anesthetist means a registered nurse who:
    (1) Is licensed as a registered professional nurse by the State in 
which the nurse practices;
    (2) Meets any licensure requirements the State imposes with respect 
to non-physician anesthetists;
    (3) Has graduated from a nurse anesthesia educational program that 
meets the standards of the Council on Accreditation of Nurse Anesthesia 
Programs, or such other accreditation organization as may be designated 
by the Secretary; and
    (4) Meets the following criteria:
    (i) Has passed a certification examination of the Council on 
Certification of Nurse Anesthetists, the Council on Recertification of 
Nurse Anesthetists, or any other certification organization that may be 
designated by the Secretary; or
    (ii) Is a graduate of a program described in paragraph (3) of this 
definition and within 24 months after that graduation meets the 
requirements of paragraph (4)(i) of this definition.
    (5) For certified registered nurse anesthetist services, the 
certified registered nurse anesthetist may review and verify (sign and 
date), rather than re-document, notes in a patient's medical record made 
by physicians; residents; nurses; medical, physician assistant, and 
advanced practice registered nurse students; or other members of the 
medical team, including, as applicable, notes documenting the certified 
registered nurse anesthetist's

[[Page 445]]

presence and participation in the service.

[57 FR 33896, July 31, 1992, as amended at 77 FR 69363, Nov. 16, 2012; 
84 FR 63190, Nov. 15, 2019]



Sec.  410.71  Clinical psychologist services and services 
and supplies incident to clinical psychologist services.

    (a) Included services. (1) Medicare Part B covers services furnished 
by a clinical psychologist, who meets the requirements specified in 
paragraph (d) of this section, that are within the scope of his or her 
State license, if the services would be covered if furnished by a 
physician or as an incident to a physician's services.
    (2) Medicare Part B covers services and supplies incident to the 
services of a clinical psychologist if the requirements of Sec.  410.26 
are met.
    (b) Application of mental health treatment limitation. The treatment 
services of a clinical psychologist and services and supplies furnished 
as an incident to those services are subject to the limitation on 
payment for outpatient mental health treatment services set forth in 
Sec.  410.155.
    (c) Payment for consultations. A clinical psychologist or an 
attending or primary care physician may not bill Medicare or the 
beneficiary for the consultation that is required under paragraph (e) of 
this section.
    (d) Qualifications. For purposes of this subpart, a clinical 
psychologist is an individual who--
    (1) Holds a doctoral degree in psychology; and
    (2) Is licensed or certified, on the basis of the doctoral degree in 
psychology, by the State in which he or she practices, at the 
independent practice level of psychology to furnish diagnostic, 
assessment, preventive, and therapeutic services directly to 
individuals.
    (e) Agreement to consult. A clinical psychologist who bills Medicare 
Part B must agree to meet the requirements of paragraphs (e)(1) through 
(e)(3) of this section. The clinical psychologist's signature on a 
Medicare provider/supplier enrollment form indicates his or her 
agreement.
    (1) Unless the beneficiary's primary care or attending physician has 
referred the beneficiary to the clinical psychologist, to inform the 
beneficiary that it is desirable for the clinical psychologist to 
consult with the beneficiary's attending or primary care physician (if 
the beneficiary has such a physician) to consider any conditions 
contributing to the beneficiary's symptoms.
    (2) If the beneficiary assents to the consultation, in accordance 
with accepted professional ethical norms and taking into consideration 
patient confidentiality--
    (i) To attempt, within a reasonable time after receiving the 
consent, to consult with the physician; and
    (ii) If attempts to consult directly with the physician are not 
successful, to notify the physician, within a reasonable time, that he 
or she is furnishing services to the beneficiary.
    (3) Unless the primary care or attending physician referred the 
beneficiary to the clinical psychologist, to document, in the 
beneficiary's medical record, the date the patient consented or declined 
consent to consultation, the date of consultation, or, if attempts to 
consult did not succeed, the date and manner of notification to the 
physician.

[63 FR 20128, Apr. 23, 1998, as amended at 78 FR 74811, Dec. 10, 2013]



Sec.  410.73  Clinical social worker services.

    (a) Definition: clinical social worker. For purposes of this part, a 
clinical social worker is defined as an individual who--
    (1) Possesses a master's or doctor's degree in social work;
    (2) After obtaining the degree, has performed at least 2 years of 
supervised clinical social work; and
    (3) Either is licensed or certified as a clinical social worker by 
the State in which the services are performed or, in the case of an 
individual in a State that does not provide for licensure or 
certification as a clinical social worker--
    (i) Is licensed or certified at the highest level of practice 
provided by the laws of the State in which the services are performed; 
and

[[Page 446]]

    (ii) Has completed at least 2 years or 3,000 hours of post master's 
degree supervised clinical social work practice under the supervision of 
a master's degree level social worker in an appropriate setting such as 
a hospital, SNF, or clinic.
    (b) Covered clinical social worker services. Medicare Part B covers 
clinical social worker services.
    (1) Definition. ``Clinical social worker services'' means, except as 
specified in paragraph (b)(2) of this section, the services of a 
clinical social worker furnished for the diagnosis and treatment of 
mental illness that the clinical social worker is legally authorized to 
perform under State law (or the State regulatory mechanism provided by 
State law) of the State in which the services are performed. The 
services must be of a type that would be covered if they were furnished 
by a physician or as an incident to a physician's professional service 
and must meet the requirements of this section.
    (2) Exception. The following services are not clinical social worker 
services for purposes of billing Medicare Part B:
    (i) Services furnished by a clinical social worker to an inpatient 
of a Medicare-participating hospital.
    (ii) Services furnished by a clinical social worker to an inpatient 
of a Medicare-participating SNF.
    (iii) Services furnished by a clinical social worker to a patient in 
a Medicare-participating dialysis facility if the services are those 
required by the conditions for coverage for ESRD facilities under Sec.  
405.2163 of this chapter.
    (c) Agreement to consult. A clinical social worker must comply with 
the consultation requirements set forth at Sec.  410.71(f) (reading 
``clinical psychologist'' as ``clinical social worker'').
    (d) Prohibited billing. (1) A clinical social worker may not bill 
Medicare for the services specified in paragraph (b)(2) of this section.
    (2) A clinical social worker or an attending or primary care 
physician may not bill Medicare or the beneficiary for the consultation 
that is required under paragraph (c) of this section.

[63 FR 20128, Apr. 23, 1998]



Sec.  410.74  Physician assistants' services.

    (a) Basic rule. Medicare Part B covers physician assistants' 
services only if the following conditions are met:
    (1) The services would be covered as physicians' services if 
furnished by a physician (a doctor of medicine or osteopathy, as set 
forth in section 1861(r)(1) of the Act).
    (2) The physician assistant--
    (i) Meets the qualifications set forth in paragraph (c) of this 
section;
    (ii) Is legally authorized to perform the services in the State in 
which they are performed;
    (iii) Performs services that are not otherwise precluded from 
coverage because of a statutory exclusion;
    (iv) Performs the services in accordance with state law and state 
scope of practice rules for physician assistants in the state in which 
the physician assistant's professional services are furnished. Any state 
laws and scope of practice rules that describe the required practice 
relationship between physicians and physician assistants, including 
explicit supervisory or collaborative practice requirements, describe a 
form of supervision for purposes of section 1861(s)(2)(K)(i) of the Act. 
For states with no explicit state law and scope of practice rules 
regarding physician supervision of physician assistant's services, 
physician supervision is a process in which a physician assistant has a 
working relationship with one or more physicians to supervise the 
delivery of their health care services. Such physician supervision is 
evidenced by documenting at the practice level the physician assistant's 
scope of practice and the working relationships the physician assistant 
has with the supervising physician/s when furnishing professional 
services.
    (v) Furnishes services that are billed by the employer of a 
physician assistant; and
    (vi) Performs the services--
    (A) In all settings in either rural and urban areas; or
    (B) As an assistant at surgery.
    (b) Services and supplies furnished incident to a physician 
assistant's services. Medicare Part B covers services and supplies 
incident to the services of a physician assistant if the requirements of 
Sec.  410.26 are met.

[[Page 447]]

    (c) Qualifications. For Medicare Part B coverage of his or her 
services, a physician assistant must meet all of the following 
conditions:
    (1) Have graduated from a physician assistant educational program 
that is accredited by the Commission on Accreditation of Allied Health 
Education Programs; or
    (2) Have passed the national certification examination that is 
administered by the National Commission on Certification of Physician 
Assistants; and
    (3) Be licensed by the State to practice as a physician assistant.
    (d) Professional services. Physician assistants can be paid for 
professional services only if the services have been professionally 
performed by them and no facility or other provider charges for the 
service or is paid any amount for the furnishing of those professional 
services.
    (1) Supervision of other nonphysician staff by a physician assistant 
does not constitute personal performance of a professional service by 
the physician assistant.
    (2) The services are provided on an assignment-related basis, and 
the physician assistant may not charge a beneficiary for a service not 
payable under this provision. If a beneficiary has made payment for a 
service, the physician assistant must make the appropriate refund to the 
beneficiary.
    (e) Medical record documentation. For physician assistants' 
services, the physician assistant may review and verify (sign and date), 
rather than re-document, notes in a patient's medical record made by 
physicians; residents; nurses; medical, physician assistant, and 
advanced practice registered nurse students; or other members of the 
medical team, including, as applicable, notes documenting the physician 
assistant's presence and participation in the service.

[63 FR 58907, Nov. 2, 1998; 64 FR 25457, May 12, 1999, as amended at 78 
FR 74811, Dec. 10, 2013; 84 FR 63190, Nov. 15, 2019]



Sec.  410.75  Nurse practitioners' services.

    (a) Definition. As used in this section, the term ``physician'' 
means a doctor of medicine or osteopathy, as set forth in section 
1861(r)(1) of the Act.
    (b) Qualifications. For Medicare Part B coverage of his or her 
services, a nurse practitioner must be a registered professional nurse 
who is authorized by the State in which the services are furnished to 
practice as a nurse practitioner in accordance with State law, and must 
meet one of the following:
    (1) Obtained Medicare billing privileges as a nurse practitioner for 
the first time on or after January 1, 2003, and meets the following 
requirements:
    (i) Be certified as a nurse practitioner by a recognized national 
certifying body that has established standards for nurse practitioners.
    (ii) Possess a master's degree in nursing or a Doctor of Nursing 
Practice (DNP) doctoral degree.
    (2) Obtained Medicare billing privileges as a nurse practitioner for 
the first time before January 1, 2003, and meets the standards in 
paragraph (b)(1)(i) of this section.
    (3) Obtained Medicare billing privileges as a nurse practitioner for 
the first time before January 1, 2001.
    (c) Services. Medicare Part B covers nurse practitioners' services 
in all settings in both rural and urban areas, only if the services 
would be covered if furnished by a physician and the nurse 
practitioner--
    (1) Is legally authorized to perform them in the State in which they 
are performed;
    (2) Is not performing services that are otherwise excluded from 
coverage because of one of the statutory exclusions; and
    (3) Performs them while working in collaboration with a physician.
    (i) Collaboration is a process in which a nurse practitioner works 
with one or more physicians to deliver health care services within the 
scope of the practitioner's expertise, with medical direction and 
appropriate supervision as provided for in jointly developed guidelines 
or other mechanisms as provided by the law of the State in which the 
services are performed.
    (ii) In the absence of State law governing collaboration, 
collaboration is a process in which a nurse practitioner has a 
relationship with one or more

[[Page 448]]

physicians to deliver health care services. Such collaboration is to be 
evidenced by nurse practitioners documenting the nurse practitioners' 
scope of practice and indicating the relationships that they have with 
physicians to deal with issues outside their scope of practice. Nurse 
practitioners must document this collaborative process with physicians.
    (iii) The collaborating physician does not need to be present with 
the nurse practitioner when the services are furnished or to make an 
independent evaluation of each patient who is seen by the nurse 
practitioner.
    (d) Services and supplies incident to a nurse practitioners' 
services. Medicare Part B covers services and supplies incident to the 
services of a nurse practitioner if the requirements of Sec.  410.26 are 
met.
    (e) Professional services. Nurse practitioners can be paid for 
professional services only when the services have been personally 
performed by them and no facility or other provider charges, or is paid, 
any amount for the furnishing of the professional services.
    (1) Supervision of other nonphysician staff by a nurse practitioner 
does not constitute personal performance of a professional service by a 
nurse practitioner.
    (2) The services are provided on an assignment-related basis, and a 
nurse practitioner may not charge a beneficiary for a service not 
payable under this provision. If a beneficiary has made payment for a 
service, the nurse practitioner must make the appropriate refund to the 
beneficiary.
    (f) Medical record documentation. For nurse practitioners' services, 
the nurse practitioner may review and verify (sign and date), rather 
than re-document, notes in a patient's medical record made by 
physicians; residents; nurses; medical, physician assistant, and 
advanced practice registered nurse students; or other members of the 
medical team, including, as applicable, notes documenting the nurse 
practitioner's presence and participation in the service.

[63 FR 58908, Nov. 2, 1998; 64 FR 25457, May 12, 1999, as amended at 64 
FR 59440, Nov. 2, 1999; 73 FR 69933, Nov. 19, 2008; 78 FR 74811, Dec. 
10, 2013; 84 FR 63191, Nov. 15, 2019]



Sec.  410.76  Clinical nurse specialists' services.

    (a) Definition. As used in this section, the term ``physician'' 
means a doctor of medicine or osteopathy, as set forth in section 
1861(r)(1) of the Act.
    (b) Qualifications. For Medicare Part B coverage of his or her 
services, a clinical nurse specialist must--
    (1) Be a registered nurse who is currently licensed to practice in 
the State where he or she practices and be authorized to perform the 
services of a clinical nurse specialist in accordance with State law;
    (2) Have a master's degree in a defined clinical area of nursing 
from an accredited educational institution or a Doctor of Nursing 
Practice (DNP) doctoral degree; and
    (3) Be certified as a clinical nurse specialist by a national 
certifying body that has established standards for clinical nurse 
specialists and that is approved by the Secretary.
    (c) Services. Medicare Part B covers clinical nurse specialists' 
services in all settings in both rural and urban areas only if the 
services would be covered if furnished by a physician and the clinical 
nurse specialist--
    (1) Is legally authorized to perform them in the State in which they 
are performed;
    (2) Is not performing services that are otherwise excluded from 
coverage by one of the statutory exclusions; and
    (3) Performs them while working in collaboration with a physician.
    (i) Collaboration is a process in which a clinical nurse specialist 
works with one or more physicians to deliver health care services within 
the scope of the practitioner's expertise, with medical direction and 
appropriate supervision as provided for in jointly developed guidelines 
or other mechanisms as provided by the law of the State in which the 
services are performed.
    (ii) In the absence of State law governing collaboration, 
collaboration is a process in which a clinical nurse specialist has a 
relationship with one or more physicians to deliver health care 
services. Such collaboration is to be evidenced by clinical nurse 
specialists documenting the clinical nurse specialists' scope of 
practice and indicating the relationships that they have with

[[Page 449]]

physicians to deal with issues outside their scope of practice. Clinical 
nurse specialists must document this collaborative process with 
physicians.
    (iii) The collaborating physician does not need to be present with 
the clinical nurse specialist when the services are furnished, or to 
make an independent evaluation of each patient who is seen by the 
clinical nurse specialist.
    (d) Services and supplies furnished incident to clinical nurse 
specialists' services. Medicare Part B covers services and supplies 
incident to the services of a clinical nurse specialist if the 
requirements of Sec.  410.26 are met.
    (e) Professional services. Clinical nurse specialists can be paid 
for professional services only when the services have been personally 
performed by them and no facility or other provider charges, or is paid, 
any amount for the furnishing of the professional services.
    (1) Supervision of other nonphysician staff by clinical nurse 
specialists does not constitute personal performance of a professional 
service by clinical nurse specialists.
    (2) The services are provided on an assignment-related basis, and a 
clinical nurse specialist may not charge a beneficiary for a service not 
payable under this provision. If a beneficiary has made payment for a 
service, the clinical nurse specialist must make the appropriate refund 
to the beneficiary.
    (f) Medical record documentation. For clinical nurse specialists' 
services, the clinical nurse specialist may review and verify (sign and 
date), rather than re-document, notes in a patient's medical record made 
by physicians; residents; nurses; medical, physician assistant, and 
advanced practice registered nurse students; or other members of the 
medical team, including, as applicable, notes documenting the clinical 
nurse specialist's presence and participation in the service.

[63 FR 58908, Nov. 2, 1998, as amended at 67 FR 80040, Dec. 31, 2002; 73 
FR 69934, Nov. 19, 2008; 78 FR 74811, Dec. 10, 2013; 84 FR 63191, Nov. 
15, 2019]



Sec.  410.77  Certified nurse-midwives' services: 
Qualifications and conditions.

    (a) Qualifications. For Medicare coverage of his or her services, a 
certified nurse-midwife must:
    (1) Be a registered nurse who is legally authorized to practice as a 
nurse-midwife in the State where services are performed;
    (2) Have successfully completed a program of study and clinical 
experience for nurse-midwives that is accredited by an accrediting body 
approved by the U.S. Department of Education; and
    (3) Be certified as a nurse-midwife by the American College of 
Nurse-Midwives or the American College of Nurse-Midwives Certification 
Council.
    (b) Services. A certified nurse-midwife's services are services 
furnished by a certified nurse-midwife and services and supplies 
furnished as an incident to the certified nurse-midwife's services 
that--
    (1) Are within the scope of practice authorized by the law of the 
State in which they are furnished and would otherwise be covered if 
furnished by a physician or as an incident to a physician's service; and
    (2) Unless required by State law, are provided without regard to 
whether the certified nurse-midwife is under the supervision of, or 
associated with, a physician or other health care provider.
    (c) Incident to services: Basic rule. Medicare Part B covers 
services and supplies incident to the services of a certified nurse-
midwife if the requirements of Sec.  410.26 are met.
    (d) Professional services. A nurse-midwife can be paid for 
professional services only when the services have been performed 
personally by the nurse-midwife.
    (1) Supervision of other nonphysician staff by a nurse-midwife does 
not constitute personal performance of a professional service by the 
nurse-midwife.
    (2) The service is provided on an assignment-related basis, and a 
nurse-midwife may not charge a beneficiary for a service not payable 
under this provision. If the beneficiary has made payment for a service, 
the nurse-midwife must make the appropriate refund to the beneficiary.

[[Page 450]]

    (3) A nurse-midwife may provide services that he or she is legally 
authorized to perform under State law as a nurse-midwife, if the 
services would otherwise be covered by the Medicare program when 
furnished by a physician or incident to a physicians' professional 
services.
    (e) Medical record documentation. For certified nurse-midwives' 
services, the certified nurse-midwife may review and verify (sign and 
date), rather than re-document, notes in a patient's medical record made 
by physicians; residents; nurses; medical, physician assistant, and 
advanced practice registered nurse students; or other members of the 
medical team, including, as applicable, notes documenting the certified 
nurse-midwife's presence and participation in the service.

[63 FR 58909, Nov. 2, 1998, as amended at 78 FR 74811, Dec. 10, 2013; 84 
FR 63191, Nov. 15, 2019]



Sec.  410.78  Telehealth services.

    (a) Definitions. For the purposes of this section the following 
definitions apply:
    (1) Asynchronous store and forward technologies means the 
transmission of a patient's medical information from an originating site 
to the physician or practitioner at the distant site. The physician or 
practitioner at the distant site can review the medical case without the 
patient being present. An asynchronous telecommunications system in 
single media format does not include telephone calls, images transmitted 
via facsimile machines and text messages without visualization of the 
patient (electronic mail). Photographs visualized by a 
telecommunications system must be specific to the patient's medical 
condition and adequate for furnishing or confirming a diagnosis and or 
treatment plan. Dermatological photographs, for example, a photograph of 
a skin lesion, may be considered to meet the requirement of a single 
media format under this provision.
    (2) Distant site means the site at which the physician or 
practitioner delivering the service is located at the time the service 
is provided via a telecommunications system.
    (3) Interactive telecommunications system means multimedia 
communications equipment that includes, at a minimum, audio and video 
equipment permitting two-way, real-time interactive communication 
between the patient and distant site physician or practitioner.
    (4) Originating site means the location of an eligible Medicare 
beneficiary at the time the service being furnished via a 
telecommunications system occurs. For asynchronous store and forward 
telecommunications technologies, the only originating sites are Federal 
telemedicine demonstration programs conducted in Alaska or Hawaii.
    (b) General rule. Medicare Part B pays for covered telehealth 
services included on the telehealth list when furnished by an 
interactive telecommunications system if the following conditions are 
met, except that for the duration of the Public Health Emergency as 
defined in Sec.  400.200 of this chapter, Medicare Part B pays for 
office and other outpatient visits, professional consultation, 
psychiatric diagnostic interview examination, individual psychotherapy, 
pharmacologic management and end stage renal disease related services 
included in the monthly capitation payment furnished by an interactive 
telecommunications system if the following conditions are met:
    (1) The physician or practitioner at the distant site must be 
licensed to furnish the service under State law. The physician or 
practitioner at the distant site who is licensed under State law to 
furnish a covered telehealth service described in this section may bill, 
and receive payment for, the service when it is delivered via a 
telecommunications system.
    (2) The practitioner at the distant site is one of the following:
    (i) A physician as described in Sec.  410.20.
    (ii) A physician assistant as described Sec.  410.74.
    (iii) A nurse practitioner as described in Sec.  410.75.
    (iv) A clinical nurse specialist as described in Sec.  410.76.
    (v) A nurse-midwife as described in Sec.  410.77.
    (vi) A clinical psychologist as described in Sec.  410.71.
    (vii) A clinical social worker as described in Sec.  410.73.

[[Page 451]]

    (viii) A registered dietitian or nutrition professional as described 
in Sec.  410.134.
    (ix) A certified registered nurse anesthetist as described in Sec.  
410.69.
    (3) The services are furnished to a beneficiary at an originating 
site, which is one of the following:
    (i) The office of a physician or practitioner.
    (ii) A critical access hospital (as described in section 1861(mm)(1) 
of the Act).
    (iii) A rural health clinic (as described in section 1861(aa)(2) of 
the Act).
    (iv) A Federally qualified health center (as defined in section 
1861(aa)(4) of the Act).
    (v) A hospital (as defined in section 1861(e) of the Act).
    (vi) A hospital-based or critical access hospital-based renal 
dialysis center (including satellites).
    (vii) A skilled nursing facility (as defined in section 1819(a) of 
the Act).
    (viii) A community mental health center (as defined in section 
1861(ff)(3)(B) of the Act).
    (ix) A renal dialysis facility (only for purposes of the home 
dialysis monthly ESRD-related clinical assessment in section 
1881(b)(3)(B) of the Act);
    (x) The home of an individual (only for purposes of the home 
dialysis ESRD-related clinical assessment in section 1881(b)(3)(B) of 
the Act).
    (xi) A mobile stroke unit (only for purposes of diagnosis, 
evaluation, or treatment of symptoms of an acute stroke provided in 
accordance with section 1834(m)(6) of the Act).
    (xii) The home of an individual (only for purposes of treatment of a 
substance use disorder or a co-occurring mental health disorder, 
furnished on or after July 1, 2019, to an individual with a substance 
use disorder diagnosis.
    (4) Except as provided in paragraph (b)(4)(iv) of this section, 
originating sites must be:
    (i) Located in a health professional shortage area (as defined under 
section 332(a)(1)(A) of the Public Health Service Act (42 U.S.C. 
254e(a)(1)(A)) that is either outside of a Metropolitan Statistical Area 
(MSA) as of December 31st of the preceding calendar year or within a 
rural census tract of an MSA as determined by the Office of Rural Health 
Policy of the Health Resources and Services Administration as of 
December 31st of the preceding calendar year, or
    (ii) Located in a county that is not included in a Metropolitan 
Statistical Area as defined in section 1886(d)(2)(D) of the Act as of 
December 31st of the preceding year, or
    (iii) An entity participating in a Federal telemedicine 
demonstration project that has been approved by, or receive funding 
from, the Secretary as of December 31, 2000, regardless of its 
geographic location.
    (iv) The geographic requirements specified in paragraph (b)(4) of 
this section do not apply to the following telehealth services:
    (A) Home dialysis monthly ESRD-related clinical assessment services 
furnished on or after January 1, 2019, at an originating site described 
in paragraphs (b)(3)(vi), (ix) or (x) of this section, in accordance 
with section 1881(b)(3)(B) of the Act; and
    (B) Services furnished on or after January 1, 2019, for purposes of 
diagnosis, evaluation, or treatment of symptoms of an acute stroke.
    (C) Services furnished on or after July 1, 2019 to an individual 
with a substance use disorder diagnosis, for purposes of treatment of a 
substance use disorder or a co-occurring mental health disorder.
    (5) The medical examination of the patient is under the control of 
the physician or practitioner at the distant site.
    (c) Telepresenter not required. A telepresenter is not required as a 
condition of payment unless a telepresenter is medically necessary as 
determined by the physician or practitioner at the distant site.
    (d) Exception to the interactive telecommunications system 
requirement. For Federal telemedicine demonstration programs conducted 
in Alaska or Hawaii only, Medicare payment is permitted for telehealth 
when asynchronous store and forward technologies, in single or 
multimedia formats, are used as a substitute for an interactive 
telecommunications system.

[[Page 452]]

    (e) Limitations. (1) A clinical psychologist and a clinical social 
worker may bill and receive payment for individual psychotherapy via a 
telecommunications system, but may not seek payment for medical 
evaluation and management services.
    (2) The physician visits required under Sec.  483.40(c) of this 
title may not be furnished as telehealth services.
    (f) Process for adding or deleting services. Except as otherwise 
provided in this paragraph (f), changes to the list of Medicare 
telehealth services are made through the annual physician fee schedule 
rulemaking process. During the Public Health Emergency, as defined in 
Sec.  400.200 of this chapter, we will use a subregulatory process to 
modify the services included on the Medicare telehealth list during the 
Public Health Emergency, taking into consideration infection control, 
patient safety, and other public health concerns resulting from the 
emergency. CMS maintains the list of services that are Medicare 
telehealth services under this section, including the current HCPCS 
codes that describe the services on the CMS website.

[66 FR 55330, Nov. 1, 2001, as amended at 67 FR 80041, Dec. 31, 2002; 69 
FR 66423, Nov. 15, 2004; 70 FR 70330, Nov. 21, 2005; 72 FR 66399, Nov. 
27, 2007; 73 FR 69934, Nov. 19, 2008; 74 FR 62005, Nov. 25, 2009; 75 FR 
73615, Nov. 29, 2010; 76 FR 73470, Nov. 28, 2011; 77 FR 69363, Nov. 16, 
2012; 78 FR 74811, Dec. 10, 2013; 79 FR 68002, Nov. 13, 2014; 80 FR 
71373, Nov. 16, 2015; 83 FR 60073, Nov. 23, 2018; 85 FR 19286, Apr. 6, 
2020; 85 FR 27621, May 8, 2020; 85 FR 85027, Dec. 28, 2020]



Sec.  410.79  Medicare Diabetes Prevention Program expanded model: 
Conditions of coverage.

    (a) Medicare Diabetes Prevention Program (MDPP) services will be 
available beginning on April 1, 2018.
    (b) Definitions. For purposes of this section, the following 
definitions apply:
    Baseline weight means the MDPP beneficiary's body weight recorded 
during that beneficiary's first core session.
    CDC-approved DPP curriculum refers to the content of the core 
sessions, core maintenance sessions, and ongoing maintenance sessions. 
The curriculum may be either the CDC-preferred curriculum as designated 
by the CDC DPRP Standards or an alternative curriculum approved for use 
in DPP by the CDC.
    Core maintenance session means an MDPP service that--
    (i) Is furnished by an MDPP supplier to an MDPP beneficiary during a 
core maintenance session interval;
    (ii) Is approximately 1 hour in length; and
    (iii) Adheres to a CDC-approved DPP curriculum for maintenance 
sessions.
    Core maintenance session interval means one of the two consecutive 
3-month time periods during months 7 through 12 of the MDPP services 
period, during which an MDPP supplier offers an MDPP beneficiary at 
least one core maintenance session per month.
    Core session means an MDPP service that--
    (i) Is furnished by an MDPP supplier to an MDPP beneficiary during 
months 1 through 6 of the MDPP services period;
    (ii) Is approximately 1 hour in length; and
    (iii) Adheres to a CDC-approved DPP curriculum for core sessions.
    Diabetes Prevention Recognition Program (DPRP) refers to a program 
administered by the Centers for Disease Control and Prevention (CDC) 
that recognizes organizations that are able to furnish diabetes 
prevention program (DPP) services, follow a CDC-approved DPP curriculum, 
and meet CDC's performance standards and reporting requirements.
    Full CDC DPRP recognition refers to the designation from the CDC 
that an organization has consistently furnished CDC-approved DPP 
sessions, met CDC-performance standards and met CDC reporting 
requirements for at least 24-36 months following the organization's 
application to participate in the DPRP.
    Make-up session means a core session, a core maintenance session, or 
an ongoing maintenance session furnished to an MDPP beneficiary when the 
MDPP beneficiary misses a regularly scheduled core session, core 
maintenance session, or ongoing maintenance session.
    MDPP beneficiary means a Medicare beneficiary who meets the criteria 
specified in paragraph (c)(1)(i) of this

[[Page 453]]

section, who has initiated the MDPP services period by attending the 
first core session, and for whom the MDPP services period has not ended 
as specified in paragraph (c)(3) of this section.
    MDPP services means structured health behavior change sessions that 
are furnished under the MDPP expanded model with the goal of preventing 
diabetes among Medicare beneficiaries with prediabetes, and that follow 
a CDC-approved curriculum. The sessions provide practical training in 
long-term dietary change, increased physical activity, and problem-
solving strategies for overcoming challenges to maintaining weight loss 
and a healthy lifestyle.
    MDPP services period means the time period, beginning on the date an 
MDPP beneficiary attends his or her first core session, over which the 
set of MDPP services is furnished to the MDPP beneficiary, to include 
the core services period described in paragraph (c)(2)(i) and, subject 
to paragraph (c)(3) of this section, one or more ongoing maintenance 
session intervals during the ongoing services period described in 
paragraph (c)(2)(ii) of this section.
    MDPP session means a core session, a core maintenance session, or an 
ongoing maintenance session.
    MDPP supplier means an entity that is enrolled in Medicare to 
furnish MDPP services as provided in Sec.  424.205 of this chapter.
    Medicare Diabetes Prevention Program (MDPP) refers to a model test 
expanded under section 1115A(c) of the Act that makes MDPP services 
available to MDPP beneficiaries.
    National Diabetes Prevention Program (National DPP) refers to an 
evidence-based intervention targeted to individuals with pre-diabetes 
that is furnished in community and health care settings and administered 
by the Centers for Disease Control and Prevention (CDC).
    Ongoing maintenance session means an MDPP service that--
    (i) Is furnished by an MDPP supplier to an MDPP beneficiary during 
an ongoing maintenance session interval;
    (ii) Is approximately 1 hour in length; and
    (iii) Adheres to a CDC-approved DPP curriculum for maintenance 
sessions.
    Ongoing maintenance session interval means one of the up to four 
consecutive 3-month time periods during the ongoing services period 
described in paragraph (c)(2)(ii) of this section, during which an MDPP 
supplier offers at least one ongoing maintenance session to an MDPP 
beneficiary per month.
    Required minimum weight loss refers to the percentage by which the 
beneficiary's updated weight is less than the baseline weight. The 
required minimum weight loss percentage is 5 percent.
    Set of MDPP services means the series of MDPP sessions, composed of 
core sessions, core maintenance sessions, and subject to paragraph 
(c)(3) of this section, ongoing maintenance sessions, offered over the 
course of the MDPP services period.
    Virtual make-up session means a make-up session that is not 
furnished in person and that is furnished in a manner consistent with 
the DPRP standards for virtual sessions.
    (c) Coverage for MDPP services--(1) Beneficiary eligibility. (i) A 
Medicare beneficiary is eligible for MDPP services offered during the 
core services period described in paragraph (c)(2)(i) of this section if 
the beneficiary meets all of the following criteria:
    (A) Is enrolled under Medicare Part B;
    (B) Attended the first core session within the most recent 12-month 
time period and, prior to attending this first core session, had not 
previously received the set of MDPP services in his or her lifetime;
    (C) Has, on the date of attendance at the first core session, a body 
mass index (BMI) of at least 25 if not self-identified as Asian or a BMI 
of at least 23 if self-identified as Asian;
    (D) Has received, within the 12-month time period prior to the date 
of attendance at the first core session, a hemoglobin A1c test with a 
value of between 5.7 and 6.4 percent, a fasting plasma glucose test with 
a value of between 110 and 125 mg/dL, or a 2-hour plasma glucose test 
(oral glucose tolerance test) with a value of between 140 and 199 mg/dL;

[[Page 454]]

    (E) Has, as of the date of attendance at the first core session, no 
previous diagnosis of diabetes, other than gestational diabetes; and
    (F) Does not have end-stage renal disease (ESRD).
    (ii) An MDPP beneficiary is eligible for the first ongoing 
maintenance session interval only if the beneficiary:
    (A) Attends at least one in-person core maintenance session during 
the final core maintenance session interval; and
    (B) Achieves or maintains the required minimum weight loss at a 
minimum of one in-person core maintenance session during the final core 
maintenance session interval.
    (iii) An MDPP beneficiary is eligible for a subsequent ongoing 
maintenance session interval only if the beneficiary:
    (A) Attends at least two ongoing maintenance sessions during the 
previous ongoing maintenance session interval, including at least one 
in-person ongoing maintenance session; and
    (B) Maintains the required minimum weight loss at a minimum of one 
in-person ongoing maintenance session furnished during the previous 
ongoing maintenance session interval.
    (iv) Weight measurements used to determine the achievement or 
maintenance of the required minimum weight loss must be taken in person 
by an MDPP supplier during an MDPP session.
    (2) MDPP services period. An MDPP beneficiary's MDPP services period 
is composed of the following periods and intervals:
    (i) The core services period, which is the first 12 months of the 
MDPP services period, and consists of:
    (A) At least 16 core sessions offered at least one week apart during 
months 1 through 6 of the MDPP services period; and
    (B) Two 3-month core maintenance session intervals offered during 
months 7 through 12 of the MDPP services period.
    (ii) Subject to paragraph (c)(3) of this section, the ongoing 
services period, which consists of up to four 3-month ongoing 
maintenance session intervals offered during months 13 through 24 of the 
MDPP services period.
    (3) Limitations on the MDPP services period.
    (i) Except as set forth in paragraph (c)(3)(ii) of this section--
    (A) The MDPP services period ends upon completion of the core 
services period described in paragraph (c)(2)(i) of this section, unless 
the MDPP beneficiary qualifies for the first ongoing maintenance session 
interval, in accordance with paragraph (c)(1)(ii) of this section.
    (B) If the MDPP beneficiary qualifies for the first ongoing 
maintenance session interval as described in paragraph (c)(1)(ii) of 
this section, the MDPP services period ends upon completion of that 
maintenance session interval, unless the MDPP beneficiary qualifies for 
a subsequent ongoing maintenance session interval, in accordance with 
paragraph (c)(1)(iii) of this section, in which case the MDPP service 
period ends upon completion of the last ongoing maintenance session 
interval for which the beneficiary qualified.
    (ii) In the case of an applicable 1135 waiver event as defined in 
paragraph (e) of this section, the MDPP services period may be suspended 
and resumed or restarted in accordance with paragraph (e) of this 
section.
    (iii) Unless sooner ended in accordance with this paragraph (c)(3), 
the MDPP services period ends automatically upon the completion of the 
fourth ongoing maintenance session interval.
    (d) Make-up sessions. (1) An MDPP supplier may offer a make-up 
session to an MDPP beneficiary who missed a regularly scheduled session. 
If an MDPP supplier offers one or more make-up sessions to an MDPP 
beneficiary, each such session must be furnished in accordance with the 
following requirements:
    (i) The curriculum furnished during the make-up session must address 
the same CDC-approved DPP curriculum topic as the regularly scheduled 
session that the beneficiary missed;
    (ii) The MDPP supplier may furnish to the beneficiary a maximum of 
one make-up session on the same day as a regularly scheduled session; 
and
    (iii) The MDPP supplier may furnish to the beneficiary a maximum of 
one make-up session per week.

[[Page 455]]

    (2) An MDPP supplier may offer virtual make-up sessions only if 
consistent with the requirements in paragraph (d)(1) of this section. 
Virtual make-up sessions are also subject to the following requirements:
    (i) Virtual make-up sessions must be furnished in a manner 
consistent with the DPRP standards for virtual sessions;
    (ii) An MDPP supplier may only offer virtual make-up sessions based 
on an individual MDPP beneficiary's request; and
    (iii) An MDPP supplier may offer to an MDPP beneficiary:
    (A) No more than 4 virtual make-up sessions within the core services 
period described in paragraph (c)(2)(i) of this section, of which no 
more than 2 virtual make-up sessions are core maintenance sessions; and
    (B) No more than 3 virtual make-up sessions that are ongoing 
maintenance sessions.
    (3) Make-up sessions furnished in accordance with paragraph (d)(1) 
of this section that an MDPP beneficiary attends in person are counted 
toward meeting the attendance requirements described in paragraph (c)(1) 
of this section and toward achieving the performance goals described in 
Sec.  414.84(b) of this chapter as if the MDPP beneficiary attended a 
regularly scheduled session. Virtual make-up sessions furnished in 
accordance with paragraph (d)(2) of this section are also counted toward 
such attendance requirements and performance goals, subject to the 
following limitations:
    (i) The MDPP beneficiary receives no more than 4 virtual make-up 
sessions within the core services period described in paragraph 
(c)(2)(i) of this section, of which no more than 2 virtual make-up 
sessions may be core maintenance sessions; and
    (ii) The MDPP beneficiary receives no more than 3 virtual make-up 
sessions that are ongoing maintenance sessions.
    (e) MDPP expanded model emergency policy. (1) Notwithstanding 
paragraphs (a) through (d) of this section, the policies described in 
this paragraph (e) apply during the Public Health Emergency (PHE) as 
defined in Sec.  400.200 of this chapter and during any future 1135 
waiver event that CMS determines may disrupts in-person MDPP services 
(an ``applicable 1135 waiver event''). For purposes of this paragraph 
(e), ``1135 waiver event'' means an emergency period and emergency area, 
as such terms are defined in section 1135(g) of the Act, for which the 
Secretary has authorized one or more waivers under section 1135 of the 
Act.
    (2)(i) CMS determines that an 1135 waiver event may disrupt in-
person MDPP services if MDPP suppliers would likely be unable to conduct 
classes in-person, or MDPP beneficiaries would likely be unable to 
attend in-person classes, for reasons related to health, safety, or site 
availability or suitability. Health and safety reasons may include, but 
are not limited to, the avoidance of transmission of contagious 
diseases, compliance with laws and regulations during an 1135 waiver 
event, or the physical safety of MDPP beneficiaries and MDPP coaches, as 
defined in Sec.  424.205(a) of this chapter, during an 1135 waiver 
event.
    (ii) If CMS determines that an 1135 waiver event may disrupt in-
person MDPP services, CMS will communicate such determination for 
purposes of the policies described in this paragraph (e), to all 
affected MDPP suppliers.
    (3) The following changes apply under this paragraph (e), when CMS 
has determined that an 1135 waiver event may disrupt in-person MDPP 
services:
    (i) The in-person attendance requirements of paragraphs 
(c)(1)(ii)(A) and (c)(1)(iii)(A) of this section do not apply.
    (ii) MDPP suppliers may start new cohorts during the PHE as defined 
in Sec.  400.200 of this chapter or an applicable 1135 waiver event only 
if a baseline weight measurement can be obtained as described in 
paragraph (e)(3)(iii) of this section.
    (iii) MDPP suppliers can obtain weight measurements for MDPP 
beneficiaries for the baseline weight and any weight loss based 
performance achievement goals in the following manner:
    (A) In-person, when the weight measurement can be obtained safely 
and in compliance with all applicable laws and regulations;

[[Page 456]]

    (B) Via digital technology, such as scales that transmit weights 
securely via wireless or cellular transmission; or
    (C) Self-reported weight measurements from the at-home digital scale 
of the MDPP beneficiary. Self-reported weights must be obtained during 
live, synchronous online video technology, such as video chatting or 
video conferencing, wherein the MDPP coach observes the beneficiary 
weighing themselves and views the weight indicated on the at-home 
digital scale, a date-stamped photo or video recording of the 
beneficiary's weight with the beneficiary visible on the scale, or a 
recording of the beneficiary's weight, with the beneficiary visible on 
the scale, submitted by the MDPP beneficiary to the MDPP supplier. The 
photo or video must clearly document the weight of the MDPP beneficiary 
as it appears on his/her digital scale on the date associated with the 
billable MDPP session.
    (iv) The virtual session limits described in paragraphs (d)(2) and 
(d)(3)(i) and (ii) of this section do not apply, and MDPP suppliers may 
provide all MDPP sessions virtually during the PHE as defined in Sec.  
400.200 of this chapter or applicable 1135 waiver event. If the 
beneficiary began the MDPP services period virtually, or changed from 
in-person to virtual services during the PHE as defined in Sec.  400.200 
of this chapter or applicable 1135 waiver event, he/she may continue to 
receive the MDPP set of services virtually even after the PHE or 1135 
waiver event has concluded, until the end of the beneficiary's MDPP 
services period, so long as the provision of virtual services complies 
with all of the following requirements:
    (A) The curriculum furnished during the virtual session addresses 
the same CDC-approved DPP curriculum topic as the regularly scheduled 
session.
    (B) The MDPP supplier furnishes to the MDPP beneficiary a maximum of 
one virtual make-up session on the same day as a regularly scheduled 
session.
    (C) The MDPP supplier furnishes to the MDPP beneficiary a maximum of 
one virtual make-up session per week.
    (D) Virtual sessions are furnished in a manner consistent with the 
DPRP standards for virtual sessions.
    (E) The MDPP supplier offers virtual sessions only upon an 
individual MDPP beneficiary's request or agreement to receive services 
virtually.
    (F) The MDPP supplier offers to an MDPP beneficiary:
    (1) No more than 16 virtual sessions offered weekly during the core 
session period, months 1 through 6 of the MDPP services period;
    (2) No more than 6 virtual sessions offered monthly during the core 
maintenance session interval periods, months 7 through 12 of the MDPP 
services period; and
    (3) No more than 12 virtual sessions offered monthly during the 
ongoing maintenance session intervals, months 13 through 24.
    (v) MDPP suppliers may suspend the in-person delivery of the set of 
MDPP services, when necessary due to the applicable 1135 waiver event, 
and subsequently resume in-person services either upon the end date of 
the 1135 waiver event emergency period or an effective date specified by 
CMS. Upon resumption of the set of MDPP services on an in-person basis, 
the following paragraphs apply:
    (A) Beneficiaries who were receiving MDPP services as of March 31, 
2020 whose in-person sessions are suspended due to the PHE as defined in 
Sec.  400.200 of this chapter may elect to restart the set of MDPP 
services at the beginning or resume with the most recent attendance 
session of record.
    (B) Beneficiaries who begin the set of MDPP services on or after 
January 1, 2021 who are in the first 12 months of the set of MDPP 
services as of the start of an applicable 1135 waiver event, whose in-
person sessions are suspended due to the applicable 1135 waiver event, 
and who elect not to continue with MDPP services virtually, may elect to 
restart the set of MDPP services at the beginning or may resume with the 
most recent attendance session of record.
    (C) Beneficiaries who began the set of MDPP services on or after 
January 1, 2021 who are in the second year of the set of MDPP services 
as of the start of an applicable 1135 waiver event, whose

[[Page 457]]

in-person sessions are suspended due to the applicable 1135 waiver 
event, and who elect not to continue with MDPP services virtually, may 
restart the ongoing maintenance session interval in which they were 
participating at the start of the applicable 1135 waiver event or may 
resume with the most recent attendance session of record.
    (D) Beneficiaries whose in-person sessions are suspended due to the 
applicable 1135 waiver event who elect to continue with MDPP services 
virtually, as described in paragraph (e)(2)(i) of this section, are not 
eligible to restart the set of MDPP services at a later date, but may 
elect to suspend the virtual set of MDPP services and resume the set of 
in-person MDPP services with the most recent attendance session of 
record.
    (E) Beneficiaries may make an election as described in paragraph 
(e)(3)(v)(A), (B), (C), or (D) of this section, as applicable, only one 
time per applicable1135 waiver event.
    (F) Beneficiary eligibility, as described in paragraph (c)(1)(i) of 
this section, will not be impacted by any changes to the beneficiary's 
body mass index (BMI) or reduction in hemoglobin A1c, fasting plasma 
glucose, or 2-hour plasma glucose test values achieved during the set of 
MDPP services or any intervening time in which a beneficiary has 
suspended the set of MDPP services. MDPP suppliers will utilize the 
following weight measurements as the baseline weight for purposes of 
determining all weight-loss achievements:
    (1) For an MDPP beneficiary who began receiving the set of MDPP 
services before March 31, 2020, has suspended services during an 
applicable 1135 waiver event, and then elects to restart the set of MDPP 
services at the first core session, the MDPP supplier must record a new 
baseline weight on the date of first core session that restarts the set 
of MDPP services.
    (2) For an MDPP beneficiary who began receiving the set of MDPP 
services on or after January 1, 2021, has suspended services during an 
applicable 1135 waiver event, and then resumes the set of MDPP services 
either at the most recent attendance session of record or restarts the 
ongoing maintenance session interval in which they were participating at 
the start of the applicable 1135 waiver event, the MDPP supplier must 
use the baseline weight recorded at the beneficiary's first core 
session.
    (vi) The minimum weight loss requirements for beneficiary 
eligibility in the ongoing maintenance session intervals described in 
paragraphs (c)(1)(ii)(B) and (c)(1)(iii)(B) of this section are waived 
only for MDPP beneficiaries who were receiving the MDPP set of services 
prior to January 1, 2021.

[81 FR 80552, Nov. 15, 2016; 81 FR 81698, Nov. 18, 2016, as amended at 
82 FR 53358, Nov. 15, 2017; 85 FR 19287, Apr. 6, 2020; 85 FR 85027, Dec. 
28, 2020]



                Subpart C_Home Health Services Under SMI



Sec.  410.80  Applicable rules.

    Home health services furnished under Medicare Part B are subject to 
the rules set forth in subpart E of part 409 of this chapter.



   Subpart D_Comprehensive Outpatient Rehabilitation Facility (CORF) 
                                Services



Sec.  410.100  Included services.

    Subject to the conditions and limitations set forth in Sec. Sec.  
410.102 and 410.105, CORF services means the following services 
furnished to an outpatient of the CORF by personnel that meet the 
qualifications set forth in Sec.  485.70 of this chapter. Payment for 
CORF services are made in accordance with Sec.  414.1105.
    (a) Physician's services. CORF facility physician services are 
administrative in nature and include consultation with and medical 
supervision of nonphysician staff, participation in plan of treatment 
reviews and patient care review conferences, and other medical and 
facility administration activities. Diagnostic and therapeutic services 
furnished to an individual CORF patient by a physician in a CORF 
facility are not CORF physician services. These services, if covered, 
are physician services under Sec.  410.20 with payment for these 
services made to the physician in accordance with part 414 subpart B.

[[Page 458]]

    (b) Physical therapy services. (1) These services include--
    (i) Testing and measurement of the function or dysfunction of the 
neuromuscular, musculoskeletal, cardiovascular and respiratory systems; 
and.
    (ii) Assessment and treatment related to dysfunction caused by 
illness or injury, and aimed at preventing or reducing disability or 
pain and restoring lost function.
    (2) The establishment of a maintenance therapy program for an 
individual whose restoration potential has been reached is a physical 
therapy service; however, maintenance therapy itself is not covered as 
part of these services.
    (c) Occupational therapy services. These services include--
    (1) Teaching of compensatory techniques to permit an individual with 
a physical impairment or limitation to engage in daily activities.
    (2) Evaluation of an individual's level of independent functioning.
    (3) Selection and teaching of task-oriented therapeutic activities 
to restore sensory-integrative function; and
    (4) Assessment of an individual's vocational potential, except when 
the assessment is related solely to vocational rehabilitation.
    (d) Speech-language pathology services. These are services for the 
diagnosis and treatment of speech and language disorders that create 
difficulties in communication.
    (e) Respiratory therapy services. (1) Respiratory therapy services 
are for the assessment, treatment, and monitoring of patients with 
deficiencies or abnormalities of cardiopulmonary function.
    (2) Respiratory therapy services include the following:
    (i) Application of techniques for support of oxygenation and 
ventilation of the patient.
    (ii) Therapeutic use and monitoring of gases, mists, and aerosols 
and related equipment.
    (iii) Bronchial hygiene therapy.
    (iv) Pulmonary rehabilitation techniques to develop strength and 
endurance of respiratory muscles and other techniques to increase 
respiratory function, such as graded activity services; these services 
include physiologic monitoring and patient education.
    (f) Prosthetic device services. These services include--
    (1) Prosthetic devices (excluding dental devices and renal dialysis 
machines), that replace all or part of an internal body organ or 
external body member (including contiguous tissue) or replace all or 
part of the function of a permanently inoperative or malfunctioning 
external body member or internal body organ; and
    (2) Services necessary to design the device, select materials and 
components, measure, fit, and align the device, and instruct the patient 
in its use.
    (g) Orthotic device services. These services include--
    (1) Orthopedic devices that support or align movable parts of the 
body, prevent or correct deformities, or improve functioning; and
    (2) Services necessary to design the device, select the materials 
and components, measure, fit, and align the device, and instruct the 
patient in its use.
    (h) Social and psychological services. Social and psychological 
services include the assessment and treatment of an individual's mental 
and emotional functioning and the response to and rate of progress as it 
relates to the individual's rehabilitation plan of treatment, including 
physical therapy services, occupational therapy services, speech-
language pathology services and respiratory therapy services.
    (i) Nursing care services. Nursing care services include nursing 
services provided by a registered nurse that are prescribed by a 
physician and are specified in or directly related to the rehabilitation 
treatment plan and necessary for the attainment of the rehabilitation 
goals of the physical therapy, occupational therapy, speech-language 
pathology, or respiratory therapy plan of treatment.
    (j) Drugs and biologicals. These are drugs and biologicals that are 
the following:
    (1) Prescribed by a physician and administered by or under the 
supervision of a physician or by a registered professional nurse; and

[[Page 459]]

    (2) Not excluded from Medicare Part B payment for reasons specified 
in Sec.  410.29.
    (k) Supplies and durable medical equipment. Supplies and durable 
medical equipment include the following:
    (1) Disposable supplies.
    (2) Durable medical equipment of the type specified in Sec.  410.38 
(except for renal dialysis systems) for a patient's use outside the 
CORF, whether purchased or rented.
    (l) Home environment evaluation. A home environment evaluation--
    (1) Is a single home visit to evaluate the potential impact of the 
home situation on the patient's rehabilitation goals.
    (2) Requires the presence of the patient and the physical therapist, 
occupational therapist, or speech-language pathologist, as appropriate.

[51 FR 41339, Nov. 14, 1986; 52 FR 4499, Feb. 12, 1987, as amended at 72 
FR 66399, Nov. 27, 2007]



Sec.  410.102  Excluded services.

    None of the services specified in Sec.  410.100 is covered as a CORF 
service if the service--
    (a) Would not be covered as an inpatient hospital service if 
furnished to a hospital inpatient;
    (b) Is not reasonable and necessary for the diagnosis or treatment 
of illness or injury or to improve the functioning of a malformed body 
member. An example would be services furnished as part of a maintenance 
program involving repetitive activities that do not require the skilled 
services of nurses or therapists.



Sec.  410.105  Requirements for coverage of CORF services.

    Services specified in Sec.  410.100 and not excluded under Sec.  
410.102 are covered as CORF services if they are furnished by a 
participating CORF (that is, a CORF that meets the conditions of subpart 
B of part 485 of this chapter, and has in effect a provider agreement 
under part 489 of this chapter) and if the following requirements are 
met:
    (a) Referral and medical history. The services must be furnished to 
an individual who is referred by a physician who certifies that the 
individual needs skilled rehabilitation services, and makes the 
following information available to the CORF before or at the time 
treatment is begun:
    (1) The individual's significant medical history.
    (2) Current medical findings.
    (3) Diagnosis(es) and contraindications to any treatment modality.
    (4) Rehabilitation goals, if determined.
    (b) When and where services are furnished. (1) All services must be 
furnished while the individual is under the care of a physician.
    (2) Except as provided in paragraph (b)(3) of this section, the 
services must be furnished on the premises of the CORF.
    (3) Exceptions. (i) Physical therapy, occupational therapy, and 
speech-language pathology services may be furnished away from the 
premises of the CORF including the individual's home when payment is not 
otherwise made under Title XVIII of the Act.
    (ii) The single home environment evaluation visit specified in Sec.  
410.100(m) is also covered.
    (c) Plan of treatment. (1) The service must be furnished under a 
written plan of treatment that--
    (i) Is established and signed by a physician before treatment is 
begun; and
    (ii) Prescribes the type, amount, frequency, and duration of the 
services to be furnished, and indicates the diagnosis and anticipated 
rehabilitation goals.
    (2) The plan must be reviewed at least every 60 days for respiratory 
therapy services and every 90 days for physical therapy, occupational 
therapy and speech-language pathology services by a facility physician 
or the referring physician who, when appropriate, consults with the 
professional personnel providing the services.
    (3) The reviewing physician must certify or recertify that the plan 
is being followed, the patient is making progress in attaining the 
rehabilitation goals, and the treatment is having no harmful effects on 
the patient.
    (d) Claims. Effective for dates of service on and after January 1, 
2020 physical therapy or occupational therapy services covered as part 
of a rehabilitation plan of treatment described in paragraph (c) of this 
section, as applicable--

[[Page 460]]

    (1) Claims for such services furnished in whole or in part by a 
physical therapist assistant or an occupational therapy assistant must 
be identified with the inclusion of the respective prescribed modifier; 
and
    (2) Effective for dates of service on and after January 1, 2022, 
such claims are paid an amount equal to 85 percent of the amount of 
payment otherwise applicable for the service as defined at section 
1834(k) of the Act.
    (3) For purposes of this paragraph, ``furnished in whole or in 
part'' means when the physical therapist assistant or occupational 
therapy assistant either--
    (i) Furnishes all the minutes of a service exclusive of the 
respective physical therapist or occupational therapist; or
    (ii) Furnishes a portion of a service separately from the part 
furnished by the physical or occupational therapist such that the 
minutes for that portion of a service exceed 10 percent of the total 
time for that service.

[51 FR 41339, Nov. 14, 1986, as amended at 56 FR 8841, Mar. 1, 1991; 72 
FR 66400, Nov. 27, 2007; 77 FR 69363, Nov. 16, 2012; 83 FR 60073, Nov. 
23, 2018; 84 FR 63191, Nov. 15, 2019]



  Subpart E_Community Mental Health Centers (CMHCs) Providing Partial 
                        Hospitalization Services



Sec.  410.110  Requirements for coverage of partial hospitalization services 
by CMHCs.

    Medicare part B covers partial hospitalization services furnished by 
or under arrangements made by a CMHC if they are provided by a CMHC as 
defined in Sec.  410.2 that has in effect a provider agreement under 
part 489 of this chapter and if the services are--
    (a) Prescribed by a physician and furnished under the general 
supervision of a physician;
    (b) Subject to certification by a physician in accordance with Sec.  
424.24(e)(1) of this subchapter; and
    (c) Furnished under a plan of treatment that meets the requirements 
of Sec.  424.24(e)(2) of this subchapter.

[59 FR 6577, Feb. 11, 1994]

Subpart F [Reserved]



                   Subpart G_Medical Nutrition Therapy

    Source: 66 FR 55331, Nov. 1, 2001, unless otherwise noted.



Sec.  410.130  Definitions.

    For the purposes of this subpart, the following definitions apply:
    Chronic renal insufficiency means the stage of renal disease 
associated with a reduction in renal function not severe enough to 
require dialysis or transplantation (glomerular filtration rate [GFR] 
13-50 ml/min/1.73m\2\).
    Diabetes means diabetes mellitus, a condition of abnormal glucose 
metabolism diagnosed using the following criteria: A fasting blood sugar 
greater than or equal to 126 mg/dL on two different occasions; a 2 hour 
post-glucose challenge greater than or equal to 200 mg/dL on 2 different 
occasions; or a random glucose test over 200 mg/dL for a person with 
symptoms of uncontrolled diabetes.
    Episode of care means services covered in a 12-month time period 
when coordinated with initial diabetes self-management training (DSMT) 
and one calendar year for each year thereafter, starting with the 
assessment and including all covered interventions based on referral(s) 
from a physician as specified in Sec.  410.132(c). The time period 
covered for gestational diabetes extends only until the pregnancy ends.
    Medical nutrition therapy services means nutritional diagnostic, 
therapeutic, and counseling services provided by a registered dietitian 
or nutrition professional for the purpose of managing diabetes or a 
renal disease.
    Physician means a doctor of medicine or osteopathy legally 
authorized to practice medicine and surgery by the State in which he or 
she performs such function or action (including a physician within the 
meaning of section of 1101(a)(7) of the Act).
    Renal disease means chronic renal insufficiency, end-stage renal 
disease when dialysis is not received, or the medical condition of a 
beneficiary for 36 months after kidney transplant.

[[Page 461]]

    Treating physician means the primary care physician or specialist 
coordinating care for the beneficiary with diabetes or renal disease.

[66 FR 55331, Nov. 1, 2001, as amended at 68 FR 63261, Nov. 7, 2003]



Sec.  410.132  Medical nutrition therapy.

    (a) Conditions for coverage of MNT services. Medicare Part B pays 
for MNT services provided by a registered dietitian or nutrition 
professional as defined in Sec.  410.134 when the beneficiary is 
referred for the service by the treating physician. Except as provided 
at Sec.  410.78, services covered consist of face-to-face nutritional 
assessments and interventions in accordance with nationally-accepted 
dietary or nutritional protocols.
    (b) Limitations on coverage of MNT services. (1) MNT services based 
on a diagnosis of renal disease as described in this subpart are not 
covered for beneficiaries receiving maintenance dialysis for which 
payment is made under section 1881 of the Act.
    (2) A beneficiary may only receive the maximum number of hours 
covered under the DSMT benefit for both DSMT and MNT during the initial 
DSMT training period unless additional hours are determined to be 
medically necessary under the national coverage determination process.
    (3) In years when the beneficiary is eligible for MNT and follow-up 
DSMT, the beneficiary may only receive the maximum number of hours 
covered under MNT unless additional hours are determined to be medically 
necessary under the national coverage determination process.
    (4) If a beneficiary has both diabetes and renal disease, the 
beneficiary may only receive the maximum number of hours covered under 
the renal MNT benefit in one episode of care unless he or she is 
receiving initial DSMT services, in which case the beneficiary would 
receive whichever is greater.
    (5) An exception to the maximum number of hours in (b)(2), (3), and 
(4) of this section may be made when the treating physician determines 
that there is a change of diagnosis, medical condition, or treatment 
regimen related to diabetes or renal disease that requires a change in 
MNT during an episode of care.
    (c) Referrals. Referral may only be made by the treating physician 
when the beneficiary has been diagnosed with diabetes or renal disease 
as defined in this subpart with documentation maintained by the 
referring physician in the beneficiary's medical record. Referrals must 
be made for each episode of care and any additional assessments or 
interventions required by a change of diagnosis, medical condition, or 
treatment regimen during an episode of care.

[66 FR 55331, Nov. 1, 2001, as amended at 72 FR 66400, Nov. 27, 2007]



Sec.  410.134  Provider qualifications.

    For Medicare Part B coverage of MNT, only a registered dietitian or 
nutrition professional may provide the services. ``Registered dietitian 
or nutrition professional'' means an individual who, on or after 
December 22, 2000:
    (a) Holds a bachelor's or higher degree granted by a regionally 
accredited college or university in the United States (or an equivalent 
foreign degree) with completion of the academic requirements of a 
program in nutrition or dietetics accredited by an appropriate national 
accreditation organization recognized for this purpose.
    (b) Has completed at least 900 hours of supervised dietetics 
practice under the supervision of a registered dietitian or nutrition 
professional.
    (c) Is licensed or certified as a dietitian or nutrition 
professional by the State in which the services are performed. In a 
State that does not provide for licensure or certification, the 
individual will be deemed to have met this requirement if he or she is 
recognized as a ``registered dietitian'' by the Commission on Dietetic 
Registration or its successor organization, or meets the requirements of 
paragraphs (a) and (b) of this section.
    (d) Exceptions. (i) A dietitian or nutritionist licensed or 
certified in a State as of December 21, 2000 is not required to meet the 
requirements of (a) and (b) of this section.

[[Page 462]]

    (ii) A ``registered dietitian'' in good standing, as recognized by 
the Commission of Dietetic Registration or its successor organization, 
is deemed to have met the requirements of (a) and (b) of this section.

[66 FR 55331, Nov. 1, 2001; 67 FR 20684, Apr. 26, 2002]



  Subpart H_Outpatient Diabetes Self-Management Training and Diabetes 
                          Outcome Measurements

    Source: 65 FR 83148, Dec. 29, 2000, unless otherwise noted.



Sec.  410.140  Definitions.

    For purposes of this subpart, the following definitions apply:
    ADA stands for the American Diabetes Association.
    Approved entity means an individual, physician, or entity accredited 
by an approved organization as meeting one of the sets of quality 
standards described in Sec.  410.144 and approved by CMS under Sec.  
410.141(e) to furnish training.
    Deemed entity means an individual, physician, or entity accredited 
by an approved organization, but that has not yet been approved by CMS 
under Sec.  410.145(b) to furnish training.
    Diabetes means diabetes mellitus, a condition of abnormal glucose 
metabolism diagnosed using the following criteria: A fasting blood sugar 
greater than or equal to 126 mg/dL on two different occasions; a 2 hour 
post-glucose challenge greater than or equal to 200 mg/dL on 2 different 
occasions; or a random glucose test over 200 mg/dL for a person with 
symptoms of uncontrolled diabetes.
    NSDSMEP stands for the National Standards for Diabetes Self 
Management Education Programs.
    Organization means a national accreditation organization.
    Rural means an area that meets one of the following conditions:
    (1) Is not urbanized (as defined by the Bureau of the Census) and 
that is designated by the chief executive officer of the State, and 
certified by the Secretary, as an area with a shortage of personal 
health services.
    (2) Is designated by the Secretary either as an area with a shortage 
of personal health services or as a health professional shortage area.
    (3) Is designated by the Indian Health Service as a health service 
delivery area as defined in Sec.  36.15 of this title.
    Training means outpatient diabetes self-management training.

[65 FR 83148, Dec. 29, 2000, as amended at 68 FR 63261, Nov. 7, 2003; 76 
FR 73471, Nov. 28, 2011]



Sec.  410.141  Outpatient diabetes self-management training.

    (a) General rule. Medicare Part B covers training defined in Sec.  
410.140 if all of the conditions and requirements of this subpart are 
met.
    (b) Conditions for coverage. The training must meet the following 
conditions:
    (1) Training orders. Following an evaluation of the beneficiary's 
need for the training, the training is ordered by the physician (or 
qualified nonphysician practitioner) (as defined in Sec.  410.32(a)(2)) 
treating the beneficiary's diabetes.
    (2) Plan of care. It is included in a comprehensive plan of care 
established by the physician (or qualified nonphysician practitioner) 
treating the beneficiary for diabetes that meets the following 
requirements:
    (i) Describes the content, number of sessions, frequency, and 
duration of the training as written by the physician (or qualified 
nonphysician practitioner) treating the beneficiary.
    (ii) Contains a statement specified by CMS and signed by the 
physician (or qualified nonphysician practitioner) managing the 
beneficiary's diabetic condition. By signing this statement, the 
physician (or qualified nonphysician practitioner) certifies that he or 
she is managing the beneficiary's diabetic condition and the training 
described in the plan of care is needed to ensure therapy compliance or 
to provide the beneficiary with the skills and knowledge to help manage 
the beneficiary's diabetes. The physician's (or qualified nonphysician 
practitioner's) statement must identify the beneficiary's specific 
medical conditions (described in paragraph (d) of this section) that the 
training will address.

[[Page 463]]

    (iii) Provides that any changes to the plan of care are signed by 
the physician (or qualified nonphysician practitioner) treating the 
beneficiary.
    (iv) Is incorporated into the approved entity's medical record for 
the beneficiary and is made available, upon request, to CMS.
    (3) Reasonable and necessary. It is reasonable and necessary for 
treating or monitoring the condition of a beneficiary who meets the 
conditions described in paragraph (d) of this section.
    (c) Types and frequency of training--(1) Initial training--
    General rule. (i) Medicare Part B covers initial training that meets 
the following conditions:
    (A) Is furnished to a beneficiary who has not previously received 
initial training under this benefit.
    (B) Is furnished within a continuous 12-month period.
    (C) Does not exceed a total of 10 hours.
    (D) Except as permitted under paragraph (c)(1)(ii) of this section, 
9 hours of the training are furnished in a group setting consisting of 2 
to 20 individuals who need not all be Medicare beneficiaries.
    (E) Is furnished in increments of no less than one-half hour.
    (F) May include 1 hour of individual training for an assessment of 
the beneficiary's training needs.
    (ii) Exception. Medicare covers training on an individual basis for 
a Medicare beneficiary who meets any of the following conditions:
    (A) No group session is available within 2 months of the date the 
training is ordered.
    (B) The beneficiary's physician (or qualified nonphysician 
practitioner) documents in the beneficiary's medical record that the 
beneficiary has special needs resulting from conditions, such as severe 
vision, hearing, or language limitations that will hinder effective 
participation in a group training session.
    (2) Follow-up training. After receiving the initial training 
described in paragraph (c)(1) of this section, Medicare covers follow-up 
training that meets the following conditions:
    (i) Consists of no more than 2 hours individual or group training 
for a beneficiary each year.
    (ii) Group training consists of 2 to 20 individuals who need not all 
be Medicare beneficiaries.
    (iii) Is furnished any time in a calendar year following the year in 
which the beneficiary completes the initial training.
    (iv) Is furnished in increments of no less than one-half hour.
    (v) The physician (or qualified nonphysician practitioner) treating 
the beneficiary must document, in the referral for training and the 
beneficiary's medical record, the specific medical condition (described 
in paragraph (d) of this section) that the follow-up training must 
address.
    (d) Beneficiaries who may be covered. Medicare Part B covers 
outpatient diabetes self-management training for a beneficiary who has 
been diagnosed with diabetes.
    (e) Who may furnish services. Training may be furnished by a 
physician, individual, or entity that meets the following conditions:
    (1) Furnishes other services for which direct Medicare payment may 
be made.
    (2) May properly receive Medicare payment under Sec.  424.73 or 
Sec.  424.80 of this chapter, which set forth prohibitions on assignment 
and reassignment of benefits.
    (3) Submits necessary documentation to, and is accredited by, an 
accreditation organization approved by CMS under Sec.  410.142 to meet 
one of the sets of quality standards described in Sec.  410.144.
    (4) Provides documentation to CMS, as requested, including diabetes 
outcome measurements set forth at Sec.  410.146.

[65 FR 83148, Dec. 29, 2000, as amended at 68 FR 63261, Nov. 7, 2003; 76 
FR 73471, Nov. 28, 2011]



Sec.  410.142  CMS process for approving national accreditation organizations.

    (a) General rule. CMS may approve and recognize a nonprofit or not-
for-profit organization with demonstrated experience in representing the 
interest of individuals with diabetes to accredit entities to furnish 
training.

[[Page 464]]

    (b) Required information and materials. An organization requesting 
CMS's approval and recognition of its accreditation program must furnish 
to CMS the following information and materials:
    (1) The requirements and quality standards that the organization 
uses to accredit entities to furnish training.
    (2) If an organization does not use the CMS quality standards or the 
NSDSMEP quality standards described in Sec.  410.144(a) or (b), a 
detailed comparison including a crosswalk between the organization's 
standards and the CMS quality standards described in Sec.  410.144(a).
    (3) Detailed information about the organization's accreditation 
process, including all of the following information:
    (i) Frequency of accreditation.
    (ii) Copies of accreditation forms, guidelines, and instructions to 
evaluators.
    (iii) Descriptions of the following:
    (A) The accreditation review process and the accreditation status 
decision making process.
    (B) The procedures used to notify a deemed entity of deficiencies in 
its outpatient diabetes self-management training program and procedures 
to monitor the correction of those deficiencies.
    (C) The procedures used to enforce compliance with the accreditation 
requirements and standards.
    (4) Detailed information about the individuals who perform 
evaluations for the organization, including all of the following 
information:
    (i) The education and experience requirements for the individuals 
who perform evaluations.
    (ii) The content and frequency of continuing education furnished to 
the individuals who perform evaluations.
    (iii) The process used to monitor the performance of individuals who 
perform evaluations.
    (iv) The organization's policies and practices for participation in 
the accreditation process by an individual who is professionally or 
financially affiliated with the entity being evaluated.
    (5) A description of the organization's data management and analysis 
system for its accreditation activities and decisions, including the 
kinds of reports, tables, and other displays generated by that system.
    (6) A description of the organization's procedures for responding to 
and investigating complaints against an approved entity, including 
policies and procedures regarding coordination of these activities with 
appropriate licensing bodies, ombudsmen programs, and CMS.
    (7) A description of the organization's policies and procedures for 
withholding or removing a certificate of accreditation for failure to 
meet the organization's standards or requirements, and other actions the 
organization takes in response to noncompliance with its standards and 
requirements.
    (8) A description of all types (for example, full or partial) and 
categories (for example, provisional, conditional, or temporary) of 
accreditation offered by the organization, the duration of each type and 
category of accreditation, and a statement identifying the types and 
categories that will serve as a basis for accreditation if CMS approves 
the organization.
    (9) A list of all of the approved entities currently accredited to 
furnish training and the type, category, and expiration date of the 
accreditation held by each of them.
    (10) The name and address of each person with an ownership or 
control interest in the organization.
    (11) Documentation that demonstrates its ability to furnish CMS with 
electronic data in CMS-compatible format.
    (12) A resource analysis that demonstrates that its staffing, 
funding, and other resources are adequate to perform the required 
accreditation activities.
    (13) A statement acknowledging that, as a condition for approval and 
recognition by CMS of its accreditation program, it agrees to comply 
with the requirements set forth in Sec. Sec.  410.142 through 410.146.
    (14) Additional information CMS requests to enable it to respond to 
the organization's request for CMS approval and recognition of its 
accreditation program to accredit entities to furnish training.

[[Page 465]]

    (c) Onsite visit. CMS may visit the prospective organization's 
offices to verify information in the organization's application, 
including, but not limited to, review of documents, and interviews with 
the organization's staff.
    (d) Notice and comment--(1) Proposed notice. CMS publishes a 
proposed notice in the Federal Register announcing its intention to 
approve an organization's request for CMS approval and recognition of 
its accreditation program and the standards it uses to accredit entities 
to furnish training. The notice includes the following information:
    (i) The basis for approving the organization.
    (ii) A description of how the organization's accreditation program 
applies and enforces quality standards that have been determined by CMS 
to meet or exceed the CMS quality standards described in Sec.  
410.144(a) or how the organization would use the NSDSMEP quality 
standards described in Sec.  410.144(b).
    (iii) An opportunity for public comment.
    (2) Final notice. (i) After considering public comments CMS receives 
on the proposed notice, it publishes a final notice in the Federal 
Register indicating whether it has approved an organization's request 
for CMS approval and recognition of its accreditation program and the 
standards it uses to accredit entities to furnish training.
    (ii) If CMS approves the request, the final notice specifies the 
effective date and the term of the approval, which may not exceed 6 
years.
    (e) Criteria CMS uses to approve national accreditation 
organizations. In deciding to approve and recognize an organization's 
accreditation program to accredit entities to furnish training, CMS 
considers the following criteria:
    (1) The organization uses and enforces quality standards that CMS 
has determined meet or exceed the CMS quality standards described in 
Sec.  410.144(a), or uses the NSDSMEP quality standards described in 
Sec.  410.144(b).
    (2) The organization meets the requirements for approved 
organizations in Sec.  410.143.
    (3) The organization is not owned or controlled by the entities it 
accredits, as defined in Sec.  413.17(b)(2) or (b)(3), respectively, of 
this chapter.
    (4) The organization does not accredit any entity it owns or 
controls.
    (f) Notice of CMS's decision. CMS notifies the prospective 
organization in writing of its decision. The notice includes the 
following information:
    (1) Statement of approval or denial.
    (2) If approved, the expiration date of CMS's approval and 
recognition of the accreditation program.
    (3) If denied, the rationale for the denial and the reconsideration 
and reapplication procedures.
    (g) Reconsideration of adverse decision. An organization that has 
received CMS's notice of denial of its request for CMS approval and 
recognition of its accreditation program to accredit entities to furnish 
training may request reconsideration of CMS's decision in accordance 
with part 488 subpart D of this chapter.
    (h) Request for approval following denial. (1) Except as provided in 
paragraph (h)(2) of this section, an organization that has received 
CMS's notice of denial of its request for CMS approval and recognition 
of its accreditation program to accredit entities to furnish training 
may submit a new request to CMS if it meets the following conditions:
    (i) Has revised its accreditation program to correct the 
deficiencies CMS noted in its denial notice.
    (ii) Demonstrates, through documentation, the use of one of the sets 
of quality standards described in Sec.  410.144.
    (iii) Resubmits the application in its entirety.
    (2) For an organization that has requested reconsideration of CMS's 
denial of its request for CMS approval and recognition of its 
accreditation program to accredit entities to furnish training, CMS will 
not consider the organization's new request until all administrative 
proceedings on the previous request have been completed.
    (i) Withdrawal. An organization requesting CMS approval and 
recognition of its accreditation program to accredit entities may 
withdraw its application at any time.

[[Page 466]]

    (j) Applying for continued CMS approval. At least 6 months before 
the expiration of CMS's approval and recognition of the organization's 
program, an organization must request from CMS continued approval and 
recognition.



Sec.  410.143  Requirements for approved accreditation organizations.

    (a) Ongoing responsibilities of an approved accreditation 
organization. An organization approved and recognized by CMS must 
undertake the following activities on an ongoing basis:
    (1) Provide to CMS in writing, on a monthly basis, all of the 
following:
    (i) Copies of all accreditation decisions and any accreditation-
related information that CMS may require (including corrective action 
plans and summaries of unmet quality standards described in Sec.  
410.144).
    (ii) Notice of all complaints related to approved entities.
    (iii) Within 30 days of taking remedial or adverse action (including 
revocation, withdrawal, or revision of an approved entity's deemed 
status) against an approved entity, information describing the remedial 
or adverse action and the circumstances that led to taking the action.
    (iv) Notice of any proposed changes in its accreditation standards 
and requirements or evaluation process. If an organization implements 
changes without CMS approval (other than changes to the NSDSMEP quality 
standards described in Sec.  410.144(b)), CMS may withdraw its approval 
and recognition of the organization's accreditation program.
    (2) If an organization does not use the NSDSMEP quality standards 
described in Sec.  410.144(b), and wishes to change its quality 
standards that CMS previously approved, the organization must submit its 
plan to alter its quality standards and include a crosswalk between the 
set of quality standards described in Sec.  410.144 and the 
organization's revised standards. If an organization implements changes 
in its quality standards without CMS approval, CMS may withdraw its 
approval and recognition of the organization's accreditation program.
    (3) If CMS notifies an organization that uses the CMS quality 
standards described in Sec.  410.144(a) that it has changed the CMS 
quality standards, the organization must meet the following 
requirements:
    (i) Submit to CMS, within 30 days of CMS's notification of a change 
in the quality standards, its organization's plan to alter its quality 
standards to conform to the revised quality standards described in Sec.  
410.144(a).
    (ii) Implement the changes to its accreditation program by the 
implementation date specified in CMS's notification of the changes in 
the quality standards.
    (b) CMS oversight of approved national accreditation organizations. 
CMS, or its agent, performs oversight activities to ensure that an 
approved organization and the entities the organization accredits 
continue to meet a set of quality standards described in Sec.  410.144. 
CMS (or its agent) uses the following procedures:
    (1) Equivalency review. CMS compares the organization's standards 
and its application and enforcement of its standards to a set of quality 
standards (described in Sec.  410.144) and processes when any of the 
following conditions exist:
    (i) CMS imposes new requirements or changes its process for 
approving and recognizing an organization.
    (ii) Except for an organization that uses the NSDSMEP quality 
standards, the organization proposes to adopt new standards or changes 
its accreditation process.
    (iii) The organization reapplies to CMS for continuation of its 
approval and recognition by CMS of its program to accredit entities to 
furnish training.
    (2) Validation reviews. CMS validates an organization's 
accreditation process by conducting evaluations of approved entities 
accredited by the organization and comparing its results to the results 
of the organization's evaluation of the approved entities.
    (3) Onsite inspections. CMS may conduct an onsite inspection of the 
organization's operations and offices to verify information and assess 
the organization's compliance with its own policies and procedures. The 
onsite inspection

[[Page 467]]

may include, but is not limited to, reviewing documents, auditing 
documentation of meetings concerning the accreditation process, 
evaluating accreditation results or the accreditation status decision 
making process, and interviewing the organization's staff.
    (4) Withdrawal of CMS approval and recognition. (i) CMS gives an 
organization written notice of CMS's intent to withdraw its approval and 
recognition of the organization's program to accredit entities if CMS 
determines through an equivalency review, validation review, onsite 
inspection, or CMS's daily experience with the organization that any of 
the following conditions exist:
    (A) Except for those accrediting organizations using quality 
standards in Sec.  410.144(b), the quality standards that the 
organization applies and enforces do not meet or exceed the CMS quality 
standards described in Sec.  410.144(a).
    (B) The organization has failed to meet the requirements for 
accreditation in Sec. Sec.  410.142 through 410.144.
    (ii) Request for reconsideration. An organization may request a 
reconsideration of CMS's decision to withdraw its approval and 
recognition of the organization in accordance with part 488, subpart D 
of this chapter.



Sec.  410.144  Quality standards for deemed entities.

    An organization approved and recognized by CMS may accredit an 
entity to meet one of the following sets of quality standards:
    (a) CMS quality standards. Standards prescribed by CMS, which 
include the following:
    (1) Organizational structure. (i) Provides the educational resources 
to support the programs offered and the beneficiaries served, including 
adequate space, personnel, budget, instructional materials, 
confidentiality, privacy, and operational support.
    (ii) Defines clearly and documents the organizational relationships, 
lines of authority, staffing, job descriptions, and operational 
policies.
    (iii) Maintains a written policy that affirms education as an 
integral component of diabetes care.
    (iv) Includes in its operational policies, specific standards and 
procedures identifying the amount of collaborative, interactive, skill-
based training methods and didactic training methods furnished to the 
beneficiary.
    (v) Assesses the service area to define the target population in 
order to appropriately allocate personnel and resources.
    (vi) Identifies in its operational policies, the minimal amount that 
each team member must be involved in the following:
    (A) Development of training materials.
    (B) Instruction of beneficiaries.
    (2) Environment. Maintains a safe and sanitary environment, properly 
constructed, equipped, and maintained to protect the health and safety 
of all patients and that meets all applicable fire protection and life 
safety codes.
    (3) Program staff. (i) Requires a program coordinator who is 
responsible for program planning, implementation, and evaluation.
    (ii) Requires nonphysician professional staff to obtain 12 hours of 
continuing diabetes education concerning educational principles and 
behavior change strategies every 2 years.
    (4) Team approach. (i) Except as provided in paragraph (a)(4)(ii) of 
this section for a rural area, furnishes services using a 
multidisciplinary instructional team that meets the following 
requirements:
    (A) The team includes at least a registered dietitian, as recognized 
under State law, and a certified diabetes educator (CDE), certified by a 
qualified organization that has registered with CMS, who have didactic 
experience and knowledge of diabetes clinical and educational issues. 
(If the team includes a registered nurse, an approved entity may delay 
implementation of the requirement for a CDE until February 27, 2004.)
    (B) The team is qualified to teach the training content areas 
required in paragraph (a)(5) of this section.
    (C) All appropriate team members must be present during the portion 
of the training for which they are responsible and must directly furnish 
the training within the scope of their practices.
    (ii) In a rural area, an individual who is qualified as a registered 
dietitian

[[Page 468]]

and as a CDE that is currently certified by an organization approved by 
CMS (or until February 27, 2004 an individual who is qualified as a 
registered dietitian and as a registered nurse) may furnish training and 
is deemed to meet the multidisciplinary team requirement in paragraph 
(a)(4)(i) of this section.
    (5) Training content. Offers training and is capable of meeting the 
needs of its patients on the following subjects:
    (i) Diabetes overview/pathophysiology of diabetes.
    (ii) Nutrition.
    (iii) Exercise and activity.
    (iv) Diabetes medications (including skills related to the self-
administration of injectable drugs).
    (v) Self-monitoring and use of the results.
    (vi) Prevention, detection, and treatment of acute complications.
    (vii) Prevention, detection, and treatment of chronic complications.
    (viii) Foot, skin, and dental care.
    (ix) Behavior change strategies, goal setting, risk factor 
reduction, and problem solving.
    (x) Preconception care, pregnancy, and gestational diabetes.
    (xi) Relationships among nutrition, exercise, medication, and blood 
glucose levels.
    (xii) Stress and psychosocial adjustment.
    (xiii) Family involvement and social support.
    (xiv) Benefits, risks, and management options for improving glucose 
control.
    (xv) Use of health care systems and community resources.
    (6) Training methods. (i) Offers individual and group instruction 
for effective training.
    (ii) Uses instructional methods and materials that are appropriate 
for the target population, and participants being served.
    (iii) Uses primarily interactive, collaborative, skill-based 
training methods and maximizes the use of interactive training methods.
    (7) Review of plan of care and goals. (i) Reviews each beneficiary's 
plan of care.
    (ii) Develops and updates an individual assessment, in collaboration 
with each beneficiary, that includes relevant medical history, present 
health status, health service or resource utilization, risk factors, 
diabetes knowledge and skills, cultural influences, health beliefs and 
attitudes, health behaviors and goals, support systems, barriers to 
learning, and socioeconomic factors.
    (iii) Based on the assessment, develops, in collaboration with each 
beneficiary, an individual education plan. Includes in the education 
plan, the goals for education, the periodic updates, the specific amount 
of interactive, collaborative, skill-based training methods and didactic 
training methods that have been and will be furnished.
    (iv) Documents the results, including assessment, intervention, 
evaluation and follow-up in the beneficiary's medical record.
    (v) Forwards a copy of the documentation in paragraph (a)(7)(ii) 
through (iv) of this section to the referring physician (or qualified 
nonphysician practitioner).
    (vi) Periodically updates the beneficiary's referring physician (or 
qualified nonphysician practitioner) about the beneficiary's educational 
status.
    (8) Educational intervention. Offers appropriate and timely 
educational intervention based on referral from the beneficiary's 
physician (or qualified nonphysician practitioner) and based on periodic 
reassessments of health status, knowledge, skills, attitudes, goals, and 
self-care behaviors.
    (9) Performance measurement and quality improvement. Establishes and 
maintains an effective internal performance measurement and quality 
improvement program that focuses on maximizing outcomes by improving 
patient safety and quality of care. The program must meet the following 
requirements:
    (i) Stresses health outcomes (for example, improved beneficiary 
diabetes control, beneficiary understanding, or beneficiary compliance) 
and provides for the collection, analysis, and reporting of data that 
permits measurement of performance outcomes, or other quality 
indicators.
    (ii) Requires an entity to take the following actions:

[[Page 469]]

    (A) Evaluate itself on an annual basis as to its effectiveness in 
using performance measures.
    (B) Improve its performance on at least one outcome or quality 
indicator each year.
    (10) Quality improvement. Has an agreement with a QIO to participate 
in quality improvement projects defined by the QIO, or if a program 
elects not to participate in a QIO project, it must be able to 
demonstrate a level of achievement through a project of its own design 
that is comparable to or better than the achievement to be expected from 
participation in the QIO quality improvement project.
    (b) The National Standards for Diabetes Self-Management Education 
Programs. The set of quality standards contained in the NSDSMEP or any 
NSDSMEP standards subsequently revised.
    (c) Standards of a national accreditation organization that 
represents individuals with diabetes. Standards that meet or exceed the 
CMS quality standards described in paragraph (a) of this section that 
have been developed by a national organization (and approved by CMS) 
that is either a nonprofit or not-for-profit organization with 
demonstrated experience in representing the interest of individuals, 
including health care professionals and Medicare beneficiaries, with 
diabetes.



Sec.  410.145  Requirements for entities.

    (a) Deemed entities. (1) Except as permitted in paragraph (a)(2) of 
this section, an entity may be deemed to meet a set of quality standards 
described in Sec.  410.144 if the following conditions are met:
    (i) The entity has submitted necessary documentation and is fully 
accredited (and periodically reaccredited) by an organization approved 
by CMS under Sec.  410.142.
    (ii) The entity is not accredited by an organization that owns or 
controls the entity.
    (2) Before August 27, 2002 CMS may deem an entity to meet the 
NSDSMEP quality standards described in Sec.  410.144(b), if the entity 
provides the Medicare contractor that will process its claims with a 
copy of a current certificate the entity received from the ADA that 
verifies the training program it furnishes meets the NSDSMEP quality 
standards described in Sec.  410.144(b).
    (b) Approved entities. An entity may be approved to furnish training 
if the entity meets the following conditions:
    (1) Before submitting a claim for Medicare payment, forwards a copy 
of its certificate or proof of accreditation from an organization 
approved by CMS under Sec.  410.142 indicating that the entity meets a 
set of quality standards described in Sec.  410.144, or before August 
27, 2002, submits documentation of its current ADA recognition status.
    (2) Agrees to submit to evaluation (including onsite inspections) by 
CMS (or its agent) to validate its approved organization's accreditation 
process.
    (3) Authorizes its approved organization to release to CMS a copy of 
its most recent accreditation evaluation, and any accreditation-related 
information that CMS may require.
    (4) At a minimum, allows the QIO (under a contract with CMS) access 
to beneficiary or group training records.
    (c) Effective dates--(1) Deemed to meet quality standards. Except as 
permitted in paragraph (c)(2) of this section, the date on which an 
entity is deemed to meet a set of quality standards described in Sec.  
410.144 is the later of one of the following dates:
    (i) The date CMS approves and recognizes the accreditation 
organization to accredit entities to furnish training.
    (ii) The date an organization accredits the entity to meet a set of 
quality standards described in Sec.  410.144.
    (2) Approved to furnish training. CMS covers the training furnished 
by an entity beginning on the later of one of the following dates:
    (i) The date CMS approves the deemed entity as meeting the 
conditions for coverage in Sec.  410.141(e).
    (ii) The date the entity is deemed to meet a set of quality 
standards described in Sec.  410.144.
    (d) Removal of approved status--(1) General rule. CMS removes an 
entity's approved status for any of the following reasons:
    (i) CMS determines, on the basis of its own evaluation or the 
results of the accreditation evaluation, that the entity does not meet a 
set of quality standards described in Sec.  410.144.

[[Page 470]]

    (ii) CMS withdraws its approval of the organization that deemed the 
entity to meet a set of quality standards described in Sec.  410.144.
    (iii) The entity fails to meet the requirements of paragraphs (a) 
and (b) of this section.
    (2) Effective date. The effective date of CMS's removal of an 
entity's approved status is 60 days after the date of CMS's notice to 
the entity.



Sec.  410.146  Diabetes outcome measurements.

    (a) Information collection. An approved entity must collect and 
record in an organized systematic manner the following patient 
assessment information at least on a quarterly basis for a beneficiary 
who receives training under Sec.  410.141:
    (1) Medical information that includes the following:
    (i) Duration of the diabetic condition.
    (ii) Use of insulin or oral agents.
    (iii) Height and weight by date.
    (iv) Results and date of last lipid test.
    (v) Results and date of last HbA1C.
    (vi) Information on self-monitoring (frequency and results).
    (vii) Blood pressure with the corresponding dates.
    (viii) Date of the last eye exam.
    (2) Other information that includes the following:
    (i) Educational goals.
    (ii) Assessment of educational needs.
    (iii) Training goals.
    (iv) Plan for a follow-up assessment of achievement of training 
goals between 6 months and 1 year after the beneficiary completes the 
training.
    (v) Documentation of the training goals assessment.
    (b) Follow-up assessment information. An approved entity may obtain 
information from the beneficiary's survey, primary care physician 
contact, and follow-up visits.



                    Subpart I_Payment of SMI Benefits

    Source: 51 FR 41339, Nov. 14, 1986, unless otherwise noted. 
Redesignated at 59 FR 6577, Feb. 11, 1994.



Sec.  410.150  To whom payment is made.

    (a) General rules. (1) Any SMI enrollee is, subject to the 
conditions, limitations, and exclusions set forth in this part and in 
parts 405, 416 and 424 of this chapter, entitled to have payment made as 
specified in paragraph (b) of this section.
    (2) The services specified in paragraphs (b)(5) through (b)(14) of 
this section must be furnished by a facility that has in effect a 
provider agreement or other appropriate agreement to participate in 
Medicare.
    (b) Specific rules. Subject to the conditions set forth in paragraph 
(a) of this section, Medicare Part B pays as follows:
    (1) To the individual, or to a physician or other supplier on the 
individual's behalf, for medical and other health services furnished by 
the physician or other supplier.
    (2) To a nonparticipating hospital on the individual's behalf for 
emergency outpatient services furnished by the hospital, in accordance 
with subpart G of part 424 of this chapter.
    (3) To the individual, for emergency outpatient services furnished 
by a nonparticipating hospital, in accordance with Sec.  424.53 of this 
chapter.
    (4) To the individual, for physicians' services and ambulance 
services furnished outside the United States in accordance with Sec.  
424.53 of this chapter.
    (5) To a provider on the individual's behalf for medical and other 
health services furnished by the provider (or by others under 
arrangements made with them by the provider).
    (6) To a home health agency on the individual's behalf for home 
health services furnished by the home health agency.
    (7) To a clinic, rehabilitation agency, or public health agency on 
the individual's behalf for outpatient physical therapy or speech 
pathology services furnished by the clinic or agency (or by others under 
arrangements made with them by the clinic or agency).
    (8) To a rural health clinic or Federally qualified health center on 
the individual's behalf for rural health clinic or Federally qualified 
health center services furnished by the rural health clinic or Federally 
qualified health center, respectively.

[[Page 471]]

    (9) To an ambulatory surgical center (ASC) on the individual's 
behalf for covered ambulatory surgical center facility services that are 
furnished in connection with surgical procedures performed in an ASC, as 
provided in part 416 of this chapter.
    (10) To a comprehensive outpatient rehabilitation facility (CORF) on 
the individual's behalf for comprehensive outpatient rehabilitation 
facility services furnished by the CORF.
    (11) To a renal dialysis facility, on the individual's behalf, for 
institutional or home dialysis services, supplies, and equipment 
furnished by the facility.
    (12) To a critical access hospital (CAH) on the individual's behalf 
for outpatient CAH services furnished by the CAH.
    (13) To a community mental health center (CMHC) on the individual's 
behalf, for partial hospitalization services furnished by the CMHC (or 
by others under arrangements made with them by the CMHC).
    (14) To an SNF for services (other than those described in Sec.  
411.15(p)(2) of this chapter) that it furnishes to a resident (as 
defined in Sec.  411.15(p)(3) of this chapter) of the SNF who is not in 
a covered Part A stay.
    (15) To the qualified employer of a physician assistant for 
professional services furnished by the physician assistant and for 
services and supplies furnished incident to his or her services. Payment 
is made to the employer of a physician assistant regardless of whether 
the physician assistant furnishes services under a W-2, employer-
employee employment relationship, or whether the physician assistant is 
an independent contractor who receives a 1099 reflecting the 
relationship. Both types of relationships must conform to the 
appropriate guidelines provided by the Internal Revenue Service. A 
qualified employer is not a group of physician assistants that 
incorporate to bill for their services. Payment is made only if no 
facility or other provider charges or is paid any amount for services 
furnished by a physician assistant.
    (16) To a nurse practitioner or clinical nurse specialist for 
professional services furnished by a nurse practitioner or clinical 
nurse specialist in all settings in both rural and nonrural areas and 
for services and supplies furnished incident to those services. Payment 
is made only if no facility or other provider charges, or is paid, any 
amount for the furnishing of the professional services of the nurse 
practitioner or clinical nurse specialist.
    (17) To a clinical psychologist on the individual's behalf for 
clinical psychologist services and for services and supplies furnished 
as an incident to his or her services.
    (18) To a clinical social worker on the individual's behalf for 
clinical social worker services.
    (19) To a participating HHA, for home health services (including 
medical supplies described in section 1861(m)(5) of the Act, but 
excluding durable medical equipment to the extent provided for in such 
section) furnished to an individual who at the time the item or service 
is furnished is under a plan of care of an HHA (without regard to 
whether the item or service is furnished by the HHA directly, under 
arrangement with the HHA, or under any other contracting or consulting 
arrangement).
    (20) To a certified nurse-midwife for professional services 
furnished by the certified nurse-midwife in all settings and for 
services and supplies furnished incident to those services. Payment is 
made only if no facility or other provider charges or is paid any amount 
for the furnishing of the professional services of the certified nurse-
midwife.

[51 FR 41339, Nov. 14, 1986, as amended at 53 FR 6648, Mar. 2, 1988; 57 
FR 24981, June 12, 1992; 58 FR 30668, May 26, 1993; 59 FR 6577, Feb. 11, 
1994; 63 FR 20129, Apr. 23, 1998; 63 FR 26308, May 12, 1998; 63 FR 
58909, Nov. 2, 1998; 65 FR 41211, July 3, 2000; 66 FR 39599, July 31, 
2001; 75 FR 73615, Nov. 29, 2010]



Sec.  410.152  Amounts of payment.

    (a) General provisions--(1) Exclusion from incurred expenses. As 
used in this section, ``incurred expenses'' are expenses incurred by an 
individual, during his or her coverage period, for covered Part B 
services, excluding the following:
    (i) Expenses incurred for services for which the beneficiary is 
entitled to have payment made under Medicare Part A or would be so 
entitled except

[[Page 472]]

for the application of the Part A deductible and coinsurance 
requirements.
    (ii) Expenses incurred in meeting the Part B blood deductible (Sec.  
410.161).
    (iii) In the case of services payable under a formula that takes 
into account reasonable charges, reasonable costs, customary charges, 
customary (insofar as reasonable) charges, charges related to reasonable 
costs, fair compensation, a pre-treatment prospective payment rate, or a 
standard overhead amount, or any combination of two or more of these 
factors, expenses in excess of any factor taken into account under that 
formula.
    (iv) Expenses in excess of the outpatient mental health treatment 
limitation described in Sec.  410.155.
    (v) In the case of expenses incurred for outpatient physical therapy 
services including speech-language pathology services, the expenses 
excluded are from the incurred expenses under Sec.  410.60(e). In the 
case of expenses incurred for outpatient occupational therapy including 
speech-language pathology services, the expenses excluded are from the 
incurred expenses under Sec.  410.59(e).
    (2) Other applicable provisions. Medicare Part B pays for incurred 
expenses the amounts specified in paragraphs (b) through (k) of this 
section, subject to the following:
    (i) The principles and procedures for determining reasonable costs 
and reasonable charges and the conditions for Medicare payment, as set 
forth in parts 405 (subparts E and X), 413, and 424 of this chapter.
    (ii) The Part B annual deductible (Sec.  410.160).
    (iii) The special rules for payment to health maintenance 
organizations (HMOs), health care prepayment plans (HCPPs), and 
competitive medical plans (CMPs) that are set forth in part 417 of this 
chapter. (A prepayment organization that does not qualify as an HMO, 
CMP, or HCPP is paid in accordance with paragraph (b)(4) of this 
section.)
    (b) Basic rules for payment. Except as specified in paragraphs (c) 
through (h) of this section, Medicare Part B pays the following amounts:
    (1) For services furnished by, or under arrangements made by, a 
provider other than a nominal charge provider, whichever of the 
following is less:
    (i) 80 percent of the reasonable cost of the services.
    (ii) The reasonable cost of, or the customary charges for, the 
services, whichever is less, minus 20 percent of the customary (insofar 
as reasonable) charges for the services.
    (2) For services furnished by, or under arrangements made by, a 
nominal charge provider, 80 percent of fair compensation.
    (3) For emergency outpatient hospital services furnished by a 
nonparticipating hospital that is eligible to receive payment for those 
services under subpart G of part 424 of this chapter, the amount 
specified in paragraph (b)(1) of this section.
    (4) For services furnished by a person or an entity other than those 
specified in paragraphs (b)(1) through (b)(3) of this section, 80 
percent of the reasonable charges or 80 percent of the payment amount 
computed on any other payment basis for the services.
    (c) Amount of payment: Home health services other than durable 
medical equipment (DME). For home health services other than DME 
furnished by, or under arrangements made by, a participating HHA, 
Medicare Part B pays the following amounts:
    (1) For services furnished by an HHA that is a nominal charge 
provider, 100 percent of fair compensation.
    (2) For services furnished by an HHA that is not a nominal charge 
provider, the lesser of the reasonable cost of the services and the 
customary charges for the services.
    (d) Amount of payment: DME furnished as a home health service--(1) 
Basic rule. Except as specified in paragraph (d)(2) of this section--
    (i) For DME furnished by an HHA that is a nominal charge provider, 
Medicare Part B pays 80 percent of fair compensation.
    (ii) For DME furnished by an HHA that is not a nominal charge 
provider, Medicare Part B pays the lesser of the following:
    (A) 80 percent of the reasonable cost of the service.
    (B) The reasonable cost of, or the customary charge for, the 
service,

[[Page 473]]

whichever is less, minus 20 percent of the customary (insofar as 
reasonable) charge for the service.
    (2) Exception. If the DME is used DME purchased by or on behalf of 
the beneficiary at a price at least 25 percent less than the reasonable 
charge for new equipment--
    (i) For used DME furnished by an HHA that is a nominal charge 
provider, Medicare Part B pays 100 percent of fair compensation.
    (ii) For used DME furnished by an HHA that is not a nominal charge 
provider, Medicare Part B pays 100 percent of the reasonable cost of, or 
the customary charge for, the services, whichever is less.
    (e) Amount of payment: Renal dialysis services, supplies, and 
equipment. Effective for services furnished on or after August 1, 1983, 
Medicare Part B pays for the institutional dialysis services specified 
in Sec.  409.250 and the home dialysis services, supplies, and equipment 
specified in Sec.  409.252, as follows:
    (1) Except as provided in paragraph (d)(2) of this section, 80 
percent of the per treatment prospective reimbursement rate established 
under Sec.  413.170 of this chapter, for outpatient maintenance dialysis 
furnished by ESRD facilities approved in accordance with part 494 of 
this chapter.
    (2) Exception. If a home dialysis patient elects to obtain home 
dialysis supplies or equipment (or both) from a party other than an 
approved ESRD facility, payment is in accordance with paragraph (b)(4) 
of this section.
    (f) Amount of payment: Rural health clinic (RHC) and Federally 
qualified health center (FQHC) services. Medicare Part B pays, for 
services by a participating RHC or FQHC that is authorized to bill under 
the reasonable cost system, 80 percent of the costs determined under 
subpart X of part 405 of this chapter, to the extent those costs are 
reasonable and related to the cost of furnishing RHC or FQHC services or 
reasonable on the basis of other tests specified by CMS.
    (g) Amount of payment: Used durable medical equipment furnished by 
otherthan an HHA. Medicare Part B pays the following amounts for used 
DME purchased by or on behalf of the beneficiary at a price at least 25 
percent less than the reasonable charge for comparable new equipment:
    (1) For used DME furnished by, or under arrangements made by, a 
nominal charge provider, 100 percent of fair compensation.
    (2) For used DME furnished by or under arrangements made by a 
provider that is not a nominal charge provider, 100 percent of the 
reasonable cost of the service or the customary charge for the service, 
whichever is less.
    (3) For used DME furnished by other than a provider, 100 percent of 
the reasonable charge.
    (h) Amount of payment: Pneumococcal vaccine. Medicare Part B pays 
for pneumococcal vaccine and its administration as follows:
    (1) For services furnished by a nominal charge provider, 100 percent 
of fair compensation.
    (2) For services furnished by a provider that is not a nominal 
charge provider, the reasonable cost of the services or the customary 
charge for the service, whichever is less.
    (3) For services furnished by other than a provider, a rural health 
clinic or a Federally qualified health center, 100 percent of the 
reasonable charge.
    (4) For services furnished by a rural health clinic or a Federally 
qualified health center, 100 percent of the reasonable cost.
    (i) Amount of payment: ASC facility services. (1) For ASC facility 
services furnished on or after July 1, 1987 and before January 1, 2008, 
in connection with the surgical procedures specified in part 416 of this 
chapter, Medicare Part B pays 80 percent of a standard overhead amount 
as specified in Sec.  416.120(c) of this chapter, except that, for 
screening flexible sigmoidoscopies and screening colonoscopies, Part B 
coinsurance is 25 percent of the standard overhead amount and Medicare 
Part B pays 75 percent of the standard overhead amount.
    (2) For ASC services furnished on or after January 1, 2008, in 
connection with the covered surgical procedures specified in Sec.  
416.166 of this subchapter, except as provided in paragraphs (i)(2)(i), 
(i)(2)(ii), and (l) of this section, Medicare Part B pays the lesser of 
80

[[Page 474]]

percent of the actual charge or 80 percent of the prospective payment 
amount, geographically adjusted, if applicable, as determined under 
Subpart F of Part 416 of this subchapter. Part B coinsurance is 20 
percent of the actual charge or 20 percent of the prospective payment 
amount, geographically adjusted, if applicable
    (i) If the limitation described in Sec.  416.167(b)(3) of this 
subchapter applies, Medicare pays 80 percent of the amount determined 
under Subpart B of Part 414 of this subchapter and Part B coinsurance is 
20 percent of the applicable payment amount, except as provided in 
paragraph (l) of this section.
    (ii) Between January 1, 2008 and December 31, 2010, Medicare Part B 
pays 75 percent of the applicable payment amount for screening flexible 
sigmoidoscopies and screening colonoscopies, and Part B coinsurance is 
25 percent of the applicable payment amount.
    (j) Amount of payment: services of Federally funded health 
facilities prior to October 1, 1991. Medicare Part B pays 80 percent of 
charges related to the reasonable costs that a Federally funded health 
facility incurs in furnishing the services. See Sec.  411.8(b)(6) of 
this chapter.
    (k) Amount of payment: Outpatient CAH services. (1) Payment for CAH 
outpatient services is the reasonable cost of the CAH in providing these 
services, as determined in accordance with section 1861(v)(1)(A) of the 
Act, with Sec.  413.70(b) and (c) of this chapter, and with the 
applicable principles of cost reimbursement in part 413 and in part 415 
of this chapter.
    (2) Payment for CAH outpatient services is subject to the applicable 
Medicare Part B deductible and coinsurance amounts, except as described 
in Sec.  413.70(b)(2)(iii) of this chapter, with Part B coinsurance 
being calculated as 20 percent of the customary (insofar as reasonable) 
charges of the CAH for the services.
    (l) Amount of payment: Preventive services. Medicare Part B pays 100 
percent of the Medicare payment amount established under the applicable 
payment methodology for the service setting for providers and suppliers 
for the following preventive services:
    (1) Pneumococcal (as specified in paragraph (h) of this section), 
influenza, hepatitis B, and COVID-19 vaccine and administration.
    (2) Screening mammography.
    (3) Screening pap tests and screening pelvic exam.
    (4) Prostate cancer screening tests (excluding digital rectal 
examinations).
    (5) Colorectal cancer screening tests (excluding barium enemas).
    (6) Bone mass measurement.
    (7) Medical nutrition therapy (MNT) services.
    (8) Cardiovascular screening blood tests.
    (9) Diabetes screening tests.
    (10) Ultrasound screening for abdominal aortic aneurysm (AAA).
    (11) Additional preventive services identified for coverage through 
the national coverage determination (NCD) process.
    (12) Initial Preventive Physical Examination (IPPE).
    (13) Annual Wellness Visit (AWV), providing Personalized Prevention 
Plan Services (PPPS).

[51 FR 41339, Nov. 14, 1986; 52 FR 4499, Feb. 12, 1987]

    Editorial Note: For Federal Register citations affecting Sec.  
410.152, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.  410.155  Outpatient mental health treatment limitation.

    (a) Limitation. For services subject to the limitation as specified 
in paragraph (b) of this section, the percentage of the expenses 
incurred for such services during a calendar year that is considered 
incurred expenses under Medicare Part B when determining the amount of 
payment and deductible under Sec.  410.152 and Sec.  410.160 of this 
part, respectively, is as follows:
    (1) For expenses incurred in years before 2010, 62\1/2\ percent.
    (2) For expenses incurred in 2010 and 2011, 68\3/4\ percent.
    (3) For expenses incurred in 2012, 75 percent.
    (4) For expenses incurred in 2013, 81\1/4\ percent.
    (5) For expenses incurred in CY 2014 and subsequent years, 100 
percent.

[[Page 475]]

    (b) Application of the limitation--(1) Services subject to the 
limitation. Except as specified in paragraph (b)(2) of this section, 
services furnished by physicians and other practitioners, whether 
furnished directly or incident to those practitioners' services, are 
subject to the limitation if they are furnished in connection with the 
treatment of a mental, psychoneurotic, or personality disorder (that is, 
any condition identified by a diagnosis code within the range of 290 
through 319) and are furnished to an individual who is not an inpatient 
of a hospital:
    (i) Services furnished by physicians and other practitioners, 
whether furnished directly or as an incident to those practitioners' 
services.
    (ii) Services provided by a CORF.
    (2) Services not subject to the limitation. Services not subject to 
the limitation include the following:
    (i) Services furnished to a hospital inpatient.
    (ii) Brief office visits for the sole purpose of monitoring or 
changing drug prescriptions used in the treatment of mental, 
psychoneurotic, or personality disorders billed under HCPCS code M0064 
(or its successor).
    (iii) Partial hospitalization services not directly provided by a 
physician.
    (iv) Psychiatric diagnostic services billed under CPT codes 90801 
and 90802 (or successor codes) and diagnostic psychological and 
neuropsychological tests billed under CPT code range 96101 through 96125 
(or successor codes) that are performed to establish a diagnosis.
    (v) Medical management such as that furnished under CPT code 90862 
(or its successor code), as opposed to psychotherapy, furnished to a 
patient diagnosed with Alzheimer's disease or a related disorder.
    (3) Payment amounts. The Medicare payment amount and the patient 
liability amounts for outpatient mental health services subject to the 
limitation for each year during which the limitation is phased out are 
as follows:

------------------------------------------------------------------------
                                        Recognized
            Calendar year                incurred    Patient    Medicare
                                         expenses      pays       pays
------------------------------------------------------------------------
CY 2009 and prior calendar years.....       62.50%        50%        50%
CYs 2010 and 2011....................       68.75%        45%        55%
CY 2012..............................       75.00%        40%        60%
CY 2013..............................       81.25%        35%        65%
CY 2014..............................      100.00%        20%        80%
------------------------------------------------------------------------

    (c) General formula. A general formula for calculating the amount of 
Medicare payment and the patient liability for outpatient mental health 
services subject to the limitation is as follows:
    (1) Multiply the Medicare approved amount by the percentage of 
incurred expenses that is recognized as incurred expenses for Medicare 
payment purposes for the year involved;
    (2) Subtract from this amount the amount of any remaining Part B 
deductible for the patient and year involved; and,
    (3) Multiply this amount by 0.80 (80 percent) to obtain the Medicare 
payment amount.
    (4) Subtract the Medicare payment amount from the Medicare-approved 
amount to obtain the patient liability amount.

[63 FR 20129, Apr. 23, 1998, as amended at 73 FR 69934, Nov. 19, 2008; 
74 FR 62005, Nov. 25, 2009]



Sec.  410.160  Part B annual deductible.

    (a) Basic rule. Except as provided in paragraph (b) of this section, 
incurred expenses (as defined in Sec.  410.152) are subject to, and 
count toward meeting the annual deductible.
    (b) Exceptions. Expenses incurred for the following services are not 
subject to the Part B annual deductible and do not count toward meeting 
that deductible:
    (1) Home health services.
    (2) Pneumococcal, influenza, and hepatitis b, and COVID-19 vaccines 
and their administration.
    (3) Federally qualified health center services.
    (4) ASC facility services furnished before July 1987 and physician 
services furnished before April 1988 that met the requirements for 
payment of 100 percent of the reasonable charges.
    (5) Screening mammography services as described in Sec.  410.34 (c) 
and (d).
    (6) Screening pelvic examinations as described in Sec.  410.56.
    (7) Beginning January 1, 2007, colorectal cancer screening tests as 
described in Sec.  410.37.

[[Page 476]]

    (8) Beginning January 1, 2011, for a surgical service, and beginning 
January 1, 2015, for an anesthesia service, furnished in connection 
with, as a result of, and in the same clinical encounter as a planned 
colorectal cancer screening test. A surgical or anesthesia service 
furnished in connection with, as a result of, and in the same clinical 
encounter as a colorectal cancer screening test means--a surgical or 
anesthesia service furnished on the same date as a planned colorectal 
cancer screening test as described in Sec.  410.37.
    (9) Beginning January 1, 2009, initial preventive physical 
examinations as described in Sec.  410.16.
    (10) Bone mass measurement.
    (11) Medical nutrition therapy (MNT) services.
    (12) Annual Wellness Visit (AWV), providing Personalized Prevention 
Plan Services (PPPS).
    (13) Additional preventive services identified for coverage through 
the national coverage determination (NCD) process.
    (c) Application of the Part B annual deductible. (1) Before payment 
is made under Sec.  410.152, an individual's incurred expenses for the 
calendar year are reduced by the Part B annual deductible.
    (2) The Part B annual deductible is applied to incurred expenses in 
the order in which claims for those expenses are processed by the 
Medicare program.
    (3) Only one Part B annual deductible may be imposed for any 
calendar year and it may be met by any combination of expenses incurred 
in that year.
    (d) Special rule for services reimbursable on a formula basis. (1) 
In applying the formula that takes into account reasonable costs, 
customary charges, and customary (insofar as reasonable) charges, and is 
used to determine payment for services furnished by a provider that is 
not a nominal charge provider, the Medicare intermediary takes the 
following steps:
    (i) Reduces the customary charges for the services by an amount 
equal to any unmet portion of the deductible for the calendar year, in 
accordance with paragraph (b) of this section. (The amount of this 
reduction is considered to be the amount of the deductible that is met 
on the basis of the services to which it is applied.)
    (ii) Determines 20 percent of any remaining portion of the customary 
(insofar as reasonable) charge.
    (iii) Determines the lesser of the reasonable cost of the services 
and the customary charges for the services.
    (iv) Reduces the amount determined under paragraph (c)(1)(iii) of 
this section by the sum of the reduction made under paragraph (c)(1)(i) 
of this section and the amount determined under parargaph (c)(1)(ii) of 
this section.
    (v) Reduces the reasonable cost of the services by the amount of the 
reduction made under paragraph (c)(1)(i) of this section and multiplies 
the result by 80 percent.
    (2) In accordance with Sec.  410.152(b)(1), the amount payable is 
the amount determined under paragraph (c)(1)(iv) of this section, or the 
amount determined under paragraph (c)(1)(v) of this section, whichever 
is less.
    (e) Special rule for services of an independent rural health clinic. 
Application of the Part B annual deductible to rural health clinic 
services is in accordance with Sec.  405.2425(b)(2) of this chapter.
    (f) Amount of the Part B annual deductible. (1) Beginning with 
expenses for services furnished during calendar year 2006, and for all 
succeeding years, the annual deductible is the previous year's 
deductible plus the annual percentage increase in the monthly actuarial 
rate for Medicare enrollees age 65 and over, rounded to the nearest 
dollar.
    (2) For 2005, the deductible is $110.
    (3) From 1991 through 2004, the deductible was $100.
    (4) From 1982 through 1990, the deductible was $75.
    (5) From 1973 through 1981, the deductible was $60.
    (6) From 1966 through 1972, the deductible was $50.
    (g) Carryover of Part B annual deductible. For calendar years before 
1982, the Part B annual deductible was reduced by the amount of expenses 
incurred during the last quarter of the preceding year that was applied 
to meet the deductible for that preceding year. Example: If $20 of 
expenses incurred in November 1980 was used to meet the 1980

[[Page 477]]

deductible, the 1981 deductible was reduced to $40 ($60-$20).
    (h) Examples of application of the annual deductible. (1) Mr. A 
submitted claims for the following expenses incurred during 1982: $20 
for services furnished in March by physician X; $30 for services 
furnished in April by physician Y; $50 for services furnished in June by 
physician Z, for a total of $100. The carrier determined that the 
charges as submitted were the reasonable charges. The first $75 of 
expenses for which claims were processed is applied to meet the $75 
deductible for that year. Medicare Part B pays 80 percent of the 
remaining $25, or $20.
    (2) Mr. B submitted a claim that included a $25 charge by a doctor 
for an examination to prescribe a hearing aid and an $80 charge for 
office surgery. This was the first claim relating to Mr. B's medical 
expenses processed in the calendar year. The carrier disallowed the $25 
charge because the type of examination is not covered by Medicare. The 
carrier reduced the $80 surgery charge to a reasonable charge of $40. 
Only the $40 reasonable charge for covered services will count toward 
meeting Mr. B's deductible. Since the remainder of the surgery charge 
constitutes and excess over the reasonable charge, it cannot be applied 
to satisfy Mr. B's deductible.
    (3) Mr. C became entitled to Medicare Part B benefits on July 1, 
1982. He incurred expenses of $200 in July, August, and September. The 
carrier determined that the changes as submitted were reasonable. Even 
though Mr. C was entitled to benefits for only half the year, he must 
meet the full $75 deductible. Thus, $75 of this expense constitutes Mr. 
C's deductible. Medicare would pay $100, which is 80 percent of the 
remaining $125.

[51 FR 41339, Nov. 14, 1986, as amended at 56 FR 8842, 8852, Mar. 1, 
1991; 57 FR 24981, June 12, 1992; 62 FR 59101, Oct. 31, 1997; 69 FR 
66423, Nov. 15, 2004; 71 FR 69785, Dec. 1, 2006; 73 FR 69934, Nov. 19, 
2008; 75 FR 73615, Nov. 29, 2010; 77 FR 69363, Nov. 16, 2012; 80 FR 
71373, Nov. 16, 2015; 85 FR 71197, Nov. 6, 2020]



Sec.  410.161  Part B blood deductible.

    (a) General rules. (1) As used in this section, packed red cells 
means the red blood cells that remain after plasma is separated from 
whole blood.
    (2) A unit of packed red cells is treated as the equivalent of a 
pint of whole blood, which in this section is referred to as a unit of 
whole blood.
    (3) Medicare does not pay for the first 3 units of whole blood or 
units of packed red cells that are furnished under Part A or Part B in a 
calendar year. The Part B blood deductible is reduced to the extent that 
a blood deductible has been applied under Part A.
    (4) The blood deductible does not apply to other blood components 
such as platelets, fibrinogen, plasma, gamma globulin and serum albumin, 
or to the costs of processing, storing, and administering blood.
    (5) The blood deductible is in addition to the Part B annual 
deductible specified in Sec.  410.160.
    (b) Beneficiary's responsibility for the first 3 units of blood. (1) 
The beneficiary is responsible for the first three units of whole blood 
or packed red cells received during a calendar year.
    (2) If the blood is furnished by a hospital or CAH, the rules set 
forth in Sec.  409.87 (b), (c), and (d) of this chapter apply.
    (3) If the blood is furnished by a physician, clinic, or other 
supplier that has accepted assignment of Medicare benefits, or claims 
payment under Sec.  424.64 of this chapter because the beneficiary died 
without assigning benefits, the supplier may charge the beneficiary the 
reasonable charge for the first 3 units, to the extent that those units 
are not replaced.

[51 FR 41339, Nov. 14, 1986, as amended at 53 FR 6648, Mar. 2, 1988; 56 
FR 8852, Mar. 1, 1991; 58 FR 30668, May 26, 1993]



Sec.  410.163  Payment for services furnished to kidney donors.

    Notwithstanding any other provisions of this chapter, there are no 
deductible or coinsurance requirements with respect to services 
furnished to an individual who donates a kidney for transplant surgery.

[[Page 478]]



Sec.  410.165  Payment for rural health clinic services 
and ambulatory surgical center services: Conditions.

    (a) Medicare Part B pays for covered rural health clinic and 
Federally qualified health center services if--
    (1) The services are furnished in accordance with the requirements 
of subpart X of part 405 of this chapter and subpart A of part 491 of 
this chapter; and
    (2) The clinic or center files a written request for payment on the 
form and in the manner prescribed by CMS.
    (b) Medicare Part B pays for covered ambulatory surgical center 
(ASC) services if--
    (1) The services are furnished in accordance with the requirements 
of part 416 of this chapter; and
    (2) The ASC files a written request for payment on the form and in 
the manner prescribed by CMS.

[51 FR 41339, Nov. 14, 1986, as amended at 57 FR 24981, June 12, 1992]



Sec.  410.170  Payment for home health services, for medical and other 
health services furnished by a provider or an approved ESRD facility, 
and for comprehensive outpatient rehabilitation facility (CORF) services: 
Conditions.

    Payment under Medicare Part B, for home health services, for medical 
and other health services, or for CORF services, may be made to the 
provider or facility only if the following conditions are met:
    (a) Request for payment. A written request for payment is filed by 
or on behalf of the individual to whom the services were furnished.
    (b) Physician or allowed practitioner certification. For home health 
services, a physician or allowed practitioner provides certification and 
recertification in accordance with Sec.  424.22 of this chapter.
    (c) In the case of home dialysis support services described in Sec.  
410.52, the services are furnished in accordance with a written plan 
prepared and periodically reviewed by a team that includes the patient's 
physician and other professionals familiar with the patient's condition 
as required by Sec.  494.90 of this chapter.

[51 FR 41339, Nov. 14, 1986, as amended at 53 FR 6648, Mar. 2, 1988; 73 
FR 20474, Apr. 15, 2008; 85 FR 70354, Nov. 4, 2020]



Sec.  410.172  Payment for partial hospitalization services in CMHCs: 
Conditions.

    Medicare Part B pays for partial hospitalization services furnished 
in a CMHC on behalf of an individual only if the following conditions 
are met:
    (a) The CMHC files a written request for payment on the CMS form 
1450 and in the manner prescribed by CMS; and
    (b) The services are furnished in accordance with the requirements 
described in Sec.  410.110.

[59 FR 6578, Feb. 11, 1994]



Sec.  410.175  Alien absent from the United States.

    (a) Medicare does not pay Part B benefits for services furnished to 
an individual who is not a citizen or a national of the United States if 
those services are furnished in any month for which the individual is 
not paid monthly social security cash benefits (or would not be paid if 
he or she were entitled to those benefits) because he or she has been 
outside the United States continuously for 6 full calendar months.
    (b) Payment of benefits resumes with services furnished during the 
first full calendar month the alien is back in the United States.

[53 FR 6634, Mar. 2, 1988]



PART 411_EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE PAYMENT--
Table of Contents



    Subpart A_General Exclusions and Exclusion of Particular Services

Sec.
411.1 Basis and scope.
411.2 Conclusive effect of QIO determinations on payment of claims.
411.4 Services for which neither the beneficiary nor any other person is 
          legally obligated to pay.
411.6 Services furnished by a Federal provider of services or other 
          Federal agency.
411.7 Services that must be furnished at public expense under a Federal 
          law or Federal Government contract.

[[Page 479]]

411.8 Services paid for by a Government entity.
411.9 Services furnished outside the United States.
411.10 Services required as a result of war.
411.12 Charges imposed by an immediate relative or member of the 
          beneficiary's household.
411.15 Particular services excluded from coverage.

   Subpart B_Insurance Coverage That Limits Medicare Payment: General 
                               Provisions

411.20 Basis and scope.
411.21 Definitions.
411.22 Reimbursement obligations of primary payers and entities that 
          received payment from primary payers.
411.23 Beneficiary's cooperation.
411.24 Recovery of conditional payments.
411.25 Primary payer's notice of primary payment responsibility.
411.26 Subrogation and right to intervene.
411.28 Waiver of recovery and compromise of claims.
411.30 Effect of primary payment on benefit utilization and deductibles.
411.31 Authority to bill primary payers for full charges.
411.32 Basis for Medicare secondary payments.
411.33 Amount of Medicare secondary payment.
411.35 Limitations on charges to a beneficiary or other party when a 
          workers' compensation plan, a no-fault insurer, or an employer 
          group health plan is primary payer.
411.37 Amount of Medicare recovery when a primary payment is made as a 
          result of a judgment or settlement.
411.39 Automobile and liability insurance (including self-insurance), 
          no-fault insurance, and workers' compensation: Final 
          conditional payment amounts via Web portal.

  Subpart C_Limitations on Medicare Payment for Services Covered Under 
                          Workers' Compensation

411.40 General provisions.
411.43 Beneficiary's responsibility with respect to workers' 
          compensation.
411.45 Basis for conditional Medicare payment in workers' compensation 
          cases.
411.46 Lump-sum payments.
411.47 Apportionment of a lump-sum compromise settlement of a workers' 
          compensation claim.

  Subpart D_Limitations on Medicare Payment for Services Covered Under 
                     Liability or No-Fault Insurance

411.50 General provisions.
411.51 Beneficiary's responsibility with respect to no-fault insurance.
411.52 Basis for conditional Medicare payment in liability cases.
411.53 Basis for conditional Medicare payment in no-fault cases.
411.54 Limitation on charges when a beneficiary has received a liability 
          insurance payment or has a claim pending against a liability 
          insurer.

Subpart E_Limitations on Payment for Services Covered Under Group Health 
                        Plans: General Provisions

411.100 Basis and scope.
411.101 Definitions.
411.102 Basic prohibitions and requirements.
411.103 Prohibition against financial and other incentives.
411.104 Current employment status.
411.106 Aggregation rules.
411.108 Taking into account entitlement to Medicare.
411.110 Basis for determination of nonconformance.
411.112 Documentation of conformance.
411.114 Determination of nonconformance.
411.115 Notice of determination of nonconformance.
411.120 Appeals.
411.121 Hearing procedures.
411.122 Hearing officer's decision.
411.124 Administrator's review of hearing decision.
411.126 Reopening of determinations and decisions.
411.130 Referral to Internal Revenue Service (IRS).

 Subpart F_Special Rules: Individuals Eligible or Entitled on the Basis 
         of ESRD, Who Are Also Covered Under Group Health Plans

411.160 Scope.
411.161 Prohibition against taking into account Medicare eligibility or 
          entitlement or differentiating benefits.
411.162 Medicare benefits secondary to group health plan benefits.
411.163 Coordination of benefits: Dual entitlement situations.
411.165 Basis for conditional Medicare payments.

  Subpart G_Special Rules: Aged Beneficiaries and Spouses Who Are Also 
                    Covered Under Group Health Plans

411.170 General provisions.
411.172 Medicare benefits secondary to group health plan benefits.

[[Page 480]]

411.175 Basis for Medicare primary payments.

  Subpart H_Special Rules: Disabled Beneficiaries Who Are Also Covered 
                     Under Large Group Health Plans

411.200 Basis.
411.201 Definitions.
411.204 Medicare benefits secondary to LGHP benefits.
411.206 Basis for Medicare primary payments and limits on secondary 
          payments.

Subpart I [Reserved]

   Subpart J_Financial Relationships Between Physicians and Entities 
                  Furnishing Designated Health Services

411.350 Scope of subpart.
411.351 Definitions.
411.352 Group practice.
411.353 Prohibition on certain referrals by physicians and limitations 
          on billing.
411.354 Financial relationship, compensation, and ownership or 
          investment interest.
411.355 General exceptions to the referral prohibition related to both 
          ownership/investment and compensation.
411.356 Exceptions to the referral prohibition related to ownership or 
          investment interests.
411.357 Exceptions to the referral prohibition related to compensation 
          arrangements.
411.361 Reporting requirements.
411.362 Additional requirements concerning physician ownership and 
          investment in hospitals.

             Subpart K_Payment for Certain Excluded Services

411.370 Advisory opinions relating to physician referrals.
411.372 Procedure for submitting a request.
411.373 Certification.
411.375 Fees for the cost of advisory opinions.
411.377 Expert opinions from outside sources.
411.378 Withdrawing a request.
411.379 When CMS accepts a request.
411.380 When CMS issues a formal advisory opinion.
411.382 CMS' right to rescind advisory opinions.
411.384 Disclosing advisory opinions and supporting information.
411.386 CMS's advisory opinions as exclusive.
411.387 Effect of an advisory opinion.
411.388 When advisory opinions are not admissible evidence.
411.389 Range of the advisory opinion.

             Subpart K_Payment for Certain Excluded Services

411.400 Payment for custodial care and services not reasonable and 
          necessary.
411.402 Indemnification of beneficiary.
411.404 Criteria for determining that a beneficiary knew that services 
          were excluded from coverage as custodial care or as not 
          reasonable and necessary.
411.406 Criteria for determining that a provider, practitioner, or 
          supplier knew that services were excluded from coverage as 
          custodial care or as not reasonable and necessary.
411.408 Refunds of amounts collected for physician services not 
          reasonable and necessary, payment not accepted on an 
          assignment-related basis.

    Authority: 42 U.S.C. 1302, 1395w-101 through 1395w-152, 1395hh, and 
1395nn.

    Source: 54 FR 41734, Oct. 11, 1989, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 411 appear at 71 FR 
9471, Feb. 24, 2006



    Subpart A_General Exclusions and Exclusion of Particular Services



Sec.  411.1  Basis and scope.

    (a) Statutory basis. Sections 1814(a) and 1835(a) of the Act require 
that a physician certify or recertify a patient's need for home health 
services but, in general, prohibit a physician from certifying or 
recertifying the need for services if the services will be furnished by 
an HHA in which the physician has a significant ownership interest, or 
with which the physician has a significant financial or contractual 
relationship. Sections 1814(c), 1835(d), and 1862 of the Act exclude 
from Medicare payment certain specified services. The Act provides 
special rules for payment of services furnished by the following: 
Federal providers or agencies (sections 1814(c) and 1835(d)); hospitals 
and physicians outside of the U.S. (sections 1814(f) and 1862(a)(4)); 
and hospitals and SNFs of the Indian Health Service (section 1880 of the 
Act). Section 1877 of the Act sets forth limitations on referrals and 
payment for designated health services furnished by entities with which 
the referring physician (or an immediate family

[[Page 481]]

member of the referring physician) has a financial relationship.
    (b) Scope. This subpart identifies:
    (1) The particular types of services that are excluded;
    (2) The circumstances under which Medicare denies payment for 
certain services that are usually covered; and
    (3) The circumstances under which Medicare pays for services usually 
excluded from payment.

[54 FR 41734, Oct. 11, 1989, as amended at 60 FR 41978, Aug. 14, 1995; 
60 FR 45361, Aug. 31, 1995; 66 FR 952, Jan. 4, 2001]



Sec.  411.2  Conclusive effect of QIO determinations on payment of claims.

    If a utilization and quality control quality improvement 
organization (QIO) has assumed review responsibility, in accordance with 
part 466 of this chapter, for services furnished to Medicare 
beneficiaries, Medicare payment is not made for those services unless 
the conditions of subpart C of part 466 of this chapter are met.



Sec.  411.4  Services for which neither the beneficiary nor any other person 
is legally obligated to pay.

    (a) General rule. Except as provided in Sec.  411.8(b) (for services 
paid by a governmental entity), Medicare does not pay for a service if--
    (1) The beneficiary has no legal obligation to pay for the service; 
and
    (2) No other person or organization (such as a prepayment plan of 
which the beneficiary is a member) has a legal obligation to provide or 
pay for that service.
    (b) Special conditions for services furnished to individuals in 
custody of penal authorities. Individuals who are in custody include, 
but are not limited to, individuals who are under arrest, incarcerated, 
imprisoned, escaped from confinement, under supervised release, on 
medical furlough, required to reside in mental health facilities, 
required to reside in halfway houses, required to live under home 
detention, or confined completely or partially in any way under a penal 
statute or rule. Payment may be made for services furnished to 
individuals or groups of individuals who are in the custody of police or 
other penal authorities or in the custody of a government agency under a 
penal statute only if the following conditions are met:
    (1) State or local law requires those individuals or groups of 
individuals to repay the cost of medical services they receive while in 
custody.
    (2) The State or local government entity enforces the requirement to 
pay by billing all such individuals, whether or not covered by Medicare 
or any other health insurance, and by pursuing collection of the amounts 
they owe in the same way and with the same vigor that it pursues the 
collection of other debts.

[54 FR 41734, Oct. 11, 1989, as amended at 72 FR 47410, Aug. 22, 2007]



Sec.  411.6  Services furnished by a Federal provider of services 
or other Federal agency.

    (a) Basic rule. Except as provided in paragraph (b) of this section, 
Medicare does not pay for services furnished by a Federal provider of 
services or other Federal agency.
    (b) Exceptions. Payment may be made--
    (1) For emergency hospital services, if the conditions of Sec.  
424.103 of this chapter are met;
    (2) For services furnished by a participating Federal provider which 
CMS has determined is providing services to the public generally as a 
community institution or agency;
    (3) For services furnished by participating hospitals and SNFs of 
the Indian Health Service; and
    (4) For services furnished under arrangements (as defined in Sec.  
409.3 of this chapter) made by a participating hospital.



Sec.  411.7  Services that must be furnished at public expense 
under a Federal law or Federal Government contract.

    (a) Basic rule. Except as provided in paragraph (b) of this section, 
payment may not be made for services that any provider or supplier is 
obligated to furnish at public expense, in accordance with a law of, or 
a contract with, the United States.
    (b) Exception. Payment may be made for services that a hospital or 
SNF of the Indian Health Service is obligated to furnish at public 
expense.

[[Page 482]]



Sec.  411.8  Services paid for by a Government entity.

    (a) Basic rule. Except as provided in paragraph (b) of this section, 
Medicare does not pay for services that are paid for directly or 
indirectly by a government entity.
    (b) Exceptions. Payment may be made for the following:
    (1) Services furnished under a health insurance plan established for 
employees of the government entity.
    (2) Services furnished under a title of the Social Security Act 
other than title XVIII.
    (3) Services furnished in or by a participating general or special 
hospital that--
    (i) Is operated by a State or local government agency; and
    (ii) Serves the general community.
    (4) Services furnished in a hospital or elsewhere, as a means of 
controlling infectious diseases or because the individual is medically 
indigent.
    (5) Services furnished by a participating hospital or SNF of the 
Indian Health Service.
    (6) Services furnished by a public or private health facility that--
    (i) Is not a Federal provider or other facility operated by a 
Federal agency;
    (ii) Receives U.S. government funds under a Federal program that 
provides support to facilities that furnish health care services;
    (iii) Customarily seeks payment for services not covered under 
Medicare from all available sources, including private insurance and 
patients' cash resources; and
    (iv) Limits the amounts it collects or seeks to collect from a 
Medicare Part B beneficiary and others on the beneficiary's behalf to:
    (A) Any unmet deductible applied to the charges related to the 
reasonable costs that the facility incurs in providing the covered 
services;
    (B) Twenty percent of the remainder of those charges;
    (C) The charges for noncovered services.
    (7) Rural health clinic services that meet the requirements set 
forth in part 491 of this chapter.

[54 FR 41734, Oct. 11, 1989, as amended at 56 FR 2139, Jan. 22, 1991]



Sec.  411.9  Services furnished outside the United States.

    (a) Basic rule. Except as specified in paragraph (b) of this 
section, Medicare does not pay for services furnished outside the United 
States. For purposes of this paragraph (a), the following rules apply:
    (1) The United States includes the 50 States, the District of 
Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, The 
Northern Mariana Islands, and for purposes of services rendered on board 
ship, the territorial waters adjoining the land areas of the United 
States.
    (2) Services furnished on board ship are considered to have been 
furnished in United States territorial waters if they were furnished 
while the ship was in a port of one of the jurisdictions listed in 
paragraph (a)(1) of this section, or within 6 hours before arrival at, 
or 6 hours after departure from, such a port.
    (3) A hospital that is not physically situated in one of the 
jurisdictions listed in paragraph (a)(1) of this section is considered 
to be outside the United States, even if it is owned or operated by the 
United States Government.
    (b) Exception. Under the circumstances specified in subpart H of 
part 424 of this chapter, payment may be made for covered inpatient 
services furnished in a foreign hospital and, on the basis of an 
itemized bill, for covered physicians' services and ambulance service 
furnished in connection with those inpatient services, but only for the 
period during which the inpatient hospital services are furnished.



Sec.  411.10  Services required as a result of war.

    Medicare does not pay for services that are required as a result of 
war, or an act of war, that occurs after the effective date of a 
beneficiary's current coverage for hospital insurance benefits or 
supplementary medical insurance benefits.



Sec.  411.12  Charges imposed by an immediate relative or member of 
the beneficiary's household.

    (a) Basic rule. Medicare does not pay for services usually covered 
under

[[Page 483]]

Medicare if the charges for those services are imposed by--
    (1) An immediate relative of the beneficiary; or
    (2) A member of the beneficiary's household.
    (b) Definitions. As used in this section--
    Immediate relative means any of the following:
    (1) Husband or wife.
    (2) Natural or adoptive parent, child, or sibling.
    (3) Stepparent, stepchild, stepbrother, or stepsister.
    (4) Father-in-law, mother-in-law, son-in-law, daughter-in-law, 
brother-in-law, or sister-in-law.
    (5) Grandparent or grandchild.
    (6) Spouse of grandparent or grandchild.
    Member of the household means any person sharing a common abode as 
part of a single family unit, including domestic employees and others 
who live together as part of a family unit, but not including a mere 
roomer or boarder.
    Professional corporation means a corporation that is completely 
owned by one or more physicians and is operated for the purpose of 
conducting the practice of medicine, osteopathy dentistry, podiatry, 
optometry, or chiropractic, or is owned by other health care 
professionals as authorized by State law.
    (c) Applicability of the exclusion. The exclusion applies to the 
following charges in the specified circumstances:
    (1) Physicians' services. (i) Charges for physicians' services 
furnished by an immediate relative of the beneficiary or member of the 
beneficiary's household, even if the bill or claim is submitted by 
another individual or by an entity such as a partnership or a 
professional corporation.
    (ii) Charges for services furnished incident to a physician's 
professional services (for example by the physician's nurse or 
technician), only if the physician who ordered or supervised the 
services has an excluded relationship to the beneficiary.
    (2) Services other than physicians' services. (i) Charges imposed by 
an individually owned provider or supplier if the owner has an excluded 
relationship to the beneficiary; and
    (ii) Charges imposed by a partnership if any of the partners has an 
excluded relationship to the beneficiary.
    (d) Exception to the exclusion. The exclusion does not apply to 
charges imposed by a corporation other than a professional corporation.



Sec.  411.15  Particular services excluded from coverage.

    The following services are excluded from coverage:
    (a) Routine physical checkups such as:
    (1) Examinations performed for a purpose other than treatment or 
diagnosis of a specific illness, symptoms, complaint, or injury, except 
for screening mammography, colorectal cancer screening tests, screening 
pelvic exams, prostate cancer screening tests, glaucoma screening exams, 
ultrasound screening for abdominal aortic aneurysms (AAA), 
cardiovascular disease screening tests, diabetes screening tests, a 
screening electrocardiogram, initial preventive physical examinations 
that meet the criteria specified in paragraphs (k)(6) through (k)(15) of 
this section, additional preventive services that meet the criteria in 
Sec.  410.64 of this chapter, or annual wellness visits providing 
personalized prevention plan services.
    (2) Examinations required by insurance companies, business 
establishments, government agencies, or other third parties.
    (b) Low vision aid exclusion--(1) Scope. The scope of the eyeglass 
exclusion encompasses all devices irrespective of their size, form, or 
technological features that use one or more lens to aid vision or 
provide magnification of images for impaired vision.
    (2) Exceptions. (i) Post-surgical prosthetic lenses customarily used 
during convalescence for eye surgery in which the lens of the eye was 
removed (for example, cataract surgery).
    (ii) Prosthetic intraocular lenses and one pair of conventional 
eyeglasses or contact lenses furnished subsequent to each cataract 
surgery with insertion of an intraocular lens.
    (iii) Prosthetic lenses used by Medicare beneficiaries who are 
lacking the natural lens of the eye and who were not furnished with an 
intraocular lens.

[[Page 484]]

    (c) Eye examinations for the purpose of prescribing, fitting, or 
changing eyeglasses or contact lenses for refractive error only and 
procedures performed in the course of any eye examination to determine 
the refractive state of the eyes, without regard to the reason for the 
performance of the refractive procedures. Refractive procedures are 
excluded even when performed in connection with otherwise covered 
diagnosis or treatment of illness or injury.
    (d) Hearing aids or examinations for the purpose of prescribing, 
fitting, or changing hearing aids.
    (1) Scope. The scope of the hearing aid exclusion encompasses all 
types of air conduction hearing aids that provide acoustic energy to the 
cochlea via stimulation of the tympanic membrane with amplified sound 
and bone conduction hearing aids that provide mechanical stimulation of 
the cochlea via stimulation of the scalp with amplified mechanical 
vibration or by direct contact with the tympanic membrane or middle ear 
ossicles.
    (2) Devices not subject to the hearing aid exclusion. Paragraph 
(d)(1) of this section shall not apply to the following devices that 
produce the perception of sound by replacing the function of the middle 
ear, cochlea, or auditory nerve:
    (i) Osseointegrated implants in the skull bone that provide 
mechanical energy to the cochlea via a mechanical transducer, or
    (ii) Cochlear implants and auditory brainstem implants that replace 
the function of cochlear structures or auditory nerve and provide 
electrical energy to auditory nerve fibers and other neural tissue via 
implanted electrode arrays.
    (e) Immunizations, except for--
    (1) Vaccinations or inoculations directly related to the treatment 
of an injury or direct exposure such as antirabies treatment, tetanus 
antitoxin or booster vaccine, botulin antitoxin, antivenom sera, or 
immune globulin;
    (2) Pneumococcal vaccinations that are reasonable and necessary for 
the prevention of illness;
    (3) Hepatitis B vaccinations that are reasonable and necessary for 
the prevention of illness for those individuals, as defined in Sec.  
410.63(a) of this chapter, who are at high or intermediate risk of 
contracting hepatitis B;
    (4) Influenza vaccinations that are reasonable and necessary for the 
prevention of illness; and
    (5) COVID-19 vaccinations that are reasonable and necessary for the 
prevention of illness.
    (f) Orthopedic shoes or other supportive devices for the feet, 
except when shoes are integral parts of leg braces.
    (g) Custodial care, except as necessary for the palliation or 
management of terminal illness, as provided in part 418 of this chapter. 
(Custodial care is any care that does not meet the requirements for 
coverage as SNF care as set forth in Sec. Sec.  409.31 through 409.35 of 
this chapter.)
    (h) Cosmetic surgery and related services, except as required for 
the prompt repair of accidental injury or to improve the functioning of 
a malformed body member.
    (i) Dental services in connection with the care, treatment, filling, 
removal, or replacement of teeth, or structures directly supporting the 
teeth, except for inpatient hospital services in connection with such 
dental procedures when hospitalization is required because of--
    (1) The individual's underlying medical condition and clinical 
status; or
    (2) The severity of the dental procedures. \1\
---------------------------------------------------------------------------

    \1\ Before July 1981, inpatient hospital care in connection with 
dental procedures was covered only when required by the patient's 
underlying medical condition and clinical status.
---------------------------------------------------------------------------

    (j) Personal comfort services, except as necessary for the 
palliation or management of terminal illness as provided in part 418 of 
this chapter. The use of a television set or a telephone are examples of 
personal comfort services.
    (k) Any services that are not reasonable and necessary for one of 
the following purposes:
    (1) For the diagnosis or treatment of illness or injury or to 
improve the functioning of a malformed body member.
    (2) In the case of hospice services, for the palliation or 
management of terminal illness, as provided in part 418 of this chapter.
    (3) In the case of pneumococcal vaccine for the prevention of 
illness.

[[Page 485]]

    (4) In the case of the patient outcome assessment program 
established under section 1875(c) of the Act, for carrying out the 
purpose of that section.
    (5) In the case of hepatitis B vaccine, for the prevention of 
illness for those individuals at high or intermediate risk of 
contracting hepatitis B. (Section 410.63(a) of this chapter sets forth 
criteria for identifying those individuals.)
    (6) In the case of screening mammography, for the purpose of early 
detection of breast cancer subject to the conditions and limitations 
specified in Sec.  410.34 of this chapter.
    (7) In the case of colorectal cancer screening tests, for the 
purpose of early detection of colorectal cancer subject to the 
conditions and limitations specified in Sec.  410.37 of this chapter.
    (8) In the case of screening pelvic examinations, for the purpose of 
early detection of cervical or vaginal cancer subject to the conditions 
and limitations specified in Sec.  410.56 of this chapter.
    (9) In the case of prostate cancer screening tests, for the purpose 
of early detection of prostate cancer, subject to the conditions and 
limitations specified in Sec.  410.39 of this chapter.
    (10) In the case of screening exams for glaucoma, for the purpose of 
early detection of glaucoma, subject to the conditions and limitations 
specified in Sec.  410.23 of this chapter.
    (11) In the case of initial preventive physical examinations, with 
the goal of health promotion and disease prevention, subject to the 
conditions and limitations specified in Sec.  410.16 of this chapter.
    (12) In the case of ultrasound screening for abdominal aortic 
aneurysms, with the goal of early detection of abdominal aortic 
aneurysms, subject to the conditions and limitation specified in Sec.  
410.19 of this chapter.
    (13) In the case of cardiovascular disease screening tests for the 
early detection of cardiovascular disease or abnormalities associated 
with an elevated risk for that disease, subject to the conditions 
specified in Sec.  410.17 of this chapter.
    (14) In the case of diabetes screening tests furnished to an 
individual at risk for diabetes for the purpose of the early detection 
of that disease, subject to the conditions specified in Sec.  410.18 of 
this chapter.
    (15) In the case of additional preventive services not otherwise 
described in this title, subject to the conditions and limitation 
specified in Sec.  410.64 of this chapter.
    (16) In the case of an annual wellness visit providing a 
personalized prevention plan, subject to the conditions and limitations 
specified in Sec.  410.15 of this subpart.
    (l) Foot care--(1) Basic rule. Except as provided in paragraph 
(l)(2) of this section, any services furnished in connection with the 
following:
    (i) Routine foot care, such as the cutting or removal of corns, or 
calluses, the trimming of nails, routine hygienic care (preventive 
maintenance care ordinarily within the realm of self care), and any 
service performed in the absence of localized illness, injury, or 
symptoms involving the feet.
    (ii) The evaluation or treatment of subluxations of the feet 
regardless of underlying pathology. (Subluxations are structural 
misalignments of the joints, other than fractures or complete 
dislocations, that require treatment only by nonsurgical methods.
    (iii) The evaluation or treatment of flattened arches (including the 
prescription of supportive devices) regardless of the underlying 
pathology.
    (2) Exceptions. (i) Treatment of warts is not excluded.
    (ii) Treatment of mycotic toenails may be covered if it is furnished 
no more often than every 60 days or the billing physician documents the 
need for more frequent treatment.
    (iii) The services listed in paragraph (l)(1) of this section are 
not excluded if they are furnished--
    (A) As an incident to, at the same time as, or as a necessary 
integral part of a primary covered procedure performed on the foot; or
    (B) As initial diagnostic services (regardless of the resulting 
diagnosis) in connection with a specific symptom or complaint that might 
arise from a condition whose treatment would be covered.
    (m) Services to hospital patients--(1) Basic rule. Except as 
provided in paragraph (m)(3) of this section, any service

[[Page 486]]

furnished to an inpatient of a hospital or to a hospital outpatient (as 
defined in Sec.  410.2 of this chapter) during an encounter (as defined 
in Sec.  410.2 of this chapter) by an entity other than the hospital 
unless the hospital has an arrangement (as defined in Sec.  409.3 of 
this chapter) with that entity to furnish that particular service to the 
hospital's patients. As used in this paragraph (m)(1), the term 
``hospital'' includes a CAH.
    (2) Scope of exclusion. Services subject to exclusion from coverage 
under the provisions of this paragraph (m) include, but are not limited 
to, clinical laboratory services; pacemakers and other prostheses and 
prosthetic devices (other than dental) that replace all or part of an 
internal body organ (for example, intraocular lenses); artificial limbs, 
knees, and hips; equipment and supplies covered under the prosthetic 
device benefits; and services incident to a physician service.
    (3) Exceptions. The following services are not excluded from 
coverage:
    (i) Physicians' services that meet the criteria of Sec.  415.102(a) 
of this chapter for payment on a reasonable charge or fee schedule 
basis.
    (ii) Physician assistant services, as defined in section 
1861(s)(2)(K)(i) of the Act, that are furnished after December 31, 1990.
    (iii) Nurse practitioner and clinical nurse specialist services, as 
defined in section 1861(s)(2)(K)(ii) of the Act.
    (iv) Certified nurse-midwife services, as defined in section 
1861(ff) of the Act, that are furnished after December 31, 1990.
    (v) Qualified psychologist services, as defined in section 1861(ii) 
of the Act, that are furnished after December 31, 1990.
    (vi) Services of an anesthetist, as defined in Sec.  410.69 of this 
chapter.
    (n) Certain services of an assistant-at-surgery. (1) Services of an 
assistant-at-surgery in a cataract operation (including subsequent 
insertion of an intraocular lens) unless, before the surgery is 
performed, the appropriate QIO or a carrier has approved the use of such 
an assistant in the surgical procedure based on the existence of a 
complicating medical condition.
    (2) Services on an assistant-at-surgery in a surgical procedure (or 
class of surgical procedures) for which assistants-at-surgery on average 
are used in fewer than 5 percent of such procedures nationally.
    (o) Experimental or investigational devices, except for certain 
devices.
    (1) Categorized by the FDA as a Category B (Nonexperimental/
investigational) device as defined in Sec.  405.201(b) of the chapter; 
and
    (2) Furnished in accordance with the coverage requirements in Sec.  
405.211(b).
    (p) Services furnished to SNF residents--(1) Basic rule. Except as 
provided in paragraph (p)(2) of this section, any service furnished to a 
resident of an SNF during a covered Part A stay by an entity other than 
the SNF, unless the SNF has an arrangement (as defined in Sec.  409.3 of 
this chapter) with that entity to furnish that particular service to the 
SNF's residents. Services subject to exclusion under this paragraph 
include, but are not limited to--
    (i) Any physical, occupational, or speech-language therapy services, 
regardless of whether the services are furnished by (or under the 
supervision of) a physician or other health care professional, and 
regardless of whether the resident who receives the services is in a 
covered Part A stay; and
    (ii) Services furnished as an incident to the professional services 
of a physician or other health care professional specified in paragraph 
(p)(2) of this section.
    (2) Exceptions. The following services are not excluded from 
coverage, provided that the claim for payment includes the SNF's 
Medicare provider number in accordance with Sec.  424.32(a)(5) of this 
chapter:
    (i) Physicians' services that meet the criteria of Sec.  415.102(a) 
of this chapter for payment on a fee schedule basis.
    (ii) Services performed under a physician's supervision by a 
physician assistant who meets the applicable definition in section 
1861(aa)(5) of the Act.
    (iii) Services performed by a nurse practitioner or clinical nurse 
specialist who meets the applicable definition in section 1861(aa)(5) of 
the Act and is working in collaboration (as defined in section 
1861(aa)(6) of the Act) with a physician.

[[Page 487]]

    (iv) Services performed by a certified nurse-midwife, as defined in 
section 1861(gg) of the Act.
    (v) Services performed by a qualified psychologist, as defined in 
section 1861(ii) of the Act.
    (vi) Services performed by a certified registered nurse anesthetist, 
as defined in section 1861(bb) of the Act.
    (vii) Dialysis services and supplies, as defined in section 
1861(s)(2)(F) of the Act, and those ambulance services that are 
furnished in conjunction with them.
    (viii) Erythropoietin (EPO) for dialysis patients, as defined in 
section 1861(s)(2)(O) of the Act.
    (ix) Hospice care, as defined in section 1861(dd) of the Act.
    (x) An ambulance trip that initially conveys an individual to the 
SNF to be admitted as a resident, or that conveys an individual from the 
SNF in connection with one of the circumstances specified in paragraphs 
(p)(3)(i) through (p)(3)(iv) of this section as ending the individual's 
status as an SNF resident.
    (xi) The transportation costs of electrocardiogram equipment (HCPCS 
code R0076), but only with respect to those electrocardiogram test 
services furnished during 1998.
    (xii) Services described in subparagraphs (p)(2)(i) through (vi) of 
this section when furnished via telehealth under section 
1834(m)(4)(C)(ii)(VII) of the Act.
    (xiii) Those chemotherapy items identified, as of July 1, 1999, by 
HCPCS codes J9000-J9020, J9040-J9151, J9170-J9185, J9200-J9201, J9206-
J9208, J9211, J9230-J9245, and J9265-J9600, and as of January 1, 2004, 
by HCPCS codes A9522, A9523, A9533, and A9534 (as subsequently modified 
by CMS), and any additional chemotherapy items identified by CMS.
    (xiv) Those chemotherapy administration services identified, as of 
July 1, 1999, by HCPCS codes 36260-36262, 36489, 36530-36535, 36640, 
36823, and 96405-96542 (as subsequently modified by CMS), and any 
additional chemotherapy administration services identified by CMS.
    (xv) Those radioisotope services identified, as of July 1, 1999, by 
HCPCS codes 79030-79440 (as subsequently modified by CMS), and any 
additional radioisotope services identified by CMS.
    (xvi) Those customized prosthetic devices (including artificial 
limbs and their components) identified, as of July 1, 1999, by HCPCS 
codes L5050-L5340, L5500-L5611, L5613-L5986, L5988, L6050-L6370, L6400-
6880, L6920-L7274, and L7362-L7366 (as subsequently modified by CMS) and 
any additional customized prosthetic devices identified by CMS, which 
are delivered for a resident's use during a stay in the SNF and intended 
to be used by the resident after discharge from the SNF.
    (xvii) Those blood clotting factors indicated for the treatment of 
patients with hemophilia and other bleeding disorders identified, as of 
July 1, 2020, by HCPCS codes J7170, J7175, J7177-J7183, J7185-J7190, 
J7192-J7195, J7198-J7203, J7205, and J7207-J7211 (as subsequently 
modified by CMS) and items and services related to the furnishing of 
such factors, and any additional blood clotting factors identified by 
CMS and items and services related to the furnishing of such factors.
    (xviii) Those RHC and FQHC services that are described in Sec.  
405.2411(b)(2) of this chapter.
    (3) SNF resident defined. For purposes of this paragraph, a 
beneficiary who is admitted to a Medicare-participating SNF is 
considered to be a resident of the SNF for the duration of the 
beneficiary's covered Part A stay. In addition, for purposes of the 
services described in paragraph (p)(1)(i) of this section, a beneficiary 
who is admitted to a Medicare-participating SNF is considered to be a 
resident of the SNF regardless of whether the beneficiary is in a 
covered Part A stay. Whenever the beneficiary leaves the facility, the 
beneficiary's status as an SNF resident for purposes of this paragraph 
(along with the SNF's responsibility to furnish or make arrangements for 
the services described in paragraph (p)(1) of this section) ends when 
one of the following events occurs--
    (i) The beneficiary is admitted as an inpatient to a Medicare-
participating hospital or CAH, or as a resident to another SNF;
    (ii) The beneficiary receives services from a Medicare-participating 
home health agency under a plan of care;

[[Page 488]]

    (iii) The beneficiary receives outpatient services from a Medicare-
participating hospital or CAH (but only for those services that CMS 
designates as being beyond the general scope of SNF comprehensive care 
plans, as required under Sec.  483.21(b) of this chapter); or
    (iv) The beneficiary is formally discharged (or otherwise departs) 
from the SNF, unless the beneficiary is readmitted (or returns) to that 
or another SNF before the following midnight.
    (q) Assisted suicide. Any health care service used for the purpose 
of causing, or assisting to cause, the death of any individual. This 
does not pertain to the withholding or withdrawing of medical treatment 
or care, nutrition or hydration or to the provision of a service for the 
purpose of alleviating pain or discomfort, even if the use may increase 
the risk of death, so long as the service is not furnished for the 
specific purpose of causing death.
    (r) A home health service (including medical supplies described in 
section 1861(m)(5) of the Act, but excluding durable medical equipment 
to the extent provided for in such section) as defined in section 
1861(m) of the Act furnished to an individual who is under a plan of 
care of an HHA, unless that HHA has submitted a claim for payment for 
such services.
    (s) Unless Sec.  414.404(d) or Sec.  414.408(e)(2) of this 
subchapter applies, Medicare does not make payment if an item or service 
that is included in a competitive bidding program (as described in part 
414, subpart F of this subchapter) is furnished by a supplier other than 
a contract supplier (as defined in Sec.  414.402 of this subchapter).

[54 FR 41734, Oct. 11, 1989; 55 FR 1820, Jan. 19, 1990]

    Editorial Note: For Federal Register citations affecting Sec.  
411.15, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



   Subpart B_Insurance Coverage That Limits Medicare Payment: General 
                               Provisions



Sec.  411.20  Basis and scope.

    (a) Statutory basis. (1) Section 1862(b)(2)(A)(i) of the Act 
precludes Medicare payment for services to the extent that payment has 
been made or can reasonably be expected to be made under a group health 
plan with respect to--
    (i) A beneficiary entitled to Medicare on the basis of ESRD during 
the first 18 months of that entitlement;
    (ii) A beneficiary who is age 65 or over, entitled to Medicare on 
the basis of age, and covered under the plan by virtue of his or her 
current employment status or the current employment status of a spouse 
of any age; or
    (iii) A beneficiary who is under age 65, entitled to Medicare on the 
basis of disability, and covered under the plan by virtue of his or her 
current employment status or the current employment status of a family 
member.
    (2) Section 1862(b)(2)(A)(ii) of the Act precludes Medicare payment 
for services to the extent that payment has been made or can reasonably 
be expected to be made under any of the following:
    (i) Workers' compensation.
    (ii) Liability insurance.
    (iii) No-fault insurance.
    (b) Scope. This subpart sets forth general rules that apply to the 
types of insurance specified in paragraph (a) of this section. Other 
general rules that apply to group health plans are set forth in subpart 
E of this part.

[60 FR 45361, Aug. 31, 1995, as amended at 71 FR 9470, Feb. 24, 2006]



Sec.  411.21  Definitions.

    In this subpart B and in subparts C through H of this part, unless 
the context indicates otherwise--
    Conditional payment means a Medicare payment for services for which 
another payer is responsible, made either on the bases set forth in 
subparts C through H of this part, or because the intermediary or 
carrier did not know that the other coverage existed.

[[Page 489]]

    Coverage or covered services, when used in connection with primary 
payments, means services for which a primary payer would pay if a proper 
claim were filed.
    Monthly capitation payment means a comprehensive monthly payment 
that covers all physician services associated with the continuing 
medical management of a maintenance dialysis patient who dialyses at 
home or as an outpatient in an approved ESRD facility.
    Plan means any arrangement, oral or written, by one or more 
entities, to provide health benefits or medical care or assume legal 
liability for injury or illness.
    Primary payer means, when used in the context in which Medicare is 
the secondary payer, any entity that is or was required or responsible 
to make payment with respect to an item or service (or any portion 
thereof) under a primary plan. These entities include, but are not 
limited to, insurers or self-insurers, third party administrators, and 
all employers that sponsor or contribute to group health plans or large 
group health plans.
    Primary payment means, when used in the context in which Medicare is 
the secondary payer, payment by a primary payer for services that are 
also covered under Medicare.
    Primary plan means, when used in the context in which Medicare is 
the secondary payer, a group health plan or large group health plan, a 
workers' compensation law or plan, an automobile or liability insurance 
policy or plan (including a self-insured plan), or no-fault insurance.
    Prompt or promptly, when used in connection with primary payments, 
except as provided in Sec.  411.50, for payments by liability insurers, 
means payment within 120 days after receipt of the claim.
    Proper claim means a claim that is filed timely and meets all other 
claim filing requirements specified by the plan, program, or insurer.
    Secondary, when used to characterize Medicare benefits, means that 
those benefits are payable only to the extent that payment has not been 
made and cannot reasonably be expected to be made under other coverage 
that is primary to Medicare.
    Secondary payments means payments made for Medicare covered services 
or portions of services that are not payable under other coverage that 
is primary to Medicare.

[54 FR 41734, Oct. 11, 1989, as amended at 60 FR 45361, Aug. 31, 1995; 
71 FR 9470, Feb. 24, 2006]



Sec.  411.22  Reimbursement obligations of primary payers and entities 
that received payment from primary payers.

    (a) A primary payer, and an entity that receives payment from a 
primary payer, must reimburse CMS for any payment if it is demonstrated 
that the primary payer has or had a responsibility to make payment.
    (b) A primary payer's responsibility for payment may be demonstrated 
by--
    (1) A judgment;
    (2) A payment conditioned upon the recipient's compromise, waiver, 
or release (whether or not there is a determination or admission of 
liability) of payment for items or services included in a claim against 
the primary payer or the primary payer's insured; or
    (3) By other means, including but not limited to a settlement, 
award, or contractual obligation.
    (c) The primary payer must make payment to either of the following:
    (1) To the entity designated to receive repayments if the 
demonstration of primary payer responsibilities is other than receipt of 
a recovery demand letter from CMS or designated contractor.
    (2) As directed in a recovery demand letter.

[71 FR 9470, Feb. 24, 2006, as amended at 73 FR 9684, Feb. 22, 2008]



Sec.  411.23  Beneficiary's cooperation.

    (a) If CMS takes action to recover conditional payments, the 
beneficiary must cooperate in the action.
    (b) If CMS's recovery action is unsuccessful because the beneficiary 
does not cooperate, CMS may recover from the beneficiary.



Sec.  411.24  Recovery of conditional payments.

    If a Medicare conditional payment is made, the following rules 
apply:

[[Page 490]]

    (a) Release of information. The filing of a Medicare claim by on or 
behalf of the beneficiary constitutes an express authorization for any 
entity, including State Medicaid and workers' compensation agencies, and 
data depositories, that possesses information pertinent to the Medicare 
claim to release that information to CMS. This information will be used 
only for Medicare claims processing and for coordination of benefits 
purposes.
    (b) Right to initiate recovery. CMS may initiate recovery as soon as 
it learns that payment has been made or could be made under workers' 
compensation, any liability or no-fault insurance, or an employer group 
health plan.
    (c) Amount of recovery. (1) If it is not necessary for CMS to take 
legal action to recover, CMS recovers the lesser of the following:
    (i) The amount of the Medicare primary payment.
    (ii) The full primary payment amount that the primary payer is 
obligated to pay under this part without regard to any payment, other 
than a full primary payment that the primary payer has paid or will 
make, or, in the case of a primary payment beneficiary, the amount of 
the primary payment.
    (2) If it is necessary for CMS to take legal action to recover from 
the primary payer, CMS may recover twice the amount specified in 
paragraph (c)(1)(i) of this section.
    (d) Methods of recovery. CMS may recover by direct collection or by 
offset against any monies CMS owes the entity responsible for refunding 
the conditional payment.
    (e) Recovery from primary payers. CMS has a direct right of action 
to recover from any primary payer.
    (f) Claims filing requirements. (1) CMS may recover without regard 
to any claims filing requirements that the insurance program or plan 
imposes on the beneficiary or other claimant such as a time limit for 
filing a claim or a time limit for notifying the plan or program about 
the need for or receipt of services.
    (2) However, CMS will not recover its payment for particular 
services in the face of a claims filing requirement unless it has filed 
a claim for recovery by the end of the year following the year in which 
the Medicare intermediary or carrier that paid the claim has notice that 
the third party is a primary plan to Medicare for those particular 
services. (A notice received during the last three months of a year is 
considered received during the following year.)
    (g) Recovery from parties that receive primary payments. CMS has a 
right of action to recover its payments from any entity, including a 
beneficiary, provider, supplier, physician, attorney, State agency or 
private insurer that has received a primary payment.
    (h) Reimbursement to Medicare. If the beneficiary or other party 
receives a primary payment, the beneficiary or other party must 
reimburse Medicare within 60 days.
    (i) Special rules. (1) In the case of liability insurance 
settlements and disputed claims under employer group health plans, 
workers' compensation insurance or plan, and no-fault insurance, the 
following rule applies: If Medicare is not reimbursed as required by 
paragraph (h) of this section, the primary payer must reimburse Medicare 
even though it has already reimbursed the beneficiary or other party.
    (2) The provisions of paragraph (i)(1) of this section also apply if 
a primary payer makes its payment to an entity other than Medicare when 
it is, or should be, aware that Medicare has made a conditional primary 
payment.
    (3) In situations that involve procurement costs, the rule of Sec.  
411.37(b) applies.
    (j) Recovery against Medicaid agency. If a primary payment is made 
to a State Medicaid agency and that agency does not reimburse Medicare, 
CMS may reduce any Federal funds due the Medicaid agency (under title 
XIX of the Act) by an amount equal to the Medicare payment or the 
primary payment, whichever is less.
    (k) Recovery against Medicare contractor. If a Medicare contractor, 
including an intermediary or carrier, also insures, underwrites, or 
administers as a third party administrator, a program or plan that is 
primary to Medicare, and does not reimburse Medicare, CMS may offset the 
amount owed against any funds due the intermediary or carrier under 
title XVIII of

[[Page 491]]

the Act or due the contractor under the contract.
    (l) Recovery when there is failure to file a proper claim--(1) Basic 
rule. If Medicare makes a conditional payment with respect to services 
for which the beneficiary or provider or supplier has not filed a proper 
claim with a primary payer, and Medicare is unable to recover from the 
primary payer, Medicare may recover from the beneficiary or provider or 
supplier that was responsible for the failure to file a proper claim.
    (2) Exceptions. (i) This rule does not apply in the case of 
liability insurance nor when failure to file a proper claim is due to 
mental or physical incapacity of the beneficiary.
    (ii) CMS will not recover from providers or suppliers that are in 
compliance with the requirements of Sec.  489.20 of this chapter and can 
show that the reason they failed to file a proper claim is that the 
beneficiary, or someone acting on his or her behalf, failed to give, or 
gave erroneous, information regarding coverage that is primary to 
Medicare.
    (m) Interest charges. (1) With respect to recovery of payments for 
items and services furnished before October 31, 1994, CMS charges 
interest, exercising common law authority in accordance with 45 CFR 
30.13, consistent with the Federal Claims Collection Act (31 U.S.C. 
3711).
    (2) In addition to its common law authority with respect to recovery 
of payments for items and services furnished on or after October 31, 
1994, CMS charges interest in accordance with section 1862(b)(2)(B)(i) 
of the Act. Under that provision--
    (i) CMS may charge interest if reimbursement is not made to the 
appropriate trust fund before the expiration of the 60-day period that 
begins on the date on which notice or other information is received by 
CMS that payment has been or could be made under a primary plan;
    (ii) Interest may accrue from the date when that notice or other 
information is received by CMS, is charged until reimbursement is made, 
and is applied for full 30-day periods; and
    (iii) The rate of interest is that provided at Sec.  405.378(d) of 
this chapter.

[54 FR 41734, Oct. 11, 1989, as amended at 55 FR 1820, Jan. 19, 1990; 60 
FR 45361, 45362, Aug. 31, 1995; 69 FR 45607, July 30, 2004; 71 FR 9470, 
Feb. 24, 2006]



Sec.  411.25  Primary payer's notice of primary payment responsibility.

    (a) If it is demonstrated to a primary payer that CMS has made a 
Medicare primary payment for services for which the primary payer has 
made or should have made primary payment, it must provide notice about 
primary payment responsibility and information about the underlying MSP 
situation to the entity or entities designated by CMS to receive and 
process that information.
    (b) The notice must describe the specific situation and the 
circumstances (including the particular type of insurance coverage as 
specified in Sec.  411.20(a)) and, if appropriate, the time period 
during which the insurer is primary to Medicare.
    (c) The primary payer must provide additional information to the 
designated entity or entities as the designated entity or entities may 
require this information to update CMS' system of records.

[54 FR 41734, Oct. 11, 1989, as amended at 55 FR 1820, Jan. 19, 1990; 73 
FR 9684, Feb. 22, 2008]



Sec.  411.26  Subrogation and right to intervene.

    (a) Subrogation. With respect to services for which Medicare paid, 
CMS is subrogated to any individual, provider, supplier, physician, 
private insurer, State agency, attorney, or any other entity entitled to 
payment by a primary payer.
    (b) Right to intervene. CMS may join or intervene in any action 
related to the events that gave rise to the need for services for which 
Medicare paid.



Sec.  411.28  Waiver of recovery and compromise of claims.

    (a) CMS may waive recovery, in whole or in part, if the probability 
of recovery, or the amount involved, does not warrant pursuit of the 
claim.

[[Page 492]]

    (b) General rules applicable to compromise of claims are set forth 
in subpart F of part 401 and Sec.  405.376 of this chapter.
    (c) Other rules pertinent to recovery are contained in subpart C of 
part 405 of this chapter.

[54 FR 41734, Oct. 11, 1989, as amended at 61 FR 63749, Dec. 2, 1996]



Sec.  411.30  Effect of primary payment on benefit utilization and deductibles.

    (a) Benefit utilization. Inpatient psychiatric hospital and SNF care 
that is paid for by a primary payer is not counted against the number of 
inpatient care days available to the beneficiary under Medicare Part A.
    (b) Deductibles. Expenses for Medicare covered services that are 
paid for by primary payers are credited toward the Medicare Part A and 
Part B deductibles.



Sec.  411.31  Authority to bill primary payers for full charges.

    (a) The fact that Medicare payments are limited to the DRG amount, 
or the reasonable charge, reasonable cost, capitation or fee schedule 
rate, does not affect the amount that a primary payer may pay.
    (b) With respect to workers' compensation plans, no-fault insurers, 
and employer group health plans, a provider or supplier may bill its 
full charges and expect those charges to be paid unless there are limits 
imposed by laws other than title XVIII of the Act or by agreements with 
the primary payer.



Sec.  411.32  Basis for Medicare secondary payments.

    (a) Basic rules. (1) Medicare benefits are secondary to benefits 
payable by a primary payer even if State law or the primary payer states 
that its benefits are secondary to Medicare benefits or otherwise limits 
its payments to Medicare beneficiaries.
    (2) Except as provided in paragraph (b) of this section, Medicare 
makes secondary payments, within the limits specified in paragraph (c) 
of this section and in Sec.  411.33, to supplement the primary payment 
if that payment is less than the charges for the services and, in the 
case of services paid on other than a reasonable charge basis, less than 
the gross amount payable by Medicare under Sec.  411.33(e).
    (b) Exception. Medicare does not make a secondary payment if the 
provider or supplier is either obligated to accept, or voluntarily 
accepts, as full payment, a primary payment that is less than its 
charges.
    (c) General limitation: Failure to file a proper claim. When a 
provider or supplier, or a beneficiary who is not physically or mentally 
incapacitated, receives a reduced primary payment because of failure to 
file a proper claim, the Medicare secondary payment may not exceed the 
amount that would have been payable under Sec.  411.33 if the primary 
payer had paid on the basis of a proper claim.

The provider, supplier, or beneficiary must inform CMS that a reduced 
payment was made, and the amount that would have been paid if a proper 
claim had been filed.



Sec.  411.33  Amount of Medicare secondary payment.

    (a) Services for which CMS pays on a Medicare fee schedule or 
reasonable charge basis. The Medicare secondary payment is the lowest of 
the following:
    (1) The actual charge by the supplier (or the amount the supplier is 
obligated to accept as payment in full if that is less than the charges) 
minus the amount paid by the primary payer.
    (2) The amount that Medicare would pay if the services were not 
covered by a primary payer.
    (3) The higher of the Medicare fee schedule, Medicare reasonable 
charge, or other amount which would be payable under Medicare (without 
regard to any applicable Medicare deductible or coinsurance amounts) or 
the primary payer's allowable charge (without regard to any deductible 
or co-insurance imposed by the policy or plan) minus the amount actually 
paid by the primary payer.
    (b) Example: An individual received treatment from a physician for 
which the physician charged $175. The primary payer allowed $150 of the 
charge and paid 80 percent of this amount or $120. The Medicare fee 
schedule for this treatment is $125. The individual's Part

[[Page 493]]

B deductible had been met. As secondary payer, Medicare pays the lowest 
of the following amounts:
    (1) Excess of actual charge minus the primary payment: $175-120 = 
$55.
    (2) Amount Medicare would pay if the services were not covered by a 
primary payer: .80 x $125 = $100.
    (3) Primary payer's allowable charge without regard to its 
coinsurance (since that amount is higher than the Medicare fee schedule 
in this case) minus amount paid by the primary payer: $150-120 = $30.

The Medicare payment is $30.
    (c)-(d) [Reserved]
    (e) Services reimbursed on a basis other than fee schedule, 
reasonable charge, or monthly capitation rate. The Medicare secondary 
payment is the lowest of the following:
    (1) The gross amount payable by Medicare (that is, the amount 
payable without considering the effect of the Medicare deductible and 
coinsurance or the payment by the primary payer), minus the applicable 
Medicare deductible and coinsurance amounts.
    (2) The gross amount payable by Medicare, minus the amount paid by 
the primary payer.
    (3) The provider's charges (or the amount the provider is obligated 
to accept as payment in full, if that is less than the charges), minus 
the amount payable by the primary payer.
    (4) The provider's charges (or the amount the provider is obligated 
to accept as payment in full if that is less than the charges), minus 
the applicable Medicare deductible and coinsurance amounts.
    (f) Examples: (1) A hospital furnished 7 days of inpatient hospital 
care in 1987 to a Medicare beneficiary. The provider's charges for 
Medicare-covered services totaled $2,800. The primary payer paid $2,360. 
No part of the Medicare inpatient hospital deductible of $520 had been 
met. If the gross amount payable by Medicare in this case is $2,700, 
then as secondary payer, Medicare pays the lowest of the following 
amounts:
    (i) The gross amount payable by Medicare minus the Medicare 
inpatient hospital deductible: $2,700-$520 = $2,180.
    (ii) The gross amount payable by Medicare minus the primary payment: 
$2,700-$2,360 = $340.
    (iii) The provider's charges minus the primary payment: $2,800-
$2,360 = $440.
    (iv) The provider's charges minus the Medicare deductible: $2,800-
$520 = $2,280. Medicare's secondary payment is $340 and the combined 
payment made by the primary payer and Medicare on behalf of the 
beneficiary is $2,700. The $520 deductible was satisfied by the primary 
payment so that the beneficiary incurred no out-of-pocket expenses.
    (2) A hospital furnished 1 day of inpatient hospital care in 1987 to 
a Medicare beneficiary. The provider's charges for Medicare-covered 
services totalled $750. The primary payer paid $450. No part of the 
Medicare inpatient hospital deductible had been met previously. The 
primary payment is credited toward that deductible. If the gross amount 
payable by Medicare in this case is $850, then as secondary payer, 
Medicare pays the lowest of the following amounts:
    (i) The gross amount payable by Medicare minus the Medicare 
deductible: $850-$520 = $330.
    (ii) The gross amount payable by Medicare minus the primary payment: 
$850-$450 = $400.
    (iii) The provider's charges minus the primary payment: $750-$450 = 
$300.
    (iv) The provider's charges minus the Medicare deductible: $750-$520 
= $230. Medicare's secondary payment is $230, and the combined payment 
made by the primary payer and Medicare on behalf of the beneficiary is 
$680. The hospital may bill the beneficiary $70 (the $520 deductible 
minus the $450 primary payment). This fully discharges the beneficiary's 
deductible obligation.
    (3) An ESRD beneficiary received 8 dialysis treatments for which a 
facility charged $160 per treatment for a total of $1,280. No part of 
the beneficiary's $75 Part B deductible had been met. The primary payer 
paid $1,024 for Medicare-covered services. The composite rate per 
dialysis treatment at this facility is $131 or $1,048 for 8 treatments. 
As secondary payer, Medicare pays the lowest of the following:
    (i) The gross amount payable by Medicare minus the applicable 
Medicare deductible and coinsurance:

[[Page 494]]

$1,048-$75-$194.60 = $778.40. (The coinsurance is calculated as follows: 
$1,048 composite rate-$75 deductible = $973 x .20 = $194.60).
    (ii) The gross amount payable by Medicare minus the primary payment: 
$1,048-$1,024 = $24.
    (iii) The provider's charges minus the primary payment: $1,280-
$1,024 = $256.
    (iv) The provider's charge minus the Medicare deductible and 
coinsurance: $1,280-$75-$194.60 = 1010.40. Medicare pays $24. The 
beneficiary's Medicare deductible and coinsurance were met by the 
primary payment.
    (4) A hospital furnished 5 days of inpatient care in 1987 to a 
Medicare beneficiary. The provider's charges for Medicare-covered 
services were $4,000 and the gross amount payable was $3,500. The 
provider agreed to accept $3,000 from the primary payer as payment in 
full. The primary payer paid $2,900 due to a deductible requirement 
under the primary plan. Medicare considers the amount the provider is 
obligated to accept as full payment ($3,000) to be the provider charges. 
The Medicare secondary payment is the lowest of the following:
    (i) The gross amount payable by Medicare minus the Medicare 
inpatient deductible: $3,500-$520 = $2,980.
    (ii) The gross amount payable by Medicare minus the primary payment: 
$3,500-$2,900 = $600.
    (iii) The provider's charge minus the primary payment: $3,000-$2,900 
= $100.
    (iv) The provider's charges minus the Medicare inpatient deductible: 
$3,000-$520 = $2,480. The Medicare secondary payment is $100. When 
Medicare is the secondary payer, the combined payment made by the 
primary payer and Medicare on behalf of the beneficiary is $3,000. The 
beneficiary has no liability for Medicare-covered services since the 
primary payment satisfied the $520 deductible.

[54 FR 41734, Oct. 11, 1989, as amended at 55 FR 1820, Jan. 19, 1990; 60 
FR 45362, Aug. 31, 1995; 71 FR 9470, Feb. 24, 2006]



Sec.  411.35  Limitations on charges to a beneficiary or other party 
when a workers' compensation plan, a no-fault insurer, or an employer 
group health plan is primary payer.

    (a) Definition. As used in this section Medicare-covered services 
means services for which Medicare benefits are payable or would be 
payable except for the Medicare deductible and coinsurance provisions 
and the amounts payable by the primary payer.
    (b) Applicability. This section applies when a workers' compensation 
plan, a no-fault insurer or an employer group health plan is primary to 
Medicare.
    (c) Basic rule. Except as provided in paragraph (d) of this section, 
the amounts the provider or supplier may collect or seek to collect, for 
the Medicare-covered services from the beneficiary or any entity other 
than the workers' compensation plan, the no-fault insurer, or the 
employer plan and Medicare, are limited to the following:
    (1) The amount paid or payable by the primary payer to the 
beneficiary. If this amount exceeds the amount payable by Medicare 
(without regard to deductible or coinsurance), the provider or supplier 
may retain the primary payment in full without violating the terms of 
the provider agreement or the conditions of assignment.
    (2) The amount, if any, by which the applicable Medicare deductible 
and coinsurance amounts exceed any primary payment made or due to the 
beneficiary or to the provider or supplier for the medical services.
    (3) The amount of any charges that may be made to a beneficiary 
under Sec.  413.35 of this chapter when cost limits are applied to the 
services, or under Sec.  489.32 of this chapter when the services are 
partially covered, but only to the extent that the primary payer is not 
responsible for those charges.
    (d) Exception. The limitations of paragraph (c) of this section do 
not apply if the services were furnished by a supplier that is not a 
participating supplier and has not accepted assignment for the services 
or claimed payment under Sec.  424.64 of this chapter.

[[Page 495]]



Sec.  411.37  Amount of Medicare recovery when a primary payment is made 
as a result of a judgment or settlement.

    (a) Recovery against the party that received payment--(1) General 
rule. Medicare reduces its recovery to take account of the cost of 
procuring the judgment or settlement, as provided in this section, if--
    (i) Procurement costs are incurred because the claim is disputed; 
and
    (ii) Those costs are borne by the party against which CMS seeks to 
recover.
    (2) Special rule. If CMS must file suit because the party that 
received payment opposes CMS's recovery, the recovery amount is as set 
forth in paragraph (e) of this section.
    (b) Recovery against the primary payer. If CMS seeks recovery from 
the primary payer, in accordance with Sec.  411.24(i), the recovery 
amount will be no greater than the amount determined under paragraph (c) 
or (d) or (e) of this section.
    (c) Medicare payments are less than the judgment or settlement 
amount. If Medicare payments are less than the judgment or settlement 
amount, the recovery is computed as follows:
    (1) Determine the ratio of the procurement costs to the total 
judgment or settlement payment.
    (2) Apply the ratio to the Medicare payment. The product is the 
Medicare share of procurement costs.
    (3) Subtract the Medicare share of procurement costs from the 
Medicare payments. The remainder is the Medicare recovery amount.
    (d) Medicare payments equal or exceed the judgment or settlement 
amount. If Medicare payments equal or exceed the judgment or settlement 
amount, the recovery amount is the total judgment or settlement payment 
minus the total procurement costs.
    (e) CMS incurs procurement costs because of opposition to its 
recovery. If CMS must bring suit against the party that received payment 
because that party opposes CMS's recovery, the recovery amount is the 
lower of the following:
    (1) Medicare payment.
    (2) The total judgment or settlement amount, minus the party's total 
procurement cost.



Sec.  411.39  Automobile and liability insurance (including self-insurance), 
no-fault insurance, and workers' compensation: Final conditional 
payment amounts via Web portal.

    (a) Definitions. For the purpose of this section the following 
definitions are applicable:
    Applicable plan means the following laws, plans, or other 
arrangements, including the fiduciary or administrator for such law, 
plan or arrangement:
    (1) Liability insurance (including self-insurance).
    (2) No fault insurance.
    (3) Workers' compensation laws or plans.
    (b) Accessing conditional payment information through the Medicare 
Secondary Payer Web portal--(1) Beneficiary access. A beneficiary may 
access his or her Medicare Secondary Payer conditional payment 
information via the Medicare Secondary Payer Recovery Portal (Web 
portal), provided the following conditions are met:
    (i) The beneficiary creates an account to access his or her Medicare 
information through the CMS Web site.
    (ii) The appropriate Medicare contractor has received initial notice 
of a pending liability insurance (including self-insurance), no-fault 
insurance, or workers' compensation settlement, judgment, award, or 
other payment and has posted the recovery case on the Web portal.
    (2) Beneficiary's attorney or other representative or applicable 
plan's access using the multifactor authentication process. A 
beneficiary's attorney or other representative or an applicable plan may 
do the following:
    (i) Access conditional payment information via the MSP Recovery 
Portal (Web portal).
    (ii) Dispute claims.
    (iii) Upload settlement information via the Web portal using 
multifactor authentication.
    (c) Obtaining a final conditional payment amount. (1) A beneficiary, 
or his or her attorney or other representative, or an authorized 
applicable plan, may obtain a final conditional payment amount related 
to a pending liability

[[Page 496]]

insurance (including self-insurance), no-fault insurance, or workers' 
compensation settlement, judgment, award, or other payment using the 
following process:
    (i) The beneficiary, his or her attorney or other representative, or 
an applicable plan, provides initial notice of a pending liability 
insurance (including self-insurance), no-fault insurance, and workers' 
compensation settlement, judgment, award, or other payment to the 
appropriate Medicare contractor before accessing information via the Web 
portal.
    (ii) The Medicare contractor compiles claims for which Medicare has 
paid conditionally that are related to the pending settlement, judgment, 
award, or other payment within 65 days or less of receiving the initial 
notice of the pending settlement, judgment, award, or other payment and 
posts a recovery case on the Web portal.
    (iii) If the underlying liability insurance (including self-
insurance), no-fault insurance, or workers' compensation claim derives 
from one of the following, the beneficiary, or his or her attorney or 
other representative, must provide notice to CMS' contractor via the Web 
portal in order to obtain a final conditional payment summary statement 
and amount through the Web portal:
    (A) Alleged exposure to a toxic substance.
    (B) Environmental hazard.
    (C) Ingestion of pharmaceutical drug or other product or substance.
    (D) Implantation of a medical device, joint replacement, or 
something similar.
    (iv) Up to 120 days before the anticipated date of a settlement, 
judgment, award, or other payment, the beneficiary, or his or her 
attorney, other representative, or authorized applicable plan may notify 
CMS, once and only once, via the Web portal, that a settlement, 
judgment, award or other payment is expected to occur within 120 days or 
less from the date of notification.
    (A) CMS may extend its response timeframe by an additional 30 days 
when it determines that additional time is required to address claims 
that Medicare has paid conditionally that are related to the settlement, 
judgment, award, or other payment in situations including, but not 
limited to, the following:
    (1) A recovery case that requires manual filtering to ensure that 
associated claims are related to the pending settlement, judgment, 
award, or other payment.
    (2) Internal CMS systems failures not otherwise considered caused by 
exceptional circumstances.
    (B) In exceptional circumstances, CMS may further extend its 
response timeframe by the number of days required to address the issue 
that resulted from such exceptional circumstances. Exceptional 
circumstances include, but are not limited to the following:
    (1) Systems failure(s) due to consequences of extreme adverse 
weather (loss of power, flooding, etc.).
    (2) Security breaches of facilities or network(s).
    (3) Terror threats; strikes and similar labor actions.
    (4) Civil unrest, uprising, or riot.
    (5) Destruction of business property (as by fire, etc.).
    (6) Sabotage.
    (7) Workplace attack on personnel.
    (8) Similar circumstances beyond the ordinary control of government, 
private sector officers or management.
    (v) The beneficiary, or his or her attorney, or other representative 
may then address discrepancies by disputing individual conditional 
payments, once and only once, if he or she believes that the conditional 
payment included in the most up-to-date conditional payment summary 
statement is unrelated to the pending liability insurance (including 
self-insurance), no-fault insurance, or workers' compensation 
settlement, judgment, award, or other payment.
    (A) The dispute process is not an appeals process, nor does it 
establish a right of appeal regarding that dispute. There will be no 
administrative or judicial review related to this dispute process.
    (B) The beneficiary, or his or her attorney or other representative 
may be required to submit supporting documentation in the form and 
manner

[[Page 497]]

specified by the Secretary to support his or her dispute.
    (vi) Disputes submitted through the Web portal and after the 
beneficiary, or his or her attorney, other representative, or authorized 
applicable plan has notified CMS that he or she is 120 days or less from 
the anticipated date of a settlement, judgment, award, or other payment, 
are resolved within 11 business days of receipt of the dispute and any 
required supporting documentation.
    (vii) When any disputes have been fully resolved, the beneficiary, 
or his or her attorney or other representative, may download or 
otherwise request a time and date stamped conditional payment summary 
statement through the Web portal.
    (A) If the download or request is within 3 days of the date of 
settlement, judgment, award, or other payment, that conditional payment 
summary statement will constitute Medicare's final conditional payment 
amount.
    (B) If the beneficiary, or his or her attorney or other 
representative, is within 3 days of the date of settlement, judgment, 
award, or other payment and any claim disputes have not been fully 
resolved, he or she may not download or otherwise request a final 
conditional payment summary statement.
    (viii) Within 30 days or less of securing a settlement, judgment, 
award, or other payment, the beneficiary, or his or her attorney or 
other representative, must submit through the Web portal documentation 
specified by the Secretary, including, but not limited to the following:
    (A) The date of settlement, judgment, award, or other payment, 
including the total settlement amount, the attorney fee amount or 
percentage.
    (B) Additional costs borne by the beneficiary to obtain his or her 
settlement, judgment, award, or other payment.
    (1) If settlement information is not provided within 30 days or less 
of securing the settlement, the final conditional payment amount 
obtained through the Web portal is void.
    (2) [Reserved]
    (ix) Once settlement, judgment, award, or other payment information 
is received, CMS applies a pro rata reduction to the final conditional 
payment amount in accordance with Sec.  411.37 and issues a final MSP 
recovery demand letter.
    (2) An applicable plan may only obtain a final conditional payment 
amount related to a pending liability insurance (including self-
insurance), no-fault insurance, or workers' compensation settlement, 
judgment, award, or other payment in the form and manner described in 
Sec.  411.38(b) if the applicable plan has properly registered to use 
the Web portal and has obtained from the beneficiary, and submitted to 
the appropriate CMS contractor, proper proof of representation. The 
applicable plan may obtain read only access if the applicable plan 
obtains from the beneficiary, and submits to the appropriate CMS 
contractor, proper consent to release.
    (d) Obligations with respect to future medical items and services. 
Final conditional payment amounts obtained via the Web portal represent 
Medicare covered and otherwise reimbursable items and services that are 
related to the beneficiary's settlement, judgment, award, or other 
payment furnished before the time and date stamped on the final 
conditional payment summary form.

[78 FR 57804, Sept. 20, 2013, as amended at 81 FR 30492, May 17, 2016]



  Subpart C_Limitations on Medicare Payment for Services Covered Under 
                          Workers' Compensation



Sec.  411.40  General provisions.

    (a) Definition. ``Workers' compensation plan of the United States'' 
includes the workers' compensation plans of the 50 States, the District 
of Columbia, American Samoa, Guam, Puerto Rico, and the Virgin Islands, 
as well as the systems provided under the Federal Employees' 
Compensation Act and the Longshoremen's and Harbor Workers' Compensation 
Act.
    (b) Limitations on Medicare payment. (1) Medicare does not pay for 
any services for which--
    (i) Payment has been made, or can reasonably be expected to be made

[[Page 498]]

under a workers' compensation law or plan of the United States or a 
state; or
    (ii) Payment could be made under the Federal Black Lung Program, but 
is precluded solely because the provider of the services has failed to 
secure, from the Department of Labor, a provider number to include in 
the claim.
    (2) If the payment for a service may not be made under workers' 
compensation because the service is furnished by a source not authorized 
to provide that service under the particular workers' compensation 
program, Medicare pays for the service if it is a covered service.
    (3) Medicare makes secondary payments in accordance with Sec. Sec.  
411.32 and 411.33.

[54 FR 41734, Oct. 11, 1989, as amended at 71 FR 9470, Feb. 24, 2006]



Sec.  411.43  Beneficiary's responsibility with respect to 
workers' compensation.

    (a) The beneficiary is responsible for taking whatever action is 
necessary to obtain any payment that can reasonably be expected under 
workers' compensation.
    (b) Except as specified in Sec.  411.45(a), Medicare does not pay 
until the beneficiary has exhausted his or her remedies under workers' 
compensation.
    (c) Except as specified in Sec.  411.45(b), Medicare does not pay 
for services that would have been covered under workers' compensation if 
the beneficiary had filed a proper claim.
    (d) However, if a claim is denied for reasons other than not being a 
proper claim, Medicare pays for the services if they are covered under 
Medicare.



Sec.  411.45  Basis for conditional Medicare payment in workers' 
compensation cases.

    (a) A conditional Medicare payment may be made under either of the 
following circumstances:
    (1) The beneficiary has filed a proper claim for workers' 
compensation benefits, but the intermediary or carrier determines that 
the workers' compensation carrier will not pay promptly. This includes 
cases in which a workers' compensation carrier has denied a claim.
    (2) The beneficiary, because of physical or mental incapacity, 
failed to file a proper claim.
    (b) Any conditional payment that CMS makes is conditioned on 
reimbursement to CMS in accordance with subpart B of this part.

[71 FR 9470, Feb. 24, 2006, as amended at 73 FR 9685, Feb. 22, 2008]



Sec.  411.46  Lump-sum payments.

    (a) Lump-sum commutation of future benefits. If a lump-sum 
compensation award stipulates that the amount paid is intended to 
compensate the individual for all future medical expenses required 
because of the work-related injury or disease, Medicare payments for 
such services are excluded until medical expenses related to the injury 
or disease equal the amount of the lump-sum payment.
    (b) Lump-sum compromise settlement. (1) A lump-sum compromise 
settlement is deemed to be a workers' compensation payment for Medicare 
purposes, even if the settlement agreement stipulates that there is no 
liability under the workers' compensation law or plan.
    (2) If a settlement appears to represent an attempt to shift to 
Medicare the responsibility for payment of medical expenses for the 
treatment of a work-related condition, the settlement will not be 
recognized. For example, if the parties to a settlement attempt to 
maximize the amount of disability benefits paid under workers' 
compensation by releasing the workers' compensation carrier from 
liability for medical expenses for a particular condition even though 
the facts show that the condition is work-related, Medicare will not pay 
for treatment of that condition.
    (c) Lump-sum compromise settlement: Effect on services furnished 
before the date of settlement. Medicare pays for medical expenses 
incurred before the lump-sum compromise settlement only to the extent 
specified in Sec.  411.47.
    (d) Lump-sum compromise settlement: Effect on payment for services 
furnished after the date of settlement--(1) Basic rule. Except as 
specified in paragraph (d)(2) of this section, if a lump-sum compromise 
settlement forecloses the

[[Page 499]]

possibility of future payment of workers' compensation benefits, medical 
expenses incurred after the date of the settlement are payable under 
Medicare.
    (2) Exception. If the settlement agreement allocates certain amounts 
for specific future medical services, Medicare does not pay for those 
services until medical expenses related to the injury or disease equal 
the amount of the lump-sum settlement allocated to future medical 
expenses.



Sec.  411.47  Apportionment of a lump-sum compromise settlement of 
a workers' compensation claim.

    (a) Determining amount of compromise settlement considered as a 
payment for medical expenses. (1) If a compromise settlement allocates a 
portion of the payment for medical expenses and also gives reasonable 
recognition to the income replacement element, that apportionment may be 
accepted as a basis for determining Medicare payments.
    (2) If the settlement does not give reasonable recognition to both 
elements of a workers' compensation award or does not apportion the sum 
granted, the portion to be considered as payment for medical expenses is 
computed as follows:
    (i) Determine the ratio of the amount awarded (less the reasonable 
and necessary costs incurred in procuring the settlement) to the total 
amount that would have been payable under workers' compensation if the 
claim had not been compromised.
    (ii) Multiply that ratio by the total medical expenses incurred as a 
result of the injury or disease up to the date of the settlement. The 
product is the amount of the workers' compensation settlement to be 
considered as payment for medical expenses.

    Example: As the result of a work injury, an individual suffered loss 
of income and incurred medical expenses for which the total workers' 
compensation payment would have been $24,000 if the case had not been 
compromised. The medical expenses amounted to $18,000. The workers' 
compensation carrier made a settlement with the beneficiary under which 
it paid $8,000 in total. A separate award was made for legal fees. Since 
the workers' compensation compromise settlement was for one-third of the 
amount which would have been payable under workers' compensation had the 
case not been compromised ($8,000/$24,000=\1/3\), the workers' 
compensation compromise settlement is considered to have paid for one-
third of the total medical expenses (\1/3\ x $18,000 = $6,000).

    (b) Determining the amount of the Medicare overpayment. When 
conditional Medicare payments have been made, and the beneficiary 
receives a compromise settlement payment, the Medicare overpayment is 
determined as set forth in this paragraph (b). The amount of the 
workers' compensation payment that is considered to be for medical 
expenses (as determined under paragraph (a) of this section) is applied, 
at the workers' compensation rate of payment prevailing in the 
particular jurisdiction, in the following order:
    (1) First to any beneficiary payments for services payable under 
workers' compensation but not covered under Medicare.
    (2) Then to any beneficiary payments for services payable under 
workers' compensation and also covered under Medicare Part B. (These 
include deductible and coinsurance amounts and, in unassigned cases, the 
charge in excess of the reasonable charge.)
    (3) Last to any beneficiary payments for services payable under 
workers' compensation and also covered under Medicare Part A. (These 
include Part A deductible and coinsurance amounts and charges for 
services furnished after benefits are exhausted.)

The difference between the amount of the workers' compensation payment 
for medical expenses and any beneficiary payments constitutes the 
Medicare overpayment. The beneficiary is liable for that amount.

    Example: In the example in paragraph (a) of this section, it was 
determined that the workers' compensation settlement paid for $6,000 of 
the total medical expenses. The $18,000 in medical expenses included 
$1,500 in charges for services not covered under Medicare, $7,500 in 
charges for services covered under Medicare Part B, and $9,000 in 
hospital charges for services covered under Medicare Part A. All charges 
were at the workers' compensation payment rate, that is, in amounts the 
provider or supplier must accept as payment in full.
    The Medicare reasonable charge for physicians' services was $7,000 
and Medicare paid $5,600 (80 percent of the reasonable charge). The Part 
B deductible had been met. The

[[Page 500]]

Medicare payment rate for the hospital services was $8,000. Medicare 
paid the hospital $7,480 ($8,000--the Part A deductible of $520).
    In this situation, the beneficiary's payments totalled $3,920:

Services not covered under Medicare............................   $1,500
Excess of physicians' charges over reasonable charges..........      500
Medicare Part B coinsurance....................................    1,400
Part A deductible..............................................      520
                                                                --------
      Total....................................................    3,920
 

    The Medicare overpayment, for which the beneficiary is liable, would 
be $2,080 ($6,000-$3,920).



  Subpart D_Limitations on Medicare Payment for Services Covered Under 
                     Liability or No-Fault Insurance



Sec.  411.50  General provisions.

    (a) Limits on applicability. The provisions of this subpart C do not 
apply to any services required because of accidents that occurred before 
December 5, 1980.
    (b) Definitions.
    Automobile means any self-propelled land vehicle of a type that must 
be registered and licensed in the State in which it is owned.
    Liability insurance means insurance (including a self-insured plan) 
that provides payment based on legal liability for injury or illness or 
damage to property. It includes, but is not limited to, automobile 
liability insurance, uninsured motorist insurance, underinsured motorist 
insurance, homeowners' liability insurance, malpractice insurance, 
product liability insurance, and general casualty insurance.
    Liability insurance payment means a payment by a liability insurer, 
or an out-of-pocket payment, including a payment to cover a deductible 
required by a liability insurance policy, by any individual or other 
entity that carries liability insurance or is covered by a self-insured 
plan.
    No-fault insurance means insurance that pays for medical expenses 
for injuries sustained on the property or premises of the insured, or in 
the use, occupancy, or operation of an automobile, regardless of who may 
have been responsible for causing the accident. This insurance includes 
but is not limited to automobile, homeowners, and commercial plans. It 
is sometimes called ``medical payments coverage'', ``personal injury 
protection'', or ``medical expense coverage''.
    Prompt or promptly, when used in connection with payment by a 
liability insurer means payment within 120 days after the earlier of the 
following:
    (1) The date a claim is filed with an insurer or a lien is filed 
against a potential liability settlement.
    (2) The date the service was furnished or, in the case of inpatient 
hospital services, the date of discharge.
    Self-insured plan means a plan under which an individual, or a 
private or governmental entity, carries its own risk instead of taking 
out insurance with a carrier. This term includes a plan of an individual 
or other entity engaged in a business, trade, or profession, a plan of a 
non-profit organization such as a social, fraternal, labor, educational, 
religious, or professional organization, and the plan established by the 
Federal government to pay liability claims under the Federal Tort Claims 
Act. An entity that engages in a business, trade, or profession is 
deemed to have a self-insured plan for purposes of liability insurance 
if it carries its own risk (whether by a failure to obtain insurance, or 
otherwise) in whole or in part.
    Underinsured motorist insurance means insurance under which the 
policyholder's level of protection against losses caused by another is 
extended to compensate for inadequate coverage in the other party's 
policy or plan.
    Uninsured motorist insurance means insurance under which the 
policyholder's insurer will pay for damages caused by a motorist who has 
no automobile liability insurance or who carries less than the amount of 
insurance required by law, or is underinsured.
    (c) Limitation on payment for services covered under no-fault 
insurance. Except as provided under Sec. Sec.  411.52 and 411.53 with 
respect to conditional payments. Medicare does not pay for the 
following:
    (1) Services for which payment has been made or can reasonably be 
expected to be made under automobile no-fault insurance.
    (2) Services furnished on or after November 13, 1989 for which 
payment has

[[Page 501]]

been made or can reasonably be expected to be made under any no-fault 
insurance other than automobile no-fault.

[54 FR 41734, Oct. 11, 1989, as amended at 55 FR 1820, Jan. 19, 1990; 71 
FR 9470, Feb. 24, 2006]



Sec.  411.51  Beneficiary's responsibility with respect to no-fault insurance.

    (a) The beneficiary is responsible for taking whatever action is 
necessary to obtain any payment that can reasonably be expected under 
no-fault insurance.
    (b) Except as specified in Sec.  411.53, Medicare does not pay until 
the beneficiary has exhausted his or her remedies under no-fault 
insurance.
    (c) Except as specified in Sec.  411.53, Medicare does not pay for 
services that would have been covered by the no-fault insurance if the 
beneficiary had filed a proper claim.
    (d) However, if a claim is denied for reasons other than not being a 
proper claim, Medicare pays for the services if they are covered under 
Medicare.



Sec.  411.52  Basis for conditional Medicare payment in liability cases.

    (a) A conditional Medicare payment may be made in liability cases 
under either of the following circumstances:
    (1) The beneficiary has filed a proper claim for liability insurance 
benefits but the intermediary or carrier determines that the liability 
insurer will not pay promptly for any reason other than the 
circumstances described in Sec.  411.32(a)(1). This includes cases in 
which the liability insurance carrier has denied the claim.
    (2) The beneficiary has not filed a claim for liability insurance 
benefits.
    (b) Any conditional payment that CMS makes is conditioned on 
reimbursement to CMS in accordance with subpart B of this part.

[71 FR 9470, Feb. 24, 2006]



Sec.  411.53  Basis for conditional Medicare payment in no-fault cases.

    (a) A conditional Medicare payment may be made in no-fault cases 
under either of the following circumstances:
    (1) The beneficiary has filed a proper claim for no-fault insurance 
benefits but the intermediary or carrier determines that the no-fault 
insurer will not pay promptly for any reason other than the 
circumstances described in Sec.  411.32(a)(1). This includes cases in 
which the no-fault insurance carrier has denied the claim.
    (2) The beneficiary, because of physical or mental incapacity, 
failed to meet a claim-filing requirement stipulated in the policy.
    (b) Any conditional payment that CMS makes is conditioned on 
reimbursement to CMS in accordance with subpart B of this part.

[71 FR 9470, Feb. 24, 2006]



Sec.  411.54  Limitation on charges when a beneficiary has received 
a liability insurance payment or has a claim pending against 
a liability insurer.

    (a) Definition. As used in this section, Medicare-covered services 
means services for which Medicare benefits are payable or would be 
payable except for applicable Medicare deductible and coinsurance 
provisions. Medicare benefits are payable notwithstanding potential 
liability insurance payments, but are recoverable in accordance with 
Sec.  411.24.
    (b) Applicability. This section applies when a beneficiary has 
received a liability insurance payment or has a claim pending against a 
liability insurer for injuries or illness allegedly caused by another 
party.
    (c) Itemized bill. A hospital must, upon request, furnish to the 
beneficiary or his or her representative an itemized bill of the 
hospital's charges.
    (d) Exception--(1) Prepaid health plans. If the services were 
furnished through an organization that has a contact under section 1876 
of the Act (that is, an HMO or CMP), or through an organization that is 
paid under section 1833(a)(1)(A) of the Act (that is, through an HCPP) 
the rules of Sec.  417.528 of this chapter apply.
    (2) Special rules for Oregon. For the State of Oregon, because of a 
court decision, and in the absence of a reversal on appeal or a 
statutory clarification overturning the decision, there are the 
following special rules:
    (i) The provider or supplier may elect to bill a liability insurer 
or place a lien against the beneficiary's liability settlement for 
Medicare covered services, rather than bill only Medicare for

[[Page 502]]

Medicare covered services, if the liability insurer pays within 120 days 
after the earlier of the following dates:
    (A) The date the provider or supplier files a claim with the insurer 
or places a lien against a potential liability settlement.
    (B) The date the services were provided or, in the case of inpatient 
hospital services, the date of discharge.
    (ii) If the liability insurer does not pay within the 120-day 
period, the provider or supplier:
    (A) Must withdraw its claim with the liability insurer and/or 
withdraw its lien against a potential liability settlement.
    (B) May only bill Medicare for Medicare covered services.
    (C) May bill the beneficiary only for applicable Medicare deductible 
and co-insurance amounts plus the amount of any charges that may be made 
to a beneficiary under 413.35 of this chapter (when cost limits are 
applied to these services) or under 489.32 of this chapter (when 
services are partially covered).

[54 FR 41734, Oct. 11, 1989, as amended at 68 FR 43942, July 25, 2003]



Subpart E_Limitations on Payment for Services Covered Under Group Health 
                        Plans: General Provisions

    Source: 60 FR 45362, Aug. 31, 1995, unless otherwise noted.



Sec.  411.100  Basis and scope.

    (a) Statutory basis. (1) Section 1862(b) of the Act provides in part 
that Medicare is secondary payer, under specified conditions, for 
services covered under any of the following:
    (i) Group health plans of employers that employ at least 20 
employees and that cover Medicare beneficiaries age 65 or older who are 
covered under the plan by virtue of the individual's current employment 
status with an employer or the current employment status of a spouse of 
any age. (Section 1862(b)(1)(A))
    (ii) Group health plans (without regard to the number of individuals 
employed and irrespective of current employment status) that cover 
individuals who have ESRD. Except as provided in Sec.  411.163, group 
health plans are always primary payers throughout the first 18 months of 
ESRD-based Medicare eligibility or entitlement. (Section 1862(b)(1)(C))
    (iii) Large group health plans (that is, plans of employers that 
employ at least 100 employees) and that cover Medicare beneficiaries who 
are under age 65, entitled to Medicare on the basis of disability, and 
covered under the plan by virtue of the individual's or a family 
member's current employment status with an employer. (Section 
1862(b)(1)(B))
    (2) Sections 1862(b)(1)(A), (B), and (C) of the Act provide that 
group health plans and large group health plans may not take into 
account that the individuals described in paragraph (a)(1) of this 
section are entitled to Medicare on the basis of age or disability, or 
eligible for, or entitled to Medicare on the basis of ESRD.
    (3) Section 1862(b)(1)(A)(i)(II) of the Act provides that group 
health plans of employers of 20 or more employees must provide to any 
employee or spouse age 65 or older the same benefits, under the same 
conditions, that it provides to employees and spouses under 65. The 
requirement applies regardless of whether the individual or spouse 65 or 
older is entitled to Medicare.
    (4) Section 1862(b)(1)(C)(ii) of the Act provides that group health 
plans may not differentiate in the benefits they provide between 
individuals who have ESRD and other individuals covered under the plan 
on the basis of the existence of ESRD, the need for renal dialysis, or 
in any other manner. Actions that constitute ``differentiating'' are 
listed in Sec.  411.161(b).
    (b) Scope. This subpart sets forth general rules pertinent to--
    (1) Medicare payment for services that are covered under a group 
health plan and are furnished to certain beneficiaries who are entitled 
on the basis of ESRD, age, or disability.
    (2) The prohibition against taking into account Medicare entitlement 
based on age or disability, or Medicare eligibility or entitlement based 
on ESRD.
    (3) The prohibition against differentiation in benefits between 
individuals

[[Page 503]]

who have ESRD and other individuals covered under the plan.
    (4) The requirement to provide to those 65 or over the same benefits 
under the same conditions as are provided to those under 65.
    (5) The appeals procedures for group health plans that CMS 
determines are nonconforming plans.



Sec.  411.101  Definitions.

    As used in this subpart and in subparts F through H of this part--
    COBRA stands for Consolidated Omnibus Budget Reconciliation Act of 
1985.
    Days means calendar days.
    Employee (subject to the special rules in Sec.  411.104) means an 
individual who--
    (1) Is working for an employer; or
    (2) Is not working for an employer but is receiving payments that 
are subject to FICA taxes, or would be subject to FICA taxes except that 
the employer is exempt from those taxes under the Internal Revenue Code.
    Employer means, in addition to individuals (including self-employed 
persons) and organizations engaged in a trade or business, other 
entities exempt from income tax such as religious, charitable, and 
educational institutions, the governments of the United States, the 
individual States, Puerto Rico, the Virgin Islands, Guam, American 
Samoa, the Northern Mariana Islands, and the District of Columbia, and 
the agencies, instrumentalities, and political subdivisions of these 
governments.
    FICA stands for the Federal Insurance Contributions Act, the law 
that imposes social security taxes on employers and employees under 
section 21 of the Internal Revenue Code.
    Group health plan (GHP) means any arrangement made by one or more 
employers or employee organizations to provide health care directly or 
through other methods such as insurance or reimbursement, to current or 
former employees, the employer, others associated or formerly associated 
with the employer in a business relationship, or their families, that--
    (1) Is of, or contributed to by, one or more employers or employee 
organizations.
    (2) If it involves more than one employer or employee organization, 
provides for common administration.
    (3) Provides substantially the same benefits or the same benefit 
options to all those enrolled under the arrangement.

The term includes self-insured plans, plans of governmental entities 
(Federal, State and local), and employee organization plans; that is, 
union plans, employee health and welfare funds or other employee 
organization plans. The term also includes employee-pay-all plans, which 
are plans under the auspices of one or more employers or employee 
organizations but which receive no financial contributions from them. 
The term does not include a plan that is unavailable to employees; for 
example, a plan only for self-employed persons.
    IRC stands for Internal Revenue Code.
    IRS stands for Internal Revenue Service.
    Large group health plan (LGHP) means a GHP that covers employees of 
either--
    (1) A single employer or employee organization that employed at 
least 100 full-time or part-time employees on 50 percent or more of its 
regular business days during the previous calendar year; or
    (2) Two or more employers, or employee organizations, at least one 
of which employed at least 100 full-time or part-time employees on 50 
percent or more of its regular business days during the previous 
calendar year.
    MSP stands for Medicare secondary payer.
    Multi-employer plan means a plan that is sponsored jointly by two or 
more employers (sometimes called a multiple-employer plan) or by 
employers and unions (sometimes under the Taft-Hartley law).
    Self-employed person encompasses consultants, owners of businesses, 
and directors of corporations, and members of the clergy and religious 
orders who are paid for their services by a religious body or other 
entity.
    Similarly situated individual means--
    (1) In the case of employees, other employees enrolled or seeking to 
enroll in the plan; and

[[Page 504]]

    (2) In the case of other categories of individuals, other persons in 
any of those categories who are enrolled or seeking to enroll in the 
plan.



Sec.  411.102  Basic prohibitions and requirements.

    (a) ESRD. (1) A group health plan of any size--(i) May not take into 
account the ESRD-based Medicare eligibility or entitlement of any 
individual who is covered or seeks to be covered under the plan; and
    (ii) May not differentiate in the benefits it provides between 
individuals with ESRD and other individuals covered under the plan, on 
the basis of the existence of ESRD, or the need for dialysis, or in any 
other manner.
    (2) The prohibitions of paragraph (a) of this section do not 
prohibit a plan from paying benefits secondary to Medicare after the 
first 18 months of ESRD-based eligibility or entitlement.
    (b) Age. A GHP of an employer or employee organization of at least 
20 employees--
    (1) May not take into account the age-based Medicare entitlement of 
an individual or spouse age 65 or older who is covered (or seeks to be 
covered) under the plan by virtue of current employment status; and
    (2) Must provide, to employees age 65 or older and to spouses age 65 
or older of employees of any age, the same benefits under the same 
conditions as it provides to employees and spouses under age 65.
    (c) Disability. A GHP of an employer or employee organization of at 
least 100 employees may not take into account the disability-based 
Medicare entitlement of any individual who is covered (or seeks to be 
covered) under the plan by virtue of current employment status.



Sec.  411.103  Prohibition against financial and other incentives.

    (a) General rule. An employer or other entity (for example, an 
insurer) is prohibited from offering Medicare beneficiaries financial or 
other benefits as incentives not to enroll in, or to terminate 
enrollment in, a GHP that is, or would be, primary to Medicare. This 
prohibition precludes offering to Medicare beneficiaries an alternative 
to the employer primary plan (for example, coverage of prescription 
drugs) unless the beneficiary has primary coverage other than Medicare. 
An example would be primary coverage through his own or a spouse's 
employer.
    (b) Penalty for violation. (1) Any entity that violates the 
prohibition of paragraph (a) of this section is subject to a civil money 
penalty of up to $5,000 as adjusted annually under 45 CFR part 102 for 
each violation; and
    (2) The provisions of section 1128A of the Act (other than 
subsections (a) and (b)) apply to the civil money penalty of up to 
$5,000 as adjusted annually under 45 CFR part 102 in the same manner as 
the provisions apply to a penalty or proceeding under section 1128A(a).

[60 FR 45362, Aug. 31, 1995, as amended at 81 FR 61561, Sept. 6, 2016]



Sec.  411.104  Current employment status.

    (a) General rule. An individual has current employment status if--
    (1) The individual is actively working as an employee, is the 
employer (including a self-employed person), or is associated with the 
employer in a business relationship; or
    (2) The individual is not actively working and--
    (i) Is receiving disability benefits from an employer for up to 6 
months (the first 6 months of employer disability benefits are subject 
to FICA taxes); or
    (ii) Retains employment rights in the industry and has not had his 
employment terminated by the employer, if the employer provides the 
coverage (or has not had his membership in the employee organization 
terminated, if the employee organization provides the coverage), is not 
receiving disability benefits from an employer for more than 6 months, 
is not receiving disability benefits from Social Security, and has GHP 
coverage that is not pursuant to COBRA continuation coverage (26 U.S.C. 
4980B; 29 U.S.C. 1161-1168; 42 U.S.C. 300bb-1 et seq.). Whether or not 
the individual is receiving pay during the period of nonwork is not a 
factor.
    (b) Persons who retain employment rights. For purposes of paragraph 
(a)(2) of this section, persons who retain employment rights include but 
are not limited to--

[[Page 505]]

    (1) Persons who are furloughed, temporarily laid off, or who are on 
sick leave;
    (2) Teachers and seasonal workers who normally do not work 
throughout the year; and
    (3) Persons who have health coverage that extends beyond or between 
active employment periods; for example, based on an hours bank 
arrangement. (Active union members often have hours bank coverage.)
    (c) Coverage by virtue of current employment status. An individual 
has coverage by virtue of current employment status with an employer 
if--
    (1) the individual has GHP or LGHP coverage based on employment, 
including coverage based on a certain number of hours worked for that 
employer or a certain level of commissions earned from work for that 
employer at any time; and
    (2) the individual has current employment status with that employer, 
as defined in paragraph (a) of this section.
    (d) Special rule: Self-employed person. A self-employed individual 
is considered to have GHP or LGHP coverage by virtue of current 
employment status during a particular tax year only if, during the 
preceding tax year, the individual's net earnings, from work in that 
year related to the employer that offers the group health coverage, are 
at least equal to the amount specified in section 211(b)(2) of the Act, 
which defines ``self-employment income'' for social security purposes.
    (e) Special Rule: members of religious orders and members of 
clergy--(1) Members of religious orders who have not taken a vow of 
poverty. A member of a religious order who has not taken a vow of 
poverty is considered to have current employment status with the 
religious order if--
    (i) The religious order pays FICA taxes on behalf of that member; or
    (ii) The individual is receiving cash remuneration from the 
religious order.
    (2) Members of religious orders who have taken a vow of poverty. A 
member of a religious order whose members are required to take a vow of 
poverty is not considered to be employed by the order if the services he 
or she performs as a member of the order are considered employment only 
because the order elects social security coverage under section 3121(r) 
of the IRC. This exemption applies retroactively to services performed 
as a member of the order, beginning with the effective dates of the MSP 
provisions for the aged and the disabled, respectively. The exemption 
does not apply to services performed for employers outside of the order.
    (3) Members of the clergy. A member of the clergy is considered to 
have current employment status with a church or other religious 
organization if the individual is receiving cash remuneration from the 
church or other religious organization for services rendered.
    (f) Special rule: Delayed compensation subject to FICA taxes. An 
individual who is not working is not considered an employee solely on 
the basis of receiving delayed compensation payments for previous 
periods of work even if those payments are subject to FICA taxes (or 
would be subject to FICA taxes if the employer were not exempt from 
paying those taxes). For example, an individual who is not working in 
1993 and receives payments subject to FICA taxes for work performed in 
1992 is not considered to be an employee in 1993 solely on the basis of 
receiving those payments.



Sec.  411.106  Aggregation rules.

    The following rules apply in determining the number and size of 
employers, as required by the MSP provisions for the aged and disabled:
    (a) All employers that are treated as a single employer under 
subsection (a) or (b) of section 52 of the Internal Revenue Code (IRC) 
of 1986 (26 U.S.C. 52 (a) and (b)) are treated as a single employer.
    (b) All employees of the members of an affiliated service group (as 
defined in section 414(m) of the IRC (26 U.S.C. 414m)) are treated as 
employed by a single employer.
    (c) Leased employees (as defined in section 414(n)(2) of the IRC (26 
U.S.C. 414(n)(2)) are treated as employees of the person for whom they 
perform services to the same extent as they are treated under section 
414(n) of the IRC.
    (d) In applying the IRC provisions identified in this section, CMS 
relies

[[Page 506]]

upon regulations and decisions of the Secretary of the Treasury 
respecting those provisions.



Sec.  411.108  Taking into account entitlement to Medicare.

    (a) Examples of actions that constitute ``taking into account''. 
Actions by GHPs or LGHPs that constitute taking into account that an 
individual is entitled to Medicare on the basis of ESRD, age, or 
disability (or eligible on the basis of ESRD) include, but are not 
limited to, the following:
    (1) Failure to pay primary benefits as required by subparts F, G, 
and H of this part 411.
    (2) Offering coverage that is secondary to Medicare to individuals 
entitled to Medicare.
    (3) Terminating coverage because the individual has become entitled 
to Medicare, except as permitted under COBRA continuation coverage 
provisions (26 U.S.C. 4980B(f)(2)(B)(iv); 29 U.S.C. 1162.(2)(D); and 42 
U.S.C. 300bb-2.(2)(D)).
    (4) In the case of a LGHP, denying or terminating coverage because 
an individual is entitled to Medicare on the basis of disability without 
denying or terminating coverage for similarly situated individuals who 
are not entitled to Medicare on the basis of disability.
    (5) Imposing limitations on benefits for a Medicare entitled 
individual that do not apply to others enrolled in the plan, such as 
providing less comprehensive health care coverage, excluding benefits, 
reducing benefits, charging higher deductibles or coinsurance, providing 
for lower annual or lifetime benefit limits, or more restrictive pre-
existing illness limitations.
    (6) Charging a Medicare entitled individual higher premiums.
    (7) Requiring a Medicare entitled individual to wait longer for 
coverage to begin.
    (8) Paying providers and suppliers less for services furnished to a 
Medicare beneficiary than for the same services furnished to an enrollee 
who is not entitled to Medicare.
    (9) Providing misleading or incomplete information that would have 
the effect of inducing a Medicare entitled individual to reject the 
employer plan, thereby making Medicare the primary payer. An example of 
this would be informing the beneficiary of the right to accept or reject 
the employer plan but failing to inform the individual that, if he or 
she rejects the plan, the plan will not be permitted to provide or pay 
for secondary benefits.
    (10) Including in its health insurance cards, claims forms, or 
brochures distributed to beneficiaries, providers, and suppliers, 
instructions to bill Medicare first for services furnished to Medicare 
beneficiaries without stipulating that such action may be taken only 
when Medicare is the primary payer.
    (11) Refusing to enroll an individual for whom Medicare would be 
secondary payer, when enrollment is available to similarly situated 
individuals for whom Medicare would not be secondary payer.
    (b) Permissible actions. (1) If a GHP or LGHP makes benefit 
distinctions among various categories of individuals (distinctions 
unrelated to the fact that the individual is disabled, based, for 
instance, on length of time employed, occupation, or marital status), 
the GHP or LGHP may make the same distinctions among the same categories 
of individuals entitled to Medicare whose plan coverage is based on 
current employment status. For example, if a GHP or LGHP does not offer 
coverage to employees who have worked less than one year and who are not 
entitled to Medicare on the basis of disability or age, the GHP or LGHP 
is not required to offer coverage to employees who have worked less than 
one year and who are entitled to Medicare on the basis of disability or 
age.
    (2) A GHP or LGHP may pay benefits secondary to Medicare for an aged 
or disabled beneficiary who has current employment status if the plan 
coverage is COBRA continuation coverage because of reduced hours of 
work. Medicare is primary payer for this beneficiary because, although 
he or she has current employment status, the GHP coverage is by virtue 
of the COBRA law rather than by virtue of the current employment status.
    (3) A GHP may terminate COBRA continuation coverage of an individual 
who becomes entitled to Medicare on

[[Page 507]]

the basis of ESRD, when permitted under the COBRA provisions.

[60 FR 45362, Aug. 31, 1995; 60 FR 53876, Oct. 18, 1995]



Sec.  411.110  Basis for determination of nonconformance.

    (a) A ``determination of nonconformance'' is a CMS determination 
that a GHP or LGHP is a nonconforming plan as provided in this section.
    (b) CMS makes a determination of nonconformance for a GHP or LGHP 
that, at any time during a calendar year, fails to comply with any of 
the following statutory provisions:
    (1) The prohibition against taking into account that a beneficiary 
who is covered or seeks to be covered under the plan is entitled to 
Medicare on the basis of ESRD, age, or disability, or eligible on the 
basis of ESRD.
    (2) The nondifferentiation clause for individuals with ESRD.
    (3) The equal benefits clause for the working aged.
    (4) The obligation to refund conditional Medicare primary payments.
    (c) CMS may make a determination of nonconformance for a GHP or LGHP 
that fails to respond to a request for information, or to provide 
correct information, either voluntarily or in response to a CMS request, 
on the plan's primary payment obligation with respect to a given 
beneficiary, if that failure contributes to either or both of the 
following:
    (1) Medicare erroneously making a primary payment.
    (2) A delay or foreclosure of CMS's ability to recover an erroneous 
primary payment.



Sec.  411.112  Documentation of conformance.

    (a) Acceptable documentation. CMS may require a GHP or LGHP to 
demonstrate that it has complied with the Medicare secondary payer 
provisions and to submit supporting documentation by an official 
authorized to act on behalf of the entity, under penalty of perjury. The 
following are examples of documentation that may be acceptable:
    (1) A copy of the employer's plan or policy that specifies the 
services covered, conditions of coverage, benefit levels and limitations 
with respect to persons entitled to Medicare on the basis of ESRD, age, 
or disability as compared to the provisions applicable to other 
enrollees and potential enrollees.
    (2) An explanation of the plan's allegation that it does not owe CMS 
any amount CMS claims the plan owes as repayment for conditional or 
mistaken Medicare primary payments.
    (b) Lack of acceptable documentation. If a GHP or LGHP fails to 
provide acceptable evidence or documentation that it has complied with 
the MSP prohibitions and requirements set forth in Sec.  411.110, CMS 
may make a determination of nonconformance for both the year in which 
the services were furnished and the year in which the request for 
information was made.



Sec.  411.114  Determination of nonconformance.

    (a) Starting dates for determination of nonconformance. CMS's 
authority to determine nonconformance of GHPs begins on the following 
dates:
    (1) On January 1, 1987 for MSP provisions that affect the disabled.
    (2) On December 20, 1989 for MSP provisions that affect ESRD 
beneficiaries and the working aged.
    (3) On August 10, 1993 for failure to refund mistaken Medicare 
primary payments.
    (b) Special rule for failure to repay. A GHP that fails to comply 
with Sec.  411.110 (a)(1), (a)(2), or (a)(3) in a particular year is 
nonconforming for that year. If, in a subsequent year, that plan fails 
to repay the resulting mistaken primary payments (in accordance with 
Sec.  411.110(a)(4)), the plan is also nonconforming for the subsequent 
year. For example, if a plan paid secondary for the working aged in 
1991, that plan was nonconforming for 1991. If in 1994 CMS identifies 
mistaken primary payments attributable to the 1991 violation, and the 
plan refuses to repay, it is also nonconforming for 1994.



Sec.  411.115  Notice of determination of nonconformance.

    (a) Notice to the GHP or LGHP. (1) If CMS determines that a GHP or 
an LGHP is nonconforming with respect to a particular calendar year, CMS

[[Page 508]]

mails to the plan written notice of the following:
    (i) The determination.
    (ii) The basis for the determination.
    (iii) The right of the parties to request a hearing.
    (iv) An explanation of the procedure for requesting a hearing.
    (v) The tax that may be assessed by the IRS in accordance with 
section 5000 of the IRC.
    (vi) The fact that if none of the parties requests a hearing within 
65 days from the date of its notice, the determination is binding on all 
parties unless it is reopened in accordance with Sec.  411.126.
    (2) The notice also states that the plan must, within 30 days from 
the date on its notice, submit to CMS the names and addresses of all 
employers and employee organizations that contributed to the plan during 
the calendar year for which CMS has determined nonconformance.
    (b) Notice to contributing employers and employee organizations. CMS 
mails written notice of the determination, including all the information 
specified in paragraph (a)(1) of this section, to all contributing 
employers and employee organizations already known to CMS or identified 
by the plan in accordance with paragraph (a)(2) of this section. 
Employers and employee organizations have 65 days from the date of their 
notice to request a hearing.



Sec.  411.120  Appeals.

    (a) Parties to the determination. The parties to the determination 
are CMS, the GHP or LGHP for which CMS determined nonconformance, and 
any employers or employee organizations that contributed to the plan 
during the calendar year for which CMS determined nonconformance.
    (b) Request for hearing. (1) A party's request for hearing must be 
in writing (not in facsimile or other electronic medium) and in the 
manner stipulated in the notice of nonconformance; it must be filed 
within 65 days from the date on the notice.
    (2) The request may include rationale showing why the parties 
believe that CMS's determination is incorrect and supporting 
documentation.
    (3) A request is considered filed on the date it is received by the 
appropriate office, as shown by the receipt date stamped on the request.



Sec.  411.121  Hearing procedures.

    (a) Nature of hearing. (1) If any of the parties requests a hearing 
within 65 days from the date on the notice of the determination of 
nonconformance, the CMS Administrator appoints a hearing officer.
    (2) If no party files a request within the 65-day period, the 
initial determination of nonconformance is binding upon all parties 
unless it is reopened in accordance with Sec.  411.126.
    (3) If more than one party requests a hearing the hearing officer 
conducts a single hearing in which all parties may participate.
    (4) On the record review. Ordinarily, the hearing officer makes a 
decision based upon review of the data and documents on which CMS based 
its determination of nonconformance and any other documentation 
submitted by any of the parties within 65 days from the date on the 
notice.
    (5) Oral hearing. The hearing officer may provide for an oral 
hearing either on his or her own motion or in response to a party's 
request if the party demonstrates to the hearing officer's satisfaction 
that an oral hearing is necessary. Within 30 days of receipt of the 
request, the hearing officer gives all known parties written notice of 
the request and whether the request for oral hearing is granted.
    (b) Notice of time and place of oral hearing. If the hearing officer 
provides an oral hearing, he or she gives all known parties written 
notice of the time and place of the hearing at least 30 days before the 
scheduled date.
    (c) Prehearing discovery. (1) The hearing officer may permit 
prehearing discovery if it is requested by a party at least 10 days 
before the scheduled date of the hearing.
    (2) If the hearing officer approves the request, he or she--
    (i) Provides a reasonable time for inspection and reproduction of 
documents; and
    (ii) In ruling on discovery matters, is guided by the Federal Rules 
of Civil Procedure. (28 U.S.C.A. Rules 26-37)

[[Page 509]]

    (3) The hearing officer's orders on all discovery matters are final.
    (d) Conduct of hearing. The hearing officer determines the conduct 
of the hearing, including the order in which the evidence and the 
allegations are presented.
    (e) Evidence at hearing. (1) The hearing officer inquires into the 
matters at issue and may receive from all parties documentary and other 
evidence that is pertinent and material, including the testimony of 
witnesses, and evidence that would be inadmissible in a court of law.
    (2) Evidence may be received at any time before the conclusion of 
the hearing.
    (3) The hearing officer gives the parties opportunity for submission 
and consideration of evidence and arguments and, in ruling on the 
admissibility of evidence, excludes irrelevant, immaterial, or unduly 
repetitious evidence.
    (4) The hearing officer's ruling on admissibility of evidence is 
final and not subject to further review.
    (f) Subpoenas. (1) The hearing officer may, either on his or her own 
motion or upon the request of any party, issue subpoenas for either or 
both of the following if they are reasonably necessary for full 
presentation of the case:
    (i) The attendance and testimony of witnesses.
    (ii) The production of books, records, correspondence, papers, or 
other documents that are relevant and material to any matter at issue.
    (2) A party that wishes the issuance of a subpoena must, at least 10 
days before the date fixed for the hearing, file with the hearing 
officer a written request that identifies the witnesses or documents to 
be produced and describes the address or location in sufficient detail 
to permit the witnesses or documents to be found.
    (3) The request for a subpoena must state the pertinent facts that 
the party expects to establish by the witnesses or documents and whether 
those facts could be established by other evidence without the use of a 
subpoena.
    (4) The hearing officer issues the subpoenas at his or her 
discretion, and CMS assumes the cost of the issuance and the fees and 
mileage of any subpoenaed witness, in accordance with section 205(d) of 
the Act (42 U.S.C. 405(d)).
    (g) Witnesses. Witnesses at the hearing testify under oath or 
affirmation, unless excused by the hearing officer for cause. The 
hearing officer may examine the witnesses and shall allow the parties to 
examine and cross-examine witnesses.
    (h) Record of hearing. A complete record of the proceedings at the 
hearing is made and transcribed in all cases. It is made available to 
the parties upon request. The record is not closed until a decision has 
been issued.
    (i) Sources of hearing officer's authority. In the conduct of the 
hearing, the hearing officer complies with all the provisions of title 
XVIII of the Act and implementing regulations, as well as with CMS 
Rulings issued under Sec.  401.108 of this chapter. The hearing officer 
gives great weight to interpretive rules, general statements of policy, 
and rules of agency organization, procedure, or practice established by 
CMS.



Sec.  411.122  Hearing officer's decision.

    (a) Timing. (1) If the decision is based on a review of the record, 
the hearing officer mails the decision to all known parties within 120 
days from the date of receipt of the request for hearing.
    (2) If the decision is based on an oral hearing, the hearing officer 
mails the decision to all known parties within 120 days from the 
conclusion of the hearing.
    (b) Basis, content, and distribution of hearing decision. (1) The 
written decision is based on substantial evidence and contains findings 
of fact, a statement of reasons, and conclusions of law.
    (2) The hearing officer mails a copy of the decision to each of the 
parties, by certified mail, return receipt requested, and includes a 
notice that the administrator may review the hearing decision at the 
request of a party or on his or her own motion.
    (c) Effect of hearing decision. The hearing officer's decision is 
the final Departmental decision and is binding upon all parties unless 
the Administrator chooses to review that decision in accordance with 
Sec.  411.124 or it is reopened by the hearing officer in accordance 
with Sec.  411.126.

[[Page 510]]



Sec.  411.124  Administrator's review of hearing decision.

    (a) Request for review. A party's request for review of a hearing 
officer's decision must be in writing (not in facsimile or other 
electronic medium) and must be received by the Administrator within 25 
days from the date on the decision.
    (b) Office of the Attorney Advisor responsibility. The Office of the 
Attorney Advisor examines the hearing officer's decision, the requests 
made by any of the parties or CMS, and any submission made in accordance 
with the provisions of this section in order to assist the Administrator 
in deciding whether to review the decision.
    (c) Administrator's discretion. The Administrator may--
    (1) Review or decline to review the hearing officer's decision;
    (2) Exercise this discretion on his or her own motion or in response 
to a request from any of the parties; and
    (3) Delegate review responsibility to the Deputy Administrator. (As 
used in this section, the term ``Administrator'' includes ``Deputy 
Administrator'' if review responsibility has been delegated.)
    (d) Basis for decision to review. In deciding whether to review a 
hearing officer's decision, the Administrator considers--
    (1) Whether the decision--
    (i) Is based on a correct interpretation of law, regulation, or CMS 
Ruling;
    (ii) Is supported by substantial evidence;
    (iii) Presents a significant policy issue having a basis in law and 
regulations;
    (iv) Requires clarification, amplification, or an alternative legal 
basis for the decision; and
    (v) Is within the authority provided by statute, regulation, or CMS 
Ruling; and
    (2) Whether review may lead to the issuance of a CMS Ruling or other 
directive needed to clarify a statute or regulation.
    (e) Notice of decision to review or not to review. (1) The 
Administrator gives all parties prompt written notice of his or her 
decision to review or not to review.
    (2) The notice of a decision to review identifies the specific 
issues the Administrator will consider.
    (f) Response to notice of decision to review. (1) Within 20 days 
from the date on a notice of the Administrator's decision to review a 
hearing officer's decision, any of the parties may file with the 
Administrator any or all of the following:
    (i) Proposed findings and conclusions.
    (ii) Supporting views or exceptions to the hearing officer's 
decision.
    (iii) Supporting reasons for the proposed findings and exceptions.
    (iv) A rebuttal to another party's request for review or to other 
submissions already filed with the Administrator.
    (2) The submissions must be limited to the issues the Administrator 
has decided to review and confined to the record established by the 
hearing officer.
    (3) All communications from the parties concerning a hearing 
officer's decision being reviewed by the Administrator must be in 
writing (not in facsimile or other electronic medium) and must include a 
certification that copies have been sent to all other parties.
    (4) The Administrator does not consider any communication that does 
not meet the requirements of this paragraph.
    (g) Administrator's review decision. (1) The Administrator bases his 
or her decision on the following:
    (i) The entire record developed by the hearing officer.
    (ii) Any materials submitted in connection with the hearing or under 
paragraph (f) of this section.
    (iii) Generally known facts not subject to reasonable dispute.
    (2) The Administrator mails copies of the review decision to all 
parties within 120 days from the date of the hearing officer's decision.
    (3) The Administrator's review decision may affirm, reverse, or 
modify the hearing decision or may remand the case to the hearing 
officer.
    (h) Basis and effect of remand--(1) Basis. The bases for remand do 
not include the following:
    (i) Evidence that existed at the time of the hearing and that was 
known or

[[Page 511]]

could reasonably have been expected to be known.
    (ii) A court case that was either not available at the time of the 
hearing or was decided after the hearing.
    (iii) Change of the parties' representation.
    (iv) An alternative legal basis for an issue in dispute.
    (2) Effect of remand. (i) The Administrator may instruct the hearing 
officer to take further action with respect to the development of 
additional facts or new issues or to consider the applicability of laws 
or regulations other than those considered during the hearing.
    (ii) The hearing officer takes the action in accordance with the 
Administrator's instructions in the remand notice and again issues a 
decision.
    (iii) The Administrator may review or decline to review the hearing 
officer's remand decision in accordance with the procedures set forth in 
this section.
    (i) Finality of decision. The Administrator's review decision, or 
the hearing officer's decision following remand, is the final 
Departmental decision and is binding on all parties unless the 
Administrator chooses to review the decision in accordance with this 
section, or the decision is reopened in accordance with Sec.  411.126.



Sec.  411.126  Reopening of determinations and decisions.

    (a) A determination that a GHP or LGHP is a nonconforming GHP or the 
decision or revised decision of a hearing officer or of the CMS 
Administrator may be reopened within 12 months from the date on the 
notice of determination or decision or revised decision, for any reason 
by the entity that issued the determination or decision.
    (b) The decision to reopen or not to reopen is not appealable.



Sec.  411.130  Referral to Internal Revenue Service (IRS).

    (a) CMS responsibility. After CMS determines that a plan has been a 
nonconforming GHP in a particular year, it refers its determination to 
the IRS, but only after the parties have exhausted all CMS appeal rights 
with respect to the determination.
    (b) IRS responsibility. The IRS administers section 5000 of the IRC, 
which imposes a tax on employers (other than governmental entities) and 
employee organizations that contribute to a nonconforming GHP. The tax 
is equal to 25 percent of the employer's or employee organization's 
expenses, incurred during the calendar year in which the plan is a 
nonconforming GHP, for each GHP, both conforming and nonconforming, to 
which the employer or employee organization contributes.



 Subpart F_Special Rules: Individuals Eligible or Entitled on the Basis 
         of ESRD, Who Are Also Covered Under Group Health Plans



Sec.  411.160  Scope.

    This subpart sets forth special rules that apply to individuals who 
are eligible for, or entitled to, Medicare on the basis of ESRD. 
(Section 406.13 of this chapter contains the rules for eligibility and 
entitlement based on ESRD.)

[60 FR 45367, Aug. 31, 1995]



Sec.  411.161  Prohibition against taking into account Medicare eligibility 
or entitlement or differentiating benefits.

    (a) Taking into account--(1) Basic rule. A GHP may not take into 
account that an individual is eligible for or entitled to Medicare 
benefits on the basis of ESRD during the coordination period specified 
in Sec.  411.162(b) and (c). Examples of actions that constitute taking 
into account Medicare entitlement are listed in Sec.  411.108(a).
    (2) Applicability. This prohibition applies for ESRD-based Medicare 
eligibility to the same extent as for ESRD-based Medicare entitlement. 
An individual who has ESRD but who has not filed an application for 
entitlement to Medicare on that basis is eligible for Medicare based on 
ESRD for purposes of paragraphs (b)(2) and (c)(2) through (c)(4) of 
Sec.  411.162 if the individual meets the other requirements of Sec.  
406.13 of this chapter.
    (3) Relation to COBRA continuation coverage. This rule does not 
prohibit the termination of GHP coverage under title X of COBRA when 
termination of

[[Page 512]]

that coverage is expressly permitted, upon entitlement to Medicare, 
under 26 U.S.C. 4980B(f)(2)(B)(iv); 29 U.S.C. 1162.(2)(D); or 42 U.S.C. 
300bb-2.(2)(D).\1\ (Situations in which Medicare is secondary to COBRA 
continuation coverage are set forth in Sec.  411.162(a)(3).)
---------------------------------------------------------------------------

    \1\ COBRA requires that certain group health plans offer 
continuation of plan coverage for 18 to 36 months after the occurrence 
of certain ``qualifying events,'' including loss of employment or 
reduction of employment hours. Those are events that otherwise would 
result in loss of group health plan coverage unless the individual is 
given the opportunity to elect, and does so elect, to continue plan 
coverage at his or her own expense. With one exception, the COBRA 
amendments expressly permit termination of continuation coverage upon 
entitlement to Medicare. The exception is that the plan may not 
terminate continuation coverage of an individual (and his or her 
qualified dependents) if the individual retires on or before the date 
the employer substantially eliminates regular plan coverage by filing 
for Chapter 11 bankruptcy (26 U.S.C. 4980B(g)(1)(D) and 29 U.S.C. 
1167.(3)(C)).
---------------------------------------------------------------------------

    (b) Nondifferentiation. (1) A GHP may not differentiate in the 
benefits it provides between individuals who have ESRD and others 
enrolled in the plan, on the basis of the existence of ESRD, or the need 
for renal dialysis, or in any other manner.
    (2) GHP actions that constitute differentiation in plan benefits 
(and that may also constitute ``taking into account'' Medicare 
eligibility or entitlement) include, but are not limited to the 
following:
    (i) Terminating coverage of individuals with ESRD, when there is no 
basis for such termination unrelated to ESRD (such as failure to pay 
plan premiums) that would result in termination for individuals who do 
not have ESRD.
    (ii) Imposing on persons who have ESRD, but not on others enrolled 
in the plan, benefit limitations such as less comprehensive health plan 
coverage, reductions in benefits, exclusions of benefits, a higher 
deductible or coinsurance, a longer waiting period, a lower annual or 
lifetime benefit limit, or more restrictive preexisting illness 
limitations.
    (iii) Charging individuals with ESRD higher premiums.
    (iv) Paying providers and suppliers less for services furnished to 
individuals who have ESRD than for the same services furnished to those 
who do not have ESRD, such as paying 80 percent of the Medicare rate for 
renal dialysis on behalf of a plan enrollee who has ESRD and the usual, 
reasonable and customary charge for renal dialysis on behalf of an 
enrollee who does not have ESRD.
    (v) Failure to cover routine maintenance dialysis or kidney 
transplants, when a plan covers other dialysis services or other organ 
transplants.
    (c) Uniform Limitations on particular services permissible. A plan 
is not prohibited from limiting covered utilization of a particular 
service as long as the limitation applies uniformly to all plan 
enrollees. For instance, if a plan limits its coverage of renal dialysis 
sessions to 30 per year for all plan enrollees, the plan would not be 
differentiating in the benefits it provides between plan enrollees who 
have ESRD and those who do not.
    (d) Benefits secondary to Medicare. (1) The prohibition against 
differentiation of benefits does not preclude a plan from paying 
benefits secondary to Medicare after the expiration of the coordination 
period described in Sec.  411.162(b) and (c), but a plan may not 
otherwise differentiate, as described in paragraph (b) of this section, 
in the benefits it provides.
    (2) Example--

    Mr. Smith works for employer A, and he and his wife are covered 
through employer A's GHP (Plan A). Neither is eligible for Medicare nor 
has ESRD. Mrs. Smith works for employer B, and is also covered by 
employer B's plan (Plan B). Plan A is more comprehensive than Plan B and 
covers certain items and services which Plan B does not cover, such as 
prescription drugs. If Mrs. Smith obtains a medical service, Plan B pays 
primary and Plan A pays secondary. That is, Plan A covers Plan B 
copayment amounts and items and services that Plan A covers but that 
Plan B does not.
    Mr. Jones also works for employer A, and he and his wife are covered 
by Plan A. Mrs. Jones does not have other GHP coverage. Mrs. Jones 
develops ESRD and becomes entitled to Medicare on that basis. Plan A 
pays primary to Medicare during the first 18 months of Medicare 
entitlement based on ESRD. When Medicare becomes the primary

[[Page 513]]

payer, the plan converts Mrs. Jones' coverage to a Medicare supplement 
policy. That policy pays Medicare deductible and coinsurance amounts but 
does not pay for items and services not covered by Medicare, which plan 
A would have covered. That conversion is impermissible because the plan 
is providing a lower level of coverage for Mrs. Jones, who has ESRD, 
than it provides for Mrs. Smith, who does not. In other words, if Plan A 
pays secondary to primary payers other than Medicare, it must provide 
the same level of secondary benefits when Medicare is primary in order 
to comply with the nondifferentiation provision.

[60 FR 45368, Aug. 31, 1995]



Sec.  411.162  Medicare benefits secondary to group health plan benefits.

    (a) General provisions--(1) Basic rule. Except as provided in Sec.  
411.163 (with respect to certain individuals who are also entitled on 
the basis of age or disability), Medicare is secondary to any GHP 
(including a retirement plan), with respect to benefits that are payable 
to an individual who is entitled to Medicare on the basis of ESRD, for 
services furnished during any coordination period determined in 
accordance with paragraphs (b) and (c) of this section. (No Medicare 
benefits are payable on behalf of an individual who is eligible but not 
yet entitled.)
    (2) Medicare benefits secondary without regard to size of employer 
and beneficiary's employment status. The size of employer and employment 
status requirements of the MSP provisions for the aged and disabled do 
not apply with respect to ESRD beneficiaries.
    (3) COBRA continuation coverage. Medicare is secondary payer for 
benefits that a GHP--
    (i) Is required to keep in effect under COBRA continuation 
requirements (as explained in the footnote to Sec.  411.161(a)(3)), even 
after the individual becomes entitled to Medicare; or
    (ii) Voluntarily keeps in effect after the individual becomes 
entitled to Medicare on the basis of ESRD, even though not obligated to 
do so under the COBRA provisions.
    (4) Medicare payments during the coordination period. During the 
coordination period, CMS makes Medicare payments as follows:
    (i) Primary payments only for Medicare covered services that are--
    (A) Furnished to Medicare beneficiaries who have declined to enroll 
in the GHP;
    (B) Not covered under the plan; \1\
---------------------------------------------------------------------------

    \1\ CMS does not pay if noncoverage of services constitutes 
differentiation as prohibited by Sec.  411.161(b).
---------------------------------------------------------------------------

    (C) Covered under the plan but not available to particular enrollees 
because they have exhausted their benefits; or
    (D) Furnished to individuals whose COBRA continuation coverage has 
been terminated because of the individual's Medicare entitlement.
    (ii) Secondary payments, within the limits specified in Sec. Sec.  
411.32 and 411.33, to supplement the amount paid by the GHP if that plan 
pays only a portion of the charge for the services.
    (b) Beginning of coordination period. (1) For individuals who start 
a course of maintenance dialysis or who receive a kidney transplant 
before December 1989, the coordination period begins with the earlier 
of--
    (i) The month in which the individual initiated a regular course of 
renal dialysis; or
    (ii) In the case of an individual who received a kidney transplant, 
the first month in which the individual became entitled to Medicare, or, 
if earlier, the first month for which the individual would have been 
entitled to Medicare benefits if he or she had filed an application for 
such benefits.
    (2) For individuals other than those specified in paragraph (b)(1) 
of this section, the coordination period begins with the earlier of--
    (i) The first month in which the individual becomes entitled to 
Medicare part A on the basis of ESRD; or
    (ii) The first month the individual would have become entitled to 
Medicare part A on the basis of ESRD if he or she had filed an 
application for such benefits.
    (c) End of coordination period. (1) For individuals who start a 
regular course of renal dialysis or who receive a kidney transplant 
before December 1989, the coordination period ends with the earlier of 
the end of the 12th month of dialysis or the end of the 12th month of a 
transplant. The 12th month of dialysis may be any time from the 9th

[[Page 514]]

month through the 12th month of Medicare entitlement, depending on the 
extent to which the individual was subject to a waiting period before 
becoming entitled to Medicare.
    (2) The coordination period for the following individuals ends with 
the earlier of the 12th month of eligibility or the 12th month of 
entitlement to Medicare part A:
    (i) Individuals, other than those specified in paragraph (c)(1) of 
this section, who became entitled to Medicare part A solely on the basis 
of ESRD during December 1989 and January 1990.
    (ii) Individuals, other than those specified in paragraph (c)(1) of 
this section, who could have become entitled to Medicare Part A solely 
on the basis of ESRD during December 1989 and January 1990 if they had 
filed an application.
    (iii) Individuals who become entitled to Medicare part A on the 
basis of ESRD after September 1997.
    (iv) Individuals who can become entitled to Medicare part A on the 
basis of ESRD after September 1997.
    (3) The coordination period for the following individuals ends with 
the earlier of the end of the 18th month of eligibility or the 18th 
month of entitlement to Medicare part A:
    (i) Individuals, other than those specified in paragraph (c)(1) of 
this section, who become entitled to Medicare part A on the basis of 
ESRD from February 1990 through April 1997.
    (ii) Individuals, other than those specified in paragraph (c)(1) of 
this section, who could become entitled to Medicare part A on the basis 
of ESRD from February 1990 through April 1997 if they would file an 
application.
    (4) The coordination periods for the following individuals ends 
September 30, 1998:
    (i) Individuals who become entitled to Medicare part A on the basis 
of ESRD from May 1997, through September 1997.
    (ii) Individuals who could become entitled to Medicare part A on the 
basis of ESRD from May 1997, through September 1997, if they would file 
an application.
    (d) Examples. Based on the rules specified in paragraphs (b) and (c) 
of this section and the rules specified in Sec.  406.13 of this 
subchapter, the following examples illustrate how to determine, in 
different situations, the number of months during which Medicare is 
secondary payer.
    (1) An individual began dialysis on November 4, 1989. He did not 
initiate a course in self-dialysis training nor did he receive a kidney 
transplant during the first 3 calendar months of dialysis. Thus, he 
became entitled to Medicare on February 1, 1990. Since this individual 
began dialysis before December 1989, the 12-month period began with the 
first month of dialysis, November 1989, and ended October 31, 1990. The 
coordination period in this case is 9 months, February 1990 through 
October 1990.
    (2) An individual began dialysis on January 29, 1990. He did not 
initiate a course in self-dialysis training nor did he receive a kidney 
transplant during the first 3 calendar months of dialysis. Thus, he 
became entitled to Medicare on April 1, 1990. Since the individual began 
dialysis after November 1989, and became entitled to Medicare after 
January 1990, the coordination period began with the first month of 
entitlement, April 1990, and ended September 30, 1991, the end of the 
18th month of entitlement.
    (3) An individual began a regular course of maintenance dialysis on 
February 10, 1990. He did not initiate a course of self-dialysis 
training nor did he receive a kidney transplant during the first 3 
calendar months of dialysis. Thus, he became entitled to Medicare on May 
1, 1990. Medicare is secondary payer from May 1, 1990 through October 
1991, a total of 18 months.
    (4) The same facts exist as in the example under paragraph (d)(3), 
except that the individual began a course of self-dialysis training 
during the first 3 calendar months of dialysis. Thus, the effective date 
of his Medicare entitlement is February 1, 1990, and Medicare is 
secondary payer from February 1, 1990 through July 1991, a total of 18 
months.
    (5) An individual began dialysis on September 15, 1990. He did not 
initiate a course of self-dialysis training nor did he receive a kidney 
transplant during the first 3 calendar months of dialysis. Thus, he 
became entitled to

[[Page 515]]

Medicare effective December 1, 1990. Medicare is secondary payer from 
December 1, 1990 through May 1992, a total of 18 months.
    (6) An individual began dialysis on November 17, 1990. He initiates 
a course of self-dialysis training in January 1991, and thus becomes 
entitled to Medicare effective November 1, 1990. Medicare is secondary 
payer from November 1, 1990, through April 1992, a total of 18 months.
    (7) An individual began a regular course of dialysis on December 10, 
1990. He does not initiate a course of self-dialysis training nor does 
he receive a kidney transplant. He decides to delay his enrollment in 
Medicare because his employer group health plan pays charges in full and 
he does not wish to incur part B premiums at this time. However, in 
March 1992, he files for part A and part B Medicare entitlement, and 
stipulates that he wants his Medicare entitlement to be effective March 
1, 1992 (one year later than he could have become entitled). Since this 
individual could have been entitled to Medicare as early as March 1, 
1991, Medicare is secondary payer only from March 1, 1992, through 
August 1992, a period of 6 months.

(While Medicare is secondary payer for only the last 6 months of this 
period, the Medicare program is effectively secondary payer for the full 
coordination period, due to the fact that the individual delayed his 
Medicare enrollment on account of his employer plan coverage and 
Medicare made no payments at all during the deferred period.)
    (8) The same facts exist as in the example under paragraph (d)(7) of 
this section, except that the individual defers Medicare entitlement 
beyond August 1992. (For purposes of this example, Medicare entitlement 
is not retroactive, but rather takes effect after August 1992.) There 
would be no period during which Medicare is secondary payer in this 
situation. This is because Medicare entitlement does not begin until 
after the 18-month period expires as specified in paragraph (c)(3)(ii) 
of this section. Medicare would become primary payer as of the effective 
date of Medicare entitlement. The employer plan is required to pay 
primary from December 1, 1990, through August 1992, a total of 21 
months.
    (9) An individual becomes entitled to Medicare on December 1, 1997. 
The employer plan is primary payer, and Medicare is secondary payer, 
from December 1, 1997, through November 30, 1998, a period of 12 months. 
Medicare becomes primary payer on December 1, 1998, because the 
extension of the coordination period from 12 to 18 months applies only 
to items and services furnished before October 1, 1998.
    (10) An individual becomes entitled to Medicare on August 1, 1997. 
Medicare is secondary payer from August 1, 1997, through September 30, 
1998, a period of 14 months. Medicare becomes primary payer on October 
1, 1998, because the coordination period has expired.
    (e) [Reserved]
    (f) Determinations for subsequent periods of ESRD eligibility. If an 
individual has more than one period of eligibility based on ESRD, a 
coordination period will be determined for each period of eligibility in 
accordance with this section.

[57 FR 36015, Aug. 12, 1992; 57 FR 45113, Sept. 30, 1992. Redesignated 
and amended at 60 FR 45362, 45368, Aug. 31, 1995]



Sec.  411.163  Coordination of benefits: Dual entitlement situations.

    (a) Basic rule. Coordination of benefits is governed by this section 
if an individual is eligible for or entitled to Medicare on the basis of 
ESRD and also entitled on the basis of age or disability.
    (b) Specific rules. \1\ (1) Coordination period ended before August 
1993. If the first 18 months of ESRD-based eligibility or entitlement 
ended before August 1993, Medicare was primary payer from the

[[Page 516]]

first month of dual eligibility or entitlement, regardless of when dual 
eligibility or entitlement began.
---------------------------------------------------------------------------

    \1\ A lawsuit was filed in United States District Court for the 
District of Columbia on May 5, 1995 (National Medical Care, Inc. v. 
Shalala, Civil Action No. 95-0860), challenging the implementation of 
one aspect of the OBRA '93 provisions with respect to group health plan 
retirement coverage. The court issued a preliminary injunction order on 
June 6, 1995, which enjoins the Secretary from applying the rule 
contained in Sec.  411.163(b)(4) for items and services furnished 
between August 10, 1993 and April 24, 1995, pending the court's decision 
on the merits. CMS will modify the rules, if required, based on the 
final ruling by the court.
---------------------------------------------------------------------------

    (2) First month of ESRD-based eligibility or entitlement and first 
month of dual eligibility/entitlement after February 1992 and before 
August 10, 1993. Except as provided in paragraph (b)(4) of this section, 
if the first month of ESRD-based eligibility or entitlement and first 
month of dual eligibility/entitlement were after February 1992 and 
before August 10, 1993, Medicare--
    (i) Is primary payer from the first month of dual eligibility/
entitlement through August 9, 1993;
    (ii) Is secondary payer from August 10, 1993, through the 18th month 
of ESRD-based eligibility or entitlement; and
    (iii) Again becomes primary payer after the 18th month of ESRD-based 
eligibility or entitlement.
    (3) First month of ESRD-based eligibility or entitlement after 
February 1992 and first month of dual eligibility/entitlement after 
August 9, 1993. Except as provided in paragraph (b)(4) of this section, 
if the first month of ESRD-based eligibility or entitlement is after 
February 1992, and the first month of dual eligibility/entitlement is 
after August 9, 1993, the rules of Sec.  411.162(b) and (c) apply; that 
is, Medicare--
    (i) Is secondary payer during the first 18 months of ESRD-based 
eligibility or entitlement; and
    (ii) Becomes primary after the 18th month of ESRD-based eligibility 
or entitlement.
    (4) Medicare continues to be primary after an aged or disabled 
beneficiary becomes eligible on the basis of ESRD. (i) Applicability of 
the rule. Medicare remains the primary payer when an individual becomes 
eligible for Medicare based on ESRD if all of the following conditions 
are met:
    (A) The individual is already entitled on the basis of age or 
disability when he or she becomes eligible on the basis of ESRD.
    (B) The MSP prohibition against ``taking into account'' age-based or 
disability-based entitlement does not apply because plan coverage was 
not ``by virtue of current employment status'' or the employer had fewer 
than 20 employees (in the case of the aged) or fewer than 100 employees 
(in the case of the disabled).
    (C) The plan is paying secondary to Medicare because the plan had 
justifiably taken into account the age-based or disability-based 
entitlement.
    (ii) Effect of the rule. The plan may continue to pay benefits 
secondary to Medicare under paragraph (b)(4)(i) of this section. 
However, the plan may not differentiate in the services covered and the 
payments made between persons who have ESRD and those who do not.
    (c) Examples. (1) (Rule (b)(1).) Mr. A, who is covered by a GHP, 
became entitled to Medicare on the basis of ESRD in January 1992. On 
December 20, 1992, Mr. A attained age 65 and became entitled on the 
basis of age. Since prior law was still in effect (OBRA '93 amendment 
was effective in August 1993), Medicare became primary payer as of 
December 1992, when dual entitlement began.
    (2) (Rule (b)(2).) Miss B, who has GHP coverage, became entitled to 
Medicare on the basis of ESRD in July 1992, and also entitled on the 
basis of disability in June 1993. Medicare was primary payer from June 
1993 through August 9, 1993, because the plan permissibly took into 
account the ESRD-based entitlement (ESRD was not the ``sole'' basis of 
Medicare entitlement); secondary payer from August 10, 1993, through 
December 1993, the 18th month of ESRD-based entitlement (the plan is no 
longer permitted to take into account ESRD-based entitlement that is not 
the ``sole'' basis of Medicare entitlement); and again became primary 
payer beginning January 1994.
    (3) (Rule (b)(3).) Mr. C, who is 67 years old and entitled to 
Medicare on the basis of age, has GHP coverage by virtue of current 
employment status. Mr. C is diagnosed as having ESRD and begins a course 
of maintenance dialysis on June 27, 1993. Effective September 1, 1993, 
Mr. C. is eligible for Medicare on the basis of ESRD. Medicare, which 
was secondary because Mr. C's GHP coverage was by virtue of current 
employment, continues to be secondary payer through February 1995, the 
18th month of ESRD-based eligibility, and becomes primary payer 
beginning March 1995.

[[Page 517]]

    (4) (Rule (b)(3).) Mr. D retired at age 62 and maintained GHP 
coverage as a retiree. In January 1994, at the age of 64, Mr. D became 
entitled to Medicare based on ESRD. Seven months into the 18-month 
coordination period (July 1994) Mr. D turned age 65. The coordination 
period continues without regard to age-based entitlement, with the 
retirement plan continuing to pay primary benefits through June 1995, 
the 18th month of ESRD-based entitlement. Thereafter, Medicare becomes 
the primary payer.
    (5) (Rule (b)(3).) Mrs. E retired at age 62 and maintained GHP 
coverage as a retiree. In July 1994, she simultaneously became eligible 
for Medicare based on ESRD (maintenance dialysis began in April 1994) 
and entitled based on age. The retirement plan must pay benefits primary 
to Medicare from July 1994 through December 1995, the first 18 months of 
ESRD-based eligibility. Thereafter, Medicare becomes the primary payer.
    (6) (Rule (b)(3).) Mr. F, who is 67 years of age, is working and has 
GHP coverage because of his employment status, subsequently develops 
ESRD, and begins a course of maintenance dialysis in October 1994. He 
becomes eligible for Medicare based on ESRD effective January 1, 1995. 
Under the working aged provision, the plan continues to pay primary to 
Medicare through December 1994. On January 1, 1995, the working aged 
provision ceases to apply and the ESRD MSP provision takes effect. In 
September 1995, Mr. F retires. The GHP must ignore Mr. F's retirement 
status and continue to pay primary to Medicare through June 1996, the 
end of the 18-month coordination period.
    (7) (Rule (b)(4).) Mrs. G, who is 67 years of age, is retired. She 
has GHP retirement coverage through her former employer. Her plan 
permissibly took into account her age-based Medicare entitlement when 
she retired and is paying benefits secondary to Medicare. Mrs. G 
subsequently develops ESRD and begins a course of maintenance dialysis 
in October 1995. She automatically becomes eligible for Medicare based 
on ESRD effective January 1, 1996. The plan continues to be secondary on 
the basis of Mrs. G's age-based entitlement as long as the plan does not 
differentiate in the services it provides to Mrs. G and does not do 
anything else that would constitute ``taking into account'' her ESRD-
based eligibility.

[60 FR 45369, Aug. 31, 1995; 60 FR 53876, Oct. 18, 1995]



Sec.  411.165  Basis for conditional Medicare payments.

    (a) General rule. Except as specified in paragraph (b) of this 
section, the Medicare intermediary or carrier may make a conditional 
payment if--
    (1) The beneficiary, the provider, or the supplier that has accepted 
assignment files a proper claim under the group health plan and the plan 
denies the claim in whole or in part; or
    (2) The beneficiary, because of physical or mental incapacity, fails 
to file a proper claim.
    (b) Exception. Medicare does not make conditional primary payments 
under either of the following circumstances:
    (1) The claim is denied for one of the following reasons:
    (i) It is alleged that the group health plan is secondary to 
Medicare.
    (ii) The group health plan limits its payments when the individual 
is entitled to Medicare.
    (iii) Failure to file a proper claim if that failure is for any 
reason other than the physical or mental incapacity of the beneficiary.
    (2) The group health plan fails to furnish information requested by 
CMS and necessary to determine whether the employer plan is primary to 
Medicare.

[57 FR 36015, Aug. 12, 1992. Redesignated and amended at 60 FR 45362, 
45370, Aug. 31, 1995; 60 FR 53877, Oct. 18, 1995]



  Subpart G_Special Rules: Aged Beneficiaries and Spouses Who Are Also 
                    Covered Under Group Health Plans



Sec.  411.170  General provisions.

    (a) Basis. (1) This subpart is based on certain provisions of 
section 1862(b) of the Act, which impose specific requirements and 
limitations with respect to--

[[Page 518]]

    (i) Individuals who are entitled to Medicare on the basis of age; 
and
    (ii) GHPs of at least one employer of 20 or more employees that 
cover those individuals.
    (2) Under these provisions, the following rules apply:
    (i) An employer is considered to employ 20 or more employees if the 
employer has 20 or more employees for each working day in each of 20 or 
more calendar weeks in the current calendar year or the preceding 
calendar year.
    (ii) The plan may not take into account the Medicare entitlement 
of--
    (A) An individual age 65 or older who is covered or seeks to be 
covered under the plan by virtue of current employment status; or
    (B) The spouse, including divorced or common-law spouse age 65 or 
older of an individual (of any age) who is covered or seeks to be 
covered by virtue of current employment status. (Section 411.108 gives 
examples of actions that constitute ``taking into account.'')
    (iii) Regardless of whether entitled to Medicare, employees and 
spouses age 65 or older, including divorced or common-law spouses of 
employees of any age, are entitled to the same plan benefits under the 
same conditions as employees and spouses under age 65.
    (b) [Reserved]
    (c) Determination of ``aged''. (1) An individual attains a 
particular age on the day preceding the anniversary of his or her birth.
    (2) The period during which an individual is considered to be 
``aged'' begins on the first day of the month in which that individual 
attains age 65.
    (3) For services furnished before May 1986, the period during which 
an individual is considered ``aged'' ends as follows:
    (i) For services furnished before July 18, 1984, it ends on the last 
day of the month in which the individual attains age 70.
    (ii) For services furnished between July 18, 1984 and April 30, 
1986, it ends on the last day of the month before the month the 
individual attains age 70.
    (4) For services furnished on or after May 1, 1986, the period has 
no upper age limit.

[54 FR 41734, Oct. 11, 1989. Redesignated and amended at 60 FR 45362, 
45370, Aug. 31, 1995]



Sec.  411.172  Medicare benefits secondary to group health plan benefits.

    (a) Conditions that the individual must meet. Medicare Part A and 
Part B benefits are secondary to benefits payable by a GHP for services 
furnished during any month in which the individual--
    (1) Is aged;
    (2) Is entitled to Medicare Part A benefits under Sec.  406.10 of 
this chapter; and
    (3) Meets one of the following conditions:
    (i) Is covered under a GHP of an employer that has at least 20 
employees (including a multi-employer plan in which at least one of the 
participating employers meets that condition), and coverage under the 
plan is by virtue of the individual's current employment status.
    (ii) Is the aged spouse (including a divorced or common-law spouse) 
of an individual (of any age) who is covered under a GHP described in 
paragraph (a)(3)(i) of this section by virtue of the individual's 
current employment status.
    (b) Special rule for multi-employer plans. The requirements and 
limitations of paragraph (a) of this section and of (a)(2)(iii) of Sec.  
411.170 do not apply with respect to individuals enrolled in a multi-
employer plan if--
    (1) The individuals are covered by virtue of current employment 
status with an employer that has fewer than 20 employees; and
    (2) The plan requests an exception and identifies the individuals 
for whom it requests the exception as meeting the conditions specified 
in paragraph (b)(1) of this section.
    (c) Refusal to accept group health plan coverage. An employee or 
spouse may refuse the health plan offered by the employer. If the 
employee or spouse refuses the plan--
    (1) Medicare is primary payer for that individual; and
    (2) The plan may not offer that individual coverage complementary to 
Medicare.
    (d) Reemployed retiree or annuitant. A reemployed retiree or 
annuitant who is covered by a GHP and who performs

[[Page 519]]

sufficient services to qualify for coverage on that basis (that is, 
other employees in the same category are provided health benefits) is 
considered covered ``by reason of current employment status'' even if:
    (1) The employer provides the same GHP coverage to retirees; or
    (2) The premiums for the plan are paid from a retirement or pension 
fund.
    (e) Secondary payments. Medicare pays secondary benefits, within the 
limitations specified in Sec. Sec.  411.32 and 411.33, to supplement the 
primary benefits paid by the group health plan if that plan pays only a 
portion of the charge for the services.
    (f) Disabled aged individuals who are considered employed. (1) For 
services furnished on or after November 12, 1985, and before July 17, 
1987, a disabled, nonworking individual age 65 or older was considered 
employed if he or she--
    (i) Was receiving, from an employer, disability payments that were 
subject to tax under the Federal Insurance Contributions Act (FICA); and
    (ii) For the month before the month of attainment of age 65, was not 
entitled to disability benefits under title II of the Act and 20 CFR 
404.315 of the SSA regulations.
    (2) For services furnished on or after July 17, 1987, an individual 
is considered employed if he or she receives, from an employer, 
disability benefits that are subject to tax under FICA, even if he or 
she was entitled to Social Security disability benefits before attaining 
age 65.
    (g) Individuals entitled to Medicare on the basis of age who are 
also eligible for or entitled to Medicare on the basis of ESRD. If an 
aged individual is, or could upon filing an application become, entitled 
to Medicare on the basis of ESRD, the coordination of benefits rules of 
subpart F of this part apply.

[54 FR 41734, Oct. 11, 1989, as amended at 55 FR 1820, Jan. 19, 1990. 
Redesignated and amended at 60 FR 45362, 45370, Aug. 31, 1995; 60 FR 
53877, Oct. 18, 1995]



Sec.  411.175  Basis for Medicare primary payments.

    (a) General rule. CMS makes Medicare primary payments for covered 
services that are--
    (1) Furnished to Medicare beneficiaries who have declined to enroll 
in the GHP;
    (2) Not covered by the plan for any individuals or spouses who are 
enrolled by virtue of the individual's current employment status;
    (3) Covered under the plan but not available to particular 
individuals or spouses enrolled by virtue of current employment status 
because they have exhausted their benefits under the plan;
    (4) Furnished to individuals whose COBRA continuation coverage has 
been terminated because of the individual's Medicare entitlement; or
    (5) Covered under COBRA continuation coverage notwithstanding the 
individual's Medicare entitlement.
    (b) Conditional Medicare payments: Basic rule. Except as provided in 
paragraph (c) of this section, Medicare may make a conditional primary 
payment if--
    (1) The beneficiary, the provider, or the supplier that has accepted 
assignment has filed a proper claim under the group health plan and the 
plan has denied the claim in whole or in part; or
    (2) The beneficiary, because of physical or mental incapacity, 
failed to file proper claim.
    (c) Conditional primary payments: Exception. Medicare does not make 
conditional primary payments under either of the following 
circumstances:
    (1) The claim is denied for one of the following reasons:
    (i) It is alleged that the group health plan is secondary to 
Medicare.
    (ii) The plan limits its payments when the individual is entitled to 
Medicare.
    (iii) The plan covers the services for individuals or spouses who 
are enrolled in the plan by virtue of current employment status and are 
under age 65 but not for individuals and spouses who are enrolled on the 
same basis but are age 65 or older.
    (iv) Failure to file a proper claim if that failure is for any 
reason other than physical or mental incapacity of the beneficiary.
    (2) The group health plan fails to furnish information requested by 
CMS and

[[Page 520]]

necessary to determine whether the employer plan is primary to Medicare.

[54 FR 41734, Oct. 11, 1989. Redesignated and amended at 60 FR 45362, 
45371, Aug. 31, 1995]



  Subpart H_Special Rules: Disabled Beneficiaries Who Are Also Covered 
                     Under Large Group Health Plans

    Source: 60 FR 45371, Aug. 31, 1995, unless otherwise noted.



Sec.  411.200  Basis.

    (a) This subpart is based on certain provisions of section 1862(b) 
of the Act, which impose specific requirements and limitations with 
respect to--
    (1) Individuals who are entitled to Medicare on the basis of 
disability; and
    (2) Large group health plans (LGHPs) that cover those individuals.
    (b) Under these provisions, the LGHP may not take into account the 
Medicare entitlement of a disabled individual who is covered (or seeks 
to be covered) under the plan by virtue of his or her own current 
employment status or that of a member of his or her family. (Sec.  
411.108 gives examples of actions that constitute taking into account.)



Sec.  411.201  Definitions.

    As used in this subpart--
    Entitled to Medicare on the basis of disability means entitled or 
deemed entitled on the basis of entitlement to social security 
disability benefits or railroad retirement disability benefits. (Sec.  
406.12 of this chapter explains the requirements an individual must meet 
in order to be entitled or deemed to be entitled to Medicare on the 
basis of disability.)
    Family member means a person who is enrolled in an LGHP based on 
another person's enrollment; for example, the enrollment of the named 
insured individual. Family members may include a spouse (including a 
divorced or common-law spouse), a natural, adopted, foster, or 
stepchild, a parent, or a sibling.



Sec.  411.204  Medicare benefits secondary to LGHP benefits.

    (a) Medicare benefits are secondary to benefits payable by an LGHP 
for services furnished during any month in which the individual--
    (1) Is entitled to Medicare Part A benefits under Sec.  406.12 of 
this chapter;
    (2) Is covered under an LGHP; and
    (3) Has LGHP coverage by virtue of his or her own or a family 
member's current employment status.
    (b) Individuals entitled to Medicare on the basis of disability who 
are also eligible for, or entitled to, Medicare on the basis of ESRD. If 
a disabled individual is, or could upon filing an application become, 
entitled to Medicare on the basis of ESRD, the coordination of benefits 
rules of subpart F of this part apply.



Sec.  411.206  Basis for Medicare primary payments and limits 
on secondary payments.

    (a) General rule. CMS makes Medicare primary payments for services 
furnished to disabled beneficiaries covered under the LGHP by virtue of 
their own or a family member's current employment status if the services 
are--
    (1) Furnished to Medicare beneficiaries who have declined to enroll 
in the GHP;
    (2) Not covered under the plan for the disabled individual or 
similarly situated individuals;
    (3) Covered under the plan but not available to particular disabled 
individuals because they have exhausted their benefits under the plan;
    (4) Furnished to individuals whose COBRA continuation coverage has 
been terminated because of the individual's Medicare entitlement; or
    (5) Covered under COBRA continuation coverage notwithstanding the 
individual's Medicare entitlement.
    (b) Conditional primary payments: Basic rule. Except as provided in 
paragraph (c) of this section, CMS may make a conditional Medicare 
primary payment for any of the following reasons:
    (1) The beneficiary, the provider, or the supplier that has accepted 
assignment has filed a proper claim with the LGHP and the LGHP has 
denied the claim in whole or in part.
    (2) The beneficiary, because of physical or mental incapacity, 
failed to file a proper claim.

[[Page 521]]

    (c) Conditional primary payments: Exceptions. CMS does not make 
conditional Medicare primary payments if--
    (1) The LGHP denies the claim in whole or in part for one of the 
following reasons:
    (i) It is alleged that the LGHP is secondary to Medicare.
    (ii) The LGHP limits its payments when the individual is entitled to 
Medicare.
    (iii) The LGHP does not provide the benefits to individuals who are 
entitled to Medicare on the basis of disability and covered under the 
plan by virtue of current employment status but does provide the 
benefits to other similarly situated individuals enrolled in the plan.
    (iv) The LGHP takes into account entitlement to Medicare in any 
other way.
    (v) There was failure to file a proper claim for any reason other 
than physical or mental incapacity of the beneficiary.
    (2) The LGHP, an employer or employee organization, or the 
beneficiary fails to furnish information that is requested by CMS and 
that is necessary to determine whether the LGHP is primary to Medicare.
    (d) Limit on secondary payments. The provisions of Sec.  411.172(e) 
also apply to services furnished to the disabled under this subpart.

Subpart I [Reserved]



   Subpart J_Financial Relationships Between Physicians and Entities 
                  Furnishing Designated Health Services

    Source: 69 FR 16126, Mar. 26, 2004, unless otherwise noted.



Sec.  411.350  Scope of subpart.

    (a) This subpart implements section 1877 of the Act, which generally 
prohibits a physician from making a referral under Medicare for 
designated health services to an entity with which the physician or a 
member of the physician's immediate family has a financial relationship.
    (b) This subpart does not provide for exceptions or immunity from 
civil or criminal prosecution or other sanctions applicable under any 
State laws or under Federal law other than section 1877 of the Act. For 
example, although a particular arrangement involving a physician's 
financial relationship with an entity may not prohibit the physician 
from making referrals to the entity under this subpart, the arrangement 
may nevertheless violate another provision of the Act or other laws 
administered by HHS, the Federal Trade Commission, the Securities and 
Exchange Commission, the Internal Revenue Service, or any other Federal 
or State agency.
    (c) This subpart requires, with some exceptions, that certain 
entities furnishing covered services under Medicare report information 
concerning ownership, investment, or compensation arrangements in the 
form, in the manner, and at the times specified by CMS.
    (d) This subpart does not alter an individual's or entity's 
obligations under--
    (1) The rules regarding reassignment of claims (Sec.  424.80 of this 
chapter);
    (2) The rules regarding purchased diagnostic tests (Sec.  414.50 of 
this chapter);
    (3) The rules regarding payment for services and supplies incident 
to a physician's professional services (Sec.  410.26 of this chapter); 
or
    (4) Any other applicable Medicare laws, rules, or regulations.

[85 FR 77656, Dec. 2, 2020]



Sec.  411.351  Definitions.

    The definitions in this subpart apply only for purposes of section 
1877 of the Act and this subpart. As used in this subpart, unless the 
context indicates otherwise:
    Centralized building means all or part of a building, including, for 
purposes of this subpart only, a mobile vehicle, van, or trailer that is 
owned or leased on a full-time basis (that is, 24 hours per day, 7 days 
per week, for a term of not less than 6 months) by a group practice and 
that is used exclusively by the group practice. Space in a building or a 
mobile vehicle, van, or trailer that is shared by more than one group 
practice, by a group practice and one or more solo practitioners, or by 
a group

[[Page 522]]

practice and another provider or supplier (for example, a diagnostic 
imaging facility) is not a centralized building for purposes of this 
subpart. This provision does not preclude a group practice from 
providing services to other providers or suppliers (for example, 
purchased diagnostic tests) in the group practice's centralized 
building. A group practice may have more than one centralized building.
    Clinical laboratory services means the biological, microbiological, 
serological, chemical, immunohematological, hematological, biophysical, 
cytological, pathological, or other examination of materials derived 
from the human body for the purpose of providing information for the 
diagnosis, prevention, or treatment of any disease or impairment of, or 
the assessment of the health of, human beings, including procedures to 
determine, measure, or otherwise describe the presence or absence of 
various substances or organisms in the body, as specifically identified 
by the List of CPT/HCPCS Codes. All services so identified on the List 
of CPT/HCPCS Codes are clinical laboratory services for purposes of this 
subpart. Any service not specifically identified as a clinical 
laboratory service on the List of CPT/HCPCS Codes is not a clinical 
laboratory service for purposes of this subpart.
    Commercially reasonable means that the particular arrangement 
furthers a legitimate business purpose of the parties to the arrangement 
and is sensible, considering the characteristics of the parties, 
including their size, type, scope, and specialty. An arrangement may be 
commercially reasonable even if it does not result in profit for one or 
more of the parties.
    Consultation means a professional service furnished to a patient by 
a physician if the following conditions are satisfied:
    (1) The physician's opinion or advice regarding evaluation or 
management or both of a specific medical problem is requested by another 
physician.
    (2) The request and need for the consultation are documented in the 
patient's medical record.
    (3) After the consultation is provided, the physician prepares a 
written report of his or her findings, which is provided to the 
physician who requested the consultation.
    (4) With respect to radiation therapy services provided by a 
radiation oncologist, a course of radiation treatments over a period of 
time will be considered to be pursuant to a consultation, provided that 
the radiation oncologist communicates with the referring physician on a 
regular basis about the patient's course of treatment and progress.
    Cybersecurity means the process of protecting information by 
preventing, detecting, and responding to cyberattacks.
    Designated health services (DHS) means any of the following services 
(other than those provided as emergency physician services furnished 
outside of the U.S.), as they are defined in this section:
    (1)(i) Clinical laboratory services.
    (ii) Physical therapy, occupational therapy, and outpatient speech-
language pathology services.
    (iii) Radiology and certain other imaging services.
    (iv) Radiation therapy services and supplies.
    (v) Durable medical equipment and supplies.
    (vi) Parenteral and enteral nutrients, equipment, and supplies.
    (vii) Prosthetics, orthotics, and prosthetic devices and supplies.
    (viii) Home health services.
    (ix) Outpatient prescription drugs.
    (x) Inpatient and outpatient hospital services.
    (2) Except as otherwise noted in this subpart, the term ``designated 
health services'' or DHS means only DHS payable, in whole or in part, by 
Medicare. DHS do not include services that are paid by Medicare as part 
of a composite rate (for example, SNF Part A payments or ASC services 
identified at Sec.  416.164(a)), except to the extent that services 
listed in paragraphs (1)(i) through (1)(x) of this definition are 
themselves payable under a composite rate (for example, all services 
provided as home health services or inpatient and outpatient hospital 
services are DHS). For services furnished to inpatients by a hospital, a 
service is not a designated health service payable, in whole or in part, 
by Medicare if the

[[Page 523]]

furnishing of the service does not increase the amount of Medicare's 
payment to the hospital under any of the following prospective payment 
systems (PPS):
    (i) Acute Care Hospital Inpatient (IPPS);
    (ii) Inpatient Rehabilitation Facility (IRF PPS);
    (iii) Inpatient Psychiatric Facility (IPF PPS); or
    (iv) Long-Term Care Hospital (LTCH PPS).
    Does not violate the anti-kickback statute, as used in this subpart 
only, means that the particular arrangement--
    (1)(i) Meets a safe harbor under the anti-kickback statute, as set 
forth at Sec.  1001.952 of this title, ``Exceptions'';
    (ii) Has been specifically approved by the OIG in a favorable 
advisory opinion issued to a party to the particular arrangement (for 
example, the entity furnishing DHS) with respect to the particular 
arrangement (and not a similar arrangement), provided that the 
arrangement is conducted in accordance with the facts certified by the 
requesting party and the opinion is otherwise issued in accordance with 
part 1008 of this title, ``Advisory Opinions by the OIG''; or
    (iii) Does not violate the anti-kickback provisions in section 
1128B(b) of the Act.
    (2) For purposes of this definition, a favorable advisory opinion 
means an opinion in which the OIG opines that--
    (i) The party's specific arrangement does not implicate the anti-
kickback statute, does not constitute prohibited remuneration, or fits 
in a safe harbor under Sec.  1001.952 of this title; or
    (ii) The party will not be subject to any OIG sanctions arising 
under the anti-kickback statute (for example, under sections 1128A(a)(7) 
and 1128(b)(7) of the Act) in connection with the party's specific 
arrangement.
    Downstream contractor means a ``first tier contractor'' as defined 
at Sec.  1001.952(t)(2)(iii) of this title or a ``downstream 
contractor'' as defined at Sec.  1001.952(t)(2)(i) of this title.
    Durable medical equipment (DME) and supplies has the meaning given 
in section 1861(n) of the Act and Sec.  414.202 of this chapter.
    Electronic health record means a repository of consumer health 
status information in computer processable form used for clinical 
diagnosis and treatment for a broad array of clinical conditions.
    Employee means any individual who, under the common law rules that 
apply in determining the employer-employee relationship (as applied for 
purposes of section 3121(d)(2) of the Internal Revenue Code of 1986), is 
considered to be employed by, or an employee of, an entity. (Application 
of these common law rules is discussed in 20 CFR 404.1007 and 26 CFR 
31.3121(d)-1(c).)
    Entity means--
    (1) A physician's sole practice or a practice of multiple physicians 
or any other person, sole proprietorship, public or private agency or 
trust, corporation, partnership, limited liability company, foundation, 
nonprofit corporation, or unincorporated association that furnishes DHS. 
An entity does not include the referring physician himself or herself, 
but does include his or her medical practice. A person or entity is 
considered to be furnishing DHS if it--
    (i) Is the person or entity that has performed services that are 
billed as DHS; or
    (ii) Is the person or entity that has presented a claim to Medicare 
for the DHS, including the person or entity to which the right to 
payment for the DHS has been reassigned in accordance with Sec.  
424.80(b)(1) (employer) or (b)(2) (payment under a contractual 
arrangement) of this chapter (other than a health care delivery system 
that is a health plan (as defined at Sec.  1001.952(l) of this title), 
and other than any managed care organization (MCO), provider-sponsored 
organization (PSO), or independent practice association (IPA) with which 
a health plan contracts for services provided to plan enrollees).
    (2) A health plan, MCO, PSO, or IPA that employs a supplier or 
operates a facility that could accept reassignment from a supplier under 
Sec.  424.80(b)(1) and (b)(2) of this chapter, with respect to any DHS 
provided by that supplier.
    (3) For purposes of this subpart, ``entity'' does not include a 
physician's practice when it bills Medicare for the technical component 
or professional

[[Page 524]]

component of a diagnostic test for which the anti-markup provision is 
applicable in accordance with Sec.  414.50 of this chapter and Pub. 100-
04, Medicare Claims Processing Manual, Chapter 1, Section 30.2.9.
    Fair market value means--
    (1) General. The value in an arm's-length transaction, consistent 
with the general market value of the subject transaction.
    (2) Rental of equipment. With respect to the rental of equipment, 
the value in an arm's-length transaction of rental property for general 
commercial purposes (not taking into account its intended use), 
consistent with the general market value of the subject transaction.
    (3) Rental of office space. With respect to the rental of office 
space, the value in an arm's-length transaction of rental property for 
general commercial purposes (not taking into account its intended use), 
without adjustment to reflect the additional value the prospective 
lessee or lessor would attribute to the proximity or convenience to the 
lessor where the lessor is a potential source of patient referrals to 
the lessee, and consistent with the general market value of the subject 
transaction.
    General market value means--
    (1) Assets. With respect to the purchase of an asset, the price that 
an asset would bring on the date of acquisition of the asset as the 
result of bona fide bargaining between a well-informed buyer and seller 
that are not otherwise in a position to generate business for each 
other.
    (2) Compensation. With respect to compensation for services, the 
compensation that would be paid at the time the parties enter into the 
service arrangement as the result of bona fide bargaining between well-
informed parties that are not otherwise in a position to generate 
business for each other.
    (3) Rental of equipment or office space. With respect to the rental 
of equipment or the rental of office space, the price that rental 
property would bring at the time the parties enter into the rental 
arrangement as the result of bona fide bargaining between a well-
informed lessor and lessee that are not otherwise in a position to 
generate business for each other.
    Home health services means the services described in section 1861(m) 
of the Act and part 409, subpart E of this chapter.
    Hospital means any entity that qualifies as a ``hospital'' under 
section 1861(e) of the Act, as a ``psychiatric hospital'' under section 
1861(f) of the Act, or as a ``critical access hospital'' under section 
1861(mm)(1) of the Act, and refers to any separate legally organized 
operating entity plus any subsidiary, related entity, or other entities 
that perform services for the hospital's patients and for which the 
hospital bills. However, a ``hospital'' does not include entities that 
perform services for hospital patients ``under arrangements'' with the 
hospital.
    HPSA means, for purposes of this subpart, an area designated as a 
health professional shortage area under section 332(a)(1)(A) of the 
Public Health Service Act for primary medical care professionals (in 
accordance with the criteria specified in part 5 of this title).
    Immediate family member or member of a physician's immediate family 
means husband or wife; birth or adoptive parent, child, or sibling; 
stepparent, stepchild, stepbrother, or stepsister; father-in-law, 
mother-in-law, son-in-law, daughter-in-law, brother-in-law, or sister-
in-law; grandparent or grandchild; and spouse of a grandparent or 
grandchild.
    ``Incident to'' services or services ``incident to'' means those 
services and supplies that meet the requirements of section 
1861(s)(2)(A) of the Act, Sec.  410.26 of this chapter, and Pub. 100-02, 
Medicare Benefit Policy Manual, Chapter 15, Sections 60, 60.1, 60.2, 
60.3, and 60.4.
    Inpatient hospital services means those services defined in section 
1861(b) of the Act and Sec.  409.10(a) and (b) of this chapter and 
include inpatient psychiatric hospital services listed in section 
1861(c) of the Act and inpatient critical access hospital services, as 
defined in section 1861(mm)(2) of the Act. ``Inpatient hospital 
services'' do not include emergency inpatient services provided by a 
hospital located outside of the U.S. and covered under the authority in 
section 1814(f)(2) of the Act and part 424, subpart H of this chapter,

[[Page 525]]

or emergency inpatient services provided by a nonparticipating hospital 
within the U.S., as authorized by section 1814(d) of the Act and 
described in part 424, subpart G of this chapter. ``Inpatient hospital 
services'' also do not include dialysis furnished by a hospital that is 
not certified to provide end-stage renal dialysis (ESRD) services under 
subpart U of part 405 of this chapter. ``Inpatient hospital services'' 
include services that are furnished either by the hospital directly or 
under arrangements made by the hospital with others. ``Inpatient 
hospital services'' do not include professional services performed by 
physicians, physician assistants, nurse practitioners, clinical nurse 
specialists, certified nurse midwives, and certified registered nurse 
anesthetists and qualified psychologists if Medicare reimburses the 
services independently and not as part of the inpatient hospital service 
(even if they are billed by a hospital under an assignment or 
reassignment).
    Interoperable means--
    (1) Able to securely exchange data with and use data from other 
health information technology; and
    (2) Allows for complete access, exchange, and use of all 
electronically accessible health information for authorized use under 
applicable State or Federal law.
    Isolated financial transaction--(1) Isolated financial transaction 
means a one-time transaction involving a single payment between two or 
more persons or a one-time transaction that involves integrally related 
installment payments, provided that--
    (i) The total aggregate payment is fixed before the first payment is 
made and does not take into account the volume or value of referrals or 
other business generated by the physician; and
    (ii) The payments are immediately negotiable, guaranteed by a third 
party, secured by a negotiable promissory note, or subject to a similar 
mechanism to ensure payment even in the event of default by the 
purchaser or obligated party.
    (2) An isolated financial transaction includes a one-time sale of 
property or a practice, single instance of forgiveness of an amount owed 
in settlement of a bona fide dispute, or similar one-time transaction, 
but does not include a single payment for multiple or repeated services 
(such as payment for services previously provided but not yet 
compensated).
    Laboratory means an entity furnishing biological, microbiological, 
serological, chemical, immunohematological, hematological, biophysical, 
cytological, pathological, or other examination of materials derived 
from the human body for the purpose of providing information for the 
diagnosis, prevention, or treatment of any disease or impairment of, or 
the assessment of the health of, human beings. These examinations also 
include procedures to determine, measure, or otherwise describe the 
presence or absence of various substances or organisms in the body. 
Entities only collecting or preparing specimens (or both) or only 
serving as a mailing service and not performing testing are not 
considered laboratories.
    List of CPT/HCPCS Codes means the list of CPT and HCPCS codes that 
identifies those items and services that are DHS under section 1877 of 
the Act or that may qualify for certain exceptions under section 1877 of 
the Act. It is updated annually, as published in the Federal Register, 
and is posted on the CMS website at http://www.cms.hhs.gov/
PhysicianSelfReferral/11_ _ List__ of__Codes.asp TopOfPage.
    Locum tenens physician (or substitute physician) means a physician 
who substitutes in exigent circumstances for another physician, in 
accordance with section 1842(b)(6)(D) of the Act and Pub. 100-04, 
Medicare Claims Processing Manual, Chapter 1, Section 30.2.11.
    Member of the group or member of a group practice means, for 
purposes of this subpart, a direct or indirect physician owner of a 
group practice (including a physician whose interest is held by his or 
her individual professional corporation or by another entity), a 
physician employee of the group practice (including a physician employed 
by his or her individual professional corporation that has an equity 
interest in the group practice), a locum tenens physician (as defined in 
this section),

[[Page 526]]

or an on-call physician while the physician is providing on-call 
services for members of the group practice. A physician is a member of 
the group during the time he or she furnishes ``patient care services'' 
to the group as defined in this section. An independent contractor or a 
leased employee is not a member of the group (unless the leased employee 
meets the definition of an ``employee'' under this section).
    Outpatient hospital services means the therapeutic, diagnostic, and 
partial hospitalization services listed under sections 1861(s)(2)(B) and 
(s)(2)(C) of the Act; outpatient services furnished by a psychiatric 
hospital, as defined in section 1861(f) of the Act; and outpatient 
critical access hospital services, as defined in section 1861(mm)(3) of 
the Act. ``Outpatient hospital services'' do not include emergency 
services furnished by nonparticipating hospitals and covered under the 
conditions described in section 1835(b) of the Act and subpart G of part 
424 of this chapter. ``Outpatient hospital services'' include services 
that are furnished either by the hospital directly or under arrangements 
made by the hospital with others. ``Outpatient hospital services'' do 
not include professional services performed by physicians, physician 
assistants, nurse practitioners, clinical nurse specialists, certified 
nurse midwives, certified registered nurse anesthetists, and qualified 
psychologists if Medicare reimburses the services independently and not 
as part of the outpatient hospital service (even if they are billed by a 
hospital under an assignment or reassignment).
    Outpatient prescription drugs means all drugs covered by Medicare 
Part B or D, except for those drugs that are ``covered ancillary 
services,'' as defined at Sec.  416.164(b) of this chapter, for which 
separate payment is made to an ambulatory surgical center.
    Parenteral and enteral nutrients, equipment, and supplies means the 
following services (including all HCPCS level 2 codes for these 
services):
    (1) Parenteral nutrients, equipment, and supplies, meaning those 
items and supplies needed to provide nutriment to a patient with 
permanent, severe pathology of the alimentary tract that does not allow 
absorption of sufficient nutrients to maintain strength commensurate 
with the patient's general condition, as described in Pub. 100-03, 
Medicare National Coverage Determinations Manual, Chapter 1, Section 
180.2, as amended or replaced from time to time; and
    (2) Enteral nutrients, equipment, and supplies, meaning items and 
supplies needed to provide enteral nutrition to a patient with a 
functioning gastrointestinal tract who, due to pathology to or 
nonfunction of the structures that normally permit food to reach the 
digestive tract, cannot maintain weight and strength commensurate with 
his or her general condition, as described in Pub. 100-03, Medicare 
National Coverage Determinations Manual, Chapter 1, Section 180.2.
    Patient care services means any task(s) performed by a physician in 
the group practice that address the medical needs of specific patients 
or patients in general, regardless of whether they involve direct 
patient encounters or generally benefit a particular practice. Patient 
care services can include, for example, the services of physicians who 
do not directly treat patients, such as time spent by a physician 
consulting with other physicians or reviewing laboratory tests, or time 
spent training staff members, arranging for equipment, or performing 
administrative or management tasks.
    Physical therapy, occupational therapy, and outpatient speech-
language pathology services means those particular services so 
identified on the List of CPT/HCPCS Codes. All services so identified on 
the List of CPT/HCPCS Codes are physical therapy, occupational therapy, 
and outpatient speech-language pathology services for purposes of this 
subpart. Any service not specifically identified as physical therapy, 
occupational therapy or outpatient speech-language pathology on the List 
of CPT/HCPCS Codes is not a physical therapy, occupational therapy, or 
outpatient speech-language pathology service for purposes of this 
subpart. The list of codes identifying physical therapy, occupational 
therapy, and outpatient speech-language pathology services for purposes 
of this regulation includes the following:

[[Page 527]]

    (1) Physical therapy services, meaning those outpatient physical 
therapy services described in section 1861(p) of the Act that are 
covered under Medicare Part A or Part B, regardless of who provides 
them, if the services include--
    (i) Assessments, function tests, and measurements of strength, 
balance, endurance, range of motion, and activities of daily living;
    (ii) Therapeutic exercises, massage, and use of physical medicine 
modalities, assistive devices, and adaptive equipment; or
    (iii) Establishment of a maintenance therapy program for an 
individual whose restoration potential has been reached; however, 
maintenance therapy itself is not covered as part of these services.
    (2) Occupational therapy services, meaning those services described 
in section 1861(g) of the Act that are covered under Medicare Part A or 
Part B, regardless of who provides them, if the services include--
    (i) Teaching of compensatory techniques to permit an individual with 
a physical or cognitive impairment or limitation to engage in daily 
activities;
    (ii) Evaluation of an individual's level of independent functioning;
    (iii) Selection and teaching of task-oriented therapeutic activities 
to restore sensory-integrative function; or
    (iv) Assessment of an individual's vocational potential, except when 
the assessment is related solely to vocational rehabilitation.
    (3) Outpatient speech-language pathology services, meaning those 
services as described in section 1861(ll)(2) of the Act that are for the 
diagnosis and treatment of speech, language, and cognitive disorders 
that include swallowing and other oral-motor dysfunctions.
    Physician has the meaning set forth in section 1861(r) of the Act. A 
physician and the professional corporation of which he or she is a sole 
owner are the same for purposes of this subpart.
    Physician in the group practice means a member of the group 
practice, as well as an independent contractor physician during the time 
the independent contractor is furnishing patient care services (as 
defined in this section) for the group practice under a contractual 
arrangement directly with the group practice to provide services to the 
group practice's patients in the group practice's facilities. The 
contract must contain the same restrictions on compensation that apply 
to members of the group practice under Sec.  411.352(g) (or the contract 
must satisfy the requirements of the personal service arrangements 
exception in Sec.  411.357(d)), and the independent contractor's 
arrangement with the group practice must comply with the reassignment 
rules in Sec.  424.80(b)(2) of this chapter (see also Pub. L. 100-04, 
Medicare Claims Processing Manual, Chapter 1, Section 30.2.7, as amended 
or replaced from time to time). Referrals from an independent contractor 
who is a physician in the group practice are subject to the prohibition 
on referrals in Sec.  411.353(a), and the group practice is subject to 
the limitation on billing for those referrals in Sec.  411.353(b).
    Physician incentive plan means any compensation arrangement between 
an entity (or downstream contractor) and a physician or physician group 
that may directly or indirectly have the effect of reducing or limiting 
services furnished with respect to individuals enrolled with the entity.
    Physician organization means a physician, a physician practice, or a 
group practice that complies with the requirements of Sec.  411.352.
    Plan of care means the establishment by a physician of a course of 
diagnosis or treatment (or both) for a particular patient, including the 
ordering of services.
    Professional courtesy means the provision of free or discounted 
health care items or services to a physician or his or her immediate 
family members or office staff.
    Prosthetics, Orthotics, and Prosthetic Devices and Supplies means 
the following services (including all HCPCS level 2 codes for these 
items and services that are covered by Medicare):
    (1) Orthotics, meaning leg, arm, back, and neck braces, as listed in 
section 1861(s)(9) of the Act.
    (2) Prosthetics, meaning artificial legs, arms, and eyes, as 
described in section 1861(s)(9) of the Act.
    (3) Prosthetic devices, meaning devices (other than a dental device) 
listed in

[[Page 528]]

section 1861(s)(8) of the Act that replace all or part of an internal 
body organ, including colostomy bags, and one pair of conventional 
eyeglasses or contact lenses furnished subsequent to each cataract 
surgery with insertion of an intraocular lens.
    (4) Prosthetic supplies, meaning supplies that are necessary for the 
effective use of a prosthetic device (including supplies directly 
related to colostomy care).
    Radiation therapy services and supplies means those particular 
services and supplies, including (effective January 1, 2007) therapeutic 
nuclear medicine services and supplies, so identified on the List of 
CPT/HCPCS Codes. All services and supplies so identified on the List of 
CPT/HCPCS Codes are radiation therapy services and supplies for purposes 
of this subpart. Any service or supply not specifically identified as 
radiation therapy services or supplies on the List of CPT/HCPCS Codes is 
not a radiation therapy service or supply for purposes of this subpart. 
The list of codes identifying radiation therapy services and supplies is 
based on section 1861(s)(4) of the Act and Sec.  410.35 of this chapter.
    Radiology and certain other imaging services means those particular 
services so identified on the List of CPT/HCPCS Codes. All services 
identified on the List of CPT/HCPCS Codes are radiology and certain 
other imaging services for purposes of this subpart. Any service not 
specifically identified as radiology and certain other imaging services 
on the List of CPT/HCPCS Codes is not a radiology or certain other 
imaging service for purposes of this subpart. The list of codes 
identifying radiology and certain other imaging services includes the 
professional and technical components of any diagnostic test or 
procedure using x-rays, ultrasound, computerized axial tomography, 
magnetic resonance imaging, nuclear medicine (effective January 1, 
2007), or other imaging services. All codes identified as radiology and 
certain other imaging services are covered under section 1861(s)(3) of 
the Act and Sec. Sec.  410.32 and 410.34 of this chapter, but do not 
include--
    (1) X-ray, fluoroscopy, or ultrasound procedures that require the 
insertion of a needle, catheter, tube, or probe through the skin or into 
a body orifice;
    (2) Radiology or certain other imaging services that are integral to 
the performance of a medical procedure that is not identified on the 
list of CPT/HCPCS codes as a radiology or certain other imaging service 
and is performed--
    (i) Immediately prior to or during the medical procedure; or
    (ii) Immediately following the medical procedure when necessary to 
confirm placement of an item placed during the medical procedure.
    (3) Radiology and certain other imaging services that are ``covered 
ancillary services,'' as defined at Sec.  416.164(b), for which separate 
payment is made to an ASC.
    Referral--
    (1) Means either of the following:
    (i) Except as provided in paragraph (2) of this definition, the 
request by a physician for, or ordering of, or the certifying or 
recertifying of the need for, any designated health service for which 
payment may be made under Medicare Part B, including a request for a 
consultation with another physician and any test or procedure ordered by 
or to be performed by (or under the supervision of) that other 
physician, but not including any designated health service personally 
performed or provided by the referring physician. A designated health 
service is not personally performed or provided by the referring 
physician if it is performed or provided by any other person, including, 
but not limited to, the referring physician's employees, independent 
contractors, or group practice members.
    (ii) Except as provided in paragraph (2) of this definition, a 
request by a physician that includes the provision of any designated 
health service for which payment may be made under Medicare, the 
establishment of a plan of care by a physician that includes the 
provision of such a designated health service, or the certifying or 
recertifying of the need for such a designated health service, but not 
including any designated health service personally performed or provided 
by the referring physician. A designated health service is not 
personally performed or provided

[[Page 529]]

by the referring physician if it is performed or provided by any other 
person including, but not limited to, the referring physician's 
employees, independent contractors, or group practice members.
    (2) Does not include a request by a pathologist for clinical 
diagnostic laboratory tests and pathological examination services, by a 
radiologist for diagnostic radiology services, and by a radiation 
oncologist for radiation therapy or ancillary services necessary for, 
and integral to, the provision of radiation therapy, if--
    (i) The request results from a consultation initiated by another 
physician (whether the request for a consultation was made to a 
particular physician or to an entity with which the physician is 
affiliated); and
    (ii) The tests or services are furnished by or under the supervision 
of the pathologist, radiologist, or radiation oncologist, or under the 
supervision of a pathologist, radiologist, or radiation oncologist, 
respectively, in the same group practice as the pathologist, 
radiologist, or radiation oncologist.
    (3) Can be in any form, including, but not limited to, written, 
oral, or electronic.
    (4) A referral is not an item or service for purposes of section 
1877 of the Act and this subpart.
    Referring physician means a physician who makes a referral as 
defined in this section or who directs another person or entity to make 
a referral or who controls referrals made by another person or entity. A 
referring physician and the professional corporation of which he or she 
is a sole owner are the same for purposes of this subpart.
    Remuneration means any payment or other benefit made directly or 
indirectly, overtly or covertly, in cash or in kind, except that the 
following are not considered remuneration for purposes of this section:
    (1) The forgiveness of amounts owed for inaccurate tests or 
procedures, mistakenly performed tests or procedures, or the correction 
of minor billing errors.
    (2) The furnishing of items, devices, or supplies that are, in fact, 
used solely for one or more of the following purposes:
    (i) Collecting specimens for the entity furnishing the items, 
devices or supplies;
    (ii) Transporting specimens for the entity furnishing the items, 
devices or supplies;
    (iii) Processing specimens for the entity furnishing the items, 
devices or supplies;
    (iv) Storing specimens for the entity furnishing the items, devices 
or supplies;
    (v) Ordering tests or procedures for the entity furnishing the 
items, devices or supplies; or
    (vi) Communicating the results of tests or procedures for the entity 
furnishing the items, devices or supplies.
    (3) A payment made by an insurer or a self-insured plan (or a 
subcontractor of the insurer or self-insured plan) to a physician to 
satisfy a claim, submitted on a fee-for-service basis, for the 
furnishing of health services by that physician to an individual who is 
covered by a policy with the insurer or by the self-insured plan, if--
    (i) The health services are not furnished, and the payment is not 
made, under a contract or other arrangement between the insurer or the 
self-insured plan (or a subcontractor of the insurer or self-insured 
plan) and the physician;
    (ii) The payment is made to the physician on behalf of the covered 
individual and would otherwise be made directly to the individual; and
    (iii) The amount of the payment is set in advance, does not exceed 
fair market value, and is not determined in any manner that takes into 
account the volume or value of referrals.
    Rural area means an area that is not an urban area as defined at 
Sec.  412.62(f)(1)(ii) of this chapter.
    Same building means a structure with, or combination of structures 
that share, a single street address as assigned by the U.S. Postal 
Service, excluding all exterior spaces (for example, lawns, courtyards, 
driveways, parking lots) and interior loading docks or parking garages. 
For purposes of this section, the ``same building'' does not include a 
mobile vehicle, van, or trailer.
    Specialty hospital means:

[[Page 530]]

    (1) A subsection (d) hospital (as defined in section 1886(d)(1)(B) 
of the Act) that is primarily or exclusively engaged in the care and 
treatment of one of the following:
    (i) Patients with a cardiac condition;
    (ii) Patients with an orthopedic condition;
    (iii) Patients receiving a surgical procedure; or
    (iv) Any other specialized category of services that the Secretary 
designates as inconsistent with the purpose of permitting physician 
ownership and investment interests in a hospital.
    (2) A ``specialty hospital'' does not include any hospital--
    (i) Determined by the Secretary to be in operation before or under 
development as of November 18, 2003;
    (ii) For which the number of physician investors at any time on or 
after such date is no greater than the number of such investors as of 
such date;
    (iii) For which the type of categories described above is no 
different at any time on or after such date than the type of such 
categories as of such date;
    (iv) For which any increase in the number of beds occurs only in the 
facilities on the main campus of the hospital and does not exceed 50 
percent of the number of beds in the hospital as of November 18, 2003, 
or 5 beds, whichever is greater; and
    (v) That meets such other requirements as the Secretary may specify.
    Target patient population means an identified patient population 
selected by a value-based enterprise or its VBE participants based on 
legitimate and verifiable criteria that--
    (1) Are set out in writing in advance of the commencement of the 
value-based arrangement; and
    (2) Further the value-based enterprise's value-based purpose(s).
    Transaction means an instance of two or more persons or entities 
doing business.
    Value-based activity means any of the following activities, provided 
that the activity is reasonably designed to achieve at least one value-
based purpose of the value-based enterprise:
    (1) The provision of an item or service;
    (2) The taking of an action; or
    (3) The refraining from taking an action.
    Value-based arrangement means an arrangement for the provision of at 
least one value-based activity for a target patient population to which 
the only parties are--
    (1) The value-based enterprise and one or more of its VBE 
participants; or
    (2) VBE participants in the same value-based enterprise.
    Value-based enterprise (VBE) means two or more VBE participants--
    (1) Collaborating to achieve at least one value-based purpose;
    (2) Each of which is a party to a value-based arrangement with the 
other or at least one other VBE participant in the value-based 
enterprise;
    (3) That have an accountable body or person responsible for the 
financial and operational oversight of the value-based enterprise; and
    (4) That have a governing document that describes the value-based 
enterprise and how the VBE participants intend to achieve its value-
based purpose(s).
    Value-based purpose means any of the following:
    (1) Coordinating and managing the care of a target patient 
population;
    (2) Improving the quality of care for a target patient population;
    (3) Appropriately reducing the costs to or growth in expenditures of 
payors without reducing the quality of care for a target patient 
population; or
    (4) Transitioning from health care delivery and payment mechanisms 
based on the volume of items and services provided to mechanisms based 
on the quality of care and control of costs of care for a target patient 
population.
    VBE participant means a person or entity that engages in at least 
one value-based activity as part of a value-based enterprise.

[85 FR 77656, Dec. 2, 2020]



Sec.  411.352  Group practice.

    For purposes of this subpart, a group practice is a physician 
practice that meets the following conditions:
    (a) Single legal entity. The group practice must consist of a single 
legal entity operating primarily for the purpose of being a physician 
group practice in any organizational form recognized by

[[Page 531]]

the State in which the group practice achieves its legal status, 
including, but not limited to, a partnership, professional corporation, 
limited liability company, foundation, nonprofit corporation, faculty 
practice plan, or similar association. The single legal entity may be 
organized by any party or parties, including, but not limited to, 
physicians, health care facilities, or other persons or entities 
(including, but not limited to, physicians individually incorporated as 
professional corporations). The single legal entity may be organized or 
owned (in whole or in part) by another medical practice, provided that 
the other medical practice is not an operating physician practice (and 
regardless of whether the medical practice meets the conditions for a 
group practice under this section). For purposes of this subpart, a 
single legal entity does not include informal affiliations of physicians 
formed substantially to share profits from referrals, or separate group 
practices under common ownership or control through a physician practice 
management company, hospital, health system, or other entity or 
organization. A group practice that is otherwise a single legal entity 
may itself own subsidiary entities. A group practice operating in more 
than one State will be considered to be a single legal entity 
notwithstanding that it is composed of multiple legal entities, provided 
that--
    (1) The States in which the group practice is operating are 
contiguous (although each State need not be contiguous to every other 
State);
    (2) The legal entities are absolutely identical as to ownership, 
governance, and operation; and
    (3) Organization of the group practice into multiple entities is 
necessary to comply with jurisdictional licensing laws of the States in 
which the group practice operates.
    (b) Physicians. The group practice must have at least two physicians 
who are members of the group (whether employees or direct or indirect 
owners), as defined at Sec.  411.351.
    (c) Range of care. Each physician who is a member of the group, as 
defined at Sec.  411.351, must furnish substantially the full range of 
patient care services that the physician routinely furnishes, including 
medical care, consultation, diagnosis, and treatment, through the joint 
use of shared office space, facilities, equipment, and personnel.
    (d) Services furnished by group practice members. (1) Except as 
otherwise provided in paragraphs (d)(3) through (6) of this section, 
substantially all of the patient care services of the physicians who are 
members of the group (that is, at least 75 percent of the total patient 
care services of the group practice members) must be furnished through 
the group and billed under a billing number assigned to the group, and 
the amounts received must be treated as receipts of the group. Patient 
care services must be measured by one of the following:
    (i) The total time each member spends on patient care services 
documented by any reasonable means (including, but not limited to, time 
cards, appointment schedules, or personal diaries). (For example, if a 
physician practices 40 hours a week and spends 30 hours a week on 
patient care services for a group practice, the physician has spent 75 
percent of his or her time providing patient care services for the 
group.)
    (ii) Any alternative measure that is reasonable, fixed in advance of 
the performance of the services being measured, uniformly applied over 
time, verifiable, and documented.
    (2) The data used to calculate compliance with this substantially 
all test and related supportive documentation must be made available to 
the Secretary upon request.
    (3) The substantially all test set forth in paragraph (d)(1) of this 
section does not apply to any group practice that is located solely in a 
HPSA, as defined at Sec.  411.351.
    (4) For a group practice located outside of a HPSA (as defined at 
Sec.  411.351), any time spent by a group practice member providing 
services in a HPSA should not be used to calculate whether the group 
practice has met the substantially all test, regardless of whether the 
member's time in the HPSA is spent in a group practice, clinic, or 
office setting.
    (5) During the start up period (not to exceed 12 months) that begins 
on the date of the initial formation of a new

[[Page 532]]

group practice, a group practice must make a reasonable, good faith 
effort to ensure that the group practice complies with the substantially 
all test requirement set forth in paragraph (d)(1) of this section as 
soon as practicable, but no later than 12 months from the date of the 
initial formation of the group practice. This paragraph (d)(5) does not 
apply when an existing group practice admits a new member or 
reorganizes.
    (6)(i) If the addition to an existing group practice of a new member 
who would be considered to have relocated his or her medical practice 
under Sec.  411.357(e)(2) would result in the existing group practice 
not meeting the substantially all test set forth in paragraph (d)(1) of 
this section, the group practice will have 12 months following the 
addition of the new member to come back into full compliance, provided 
that--
    (A) For the 12-month period the group practice is fully compliant 
with the substantially all test if the new member is not counted as a 
member of the group for purposes of Sec.  411.352; and
    (B) The new member's employment with, or ownership interest in, the 
group practice is documented in writing no later than the beginning of 
his or her new employment, ownership, or investment.
    (ii) This paragraph (d)(6) does not apply when an existing group 
practice reorganizes or admits a new member who is not relocating his or 
her medical practice.
    (e) Distribution of expenses and income. The overhead expenses of, 
and income from, the practice must be distributed according to methods 
that are determined before the receipt of payment for the services 
giving rise to the overhead expense or producing the income. Nothing in 
this section prevents a group practice from adjusting its compensation 
methodology prospectively, subject to restrictions on the distribution 
of revenue from DHS under paragraph (i) of this section.
    (f) Unified business. (1) The group practice must be a unified 
business having at least the following features:
    (i) Centralized decision-making by a body representative of the 
group practice that maintains effective control over the group's assets 
and liabilities (including, but not limited to, budgets, compensation, 
and salaries); and
    (ii) Consolidated billing, accounting, and financial reporting.
    (2) Location and specialty-based compensation practices are 
permitted with respect to revenues derived from services that are not 
DHS and may be permitted with respect to revenues derived from DHS under 
paragraph (i) of this section.
    (g) Volume or value of referrals. No physician who is a member of 
the group practice directly or indirectly receives compensation based on 
the volume or value of his or her referrals, except as provided in 
paragraph (i) of this section.
    (h) Physician-patient encounters. Members of the group must 
personally conduct no less than 75 percent of the physician-patient 
encounters of the group practice.
    (i) Special rule for productivity bonuses and profit shares. (1) A 
physician in the group practice may be paid a share of overall profits 
of the group, provided that the share is not determined in any manner 
that is directly related to the volume or value of referrals of DHS by 
the physician. A physician in the group practice may be paid a 
productivity bonus based on services that he or she has personally 
performed, or services ``incident to'' such personally performed 
services, or both, provided that the bonus is not determined in any 
manner that is directly related to the volume or value of referrals of 
DHS by the physician (except that the bonus may directly relate to the 
volume or value of DHS referrals by the physician if the referrals are 
for services ``incident to'' the physician's personally performed 
services).
    (2) Overall profits means the group's entire profits derived from 
DHS payable by Medicare or Medicaid or the profits derived from DHS 
payable by Medicare or Medicaid of any component of the group practice 
that consists of at least five physicians. Overall profits should be 
divided in a reasonable and verifiable manner that is not directly 
related to the volume or value of the physician's referrals of DHS. The 
share of overall profits will be deemed not to relate directly to the 
volume or

[[Page 533]]

value of referrals if one of the following conditions is met:
    (i) The group's profits are divided per capita (for example, per 
member of the group or per physician in the group).
    (ii) Revenues derived from DHS are distributed based on the 
distribution of the group practice's revenues attributed to services 
that are not DHS payable by any Federal health care program or private 
payer.
    (iii) Revenues derived from DHS constitute less than 5 percent of 
the group practice's total revenues, and the allocated portion of those 
revenues to each physician in the group practice constitutes 5 percent 
or less of his or her total compensation from the group.
    (3) A productivity bonus must be calculated in a reasonable and 
verifiable manner that is not directly related to the volume or value of 
the physician's referrals of DHS. A productivity bonus will be deemed 
not to relate directly to the volume or value of referrals of DHS if one 
of the following conditions is met:
    (i) The bonus is based on the physician's total patient encounters 
or relative value units (RVUs). (The methodology for establishing RVUs 
is set forth in Sec.  414.22 of this chapter.)
    (ii) The bonus is based on the allocation of the physician's 
compensation attributable to services that are not DHS payable by any 
Federal health care program or private payer.
    (iii) Revenues derived from DHS are less than 5 percent of the group 
practice's total revenues, and the allocated portion of those revenues 
to each physician in the group practice constitutes 5 percent or less of 
his or her total compensation from the group practice.
    (4) Supporting documentation verifying the method used to calculate 
the profit share or productivity bonus under paragraphs (i)(2) and (3) 
of this section, and the resulting amount of compensation, must be made 
available to the Secretary upon request.

[85 FR 77656, Dec. 2, 2020]

    Effective Date Note: At 86 FR 77682, Dec. 2, 2020, Sec.  411.352 was 
amended by revising paragraph (i), effective Jan. 1, 2022. For the 
convenience of the user, the revised text is set forth as follows:



Sec.  411.352  Group practice.

                                * * * * *

    (i) Special rules for profit shares and productivity bonuses--(1) 
Overall profits. (i) Notwithstanding paragraph (g) of this section, a 
physician in the group may be paid a share of overall profits that is 
not directly related to the volume or value of the physician's 
referrals.
    (ii) Overall profits means the profits derived from all the 
designated health services of any component of the group that consists 
of at least five physicians, which may include all physicians in the 
group. If there are fewer than five physicians in the group, overall 
profits means the profits derived from all the designated health 
services of the group.
    (iii) Overall profits must be divided in a reasonable and verifiable 
manner. The share of overall profits will be deemed not to directly 
relate to the volume or value of referrals if one of the following 
conditions is met:
    (A) Overall profits are divided per capita (for example, per member 
of the group or per physician in the group).
    (B) Overall profits are distributed based on the distribution of the 
group's revenues attributed to services that are not designated health 
services and would not be considered designated health services if they 
were payable by Medicare.
    (C) Revenues derived from designated health services constitute less 
than 5 percent of the group's total revenues, and the portion of those 
revenues distributed to each physician in the group constitutes 5 
percent or less of his or her total compensation from the group.
    (2) Productivity bonuses. (i) Notwithstanding paragraph (g) of this 
section, a physician in the group may be paid a productivity bonus based 
on services that he or she has personally performed, or services 
``incident to'' such personally performed services, that is not directly 
related to the volume or value of the physician's referrals (except that 
the bonus may directly relate to the volume or value of the physician's 
referrals if the referrals are for services ``incident to'' the 
physician's personally performed services).
    (ii) A productivity bonus must be calculated in a reasonable and 
verifiable manner. A productivity bonus will be deemed not to relate 
directly to the volume or value of referrals if one of the following 
conditions is met:
    (A) The productivity bonus is based on the physician's total patient 
encounters or the relative value units (RVUs) personally performed by 
the physician.
    (B) The services on which the productivity bonus is based are not 
designated health

[[Page 534]]

services and would not be considered designated health services if they 
were payable by Medicare.
    (C) Revenues derived from designated health services constitute less 
than 5 percent of the group's total revenues, and the portion of those 
revenues distributed to each physician in the group constitutes 5 
percent or less of his or her total compensation from the group.
    (3) Value-based enterprise participation. Notwithstanding paragraph 
(g) of this section, profits from designated health services that are 
directly attributable to a physician's participation in a value-based 
enterprise, as defined at Sec.  411.351, may be distributed to the 
participating physician.
    (4) Supporting documentation. Supporting documentation verifying the 
method used to calculate the profit share or productivity bonus under 
paragraphs (i)(1), (2), and (3) of this section, and the resulting 
amount of compensation, must be made available to the Secretary upon 
request.



Sec.  411.353  Prohibition on certain referrals by physicians and limitations 
on billing.

    (a) Prohibition on referrals. Except as provided in this subpart, a 
physician who has a direct or indirect financial relationship with an 
entity, or who has an immediate family member who has a direct or 
indirect financial relationship with the entity, may not make a referral 
to that entity for the furnishing of DHS for which payment otherwise may 
be made under Medicare. A physician's prohibited financial relationship 
with an entity that furnishes DHS is not imputed to his or her group 
practice or its members or its staff. However, a referral made by a 
physician's group practice, its members, or its staff may be imputed to 
the physician if the physician directs the group practice, its members, 
or its staff to make the referral or if the physician controls referrals 
made by his or her group practice, its members, or its staff.
    (b) Limitations on billing. An entity that furnishes DHS pursuant to 
a referral that is prohibited by paragraph (a) of this section may not 
present or cause to be presented a claim or bill to the Medicare program 
or to any individual, third party payer, or other entity for the DHS 
performed pursuant to the prohibited referral.
    (c) Denial of payment for services furnished under a prohibited 
referral. (1) Except as provided in paragraph (e) of this section, no 
Medicare payment may be made for a designated health service that is 
furnished pursuant to a prohibited referral.
    (2) When payment for a designated health service is denied on the 
basis that the service was furnished pursuant to a prohibited referral, 
and such payment denial is appealed--
    (i) The ultimate burden of proof (burden of persuasion) at each 
level of appeal is on the entity submitting the claim for payment to 
establish that the service was not furnished pursuant to a prohibited 
referral (and not on CMS or its contractors to establish that the 
service was furnished pursuant to a prohibited referral); and
    (ii) The burden of production on each issue at each level of appeal 
is initially on the claimant, but may shift to CMS or its contractors 
during the course of the appellate proceeding, depending on the evidence 
presented by the claimant.
    (d) Refunds. An entity that collects payment for a designated health 
service that was performed pursuant to a prohibited referral must refund 
all collected amounts on a timely basis, as defined at Sec.  1003.101 of 
this title.
    (e) Exception for certain entities. Payment may be made to an entity 
that submits a claim for a designated health service if--
    (1) The entity did not have actual knowledge of, and did not act in 
reckless disregard or deliberate ignorance of, the identity of the 
physician who made the referral of the designated health service to the 
entity; and
    (2) The claim otherwise complies with all applicable Federal and 
State laws, rules, and regulations.
    (f) Exception for certain arrangements involving temporary 
noncompliance. (1) Except as provided in paragraphs (f)(2) through (4) 
of this section, an entity may submit a claim or bill and payment may be 
made to an entity that submits a claim or bill for a designated health 
service if--
    (i) The financial relationship between the entity and the referring 
physician fully complied with an applicable exception under Sec.  
411.355, 411.356, or 411.357 for at least 180 consecutive calendar days 
immediately preceding the date

[[Page 535]]

on which the financial relationship became noncompliant with the 
exception; and
    (ii) The financial relationship has fallen out of compliance with 
the exception for reasons beyond the control of the entity, and the 
entity promptly takes steps to rectify the noncompliance.
    (2) Paragraph (f)(1) of this section applies only to DHS furnished 
during the period of time it takes the entity to rectify the 
noncompliance, which must not exceed 90 consecutive calendar days 
following the date on which the financial relationship became 
noncompliant with an exception.
    (3) Paragraph (f)(1) may be used by an entity only once every 3 
years with respect to the same referring physician.
    (4) Paragraph (f)(1) does not apply if the exception with which the 
financial relationship previously complied was Sec.  411.357(k) or (m).
    (g) [Reserved]
    (h) Special rule for reconciling compensation. An entity may submit 
a claim or bill and payment may be made to an entity that submits a 
claim or bill for a designated health service if--
    (1) No later than 90 consecutive calendar days following the 
expiration or termination of a compensation arrangement, the entity and 
the physician (or immediate family member of a physician) that are 
parties to the compensation arrangement reconcile all discrepancies in 
payments under the arrangement such that, following the reconciliation, 
the entire amount of remuneration for items or services has been paid as 
required under the terms and conditions of the arrangement; and
    (2) Except for the discrepancies in payments described in paragraph 
(h)(1) of this section, the compensation arrangement fully complies with 
an applicable exception in this subpart.

[85 FR 77656, Dec. 2, 2020]



Sec.  411.354  Financial relationship, compensation, and ownership 
or investment interest.

    (a) Financial relationships--(1) Financial relationship means--
    (i) A direct or indirect ownership or investment interest (as 
defined in paragraph (b) of this section) in any entity that furnishes 
DHS; or
    (ii) A direct or indirect compensation arrangement (as defined in 
paragraph (c) of this section) with an entity that furnishes DHS.
    (2) Types of financial relationships. (i) A direct financial 
relationship exists if remuneration passes between the referring 
physician (or a member of his or her immediate family) and the entity 
furnishing DHS without any intervening persons or entities between the 
entity furnishing DHS and the referring physician (or a member of his or 
her immediate family).
    (ii) An indirect financial relationship exists under the conditions 
described in paragraphs (b)(5) and (c)(2) of this section.
    (b) Ownership or investment interest. An ownership or investment 
interest in the entity may be through equity, debt, or other means, and 
includes an interest in an entity that holds an ownership or investment 
interest in any entity that furnishes DHS.
    (1) An ownership or investment interest includes, but is not limited 
to, stock, stock options other than those described in paragraph 
(b)(3)(ii) of this section, partnership shares, limited liability 
company memberships, as well as loans, bonds, or other financial 
instruments that are secured with an entity's property or revenue or a 
portion of that property or revenue.
    (2) An ownership or investment interest in a subsidiary company is 
neither an ownership or investment interest in the parent company, nor 
in any other subsidiary of the parent, unless the subsidiary company 
itself has an ownership or investment interest in the parent or such 
other subsidiaries. It may, however, be part of an indirect financial 
relationship.
    (3) Ownership and investment interests do not include, among other 
things--
    (i) An interest in an entity that arises from a retirement plan 
offered by that entity to the physician (or a member of his or her 
immediate family) through the physician's (or immediate family member's) 
employment with that entity;
    (ii) Stock options and convertible securities received as 
compensation until

[[Page 536]]

the stock options are exercised or the convertible securities are 
converted to equity (before this time the stock options or convertible 
securities are compensation arrangements as defined in paragraph (c) of 
this section);
    (iii) An unsecured loan subordinated to a credit facility (which is 
a compensation arrangement as defined in paragraph (c) of this section);
    (iv) An ``under arrangements'' contract between a hospital and an 
entity owned by one or more physicians (or a group of physicians) 
providing DHS ``under arrangements'' with the hospital (such a contract 
is a compensation arrangement as defined in paragraph (c) of this 
section);
    (v) A security interest held by a physician in equipment sold by the 
physician to a hospital and financed through a loan from the physician 
to the hospital (such an interest is a compensation arrangement as 
defined in paragraph (c) of this section);
    (vi) A titular ownership or investment interest that excludes the 
ability or right to receive the financial benefits of ownership or 
investment, including, but not limited to, the distribution of profits, 
dividends, proceeds of sale, or similar returns on investment; or
    (vii) An interest in an entity that arises from an employee stock 
ownership plan (ESOP) that is qualified under Internal Revenue Code 
section 401(a).
    (4) An ownership or investment interest that meets an exception set 
forth in Sec.  411.355 or Sec.  411.356 need not also meet an exception 
for compensation arrangements set forth in Sec.  411.357 with respect to 
profit distributions, dividends, or interest payments on secured 
obligations.
    (5)(i) An indirect ownership or investment interest exists if--
    (A) Between the referring physician (or immediate family member) and 
the entity furnishing DHS there exists an unbroken chain of any number 
(but no fewer than one) of persons or entities having ownership or 
investment interests; and
    (B) The entity furnishing DHS has actual knowledge of, or acts in 
reckless disregard or deliberate ignorance of, the fact that the 
referring physician (or immediate family member) has some ownership or 
investment interest (through any number of intermediary ownership or 
investment interests) in the entity furnishing the DHS.
    (ii) An indirect ownership or investment interest exists even though 
the entity furnishing DHS does not know, or acts in reckless disregard 
or deliberate ignorance of, the precise composition of the unbroken 
chain or the specific terms of the ownership or investment interests 
that form the links in the chain.
    (iii) Notwithstanding anything in this paragraph (b)(5), common 
ownership or investment in an entity does not, in and of itself, 
establish an indirect ownership or investment interest by one common 
owner or investor in another common owner or investor.
    (iv) An indirect ownership or investment interest requires an 
unbroken chain of ownership interests between the referring physician 
and the entity furnishing DHS such that the referring physician has an 
indirect ownership or investment interest in the entity furnishing DHS.
    (c) Compensation arrangement. A compensation arrangement is any 
arrangement involving remuneration, direct or indirect, between a 
physician (or a member of a physician's immediate family) and an entity. 
An ``under arrangements'' contract between a hospital and an entity 
providing DHS ``under arrangements'' to the hospital creates a 
compensation arrangement for purposes of these regulations. A 
compensation arrangement does not include the portion of any business 
arrangement that consists solely of the remuneration described in 
section 1877(h)(1)(C) of the Act and in paragraphs (1) through (3) of 
the definition of the term ``remuneration'' at Sec.  411.351. (However, 
any other portion of the arrangement may still constitute a compensation 
arrangement.)
    (1)(i) A direct compensation arrangement exists if remuneration 
passes between the referring physician (or a member of his or her 
immediate family) and the entity furnishing DHS without any intervening 
persons or entities.
    (ii) Except as provided in paragraph (c)(3)(ii)(C) of this section, 
a physician is deemed to ``stand in the shoes'' of

[[Page 537]]

his or her physician organization and have a direct compensation 
arrangement with an entity furnishing DHS if--
    (A) The only intervening entity between the physician and the entity 
furnishing DHS is his or her physician organization; and
    (B) The physician has an ownership or investment interest in the 
physician organization.
    (iii) A physician (other than a physician described in paragraph 
(c)(1)(ii)(B) of this section) is permitted to ``stand in the shoes'' of 
his or her physician organization and have a direct compensation 
arrangement with an entity furnishing DHS if the only intervening entity 
between the physician and the entity furnishing DHS is his or her 
physician organization.
    (2) An indirect compensation arrangement exists if all of the 
conditions of paragraphs (c)(2)(i) through (iii) of this section exist:
    (i) Between the referring physician (or a member of his or her 
immediate family) and the entity furnishing DHS there exists an unbroken 
chain of any number (but not fewer than one) of persons or entities that 
have financial relationships (as defined in paragraph (a) of this 
section) between them (that is, each link in the chain has either an 
ownership or investment interest or a compensation arrangement with the 
preceding link).
    (ii)(A) The referring physician (or immediate family member) 
receives aggregate compensation from the person or entity in the chain 
with which the physician (or immediate family member) has a direct 
financial relationship that varies with the volume or value of referrals 
or other business generated by the referring physician for the entity 
furnishing the DHS and the individual unit of compensation received by 
the physician (or immediate family member)--
    (1) Is not fair market value for items or services actually 
provided;
    (2) Includes the physician's referrals to the entity furnishing DHS 
as a variable, resulting in an increase or decrease in the physician's 
(or immediate family member's) compensation that positively correlates 
with the number or value of the physician's referrals to the entity; or
    (3) Includes other business generated by the physician for the 
entity furnishing DHS as a variable, resulting in an increase or 
decrease in the physician's (or immediate family member's) compensation 
that positively correlates with the physician's generation of other 
business for the entity.
    (B) For purposes of applying paragraph (c)(2)(ii)(A) of this 
section, a positive correlation between two variables exists when one 
variable decreases as the other variable decreases, or one variable 
increases as the other variable increases.
    (C) If the financial relationship between the physician (or 
immediate family member) and the person or entity in the chain with 
which the referring physician (or immediate family member) has a direct 
financial relationship is an ownership or investment interest, the 
determination whether the aggregate compensation varies with the volume 
or value of referrals or other business generated by the referring 
physician for the entity furnishing the DHS will be measured by the 
nonownership or noninvestment interest closest to the referring 
physician (or immediate family member). (For example, if a referring 
physician has an ownership interest in company A, which owns company B, 
which has a compensation arrangement with company C, which has a 
compensation arrangement with entity D that furnishes DHS, we would look 
to the aggregate compensation between company B and company C for 
purposes of this paragraph (c)(2)(ii)).
    (iii) The entity furnishing DHS has actual knowledge of, or acts in 
reckless disregard or deliberate ignorance of, the fact that the 
referring physician (or immediate family member) receives aggregate 
compensation that varies with the volume or value of referrals or other 
business generated by the referring physician for the entity furnishing 
the DHS.
    (iv)(A) For purposes of paragraph (c)(2)(i) of this section, except 
as provided in paragraph (c)(3)(ii)(C) of this section, a physician is 
deemed to ``stand in the shoes'' of his or her physician organization if 
the physician has

[[Page 538]]

an ownership or investment interest in the physician organization.
    (B) For purposes of paragraph (c)(2)(i) of this section, a physician 
(other than a physician described in paragraph (c)(2)(iv)(A) of this 
section) is permitted to ``stand in the shoes'' of his or her physician 
organization.
    (3)(i) For purposes of paragraphs (c)(1)(ii) and (c)(2)(iv) of this 
section, a physician who ``stands in the shoes'' of his or her physician 
organization is deemed to have the same compensation arrangements (with 
the same parties and on the same terms) as the physician organization. 
When applying the exceptions in Sec. Sec.  411.355 and 411.357 to 
arrangements in which a physician stands in the shoes of his or her 
physician organization, the ``parties to the arrangements'' are 
considered to be--
    (A) With respect to a signature requirement, the physician 
organization and any physician who ``stands in the shoes'' of the 
physician organization as required under paragraph (c)(1)(ii) or 
(c)(2)(iv)(A) of this section; and
    (B) With respect to all other requirements of the exception, 
including the relevant referrals and other business generated between 
the parties, the entity furnishing DHS and the physician organization 
(including all members, employees, and independent contractor 
physicians).
    (ii) The provisions of paragraphs (c)(1)(ii) and (c)(2)(iv)(A) of 
this section--
    (A) Need not apply during the original term or current renewal term 
of an arrangement that satisfied the requirements of Sec.  411.357(p) as 
of September 5, 2007 (see 42 CFR parts 400-413, revised as of October 1, 
2007);
    (B) Do not apply to an arrangement that satisfies the requirements 
of Sec.  411.355(e); and
    (C) Do not apply to a physician whose ownership or investment 
interest is titular only. A titular ownership or investment interest is 
an ownership or investment interest that excludes the ability or right 
to receive the financial benefits of ownership or investment, including, 
but not limited to, the distribution of profits, dividends, proceeds of 
sale, or similar returns on investment.
    (iii) An arrangement structured to comply with an exception in Sec.  
411.357 (other than Sec.  411.357(p)), but which would otherwise qualify 
as an indirect compensation arrangement under this paragraph as of 
August 19, 2008, need not be restructured to satisfy the requirements of 
Sec.  411.357(p) until the expiration of the original term or current 
renewal term of the arrangement.
    (4)(i) Exceptions applicable to indirect compensation arrangements--
General. Except as provided in this paragraph (c)(4) of this section, 
only the exceptions at Sec. Sec.  411.355 and 411.357(p) are applicable 
to indirect compensation arrangements.
    (ii) Special rule for indirect compensation arrangements involving a 
MCO or IPA and a referring physician. Only the exceptions at Sec. Sec.  
411.355, 411.357(n), and 411.357(p) are applicable in the case of an 
indirect compensation arrangement in which the entity furnishing DHS 
described in paragraph (c)(2)(i) of this section is a MCO or IPA.
    (iii) Special rule for indirect compensation arrangements involving 
value-based arrangements. When an unbroken chain described in paragraph 
(c)(2)(i) of this section includes a value-based arrangement (as defined 
at Sec.  411.351) to which the physician (or the physician organization 
in whose shoes the physician stands under this paragraph) is a direct 
party--
    (A) Only the exceptions at Sec. Sec.  411.355, 411.357(p), and 
411.357(aa) are applicable to the indirect compensation arrangement if 
the entity furnishing DHS is not a MCO or IPA; and
    (B) Only the exceptions at Sec. Sec.  411.355, 411.357(n), 
411.357(p), and 411.357(aa) are applicable to the indirect compensation 
arrangement if the entity furnishing DHS is a MCO or IPA.
    (d) Special rules on compensation. The following special rules apply 
only to compensation under section 1877 of the Act and subpart J of this 
part:
    (1) Set in advance. (i) Compensation is deemed to be ``set in 
advance'' if the aggregate compensation, a time-based or per-unit of 
service-based (whether per-use or per-service) amount, or a specific 
formula for calculating the compensation is set out in writing before 
the furnishing of the items, services, office space, or equipment for

[[Page 539]]

which the compensation is to be paid. The formula for determining the 
compensation must be set forth in sufficient detail so that it can be 
objectively verified.
    (ii) Notwithstanding paragraph (d)(1)(i) of this section, 
compensation (or a formula for determining the compensation) may be 
modified at any time during the course of a compensation arrangement and 
satisfy the requirement that it is ``set in advance'' if all of the 
following conditions are met:
    (A) All requirements of an applicable exception in Sec. Sec.  
411.355 through 411.357 are met on the effective date of the modified 
compensation (or the formula for determining the modified compensation).
    (B) The modified compensation (or the formula for determining the 
modified compensation) is determined before the furnishing of the items, 
services, office space, or equipment for which the modified compensation 
is to be paid.
    (C) Before the furnishing of the items, services, office space, or 
equipment for which the modified compensation is to be paid, the formula 
for the modified compensation is set forth in writing in sufficient 
detail so that it can be objectively verified. Paragraph (e)(4) of this 
section does not apply for purposes of this paragraph (d)(1)(ii)(C).
    (2) Unit-based compensation and the volume or value standard. Unit-
based compensation (including time-based or per-unit of service-based 
compensation) is deemed not to take into account the volume or value of 
referrals if the compensation is fair market value for items or services 
actually provided and does not vary during the course of the 
compensation arrangement in any manner that takes into account referrals 
of designated health services. This paragraph (d)(2) does not apply for 
purposes of paragraphs (d)(5)(i) and (6)(i) of this section.
    (3) Unit-based compensation and the other business generated 
standard. Unit-based compensation (including time-based or per-unit of 
service-based compensation) is deemed not to take into account other 
business generated between the parties or other business generated by 
the referring physician if the compensation is fair market value for 
items and services actually provided and does not vary during the course 
of the compensation arrangement in any manner that takes into account 
referrals or other business generated by the referring physician, 
including private pay health care business (except for services 
personally performed by the referring physician, which are not 
considered ``other business generated'' by the referring physician). 
This paragraph (d)(3) does not apply for purposes of paragraphs 
(d)(5)(ii) and (d)(6)(ii) of this section.
    (4) Directed referral requirement. If a physician's compensation 
under a bona fide employment relationship, personal service arrangement, 
or managed care contract is conditioned on the physician's referrals to 
a particular provider, practitioner, or supplier, all of the following 
conditions must be met.
    (i) The compensation, or a formula for determining the compensation, 
is set in advance for the duration of the arrangement. Any changes to 
the compensation (or the formula for determining the compensation) must 
be made prospectively.
    (ii) The compensation is consistent with the fair market value of 
the physician's services.
    (iii) The compensation arrangement otherwise satisfies the 
requirements of an applicable exception at Sec.  411.355 or Sec.  
411.357.
    (iv) The compensation arrangement complies with both of the 
following conditions:
    (A) The requirement to make referrals to a particular provider, 
practitioner, or supplier is set out in writing and signed by the 
parties.
    (B) The requirement to make referrals to a particular provider, 
practitioner, or supplier does not apply if the patient expresses a 
preference for a different provider, practitioner, or supplier; the 
patient's insurer determines the provider, practitioner, or supplier; or 
the referral is not in the patient's best medical interests in the 
physician's judgment.
    (v) The required referrals relate solely to the physician's services 
covered by the scope of the employment, personal service arrangement, or 
managed

[[Page 540]]

care contract, and the referral requirement is reasonably necessary to 
effectuate the legitimate business purposes of the compensation 
arrangement. In no event may the physician be required to make referrals 
that relate to services that are not provided by the physician under the 
scope of his or her employment, personal service arrangement, or managed 
care contract.
    (vi) Regardless of whether the physician's compensation takes into 
account the volume or value of referrals by the physician as set forth 
at paragraph (d)(5)(i) of this section, neither the existence of the 
compensation arrangement nor the amount of the compensation is 
contingent on the number or value of the physician's referrals to the 
particular provider, practitioner, or supplier. The requirement to make 
referrals to a particular provider, practitioner, or supplier may 
require that the physician refer an established percentage or ratio of 
the physician's referrals to a particular provider, practitioner, or 
supplier.
    (5) Compensation to a physician. (i) Compensation from an entity 
furnishing designated health services to a physician (or immediate 
family member of the physician) takes into account the volume or value 
of referrals only if the formula used to calculate the physician's (or 
immediate family member's) compensation includes the physician's 
referrals to the entity as a variable, resulting in an increase or 
decrease in the physician's (or immediate family member's) compensation 
that positively correlates with the number or value of the physician's 
referrals to the entity.
    (ii) Compensation from an entity furnishing designated health 
services to a physician (or immediate family member of the physician) 
takes into account the volume or value of other business generated only 
if the formula used to calculate the physician's (or immediate family 
member's) compensation includes other business generated by the 
physician for the entity as a variable, resulting in an increase or 
decrease in the physician's (or immediate family member's) compensation 
that positively correlates with the physician's generation of other 
business for the entity.
    (iii) For purposes of applying this paragraph (d)(5), a positive 
correlation between two variables exists when one variable decreases as 
the other variable decreases, or one variable increases as the other 
variable increases.
    (iv) This paragraph (d)(5) does not apply for purposes of applying 
the special rules in paragraphs (d)(2) and (3) of this section or the 
exceptions at Sec.  411.357(m), (s), (u), (v), (w), and (bb).
    (6) Compensation from a physician. (i) Compensation from a physician 
(or immediate family member of the physician) to an entity furnishing 
designated health services takes into account the volume or value of 
referrals only if the formula used to calculate the entity's 
compensation includes the physician's referrals to the entity as a 
variable, resulting in an increase or decrease in the entity's 
compensation that negatively correlates with the number or value of the 
physician's referrals to the entity.
    (ii) Compensation from a physician (or immediate family member of 
the physician) to an entity furnishing designated health services takes 
into account the volume or value of other business generated only if the 
formula used to calculate the entity's compensation includes other 
business generated by the physician for the entity as a variable, 
resulting in an increase or decrease in the entity's compensation that 
negatively correlates with the physician's generation of other business 
for the entity.
    (iii) For purposes of applying this paragraph (d)(6), a negative 
correlation between two variables exists when one variable increases as 
the other variable decreases, or when one variable decreases as the 
other variable increases.
    (iv) This paragraph (d)(6) does not apply for purposes of applying 
the special rules in paragraphs (d)(2) and (3) of this section or the 
exceptions at Sec.  411.357(m), (s), (u), (v), (w), and (bb).
    (e) Special rule on compensation arrangements--(1) Application. This 
paragraph (e) applies only to compensation arrangements as defined in 
section 1877 of the Act and this subpart.
    (2) Writing requirement. In the case of any requirement in this 
subpart for a compensation arrangement to be in

[[Page 541]]

writing, such requirement may be satisfied by a collection of documents, 
including contemporaneous documents evidencing the course of conduct 
between the parties.
    (3) Signature requirement. In the case of any signature requirement 
in this subpart, such requirement may be satisfied by an electronic or 
other signature that is valid under applicable Federal or State law.
    (4) Special rule on writing and signature requirements. In the case 
of any requirement in this subpart for a compensation arrangement to be 
in writing and signed by the parties, the writing requirement or the 
signature requirement is satisfied if--
    (i) The compensation arrangement between the entity and the 
physician fully complies with an applicable exception in this subpart 
except with respect to the writing or signature requirement of the 
exception; and
    (ii) The parties obtain the required writing(s) or signature(s) 
within 90 consecutive calendar days immediately following the date on 
which the compensation arrangement became noncompliant with the 
requirements of the applicable exception (that is, the date on which the 
writing(s) or signature(s) were required under the applicable exception 
but the parties had not yet obtained them).

[85 FR 77656, Dec. 2, 2020]



Sec.  411.355  General exceptions to the referral prohibition related to 
both ownership/investment and compensation.

    The prohibition on referrals set forth in Sec.  411.353 does not 
apply to the following types of services:
    (a) Physician services. (1) Physician services as defined at Sec.  
410.20(a) of this chapter that are furnished--
    (i) Personally by another physician who is a member of the referring 
physician's group practice or is a physician in the same group practice 
(as defined at Sec.  411.351) as the referring physician; or
    (ii) Under the supervision of another physician who is a member of 
the referring physician's group practice or is a physician in the same 
group practice (as defined at Sec.  411.351) as the referring physician, 
provided that the supervision complies with all other applicable 
Medicare payment and coverage rules for the physician services.
    (2) For purposes of this paragraph (a), ``physician services'' 
include only those ``incident to'' services (as defined at Sec.  
411.351) that are physician services under Sec.  410.20(a) of this 
chapter.
    (b) In-office ancillary services. Services (including certain items 
of durable medical equipment (DME), as defined in paragraph (b)(4) of 
this section, and infusion pumps that are DME (including external 
ambulatory infusion pumps), but excluding all other DME and parenteral 
and enteral nutrients, equipment, and supplies (such as infusion pumps 
used for PEN)), that meet the following conditions:
    (1) Individual who furnishes the service. They are furnished 
personally by one of the following individuals:
    (i) The referring physician.
    (ii) A physician who is a member of the same group practice as the 
referring physician.
    (iii) An individual who is supervised by the referring physician or, 
if the referring physician is in a group practice, by another physician 
in the group practice, provided that the supervision complies with all 
other applicable Medicare payment and coverage rules for the services.
    (2) Location where service is furnished. They are furnished in one 
of the following locations:
    (i) The same building (as defined at Sec.  411.351), but not 
necessarily in the same space or part of the building, in which all of 
the conditions of paragraph (b)(2)(i)(A), (b)(2)(i)(B), or (b)(2)(i)(C) 
of this section are satisfied:
    (A)(1) The referring physician or his or her group practice (if any) 
has an office that is normally open to the physician's or group's 
patients for medical services at least 35 hours per week; and
    (2) The referring physician or one or more members of the referring 
physician's group practice regularly practices medicine and furnishes 
physician services to patients at least 30 hours per week. The 30 hours 
must include some physician services that are unrelated to the 
furnishing of DHS payable by Medicare, any other Federal health care 
payer, or a private payer, even

[[Page 542]]

though the physician services may lead to the ordering of DHS; or
    (B)(1) The patient receiving the DHS usually receives physician 
services from the referring physician or members of the referring 
physician's group practice (if any);
    (2) The referring physician or the referring physician's group 
practice owns or rents an office that is normally open to the 
physician's or group's patients for medical services at least 8 hours 
per week; and
    (3) The referring physician regularly practices medicine and 
furnishes physician services to patients at least 6 hours per week. The 
6 hours must include some physician services that are unrelated to the 
furnishing of DHS payable by Medicare, any other Federal health care 
payer, or a private payer, even though the physician services may lead 
to the ordering of DHS; or
    (C)(1) The referring physician is present and orders the DHS during 
a patient visit on the premises as set forth in paragraph 
(b)(2)(i)(C)(2) of this section or the referring physician or a member 
of the referring physician's group practice (if any) is present while 
the DHS is furnished during occupancy of the premises as set forth in 
paragraph (b)(2)(i)(C)(2) of this section;
    (2) The referring physician or the referring physician's group 
practice owns or rents an office that is normally open to the 
physician's or group's patients for medical services at least 8 hours 
per week; and
    (3) The referring physician or one or more members of the referring 
physician's group practice regularly practices medicine and furnishes 
physician services to patients at least 6 hours per week. The 6 hours 
must include some physician services that are unrelated to the 
furnishing of DHS payable by Medicare, any other Federal health care 
payer, or a private payer, even though the physician services may lead 
to the ordering of DHS.
    (ii) A centralized building (as defined at Sec.  411.351) that is 
used by the group practice for the provision of some or all of the group 
practice's clinical laboratory services.
    (iii) A centralized building (as defined at Sec.  411.351) that is 
used by the group practice for the provision of some or all of the group 
practice's DHS (other than clinical laboratory services).
    (3) Billing of the service. They are billed by one of the following:
    (i) The physician performing or supervising the service.
    (ii) The group practice of which the performing or supervising 
physician is a member under a billing number assigned to the group 
practice.
    (iii) The group practice if the supervising physician is a 
``physician in the group practice'' (as defined at Sec.  411.351) under 
a billing number assigned to the group practice.
    (iv) An entity that is wholly owned by the performing or supervising 
physician or by that physician's group practice under the entity's own 
billing number or under a billing number assigned to the physician or 
group practice.
    (v) An independent third party billing company acting as an agent of 
the physician, group practice, or entity specified in paragraphs 
(b)(3)(i) through (iv) of this section under a billing number assigned 
to the physician, group practice, or entity, provided that the billing 
arrangement meets the requirements of Sec.  424.80(b)(5) of this 
chapter. For purposes of this paragraph (b)(3), a group practice may 
have, and bill under, more than one Medicare billing number, subject to 
any applicable Medicare program restrictions.
    (4) Durable Medical Equipment. For purposes of this paragraph (b), 
DME covered by the in-office ancillary services exception means canes, 
crutches, walkers and folding manual wheelchairs, and blood glucose 
monitors, that meet the following conditions:
    (i) The item is one that a patient requires for the purpose of 
ambulating, a patient uses in order to depart from the physician's 
office, or is a blood glucose monitor (including one starter set of test 
strips and lancets, consisting of no more than 100 of each). A blood 
glucose monitor may be furnished only by a physician or employee of a 
physician or group practice that also furnishes outpatient diabetes 
self-management training to the patient.
    (ii) The item is furnished in a building that meets the ``same 
building'' requirements in the in-office ancillary

[[Page 543]]

services exception as part of the treatment for the specific condition 
for which the patient-physician encounter occurred.
    (iii) The item is furnished personally by the physician who ordered 
the DME, by another physician in the group practice, or by an employee 
of the physician or the group practice.
    (iv) A physician or group practice that furnishes the DME meets all 
DME supplier standards set forth in Sec.  424.57(c) of this chapter.
    (v) [Reserved]
    (vi) All other requirements of the in-office ancillary services 
exception in this paragraph (b) are met.
    (5) Furnishing a service. A designated health service is 
``furnished'' for purposes of this paragraph (b) in the location where 
the service is actually performed upon a patient or where an item is 
dispensed to a patient in a manner that is sufficient to meet the 
applicable Medicare payment and coverage rules.
    (6) Special rule for home care physicians. In the case of a 
referring physician whose principal medical practice consists of 
treating patients in their private homes, the ``same building'' 
requirements of paragraph (b)(2)(i) of this section are met if the 
referring physician (or a qualified person accompanying the physician, 
such as a nurse or technician) provides the DHS contemporaneously with a 
physician service that is not a designated health service provided by 
the referring physician to the patient in the patient's private home. 
For purposes of paragraph (b)(5) of this section only, a private home 
does not include a nursing, long-term care, or other facility or 
institution, except that a patient may have a private home in an 
assisted living or independent living facility.
    (7) Disclosure requirement for certain imaging services. (i) With 
respect to magnetic resonance imaging, computed tomography, and positron 
emission tomography services identified as ``radiology and certain other 
imaging services'' on the List of CPT/HCPCS Codes, the referring 
physician must provide written notice to the patient at the time of the 
referral that the patient may receive the same services from a person 
other than one described in paragraph (b)(1) of this section. Except as 
set forth in paragraph (b)(7)(ii) of this section, the written notice 
must include a list of at least 5 other suppliers (as defined at Sec.  
400.202 of this chapter) that provide the services for which the 
individual is being referred and which are located within a 25-mile 
radius of the referring physician's office location at the time of the 
referral. The notice should be written in a manner sufficient to be 
reasonably understood by all patients and should include for each 
supplier on the list, at a minimum, the supplier's name, address, and 
telephone number.
    (ii) If there are fewer than 5 other suppliers located within a 25-
mile radius of the physician's office location at the time of the 
referral, the physician must list all of the other suppliers of the 
imaging service that are present within a 25-mile radius of the 
referring physician's office location. Provision of the written list of 
alternate suppliers will not be required if no other suppliers provide 
the services for which the individual is being referred within the 25-
mile radius.
    (c) Services furnished by an organization (or its contractors or 
subcontractors) to enrollees. Services furnished by an organization (or 
its contractors or subcontractors) to enrollees of one of the following 
prepaid health plans (not including services provided to enrollees in 
any other plan or line of business offered or administered by the same 
organization):
    (1) An HMO or a CMP in accordance with a contract with CMS under 
section 1876 of the Act and part 417, subparts J through M of this 
chapter.
    (2) A health care prepayment plan in accordance with an agreement 
with CMS under section 1833(a)(1)(A) of the Act and part 417, subpart U 
of this chapter.
    (3) An organization that is receiving payments on a prepaid basis 
for Medicare enrollees through a demonstration project under section 
402(a) of the Social Security Amendments of 1967 (42 U.S.C. 1395b-1) or 
under section 222(a) of the Social Security Amendments of 1972 (42 
U.S.C. 1395b-1 note).
    (4) A qualified HMO (within the meaning of section 1310(d) of the 
Public Health Service Act).

[[Page 544]]

    (5) A coordinated care plan (within the meaning of section 
1851(a)(2)(A) of the Act) offered by a Medicare Advantage organization 
in accordance with a contract with CMS under section 1857 of the Act and 
part 422 of this chapter.
    (6) A MCO contracting with a State under section 1903(m) of the Act.
    (7) A prepaid inpatient health plan (PIHP) or prepaid ambulance 
health plan (PAHP) contracting with a State under part 438 of this 
chapter.
    (8) A health insuring organization (HIO) contracting with a State 
under part 438, subpart D of this chapter.
    (9) An entity operating under a demonstration project under sections 
1115(a), 1915(a), 1915(b), or 1932(a) of the Act.
    (d) [Reserved]
    (e) Academic medical centers. (1) Services provided by an academic 
medical center if all of the following conditions are met:
    (i) The referring physician--
    (A) Is a bona fide employee of a component of the academic medical 
center on a full-time or substantial part-time basis. (A ``component'' 
of an academic medical center means an affiliated medical school, 
faculty practice plan, hospital, teaching facility, institution of 
higher education, departmental professional corporation, or nonprofit 
support organization whose primary purpose is supporting the teaching 
mission of the academic medical center.) The components need not be 
separate legal entities;
    (B) Is licensed to practice medicine in the State(s) in which he or 
she practices medicine;
    (C) Has a bona fide faculty appointment at the affiliated medical 
school or at one or more of the educational programs at the accredited 
academic hospital (as defined at Sec.  411.355(e)(3)); and
    (D) Provides either substantial academic services or substantial 
clinical teaching services (or a combination of academic services and 
clinical teaching services) for which the faculty member receives 
compensation as part of his or her employment relationship with the 
academic medical center. Parties should use a reasonable and consistent 
method for calculating a physician's academic services and clinical 
teaching services. A physician will be deemed to meet this requirement 
if he or she spends at least 20 percent of his or her professional time 
or 8 hours per week providing academic services or clinical teaching 
services (or a combination of academic services or clinical teaching 
services). A physician who does not spend at least 20 percent of his or 
her professional time or 8 hours per week providing academic services or 
clinical teaching services (or a combination of academic services or 
clinical teaching services) is not precluded from qualifying under this 
paragraph (e)(1)(i)(D).
    (ii) The compensation paid to the referring physician must meet all 
of the following conditions:
    (A) The total compensation paid by each academic medical center 
component to the referring physician is set in advance.
    (B) In the aggregate, the compensation paid by all academic medical 
center components to the referring physician does not exceed fair market 
value for the services provided.
    (C) The total compensation paid by each academic medical center 
component is not determined in any manner that takes into account the 
volume or value of referrals or other business generated by the 
referring physician within the academic medical center.
    (D) If any compensation paid to the referring physician is 
conditioned on the physician's referrals to a particular provider, 
practitioner, or supplier, the arrangement satisfies the conditions of 
Sec.  411.354(d)(4).
    (iii) The academic medical center must meet all of the following 
conditions:
    (A) All transfers of money between components of the academic 
medical center must directly or indirectly support the missions of 
teaching, indigent care, research, or community service.
    (B) The relationship of the components of the academic medical 
center must be set forth in one or more written agreements or other 
written documents that have been adopted by the governing body of each 
component. If the academic medical center is one legal entity, this 
requirement will be satisfied if transfers of funds between components 
of the academic medical

[[Page 545]]

center are reflected in the routine financial reports covering the 
components.
    (C) All money paid to a referring physician for research must be 
used solely to support bona fide research or teaching and must be 
consistent with the terms and conditions of the grant.
    (2) The ``academic medical center'' for purposes of this section 
consists of--
    (i) An accredited medical school (including a university, when 
appropriate) or an accredited academic hospital (as defined at paragraph 
(e)(3) of this section);
    (ii) One or more faculty practice plans affiliated with the medical 
school, the affiliated hospital(s), or the accredited academic hospital; 
and
    (iii) One or more affiliated hospitals in which a majority of the 
physicians on the medical staff consists of physicians who are faculty 
members and a majority of all hospital admissions is made by physicians 
who are faculty members. The hospital for purposes of this paragraph 
(e)(2)(iii) may be the same hospital that satisfies the requirement of 
paragraph (e)(2)(i) of this section. For purposes of this paragraph 
(e)(2)(iii), a faculty member is a physician who is either on the 
faculty of the affiliated medical school or on the faculty of one or 
more of the educational programs at the accredited academic hospital. In 
meeting this paragraph (e)(2)(iii), faculty from any affiliated medical 
school or accredited academic hospital education program may be 
aggregated, and residents and non-physician professionals need not be 
counted. Any faculty member may be counted, including courtesy and 
volunteer faculty. For purposes of determining whether the majority of 
physicians on the medical staff consists of faculty members, the 
affiliated hospital must include or exclude all individual physicians 
with the same class of privileges at the affiliated hospital (for 
example, physicians holding courtesy privileges).
    (3) An accredited academic hospital for purposes of this section 
means a hospital or a health system that sponsors four or more approved 
medical education programs.
    (f) Implants furnished by an ASC. Implants furnished by an ASC, 
including, but not limited to, cochlear implants, intraocular lenses, 
and other implanted prosthetics, implanted prosthetic devices, and 
implanted DME that meet the following conditions:
    (1) The implant is implanted by the referring physician or a member 
of the referring physician's group practice in an ASC that is certified 
by Medicare under part 416 of this chapter and with which the referring 
physician has a financial relationship.
    (2) The implant is implanted in the patient during a surgical 
procedure paid by Medicare to the ASC as an ASC procedure under Sec.  
416.65 of this chapter.
    (3) [Reserved]
    (4) [Reserved]
    (5) The exception set forth in this paragraph (f) does not apply to 
any financial relationships between the referring physician and any 
entity other than the ASC in which the implant is furnished to, and 
implanted in, the patient.
    (g) EPO and other dialysis-related drugs. EPO and other dialysis-
related drugs that meet the following conditions:
    (1) The EPO and other dialysis-related drugs are furnished in or by 
an ESRD facility. For purposes of this paragraph (g)(1), ``EPO and other 
dialysis-related drugs'' means certain outpatient prescription drugs 
that are required for the efficacy of dialysis and identified as 
eligible for this exception on the List of CPT/HCPCS Codes; and 
``furnished'' means that the EPO or dialysis-related drugs are 
administered to a patient in the ESRD facility or, in the case of EPO or 
Aranesp (or equivalent drug identified on the List of CPT/HCPCS Codes) 
only, are dispensed by the ESRD facility for use at home.
    (2) [Reserved]
    (3) [Reserved]
    (4) The exception set forth in this paragraph (g) does not apply to 
any financial relationship between the referring physician and any 
entity other than the ESRD facility that furnishes the EPO and other 
dialysis-related drugs to the patient.
    (h) Preventive screening tests, immunizations, and vaccines. 
Preventive screening tests, immunizations, and

[[Page 546]]

vaccines that meet the following conditions:
    (1) The preventive screening tests, immunizations, and vaccines are 
subject to CMS-mandated frequency limits.
    (2) [Reserved]
    (3) [Reserved]
    (4) The preventive screening tests, immunizations, and vaccines must 
be covered by Medicare and must be listed as eligible for this exception 
on the List of CPT/HCPCS Codes.
    (i) Eyeglasses and contact lenses following cataract surgery. 
Eyeglasses and contact lenses that are covered by Medicare when 
furnished to patients following cataract surgery that meet the following 
conditions:
    (1) The eyeglasses or contact lenses are provided in accordance with 
the coverage and payment provisions set forth in Sec. Sec.  
410.36(a)(2)(ii) and 414.228 of this chapter, respectively.
    (2) [Reserved]
    (j) Intra-family rural referrals. (1) Services provided pursuant to 
a referral from a referring physician to his or her immediate family 
member or to an entity furnishing DHS with which the immediate family 
member has a financial relationship, if all of the following conditions 
are met:
    (i) The patient who is referred resides in a rural area as defined 
at Sec.  411.351 of this subpart;
    (ii) Except as provided in paragraph (j)(1)(iii) of this section, in 
light of the patient's condition, no other person or entity is available 
to furnish the services in a timely manner within 25 miles of or 45 
minutes transportation time from the patient's residence;
    (iii) In the case of services furnished to patients where they 
reside (for example, home health services or DME), no other person or 
entity is available to furnish the services in a timely manner in light 
of the patient's condition; and
    (2) The referring physician or the immediate family member must make 
reasonable inquiries as to the availability of other persons or entities 
to furnish the DHS. However, neither the referring physician nor the 
immediate family member has any obligation to inquire as to the 
availability of persons or entities located farther than 25 miles of or 
45 minutes transportation time from (whichever test the referring 
physician utilized for purposes of paragraph (j)(1)(ii)) the patient's 
residence.

[85 FR 77656, Dec. 2, 2020]



Sec.  411.356  Exceptions to the referral prohibition related to ownership 
or investment interests.

    For purposes of Sec.  411.353, the following ownership or investment 
interests do not constitute a financial relationship:
    (a) Publicly traded securities. Ownership of investment securities 
(including shares or bonds, debentures, notes, or other debt 
instruments) that at the time the DHS referral was made could be 
purchased on the open market and that meet the requirements of 
paragraphs (a)(1) and (2) of this section.
    (1) They are either--
    (i) Listed for trading on the New York Stock Exchange, the American 
Stock Exchange, or any regional exchange in which quotations are 
published on a daily basis, or foreign securities listed on a recognized 
foreign, national, or regional exchange in which quotations are 
published on a daily basis;
    (ii) Traded under an automated interdealer quotation system operated 
by the National Association of Securities Dealers; or
    (iii) Listed for trading on an electronic stock market or over-the-
counter quotation system in which quotations are published on a daily 
basis and trades are standardized and publicly transparent.
    (2) They are in a corporation that had stockholder equity exceeding 
$75 million at the end of the corporation's most recent fiscal year or 
on average during the previous 3 fiscal years. ``Stockholder equity'' is 
the difference in value between a corporation's total assets and total 
liabilities.
    (b) Mutual funds. Ownership of shares in a regulated investment 
company as defined in section 851(a) of the Internal Revenue Code of 
1986, if the company had, at the end of its most recent fiscal year, or 
on average during the previous 3 fiscal years, total assets exceeding 
$75 million.

[[Page 547]]

    (c) Specific providers. Ownership or investment interest in the 
following entities, for purposes of the services specified:
    (1) A rural provider, in the case of DHS furnished in a rural area 
(as defined at Sec.  411.351 of this part) by the provider. A ``rural 
provider'' is an entity that furnishes substantially all (not less than 
75 percent) of the DHS that it furnishes to residents of a rural area 
and, for the 18-month period beginning on December 8, 2003 (or such 
other period as Congress may specify), is not a specialty hospital, and 
in the case where the entity is a hospital, the hospital meets the 
requirements of Sec.  411.362 no later than September 23, 2011.
    (2) A hospital that is located in Puerto Rico, in the case of DHS 
furnished by such a hospital.
    (3) A hospital that is located outside of Puerto Rico, in the case 
of DHS furnished by such a hospital, if--
    (i) The referring physician is authorized to perform services at the 
hospital;
    (ii) Effective for the 18-month period beginning on December 8, 2003 
(or such other period as Congress may specify), the hospital is not a 
specialty hospital;
    (iii) The ownership or investment interest is in the entire hospital 
and not merely in a distinct part or department of the hospital; and
    (iv) The hospital meets the requirements described in Sec.  411.362 
not later than September 23, 2011.

[85 FR 77656, Dec. 2, 2020]



Sec.  411.357  Exceptions to the referral prohibition related to 
compensation arrangements.

    For purposes of Sec.  411.353, the following compensation 
arrangements do not constitute a financial relationship:
    (a) Rental of office space. Payments for the use of office space 
made by a lessee to a lessor if the arrangement meets the following 
requirements:
    (1) The lease arrangement is set out in writing, is signed by the 
parties, and specifies the premises it covers.
    (2) The duration of the lease arrangement is at least 1 year. To 
meet this requirement, if the lease arrangement is terminated with or 
without cause, the parties may not enter into a new lease arrangement 
for the same space during the first year of the original lease 
arrangement.
    (3) The space rented or leased does not exceed that which is 
reasonable and necessary for the legitimate business purposes of the 
lease arrangement and is used exclusively by the lessee when being used 
by the lessee (and is not shared with or used by the lessor or any 
person or entity related to the lessor), except that the lessee may make 
payments for the use of space consisting of common areas if the payments 
do not exceed the lessee's pro rata share of expenses for the space 
based upon the ratio of the space used exclusively by the lessee to the 
total amount of space (other than common areas) occupied by all persons 
using the common areas. For purposes of this paragraph (a), exclusive 
use means that the lessee (and any other lessees of the same office 
space) uses the office space to the exclusion of the lessor (or any 
person or entity related to the lessor). The lessor (or any person or 
entity related to the lessor) may not be an invitee of the lessee to use 
the office space.
    (4) The rental charges over the term of the lease arrangement are 
set in advance and are consistent with fair market value.
    (5) The rental charges over the term of the lease arrangement are 
not determined--
    (i) In any manner that takes into account the volume or value of 
referrals or other business generated between the parties; or
    (ii) Using a formula based on--
    (A) A percentage of the revenue raised, earned, billed, collected, 
or otherwise attributable to the services performed or business 
generated in the office space; or
    (B) Per-unit of service rental charges, to the extent that such 
charges reflect services provided to patients referred by the lessor to 
the lessee.
    (6) The lease arrangement would be commercially reasonable even if 
no referrals were made between the lessee and the lessor.
    (7) If the lease arrangement expires after a term of at least 1 
year, a holdover lease arrangement immediately following the expiration 
of the lease

[[Page 548]]

arrangement satisfies the requirements of paragraph (a) of this section 
if the following conditions are met:
    (i) The lease arrangement met the conditions of paragraphs (a)(1) 
through (6) of this section when the arrangement expired;
    (ii) The holdover lease arrangement is on the same terms and 
conditions as the immediately preceding arrangement; and
    (iii) The holdover lease arrangement continues to satisfy the 
conditions of paragraphs (a)(1) through (6) of this section.
    (b) Rental of equipment. Payments made by a lessee to a lessor for 
the use of equipment under the following conditions:
    (1) The lease arrangement is set out in writing, is signed by the 
parties, and specifies the equipment it covers.
    (2) The equipment leased does not exceed that which is reasonable 
and necessary for the legitimate business purposes of the lease 
arrangement and is used exclusively by the lessee when being used by the 
lessee (and is not shared with or used by the lessor or any person or 
entity related to the lessor). For purposes of this paragraph (b), 
exclusive use means that the lessee (and any other lessees of the same 
equipment) uses the equipment to the exclusion of the lessor (or any 
person or entity related to the lessor). The lessor (or any person or 
entity related to the lessor) may not be an invitee of the lessee to use 
the equipment.
    (3) The duration of the lease arrangement is at least 1 year. To 
meet this requirement, if the lease arrangement is terminated with or 
without cause, the parties may not enter into a new lease arrangement 
for the same equipment during the first year of the original lease 
arrangement.
    (4) The rental charges over the term of the lease arrangement are 
set in advance, are consistent with fair market value, and are not 
determined--
    (i) In any manner that takes into account the volume or value of 
referrals or other business generated between the parties; or
    (ii) Using a formula based on--
    (A) A percentage of the revenue raised, earned, billed, collected, 
or otherwise attributable to the services performed on or business 
generated through the use of the equipment; or
    (B) Per-unit of service rental charges, to the extent that such 
charges reflect services provided to patients referred by the lessor to 
the lessee.
    (5) The lease arrangement would be commercially reasonable even if 
no referrals were made between the parties.
    (6) If the lease arrangement expires after a term of at least 1 
year, a holdover lease arrangement immediately following the expiration 
of the lease arrangement satisfies the requirements of this paragraph 
(b) if the following conditions are met:
    (i) The lease arrangement met the conditions of paragraphs (b)(1) 
through (5) of this section when the arrangement expired;
    (ii) The holdover lease arrangement is on the same terms and 
conditions as the immediately preceding lease arrangement; and
    (iii) The holdover lease arrangement continues to satisfy the 
conditions of paragraphs (b)(1) through (5) of this section.
    (c) Bona fide employment relationships. Any amount paid by an 
employer to a physician (or immediate family member) who has a bona fide 
employment relationship with the employer for the provision of services 
if the following conditions are met:
    (1) The employment is for identifiable services.
    (2) The amount of the remuneration under the employment is--
    (i) Consistent with the fair market value of the services; and
    (ii) Except as provided in paragraph (c)(4) of this section, is not 
determined in any manner that takes into account the volume or value of 
referrals by the referring physician.
    (3) The remuneration is provided under an arrangement that would be 
commercially reasonable even if no referrals were made to the employer.
    (4) Paragraph (c)(2)(ii) of this section does not prohibit payment 
of remuneration in the form of a productivity bonus based on services 
performed personally by the physician (or immediate family member of the 
physician).

[[Page 549]]

    (5) If remuneration to the physician is conditioned on the 
physician's referrals to a particular provider, practitioner, or 
supplier, the arrangement satisfies the conditions of Sec.  
411.354(d)(4).
    (d) Personal service arrangements--(1) General. Remuneration from an 
entity under an arrangement or multiple arrangements to a physician or 
his or her immediate family member, or to a group practice, including 
remuneration for specific physician services furnished to a nonprofit 
blood center, if the following conditions are met:
    (i) Each arrangement is set out in writing, is signed by the 
parties, and specifies the services covered by the arrangement.
    (ii) Except for services provided under an arrangement that 
satisfies all of the conditions of paragraph (z) of this section, the 
arrangement(s) covers all of the services to be furnished by the 
physician (or an immediate family member of the physician) to the 
entity. This requirement is met if all separate arrangements between the 
entity and the physician and the entity and any family members 
incorporate each other by reference or if they cross-reference a master 
list of contracts that is maintained and updated centrally and is 
available for review by the Secretary upon request. The master list must 
be maintained in a manner that preserves the historical record of 
contracts. A physician or family member may ``furnish'' services through 
employees whom they have hired for the purpose of performing the 
services; through a wholly-owned entity; or through locum tenens 
physicians (as defined at Sec.  411.351, except that the regular 
physician need not be a member of a group practice).
    (iii) The aggregate services covered by the arrangement do not 
exceed those that are reasonable and necessary for the legitimate 
business purposes of the arrangement(s).
    (iv) The duration of each arrangement is at least 1 year. To meet 
this requirement, if an arrangement is terminated with or without cause, 
the parties may not enter into the same or substantially the same 
arrangement during the first year of the original arrangement.
    (v) The compensation to be paid over the term of each arrangement is 
set in advance, does not exceed fair market value, and, except in the 
case of a physician incentive plan (as defined at Sec.  411.351), is not 
determined in any manner that takes into account the volume or value of 
referrals or other business generated between the parties.
    (vi) The services to be furnished under each arrangement do not 
involve the counseling or promotion of a business arrangement or other 
activity that violates any Federal or State law.
    (vii) If the arrangement expires after a term of at least 1 year, a 
holdover arrangement immediately following the expiration of the 
arrangement satisfies the requirements of paragraph (d) of this section 
if the following conditions are met:
    (A) The arrangement met the conditions of paragraphs (d)(1)(i) 
through (vi) of this section when the arrangement expired;
    (B) The holdover arrangement is on the same terms and conditions as 
the immediately preceding arrangement; and
    (C) The holdover arrangement continues to satisfy the conditions of 
paragraphs (d)(1)(i) through (vi) of this section.
    (viii) If remuneration to the physician is conditioned on the 
physician's referrals to a particular provider, practitioner, or 
supplier, the arrangement satisfies the conditions of Sec.  
411.354(d)(4).
    (2) Physician incentive plan exception. In the case of a physician 
incentive plan (as defined at Sec.  411.351) between a physician and an 
entity (or downstream contractor), the compensation may be determined in 
any manner (through a withhold, capitation, bonus, or otherwise) that 
takes into account the volume or value of referrals or other business 
generated between the parties, if the plan meets the following 
requirements:
    (i) No specific payment is made directly or indirectly under the 
plan to a physician or a physician group as an inducement to reduce or 
limit medically necessary services furnished with respect to a specific 
individual enrolled with the entity.
    (ii) Upon request of the Secretary, the entity provides the 
Secretary with

[[Page 550]]

access to information regarding the plan (including any downstream 
contractor plans), in order to permit the Secretary to determine whether 
the plan is in compliance with paragraph (d)(2) of this section.
    (iii) In the case of a plan that places a physician or a physician 
group at substantial financial risk as defined at Sec.  422.208, the 
entity or any downstream contractor (or both) complies with the 
requirements concerning physician incentive plans set forth in 
Sec. Sec.  422.208 and 422.210 of this chapter.
    (iv) If remuneration to the physician is conditioned on the 
physician's referrals to a particular provider, practitioner, or 
supplier, the arrangement satisfies the conditions of Sec.  
411.354(d)(4).
    (e) Physician recruitment. (1) Remuneration provided by a hospital 
to recruit a physician that is paid directly to the physician and that 
is intended to induce the physician to relocate his or her medical 
practice to the geographic area served by the hospital in order to 
become a member of the hospital's medical staff, if all of the following 
conditions are met:
    (i) The arrangement is set out in writing and signed by both 
parties;
    (ii) The arrangement is not conditioned on the physician's referral 
of patients to the hospital;
    (iii) The amount of remuneration under the arrangement is not 
determined in any manner that takes into account the volume or value of 
actual or anticipated referrals by the physician or other business 
generated between the parties; and
    (iv) The physician is allowed to establish staff privileges at any 
other hospital(s) and to refer business to any other entities (except as 
referrals may be restricted under an employment or services arrangement 
that complies with Sec.  411.354(d)(4)).
    (2)(i) Geographic area served by the hospital--defined. The 
``geographic area served by the hospital'' is the area composed of the 
lowest number of contiguous zip codes from which the hospital draws at 
least 75 percent of its inpatients. The geographic area served by the 
hospital may include one or more zip codes from which the hospital draws 
no inpatients, provided that such zip codes are entirely surrounded by 
zip codes in the geographic area described above from which the hospital 
draws at least 75 percent of its inpatients.
    (ii) Noncontiguous zip codes. With respect to a hospital that draws 
fewer than 75 percent of its inpatients from all of the contiguous zip 
codes from which it draws inpatients, the ``geographic area served by 
the hospital'' will be deemed to be the area composed of all of the 
contiguous zip codes from which the hospital draws its inpatients.
    (iii) Special optional rule for rural hospitals. In the case of a 
hospital located in a rural area (as defined at Sec.  411.351), the 
``geographic area served by the hospital'' may also be the area composed 
of the lowest number of contiguous zip codes from which the hospital 
draws at least 90 percent of its inpatients. If the hospital draws fewer 
than 90 percent of its inpatients from all of the contiguous zip codes 
from which it draws inpatients, the ``geographic area served by the 
hospital'' may include noncontiguous zip codes, beginning with the 
noncontiguous zip code in which the highest percentage of the hospital's 
inpatients resides, and continuing to add noncontiguous zip codes in 
decreasing order of percentage of inpatients.
    (iv) Relocation of medical practice. A physician will be considered 
to have relocated his or her medical practice if the medical practice 
was located outside the geographic area served by the hospital and--
    (A) The physician moves his or her medical practice at least 25 
miles and into the geographic area served by the hospital; or
    (B) The physician moves his medical practice into the geographic 
area served by the hospital, and the physician's new medical practice 
derives at least 75 percent of its revenues from professional services 
furnished to patients (including hospital inpatients) not seen or 
treated by the physician at his or her prior medical practice site 
during the preceding 3 years, measured on an annual basis (fiscal or 
calendar year). For the initial ``start up'' year of the recruited 
physician's practice, the 75 percent test in the preceding sentence will 
be satisfied if there is a reasonable expectation that the recruited 
physician's medical practice for the

[[Page 551]]

year will derive at least 75 percent of its revenues from professional 
services furnished to patients not seen or treated by the physician at 
his or her prior medical practice site during the preceding 3 years.
    (3) The recruited physician will not be subject to the relocation 
requirement of this paragraph (e), provided that he or she establishes 
his or her medical practice in the geographic area served by the 
recruiting hospital, if--
    (i) He or she is a resident or physician who has been in practice 1 
year or less;
    (ii) He or she was employed on a full-time basis for at least 2 
years immediately prior to the recruitment arrangement by one of the 
following (and did not maintain a private practice in addition to such 
full-time employment):
    (A) A Federal or State bureau of prisons (or similar entity 
operating one or more correctional facilities) to serve a prison 
population;
    (B) The Department of Defense or Department of Veterans Affairs to 
serve active or veteran military personnel and their families; or
    (C) A facility of the Indian Health Service to serve patients who 
receive medical care exclusively through the Indian Health Service; or
    (iii) The Secretary has deemed in an advisory opinion issued under 
section 1877(g) of the Act that the physician does not have an 
established medical practice that serves or could serve a significant 
number of patients who are or could become patients of the recruiting 
hospital.
    (4) In the case of remuneration provided by a hospital to a 
physician either indirectly through payments made to another physician 
practice, or directly to a physician who joins a physician practice, the 
following additional conditions must be met:
    (i) The writing in paragraph (e)(1) of this section is also signed 
by the physician practice if the remuneration is provided indirectly to 
the physician through payments made to the physician practice and the 
physician practice does not pass directly through to the physician all 
of the remuneration from the hospital.
    (ii) Except for actual costs incurred by the physician practice in 
recruiting the new physician, the remuneration is passed directly 
through to or remains with the recruited physician.
    (iii) In the case of an income guarantee of any type made by the 
hospital to a recruited physician who joins a physician practice, the 
costs allocated by the physician practice to the recruited physician do 
not exceed the actual additional incremental costs attributable to the 
recruited physician. With respect to a physician recruited to join a 
physician practice located in a rural area or HPSA, if the physician is 
recruited to replace a physician who, within the previous 12-month 
period, retired, relocated outside of the geographic area served by the 
hospital, or died, the costs allocated by the physician practice to the 
recruited physician do not exceed either--
    (A) The actual additional incremental costs attributable to the 
recruited physician; or
    (B) The lower of a per capita allocation or 20 percent of the 
practice's aggregate costs.
    (iv) Records of the actual costs and the passed-through amounts are 
maintained for a period of at least 6 years and made available to the 
Secretary upon request.
    (v) The remuneration from the hospital under the arrangement is not 
determined in any manner that takes into account the volume or value of 
actual or anticipated referrals by the recruited physician or the 
physician practice (or any physician affiliated with the physician 
practice) receiving the direct payments from the hospital.
    (vi) The physician practice may not impose on the recruited 
physician practice restrictions that unreasonably restrict the recruited 
physician's ability to practice medicine in the geographic area served 
by the hospital.
    (5) Recruitment of a physician by a hospital located in a rural area 
(as defined at Sec.  411.351) to an area outside the geographic area 
served by the hospital is permitted under this exception if the 
Secretary determines in an advisory opinion issued under section 1877(g) 
of

[[Page 552]]

the Act that the area has a demonstrated need for the recruited 
physician and all other requirements of this paragraph (e) are met.
    (6)(i) This paragraph (e) applies to remuneration provided by a 
federally qualified health center or a rural health clinic in the same 
manner as it applies to remuneration provided by a hospital.
    (ii) The ``geographic area served'' by a federally qualified health 
center or a rural health clinic is the area composed of the lowest 
number of contiguous or noncontiguous zip codes from which the federally 
qualified health center or rural health clinic draws at least 90 percent 
of its patients, as determined on an encounter basis. The geographic 
area served by the federally qualified health center or rural health 
clinic may include one or more zip codes from which the federally 
qualified health center or rural health clinic draws no patients, 
provided that such zip codes are entirely surrounded by zip codes in the 
geographic area described above from which the federally qualified 
health center or rural health clinic draws at least 90 percent of its 
patients.
    (f) Isolated transactions. Isolated financial transactions, such as 
a one-time sale of property or a practice, or a single instance of 
forgiveness of an amount owed in settlement of a bona fide dispute, if 
all of the following conditions are met:
    (1) The amount of remuneration under the isolated financial 
transaction is--
    (i) Consistent with the fair market value of the isolated financial 
transaction; and
    (ii) Not determined in any manner that takes into account the volume 
or value of referrals by the referring physician or other business 
generated between the parties.
    (2) The remuneration is provided under an arrangement that would be 
commercially reasonable even if the physician made no referrals to the 
entity.
    (3) There are no additional transactions between the parties for 6 
months after the isolated transaction, except for transactions that are 
specifically excepted under the other provisions in Sec. Sec.  411.355 
through 411.357 and except for commercially reasonable post-closing 
adjustments that do not take into account the volume or value of 
referrals or other business generated by the referring physician.
    (4) An isolated financial transaction that is an instance of 
forgiveness of an amount owed in settlement of a bona fide dispute is 
not part of the compensation arrangement giving rise to the bona fide 
dispute.
    (g) Certain arrangements with hospitals. Remuneration provided by a 
hospital to a physician if the remuneration does not relate, directly or 
indirectly, to the furnishing of DHS. To qualify as ``unrelated,'' 
remuneration must be wholly unrelated to the furnishing of DHS and must 
not in any way take into account the volume or value of a physician's 
referrals. Remuneration relates to the furnishing of DHS if it--
    (1) Is an item, service, or cost that could be allocated in whole or 
in part to Medicare or Medicaid under cost reporting principles;
    (2) Is furnished, directly or indirectly, explicitly or implicitly, 
in a selective, targeted, preferential, or conditioned manner to medical 
staff or other persons in a position to make or influence referrals; or
    (3) Otherwise takes into account the volume or value of referrals or 
other business generated by the referring physician.
    (h) Group practice arrangements with a hospital. An arrangement 
between a hospital and a group practice under which DHS are furnished by 
the group but are billed by the hospital if the following conditions are 
met:
    (1) With respect to services furnished to an inpatient of the 
hospital, the arrangement is pursuant to the provision of inpatient 
hospital services under section 1861(b)(3) of the Act.
    (2) The arrangement began before, and has continued in effect 
without interruption since, December 19, 1989.
    (3) With respect to the DHS covered under the arrangement, at least 
75 percent of these services furnished to patients of the hospital are 
furnished by the group under the arrangement.
    (4) The arrangement is in accordance with a written agreement that 
specifies

[[Page 553]]

the services to be furnished by the parties and the compensation for 
services furnished under the agreement.
    (5) The compensation paid over the term of the agreement is 
consistent with fair market value, and the compensation per unit of 
service is fixed in advance and is not determined in any manner that 
takes into account the volume or value of referrals or other business 
generated between the parties.
    (6) The compensation is provided in accordance with an agreement 
that would be commercially reasonable even if no referrals were made to 
the entity.
    (7) If remuneration to the physician is conditioned on the 
physician's referrals to a particular provider, practitioner, or 
supplier, the arrangement satisfies the conditions of Sec.  
411.354(d)(4).
    (i) Payments by a physician. Payments made by a physician (or his or 
her immediate family member)--
    (1) To a laboratory in exchange for the provision of clinical 
laboratory services; or
    (2) To an entity as compensation for any other items or services--
    (i) That are furnished at a price that is consistent with fair 
market value; and
    (ii) To which the exceptions in paragraphs (a) through (h) of this 
section are not applicable.
    (3) For purposes of this paragraph (i), ``services'' means services 
of any kind (not merely those defined as ``services'' for purposes of 
the Medicare program in Sec.  400.202 of this chapter).
    (j) Charitable donations by a physician. Bona fide charitable 
donations made by a physician (or immediate family member) to an entity 
if all of the following conditions are satisfied:
    (1) The charitable donation is made to an organization exempt from 
taxation under the Internal Revenue Code (or to a supporting 
organization);
    (2) The donation is neither solicited, nor offered, in any manner 
that takes into account the volume or value of referrals or other 
business generated between the physician and the entity; and
    (k) Nonmonetary compensation. (1) Compensation from an entity in the 
form of items or services (not including cash or cash equivalents) that 
does not exceed an aggregate of $300 per calendar year, as adjusted for 
inflation in accordance with paragraph (k)(2) of this section, if all of 
the following conditions are satisfied:
    (i) The compensation is not determined in any manner that takes into 
account the volume or value of referrals or other business generated by 
the referring physician.
    (ii) The compensation may not be solicited by the physician or the 
physician's practice (including employees and staff members).
    (2) The annual aggregate nonmonetary compensation limit in this 
paragraph (k) is adjusted each calendar year to the nearest whole dollar 
by the increase in the Consumer Price Index--Urban All Items (CPI-U) for 
the 12-month period ending the preceding September 30. CMS displays 
after September 30 each year both the increase in the CPI-U for the 12-
month period and the new nonmonetary compensation limit on the physician 
self-referral website at http://www.cms.hhs.gov/PhysicianSelfReferral/
10_CPI-U_ Updates.asp.
    (3) Where an entity has inadvertently provided nonmonetary 
compensation to a physician in excess of the limit (as set forth in 
paragraph (k)(1) of this section), such compensation is deemed to be 
within the limit if--
    (i) The value of the excess nonmonetary compensation is no more than 
50 percent of the limit; and
    (ii) The physician returns to the entity the excess nonmonetary 
compensation (or an amount equal to the value of the excess nonmonetary 
compensation) by the end of the calendar year in which the excess 
nonmonetary compensation was received or within 180 consecutive calendar 
days following the date the excess nonmonetary compensation was received 
by the physician, whichever is earlier.
    (iii) This paragraph (k)(3) may be used by an entity only once every 
3 years with respect to the same referring physician.
    (4) In addition to nonmonetary compensation up to the limit 
described in paragraph (k)(1) of this section, an entity that has a 
formal medical staff may provide one local medical staff appreciation 
event per year for the entire medical staff. Any gifts or gratuities

[[Page 554]]

provided in connection with the medical staff appreciation event are 
subject to the limit in paragraph (k)(1).
    (l) Fair market value compensation. Compensation resulting from an 
arrangement between an entity and a physician (or an immediate family 
member) or any group of physicians (regardless of whether the group 
meets the definition of a group practice set forth in Sec.  411.352) for 
the provision of items or services or for the lease of office space or 
equipment by the physician (or an immediate family member) or group of 
physicians to the entity, or by the entity to the physician (or an 
immediate family member) or a group of physicians, if the arrangement 
meets the following conditions:
    (1) The arrangement is in writing, signed by the parties, and covers 
only identifiable items, services, office space, or equipment. The 
writing specifies--
    (i) The items, services, office space, or equipment covered under 
the arrangement;
    (ii) The compensation that will be provided under the arrangement; 
and
    (iii) The timeframe for the arrangement.
    (2) An arrangement may be for any period of time and contain a 
termination clause. An arrangement may be renewed any number of times if 
the terms of the arrangement and the compensation for the same items, 
services, office space, or equipment do not change. Other than an 
arrangement that satisfies all of the conditions of paragraph (z) of 
this section, the parties may not enter into more than one arrangement 
for the same items, services, office space, or equipment during the 
course of a year.
    (3) The compensation must be set in advance, consistent with fair 
market value, and not determined in any manner that takes into account 
the volume or value of referrals or other business generated by the 
referring physician. Compensation for the rental of office space or 
equipment may not be determined using a formula based on--
    (i) A percentage of the revenue raised, earned, billed, collected, 
or otherwise attributable to the services performed or business 
generated in the office space or to the services performed on or 
business generated through the use of the equipment; or
    (ii) Per-unit of service rental charges, to the extent that such 
charges reflect services provided to patients referred by the lessor to 
the lessee.
    (4) The arrangement would be commercially reasonable even if no 
referrals were made between the parties.
    (5) The arrangement does not violate the anti-kickback statute 
(section 1128B(b) of the Act).
    (6) The services to be performed under the arrangement do not 
involve the counseling or promotion of a business arrangement or other 
activity that violates a Federal or State law.
    (7) The arrangement satisfies the requirements of Sec.  
411.354(d)(4) in the case of--
    (i) Remuneration to the physician that is conditioned on the 
physician's referrals to a particular provider, practitioner, or 
supplier; or
    (ii) Remuneration paid to the group of physicians that is 
conditioned on one or more of the group's physicians' referrals to a 
particular provider, practitioner, or supplier.
    (m) Medical staff incidental benefits. Compensation in the form of 
items or services (not including cash or cash equivalents) from a 
hospital to a member of its medical staff when the item or service is 
used on the hospital's campus, if all of the following conditions are 
met:
    (1) The compensation is offered to all members of the medical staff 
practicing in the same specialty (but not necessarily accepted by every 
member to whom it is offered) and is not offered in any manner that 
takes into account the volume or value of referrals or other business 
generated between the parties.
    (2) Except with respect to identification of medical staff on a 
hospital website or in hospital advertising, the compensation is 
provided only during periods when the medical staff members are making 
rounds or are engaged in other services or activities that benefit the 
hospital or its patients.
    (3) The compensation is provided by the hospital and used by the 
medical staff members only on the hospital's campus. Compensation, 
including, but

[[Page 555]]

not limited to, internet access, pagers, or two-way radios, used away 
from the campus only to access hospital medical records or information 
or to access patients or personnel who are on the hospital campus, as 
well as the identification of the medical staff on a hospital website or 
in hospital advertising, meets the ``on campus'' requirement of this 
paragraph (m).
    (4) The compensation is reasonably related to the provision of, or 
designed to facilitate directly or indirectly the delivery of, medical 
services at the hospital.
    (5) The compensation is of low value (that is, less than $25) with 
respect to each occurrence of the benefit (for example, each meal given 
to a physician while he or she is serving patients who are hospitalized 
must be of low value). The $25 limit in this paragraph (m)(5) is 
adjusted each calendar year to the nearest whole dollar by the increase 
in the Consumer Price Index--Urban All Items (CPI-I) for the 12 month 
period ending the preceding September 30. CMS displays after September 
30 each year both the increase in the CPI-I for the 12 month period and 
the new limits on the physician self-referral website at http://
www.cms.hhs.gov/PhysicianSelf Referral/10_CPI-U_ Updates.asp.
    (6) The compensation is not determined in any manner that takes into 
account the volume or value of referrals or other business generated 
between the parties.
    (7) [Reserved]
    (8) Other facilities and health care clinics (including, but not 
limited to, federally qualified health centers) that have bona fide 
medical staffs may provide compensation under this paragraph (m) on the 
same terms and conditions applied to hospitals under this paragraph (m).
    (n) Risk-sharing arrangements. Compensation paid directly or 
indirectly by a MCO or an IPA to a physician pursuant to a risk-sharing 
arrangement (including, but not limited to, withholds, bonuses, and risk 
pools) for services provided by the physician to enrollees of a health 
plan. For purposes of this paragraph (n), ``health plan'' and 
``enrollees'' have the meanings set forth in Sec.  1001.952(l) of this 
title.
    (o) Compliance training. Compliance training provided by an entity 
to a physician (or to the physician's immediate family member or office 
staff) who practices in the entity's local community or service area, 
provided that the training is held in the local community or service 
area. For purposes of this paragraph (o), ``compliance training'' means 
training regarding the basic elements of a compliance program (for 
example, establishing policies and procedures, training of staff, 
internal monitoring, or reporting); specific training regarding the 
requirements of Federal and State health care programs (for example, 
billing, coding, reasonable and necessary services, documentation, or 
unlawful referral arrangements); or training regarding other Federal, 
State, or local laws, regulations, or rules governing the conduct of the 
party for whom the training is provided. For purposes of this paragraph, 
``compliance training'' includes programs that offer continuing medical 
education credit, provided that compliance training is the primary 
purpose of the program.
    (p) Indirect compensation arrangements. Indirect compensation 
arrangements, as defined at Sec.  411.354(c)(2), if all of the following 
conditions are satisfied:
    (1)(i) The compensation received by the referring physician (or 
immediate family member) described in Sec.  411.354(c)(2)(ii) is fair 
market value for services and items actually provided and not determined 
in any manner that takes into account the volume or value of referrals 
or other business generated by the referring physician for the entity 
furnishing DHS.
    (ii) Compensation for the rental of office space or equipment may 
not be determined using a formula based on--
    (A) A percentage of the revenue raised, earned, billed, collected, 
or otherwise attributable to the services performed or business 
generated in the office space or to the services performed on or 
business generated through the use of the equipment; or
    (B) Per-unit of service rental charges, to the extent that such 
charges reflect services provided to patients referred by the lessor to 
the lessee.

[[Page 556]]

    (2) The compensation arrangement described in Sec.  
411.354(c)(2)(ii) is set out in writing, signed by the parties, and 
specifies the services covered by the arrangement, except in the case of 
a bona fide employment relationship between an employer and an employee, 
in which case the arrangement need not be set out in writing, but must 
be for identifiable services and be commercially reasonable even if no 
referrals are made to the employer.
    (3) [Reserved]
    (4) If remuneration to the physician is conditioned on the 
physician's referrals to a particular provider, practitioner, or 
supplier, the compensation arrangement described in Sec.  
411.354(c)(2)(ii) satisfies the conditions of Sec.  411.354(d)(4).
    (q) Referral services. Remuneration that meets all of the conditions 
set forth in Sec.  1001.952(f) of this title.
    (r) Obstetrical malpractice insurance subsidies. Remuneration that 
meets all of the conditions of paragraph (r)(1) or (2) of this section.
    (1) Remuneration that meets all of the conditions set forth in Sec.  
1001.952(o) of this title.
    (2) A payment from a hospital, federally qualified health center, or 
rural health clinic that is used to pay for some or all of the costs of 
malpractice insurance premiums for a physician who engages in 
obstetrical practice as a routine part of his or her medical practice, 
if all of the following conditions are met:
    (i)(A) The physician's medical practice is located in a rural area, 
a primary care HPSA, or an area with demonstrated need for the 
physician's obstetrical services as determined by the Secretary in an 
advisory opinion issued in accordance with section 1877(g)(6) of the 
Act; or
    (B) At least 75 percent of the physician's obstetrical patients 
reside in a medically underserved area or are members of a medically 
underserved population.
    (ii) The arrangement is set out in writing, is signed by the 
physician and the hospital, federally qualified health center, or rural 
health clinic providing the payment, and specifies the payment to be 
made by the hospital, federally qualified health center, or rural health 
clinic and the terms under which the payment is to be provided.
    (iii) The arrangement is not conditioned on the physician's referral 
of patients to the hospital, federally qualified health center, or rural 
health clinic providing the payment.
    (iv) The hospital, federally qualified health center, or rural 
health clinic does not determine the amount of the payment in any manner 
that takes into account the volume or value of referrals by the 
physician or any other business generated between the parties.
    (v) The physician is allowed to establish staff privileges at any 
hospital(s), federally qualified health center(s), or rural health 
clinic(s) and to refer business to any other entities (except as 
referrals may be restricted under an employment arrangement or services 
arrangement that complies with Sec.  411.354(d)(4)).
    (vi) The payment is made to a person or organization (other than the 
physician) that is providing malpractice insurance (including a self-
funded organization).
    (vii) The physician treats obstetrical patients who receive medical 
benefits or assistance under any Federal health care program in a 
nondiscriminatory manner.
    (viii) The insurance is a bona fide malpractice insurance policy or 
program, and the premium, if any, is calculated based on a bona fide 
assessment of the liability risk covered under the insurance.
    (ix)(A) For each coverage period (not to exceed 1 year), at least 75 
percent of the physician's obstetrical patients treated under the 
coverage of the obstetrical malpractice insurance during the prior 
period (not to exceed 1 year)--
    (1) Resided in a rural area, HPSA, medically underserved area, or an 
area with a demonstrated need for the physician's obstetrical services 
as determined by the Secretary in an advisory opinion issued in 
accordance with section 1877(g)(6) of the Act; or
    (2) Were part of a medically underserved population.
    (B) For the initial coverage period (not to exceed 1 year), the 
requirements of paragraph (r)(2)(ix)(A) of this

[[Page 557]]

section will be satisfied if the physician certifies that he or she has 
a reasonable expectation that at least 75 percent of the physician's 
obstetrical patients treated under the coverage of the malpractice 
insurance will--
    (1) Reside in a rural area, HPSA, medically underserved area, or an 
area with a demonstrated need for the physician's obstetrical services 
as determined by the Secretary in an advisory opinion issued in 
accordance with section 1877(g)(6) of the Act; or
    (2) Be part of a medically underserved population.
    (3) For purposes of paragraph (r)(2) of this section, costs of 
malpractice insurance premiums means:
    (i) For physicians who engage in obstetrical practice on a full-time 
basis, any costs attributable to malpractice insurance; or
    (ii) For physicians who engage in obstetrical practice on a part-
time or sporadic basis, the costs attributable exclusively to the 
obstetrical portion of the physician's malpractice insurance, and 
related exclusively to obstetrical services provided--
    (A) In a rural area, primary care HPSA, or an area with demonstrated 
need for the physician's obstetrical services, as determined by the 
Secretary in an advisory opinion issued in accordance with section 
1877(g)(6) of the Act; or
    (B) In any area, provided that at least 75 percent of the 
physician's obstetrical patients treated in the coverage period (not to 
exceed 1 year) resided in a medically underserved area or were part of a 
medically underserved population.
    (s) Professional courtesy. Professional courtesy (as defined at 
Sec.  411.351) offered by an entity with a formal medical staff to a 
physician or a physician's immediate family member or office staff if 
all of the following conditions are met:
    (1) The professional courtesy is offered to all physicians on the 
entity's bona fide medical staff or in such entity's local community or 
service area, and the offer does not take into account the volume or 
value of referrals or other business generated between the parties;
    (2) The health care items and services provided are of a type 
routinely provided by the entity;
    (3) The entity has a professional courtesy policy that is set out in 
writing and approved in advance by the entity's governing body;
    (4) The professional courtesy is not offered to a physician (or 
immediate family member) who is a Federal health care program 
beneficiary, unless there has been a good faith showing of financial 
need; and
    (t) Retention payments in underserved areas--(1) Bona fide written 
offer. Remuneration provided by a hospital directly to a physician on 
the hospital's medical staff to retain the physician's medical practice 
in the geographic area served by the hospital (as defined in paragraph 
(e)(2) of this section), if all of the following conditions are met:
    (i) The physician has a bona fide firm, written recruitment offer or 
offer of employment from a hospital, academic medical center (as defined 
at Sec.  411.355(e)), or physician organization (as defined at Sec.  
411.351) that is not related to the hospital making the payment, and the 
offer specifies the remuneration being offered and requires the 
physician to move the location of his or her medical practice at least 
25 miles and outside of the geographic area served by the hospital 
making the retention payment.
    (ii) The requirements of paragraphs (e)(1)(i) through (iv) of this 
section are satisfied.
    (iii) Any retention payment is subject to the same obligations and 
restrictions, if any, on repayment or forgiveness of indebtedness as the 
written recruitment offer or offer of employment.
    (iv) The retention payment does not exceed the lower of--
    (A) The amount obtained by subtracting the physician's current 
income from physician and related services from the income the physician 
would receive from comparable physician and related services in the 
written recruitment or employment offer, provided that the respective 
incomes are determined using a reasonable and consistent methodology, 
and that they are calculated uniformly over no more than a 24-month 
period; or

[[Page 558]]

    (B) The reasonable costs the hospital would otherwise have to expend 
to recruit a new physician to the geographic area served by the hospital 
to join the medical staff of the hospital to replace the retained 
physician.
    (v) The requirements of paragraph (t)(3) of this setion are 
satisfied.
    (2) Written certification from physician. Remuneration provided by a 
hospital directly to a physician on the hospital's medical staff to 
retain the physician's medical practice in the geographic area served by 
the hospital (as defined in paragraph (e)(2) of this section), if all of 
the following conditions are met:
    (i) The physician furnishes to the hospital before the retention 
payment is made a written certification that the physician has a bona 
fide opportunity for future employment by a hospital, academic medical 
center (as defined at Sec.  411.355(e)), or physician organization (as 
defined at Sec.  411.351) that requires the physician to move the 
location of his or her medical practice at least 25 miles and outside 
the geographic area served by the hospital. The certification contains 
at least the following--
    (A) Details regarding the steps taken by the physician to effectuate 
the employment opportunity;
    (B) Details of the physician's employment opportunity, including the 
identity and location of the physician's future employer or employment 
location or both, and the anticipated income and benefits (or a range 
for income and benefits);
    (C) A statement that the future employer is not related to the 
hospital making the payment;
    (D) The date on which the physician anticipates relocating his or 
her medical practice outside of the geographic area served by the 
hospital; and
    (E) Information sufficient for the hospital to verify the 
information included in the written certification.
    (ii) The hospital takes reasonable steps to verify that the 
physician has a bona fide opportunity for future employment that 
requires the physician to relocate outside the geographic area served by 
the hospital.
    (iii) The requirements of paragraphs (e)(1)(i) through (iv) of this 
section are satisfied.
    (iv) The retention payment does not exceed the lower of--
    (A) An amount equal to 25 percent of the physician's current annual 
income (averaged over the previous 24 months), using a reasonable and 
consistent methodology that is calculated uniformly; or
    (B) The reasonable costs the hospital would otherwise have to expend 
to recruit a new physician to the geographic area served by the hospital 
to join the medical staff of the hospital to replace the retained 
physician.
    (v) The requirements of paragraph (t)(3) of this section are 
satisfied.
    (3) Additional requirements. Remuneration provided under paragraph 
(t)(1) or (2) of this section must meet the following additional 
requirements:
    (i)(A) The physician's current medical practice is located in a 
rural area or HPSA (regardless of the physician's specialty) or is 
located in an area with demonstrated need for the physician as 
determined by the Secretary in an advisory opinion issued in accordance 
with section 1877(g)(6) of the Act; or
    (B) At least 75 percent of the physician's patients reside in a 
medically underserved area or are members of a medically underserved 
population.
    (ii) The hospital does not enter into a retention arrangement with a 
particular referring physician more frequently than once every 5 years.
    (iii) The amount and terms of the retention payment are not altered 
during the term of the arrangement in any manner that takes into account 
the volume or value of referrals or other business generated by the 
physician.
    (4) Waiver of relocation requirement. The Secretary may waive the 
relocation requirement of paragraphs (t)(1) and (t)(2) of this section 
for payments made to physicians practicing in a HPSA or an area with 
demonstrated need for the physician through an advisory opinion issued 
in accordance with section 1877(g)(6) of the Act, if the retention 
payment arrangement otherwise complies with all of the conditions of 
this paragraph (t).
    (5) Application to other entities. This paragraph (t) applies to 
remuneration provided by a federally qualified health center or a rural 
health clinic in the

[[Page 559]]

same manner as it applies to remuneration provided by a hospital.
    (u) Community-wide health information systems. Items or services of 
information technology provided by an entity to a physician that allow 
access to, and sharing of, electronic health care records and any 
complementary drug information systems, general health information, 
medical alerts, and related information for patients served by community 
providers and practitioners, in order to enhance the community's overall 
health, provided that--
    (1) The items or services are available as necessary to enable the 
physician to participate in a community-wide health information system, 
are principally used by the physician as part of the community-wide 
health information system, and are not provided to the physician in any 
manner that takes into account the volume or value of referrals or other 
business generated by the physician;
    (2) The community-wide health information systems are available to 
all providers, practitioners, and residents of the community who desire 
to participate; and
    (v) Electronic prescribing items and services. Nonmonetary 
remuneration (consisting of items and services in the form of hardware, 
software, or information technology and training services) necessary and 
used solely to receive and transmit electronic prescription information, 
if all of the following conditions are met:
    (1) The items and services are provided by a--
    (i) Hospital to a physician who is a member of its medical staff;
    (ii) Group practice (as defined at Sec.  411.352) to a physician who 
is a member of the group (as defined at Sec.  411.351); or
    (iii) PDP sponsor or MA organization to a prescribing physician.
    (2) The items and services are provided as part of, or are used to 
access, an electronic prescription drug program that meets the 
applicable standards under Medicare Part D at the time the items and 
services are provided.
    (3) The donor (or any person on the donor's behalf) does not take 
any action to limit or restrict the use or compatibility of the items or 
services with other electronic prescribing or electronic health records 
systems.
    (4) For items or services that are of the type that can be used for 
any patient without regard to payer status, the donor does not restrict, 
or take any action to limit, the physician's right or ability to use the 
items or services for any patient.
    (5) Neither the physician nor the physician's practice (including 
employees and staff members) makes the receipt of items or services, or 
the amount or nature of the items or services, a condition of doing 
business with the donor.
    (6) Neither the eligibility of a physician for the items or 
services, nor the amount or nature of the items or services, is 
determined in a manner that takes into account the volume or value of 
referrals or other business generated between the parties.
    (7) The arrangement is set forth in a written agreement that--
    (i) Is signed by the parties;
    (ii) Specifies the items and services being provided and the donor's 
cost of the items and services; and
    (iii) Covers all of the electronic prescribing items and services to 
be provided by the donor. This requirement is met if all separate 
agreements between the donor and the physician (and the donor and any 
family members of the physician) incorporate each other by reference or 
if they cross-reference a master list of agreements that is maintained 
and updated centrally and is available for review by the Secretary upon 
request. The master list must be maintained in a manner that preserves 
the historical record of agreements.
    (8) The donor does not have actual knowledge of, and does not act in 
reckless disregard or deliberate ignorance of, the fact that the 
physician possesses or has obtained items or services equivalent to 
those provided by the donor.
    (w) Electronic health records items and services. Nonmonetary 
remuneration (consisting of items and services in the form of software 
or information technology and training services, including cybersecurity 
software and services) necessary and used predominantly to create, 
maintain, transmit, receive, or

[[Page 560]]

protect electronic health records, if all of the following conditions 
are met:
    (1) The items and services are provided to a physician by an entity 
(as defined at Sec.  411.351) that is not a laboratory company.
    (2) The software is interoperable (as defined at Sec.  411.351) at 
the time it is provided to the physician. For purposes of this paragraph 
(w), software is deemed to be interoperable if, on the date it is 
provided to the physician, it is certified by a certifying body 
authorized by the National Coordinator for Health Information Technology 
to certification criteria identified in the then-applicable version of 
45 CFR part 170.
    (3) [Reserved]
    (4)(i) Before receipt of the initial donation of items and services 
or the donation of replacement items and services, the physician pays 15 
percent of the donor's cost for the items and services.
    (ii) Except as provided in paragraph (w)(4)(i) of this section, with 
respect to items and services received from the donor after the initial 
donation of items and services or the donation of replacement items and 
services, the physician pays 15 percent of the donor's cost for the 
items and services at reasonable intervals.
    (iii) The donor (or any party related to the donor) does not finance 
the physician's payment or loan funds to be used by the physician to pay 
for the items and services.
    (5) Neither the physician nor the physician's practice (including 
employees and staff members) makes the receipt of items or services, or 
the amount or nature of the items or services, a condition of doing 
business with the donor.
    (6) Neither the eligibility of a physician for the items or 
services, nor the amount or nature of the items or services, is 
determined in any manner that directly takes into account the volume or 
value of referrals or other business generated between the parties. For 
purposes of this paragraph (w), the determination is deemed not to 
directly take into account the volume or value of referrals or other 
business generated between the parties if any one of the following 
conditions is met:
    (i) The determination is based on the total number of prescriptions 
written by the physician (but not the volume or value of prescriptions 
dispensed or paid by the donor or billed to the program);
    (ii) The determination is based on the size of the physician's 
medical practice (for example, total patients, total patient encounters, 
or total relative value units);
    (iii) The determination is based on the total number of hours that 
the physician practices medicine;
    (iv) The determination is based on the physician's overall use of 
automated technology in his or her medical practice (without specific 
reference to the use of technology in connection with referrals made to 
the donor);
    (v) The determination is based on whether the physician is a member 
of the donor's medical staff, if the donor has a formal medical staff;
    (vi) The determination is based on the level of uncompensated care 
provided by the physician; or
    (vii) The determination is made in any reasonable and verifiable 
manner that does not directly take into account the volume or value of 
referrals or other business generated between the parties.
    (7) The arrangement is set forth in a written agreement that--
    (i) Is signed by the parties;
    (ii) Specifies the items and services being provided, the donor's 
cost of the items and services, and the amount of the physician's 
contribution; and
    (iii) Covers all of the electronic health records items and services 
to be provided by the donor. This requirement is met if all separate 
agreements between the donor and the physician (and the donor and any 
family members of the physician) incorporate each other by reference or 
if they cross-reference a master list of agreements that is maintained 
and updated centrally and is available for review by the Secretary upon 
request. The master list must be maintained in a manner that preserves 
the historical record of agreements.
    (8) [Reserved]
    (9) For items or services that are of the type that can be used for 
any patient without regard to payer status,

[[Page 561]]

the donor does not restrict, or take any action to limit, the 
physician's right or ability to use the items or services for any 
patient.
    (10) The items and services do not include staffing of physician 
offices and are not used primarily to conduct personal business or 
business unrelated to the physician's medical practice.
    (x) Assistance to compensate a nonphysician practitioner. (1) 
Remuneration provided by a hospital to a physician to compensate a 
nonphysician practitioner to provide NPP patient care services, if all 
of the following conditions are met:
    (i) The arrangement--
    (A) Is set out in writing and signed by the hospital, the physician, 
and the nonphysician practitioner; and
    (B) Commences before the physician (or the physician organization in 
whose shoes the physician stands under Sec.  411.354(c)) enters into the 
compensation arrangement described in paragraph (x)(1)(vi)(A) of this 
section.
    (ii) The arrangement is not conditioned on--
    (A) The physician's referrals to the hospital; or
    (B) The nonphysician practitioner's NPP referrals to the hospital.
    (iii) The remuneration from the hospital--
    (A) Does not exceed 50 percent of the actual compensation, signing 
bonus, and benefits paid by the physician to the nonphysician 
practitioner during a period not to exceed the first 2 consecutive years 
of the compensation arrangement between the nonphysician practitioner 
and the physician (or the physician organization in whose shoes the 
physician stands); and
    (B) Is not determined in any manner that takes into account the 
volume or value of actual or anticipated referrals by--
    (1) Referrals by the physician (or any physician in the physician's 
practice) or other business generated between the parties; or
    (2) NPP referrals by the nonphysician practitioner (or any 
nonphysician practitioner in the physician's practice) or other business 
generated between the parties.
    (iv) The compensation, signing bonus, and benefits paid to the 
nonphysician practitioner by the physician does not exceed fair market 
value for the NPP patient care services furnished by the nonphysician 
practitioner to patients of the physician's practice.
    (v) The nonphysician practitioner has not, within 1 year of the 
commencement of his or her compensation arrangement with the physician 
(or the physician organization in whose shoes the physician stands under 
Sec.  411.354(c))--
    (A) Furnished NPP patient care services in the geographic area 
served by the hospital; or
    (B) Been employed or otherwise engaged to provide NPP patient care 
services by a physician or a physician organization that has a medical 
practice site located in the geographic area served by the hospital, 
regardless of whether the nonphysician practitioner furnished NPP 
patient care services at the medical practice site located in the 
geographic area served by the hospital.
    (vi)(A) The nonphysician practitioner has a compensation arrangement 
directly with the physician or the physician organization in whose shoes 
the physician stands under Sec.  411.354(c); and
    (B) Substantially all of the NPP patient care services that the 
nonphysician practitioner furnishes to patients of the physician's 
practice are primary care services or mental health care services.
    (vii) The physician does not impose practice restrictions on the 
nonphysician practitioner that unreasonably restrict the nonphysician 
practitioner's ability to provide NPP patient care services in the 
geographic area served by the hospital.
    (2) Records of the actual amount of remuneration provided under 
paragraph (x)(1) of this section by the hospital to the physician, and 
by the physician to the nonphysician practitioner, must be maintained 
for a period of at least 6 years and made available to the Secretary 
upon request.
    (3) For purposes of this paragraph (x), ``nonphysician 
practitioner'' means a physician assistant as defined in section 
1861(aa)(5) of the Act, a nurse practitioner or clinical nurse 
specialist as defined in section 1861(aa)(5) of the Act, a certified 
nurse-midwife as defined in

[[Page 562]]

section 1861(gg) of the Act, a clinical social worker as defined in 
section 1861(hh) of the Act, or a clinical psychologist as defined at 
Sec.  410.71(d) of this subchapter.
    (4) For purposes of this paragraph (x), the following terms have the 
meanings indicated.
    (i) ``NPP patient care services'' means direct patient care services 
furnished by a nonphysician practitioner that address the medical needs 
of specific patients or any task performed by a nonphysician 
practitioner that promotes the care of patients of the physician or 
physician organization with which the nonphysician practitioner has a 
compensation arrangement.
    (ii) ``NPP referral'' means a request by a nonphysician practitioner 
that includes the provision of any designated health service for which 
payment may be made under Medicare, the establishment of any plan of 
care by a nonphysician practitioner that includes the provision of such 
a designated health service, or the certifying or recertifying of the 
need for such a designated health service, but does not include any 
designated health service personally performed or provided by the 
nonphysician practitioner.
    (5) For purposes of paragraph (x)(1) of this section, ``geographic 
area served by the hospital'' has the meaning set forth in paragraph 
(e)(2) of this section.
    (6) For purposes of paragraph (x)(1) of this section, a 
``compensation arrangement'' between a physician (or the physician 
organization in whose shoes the physician stands under Sec.  411.354(c)) 
and a nonphysician practitioner--
    (i) Means an employment, contractual, or other arrangement under 
which remuneration passes between the parties; and
    (ii) Does not include a nonphysician practitioner's ownership or 
investment interest in a physician organization.
    (7)(i) This paragraph (x) may be used by a hospital, federally 
qualified health center, or rural health clinic only once every 3 years 
with respect to the same referring physician.
    (ii) Paragraph (x)(7)(i) of this section does not apply to 
remuneration provided by a hospital, federally qualified health center, 
or rural health clinic to a physician to compensate a nonphysician 
practitioner to provide NPP patient care services if--
    (A) The nonphysician practitioner is replacing a nonphysician 
practitioner who terminated his or her employment or contractual 
arrangement to provide NPP patient care services with the physician (or 
the physician organization in whose shoes the physician stands) within 1 
year of the commencement of the employment or contractual arrangement; 
and
    (B) The remuneration provided to the physician is provided during a 
period that does not exceed 2 consecutive years as measured from the 
commencement of the compensation arrangement between the nonphysician 
practitioner who is being replaced and the physician (or the physician 
organization in whose shoes the physician stands).
    (8)(i) This paragraph (x) applies to remuneration provided by a 
federally qualified health center or a rural health clinic in the same 
manner as it applies to remuneration provided by a hospital.
    (ii) The ``geographic area served'' by a federally qualified health 
center or a rural health clinic has the meaning set forth in paragraph 
(e)(6)(ii) of this section.
    (y) Timeshare arrangements. Remuneration provided under an 
arrangement for the use of premises, equipment, personnel, items, 
supplies, or services if the following conditions are met:
    (1) The arrangement is set out in writing, signed by the parties, 
and specifies the premises, equipment, personnel, items, supplies, and 
services covered by the arrangement.
    (2) The arrangement is between a physician (or the physician 
organization in whose shoes the physician stands under Sec.  411.354(c)) 
and--
    (i) A hospital; or
    (ii) Physician organization of which the physician is not an owner, 
employee, or contractor.
    (3) The premises, equipment, personnel, items, supplies, and 
services covered by the arrangement are used--
    (i) Predominantly for the provision of evaluation and management 
services to patients; and
    (ii) On the same schedule.

[[Page 563]]

    (4) The equipment covered by the arrangement is--
    (i) Located in the same building where the evaluation and management 
services are furnished;
    (ii) Not used to furnish designated health services other than those 
incidental to the evaluation and management services furnished at the 
time of the patient's evaluation and management visit; and
    (iii) Not advanced imaging equipment, radiation therapy equipment, 
or clinical or pathology laboratory equipment (other than equipment used 
to perform CLIA-waived laboratory tests).
    (5) The arrangement is not conditioned on the referral of patients 
by the physician who is a party to the arrangement to the hospital or 
physician organization of which the physician is not an owner, employee, 
or contractor.
    (6) The compensation over the term of the arrangement is set in 
advance, consistent with fair market value, and not determined--
    (i) In any manner that takes into account the volume or value of 
referrals or other business generated between the parties; or
    (ii) Using a formula based on--
    (A) A percentage of the revenue raised, earned, billed, collected, 
or otherwise attributable to the services provided while using the 
premises, equipment, personnel, items, supplies, or services covered by 
the arrangement; or
    (B) Per-unit of service fees that are not time-based, to the extent 
that such fees reflect services provided to patients referred by the 
party granting permission to use the premises, equipment, personnel, 
items, supplies, or services covered by the arrangement to the party to 
which the permission is granted.
    (7) The arrangement would be commercially reasonable even if no 
referrals were made between the parties.
    (8) [Reserved]
    (9) The arrangement does not convey a possessory leasehold interest 
in the office space that is the subject of the arrangement.
    (z) Limited remuneration to a physician. (1) Remuneration from an 
entity to a physician for the provision of items or services provided by 
the physician to the entity that does not exceed an aggregate of $5,000 
per calendar year, as adjusted for inflation in accordance with 
paragraph (z)(3) of this section, if all of the following conditions are 
satisfied:
    (i) The compensation is not determined in any manner that takes into 
account the volume or value of referrals or other business generated by 
the physician.
    (ii) The compensation does not exceed the fair market value of the 
items or services.
    (iii) The arrangement would be commercially reasonable even if no 
referrals were made between the parties.
    (iv) Compensation for the lease of office space or equipment is not 
determined using a formula based on--
    (A) A percentage of the revenue raised, earned, billed, collected, 
or otherwise attributable to the services performed or business 
generated in the office space or to the services performed on or 
business generated through the use of the equipment; or
    (B) Per-unit of service rental charges, to the extent that such 
charges reflect services provided to patients referred by the lessor to 
the lessee.
    (v) Compensation for the use of premises or equipment is not 
determined using a formula based on--
    (A) A percentage of the revenue raised, earned, billed, collected, 
or otherwise attributable to the services provided while using the 
premises or equipment covered by the arrangement; or
    (B) Per-unit of service fees that are not time-based, to the extent 
that such fees reflect services provided to patients referred by the 
party granting permission to use the premises or equipment covered by 
the arrangement to the party to which the permission is granted.
    (vi) If remuneration to the physician is conditioned on the 
physician's referrals to a particular provider, practitioner, or 
supplier, the arrangement satisfies the conditions of Sec.  
411.354(d)(4).
    (2) A physician may provide items or services through employees whom 
the physician has hired for the purpose of performing the services; 
through a wholly-owned entity; or through locum tenens physicians (as 
defined at

[[Page 564]]

Sec.  411.351, except that the regular physician need not be a member of 
a group practice).
    (3) The annual aggregate remuneration limit in this paragraph (z) is 
adjusted each calendar year to the nearest whole dollar by the increase 
in the Consumer Price Index--Urban All Items (CPI-U) for the 12-month 
period ending the preceding September 30. CMS displays after September 
30 each year both the increase in the CPI-U for the 12-month period and 
the new remuneration limit on the physician self-referral website at 
http://www.cms.hhs.gov/PhysicianSelf Referral/10_CPI-U_ Updates.asp.
    (aa) Arrangements that facilitate value-based health care delivery 
and payment--(1) Full financial risk--Remuneration paid under a value-
based arrangement, as defined at Sec.  411.351, if the following 
conditions are met:
    (i) The value-based enterprise is at full financial risk (or is 
contractually obligated to be at full financial risk within the 12 
months following the commencement of the value-based arrangement) during 
the entire duration of the value-based arrangement.
    (ii) The remuneration is for or results from value-based activities 
undertaken by the recipient of the remuneration for patients in the 
target patient population.
    (iii) The remuneration is not an inducement to reduce or limit 
medically necessary items or services to any patient.
    (iv) The remuneration is not conditioned on referrals of patients 
who are not part of the target patient population or business not 
covered under the value-based arrangement.
    (v) If remuneration paid to the physician is conditioned on the 
physician's referrals to a particular provider, practitioner, or 
supplier, the value-based arrangement complies with both of the 
following conditions:
    (A) The requirement to make referrals to a particular provider, 
practitioner, or supplier is set out in writing and signed by the 
parties.
    (B) The requirement to make referrals to a particular provider, 
practitioner, or supplier does not apply if the patient expresses a 
preference for a different provider, practitioner, or supplier; the 
patient's insurer determines the provider, practitioner, or supplier; or 
the referral is not in the patient's best medical interests in the 
physician's judgment.
    (vi) Records of the methodology for determining and the actual 
amount of remuneration paid under the value-based arrangement must be 
maintained for a period of at least 6 years and made available to the 
Secretary upon request.
    (vii) For purposes of this paragraph (aa), ``full financial risk'' 
means that the value-based enterprise is financially responsible on a 
prospective basis for the cost of all patient care items and services 
covered by the applicable payor for each patient in the target patient 
population for a specified period of time. For purposes of this 
paragraph (aa), ``prospective basis'' means that the value-based 
enterprise has assumed financial responsibility for the cost of all 
patient care items and services covered by the applicable payor prior to 
providing patient care items and services to patients in the target 
patient population.
    (2) Value-based arrangements with meaningful downside financial risk 
to the physician--Remuneration paid under a value-based arrangement, as 
defined at Sec.  411.351, if the following conditions are met:
    (i) The physician is at meaningful downside financial risk for 
failure to achieve the value-based purpose(s) of the value-based 
enterprise during the entire duration of the value-based arrangement.
    (ii) A description of the nature and extent of the physician's 
downside financial risk is set forth in writing.
    (iii) The methodology used to determine the amount of the 
remuneration is set in advance of the undertaking of value-based 
activities for which the remuneration is paid.
    (iv) The remuneration is for or results from value-based activities 
undertaken by the recipient of the remuneration for patients in the 
target patient population.
    (v) The remuneration is not an inducement to reduce or limit 
medically necessary items or services to any patient.

[[Page 565]]

    (vi) The remuneration is not conditioned on referrals of patients 
who are not part of the target patient population or business not 
covered under the value-based arrangement.
    (vii) If remuneration paid to the physician is conditioned on the 
physician's referrals to a particular provider, practitioner, or 
supplier, the value-based arrangement complies with both of the 
following conditions:
    (A) The requirement to make referrals to a particular provider, 
practitioner, or supplier is set out in writing and signed by the 
parties.
    (B) The requirement to make referrals to a particular provider, 
practitioner, or supplier does not apply if the patient expresses a 
preference for a different provider, practitioner, or supplier; the 
patient's insurer determines the provider, practitioner, or supplier; or 
the referral is not in the patient's best medical interests in the 
physician's judgment.
    (viii) Records of the methodology for determining and the actual 
amount of remuneration paid under the value-based arrangement must be 
maintained for a period of at least 6 years and made available to the 
Secretary upon request.
    (ix) For purposes of this paragraph (aa), ``meaningful downside 
financial risk'' means that the physician is responsible to repay or 
forgo no less than 10 percent of the total value of the remuneration the 
physician receives under the value-based arrangement.
    (3) Value-based arrangements. Remuneration paid under a value-based 
arrangement, as defined at Sec.  411.351, if the following conditions 
are met:
    (i) The arrangement is set forth in writing and signed by the 
parties. The writing includes a description of--
    (A) The value-based activities to be undertaken under the 
arrangement;
    (B) How the value-based activities are expected to further the 
value-based purpose(s) of the value-based enterprise;
    (C) The target patient population for the arrangement;
    (D) The type or nature of the remuneration;
    (E) The methodology used to determine the remuneration; and
    (F) The outcome measures against which the recipient of the 
remuneration is assessed, if any.
    (ii) The outcome measures against which the recipient of the 
remuneration is assessed, if any, are objective, measurable, and 
selected based on clinical evidence or credible medical support.
    (iii) Any changes to the outcome measures against which the 
recipient of the remuneration will be assessed are made prospectively 
and set forth in writing.
    (iv) The methodology used to determine the amount of the 
remuneration is set in advance of the undertaking of value-based 
activities for which the remuneration is paid.
    (v) The remuneration is for or results from value-based activities 
undertaken by the recipient of the remuneration for patients in the 
target patient population.
    (vi) The arrangement is commercially reasonable.
    (vii)(A) No less frequently than annually, or at least once during 
the term of the arrangement if the arrangement has a duration of less 
than 1 year, the value-based enterprise or one or more of the parties 
monitor:
    (1) Whether the parties have furnished the value-based activities 
required under the arrangement;
    (2) Whether and how continuation of the value-based activities is 
expected to further the value-based purpose(s) of the value-based 
enterprise; and
    (3) Progress toward attainment of the outcome measure(s), if any, 
against which the recipient of the remuneration is assessed.
    (B) If the monitoring indicates that a value-based activity is not 
expected to further the value-based purpose(s) of the value-based 
enterprise, the parties must terminate the ineffective value-based 
activity. Following completion of monitoring that identifies an 
ineffective value-based activity, the value-based activity is deemed to 
be reasonably designed to achieve at least one value-based purpose of 
the value-based enterprise--
    (1) For 30 consecutive calendar days after completion of the 
monitoring, if the parties terminate the arrangement; or

[[Page 566]]

    (2) For 90 consecutive calendar days after completion of the 
monitoring, if the parties modify the arrangement to terminate the 
ineffective value-based activity.
    (C) If the monitoring indicates that an outcome measure is 
unattainable during the remaining term of the arrangement, the parties 
must terminate or replace the unattainable outcome measure within 90 
consecutive calendar days after completion of the monitoring.
    (viii) The remuneration is not an inducement to reduce or limit 
medically necessary items or services to any patient.
    (ix) The remuneration is not conditioned on referrals of patients 
who are not part of the target patient population or business not 
covered under the value-based arrangement.
    (x) If the remuneration paid to the physician is conditioned on the 
physician's referrals to a particular provider, practitioner, or 
supplier, the value-based arrangement complies with both of the 
following conditions:
    (A) The requirement to make referrals to a particular provider, 
practitioner, or supplier is set out in writing and signed by the 
parties.
    (B) The requirement to make referrals to a particular provider, 
practitioner, or supplier does not apply if the patient expresses a 
preference for a different provider, practitioner, or supplier; the 
patient's insurer determines the provider, practitioner, or supplier; or 
the referral is not in the patient's best medical interests in the 
physician's judgment.
    (xi) Records of the methodology for determining and the actual 
amount of remuneration paid under the value-based arrangement must be 
maintained for a period of at least 6 years and made available to the 
Secretary upon request.
    (xii) For purposes of this paragraph (aa)(3), ``outcome measure'' 
means a benchmark that quantifies:
    (A) Improvements in or maintenance of the quality of patient care; 
or
    (B) Reductions in the costs to or reductions in growth in 
expenditures of payors while maintaining or improving the quality of 
patient care.
    (bb) Cybersecurity technology and related services. (1) Nonmonetary 
remuneration (consisting of technology and services) necessary and used 
predominantly to implement, maintain, or reestablish cybersecurity, if 
all of the following conditions are met:
    (i) Neither the eligibility of a physician for the technology or 
services, nor the amount or nature of the technology or services, is 
determined in any manner that directly takes into account the volume or 
value of referrals or other business generated between the parties.
    (ii) Neither the physician nor the physician's practice (including 
employees and staff members) makes the receipt of technology or 
services, or the amount or nature of the technology or services, a 
condition of doing business with the donor.
    (iii) The arrangement is documented in writing.
    (2) For purposes of this paragraph (bb), ``technology'' means any 
software or other types of information technology.

[85 FR 77656, Dec. 2, 2020]



Sec.  411.361  Reporting requirements.

    (a) Basic rule. Except as provided in paragraph (b) of this section, 
all entities furnishing services for which payment may be made under 
Medicare must submit information to CMS or to the Office of Inspector 
General (OIG) concerning their reportable financial relationships (as 
defined in paragraph (d) of this section), in the form, manner, and at 
the times that CMS or OIG specifies.
    (b) Exception. The requirements of paragraph (a) of this section do 
not apply to entities that furnish 20 or fewer Part A and Part B 
services during a calendar year, or to any Medicare covered services 
furnished outside the United States.
    (c) Required information. The information requested by CMS or OIG 
can include the following:
    (1) The name and unique physician identification number (UPIN) or 
the national provider identifier (NPI) of each physician who has a 
reportable financial relationship with the entity.
    (2) The name and UPIN or NPI of each physician who has an immediate

[[Page 567]]

family member (as defined at Sec.  411.351) who has a reportable 
financial relationship with the entity.
    (3) The covered services furnished by the entity.
    (4) With respect to each physician identified under paragraphs 
(c)(1) and (c)(2) of this section, the nature of the financial 
relationship (including the extent or value of the ownership or 
investment interest or the compensation arrangement) as evidenced in 
records that the entity knows or should know about in the course of 
prudently conducting business, including, but not limited to, records 
that the entity is already required to retain to comply with the rules 
of the Internal Revenue Service and the Securities and Exchange 
Commission and other rules of the Medicare and Medicaid programs.
    (d) Reportable financial relationships. For purposes of this 
section, a reportable financial relationship is any ownership or 
investment interest, as defined at Sec.  411.354(b) or any compensation 
arrangement, as defined at Sec.  411.354(c), except for ownership or 
investment interests that satisfy the exceptions set forth in Sec.  
411.356(a) or Sec.  411.356(b) regarding publicly traded securities and 
mutual funds.
    (e) Form and timing of reports. Entities that are subject to the 
requirements of this section must submit the required information, upon 
request, within the time period specified by the request. Entities are 
given at least 30 days from the date of the request to provide the 
information. Entities must retain the information, and documentation 
sufficient to verify the information, for the length of time specified 
by the applicable regulatory requirements for the information, and, upon 
request, must make that information and documentation available to CMS 
or OIG.
    (f) Consequences of failure to report. Any person who is required, 
but fails, to submit information concerning his or her financial 
relationships in accordance with this section is subject to a civil 
money penalty of up to $10,000 as adjusted annually under 45 CFR part 
102 for each day following the deadline established under paragraph (e) 
of this section until the information is submitted. Assessment of these 
penalties will comply with the applicable provisions of part 1003 of 
this title.
    (g) Public disclosure. Information furnished to CMS or OIG under 
this section is subject to public disclosure in accordance with the 
provisions of part 401 of this chapter.

[72 FR 51098, Sept. 5, 2007, as amended at 80 FR 71378, Nov. 16, 2015; 
81 FR 61561, Sept. 6, 2016]



Sec.  411.362  Additional requirements concerning physician ownership 
and investment in hospitals.

    (a) Definitions. For purposes of this section--
    Baseline number of operating rooms, procedure rooms, and beds means 
the number of operating rooms, procedure rooms, and beds for which the 
applicable hospital or high Medicaid facility is licensed as of March 
23, 2010 (or, in the case of a hospital that did not have a provider 
agreement in effect as of such date, but does have a provider agreement 
in effect on December 31, 2010, the date of effect of such agreement). 
For purposes of determining the number of beds in a hospital's baseline 
number of operating rooms, procedure rooms, and beds, a bed is included 
if the bed is considered licensed for purposes of State licensure, 
regardless of the specific number of beds identified on the physical 
license issued to the hospital by the State.
    External data source means a data source that--
    (1) Is generated, maintained, or under the control of a State 
Medicaid agency;
    (2) Is reliable and transparent;
    (3) Maintains data that, for purposes of the process described in 
paragraph (c) of this section, are readily available and accessible to 
the requesting hospital, comparison hospitals, and CMS; and
    (4) Maintains or generates data that, for purposes of the process 
described in paragraph (c) of this section, are accurate, complete, and 
objectively verifiable.
    Main campus of the hospital means ``campus'' as defined at Sec.  
413.65(a)(2).
    Ownership or investment interest means for purposes of this section, 
a direct or indirect ownership or investment interest in a hospital.

[[Page 568]]

    (1) A direct ownership or investment interest in a hospital exists 
if the ownership or investment interest in the hospital is held without 
any intervening persons or entities between the hospital and the owner 
or investor.
    (2) An indirect ownership or investment interest in a hospital 
exists if--
    (i) Between the owner or investor and the hospital there exists an 
unbroken chain of any number (but no fewer than one) of persons or 
entities having ownership or investment interests; and
    (ii) The hospital has actual knowledge of, or acts in reckless 
disregard or deliberate ignorance of, the fact that the owner or 
investor has some ownership or investment interest (through any number 
of intermediary ownership or investment interests) in the hospital.
    (3) An indirect ownership or investment interest in a hospital 
exists even though the hospital does not know, or acts in reckless 
disregard or deliberate ignorance of, the precise composition of the 
unbroken chain or the specific terms of the ownership or investment 
interests that form the links in the chain.
    Physician owner or investor means a physician (or immediate family 
member of the physician) with a direct or an indirect ownership or 
investment interest in the hospital.
    Procedure room means a room in which catheterizations, 
angiographies, angiograms, and endoscopies are performed, except such 
term shall not include an emergency room or department (exclusive of 
rooms in which catheterizations, angiographies, angiograms, and 
endoscopies are performed).
    Public advertising for the hospital means any public communication 
paid for by the hospital that is primarily intended to persuade 
individuals to seek care at the hospital.
    (b) General requirements. (1) Physician ownership and provider 
agreement. The hospital had physician ownership or investment on 
December 31, 2010; and a provider agreement under section 1866 of the 
Act in effect on that date.
    (2) Prohibition on facility expansion. The hospital may not increase 
the number of operating rooms, procedure rooms, and beds beyond that for 
which the hospital is licensed on March 23, 2010 (or, in the case of a 
hospital that did not have a provider agreement in effect as of this 
date, but does have a provider agreement in effect on December 31, 2010, 
the effective date of such agreement), unless an exception is granted 
pursuant to paragraph (c) of this section.
    (3) Disclosure of conflicts of interest. (i) At such time and in 
such manner as specified by CMS, the hospital must submit an annual 
report to CMS containing a detailed description of the identity of each 
owner or investor in the hospital and the nature and extent of all 
ownership and investment interests in the hospital.
    (ii) The hospital must--
    (A) Require each referring physician owner or investor who is a 
member of the hospital's medical staff to agree, as a condition of 
continued medical staff membership or admitting privileges, to provide 
written disclosure of his or her ownership or investment interest in the 
hospital (and, if applicable, the ownership or investment interest of 
any treating physician) to all patients whom the physician refers to the 
hospital. Disclosure must be required by a time that permits the patient 
to make a meaningful decision regarding the receipt of care.
    (B) Not condition any physician ownership or investment interests 
either directly or indirectly on the physician owner or investor making 
or influencing referrals to the hospital or otherwise generating 
business for the hospital.
    (C) Disclose on any public Web site for the hospital and in any 
public advertising for the hospital that the hospital is owned or 
invested in by physicians. Any language that would put a reasonable 
person on notice that the hospital may be physician-owned would be 
deemed a sufficient statement of physician ownership or investment. For 
purposes of this section, a public Web site for the hospital does not 
include, by way of example: social media Web sites; electronic patient 
payment portals; electronic patient care portals; and electronic health 
information exchanges.

[[Page 569]]

    (4) Ensuring bona fide investment. The hospital satisfies the 
following criteria:
    (i) The percentage of the total value of the ownership or investment 
interests held in the hospital, or in an entity whose assets include the 
hospital, by physician owners or investors in the aggregate does not 
exceed such percentage as of March 23, 2010.
    (ii) Any ownership or investment interests that the hospital offers 
to a physician owner or investor are not offered on more favorable terms 
than the terms offered to a person who is not a physician owner or 
investor.
    (iii) The hospital (or any owner or investor in the hospital) does 
not directly or indirectly provide loans or financing for any investment 
in the hospital by a physician owner or investor.
    (iv) The hospital (or any owner or investor in the hospital) does 
not directly or indirectly guarantee a loan, make a payment toward a 
loan, or otherwise subsidize a loan, for any individual physician owner 
or investor or group of physician owners or investors that is related to 
acquiring any ownership or investment interest in the hospital.
    (v) Ownership or investment returns are distributed to each owner or 
investor in the hospital in an amount that is directly proportional to 
the ownership or investment interest of such owner or investor in the 
hospital.
    (vi) Physician owners and investors do not receive, directly or 
indirectly, any guaranteed receipt of or right to purchase other 
business interests related to the hospital, including the purchase or 
lease of any property under the control of other owners or investors in 
the hospital or located near the premises of the hospital.
    (vii) The hospital does not offer a physician owner or investor the 
opportunity to purchase or lease any property under the control of the 
hospital or any other owner or investor in the hospital on more 
favorable terms than the terms offered to an individual who is not a 
physician owner or investor.
    (5) Patient safety. The hospital satisfies the following criteria:
    (i) If the hospital does not have a physician available on the 
premises to provide services during all hours in which the hospital is 
providing services to the patient, the hospital must disclose this 
information to the patient. Before providing services to the patient, 
the hospital must receive a signed acknowledgment from the patient 
stating that the patient understands that a physician may not be present 
during all hours services are furnished to the patient.
    (ii) The hospital must have the capacity to provide assessment and 
initial treatment for all patients, and the ability to refer and 
transfer patients to hospitals with the capability to treat the needs of 
the patient that the hospital is unable to address. For purposes of this 
paragraph, the hospital inpatient stay or outpatient visit begins with 
the provision of a package of information regarding scheduled 
preadmission testing and registration for a planned hospital admission 
for inpatient care or an outpatient service.
    (6) Prohibition on conversion from an ambulatory surgery center. The 
hospital must not have been converted from an ambulatory surgical center 
to a hospital on or after March 23, 2010.
    (c) Criteria for an individual hospital seeking an exception to the 
prohibition on facility expansion-- (1) General. An applicable hospital 
may request an exception from the prohibition on facility expansion up 
to once every 2 years from the date of a CMS decision on the hospital's 
most recent request. A high Medicaid facility may request an exception 
from the prohibition on facility expansion at any time, provided that it 
has not submitted another request for an exception to the prohibition on 
facility expansion for which CMS has not issued a decision.
    (2) Criteria for applicable hospital. An applicable hospital is a 
hospital that satisfies all of the following criteria:
    (i) Population increase. Is located in a county that has a 
percentage increase in population that is at least 150 percent of the 
percentage increase in population of the State in which the hospital is 
located during the most recent 5-year period for which data are 
available as of the date that the hospital submits its request. To 
calculate State and county population growth, a hospital must use Bureau 
of the Census estimates.

[[Page 570]]

    (ii) Medicaid inpatient admissions. Has an annual percent of total 
inpatient admissions under Medicaid that is equal to or greater than the 
average percent with respect to such admissions for all hospitals 
located in the county in which the hospital is located during the most 
recent 12-month period for which data are available as of the date that 
the hospital submits its request. For purposes of this paragraph, the 
most recent 12-month period for which data are available means the most 
recent 12-month period for which the data source used contains all data 
from the requesting hospital and each hospital located in the same 
county as the requesting hospital.
    (A) Until such time that the Healthcare Cost Report Information 
System (HCRIS) contains sufficiently complete inpatient Medicaid 
discharge data, a hospital may use filed Medicare hospital cost report 
data or data from an external data source (as defined in paragraph (a) 
of this section) to estimate its annual percent of total inpatient 
admissions under Medicaid and the average percent with respect to such 
admissions for all hospitals located in the county in which the hospital 
is located.
    (B) On or after such date that the Secretary determines that HCRIS 
contains sufficiently complete inpatient Medicaid discharge data, a 
hospital may use only filed Medicare hospital cost report data to 
estimate its annual percent of total inpatient admissions under Medicaid 
and the average percent with respect to such admissions for all 
hospitals located in the county in which the hospital is located.
    (iii) Nondiscrimination. Does not discriminate against beneficiaries 
of Federal health care programs and does not permit physicians 
practicing at the hospital to discriminate against such beneficiaries.
    (iv) Average bed capacity. Is located in a State in which the 
average bed capacity in the State is less than the national average bed 
capacity during the most recent fiscal year for which HCRIS, as of the 
date that the hospital submits its request, contains data from a 
sufficient number of hospitals to determine a State's average bed 
capacity and the national average bed capacity. CMS will provide on its 
Web site State average bed capacities and the national average bed 
capacity. For purposes of this paragraph (c)(2)(iv), ``sufficient 
number'' means the number of hospitals, as determined by CMS that would 
ensure that the determination under this paragraph (c)(2)(iv) would not 
materially change after additional hospital data are reported.
    (v) Average bed occupancy. Has an average bed occupancy rate that is 
greater than the average bed occupancy rate in the State in which the 
hospital is located during the most recent fiscal year for which HCRIS, 
as of the date that the hospital submits its request, contains data from 
a sufficient number of hospitals to determine the requesting hospital's 
average bed occupancy rate and the relevant State's average bed 
occupancy rate. A hospital must use filed hospital cost report data to 
determine its average bed occupancy rate. CMS will provide on its Web 
site State average bed occupancy rates. For purposes of this paragraph 
(c)(2)(v), ``sufficient number'' means the number of hospitals, as 
determined by CMS that would ensure that the determination under this 
paragraph (c)(2)(v) would not materially change after additional 
hospital data are reported.
    (3) Criteria for high Medicaid facility. A high Medicaid facility is 
a hospital that satisfies all of the following criteria:
    (i) Sole hospital. Is not the sole hospital in the county in which 
the hospital is located.
    (ii) Medicaid inpatient admissions. With respect to each of the 3 
most recent 12-month periods for which data are available as of the date 
the hospital submits its request, has an annual percent of total 
inpatient admissions under Medicaid that is estimated to be greater than 
such percent with respect to such admissions for any other hospital 
located in the county in which the hospital is located. For purposes of 
this paragraph, the most recent 12-month period for which data are 
available means the most recent 12-month period for which the data 
source used contains all data from the requesting hospital and every 
hospital located in the same county as the requesting hospital.

[[Page 571]]

    (A) Until such time that the Healthcare Cost Report Information 
System (HCRIS) contains sufficiently complete inpatient Medicaid 
discharge data, a hospital may use filed Medicare hospital cost report 
data or data from an external data source (as defined in paragraph (a) 
of this section) to estimate its annual percentage of total inpatient 
admissions under Medicaid and the annual percentages of total inpatient 
admissions under Medicaid for every other hospital located in the county 
in which the hospital is located.
    (B) On or after such date that the Secretary determines that HCRIS 
contains sufficiently complete inpatient Medicaid discharge data, a 
hospital may use only filed Medicare hospital cost report data to 
estimate its annual percentage of total inpatient admissions under 
Medicaid and the annual percentages of total inpatient admissions under 
Medicaid for every other hospital located in the county in which the 
hospital is located.
    (iii) Nondiscrimination. Does not discriminate against beneficiaries 
of Federal health care programs and does not permit physicians 
practicing at the hospital to discriminate against such beneficiaries.
    (4) Procedure for submitting a request.
    (i) A hospital must either mail an original and one copy of the 
written request to CMS or submit the request electronically to CMS. If a 
hospital submits the request electronically, the hospital must mail an 
original hard copy of the signed certification set forth in paragraph 
(c)(4)(iii) of this section to CMS.
    (ii) A request must include the following information:
    (A) The name, address, National Provider Identification number(s) 
(NPI), Tax Identification Number(s) (TIN), and CMS Certification 
Number(s) (CCN) of the hospital requesting an exception.
    (B) The county in which the hospital requesting an exception is 
located.
    (C) The name, title, address, and daytime telephone number of a 
contact person who will be available to discuss the request with CMS on 
behalf of the hospital.
    (D) A statement identifying the hospital as an applicable hospital 
or high Medicaid facility and a detailed explanation with supporting 
documentation regarding whether and how the hospital satisfies each of 
the criteria for an applicable hospital or high Medicaid facility. The 
request must state that the hospital does not discriminate against 
beneficiaries of Federal health care programs and does not permit 
physicians practicing at the hospital to discriminate against such 
beneficiaries.
    (E) Documentation supporting the hospital's calculations of its 
baseline number of operating rooms, procedure rooms, and beds; the 
hospital's number of operating rooms, procedure rooms, and beds for 
which the hospital is licensed as of the date that the hospital submits 
a request for an exception; and the additional number of operating 
rooms, procedure rooms, and beds by which the hospital requests to 
expand.
    (iii) A request must include the following certification signed by 
an authorized representative of the hospital: ``With knowledge of the 
penalties for false statements provided by 18 U.S.C. 1001, I certify 
that all of the information provided in the request and all of the 
documentation provided with the request is true and correct to the best 
of my knowledge and belief.'' An authorized representative is the chief 
executive officer, chief financial officer, or other comparable officer 
of the hospital.
    (5) Community input and timing of complete request. Upon submitting 
a request for an exception and until the hospital receives a CMS 
decision, the hospital must disclose on any public Web site for the 
hospital that it is requesting an exception and must also provide actual 
notification that it is requesting an exception, in either electronic or 
hard copy form, directly to hospitals whose data are part of the 
comparisons in paragraphs (c)(2)(ii) and (c)(3)(ii) of this section. 
Individuals and entities in the hospital's community may provide input 
with respect to the hospital's request no later than 30 days after CMS 
publishes notice of the hospital's request in the Federal Register. Such 
input must take the form of written comments. The written comments must 
be either mailed or submitted electronically to CMS. If CMS receives

[[Page 572]]

written comments from the community, the hospital has 30 days after CMS 
notifies the hospital of the written comments to submit a rebuttal 
statement.
    (i) If only filed Medicare hospital cost report data are used in the 
hospital's request, the written comments, and the hospital's rebuttal 
statement--
    (A) A request will be deemed complete at the end of the 30-day 
comment period if CMS does not receive written comments from the 
community.
    (B) A request will be deemed complete at the end of the 30-day 
rebuttal period, regardless of whether the hospital submits a rebuttal 
statement, if CMS receives written comments from the community.
    (ii) If data from an external data source are used in the hospital's 
request, the written comments, or the hospital's rebuttal statement--
    (A) A request will be deemed complete no later than 180 days after 
the end of the 30-day comment period if CMS does not receive written 
comments from the community.
    (B) A request will be deemed complete no later than 180 days after 
the end of the 30-day rebuttal period, regardless of whether the 
hospital submits a rebuttal statement, if CMS receives written comments 
from the community.
    (6) Permitted increase in facility capacity. With respect to an 
applicable hospital only, a permitted increase under this section--
    (i) May not result in the number of operating rooms, procedure 
rooms, and beds for which the hospital is licensed exceeding 200 percent 
of the hospital's baseline number of operating rooms, procedure rooms, 
and beds; and
    (ii) May occur only in facilities on the hospital's main campus.
    (7) Publication of final decisions. Not later than 60 days after 
receiving a complete request, CMS will publish the final decision in the 
Federal Register.
    (8) Limitation on review. There shall be no administrative or 
judicial review under section 1869, section 1878, or otherwise of the 
process under this section (including the establishment of such 
process).

[75 FR 72260, Nov. 24, 2010, as amended at 76 FR 74581, Nov. 30, 2011; 
79 FR 67029, Nov. 10, 2014; 80 FR 71378, Nov. 16, 2015; 85 FR 86299, 
Dec. 29, 2020]



Sec.  411.370  Advisory opinions relating to physician referrals.

    (a) Period during which CMS accepts requests. The provisions of 
Sec.  411.370 through Sec.  411.389 apply to requests for advisory 
opinions that are submitted to CMS during any time period in which CMS 
is required by law to issue the advisory opinions described in this 
subpart.
    (b) Matters that qualify for advisory opinions and who may request 
one. Any individual or entity may request a written advisory opinion 
from CMS concerning whether a physician's referral relating to 
designated health services (other than clinical laboratory services) is 
prohibited under section 1877 of the Act. In the advisory opinion, CMS 
will determine whether a business arrangement described by the parties 
to that arrangement appears to constitute a ``financial relationship'' 
(as defined in section 1877(a)(2) of the Act) that could potentially 
restrict a physician's referrals, and whether the arrangement or the 
designated health services at issue appear to qualify for any of the 
exceptions to the referral prohibition described in section 1877 of the 
Act.
    (1) The request must relate to an existing arrangement or one into 
which the requestor, in good faith, specifically plans to enter. The 
planned arrangement may be contingent upon the party or parties 
receiving a favorable advisory opinion. CMS does not consider, for 
purposes of an advisory opinion, requests that involve the activities of 
third parties.
    (2) The requestor must be a party to the existing or proposed 
arrangement.
    (c) Matters not subject to advisory opinions. CMS will not address 
through an advisory opinion--
    (1) Whether the fair market value was, or will be, paid or received 
for any goods, services, or property; and
    (2) Whether an individual is a bona fide employee within the 
requirements

[[Page 573]]

of section 3121(d)(2) of the Internal Revenue Code of 1986.
    (d) Facts subject to advisory opinions. The requestor must include 
in the advisory opinion request a complete description of the 
arrangement that the requestor is undertaking, or plans to undertake, as 
described in Sec.  411.372.
    (e) Acceptance of requests. (1) CMS does not accept an advisory 
opinion request or issue an advisory opinion if--
    (i) The request is not related to a named individual or entity;
    (ii) The request does not describe the arrangement at issue with a 
level of detail sufficient for CMS to issue an opinion, and the 
requestor does not timely respond to CMS requests for additional 
information;
    (iii) CMS is aware, after consultation with OIG and DOJ, that the 
same course of action is under investigation, or is or has been the 
subject of a proceeding involving the Department of Health and Human 
Services or another governmental agency;
    (iv) CMS believes that it cannot make an informed opinion or could 
only make an informed opinion after extensive investigation, clinical 
study, testing, or collateral inquiry; or
    (v) CMS determines that the arrangement or course of conduct at 
issue is or would be in violation of applicable State or Federal law or 
regulation.
    (2) CMS may elect not to accept an advisory opinion request if it 
determines, after consultation with OIG and DOJ:
    (i) The course of action described is substantially similar to a 
course of conduct that is under investigation or the subject of a 
proceeding involving the Department or other law enforcement agencies; 
and
    (ii) Issuing an advisory opinion could interfere with the 
investigation or proceeding.
    (f) Effects of an advisory opinion on other Governmental authority. 
Nothing in this part limits the investigatory or prosecutorial authority 
of the OIG, the Department of Justice, or any other agency of the 
Government. In addition, in connection with any request for an advisory 
opinion, CMS, the OIG, or the Department of Justice may conduct whatever 
independent investigation it believes appropriate.

[69 FR 57227, Sept. 24, 2004, as amended at 72 FR 51098, Sept. 5, 2007; 
84 FR 63191, Nov. 15, 2019]



Sec.  411.372  Procedure for submitting a request.

    (a) Format for a request. A party or parties must submit a request 
for an advisory opinion to CMS according to the instructions specified 
on the CMS Web site.
    (b) Information CMS requires with all submissions. The request must 
include the following:
    (1) The name, address, telephone number, and Taxpayer Identification 
Number of the requestor.
    (2) The names and addresses, to the extent known, of all other 
actual and potential parties to the arrangement that is the subject of 
the request.
    (3) The name, title, address, and daytime telephone number of a 
contact person who will be available to discuss the request with CMS on 
behalf of the requestor.
    (4) A complete and specific description of all relevant information 
bearing on the arrangement, including--
    (i) A complete description of the arrangement that the requestor is 
undertaking, or plans to undertake, including:
    (A) The purpose of the arrangement; the nature of each party's 
(including each entity's) contribution to the arrangement; the direct or 
indirect relationships between the parties, with an emphasis on the 
relationships between physicians involved in the arrangement (or their 
immediate family members who are involved); and
    (B) Any entities that provide designated health services; the types 
of services for which a physician wishes to refer, and whether the 
referrals will involve Medicare or Medicaid patients;
    (ii) Complete copies of all relevant documents or relevant portions 
of documents that affect or could affect the arrangement, such as 
personal service or employment contracts, leases, deeds, pension or 
insurance plans, or financial statements (or, if these relevant 
documents do not yet exist, a complete description, to the best of the

[[Page 574]]

requestor's knowledge, of what these documents are likely to contain);
    (iii) Detailed statements of all collateral or oral understandings, 
if any; and
    (iv) Descriptions of any other arrangements or relationships that 
could affect CMS's analysis.
    (5) The identity of all entities involved either directly or 
indirectly in the arrangement, including their names, addresses, legal 
form, ownership structure, nature of the business (products and 
services) and, if relevant, their Medicare and Medicaid provider 
numbers. The requestor must also include a brief description of any 
other entities that could affect the outcome of the opinion, including 
those with which the requestor, the other parties, or the immediate 
family members of involved physicians, have any financial relationships 
(either direct or indirect, and as defined in section 1877(a)(2) of the 
Act and Sec.  411.354), or in which any of the parties holds an 
ownership or control interest as defined in section 1124(a)(3) of the 
Act.
    (6) At the option of the requestor, a discussion of the specific 
issues or questions to be addressed by CMS including, if possible, a 
discussion of why the requestor believes the referral prohibition in 
section 1877 of the Act might or might not be triggered by the 
arrangement and which, if any, exceptions the requestor believes might 
apply. The requestor should attempt to designate which facts are 
relevant to each issue or question raised in the request and should cite 
the provisions of law under which each issue or question arises.
    (7) An indication of whether the parties involved in the request 
have also asked for or are planning to ask for an advisory opinion on 
the arrangement in question from the OIG under section 1128D(b) of the 
Act (42 U.S.C. 1320a-7d(b)) and whether the arrangement is or is not, to 
the best of the requestor's knowledge, the subject of an investigation.
    (8) The certification(s) described in Sec.  411.373. The 
certification(s) must be signed by--
    (i) The requestor, if the requestor is an individual;
    (ii) The chief executive officer, or other authorized officer, of 
the requestor, if the requestor is a corporation;
    (iii) The managing partner of the requestor, if the requestor is a 
partnership; or
    (iv) A managing member, if the requestor is a limited liability 
company.
    (c) Additional information CMS might require. If the request does 
not contain all of the information required by paragraph (b) of this 
section, or, if either before or after accepting the request, CMS 
believes it needs more information in order to render an advisory 
opinion, it may request whatever additional information or documents it 
deems necessary. Additional information must be provided in writing, 
signed by the same person who signed the initial request (or by an 
individual in a comparable position), and be certified as described in 
Sec.  411.373.
    (d) Requests for expedited review. Parties may seek expedited review 
of arrangements under Sec.  411.380(c)(1)(i) for a determination as to 
whether the arrangement or course of conduct is indistinguishable in all 
material aspects from an arrangement or course of conduct that was the 
subject of a prior advisory opinion. Parties seeking such expedited 
review must identify the relevant advisory opinion and provide an 
explanation of why the subject arrangement is indistinguishable from the 
arrangement that was the subject of the prior relevant advisory opinion. 
Requestors should clearly and prominently indicate in their submission 
to CMS that they are seeking expedited review.

[69 FR 57227, Sept. 24, 2004, as amended at 81 FR 80553, Nov. 15, 2016; 
84 FR 63191, Nov. 15, 2019]



Sec.  411.373  Certification.

    (a) Every request must include the following signed certification: 
``With knowledge of the penalties for false statements provided by 18 
U.S.C. 1001 and with knowledge that this request for an advisory opinion 
is being submitted to the Department of Health and Human Services, I 
certify that all of the information provided is true and correct, and 
constitutes a complete description of the facts regarding which an 
advisory opinion is sought, to the best of my knowledge and belief.''

[[Page 575]]

    (b) If the advisory opinion relates to a proposed arrangement, in 
addition to the certification required by paragraph (a) of this section, 
the following certification must be included and signed by the 
requestor: ``The arrangement described in this request for an advisory 
opinion is one into which [the requestor], in good faith, plans to 
enter.'' This statement may be made contingent on a favorable advisory 
opinion, in which case the requestor should add one of the following 
phrases to the certification:
    (1) ``if CMS issues a favorable advisory opinion.''
    (2) ``if CMS and the OIG issue favorable advisory opinions.''

[69 FR 57227, Sept. 24, 2004]



Sec.  411.375  Fees for the cost of advisory opinions.

    (a) Hourly rate. CMS will charge an hourly rate of $220. Parties may 
request an estimate from CMS after submitting a complete request. Before 
issuing the advisory opinion, CMS will calculate the final fee for 
responding to the request.
    (b) Agreement to pay all costs. (1) By submitting the request for an 
advisory opinion, the requestor agrees, except as indicated in paragraph 
(c)(3) of this section, to pay all costs the Department incurs in 
responding to the request for an advisory opinion.
    (2) In its request for an advisory opinion, the requestor may 
designate a triggering dollar amount. If CMS estimates that the costs of 
processing the advisory opinion request have reached or are likely to 
exceed the designated triggering dollar amount, CMS notifies the 
requestor.
    (3) If CMS notifies the requestor that the actual or estimated cost 
of processing the request has reached or is likely to exceed the 
triggering dollar amount, CMS stops processing the request until the 
requestor makes a written request for CMS to continue. If CMS is delayed 
in processing the request for an advisory opinion because of this 
procedure, the time within which CMS must issue an advisory opinion is 
suspended until the requestor asks CMS to continue working on the 
request.
    (4) If the requestor chooses not to pay for CMS to complete an 
advisory opinion, or withdraws the request, the requestor is still 
obligated to pay for all costs CMS has identified as costs it incurred 
in processing the request for an advisory opinion, up to that point.
    (5) If the costs CMS has incurred in responding to the request are 
greater than the amount the requestor has paid, CMS, before issuing the 
advisory opinion, notifies the requestor of any additional amount that 
is due. CMS does not issue an advisory opinion until the requestor has 
paid the full amount that is owed. Once the requestor has paid CMS the 
total amount due for the costs of processing the request, CMS issues the 
advisory opinion. The time period CMS has for issuing advisory opinions 
is suspended from the time CMS notifies the requestor of the amount owed 
until the time CMS receives full payment.
    (c) Fees for outside experts. (1) In addition to the fees identified 
in this section, the requestor also must pay any required fees for 
expert opinions, if any, from outside sources, as described in Sec.  
411.377.
    (2) The time period for issuing an advisory opinion is suspended 
from the time that CMS notifies the requestor that it needs an outside 
expert opinion until the time CMS receives that opinion.

[69 FR 57228, Sept. 24, 2004, as amended at 84 FR 63192, Nov. 15, 2019]



Sec.  411.377  Expert opinions from outside sources.

    (a) CMS may request expert advice from qualified sources if CMS 
believes that the advice is necessary to respond to a request for an 
advisory opinion. For example, CMS may require the use of accountants or 
business experts to assess the structure of a complex business 
arrangement or to ascertain a physician's or immediate family member's 
financial relationship with entities that provide designated health 
services.
    (b) If CMS determines that it needs to obtain expert advice in order 
to issue a requested advisory opinion, CMS notifies the requestor of 
that fact and provides the identity of the appropriate expert and an 
estimate of the

[[Page 576]]

costs of the expert advice. As indicated in Sec.  411.375(d), the 
requestor must pay the estimated cost of the expert advice.
    (c) Once CMS has received payment for the estimated cost of the 
expert advice, CMS arranges for the expert to provide a prompt review of 
the issue or issues in question. CMS considers any additional expenses 
for the expert advice, beyond the estimated amount, as part of the costs 
CMS has incurred in responding to the request, and the responsibility of 
the requestor, as described in Sec.  411.375(c).

[69 FR 57229, Sept. 24, 2004]



Sec.  411.378  Withdrawing a request.

    The party requesting an advisory opinion may withdraw the request 
before CMS issues a formal advisory opinion. This party must submit the 
withdrawal in writing to the same address as the request, as indicated 
in Sec.  411.372(a). Even if the party withdraws the request, the party 
must pay the costs the Department has expended in processing the 
request, as discussed in Sec.  411.375. CMS reserves the right to keep 
any request for an advisory opinion and any accompanying documents and 
information, and to use them for any governmental purposes permitted by 
law.

[69 FR 57229, Sept. 24, 2004]



Sec.  411.379  When CMS accepts a request.

    (a) Upon receiving a request for an advisory opinion, CMS promptly 
makes an initial determination of whether the request contains a level 
of detail sufficient for CMS to process the request.
    (b) If CMS determines that the request submitted lacks details 
necessary for CMS to process the request, CMS will provide notification 
to the requestor within 15 working days of receiving the request.
    (c) If the requestor provides the additional information CMS has 
requested, or otherwise resubmits the request, CMS processes the 
resubmission in accordance with paragraphs (a) and (b) of this section 
as if it were an initial request for an advisory opinion.
    (d) CMS formally accepts a request when CMS determines that the 
request (inclusive of any supplemental submissions) describes the 
arrangement at issue with sufficient detail and that the grounds for 
rejection of a request listed at Sec.  411.370(e) do not apply. Upon 
accepting the request, CMS notifies the requestor by regular U.S. mail 
of the date that CMS formally accepts the request.
    (e) The applicable time period that CMS has to issue an advisory 
opinion set forth in Sec.  411.380(c) does not begin until CMS formally 
accepts the request for an advisory opinion.

[69 FR 57229, Sept. 24, 2004, as amended at 84 FR 63192, Nov. 15, 2019]



Sec.  411.380  When CMS issues a formal advisory opinion.

    (a) CMS considers an advisory opinion to be issued once it has 
received payment and once the opinion has been dated, numbered, and 
signed by an authorized CMS official.
    (b) An advisory opinion contains a description of the material facts 
known to CMS that relate to the arrangement that is the subject of the 
advisory opinion, and states CMS's opinion about the subject matter of 
the request based on those facts. If necessary, CMS includes in the 
advisory opinion material facts that could be considered confidential 
information or trade secrets within the meaning of 18 U.S.C. 1095.
    (c)(1) Except as set forth in paragraph (c)(2) of this section, CMS 
issues an advisory opinion in accordance with the provisions of this 
part within 60 working days after the date on which it formally accepts 
the advisory opinion request.
    (i) In the case of a request for a determination that an arrangement 
or course of conduct is indistinguishable in all material aspects from 
another arrangement or course of conduct that was the subject of a prior 
opinion, CMS issues an advisory opinion within 30 working days after the 
date on which it formally accepts the advisory opinion request.
    (ii) In the case of a request that CMS determines, in its 
discretion, involves complex legal issues or highly complicated fact 
patterns, CMS issues an advisory opinion within a reasonable time period 
after the date on which it formally accepts the advisory opinion 
request.

[[Page 577]]

    (iii) If the last day of the 60-working day or 30-working day time 
period falls on a Saturday, Sunday, or Federal holiday, CMS may issue 
the advisory opinion at the close of business on the first business day 
following the weekend or holiday.
    (2) The applicable time period for issuing an advisory opinion is 
suspended from the time CMS;
    (i) Notifies the requestor that the costs have reached or are likely 
to exceed the triggering amount as described in Sec.  411.375(c)(2) 
until CMS receives written notice from the requestor to continue 
processing the request;
    (ii) Requests additional information from the requestor until CMS 
receives the additional information;
    (iii) Notifies the requestor of the full amount due until CMS 
receives payment of this amount; and
    (iv) Notifies the requestor of the need for expert advice until CMS 
receives the expert advice.
    (d) After CMS has notified the requestor of the full amount owed and 
has received full payment of that amount, CMS issues the advisory 
opinion and promptly mails it to the requestor by regular first class 
U.S. mail.

[69 FR 57229, Sept. 24, 2004, as amended at 84 FR 63192, Nov. 15, 2019]



Sec.  411.382  CMS' right to rescind advisory opinions.

    (a)(1) Any advice CMS gives in an advisory opinion does not 
prejudice its right to reconsider the questions involved in the opinion, 
and CMS may rescind or revoke the opinion if it determines that there is 
good cause to rescind or revoke the opinion.
    (2) Good cause shall exist where--
    (i) There is a material change in the law that affects the 
conclusions reached in an opinion; or
    (ii) A party that has received a negative advisory opinion seeks 
reconsideration based on new facts or law.
    (b) CMS provides advance notice to the requestor and to the public 
of its decision to rescind or revoke the opinion so that the requestor 
and other parties may discontinue any course of action they have taken 
in accordance with, or in good faith reliance on, the advisory opinion.
    (c) CMS does not proceed against the requestor with respect to any 
action the requestor and the involved parties have taken in good faith 
reliance upon CMS' advice under this part, provided--
    (1) The requestor presented to CMS a full, complete and accurate 
description of all the relevant facts; and
    (2) The parties promptly discontinue the action upon receiving 
notice that CMS had rescinded or revoked its approval, or discontinue 
the action within a reasonable ``wind down'' period, as determined by 
CMS.

[84 FR 63193, Nov. 15, 2019]



Sec.  411.384  Disclosing advisory opinions and supporting information.

    (a) Advisory opinions that CMS issues and releases in accordance 
with the procedures set forth in this subpart are available to the 
public.
    (b) Promptly after CMS issues an advisory opinion and releases it to 
the requestor, CMS makes available a copy of the advisory opinion on the 
CMS Web site.
    (c) Any predecisional document, or part of such predecisional 
document, that is prepared by CMS, the Department of Justice, or any 
other Department or agency of the United States in connection with an 
advisory opinion request under the procedures set forth in this part is 
exempt from disclosure under 5 U.S.C. 552, and will not be made publicly 
available.
    (d) Documents submitted by the requestor to CMS in connection with a 
request for an advisory opinion are available to the public to the 
extent they are required to be made available by 5 U.S.C. 552, through 
procedures set forth in 45 CFR part 5.
    (e) Nothing in this section limits CMS's obligation, under 
applicable laws, to publicly disclose the identity of the requesting 
party or parties, and the nature of the action CMS has taken in response 
to the request.

[69 FR 57230, Sept. 24, 2004, as amended at 80 FR 71379, Nov. 16, 2015; 
84 FR 63193, Nov. 15, 2019]



Sec.  411.386  CMS's advisory opinions as exclusive.

    The procedures described in this subpart constitute the only method 
by which any individuals or entities can

[[Page 578]]

obtain a binding advisory opinion on the subject of a physician's 
referrals, as described in Sec.  411.370. CMS has not and does not issue 
a binding advisory opinion on the subject matter in Sec.  411.370, in 
either oral or written form, except through written opinions it issues 
in accordance with this subpart.

[69 FR 57230, Sept. 24, 2004]



Sec.  411.387  Effect of an advisory opinion.

    (a) An advisory opinion is binding on the Secretary, and a favorable 
advisory opinion shall preclude imposition of sanctions under section 
1877(g) of the Act with respect to:
    (1) The individuals or entities requesting the opinion; and
    (2) Individuals or entities that are parties to the specific 
arrangement with respect to which such advisory opinion has been issued.
    (b) The Secretary will not pursue sanctions under section 1877(g) of 
the Act against any party to an arrangement that CMS determines is 
indistinguishable in all its material aspects from an arrangement with 
respect to which CMS issued a favorable advisory opinion.
    (c) Individuals and entities may rely on an advisory opinion as non-
binding guidance that illustrates the application of the physician self-
referral law and regulations to the specific facts and circumstances 
described in the advisory opinion.

[84 FR 63193, Nov. 15, 2019]



Sec.  411.388  When advisory opinions are not admissible evidence.

    The failure of a party to seek or to receive an advisory opinion may 
not be introduced into evidence to prove that the party either intended 
or did not intend to violate the provisions of sections 1128, 1128A or 
1128B of the Act.

[69 FR 57230, Sept. 24, 2004]



Sec.  411.389  Range of the advisory opinion.

    (a) An advisory opinion states only CMS's opinion regarding the 
subject matter of the request. If the subject of an advisory opinion is 
an arrangement that must be approved by or is regulated by any other 
agency, CMS's advisory opinion cannot be read to indicate CMS's views on 
the legal or factual issues that may be raised before that agency.
    (b) An advisory opinion that CMS issues under this part does not 
bind or obligate any agency other than the Department. It does not 
affect the requestor's, or anyone else's, obligations to any other 
agency, or under any statutory or regulatory provision other than that 
which is the specific subject matter of the advisory opinion.

[69 FR 57230, Sept. 24, 2004]



             Subpart K_Payment for Certain Excluded Services



Sec.  411.400  Payment for custodial care and services not reasonable 
and necessary.

    (a) Conditions for payment. Notwithstanding the exclusions set forth 
in Sec.  411.15 (g) and (k). Medicare pays for ``custodial care'' and 
``services not reasonable and necessary'' if the following conditions 
are met:
    (1) The services were funished by a provider or by a practitioner or 
supplier that had accepted assignment of benefits for those services.
    (2) Neither the beneficiary nor the provider, practitioner, or 
supplier knew, or could reasonably have been expected to know, that the 
services were excluded from coverage under Sec.  411.15 (g) or (k).
    (b) Time limits on payment--(1) Basic rule. Except as provided in 
paragraph (b)(2) of this section, payment may not be made for inpatient 
hospital care, posthospital SNF care, or home health services furnished 
after the earlier of the following:
    (i) The day on which the beneficiary has been determined, under 
Sec.  411.404, to have knowledge, actual or imputed, that the services 
were excluded from coverage by reason of Sec.  411.15(g) or Sec.  
411.15(k).
    (ii) The day on which the provider has been determined, under Sec.  
411.406 to have knowledge, actual or imputed, that the services are 
excluded from coverage by reason of Sec.  411.15(g) or Sec.  411.15(k).
    (2) Exception. Payment may be made for services furnished during the 
first day after the limit established in paragraph (b)(1) of this 
section, if the QIO

[[Page 579]]

or the intermediary determines that the additional period of one day is 
necessary for planning post-discharge care. It the QIO or the 
intermediary determines that yet another day is necessary for planning 
post-discharge care, payment may be made for services furnished during 
the second day after the limit established in paragraph (b)(1) of this 
section.



Sec.  411.402  Indemnification of beneficiary.

    (a) Conditions for indemnification. If Medicare payment is precluded 
because the conditions of Sec.  411.400(a)(2) are not met. Medicare 
indemnifies the beneficiary (and recovers from the provider, 
practitioner, or supplier), if the following conditions are met:
    (1) The beneficiary paid the provider, practitioner, or supplier 
some or all of the charges for the excluded services.
    (2) The beneficiary did not know and could not reasonably have been 
expected to know that the services were not covered.
    (3) The provider, practitioner, or supplier knew, or could 
reasonably have been expected to know that the services were not 
covered.
    (4) The beneficiary files a proper request for indemnification 
before the end of the sixth month after whichever of the following is 
later:
    (i) The month is which the beneficiary paid the provider, 
practitioner, or supplier.
    (ii) The month in which the intermediary or carrier notified the 
beneficiary (or someone on his or her behalf) that the beneficiary would 
not be liable for the services.

For good cause shown by the beneficiary, the 6-month period may be 
extended.
    (b) Amount of indemnification. \1\ The amount of indemnification is 
the total that the beneficiary paid the provider, practitioner, or 
supplier.
---------------------------------------------------------------------------

    \1\ For services furnished before 1988, the indemnification amount 
was reduced by any deductible or coinsurance amounts that would have 
been applied if the services had been covered.
---------------------------------------------------------------------------

    (c) Effect of indemnification. The amount of indemnification is 
considered an overpayment to the provider, practitioner, or supplier, 
and as such is recoverable under this part or in accordance with other 
applicable provisions of law.



Sec.  411.404  Criteria for determining that a beneficiary knew that services 
were excluded from coverage as custodial care or as not reasonable 
and necessary.

    (a) Basic rule. A beneficiary who receives services that constitute 
custodial care under Sec.  411.15(g) or that are not reasonable and 
necessary under Sec.  411.15(k), is considered to have known that the 
services were not covered if the criteria of paragraphs (b) and (c) of 
this section are met.
    (b) Written notice. (1) Written notice is given to the beneficiary, 
or to someone acting on his or her behalf, that the services were not 
covered because they did not meet Medicare coverage guidelines.
    (2) A notice concerning similar or reasonably comparable services 
furnished on a previous occasion also meets this criterion.
    (3) After a beneficiary is notified that there is no Medicare 
payment for a service that is not covered by Medicare, he or she is 
presumed to know that there is no Medicare payment for any form of 
subsequent treatment for the non-covered condition.
    (c) Source of notice. The notice was given by one of the following:
    (1) The QIO, intermediary, or carrier.
    (2) The group or committee responsible for utilization review for 
the provider that furnished the services.
    (3) The provider, practitioner, or supplier that furnished the 
service.

[54 FR 41734, Oct. 11, 1989, as amended at 69 FR 66423, Nov. 15, 2004]



Sec.  411.406  Criteria for determining that a provider, practitioner, 
or supplier knew that services were excluded from coverage as custodial care 
or as not reasonable and necessary.

    (a) Basic rule. A provider, practitioner, or supplier that furnished 
services which constitute custodial care under Sec.  411.15(g) or that 
are not reasonable and necessary under Sec.  411.15(k) is considered to 
have known that the services were not covered if any one of the 
conditions specified in paragraphs (b) through (e) of this section is 
met.

[[Page 580]]

    (b) Notice from the QIO, intermediary or carrier. The QIO, 
intermediary, or carrier had informed the provider, practitioner, or 
supplier that the services furnished were not covered, or that similar 
or reasonably comparable services were not covered.
    (c) Notice from the utilization review committee or the 
beneficiary's attending phyician. The utilization review group or 
committee for the provider or the beneficiary's attending physician had 
informed the provider that these services were not covered.
    (d) Notice from the provider, practitioner, or supplier to the 
beneficiary. Before the services were furnished, the provider, 
practitioner or supplier informed the beneficiary that--
    (1) The services were not covered; or
    (2) The beneficiary no longer needed covered services.
    (e) Knowledge based on experience, actual notice, or constructive 
notice. It is clear that the provider, practitioner, or supplier could 
have been expected to have known that the services were excluded from 
coverage on the basis of the following:
    (1) Its receipt of CMS notices, including manual issuances, 
bulletins, or other written guides or directives from intermediaries, 
carriers, or QIOs, including notification of QIO screening criteria 
specific to the condition of the beneficiary for whom the furnished 
services are at issue and of medical procedures subject to preadmission 
review by a QIO.
    (2) Federal Register publications containing notice of national 
coverage decisions or of other specifications regarding noncoverage of 
an item or service.
    (3) Its knowledge of what are considered acceptable standards of 
practice by the local medical community.

[54 FR 41734, Oct. 11, 1989, as amended at 60 FR 48425, Sept. 19, 1995]



Sec.  411.408  Refunds of amounts collected for physician services 
not reasonable and necessary, payment not accepted on 
an assignment-related basis.

    (a) Basic rule. Except as provided in paragraph (d) of this section, 
a physician who furnishes a beneficiary services for which the physician 
does not undertake to claim payment on an assignment-related basis must 
refund any amounts collected from the beneficiary for services otherwise 
covered if Medicare payment is denied because the services are found to 
be not reasonable and necessary under Sec.  411.15(k).
    (b) Time limits for making refunds. A timely refund of any 
incorrectly collected amounts of money must be made to the beneficiary 
to whom the services were furnished. A refund is timely if--
    (1) A physician who does not request a review within 30 days after 
receipt of the denial notice makes the refund within that time period; 
or
    (2) A physician who files a request for review within 30 days after 
receipt of the denial notice makes the refund within 15 days after 
receiving notice of an initial adverse review determination, whether or 
not the physician further appeals the initial adverse review 
determination.
    (c) Notices and appeals. If payment is denied for nonassignment-
related claims because the services are found to be not reasonable and 
necessary, a notice of denial will be sent to both the physician and the 
beneficiary. The physician who does not accept assignment will have the 
same rights as a physician who submits claims on an assignment-related 
basis, as detailed in subpart H of part 405 and subpart B of part 473, 
to appeal the determination, and will be subject to the same time 
limitations.
    (d) When a refund is not required. A refund of any amounts collected 
for services not reasonable and necessary is not required if--
    (1) The physician did not know, and could not reasonably have been 
expected to know, that Medicare would not pay for the service; or
    (2) Before the service was provided--
    (i) The physician informed the beneficiary, or someone acting on the 
beneficiary's behalf, in writing that the physician believed Medicare 
was likely to deny payment for the specific service; and
    (ii) The beneficiary (or someone eligible to sign for the 
beneficiary under Sec.  424.36(b) of this chapter) signed a statement 
agreeing to pay for that service.

[[Page 581]]

    (e) Criteria for determining that a physician knew that services 
were excluded as not reasonable and necessary. A physician will be 
determined to have known that furnished services were excluded from 
coverage as not reasonable and necessary if one or more of the 
conditions in Sec.  411.406 of this subpart are met.
    (f) Acceptable evidence of prior notice to a beneficiary that 
Medicare was likely to deny payment for a particular service. To qualify 
for waiver of the refund requirement under paragraph (d)(2) of this 
section, the physician must inform the beneficiary (or person acting on 
his or her behalf) that the physician believes Medicare is likely to 
deny payment.
    (1) The notice must--
    (i) Be in writing, using approved notice language;
    (ii) Cite the particular service or services for which payment is 
likely to be denied; and
    (iii) Cite the physician's reasons for believing Medicare payment 
will be denied.
    (2) The notice is not acceptable evidence if--
    (i) The physician routinely gives this notice to all beneficiaries 
for whom he or she furnishes services; or
    (ii) The notice is no more than a statement to the effect that there 
is a possibility that Medicare may not pay for the service.
    (g) Applicability of sanctions to physicians who fail to make 
refunds under this section. A physician who knowingly and willfully 
fails to make refunds as required by this section may be subject to 
sanctions as provided for in chapter V, parts 1001, 1002, and 1003 of 
this title.

[55 FR 24568, June 18, 1990; 55 FR 35142, 35143, Aug. 28, 1990]



PART 412_PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL SERVICES--
Table of Contents



                      Subpart A_General Provisions

Sec.
412.1 Scope of part.
412.2 Basis of payment.
412.3 Admissions.
412.4 Discharges and transfers.
412.6 Cost reporting periods subject to the prospective payment systems.
412.8 Publication of schedules for determining prospective payment 
          rates.
412.10 Changes in the DRG classification system.

Subpart B_Hospital Services Subject to and Excluded From the Prospective 
  Payment Systems for Inpatient Operating Costs and Inpatient Capital-
                              Related Costs

412.20 Hospital services subject to the prospective payment systems.
412.22 Excluded hospitals and hospital units: General rules.
412.23 Excluded hospitals: Classifications.
412.24 Requirements under the PPS-Exempt Cancer Hospital Quality 
          Reporting (PCHQR) Program.
412.25 Excluded hospital units: Common requirements.
412.27 Excluded psychiatric units: Additional requirements.
412.29 Classification criteria for payment under the inpatient 
          rehabilitation facility prospective payment system.
412.30 [Reserved]

 Subpart C_Conditions for Payment Under the Prospective Payment Systems 
    for Inpatient Operating Costs and Inpatient Capital-Related Costs

412.40 General requirements.
412.42 Limitations on charges to beneficiaries.
412.44 Medical review requirements: Admissions and quality review.
412.46 Medical review requirements.
412.48 Denial of payment as a result of admissions and quality review.
412.50 Furnishing of inpatient hospital services directly or under 
          arrangements.
412.52 Reporting and recordkeeping requirements.

Subpart D_Basic Methodology for Determining Prospective Payment Federal 
                   Rates for Inpatient Operating Costs

412.60 DRG classification and weighting factors.
412.62 Federal rates for inpatient operating costs for fiscal year 1984.
412.63 Federal rates for inpatient operating costs for Federal fiscal 
          years 1984 through 2004.

[[Page 582]]

412.64 Federal rates for inpatient operating costs for Federal fiscal 
          year 2005 and subsequent fiscal years.

   Subpart E_Determination of Transition Period Payment Rates for the 
        Prospective Payment System for Inpatient Operating Costs

412.70 General description.
412.71 Determination of base-year inpatient operating costs.
412.72 Modification of base-year costs.
412.73 Determination of the hospital-specific rate based on a Federal 
          fiscal year 1982 base period.
412.75 Determination of the hospital-specific rate for inpatient 
          operating costs based on a Federal fiscal year 1987 base 
          period.
412.76 Recovery of excess transition period payment amounts resulting 
          from unlawful claims.
412.77 Determination of the hospital-specific rate for inpatient 
          operating costs for sole community hospitals based on a 
          Federal fiscal year 1996 base period.
412.78 Determination of the hospital-specific rate for inpatient 
          operating costs for sole community hospitals based on a 
          Federal fiscal year 2006 base period.
412.79 Determination of the hospital-specific rate for inpatient 
          operating costs for Medicare-dependent, small rural hospitals 
          based on a Federal fiscal year 2002 base period.

Subpart F_Payments for Outlier Cases, Special Treatment Payment for New 
     Technology, and Payment Adjustment for Certain Replaced Devices

                        Payment for Outlier Cases

412.80 Outlier cases: General provisions.
412.82 Payment for extended length-of-stay cases (day outliers).
412.83 Payment for extraordinarily high-cost day outliers.
412.84 Payment for extraordinarily high-cost cases (cost outliers).

Payment Adjustment for Certain Clinical Trial Cases and Expanded Access 
                            Use Immunotherapy

412.85 Payment adjustment for certain clinical trial and expanded access 
          use immunotherapy cases.
412.86 [Reserved]

          Additional Special Payment for Certain New Technology

412.87 Additional payment for new medical services and technologies: 
          General provisions.
412.88 Additional payment for new medical service or technology.

             Payment Adjustment for Certain Replaced Devices

412.89 Payment adjustment for certain replaced devices.

Subpart G_Special Treatment of Certain Facilities Under the Prospective 
              Payment System for Inpatient Operating Costs

412.90 General rules.
412.92 Special treatment: Sole community hospitals.
412.96 Special treatment: Referral centers.
412.98 [Reserved]
412.100 Special treatment: Renal transplantation centers.
412.101 Special treatment: Inpatient hospital payment adjustment for 
          low-volume hospitals.
412.102 Special treatment: Hospitals located in areas that are changing 
          from urban to rural as a result of a geographic redesignation.
412.103 Special treatment: Hospitals located in urban areas and that 
          apply for reclassification as rural.
412.104 Special treatment: Hospitals with high percentage of ESRD 
          discharges.
412.105 Special treatment: Hospitals that incur indirect costs for 
          graduate medical education programs.
412.106 Special treatment: Hospitals that serve a disproportionate share 
          of low-income patients.
412.107 Special treatment: Hospitals that receive an additional update 
          for FYs 1998 and 1999.
412.108 Special treatment: Medicare-dependent, small rural hospitals.
412.109 Special treatment: Essential access community hospitals (EACHs).

  Subpart H_Payments to Hospitals Under the Prospective Payment Systems

412.110 Total Medicare payment.
412.112 Payments determined on a per case basis.
412.113 Other payments.
412.115 Additional payments.
412.116 Method of payment.
412.120 Reductions to total payments.
412.125 Effect of change of ownership on payments under the prospective 
          payment systems.
412.130 Retroactive adjustments for incorrectly excluded hospitals and 
          units.

[[Page 583]]

412.140 Participation, data submission, and validation requirements 
          under the Hospital Inpatient Quality Reporting (IQR) Program.

 Subpart I_Adjustments to the Base Operating DRG Payment Amounts Under 
      the Prospective Payment Systems for Inpatient Operating Costs

412.150 Basis and scope of subpart.

  Payment Adjustments Under the Hospital Readmissions Reduction Program

412.152 Definitions for the Hospital Readmissions Reduction Program.
412.154 Payment adjustments under the Hospital Readmissions Reduction 
          Program.
412.155-412.159 [Reserved]

  Incentive Payments Under the Hospital Value-Based Purchasing Program

412.160 Definitions for the Hospital Value-Based Purchasing (VBP) 
          Program.
412.161 Applicability of the Hospital Value-Based Purchasing (VBP) 
          Program
412.162 Process for reducing the base operating DRG payment amount and 
          applying the value-based incentive payment amount adjustment 
          under the Hospital Value-Based Purchasing (VBP) Program.
412.163 Process for making hospital-specific performance information 
          under the Hospital Value-Based Purchasing (VBP) Program 
          available to the public.
412.164 Measure selection under the Hospital Value-Based Purchasing 
          (VBP) Program.
412.165 Performance standards under the Hospital Value-Based Purchasing 
          (VBP) Program.
412.167 Appeal under the Hospital Value-Based Purchasing (VBP) Program.
412.168 Special rule for FY 2022.
412.169 [Reserved]

  Payment Adjustments Under the Hospital-Acquired Condition Reduction 
                                 Program

412.170 Definitions for the Hospital-Acquired Condition Reduction 
          Program.
412.172 Payment adjustments under the Hospital-Acquired Condition 
          Reduction Program.
412.190 Overall Hospital Quality Star Rating.

Subpart J [Reserved]

 Subpart K_Prospective Payment System for Inpatient Operating Costs for 
                    Hospitals Located in Puerto Rico

412.200 General provisions.
412.204 Payments to hospitals located in Puerto Rico.
412.208 Puerto Rico rates for Federal fiscal year 1988.
412.210 Puerto Rico rates for Federal fiscal years 1989 through 2003.
412.211 Puerto Rico rates for Federal fiscal year 2004 and subsequent 
          fiscal years.
412.212 National rate.
412.220 Special treatment of certain hospitals located in Puerto Rico.

      Subpart L_The Medicare Geographic Classification Review Board

                Criteria and Conditions for Redesignation

412.230 Criteria for an individual hospital seeking redesignation to 
          another rural area or an urban area.
412.232 Criteria for all hospitals in a rural county seeking urban 
          redesignation.
412.234 Criteria for all hospitals in an urban county seeking 
          redesignation to another urban area.

                       Composition and Procedures

412.246 MGCRB members.
412.248 Number of members needed for a decision or a hearing.
412.250 Sources of MGCRB's authority.
412.252 Applications.
412.254 Proceedings before MGCRB.
412.256 Application requirements.
412.258 Parties to MGCRB proceeding.
412.260 Time and place of the oral hearing.
412.262 Disqualification of an MGCRB member.
412.264 Evidence and comments in MGCRB proceeding.
412.266 Availability of wage data.
412.268 Subpoenas.
412.270 Witnesses.
412.272 Record of proceedings before the MGCRB.
412.273 Withdrawing an application, terminating an approved 3-year 
          reclassification, or canceling a previous withdrawal or 
          termination.
412.274 Scope and effect of an MGCRB decision.
412.276 Timing of MGCRB decision and its appeal.
412.278 Administrator's review.
412.280 Representation.

  Subpart M_Prospective Payment System for Inpatient Hospital Capital 
                                  Costs

                           General Provisions

412.300 Scope of subpart and definition.
412.302 Introduction to capital costs.
412.304 Implementation of the capital prospective payment system.

[[Page 584]]

 Basic Methodology for Determining the Federal Rate for Capital-Related 
                                  Costs

412.308 Determining and updating the Federal rate.
412.312 Payment based on the Federal rate.
412.316 Geographic adjustment factors.
412.320 Disproportionate share adjustment factor.
412.322 Indirect medical education adjustment factor.

  Determination of Transition Period Payment Rates for Capital-Related 
                                  Costs

412.324 General description.
412.328 Determining and updating the hospital-specific rate.
412.331 Determining hospital-specific rates in cases of hospital merger, 
          consolidation, or dissolution.
412.332 Payment based on the hospital-specific rate.
412.336 Transition period payment methodologies.
412.340 Fully prospective payment methodology.
412.344 Hold-harmless payment methodology.
412.348 Exception payments.
412.352 Budget neutrality adjustment.

                 Special Rules for Puerto Rico Hospitals

412.370 General provisions for hospitals located in Puerto Rico.
412.374 Payments to hospitals located in Puerto Rico.

Subpart N_Prospective Payment System for Hospital Inpatient Services of 
                    Inpatient Psychiatric Facilities

412.400 Basis and scope of subpart.
412.402 Definitions.
412.404 Conditions for payment under the prospective payment system for 
          inpatient hospital services of psychiatric facilities.
412.405 Preadmission services as inpatient operating costs under the 
          inpatient psychiatric facility prospective payment system.
412.422 Basis of payment.
412.424 Methodology for calculating the Federal per diem payment amount.
412.426 Transition period.
412.428 Publication of changes to the inpatient psychiatric facility 
          prospective payment system.
412.432 Method of payment under the inpatient psychiatric facility 
          prospective payment system.
412.434 Reconsideration and appeals procedures of Inpatient Psychiatric 
          Facilities Quality Reporting (IPFQR) Program decisions.

    Subpart O_Prospective Payment System for Long-Term Care Hospitals

412.500 Basis and scope of subpart.
412.503 Definitions.
412.505 Conditions for payment under the prospective payment system for 
          long-term care hospitals.
412.507 Limitation on charges to beneficiaries.
412.508 Medical review requirements.
412.509 Furnishing of inpatient hospital services directly or under 
          arrangement.
412.511 Reporting and recordkeeping requirements.
412.513 Patient classification system.
412.515 LTC-DRG weighting factors.
412.517 Revision of LTC-DRG group classifications and weighting factors.
412.521 Basis of payment.
412.522 Application of site neutral payment rate.
412.523 Methodology for calculating the Federal prospective payment 
          rates.
412.525 Adjustments to the Federal prospective payment.
412.526 Payment provisions for a ``subclause (II)'' long-term care 
          hospital.
412.529 Special payment provisions for short-stay outliers.
412.531 Special payment provisions when an interruption of a stay occurs 
          in a long-term care hospital.
412.533 Transition payments.
412.534 Special payment provisions for long-term care hospitals-within-
          hospitals and satellites of long-term care hospitals, 
          effective for discharges occurring in cost reporting periods 
          beginning on or before September 30, 2016.
412.535 Publication of the Federal prospective payment rates.
412.536 Special payment provisions for long-term care hospitals and 
          satellites of long-term care hospitals that discharge Medicare 
          patients admitted from a hospital not located in the same 
          building or on the same campus as the long-term care hospital 
          or satellite of the long-term care hospital, effective for 
          discharges occurring on or before September 30, 2016 or in 
          cost reporting periods beginning on or before June 30, 2016.
412.538 [Reserved]
412.540 Method of payment for preadmission services under the long-term 
          care hospital prospective payment system.
412.541 Method of payment under the long-term care hospital prospective 
          payment system.

[[Page 585]]

412.560 Requirements under the Long-Term Care Hospital Quality Reporting 
          Program (LTCH QRP).

Subpart P_Prospective Payment for Inpatient Rehabilitation Hospitals and 
                          Rehabilitation Units

412.600 Basis and scope of subpart.
412.602 Definitions.
412.604 Conditions for payment under the prospective payment system for 
          inpatient rehabilitation facilities.
412.606 Patient assessments.
412.608 Patients' rights regarding the collection of patient assessment 
          data.
412.610 Assessment schedule.
412.612 Coordination of the collection of patient assessment data.
412.614 Transmission of patient assessment data.
412.616 Release of information collected using the patient assessment 
          instrument.
412.618 Assessment process for interrupted stays.
412.620 Patient classification system.
412.622 Basis of payment.
412.624 Methodology for calculating the Federal prospective payment 
          rates.
412.626 Transition period.
412.628 Publication of the Federal prospective payment rates.
412.630 Limitation on review.
412.632 Method of payment under the inpatient rehabilitation facility 
          prospective payment system.
412.634 Requirements under the Inpatient Rehabilitation Facility (IRF) 
          Quality Reporting Program (QRP).

    Authority: 42 U.S.C. 1302 and 1395hh.

    Source: 50 FR 12741, Mar. 29, 1985, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  412.1  Scope of part.

    (a) Purpose. (1) This part implements sections 1886(d) and (g) of 
the Act by establishing a prospective payment system for the operating 
costs of inpatient hospital services furnished to Medicare beneficiaries 
in cost reporting periods beginning on or after October 1, 1983, and a 
prospective payment system for the capital-related costs of inpatient 
hospital services furnished to Medicare beneficiaries in cost reporting 
periods beginning on or after October 1, 1991.
    (i) Under these prospective payment systems, payment for the 
operating and capital-related costs of inpatient hospital services 
furnished by hospitals subject to the systems (generally, short-term, 
acute-care hospitals) is made on the basis of prospectively determined 
rates and applied on a per discharge basis.
    (ii) Payment for other costs related to inpatient hospital services 
(organ acquisition costs incurred by hospitals with approved organ 
transplantation centers, the costs of qualified nonphysician 
anesthetist's services, as described in Sec.  412.113(c), direct costs 
of approved nursing and allied health educational programs, costs 
related to hematopoietic stem cell acquisition for the purpose of an 
allogeneic hematopoietic stem cell transplant as described in Sec.  
412.113(e)) is made on a reasonable cost basis.
    (iii) Payment for the direct costs of graduate medical education is 
made on a per resident amount basis in accordance with Sec. Sec.  413.75 
through 413.83 of this chapter.
    (iv) Additional payments are made for outlier cases, bad debts, 
indirect medical education costs, and for serving a disproportionate 
share of low-income patients.
    (v) Under either prospective payment system, a hospital may keep the 
difference between its prospective payment rate and its operating or 
capital-related costs incurred in furnishing inpatient services, and the 
hospital is at risk for inpatient operating or inpatient capital-related 
costs that exceed its payment rate.
    (2) This part implements section 124 of Public Law 106-113 by 
establishing a per diem prospective payment system for the inpatient 
operating and capital costs of hospital inpatient services furnished to 
Medicare beneficiaries by a psychiatric facility that meets the 
conditions of subpart N of this part.
    (3) This part implements section 1886(j) of the Act by establishing 
a prospective payment system for the inpatient operating and capital 
costs of inpatient hospital services furnished to Medicare beneficiaries 
by a rehabilitation hospital or rehabilitation unit that meets the 
conditions of Sec.  412.604.
    (4) This part implements the following regarding long-term care 
hospitals--
    (i) Section 123 of Public Law 106-113, which provides for the 
establishment of

[[Page 586]]

a prospective payment system for the costs of inpatient hospital 
services furnished to Medicare beneficiaries by long-term care hospitals 
described in section 1886(d)(1)(B)(iv) of the Act, for cost reporting 
periods beginning on or after October 1, 2002.
    (ii) The provisions of section 307(b) of Public Law 106-554, which 
state that the Secretary shall examine and may provide for appropriate 
adjustments to the long-term care hospital prospective payment system, 
including adjustments to diagnosis-related group (DRG) weights, area 
wage adjustments, geographic reclassification, outlier adjustments, 
updates, and disproportionate share adjustments consistent with section 
1886(d)(5)(F) of the Act.
    (iii) Section 114 of Public Law 110-173, which contains several 
provisions regarding long-term care hospitals, including the--
    (A) Amendment of section 1886 of the Act to add a new subsection (m) 
that references section 123 of Public Law 106-113 and section 307(b) of 
Public Law 106-554 for the establishment and implementation of a 
prospective payment system for payments under title XVIII for inpatient 
hospital services furnished by a long-term care hospital described in 
section 1886(d)(1)(B)(iv) of the Act.
    (B) Revision of the standard Federal rate for RY 2008.
    (5) This part implements section 1886(q) of the Act, which provides 
that, effective for discharges from an ``applicable hospital'' beginning 
on or after October 1, 2012, payments to those hospitals under section 
1886(d) of the Act will be reduced to account for certain excess 
readmissions, under the Hospital Readmissions Reduction Program. This 
reduction will be made through an adjustment to the hospital's base 
operating DRG payment amounts under the prospective payment system for 
inpatient operating costs.
    (6) This part implements section 1886(o)(1)(B) of the Act, which 
directs the Secretary to begin to make value-based incentive payments 
under the Hospital Value-Based Purchasing Program to hospitals for 
discharges occurring on or after October 1, 2012, through an adjustment 
to the base operating DRG payment amounts under the prospective payment 
system for inpatient operating costs.
    (7) This part implements section 1866(k) of the Act, which directs 
hospitals described in section 1886(d)(1)(B)(v) of the Act to submit 
data on quality measures to the Secretary.
    (b) Summary of content. (1) This subpart describes the basis of 
payment for inpatient hospital services under the prospective payment 
systems specified in paragraph (a)(1) of this section and sets forth the 
general basis of these systems.
    (2) Subpart B of this part sets forth all of the following:
    (i)(A) The classifications of hospitals that are included in and 
excluded from the prospective payment systems specified in paragraph 
(a)(1) of this section.
    (B) Requirements governing the inclusion or exclusion of hospitals 
in the systems as a result of changes in their classification.
    (ii) Requirements for the PPS-Exempt Cancer Hospital Quality 
Reporting (PCHQR) Program.
    (3) Subpart C sets forth certain conditions that must be met for a 
hospital to receive payment under the prospective payment systems 
specified in paragraph (a)(1) of this section.
    (4) Subpart D sets forth the basic methodology by which prospective 
payment rates for inpatient operating costs are determined under the 
prospective payment system specified in paragraph (a)(1) of this 
section.
    (5) Subpart E describes the transition ratesetting methods that are 
used to determine transition payment rates for inpatient operating costs 
during the first 4 years of the prospective payment system specified in 
paragraph (a)(1) of this section.
    (6) Subpart F sets forth the methodology for determining payments 
for outlier cases under the prospective payment system specified in 
paragraph (a)(1) of this section.
    (7) Subpart G sets forth rules for special treatment of certain 
facilities under the prospective payment system specified in paragraph 
(a)(1) of this section for inpatient operating costs.
    (8) Subpart H describes the types, amounts, and methods of payment 
to

[[Page 587]]

hospitals under the prospective payment system specified in paragraph 
(a)(1) of this section for inpatient operating costs.
    (9) Subpart K describes how the prospective payment system specified 
in paragraph (a)(1) of this section for inpatient operating costs is 
implemented for hospitals located in Puerto Rico.
    (10) Subpart L sets forth the procedures and criteria concerning 
applications from hospitals to the Medicare Geographic Classification 
Review Board for geographic redesignation under the prospective payment 
systems specified in paragraph (a)(1) of this section.
    (11) Subpart M describes how the prospective payment system 
specified in paragraph (a)(1) of this section for inpatient capital-
related costs is implemented effective with reporting periods beginning 
on or after October 1, 1991.
    (12) Subpart N describes the prospective payment system specified in 
paragraph (a)(2) of this section for inpatient psychiatric facilities 
and sets forth the general methodology for paying the operating and 
capital-related costs of inpatient hospital services furnished by 
inpatient psychiatric facilities effective with cost reporting periods 
beginning on or after January 1, 2005.
    (13) Subpart O of this part describes the prospective payment system 
specified in paragraph (a)(4) of this section for long-term care 
hospitals and sets forth the general methodology for paying for the 
operating and capital-related costs of inpatient hospital services 
furnished by long-term care hospitals, effective with cost reporting 
periods beginning on or after October 1, 2002.
    (14) Subpart P describes the prospective payment system specified in 
paragraph (a)(3) of this section for rehabilitation hospitals and 
rehabilitation units and sets forth the general methodology for paying 
for the operating and capital-related costs of inpatient hospital 
services furnished by rehabilitation hospitals and rehabilitation units 
effective with cost reporting periods beginning on or after January 1, 
2002.

[66 FR 41385, Aug. 7, 2001, as amended at 67 FR 56048, Aug. 30, 2002; 69 
FR 66976, Nov. 15, 2004; 70 FR 47484, Aug. 12, 2005; 73 FR 24879, May 6, 
2008; 77 FR 53673, Aug. 31, 2012; 85 FR 59020, Sept. 18, 2020; 86 FR 
45518, Aug. 13, 2021]



Sec.  412.2  Basis of payment.

    (a) Payment on a per discharge basis. Under both the inpatient 
operating and inpatient capital-related prospective payment systems, 
hospitals are paid a predetermined amount per discharge for inpatient 
hospital services furnished to Medicare beneficiaries. The prospective 
payment rate for each discharge (as defined in Sec.  412.4) is 
determined according to the methodology described in subpart D, E, or G 
of this part, as appropriate, for operating costs, and according to the 
methodology described in subpart M of this part for capital-related 
costs. An additional payment is made for both inpatient operating and 
inpatient capital-related costs, in accordance with subpart F of this 
part, for cases that are extraordinarily costly to treat.
    (b) Payment in full. (1) The prospective payment amount paid for 
inpatient hospital services is the total Medicare payment for the 
inpatient operating costs (as described in paragraph (c) of this 
section) and the inpatient capital-related costs (as described in 
paragraph (d) of this section) incurred in furnishing services covered 
by the Medicare program.
    (2) The full prospective payment amount, as determined under subpart 
D, E, or G and under subpart M of this part, is made for each stay 
during which there is at least one Medicare payable day of care. Payable 
days of care, for purposes of this paragraph include the following:
    (i) Limitation of liability days payable under the payment 
procedures for custodial care and services that are not reasonable and 
necessary as specified in Sec.  411.400 of this chapter.
    (ii) Guarantee of payment days, as authorized under Sec.  409.68 of 
this chapter, for inpatient hospital services furnished to an individual 
whom the hospital has reason to believe is entitled to Medicare benefits 
at the time of admission.

[[Page 588]]

    (3) If a patient is admitted to an acute care hospital and then the 
acute care hospital meets the criteria at Sec.  412.23(e) to be paid as 
a LTCH, during the course of the patient's hospitalization, Medicare 
considers all the days of the patient stay in the facility (days prior 
to and after the designation of LTCH status) to be a single episode of 
LTCH care. Medicare will not make payment under subpart H for any part 
of the hospitalization. Payment for the entire patient stay (days prior 
to and after the designation of LTCH status) will be made in accordance 
with the requirements specified in Sec.  412.521. The requirements of 
this paragraph (b)(3) apply only to a patient stay in which a patient is 
in an acute care hospital and that hospital is designated as a LTCH on 
or after October 1, 2004.
    (c) Inpatient operating costs. The prospective payment system 
provides a payment amount for inpatient operating costs, including--
    (1) Operating costs for routine services (as described in Sec.  
413.53(b) of this chapter), such as the costs of room, board, and 
routine nursing services;
    (2) Operating costs for ancillary services, such as radiology and 
laboratory services furnished to hospital inpatients;
    (3) Special care unit operating costs (intensive care type unit 
services, as described in Sec.  413.53(b) of this chapter);
    (4) Malpractice insurance costs related to services furnished to 
inpatients; and
    (5) Preadmission services otherwise payable under Medicare Part B 
furnished to a beneficiary on the date of the beneficiary's admission to 
the hospital and during the 3 calendar days immediately preceding the 
date of the beneficiary's admission to the hospital that meet the 
condition specified in paragraph (c)(5)(i) of this section and at least 
one of the conditions specified in paragraphs (c)(5)(ii) through 
(c)(5)(iv).
    (i) The services are furnished by the hospital or by an entity 
wholly owned or operated by the hospital. An entity is wholly owned by 
the hospital if the hospital is the sole owner of the entity. An entity 
is wholly operated by a hospital if the hospital has exclusive 
responsibility for conducting and overseeing the entity's routine 
operations, regardless of whether the hospital also has policymaking 
authority over the entity.
    (ii) For services furnished after January 1, 1991, the services are 
diagnostic (including clinical diagnostic laboratory tests).
    (iii) For services furnished on or after October 1, 1991, through 
June 24, 2010, the services are furnished in connection with the 
principal diagnosis that requires the beneficiary to be admitted as an 
inpatient and are not the following:
    (A) Ambulance services.
    (B) Maintenance renal dialysis.
    (iv) Nondiagnostic services furnished on or after June 25, 2010, 
other than ambulance services and maintenance renal dialysis services, 
that are furnished on the date of the beneficiary's inpatient admission 
or on the first, second, or third calendar day immediately preceding the 
date of the beneficiary's inpatient admission and the hospital does not 
attest that such services are unrelated to the beneficiary's inpatient 
admission.
    (d) Inpatient capital-related costs. For cost reporting periods 
beginning on or after October 1, 1991, the capital prospective payment 
system provides a payment amount for inpatient hospital capital-related 
costs as described in part 413, subpart G of this chapter.
    (e) Excluded costs. The following inpatient hospital costs are 
excluded from the prospective payment amounts and are paid for on a 
reasonable cost basis:
    (1) Capital-related costs for cost reporting periods beginning 
before October 1, 1991, and an allowance for return on equity, as 
described in Sec. Sec.  413.130 and 413.157, respectively, of this 
chapter.
    (2) Direct medical education costs for approved nursing and allied 
health education programs as described in Sec.  413.85 of this chapter.
    (3) Costs for direct medical and surgical services of physicians in 
teaching hospitals exercising the election in Sec.  405.521 of this 
chapter.
    (4) The acquisition costs of hearts, kidneys, livers, lungs, 
pancreas, and intestines (or multivisceral organs) incurred by approved 
transplantation centers.

[[Page 589]]

    (5) The costs of qualified nonphysician anesthetists' services, as 
described in Sec.  412.113(c).
    (6) For cost reporting periods beginning on or after October 1, 
2020, the costs of allogenic hematopoietic stem cell acquisition, as 
described in Sec.  412.113(e), for the purpose of an allogeneic 
hematopoietic stem cell transplant.
    (f) Additional payments to hospitals. In addition to payments based 
on the prospective payment system rates for inpatient operating and 
inpatient capital-related costs, hospitals receive payments for the 
following:
    (1) Outlier cases, as described in subpart F of this part.
    (2) The indirect costs of graduate medical education, as specified 
in subparts F and G of this part and in Sec.  412.105 for inpatient 
operating costs and in Sec.  412.322 for inpatient capital-related 
costs.
    (3) Costs excluded from the prospective payment rates under 
paragraph (e) of this section, as provided in Sec.  412.115.
    (4) Bad debts of Medicare beneficiaries, as provided in Sec.  
412.115(a).
    (5) ESRD beneficiary discharges if such discharges are ten percent 
or more of the hospital's total Medicare discharges, as provided in 
Sec.  412.104.
    (6) Serving a disproportionate share of low-income patients, as 
provided in Sec.  412.106 for inpatient operating costs and Sec.  
412.320 for inpatient capital-related costs.
    (7) The direct graduate medical education costs for approved 
residency programs in medicine, osteopathy, dentistry, and podiatry as 
described in Sec. Sec.  413.75-413.83 of this chapter.
    (8) For discharges on or after June 19, 1990, and before October 1, 
1994, and for discharges on or after October 1, 1997, a payment amount 
per unit for blood clotting factor provided to Medicare inpatients who 
have hemophilia. For discharges occurring on or after October 1, 2005, 
the additional payment is made based on the average sales price 
methodology specified in subpart K, part 414 of this subchapter and the 
furnishing fee specified in Sec.  410.63 of this subchapter.
    (9) Special additional payment for certain new technology as 
specified in Sec. Sec.  412.87 and 412.88 of subpart F.
    (g) Payment adjustment for certain replaced devices. CMS makes a 
payment adjustment for certain replaced devices, as provided under Sec.  
412.89.

[50 FR 12741, Mar. 29, 1985]

    Editorial Note: For Federal Register citations affecting Sec.  
412.2, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.  412.3  Admissions.

    (a) For purposes of payment under Medicare Part A, an individual is 
considered an inpatient of a hospital, including a critical access 
hospital, if formally admitted as an inpatient pursuant to an order for 
inpatient admission by a physician or other qualified practitioner in 
accordance with this section and Sec. Sec.  482.24(c), 482.12(c), and 
485.638(a)(4)(iii) of this chapter for a critical access hospital. In 
addition, inpatient rehabilitation facilities also must adhere to the 
admission requirements specified in Sec.  412.622.
    (b) The order must be furnished by a qualified and licensed 
practitioner who has admitting privileges at the hospital as permitted 
by State law, and who is knowledgeable about the patient's hospital 
course, medical plan of care, and current condition. The practitioner 
may not delegate the decision (order) to another individual who is not 
authorized by the State to admit patients, or has not been granted 
admitting privileges applicable to that patient by the hospital's 
medical staff.
    (c) The physician order must be furnished at or before the time of 
the inpatient admission.
    (d)(1) Except as specified in paragraphs (d)(2) and (3) of this 
section, an inpatient admission is generally appropriate for payment 
under Medicare Part A when the admitting physician expects the patient 
to require hospital care that crosses two midnights.
    (i) The expectation of the physician should be based on such complex 
medical factors as patient history and comorbidities, the severity of 
signs and symptoms, current medical needs, and the risk of an adverse 
event. The factors that lead to a particular clinical expectation must 
be documented in the medical record in order to be granted 
consideration.

[[Page 590]]

    (ii) If an unforeseen circumstance, such as a beneficiary's death or 
transfer, results in a shorter beneficiary stay than the physician's 
expectation of at least 2 midnights, the patient may be considered to be 
appropriately treated on an inpatient basis, and payment for an 
inpatient hospital stay may be made under Medicare Part A.
    (2) An inpatient admission for a surgical procedure specified by 
Medicare as inpatient only under Sec.  419.22(n) of this chapter is 
generally appropriate for payment under Medicare Part A regardless of 
the expected duration of care. Procedures no longer specified as 
inpatient only under Sec.  419.22(n) of this chapter are appropriate for 
payment under Medicare Part A in accordance with paragraph (d)(1) or (3) 
of this section. Claims for services and procedures removed from the 
inpatient only list under Sec.  419.22 of this chapter on or after 
January 1, 2020 are exempt from certain medical review activities.
    (i) For those services and procedures removed between January 1 and 
December 31, 2020, the exemption in this paragraph (d)(2) will last for 
2 years from the date of such removal.
    (ii) For those services and procedures removed on or after January 
1, 2021, the exemption in this paragraph (d)(2) will last until the 
Secretary determines that the service or procedure is more commonly 
performed in the outpatient setting.
    (3) Where the admitting physician expects a patient to require 
hospital care for only a limited period of time that does not cross 2 
midnights, an inpatient admission may be appropriate for payment under 
Medicare Part A based on the clinical judgment of the admitting 
physician and medical record support for that determination. The 
physician's decision should be based on such complex medical factors as 
patient history and comorbidities, the severity of signs and symptoms, 
current medical needs, and the risk of an adverse event. In these cases, 
the factors that lead to the decision to admit the patient as an 
inpatient must be supported by the medical record in order to be granted 
consideration.

[78 FR 50965, Aug. 19, 2013, as amended at 79 FR 67030, Nov. 10, 2014; 
80 FR 70602, Nov. 13, 2015; 83 FR 41700, Aug. 17, 2018; 85 FR 86300, 
Dec. 29, 2020]



Sec.  412.4  Discharges and transfers.

    (a) Discharges. Subject to the provisions of paragraphs (b) and (c) 
of this section, a hospital inpatient is considered discharged from a 
hospital paid under the prospective payment system when--
    (1) The patient is formally released from the hospital; or
    (2) The patient dies in the hospital.
    (b) Acute care transfers. A discharge of a hospital inpatient is 
considered to be a transfer for purposes of payment under this part if 
the patient is readmitted the same day (unless the readmission is 
unrelated to the initial discharge) to another hospital that is--
    (1) Paid under the prospective payment system described in subparts 
A through M of this part;
    (2) Excluded from being paid under the prospective payment system 
described in subparts A through M of this part because of participation 
in an approved statewide cost control program as described in subpart C 
of part 403 of this chapter;
    (3) An acute care hospital that would otherwise be eligible to be 
paid under the IPPS, but does not have an agreement to participate in 
the Medicare program; or
    (4) A critical access hospital.
    (c) Postacute care transfers. A discharge of a hospital inpatient is 
considered to be a transfer for purposes of this part when the patient's 
discharge is assigned, as described in Sec.  412.60(c), to one of the 
qualifying diagnosis-related groups (DRGs) listed in paragraph (d) of 
this section and the discharge is made under any of the following 
circumstances:
    (1) To a hospital or distinct part hospital unit excluded from the 
prospective payment system described in subparts A through M of this 
part under subpart B of this part.
    (2) To a skilled nursing facility.
    (3) To home under a written plan of care for the provision of home 
health services from a home health agency

[[Page 591]]

and those services begin within 3 days after the date of discharge.
    (4) For discharges occurring on or after October 1, 2018, to hospice 
care provided by a hospice program.
    (d) Qualifying DRGs. (1) For a fiscal year prior to FY 2006, for 
purposes of paragraph (c) of this section, and subject to the provisions 
of paragraph (d)(2) of this section, the qualifying DRGs must meet the 
following criteria for both of the 2 most recent years for which data 
are available:
    (i) The DRG must have a geometric mean length of stay of at least 3 
days.
    (ii) The DRG must have at least 14,000 cases identified as postacute 
care transfer cases.
    (iii) The DRG must have at least 10 percent of the postacute care 
transfers occurring before the geometric mean length of stay for the 
DRG.
    (iv) If the DRG is one of a paired DRG based on the presence or 
absence of a comorbidity or complication, one of the DRGs meets the 
criteria specified under paragraphs (d)(1)(i) through (d)(1)(iii) of 
this section.
    (v) To initially qualify, the DRG must meet the criteria specified 
in paragraphs (d)(1)(i) through (d)(1)(iv) of this section and must have 
a decline in the geometric mean length of stay for the DRG during the 
most recent 5 years of at least 7 percent. Once a DRG initially 
qualifies, the DRG is subject to the criteria specified in paragraphs 
(d)(1)(i) through (d)(1)(iv) of this section for each subsequent fiscal 
year.
    (2) For purposes of paragraph (c), a discharge is also considered to 
be a transfer if it meets the following conditions:
    (i) The discharge is assigned to a DRG that contains only cases that 
were assigned to a DRG that qualified under this paragraph within the 
previous 2 years; and
    (ii) The latter DRG was split or otherwise modified within the 
previous 2 fiscal years.
    (3) For fiscal years beginning with FY 2006, for purposes of 
paragraph (c) of this section--
    (i) The qualifying DRGs must meet the following criteria using data 
from the March 2005 update of the FY 2004 MedPAR file and Version 23.0 
of the DRG Definitions Manual (FY 2006):
    (A) The DRG has at least 2,050 total postacute care transfer cases;
    (B) At least 5.5 percent of the cases in the DRG are discharged to 
postacute care prior to the geometric mean length of stay for the DRG;
    (C) The DRG must have a geometric mean length of stay greater than 3 
days;
    (D) The DRG is paired with a DRG based on the presence or absence of 
a comorbidity or complication or major cardiovascular condition that, it 
meets the criteria specified in paragraphs (d)(3)(i)(A) and 
(d)(3)(ii)(B) of this section.
    (ii) If a DRG did not exist in Version 23.0 of the DRG Definitions 
Manual or a DRG included in Version 23.0 of the DRG Definitions Manual 
is revised, the DRG will be a qualifying DRG if it meets the following 
criteria based on the version of the DRG Definitions Manual in use when 
the new or revised DRG first becomes effective, using the most recent 
complete year of MedPAR data:
    (A) The total number of discharges to postacute care in the DRG must 
equal or exceed the 55th percentile for all DRGs;
    (B) The proportion of short-stay discharges to postacute care to 
total discharges in the DRG exceeds the 55th percentile for all DRGs;
    (C) The DRG is paired with a DRG based on the presence or absence of 
a comorbidity or a complication or major cardiovascular condition that 
meets the criteria specified under paragraphs (d)(3)(ii)(A) and 
(d)(3)(ii)(B) of this section; and
    (D) In the case of MS-DRGs that share the same base MS-DRG, if one 
MS-DRG meets the criteria specified under paragraph (d)(3)(ii)(B) of 
this section, every MS-DRG that shares the same base MS-DRG is a 
qualifying DRG.
    (e) Payment for discharges. The hospital discharging an inpatient 
(under paragraph (a) of this section) is paid in full, in accordance 
with Sec.  412.2(b).
    (f) Payment for transfers--(1) General rule. Except as provided in 
paragraph (f)(2) or (f)(3) of this section, a hospital that transfers an 
inpatient under the circumstances described in paragraph

[[Page 592]]

(b) or (c) of this section, is paid a graduated per diem rate for each 
day of the patient's stay in that hospital, not to exceed the amount 
that would have been paid under subparts D and M of this part if the 
patient had been discharged to another setting. The per diem rate is 
determined by dividing the appropriate prospective payment rate (as 
determined under subparts D and M of this part) by the geometric mean 
length of stay for the specific DRG to which the case is assigned. 
Payment is graduated by paying twice the per diem amount for the first 
day of the stay, and the per diem amount for each subsequent day, up to 
the full DRG payment.
    (2) Special rule for DRGs 209, 210, and 211 for fiscal years prior 
to FY 2006. For fiscal years prior to FY 2006, a hospital that transfers 
an inpatient under the circumstances described in paragraph (c) of this 
section and the transfer is assigned to DRGs 209, 210, or 211 is paid as 
follows:
    (i) 50 percent of the appropriate prospective payment rate (as 
determined under subparts D and M of this part) for the first day of the 
stay; and
    (ii) 50 percent of the amount calculated under paragraph (f)(1) of 
this section for each day of the stay, up to the full DRG payment.
    (3) Transfer assigned to DRG for newborns that die or are 
transferred to another hospital. If a transfer is classified into CMS 
DRG 385 (Neonates, Died or Transferred) prior to October 1, 2007, or 
into MS-DRG 789 (Neonates, Died or Transferred to Another Acute Care 
Facility) on or after October 1, 2007, the transferring hospital is paid 
in accordance with Sec.  412.2(b).
    (4) Outliers. Effective with discharges occurring on or after 
October 1, 1984, a transferring hospital may qualify for an additional 
payment for extraordinarily high-cost cases that meet the criteria for 
cost outliers as described in subpart F of this part.
    (5) Special rule for DRGs meeting specific criteria. For discharges 
occurring on or after October 1, 2005, and prior to October 1, 2007, a 
hospital that transfers an inpatient under the circumstances described 
in paragraph (c) of this section is paid using the provisions of 
paragraphs (f)(2)(i) and (f)(2)(ii) of this section if the transfer case 
is assigned to one of the DRGs meeting the following criteria:
    (i) The DRG meets the criteria specified in paragraph (d)(3)(i) or 
(d)(3)(ii) of this section.
    (ii) The average charges of the 1-day discharge cases in the DRG 
must be at least 50 percent of the average charges for all cases in the 
DRG; and
    (iii) The geometric mean length of stay for the DRG is greater than 
4 days; and
    (iv) If a DRG is paired with a DRG based on the presence or absence 
of a comorbidity or complication or a major cardiovascular complication 
that meets the criteria specified in paragraphs (f)(5)(i) through 
(f)(5)(iii) of this section, that DRG will also be paid under the 
provisions of paragraphs (f)(2)(i) and (f)(2)(ii) of this section.
    (6) Special rule for DRGs meeting specific criteria. For discharges 
occurring on or after October 1, 2007, a hospital that transfers an 
inpatient under the circumstances described in paragraph (c) of this 
section is paid using the provisions of paragraphs (f)(2)(i) and 
(f)(2)(ii) of this section if the transfer case is assigned to one of 
the DRGs meeting the following criteria:
    (i) The DRG meets the criteria specified in paragraph (d)(3)(i) or 
(d)(3)(ii) of this section;
    (ii) The average charges of the 1-day discharge cases in the DRG 
must be at least 50 percent of the average charges for all cases in the 
DRG; and
    (iii) The geometric mean length of stay for the DRG is greater than 
4 days.
    (iv) If a DRG is part of an MS-DRG group that meets the criteria 
specified in paragraphs (f)(6)(i) through (f)(6)(iii) of this section, 
that DRG will also be paid under the provisions of paragraphs (f)(2)(i) 
and (f)(2)(ii) of this section.

[63 FR 41003, July 31, 1998, as amended at 65 FR 47106, Aug. 1, 2000; 67 
FR 50111, Aug. 1, 2002; 68 FR 45469, Aug. 1, 2003; 69 FR 49240, Aug. 11, 
2004; 70 FR 47484, Aug. 12, 2005; 72 FR 47410, Aug. 22, 2007; 75 FR 
50413, Aug. 16, 2010; 83 FR 41700, Aug. 17, 2018]



Sec.  412.6  Cost reporting periods subject to the prospective payment systems.

    (a) Initial cost reporting period for each prospective payment 
system. (1) Each

[[Page 593]]

subject hospital is paid under the prospective payment system for 
operating costs for inpatient hospital services effective with the 
hospital's first cost reporting period beginning on or after October 1, 
1983 and for inpatient capital-related costs effective with the 
hospital's first cost reporting period beginning on or after October 1, 
1991.
    (2) The hospital is paid the applicable prospective payment rate for 
inpatient operating costs and capital-related costs for each discharge 
occurring on or after the first day of its first cost reporting period 
subject to the applicable prospective payment system.
    (3) If a discharged beneficiary was admitted to the hospital before 
the first day of the hospital's first cost reporting period subject to 
the prospective payment system for inpatient operating costs, the 
reasonable costs of services furnished before that day are paid under 
the cost reimbursement provisions of part 413 of this chapter. For such 
discharges, the amount otherwise payable under the applicable 
prospective payment rate is reduced by the amount paid on a reasonable 
cost basis for inpatient hospital services furnished to that beneficiary 
during the hospital stay. If the amount paid under reasonable cost 
exceeds the inpatient operating prospective payment amount, the 
reduction is limited to the inpatient operating prospective payment 
amount.
    (b) Changes in cost reporting periods. CMS recognizes a change in a 
hospital's cost reporting period made after November 30, 1982 only if 
the change has been requested in writing by the hospital and approved by 
the intermediary in accordance with Sec.  413.24(f)(3) of this chapter.

[57 FR 39819, Sept. 1, 1992]



Sec.  412.8  Publication of schedules for determining 
prospective payment rates.

    (a) Initial prospective payment rates--(1) For inpatient operating 
costs. Initial prospective payment rates for inpatient operating costs 
(for the period October 1, 1983 through September 30, 1984) were 
determined in accordance with documents published in the Federal 
Register on September 1, 1983 (48 FR 39838), and January 3, 1984 (49 FR 
324).
    (2) For inpatient capital-related costs. Initial prospective payment 
rates for inpatient capital-related costs (for the period October 1, 
1991 through September 30, 1992) were determined in accordance with the 
final rule published in the Federal Register on August 30, 1991 (56 FR 
43196).
    (b) Annual publication of schedule for determining prospective 
payment rates. (1) CMS proposes changes in the methods, amounts, and 
factors used to determine inpatient prospective payment rates in a 
Federal Register document published for public comment not later than 
the April 1 before the beginning of the Federal fiscal year in which the 
proposed changes would apply.
    (2) Except as provided in paragraph (c) of this section, CMS 
publishes a Federal Register document setting forth final methods, 
amounts, and factors for determining inpatient prospective payment rates 
not later than the August 1 before the Federal fiscal year in which the 
rates would apply.
    (c) Publication schedule for FY 2007. For FY 2007, not later than 
August 1, 2006, CMS publishes a Federal Register document setting forth 
a description of the methodology and data used in computing the 
inpatient prospective payment rates for that year.

[57 FR 39820, Sept. 1, 1992, as amended at 62 FR 46025, Aug. 29, 1997; 
71 FR 48136, Aug. 18, 2006]



Sec.  412.10  Changes in the DRG classification system.

    (a) General rule. CMS issues changes in the DRG classification 
system in a Federal Register notice at least annually. Except as 
specified in paragraphs (c) and (d) of this section, the DRG changes are 
effective prospectively with discharges occurring on or after the same 
date the payment rates are effective.
    (b) Basis for changes in the DRG classification system. All changes 
in the DRG classification system are made using the principles 
established for the DRG system. This means that cases are classified so 
each DRG is--
    (1) Clinically coherent; and
    (2) Embraces an acceptable range of resource consumption.

[[Page 594]]

    (c) Interim coverage changes--(1) Criteria. CMS makes interim 
changes to the DRG classification system during the Federal fiscal year 
to incorporate items and services newly covered under Medicare.
    (2) Implementation and effective date. CMS issues interim coverage 
changes through its administrative issuance system and makes the change 
effective as soon as is administratively feasible.
    (3) Publication for comment. CMS publishes any change made under 
paragraph (c)(1) of this section in the next annual notice of changes to 
the DRG classification system published in accordance with paragraph (a) 
of this section.
    (d) Interim changes to correct omissions and inequities--(1) 
Criteria. CMS makes interim changes to the DRG classification system to 
correct a serious omission or inequity in the system only if failure to 
make the changes would have--
    (i) A potentially substantial adverse impact on the health and 
safety of beneficiaries; or
    (ii) A significant and unwarranted fiscal impact on hospitals or the 
Medicare program.
    (2) Publication and effective date. CMS publishes these changes in 
the Federal Register in a final notice with comment period with a 
prospective effective date. The change is also published for public 
information in the next annual notice of changes to the DRG 
classification system published in accordance with paragraph (a) of this 
section.
    (e) Review by ProPAC. Changes published annually in accordance with 
paragraph (a) of this section are subject to review and comment by 
ProPAC upon publication. Interim changes to the DRG classification 
system that are made in accordance with paragraphs (c) and (d) of this 
section are subject to review by ProPAC before implementation.

[50 FR 35688, Sept. 3, 1985, as amended at 51 FR 31496, Sept. 3, 1986; 
57 FR 39820, Sept. 1, 1992]



Subpart B_Hospital Services Subject to and Excluded From the Prospective 
  Payment Systems for Inpatient Operating Costs and Inpatient Capital-
                              Related Costs



Sec.  412.20  Hospital services subject to the prospective payment systems.

    (a) Except for services described in paragraphs (b), (c), (d), and 
(e) of this section, all covered hospital inpatient services furnished 
to beneficiaries during the subject cost reporting periods are paid 
under the prospective payment system as specified in Sec.  412.1(a)(1).
    (b) Effective for cost reporting periods beginning on or after 
January 1, 2005, covered inpatient hospital services furnished to 
Medicare beneficiaries by an inpatient psychiatric facility that meets 
the conditions of Sec.  412.404 are paid under the prospective payment 
system described in subpart N of this part.
    (c)(1) Effective for cost reporting periods beginning on or after 
January 1, 2002, covered inpatient hospital services furnished to 
Medicare beneficiaries by a rehabilitation hospital or rehabilitation 
unit that meet the conditions of Sec.  412.604 are paid under the 
prospective payment system described in subpart P of this part.
    (2) CMS will not pay for services under subpart P of this part if 
the services are paid for by a health maintenance organization (HMO) or 
competitive medical plan (CMP) that elects not to have CMS make payments 
to an inpatient rehabilitation facility for services, which are 
inpatient hospital services, furnished to the HMO's or CMP's Medicare 
enrollees, as provided under part 417 of this chapter.
    (d) Effective for cost reporting periods beginning on or after 
October 1, 2002, covered inpatient hospital services furnished to 
Medicare beneficiaries by a long-term care hospital that meets the 
conditions for payment of Sec. Sec.  412.505 through 412.511 are paid 
under the prospective payment system described in subpart O of this 
part.
    (e) Inpatient hospital services will not be paid under the 
prospective payment systems specified in Sec.  412.1(a)(1)

[[Page 595]]

under any of the following circumstances:
    (1) The services are furnished by a hospital (or hospital unit) 
explicitly excluded from the prospective payment systems under 
Sec. Sec.  412.23, 412.25, 412.27, and 412.29.
    (2) The services are emergency services furnished by a 
nonparticipating hospital in accordance with Sec.  424.103 of this 
chapter.
    (3) The services are paid for by an HMO or competitive medical plan 
(CMP) that elects not to have CMS make payments directly to a hospital 
for inpatient hospital services furnished to the HMO's or CMP's Medicare 
enrollees, as provided in Sec. Sec.  417.240(d) and 417.586 of this 
chapter.

[50 FR 12741, Mar. 29, 1985, as amended at 53 FR 6648, Mar. 2, 1988; 57 
FR 39820, Sept. 1, 1992; 59 FR 45400, Sept. 1, 1994; 66 FR 41386, Aug. 
7, 2001; 67 FR 56048, Aug. 30, 2002; 68 FR 45698, Aug. 1, 2003; 69 FR 
66976, Nov. 15, 2004]



Sec.  412.22  Excluded hospitals and hospital units: General rules.

    (a) Criteria. Subject to the criteria set forth in paragraph (e) of 
this section, a hospital is excluded from the prospective payment 
systems specified in Sec.  412.1(a)(1) of this part if it meets the 
criteria for one or more of the excluded classifications described in 
Sec.  412.23. For purposes of this subpart, the term ``hospital'' 
includes a critical access hospital (CAH).
    (b) Cost reimbursement. Except for those hospitals specified in 
paragraph (c) of this section, and Sec.  412.20(b), (c), and (d), all 
excluded hospitals (and excluded hospital units, as described in Sec.  
412.23 through Sec.  412.29) are reimbursed under the cost reimbursement 
rules set forth in part 413 of this chapter, and are subject to the 
ceiling on the rate of hospital cost increases as specified in Sec.  
413.40 of this chapter.
    (c) Special payment provisions. The following classifications of 
hospitals are paid under special provisions and therefore are not 
generally subject to the cost reimbursement or prospective payment rules 
of this chapter.
    (1) Veterans Administration hospitals.
    (2) Hospitals reimbursed under State cost control systems approved 
under part 403 of this chapter.
    (3) Hospitals reimbursed in accordance with demonstration projects 
authorized under section 402(a) of Public Law 90-248 (42 U.S.C. 1395b-1) 
or section 222(a) of Public Law 92-603 (42 U.S.C. 1395b-1 (note)).
    (4) Nonparticipating hospitals furnishing emergency services to 
Medicare beneficiaries.
    (d) Changes in hospitals' status. For purposes of exclusion from the 
prospective payment systems under this subpart, the status of each 
currently participating hospital (excluded or not excluded) is 
determined at the beginning of each cost reporting period and is 
effective for the entire cost reporting period. Any changes in the 
status of the hospital are made only at the start of a cost reporting 
period.
    (e) Hospitals-within-hospitals. A hospital-within-a-hospital is a 
hospital that occupies space in a building also used by another 
hospital, or in one or more separate buildings located on the same 
campus as buildings used by another hospital. Prior to October 1, 2017, 
except as provided in paragraphs (e)(1)(vi) and (f) of this section, a 
hospital-within-a-hospital must meet the following criteria in order to 
be excluded from the prospective payment systems specified in Sec.  
412.1(a)(1). On or after October 1, 2017, except as provided in 
paragraphs (e)(1)(vi) and (f) of this section, a hospital-within-
hospital that is excluded from the prospective payment systems specified 
in Sec.  412.1(a)(1) that occupies space in a building also used by a 
hospital which is not excluded from the prospective payment systems 
specified in Sec.  412.1(a)(1), or in one or more separate buildings 
located on the same campus as buildings used by a hospital not excluded 
from the prospective payment systems specified in Sec.  412.1(a)(1) must 
meet the following criteria in order to be excluded from the prospective 
payment systems specified in Sec.  412.1(a)(1).
    (1) Except as specified in paragraph (f) of this section, for cost 
reporting periods beginning on or after October 1, 1997--
    (i) Separate governing body. The hospital has a governing body that 
is separate from the governing body of the hospital occupying space in 
the same building or on the same campus. The

[[Page 596]]

hospital's governing body is not under the control of the hospital 
occupying space in the same building or on the same campus, or of any 
third entity that controls both hospitals.
    (ii) Separate chief medical officer. The hospital has a single chief 
medical officer who reports directly to the governing body and who is 
responsible for all medical staff activities of the hospital. The chief 
medical officer of the hospital is not employed by or under contract 
with either the hospital occupying space in the same building or on the 
same campus or any third entity that controls both hospitals.
    (iii) Separate medical staff. The hospital has a medical staff that 
is separate from the medical staff of the hospital occupying space in 
the same building or on the same campus. The hospital's medical staff is 
directly accountable to the governing body for the quality of medical 
care provided in the hospital, and adopts and enforces by-laws governing 
medical staff activities, including criteria and procedures for 
recommending to the governing body the privileges to be granted to 
individual practitioners.
    (iv) Chief executive officer. The hospital has a single chief 
executive officer through whom all administration authority flows, and 
who exercises control and surveillance over all administrative 
activities of the hospital. The chief executive officer is not employed 
by, or under contract with, either the hospital occupying space in the 
same building or on the same campus or any third entity that controls 
both hospitals.
    (v) Performance of basic hospital functions. Prior to October 1, 
2017, the hospital meets one of the following criteria:
    (A) The hospital performs the basic functions specified in 
Sec. Sec.  482.21 through 482.27, 482.30, 482.42, 482.43, and 482.45 of 
this chapter through the use of employees or under contracts or other 
agreements with entities other than the hospital occupying space in the 
same building or on the same campus, or a third entity that controls 
both hospitals. Food and dietetic services and housekeeping, 
maintenance, and other services necessary to maintain a clean and safe 
physical environment could be obtained under contracts or other 
agreements with the hospital occupying space in the same building or on 
the same campus, or with a third entity that controls both hospitals.
    (B) For the same period of at least 6 months used to determine 
compliance with the criterion regarding the age of patients in Sec.  
412.23(d)(2) or the length-of-stay criterion in Sec.  412.23(e)(2), or 
for hospitals other than children's or long-term care hospitals, for a 
period of at least 6 months immediately preceding the first cost 
reporting period for which exclusion is sought, the cost of the services 
that the hospital obtains under contracts or other agreements with the 
hospital occupying space in the same building or on the same campus, or 
with a third entity that controls both hospitals, is no more than 15 
percent of the hospital's total inpatient operating costs, as defined in 
Sec.  412.2(c). For purposes of this paragraph (e)(1)(v)(B), however, 
the costs of preadmission services are those specified under Sec.  
413.40(c)(2) rather than those specified under Sec.  412.2(c)(5).
    (C) For the same period of at least 6 months used to determine 
compliance with the criterion regarding the age of inpatients in Sec.  
412.23(d)(2) or the length-of-stay criterion in Sec.  412.23(e)(2), or 
for hospitals other than children's or long-term care hospitals, for the 
period of at least 6 months immediately preceding the first cost 
reporting period for which exclusion is sought, the hospital has an 
inpatient population of whom at least 75 percent were referred to the 
hospital from a source other than another hospital occupying space in 
the same building or on the same campus.
    (vi) Effective October 1, 2008, if a State hospital that is 
occupying space in the same building or on the same campus as another 
State hospital cannot meet the criterion under paragraph (e)(1)(i) of 
this section solely because its governing body is under the control of 
the State hospital with which it shares a building or a campus, or is 
under the control of a third entity that also controls the State 
hospital with which it shares a building or a campus, the State hospital 
can nevertheless qualify for an exclusion if it meets the other 
applicable criteria in this section and--

[[Page 597]]

    (A) Both State hospitals occupy space in the same building or on the 
same campus and have been continuously owned and operated by the State 
since October 1, 1995;
    (B) Is required by State law to be subject to the governing 
authority of the State hospital with which it shares space or the 
governing authority of a third entity that controls both hospitals; and
    (C) Was excluded from the inpatient prospective payment system 
before October 1, 1995, and continues to be excluded from the inpatient 
prospective payment system through September 30, 2008.
    (2) Effective for long-term care hospitals-within-hospitals for cost 
reporting periods beginning on or after October 1, 2004, the hospital 
must meet the governance and control requirements at paragraphs 
(e)(1)(i) through (e)(1)(iv) of this section.
    (3) Notification of co-located status. A long-term care hospital 
that occupies space in a building used by another hospital, or in one or 
more entire buildings located on the same campus as buildings used by 
another hospital and that meets the criteria of paragraphs (e)(1) or 
(e)(2) of this section must notify its fiscal intermediary and CMS in 
writing of its co-location and identify by name, address, and Medicare 
provider number those hospital(s) with which it is co-located.
    (f) Application for certain hospitals. Except as provided in 
paragraph (f)(3) of this section, if a hospital was excluded from the 
prospective payment systems under the provisions of this section on or 
before September 30, 1995, and at that time occupied space in a building 
also used by another hospital, or in one or more buildings located on 
the same campus as buildings used by another hospital, the criteria in 
paragraph (e) of this section do not apply to the hospital as long as 
the hospital--
    (1) Continues to operate under the same terms and conditions, 
including the number of beds, unless the hospital is a children's 
hospital as defined at Sec.  412.23(d), and square footage considered to 
be part of the hospital for purposes of Medicare participation and 
payment in effect on September 30, 1995; or
    (2) In the case of a hospital that changes the terms and conditions 
under which it operates after September 30, 1995, but before October 1, 
2003, continues to operate under the same terms and conditions, 
including the number of beds, unless the hospital is a children's 
hospital as defined at Sec.  412.23(d), and square footage considered to 
be part of the hospital for purposes of Medicare participation and 
payment in effect on September 30, 2003.
    (3) For cost reporting periods beginning on or after October 1, 
2006, in applying the provisions of paragraph (f)(1) or (f)(2) of this 
section, any hospital that was excluded from the prospective payment 
systems under the provisions of this section on or before September 30, 
1995, and at that time occupied space in a building also used by another 
hospital, or in one or more buildings located on the same campus as 
buildings used by another hospital may increase or decrease the square 
footage or decrease the number of beds considered to be part of the 
hospital at any time without affecting the provisions of paragraph 
(f)(1) or (f)(2) of this section.
    (i) If a hospital to which the provisions of paragraph (f)(1) of 
this section applies decreases its number of beds below the number of 
beds considered to be part of the hospital on September 30, 1995, it may 
subsequently increase the number of beds at any time as long as the 
resulting total number of beds considered to be part of the hospital 
does not exceed the number of beds at the hospital on September 30, 
1995.
    (ii) If a hospital to which the provisions of paragraph (f)(2) of 
this section applies decreases its number of beds below the number of 
beds considered to be part of the hospital on September 30, 2003, it may 
subsequently increase the number of beds at any time as long as the 
resulting total number of beds considered to be part of the hospital 
does not exceed the number of beds at the hospital on September 30, 
2003.
    (g) Definition of control. For purposes of this section, control 
exists if an individual or an organization has the

[[Page 598]]

power, directly or indirectly, significantly to influence or direct the 
actions or policies of an organization or institution.
    (h) Satellite facilities. (1) For purposes of paragraphs (h)(2) 
through (h)(5) of this section, a satellite facility is a part of a 
hospital that provides inpatient services in a building also used by 
another hospital, or in one or more entire buildings located on the same 
campus as buildings used by another hospital.
    (2) Except as provided in paragraphs (h)(3), (h)(4), (h)(5), (h)(7) 
and (h)(8) of this section, effective for cost reporting periods 
beginning on or after October 1, 1999, a hospital that has a satellite 
facility must meet the following criteria in order to be excluded from 
the acute care hospital inpatient prospective payment systems for any 
period:
    (i) In the case of a hospital (other than a children's hospital) 
that was excluded from the prospective payment systems for the most 
recent cost reporting period beginning before October 1, 1997, the 
hospital's number of State-licensed and Medicare-certified beds, 
including those at the satellite facilities, does not exceed the 
hospital's number of State-licensed and Medicare-certified beds on the 
last day of the hospital's last cost reporting period beginning before 
October 1, 1997.
    (ii) The satellite facility independently complies with--
    (A) For psychiatric hospitals, the requirements under Sec.  
412.23(a);
    (B) For rehabilitation hospitals, the requirements under Sec.  
412.23(b)(2);
    (C) For the children's hospitals, the requirements under Sec.  
412.23(d)(2); or
    (D) For long-term care hospitals, the requirements under Sec. Sec.  
412.23(e)(1) through (e)(3)(i).
    (iii) The satellite facility meets all of the following 
requirements:
    (A) Effective for cost reporting periods beginning on or after 
October 1, 2002, it is not under the control of the governing body or 
chief executive officer of the hospital in which it is located, and it 
furnishes inpatient care through the use of medical personnel who are 
not under the control of the medical staff or chief medical officer of 
the hospital in which it is located.
    (1) Except as provided in paragraph (h)(2)(iii)(A)(2) of this 
section, effective for cost reporting periods beginning on or after 
October 1, 2009, the governing body of the hospital of which the 
satellite facility is a part is not under the control of any third 
entity that controls both the hospital of which the satellite facility 
is a part and the hospital with which the satellite facility is co-
located.
    (2) If a hospital and its satellite facility were excluded from the 
inpatient prospective payment system under the provisions of this 
section for the most recent cost reporting period beginning prior to 
October 1, 2009, the hospital does not have to meet the requirements of 
paragraph (h)(2)(iii)(A)(1) of this section, with respect to that 
satellite facility, in order to retain its IPPS-excluded status.
    (3) A hospital described in paragraph (h)(2)(iii)(A)(2) of this 
section that establishes an additional satellite facility in a cost 
reporting period beginning on or after October 1, 2009, must meet the 
criteria in this section, including the provisions of paragraph 
(h)(2)(iii)(A)(1) of this section with respect to the additional 
satellite facility, in order to be excluded from the inpatient 
prospective payment system.
    (B) It maintains admission and discharge records that are separately 
identified from those of the hospital in which it is located and are 
readily available.
    (C) It has beds that are physically separate from (that is, not 
commingled with) the beds of the hospital in which it is located.
    (D) It is serviced by the same fiscal intermediary as the hospital 
of which it is a part.
    (E) It is treated as a separate cost center of the hospital of which 
it is a part.
    (F) For cost reporting and apportionment purposes, it uses an 
accounting system that properly allocates costs and maintains adequate 
statistical data to support the basis of allocation.
    (G) It reports its costs on the cost report of the hospital of which 
it is a part, covering the same fiscal period and using the same method 
of apportionment as the hospital of which it is a part.

[[Page 599]]

    (4) On or after October 1, 2018, a satellite facility that is part 
of a hospital excluded from the prospective payment systems specified in 
Sec.  412.1(a)(1) that provides inpatient services in a building also 
used by another hospital that is excluded from the prospective payment 
systems specified in Sec.  412.1(a)(1), or in one or more entire 
buildings located on the same campus as buildings used by another 
hospital that is excluded from the prospective payment systems specified 
in Sec.  412.1(a)(1), is not required to meet the criteria specified in 
paragraphs (h)(2)(iii)(A)(1) through (3) of this section in order to be 
excluded from the inpatient prospective payment system. A satellite 
facility that is part of a hospital excluded from the prospective 
payment systems specified in Sec.  412.1(a)(1) which is located in a 
building also used by another hospital that is not excluded from the 
prospective payment systems specified in Sec.  412.1(a)(1), or in one or 
more entire buildings located on the same campus as buildings used by 
another hospital that is not excluded from the prospective payment 
systems specified in Sec.  412.1(a)(1), is required to meet the criteria 
specified in paragraphs (h)(2)(iii)(A)(1) through (3) of this section in 
order to be excluded from the prospective payment systems specified in 
Sec.  412.1(a)(1).
    (3) Except as provided in paragraphs (h)(4) and (h)(5) of this 
section, the provisions of paragraph (h)(2) of this section do not apply 
to--
    (i) Any hospital structured as a satellite facility on September 30, 
1999, and excluded from the prospective payment systems on that date, to 
the extent the hospital continues operating under the same terms and 
conditions, including the number of beds and square footage considered, 
for the purposes of Medicare participation and payment, to be part of 
the hospital, in effect on September 30, 1999; or
    (ii) Any hospital excluded from the prospective payment systems 
under Sec.  412.23(e)(2)(ii).
    (4) For cost reporting periods beginning before October 1, 2006, in 
applying the provisions of paragraph (h)(3) of this section, any 
hospital structured as a satellite facility on September 30, 1999, may 
increase or decrease the square footage of the satellite facility or may 
decrease the number of beds in the satellite facility if these changes 
are made necessary by relocation of a facility--
    (i) To permit construction or renovation necessary for compliance 
with changes in Federal, State, or local law; or
    (ii) Because of catastrophic events such as fires, floods, 
earthquakes, or tornadoes.
    (5) For cost reporting periods beginning on or after October 1, 
2006, in applying the provisions of paragraph (h)(3) of this section--
    (i) Any hospital structured as a satellite facility on September 30, 
1999, may increase or decrease the square footage or decrease the number 
of beds considered to be part of the satellite facility at any time 
without affecting the provisions of paragraph (h)(3) of this section; 
and
    (ii) If the satellite facility decreases its number of beds below 
the number of beds considered to be part of the satellite facility on 
September 30, 1999, it may subsequently increase the number of beds at 
any time as long as the resulting total number of beds considered to be 
part of the satellite facility does not exceed the number of beds at the 
satellite facility on September 30, 1999.
    (6) Notification of co-located status. A satellite of a long-term 
care hospital that occupies space in a building used by another 
hospital, or in one or more entire buildings located on the same campus 
as buildings used by another hospital and that meets the criteria of 
paragraphs (h)(1) through (h)(5) of this section must notify its fiscal 
intermediary and CMS in writing of its co-location and identify by name, 
address, and Medicare provider number, those hospital(s) with which it 
is co-located.
    (7) The provisions of paragraph (h)(2)(i) of this section do not 
apply to any long-term care hospital that is subject to the long-term 
care hospital prospective payment system under Subpart O of this 
subpart, effective for cost reporting periods occurring on or after 
October 1, 2002, and that elects to be paid based on 100 percent of the 
Federal prospective payment rate as specified in Sec.  412.533(c), 
beginning with the first cost reporting period following

[[Page 600]]

that election, or when the LTCH is fully transitioned to 100 percent of 
the Federal prospective rate, or to a new long-term care hospital, as 
defined in Sec.  412.23(e)(4).
    (8) The provisions of paragraph (h)(2)(i) of this section do not 
apply to any inpatient rehabilitation facility that is subject to the 
inpatient rehabilitation facility prospective payment system under 
subpart P of this part, effective for cost reporting periods beginning 
on or after October 1, 2003.
    (i)(1) Requirements for extended neoplastic disease care hospitals. 
For cost reporting periods beginning on or after January 1, 2015, an 
extended neoplastic disease care hospital is a hospital that was first 
excluded from the prospective payment system under this section in 1986 
which has an average inpatient length of stay for all patients, 
including both Medicare and non-Medicare inpatients, of greater than 20 
days and demonstrates that at least 80 percent of its annual Medicare 
inpatient discharges in the 12-month cost reporting period ending in 
fiscal year 1997 have a principal diagnosis that reflects a finding of 
neoplastic disease as defined in paragraph (f)(1)(iv) of this section.
    (2) Payment to extended neoplastic disease care hospitals. Payment 
for inpatient operating costs for hospitals classified under paragraph 
(i)(1) of this section is made as set forth in Sec.  412.526(c)(3). 
Payment for capital costs for hospitals classified under paragraph 
(i)(1) of this section is made as set forth in Sec.  412.526(c)(4).

[50 FR 12741, Mar. 29, 1985]

    Editorial Note: For Federal Register citations affecting Sec.  
412.22, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.  412.23  Excluded hospitals: Classifications.

    Hospitals that meet the requirements for the classifications set 
forth in this section are not reimbursed under the prospective payment 
systems specified in Sec.  412.1(a)(1):
    (a) Psychiatric hospitals. A psychiatric hospital must--
    (1) Meet the following requirements to be excluded from the 
prospective payment system as specified in Sec.  412.1(a)(1) and to be 
paid under the prospective payment system as specified in Sec.  
412.1(a)(2) and in subpart N of this part;
    (2) Be primarily engaged in providing, by or under the supervision 
of a psychiatrist, psychiatric services for the diagnosis and treatment 
of mentally ill persons; and
    (3) Meet the conditions of participation for hospitals and special 
conditions of participation for psychiatric hospitals set forth in part 
482 of this chapter.
    (b) Rehabilitation hospitals. A rehabilitation hospital or unit must 
meet the requirements specified in Sec.  412.29 of this subpart to be 
excluded from the prospective payment systems specified in Sec.  
412.1(a)(1) of this subpart and to be paid under the prospective payment 
system specified in Sec.  412.1(a)(3) of this subpart and in subpart P 
of this part.
    (c) [Reserved]
    (d) Children's hospitals. A children's hospital must--
    (1) Have a provider agreement under part 489 of this chapter to 
participate as a hospital; and
    (2) Be engaged in furnishing services to inpatients who are 
predominantly individuals under the age of 18.
    (e) Long-term care hospitals. A long-term care hospital must meet 
the requirements of paragraph (e)(1) and (e)(2) of this section and, 
when applicable, the additional requirement of Sec.  412.22(e), to be 
excluded from the prospective payment system specified in Sec.  
412.1(a)(1) and to be paid under the prospective payment system 
specified in Sec.  412.1(a)(4) and in Subpart O of this part.
    (1) Provider agreements. The hospital must have a provider agreement 
under Part 489 of this chapter to participate as a hospital; and
    (2) Average length of stay. (i) The hospital must have an average 
Medicare inpatient length of stay of greater than 25 days (which 
includes all covered and noncovered days of stay of Medicare patients) 
as calculated under paragraph (e)(3) of this section; or
    (ii) For cost reporting periods beginning on or after August 5, 1997 
and on or before December 31, 2014, a hospital that was first excluded 
from the prospective payment system under this

[[Page 601]]

section in 1986 meets the length-of-stay criterion if it has an average 
inpatient length of stay for all patients, including both Medicare and 
non-Medicare inpatients, of greater than 20 days and demonstrates that 
at least 80 percent of its annual Medicare inpatient discharges in the 
12-month cost reporting period ending in fiscal year 1997 have a 
principal diagnosis that reflects a finding of neoplastic disease as 
defined in paragraph (f)(1)(iv) of this section.
    (3) Calculation of average length of stay. (i) Subject to the 
provisions of paragraphs (e)(3)(ii) through (vii) of this section, the 
average Medicare inpatient length of stay specified under paragraph 
(e)(2)(i) of this section is calculated by dividing the total number of 
covered and noncovered days of stay of Medicare inpatients (less leave 
or pass days) by the number of total Medicare discharges for the 
hospital's most recent complete cost reporting period. Subject to the 
provisions of paragraphs (e)(3)(ii) through (vii) of this section, the 
average inpatient length of stay specified under paragraph (e)(2)(ii) of 
this section is calculated by dividing the total number of days for all 
patients, including both Medicare and non-Medicare inpatients (less 
leave or pass days) by the number of total discharges for the hospital's 
most recent complete cost reporting period.
    (ii) Effective for cost reporting periods beginning on or after July 
1, 2004, in calculating the hospital's average length of stay, if the 
days of a stay of an inpatient involves days of care furnished during 
two or more separate consecutive cost reporting periods, that is, an 
admission during one cost reporting period and a discharge during a 
future consecutive cost reporting period, the total number of days of 
the stay are considered to have occurred in the cost reporting period 
during which the inpatient was discharged. However, if after application 
of this provision, a hospital fails to meet the average length of stay 
specified under paragraphs (e)(2)(i) and (ii) of this section, Medicare 
will determine the hospital's average inpatient length of stay for cost 
reporting periods beginning on or after July 1, 2004, but before July 1, 
2005, by dividing the applicable total days for Medicare inpatients 
under paragraph (e)(2)(i) of this section or the total days for all 
inpatients under paragraph (e)(2)(ii) of this section, during the cost 
reporting period when they occur, by the number of discharges occurring 
during the same cost reporting period.
    (iii) If a change in a hospital's average length of stay specified 
under paragraph (e)(2)(i) or paragraph (e)(2)(ii) of this section is 
indicated, the calculation is made by the same method for the period of 
at least 5 months of the immediately preceding 6-month period.
    (iv) If a hospital seeks exclusion from the inpatient prospective 
payment system as a long-term care hospital and a change of ownership 
(as described in Sec.  489.18 of this chapter) occurs within the period 
of at least 5 months of the 6-month period preceding its petition for 
long-term care hospital status, the hospital may be excluded from the 
inpatient prospective payment system as a long-term care hospital for 
the next cost reporting period if, for the period of at least 5 months 
of the 6 months immediately preceding the start of the cost reporting 
period for which the hospital is seeking exclusion from the inpatient 
prospective payment system as a long-term care hospital (including time 
before the change of ownership), the hospital has met the required 
average length of stay, has continuously operated as a hospital, and has 
continuously participated as a hospital in Medicare.
    (v) For periods beginning on or after October 1, 2011, a hospital 
that is excluded from the inpatient prospective payment system as a 
long-term care hospital that plans to undergo a change of ownership (as 
described in Sec.  489.18 of this chapter) must notify its fiscal 
intermediary or MAC within 30 days of the effective date of such change 
of ownership, as specified in Sec.  424.516(e) of this subchapter. The 
hospital will continue to be excluded from the inpatient prospective 
payment system as a long-term care hospital for the cost reporting 
period following the change of ownership only if, for the period of at 
least 5 months of the 6 months immediately preceding the change of 
ownership, the hospital meets the required average length of

[[Page 602]]

stay (calculated in accordance with paragraph (e)(3)(i) of this 
section).
    (vi) For cost reporting periods beginning on or after October 1, 
2015, the Medicare inpatient days and discharges that are paid at the 
site neutral payment rate specified at Sec.  412.522(c)(1) or paid under 
a Medicare Advantage plan (Medicare Part C) will not be included in the 
calculation of the Medicare inpatient average length of stay specified 
under paragraph (e)(2)(i) of this section.
    (vii) For cost reporting periods beginning on or after October 1, 
2019, the Medicare inpatient days and discharges that are associated 
with patients discharged from a unit of the hospital will not be 
included in the calculation of the Medicare inpatient average length of 
stay specified under paragraph (e)(2)(i) of this section.
    (4) Rules applicable to new long-term care hospitals--(i) 
Definition. For purposes of payment under the long-term care hospital 
prospective payment system under subpart O of this part, a new long-term 
care hospital is a provider of inpatient hospital services that meets 
the qualifying criteria in paragraphs (e)(1) and (e)(2) of this section 
and, under present or previous ownership (or both), its first cost 
reporting period as a LTCH begins on or after October 1, 2002.
    (ii) Satellite facilities and remote locations of hospitals seeking 
to become new long-term care hospitals. Except as specified in paragraph 
(e)(4)(iii) of this section, a satellite facility (as defined in Sec.  
412.22(h)) or a remote location of a hospital (as defined in Sec.  
413.65(a)(2) of this chapter) that voluntarily reorganizes as a separate 
Medicare participating hospital, with or without a concurrent change in 
ownership, and that seeks to qualify as a new long-term care hospital 
for Medicare payment purposes must demonstrate through documentation 
that it meets the average length of stay requirement as specified under 
paragraphs (e)(2)(i) or (e)(2)(ii) of this section based on discharges 
that occur on or after the effective date of its participation under 
Medicare as a separate hospital.
    (iii) Provider-based facility or organization identified as a 
satellite facility and remote location of a hospital prior to July 1, 
2003. Satellite facilities and remote locations of hospitals that became 
subject to the provider-based status rules under Sec.  413.65 as of July 
1, 2003, that become separately participating hospitals, and that seek 
to qualify as long-term care hospitals for Medicare payment purposes may 
submit to the fiscal intermediary discharge data gathered during 5 
months of the immediate 6 months preceding the facility's separation 
from the main hospital for calculation of the average length of stay 
specified under paragraph (e)(2)(i) or paragraph (e)(2)(ii) of this 
section.
    (5) Freestanding long-term care hospital. For purposes of this 
paragraph, a freestanding long-term care hospital means a hospital that 
meets the requirements of paragraph (e)(1) and (2) of this section and 
all of the following:
    (i) Does not occupy space in a building also used by another 
hospital.
    (ii) Does not occupy space in one or more separate or entire 
buildings located on the same campus as buildings used by another 
hospital.
    (iii) Is not part of a hospital that provides inpatient services in 
a building also used by another hospital.
    (6) Moratorium on the establishment of new long-term care hospitals 
and long-term care hospital satellite facilities--(i) General rule. 
Except as specified in paragraphs (e)(6)(ii) and (e)(6)(iii) of this 
section for the period beginning December 29, 2007 and ending December 
28, 2012, and the period beginning April 1, 2014 and ending September 
30, 2017, a moratorium applies to the establishment and classification 
of a long-term care hospital as described in paragraphs (e) and (e)(1) 
through (e)(5) of this section or a long-term care hospital satellite 
facility as described in Sec.  412.22(h).
    (ii) Exception. The moratorium specified in paragraph (e)(6)(i) of 
this section is not applicable to the establishment and classification 
of a long-term care hospital that meets the requirements of paragraphs 
(e) introductory text and (e)(1) through (e)(5) of this section, or a 
long-term care hospital satellite facility that meets the requirements 
of Sec.  412.22(h), if the long-term care hospital or long-term care 
satellite facility meets one or more of the

[[Page 603]]

following criteria on or before December 27, 2007, or prior to April 1, 
2014, as applicable:
    (A) Began its qualifying period for payment in accordance with 
paragraph (e) of this section.
    (B)(1) Has a binding written agreement with an outside, unrelated 
party for the actual construction, renovation, lease or demolition for a 
long-term care hospital; and
    (2)(i) Has expended prior to December 29, 2007, at least 10 percent 
(or, if less, $2.5 million) of the estimated cost of the project 
specified in paragraph (e)(6)(ii)(B)(1) of his section; or
    (ii) Has expended, before April 1, 2014, at least 10 percent (or, if 
less, $2.5 million) of the estimated cost of the project specified in 
paragraph (e)(6)(ii)(B)(1) of this section.
    (C) Had obtained an approved certificate of need from the State, 
when required by State law.
    (7) Moratorium on increasing the number of beds in existing long-
term care hospitals and existing long-term care hospital satellite 
facilities. (i) For purposes of this paragraph, an existing long-term 
care hospital or long-term care hospital satellite facility means a 
long-term care hospital that meets the requirements of paragraph(e) of 
this section or a long-term care hospital satellite facility that meets 
the requirements of Sec.  412.22(h) that received payment under the 
provisions of subpart O of this part prior to the dates noted in the 
following moratorium clauses.
    (ii) December 29, 2007, through December 28, 2007--
    (A) Except as specified in paragraph (e)(7)(ii)(B) and (C) of this 
section, the number of Medicare-certified beds in an existing long-term 
care hospital or an existing long-term care hospital satellite facility 
as defined in paragraph (e)(7)(i) of this section must not be increased 
beyond the number of Medicare-certified beds on December 29, 2007.
    (B) Except as specified in paragraph (e)(7)(ii)(C) of this section, 
the moratorium specified in paragraph (e)(7)(ii)(A) of this section is 
not applicable to--
    (1) An existing long-term care hospital or existing long-term care 
hospital satellite facility as defined in paragraph (e)(7)(i) of this 
section that meets both of the following requirements:
    (i) Is located in a State where there is only one other long-term 
care hospital that meets the criteria specified in Sec.  412.23(e) of 
this subpart.
    (ii) Requests an increase in the number of Medicare-certified beds 
after the closure or decrease in the number of Medicare-certified beds 
of another long-term care hospital in the State; or
    (2) An existing long-term care hospital or existing long-term care 
hospital satellite facility as defined in paragraph (e)(7)(i) of this 
section that obtained a certificate of need for an increase in beds and 
that meets both of the following requirements:
    (i) Is in a State for which such certificate of need is required, 
and
    (ii) Such certificate was issued on or after April 1, 2005, and 
before December 29, 2007.
    (C) The exceptions specified in paragraph (e)(7)(ii)(B) of this 
section do not affect the limitation on increasing beds under Sec.  
412.22(f) and Sec.  412.22(h)(3) of subpart.
    (iii) April 1, 2014 through September 30, 2017--The number of 
Medicare-certified beds in an existing long-term care hospital or an 
existing long-term care hospital satellite facility must not be 
increased beyond the number of Medicare-certified beds prior to April 1, 
2014, unless one of the exceptions specified in paragraph (e)(6)(ii) of 
this section is met.
    (8) Application of LTCH moratorium on the increase in beds at 
section 114(d)(1)(B) of Public Law 110-173 to LTCHs and LTCH satellite 
facilities established or classified as such under section 114(d)(2) of 
Public Law 110-173. Effective for the period beginning October 1, 2011, 
and ending December 28, 2012, for long-term care hospitals and long-term 
care hospital satellite facilities established under paragraph 
(e)(6)(ii) of this section for the period beginning December 29, 2007, 
and ending September 30, 2011, the moratorium under paragraph (e)(7) of 
this section applies and the number of Medicare-certified beds must not 
be increased beyond the number of beds that were certified by Medicare 
at the long-term care hospital or the long-term care hospital satellite 
facility as of October 1, 2011.

[[Page 604]]

    (f) Cancer hospitals--(1) General rule. Except as provided in 
paragraph (f)(2) of this section, if a hospital meets the following 
criteria, it is classified as a cancer hospital and is excluded from the 
prospective payment systems beginning with its first cost reporting 
period beginning on or after October 1, 1989. A hospital classified 
after December 19, 1989, is excluded beginning with its first cost 
reporting period beginning after the date of its classification.
    (i) It was recognized as a comprehensive cancer center or clinical 
cancer research center by the National Cancer Institute of the National 
Institutes of Health as of April 20, 1983.
    (ii) It is classified on or before December 31, 1990, or, if on 
December 19, 1989, the hospital was located in a State operating a 
demonstration project under section 1814(b) of the Act, the 
classification is made on or before December 31, 1991.
    (iii) It demonstrates that the entire facility is organized 
primarily for treatment of and research on cancer (that is, the facility 
is not a subunit of an acute general hospital or university-based 
medical center).
    (iv) It shows that at least 50 percent of its total discharges have 
a principal diagnosis that reflects a finding of neoplastic disease. 
(The principal diagnosis for this purpose is defined as the condition 
established after study to be chiefly responsible for occasioning the 
admission of the patient to the hospital. For the purposes of meeting 
this definition, only discharges with ICD-9-CM principal diagnosis codes 
of 140 through 239, V58.0, V58.1, V66.1, V66.2, or 990 will be 
considered to reflect neoplastic disease.)
    (2) Alternative. A hospital that applied for and was denied, on or 
before December 31, 1990, classification as a cancer hospital under the 
criteria set forth in paragraph (f)(1) of this section is classified as 
a cancer hospital and is excluded from the prospective payment systems 
beginning with its first cost reporting period beginning on or after 
January 1, 1991, if it meets the criterion set forth in paragraph 
(f)(1)(i) of this section and the hospital is--
    (i) Licensed for fewer than 50 acute care beds as of August 5, 1997;
    (ii) Is located in a State that as of December 19, 1989, was not 
operating a demonstration project under section 1814(b) of the Act; and
    (iii) Demonstrates that, for the 4-year period ending on December 
31, 1996, at least 50 percent of its total discharges have a principal 
diagnosis that reflects a finding of neoplastic disease as defined in 
paragraph (f)(1)(iv) of this section.
    (3) PCHQR Program. All hospitals classified as cancer hospitals 
under this paragraph must comply with the requirements of the PPS-Exempt 
Cancer Hospital Quality Reporting Program, as described in Sec.  412.24.
    (g) Hospitals outside the 50 States, the District of Columbia, or 
Puerto Rico. A hospital is excluded from the prospective payment systems 
if it is not located in one of the fifty States, the District of 
Columbia, or Puerto Rico.
    (h) Hospitals reimbursed under special arrangements. A hospital must 
be excluded from prospective payment for inpatient hospital services if 
it is reimbursed under special arrangement as provided in Sec.  
412.22(c).
    (i) Changes in classification of hospitals. For purposes of 
exclusions from the prospective payment system, the classification of a 
hospital is effective for the hospital's entire cost reporting period. 
Any changes in the classification of a hospital are made only at the 
start of a cost reporting period.

[50 FR 12741, Mar. 29, 1985]

    Editorial Note: For Federal Register citations affecting Sec.  
412.23, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.  412.24  Requirements under the PPS-Exempt Cancer Hospital 
Quality Reporting (PCHQR) Program.

    (a) Applicability. The PCHQR Program applies to hospitals that are 
classified as cancer hospitals (PCHs) under the criteria described in 
Sec.  412.23(f)(1) or (2).
    (b) Participation in the PCHQR Program. In order to participate in 
the PCHQR Program, a PCH must do both of the following:
    (1) Register with QualityNet (http://qualitynet.cms.gov) prior to 
reporting,

[[Page 605]]

including designating a QualityNet security official who completes all 
steps of the PCHQR Program registration process as described on the 
QualityNet website.
    (2) Enroll in CDC's National Healthcare Safety Network (https://
www.cdc.gov/nhsn/enrollment/index.html).
    (c) Submission of PCHQR Program data. Except as provided in 
paragraph (e) of this section, PCHs that participate in the PCHQR 
Program must submit to CMS data on quality measures specified under 
section 1833(k)(3) of the Act in a form and manner, and at a time, 
specified by CMS. PCHs that participate in the PCHQR Program must also 
submit an annual online Data Accuracy and Completeness Acknowledgement 
via the Hospital Quality Reporting (HQR) system that attests to the 
accuracy and completeness of these data by the deadline specified by CMS 
on the QualityNet website (http://qualitynet.cms.gov).
    (d) Quality measure updates, retention, and removal--(1) Updating of 
measure specifications. CMS uses rulemaking to make substantive updates 
to the specifications of measures used in the PCHQR Program. CMS 
announces technical measure specification updates through the QualityNet 
website (http://qualitynet.cms.gov) and listserv announcements.
    (2) Measure retention. All quality measures specified under section 
1866(k)(3) for the PCHQR Program measure set remain in the measure set 
unless CMS, through rulemaking, removes or replaces them.
    (3) Measure removal factors--(i) General rule. CMS may remove or 
replace a quality measure based on one or more of the following factors:
    (A) Factor 1. Measure performance among PCHs is so high and 
unvarying that meaningful distinctions and improvements in performance 
can no longer be made.
    (B) Factor 2. A measure does not align with current clinical 
guidelines or practice.
    (C) Factor 3. The availability of a more broadly applicable measure 
(across settings or populations) or the availability of a measure that 
is more proximal in time to desired patient outcomes for the particular 
topic.
    (D) Factor 4. Performance or improvement on a measure does not 
result in better patient outcomes.
    (E) Factor 5. The availability of a measure that is more strongly 
associated with desired patient outcomes for the particular topic.
    (F) Factor 6. The collection or public reporting of a measure leads 
to negative unintended consequences other than patient harm.
    (G) Factor 7. It is not feasible to implement the measure 
specifications.
    (H) Factor 8. The costs associated with a measure outweigh the 
benefit of its continued use in the program.
    (ii) Exception. CMS may retain a quality measure that meets one or 
more of the measure removal factors described in paragraph (d)(3)(i) of 
this section if the continued collection of data on the quality measure 
would align with a stated CMS or HHS policy objective, including, but 
not limited to, an objective to increase the number of quality measures 
that a PCH can report electronically, or an objective to collect data on 
the measure in one or more other CMS quality reporting programs.
    (e) Extraordinary circumstances exceptions (ECEs). (1) CMS may grant 
an ECE to a PCH that has requested an extension or exception with 
respect to quality data reporting requirements in the event of 
extraordinary circumstances beyond the control of the PCH.
    (2) CMS may grant an ECE to one or more PCHs that has not requested 
an exception if CMS determines that--
    (i) An extraordinary circumstance has affected an entire region or 
locale; or
    (ii) A systemic problem with one of CMS' data collection systems has 
directly affected the ability of the PCH to submit data in accordance 
with paragraph (c) of this section.
    (3) A PCH participating in the PCHQR Program that wishes to request 
an ECE must submit an ECE request to CMS via the QualityNet website 
(https://qualitynet.cms.gov/pch/pchqr/resource) within 90 days of the 
date that the extraordinary circumstances occurred, along with the 
following information:
    (i) The PCH's CCN, name, reason for requesting an extension or 
exception,

[[Page 606]]

and evidence of the impact of extraordinary circumstances, including but 
not limited to photographs and media articles;
    (ii) The date when the PCH will again be able to submit PCHQR 
Program data and a justification for that proposed date;
    (iii) The following contact information for the PCH's CEO and any 
other designated personnel:
    (A) Name.
    (B) Email address.
    (C) Telephone number.
    (D) Physical mailing address (not a post office box); and
    (iv) The signature of the PCH's CEO or designee on the ECE request.
    (f) Public reporting of PCHQR Program data. CMS makes data submitted 
by PCHs under the PCHQR Program available to the public on the Provider 
Data Catalog website (https://data.cms.gov/provider-data/). Prior to 
making any such data submitted by a PCH available to the public, CMS 
gives the PCH an opportunity to review the data via the Hospital Quality 
Reporting (HQR) system (https://hqr.cms.gov/hqrng/login) and announces 
the timeline for review on the QualityNet website (http://
qualitynet.cms.gov) and applicable listservs.

[86 FR 45518, Aug. 13, 2021]



Sec.  412.25  Excluded hospital units: Common requirements.

    (a) Basis for exclusion. In order to be excluded from the 
prospective payment systems as specified in Sec.  412.1(a)(1) and be 
paid under the inpatient psychiatric facility prospective payment system 
as specified in Sec.  412.1(a)(2) or the inpatient rehabilitation 
facility prospective payment system as specified in Sec.  412.1(a)(3), a 
psychiatric or rehabilitation unit must meet the following requirements.
    (1) Be part of an institution that--
    (i) Has in effect an agreement under part 489 of this chapter to 
participate as a hospital;
    (ii) Prior to October 1, 2019, is not excluded in its entirety from 
the prospective payment systems; and
    (iii) Unless it is a unit in a critical access hospital, the 
hospital of which an IRF is a unit must have at least 10 staffed and 
maintained hospital beds that are paid under the applicable payment 
system under which the hospital is paid, or at least 1 staffed and 
maintained hospital bed for every 10 certified inpatient rehabilitation 
facility beds, whichever number is greater. Otherwise, the IRF will be 
classified as an IRF hospital, rather than an IRF unit. In the case of 
an inpatient psychiatric facility unit, the hospital must have enough 
beds that are paid under the applicable payment system under which the 
hospital is paid to permit the provision of adequate cost information, 
as required by Sec.  413.24(c) of this chapter.
    (2) Have written admission criteria that are applied uniformly to 
both Medicare and non-Medicare patients.
    (3) Have admission and discharge records that are separately 
identified from those of the hospital in which it is located and are 
readily available.
    (4) Have policies specifying that necessary clinical information is 
transferred to the unit when a patient of the hospital is transferred to 
the unit.
    (5) Meet applicable State licensure laws.
    (6) Have utilization review standards applicable for the type of 
care offered in the unit.
    (7) Have beds physically separate from (that is, not commingled 
with) the hospital's other beds.
    (8) Be serviced by the same fiscal intermediary as the hospital.
    (9) Be treated as a separate cost center for cost finding and 
apportionment purposes.
    (10) Use an accounting system that properly allocates costs.
    (11) Maintain adequate statistical data to support the basis of 
allocation.
    (12) Report its costs in the hospital's cost report covering the 
same fiscal period and using the same method of apportionment as the 
hospital.
    (13) As of the first day of the first cost reporting period for 
which all other exclusion requirements are met, the unit is fully 
equipped and staffed and is capable of providing hospital inpatient 
psychiatric or rehabilitation care regardless of whether there are any 
inpatients in the unit on that date.
    (b) Changes in the size of excluded units. Except in the special 
cases noted at the end of this paragraph, changes in the number of beds 
or square footage

[[Page 607]]

considered to be part of an excluded unit under this section are allowed 
one time during a cost reporting period if the hospital notifies its 
Medicare contractor and the CMS RO in writing of the planned change at 
least 30 days before the date of the change. The hospital must maintain 
the information needed to accurately determine costs that are 
attributable to the excluded unit. A change in bed size or a change in 
square footage may occur at any time during a cost reporting period and 
must remain in effect for the rest of that cost reporting period. 
Changes in bed size or square footage may be made at any time if these 
changes are made necessary by relocation of a unit to permit 
construction or renovation necessary for compliance with changes in 
Federal, State, or local law affecting the physical facility or because 
of catastrophic events such as fires, floods, earthquakes, or tornadoes.
    (c) Changes in the status of hospital units. For purposes of 
exclusions from the prospective payment systems under this section, the 
status of each hospital unit (excluded or not excluded) is determined as 
specified in paragraphs (c)(1) and (c)(2) of this section.
    (1) The status of a hospital unit may be changed from not excluded 
to excluded only at the start of the cost reporting period. If a unit is 
added to a hospital after the start of a cost reporting period, it 
cannot be excluded from the prospective payment systems before the start 
of a hospital's next cost reporting period.
    (2) The status of a hospital unit may be changed from excluded to 
not excluded at any time during a cost reporting period, but only if the 
hospital notifies the fiscal intermediary and the CMS Regional Office in 
writing of the change at least 30 days before the date of the change, 
and maintains the information needed to accurately determine costs that 
are or are not attributable to the excluded unit. A change in the status 
of a unit from excluded to not excluded that is made during a cost 
reporting period must remain in effect for the rest of that cost 
reporting period.
    (d) Number of excluded units. Each hospital may have only one unit 
of each type (psychiatric or rehabilitation) excluded from the 
prospective payment systems specified in Sec.  412.1(a)(1). A hospital 
excluded from the prospective payment systems as specified in Sec.  
412.1(a)(1) may not have an excluded unit (psychiatric or 
rehabilitation) that is excluded on the same basis as the hospital.
    (e) Satellite facilities. (1) For purposes of paragraphs (e)(2) 
through (e)(5) of this section, a satellite facility is a part of a 
hospital unit that provides inpatient services in a building also used 
by another hospital, or in one or more entire buildings located on the 
same campus as buildings used by another hospital.
    (2) Except as provided in paragraphs (e)(3) and (e)(6) of this 
section, effective for cost reporting periods beginning on or after 
October 1, 1999, a hospital that has a satellite facility must meet the 
following criteria in order to be excluded from the acute care hospital 
inpatient prospective payment systems for any period:
    (i) In the case of a unit excluded from the prospective payment 
systems for the most recent cost reporting period beginning before 
October 1, 1997, the unit's number of State-licensed and Medicare-
certified beds, including those at the satellite facility, does not 
exceed the unit's number of State-licensed and Medicare-certified beds 
on the last day of the unit's last cost reporting period beginning 
before October 1, 1997.
    (ii) The satellite facility independently complies with--
    (A) For a rehabilitation unit, the requirements under Sec.  412.29 
of this subpart; or
    (B) For a psychiatric unit, the requirements under Sec.  412.27(a).
    (iii) The satellite facility meets all of the following 
requirements:
    (A) Except as provided in paragraph (e)(2)(iv) of this section, it 
is not under the control of the governing body or chief executive 
officer of the hospital in which it is located, and it furnishes 
inpatient care through the use of medical personnel who are not under 
the control of the medical staff or chief medical officer of the 
hospital in which it is located.
    (B) It maintains admission and discharge records that are separately

[[Page 608]]

identified from those of the hospital in which it is located and are 
readily available.
    (C) It has beds that are physically separate from (that is, not 
commingled with) the beds of the hospital in which it is located.
    (D) It is serviced by the same fiscal intermediary as the hospital 
unit of which it is a part.
    (E) It is treated as a separate cost center of the hospital unit of 
which it is a part.
    (F) For cost reporting and apportionment purposes, it uses an 
accounting system that properly allocates costs and maintains adequate 
statistical data to support the basis of allocation.
    (G) It reports its costs on the cost report of the hospital of which 
it is a part, covering the same fiscal period and using the same method 
of apportionment as the hospital of which it is a part.
    (iv) Effective for cost reporting periods beginning on or after 
October 1, 2019, the requirements of paragraph (e)(2)(iii)(A) of this 
section do not apply to a satellite facility of a unit that is part of a 
hospital excluded from the prospective payment systems specified in 
Sec.  412.1(a)(1) that does not furnish services in a building also used 
by another hospital that is not excluded from the prospective payment 
systems specified in Sec.  412.1(a)(1), or in one or more entire 
buildings located on the same campus as buildings used by another 
hospital that is not excluded from the prospective payment systems 
specified in Sec.  412.1(a)(1).
    (3) Except as specified in paragraphs (e)(4) and (e)(5) of this 
section, the provisions of paragraph (e)(2) of this section do not apply 
to any unit structured as a satellite facility on September 30, 1999, 
and excluded from the prospective payment systems on that date, to the 
extent the unit continues operating under the same terms and conditions, 
including the number of beds and square footage considered to be part of 
the unit at the satellite facility on September 30, 1999.
    (4) In applying the provisions of paragraph (e)(3) of this section, 
any unit structured as a satellite facility on September 30, 1999, may 
increase or decrease the square footage of the satellite facility or may 
decrease the number of beds in the satellite facility considered to be 
part of the satellite facility at any time, if these changes are made by 
the relocation of a facility--
    (i) To permit construction or renovation necessary for compliance 
with changes in Federal, State, or local law affecting the physical 
facility; or
    (ii) Because of catastrophic events such as fires, floods, 
earthquakes, or tornadoes.
    (5) For cost reporting periods beginning on or after October 1, 
2006, in applying the provisions of paragraph (e)(3) of this section--
    (i) Any unit structured as a satellite facility on September 30, 
1999, may increase the square footage of the unit only at the beginning 
of a cost reporting period or decrease the square footage or number of 
beds considered to be part of the satellite facility subject to the 
provisions of paragraph (b)(2) of this section, without affecting the 
provisions of paragraph (e)(3) of this section; and
    (ii) If the unit structured as a satellite facility decreases its 
number of beds below the number of beds considered to be part of the 
satellite facility on September 30, 1999, subject to the provisions of 
paragraph (b)(2) of this section, it may subsequently increase the 
number of beds at the beginning or a cost reporting period as long as 
the resulting total number of beds considered to be part of the 
satellite facility does not exceed the number of beds at the satellite 
facility on September 30, 1999.
    (6) The provisions of paragraph (e)(2)(i) of this section do not 
apply to any inpatient rehabilitation facility that is subject to the 
inpatient rehabilitation facility prospective payment system under 
subpart P of this part, effective for cost reporting periods beginning 
on or after October 1, 2003.
    (f) Changes in classification of hospital units. For purposes of 
exclusions from the prospective payment system under this section, the 
classification of a hospital unit is effective for the unit's entire 
cost reporting period. Any changes in the classification of a hospital 
unit is made only at the start of a cost reporting period.

[[Page 609]]

    (g) CAH units not meeting applicable requirements. If a psychiatric 
or rehabilitation unit of a CAH does not meet the requirements of Sec.  
485.647 with respect to a cost reporting period, no payment may be made 
to the CAH for services furnished in that unit for that period. Payment 
to the CAH for services in the unit may resume only after the start of 
the first cost reporting period beginning after the unit has 
demonstrated to CMS that the unit meets the requirements of Sec.  
485.647.

[50 FR 12741, Mar. 29, 1985]

    Editorial Note: For Federal Register citations affecting Sec.  
412.25, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.  412.27  Excluded psychiatric units: Additional requirements.

    In order to be excluded from the prospective payment system as 
specified in Sec.  412.1(a)(1), and paid under the prospective payment 
system as specified in Sec.  412.1(a)(2), a psychiatric unit must meet 
the following requirements:
    (a) Admit only patients whose admission to the unit is required for 
active treatment, of an intensity that can be provided appropriately 
only in an inpatient hospital setting, of a psychiatric principal 
diagnosis that is listed in the International Classification of 
Diseases, Tenth Revision, Clinical Modification.
    (b) Furnish, through the use of qualified personnel, psychological 
services, social work services, psychiatric nursing, and therapeutic 
activities.
    (c) Maintain medical records that permit determination of the degree 
and intensity of the treatment provided to individuals who are furnished 
services in the unit, and that meet the following requirements:
    (1) Development of assessment/diagnostic data. Medical records must 
stress the psychiatric components of the record, including history of 
findings and treatment provided for the psychiatric condition for which 
the inpatient is treated in the unit.
    (i) The identification data must include the inpatient's legal 
status.
    (ii) A provisional or admitting diagnosis must be made on every 
inpatient at the time of admission, and must include the diagnoses of 
intercurrent diseases as well as the psychiatric diagnoses.
    (iii) The reasons for admission must be clearly documented as stated 
by the inpatient or others significantly involved, or both.
    (iv) The social service records, including reports of interviews 
with inpatients, family members, and others must provide an assessment 
of home plans and family attitudes, and community resource contacts as 
well as a social history.
    (v) When indicated, a complete neurological examination must be 
recorded at the time of the admission physical examination.
    (2) Psychiatric evaluation. Each inpatient must receive a 
psychiatric evaluation that must--
    (i) Be completed within 60 hours of admission;
    (ii) Include a medical history;
    (iii) Contain a record of mental status;
    (iv) Note the onset of illness and the circumstances leading to 
admission;
    (v) Describe attitudes and behavior;
    (vi) Estimate intellectual functioning, memory functioning, and 
orientation; and
    (vii) Include an inventory of the inpatient's assets in descriptive, 
not interpretative fashion.
    (3) Treatment plan. (i) Each inpatient must have an individual 
comprehensive treatment plan that must be based on an inventory of the 
inpatient's strengths and disabilities. The written plan must include a 
substantiated diagnosis; short-term and long-term goals; the specific 
treatment modalities utilized; the responsibilities of each member of 
the treatment team; and adequate documentation to justify the diagnosis 
and the treatment and rehabilitation activities carried out; and
    (ii) The treatment received by the inpatient must be documented in 
such a way as to assure that all active therapeutic efforts are 
included.
    (4) Recording progress. Progress notes must be recorded by the 
doctor of medicine or osteopathy responsible for the care of the 
inpatient, a nurse, social worker and, when appropriate, others 
significantly involved in active treatment modalities. The frequency of

[[Page 610]]

progress notes is determined by the condition of the inpatient but must 
be recorded at least weekly for the first two months and at least once a 
month thereafter and must contain recommendations for revisions in the 
treatment plan as indicated as well as precise assessment of the 
inpatient's progress in accordance with the original or revised 
treatment plan.
    (5) Discharge planning and discharge summary. The record of each 
patient who has been discharged must have a discharge summary that 
includes a recapitulation of the inpatient's hospitalization in the unit 
and recommendations from appropriate services concerning follow-up or 
aftercare as well as a brief summary of the patient's condition on 
discharge.
    (d) Meet special staff requirements in that the unit must have 
adequate numbers of qualified professional and supportive staff to 
evaluate inpatients, formulate written, individualized, comprehensive 
treatment plans, provide active treatment measures and engage in 
discharge planning, as follows:
    (1) Personnel. The unit must employ or undertake to provide adequate 
numbers of qualified professional, technical, and consultative personnel 
to--
    (i) Evaluate inpatients;
    (ii) Formulate written, individualized, comprehensive treatment 
plans;
    (iii) Provide active treatment measures; and
    (iv) Engage in discharge planning.
    (2) Director of inpatient psychiatric services: Medical staff. 
Inpatient psychiatric services must be under the supervision of a 
clinical director, service chief, or equivalent who is qualified to 
provide the leadership required for an intensive treatment program. The 
number and qualifications of doctors of medicine and osteopathy must be 
adequate to provide essential psychiatric services.
    (i) The clinical director, service chief, or equivalent must meet 
the training and experience requirements for examination by the American 
Board of Psychiatry and Neurology or the American Osteopathic Board of 
Neurology and Psychiatry.
    (ii) The director must monitor and evaluate the quality and 
appropriateness of services and treatment provided by the medical staff.
    (3) Nursing services. The unit must have a qualified director of 
psychiatric nursing services. In addition to the director of nursing, 
there must be adequate numbers of registered nurses, licensed practical 
nurses, and mental health workers to provide nursing care necessary 
under each inpatient's active treatment program and to maintain progress 
notes on each inpatient.
    (i) The director of psychiatric nursing services must be a 
registered nurse who has a master's degree in psychiatric or mental 
health nursing, or its equivalent, from a school of nursing accredited 
by the National League for Nursing, or be qualified by education and 
experience in the care of the mentally ill. The director must 
demonstrate competence to participate in interdisciplinary formulation 
of individual treatment plans; to give skilled nursing care and therapy; 
and to direct, monitor, and evaluate the nursing care furnished.
    (ii) The staffing pattern must ensure the availability of a 
registered nurse 24 hours each day. There must be adequate numbers of 
registered nurses, licensed practical nurses, and mental health workers 
to provide the nursing care necessary under each inpatient's active 
treatment program.
    (4) Psychological services. The unit must provide or have available 
psychological services to meet the needs of the inpatients. The services 
must be furnished in accordance with acceptable standards of practice, 
service objectives, and established policies and procedures.
    (5) Social services. There must be a director of social services who 
monitors and evaluates the quality and appropriateness of social 
services furnished. The services must be furnished in accordance with 
accepted standards of practice and established policies and procedures. 
Social service staff responsibilities must include, but are not limited 
to, participating in discharge planning, arranging for follow-up care, 
and developing mechanisms for exchange of appropriate information with 
sources outside the hospital.

[[Page 611]]

    (6) Therapeutic activities. The unit must provide a therapeutic 
activities program.
    (i) The program must be appropriate to the needs and interests of 
inpatients and be directed toward restoring and maintaining optimal 
levels of physical and psychosocial functioning.
    (ii) The number of qualified therapists, support personnel, and 
consultants must be adequate to provide comprehensive therapeutic 
activities consistent with each inpatient's active treatment program.

[50 FR 12741, Mar. 29, 1985, as amended at 57 FR 39820, Sept. 1, 1992; 
59 FR 45397, 45400, Sept. 1, 1994; 69 FR 66976, Nov. 15, 2004; 71 FR 
27086, May 9, 2006; 83 FR 38619, Aug. 6, 2018]



Sec.  412.29  Classification criteria for payment under the inpatient 
rehabilitation facility prospective payment system.

    To be excluded from the prospective payment systems described in 
Sec.  412.1(a)(1) and to be paid under the prospective payment system 
specified in Sec.  412.1(a)(3), an inpatient rehabilitation hospital or 
an inpatient rehabilitation unit of a hospital (otherwise referred to as 
an IRF) must meet the following requirements:
    (a) Have (or be part of a hospital that has) a provider agreement 
under part 489 of this chapter to participate as a hospital.
    (b) Except in the case of a ``new'' IRF or ``new'' IRF beds, as 
defined in paragraph (c) of this section, an IRF must show that, during 
its most recent, consecutive, and appropriate 12-month time period (as 
defined by CMS or the Medicare contractor), it served an inpatient 
population that meets the following criteria:
    (1) For cost reporting periods beginning on or after July 1, 2004, 
and before July 1, 2005, the IRF served an inpatient population of whom 
at least 50 percent, and for cost reporting periods beginning on or 
after July 1, 2005, the IRF served an inpatient population of whom at 
least 60 percent required intensive rehabilitation services for 
treatment of one or more of the conditions specified at paragraph (b)(2) 
of this section. A patient with a comorbidity, as defined at Sec.  
412.602 of this part, may be included in the inpatient population that 
counts toward the required applicable percentage if--
    (i) The patient is admitted for inpatient rehabilitation for a 
condition that is not one of the conditions specified in paragraph 
(b)(2) of this section;
    (ii) The patient has a comorbidity that falls in one of the 
conditions specified in paragraph (b)(2) of this section; and
    (iii) The comorbidity has caused significant decline in functional 
ability in the individual that, even in the absence of the admitting 
condition, the individual would require the intensive rehabilitation 
treatment that is unique to inpatient rehabilitation facilities paid 
under subpart P of this part and that cannot be appropriately performed 
in another care setting covered under this title.
    (2) List of conditions.
    (i) Stroke.
    (ii) Spinal cord injury.
    (iii) Congenital deformity.
    (iv) Amputation.
    (v) Major multiple trauma.
    (vi) Fracture of femur (hip fracture).
    (vii) Brain injury.
    (viii) Neurological disorders, including multiple sclerosis, motor 
neuron diseases, polyneuropathy, muscular dystrophy, and Parkinson's 
disease.
    (ix) Burns.
    (x) Active, polyarticular rheumatoid arthritis, psoriatic arthritis, 
and seronegative arthropathies resulting in significant functional 
impairment of ambulation and other activities of daily living that have 
not improved after an appropriate, aggressive, and sustained course of 
outpatient therapy services or services in other less intensive 
rehabilitation settings immediately preceding the inpatient 
rehabilitation admission or that result from a systemic disease 
activation immediately before admission, but have the potential to 
improve with more intensive rehabilitation.
    (xi) Systemic vasculidities with joint inflammation, resulting in 
significant functional impairment of ambulation and other activities of 
daily living that have not improved after an appropriate, aggressive, 
and sustained course of outpatient therapy services or services in other 
less intensive rehabilitation settings immediately preceding

[[Page 612]]

the inpatient rehabilitation admission or that result from a systemic 
disease activation immediately before admission, but have the potential 
to improve with more intensive rehabilitation.
    (xii) Severe or advanced osteoarthritis (osteoarthrosis or 
degenerative joint disease) involving two or more major weight bearing 
joints (elbow, shoulders, hips, or knees, but not counting a joint with 
a prosthesis) with joint deformity and substantial loss of range of 
motion, atrophy of muscles surrounding the joint, significant functional 
impairment of ambulation and other activities of daily living that have 
not improved after the patient has participated in an appropriate, 
aggressive, and sustained course of outpatient therapy services or 
services in other less intensive rehabilitation settings immediately 
preceding the inpatient rehabilitation admission but have the potential 
to improve with more intensive rehabilitation. (A joint replaced by a 
prosthesis no longer is considered to have osteoarthritis, or other 
arthritis, even though this condition was the reason for the joint 
replacement.)
    (xiii) Knee or hip joint replacement, or both, during an acute 
hospitalization immediately preceding the inpatient rehabilitation stay 
and also meet one or more of the following specific criteria:
    (A) The patient underwent bilateral knee or bilateral hip joint 
replacement surgery during the acute hospital admission immediately 
preceding the IRF admission.
    (B) The patient is extremely obese with a Body Mass Index of at 
least 50 at the time of admission to the IRF.
    (C) The patient is age 85 or older at the time of admission to the 
IRF.
    (c) In the case of new IRFs (as defined in paragraph (c)(1) of this 
section) or new IRF beds (as defined in paragraph (c)(2)of this 
section), the IRF must provide a written certification that the 
inpatient population it intends to serve meets the requirements of 
paragraph (b) of this section. This written certification will apply 
until the end of the IRF's first full 12-month cost reporting period or, 
in the case of new IRF beds, until the end of the cost reporting period 
during which the new beds are added to the IRF.
    (1) New IRFs. An IRF hospital or IRF unit is considered new if it 
has not been paid under the IRF PPS in subpart P of this part for at 
least 5 calendar years. A new IRF will be considered new from the point 
that it first participates in Medicare as an IRF until the end of its 
first full 12-month cost reporting period.
    (2) New IRF beds. Any IRF beds that are added to an existing IRF 
must meet all applicable State Certificate of Need and State licensure 
laws. New IRF beds may be added one time at any point during a cost 
reporting period and will be considered new for the rest of that cost 
reporting period. A full 12-month cost reporting period must elapse 
between the delicensing or decertification of IRF beds in an IRF 
hospital or IRF unit and the addition of new IRF beds to that IRF 
hospital or IRF unit. Before an IRF can add new beds, it must receive 
written approval from the appropriate CMS RO, so that the CMS RO can 
verify that a full 12-month cost reporting period has elapsed since the 
IRF has had beds delicensed or decertified. New IRF beds are included in 
the compliance review calculations under paragraph (b) of this section 
from the time that they are added to the IRF.
    (3) Change of ownership or leasing. An IRF hospital or IRF unit that 
undergoes a change of ownership or leasing, as defined in Sec.  489.18 
of this chapter, retains its excluded status and will continue to be 
paid under the prospective payment system specified in Sec.  412.1(a)(3) 
before and after the change of ownership or leasing if the new owner(s) 
of the IRF accept assignment of the previous owners' Medicare provider 
agreement and the IRF continues to meet all of the requirements for 
payment under the IRF prospective payment system. If the new owner(s) do 
not accept assignment of the previous owners' Medicare provider 
agreement, the IRF is considered to be voluntarily terminated and the 
new owner(s) may re-apply to participate in the Medicare program. If the 
IRF does not continue to meet all of the requirements for payment under 
the IRF prospective payment system, then the IRF

[[Page 613]]

loses its excluded status and is paid according to the prospective 
payment systems described in Sec.  412.1(a)(1).
    (4) Mergers. If an IRF hospital (or a hospital with an IRF unit) 
merges with another hospital and the owner(s) of the merged hospital 
accept assignment of the IRF hospital's provider agreement (or the 
provider agreement of the hospital with the IRF unit), then the IRF 
hospital or IRF unit retains its excluded status and will continue to be 
paid under the prospective payment system specified in Sec.  412.1(a)(3) 
before and after the merger, as long as the IRF hospital or IRF unit 
continues to meet all of the requirements for payment under the IRF 
prospective payment system. If the owner(s) of the merged hospital do 
not accept assignment of the IRF hospital's provider agreement (or the 
provider agreement of the hospital with the IRF unit), then the IRF 
hospital or IRF unit is considered voluntarily terminated and the 
owner(s) of the merged hospital may reapply to the Medicare program to 
operate a new IRF.
    (d) Except for care furnished to patients in a freestanding IRF 
hospital solely to relieve acute care hospital capacity in a state (or 
region, as applicable) that is experiencing a surge, as defined in Sec.  
412.622 of this chapter, during the Public Health Emergency, as defined 
in Sec.  400.200 of this chapter, have in effect a preadmission 
screening procedure under which each prospective patient's condition and 
medical history are reviewed to determine whether the patient is likely 
to benefit significantly from an intensive inpatient hospital program. 
This procedure must ensure that the preadmission screening for each 
Medicare Part A fee-for-Service patient is reviewed and approved by a 
rehabilitation physician prior to the patient's admission to the IRF.
    (e) Except for care furnished to patients in a freestanding IRF 
hospital solely to relieve acute care hospital capacity in a state (or 
region, as applicable) that is experiencing a surge, as defined in Sec.  
412.622, during the Public Health Emergency, as defined in Sec.  400.200 
of this chapter, have in effect a procedure to ensure that patients 
receive close medical supervision, as evidenced by at least 3 face-to-
face visits per week by a licensed physician with specialized training 
and experience in inpatient rehabilitation to assess the patient both 
medically and functionally, as well as to modify the course of treatment 
as needed to maximize the patient's capacity to benefit from the 
rehabilitation process except that during the Public Health Emergency, 
as defined in Sec.  400.200 of this chapter, for the COVID-19 pandemic 
such visits may be conducted using telehealth services (as defined in 
section 1834(m)(4)(F) of the Act). Beginning with the second week, as 
defined in Sec.  412.622, of admission to the IRF, a non-physician 
practitioner who is determined by the IRF to have specialized training 
and experience in inpatient rehabilitation may conduct 1 of the 3 
required face-to-face visits with the patient per week, provided that 
such duties are within the non-physician practitioner's scope of 
practice under applicable state law.
    (f) Furnish, through the use of qualified personnel, rehabilitation 
nursing, physical therapy, and occupational therapy, plus, as needed, 
speech-language pathology, social services, psychological services 
(including neuropsychological services), and orthotic and prosthetic 
services.
    (g) Have a director of rehabilitation who--
    (1) Provides services to the IRF hospital and its inpatients on a 
full-time basis or, in the case of a rehabilitation unit, at least 20 
hours per week;
    (2) Is a doctor of medicine or osteopathy;
    (3) Is licensed under State law to practice medicine or surgery; and
    (4) Has had, after completing a one-year hospital internship, at 
least 2 years of training or experience in the medical-management of 
inpatients requiring rehabilitation services.
    (h) Except for care furnished to patients in a freestanding IRF 
hospital solely to relieve acute care hospital capacity in a state (or 
region, as applicable) that is experiencing a surge, as defined in Sec.  
412.622 of this chapter, during the Public Health Emergency, as defined 
in Sec.  400.200 of this chapter, have a plan of treatment for each 
inpatient

[[Page 614]]

that is established, reviewed, and revised as needed by a physician in 
consultation with other professional personnel who provide services to 
the patient.
    (i) Except for care furnished to patients in a freestanding IRF 
hospital solely to relieve acute care hospital capacity in a state (or 
region, as applicable) that is experiencing a surge, as defined in Sec.  
412.622 of this chapter, during the Public Health Emergency, as defined 
in Sec.  400.200 of this chapter, use a coordinated interdisciplinary 
team approach in the rehabilitation of each inpatient, as documented by 
the periodic clinical entries made in the patient's medical record to 
note the patient's status in relationship to goal attainment and 
discharge plans, and that team conferences are held at least once per 
week to determine the appropriateness of treatment.
    (j) Retroactive adjustments. If a new IRF (or new beds that are 
added to an existing IRF) are excluded from the prospective payment 
systems specified in Sec.  412.1(a)(1) and paid under the prospective 
payment system specified in Sec.  412.1(a)(3) for a cost reporting 
period under paragraph (c) of this section, but the inpatient population 
actually treated during that period does not meet the requirements of 
paragraph (b) of this section, we adjust payments to the IRF 
retroactively in accordance with the provisions in Sec.  412.130.

[76 FR 47891, Aug. 5, 2011, as amended at 78 FR 47934, Aug. 6, 2013; 85 
FR 19287, Apr. 6, 2020; 85 FR 27621, May 8, 2020; 85 FR 48462, Aug. 10, 
2020]



Sec.  412.30  [Reserved]



 Subpart C_Conditions for Payment Under the Prospective Payment Systems 
    for Inpatient Operating Costs and Inpatient Capital-Related Costs



Sec.  412.40  General requirements.

    (a) A hospital must meet the conditions of this subpart to receive 
payment under the prospective payment systems for inpatient hospital 
services furnished to Medicare beneficiaries.
    (b) If a hospital fails to comply fully with these conditions with 
respect to inpatient hospital services furnished to one or more Medicare 
beneficiaries, CMS may, as appropriate--
    (1) Withhold Medicare payment (in full or in part) to the hospital 
until the hospital provides adequate assurances of compliance; or
    (2) Terminate the hospital's provider agreement.

[50 FR 12741, Mar. 29, 1985, as amended at 57 FR 39821, Sept. 1, 1992]



Sec.  412.42  Limitations on charges to beneficiaries.

    (a) Prohibited charges. A hospital may not charge a beneficiary for 
any services for which payment is made by Medicare, even if the 
hospital's costs of furnishing services to that beneficiary are greater 
than the amount the hospital is paid under the prospective payment 
systems.
    (b) Permitted charges--Stay covered. A hospital receiving payment 
under the prospective payment systems for a covered hospital stay (that 
is, a stay that includes at least one covered day) may charge the 
Medicare beneficiary or other person only for the following:
    (1) The applicable deductible and coinsurance amounts under 
Sec. Sec.  409.82, 409.83, and 409.87 of this chapter.
    (2) Noncovered items and services, furnished at any time during a 
covered stay, unless they are excluded from coverage only on the basis 
of the following:
    (i) The exclusion of custodial care under Sec.  411.15(g) of this 
chapter (see paragraph (c) of this section for when charges may be made 
for custodial care).
    (ii) The exclusion of medically unnecessary items and services under 
Sec.  411.15(k) of this chapter (see paragraphs (c) and (d) of this 
section for when charges may be made for medically unnecessary items and 
services).
    (iii) The exclusion under Sec.  411.15(m) of this chapter of 
nonphysician services furnished to hospital inpatients by other than the 
hospital or a provider or supplier under arrangements made by the 
hospital.
    (iv) The exclusion of items and services furnished when the patient 
is not entitled to Medicare Part A benefits under subpart A of part 406 
of this chapter (see paragraph (e) of this section for when charges may 
be made for

[[Page 615]]

items and services furnished when the patient is not entitled to 
benefits).
    (v) The exclusion of items and services furnished after Medicare 
Part A benefits are exhausted under Sec.  409.61 of this chapter (see 
paragraph (e) of this section for when charges may be made for items and 
services furnished after benefits are exhausted).
    (c) Custodial care and medically unnecessary inpatient hospital 
care. A hospital may charge a beneficiary for services excluded from 
coverage on the basis of Sec.  411.15(g) of this chapter (custodial 
care) or Sec.  411.15(k) of this chapter (medically unnecessary 
services) and furnished by the hospital after all of the following 
conditions have been met:
    (1) The hospital (acting directly or through its utilization review 
committee) determines that the beneficiary no longer requires inpatient 
hospital care. (The phrase ``inpatient hospital care'' includes cases 
where a beneficiary needs a SNF level of care, but, under Medicare 
criteria, a SNF-level bed is not available. This also means that a 
hospital may find that a patient awaiting SNF placement no longer 
requires inpatient hospital care because either a SNF-level bed has 
become available or the patient no longer requires SNF-level care.)
    (2) The attending physician agrees with the hospital's determination 
in writing (for example, by issuing a written discharge order). If the 
hospital believes that the beneficiary does not require inpatient 
hospital care but is unable to obtain the agreement of the physician, it 
may request an immediate review of the case by the QIO as described in 
Sec.  405.1208 of this chapter. Concurrence by the QIO in the hospital's 
determination will serve in lieu of the physician's agreement.
    (3) The hospital (acting directly or through its utilization review 
committee) notifies the beneficiary (or his or her representative) of 
his or her discharge rights in writing consistent with Sec.  405.1205 
and notifies the beneficiary, in accordance with Sec.  405.1206 of this 
chapter (if applicable) that in the hospital's opinion, and with the 
attending physician's concurrence or that of the QIO, the beneficiary no 
longer requires inpatient hospital care.
    (4) If the beneficiary remains in the hospital after the appropriate 
notification, and the hospital, the physician who concurred in the 
hospital determination on which the notice was based, or QIO 
subsequently finds that the beneficiary requires an acute level of 
inpatient hospital care, the hospital may not charge the beneficiary for 
continued care until the hospital once again determines that the 
beneficiary no longer requires inpatient care, secures concurrence, and 
notifies the beneficiary, as required in paragraphs (c)(1), (c)(2), and 
(c)(3) of this section.
    (d) Medically unnecessary diagnostic and therapeutic services. A 
hospital may charge a beneficiary for diagnostic procedures and studies, 
and therapeutic procedures and courses of treatment (for example, 
experimental procedures) that are excluded from coverage under Sec.  
411.15(k) of this chapter (medically unnecessary items and services), 
even though the beneficiary requires continued inpatient hospital care, 
if those services are furnished after the beneficiary (or the person 
acting on his or her behalf) has acknowledged in writing that the 
hospital (acting directly or through its utilization review committee 
and with the concurrence of the intermediary) has informed him or her as 
follows:
    (1) In the hospital's opinion, which has been agreed to by the 
intermediary, the services to be furnished are not considered reasonable 
and necessary under Medicare.
    (2) Customary charges will be made if he or she receives the 
services.
    (3) If the beneficiary receives the services, a formal determination 
on the validity of the hospital's finding is made by the intermediary 
and, to the extent that the decision requires the exercise of medical 
judgment, the QIO.
    (4) The determination is appealable by the hospital, the attending 
physician, or the beneficiary under the appeals procedure that applies 
to determinations affecting Medicare Part A payment.
    (5) The charges for the services will be invalid and, to the extent 
collected, will be refunded by the hospital if the services are found to 
be covered by Medicare.

[[Page 616]]

    (e) Services furnished on days when the individual is not entitled 
to Medicare Part A benefits or has exhausted the available benefits. The 
hospital may charge the beneficiary its customary charges for noncovered 
items and services furnished on outlier days (as described in Subpart F 
of this part) for which payment is denied because the beneficiary is not 
entitled to Medicare Part A or his or her Medicare Part A benefits are 
exhausted. (1) If payment is considered for outlier days, the entire 
stay is reviewed and days up to the number of days in excess of the 
outlier threshold may be denied on the basis of nonentitlement to Part A 
or exhaustion of benefits. (2) In applying this rule, the latest days 
will be denied first.
    (f) Differential for private room or other luxury services. The 
hospital may charge the beneficiary the customary charge differential 
for a private room or other luxury service that is more expensive than 
is medically required and is furnished for the personal comfort of the 
beneficiary at his or her request (or the request of the person acting 
on his or her behalf).
    (g) Review. (1) The QIO or intermediary may review any cases in 
which the hospital advises the beneficiary (or the person acting on his 
or her behalf) of the noncoverage of the services in accordance with 
paragraph (c)(3) or (d) of this section.
    (2) The hospital must identify such cases to the QIO or intermediary 
in accordance with CMS instructions.

[50 FR 12741, Mar. 29, 1985, as amended at 50 FR 35688, Sept. 3, 1985; 
54 FR 41747, Oct. 11, 1989; 57 FR 39821, Sept. 1, 1992; 71 FR 48137, 
Aug. 18, 2006; 71 FR 68722, Nov. 27, 2006; 85 FR 72909, Nov. 16, 2020]



Sec.  412.44  Medical review requirements: Admissions and quality review.

    Beginning on November 15, 1984, a hospital must have an agreement 
with a QIO to have the QIO review, on an ongoing basis, the following:
    (a) The medical necessity, reasonableness and appropriateness of 
hospital admissions and discharges.
    (b) The medical necessity, reasonableness and appropriateness of 
inpatient hospital care for which additional payment is sought under the 
outlier provisions of Sec. Sec.  412.82 and 412.84 of this chapter.
    (c) The validity of the hospital's diagnostic and procedural 
information.
    (d) The completeness, adequacy, and quality of the services 
furnished in the hospital.
    (e) Other medical or other practices with respect to beneficiaries 
or billing for services furnished to beneficiaries.

[50 FR 15326, Apr. 17, 1985, as amended at 50 FR 35689, Sept. 3, 1985; 
50 FR 41886, Oct. 16, 1985]



Sec.  412.46  Medical review requirements.

    (a) Physician acknowledgement. (1) Basis. Because payment under the 
prospective payment system is based in part on each patient's principal 
and secondary diagnoses and major procedures performed, as evidenced by 
the physician's entries in the patient's medical record, physicians must 
complete an acknowledgement statement to this effect.
    (2) Content of physician acknowledgement statement. When a claim is 
submitted, the hospital must have on file a signed and dated 
acknowledgement from the attending physician that the physician has 
received the following notice:

    Notice to Physicians: Medicare payment to hospitals is based in part 
on each patient's principal and secondary diagnoses and the major 
procedures performed on the patient, as attested to by the patient's 
attending physician by virtue of his or her signature in the medical 
record. Anyone who misrepresents, falsifies, or conceals essential 
information required for payment of Federal funds, may be subject to 
fine, imprisonment, or civil penalty under applicable Federal laws.

    (3) Completion of acknowledgement. The acknowledgement must be 
completed by the physician at the time that the physician is granted 
admitting privileges at the hospital, or before or at the time the 
physician admits his or her first patient. Existing acknowledgements 
signed by physicians already on staff remain in effect as long as the 
physician has admitting privileges at the hospital.
    (b) Physician's order and certification regarding medical necessity. 
No presumptive weight shall be assigned to the physician's order under 
Sec.  412.3 or the

[[Page 617]]

physician's certification under Subpart B of Part 424 of the chapter in 
determining the medical necessity of inpatient hospital services under 
section 1862(a)(1) of the Act. A physician's order or certification will 
be evaluated in the context of the evidence in the medical record.

[78 FR 50965, Aug. 19, 2013]



Sec.  412.48  Denial of payment as a result of admissions and quality review.

    (a) If CMS determines, on the basis of information supplied by a QIO 
that a hospital has misrepresented admissions, discharges, or billing 
information, or has taken an action that results in the unnecessary 
admission of an individual entitled to benefits under Part A, 
unnecessary multiple admissions of an individual, or other inappropriate 
medical or other practices with respect to beneficiaries or billing for 
services furnished to beneficiaries, CMS may as appropriate--
    (1) Deny payment (in whole or in part) under Part A with respect to 
inpatient hospital services provided with respect to such an unnecessary 
admission or subsequent readmission of an individual; or
    (2) Require the hospital to take other corrective action necessary 
to prevent or correct the inappropriate practice.
    (b) When payment with respect to admission of an individual patient 
is denied by a QIO under paragraph (a)(1) of this section, and liability 
is not waived in accordance with Sec. Sec.  411.400 through 411.402 of 
this chapter, notice and appeals are provided under procedures 
established by CMS to implement the provisions of section 1155 of the 
Act, Right to Hearing and Judicial Review.
    (c) A determination under paragraph (a) of this section, if it is 
related to a pattern of inappropriate admissions and billing practices 
that has the effect of circumventing the prospective payment systems, is 
referred to the Department's Office of Inspector General, for handling 
in accordance with Sec.  1001.301 of this title.

[50 FR 12741, Mar. 29, 1985, as amended at 50 FR 35688, 35689, Sept. 3, 
1985; 51 FR 34787, Sept. 30, 1986; 57 FR 39821, Sept. 1, 1992; 71 FR 
48137, Aug. 18, 2006]



Sec.  412.50  Furnishing of inpatient hospital services directly 
or under arrangements.

    (a) The applicable payments made under the prospective payment 
systems, as described in subparts H and M of this part, are payment in 
full for all inpatient hospital services, as defined in Sec.  409.10 of 
this chapter. Inpatient hospital services do not include the following 
types of services:
    (1) Physician services that meet the requirements of Sec.  
415.102(a) of this chapter for payment on a fee schedule basis.
    (2) Physician assistant services, as defined in section 
1861(s)(2)(K)(i) of the Act.
    (3) Nurse practitioner and clinical nurse specialist services, as 
defined in section 1861(s)(2)(K)(ii) of the Act.
    (4) Certified nurse mid-wife services, as defined in section 
1861(gg) of the Act.
    (5) Qualified psychologist services, as defined in section 1861(ii) 
of the Act.
    (6) Services of an anesthetist, as defined in Sec.  410.69 of this 
chapter.
    (b) CMS does not pay any provider or supplier other than the 
hospital for services furnished to a beneficiary who is an inpatient, 
except for the services described in paragraphs (a)(1) through (a)(6) of 
this section.
    (c) The hospital must furnish all necessary covered services to the 
beneficiary either directly or under arrangements (as defined in Sec.  
409.3 of this chapter).

[50 FR 12741, Mar. 29, 1985, as amended at 53 FR 38527, Sept. 30, 1988; 
57 FR 39821, Sept. 1, 1992; 60 FR 63188, Dec. 8, 1995; 65 FR 18537, Apr. 
7, 2000]



Sec.  412.52  Reporting and recordkeeping requirements.

    All hospitals participating in the prospective payment systems must 
meet the recordkeeping and cost reporting requirements of Sec. Sec.  
413.20 and 413.24 of this chapter.

[50 FR 12741, Mar. 29, 1985, as amended at 51 FR 34793, Sept. 30, 1986; 
57 FR 39821, Sept. 1, 1992]

[[Page 618]]



Subpart D_Basic Methodology for Determining Prospective Payment Federal 
                   Rates for Inpatient Operating Costs



Sec.  412.60  DRG classification and weighting factors.

    (a) Diagnosis-related groups. CMS establishs a classification of 
inpatient hospital discharges by Diagnosis-Related Groups (DRGs).
    (b) DRG weighting factors. CMS assigns, for each DRG, an appropriate 
weighting factor that reflects the estimated relative cost of hospital 
resources used with respect to discharges classified within that group 
compared to discharges classified within other groups.
    (c) Assignment of discharges to DRGs. CMS establishs a methodology 
for classifying specific hospital discharges within DRGs which ensures 
that each hospital discharge is appropriately assigned to a single DRG 
based on essential data abstracted from the inpatient bill for that 
discharge.
    (1) The classification of a particular discharge is based, as 
appropriate, on the patient's age, sex, principal diagnosis (that is, 
the diagnosis established after study to be chiefly responsible for 
causing the patient's admission to the hospital), secondary diagnoses, 
procedures performed, and discharge status.
    (2) Each discharge is assigned to only one DRG (related, except as 
provided in paragraph (c)(3) of this section, to the patient's principal 
diagnosis) regardless of the number of conditions treated or services 
furnished during the patient's stay.
    (3) When the discharge data submitted by a hospital show a surgical 
procedure unrelated to a patient's principal diagnosis, the bill is 
returned to the hospital for validation and reverification. CMS's DRG 
classification system provides a DRG, and an appropriate weighting 
factor, for the group of cases for which the unrelated diagnosis and 
procedure are confirmed.
    (d) Review of DRG assignment. (1) A hospital has 60 days after the 
date of the notice of the initial assignment of a discharge to a DRG to 
request a review of that assignment. The hospital may submit additional 
information as a part of its request.
    (2) The intermediary reviews the hospital's request and any 
additional information and decides whether a change in the DRG 
assignment is appropriate. If the intermediary decides that a higher-
weighted DRG should be assigned, the case will be reviewed by the 
appropriate QIO as specified in Sec.  466.71(c)(2) of this chapter.
    (3) Following the 60-day period described in paragraph (d)(1) of 
this section, the hospital may not submit additional information with 
respect to the DRG assignment or otherwise revise its claim.
    (e) Revision of DRG classification and weighting factors. Beginning 
with discharges in fiscal year 1988, CMS adjusts the classifications and 
weighting factors established under paragraphs (a) and (b) of this 
section at least annually to reflect changes in treatment patterns, 
technology, and other factors that may change the relative use of 
hospital resources.

[50 FR 12741, Mar. 29, 1985, as amended at 52 FR 33057, Sept. 1, 1987; 
57 FR 39821, Sept. 1, 1992; 59 FR 45397, Sept. 1, 1994]



Sec.  412.62  Federal rates for inpatient operating costs for fiscal year 1984.

    (a) General rule. CMS determines national adjusted DRG prospective 
payment rates for operating costs, for each inpatient hospital discharge 
in fiscal year 1984 involving inpatient hospital services of a hospital 
in the United States subject to the prospective payment system under 
subpart B of this part, and determines regional adjusted DRG prospective 
payment rates for inpatient operating costs for such discharges in each 
region, for which payment may be made under Medicare Part A. Such rates 
are determined for hospitals located in urban or rural areas within the 
United States and within each such region, respectively, as described in 
paragraphs (b) through (k) of this section.
    (b) Determining allowable individual hospital inpatient operating 
costs. CMS determines the Medicare allowable operating costs per 
discharge of inpatient hospital services for each hospital in the data 
base for the most recent cost reporting period for which data are 
available.

[[Page 619]]

    (c) Updating for fiscal year 1984. CMS updates each amount 
determined under paragraph (b) of this section for fiscal year 1984 by--
    (1) Updating for fiscal year 1983 by the estimated average rate of 
change of hospital costs industry-wide between the cost reporting period 
used under paragraph (b) of this section and fiscal year 1983; and
    (2) Projecting for fiscal year 1984 by the applicable percentage 
increase in the hospital market basket for fiscal year 1984.
    (d) Standardizing amounts. CMS standardizes the amount updated under 
paragraph (c) of this section for each hospital by--
    (1) Adjusting for area variations in case mix among hospitals;
    (2) Excluding an estimate of indirect medical education costs;
    (3) Adjusting for area variations in hospital wage levels; and
    (4) Adjusting for the effects of a higher cost of living for 
hospitals located in Alaska and Hawaii.
    (e) Computing urban and rural averages. CMS computes an average of 
the standardized amounts determined under paragraph (d) of this section 
for urban and rural hospitals in the United States and for urban and 
rural hospitals in each region.
    (f) Geographic classifications. (1) For purposes of paragraph (e) of 
this section, the following definitions apply:
    (i) The term region means one of the nine census divisions, 
comprising the fifty States and the District of Columbia, established by 
the Bureau of the Census for statistical and reporting purposes.
    (ii) The term urban area means--
    (A) A Metropolitan Statistical Area (MSA) or New England County 
Metropolitan Area (NECMA), as defined by the Executive Office of 
Management and Budget; or
    (B) The following New England counties, which are deemed to be parts 
of urban areas under section 601(g) of the Social Security Amendments of 
1983 (Pub. L. 98-21, 42 U.S.C. 1395ww (note)): Litchfield County, 
Connecticut; York County, Maine; Sagadahoc County, Maine; Merrimack 
County, New Hampshire; and Newport County, Rhode Island.
    (iii) The term rural area means any area outside an urban area.
    (iv) The phrase hospital reclassified as rural means a hospital 
located in a county that was part of an MSA or NECMA, as defined by the 
Executive Office of Management and Budget, but is not part of an MSA or 
NECMA as a result of an Executive Office of Management and Budget 
redesignation occurring after April 20, 1983.
    (2) For hospitals within an MSA or NECMA that crosses census 
division boundaries, the following provisions apply:
    (i) The MSA or NECMA is deemed to belong to the census division in 
which most of the hospitals within the MSA or NECMA are located.
    (ii) If a hospital would receive a lower Federal rate because most 
of the hospitals are located in a census division with a lower Federal 
rate than the rate applicable to the census division in which the 
hospital is located, the payment rate will not be reduced for the 
hospital's cost reporting period beginning before October 1, 1984.
    (iii) If an equal number of hospitals within the MSA or NECMA are 
located in each census division, such hospitals are deemed to be in the 
census division with the higher Federal rate.
    (g) Adjusting the average standardized amounts. CMS adjusts each of 
the average standardized amounts determined under paragraphs (c), (d), 
and (e) of this section by factors representing CMS's estimates of the 
following:
    (1) The amount of payment that would have been made under Medicare 
Part B for nonphysician services to hospital inpatients during the first 
cost reporting period subject to prospective payment were it not for the 
fact that such services must be furnished either directly by hospitals 
or under arrangements in order for any Medicare payment to be made after 
September 30, 1983 (the effective date of Sec.  405.310(m) of this 
chapter).
    (2) The amount of FICA taxes that would be incurred during the first 
cost reporting period subject to the prospective payment system, by 
hospitals that had not incurred such taxes for any or all of their 
employees during the base period described in paragraph (c) of this 
section.

[[Page 620]]

    (h) Reducing for value of outlier payments. CMS reduces each of the 
adjusted average standardized amounts determined under paragraphs (c) 
through (g) of this section by a proportion equal to the proportion 
(estimated by CMS) of the total amount of payments based on DRG 
prospective payment rates that are additional payments for outlier cases 
under subpart F of this part.
    (i) Maintaining budget neutrality. (1) CMS adjusts each of the 
reduced standardized amounts determined under paragraphs (c) through (h) 
of this section as required for fiscal year 1984 so that the estimated 
amount of aggregate payments made, excluding the hospital-specific 
portion (that is, the total of the Federal portion of transition 
payments, plus any adjustments and special treatment of certain classes 
of hospitals for Federal fiscal year 1984) is not greater or less than 
25 percent of the payment amounts that would have been payable for the 
inpatient operating costs for those same hospitals for fiscal year 1984 
under the Social Security Act as in effect on April 19, 1983.
    (2) The aggregate payments considered under this paragraph exclude 
payments for per case review by a utilization and quality control 
quality improvement organization, as allowed under section 1866(a)(1)(F) 
of the Act.
    (j) Computing Federal rates for inpatient operating costs for urban 
and rural hospitals in the United States and in each region. For each 
discharge classified within a DRG, CMS establishes a national 
prospective payment rate for inpatient operating costs and a regional 
prospective payment rate for inpatient operating costs for each region, 
as follows:
    (1) For hospitals located in an urban area in the United States or 
in that region respectively, the rate equals the product of--
    (i) The adjusted average standardized amount (computed under 
paragraphs (c) through (i) of this section) for hospitals located in an 
urban area in the United States or in that region; and
    (ii) The weighting factor determined under Sec.  412.60(b) for that 
DRG.
    (2) For hospitals located in a rural area in the United States or in 
that region respectively, the rate equals the product of--
    (i) The adjusted average standardized amount (computed under 
paragraphs (c) through (i) of this section) for hospitals located in a 
rural area in the United States or that region; and
    (ii) The weighting factor determined under Sec.  412.60(b) for that 
DRG.
    (k) Adjusting for different area wage levels. CMS adjusts the 
proportion (as estimated by CMS from time to time) of Federal rates 
computed under paragraph (j) of this section that are attributable to 
wages and labor-related costs, for area differences in hospital wage 
levels by a factor (established by CMS) reflecting the relative hospital 
wage level in the geographic area (that is, urban or rural area as 
determined under the provisions of paragraph (f) of this section) of the 
hospital compared to the national average hospital wage level.

[50 FR 12741, Mar. 29, 1985, as amended at 51 FR 34793, Sept. 30, 1986; 
53 FR 38527, Sept. 30, 1988; 57 FR 39821, Sept. 1, 1992; 58 FR 46337, 
Sept. 1, 1993]



Sec.  412.63  Federal rates for inpatient operating costs 
for Federal fiscal years 1984 through 2004.

    (a) General rule. (1) CMS determines a national adjusted prospective 
payment rate for inpatient operating costs for each inpatient hospital 
discharge in Federal fiscal years 1985 through 2004 involving inpatient 
hospital service of a hospital in the United States, subject to the PPS, 
and determines a regional adjusted PPS rate for operating costs for such 
discharges in each region for which payment may be made under Medicare 
Part A.
    (2) Each such rate is determined for hospitals located in urban or 
rural areas within the United States and within each such region, 
respectively, as described under paragraphs (b) through (u) of this 
section.
    (b) Geographic classifications. Effective for fiscal years 1985 
through 2004, the following rules apply.
    (1) For purposes of this section, the definitions set forth in Sec.  
412.62(f) apply, except that, effective January 1, 2000, a hospital 
reclassified as rural may mean a reclassification that results from a 
geographic redesignation as set forth

[[Page 621]]

in Sec.  412.62(f)(1)(iv) or a reclassification that results from an 
urban hospital applying for reclassification as rural as set forth in 
Sec.  412.103.
    (2) For hospitals within an MSA or NECMA that crosses census 
division boundaries, the following provisions apply:
    (i) The MSA or NECMA is deemed to belong to the census division in 
which most of the hospitals within the MSA or NECMA are located.
    (ii) A hospital that met the conditions specified in Sec.  
412.62(f)(2)(ii) and therefore did not receive a lower Federal rate that 
would have applied for cost reporting periods beginning before October 
1, 1984, receives the lower Federal rate applicable to all hospitals in 
the MSA or NECMA in which it is located effective with the hospital's 
cost reporting period that begins on or after October 1, 1984.
    (iii) The higher Federal rate is payable to all hospitals in the MSA 
or NECMA if an equal number of hospitals within the MSA or NECMA are 
located in each census division.
    (3) For discharges occurring on or after October 1, 1988, a hospital 
located in a rural county adjacent to one or more urban areas is deemed 
to be located in an urban area and receives the Federal payment amount 
for the urban area to which the greater number of workers in the county 
commute if the rural county would otherwise be considered part of an 
urban area, under the standards for designating MSAs or NECMAs if the 
commuting rates used in determining outlying counties were determined on 
the basis of the aggregate number of resident workers who commute to 
(and, if applicable under the standards, from) the central county or 
central counties of all adjacent MSAs or NECMAs. These EOMB standards 
are set forth in the notice of final standards for classification of 
MSAs published in the Federal Register on January 3, 1980 (45 FR 956), 
and available from CMS, East High Rise Building, room 132, 6325 Security 
Boulevard, Baltimore, Maryland 21207.
    (4) For purposes of this section, any change in an MSA or NECMA 
designation is recognized on the October 1 following the effective date 
of the change.
    (5) For discharges occurring on or after October 1, 1988, for 
hospitals that consist of two or more separately located inpatient 
hospital facilities the national adjusted prospective payment rate is 
based on the geographic location of the hospital facility at which the 
discharge occurs.
    (c) Updating previous standardized amounts. (1) For discharges 
occurring in fiscal year 1985 through fiscal year 2003, CMS computes 
average standardized amounts for hospitals in urban areas and rural 
areas within the United States, and in urban areas and rural areas 
within each region. For discharges occurring in fiscal year 2004, CMS 
computes an average standardized amount for hospitals located in all 
areas.
    (2) Each of those amounts is equal to the respective adjusted 
average standardized amount computed for fiscal year 1984 under Sec.  
412.62(g)--
    (i) Increased for fiscal year 1985 by the applicable percentage 
increase in the hospital market basket;
    (ii) Adjusted by the estimated amount of Medicare payment for 
nonphysician services furnished to hospital inpatients that would have 
been paid under Part B were it not for the fact that such services must 
be furnished either directly by hospitals or under arrangements;
    (iii) Reduced by a proportion equal to the proportion (estimated by 
CMS) of the total amount of prospective payments that are additional 
payment amounts attributable to outlier cases under subpart F of this 
part; and
    (iv) Adjusted for budget neutrality under paragraph (h) of this 
section.
    (3) For fiscal year 1986 and thereafter. CMS computes, for urban and 
rural hospitals in the United States and for urban and rural hospitals 
in each region, average standardized amount equal to the respective 
adjusted average standardized amounts computed for the previous fiscal 
year--
    (i) Increased by the applicable percentage increase determined under 
paragraphs (d) through (g) of this section;
    (ii) Adjusted by the estimated amount of Medicare payment for 
nonphysician services furnished to hospital inpatients that would have 
been paid

[[Page 622]]

under Part B were it not for the fact that such services must be 
furnished either directly by hospitals or under arrangements; and
    (iii) For discharges occurring on or after October 1, 1985 and 
before October 1, 1986, reduced by a proportion (estimated by CMS) of 
the amount of payments based on the total amount of prospective payments 
that are additional payment amounts attributable to outlier cases under 
subpart F of this part, and for discharges occurring on or after October 
1, 1986, reduced by a proportion (estimated by CMS) of the amount of 
payments that, based on the total amount of prospective payments for 
urban hospitals and the total amount of prospective payments for rural 
hospitals, are additional payments attributable to outlier cases in such 
hospitals under subpart F of this part.
    (4) For fiscal years 1987 through 1990 CMS standardizes the average 
standardized amounts by excluding an estimate of the payments for 
hospitals that serve a disproportionate share of low-income patients.
    (5) For fiscal years 1987 through 2004, CMS standardizes the average 
standardized amounts by excluding an estimate of indirect medical 
education payments.
    (6) For fiscal years 1988 through 2003, CMS computes average 
standardized amounts for hospitals located in large urban areas, other 
urban areas, and rural areas. The term large urban area means an MSA 
with a population of more than 1,000,000 or an NECMA, with a population 
of more than 970,000 based on the most recent available population data 
published by the Census Bureau. For fiscal year 2004, CMS computes an 
average standardized amount for hospitals located in all areas.
    (d) Applicable percentage change for fiscal year 1986. (1) The 
applicable percentage change for fiscal year 1986 is--
    (i) For discharges occurring on or after October 1, 1985 and before 
May 1. 1986, zero percent; and
    (ii) For discharges occurring on or after May 1, 1986, one-half of 
one percent.
    (2) For purposes of determining the standardized amounts for 
discharges occurring on or after October 1, 1986, the applicable 
percentage increase for fiscal year 1986 is deemed to have been one-half 
of one percent.
    (e) Applicable percentage change for fiscal year 1987. The 
applicable percentage change for fiscal year 1987 is 1.15 percent.
    (f) Applicable percentage change for fiscal year 1988. (1) The 
applicable percentage change for fiscal year 1988 is--
    (i) For discharges occurring on or after October 1, 1987 and before 
November 21, 1987, zero percent;
    (ii) For discharges occurring on or after November 21, 1987 and 
before April 1, 1988, 2.7 percent; and
    (iii) For discharges occurring on or after April 1, 1988 and before 
October 1, 1988--
    (A) 3.0 percent for hospitals located in rural areas;
    (B) 1.5 percent for hospitals located in large urban areas; and
    (C) 1.0 percent for hospitals located in other urban areas.
    (2) For purposes of determining the standardized amounts for 
discharges occurring on or after October 1, 1988 (for Federal fiscal 
year 1989), the applicable percentage change for fiscal year 1988 is 
deemed to have been--
    (i) 3.0 percent for hospitals located in rural areas;
    (ii) 1.5 percent for hospitals located in large urban areas; and
    (iii) 1.0 percent for hospitals located in other urban areas.
    (g) Applicable percentage change for fiscal year 1989. The 
applicable percentage change for fiscal year 1989 is the percentage 
increase in the market basket index (as defined in Sec.  413.40(a)(3) of 
this chapter)--
    (1) Minus 1.5 percentage points for hospitals located in rural 
areas;
    (2) Minus 2.0 percentage points for hospitals in large urban areas; 
and
    (3) Minus 2.5 percentage points for hospitals in other urban areas.
    (h) Applicable percentage change for fiscal year 1990. (1) The 
applicable percentage change for fiscal year 1990 is--
    (i) For discharges occurring on or after October 1, 1989 and before 
January 1, 1990, 5.5 percent; and
    (ii) For discharges occurring on or after January 1, 1990 and before 
October 1, 1990--

[[Page 623]]

    (A) 9.72 percent for hospitals located in rural areas;
    (B) 5.62 percent for hospitals located in large urban areas; and
    (C) 4.97 percent for hospitals located in other urban areas.
    (2) For purposes of determining the standardized amounts for 
discharges occurring on or after October 1, 1990, the applicable 
percentage change for fiscal year 1990 is deemed to have been the 
percentage change provided for in paragraph (h)(1)(ii) of this section.
    (i) Applicable percentage change for fiscal year 1991. (1) The 
applicable percentage change for fiscal year 1991 is--
    (i) For discharges occurring on or after October 1, 1990 and before 
October 21, 1990, 5.2 percent;
    (ii) For discharges occurring on or after October 21, 1990 and 
before January 1, 1991, 0.0 percent; and
    (iii) For discharges occurring on or after January 1, 1991 and 
before October 1, 1991--
    (A) 4.5 percent for hospitals located in rural areas; and
    (B) 3.2 percent for hospitals located in large urban areas and other 
urban areas.
    (2) For purposes of determining the standardized amounts for 
discharges occurring on or after October 1, 1991, the applicable 
percentage change for fiscal year 1991 is deemed to have been the 
percentage change provided for in paragraph (i)(1)(iii) of this section.
    (j) Applicable percentage change for fiscal year 1992. The 
applicable percentage change for fiscal year 1992 is the percentage 
increase in the market basket index for prospective payment hospitals 
(as defined in Sec.  413.40(a)(3) of this chapter)--
    (1) Minus 0.6 percentage points for hospitals located in rural 
areas.
    (2) Minus 1.6 percentage points for hospitals located in large urban 
areas and other urban areas.
    (k) Applicable percentage change for fiscal year 1993. The 
applicable percentage change for fiscal year 1993 is the percentage 
increase in the market basket index for prospective payment hospitals 
(as defined in Sec.  413.40(a)(3) of this chapter)--
    (1) Minus 0.55 percentage points for hospitals located in rural 
areas.
    (2) Minus 1.55 percentage points for hospitals located in large 
urban areas and other urban areas.
    (l) Applicable percentage change for fiscal year 1994. The 
applicable percentage change for fiscal year 1994 is the percentage 
increase in the market basket index for prospective payment hospitals 
(as defined in Sec.  413.40(a) of this chapter)--
    (1) Minus 1.0 percentage point for hospitals located in rural areas.
    (2) Minus 2.5 percentage points for hospitals located in large urban 
areas and other urban areas.
    (m) Applicable percentage change for fiscal year 1995. The 
applicable percentage change for fiscal year 1995 is the percentage 
increase in the market basket index for prospective payment hospitals 
(as defined in Sec.  413.40(a) of this chapter)--
    (1) Plus, for hospitals located in rural areas, the percentage 
increase necessary so that the average standardized amounts computed 
under paragraph (c) through (i) of this section are equal to the average 
standardized amounts for hospitals located in an urban area other than a 
large urban area.
    (2) Minus 2.5 percentage points for hospitals located in large urban 
areas and other urban areas.
    (n) Applicable percentage change for fiscal year 1996. The 
applicable percentage change for fiscal year 1996 is the percentage 
increase in the market basket index for prospective payment hospitals 
(as defined in Sec.  413.40(a) of this chapter) minus 2.0 percentage 
points for all areas.
    (o) Applicable percentage change for fiscal year 1997. The 
applicable percentage change for fiscal year 1997 is the percentage 
increase in the market basket index for prospective payment hospitals 
(as defined in Sec.  413.40(a) of this chapter) minus 0.5 percentage 
point for all areas.
    (p) Applicable percentage change for fiscal year 1998. The 
applicable percentage change for fiscal year 1998 is 0 percent for 
hospitals in all areas.
    (q) Applicable percentage change for fiscal year 1999. The 
applicable percentage change for fiscal year 1999 is the percentage 
increase in the market basket index for prospective payment hospitals 
(as defined in Sec.  413.40(a) of this

[[Page 624]]

subchapter) minus 1.9 percentage points for hospitals in all areas.
    (r) Applicable percentage change for fiscal year 2000. The 
applicable percentage change for fiscal year 2000 is the percentage 
increase in the market basket index for prospective payment hospitals 
(as defined in Sec.  413.40(a) of this chapter) minus 1.8 percentage 
points for hospitals in all areas.
    (s) Applicable percentage change for fiscal year 2001. The 
applicable percentage change for discharges occurring in fiscal year 
2001 is the percentage increase in the market basket index for 
prospective payment hospitals (as defined in Sec.  413.40(a) of this 
subchapter) for hospitals in all areas as follows:
    (1) For discharges occurring on October 1, 2000 or before April 1, 
2001 the percentage increase in the market basket index for prospective 
payment hospitals (as defined in Sec.  41340(a) of this subchapter) for 
sole community hospitals and the increase in the market basket index 
minus 1.1 percentage points for other hospitals in all areas; and
    (2) For discharges occurring on April 1, 2001 or before October 1, 
2001 the percentage increase in the market basket index for prospective 
payment hospitals (as defined in Sec.  413.40(a) of this subchapter) for 
sole community hospitals and the increase in the market basket index 
plus 1.1 percentage points for other hospitals in all areas.
    (t) Applicable percentage change for fiscal years 2002 and 2003. The 
applicable percentage change for fiscal years 2002 and 2003 is the 
percentage increase in the market basket index for prospective payment 
hospitals (as defined in Sec.  413.40(a) of this subchapter) minus 0.55 
percentage points for hospitals in all areas.
    (u) Applicable percentage change for fiscal year 2004. The 
applicable percentage change for fiscal year 2004 is the percentage 
increase in the market basket index for prospective payment hospitals 
(as defined in Sec.  413.40(a) of this subchapter) for hospitals in all 
areas.
    (v) Maintaining budget neutrality for fiscal year 1985. (1) For 
fiscal year 1985, CMS will adjust each of the reduced standardized 
amounts determined under paragraph (c) of this section as required for 
fiscal year 1985 to ensure that the estimated amount of aggregate 
payments made, excluding the hospital-specific portion (that is, the 
total of the Federal portion of transition payments, plus any 
adjustments and special treatment of certain classes of hospitals for 
fiscal year 1985) is not greater or less than 50 percent of the payment 
amounts that would have been payable for the inpatient operating costs 
for those same hospitals for fiscal year 1985 under the law as in effect 
on April 19, 1983.
    (2) The aggregate payments considered under this paragraph exclude 
payments for per case review by a utilization and quality control 
quality improvement organization, as allowed under section 1866(a)(1)(F) 
of the Act.
    (w) Computing Federal rates for inpatient operating costs for 
hospitals located in large urban and other areas. For each discharge 
classified within a DRG, CMS establishes for the fiscal year a national 
prospective payment rate and a regional prospective payment rate for 
inpatient operating costs, for each region, as follows:
    (1) For hospitals located in a large urban area in the United States 
or that region respectively, the rate equals the product of--
    (i) The adjusted average standardized amount (computed under 
paragraph (c) of this section) for the fiscal year for hospitals located 
in a large urban area in the United States or in that region; and
    (ii) The weighting factor determined under Sec.  412.60(b) for that 
DRG.
    (2) For hospitals located in an other area in the United States or 
that region respectively, the rate equals the product of--
    (i) The adjusted average standardized amount (computed under 
paragraph (c) of this section) for the fiscal year for hospitals located 
in an other area in the United States or that region; and
    (ii) The weighting factor (determined under Sec.  412.60(b)) for 
that DRG.
    (x) Adjusting for different area wage levels. (1) CMS adjusts the 
proportion (as estimated by CMS from time to time) of Federal rates for 
inpatient operating costs computed under paragraph (j) of this section 
that are attributable to wages and labor-related costs for area 
differences in hospital wage

[[Page 625]]

levels by a factor (established by CMS based on survey data) reflecting 
the relative level of hospital wages and wage-related costs in the 
geographic area (that is, urban or rural area as determined under the 
provisions of paragraph (b) of this section) of the hospital compared to 
the national average level of hospital wages and wage-related costs. The 
wage index is updated annually.
    (2)(i) CMS makes a midyear correction to the wage index for an area 
only if a hospital can show that--
    (A) The intermediary or CMS made an error in tabulating its data; 
and
    (B) The hospital could not have known about the error, or did not 
have the opportunity to correct the error, before the beginning of the 
Federal fiscal year.
    (ii) A midyear correction to the wage index is effective 
prospectively from the date the change is made to the wage index.
    (3) If a judicial decision reverses a CMS denial of a hospital's 
wage data revision request, CMS pays the hospital by applying a revised 
wage index that reflects the revised wage data as if CMS's decision had 
been favorable rather than unfavorable.

[50 FR 12741, Mar. 29, 1985]

    Editorial Note: For Federal Register citations affecting Sec.  
412.63, see the List of CFR Sections Affected, which appears in the 
finding Aids section of the printed volume and at www.govinfo.gov.



Sec.  412.64  Federal rates for inpatient operating costs for Federal 
fiscal year 2005 and subsequent fiscal years.

    (a) General rule. CMS determines a national adjusted prospective 
payment rate for inpatient operating costs for each inpatient hospital 
discharge in Federal fiscal year 2005 and subsequent fiscal years 
involving inpatient hospital services of a hospital in the United States 
subject to the prospective payment system for which payment may be made 
under Medicare Part A.
    (b) Geographic classifications. (1) For purposes of this section, 
the following definitions apply:
    (i) The term region means one of the 9 metropolitan divisions 
comprising the 50 States and the District of Columbia, established by 
the Executive Office of Management and Budget for statistical and 
reporting purposes.
    (ii) The term urban area means--
    (A) A Metropolitan Statistical Area or a Metropolitan division (in 
the case where a Metropolitan Statistical Area is divided into 
Metropolitan Divisions), as defined by the Executive Office of 
Management and Budget; or
    (B) For discharges occurring on or after October 1, 1983, and before 
October 1, 2007, the following New England counties are deemed to be 
parts of urban areas under section 601(g) of the Social Security 
Amendments of 1983 (Pub. L. 98-21, 42 U.S.C. 1395ww (note); Litchfield 
County, Connecticut; York County, Maine; Sagadahoc County, Maine; 
Merrimack County, New Hampshire; and Newport County, Rhode Island.
    (C) The term rural area means any area outside an urban area.
    (2) For hospitals within an MSA that crosses census division 
boundaries, the MSA is deemed to belong to the census division in which 
most of the hospitals within the MSA are located.
    (3)(i) For discharges occurring on or after October 1, 2004, a 
hospital that is located in a rural county adjacent to one or more urban 
areas is deemed to be located in an urban area and receives the Federal 
payment amount for the urban area to which the greater number of workers 
in the county commute if the rural county would otherwise be considered 
part of an urban area, under the standards for designating MSAs if the 
commuting rates used in determining outlying counties were determined on 
the basis of the aggregate number of resident workers who commute to 
(and, if applicable under the standards, from) the central county or 
central counties of all adjacent MSAs. Qualifying counties are 
determined based upon OMB standards, using the most recent OMB standards 
for delineating statistical areas adopted by CMS.
    (ii) For discharges occurring on or after October 1, 2007, hospitals 
in the following New England counties, if not already located in an 
urban area, are deemed to be located in urban areas under section 601(g) 
of the Social Security Amendments of 1983 (Pub. L. 98-21,

[[Page 626]]

42 U.S.C. 1395ww (note): Litchfield County, Connecticut; York County, 
Maine; Sagadahoc County, Maine; Merrimack County, New Hampshire; and 
Newport County, Rhode Island.
    (4) For purposes of this section, any change in an MSA designation 
is recognized on October 1 following the effective date of the change. 
Such a change in MSA designation may occur as a result of redesignation 
of an MSA by the Executive Office of Management and Budget.
    (5) For hospitals that consist of two or more separately located 
inpatient hospital facilities, the national adjusted prospective payment 
rate is based on the geographic location of the hospital facility at 
which the discharge occurred.
    (c) Computing the standardized amount. CMS computes an average 
standardized amount that is applicable to all hospitals located in all 
areas, updated by the applicable percentage increase specified in 
paragraph (d) of this section. CMS standardizes the average standardized 
amount by excluding an estimate of indirect medical education payments.
    (d) Applicable percentage change for fiscal year 2005 and for 
subsequent fiscal years. (1) The applicable percentage change for 
updating the standardized amount for all hospitals in all areas is--
    (i) For fiscal year 2005 through fiscal year 2009, the percentage 
increase in the market basket index (as defined in Sec.  413.40(a)(3) of 
this chapter) for prospective payment hospitals, subject to the 
provisions of paragraph (d)(2) of this section.
    (ii) For fiscal year 2010, for discharges--
    (A) On or after October 1, 2009 and before April 1, 2010, the 
percentage increase in the market basket index (as defined in Sec.  
413.40(a)(3) of this chapter) for prospective payment hospitals, subject 
to the provisions of paragraph (d)(2) of this section; and
    (B) On or after April 1, 2010 and before October 1, 2010, the 
percentage increase in the market basket index (as defined in Sec.  
413.40(a)(3) of this chapter) for prospective payment hospitals, subject 
to the provisions of paragraph (d)(2) of this section, less 0.25 
percentage point.
    (iii) For fiscal year 2011, the percentage increase in the market 
basket index (as defined in Sec.  413.40(a)(3) of this subchapter) for 
prospective payment hospitals, subject to the provisions of paragraph 
(d)(2) of this section, less 0.25 percentage point.
    (iv) For fiscal years 2012 and 2013, the percentage increase in the 
market basket index (as defined in Sec.  413.40(a)(3) of this chapter) 
for prospective payment hospitals, subject to the provisions of 
paragraph (d)(2) of this section, less a multifactor productivity 
adjustment (as determined by CMS) and less 0.1 percentage point.
    (v) For fiscal year 2014, the percentage increase in the market 
basket index (as defined in Sec.  413.40(a)(3) of this chapter) for 
prospective payment hospitals, subject to the provisions of paragraph 
(d)(2) of this section, less a multifactor productivity adjustment (as 
determined by CMS) and less 0.3 percentage point.
    (vi) For fiscal years 2015 and 2016, the percentage increase in the 
market basket index (as defined in Sec.  413.40(a)(3) of this chapter) 
for prospective payment hospitals, subject to the provisions of 
paragraphs (d)(2) and (3) of this section, less a multifactor 
productivity adjustment (as determined by CMS) and less 0.2 percentage 
point.
    (vii) For fiscal years 2017, 2018, and 2019, the percentage increase 
in the market basket index (as defined in Sec.  413.40(a)(3) of this 
chapter) for prospective payment hospitals, subject to the provisions of 
paragraphs (d)(2) and (3) of this section, less a multifactor 
productivity adjustment (as determined by CMS) and less 0.75 percentage 
point.
    (viii) For fiscal year 2020 and subsequent fiscal years, the 
percentage increase in the market basket index (as defined in Sec.  
413.40(a)(3) of this chapter) for prospective payment hospitals, subject 
to the provisions of paragraphs (d)(2) and (3) of this section, less a 
multifactor productivity adjustment (as determined by CMS).
    (2)(i) In the case of a ``subsection (d) hospital,'' as defined 
under section 1886(d)(1)(B) of the Act, that does not submit quality 
data on a quarterly

[[Page 627]]

basis to CMS, in the form and manner specified by CMS, the percentage 
increase in the market basket index (as defined in Sec.  413.40(a)(3) of 
this chapter) for prospective payment hospitals is reduced--
    (A) For fiscal years 2005 and 2006, by 0.4 percentage points; and
    (B) For fiscal year 2007 through 2014, by 2 percentage points.
    (C) For fiscal year 2015 and subsequent fiscal years, by one-fourth.
    (ii) Any reduction pursuant to this paragraph (d)(2) will apply only 
to the fiscal year involved and will not be taken into account in 
computing the applicable percentage change for a subsequent fiscal year.
    (3)(i) Beginning fiscal year 2015, in the case of a ``subsection (d) 
hospital,'' as defined under section 1886(d)(1)(B) of the Act, that is 
not a meaningful electronic health record (EHR) user as defined in part 
495 of this chapter for the applicable EHR reporting period and does not 
receive an exception, three-fourths of the percentage increase in the 
market basket index (as defined in Sec.  413.40(a)(3) of this chapter) 
for prospective payment hospitals is reduced--
    (A) For fiscal year 2015, by 33\1/3\ percent;
    (B) For fiscal year 2016, by 66\2/3\ percent; and
    (C) For fiscal year 2017 and subsequent fiscal years, by 100 
percent.
    (ii) Beginning fiscal year 2022, in the case of a ``subsection (d) 
Puerto Rico hospital,'' as defined under section 1886(d)(9)(A) of the 
Act, that is not a meaningful EHR user as defined in part 495 of this 
chapter for the applicable EHR reporting period and does not receive an 
exception, three-fourths of the percentage increase in the market basket 
index (as defined in Sec.  413.40(a)(3) of this chapter) for prospective 
payment hospitals is reduced--
    (A) For fiscal year 2022, by 33\1/3\ percent;
    (B) For fiscal year 2023, by 66\2/3\ percent; and
    (C) For fiscal year 2024 and subsequent fiscal years, by 100 
percent.
    (4) Exception--(i) General rules. The Secretary may, on a case-by-
case basis, exempt an eligible hospital that is not a qualifying 
eligible hospital from the application of the reduction under paragraph 
(d)(3) of this section if the Secretary determines that compliance with 
the requirement for being a meaningful EHR user would result in a 
significant hardship for the eligible hospital.
    (ii) To be considered for an exception, a hospital must submit an 
application, in the manner specified by CMS, demonstrating that it meets 
one or more than one of the criteria specified in this paragraph (d)(4) 
of this section. These types of exceptions are subject to annual 
renewal, but in no case may a hospital be granted this type of exception 
for more than 5 years. (See Sec.  495.4 for definitions of payment 
adjustment year, EHR reporting period, and meaningful EHR user.)
    (A) During any 90-day period from the beginning of the fiscal year 
that is 2 years before the payment adjustment year to July 1 of the year 
before the payment adjustment year, or a later date specified by CMS, 
the hospital was located in an area without sufficient Internet access 
to comply with the meaningful use objectives requiring internet 
connectivity, and faced insurmountable barriers to obtaining such 
internet connectivity. Applications requesting this exception must be 
submitted by July 1 of the year before the applicable payment adjustment 
year, or a later date specified by CMS.
    (B)(1) During the fiscal year that is 2 fiscal years before the 
payment adjustment year, the hospital that has previously demonstrated 
meaningful use faces extreme and uncontrollable circumstances that 
prevent it from becoming a meaningful EHR user. Applications requesting 
this exception must be submitted by July 1 of the year before the 
applicable payment adjustment year, or a later date specified by CMS.
    (2) During the fiscal year preceding the payment adjustment year, 
the hospital that has not previously demonstrated meaningful use faces 
extreme and uncontrollable circumstances that prevent it from becoming a 
meaningful EHR user. Applications requesting this exception must

[[Page 628]]

be submitted by July 1 of the year before the applicable payment 
adjustment year, or a later date specified by CMS.
    (C) The hospital is new in the payment adjustment year, and has not 
previously operated (under previous or present ownership). This 
exception expires beginning with the first Federal fiscal year that 
begins on or after the hospital has had at least one 12-month (or 
longer) cost reporting period after they accept their first Medicare 
covered patient. For purposes of this exception, the following hospitals 
are not considered new hospitals:
    (1) A hospital that builds new or replacement facilities at the same 
or another location even if coincidental with a change of ownership, a 
change in management, or a lease arrangement.
    (2) A hospital that closes and subsequently reopens.
    (3) A hospital that changes its status from a CAH to a hospital that 
is subject to the Medicare hospital inpatient prospective payment 
systems.
    (iii) Exception for decertified EHR technology. Beginning with the 
fiscal year 2019 payment adjustment year, the Secretary shall exempt an 
eligible hospital that is not a qualifying eligible hospital from the 
application of the reduction under paragraph (d)(3) of this section if 
the Secretary determines that compliance with the requirement for being 
a meaningful EHR user is not possible because the certified EHR 
technology used by the eligible hospital has been decertified under 
ONC's Health IT Certification Program. To be considered for an 
exception, an eligible hospital must submit an application, in the 
manner specified by CMS, demonstrating that the certified EHR technology 
was decertified during the 12-month period preceding the applicable EHR 
reporting period for the payment adjustment year, or during the 
applicable EHR reporting period for the payment adjustment year, and 
that the eligible hospital made a good faith effort to obtain another 
certified EHR technology for that EHR reporting period. (See Sec.  495.4 
of this chapter for definitions of payment adjustment year, EHR 
reporting period, and meaningful EHR user.) Applications requesting this 
exception must be submitted by July 1 of the year before the applicable 
payment adjustment year, or a later date specified by CMS. This 
exception is subject to annual renewal, but in no case may an eligible 
hospital be granted an exception under paragraph (d)(4) of this section 
for more than 5 years.
    (5) A State in which hospitals are paid for services under section 
1814(b)(3) of the Act must--
    (i) Adjust the payments to each eligible hospital in the State that 
is not a meaningful EHR user in a manner that is designed to result in 
an aggregate reduction in payments to hospitals in the State that is 
equivalent to the aggregate reduction that would have occurred if 
payments had been reduced to each eligible hospital in the State in a 
manner comparable to the reduction under paragraph (d)(3) of this 
section; and
    (ii) Provide to the Secretary, by January 1, 2013, a report on the 
method that it proposes to employ in order to make the requisite payment 
adjustment described in paragraph (d)(5)(i) of this section.
    (e) Maintaining budget neutrality. (1) CMS makes an adjustment to 
the standardized amount to ensure that--
    (i) Changes to the DRG classifications and recalibrations of the DRG 
relative weights are made in a manner so that aggregate payments to 
hospitals are not affected; and
    (ii) Except as provided in paragraphs (e)(4) and (h)(4)(vii) of this 
section, the annual updates and adjustments to the wage index under 
paragraph (h) of this section are made in a manner that ensures that 
aggregate payments are not affected; and
    (2) CMS also makes an adjustment to the rates to ensure that 
aggregate payments after implementation of reclassifications under 
subpart L of this part are equal to the aggregate prospective payments 
that would have been made in the absence of these provisions.
    (3) To the extent CMS determines that changes to the DRG 
classification and recalibrations of the DRG relative weights for a 
previous year (or estimates that such adjustments for a future fiscal 
year) did (or are likely to) result in a change in aggregate payments 
under this subsection during the

[[Page 629]]

fiscal year that are a result of changes in coding or classification of 
discharges that do not reflect real changes in case mix, CMS may adjust 
the standardized amount for subsequent fiscal years so as to eliminate 
the effect of such coding and classification changes.
    (4) CMS makes an adjustment to the wage index to ensure that 
aggregate payments after implementation of the rural floor under section 
4410 of the Balanced Budget Act of 1997 (Pub. L. 105-33) and, for 
discharges on or after October 1, 2004, and before October 1, 2018, the 
imputed floor under paragraph (h)(4) of this section are equal to the 
aggregate prospective payments that would have been made in the absence 
of such provisions as follows:
    (i) Beginning October 1, 2008, such adjustment is transitioned from 
a nationwide to a statewide adjustment as follows:
    (A) From October 1, 2008 through September 30, 2009, the wage index 
is a blend of 20 percent of a wage index with a statewide adjustment and 
80 percent of a wage index with a nationwide adjustment.
    (B) From October 1, 2009 through September 30, 2010, the wage index 
is a blend of 50 percent of a wage index with a statewide adjustment and 
50 percent of a wage index with a nationwide adjustment.
    (ii) Beginning October 1, 2010, such adjustment is a full nationwide 
adjustment.
    (5) CMS makes an adjustment to the standardized amount to ensure 
that the reasonable cost based payments for allogeneic hematopoietic 
stem cell acquisition costs are made in a manner so that aggregate 
payments to hospitals are not affected.
    (f) Adjustment for outlier payments. CMS reduces the adjusted 
average standardized amount determined under paragraph (c) through (e) 
of this section by a proportion equal to the proportion (estimated by 
CMS) to the total amount of payments based on DRG prospective payment 
rates that are additional payments for outlier cases under subpart F of 
this part.
    (g) Computing Federal rates for inpatient operating costs for 
hospitals located in all areas. For each discharge classified within a 
DRG, CMS establishes for the fiscal year a national prospective payment 
rate for inpatient operating costs based on the standardized amount for 
the fiscal year and the weighting factor determined under Sec.  
412.60(b) for that DRG.
    (h) Adjusting for different area wage levels. CMS adjusts the 
proportion of the Federal rate for inpatient operating costs that are 
attributable to wages and labor-related costs for area differences in 
hospital wage levels by a factor (established by CMS based on survey 
data) reflecting the relative level of hospital wages and wage-related 
costs in the geographic area (that is, urban or rural area as determined 
under the provisions of paragraph (b) of this section) of the hospital 
compared to the national average level of hospital wages and wage-
related costs. The adjustment described in this paragraph (h) also takes 
into account the earnings and paid hours of employment by occupational 
category.
    (1) The wage index is updated annually.
    (2) CMS determines the proportion of the Federal rate that is 
attributable to wages and labor-related costs from time to time, 
employing a methodology that is described in the annual regulation 
updating the system of payment for inpatient hospital operating costs.
    (3) For discharges occurring on or after October 1, 2004, CMS 
employs 62 percent as the proportion of the rate that is adjusted for 
the relative level of hospital wages and wage-related costs, unless 
employing that percentage would result in lower payments for the 
hospital than employing the proportion determined under the methodology 
described in paragraph (h)(2) of this section.
    (4) For discharges on or after October 1, 2004 and before October 1, 
2018, and for discharges on or after October 1, 2021, CMS establishes a 
minimum wage index for each all-urban State, as defined in paragraph 
(h)(5) of this section. This minimum wage index value is computed using 
the following methodology:
    (i) CMS computes the ratio of the lowest-to-highest wage index for 
each all-urban State;

[[Page 630]]

    (ii) CMS computes the average of the ratios of the lowest-to-highest 
wage indexes of all the all-urban States;
    (iii) For each all-urban State, CMS determines the higher of the 
State's own lowest-to-highest rate (as determined under paragraph 
(h)(4)(i) of this section) or the average lowest-to-highest rate (as 
determined under paragraph (h)(4)(ii) of this section);
    (iv) For each State, CMS multiplies the rate determined under 
paragraph (h)(4)(iii) of this section by the highest wage index value in 
the State;
    (v) The product determined under paragraph (h)(4)(iv) of this 
section is the minimum wage index value for the State, except as 
provided under paragraph (h)(4)(vi) of this section;
    (vi) For discharges on or after October 1, 2012 and before October 
1, 2018, and for discharges on or after October 1, 2021, the minimum 
wage index value for the State is the higher of the value determined 
under paragraph (h)(4)(iv) of this section or the value computed using 
the following alternative methodology:
    (A) CMS estimates a percentage representing the average percentage 
increase in wage index for hospitals receiving the rural floor due to 
such floor.
    (B) For each all-urban State, CMS makes a onetime determination of 
the lowest hospital wage index in the State (including all adjustments 
to the hospital's wage index, except for the rural floor, the rural 
floor budget neutrality, and the outmigration adjustment) and increases 
this wage index by the percentage determined under paragraph 
(h)(4)(vi)(A) of this section, the result of which establishes the 
alternative minimum wage index value for the State.
    (vii) For discharges on or after October 1, 2021, the minimum wage 
index computed under this paragraph must not be applied in a budget 
neutral manner.
    (5)(i) For purposes of paragraph (h)(4) of this section, for 
discharges on or after October 1, 2004 and before October 1, 2018, an 
all-urban State is a State with no rural areas, as defined in this 
section, or a State in which there are no hospitals classified as rural. 
For purposes of this definition, a State with rural areas and with 
hospitals reclassified as rural under Sec.  412.103 is not an all-urban 
State.
    (ii) For purposes of paragraph (h)(4) of this section, for 
discharges on or after October 1, 2021, an all-urban State is a State 
with no rural areas, as defined in this section, or a State in which 
there are no hospitals classified as rural under section 1886 of the 
Act. For purposes of this definition, a hospital is classified as rural 
under section 1886 of the Act if it is assigned the State's rural area 
wage index value.
    (6) If a new rural hospital that is subject to the hospital 
inpatient prospective payment system opens in a State that has an 
imputed rural floor and has rural areas, CMS uses the imputed floor as 
the hospital's wage index until the hospital's first cost report as an 
inpatient prospective payment system provider is contemporaneous with 
the cost reporting period being used to develop a given fiscal year's 
wage index.
    (i) Adjusting the wage index to account for commuting patterns of 
hospital workers--(1) General criteria. For discharges occurring on or 
after October 1, 2004, CMS adjusts the hospital wage index for hospitals 
located in qualifying counties to recognize the commuting patterns of 
hospital employees. A qualifying county is a county that meets all of 
the following criteria:
    (i) Hospital employees in the county commute to work in an MSA (or 
MSAs) with a wage index (or wage indices) higher than the wage index of 
the MSA or rural statewide area in which the county is located.
    (ii) At least 10 percent of the county's hospital employees commute 
to an MSA (or MSAs) with a higher wage index (or wage indices).
    (iii) The 3-year average hourly wage of the hospital(s) in the 
county equals or exceeds the 3-year average hourly wage of all hospitals 
in the MSA or rural statewide area in which the county is located.
    (2) Amount of adjustment. A hospital located in a county that meets 
the criteria under paragraphs (i)(1)(i) through (i)(1)(iii) of this 
section will receive an increase in its wage index that is equal to a 
weighted average of the difference between the postreclassified wage 
index of the MSA (or MSAs) with the

[[Page 631]]

higher wage index (or wage indices) and the postreclassified wage index 
of the MSA or rural statewide area in which the qualifying county is 
located, weighted by the overall percentage of the hospital employees 
residing in the qualifying county who are employed in any MSA with a 
higher wage index.
    (3) Process for determining the adjustment. (i) CMS will use the 
most accurate data available, as determined by CMS, to determine the 
out-migration percentage for each county.
    (ii) CMS will include, in its annual proposed and final notices of 
updates to the hospital inpatient prospective payment system, a listing 
of qualifying counties and the hospitals that are eligible to receive 
the adjustment to their wage indexes for commuting hospital employees, 
and the wage index increase applicable to each qualifying county.
    (iii) Any wage index adjustment made under this paragraph (i) is 
effective for a period of 3 fiscal years, except that hospitals in a 
qualifying county may elect to waive the application of the wage index 
adjustment. A hospital may waive the application of the wage index 
adjustment by notifying CMS in writing within 45 days of the date of 
public display of the annual notice of proposed rulemaking for the 
hospital inpatient prospective payment system at the Office of the 
Federal Register.
    (iv) A hospital in a qualifying county that receives a wage index 
adjustment under this paragraph (i) is not eligible for reclassification 
under subpart L of this part or section 1886(d)(8) of the Act.
    (j) Wage index assignment for rural referral centers for FY 2005. 
(1) CMS makes an exception to the wage index assignment of a rural 
referral center for FY 2005 if the rural referral center meets the 
following conditions:
    (i) The rural referral center was reclassified for FY 2004 by the 
MGCRB to another MSA, but, upon applying to the MGCRB for FY 2005, was 
found to be ineligible for reclassification because its average hourly 
wage was less than 84 percent (but greater than 82 percent) of the 
average hourly wage of the hospitals geographically located in the MSA 
to which the rural referral center applied for reclassification for FY 
2005.
    (ii) The hospital may not qualify for any geographic 
reclassification under subpart L of this part, effective for discharges 
occurring on or after October 1, 2004.
    (2) CMS will assign a rural referral center that meets the 
conditions of paragraph (j)(1) of this section the wage index value of 
the MSA to which it was reclassified by the MGCRB in FY 2004. The wage 
index assignment is applicable for discharges occurring during the 3-
year period beginning October 1, 2004 and ending September 30, 2007.
    (k) Midyear corrections to the wage index. (1) CMS makes a midyear 
correction to the wage index for an area only if a hospital can show 
that--
    (i) The intermediary or CMS made an error in tabulating its data; 
and
    (ii) The hospital could not have known about the error, or did not 
have the opportunity to correct the error, before the beginning of the 
Federal fiscal year.
    (2)(i) Except as provided in paragraph (k)(2)(ii) of this section, a 
midyear correction to the wage index is effective prospectively from the 
date the change is made to the wage index.
    (ii) Effective October 1, 2005, a change to the wage index may be 
made retroactively to the beginning of the Federal fiscal year, if, for 
the fiscal year in question, CMS determines all of the following--
    (A) The fiscal intermediary or CMS made an error in tabulating data 
used for the wage index calculation;
    (B) The hospital knew about the error in its wage data and requested 
the fiscal intermediary and CMS to correct the error both within the 
established schedule for requesting corrections to the wage data (which 
is at least before the beginning of the fiscal year for the applicable 
update to the hospital inpatient prospective payment system) and using 
the established process; and
    (C) CMS agreed before October 1 that the fiscal intermediary or CMS 
made an error in tabulating the hospital's wage data and the wage index 
should be corrected.

[[Page 632]]

    (l) Judicial decision. If a judicial decision reverses a CMS denial 
of a hospital's wage data revision request, CMS pays the hospital by 
applying a revised wage index that reflects the revised wage data as if 
CMS's decision had been favorable rather than unfavorable.
    (m) Adjusting the wage index to account for the Frontier State 
floor--(1) General criteria. For discharges occurring on or after 
October 1, 2010, CMS adjusts the hospital wage index for hospitals 
located in qualifying States to recognize the wage index floor 
established for frontier States. A qualifying frontier State meets both 
of the following criteria:
    (i) At least 50 percent of counties located within the State have a 
reported population density less than 6 persons per square mile.
    (ii) The State does not receive a nonlabor-related share adjustment 
determined by the Secretary to take into account the unique 
circumstances of hospitals located in Alaska and Hawaii.
    (2) Amount of wage index adjustment. A hospital located in a 
qualifying State will receive a wage index value not less than 1.00.
    (3) Process for determining and posting wage index adjustments. (i) 
CMS uses the most recent Population Estimate data published by the U.S. 
Census Bureau to determine county definitions and population density. 
This analysis will be periodically revised, such as for updates to the 
decennial census data.
    (ii) CMS will include a listing of qualifying frontier States and 
denote the hospitals receiving a wage index increase attributable to 
this provision in its annual updates to the hospital inpatient 
prospective payment system published in the Federal Register.

[69 FR 49242, Aug. 11, 2004]

    Editorial Note: For Federal Register citations affecting Sec.  
412.64, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



   Subpart E_Determination of Transition Period Payment Rates for the 
        Prospective Payment System for Inpatient Operating Costs



Sec.  412.70  General description.

    For discharges occurring on or after April 1, 1988, and before 
October 1, 1996, payments to a hospital are based on the greater of the 
national average standardized amount or the sum of 85 percent of the 
national average standardized amount and 15 percent of the average 
standardized amount for the region in which the hospital is located.

[57 FR 39822, Sept. 1, 1992, as amended at 58 FR 46338, Sept. 1, 1993]



Sec.  412.71  Determination of base-year inpatient operating costs.

    (a) Base-year costs. (1) For each hospital, the intermediary will 
estimate the hospital's Medicare Part A allowable inpatient operating 
costs, as described in Sec.  412.2(c), for the 12-month or longer cost 
reporting period ending on or after September 30, 1982 and before 
September 30, 1983.
    (2) If the hospital's last cost reporting period ending before 
September 30, 1983 is for less than 12 months, the base period will be 
the hospital's most recent 12-month or longer cost reporting period 
ending before such short reporting period, with an appropriate 
adjustment for inflation. (The rules applicable to new hospitals are set 
forth in Sec.  412.74.)
    (b) Modifications to base-year costs. Prior to determining the 
hospital-specific rate, the intermediary will adjust the hospital's 
estimated base-year inpatient operating costs, as necessary, to include 
malpractice insurance costs in accordance with Sec.  413.53(a)(1)(i) of 
this chapter, and exclude the following:
    (1) Medical education costs as described in Sec.  413.85 of this 
chapter.
    (2) Capital-related costs as described in Sec.  413.130 of this 
chapter.
    (3) Kidney acquisition costs incurred by hospitals approved as renal 
transplantation centers as described in Sec.  412.100. Kidney 
acquisition costs in the base year will be determined by multiplying the 
hospital's average kidney acquisition cost per kidney times

[[Page 633]]

the number of kidney transplants covered by Medicare Part A during the 
base period.
    (4) Higher costs that were incurred for purposes of increasing base-
year costs.
    (5) One-time nonrecurring higher costs or revenue offsets that have 
the effect of distorting base-year costs as an appropriate basis for 
computing the hospital-specific rate.
    (6) Higher costs that result from changes in hospital accounting 
principles initiated in the base year.
    (7) The costs of qualified nonphysician anesthetists' services, as 
described in Sec.  412.113(c).
    (c) Hospital's request for adjustment of base-year inpatient 
operating costs. (1) Before the date it becomes subject to the 
prospective payment system for inpatient operating costs, a hospital may 
request the intermediary to further adjust its estimated base-period 
costs to take into account the following:
    (i) Services paid for under Medicare Part B during the hospital's 
base year that will be paid for under prospective payments. The base-
year costs may be increased to include estimated payments for certain 
services previously billed as physicians' services before the effective 
date of Sec.  415.102(a) of this chapter, and estimated payments for 
nonphysicians' services that were not furnished either directly or under 
arrangements before October 1, 1983 (the effective date of Sec.  
405.310(m) of this chapter), but may not include the costs of 
anesthetists' services for which a physician employer continues to bill 
under Sec.  405.553(b)(4) of this chapter.
    (ii) The payment of FICA taxes during cost reporting periods subject 
to the prospective payment system, if the hospital had not paid such 
taxes for all its employees during its base period and will be required 
to participate effective January 1, 1984.
    (2) If a hospital requests that its base-period costs be adjusted 
under paragraph (c)(1) of this section, it must timely provide the 
intermediary with sufficient documentation to justify the adjustment, 
and adequate data to compute the adjusted costs. The intermediary 
decides whether to use part or all of the data on the basis of audit, 
survey and other information available.
    (d) Intermediary's determination. The intermediary uses the best 
data available at the time in estimating each hospital's base-year costs 
and the modifications to those costs authorized by paragraphs (b) and 
(c) of this section. The intermediary's estimate of base-year costs and 
modifications thereto is final and may not be changed after the first 
day of the first cost reporting period beginning on or after October 1, 
1983, except as provided in Sec.  412.72.

[50 FR 12741, Mar. 29, 1985, as amended at 51 FR 34793, Sept. 30, 1986; 
52 FR 33057, Sept. 1, 1987; 57 FR 33897, July 31, 1992; 57 FR 39822, 
Sept. 1, 1992; 59 FR 45398, Sept. 1, 1994; 60 FR 63188, Dec. 8, 1995]



Sec.  412.72  Modification of base-year costs.

    (a) Bases for modification of base-year costs. Base-year costs as 
determined under Sec.  412.71(d) may be modified under the following 
circumstances:
    (1) Inadvertent omissions. (i) A hospital that becomes subject to 
the prospective payment system beginning on or after October 1, 1983 and 
before November 16, 1983 has until November 15, 1983 to request its 
intermediary to reestimate its base-period costs to take into account 
inadvertent omissions in its previous submissions to the intermediary 
related to changes made by the prospective payment legislation for 
purposes of estimating the base-period costs.
    (ii) The intermediary may also initiate changes to the estimation--
    (A) For any reason before the date the hospital becomes subject to 
prospective payment; and
    (B) Before November 16, 1983, for corrections to take into account 
inadvertent omissions in the hospital's previous submissions related to 
changes made by the prospective payment legislation for purposes of 
estimating the base-period costs.
    (iii) Such omissions pertain to adjustments to exclude capital-
related costs and the direct medical education costs of approved 
educational activities and to adjustments specified in Sec.  412.71(c).

[[Page 634]]

    (iv) The intermediary must notify the provider of any change to the 
hospital-specific amount as a result of the provider's request within 30 
days of receipt of the additional data.
    (v) Any change to base-period costs made under this paragraph (a)(1) 
will be made effective retroactively, beginning with the first day of 
the affected hospital's fiscal year.
    (2) Correction of mathematical errors of calculations. (i) The 
hospital must report mathematical errors of calculations to the 
intermediary within 90 days of the intermediary's notification to the 
hospital of the hospital's payments rates.
    (ii) The intermediary may also identify such errors and initiate 
their correction during this period.
    (iii) The intermediary will either make an appropriate adjustment or 
notify the hospital that no adjustment is warranted within 30 days of 
receipt of the hospital's report of an error.
    (iv) Corrections of errors of calculation will be effective with the 
first day of the hospital's first cost reporting period subject to the 
prospective payment system.
    (3) Recognition of additional costs. (i) The intermediary may adjust 
base-period costs to take into account additional costs recognized as 
allowable costs for the hospital's base year as the result of any of the 
following:
    (A) A reopening and revision of the hospital's base-year notice of 
amount of program reimbursement under Sec. Sec.  405.1885 through 
405.1889 of this chapter.
    (B) A prehearing order or finding issued during the provider payment 
appeals process by the appropriate reviewing authority under Sec.  
405.1821 or Sec.  405.1853 of this chapter that resolved a matter at 
issue in the hospital's base-year notice of amount of program 
reimbursement.
    (C) An affirmation, modification, or reversal of a Provider 
Reimbursement Review Board decision by the Administrator of CMS under 
Sec.  405.1875 of this chapter that resolved a matter at issue in the 
hospital's base-year notice of amount of program reimbursement.
    (D) An administrative or judicial review decision under Sec.  
405.1831, Sec.  405.1871, or Sec.  405.1877 of this chapter that is 
final and no longer subject to review under applicable law or 
regulations by a higher reviewing authority, and that resolved a matter 
at issue in the hospital's base-year notice of amount of program 
reimbursement.
    (ii) The intermediary will recalculate the hospital's base-year 
costs, incorporating the additional costs recognized as allowable for 
the hospital's base year. Adjustments to base-year costs to take into 
account these additional costs--
    (A) Will be effective with the first day of the hospital's first 
cost reporting period beginning on or after the date of the revision, 
order or finding, or review decision; and
    (B) Will not be used to recalculate the hospital-specific portion as 
determined for fiscal years beginning before the date of the revision, 
order or finding, or review decision.
    (4) Successful appeal. The intermediary may modify base-year costs 
to take into account a successful appeal relating to modifications to 
base-year costs that were made under Sec.  412.71(b). If a hospital 
successfully contests a modification to base-year costs--
    (i) The intermediary will recalculate the hospital's base-year costs 
to reflect the modification determined appropriate as a result of the 
appeal; and
    (ii) Such adjustments will be effective retroactively to the time of 
the intermediary's initial estimation of base-year costs.
    (5) Unlawfully claimed costs. The intermediary may modify base-year 
costs to exclude costs that were unlawfully claimed as determined as a 
result of criminal conviction, imposition of a civil judgment under the 
False Claims Act (31 U.S.C. 3729-3731), or a proceeding for exclusion 
from the Medicare program. In addition to adjusting base-year costs, CMS 
will recover both the excess costs reimbursed for the base period and 
the additional amounts paid due to the inappropriate increase of the 
hospital-specific portion of the hospital's transition payment rates. 
The amount to be recovered will be computed on the basis of the final 
resolution of the amount of the inappropriate base-year costs.

[[Page 635]]

    (b) Right to administrative and judicial review. (1) An 
intermediary's estimation of a hospital's base-year costs, and 
modifications, made for purposes of determining the hospital-specific 
rate, are subject to administrative and judicial review. Review will be 
available to a hospital upon receipt of its notice of amount of program 
reimbursement following the close of its cost reporting period, but only 
with respect to whether the intermediary followed the provisions of 
Sec. Sec.  412.71 and 412.72. (Sections 405.1803 and 405.1807 of this 
chapter set forth the rules for intermediary determinations and notice 
of amount of program reimbursement and the effect of those 
determinations.)
    (2) In any administrative or judicial review of whether the 
intermediary used the best data available at the time, as required by 
Sec.  412.71(d), an intermediary's estimation will be revised on the 
basis of this review only if the estimation was unreasonable and clearly 
erroneous in light of the data available at the time the estimation was 
made.
    (3) Specifically excluded from administrative or judicial review are 
any issues based on data, information, or arguments not presented to the 
intermediary at the time of the estimation.



Sec.  412.73  Determination of the hospital-specific rate based on 
a Federal fiscal year 1982 base period.

    (a) Costs on a per discharge basis. The intermediary will determine 
the hospital's estimated adjusted base-year operating cost per discharge 
by dividing the total adjusted operating costs by the number of 
discharges in the base period.
    (b) Case-mix adjustment. The intermediary will divide the adjusted 
base-year costs by the hospital's 1981 case-mix index. If the hospital's 
case-mix index is statistically unreliable (as determined by CMS), the 
hospital's base-year costs will be divided by the lower of the 
following:
    (1) The hospital's estimated case-mix index.
    (2) The average case-mix index for the appropriate classifications 
of all hospitals subject to cost limits established under Sec.  413.30 
of this chapter for cost reporting periods beginning on or after October 
1, 1982 and before October 1, 1983.
    (c) Updating base-year costs--(1) For Federal fiscal year 1984. The 
case-mix adjusted base-year cost per discharge will be updated by the 
applicable updating factor, that is, the rate-of-increase percentage 
determined under Sec.  413.40(c)(3) of this chapter, as adjusted for 
budget neutrality.
    (2) For Federal fiscal year 1985. The amount determined under 
paragraph (c)(1) of this section will be updated by the applicable 
updating factor, as adjusted for budget neutrality.
    (3) For Federal fiscal year 1986. (i) The amount determined under 
paragraph (c)(2) of this section is updated by--
    (A) Zero percent for the first seven months of the hospital's cost 
reporting period; and
    (B) One-half of one percent for the remaining five months of the 
hospital's cost reporting period.
    (ii) For purposes of determining the updated base-year costs for 
cost reporting periods beginning in Federal fiscal year 1987 (that is, 
on or after October 1, 1986 and before October 1, 1987), the update 
factor for the previous cost reporting period is deemed to have been 
one-half of one percent.
    (4) For Federal fiscal year 1987. The amount determined under 
paragraph (c)(3)(ii) of this section is updated by 1.15 percent.
    (5) For Federal fiscal year 1988. (i) For purposes of determining 
the prospective payment rates for sole community hospitals under Sec.  
412.92(d) for cost reporting periods beginning in Federal fiscal year 
1988 (that is, on or after October 1, 1987 and before October 1, 1988), 
the base-year cost per discharge is updated as follows:
    (A) For the first 51 days of the hospital's cost reporting period, 
by zero percent.
    (B) For the next 132 days of the hospital's cost reporting period, 
by 2.7 percent.
    (C) For the remainder of the hospital's cost reporting period, by--
    (1) 3.0 percent for hospitals located in rural areas;
    (2) 1.5 percent for hospitals located in large urban areas; and

[[Page 636]]

    (3) 1.0 percent for hospitals located in other urban areas.
    (ii) For purposes of determining the updated base-year costs for 
cost reporting periods beginning in Federal fiscal year 1989 (that is, 
beginning on or after October 1, 1988 and before October 1, 1989), the 
update factor for the cost reporting period beginning during federal 
Fiscal year 1988 is deemed to have been--
    (A) 3.0 percent for hospitals located in rural areas;
    (B) 1.5 percent for hospitals located in large urban areas; and
    (C) 1.0 percent for hospitals located in other urban areas.
    (6) For Federal fiscal year 1989. For cost reporting periods 
beginning in Federal fiscal year 1989, the update factor is determined 
using the methodology set forth in Sec.  412.63(g).
    (7) For Federal fiscal year 1990. (i) Except as described in 
paragraph (c)(7)(ii) of this section, for cost reporting periods 
beginning in Federal fiscal year 1990, the base-period cost per 
discharge is updated as follows:
    (A) For cost reporting periods beginning on or after October 1, 1989 
and before January 1, 1990, by 5.5 percent for discharges occurring 
before January 1, 1990 and by the factors set forth in paragraph 
(c)(7)(i)(B) of this section for discharges occurring on or after 
January 1, 1990.
    (B) For cost reporting periods beginning on or after January 1, 1990 
and before October 1, 1990, by--
    (1) 9.72 percent for hospitals located in rural areas;
    (2) 5.62 percent for hospitals located in large urban areas; and
    (3) 4.97 percent for hospitals located in other urban areas.
    (ii) For discharges occurring on or after October 21, 1990 and 
before January 1, 1991, the base-period cost per discharge, updated as 
set forth in paragraph (c)(7)(i) of this section, is reduced by 5.5 
percent.
    (iii) For purposes of determining the updated base-period costs for 
cost reporting periods beginning in Federal fiscal year 1991 (that is, 
beginning on or after October 1, 1990 and before October 1, 1991), the 
update factor for the cost reporting period beginning during Federal 
fiscal year 1990 is deemed to have been the percentage change provided 
for in paragraph (c)(7)(i)(B) of this section.
    (8) For Federal fiscal year 1991. (i) Except as described in 
paragraph (c)(8)(ii) of this section, for cost reporting periods 
beginning in Federal fiscal year 1991, the base-period cost per 
discharge is updated by 5.2 percent.
    (ii) For discharges occurring on or after October 21, 1990 and 
before January 1, 1991, the base-period cost per discharge is updated by 
0.0 percent.
    (iii) For purposes of determining the updated base period costs for 
cost reporting periods beginning in Federal fiscal year 1992, the update 
factor for the cost reporting period beginning during Federal fiscal 
year 1991 is deemed to have been the percentage change provided for in 
paragraph (c)(8)(i) of this section.
    (9) For Federal fiscal years 1992 and 1993. For Federal fiscal years 
1992 and 1993, the update factor is the percentage increase in the 
market basket index for prospective payment hospitals (as defined in 
Sec.  413.40(a) of this chapter).
    (10) For Federal fiscal year 1994. For Federal fiscal year 1994, the 
update factor is the percentage increase in the market basket index for 
prospective payment hospitals (as defined in Sec.  413.40(a) of the 
chapter) minus 2.3 percentage points. For purposes of determining the 
hospital-specific rate for Federal fiscal year 1994 and subsequent 
years, this update factor is adjusted to take into account the portion 
of the 12-month cost reporting period beginning during Federal fiscal 
year 1993 that occurs in Federal fiscal year 1994.
    (11) For Federal fiscal year 1995. For Federal fiscal year 1995, the 
update factor is the percentage increase in the market basket index for 
prospective payment hospitals (as defined in Sec.  413.40(a) of this 
chapter) minus 2.2 percentage points.
    (12) For Federal fiscal years 1996 through 2000. For Federal fiscal 
years 1996 through 2000, the update factor is the applicable percentage 
change for other prospective payment hospitals in each respective year 
as set forth in Sec. Sec.  412.63(n) through (r).

[[Page 637]]

    (13) For Federal fiscal year 2001. For Federal fiscal year 2001, the 
update factor is the percentage increase in the market basket index for 
prospective payment hospitals (as defined in Sec.  413.40(a) of this 
chapter).
    (14) For Federal fiscal year 2002. For Federal fiscal year 2002, the 
update factor is the percentage increase in the market basket index for 
prospective payment hospitals (as defined in Sec.  413.40(a) of this 
chapter) minus 1.1 percentage points.
    (15) For Federal fiscal year 2003 through Federal fiscal year 2009. 
For Federal fiscal year 2003 through Federal fiscal year 2009, the 
update factor is the percentage increase in the market basket index for 
prospective payment hospitals (as defined in Sec.  413.40(a) of this 
chapter).
    (16) For Federal fiscal year 2010 and subsequent years. For Federal 
fiscal year 2010 and subsequent years, the update factor is the 
percentage increase specified in Sec.  412.64(d).
    (d) Budget neutrality--(1) Federal fiscal year 1984. For cost 
reporting periods beginning on or after October 1, 1983 and before 
October 1, 1984, CMS adjusts the target rate percentage used under 
paragraph (c)(1) of this section. This adjustment is based on a factor 
actuarially estimated to ensure that the estimated amount of aggregate 
Medicare payments based on the hospital-specific portion of the 
transition payment rates is neither greater nor less than 75 percent of 
the amounts that would have been payable for the inpatient operating 
costs for those same hospitals for fiscal year 1984 under the law in 
effect before April 20, 1983.
    (2) Federal fiscal year 1985. For cost reporting periods beginning 
on or after October 1, 1984 and before October 1, 1985, CMS adjusts the 
target rate percentage used under paragraph (c)(2) of this section. This 
adjustment is based on a factor actuarially estimated to ensure that the 
estimated amount of aggregate Medicare payment based on the hospital-
specific portion of the transition payment rates is neither greater nor 
less than 50 percent of the amounts that would have been payable for the 
inpatient operating costs for those same hospitals for fiscal year 1985 
under the Social Security Act as in effect on April 19, 1983.
    (e) DRG adjustment. The applicable hospital-specific cost per 
discharge is multiplied by the appropriate DRG weighting factor to 
determine the hospital-specific base payment amount (target amount) for 
a particular covered discharge.
    (f) Maintaining budget neutrality. CMS makes an adjustment to the 
hospital-specific rate to ensure that changes to the DRG classifications 
and recalibrations of the DRG relative weights are made in a manner so 
that aggregate payments to section 1886(d) hospitals are not affected.

[50 FR 12741, Mar. 29, 1985, as amended at 51 FR 16787, May 6, 1986; 51 
FR 34793, Sept. 30, 1986; 51 FR 42234, Nov. 24, 1986; 52 FR 33057, Sept. 
1, 1987; 53 FR 38528, Sept. 30, 1988; 55 FR 15173, Apr. 20, 1990; 56 FR 
573, Jan. 7, 1991; 57 FR 39822, Sept. 1, 1992; 58 FR 46338, Sept. 1, 
1993; 59 FR 1658, Jan. 12, 1994; 59 FR 32383, June 23, 1994; 65 FR 
47106, Aug. 1, 2000; 70 FR 47485, Aug. 12, 2005; 75 FR 50413, Aug. 16, 
2010]



Sec.  412.75  Determination of the hospital-specific rate for inpatient 
operating costs based on a Federal fiscal year 1987 base period.

    (a) Base-period costs--(1) General rule. Except as provided in 
paragraph (a)(2) of this section, for each hospital, the intermediary 
determines the hospital's Medicare part A allowable inpatient operating 
costs, as described in Sec.  412.2(c), for the 12-month or longer cost 
reporting period ending on or after September 30, 1987 and before 
September 30, 1988.
    (2) Exceptions. (i) If the hospital's last cost reporting period 
ending before September 30, 1988 is for less than 12 months, the base 
period is the hospital's most recent 12-month or longer cost reporting 
period ending before the short period report.
    (ii) If the hospital does not have a cost reporting period ending on 
or after September 30, 1987 and before September 30, 1988 and does have 
a cost reporting period beginning on or after October 1, 1986 and before 
October 1, 1987, that cost reporting period is the base period unless 
the cost reporting period is for less than 12 months. In that case, the 
base period is the hospital's most recent 12-month or longer

[[Page 638]]

cost reporting period ending before the short cost reporting period.
    (b) Costs on a per discharge basis. The intermediary determines the 
hospital's average base-period operating cost per discharge by dividing 
the total operating costs by the number of discharges in the base 
period. For purposes of this section, a transfer as defined in Sec.  
412.4(b) is considered to be a discharge.
    (c) Case-mix adjustment. The intermediary divides the average base-
period cost per discharge by the hospital's case-mix index for the base 
period.
    (d) Updating base-period costs. For purposes of determining the 
updated base-period costs for cost reporting periods beginning in 
Federal fiscal year 1988, the update factor is determined using the 
methodology set forth in Sec. Sec.  412.73(c)(15) and 412.73(c)(16).
    (e) DRG adjustment. The applicable hospital-specific cost per 
discharge is multiplied by the appropriate DRG weighting factor to 
determine the hospital-specific base payment amount (target amount) for 
a particular covered discharge.
    (f) Notice of hospital-specific rate. The intermediary furnishes the 
hospital a notice of its hospital-specific rate, which contains a 
statment of the hospital's Medicare part A allowable inpatient operating 
costs, number of Medicare discharges, and case-mix index adjustment 
factor used to determine the hospital's cost per discharge for the 
Federal fiscal year 1987 base period.
    (g) Right to administrative and judicial review. An intermediary's 
determination of the hospital-specific rate for a hospital is subject to 
administrative and judicial review. Review is available to a hospital 
upon receipt of the notice of the hospital-specific rate. This notice is 
treated as a final intermediary determination of the amount of program 
reimbursement for purposes of subpart R of part 405 of this chapter, 
governing provider reimbursement determinations and appeals.
    (h) Modification of hospital-specific rate. (1) The intermediary 
recalculates the hospital-specific rate to reflect the following:
    (i) Any modifications that are determined as a result of 
administrative or judicial review of the hospital-specific rate 
determinations; or
    (ii) Any additional costs that are recognized as allowable costs for 
the hospital's base period as a result of administrative or judicial 
review of the base-period notice of amount of program reimbursement.
    (2) With respect to either the hospital-specific rate determination 
or the amount of program reimbursement determination, the actions taken 
on administrative or judicial review that provide a basis for 
recalculations of the hospital-specific rate include the following:
    (i) A reopening and revision of the hospital's base-period notice of 
amount of program reimbursement under Sec. Sec.  405.1885 through 
405.1889 of this chapter.
    (ii) A prehearing order or finding issued during the provider 
payment appeals process by the appropriate reviewing authority under 
Sec.  405.1821 or Sec.  405.1853 of this chapter that resolved a matter 
at issue in the hospital's base-period notice of amount of program 
reimbursement.
    (iii) An affirmation, modification, or reversal of a Provider 
Reimbursement Review Board decision by the Administrator of CMS under 
Sec.  405.1875 of this chapter that resolved a matter at issue in the 
hospital's base-period notice of amount of program reimbursement.
    (iv) An administrative or judicial review decision under Sec. Sec.  
405.1831, 405.1871, or 405.1877 of this chapter that is final and no 
longer subject to review under applicable law or regulations by a higher 
reviewing authority, and that resolved a matter at issue in the 
hospital's base-period notice of amount of program reimbursement.
    (v) A final, nonappealable court judgment relating to the base-
period costs.
    (3) The adjustments to the hospital-specific rate made under 
paragraphs (h) (1) and (2) of this section are effective retroactively 
to the time of the intermediary's initial determination of the rate.
    (i) Maintaining budget neutrality. CMS makes an adjustment to the 
hospital-specific rate to ensure that changes to the DRG classifications 
and recalibrations of the DRG relative weights are made in a manner so 
that aggregate

[[Page 639]]

payments to section 1886(d) hospitals are not affected.

[55 FR 15173, Apr. 20, 1990, as amended at 55 FR 36069, Sept. 4, 1990; 
55 FR 39775, Sept. 2, 1990; 56 FR 573, Jan. 7, 1991; 55 FR 46887, Nov. 
7, 1990; 57 FR 39822, Sept. 1, 1992; 58 FR 46338, Sept. 1, 1993; 65 FR 
47106, Aug. 1, 2000; 70 FR 47485, Aug. 12, 2005; 75 FR 50414, Aug. 16, 
2010]



Sec.  412.76  Recovery of excess transition period payment amounts 
resulting from unlawful claims.

    If a hospital's base-year costs, as estimated for purposes of 
determining the hospital-specific portion, are determined, by criminal 
conviction or imposition of a civil money penalty or assessment, to 
include costs that were unlawfully claimed, the hospital's base-period 
costs are adjusted to remove the effect of the excess costs, and CMS 
recovers both the excess costs reimbursed for the base period and the 
additional amounts paid due to the inappropriate increase of the 
hospital-specific portion of the hospital's transition payment rates.

[50 FR 12741, Mar. 29, 1985, as amended at 57 FR 39822, Sept. 1, 1992. 
Redesignated at 65 FR 47106, Aug. 1, 2000, and further redesignated at 
73 FR 48754, Aug. 19, 2008]



Sec.  412.77  Determination of the hospital-specific rate for inpatient 
operating costs for sole community hospitals based on a Federal fiscal year 
1996 base period.

    (a) Applicability. (1) This section applies to a hospital that has 
been designated as a sole community hospital, as described in Sec.  
412.92. If the 1996 hospital-specific rate exceeds the rate that would 
otherwise apply, that is, either the Federal rate under Sec.  412.64 (or 
under Sec.  412.63 for periods prior to FY 2005) or the hospital-
specific rates for either FY 1982 under Sec.  412.73 or FY 1987 under 
Sec.  412.75, this 1996 rate will be used in the payment formula set 
forth in Sec.  412.92(d)(1).
    (2) This section applies only to cost reporting periods beginning on 
or after October 1, 2000.
    (3) The formula for determining the hospital-specific costs for 
hospitals described under paragraph (a)(1) of this section is set forth 
in paragraph (f) of this section.
    (b) Based costs for hospitals subject to fiscal year 1996 rebasing--
(1) General rule. Except as provided in paragraph (b)(2) of this 
section, for each hospital eligible under paragraph (a) of this section, 
the intermediary determines the hospital's Medicare Part A allowable 
inpatient operating costs, as described in Sec.  412.2(c), for the 12-
month or longer cost reporting period ending on or after September 30, 
1996 and before September 30, 1997, and computes the hospital-specific 
rate for purposes of determining prospective payment rates for inpatient 
operating costs as determined under Sec.  412.92(d).
    (2) Exceptions. (i) If the hospital's last cost reporting period 
ending before September 30, 1997 is for less than 12 months, the base 
period is the hospital's most recent 12-month or longer cost reporting 
period ending before the short period report.
    (ii) If the hospital does not have a cost reporting period ending on 
or after September 30, 1996 and before September 30, 1997, and does have 
a cost reporting period beginning on or after October 1, 1995 and before 
October 1, 1996, that cost reporting period is the base period unless 
the cost reporting period is for less than 12 months. If that cost 
reporting period is for less than 12 months, the base period is the 
hospital's most recent 12-month or longer cost reporting period ending 
before the short cost reporting period. If a hospital has no cost 
reporting period beginning in fiscal year 1996, the hospital will not 
have a hospital-specific rate based on fiscal year 1996.
    (c) Costs on a per discharge basis. The intermediary determines the 
hospital's average base-period operating cost per discharge by dividing 
the total operating costs by the number of discharges in the base 
period. For purposes of this section, a transfer as defined in Sec.  
412.4(b) is considered to be a discharge.
    (d) Case-mix adjustment. The intermediary divides the average base-
period cost per discharge by the hospital's case-mix index for the base 
period.
    (e) Updating base-period costs. For purposes of determining the 
updated base-period costs for cost reporting periods beginning in 
Federal fiscal year 1996, the update factor is determined using

[[Page 640]]

the methodology set forth in Sec.  412.73(c)(12) through (c)(16).
    (f) DRG adjustment. The applicable hospital-specific cost per 
discharge is multiplied by the appropriate DRG weighting factor to 
determine the hospital-specific base payment amount (target amount) for 
a particular covered discharge.
    (g) Notice of hospital-specific rates. The intermediary furnishes a 
hospital eligible for rebasing a notice of the hospital-specific rate as 
computed in accordance with this section. The notice will contain a 
statement of the hospital's Medicare Part A allowable inpatient 
operating costs, the number of Medicare discharges, and the case-mix 
index adjustment factor used to determine the hospital's cost per 
discharge for the Federal fiscal year 1996 base period.
    (h) Right to administrative and judicial review. An intermediary's 
determination of the hospital-specific rate for a hospital is subject to 
administrative and judicial review. Review is available to a hospital 
upon receipt of the notice of the hospital-specific rate. This notice is 
treated as a final intermediary determination of the amount of program 
reimbursement for purposes of subpart R of part 405 of this chapter.
    (i) Modification of hospital-specific rate. (1) The intermediary 
recalculates the hospital-specific rate to reflect the following:
    (i) Any modifications that are determined as a result of 
administrative or judicial review of the hospital-specific rate 
determinations; or
    (ii) Any additional costs that are recognized as allowable costs for 
the hospital's base period as a result of administrative or judicial 
review of the base-period notice of amount of program reimbursement.
    (2) With respect to either the hospital-specific rate determination 
or the amount of program reimbursement determination, the actions taken 
on administrative or judicial review that provide a basis for the 
recalculations of the hospital-specific rate include the following:
    (i) A reopening and revision of the hospital's base-period notice of 
amount of program reimbursement under Sec. Sec.  405.1885 through 
405.1889 of this chapter.
    (ii) A prehearing order or finding issued during the provider 
payment appeals process by the appropriate reviewing authority under 
Sec.  405.1821 or Sec.  405.1853 of this chapter that resolved a matter 
at issue in the hospital's base-period notice of amount of program 
reimbursement.
    (iii) An affirmation, modification, or reversal of a Provider 
Reimbursement Review Board decision by the Administrator of CMS under 
Sec.  405.1875 of this chapter that resolved a matter at issue in the 
hospital's base-period notice of amount of program reimbursement.
    (iv) An administrative or judicial review decision under Sec.  
405.1831, Sec.  405.1871, or Sec.  405.1877 of this chapter that is 
final and no longer subject to review under applicable law or 
regulations by a higher reviewing authority, and that resolved a matter 
at issue in the hospital's base-period notice of amount of program 
reimbursement.
    (v) A final, nonappealable court judgment relating to the base-
period costs.
    (3) The adjustments to the hospital-specific rate made under 
paragraphs (i)(1) and (i)(2) of this section are effective retroactively 
to the time of the intermediary's initial determination of the rate.
    (j) Maintaining budget neutrality. CMS makes an adjustment to the 
hospital-specific rate to ensure that changes to the DRG classifications 
and recalibrations of the DRG relative weights are made in a manner so 
that aggregate payments to section 1886(d) hospitals are not affected.

[65 FR 47106, Aug. 1, 2000, as amended at 66 FR 32192, June 13, 2001; 70 
FR 47485, Aug. 12, 2005; 75 FR 50414, Aug. 16, 2010]



Sec.  412.78  Determination of the hospital-specific rate for inpatient 
operating costs for sole community hospitals based on a Federal fiscal year 
2006 base period.

    (a) Applicability. (1) This section applies to a hospital that has 
been designated as a sole community hospital, as described in Sec.  
412.92. If the 2006 hospital-specific rate exceeds the rate that would 
otherwise apply, that is, either the Federal rate under Sec.  412.64 or 
the hospital-specific rates for either FY

[[Page 641]]

1982 under Sec.  412.73, FY 1987 under Sec.  412.75 or FY 1996 under 
Sec.  412.77, this 2006 rate will be used in the payment formula set 
forth in Sec.  412.92(d)(1).
    (2) This section applies only to cost reporting periods beginning on 
or after January 1, 2009.
    (3) The formula for determining the hospital-specific costs for 
hospitals described under paragraph (a)(1) of this section is set forth 
in paragraph (f) of this section.
    (b) Based costs for hospitals subject to fiscal year 2006 rebasing--
(1) General rule. Except as provided in paragraph (b)(2) of this 
section, for each hospital eligible under paragraph (a) of this section, 
the intermediary determines the hospital's Medicare Part A allowable 
inpatient operating costs, as described in Sec.  412.2(c), for the 12-
month or longer cost reporting period ending on or after September 30, 
2006, and before September 30, 2007, and computes the hospital-specific 
rate for purposes of determining prospective payment rates for inpatient 
operating costs as determined under Sec.  412.92(d).
    (2) Exceptions. (i) If the hospital's last cost reporting period 
ending before September 30, 2007 is for less than 12 months, the base 
period is the hospital's most recent 12-month or longer cost reporting 
period ending before the short period report.
    (ii) If the hospital does not have a cost reporting period ending on 
or after September 30, 2006 and before September 30, 2007, and does have 
a cost reporting period beginning on or after October 1, 2005 and before 
October 1, 2006, that cost reporting period is the base period unless 
the cost reporting period is for less than 12 months. If that cost 
reporting period is for less than 12 months, the base period is the 
hospital's most recent 12-month or longer cost reporting period ending 
before the short cost reporting period. If a hospital has no cost 
reporting period beginning in fiscal year 2006, the hospital will not 
have a hospital-specific rate based on fiscal year 2006.
    (c) Costs on a per discharge basis. The intermediary determines the 
hospital's average base-period operating cost per discharge by dividing 
the total operating costs by the number of discharges in the base 
period. For purposes of this section, a transfer as defined in Sec.  
412.4(b) is considered to be a discharge.
    (d) Case-mix adjustment. The intermediary divides the average base-
period cost per discharge by the hospital's case-mix index for the base 
period.
    (e) Updating base-period costs. For purposes of determining the 
updated base-period costs for cost reporting periods beginning in 
Federal fiscal year 2006, the update factor is determined using the 
methodology set forth inSec. Sec.  412.73(c)(15) and 412.73(c)(16).
    (f) DRG adjustment. The applicable hospital-specific cost per 
discharge is multiplied by the appropriate DRG weighting factor to 
determine the hospital-specific base payment amount (target amount) for 
a particular covered discharge.
    (g) Notice of hospital-specific rates. The intermediary furnishes a 
hospital eligible for rebasing a notice of the hospital-specific rate as 
computed in accordance with this section. The notice will contain a 
statement of the hospital's Medicare Part A allowable inpatient 
operating costs, the number of Medicare discharges, and the case-mix 
index adjustment factor used to determine the hospital's cost per 
discharge for the Federal fiscal year 2006 base period.
    (h) Right to administrative and judicial review. An intermediary's 
determination under this section of the hospital-specific rate for a 
hospital is subject to administrative and judicial review in accordance 
with Sec.  412.77(h).
    (i) Modification of hospital-specific rate. The intermediary 
recalculates the hospital-specific rate determined under this section in 
the manner set forth in Sec.  412.77(i).
    (j) Maintaining budget neutrality. CMS makes an adjustment to the 
hospital-specific rate determined under this section in the manner set 
forth in Sec.  412.77(j).

[73 FR 48754, Aug. 19, 2008, as amended at 75 FR 50414, Aug. 16, 2010]

[[Page 642]]



Sec.  412.79  Determination of the hospital-specific rate for inpatient 
operating costs for Medicare-dependent, small rural hospitals based on 
a Federal fiscal year 2002 base period.

    (a) Base-period costs--(1) General rule. Except as provided in 
paragraph (a)(2) of this section, for each MDH, the intermediary 
determines the MDH's Medicare Part A allowable inpatient operating 
costs, as described in Sec.  412.2(c), for the 12-month or longer cost 
reporting period beginning on or after October 1, 2001, and before 
October 1, 2002.
    (2) Exceptions. (i) If the MDH's last cost reporting period 
beginning before October 1, 2002, is for less than 12 months, the base 
period is the MDH's most recent 12-month or longer cost reporting period 
beginning before that short cost reporting period.
    (ii) If the MDH does not have a cost reporting period beginning on 
or after October 1, 2001, and before October 1, 2002, and does have a 
cost reporting period beginning on or after October 1, 2000, and before 
October 1, 2001, that cost reporting period is the base period unless 
the cost reporting is for less than 12 months. In that case, the base 
period is the MDH's most recent 12-month or longer cost reporting period 
beginning before that short cost reporting period.
    (b) Costs on a per discharge basis. The intermediary determines the 
MDH's average base-period operating cost per discharge by dividing the 
total operating costs by the number of discharges in the base period. 
For purposes of this section, a transfer as described in Sec.  412.4(b) 
is considered to be a discharge.
    (c) Case-mix adjustment. The intermediary divides the average base-
period cost per discharge by the MDH's case-mix index for the base 
period.
    (d) Updating base period costs. For purposes of determining the 
updated base-period costs for cost reporting periods beginning in 
Federal fiscal year 2002, the update factor is determined using the 
methodology set forth in Sec.  412.73(c)(14) through (c)(16).
    (e) DRG adjustment. The applicable hospital-specific cost per 
discharge is multiplied by the appropriate DRG weighting factor to 
determine the hospital-specific base payment amount (target amount) for 
a particular covered discharge.
    (f) Notice of hospital-specific rate. The intermediary furnishes the 
MDH a notice of its hospital-specific rate which contains a statement of 
the hospital's Medicare Part A allowable inpatient operating costs, 
number of Medicare discharges, and case-mix index adjustment factor used 
to determine the hospital's cost per discharge for the Federal fiscal 
year 2002 base period.
    (g) Right to administrative and judicial review. An intermediary's 
determination of the hospital-specific rate for a hospital is subject to 
administrative and judicial review. Review is available to an MDH upon 
receipt of the notice of the hospital-specific rate. The notice is 
treated as a final intermediary determination of the amount of program 
reimbursement for purposes of subpart R of part 405 of this chapter, 
governing provider reimbursement determinations and appeals.
    (h) Modification of hospital-specific rate. (1) The intermediary 
recalculates the hospital-specific rate to reflect the following:
    (i) Any modifications that are determined as a result of 
administrative or judicial review of the hospital-specific rate 
determinations; or
    (ii) Any additional costs that are recognized as allowable costs for 
the MDH's base period as a result of administrative or judicial review 
of the base-period notice of amount of program reimbursement.
    (2) With respect to either the hospital-specific rate determination 
or the amount of program reimbursement determination, the actions taken 
on administrative or judicial review that provide a basis for 
recalculations of the hospital-specific rate include the following:
    (i) A reopening and revision of the MDH's base-period notice of 
amount of program reimbursement under Sec. Sec.  405.1885 through 
405.1889 of this chapter.
    (ii) A prehearing order or finding issued during the provider 
payment appeals process by the appropriate reviewing authority under 
Sec.  405.1821 or Sec.  405.1853 of this chapter that resolved a

[[Page 643]]

matter at issue in the MDH's base-period notice of amount of program 
reimbursement.
    (iii) An affirmation, modification, or reversal of a Provider 
Reimbursement Review Board decision by the Administrator of CMS under 
Sec.  405.1875 of this chapter that resolved a matter at issue in the 
hospital's base-period notice of amount of program reimbursement.
    (iv) An administrative or judicial review decision under Sec.  
405.1831, Sec.  405.1871, or Sec.  405.1877 of this chapter that is 
final and no longer subject to review under applicable law or 
regulations by a higher reviewing authority, and that resolved a matter 
at issue in the hospital's base-period notice of amount of program 
reimbursement.
    (v) A final, nonappealable court judgment relating to the base-
period costs.
    (3) The adjustments to the hospital-specific rate made under 
paragraphs (h)(1) and (2) of this section are effective retroactively to 
the time of the intermediary's initial determination of the rate.
    (i) Maintaining budget neutrality. CMS makes an adjustment to the 
hospital-specific rate to ensure that changes to the DRG classifications 
and recalibrations of the DRG relative weights are made in a manner so 
that aggregate payments to section 1886(d) hospitals are not affected.

[71 FR 48137, Aug. 18, 2006, as amended at 75 FR 50414, Aug. 16, 2010]



Subpart F_Payments for Outlier Cases, Special Treatment Payment for New 
     Technology, and Payment Adjustment for Certain Replaced Devices

                        Payment for Outlier Cases



Sec.  412.80  Outlier cases: General provisions.

    (a) Basic rule--(1) Discharges occurring on or after October 1, 1994 
and before October 1, 1997. For discharges occurring on or after October 
1, 1994, and before October 1, 1997, except as provided in paragraph (b) 
of this section concerning transferring hospitals, CMS provides for 
additional payment, beyond standard DRG payments, to a hospital for 
covered inpatient hospital services furnished to a Medicare beneficiary 
if either of the following conditions is met:
    (i) The beneficiary's length-of-stay (including days at the SNF 
level of care if a SNF bed is not available in the area) exceeds the 
mean length-of-stay for the applicable DRG by the lesser of the 
following:
    (A) A fixed number of days, as specified by CMS; or
    (B) A fixed number of standard deviations, as specified by CMS.
    (ii) The beneficiary's length-of-stay does not exceed criteria 
established under paragraph (a)(1)(i) of this section, but the 
hospital's charges for covered services furnished to the beneficiary, 
adjusted to operating costs and capital costs by applying cost-to-charge 
ratios as described in Sec.  412.84(h), exceed the DRG payment for the 
case plus a fixed dollar amount (adjusted for geographic variation in 
costs) as specified by CMS.
    (2) Discharges occurring on or after October 1, 1997 and before 
October 1, 2001. For discharges occurring on or after October 1, 1997 
and before October 1, 2001, except as provided in paragraph (b) of this 
section concerning transfers, CMS provides for additional payment, 
beyond standard DRG payments, to a hospital for covered inpatient 
hospital services furnished to a Medicare beneficiary if the hospital's 
charges for covered services, adjusted to operating costs and capital 
costs by applying cost-to-charge ratios, as described in Sec.  
412.84(h), exceed the DRG payment for the case, payments for indirect 
costs of graduate medical education (Sec.  412.105), and payments for 
serving disproportionate share of low-income patients (Sec.  412.106), 
plus a fixed dollar amount (adjusted for geographic variation in costs) 
as specified by CMS.
    (3) Discharges occurring on or after October 1, 2001. For discharges 
occurring on or after October 1, 2001, except as provided in paragraph 
(b) of this section concerning transfers, CMS provides for additional 
payment, beyond standard DRG payments and beyond additional payments for 
new medical services or technology specified in Sec. Sec.  412.87 and 
412.88, to a hospital for covered inpatient hospital services furnished 
to a Medicare beneficiary if the

[[Page 644]]

hospital's charges for covered services, adjusted to operating costs and 
capital costs by applying cost-to-charge ratios as described in Sec.  
412.84(h), exceed the DRG payment for the case (plus payments for 
indirect costs of graduate medical education (Sec.  412.105), payments 
for serving a disproportionate share of low-income patients (Sec.  
412.106), and additional payments for new medical services or 
technologies) plus a fixed dollar amount (adjusted for geographic 
variation in costs) as specified by CMS.
    (b) Outlier cases in transferring hospitals. CMS provides cost 
outlier payments to a transferring hospital for cases paid in accordance 
with Sec.  412.4(f), if the hospital's charges for covered services 
furnished to the beneficiary, adjusted to costs by applying cost-to-
charge ratios as described in Sec.  412.84(h), exceed the DRG payment 
for the case plus a fixed dollar amount (adjusted for geographic 
variation in costs) as specified by CMS, divided by the geometric mean 
length of stay for the DRG, and multiplied by an applicable factor 
determined as follows:
    (1) For transfer cases paid in accordance with Sec.  412.4(f)(1), 
the applicable factor is equal to the length of stay plus 1 day.
    (2) For transfer cases paid in accordance with Sec.  412.4(f)(2), 
the applicable factor is equal to 0.5 plus the product of the length of 
stay plus 1 day multiplied by 0.5.
    (c) Publication and revision of outlier criteria. CMS will issue 
threshold criteria for determining outlier payment in the annual notice 
of the prospective payment rates published in accordance with Sec.  
412.8(b).

[62 FR 46028, Aug. 29, 1997, as amended at 63 FR 41003, July 31, 1998; 
66 FR 46924, Sept. 7, 2001; 67 FR 50111, Aug. 1, 2002]



Sec.  412.82  Payment for extended length-of-stay cases (day outliers).

    (a) For discharges occurring before October 1, 1997, if the hospital 
stay reflected by a discharge includes covered days of care beyond the 
applicable threshold criterion, the intermediary will make an additional 
payment, on a per diem basis, to the discharging hospital for those 
days. A special request or submission by the hospital is not necessary 
to initiate this payment. However, a hospital may request payment for 
day outliers before the medical review required in paragraph (b) of this 
section.
    (b) The QIO must review and approve to the extent required by CMS--
    (1) The medical necessity and appropriateness of the admission and 
outlier services in the context of the entire stay;
    (2) The validity of the diagnostic and procedural coding; and
    (3) The granting of grace days.
    (c) Except as provided in Sec.  412.83, the per diem payment made 
under paragraph (a) of this section is derived by taking a percentage of 
the average per diem payment for the applicable DRG, as calculated by 
dividing the Federal prospective payment rate for inpatient operating 
costs and inpatient capital-related costs determined under subpart D of 
this part, by the arithmetic mean length of stay for that DRG. CMS 
issues the applicable percentage of the average per diem payment in the 
annual publication of the prospective payment rates in accordance with 
Sec.  412.8(b).
    (d) Any days in a covered stay identified as noncovered reduce the 
number of days reimbursed at the day outlier rate but not to exceed the 
number of days that occur after the day outlier threshold.

[50 FR 12741, Mar. 29, 1985, as amended at 50 FR 15326, Apr. 17, 1985; 
50 FR 35689, Sept. 3, 1985; 53 FR 38529, Sept. 30, 1988; 57 FR 39822, 
Sept. 1, 1992; 59 FR 45398, Sept. 1, 1994; 62 FR 46028, Aug. 29, 1997; 
85 FR 59020, Sept. 18, 2020]



Sec.  412.84  Payment for extraordinarily high-cost cases (cost outliers).

    (a) A hospital may request its intermediary to make an additional 
payment for inpatient hospital services that meet the criteria 
established in accordance with Sec.  412.80(a).
    (b) The hospital must request additional payment--
    (1) With initial submission of the bill; or
    (2) Within 60 days of receipt of the intermediary's initial 
determination.
    (c) Except as specified in paragraph (e) of this section, an 
additional payment for a cost outlier case is made prior to medical 
review.

[[Page 645]]

    (d) As described in paragraph (f) of this section, the QIO reviews a 
sample of cost outlier cases after payment. The charges for any services 
identified as noncovered through this review are denied and any outlier 
payment made for these services are recovered, as appropriate, after a 
determination as to the provider's liability has been made.
    (e) If the QIO finds a pattern of inappropriate utilization by a 
hospital, all cost outlier cases from that hospital are subject to 
medical review, and this review may be conducted prior to payment until 
the QIO determines that appropriate corrective actions have been taken.
    (f) The QIO reviews the cost outlier cases, using the medical 
records and itemized charges, to verify the following:
    (1) The admission was medically necessary and appropriate.
    (2) Services were medically necessary and delivered in the most 
appropriate setting.
    (3) Services were ordered by the physician, actually furnished, and 
not duplicatively billed.
    (4) The diagnostic and procedural codings are correct.
    (g) The intermediary bases the operating and capital costs of the 
discharge on the billed charges for covered inpatient services adjusted 
by the cost to charge ratios applicable to operating and capital costs, 
respectively, as described in paragraph (h) of this section.
    (h) For discharges occurring before October 1, 2003, the operating 
and capital cost-to-charge ratios used to adjust covered charges are 
computed annually by the intermediary for each hospital based on the 
latest available settled cost report for that hospital and charge data 
for the same time period as that covered by the cost report. For 
discharges occurring before August 8, 2003, statewide cost-to-charge 
ratios are used in those instances in which a hospital's operating or 
capital cost-to-charge ratios fall outside reasonable parameters. CMS 
sets forth the reasonable parameters and the statewide cost-to-charge 
ratios in each year's annual notice of prospective payment rates 
published in the Federal Register in accordance with Sec.  412.8(b).
    (i)(1) For discharges occurring on or after August 8, 2003, CMS may 
specify an alternative to the ratios otherwise applicable under 
paragraphs (h) or (i)(2) of this section. A hospital may also request 
that its fiscal intermediary use a different (higher or lower) cost-to-
charge ratio based on substantial evidence presented by the hospital. 
Such a request must be approved by the CMS Regional Office.
    (2) For discharges occurring on or after October 1, 2003, the 
operating and capital cost-to-charge ratios applied at the time a claim 
is processed are based on either the most recent settled cost report or 
the most recent tentative settled cost report, whichever is from the 
latest cost reporting period.
    (3) For discharges occurring on or after August 8, 2003, the fiscal 
intermediary may use a statewide average cost-to-charge ratio if it is 
unable to determine an accurate operating or capital cost-to-charge 
ratio for a hospital in one of the following circumstances:
    (i) New hospitals that have not yet submitted their first Medicare 
cost report. (For this purpose, a new hospital is defined as an entity 
that has not accepted assignment of an existing hospital's provider 
agreement in accordance with Sec.  489.18 of this chapter.)
    (ii) Hospitals whose operating or capital cost-to-charge ratio is in 
excess of 3 standard deviations above the corresponding national 
geometric mean. This mean is recalculated annually by CMS and published 
in the annual notice of prospective payment rates issued in accordance 
with Sec.  412.8(b).
    (iii) Other hospitals for whom the fiscal intermediary obtains 
accurate data with which to calculate either an operating or capital 
cost-to-charge ratio (or both) are not available.
    (4) For discharges occurring on or after August 8, 2003, any 
reconciliation of outlier payments will be based on operating and 
capital cost-to-charge ratios calculated based on a ratio of costs to 
charges computed from the relevant cost report and charge data 
determined at the time the cost report coinciding with the discharge is 
settled.
    (j) If any of the services are determined to be noncovered, the 
charges

[[Page 646]]

for these services will be deducted from the requested amount of 
reimbursement but not to exceed the amount claimed above the cost 
outlier threshold.
    (k) Except as provided in paragraph (l) of this section, the 
additional amount is derived by first taking 80 percent of the 
difference between the hospital's adjusted operating cost for the 
discharge (as determined under paragraph (g) of this section) and the 
operating threshold criteria established under Sec.  412.80(a)(1)(ii); 
80 percent is also taken of the difference between the hospital's 
adjusted capital cost for the discharge (as determined under paragraph 
(g) of this section) and the capital threshold criteria established 
under Sec.  412.80(a)(1)(ii). The resulting capital amount is then 
multiplied by the applicable Federal portion of the payment as 
determined in Sec.  412.340(a) or Sec.  412.344(a).
    (l) For discharges occurring on or after April 1, 1988, the 
additional payment amount for the DRGs related to burn cases, which are 
identified in the most recent annual notice of prospective payment rates 
published in accordance with Sec.  412.8(b), is computed under the 
provisions of paragraph (k) of this section except that the payment is 
made using 90 percent of the difference between the hospital's adjusted 
cost for the discharge and the threshold criteria.
    (m) Effective for discharges occurring on or after August 8, 2003, 
at the time of any reconciliation under paragraph (i)(4) of this 
section, outlier payments may be adjusted to account for the time value 
of any underpayments or overpayments. Any adjustment will be based upon 
a widely available index to be established in advance by the Secretary, 
and will be applied from the midpoint of the cost reporting period to 
the date of reconciliation.

[50 FR 12741, Mar. 29, 1985, as amended at 50 FR 35689, Sept. 3, 1985; 
51 FR 31496, Sept. 3, 1986; 53 FR 38529, Sept. 30, 1988; 54 FR 36494, 
Sept. 1, 1989; 55 FR 15174, Apr. 20, 1990; 56 FR 43448, Aug. 30, 1991; 
57 FR 39823, Sept. 1, 1992; 59 FR 45398, Sept. 1, 1994; 62 FR 46028, 
Aug. 29, 1997; 68 FR 34515, June 9, 2003; 71 FR 48138, Aug. 18, 2006]

Payment Adjustment for Certain Clinical Trial Cases and Expanded Access 
                            Use Immunotherapy



Sec.  412.85  Payment adjustment for certain clinical trial 
and expanded access use immunotherapy cases.

    (a) General rule. For discharges occurring on or after October 1, 
2020, the amount of payment for a discharge described in paragraph (b) 
of this section is adjusted as described in paragraph (c) of this 
section.
    (b) Discharges subject to payment adjustment. Payment is adjusted in 
accordance with paragraph (c) of this section for discharges assigned to 
MS-DRG 018 involving expanded access use of immunotherapy, or that are 
part of an applicable clinical trial as determined by CMS based on the 
reporting of a diagnosis code indicating the encounter is part of a 
clinical research program on the claim for the discharge.
    (c) Adjustment. The DRG weighting factor determined under Sec.  
412.60(b) is adjusted by a factor that reflects the average cost for 
cases to be assigned to MS-DRG 018 that involve expanded access use of 
immunotherapy, or are part of an applicable clinical trial, to the 
average cost for cases to be assigned to MS-DRG 018 that do not involve 
expanded access use of immunotherapy and are not part of an applicable 
clinical trial.

[85 FR 59020, Sept. 18, 2020]



Sec.  412.83  Payment for extraordinarily high-cost day outliers.

    For discharges occurring before October 1, 1997, if a discharge that 
qualifies for an additional payment under the provisions of Sec.  412.82 
has charges adjusted to costs that exceed the cost outlier threshold 
criteria for an extraordinarily high-cost case as set forth in Sec.  
412.80(a)(1)(ii), the additional payment made for the discharge is the 
greater of--
    (a) The applicable per diem payment computed under Sec.  412.82 (c) 
or (d); or
    (b) The payment that would be made under Sec.  412.84 (i) or (j) if 
the case had

[[Page 647]]

not met the day outlier criteria threshold set forth in Sec.  
412.80(a)(1)(i).

[53 FR 38529, Sept. 30, 1988, as amended at 62 FR 46028, Aug. 29, 1997. 
Redesignated at 85 FR 59020, Sept. 18, 2020]



412.86  [Reserved]

          Additional Special Payment for Certain New Technology



Sec.  412.87  Additional payment for new medical services and technologies: 
General provisions.

    (a) Basis. Sections 412.87 and 412.88 implement sections 
1886(d)(5)(K) and 1886(d)(5)(L) of the Act, which authorize the 
Secretary to establish a mechanism to recognize the costs of new medical 
services and technologies under the hospital inpatient prospective 
payment system.
    (b) Eligibility criteria. For discharges occurring on or after 
October 1, 2001, CMS provides for additional payments (as specified in 
Sec.  412.88) beyond the standard DRG payments and outlier payments to a 
hospital for discharges involving covered inpatient hospital services 
that are new medical services and technologies, if the following 
conditions are met:
    (1) A new medical service or technology represents an advance that 
substantially improves, relative to technologies previously available, 
the diagnosis or treatment of Medicare beneficiaries.
    (i) The totality of the circumstances is considered when making a 
determination that a new medical service or technology represents an 
advance that substantially improves, relative to services or 
technologies previously available, the diagnosis or treatment of 
Medicare beneficiaries.
    (ii) A determination that a new medical service or technology 
represents an advance that substantially improves, relative to services 
or technologies previously available, the diagnosis or treatment of 
Medicare beneficiaries means one of the following:
    (A) The new medical service or technology offers a treatment option 
for a patient population unresponsive to, or ineligible for, currently 
available treatments.
    (B) The new medical service or technology offers the ability to 
diagnose a medical condition in a patient population where that medical 
condition is currently undetectable, or offers the ability to diagnose a 
medical condition earlier in a patient population than allowed by 
currently available methods and there must also be evidence that use of 
the new medical service or technology to make a diagnosis affects the 
management of the patient.
    (C) The use of the new medical service or technology significantly 
improves clinical outcomes relative to services or technologies 
previously available as demonstrated by one or more of the outcomes 
described in paragraphs (b)(1)(ii)(C(1) through (7) of this section.
    (1) A reduction in at least one clinically significant adverse 
event, including a reduction in mortality or a clinically significant 
complication.
    (2) A decreased rate of at least one subsequent diagnostic or 
therapeutic intervention.
    (3) A decreased number of future hospitalizations or physician 
visits.
    (4) A more rapid beneficial resolution of the disease process 
treatment including, but not limited to, a reduced length of stay or 
recovery time
    (5) An improvement in one or more activities of daily living
    (6) An improved quality of life
    (7) A demonstrated greater medication adherence or compliance.
    (D) The totality of the information otherwise demonstrates that the 
new medical service or technology substantially improves, relative to 
technologies previously available, the diagnosis or treatment of 
Medicare beneficiaries.
    (iii) Evidence from published or unpublished information sources 
from within the United States or elsewhere may be sufficient to 
establish that a new medical service or technology represents an advance 
that substantially improves, relative to services or technologies 
previously available, the diagnosis or treatment of Medicare 
beneficiaries. Information source may include the following:
    (A) Clinical trials;
    (B) Peer reviewed journal articles;
    (C) Study results;
    (D) Meta-analyses;
    (E) Consensus statements;

[[Page 648]]

    (F) White papers;
    (G) Patient surveys;
    (H) Case studies;
    (I) Reports;
    (J) Systematic literature reviews;
    (K) Letters from major healthcare associations;
    (L) Editorials and letters to the editor; and,
    (M) Public comments.
    (N) Other appropriate information sources may be considered.
    (iv) The medical condition diagnosed or treated by the new medical 
service or technology may have a low prevalence among Medicare 
beneficiaries.
    (v) The new medical service or technology may represent an advance 
that substantially improves, relative to services or technologies 
previously available, the diagnosis or treatment of a subpopulation of 
patients with the medical condition diagnosed or treated by the new 
medical service or technology.
    (2) A medical service or technology may be considered new within 2 
or 3 years after the point at which data begin to become available 
reflecting the inpatient hospital code (as defined in section 
1886(d)(5)(K)(iii) of the Social Security Act) assigned to the new 
service or technology (depending on when a new code is assigned and data 
on the new service or technology become available for DRG 
recalibration). After CMS has recalibrated the DRGs, based on available 
data, to reflect the costs of an otherwise new medical service or 
technology, the medical service or technology will no longer be 
considered ``new'' under the criterion of this section.
    (3) The DRG prospective payment rate otherwise applicable to 
discharges involving the medical service or technology is determined to 
be inadequate, based on application of a threshold amount to estimated 
charges incurred with respect to such discharges. To determine whether 
the payment would be adequate, CMS will determine whether the charges of 
the cases involving a new medical service or technology will exceed a 
threshold amount that is the lesser of 75 percent of the standardized 
amount (increased to reflect the difference between cost and charges) or 
75 percent of one standard deviation beyond the geometric mean 
standardized charge for all cases in the DRG to which the new medical 
service or technology is assigned (or the case-weighted average of all 
relevant DRGs if the new medical service or technology occurs in many 
different DRGs). Standardized charges reflect the actual charges of a 
case adjusted by the prospective payment system payment factors 
applicable to an individual hospital, such as the wage index, the 
indirect medical education adjustment factor, and the disproportionate 
share adjustment factor.
    (c) Eligibility criteria for alternative pathway for certain 
transformative new devices. For discharges occurring on or after October 
1, 2020, CMS provides for additional payments (as specified in Sec.  
412.88) beyond the standard DRG payments and outlier payments to a 
hospital for discharges involving covered inpatient hospital services 
that are new medical devices, if the following conditions are met:
    (1) A new medical device is part of the Food and Drug 
Administration's (FDA) Breakthrough Devices Program and has received 
marketing authorization for the indication covered by the Breakthrough 
Device designation.
    (2) A medical device that meets the condition in paragraph (c)(1) of 
this section will be considered new for not less than 2 years and not 
more than 3 years after the point at which data begin to become 
available reflecting the inpatient hospital code (as defined in section 
1886(d)(5)(K)(iii) of the Social Security Act) assigned to the new 
technology (depending on when a new code is assigned and data on the new 
technology become available for DRG recalibration). After CMS has 
recalibrated the DRGs, based on available data, to reflect the costs of 
an otherwise new medical technology, the medical technology will no 
longer be considered ``new'' under the criterion of this section.
    (3) The new medical device meets the conditions described in 
paragraph (b)(3) of this section.
    (d) Eligibility criteria for alternative pathway for certain 
antimicrobial products. (1)(i) A new medical product is designated by 
FDA as a Qualified Infectious Disease Product and has received

[[Page 649]]

marketing authorization for the indication covered by the Qualified 
Infectious Disease Product designation; or
    (ii) For discharges occurring on or after October 1, 2021, a new 
medical product is approved under FDA's Limited Population Pathway for 
Antibacterial and Antifungal Drugs (LPAD) and used for the indication 
approved under the LPAD pathway.
    (2) A medical product that meets the condition in paragraph (d)(1) 
of this section will be considered new for not less than 2 years and not 
more than 3 years after the point at which data begin to become 
available reflecting the inpatient hospital code (as defined in section 
1886(d)(5)(K)(iii) of the Social Security Act) assigned to the new 
technology (depending on when a new code is assigned and data on the new 
technology become available for DRG recalibration). After CMS has 
recalibrated the DRGs, based on available data, to reflect the costs of 
an otherwise new medical technology, the medical technology will no 
longer be considered ``new'' under the criterion of this section.
    (3) The new medical product meets the conditions described in 
paragraph (b)(3) of this section.
    (e) Announcement of determinations and deadline for consideration of 
new medical service or technology applications, and conditional approval 
for certain antimicrobial products. (1) CMS will consider whether a new 
medical service or technology meets the eligibility criteria specified 
in paragraph (b), (c), or (d) of this section and announce the results 
in the Federal Register as part of its annual updates and changes to the 
IPPS. CMS will only consider any particular new medical service or 
technology for add-on payments under paragraph (b), (c), or (d) of this 
section.
    (2) Except as provided for in paragraph (e)(3) of this section, CMS 
only considers, for add-on payments for a particular fiscal year, an 
application for which the new medical service or technology has received 
FDA marketing authorization by July 1 prior to the particular fiscal 
year.
    (3) A technology for which an application is submitted under an 
alternative pathway for certain antimicrobial products under paragraph 
(d) of this section that does not receive FDA marketing authorization by 
the July 1 deadline specified in paragraph (e)(2) of this section may be 
conditionally approved for the new technology add-on payment for a 
particular fiscal year, effective for discharges beginning in the first 
quarter after FDA marketing authorization is granted, provided that FDA 
marketing authorization is granted before July 1 of the fiscal year for 
which the applicant applied for new technology add-on payments.

[66 FR 46924, Sept. 7, 2001, as amended at 68 FR 45469, Aug. 1, 2003; 69 
FR 49243, Aug. 11, 2004; 73 FR 48755, Aug. 19, 2008; 74 FR 43997, Aug. 
27, 2009; 82 FR 38511, Aug. 14, 2017; 84 FR 42611, Aug. 16, 2019; 85 FR 
59020, Sept. 18, 2020]



Sec.  412.88  Additional payment for new medical service or technology.

    (a) For discharges involving new medical services or technologies 
that meet the criteria specified in Sec.  412.87, Medicare payment will 
be:
    (1) One of the following:
    (i) The full DRG payment (including adjustments for indirect medical 
education and disproportionate share but excluding outlier payments);
    (ii) The payment determined under Sec.  412.4(f) for transfer cases;
    (iii) The payment determined under Sec.  412.92(d) for sole 
community hospitals; or
    (iv) The payment determined under Sec.  412.108(c) for Medicare-
dependent hospitals; plus
    (2)(i) For discharges occurring before October 1, 2019. If the costs 
of the discharge (determined by applying the operating cost-to-charge 
ratios as described in Sec.  412.84(h)) exceed the full DRG payment, an 
additional amount equal to the lesser of--
    (A) 50 percent of the costs of the new medical service or 
technology; or
    (B) 50 percent of the amount by which the costs of the case exceed 
the standard DRG payment.
    (ii) For discharges occurring on or after October 1, 2019. (A) 
Except as provided under paragraph (a)(2)(ii)(B) of this section, if the 
costs of the discharge (determined by applying the operating cost-to-
charge ratios as described in

[[Page 650]]

Sec.  412.84(h)) exceed the full DRG payment, an additional amount equal 
to the lesser of--
    (1) 65 percent of the costs of the new medical service or 
technology; or
    (2) 65 percent of the amount by which the costs of the case exceed 
the standard DRG payment.
    (B) For a medical product designated by FDA as a Qualified 
Infectious Disease Product or, for discharges occurring on or after 
October 1, 2020, for a product approved under FDA's Limited Population 
Pathway for Antibacterial and Antifungal Drugs, if the costs of the 
discharge (determined by applying the operating cost-to-charge ratios as 
described in Sec.  412.84(h)) exceed the full DRG payment, an additional 
amount equal to the lesser of--
    (1) 75 percent of the costs of the new medical service or 
technology; or
    (2) 75 percent of the amount by which the costs of the case exceed 
the standard DRG payment.
    (b)(1) For discharges occurring before October 1, 2019. Unless a 
discharge case qualifies for outlier payment under Sec.  412.84, 
Medicare will not pay any additional amount beyond the DRG payment plus 
50 percent of the estimated costs of the new medical service or 
technology.
    (2) For discharges occurring on or after October 1, 2019. Unless a 
discharge case qualifies for outlier payment under Sec.  412.84, 
Medicare will not pay any additional amount beyond the DRG payment 
plus--
    (i) 65 percent of the estimated costs of the new medical service or 
technology;
    (ii) For a medical product designated by FDA as a Qualified 
Infectious Disease Product, 75 percent of the estimated costs of the new 
medical service or technology; or
    (iii) For discharges occurring on or after October 1, 2020, for a 
product approved under FDA's Limited Population Pathway for 
Antibacterial and Antifungal Drugs, 75 percent of the estimated costs of 
the new medical service or technology.

[66 FR 46924, Sept. 7, 2001, as amended at 67 FR 50111, Aug. 1, 2002; 69 
FR 49244, Aug. 11, 2004; 72 FR 47411, Aug. 22, 2007; 84 FR 42612, Aug. 
16, 2019; 85 FR 59021, Sept. 18, 2020]

             Payment Adjustment for Certain Replaced Devices



Sec.  412.89  Payment adjustment for certain replaced devices.

    (a) General rule. For discharges occurring on or after October 1, 
2007, the amount of payment for a discharge described in paragraph (b) 
of this section is reduced when--
    (1) A device is replaced without cost to the hospital;
    (2) The provider received full credit for the cost of a device; or
    (3) The provider receives a credit equal to 50 percent or more of 
the cost of the device.
    (b) Discharges subject to payment adjustment. (1) Payment is reduced 
in accordance with paragraph (a) of this section only if the 
implantation of the device determines the DRG assignment.
    (2) CMS lists the DRGs that qualify under paragraph (b)(1) of this 
section in the annual final rule for the hospital inpatient prospective 
payment system.
    (c) Amount of reduction. (1) For a device provided to the hospital 
without cost, the cost of the device is subtracted from the DRG payment.

[72 FR 47411, Aug. 22, 2007]



Subpart G_Special Treatment of Certain Facilities Under the Prospective 
              Payment System for Inpatient Operating Costs



Sec.  412.90  General rules.

    (a) Sole community hospitals. CMS may adjust the prospective payment 
rates for inpatient operating costs determined under subpart D or E of 
this part if a hospital, by reason of factors such as isolated location, 
weather conditions, travel conditions, or absence of other hosptials, is 
the sole source of inpatient hospital services reasonably available in a 
geographic area to Medicare beneficiaries. If a hospital meets the 
criteria for such an exception under Sec.  412.92(a), its prospective 
payment rates for inpatient operating costs are determined under Sec.  
412.92(d).
    (b) Referral center. CMS may adjust the prospective payment rates 
for inpatient operating costs determined under subpart D or E of this 
part if a hospital acts as a referral center for patients

[[Page 651]]

transferred from other hospitals. Criteria for identifying such referral 
centers are set forth in Sec.  412.96.
    (c) [Reserved]
    (d) Kidney acquisition costs incurred by hospitals approved as renal 
transplantation centers. CMS pays for kidney acquisition costs incurred 
by renal transplanation centers on a reasonable cost basis. The criteria 
for this special payment provision are set forth in Sec.  412.100.
    (e) Hospitals located in areas that are reclassified from urban to 
rural. (1) CMS adjusts the rural Federal payment amounts for inpatient 
operating costs for hospitals located in geographic areas that are 
reclassified from urban to rural as defined in subpart D of this part. 
This adjustment is set forth in Sec.  412.102.
    (2) CMS establishes a procedure by which certain individual 
hospitals located in urban areas may apply for reclassification as 
rural. The criteria for reclassification are set forth in Sec.  412.103.
    (f) Hospitals that have a high percentage of ESRD beneficiary 
discharges. CMS makes an additional payment to a hospital if ten percent 
or more of its total Medicare discharges in a cost reporting period 
beginning on or after October 1, 1984 are ESRD beneficiary discharges. 
In determining ESRD discharges, discharges in DRG Nos. 302, 316, and 317 
are excluded. The criteria for this additional payment are set forth in 
Sec.  412.104.
    (g) Hosptials that incur indirect costs for graduate medical 
education programs. CMS makes an additional payment for inpatient 
operating costs to a hospital for indirect medical education costs 
attributable to an approved graduate medical education program. The 
criteria for this additional payment are set forth in Sec.  412.105.
    (h) Hospitals that serve a disproportionate share of low-income 
patients. For discharges occurring on or after May 1, 1986, CMS makes an 
additional payment for inpatient operating costs to hospitals that serve 
a disproportionate share of low-income patients. The criteria for this 
additional payment are set forth in Sec.  412.106.
    (i) Hospitals that receive an additional update for FYs 1998 and 
1999. For FYs 1998 and 1999, CMS makes an upward adjustment to the 
standardized amounts for certain hospitals that do not receive indirect 
medical education or disproportionate share payments and are not 
Medicare- dependent, small rural hospitals. The criteria for identifying 
these hospitals are set forth in Sec.  412.107.
    (j) Medicare-dependent, small rural hospitals. For cost reporting 
periods beginning on or after April 1, 1990, and before October 1, 1994, 
and for discharges occurring on or after October 1, 1997 and before 
October 1, 2022, CMS adjusts the prospective payment rates for inpatient 
operating costs determined under subparts D and E of this part if a 
hospital is classified as a Medicare-dependent, small rural hospital.
    (k) Essential access community hospitals (EACHs). If a hospital was 
designated as an EACH by CMS as described in Sec.  412.109(a) and is 
located in a rural area as defined in Sec.  412.109(b), CMS determines 
the prospective payment rate for that hospital, as it does for sole 
community hospitals, under Sec.  412.92(d).

[57 FR 39823, Sept. 1, 1992, as amended at 58 FR 30669, May 26, 1993; 62 
FR 46028, Aug. 29, 1997; 64 FR 67051, Nov. 30, 1999; 65 FR 47047, Aug. 
1, 2000; 70 FR 47485, Aug. 12, 2005; 71 FR 48138, Aug. 18, 2006; 82 FR 
38511, Aug. 14, 2017; 83 FR 41701, Aug. 17, 2018]



Sec.  412.92  Special treatment: Sole community hospitals.

    (a) Criteria for classification as a sole community hospital. CMS 
classifies a hospital as a sole community hospital if it is located more 
than 35 miles from other like hospitals, or it is located in a rural 
area (as defined in Sec.  412.64) and meets one of the following 
conditions:
    (1) The hospital is located between 25 and 35 miles from other like 
hospitals and meets one of the following criteria:
    (i) No more than 25 percent of residents who become hospital 
inpatients or no more than 25 percent of the Medicare beneficiaries who 
become hospital inpatients in the hospital's service area are admitted 
to other like hospitals located within a 35-mile radius of the hospital, 
or, if larger, within its service area;
    (ii) The hospital has fewer than 50 beds and the MAC certifies that 
the

[[Page 652]]

hospital would have met the criteria in paragraph (a)(1)(i) of this 
section were it not for the fact that some beneficiaries or residents 
were forced to seek care outside the service area due to the 
unavailability of necessary specialty services at the community 
hospital; or
    (iii) Because of local topography or periods of prolonged severe 
weather conditions, the other like hospitals are inaccessible for at 
least 30 days in each 2 out of 3 years.
    (2) The hospital is located between 15 and 25 miles from other like 
hospitals but because of local topography or periods of prolonged severe 
weather conditions, the other like hospitals are inaccessible for at 
least 30 days in each 2 out of 3 years.
    (3) Because of distance, posted speed limits, and predictable 
weather conditions, the travel time between the hospital and the nearest 
like hospital is at least 45 minutes.
    (4) For a hospital with a main campus and one or more remote 
locations under a single provider agreement where services are provided 
and billed under the inpatient hospital prospective payment system and 
that meets the provider-based criteria at Sec.  413.65 of this chapter 
as a main campus and a remote location of a hospital, combined data from 
the main campus and its remote location(s) are required to demonstrate 
that the criteria specified in paragraphs (a)(1)(i) and (ii) of this 
section are met. For the mileage and rural location criteria in 
paragraph (a) of this section and the mileage, accessibility, and travel 
time criteria specified in paragraphs (a)(1) through (3) of this 
section, the hospital must demonstrate that the main campus and its 
remote location(s) each independently satisfy those requirements.
    (b) Classification procedures--(1) Request for classification as 
sole community hospital. (i) The hospital must make its request to its 
MAC.
    (ii) If a hospital is seeking sole community hospital classification 
under paragraph (a)(1)(i) or (a)(1)(ii) of this section, the hospital 
must include the following information with its request:
    (A) The hospital must provide patient origin data (for example, the 
number of patients from each zip code from which the hospital draws 
inpatients) for all inpatient discharges to document the boundaries of 
its service area.
    (B) The hospital must provide patient origin data from all other 
hospitals located within a 35 mile radius of it or, if larger, within 
its service area, to document that no more than 25 percent of either all 
of the population or the Medicare beneficiaries residing in the 
hospital's service area and hospitalized for inpatient care were 
admitted to other like hospitals for care.
    (iii)(A) If the hospital is unable to obtain the information 
required under paragraph (b)(1)(ii)(A) of this section concerning the 
residences of Medicare beneficiaries who were inpatients in other 
hospitals located within a 35 mile radius of the hospital or, if larger, 
within the hospital's service area, the hospital may request that CMS 
provide this information.
    (B) If a hospital obtains the information as requested under 
paragraph (b)(1)(iii)(A) of this section, that information is used by 
both the MAC and CMS in making the determination of the residences of 
Medicare beneficiaries under paragraphs (b)(1)(iii) and (b)(1)(iv) of 
this section, regardless of any other information concerning the 
residences of Medicare beneficiaries submitted by the hospital.
    (iv) The MAC reviews the request and send the request, with its 
recommendation, to CMS.
    (v) CMS reviews the request and the MAC's recommendation and forward 
its approval or disapproval to the MAC.
    (2) Effective dates of classification.(i) For applications received 
on or before September 30, 2018, sole community hospital status is 
effective 30 days after the date of CMS' written notification of 
approval, except as provided in paragraph (b)(2)(v) of this section. For 
applications received on or after October 1, 2018, sole community 
hospital status is effective as of the date the MAC receives the 
complete application, except as provided in paragraph (b)(2)(v) of this 
section.
    (ii) When a court order or a determination by the Provider 
Reimbursement Review Board (PRRB) reverses a CMS denial of sole 
community hospital status and no further appeal is made,

[[Page 653]]

the sole community hospital status is effective as follows:
    (A) If the hospital's application was submitted prior to October 1, 
1983, its status as a sole community hospital is effective at the start 
of the cost reporting period for which it sought exemption from the cost 
limits.
    (B) If the hospital's application for sole community hospital status 
was received on or after October 1, 1983 and on or before September 30, 
2018, the effective date is 30 days after the date of CMS' original 
written notification of denial.
    (C) If the hospital's application for sole community hospital status 
was received on or after October 1, 2018, the effective date is the date 
the MAC receives the complete application.
    (iii) When a hospital is granted retroactive approval of sole 
community hospital status by a court order or a PRRB decision and the 
hospital wishes its sole community hospital status terminated before the 
date of the court order or PRRB determination, it must submit written 
notice to the CMS regional office within 90 days of the court order or 
PRRB decision. A written request received after the 90-day period is 
effective no later than 30 days after the request is submitted.
    (iv) For applications received on or before September 30, 2018, a 
hospital classified as a sole community hospital receives a payment 
adjustment, as described in paragraph (d) of this section, effective 
with discharges occurring on or after 30 days after the date of CMS' 
approval of the classification. For applications received on or after 
October 1, 2018, a hospital classified as a sole community hospital 
receives a payment adjustment, as described in paragraph (d) of this 
section, effective with discharges occurring on or after the date the 
MAC receives the complete application.
    (v) If a hospital that is classified as an MDH under Sec.  412.108 
applies for classification as a sole community hospital because its 
status under the MDH program expires with the expiration of the MDH 
program, and that hospital's sole community hospital status is approved, 
the effective date of approval of sole community hospital status is the 
day following the expiration date of the MDH program if the hospital--
    (A) Applies for classification as a sole community hospital prior to 
30 days before the expiration of the MDH program; and
    (B) Requests that sole community hospital status be effective with 
the expiration of the MDH program.
    (3) Duration of classification. (i) An approved classification as a 
sole community hospital remains in effect without need for reapproval 
unless there is a change in the circumstances under which the 
classification was approved. An approved sole community hospital must 
notify the MAC if any change that is specified in paragraph (b)(3)(ii) 
of this section occurs. If CMS determines that a sole community hospital 
failed to comply with this requirement, CMS will cancel the hospital's 
classification as a sole community hospital effective with the date that 
the hospital no longer met the criteria for such classification, 
consistent with the provisions of Sec.  405.1885 of this chapter.
    (ii) A sole community hospital must report the following to the MAC 
within 30 days of the event:
    (A) The opening of a new hospital in its service area.
    (B) The opening of a new road between itself and a like provider 
within 35 miles.
    (C) An increase in the number of beds to more than 50 if the 
hospital qualifies as a sole community hospital under paragraph 
(a)(1)(ii) of this section.
    (D) Its geographic classification changes.
    (E) Any changes to the driving conditions that result in a decrease 
in the amount of travel time between itself and a like provider if the 
hospital qualifies as a sole community hospital under paragraph (a)(3) 
of this section.
    (iii) A sole community hospital must report to the MAC if it becomes 
aware of any change that would affect its classification as a sole 
community hospital beyond the events listed in paragraph (b)(3)(ii) of 
this section within 30 days of the event. If CMS determines that a sole 
community hospital has failed to comply with this requirement, CMS will 
cancel the hospital's classification as a sole community hospital

[[Page 654]]

effective with the date the hospital became aware of the event that 
resulted in the sole community hospital no longer meeting the criteria 
for such classification, consistent with the provisions of Sec.  
405.1885 of this chapter.
    (iv) A sole community hospital must report to the MAC any factor or 
information that could have affected its initial classification as a 
sole community hospital.
    (A) If CMS determines that a sole community hospital has failed to 
comply with the requirement of paragraph ((b)(3)(iv) of this section, 
CMS may cancel the hospital's classification as a sole community 
hospital effective with the date the hospital failed to meet the 
criteria for such classification, consistent with the provisions of 
Sec.  405.1885 of this chapter.
    (B) Effective on or after October 1, 2012, if a hospital reports to 
CMS any factor or information that could have affected its initial 
determination and CMS determines that the hospital should not have 
qualified for sole community hospital status, CMS will cancel the sole 
community hospital status effective 30 days from the date of the 
determination.
    (4) Cancellation of classification. (i) A hospital may at any time 
request cancellation of its classification as a sole community hospital, 
and be paid at rates determined under subparts D and E of this part, as 
appropriate.
    (ii) The cancellation becomes effective no later than 30 days after 
the date the hospital submits its request.
    (iii) If a hospital requests that its sole community hospital 
classification be cancelled, it may not be reclassified as a sole 
community hospital unless it meets the following conditions:
    (A) At least one full year has passed since the effective date of 
its cancellation.
    (B) The hospital meets the qualifying criteria set forth in 
paragraph (a) of this section in effect at the time it reapplies.
    (5) Automatic classification as a sole community hospital. A 
hospital that has been granted an exemption from the hospital cost 
limits before October 1, 1983, or whose request for the exemption was 
received by the appropriate intermediary before October 1, 1983, and was 
subsequently approved, is automatically classified as a sole community 
hospital unless that classification has been cancelled under paragraph 
(b)(3) of this section, or there is a change in the circumstances under 
which the classification was approved.
    (c) Terminology. As used in this section--
    (1) The term miles means the shortest distance in miles measured 
over improved roads. An improved road for this purpose is any road that 
is maintained by a local, State, or Federal government entity and is 
available for use by the general public. An improved road includes the 
paved surface up to the front entrance of the hospital.
    (2) The term like hospital means a hospital furnishing short-term, 
acute care. Effective with cost reporting periods beginning on or after 
October 1, 2002, for purposes of a hospital seeking sole community 
hospital designation, CMS will not consider the nearby hospital to be a 
like hospital if the total inpatient days attributable to units of the 
nearby hospital that provides a level of care characteristic of the 
level of care payable under the acute care hospital inpatient 
prospective payment system are less than or equal to 8 percent of the 
similarly calculated total inpatient days of the hospital seeking sole 
community hospital designation.
    (3) The term service area means the area from which a hospital draws 
at least 75 percent of its inpatients during the most recent 12-month 
cost reporting period ending before it applies for classification as a 
sole community hospital. If the most recent cost reporting period ending 
before the hospital applies for classification as a sole community 
hospital is for less than 12 months, the hospital's most recent 12-month 
or longer cost reporting period before the short period is used.
    (d) Determining prospective payment rates for inpatient operating 
costs for sole community hospitals--(1) General rule. For cost reporting 
periods beginning on or after April 1, 1990, a sole community hospital 
is paid based on whichever of the following amounts yields the greatest 
aggregate payment for the cost reporting period:

[[Page 655]]

    (i) The Federal payment rate applicable to the hospitals as 
determined under subpart D of this part.
    (ii) The hospital-specific rate as determined under Sec.  412.73.
    (iii) The hospital-specific rate as determined under Sec.  412.75.
    (iv) For cost reporting periods beginning on or after October 1, 
2000, the hospital-specific rate as determined under Sec.  412.77 
(calculated under the transition schedule set forth in paragraph (d)(2) 
of this section).
    (v) For cost reporting periods beginning on or after January 1, 
2009, the hospital-specific rate as determined under Sec.  412.78.
    (2) Transition of FY 1996 hospital-specific rate. The MAC calculates 
the hospital-specific rate determined on the basis of the fiscal year 
1996 base period rate as follows:
    (i) For Federal fiscal year 2001, the hospital-specific rate is the 
sum of 75 percent of the greater of the amounts specified in paragraph 
(d)(1)(i), (d)(1)(ii), or (d)(1)(iii) of this section, plus 25 percent 
of the hospital-specific rate as determined under Sec.  412.77.
    (ii) For Federal fiscal year 2002, the hospital-specific rate is the 
sum of 50 percent of the greater of the amounts specified in paragraph 
(d)(1)(i), (d)(1)(ii), or (d)(1)(iii) of this section, plus 50 percent 
of the hospital-specific rate as determined under Sec.  412.77.
    (iii) For Federal fiscal year 2003, the hospital-specific rate is 
the sum of 25 percent of the greater of the amounts specified in 
paragraph (d)(1)(i), (d)(1)(ii), or (d)(1)(iii) of this section, plus 75 
percent of the hospital-specific rate as determined under Sec.  412.77.
    (iv) For Federal fiscal year 2004 and any subsequent fiscal years, 
the hospital-specific rate is 100 percent of the hospital-specific rate 
specified in paragraph (d)(1)(iv) of this section.
    (3) Adjustment to payments. A sole community hospital may receive an 
adjustment to its payments to take into account a significant decrease 
in the number of discharges, as described in paragraph (e) of this 
section.
    (e) Additional payments to sole community hospitals experiencing a 
significant volume decrease. (1) For cost reporting periods beginning on 
or after October 1, 1983, the MAC provides for a payment adjustment for 
a sole community hospital for any cost reporting period during which the 
hospital experiences, due to circumstances as described in paragraph 
(e)(2) of this section a more than five percent decrease in its total 
discharges of inpatients as compared to its immediately preceding cost 
reporting period. If either the cost reporting period in question or the 
immediately preceding cost reporting period is other than a 12-month 
cost reporting period, the MAC must convert the discharges to a monthly 
figure and multiply this figure by 12 to estimate the total number of 
discharges for a 12-month cost reporting period.
    (2) To qualify for a payment adjustment on the basis of a decrease 
in discharges, a sole community hospital must submit its request no 
later than 180 days after the date on the MAC's Notice of Amount of 
Program Reimbursement--
    (i) Submit to the MAC documentation demonstrating the size of the 
decrease in discharges, and the resulting effect on per discharge costs; 
and
    (ii) Show that the decrease is due to circumstances beyond the 
hospital's control.
    (3) Effective for cost reporting periods beginning before October 1, 
2017, the MAC determines a lump sum adjustment amount not to exceed the 
difference between the hospital's Medicare inpatient operating costs and 
the hospital's total DRG revenue for inpatient operating costs based on 
DRG-adjusted prospective payment rates for inpatient operating costs 
(including outlier payments for inpatient operating costs determined 
under subpart F of this part and additional payments made for inpatient 
operating costs for hospitals that serve a disproportionate share of 
low-income patients as determined under Sec.  412.106 and for indirect 
medical education costs as determined under Sec.  412.105). Effective 
for cost reporting periods beginning on or after October 1, 2017, the 
MAC determines a lump sum adjustment amount equal to the difference 
between the hospital's fixed Medicare inpatient operating costs and the 
hospital's total MS-DRG revenue based on MS-DRG-adjusted prospective 
payment rates for inpatient operating costs (including outlier

[[Page 656]]

payments for inpatient operating costs determined under subpart F of 
this part and additional payments made for inpatient operating costs for 
hospitals that serve a disproportionate share of low-income patients as 
determined under Sec.  412.106 and for indirect medical education costs 
as determined under Sec.  412.105) multiplied by the ratio of the 
hospital's fixed inpatient operating costs to its total inpatient 
operating costs.
    (i) In determining the adjustment amount, the MAC considers--
    (A) The individual hospital's needs and circumstances, including the 
reasonable cost of maintaining necessary core staff and services in view 
of minimum staffing requirements imposed by State agencies;
    (B) The hospital's fixed (and semi-fixed) costs, other than those 
costs paid on a reasonable cost basis under part 413 of this chapter; 
and
    (C) The length of time the hospital has experienced a decrease in 
utilization.
    (ii) The MAC makes its determination within 180 days from the date 
it receives the hospital's request and all other necessary information.
    (iii) The MAC determination is subject to review under subpart R of 
part 405 of this chapter.

[50 FR 12741, Mar. 29, 1985]

    Editorial Note: For Federal Register citations affecting Sec.  
412.92, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.  412.96  Special treatment: Referral centers.

    (a) Criteria for classification as a referral center: Basic rule. 
CMS classifies a hospital as a referral center only if the hospital is a 
Medicare participating acute care hospital and meets the applicable 
criteria of paragraph (b) or (c) of this section.
    (b) Criteria for cost reporting periods beginning on or after 
October 1, 1983. The hospital meets either of the following criteria:
    (1) The hospital is located in a rural area (as defined in subpart D 
of this part) and has the following number of beds, as determined under 
the provisions of Sec.  412.105(b) available for use:
    (i) Effective for discharges occurring before April 1, 1988, the 
hospital has 500 or more beds.
    (ii) Effective for discharges occurring on or after April 1, 1988, 
the hospital has 275 or more beds during its most recently completed 
cost reporting period unless the hospital submits written documentation 
with its application that its bed count has changed since the close of 
its most recently completed cost reporting period for one or more of the 
following reasons:
    (A) Merger of two or more hospitals.
    (B) Reopening of acute care beds previously closed for renovation.
    (C) Transfer to the prospective payment system of acute care beds 
previously classified as part of an excluded unit.
    (D) Expansion of acute care beds available for use and permanently 
maintained for lodging inpatients, excluding beds in corridors and other 
temporary beds.
    (2) The hospital shows that--(i) At least 50 percent of its Medicare 
patients are referred from other hospitals or from physicians not on the 
staff of the hospital; and
    (ii) At least 60 percent of the hospital's Medicare patients live 
more than 25 miles from the hospital, and at least 60 percent of all the 
services that the hospital furnishes to Medicare beneficiaries are 
furnished to beneficiaries who live more than 25 miles from the 
hospital.
    (c) Alternative criteria. For cost reporting periods beginning on or 
after October 1, 1985, a hospital that does not meet the criteria of 
paragraph (b) of this section is classified as a referral center if it 
is located in a rural area (as defined in subpart D of this part) and 
meets the criteria specified in paragraphs (c)(1) and (c)(2) of this 
section and at least one of the three criteria specified in paragraphs 
(c)(3), (c)(4), and (c)(5) of this section.
    (1) Case-mix index. CMS sets forth national and regional case-mix 
index values in each year's annual notice of prospective payment rates 
published under Sec.  412.8(b). The methodology CMS uses to calculate 
these criteria is described in paragraph (h) of this section. The case-
mix index value to be used for an

[[Page 657]]

individual hospital in the determination of whether it meets the case-
mix index criteria is that calculated by CMS from the hospital's own 
billing records for Medicare discharges as processed by the fiscal 
intermediary and submitted to CMS. The hospital's case-mix index for 
discharges (not including discharges from units excluded from the 
prospective payment system under subpart B of this part) during the same 
Federal fiscal year used to compute the case mix index values under 
paragraph (h) of this section must be at least equal to--
    (i) For hospitals applying for rural referral center status for cost 
reporting periods beginning on or after October 1, 1985 and before 
October 1, 1986, the national or regional case-mix index value; or
    (ii) For hospitals applying for rural referral center status for 
cost--reporting periods beginning on or after October 1, 1986, the 
national case-mix index value as established by CMS or the median case-
mix index value for urban hospitals located in each region. In 
calculating the median case-mix index for each region, CMS excludes the 
case-mix indexes of hospitals receiving indirect medical education 
payments as provided in Sec.  412.105.
    (2) Number of discharges. (i) CMS sets forth the national and 
regional number of discharges in each year's annual notice of 
prospective payment rates published under Sec.  412.8(b). The 
methodology CMS uses to calculate these criteria is described in 
paragraph (i) of this section. Except as provided in paragraph 
(c)(2)(ii) of this section for an osteopathic hospital, for the 
hospital's cost reporting period that began during the same fiscal year 
as the cost reporting periods used to compute the regional median 
discharges under paragraph (i) of this section, its number of discharges 
(not including discharges from units excluded from the prospective 
payments system under subpart B of this part or from newborn units) is 
at least equal to--
    (A) For hospitals applying for rural referral center status for cost 
reporting periods beginning on or after October 1, 1985 and before 
October 1, 1986, the number of discharges under either the national or 
regional criterion; or
    (B) For hospitals applying for rural referral center status for cost 
reporting periods beginning on or after October 1, 1986, 5,000 
discharges or, if less, the median number of discharges for urban 
hospitals located in each region.
    (ii) For cost reporting periods beginning on or after January 1, 
1986, an osteopathic hospital, recognized by the American Osteopathic 
Healthcare Association (or any successor organization), that is located 
in a rural area must have at least 3,000 discharges during its cost 
reporting period that began during the same fiscal year as the cost 
reporting periods used to compute the regional median discharges under 
paragraph (i) of this section to meet the number of discharges 
criterion.
    (iii) If the hospital's cost reporting period that began during the 
same fiscal year as the cost reporting periods used to compute the 
regional median discharges under paragraph (i) of this section is for 
less than 12 months or longer than 12 months, the hospital's number of 
discharges for that cost reporting period will be annualized to estimate 
the total number of discharges for a 12-month cost reporting period.
    (3) Medical staff. More than 50 percent of the hospital's active 
medical staff are specialists who meet one of the following conditions:
    (i) Are certified as specialists by one of the Member Boards of the 
American Board of Medical Specialties or the Advisory Board of 
Osteopathic Specialists.
    (ii) Have completed the current training requirements for admission 
to the certification examination of one of the Member Boards of the 
American Board of Medical Specialties or the Advisory Board of 
Osteopathic Specialists.
    (iii) Have successfully completed a residency program in a medical 
specialty accredited by the Accreditation Council of Graduate Medical 
Education or the American Osteopathic Association.
    (4) Source of inpatients. At least 60 percent of all its discharges 
are for inpatients who reside more than 25 miles from the hospital.
    (5) Volume of referrals. At least 40 percent of all inpatients 
treated at the

[[Page 658]]

hospital are referred from other hospitals or from physicians not on the 
hospital's staff.
    (d) Criteria for hospitals that have remote location(s). For a 
hospital with a main campus and one or more remote locations under a 
single provider agreement where services are provided and billed under 
the inpatient hospital prospective payment system and that meets the 
provider-based criteria at Sec.  413.65 of this chapter as a main campus 
and a remote location of a hospital, combined data from the main campus 
and its remote location(s) are required to demonstrate that the criteria 
specified in paragraphs (b)(1) and (2) and (c)(1) through (5) of this 
section are met. For the rural location criteria specified in paragraphs 
(b)(1) and (c) of this section and the mileage criteria specified in 
paragraphs (b)(2)(ii) and (c)(4) of this section, the hospital must 
demonstrate that the main campus and its remote locations each 
independently satisfy those requirements.
    (e) Payment to rural referral centers. Effective for discharges 
occurring on or after April 1, 1988, and before October 1, 1994, a 
hospital that is located in a rural area and meets the criteria of 
paragraphs (b)(1), (b)(2) or (c) of this section is paid prospective 
payments for inpatient operating costs per discharge based on the 
applicable other urban payment rates as determined in accordance with 
Sec.  412.63, as adjusted by the hospital's area wage index.
    (f) [Reserved]
    (g) Hospital cancellation of referral center status. (1) A hospital 
may at any time request cancellation of its status as a referral center 
and be paid prospective payments per discharge based on the applicable 
rural rate, as determined in accordance with subpart D of this part.
    (2) The cancellation becomes effective no later than 30 days after 
the date the hospital submits its request.
    (3) If a hospital requests that its referral center status be 
canceled, it may not be reclassified as a referral center unless it 
meets the qualifying criteria set forth in paragraph (a) of this section 
in effect at the time it reapplies.
    (4) A hospital that submits a written request on or after October 1, 
2007, to cancel its reclassification under Sec.  412.103(g) is deemed to 
have cancelled its status as a rural referral center effective on the 
same date the cancellation under Sec.  412.103(g) takes effect. The 
provision of this paragraph (g)(4) applies to hospitals that qualify as 
rural referral centers under Sec.  412.96 based on rural status acquired 
under Sec.  412.103.
    (h) Methodology for calculating case-mix index criteria. CMS 
calculates the national and regional case-mix index value criteria as 
described in paragraphs (h)(1) through (h)(4) of this section.
    (1) Updating process. CMS updates the national and regional case-mix 
index standards using the best available data from hospitals subject to 
the prospective payment system for the Federal fiscal year.
    (2) Source of data. In making the calculations described in 
paragraph (h)(1) of this section, CMS uses all inpatient hospital bills 
received for discharges subject to prospective payment during the 
Federal fiscal year being monitored.
    (3) Effective date. CMS sets forth the national and regional 
criteria in the annual notice of prospective payment rates published 
under Sec.  412.8(b). These criteria are used to determine if a hospital 
qualifies for referral center status for cost reporting periods 
beginning on or after October 1 of the Federal fiscal year to which the 
notice applies.
    (i) Methodology for calculating number of discharges criteria. For 
purposes of determining compliance with the national or regional number 
of discharges criterion under paragraph (c)(2) of this section, CMS 
calculates the criteria as follows:
    (1) Updating process. CMS updates the national and regional number 
of discharges using the best available data for levels of admissions or 
discharges or both.
    (2) Source of data. In making the calculations described in 
paragraph (i)(1) of this section, CMS uses the best available hospital 
admissions or discharge data.
    (3) Annual notice. CMS sets forth the national and regional criteria 
in the annual notice of prospective payment rates published under Sec.  
412.8(b). These criteria are compared to an applying hospital's number 
of discharges for the

[[Page 659]]

same cost reporting period used to develop the regional criteria in this 
section in determining if the hospital qualifies for referral center 
status for cost reporting periods beginning on or after October 1 of the 
Federal fiscal year to which the notice applies.

[50 FR 12741, Mar. 29, 1985]

    Editorial Note: For Federal Register citations affecting Sec.  
412.96, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.  412.98  [Reserved]



Sec.  412.100  Special treatment: Renal transplantation centers.

    (a) Adjustments for renal transplantation centers. (1) CMS adjusts 
the prospective payment rates for inpatient operating costs determined 
under subparts D and E of this part for hospitals approved as renal 
transplantation centers (described at Sec. Sec.  405.2170 and 405.2171 
of this chapter) to remove the estimated net expenses associated with 
kidney acquisition.
    (2) Kidney acquisition costs are treated apart from the prospective 
payment rate for inpatient operating costs, and payment to the hospital 
is adjusted in each reporting period to reflect an amount necessary to 
compensate the hospital for reasonable expenses of kidney acquisition.
    (b) Costs of kidney acquisition. Expenses recognized under this 
section include costs of acquiring a kidney, from a live donor or a 
cadaver, irrespective of whether the kidney was obtained by the hospital 
or through an organ procurement agency. These costs include--
    (1) Tissue typing, including tissue typing furnished by independent 
laboratories;
    (2) Donor and beneficiary evaluation;
    (3) Other costs associated with excising kidneys, such as donor 
general routine and special care services;
    (4) Operating room and other inpatient ancillary services applicable 
to the donor;
    (5) Preservation and perfusion costs;
    (6) Charges for registration of beneficiary with a kidney transplant 
registry;
    (7) Surgeons' fees for excising cadaver kidneys;
    (8) Transportation;
    (9) Costs of kidneys acquired from other providers or kidney 
procurement organizations;
    (10) Hospital costs normally classified as outpatient costs 
applicable to kidney excisions (services include donor and donee tissue 
typing, work-up, and related services furnished prior to admission);
    (11) Costs of services applicable to kidney excisions which are 
rendered by residents and interns not in approved teaching programs; and
    (12) All pre-admission physicians services, such as laboratory, 
electroencephalography, and surgeon fees for cadaver excisions, 
applicable to kidney excisions including the costs of physicians 
services.

[50 FR 12741, Mar. 29, 1985, as amended at 57 FR 39824, Sept. 1, 1992]



Sec.  412.101  Special treatment: Inpatient hospital payment adjustment 
for low-volume hospitals.

    (a) Definitions. Beginning in FY 2011, the terms used in this 
section are defined as follows:
    Medicare discharges means discharge of inpatients entitled to 
Medicare Part A, including discharges associated with individuals whose 
inpatient benefits are exhausted or whose stay was not covered by 
Medicare and also discharges of individuals enrolled in a MA 
organization under Medicare Part C.
    Road miles means ``miles'' as defined in Sec.  412.92(c)(1).
    (b) General considerations. (1) CMS provides an additional payment 
to a qualifying hospital for the higher incremental costs associated 
with a low volume of discharges. The amount of any additional payment 
for a qualifying hospital is calculated in accordance with paragraph (c) 
of this section.
    (2) In order to qualify for this adjustment, a hospital must meet 
the following criteria, subject to the provisions of paragraph (e) of 
this section:
    (i) For FY 2005 through FY 2010 and FY 2023 and subsequent fiscal 
years, a hospital must have fewer than 200 total discharges, which 
includes Medicare and non-Medicare discharges, during the fiscal year, 
based on the hospital's most recently submitted cost report, and be 
located more than 25 road miles

[[Page 660]]

(as defined in paragraph (a) of this section) from the nearest 
``subsection (d)'' (section 1886(d) of the Act) hospital.
    (ii) For FY 2011 through FY 2018, a hospital must have fewer than 
1,600 Medicare discharges, as defined in paragraph (a) of this section, 
during the fiscal year, based on the hospital's Medicare discharges from 
the most recently available MedPAR data as determined by CMS, and be 
located more than 15 road miles, as defined in paragraph (a) of this 
section, from the nearest ``subsection (d)'' (section 1886(d) of the 
Act) hospital.
    (iii) For FY 2019 through FY 2022, a hospital must have fewer than 
3,800 total discharges, which includes Medicare and non-Medicare 
discharges, during the fiscal year, based on the hospital's most 
recently submitted cost report, and be located more than 15 road miles 
(as defined in paragraph (a) of this section) from the nearest 
``subsection (d)'' (section 1886(d) of the Act) hospital.
    (3) In order to qualify for the adjustment, a hospital must provide 
its fiscal intermediary or Medicare administrative contractor with 
sufficient evidence that it meets the distance requirement specified 
under paragraph (b)(2) of this section. The fiscal intermediary or 
Medicare administrative contractor will base its determination of 
whether the distance requirement is satisfied upon the evidence 
presented by the hospital and other relevant evidence, such as maps, 
mapping software, and inquiries to State and local police, 
transportation officials, or other government officials.
    (c) Determination of the adjustment amount. The low-volume 
adjustment for hospitals that qualify under paragraph (b) of this 
section is as follows for the applicable fiscal year:
    (1) For FY 2005 through FY 2010 and FY 2023 and subsequent fiscal 
years, the adjustment is an additional 25 percent for each Medicare 
discharge.
    (2) For FY 2011 through FY 2018, the adjustment is as follows:
    (i) For low-volume hospitals with 200 or fewer Medicare discharges 
(as defined in paragraph (a) of this section), the adjustment is an 
additional 25 percent for each Medicare discharge.
    (ii) For low-volume hospitals with Medicare discharges (as defined 
in paragraph (a) of this section) of more than 200 and fewer than 1,600, 
the adjustment for each Medicare discharge is an additional percent 
calculated using the formula [(4/14)--(number of Medicare discharges/
5600)]. The ``number of Medicare discharges'' is determined as described 
in paragraph (b)(2)(ii) of this section.
    (3) For FY 2019 through FY 2022, the adjustment is as follows:
    (i) For low-volume hospitals with 500 or fewer total discharges, 
which includes Medicare and non-Medicare discharges, during the fiscal 
year, based on the hospital's most recently submitted cost report, the 
adjustment is an additional 25 percent for each Medicare discharge.
    (ii) For low-volume hospitals with more than 500 and fewer than 
3,800 total discharges, which includes Medicare and non-Medicare 
discharges, during the fiscal year, based on the hospital's most 
recently submitted cost report, the adjustment for each Medicare 
discharge is an additional percent calculated using the formula [(95/
330)-(number of total discharges/13,200)]. ``Total discharges'' is 
determined as described in paragraph (b)(2)(iii) of this section.
    (d) Eligibility of new hospitals for the adjustment. For FYs 2005 
through 2010 and FY 2019 and subsequent fiscal years, a new hospital 
will be eligible for a low-volume adjustment under this section once it 
has submitted a cost report for a cost reporting period that indicates 
that it meets discharge requirements during the applicable fiscal year 
and has provided its Medicare administrative contractor with sufficient 
evidence that it meets the distance requirement, as specified in 
paragraph (b)(2) of this section.
    (e) Special treatment regarding hospitals operated by the Indian 
Health Service (IHS) or a Tribe. (1) For discharges occurring in FY 2018 
and subsequent fiscal years--
    (i) A hospital operated by the IHS or a Tribe will be considered to 
meet the applicable mileage criterion specified under paragraph (b)(2) 
of this section if it is located more than the specified number of road 
miles from the nearest

[[Page 661]]

subsection (d) hospital operated by the IHS or a Tribe.
    (ii) A hospital, other than a hospital operated by the IHS or a 
Tribe, will be considered to meet the applicable mileage criterion 
specified under paragraph (b)(2) of this section if it is located more 
than the specified number of road miles from the nearest subsection (d) 
hospital other than a subsection (d) hospital operated by the IHS or a 
Tribe.
    (2) Subject to the requirements set forth in Sec.  405.1885 of this 
chapter, a hospital may request the application of the policy described 
in paragraph (e)(1) of this section for discharges occurring in FY 2011 
through FY 2017.

[75 FR 50414, Aug. 16, 2010, as amended at 78 FR 50965, Aug. 19, 2013; 
49 FR 15030, Mar. 18, 2014; 79 FR 50352, Aug. 22, 2014; 80 FR 49767, 
Aug. 17, 2015; 82 FR 38511, Aug. 14, 2017; 83 FR 41702, Aug. 17, 2018; 
84 FR 42613, Aug. 16, 2019]



Sec.  412.102  Special treatment: Hospitals located in areas that are changing 
from urban to rural as a result of a geographic redesignation.

    An urban hospital that was part of an MSA, but was redesignated as 
rural as a result of the most recent OMB standards for delineating 
statistical areas adopted by CMS, may receive an adjustment to its rural 
Federal payment amount for operating costs for 2 successive fiscal years 
as provided in paragraphs (a) and (b) of this section.
    (a) First year adjustment. (1) Effective on or after October 1, 1983 
and before October 1, 2014, the hospital's rural average standardized 
amount and disproportionate share payments as described in Sec.  412.106 
are adjusted on the basis of an additional amount that equals two-thirds 
of the difference between the urban standardized amount and 
disproportionate share payments applicable to the hospital before its 
geographic redesignation and the rural standardized amount and 
disproportionate share payments otherwise applicable to the Federal 
fiscal year for which the adjustment is made.
    (2) Effective on or after October 1, 2014, the hospital's rural 
disproportionate share payments as described in Sec.  412.106 are 
adjusted on the basis of an additional amount that equals two-thirds of 
the difference between the disproportionate share payments as an urban 
hospital applicable to the hospital before its geographic redesignation 
to a rural area as a result of implementation of the most recent OMB 
standards for delineating statistical areas adopted by CMS and the rural 
disproportionate share payment otherwise applicable to the Federal 
fiscal year for which the adjustment is made.
    (b) Second year adjustment. (1) Effective on or after October 1, 
1983 and before October 1, 2014, if a hospital's status continues to be 
rural as a result of geographic redesignation, its rural average 
standardized amount and disproportionate share payments are adjusted on 
the basis of an additional amount that equals one-third of the 
difference between the urban standardized amount and disproportionate 
share payments applicable to the hospital before its redesignation and 
the rural standardized amounts and disproportionate share payments 
otherwise applicable to the Federal fiscal year for which the adjustment 
is made.
    (2) Effective on or after October 1, 2014, if a hospital's status 
continues to be rural as a result of geographic redesignation, its 
disproportionate share payments are adjusted on the basis of an 
additional amount that equals one-third of the difference between the 
disproportionate share payments applicable to the hospital before its 
geographic redesignation to a rural area as a result of implementation 
of the most recent OMB standards for delineating statistical areas 
adopted by CMS and the rural disproportionate share payments otherwise 
applicable to the Federal fiscal year for which the adjustment is made.

[79 FR 50353, Aug. 22, 2014]



Sec.  412.103  Special treatment: Hospitals located in urban areas 
and that apply for reclassification as rural.

    (a) General criteria. A prospective payment hospital that is located 
in an urban area (as defined in subpart D of this part) may be 
reclassified as a rural hospital if it submits an application in 
accordance with paragraph (b) of this section and meets any of the 
following conditions:

[[Page 662]]

    (1) The hospital is located in a rural census tract of a 
Metropolitan Statistical Area (MSA) as determined under the most recent 
version of the Goldsmith Modification, the Rural-Urban Commuting Area 
codes, as determined by the Office of Rural Health Policy (ORHP) of the 
Health Resources and Services Administration, which is available via the 
ORHP Web site at: http://www.ruralhealth.hrsa.gov or from the U.S. 
Department of Health and Human Services, Health Resources and Services 
Administration, Office of Rural Health Policy, 5600 Fishers Lane, Room 
9A-55, Rockville, MD 20857.
    (2) The hospital is located in an area designated by any law or 
regulation of the State in which it is located as a rural area, or the 
hospital is designated as a rural hospital by State law or regulation.
    (3) The hospital would qualify as a rural referral center as set 
forth in Sec.  412.96, or as a sole community hospital as set forth in 
Sec.  412.92, if the hospital were located in a rural area.
    (4) For any period after September 30, 2004 and before October 1, 
2006, a CAH in a county that, in FY 2004, was not part of a MSA as 
defined by the Office of Management and Budget, but as of FY 2005 was 
included as part of an MSA as a result of the most recent census data 
and implementation of the new MSA definitions announced by OMB on June 
6, 2003, may be reclassified as being located in a rural area for 
purposes of meeting the rural location requirement in Sec.  485.610(b) 
of this chapter if it meets any of the requirements in paragraphs 
(a)(1), (a)(2), or (a)(3) of this section.
    (5) For any period after September 30, 2009, and before October 1, 
2011, a CAH in a county that, in FY 2009, was not part of an MSA as 
defined by the Office of Management and Budget, but, as of FY 2010, was 
included as part of an MSA as a result of the most recent census data 
and implementation of the new MSA definitions announced by OMB on 
November 20, 2008, may be reclassified as being located in a rural area 
for purposes of meeting the rural location requirement in Sec.  
485.610(b) of this chapter if it meets any of the requirements under 
paragraph (a)(1), (a)(2), or (a)(3) of this section.
    (6) For any period on or after October 1, 2014, a CAH in a county 
that was not in an urban area as defined by the Office of Management and 
Budget (OMB), but was included in an urban area as a result of the most 
recent OMB standards for delineating statistical areas adopted by CMS 
and the most recent Census Bureau data, may be reclassified as being 
located in a rural area for purposes of meeting the rural location 
requirement at Sec.  485.610(b) of this chapter for a period of 2 years, 
beginning with the date of the implementation of the new labor market 
area delineations, if it meets any of the requirements under paragraph 
(a)(1), (a)(2), or (a)(3) of this section.
    (7) For a hospital with a main campus and one or more remote 
locations under a single provider agreement where services are provided 
and billed under the inpatient hospital prospective payment system and 
that meets the provider-based criteria at Sec.  413.65 of this chapter 
as a main campus and a remote location of a hospital, the hospital is 
required to demonstrate that the main campus and its remote location(s) 
each independently satisfy the location conditions specified in 
paragraphs (a)(1) and (2) of this section.
    (b) Application requirements--(1) Written application. A hospital 
seeking reclassification under this section must submit a complete 
application in writing to CMS in accordance with paragraphs (b)(2) and 
(b)(3) of this section.
    (2) Contents of application. An application is complete if it 
contains an explanation of how the hospital meets the condition that 
constitutes the basis of the request for reclassification set forth in 
paragraph (a) of this section, including data and documentation 
necessary to support the request.
    (3) Submission of application. An application may be submitted to 
the CMS Regional Office by the requesting hospital by mail or by 
facsimile or other electronic means.
    (4) Notification by CMS. Within 5 business days after receiving the 
hospital's application, the CMS Regional Office will send the hospital a 
letter acknowledging receipt, with a copy to the CMS Central Office.

[[Page 663]]

    (5) Filing date. The filing date of the application is the date CMS 
receives the application.
    (6) Lock-in date for the wage index calculation and budget 
neutrality. In order for a hospital to be treated as rural in the wage 
index and budget neutrality calculations under Sec.  412.64(e)(1)(ii), 
(e)(2) and (4), and (h) for the payment rates for the next Federal 
fiscal year, the hospital's application must be approved by the CMS 
Regional Office in accordance with the requirements of this section no 
later than 60 days after the public display date at the Office of the 
Federal Register of the inpatient prospective payment system proposed 
rule for the next Federal fiscal year.
    (c) CMS review. The CMS Regional Office will review the application 
and notify the hospital of its approval or disapproval of the request 
within 60 days of the filing date.
    (d) Effective dates of reclassification. (1) Except as specified in 
paragraph (d)(2) of this section, CMS will consider a hospital that 
satisfies any of the criteria set forth in paragraph (a) of this section 
as being located in the rural area of the State in which the hospital is 
located as of that filing date.
    (2) If a hospital's complete application is received in CMS by 
September 1, 2000, and satisfies any of the criteria set forth in 
paragraph (a) of this section, CMS will consider the filing date to be 
January 1, 2000.
    (e) Withdrawal of application. A hospital may withdraw an 
application at any time prior to the date of CMS's decision as set forth 
in paragraph (c) of this section.
    (f) Duration of classification. An approved reclassification under 
this section remains in effect without need for reapproval unless there 
is a change in the circumstances under which the classification was 
approved.
    (g) Cancellation of classification--(1) Hospitals other than rural 
referral centers. Except as provided in paragraph (g)(2) of this 
section--
    (i) A hospital may cancel its rural reclassification by submitting a 
written request to the CMS Regional Office not less than 120 days prior 
to the end of its current cost reporting period.
    (ii) The hospital's cancellation of the classification is effective 
beginning with the next full cost reporting period.
    (iii) The provisions of paragraphs (g)(1)(i) and (ii) of this 
section are effective for all written requests submitted by hospitals 
before October 1, 2019 to cancel rural reclassifications.
    (2) Hospitals classified as rural referral centers. For a hospital 
that was classified as a rural referral center under Sec.  412.96 based 
on rural reclassification under this section--
    (i) A hospital may cancel its rural reclassification by submitting a 
written request to the CMS Regional Office not less than 120 days prior 
to the end of a Federal fiscal year and after being paid as rural for at 
least one 12-month cost reporting period.
    (ii) The hospital's cancellation of the classification is not 
effective until it has been paid as rural for at least one 12-month cost 
reporting period, and not until the beginning of the Federal fiscal year 
following such 12-month cost reporting period.
    (iii) The provisions of paragraphs (g)(2)(i) and (ii) of this 
section are effective for all written requests submitted by hospitals on 
or after October 1, 2007 and before October 1, 2019, to cancel rural 
reclassifications.
    (3) Cancellation of rural reclassification on or after October 1, 
2019, and before October 1, 2021. For all written requests submitted by 
hospitals on or after October, 1, 2019, and before October 1, 2021, to 
cancel rural reclassifications, a hospital may cancel its rural 
reclassification by submitting a written request to the CMS Regional 
Office not less than 120 days prior to the end of a Federal fiscal year. 
The hospital's cancellation of the classification is effective beginning 
with the next Federal fiscal year.
    (4) Cancellation of rural reclassification on or after October 1, 
2021. For all written requests submitted by hospitals on or after 
October 1, 2021, to cancel rural reclassifications, a hospital may 
cancel its rural reclassification by submitting a written request to the 
CMS Regional Office not less than 1 calendar year after the effective 
date of the rural reclassification and not less than 120 days prior to 
the end of a Federal fiscal year. The hospital's cancellation of the

[[Page 664]]

classification is effective beginning with the next Federal fiscal year.
    (5) Special rule for hospitals that opt to receive county out-
migration adjustment. A rural reclassification will be considered 
canceled effective for the next Federal fiscal year when a hospital, by 
submitting a request to CMS within 45 days of the date of public display 
of the proposed rule for the next Federal fiscal year at the Office of 
the Federal Register, opts to accept and receives its county out-
migration wage index adjustment determined under section 1886(d)(13) of 
the Act in lieu of its geographic reclassification described under 
section 1886(d)(8)(B) of the Act.

[65 FR 47048, Aug. 1, 2000, as amended at 69 FR 49244, Aug. 11, 2004; 69 
FR 60252, Oct. 7, 2004; 70 FR 47486, Aug. 12, 2005; 72 FR 47411, Aug. 
22, 2007; 74 FR 43997, Aug. 27, 2009; 79 FR 50353, Aug. 22, 2014; 81 FR 
57267, Aug. 22, 2016; 83 FR 41703, Aug. 17, 2018; 84 FR 42613, Aug. 16, 
2019; 86 FR 45519, Aug. 13, 2021]



Sec.  412.104  Special treatment: Hospitals with high percentage 
of ESRD discharges.

    (a) Criteria for classification. CMS provides an additional payment 
to a hospital for inpatient services provided to ESRD beneficiaries who 
receive a dialysis treatment during a hospital stay, if the hospital has 
established that ESRD beneficiary discharges, excluding discharges 
classified into any of the following MS-DRGs, where the beneficiary 
received dialysis services during the inpatient stay, constitute 10 
percent or more of its total Medicare discharges:
    (1) MS-DRG 019 (Simultaneous Pancreas/Kidney Transplant with 
Hemodialysis).
    (2) MS-DRGs 650 and 651 (Kidney Transplant with Hemodialysis with 
MCC, without MCC, respectively).
    (3) MS-DRGs 682, 683, and 684 (Renal Failure with MCC, with CC, 
without CC/MCC, respectively).
    (b) Additional payment. A hospital that meets the criteria of 
paragraph (a) of this section is paid an additional payment for each 
ESRD beneficiary discharge except those excluded under paragraph (a) of 
this section.
    (1) The payment is based on the estimated weekly cost of dialysis 
and the average length of stay of ESRD beneficiaries for the hospital.
    (2) The estimated weekly cost of dialysis is the average number of 
dialysis sessions furnished per week during the 12-month period that 
ended June 30, 1983 multiplied by the average cost of dialysis for the 
same period.
    (3) The average cost of dialysis includes only those costs 
determined to be directly related to the dialysis service. (These costs 
include salary, employee health and welfare, drugs, supplies, and 
laboratory services.)
    (4) The average cost of dialysis is reviewed and adjusted, if 
appropriate, at the time the composite rate reimbursement for outpatient 
dialysis is reviewed.
    (5) The payment to a hospital equals the average length of stay of 
ESRD beneficiaries in the hospital, expressed as a ratio to one week, 
times the estimated weekly cost of dialysis multiplied by the number of 
ESRD beneficiary discharges except for those excluded under paragraph 
(a) of this section. This payment is made only on the Federal portion of 
the payment rate.

[50 FR 12741, Mar. 29, 1985, as amended at 57 FR 39824, Sept. 1, 1992; 
69 FR 49244, Aug. 11, 2004; 73 FR 48755, Aug. 19, 2008; 85 FR 59021, 
Sept. 18, 2020]



Sec.  412.105  Special treatment: Hospitals that incur indirect costs 
for graduate medical education programs.

    CMS makes an additional payment to hospitals for indirect medical 
education costs using the following procedures:
    (a) Basic data. CMS determines the following for each hospital:
    (1) The hospital's ratio of full-time equivalent residents (except 
as limited under paragraph (f) of this section) to the number of beds 
(as determined under paragraph (b) of this section).
    (i) Except for the special circumstances for Medicare GME affiliated 
groups, emergency Medicare GME affiliated groups, and new programs 
described in paragraphs (f)(1)(vi) and (f)(1)(vii) of this section for 
cost reporting periods beginning on or after October 1, 1997, and for 
the special circumstances for closed hospitals or closed programs 
described in paragraph (f)(1)(ix) of this section for cost reporting 
periods beginning on or after October 1, 2002, this ratio may not exceed

[[Page 665]]

the ratio for the hospital's most recent prior cost reporting period 
after accounting for the cap on the number of allopathic and osteopathic 
full-time equivalent residents as described in paragraph (f)(1)(iv) of 
this section, and adding to the capped numerator any dental and 
podiatric full-time equivalent residents.
    (ii)(A) For new programs started prior to October 1, 2012, the 
exception for new programs described in paragraph (f)(1)(vii) of this 
section applies to each new program individually for which the full-time 
equivalent cap may be adjusted based on the period of years equal to the 
minimum accredited length of each new program.
    (B) For new programs started on or after October 1, 2012, the 
exception for new programs described in paragraph (f)(1)(vii) of this 
section applies to each new program individually during the cost 
reporting periods prior to the beginning of the applicable hospital's 
cost reporting period that coincides with or follows the start of the 
sixth program year of the first new program started, for hospitals for 
which the full-time equivalent cap may be adjusted in accordance with 
Sec.  413.79(e)(1) of this chapter, and prior to the beginning of the 
applicable hospital's cost reporting period that coincides with or 
follows the start of the sixth program year of the each individual new 
program started, for hospitals for which the full-time equivalent cap 
may be adjusted in accordance with Sec.  413.79(e)(3) of this chapter.
    (iii) The exception for closed hospitals and closed programs 
described in paragraph (f)(1)(ix) of this section applies only through 
the end of the first 12-month cost reporting period in which the 
receiving hospital trains the displaced full-time equivalent residents.
    (iv) In the cost reporting period following the last year the 
receiving hospital's full-time equivalent cap is adjusted for the 
displaced resident(s), the resident-to-bed ratio cap in paragraph (a)(1) 
of this section is calculated as if the displaced full-time equivalent 
residents had not trained at the receiving hospital in the prior year.
    (2) The hospital's DRG revenue for inpatient operating costs based 
on DRG-adjusted prospective payment rates for inpatient operating costs, 
excluding outlier payments for inpatient operating costs determined 
under subpart F of this part and additional payments made under the 
provisions of Sec.  412.106.
    (b) Determination of the number of beds. For purposes of this 
section, the number of beds in a hospital is determined by counting the 
number of available bed days during the cost reporting period and 
dividing that number by the number of days in the cost reporting period. 
This count of available bed days excludes bed days associated with--
    (1) Beds in a unit or ward that is not occupied to provide a level 
of care that would be payable under the acute care hospital inpatient 
prospective payment system at any time during the 3 preceding months 
(the beds in the unit or ward are to be excluded from the determination 
of available bed days during the current month);
    (2) Beds in a unit or ward that is otherwise occupied (to provide a 
level of care that would be payable under the acute care hospital 
inpatient prospective payment system) that could not be made available 
for inpatient occupancy within 24 hours for 30 consecutive days;
    (3) Beds in excluded distinct part hospital units;
    (4) Beds otherwise countable under this section used for outpatient 
observation services, skilled nursing swing-bed services, or inpatient 
hospice services.
    (5) Beds or bassinets in the healthy newborn nursery; and
    (6) Custodial care beds.
    (c) Measurement for teaching activity. The factor representing the 
effect of teaching activity on inpatient operating costs equals .405 for 
discharges occurring on or after May 1, 1986.
    (d) Determination of education adjustment factor. Each hospital's 
education adjustment factor is calculated as follows:
    (1) Step one. A factor representing the sum of 1.00 plus the 
hospital's ratio of full-time equivalent residents to beds, as 
determined under paragraph (a)(1) of this section, excluding beds 
temporarily added during the time frame that the Public Health Emergency 
as defined in Sec.  400.200 of this chapter is in

[[Page 666]]

effect, is raised to an exponential power equal to the factor set forth 
in paragraph (c) of this section.
    (2) Step two. The factor derived from step one is reduced by 1.00.
    (3) Step three. The factor derived from completing steps one and two 
is multiplied by ``c'', and where ``c'' is equal to the following:
    (i) For discharges occurring on or after October 1, 1988, and before 
October 1, 1997, 1.89.
    (ii) For discharges occurring during fiscal year 1998, 1.72.
    (iii) For discharges occurring during fiscal year 1999, 1.6.
    (iv) For discharges occurring during fiscal year 2000, 1.47.
    (A) Each hospital receives an amount that is equal in the aggregate 
to the difference between the amount of payments made to the hospital if 
``c'' equaled 1.6, rather than 1.47.
    (B) The payment of this amount will not affect any other payments, 
determinations, or budget neutrality adjustments.
    (v) For fiscal year 2001--
    (A) For discharges occurring on or after October 1, 2000 and before 
April 1, 2001, 1.54.
    (B) For discharges occurring on or after April 1, 2001 and before 
October 1, 2001, the adjustment factor is determined as if ``c'' equaled 
1.66, rather than 1.54. This payment increase will not apply to 
discharges occurring after fiscal year 2001 and will not be taken into 
account in calculating the payment amounts applicable for discharges 
occurring after fiscal year 2001.
    (vi) For discharges occurring during fiscal year 2002, 1.6.
    (vii) For discharges occurring on or after October 1, 2002 and 
before April 1, 2004, 1.35.
    (viii) For discharges occurring on or after April 1, 2004 and before 
October 1, 2004, 1.47.
    (ix) For discharges occurring during fiscal year 2005, 1.42.
    (x) For discharges occurring during fiscal year 2006, 1.37.
    (xi) For discharges occurring during fiscal year 2007, 1.32.
    (xii) For discharges occurring during fiscal year 2008 and 
thereafter, 1.35.
    (4) For discharges occurring on or after July 1, 2005, with respect 
to FTE residents added as a result of increases in the FTE resident cap 
under paragraph (f)(1)(iv)(C) of this section, the factor derived from 
completing steps one and two is multiplied by `c', where `c' is equal to 
0.66.
    (e)(1) Determination of payment amount. Each hospital's indirect 
medical education payment under the prospective payment system for 
inpatient operating costs is determined by multiplying the total DRG 
revenue for inpatient operating costs, as determined under paragraph 
(a)(2) of this section, by the applicable education adjustment factor 
derived in paragraph (d) of this section.
    (2) For discharges occurring on or after July 1, 2005, a hospital 
that counts additional residents as a result of an increase in its FTE 
resident cap under paragraph (f)(1)(iv)(C) of this section will receive 
indirect medical education payments based on the sum of the following 
two indirect medical education adjustment factors:
    (i) An adjustment factor that is calculated using the schedule of 
formula multipliers in paragraph (d)(3) of this section and the 
hospital's FTE resident count, not including residents attributable to 
an increase in its FTE cap under paragraph (f)(1)(iv)(C) under this 
section; and
    (ii) An adjustment factor that is calculated using the applicable 
formula multiplier under paragraph (d)(4) of this section, and the 
additional number of FTE residents that are attributable to the increase 
in the hospital's FTE resident cap under paragraph (f)(1)(iv)(C) in this 
section.
    (f) Determining the total number of full-time equivalent residents 
for cost reporting periods beginning on or after July 1, 1991. (1) For 
cost reporting periods beginning on or after July 1, 1991, the count of 
full-time equivalent residents for the purpose of determining the 
indirect medical education adjustment is determined as follows:
    (i) The resident must be enrolled in an approved teaching program. 
An approved teaching program is one that meets one of the following 
requirements:
    (A) Is approved by one of the national organizations listed in Sec.  
415.152 of this chapter.

[[Page 667]]

    (B) May count towards certification of the participant in a 
specialty or subspecialty listed in the current edition of either of the 
following publications:
    (1) The Directory of Graduate Medical Education Programs published 
by the American Medical Association.
    (2) The Annual Report and Reference Handbook published by the 
American Board of Medical Specialties.
    (C) Is approved by the Accreditation Council for Graduate Medical 
Education (ACGME) as a fellowship program in geriatric medicine.
    (D) Is a program that would be accredited except for the accrediting 
agency's reliance upon an accreditation standard that requires an entity 
to perform an induced abortion or require, provide, or refer for 
training in the performance of induced abortions, or make arrangements 
for such training, regardless of whether the standard provides 
exceptions or exemptions.
    (ii) In order to be counted, the resident must be assigned to one of 
the following areas:
    (A) The portion of the hospital subject to the hospital inpatient 
prospective payment system.
    (B) The outpatient department of a hospital that meets provider-
based status as defined at Sec.  413.65(a)(2) of this subchapter.
    (C) The portions of a hospital located in Puerto Rico that are 
subject to the hospital inpatient prospective payment system, including 
off-campus outpatient departments that meet provider-based status as 
defined at Sec.  413.65(a)(2) of this subchapter.
    (D) The portions of a hospital that are reimbursed under a 
reimbursement system authorized under section 1814(b)(3) of the Act.
    (E) Effective for discharges occurring on or after October 1, 1997, 
the time spent by a resident in a nonprovider setting in patient care 
activities, as defined in Sec.  413.75(b) of this subchapter, under an 
approved medical residency training program is counted towards the 
determination of full-time equivalency if the criteria set forth in 
Sec.  413.78(c), (d), (e), (f), or (g) of this subchapter, as 
applicable, are met.
    (iii)(A) Full-time equivalent status is based on the total time 
necessary to fill a residency slot. No individual may be counted as more 
than one full-time equivalent. If a resident is assigned to more than 
one hospital, the resident counts as a partial full-time equivalent 
based on the proportion of time worked in any areas of the hospital 
listed in paragraph (f)(1)(ii) of this section to the total time worked 
by the resident. A hospital cannot claim the time spent by residents 
training at another hospital, unless the exception provided at Sec.  
413.78(i) of this chapter applies. A part-time resident or one working 
in an area of the hospital other than those listed under paragraph 
(f)(1)(ii) of this section (such as a freestanding family practice 
center or an excluded hospital unit) would be counted as a partial full-
time equivalent based on the proportion of time assigned to an area of 
the hospital listed in paragraph (f)(1)(ii) of this section, compared to 
the total time necessary to fill a full-time residency slot.
    (B) The time spent by a resident in research that is not associated 
with the treatment or diagnosis of a particular patient is not 
countable.
    (C) Effective for cost reporting periods beginning on or after 
January 1, 1983, except for research activities described in paragraph 
(f)(1)(iii)(B) of this section, the time a resident is training in an 
approved medical residency program in a hospital setting, as described 
in paragraphs (f)(1)(ii)(A) through (f)(1)(ii)(D) of this section, must 
be spent in either patient care activities, as defined in Sec.  
413.75(b) of this subchapter, or in nonpatient care activities, such as 
didactic conferences and seminars, to be counted. This provision may not 
be applied in a manner that would require the reopening of settled cost 
reports, except those cost reports on which, as of March 23, 2010, there 
is a jurisdictionally proper appeal pending on direct GME or IME 
payments.
    (D) Effective for cost reporting periods beginning on or after 
January 1, 1983, the time spent by a resident in an approved medical 
residency program on vacation, sick leave, or other approved leave that 
does not prolong the total time the resident is participating in the 
approved program beyond the normal duration of the program is countable. 
This provision may not be applied in a manner that would require

[[Page 668]]

the reopening of settled cost reports, except those cost reports on 
which, as of March 23, 2010, there is a jurisdictionally proper appeal 
pending on direct GME or IME payments.
    (iv)(A) Effective for discharges occurring on or after October 1, 
1997, the total number of FTE residents in the fields of allopathic and 
osteopathic medicine in either a hospital or a nonhospital setting that 
meets the criteria listed in paragraph (f)(1)(ii) of this section may 
not exceed the number of such FTE residents in the hospital (or, in the 
case of a hospital located in a rural area, effective for discharges 
occurring on or after April 1, 2000, 130 percent of that number) with 
respect to the hospital's most recent cost reporting period ending on or 
before December 31, 1996.
    (B)(1) Effective for portions of cost reporting periods beginning on 
or after July 1, 2005, a hospital's otherwise applicable FTE resident 
cap may be reduced if its reference resident level, as determined under 
Sec.  413.79(c)(1)(ii)(A) of this subchapter, is less than its otherwise 
applicable FTE resident cap in a reference cost reporting period, in 
accordance with the provisions of Sec.  413.79(c)(3) of this subchapter. 
The reduction is 75 percent of the difference between the otherwise 
applicable FTE resident cap and the reference resident level.
    (2) Effective for portions of cost reporting periods beginning on or 
after July 1, 2011, a hospital's otherwise applicable FTE resident cap 
may be reduced if its reference resident level, as determined under 
Sec.  413.79(c)(1)(ii)(B) of this subchapter, is less than its otherwise 
applicable FTE resident cap in a reference cost reporting period, in 
accordance with the provisions of Sec.  413.79(m) of this subchapter. 
The reduction shall take into account the hospital's FTE resident cap as 
reduced under paragraph (f)(1)(iv)(B)(1). The reduction is 65 percent of 
the difference between the otherwise applicable FTE resident cap and the 
reference resident level.
    (C)(1) Effective for portions of cost reporting periods beginning on 
or after July 1, 2005, a hospital may qualify to receive an increase in 
its otherwise applicable FTE resident cap (up to 25 additional FTEs) if 
the criteria specified in Sec.  413.79(c)(4) of this subchapter are met.
    (2) Effective for portions of cost reporting periods beginning on or 
after July 1, 2011, a hospital may qualify to receive an increase in its 
otherwise applicable FTE resident cap (up to 75 additional FTEs) if the 
criteria specified in Sec.  413.79(n) of this subchapter are met.
    (D) A rural hospital redesignated as urban after September 30, 2004, 
as a result of the most recent census data and implementation of the new 
labor market area definitions announced by OMB on June 6, 2003, may 
retain the increases to its full-time equivalent resident cap that it 
received under paragraphs (f)(1)(iv)(A) and (f)(1)(vii) of this section 
while it was located in a rural area. Effective October 1, 2014, if a 
rural hospital is redesignated as urban due to the most recent OMB 
standards for delineating statistical areas adopted by CMS, the 
redesignated urban hospital may retain any existing increases to its FTE 
resident cap that it had received prior to when the redesignation became 
effective. Effective October 1, 2014, if a rural hospital is 
redesignated as urban due to the most recent OMB standards for 
delineating statistical areas adopted by CMS, the redesignated urban 
hospital may receive an increase to its FTE resident cap for a new 
program, in accordance with paragraph (e) of this section, if it 
received a letter of accreditation for the new program and/or started 
training residents in the new program prior to the redesignation 
becoming effective.
    (v)(A) For a hospital's cost reporting periods beginning on or after 
October 1, 1997, and before October 1, 1998, the total number of full-
time equivalent residents for payment purposes is equal to the average 
of the actual full-time equivalent resident counts (subject to the 
requirements listed in paragraphs (f)(1)(ii)(C) and (f)(1)(iv) of this 
section) for that cost reporting period and the preceding cost reporting 
period.
    (B) For a hospital's cost reporting periods beginning on or after 
October 1, 1998, the total number of full-time equivalent residents for 
payment purposes is equal to the average of the actual full-time 
equivalent resident count (subject to the requirements set

[[Page 669]]

forth in paragraphs (f)(1)(ii)(C) and (f)(1)(iv) of this section) for 
that cost reporting period and the preceding two cost reporting periods.
    (C) For new programs started prior to October 1, 2012, if a hospital 
qualified for an adjustment to the limit established under paragraph 
(f)(1)(iv) of this section for new medical residency programs created 
under paragraph (f)(1)(vii) of this section, the count of residents 
participating in new medical residency training programs above the 
number included in the hospital's full-time equivalent count for the 
cost reporting period ending during calendar year 1996 is added after 
applying the averaging rules in paragraph (f)(1)(v)(B) of this section 
for a period of years. Residents participating in new medical residency 
training programs are included in the hospital's full-time equivalent 
count before applying the averaging rules after the period of years has 
expired. For purposes of this paragraph, for each new program started, 
the period of years equals the minimum accredited length for each new 
program. The period of years for each new program begins when the first 
resident begins training in each new program.
    (D) For new programs started on or after October 1, 2012, for 
hospitals for which the full-time equivalent cap may be adjusted in 
accordance with Sec.  413.79(e) of this chapter, full-time equivalent 
residents participating in new medical residency training programs are 
excluded from the hospital's full-time equivalent count before applying 
the averaging rules during the cost reporting periods prior to the 
beginning of the applicable hospital's cost reporting period that 
coincides with or follows the start of the sixth program year of the 
first new program started, for hospitals for which the full-time 
equivalent cap may be adjusted in accordance with Sec.  413.79(e)(1) of 
this chapter, and prior to the beginning of the applicable hospital's 
cost reporting period that coincides with or follows the start of the 
sixth program year of the each individual new program started, for 
hospitals for which the full-time equivalent cap may be adjusted in 
accordance with Sec.  413.79(e)(3) of this chapter. Beginning with the 
applicable hospital's cost reporting period that coincides with or 
follows the start of the sixth program year of the first new program 
started for hospitals for which the full-time equivalent cap may be 
adjusted in accordance with Sec.  413.79(e)(1) of this chapter, and 
beginning with the applicable hospital's cost reporting period that 
coincides with or follows the start of the sixth program year of each 
individual new program started for hospitals for which the full-time 
equivalent cap may be adjusted in accordance with Sec.  413.79(e)(3) of 
this chapter, full-time equivalent residents participating in new 
medical residency training programs are included in the hospital's full-
time equivalent count before applying the averaging rules in paragraph 
(f)(1)(v)(B) of this section.
    (E) Subject to the provisions of paragraph (f)(1)(ix) of this 
section, full-time equivalent residents that are displaced by the 
closure of either another hospital or another hospital's program are 
added to the full-time equivalent count after applying the averaging 
rules in paragraph (f)(1)(v)(B) of this section for the receiving 
hospital for the duration of time that the displaced residents are 
training at the receiving hospital.
    (F) Subject to the provisions of paragraph (f)(1)(x) of this 
section, effective for cost reporting periods beginning on or after 
April 1, 2000, full-time equivalent residents at an urban hospital in a 
rural track program are included in the urban hospital's rolling average 
calculation described in this paragraph (f)(1)(v)(B).
    (vi) Hospitals that are part of the same Medicare GME affiliated 
group or emergency Medicare GME affiliated group (as defined in Sec.  
413.75(b) of this subchapter) may elect to apply the limit specified in 
paragraph (f)(1)(iv) of this section on an aggregate basis, as specified 
in Sec.  413.79(f) of this subchapter. Effective beginning on or after 
October 1, 2008, home and host hospitals with valid emergency Medicare 
GME affiliation agreements are exempt from the application of the ratio 
cap specified in paragraph (a)(1)(i) of this section.
    (vii) If a hospital establishes a new medical residency training 
program, as defined in Sec.  413.79(l) of this subchapter, the 
hospital's full-time equivalent cap

[[Page 670]]

may be adjusted in accordance with the provisions of Sec.  413.79(e) of 
this subchapter.
    (viii) A hospital that began construction of its facility prior to 
August 5, 1997, and sponsored new medical residency training programs on 
or after January 1, 1995 and on or before August 5, 1997, that either 
received initial accreditation by the appropriate accrediting body or 
temporarily trained residents at another hospital(s) until the facility 
was completed, may receive an adjustment to its full-time equivalent cap 
in accordance with the provisions of Sec.  413.79(g) of this subchapter.
    (ix)(A) A hospital may receive a temporary adjustment to its FTE 
resident cap to reflect displaced residents added because of another 
hospital's closure if the hospital meets the criteria specified in Sec.  
413.79(h)(1) and (2) of this subchapter. If a hospital that closes its 
residency training program agrees to temporarily reduce its FTE resident 
cap according to the criteria specified in Sec.  413.79(h)(1) and 
(h)(3)(ii)of this subchapter, another hospital(s) may receive a 
temporary adjustment to its FTE resident cap to reflect displaced 
residents added because of the closure of the residency training program 
if the criteria specified in Sec.  413.79(h)(1) and (h)(3)(i) of this 
subchapter are met.
    (B) A hospital may receive a permanent adjustment to its FTE 
resident cap as a result of slots that were redistributed from a closed 
hospital, as defined at Sec.  413.79(h)(1)(i) of this subchapter, if the 
hospital meets the requirements at Sec.  413.79(o) of this subchapter.
    (x) An urban hospital that establishes a new residency program (as 
defined in Sec.  413.79(l) of this subchapter), or has an existing 
residency program, with a rural track (or an integrated rural track) may 
include in its FTE count residents in those rural tracks in accordance 
with the applicable provisions of Sec.  413.79(k) of this subchapter.
    (xi) Effective for discharges occurring in cost reporting periods 
beginning on or after November 29, 1999, a hospital may receive an 
adjustment to its FTE cap of up to three additional FTEs to the extent 
that the additional residents would have been counted as primary care 
residents for purposes of the hospital's FTE cap but for the fact that 
the additional residents were on maternity or disability leave or a 
similar approved leave of absence, in accordance with the provisions of 
Sec.  413.79(i) of this subchapter.
    (xii) For discharges occurring on or after October 1, 1997, a non-
Veterans Affairs (VA) hospital may receive a temporary adjustment to its 
FTE cap to reflect residents who had been previously trained at a VA 
hospital and were subsequently transferred to the non-VA hospital, if 
the hospital meets the criteria and other provisions of Sec.  413.79(j) 
of this subchapter.
    (xiii) For a hospital that was paid under part 413 of this chapter 
as a hospital excluded from the hospital inpatient prospective payment 
system and that subsequently becomes subject to the hospital inpatient 
prospective payment system, the limit on the total number of FTE 
residents for payment purposes is determined based on the data from the 
hospital's most recent cost reporting period ending on or before 
December 31, 1996.
    (xiv) In the case of a merger of a hospital that is excluded from 
the hospital inpatient prospective payment system and an acute care 
hospital subject to the hospital inpatient prospective payment system, 
if the surviving hospital is a hospital subject to the hospital 
inpatient prospective payment system and no hospital unit that is 
excluded from the hospital inpatient prospective payment system is 
created as a result of the merger, the surviving hospital's number of 
FTE residents for payment purposes is equal to the sum of the FTE 
resident count of the hospital that is subject to the hospital inpatient 
prospective payment system as determined under paragraph (f)(1)(ii)(B) 
of this section and the limit on the total number of FTE residents for 
the excluded hospital as determined under paragraph (f)(1)(xiii) of this 
section.
    (xv) Effective for discharges occurring on or after October 1, 2005, 
an urban hospital that reclassifies to a rural area under Sec.  412.103 
for fewer than 10 continuous years and then subsequently elects to 
revert back to urban classification will not be allowed to retain the 
adjustment to its IME FTE

[[Page 671]]

resident cap that it received as a result of being reclassified as 
rural.
    (2) To include a resident in the full-time equivalent count for a 
particular cost reporting period, the hospital must furnish the 
following information. The information must be certified by an official 
of the hospital and, if different, an official responsible for 
administering the residency program.
    (i) A listing, by specialty, of all residents assigned to the 
hospital and providing services to the hospital during the cost 
reporting period.
    (ii) The name and social security number of each resident.
    (iii) The dates the resident is assigned to the hospital.
    (iv) The dates the resident is assigned to other hospitals or other 
freestanding providers and any nonprovider setting during the cost 
reporting period.
    (v) The proportion of the total time necessary to fill a residency 
slot that the resident is assigned to an area of the hospital listed 
under paragraph (f)(1)(ii) of this section.
    (3) Fiscal intermediaries must verify the correct count of 
residents.
    (g) Indirect medical education payment for managed care enrollees. 
For portions of cost reporting periods occurring on or after January 1, 
1998, a payment is made to a hospital for indirect medical education 
costs, as determined under paragraph (e) of this section, for discharges 
associated with individuals who are enrolled under a risk-sharing 
contract with an eligible organization under section 1876 of the Act or 
with a Medicare + Choice organization under title XVIII, Part C of the 
Act during the period, according to the applicable payment percentages 
described in Sec. Sec.  413.76(c)(1) through (c)(5) of this subchapter.

[50 FR 12741, Mar. 29, 1985. Redesignated at 56 FR 43241, Aug. 30, 1991]

    Editorial Note: For Federal Register citations affecting Sec.  
412.105, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.  412.106  Special treatment: Hospitals that serve a disproportionate 
share of low-income patients.

    (a) General considerations. (1) The factors considered in 
determining whether a hospital qualifies for a payment adjustment 
include the number of beds, the number of patient days, and the 
hospital's location.
    (i) The number of beds in a hospital is determined in accordance 
with Sec.  412.105(b).
    (ii) For purposes of this section, the number of patient days in a 
hospital includes only those days attributable to units or wards of the 
hospital providing acute care services generally payable under the 
prospective payment system and excludes patient days associated with--
    (A) Beds in excluded distinct part hospital units;
    (B) Beds otherwise countable under this section used for outpatient 
observation services, skilled nursing swing-bed services, or inpatient 
hospice services;
    (C) Beds in a unit or ward that is not occupied to provide a level 
of care that would be payable under the acute care hospital inpatient 
prospective payment system at any time during the 3 preceding months 
(the beds in the unit or ward are to be excluded from the determination 
of available bed days during the current month); and
    (D) Beds in a unit or ward that is otherwise occupied (to provide a 
level of care that would be payable under the acute care hospital 
inpatient prospective payment system) that could not be made available 
for inpatient occupancy within 24 hours for 30 consecutive days.
    (iii) The hospital's location, in an urban or rural area, is 
determined in accordance with the definitions in Sec.  412.64, except 
that a reclassification that results from an urban hospital reclassified 
as rural as set forth in Sec.  412.103 is classified as rural.
    (2) The payment adjustment is applied to the hospital's DRG revenue 
for inpatient operating costs based on DRG-adjusted prospective payment 
rates for inpatient operating costs, excluding outlier payments for 
inpatient operating costs under subpart F of this part and additional 
payments made under the provisions of Sec.  412.105.
    (b) Determination of a hospital's disproportionate patient 
percentage--(1) General rule. A hospital's disproportionate patient 
percentage is determined by adding the results of two

[[Page 672]]

computations and expressing that sum as a percentage.
    (2) First computation: Federal fiscal year. For each month of the 
Federal fiscal year in which the hospital's cost reporting period 
begins, CMS--
    (i) Determines the number of patient days that--
    (A) Are associated with discharges occurring during each month; and
    (B) Are furnished to patients who during that month were entitled to 
both Medicare Part A (including Medicare Advantage (Part C)) and SSI, 
excluding those patients who received only State supplementation;
    (ii) Adds the results for the whole period; and
    (iii) Divides the number determined under paragraph (b)(2)(ii) of 
this section by the total number of days that--
    (A) Are associated with discharges that occur during that period; 
and
    (B) Are furnished to patients entitled to Medicare Part A (including 
Medicare Advantage (Part C)).
    (3) First computation: Cost reporting period. If a hospital prefers 
that CMS use its cost reporting period instead of the Federal fiscal 
year, it must furnish to CMS, through its intermediary, a written 
request including the hospital's name, provider number, and cost 
reporting period end date. This exception will be performed once per 
hospital per cost reporting period, and the resulting percentage becomes 
the hospital's official Medicare Part A/SSI percentage for that period.
    (4) Second computation. The fiscal intermediary determines, for the 
same cost reporting period used for the first computation, the number of 
the hospital's patient days of service for which patients were eligible 
for Medicaid but not entitled to Medicare Part A, and divides that 
number by the total number of patient days in the same period. For 
purposes of this second computation, the following requirements apply:
    (i) For purposes of this computation, a patient is deemed eligible 
for Medicaid on a given day only if the patient is eligible for 
inpatient hospital services under an approved State Medicaid plan or 
under a waiver authorized under section 1115(a)(2) of the Act on that 
day, regardless of whether particular items or services were covered or 
paid under the State plan or the authorized waiver.
    (ii) Effective with discharges occurring on or after January 20, 
2000, for purposes of counting days under paragraph (b)(4)(i) of this 
section, hospitals may include all days attributable to populations 
eligible for Title XIX matching payments through a waiver approved under 
section 1115 of the Social Security Act.
    (iii) The hospital has the burden of furnishing data adequate to 
prove eligibility for each Medicaid patient day claimed under this 
paragraph, and of verifying with the State that a patient was eligible 
for Medicaid during each claimed patient hospital day.
    (iv) For cost reporting periods beginning on or after October 1, 
2009, the hospital must report the days in the numerator of the fraction 
in the second computation in a cost reporting period based on the date 
of discharge, the date of admission, or the dates of service. If a 
hospital seeks to change its methodology for reporting days in the 
numerator of the fraction in the second computation, the hospital must 
notify CMS, through its fiscal intermediary or MAC, in writing at least 
30 days before the beginning of the cost reporting period in which the 
change would apply. The written notification must specify the 
methodology the hospital will use, the cost reporting period to which 
the requested change would apply, and the current methodology being 
used. Such a change will be effective only on the first day of a cost 
reporting period. If a hospital changes its methodology for reporting 
such days, CMS or the fiscal intermediary or MAC may adjust the number 
of days reported for a cost reporting period if it determines that any 
of those days have been counted in a prior cost reporting period.
    (5) Disproportionate patient percentage. The intermediary adds the 
results of the first computation made under either paragraph (b)(2) or 
(b)(3) of this section and the second computation made under paragraph 
(b)(4) of this section and expresses that sum as a percentage. This is 
the hospital's disproportionate patient percentage, and is used in 
paragraph (c) of this section.

[[Page 673]]

    (c) Criteria for classification. A hospital is classified as a 
``disproportionate share'' hospital under any of the following 
circumstances:
    (1) The hospital's disproportionate patient percentage, as 
determined under paragraph (b)(5) of this section, is at least equal to 
one of the following:
    (i) 15 percent, if the hospital is located in an urban area, and has 
100 or more beds, or is located in a rural area and has 500 or more 
beds.
    (ii) 30 percent for discharges occurring before April 1, 2001, and 
15 percent for discharges occurring on or after April 1, 2001, if the 
hospital is located in a rural area and either has more than 100 beds 
and fewer than 500 beds or is classified as a sole community hospital 
under Sec.  412.92.
    (iii) 40 percent for discharges before April 1, 2001, and 15 percent 
for discharges occurring on or after April 1, 2001, if the hospital is 
located in an urban area and has fewer than 100 beds.
    (iv) 45 percent for discharges before April 1, 2001, and 15 percent 
for discharges occurring on or after April 1, 2001, if the hospital is 
located in a rural area and has 100 or fewer beds.
    (2) The hospital is located in an urban area, has 100 or more beds, 
and can demonstrate that, during its cost reporting period, more than 30 
percent of its net inpatient care revenues are derived from State and 
local government payments for care furnished to indigent patients.
    (d) Payment adjustment factor--(1) Method of adjustment. Subject to 
the reduction factor set forth in paragraph (e) of this section, if a 
hospital serves a disproportionate number of low-income patients, its 
DRG revenues for inpatient operating costs are increased by an 
adjustment factor as specified in paragraph (d)(2) of this section.
    (2) Payment adjustment factors. (i) If the hospital meets the 
criteria of paragraph (c)(1)(i) of this section, the payment adjustment 
factor is equal to one of the following:
    (A) If the hospital's disproportionate patient percentage is greater 
than 20.2 percent, the applicable payment adjustment factor is as 
follows:
    (1) For discharges occurring on or after April 1, 1990, and before 
January 1, 1991, 5.62 percent plus 65 percent of the difference between 
20.2 percent and the hospital's disproportionate patient percentage.
    (2) For discharges occurring on or after January 1, 1991, and before 
October 1, 1993, 5.62 percent plus 70 percent of the difference between 
20.2 percent and the hospital's disproportionate patient percentage.
    (3) For discharges occurring on or after October 1, 1993, and before 
October 1, 1994, 5.88 percent plus 80 percent of the difference between 
20.2 percent and the hospital's disproportionate patient percentage.
    (4) For discharges occurring on or after October 1, 1994, 5.88 
percent plus 82.5 percent of the difference between 20.2 percent and the 
hospital's disproportionate patient percentage.
    (B) If the hospital's disproportionate patient percentage is less 
than 20.2 percent, the applicable payment adjustment factor is as 
follows:
    (1) For discharges occurring on or after April 1, 1990, and before 
October 1, 1993, 2.5 percent plus 60 percent of the difference between 
15 percent and the hospital's disproportionate patient percentage.
    (2) For discharges occurring on or after October 1, 1993, 2.5 
percent plus 65 percent of the difference between 15 percent and the 
hospital's disproportionate patient percentage.
    (ii) If the hospital meets the criteria of paragraph (c)(1)(ii) of 
this section, the payment adjustment factor is equal to one of the 
following:
    (A) If the hospital is classified as a rural referral center--
    (1) For discharges occurring before April 1, 2001, the payment 
adjustment factor is 4 percent plus 60 percent of the difference between 
the hospital's disproportionate patient percentage and 30 percent.
    (2) For discharges occurring on or after April 1, 2001, and before 
April 1, 2004, the following applies:
    (i) If the hospital's disproportionate patient percentage is less 
than 19.3 percent, the applicable payment adjustment factor is 2.5 
percent plus 65 percent of the difference between 15 percent and the 
hospital's disproportionate patient percentage.

[[Page 674]]

    (ii) If the hospital's disproportionate patient percentage is 
greater than 19.3 percent and less than 30 percent, the applicable 
payment adjustment factor is 5.25 percent.
    (iii) If the hospital's disproportionate patient percentage is 
greater than or equal to 30 percent, the applicable payment adjustment 
factor is 5.25 percent plus 60 percent of the difference between 30 
percent and the hospital's disproportionate patient percentage.
    (3) For discharges occurring on or after April 1, 2004, the 
following applies:
    (i) If the hospital's disproportionate patient percentage is less 
than or equal to 20.2 percent, the applicable payment adjustment factor 
is 2.5 percent plus 65 percent of the difference between 15 percent and 
the hospital's disproportionate patient percentage.
    (ii) If the hospital's disproportionate patient percentage is 
greater than 20.2 percent, the applicable payment adjustment factor is 
5.88 percent plus 82.5 percent of the difference between 20.2 percent 
and the hospital's disproportionate patient percentage.
    (B) If the hospital is classified as a sole community hospital--
    (1) For discharges occurring before April 1, 2001, the payment 
adjustment factor is 10 percent.
    (2) For discharges occurring on or after April 1, 2001 and before 
April 1, 2004, the following applies:
    (i) If the hospital's disproportionate patient percentage is less 
than 19.3 percent, the applicable payment adjustment factor is 2.5 
percent plus 65 percent of the difference between 15 percent and the 
hospital's disproportionate patient percentage.
    (ii) If the hospital's disproportionate patient percentage is equal 
to or greater than 19.3 percent and less than 30 percent, the applicable 
payment adjustment factor is 5.25 percent.
    (iii) If the hospital's disproportionate patient percentage is equal 
to or greater than 30 percent, the applicable payment adjustment factor 
is 10 percent.
    (3) For discharges occurring on or after April 1, 2004, the 
following applies:
    (i) If the hospital's disproportionate patient percentage is less 
than or equal to 20.2 percent, the applicable payment adjustment factor 
is 2.5 percent plus 65 percent of the difference between 15 percent and 
the hospital's disproportionate patient percentage.
    (ii) If the hospital's disproportionate patient percentage is 
greater than 20.2 percent, the applicable payment adjustment factor is 
5.88 percent plus 82.5 percent of the difference between 20.2 percent 
and the hospital's disproportionate patient percentage.
    (iii) The maximum payment adjustment factor is 12 percent.
    (C) If the hospital is classified as both a rural referral center 
and a sole community hospital, the payment adjustment is--
    (1) For discharges occurring before April 1, 2001, the greater of--
    (i) 10 percent; or
    (ii) 4 percent plus 60 percent of the difference between the 
hospital's disproportionate patient percentage and 30 percent.
    (2) For discharges occurring on or after April 1, 2001 and before 
April 1, 2004, the greater of the adjustments determined under 
paragraphs (d)(2)(ii)(A) or (d)(2)(ii)(B) of this section.
    (3) For discharges occurring on or after April 1, 2004, the 
following applies:
    (i) If the hospital's disproportionate patient percentage is less 
than 20.2 percent, the applicable payment adjustment factor is 2.5 
percent plus 65 percent of the difference between 15 percent and the 
hospital's disproportionate patient percentage.
    (ii) If the hospital's disproportionate patient percentage is 
greater than 20.2 percent, the applicable payment adjustment factor is 
5.88 percent plus 82.5 percent of the difference between 20.2 percent 
and the hospital's disproportionate patient percentage.
    (D) If the hospital is classified as a rural hospital and is not 
classified as either a sole community hospital or a rural referral 
center, and has 100 or more beds--
    (1) For discharges occurring before April 1, 2001, the payment 
adjustment factor is 4 percent.
    (2) For discharges occurring on or after April 1, 2001 and before 
April 1, 2004, the following applies:

[[Page 675]]

    (i) If the hospital's disproportionate patient percentage is less 
than 19.3 percent, the applicable payment adjustment factor is 2.5 
percent plus 65 percent of the difference between the hospital's 
disproportionate patient percentage and 15 percent.
    (ii) If the hospital's disproportionate patient percentage is equal 
to or greater than 19.3 percent, the applicable payment adjustment 
factor is 5.25 percent.
    (3) For discharges occurring on or after April 1, 2004, the 
following applies:
    (i) If the hospital's disproportionate patient percentage is less 
than or equal to 20.2 percent, the applicable payment adjustment factor 
is 2.5 percent plus 65 percent of the difference between 15 percent and 
the hospital's disproportionate patient percentage.
    (ii) If the hospital's disproportionate patient percentage is 
greater than 20.2 percent, the applicable payment adjustment factor is 
5.88 percent plus 82.5 percent of the difference between 20.2 percent 
and the hospital's disproportionate patient percentage.
    (iii) The maximum payment adjustment factor is 12 percent.
    (iii) If the hospital meets the criteria of paragraph (c)(1)(iii) of 
this section--
    (A) For discharges occurring before April 1, 2001, the payment 
adjustment factor is 5 percent.
    (B) For discharges occurring on or after April 1, 2001 and before 
April 1, 2004, the following applies:
    (1) If the hospital's disproportionate patient percentage is less 
than 19.3 percent, the applicable payment adjustment factor is 2.5 
percent plus 65 percent of the difference between the hospital's 
disproportionate patient percentage and 15 percent.
    (2) If the hospital's disproportionate patient percentage is equal 
to or greater than 19.3 percent, the applicable payment adjustment 
factor is 5.25 percent.
    (C) For discharges occurring on or after April 1, 2004, the 
following applies:
    (1) If the hospital's disproportionate patient percentage is less 
than or equal to 20.2 percent, the applicable payment adjustment factor 
is 2.5 percent plus 65 percent of the difference between 15 percent and 
the hospital's disproportionate patient percentage.
    (2) If the hospital's disproportionate patient percentage is greater 
than 20.2 percent, the applicable payment adjustment factor is 5.88 
percent plus 82.5 percent of the difference between 20.2 percent and the 
hospital's disproportionate patient percentage.
    (3) The maximum payment adjustment factor is 12 percent.
    (iv) If the hospital meets the criteria of paragraph (c)(1)(iv) of 
this section--
    (A) For discharges occurring before April 1, 2001, the payment 
adjustment factor is 4 percent.
    (B) For discharges occurring on or after April 1, 2001 and before 
April 1, 2004, the following applies:
    (1) If the hospital's disproportionate patient percentage is less 
than 19.3 percent, the applicable payment adjustment factor is 2.5 
percent plus 65 percent of the difference between the hospital's 
disproportionate patient percentage and 15 percent.
    (2) If the hospital's disproportionate patient percentage is equal 
to or greater than 19.3 percent, the applicable payment adjustment 
factor is 5.25 percent.
    (C) For discharges occurring on or after April 1, 2004, the 
following applies:
    (1) If the hospital's disproportionate patient percentage is less 
than or equal to 20.2 percent, the applicable payment adjustment factor 
is 2.5 percent plus 65 percent of the difference between 15 percent and 
the hospital's disproportionate patient percentage.
    (2) If the hospital's disproportionate patient percentage is greater 
than 20.2 percent, the applicable payment adjustment factor is 5.88 
percent plus 82.5 percent of the difference between 20.2 percent and the 
hospital's disproportionate patient percentage.
    (3) Except as provided in paragraph (d)(2)(iv)(D) of this section, 
the maximum payment adjustment factor is 12 percent.
    (D) Effective for discharges occurring on or after October 1, 2006, 
for a hospital that is classified as a Medicare-dependent, small rural 
hospital under Sec.  412.108, the payment adjustment factor limitation 
specified in paragraph (d)(2)(iv)(C)(3) does not apply.

[[Page 676]]

    (v) If the hospital meets the criteria of paragraph (c)(2) of this 
section, the payment adjustment factor is as follows:
    (A) 30 percent for discharges occurring on or after April 1, 1990, 
and before October 1, 1991.
    (B) 35 percent for discharges occurring on or after October 1, 1991.
    (e) Reduction in payments beginning FY 1998. The amounts otherwise 
payable to a hospital under paragraph (d) of this section are reduced by 
the following:
    (1) For FY 1998, 1 percent.
    (2) For FY 1999, 2 percent.
    (3) For FY 2000, 3 percent.
    (4) For FY 2001:
    (i) For discharges occurring on or after October 1, 2000 and before 
April 1, 2001, 3 percent.
    (ii) For discharges occurring on or after April 1, 2001 and before 
October 1, 2001, 1 percent.
    (5) For FY 2002, 3 percent.
    (6) For FYs 2003 and thereafter, 0 percent.
    (f) Empirically justified Medicare DSH payments. Effective for 
discharges on or after October 1, 2013, the amounts otherwise payable to 
a hospital under paragraph (d) of this section are reduced by 75 
percent.
    (g) Additional payment for uncompensated care. (1) Payment rules. 
Hospitals that qualify for payments under this section for fiscal year 
2014 and each subsequent year, will receive an additional amount equal 
to the product of the following three factors:
    (i) Factor 1. For FY 2014 and each subsequent fiscal year, a factor 
equal to the difference between:
    (A) The most recently available estimates, as calculated by CMS' 
Office of the Actuary, of the aggregate amount of payments that would be 
made to such hospitals under paragraphs (a) through (e) of this section 
if paragraph (f) of this section did not apply for the fiscal year; and
    (B) The most recently available estimates, as calculated by CMS' 
Office of the Actuary, of the aggregate amount of payments that are made 
to such hospitals pursuant to paragraph (f) of this section for the 
fiscal year.
    (ii) Factor 2. For each of fiscal years 2014, 2015, 2016, and 2017, 
a factor equal to 1 minus the percent change in the percent of 
individuals under the age of 65 who are uninsured (and subtracting from 
the factor 0.1 percentage point for fiscal year 2014 and 0.2 percentage 
point for each of fiscal years 2015, 2016, and 2017), as determined by 
comparing:
    (A) 18 percent, the percent of such individuals who are uninsured in 
2013, based on the March 20, 2010 estimate of the ``Insured Share of the 
Nonelderly Population Including All Residents'' by the Congressional 
Budget Office; and
    (B) The percent of such individuals who are uninsured in the 
applicable fiscal year, based on the most recent estimate of the 
``Insured Share of the Nonelderly Population Including All Residents'' 
by the Congressional Budget Office available at the time of development 
of the annual final rule for the hospital inpatient prospective payment 
system.
    (iii) Factor 3. A factor equal to the percent, for each inpatient 
prospective payment system hospital, that represents the quotient of:
    (A) The amount of uncompensated care for such hospital as estimated 
by CMS.
    (B) The aggregate amount of uncompensated care as estimated by CMS 
for all hospitals that are estimated to receive a payment under this 
section.
    (C)(1) For fiscal years 2014 and 2015, CMS will base its estimates 
of the amount of hospital uncompensated care on the most recent 
available data on utilization for Medicaid and Medicare SSI patients, as 
determined by CMS in accordance with paragraphs (b)(2)(i) and (4) of 
this section.
    (2) For fiscal year 2016, CMS will base its estimates of the amount 
of hospital uncompensated care on utilization data for Medicaid and 
Medicare SSI patients, as determined by CMS in accordance with 
paragraphs (b)(2)(i) and (4) of this section, using data on Medicaid 
utilization from 2012 or 2011 cost reports from the most recent HCRIS 
database extract, the 2012 cost report data submitted to CMS by IHS 
hospitals, and the most recent available data on Medicare SSI 
utilization.
    (3) For fiscal year 2017, CMS will base its estimates of the amount 
of hospital uncompensated care on utilization data

[[Page 677]]

for Medicaid and Medicare SSI patients, as determined by CMS in 
accordance with paragraphs (b)(2)(i) and (4) of this section, using data 
on Medicaid utilization from 2011, 2012, and 2013 cost reports from the 
most recent HCRIS database extract, the 2011 and 2012 cost report data 
submitted to CMS by IHS hospitals, and the most recent available 3 years 
of data on Medicare SSI utilization (or, for Puerto Rico hospitals, a 
proxy for Medicare SSI utilization data).
    (4) For fiscal year 2018, CMS will base its estimates of the amount 
of hospital uncompensated care on utilization data for Medicaid and 
Medicare SSI patients, as determined by CMS in accordance with 
paragraphs (b)(2)(i) and (b)(4) of this section, using data on Medicaid 
utilization from 2012 and 2013 cost reports from the most recent HCRIS 
database extract and 2012 cost report data submitted to CMS by IHS or 
Tribal hospitals and the most recent available 2 years of data on 
Medicare SSI utilization (or, for Puerto Rico hospitals, a proxy for 
Medicare SSI utilization data), and for hospitals other than Puerto Rico 
hospitals, IHS or Tribal hospitals, and all-inclusive rate providers, 
data on uncompensated care costs, defined as charity care costs plus 
non-Medicare bad debt costs from 2014 cost reports from the most recent 
HCRIS database extract.
    (5) For fiscal year 2019, CMS will base its estimates of the amount 
of hospital uncompensated care on utilization data for Medicaid and 
Medicare SSI patients, as determined by CMS in accordance with 
paragraphs (b)(2)(i) and (4) of this section, using data on Medicaid 
utilization from 2013 cost reports from the most recent HCRIS database 
extract and the most recent available year of data on Medicare SSI 
utilization (or, for Puerto Rico hospitals, a proxy for Medicare SSI 
utilization data), and for hospitals other than Puerto Rico hospitals, 
IHS or Tribal hospitals, and all-inclusive rate providers, data on 
uncompensated care costs, defined as charity care costs plus non-
Medicare and nonreimbursable Medicare bad debt costs from 2014 and 2015 
cost reports from the most recent HCRIS database extract.
    (6) For fiscal year 2020, CMS will base its estimates of the amount 
of hospital uncompensated care on data on uncompensated care costs, 
defined as charity care costs plus non-Medicare and non-reimbursable 
Medicare bad debt costs from 2015 cost reports from the most recent 
HCRIS database extract, except that, for Puerto Rico hospitals and 
Indian Health Service or Tribal hospitals, CMS will base its estimates 
on utilization data for Medicaid and Medicare SSI patients, as 
determined by CMS in accordance with paragraphs (b)(2)(i) and (b)(4) of 
this section, using data on Medicaid utilization from 2013 cost reports 
from the most recent HCRIS database extract and the most recent 
available year of data on Medicare SSI utilization (or, for Puerto Rico 
hospitals, a proxy for Medicare SSI utilization data).
    (7) For fiscal year 2021, CMS will base its estimates of the amount 
of hospital uncompensated care on data on uncompensated care costs, 
defined as charity care costs plus non-Medicare and non-reimbursable 
Medicare bad debt costs from 2017 cost reports from the most recent 
Hospital Cost Report Information System (HCRIS) database extract, except 
that, for Puerto Rico hospitals and Indian Health Service or Tribal 
hospitals, CMS will base its estimates on utilization data for Medicaid 
and Medicare Supplemental Security Income (SSI) patients, as determined 
by CMS in accordance with paragraphs (b)(2)(i) and (b)(4) of this 
section, using data on Medicaid utilization from 2013 cost reports from 
the most recent HCRIS database extract and the most recent available 
year of data on Medicare SSI utilization (or, for Puerto Rico hospitals, 
a proxy for Medicare SSI utilization data).
    (8) For each subsequent fiscal year, for all eligible hospitals, 
except Indian Health Service and Tribal hospitals and Puerto Rico 
hospitals that have a cost report for 2013, CMS will base its estimates 
of the amount of hospital uncompensated care on data on uncompensated 
care costs, defined as charity care costs plus non-Medicare and non-
reimbursable Medicare bad debt costs from cost reports from the most 
recent cost reporting year for which audits have been conducted.

[[Page 678]]

    (9) For fiscal year 2022, for Indian Health Service and Tribal 
hospitals and Puerto Rico hospitals that have a cost report for 2013, 
CMS will base its estimates of the amount of hospital uncompensated care 
on utilization data for Medicaid and Medicare Supplemental Security 
Income (SSI) patients, as determined by CMS in accordance with 
paragraphs (b)(2)(i) and (b)(4) of this section, using data on Medicaid 
utilization from 2013 cost reports from the most recent HCRIS database 
extract and the most recent available year of data on Medicare SSI 
utilization (or, for Puerto Rico hospitals, a proxy for Medicare SSI 
utilization data).
    (2) Preclusion of administrative and judicial review. There is no 
administrative or judicial review under sections 1869 or 1878 of the 
Act, or otherwise, of the following:
    (i) Any estimate of the Secretary for the purpose of determining the 
factors in paragraph (g)(1) of this section; and
    (ii) Any period selected by the Secretary for such purposes.
    (h) Manner and timing of payments. (1) Interim payments are made 
during the payment year to each hospital that is estimated to be 
eligible for payments under this section at the time of the annual final 
rule for the hospital inpatient prospective payment system, subject to 
the final determination of eligibility at the time of cost report 
settlement for each hospital.
    (2) Final payment determinations are made at the time of cost report 
settlement, based on the final determination of each hospital's 
eligibility for payment under this section.

[54 FR 36494, Sept. 1, 1989]

    Editorial Note: For Federal Register citations affecting Sec.  
412.106, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.  412.107  Special treatment: Hospitals that receive an additional 
update for FYs 1998 and 1999.

    (a) Additional payment update. A hospital that meets the criteria 
set forth in paragraph (b) of this section receives the following 
increase to its applicable percentage amount set forth in Sec.  412.63 
(p) and (q):
    (1) For FY 1998, 0.5 percent.
    (2) For FY 1999, 0.3 percent.
    (b) Criteria for classification. A hospital is eligible for the 
additional payment update set forth in paragraph (a) of this section if 
it meets all of the following criteria:
    (1) Definition. The hospital is not a Medicare-dependent, small 
rural hospital as defined in Sec.  412.108(a) and does not receive any 
additional payment under the following provisions:
    (i) The indirect medical education adjustment made under Sec.  
412.105.
    (ii) The disproportionate share adjustment made under Sec.  412.106.
    (2) State criteria. The hospital is located in a State in which the 
aggregate payment made under Sec.  412.112 (a) and (c) for hospitals 
described in paragraph (b)(1) of this section for their cost reporting 
periods beginning in FY 1995 is less than the allowable operating costs 
described in Sec.  412.2(c) for those hospitals.
    (3) Hospital criteria. The aggregate payment made to the hospital 
under Sec.  412.112 (a) and (c) for the hospital's cost reporting period 
beginning in the fiscal year in which the additional payment update 
described in paragraph (a) of this section is made is less than the 
allowable operating cost described in Sec.  412.2(c) for that hospital.

[62 FR 46030, Aug. 29, 1997]



Sec.  412.108  Special treatment: Medicare-dependent, small rural hospitals.

    (a) Criteria for classification as a Medicare-dependent, small rural 
hospital--
    (1) General considerations. For cost reporting periods beginning on 
or after April 1, 1990, and ending before October 1, 1994, or for 
discharges occurring on or after October 1, 1997, and before October 1, 
2022, a hospital is classified as a Medicare-dependent, small rural 
hospital if it meets all of the following conditions:
    (i) It is located in a rural area (as defined in subpart D of this 
part) or it is located in a State with no rural area and satisfies any 
of the criteria under Sec.  412.103(a)(1) or (3) or under Sec.  
412.103(a)(2) as of January 1, 2018.
    (ii) The hospital has 100 or fewer beds as defined in Sec.  
412.105(b) during the cost reporting period.

[[Page 679]]

    (iii) The hospital is not also classified as a sole community 
hospital under Sec.  412.92.
    (iv) At least 60 percent of the hospital's inpatient days or 
discharges were attributable to individuals entitled to Medicare Part A 
benefits during the hospital's cost reporting period or periods as 
follows, subject to the provisions of paragraph (a)(1)(v) of this 
section:
    (A) The hospital's cost reporting period ending on or after 
September 30, 1987 and before September 30, 1988.
    (B) If the hospital does not have a cost reporting period that meets 
the criterion set forth in paragraph (a)(1)(iv)(A) of this section, the 
hospital's cost reporting period beginning on or after October 1, 1986, 
and before October 1, 1987.
    (C) At least two of the last three most recent audited cost 
reporting periods for which the Secretary has a settled cost report.
    (v) If the cost reporting period determined under paragraph 
(a)(1)(iv) of this section is for less than 12 months, the hospital's 
most recent 12-month or longer cost reporting period before the short 
period is used.
    (2) Counting days and discharges. In counting inpatient days and 
discharges for purposes of meeting the criteria in paragraph (a)(1)(iii) 
of this section, only days and discharges from acute care inpatient 
hospital stays are counted (including days and discharges from swing 
beds when used for acute care inpatient hospital services), but not 
including days and discharges from units excluded from the prospective 
payment system under Sec. Sec.  412.25 through 412.30 or from newborn 
nursery units. For purposes of this section, a transfer as defined in 
Sec.  412.4(b) is considered to be a discharge.
    (3) Criteria for hospitals that have remote location(s). For a 
hospital with a main campus and one or more remote locations under a 
single provider agreement where services are provided and billed under 
the inpatient hospital prospective payment system and that meets the 
provider-based criteria at Sec.  413.65 of this chapter as a main campus 
and a remote location of a hospital, combined data from the main campus 
and its remote location (s) are required to demonstrate that the 
criteria in paragraphs (a)(1) and (2) of this section are met. For the 
location requirement specified in paragraph (a)(1)(i) of this section, 
the hospital must demonstrate that the main campus and its remote 
locations each independently satisfy this requirement.
    (b) Classification procedures. (1) The MAC determines whether a 
hospital meets the criteria specified in paragraph (a) of this section.
    (2) A hospital must submit a written request along with qualifying 
documentation to its fiscal intermediary to be considered for MDH status 
based on the criterion under paragraph (a)(1)(iii)(C) of this section.
    (3) The MAC will make its determination and notify the hospital 
within 90 days from the date that it receives the hospital's request and 
all of the required documentation.
    (4) For applications received on or before September 30, 2018, a 
determination of MDH status made by the MAC is effective 30 days after 
the date the MAC provides written notification to the hospital. For 
applications received on or after October 1, 2018, a determination of 
MDH status made by the MAC is effective as of the date the MAC receives 
the complete application. An approved MDH status determination remains 
in effect unless there is a change in the circumstances under which the 
status was approved.
    (i) An approved MDH must notify the MAC if any change occurs that is 
specified in paragraph (b)(4)(ii) of this section occurs. If CMS 
determines that an MDH failed to comply with this requirement, CMS will 
cancel the hospital's classification as an MDH effective with the date 
that the hospital no longer met the criteria for such status, consistent 
with the provisions of Sec.  405.1885 of this chapter.
    (ii) An MDH must report the following to the MAC within 30 days of 
the event:
    (A) The number of beds increases to more than 100.
    (B) Its geographic classification changes.
    (iii) An MDH must report to the MAC if it becomes aware of any 
change that would affect its classification as an

[[Page 680]]

MDH beyond the events listed in paragraph (b)(4)(ii) of this section 
within 30 days of the event. If CMS determines that an MDH has failed to 
comply with this requirement, CMS will cancel the hospital's 
classification as an MDH effective with the date the hospital became 
aware of the event that resulted in the MDH no longer meeting the 
criteria for such classification, consistent with the provisions of 
Sec.  405.1885 of this chapter.
    (5) The MAC will evaluate on an ongoing basis, whether or not a 
hospital continues to qualify for MDH status. This evaluation includes 
an ongoing review to ensure that the hospital continues to meet all of 
the criteria specified in paragraph (a) of this section.
    (6) If the MAC determines that a hospital no longer qualifies for 
MDH status, the change in status will become effective 30 days after the 
date the MAC provides written notification to the hospital.
    (7) A hospital may reapply for MDH status following its 
disqualification only after it has completed another cost reporting 
period that has been audited and settled. The hospital must reapply for 
MDH status in writing to its MAC and submit the required documentation.
    (8) If a hospital disagrees with an MAC's determination regarding 
the hospital's initial or ongoing MDH status, the hospital may notify 
its MAC and submit other documentable evidence to support its claim that 
it meets the MDH qualifying criteria.
    (9) The MAC's initial and ongoing determination is subject to review 
under subpart R of Part 405 of this chapter. The time required by the 
MAC to review the request is considered good cause for granting an 
extension of the time limit for the hospital to apply for that review.
    (c) Payment methodology. A hospital that meets the criteria in 
paragraph (a) of this section is paid for its inpatient operating costs 
the sum of paragraphs (c)(1) and (c)(2) of this section.
    (1) The Federal payment rate applicable to the hospital, as 
determined under subpart D of this part, subject to the regional floor 
defined in Sec.  412.70(c)(6).
    (2) The amount, if any, determined as follows:
    (i) For discharges occurring during the first three 12-month cost 
reporting periods that begin on or after April 1, 1990, 100 percent of 
the amount that the Federal rate determined under paragraph (c)(1) of 
this section is exceeded by the higher of the following:
    (A) The hospital-specific rate as determined under Sec.  412.73.
    (B) The hospital-specific rate as determined under Sec.  412.75.
    (ii) For discharges occurring during any subsequent cost reporting 
period (or portion thereof) and before October 1, 1994, and for 
discharges occurring on or after October 1, 1997 and before October 1, 
2006, 50 percent of the amount that the Federal rate determined under 
paragraph (c)(1) of this section is exceeded by the higher of the 
following:
    (A) The hospital-specific rate as determined under Sec.  412.73.
    (B) The hospital-specific rate as determined under Sec.  412.75.
    (iii) For discharges occurring during cost reporting periods (or 
portions thereof) beginning on or after October 1, 2006, and before 
October 1, 2022, 75 percent of the amount that the Federal rate 
determined under paragraph (c)(1) of this section is exceeded by the 
highest of the following:
    (A) The hospital-specific rate as determined under Sec.  412.73.
    (B) The hospital-specific rate as determined under Sec.  412.75.
    (C) The hospital-specific rate as determined under Sec.  412.79.
    (d) Additional payments to hospitals experiencing a significant 
volume decrease. (1) CMS provides for a payment adjustment for a 
Medicare-dependent, small rural hospital for any cost reporting period 
during which the hospital experiences, due to circumstances as described 
in paragraph (d)(2) of this section, a more than 5 percent decrease in 
its total inpatient discharges as compared to its immediately preceding 
cost reporting period. If either the cost reporting period in question 
or the immediately preceding cost reporting period is other than a 12-
month cost reporting period, the MAC must convert the discharges to a 
monthly figure and multiply this figure by 12 to estimate

[[Page 681]]

the total number of discharges for a 12-month cost reporting period.
    (2) To qualify for a payment adjustment on the basis of a decrease 
in discharges, a Medicare-dependent, small rural hospital must submit 
its request no later than 180 days after the date on the MAC's Notice of 
Amount of Program Reimbursement and it must--
    (i) Submit to the MAC documentation demonstrating the size of the 
decrease in discharges and the resulting effect on per discharge costs; 
and
    (ii) Show that the decrease is due to circumstances beyond the 
hospital's control.
    (3) The MAC determines a lump sum adjustment amount in accordance 
with the methodology set forth in Sec.  412.92(e)(3).
    (i) In determining the adjustment amount, the MAC considers--
    (A) The individual hospital's needs and circumstances, including the 
reasonable cost of maintaining necessary core staff and services in view 
of minimum staffing requirements imposed by State agencies;
    (B) The hospital's fixed (and semi-fixed) costs, other than those 
costs paid on a reasonable cost basis under part 413 of this chapter; 
and
    (C) The length of time the hospital has experienced a decrease in 
utilization.
    (ii) The MAC makes its determination within 180 days from the date 
it receives the hospital's request and all other necessary information.
    (iii) The MAC determination is subject to review under subpart R of 
part 405 of this chapter. The time required by the MAC to review the 
request is considered good cause for granting an extension of the time 
limit for the hospital to apply for that review.

[55 FR 15175, Apr. 20, 1990; 55 FR 32088, Aug. 7, 1990]

    Editorial Note: For Federal Register citations affecting Sec.  
412.108, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.  412.109  Special treatment: Essential access community hospitals (EACHs).

    (a) General rule. For payment purposes, CMS treats as a sole 
community hospital any hospital that is located in a rural area as 
described in paragraph (b) of this section and that CMS designated as an 
EACH under section 1820(i)(1) of the Act as in effect on September 30, 
1997, for as long as the hospital continues to comply with the terms, 
conditions, and limitations that were applicable at the time CMS 
designated the hospital as an EACH. The payment methodology for sole 
community hospitals is set forth at Sec.  412.92(d).
    (b) Location in a rural area. For purposes of this section, a 
hospital is located in a rural area if it--
    (1) Is located outside any area that is a Metropolitan Statistical 
Area as defined by the Office of Management and Budget or that has been 
recognized as urban under Sec.  412.62;
    (2) Is not deemed to be located in an urban area under subpart D of 
this part.
    (3) Is not classified as an urban hospital for purposes of the 
standardized payment amount by CMS or the Medicare Geographic 
Classification Review Board; or
    (4) Is not located in a rural county that has been redesignated to 
an adjacent urban area under Sec.  412.232.
    (c) Adjustment to the hospital-specific rate for rural EACH's 
experiencing increased costs--(1) General rule. CMS increases the 
applicable hospital-specific rate of an EACH that it treats as a sole 
community hospital if, during a cost reporting period, the hospital 
experiences an increase in its Medicare inpatient operating costs per 
discharge that is directly attributable to activities related to its 
membership in a rural health network.
    (2) Request and documentation. In order for a hospital to qualify 
for an increase in its hospital-specific rate, it must meet the 
following criteria:
    (i) The hospital must submit its request to its intermediary no 
later than 180 days after the date on the intermediary's notice of 
program reimbursement.
    (ii) The request must include documentation specifically identifying 
the increased costs resulting from the hospital's participation in a 
rural health network and show that the increased costs during the cost 
reporting period

[[Page 682]]

will result in increased costs in subsequent cost reporting periods that 
are not already accounted for under the prospective payment system 
payment.
    (iii) The hospital must show that the cost increases are incremental 
costs that would not have been incurred in the absence of the hospital's 
membership in a rural health network.
    (iv) The hospital must show that the cost increases do not include 
amounts for start-up and one-time, nonrecurring costs attributable to 
its membership in a rural health network.
    (3) Intermediary recommendation. The intermediary forwards the 
following material to CMS within 60 days of receipt from the hospital:
    (i) The hospital's documentation and the intermediary's verification 
of that documentation.
    (ii) The intermediary's analysis and recommendation of the request.
    (iii) The hospital's Medicare cost report for the year in which the 
increase in costs occurred and the prior year.
    (4) CMS determination. CMS determines, within 120 days of receiving 
all necessary information from the intermediary, whether an increase in 
the hospital-specific rate is warranted and, if it is, the amount of the 
increase. CMS grants an adjustment only if a hospital's Medicare 
inpatient operating costs per discharge exceed the hospital's hospital-
specific rate. The adjusted hospital-specific rate cannot exceed the 
hospital's Medicare inpatient operating costs per discharge for the cost 
reporting period.
    (d) Termination of EACH designation. If CMS determines that a 
hospital no longer complies with the terms, conditions, and limitations 
that were applicable at the time CMS designated the hospital as an EACH, 
CMS will terminate the EACH designation of the hospital, effective with 
discharges occurring on or after 30 days after the date of the 
determination.
    (e) Review of CMS determination. A determination by CMS that a 
hospital's EACH designation should be terminated, is subject to review 
under part 405, subpart R of this chapter, including the time limits for 
filing requests for hearings as specified in Sec. Sec.  405.1811(a) and 
405.1841(a)(1) and (b) of this chapter.

[58 FR 30669, May 26, 1993, as amended at 59 FR 45398, Sept. 1, 1994; 60 
FR 45848, Sept. 1, 1995; 61 FR 21972, May 13, 1996; 62 FR 46030, Aug. 
29, 1997; 70 FR 47486, Aug. 12, 2005]



  Subpart H_Payments to Hospitals Under the Prospective Payment Systems



Sec.  412.110  Total Medicare payment.

    Under the prospective payment systems, Medicare's total payment for 
inpatient hospital services furnished to a Medicare beneficiary by a 
hospital will equal the sum of the payments listed in Sec. Sec.  412.112 
through 412.115, reduced by the amounts specified in Sec.  412.120.

[50 FR 12741, Mar. 29, 1985, as amended at 57 FR 39824, Sept. 1, 1992]



Sec.  412.112  Payments determined on a per case basis.

    A hospital is paid the following amounts on a per case basis:
    (a) The appropriate prospective payment rate for inpatient operating 
costs for each discharge as determined in accordance with subparts D, E, 
and G of this part.
    (b) Effective for cost reporting periods beginning on or after 
October 1, 1991, the appropriate prospective payment rate for capital-
related costs for each discharge as determined in accordance with 
subpart M of this part.
    (c) The appropriate outlier payment amounts determined under subpart 
F of this part.
    (d) Additional payments for new medical services and technologies 
determined under subpart F of this part.

[56 FR 43448, Aug. 30, 1991, as amended at 57 FR 39824, Sept. 1, 1992; 
68 FR 45470, Aug. 1, 2003]



Sec.  412.113  Other payments.

    (a) Capital-related costs--(1) Payment. Subject to the reductions 
described in paragraph (a)(2) of this section, payment for capital-
related costs (as described in Sec.  413.130 of this chapter) for cost 
reporting periods beginning before October 1, 1991 is determined on a 
reasonable cost basis.
    (2) Reduction to capital-related payments. (i) Except for sole 
community

[[Page 683]]

hospitals as defined in Sec.  412.92, the amount of capital-related 
payments for cost-reporting periods beginning before October 1, 1991 
(including a return on equity capital as provided under Sec.  413.157 of 
this chapter) is reduced by--
    (A) Three and one-half percent for payments attributable to portions 
of cost reporting periods occurring during Federal FY 1987;
    (B) Seven percent for payments attributable to portions of cost 
reporting periods or discharges (as the case may be) occurring during 
fiscal year 1988 and before January 1, 1988;
    (C) Twelve percent for payments attributable to portions of cost 
reporting periods or discharges (as the case may be) in fiscal year 1988 
occurring on or after January 1, 1988;
    (D) Fifteen percent for payments attributable to portions of cost 
reporting periods or discharges (as the case may be) occurring during 
fiscal year 1989 and beginning on or after January 1, 1990 and ending on 
or before September 30, 1991; and
    (E) Ten percent for payments attributable to portions of cost-
reporting periods occurring on or after October 1, 1991 and before the 
beginning of the hospital's first cost-reporting period beginning on or 
after October 1, 1991.
    (ii) If a hospital's cost reporting period encompasses more than one 
Federal fiscal year, the reductions to capital-related payments are 
determined on a prorated monthly basis.
    (3) For cost-reporting periods beginning on or after October 1, 
1991, a hospital with a hospital-specific rate above the Federal capital 
rate is paid a hold-harmless payment for old capital determined in 
accordance with subpart M of this part.
    (b) Direct medical education costs. (1) Payment for the direct 
medical education costs of interns and residents in approved programs 
for cost reporting periods beginning prior to July 1, 1985, and for 
approved education activities of nurses and paramedical health 
professionals is made as described in Sec.  413.85 of this chapter.
    (2) For cost reporting periods beginning on or after July 1, 1985, 
payment for the direct medical education costs of interns and residents 
in approved programs is made as described in Sec. Sec.  413.75 through 
413.83 of this subchapter.
    (3) Except as provided in Sec.  413.75(c) of this subchapter, for 
cost reporting periods during the prospective payment transition period, 
the costs of medical education must be determined in a manner that is 
consistent with the treatment of these costs for purposes of determining 
the hospital-specific portion of the payment rate as provided in subpart 
E of this part.
    (c) Anesthesia services furnished by hospital or CAH employed 
nonphysician anesthetists or obtained under arrangements. (1) For cost 
reporting periods beginning on or after October 1, 1984 through any part 
of a cost reporting period occurring before January 1, 1989, payment is 
determined on a reasonable cost basis for anesthesia services provided 
in the hospital or CAH by qualified nonphysician anesthetists (certified 
registered nurse anesthetists and anesthesiologist's assistants) 
employed by the hospital or CAH or obtained under arrangements.
    (2)(i) For cost reporting periods, or any part of a cost reporting 
period, beginning on or after January 1, 1989, through any part of a 
cost reporting period occurring before January 1, 1990, payment is 
determined on a reasonable cost basis for anesthesia services provided 
in a hospital or CAH by qualified nonphysician anesthetists employed by 
the hospital or CAH or obtained under arrangement, if the hospital or 
CAH demonstrates to its intermediary prior to April 1, 1989 that it 
meets the following criteria:
    (A) The hospital or CAH is located in a rural area as defined in 
Sec.  412.62(f) and is not deemed to be located in an urban area under 
the provisions of Sec.  412.64(b)(3). Effective December 2, 2010, the 
hospital or CAH is either located in a rural area as defined at Sec.  
412.62(f) and is not deemed to be located in an urban area under the 
provisions of Sec.  412.64(b)(3) or the hospital or CAH has reclassified 
as rural under the provisions at Sec.  412.103.
    (B) The hospital or CAH must have employed or contracted with a 
qualified nonphysician anesthetist, as defined in Sec.  410.69 of this 
chapter, as of January 1, 1988 to perform anesthesia services in that 
hospital or CAH. The

[[Page 684]]

hospital or CAH may employ or contract with more than one anesthetist; 
however, the total number of hours of service furnished by the 
anesthetists may not exceed 2,080 hours per year.
    (C) The hospital or CAH must provide data for its entire patient 
population to demonstrate that, during calendar year 1987, its volume of 
surgical procedures (inpatient and outpatient) requiring anesthesia 
services did not exceed 250 procedures. For purposes of this section, a 
surgical procedure requiring anesthesia services means a surgical 
procedure in which the anesthesia is administered and monitored by a 
qualified nonphysician anesthetist, a physician other than the primary 
surgeon, or an intern or resident.
    (D) Each qualified nonphysician anesthetist employed by or under 
contract with the hospital or CAH has agreed in writing not to bill on a 
reasonable charge basis for his or her patient care to Medicare 
beneficiaries in that hospital or CAH.
    (ii) To maintain its eligibility for reasonable cost payment under 
paragraph (c)(2)(i) of this section in calendar years after 1989, a 
qualified hospital or CAH must demonstrate prior to January 1 of each 
respective year that for the prior year its volume of surgical 
procedures requiring anesthesia service did not exceed 500 procedures; 
or, effective October 1, 2002, did not exceed 800 procedures.
    (iii) A hospital or CAH that did not qualify for reasonable cost 
payment for nonphysician anesthetist services furnished in calendar year 
1989 can qualify in subsequent years if it meets the criteria in 
paragraphs (c)(2)(i)(A), (B), and (D) of this section, and demonstrates 
to its intermediary prior to the start of the calendar year that it met 
these criteria. The hospital or CAH must provide data for its entire 
patient population to demonstrate that, during calendar year 1987 and 
the year immediately preceding its election of reasonable cost payment, 
its volume of surgical procedures (inpatient and outpatient) requiring 
anesthesia services did not exceed 500 procedures, or, effective October 
1, 2002, did not exceed 800 procedures.
    (iv) For administrative purposes for the calendar years after 1990, 
the volume of surgical procedures for the immediately preceding year is 
the sum of the surgical procedures for the nine month period ending 
September 30, annualized for the twelve month period.
    (d) Organ acquisition. Payment for organ acquisition costs incurred 
by hospitals with approved transplantation centers is made on a 
reasonable cost basis. The term ``Organs'' is defined in Sec.  486.302 
of this chapter.
    (e) Allogeneic hematopoietic stem cell acquisition. For cost 
reporting periods beginning on or after October 1, 2020, in the case of 
a subsection (d) hospital that furnishes an allogeneic hematopoietic 
stem cell transplant to an individual, payment to such hospital for 
hematopoietic stem cell acquisition costs is made on a reasonable cost 
basis.
    (1) An allogeneic hematopoietic stem cell transplant is the 
intravenous infusion of hematopoietic cells derived from bone marrow, 
peripheral blood stem cells, or cord blood, but not including embryonic 
stem cells, of a donor to an individual that are or may be used to 
restore hematopoietic function in such individual having an inherited or 
acquired deficiency or defect.
    (2) Allogeneic hematopoietic stem cell acquisition costs recognized 
under this paragraph (e) are costs of acquiring hematopoietic stem cells 
from a donor. These costs are as follows:
    (i) Registry fees from a national donor registry described in 42 
U.S.C. 274k, if applicable, for stem cells from an unrelated donor.
    (ii) Tissue typing of donor and recipient.
    (iii) Donor evaluation.
    (iv) Physician pre-admission/pre-procedure donor evaluation 
services.
    (v) Costs associated with the collection procedure (for example, 
general routine and special care services, procedure/operating room and 
other ancillary services, apheresis services), and transportation costs 
of stem cells if the recipient hospital incurred or paid such costs.
    (vi) Post-operative/post-procedure evaluation of donor.
    (vii) Preparation and processing of stem cells derived from bone 
marrow,

[[Page 685]]

peripheral blood stem cells, or cord blood (but not including embryonic 
stem cells).
    (3) A subsection (d) hospital that furnishes inpatient allogeneic 
hematopoietic stem cell transplants is required to hold all allogeneic 
hematopoietic stem cell acquisition charges and bill them to Medicare 
using the appropriate revenue code, when the transplant occurs.
    (4) A subsection (d) hospital must maintain an itemized statement 
that identifies, for all costs defined in paragraph (e)(2) of this 
section, the services furnished in collecting hematopoietic stem cells 
including all invoices or statements for purchased services for all 
donors and their service charges. Records must be for the person 
receiving the services (donor or recipient; for all donor sources, the 
hospital must identify the prospective recipient), and the recipient's 
Medicare beneficiary identification number.

[50 FR 12741, Mar. 29, 1985]

    Editorial Note: For Federal Register citations affecting Sec.  
412.113, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.  412.115  Additional payments.

    (a) Bad debts. An additional payment is made to each hospital in 
accordance with Sec.  413.89 of this chapter for bad debts attributable 
to deductible and coinsurance amounts related to covered services 
received by beneficiaries.
    (b) Administration of blood clotting factor. For discharges 
occurring on or after June 19, 1990, and before October 1, 1994, and for 
discharges occurring on or after October 1, 1997, an additional payment 
is made to a hospital for each unit of blood clotting factor furnished 
to a Medicare inpatient who is a hemophiliac. For discharges occurring 
on or after October 1, 2005, the additional payment is made based on the 
average sales price methodology specified in subpart K, part 414 of this 
chapter and the furnishing fee specified in Sec.  410.63 of this 
subchapter.
    (c) QIO reimbursement for cost of sending requested patient records 
to the QIO. An additional payment is made to a hospital in accordance 
with Sec.  476.78 of this chapter for the costs of sending requested 
patient records to the QIO in electronic format, by facsimile, or by 
photocopying and mailing.

[50 FR 12741, Mar. 29, 1985, as amended at 51 FR 34793, Sept. 30, 1986; 
55 FR 15175, Apr. 20, 1990; 56 FR 43448, Aug. 30, 1991; 57 FR 39825, 
Sept. 1, 1992; 57 FR 47787, Oct. 20, 1992; 58 FR 46339, Sept. 1, 1993; 
62 FR 46030, Aug. 29, 1997; 68 FR 67960, Dec. 5, 2003; 70 FR 47486, Aug. 
12, 2005; 85 FR 59022, Sept. 18, 2020]



Sec.  412.116  Method of payment.

    (a) General rules. (1) Unless the provisions of paragraphs (b) and 
(c) of this section apply, hospitals are paid for hospital inpatient 
operating costs and capital-related costs for each discharge based on 
the submission of a discharge bill.
    (2) Payments for inpatient hospital services furnished by an 
excluded psychiatric unit of a hospital (or by an excluded 
rehabilitation unit of a hospital for cost reporting periods beginning 
before January 1, 2002) are made as described in Sec. Sec.  413.64(a), 
(c), (d), and (e) of this chapter.
    (3) For cost reporting periods beginning on or after January 1, 
2005, payments for inpatient hospital services furnished by an inpatient 
psychiatric facility that meets the conditions of Sec.  412.404 are made 
as described in Sec.  412.432.
    (4) For cost reporting periods beginning on or after January 1, 
2002, payments for inpatient hospital services furnished by a 
rehabilitation hospital or a rehabilitation unit that meets the 
conditions of Sec.  412.604 are made as described in Sec.  412.632.
    (5) For cost reporting periods beginning on or after October 1, 
2002, payments for inpatient hospital services furnished by a long-term 
care hospital that meets the conditions for payment of Sec. Sec.  
412.505 through 412.511 are made as described in Sec.  412.521.
    (b) Periodic interim payments--(1) Criteria for receiving periodic 
interim payments. Effective with claims received on or after July 1, 
1987, a hospital that meets the criteria in Sec.  413.64(h) of this 
chapter may request in writing to receive periodic interim payments as 
described in this paragraph. A hospital that is receiving periodic 
interim payments also receives payment on this basis for inpatient 
hospital services

[[Page 686]]

furnished by its excluded psychiatric or rehabilitation unit.
    (i) Failure of intermediary to make prompt payment. Beginning with 
claims received in April 1987, the hospital's fiscal intermediary does 
not meet the requirements of section 1816(c)(2) of the Act, which 
provides for prompt payment of claims under Medicare Part A, for three 
consecutive calendar months. The hospital may continue to receive 
periodic interim payments until the intermediary meets the requirements 
of section 1816 (c)(2) of the Act for three consecutive calendar months. 
For purposes of this paragraph, a hospital that is receiving periodic 
interim payments as of June 30, 1987 and meets the requirements of Sec.  
413.64(h) of this chapter may continue to receive payment on this basis 
until the hospital's intermediary meets the requirements of section 
1816(c)(2) of the Act for three consecutive calendar months beginning 
with April 1987.
    (ii) Hospitals that serve a disproportionate share of low-income 
patients. The hospital is receiving periodic interim payments as of June 
30, 1987 and has a disproportionate share payment adjustment factor of 
at least 5.1 percent as determined under Sec.  412.106(c) for purposes 
of establishing the average standardized amounts for discharges 
occurring on or after October 1, 1986 and before October 1, 1987. The 
hospital's request must be made by a date prior to July 1, 1987, 
specified by the intermediary.
    (iii) Small rural hospitals. The hospital is receiving periodic 
interim payments as of June 30, 1987, makes its request by a date prior 
to July 1, 1987, specified by the intermediary, and, on July 1, 1987, 
the hospital--
    (A) Is located in a rural area as defined in Sec.  412.62(f); and
    (B) Has 100 or fewer beds available for use.
    (2) Frequency of payment. The intermediary estimates a hospital's 
prospective payments as described in paragraph (b)(3) of this section 
and makes biweekly payments equal to \1/26\ of the total estimated 
amount of payment for the year. Each payment is made two weeks after the 
end of a biweekly period of service, as described in Sec.  413.64(h)(5) 
of this chapter. These payments are subject to final settlement.
    (3) Amount of payment. (i) The biweekly interim payment amount is 
based on the total estimated Medicare discharges for the reporting 
period multiplied by the hospital's estimated average prospective 
payment amount as described in paragraph (b)(3)(ii) of this paragraph. 
These interim payments are reviewed at least twice during the reporting 
period and adjusted if necessary. Fewer reviews may be necessary if a 
hospital receives interim payments for less than a full reporting 
period.
    (ii) For purposes of determining periodic interim payments under 
this paragraph, a hospital's estimated average prospective payment 
amount is computed as follows:
    (A) If a hospital has no payment experience under the prospective 
payment system for operating costs, the intermediary computes the 
hospital's estimated average prospective payment amount for operating 
costs by multiplying its payment rates as determined under Sec.  
412.70(c), but without adjustment by a DRG weighting factor, by the 
hospital's case-mix index, and subtracting from this amount estimated 
deductibles and coinsurance.
    (B) Effective for cost-reporting periods beginning on or after 
October 1, 1991, the intermediary computes a hospital's estimated 
average prospective payment amount for capital-related costs by 
multiplying its prospective payment rate as determined under Sec.  
412.340 or Sec.  412.344(a), as applicable, and under Sec.  412.308 for 
cost reporting periods beginning on or after October 1, 2001 but without 
adjustment by a DRG weighting factor, by the hospital's case-mix index. 
The intermediary may take into account estimated additional payments per 
discharge under Sec.  412.348. If the hospital is paid under Sec.  
412.344(a)(1), the intermediary includes an estimated payment for old 
capital costs per discharge.
    (C) If a hospital has payment experience under the prospective 
payment system for operating costs, and, for cost reporting periods 
beginning on or after October 1, 1991, for inpatient capital-related 
costs, the intermediary

[[Page 687]]

computes a hospital's estimated average prospective payment amount for 
operating costs and capital-related costs based on that payment 
experience, adjusted for projected changes, and subtracts from this 
amount estimated deductibles and coinsurance.
    (4) Termination of periodic interim payments--(i) Request by the 
hospital. A hospital receiving periodic interim payments may convert to 
payments on a per discharge basis at any time.
    (ii) Removal by the intermediary. An intermediary terminates 
periodic interim payments if--
    (A) A hospital no longer meets the requirements of Sec.  413.64(h);
    (B) A hospital is receiving payment under the criterion in paragraph 
(b)(1)(i) of this section and the intemediary meets the prompt payment 
requirements of section 1816(c)(2) of the Act for three consecutive 
calendar months; or
    (C) A hospital that is receiving payment under the criterion set 
forth in paragraph (b)(1)(iii) of this section no longer meets the 
criterion.
    (iii) Limitation on reelection. If a hospital that is receiving 
periodic interim payments under the criterion set forth in paragraph 
(b)(1)(ii) or (b)(1)(iii) of this section is removed from that method of 
payment at its own request, it may reelect to receive periodic interim 
payments only under the criterion set forth in paragraph (b)(1)(i) of 
this section. However, if the hospital is removed from that method of 
payment by its intermediary because it no longer meets the requirements 
of Sec.  413.64(h) of this chapter, that hospital may subsequently 
reelect to receive periodic interim payments if it qualifies under the 
provisions of paragraph (b)(1)(ii) or (b)(1)(iii) of this section, 
subject to the requirements in Sec.  413.64(h) of this chapter.
    (c) Special interim payments for certain costs. For capital-related 
costs for cost-reporting periods beginning before October 1, 1991 and 
the direct costs of medical education, which are not included in 
prospective payments but are reimbursed as specified in Sec. Sec.  
413.130 and 413.85 of this chapter, respectively, interim payments are 
made subject to final cost settlement. Interim payments for capital-
related items for cost-reporting periods beginning before October 1, 
1991 and the estimated cost of approved medical education programs 
(applicable to inpatient costs payable under Medicare Part A and for 
kidney acquisition costs in hospitals approved as renal transplantation 
centers) are determined by estimating the reimbursable amount for the 
year based on the previous year's experience and on substantiated 
information for the current year and divided into 26 equal biweekly 
payments. Each payment is made two weeks after the end of a biweekly 
period of services, as described in Sec.  413.64(h)(5) of this chapter. 
The interim payments are reviewed by the intermediary at least twice 
during the reporting period and adjusted if necessary.
    (d) Special interim payment for unusually long lengths of stay--(1) 
First interim payment. A hospital that is not receiving periodic interim 
payments under paragraph (b) of this section may request an interim 
payment after a Medicare beneficiary has been in the hospital at least 
60 days. Payment for the interim bill is determined as if the bill were 
a final discharge bill and includes any outlier payment determined as of 
the last day for which services have been billed.
    (2) Additional interim payments. A hospital may request additional 
interim payments at intervals of at least 60 days after the date of the 
first interim bill submitted under paragraph (d)(1) of this section. 
Payment for these additional interim bills, as well as the final bill, 
is determined as if the bill were the final bill with appropriate 
adjustments made to the payment amount to reflect any previous interim 
payment made under the provisions of this paragraph (d).
    (e) Outlier payment and additional payments for new medical services 
and technologies. Payments for outlier cases and additional payments for 
new medical services and technologies (described in subpart F of this 
part) are not made on an interim basis.
    (f) Accelerated payments--(1) General rule. Upon request, an 
accelerated payment may be made to a hospital that is

[[Page 688]]

not receiving periodic interim payments under paragraph (b) of this 
section if the hospital is experiencing financial difficulties because 
of the following:
    (i) There is a delay by the intermediary in making payment to the 
hospital.
    (ii) Due to an exceptional situation, there is a temporary delay in 
the hospital's preparation and submittal of bills to the intermediary 
beyond its normal billing cycle.
    (2) Approval of payment. A hospital's request for an accelerated 
payment must be approved by the intermediary and CMS.
    (3) Amount of payment. The amount of the accelerated payment is 
computed as a percentage of the net payment for unbilled or unpaid 
covered services.
    (4) Recovery of payment. Recovery of the accelerated payment is made 
by recoupment as hospital bills are processed or by direct payment by 
the hospital.

[53 FR 1627, Jan. 21, 1988, as amended at 53 FR 38532, Sept. 30, 1988; 
54 FR 36495, Sept. 1, 1989; 56 FR 43449, Aug. 30, 1991; 57 FR 3016, Jan. 
27, 1992; 59 FR 36712, July 19, 1994; 59 FR 45400, Sept. 1, 1994; 66 FR 
41387, Aug. 7, 2001; 67 FR 56049, Aug. 30, 2002; 68 FR 45470, Aug. 1, 
2003; 69 FR 66977, Nov. 15, 2004; 71 FR 48140, Aug. 18, 2006]



Sec.  412.120  Reductions to total payments.

    (a) Deductible and coinsurance. Subject to paragraph (a)(2) of this 
section, the total Medicare payments otherwise payable to a hospital are 
reduced by the applicable deductible and coinsurance amounts related to 
inpatient hospital services as determined in accordance with Sec. Sec.  
409.82, 409.83, and 409.87 of this chapter.
    (b) Payment by workers' compensation, automobile medical, no-fault 
or liability insurance or an employer group health plan primary to 
Medicare. If workers' compensation, automobile medical, no-fault, or 
liability insurance or an employer group health plan which is primary to 
Medicare pays in full or in part, the Medicare payment is determined in 
accordance with the following guidelines:
    (1) If workers' compensation pays, in accordance with the applicable 
provisions of Sec. Sec.  405.316 through 405.321 of this chapter.
    (2) If automobile medical, no-fault, or liability insurance pays, in 
accordance with the applicable provisions of Sec. Sec.  405.322 through 
405.325 of this chapter.
    (3) If an employer group health plan which is primary to Medicare 
pays for services to ESRD beneficiaries, in accordance with the 
applicable provisions of Sec. Sec.  405.326 through 405.329 of this 
chapter.
    (4) If an employer group health plan which is primary to Medicare 
pays for services to employees age 65-69 and their spouses age 65-69, in 
accordance with the applicable provisions of Sec. Sec.  405.340 through 
405.344 of this chapter.

[50 FR 12741, Mar. 29, 1985, as amended at 55 FR 36071, Sept. 4, 1990; 
56 FR 573, Jan. 7, 1991; 57 FR 39825, Sept. 1, 1992]



Sec.  412.125  Effect of change of ownership on payments 
under the prospective payment systems.

    When a hospital's ownership changes, as described in Sec.  489.18 of 
this chapter, the following rules apply:
    (a) Payment for the operating and capital-related costs of inpatient 
hospital services for each patient, including outlier payments, as 
provided in Sec.  412.112, and payments for hemophilia clotting factor 
costs under Sec.  412.115(b), are made to the entity that is the legal 
owner on the date of discharge. Payments are not prorated between the 
buyer and seller.
    (1) The owner on the date of discharge is entitled to submit a bill 
for all inpatient hospital services furnished to a beneficiary 
regardless of when the beneficiary's coverage began or ended during a 
stay, or of how long the stay lasted.
    (2) Each bill submitted must include all information necessary for 
the intermediary to compute the payment amount, whether or not some of 
that information is attributable to a period during which a different 
party legally owned the hospital.
    (b) Other payments under Sec.  412.113 and payments for bad debts as 
described in Sec.  412.115(a), are made to each owner or operator of the 
hospital (buyer and seller) in accordance with

[[Page 689]]

the principles of reasonable cost reimbursement.

[50 FR 12741, Mar. 29, 1985, as amended at 56 FR 43449, Aug. 30, 1991]



Sec.  412.130  Retroactive adjustments for incorrectly excluded hospitals 
and units.

    (a) Hospitals for which adjustment is made. The intermediary makes 
the payment adjustment described in paragraph (b) of this section for 
the following hospitals:
    (1) A hospital that was excluded from the prospective payment 
systems specified in Sec.  412.1(a)(1) or paid under the prospective 
payment system specified in Sec.  412.1(a)(3), as a new rehabilitation 
hospital for a cost reporting period beginning on or after October 1, 
1991 based on a certification under Sec.  412.29(c) regarding the 
inpatient population the hospital planned to treat during that cost 
reporting period, if the inpatient population actually treated in the 
hospital during that cost reporting period did not meet the requirements 
of Sec.  412.29(b).
    (2) A hospital that has a unit excluded from the prospective payment 
systems specified in Sec.  412.1(a)(1) or paid under the prospective 
payment system specified in Sec.  412.1(a)(3), as a new rehabilitation 
unit for a cost reporting period beginning on or after October 1, 1991, 
based on a certification under Sec.  412.29(c) regarding the inpatient 
population the hospital planned to treat in that unit during the period, 
if the inpatient population actually treated in the unit during that 
cost reporting period did not meet the requirements of Sec.  412.29(b).
    (3) A hospital that added new beds to its existing rehabilitation 
unit for a cost reporting period beginning on or after October 1, 1991 
based on a certification under Sec.  412.29(c) regarding the inpatient 
population the hospital planned to treat in these new beds during that 
cost reporting period, if the inpatient population actually treated in 
the new beds during that cost reporting period did not meet the 
requirements of Sec.  412.29(b).
    (b) Adjustment of payment. (1) For cost reporting periods beginning 
before January 1, 2002, the intermediary adjusts the payment to the 
hospitals described in paragraph (a) of this section as follows:
    (i) The intermediary calculates the difference between the amounts 
actually paid during the cost reporting period for which the hospital, 
unit, or beds were first excluded as a new hospital, new unit, or newly 
added beds under subpart B of this part, and the amount that would have 
been paid under the prospective payment systems specified in Sec.  
412.1(a)(1) for services furnished during that period.
    (ii) The intermediary makes a retroactive adjustment for the 
difference between the amount paid to the hospital based on the 
exclusion and the amount that would have been paid under the prospective 
payment systems specified in Sec.  412.1(a)(1).
    (2) For cost reporting periods beginning on or after January 1, 
2002, the intermediary adjusts the payment to the hospitals described in 
paragraph (a) of this section as follows:
    (i) The intermediary calculates the difference between the amounts 
actually paid under subpart P of this part during the cost reporting 
period for which the hospital, unit, or beds were first classified as a 
new hospital, new unit, or newly added beds under subpart B of this 
part, and the amount that would have been paid under the prospective 
payment systems specified in Sec.  412.1(a)(1) for services furnished 
during that period.
    (ii) The intermediary makes a retroactive adjustment for the 
difference between the amount paid to the hospital under subpart P of 
this part and the amount that would have been paid under the prospective 
payment systems specified in Sec.  412.1(a)(1).

[56 FR 43241, Aug. 30, 1991, as amended at 57 FR 39825, Sept. 1, 1992; 
59 FR 45400, Sept. 1, 1994; 60 FR 45848, Sept. 1, 1995; 66 FR 41387, 
Aug. 7, 2001; 70 FR 66977, Nov. 15, 2005; 78 FR 47934, Aug. 6, 2013]



Sec.  412.140  Participation, data submission, and validation requirements 
under the Hospital Inpatient Quality Reporting (IQR) Program.

    (a) Participation in the Hospital IQR Program. In order to 
participate in the Hospital IQR Program, a section 1886(d) of the 
hospital must-

[[Page 690]]

    (1) Register on QualityNet website, before it begins to report data;
    (2) Identify and register a QualityNet security officialas part of 
the registration process under paragraph (a)(1) of this section; and
    (3) Submit a completed Notice of Participation Form to CMS if the 
hospital is participating in the program for the first time, has 
previously withdrawn from the program and would like to participate 
again, or has received a new CMS Certification Number (CCN).
    (i) A hospital that would like to participate in the program for the 
first time (and to which paragraph (a)(3)(ii) of this section does not 
apply), or that previously withdrew from the program and would now like 
to participate again, must submit to CMS a completed Notice of 
Participation Form by December 31 of the calendar year preceding the 
first quarter of the calendar year in which data submission is required 
for any given fiscal year.
    (ii) A hospital that has received a new CCN and would like to 
participate in the program must submit a completed Notice of 
Participation Form to CMS no later than 180 days from the date 
identified as the open date on the approved CMS Quality Improvement 
Evaluation System (QIES).
    (b) Withdrawal from the Hospital IQR Program. CMS will accept 
Hospital IQR Program withdrawal forms from hospitals on or before--
    (1) Prior to the FY 2016 payment determination, August 15 of the 
fiscal year preceding the fiscal year for which a Hospital IQR 
determination will be made.
    (2) Beginning with the FY 2016 payment determination, May 15 of the 
fiscal year preceding the fiscal year for which a Hospital IQR payment 
determination will be made.
    (c) Submission and validation of Hospital IQR Program data. (1) 
General rule. Except as provided in paragraph (c)(2) of this section, 
subsection (d) hospitals that participate in the Hospital IQR Program 
must submit to CMS data on measures selected under section 
1886(b)(3)(B)(viii) of the Act in a form and manner, and at a time, 
specified by CMS. A hospital must begin submitting data on the first day 
of the quarter following the date that the hospital submits a completed 
Notice of Participation form under paragraph (a)(3) of this section.
    (2) Extraordinary circumstances exceptions. CMS may grant an 
exception with respect to quality data reporting requirements in the 
event of extraordinary circumstances beyond the control of the hospital. 
CMS may grant an exception as follows:
    (i) For circumstances not relating to the reporting of electronic 
clinical quality measure data, a hospital participating in the Hospital 
IQR Program that wishes to request an exception with respect to quality 
data reporting requirements must submit its request to CMS within 90 
days of the date that the extraordinary circumstances occurred. For 
circumstances relating to the reporting of electronic clinical quality 
measures, a hospital participating in the Hospital IQR Program that 
wishes to request an exception must submit its request to CMS by April 1 
following the end of the reporting calendar year in which the 
extraordinary circumstances occurred. Specific requirements for 
submission of a request for an exception are available on QualityNet 
website.
    (ii) CMS may grant an exception to one or more hospitals that have 
not requested an exception if: CMS determines that a systemic problem 
with CMS data collection systems directly affected the ability of the 
hospital to submit data; or if CMS determines that an extraordinary 
circumstance has affected an entire region or locale.
    (d) Validation of Hospital IQR Program data. CMS may validate one or 
more measures selected under section 1886(b)(3)(B)(viii) of the Act by 
reviewing patient charts submitted by selected participating hospitals.
    (1) Upon written request by CMS or its contractor, a hospital must 
submit to CMS a sample of patient charts that the hospital used for 
purposes of data submission under the program. The specific sample that 
a hospital must submit will be identified in the written request. A 
hospital must submit the patient charts to CMS or its contractor within 
30 days of the date identified on the written request.

[[Page 691]]

    (2)(i) A hospital meets the chart-abstracted validation requirement 
with respect to a fiscal year if it achieves a 75-percent score, as 
determined by CMS.
    (ii) A hospital meets the eCQM validation requirement with respect 
to a fiscal year if it submits at least 75 percent of sampled eCQM 
measure medical records in a timely and complete manner, as determined 
by CMS.
    (e) Reconsiderations and appeals of Hospital IQR Program decisions. 
(1) A hospital may request reconsideration of a decision by CMS that the 
hospital has not met the requirements of the Hospital IQR Program for a 
particular fiscal year. Except as provided in paragraph (c)(2) of this 
section, a hospital must submit a reconsideration request to CMS no 
later than 30 days from the date identified on the Hospital Inpatient 
Quality Reporting Program Annual Payment Update Notification Letter 
provided to the hospital.
    (2) A reconsideration request must contain the following 
information:
    (i) The hospital's CMS Certification Number (CCN);
    (ii) The name of the hospital;
    (iii) Contact information for the hospital's chief executive officer 
and QualityNet security official, including each individual's name, e-
mail address, telephone number, and physical mailing address;
    (iv) A summary of the reason(s), as set forth in the Hospital 
Inpatient Quality Reporting Program Annual Payment Update Notification 
Letter, that CMS concluded the hospital did not meet the requirements of 
the Hospital IQR Program;
    (v) A detailed explanation of why the hospital believes that it 
complied with the requirements of the Hospital IQR Program for the 
applicable fiscal year;
    (vi) Any evidence that supports the hospital's reconsideration 
request, including copies of patient charts, e-mails and other 
documents; and
    (vii) If the hospital has requested reconsideration on the basis 
that CMS concluded it did not meet the validation requirement set forth 
in paragraph (d) of this section, the reconsideration request must 
contain the following additional information:
    (A) A copy of each patient chart that the hospital timely submitted 
to CMS or its contractor in response to a request made under paragraph 
(d)(1) of this section; and
    (B) A detailed explanation identifying which data the hospital 
believes was improperly validated by CMS and why the hospital believes 
that such data are correct.
    (3) A hospital that is dissatisfied with a decision made by CMS on 
its reconsideration request may file an appeal with the Provider 
Reimbursement Review Board under part 405, subpart R of this chapter.
    (f) Patient experience of care data (HCAHPS survey). HCAHPS is the 
Hospital Consumer Assessment of Healthcare Providers and Systems survey 
that measures patient experience of care after a recent hospital stay.
    (1) Approved HCAHPS survey vendors and self-administering hospitals 
must fully comply with all HCAHPS oversight activities, including 
allowing CMS and its HCAHPS Project Team to perform site visits at the 
hospitals' and survey vendors' company locations.
    (2) CMS approves an application for an entity to administer the 
HCAHPS survey as an approved HCAHPS survey vendor on behalf of one or 
more hospitals when an applicant has met the Minimum Survey Requirements 
and Rules of Participation that can be found on the official HCAHPS On-
Line Web site, and agree to comply with the current survey 
administration protocols that can be found on the official HCAHPS On-
Line Web site. An entity must be an approved HCAHPS survey vendor in 
order to administer and submit HCAHPS data to CMS on behalf of one or 
more hospitals.

[76 FR 51782, Aug. 18, 2011, as amended at 77 FR 53674, Aug. 31, 2012; 
78 FR 50966, Aug. 19, 2013; 79 FR 50354, Aug. 22, 2014; 81 FR 57267, 
Aug. 22, 2016; 82 FR 38511, Aug. 14, 2017; 86 FR 45520, Aug. 13, 2021]

[[Page 692]]



 Subpart I_Adjustments to the Base Operating DRG Payment Amounts Under 
      the Prospective Payment Systems for Inpatient Operating Costs

    Source: 77 FR 53674, Aug. 31, 2012, unless otherwise noted.



Sec.  412.150  Basis and scope of subpart.

    (a) Section 1886(q) of the Act requires the Secretary to establish a 
Hospital Readmissions Reduction program, under which payments to 
applicable hospitals are reduced in order to account for certain excess 
readmissions, effective for discharges beginning on October 1, 2012. The 
rules for determining the payment adjustment under the Hospital 
Readmission Reductions Program are specified in Sec. Sec.  412.152 and 
412.154.
    (b) Section 1886(o) of the Act requires the Secretary to establish a 
Value-Based Purchasing (VBP) Program for inpatient hospitals (Hospital 
VBP Program), which requires CMS to make value-based incentive payments 
to hospitals that meet performance standards for applicable performance 
periods, effective for discharges beginning on October 1, 2012. The 
rules for determining the payment adjustment under the Hospital Value-
Based Purchasing Program are specified in Sec. Sec.  412.160 through 
412.167.
    (c) Section 1886(p) of the Act requires the Secretary to establish 
an adjustment to hospital payments for hospital-acquired conditions, or 
a Hospital-Acquired Condition Reduction Program, under which payments to 
applicable hospitals are adjusted to provide an incentive to reduce 
hospital-acquired conditions, effective for discharges beginning on 
October 1, 2014. The rules for determining the payment adjustment under 
the Hospital-Acquired Condition Reduction Program are specified in 
Sec. Sec.  412.170 and 412.172.

[77 FR 53674, Aug. 31, 2012, as amended at 78 FR 50966, Aug. 19, 2013]

  Payment Adjustments Under the Hospital Readmissions Reduction Program



Sec.  412.152  Definitions for the Hospital Readmissions Reduction Program.

    As used in this section and in Sec.  412.154, the following 
definitions apply:
    Aggregate payments for all discharges is, for a hospital for the 
applicable period, the sum of the base operating DRG payment amounts for 
all discharges for all conditions from such hospital for such applicable 
period.
    Aggregate payments for excess readmissions is, for a hospital for 
the applicable period, the sum, for the applicable conditions, of the 
product for each applicable condition of:
    (1) The base operating DRG payment amount for the hospital for the 
applicable period for such condition or procedure;
    (2) The number of admissions for such condition or procedure for the 
hospital for the applicable period;
    (3) The excess readmission ratio for the hospital for the applicable 
period minus the peer-group median excess readmission ratio (ERR); and
    (4) The neutrality modifier, a multiplicative factor that equates 
total Medicare savings under the current stratified methodology to the 
previous non-stratified methodology.
    Applicable condition is a condition or procedure selected by the 
Secretary--
    (1) Among the conditions and procedures for which--
    (i) Readmissions represent conditions or procedures that are high 
volume or high expenditures; and
    (ii) Measures of such readmissions have been endorsed by the entity 
with a contract under section 1890(a) of the Act and such endorsed 
measures have exclusions for readmissions that are unrelated to the 
prior discharge (such as a planned readmission or transfer to another 
applicable hospital); or
    (2) Among other conditions and procedures as determined appropriate 
by the Secretary. In expanding the applicable conditions, the Secretary 
will seek endorsement of the entity with a contract under section 
1890(a) of the Act, but may apply such measures without such an 
endorsement in the

[[Page 693]]

case of a specified area or medical topic determined appropriate by the 
Secretary for which a feasible and practical measure has not been 
endorsed by the entity with a contract under section 1890(a) of the Act 
as long as due consideration is given to measures that have been 
endorsed or adopted by a consensus organization identified by the 
Secretary.
    Applicable period is, with respect to a fiscal year, the 3-year 
period (specified by the Secretary) from which data are collected in 
order to calculate excess readmission ratios and adjustments under the 
Hospital Readmissions Reduction Program.
    (1) The applicable period for FY 2022 is the 3-year period from July 
1, 2017 through June 30, 2020; and
    (2) Beginning with the FY 2023 program year, the applicable period 
is the 3-year period advanced by 1-year from the prior year's period 
from which data are collected in order to calculate excess readmission 
ratios and adjustments under the Hospital Readmissions Reduction 
Program, unless otherwise specified by the Secretary.
    Applicable period for dual eligibility is the 3-year data period 
corresponding to the applicable period for the Hospital Readmissions 
Reduction Program, unless otherwise established by the Secretary.
    Base operating DRG payment amount is the wage-adjusted DRG operating 
payment plus any applicable new technology add-on payments under subpart 
F of this part. This amount is determined without regard to any payment 
adjustments under the Hospital Value-Based Purchasing Program, as 
specified under Sec.  412.162. This amount does not include any 
additional payments for indirect medical education under Sec.  412.105, 
the treatment of a disproportionate share of low-income patients under 
Sec.  412.106, outliers under subpart F of this part, and a low volume 
of discharges under Sec.  412.101. With respect to a sole community 
hospital that receives payments under Sec.  412.92(d) this amount also 
does not include the difference between the hospital-specific payment 
rate and the Federal payment rate determined under subpart D of this 
part. With respect to a Medicare-dependent, small rural hospital that 
receives payments under Sec.  412.108(c), this amount includes the 
difference between the hospital-specific payment rate and the Federal 
payment rate determined under subpart D of this part. With respect to a 
hospital that is paid under section 1814(b)(3) of the Act, this amount 
is an amount equal to the wage-adjusted DRG payment amount plus new 
technology payments that would be paid to such hospitals, absent the 
provisions of section 1814(b)(3) of the Act.
    Dual-eligible--(1) For payment adjustment factor calculations prior 
to the FY 2021 program year, is a patient beneficiary who has been 
identified as having full benefit status in both the Medicare and 
Medicaid programs in the State Medicare Authorization Act (MMA) files 
for the month the beneficiary was discharged from the hospital; and
    (2) For payment adjustment factor calculations beginning in the FY 
2021 program year, is a patient beneficiary who has been identified as 
having full benefit status in both the Medicare and Medicaid programs in 
data sourced from the State MMA files for the month the beneficiary was 
discharged from the hospital, except for those patient beneficiaries who 
die in the month of discharge, which will be identified using the 
previous month's data as sourced from the State MMA files.
    Excess readmissions ratio is a hospital-specific ratio for each 
applicable condition for an applicable period, which is the ratio (but 
not less than 1.0) of risk-adjusted readmissions based on actual 
readmissions for an applicable hospital for each applicable condition to 
the risk-adjusted expected readmissions for the applicable hospital for 
the applicable condition.
    Floor adjustment factor is the value that the readmissions 
adjustment factor cannot be less than for a given fiscal year. The floor 
adjustment factor is set at 0.99 for FY 2013, 0.98 for FY 2014, and 0.97 
for FY 2015 and subsequent fiscal years.
    Proportion of dual-eligibles is the number of dual-eligible patients 
among all Medicare Fee-for-Service and Medicare Advantage stays during 
the applicable period.

[[Page 694]]

    Readmission is the case of an individual who is discharged from an 
applicable hospital, the admission of the individual to the same or 
another applicable hospital within a time period of 30 days from the 
date of such discharge.
    Readmissions adjustment factor is equal to the greater of:
    (1) 1 minus the ratio of the aggregate payments for excess 
readmissions to aggregate payments for all discharges; or
    (2) The floor adjustment factor.
    Wage-adjusted DRG operating payment is the applicable average 
standardized amount adjusted for resource utilization by the applicable 
MS-DRG relative weight and adjusted for differences in geographic costs 
by the applicable area wage index (and by the applicable cost-of-living 
adjustment for hospitals located in Alaska and Hawaii). This amount 
includes an applicable payment adjustment for transfers under Sec.  
412.4(f).

[77 FR 53674, Aug. 31, 2012, as amended at 78 FR 50967, Aug. 19, 2013; 
83 FR 41704, Aug. 17, 2018; 84 FR 42613, Aug. 16, 2019l 85 FR 59022, 
Sept. 18, 2020]



Sec.  412.154  Payment adjustments under the Hospital Readmissions 
Reduction Program.

    (a) Scope. This section sets forth the requirements for determining 
the payment adjustments under the Hospital Readmissions Reduction 
Program for applicable hospitals to account for excess readmissions in 
the hospital.
    (b) Payment adjustment. (1) General. To account for excess 
readmissions, except as provided for in paragraph (d) of this section, 
an applicable hospital's base operating DRG payment amount is adjusted 
for each discharge occurring during the fiscal year. The payment 
adjustment for each discharge is determined by subtracting the product 
of the base operating DRG payment amount (as defined in Sec.  412.152) 
for such discharge by the hospital's readmission payment adjustment 
factor for the fiscal year (determined under paragraph (c) of this 
section) from the base operating DRG payment amount for such discharge.
    (2) Special treatment for sole community hospitals. In the case of a 
sole community hospital that receives payments under Sec.  412.92(d) 
based on the hospital-specific rate, the difference between the 
hospital-specific rate payment and the Federal rate payment determined 
under subpart D of this part is not affected by this payment adjustment.
    (c) Methodology to calculate the readmissions payment adjustment 
factor. A hospital's readmissions payment adjustment factor is the 
higher of the ratio described in paragraph (c)(1) of this section or the 
floor adjustment factor set forth in paragraph (c)(2) of this section.
    (1) Ratio. The ratio is equal to 1 minus the ratio of the aggregate 
payments for excess readmissions as defined in Sec.  412.152 and the 
aggregate payments for all discharges as defined in Sec.  412.152.
    (2) Floor adjustment factor. The floor adjustment factor is:
    (i) For FY 2013, 0.99;
    (ii) For FY 2014, 0.98; and
    (iii) For FY 2015 and subsequent fiscal years, 0.97.
    (d) [Reserved]
    (e) Limitations on review. There is no administrative or judicial 
review under this subpart of the following:
    (1) The determination of base operating DRG payment amounts.
    (2) The methodology for determining the adjustment factor under 
paragraph (c) of this section, including the excess readmissions ratio, 
aggregate payments for excess readmissions, and aggregate payments for 
all discharges.
    (3) The applicable period.
    (4) The neutrality modifier.
    (5) The proportion of dual-eligibles.
    (6) The applicable conditions.
    (f) Reporting of hospital-specific information. CMS will make 
information available to the public regarding readmissions rates of each 
applicable hospital (as defined in Sec.  412.152) under the Hospital 
Readmissions Reduction Program.
    (1) To ensure that an applicable hospital has the opportunity to 
review and submit corrections for its excess readmission ratios for the 
applicable conditions for a fiscal year that are used to determine its 
readmissions payment adjustment factor under paragraph (c) of this 
section, CMS will provide each applicable hospital with confidential

[[Page 695]]

hospital-specific reports and discharge level information used in the 
calculation of its excess readmission ratios.
    (2) Applicable hospitals will have a period of 30 days after receipt 
of the information provided in paragraph (f)(1) of this section to 
review and submit corrections for the excess readmission ratios for each 
applicable condition that are used to calculate the readmissions payment 
adjustment factor under paragraph (c) of this section for the fiscal 
year.
    (3) The administrative claims data used to calculate an applicable 
hospital's excess readmission ratios for the applicable conditions for a 
fiscal year are not subject to review and correction under paragraph 
(f)(1) of this section.
    (4) CMS posts the excess readmission ratios for the applicable 
conditions for a fiscal year for each applicable hospital on the 
Hospital Compare website or successor website(s).

[77 FR 53674, Aug. 31, 2012, as amended at 78 FR 50967, Aug. 19, 2013; 
79 FR 50354, Aug. 22, 2014; 84 FR 42614, Aug. 16, 2019; 86 FR 45520, 
Aug. 13, 2021]



Sec. Sec.  412.155-412.159  [Reserved]

  Incentive Payments Under the Hospital Value-Based Purchasing Program



Sec.  412.160  Definitions for the Hospital Value-Based Purchasing 
(VBP) Program.

    As used in this section and in Sec. Sec.  412.161 through 412.168:
    Achievement threshold (or achievement performance standard) means 
the median (50th percentile) of hospital performance on a measure during 
a baseline period with respect to a fiscal year, for Hospital VBP 
Program measures other than the measures in the Efficiency and Cost 
Reduction domain, and the median (50th percentile) of hospital 
performance on a measure during the performance period with respect to a 
fiscal year, for the measures in the Efficiency and Cost Reduction 
domain.
    Applicable percent means the following:
    (1) For FY 2013, 1.0 percent;
    (2) For FY 2014, 1.25 percent;
    (3) For FY 2015, 1.50 percent;
    (4) For FY 2016, 1.75 percent; and
    (5) For FY 2017 and subsequent fiscal years, 2.0 percent.
    Base operating DRG payment amount means the following:
    (1) With respect to a subsection (d) hospital (as defined in section 
1886(d)(1)(B) of the Act), the wage-adjusted DRG operating payment plus 
any applicable new technology add-on payments under subpart F of this 
part. This amount is determined without regard to any payment 
adjustments under the Hospital Readmissions Reduction Program, as 
specified under Sec.  412.154. This amount does not include any 
additional payments for indirect medical education under Sec.  412.105, 
the treatment of a disproportionate share of low-income patients under 
Sec.  412.106, outliers under subpart F of this part, or a low volume of 
discharges under Sec.  412.101.
    (2) With respect to a Medicare-dependent, small rural hospital that 
receives payments under Sec.  412.108(c) or a sole community hospital 
that receives payments under Sec.  412.92(d), the wage-adjusted DRG 
operating payment plus any applicable new technology add-on payments 
under subpart F of this part. This amount does not include any 
additional payments for indirect medical education under Sec.  412.105, 
the treatment of a disproportionate share of low-income patients under 
Sec.  412.106, outliers under subpart F of this part, or a low volume of 
discharges under Sec.  412.101. With respect to a Medicare-dependent, 
small rural hospital that receives payments under Sec.  412.108(c) (for 
discharges occurring in FY 2013) or a sole community hospital that 
receives payments under Sec.  412.92(d), this amount also does not 
include the difference between the hospital-specific payment rate and 
the Federal payment rate determined under subpart D of this part.
    Benchmark means the arithmetic mean of the top decile of hospital 
performance on a measure during the baseline period with respect to a 
fiscal year, for Hospital VBP Program measures other than the measures 
in the Efficiency and Cost Reduction domain, and the arithmetic mean of 
the top decile of hospital performance on a measure during the 
performance period with respect to a fiscal year, for the

[[Page 696]]

measures in the Efficiency and Cost Reduction domain.
    Cited for deficiencies that pose immediate jeopardy means that, 
during the applicable performance period, the Secretary cited the 
hospital for immediate jeopardy on at least three surveys using the Form 
CMS-2567, Statement of Deficiencies and Plan of Correction. CMS assigns 
an immediate jeopardy citation to a performance period as follows:
    (1) If the Form CMS-2567 only contains one or more EMTALA-related 
immediate jeopardy citations, CMS uses the date that the Form CMS-2567 
is issued to the hospital;
    (2) If the Form CMS-2567 only contains one or more Medicare 
conditions of participation immediate jeopardy citations, CMS uses the 
survey end date generated in ASPEN; and
    (3) If the Form CMS-2567 contains both one or more EMTALA-related 
immediate jeopardy citations and one or more Medicare conditions of 
participation immediate jeopardy citations, CMS uses the survey end date 
generated in ASPEN.
    Domain means a grouping of measures used for purposes of calculating 
the Total Performance Score for each hospital with respect to a fiscal 
year.
    Domain score means the total number of points awarded to a hospital 
for a domain.
    Hospital means a hospital described in section 1886(d)(1)(B) of the 
Act, but does not include a hospital, with respect to a fiscal year, for 
which one or more of the following applies:
    (1) The hospital is subject to the payment reduction under section 
1886(b)(3)(B)(viii)(I) of the Act for the fiscal year;
    (2) The Secretary cited the hospital for deficiencies that pose 
immediate jeopardy to the health or safety of patients during the 
performance period that applies with respect to the fiscal year;
    (3) There are not a minimum number of measures that apply to the 
hospital for the performance period for the fiscal year; or
    (4) There are not a minimum number of cases for the measures that 
apply to the hospital for the performance period for the fiscal year.
    Immediate jeopardy has the same meaning as that term is defined in 
Sec.  489.3 of this chapter.
    Improvement threshold (or improvement performance standard) means an 
individual hospital's performance level on a measure during the baseline 
period with respect to a fiscal year.
    Linear Exchange Function is the means to translate a hospital's 
total performance score into a value-based incentive payment percentage 
such that:
    (1) Each eligible hospital's value-based incentive payment 
percentage is based on its total performance score; and
    (2) The total amount of value-based incentive payments to all 
hospitals in a fiscal year is equal to the total amount available for 
value-based incentive payments in such fiscal year.
    Performance period means the time period during which data are 
collected for the purpose of calculating hospital performance on 
measures with respect to a fiscal year.
    Performance standards are the levels of performance that hospitals 
must meet or exceed in order to earn points under the Hospital VBP 
Program, and are calculated with respect to a measure for a fiscal year 
no later than 60 days prior to the start of the performance period for 
that measure for that fiscal year. The performance standards for a 
measure may be updated as follows:
    (1) To make a single correction to correct a calculation error, data 
issue, or other problem that would significantly change the performance 
standards; or
    (2) To incorporate nonsubstantive technical updates made to the 
measure between the time that CMS first displays the performance 
standards for that measure for a fiscal year and the time that CMS 
calculates hospital performance on that measure at the conclusion of the 
performance period for that measure for a fiscal year.
    Total Performance Score means the numeric score ranging from 0 to 
100 awarded to each hospital based on its performance under the Hospital 
VBP Program with respect to a fiscal year.
    Value-based incentive payment adjustment factor is the number that 
will be

[[Page 697]]

multiplied by the base operating DRG payment amount for each discharge 
from a hospital, during a fiscal year, in order to adjust the hospital's 
payment as a result of its performance under the Hospital VBP Program.
    Value-based incentive payment percentage means the percentage of the 
base operating DRG payment amount for each discharge that a hospital has 
earned with respect to a fiscal year, based on its Total Performance 
Score for that fiscal year.
    Wage-adjusted DRG operating payment is the applicable average 
standardized amount adjusted for--
    (1) Resource utilization by the applicable MS-DRG relative weight;
    (2) Differences in geographic costs by the applicable area wage 
index (and by the applicable cost-of-living adjustment for hospitals 
located in Alaska and Hawaii); and
    (3) Any applicable payment adjustment for transfers under Sec.  
412.4(f).

[77 FR 53674, Aug. 31, 2012, as amended at 78 FR 50967, Aug. 19, 2013; 
79 FR 50354, Aug. 22, 2014; 81 FR 57268, Aug. 22, 2016; 86 FR 45520, 
Aug. 13, 2021]



Sec.  412.161  Applicability of the Hospital Value-Based Purchasing 
(VBP) Program

    The Hospital VBP Program applies to hospitals, as that term is 
defined in Sec.  412.160.

[79 FR 50355, Aug. 22, 2014]



Sec.  412.162  Process for reducing the base operating DRG payment amount 
and applying the value-based incentive payment amount adjustment 
under the Hospital Value-Based Purchasing (VBP) Program.

    (a) General. If a hospital meets or exceeds the performance 
standards that apply to the Hospital VBP Program for a fiscal year, CMS 
will make value-based incentive payments to the hospital under the 
requirements and conditions specified in this section.
    (b) Value-based incentive payment amount. (1) Available amount. The 
value-based incentive payment amount for a discharge is the portion of 
the payment amount that is attributable to the Hospital VBP Program. The 
total amount available for value based incentive payments to all 
hospitals for a fiscal year is equal to the total amount of base-
operating DRG payment reductions for that fiscal year, as estimated by 
the Secretary.
    (2) Calculation of the value-based incentive payment amount. The 
value-based incentive payment amount is calculated by multiplying the 
base operating DRG payment amount by the value-based incentive payment 
percentage.
    (3) Calculation of the value-based incentive payment percentage. The 
value-based incentive payment percentage is calculated as the product 
of: the applicable percent as defined in Sec.  412.160, the hospital's 
Total Performance Score divided by 100, and the exchange function slope.
    (c) Methodology to calculate the value-based incentive payment 
adjustment factor. The value-based incentive payment adjustment factor 
for each discharge is determined by subtracting the applicable percent 
as specified in Sec.  412.160 from the value-based incentive payment 
percentage and then adding that difference to one.



Sec.  412.163  Process for making hospital-specific performance information 
under the Hospital Value-Based Purchasing (VBP) Program 
available to the public.

    (a) CMS will make information available to the public regarding the 
performance of each hospital under the Hospital VBP Program.
    (b) To ensure that a hospital has the opportunity to review and 
submit corrections for the information to be made public under this 
section, CMS will provide each hospital with confidential hospital-
specific reports and discharge level information used in the calculation 
of its performance with respect to each measure, condition, and domain, 
and the calculation of its Total Performance Score.
    (c) Hospitals will have a period of 30 days after CMS provides the 
information specified in paragraph (b) of this section to review and 
submit corrections for the information.
    (d) CMS will post the information specified in paragraph (b) for 
each hospital on the the Hospital Compare website, which can be accessed 
via the

[[Page 698]]

Care Compare website at https://www.medicare.gov/care-compare/.

[50 FR 12741, Mar. 29, 1985, as amended at 86 FR 45520, Aug. 13, 2021]



Sec.  412.164  Measure selection under the Hospital Value-Based Purchasing 
(VBP) Program.

    (a) CMS will select measures, other than measures of readmissions, 
for purposes of the Hospital VBP Program. The measures will be selected 
from the measures specified under section 1886(b)(3)(B)(viii) of the Act 
(the Hospital Inpatient Quality Reporting Program).
    (b) CMS will post data on each measure on the Hospital Compare 
website, which can be accessed via the Care Compare website at https://
www.medicare.gov/care-compare/. for at least 1 year prior to the 
beginning of a performance period for the measure under the Hospital VBP 
Program.

[77 FR 53674, Aug. 31, 2012, as amended at 83 FR 41704, Aug. 17, 2018; 
86 FR 45520, Aug. 13, 2021]



Sec.  412.165  Performance scoring under the Hospital Value-Based Purchasing 
(VBP) Program.

    (a) Points awarded based on hospital performance. (1) CMS will award 
points to hospitals for performance on each measure for which the 
hospital reports the applicable minimum number of cases during the 
applicable performance period.
    (2) CMS will award from 1 to 9 points for achievement to each 
hospital whose performance on a measure during the applicable 
performance period meets or exceeds the achievement threshold but is 
less than the benchmark for that measure.
    (3) CMS will award from 0 to 9 points for improvement to each 
hospital whose performance on a measure during the applicable 
performance period exceeds the improvement threshold but is less than 
the benchmark for that measure.
    (4) CMS will award 10 points to a hospital whose performance on a 
measure during the applicable performance period meets or exceeds the 
benchmark for that measure.
    (b) Calculation of the Total Performance Score. The hospital's Total 
Performance Score for a program year is calculated as follows:
    (1) CMS will calculate a domain score for a hospital when it reports 
the minimum number of measures in the domain.
    (2) CMS will sum all points awarded for each measure in a domain to 
calculate an unweighted domain score.
    (3) CMS will normalize each domain score to ensure that it is 
expressed as a percentage of points earned out of 100.
    (4) CMS will weight the domain scores with the finalized domain 
weights for each fiscal year.
    (5) The sum of the weighted domain scores is the hospital's Total 
Performance Score for the fiscal year.
    (c) Extraordinary circumstances exception. (1) A hospital may 
request and CMS may grant exceptions to the Hospital VBP Program's 
requirements under this section when there are certain extraordinary 
circumstances beyond the control of the hospital.
    (2) A hospital may request an exception within 90 calendar days of 
the date that the extraordinary circumstances occurred by submitting a 
completed Extraordinary Circumstances Request Form (available on the 
Hospital Value-Based Purchasing (HVBP) Program section of the QualityNet 
website (https://qualitynet.cms.gov/)), and any available evidence of 
the impact of the extraordinary circumstances on the hospital's quality 
measure performance. The form must be sent via secure file transfer via 
the QualityNet Secure portal, secure fax, email, or conventional mail.
    (3) Following receipt of the request form, CMS will provide a 
written acknowledgement using the contact information provided in the 
request, to the CEO and any additional designated personnel, notifying 
them that the hospital's request has been received, and provide a 
written response to the CEO and any additional designated personnel 
using the contact information provided in the request.
    (4) CMS may grant an exception to one or more hospitals that have 
not requested an exception if CMS determines that an extraordinary 
circumstance has affected an entire region or locale, which may include 
the entire United States. CMS will notify

[[Page 699]]

hospitals that it has granted an exception under this paragraph via 
multiple methods, which may include memos, emails, and notices posted on 
the public QualityNet website (https://qualitynet.cms.gov/).

[50 FR 12741, Mar. 29, 1985, as amended at 85 FR 27621, May, 8, 2020; 86 
FR 45520, Aug. 13, 2021]



Sec.  412.167  Appeal under the Hospital Value-Based Purchasing (VBP) Program.

    (a) A hospital may appeal the following issues:
    (1) CMS' decision to deny a hospital's correction request that the 
hospital submitted under the review and corrections process;
    (2) Whether the achievement/improvement points were calculated 
correctly;
    (3) Whether CMS properly used the higher of the achievement/
improvement points in calculating the hospital's measure/dimension 
score;
    (4) Whether CMS correctly calculated the domain scores, including 
the normalization calculation;
    (5) Whether CMS used the proper lowest dimension score in 
calculating the hospital's HCAHPS consistency points;
    (6) Whether CMS calculated the HCAHPS consistency points correctly;
    (7) Whether the correct domain scores were used to calculate the 
Total Performance Score;
    (8) Whether each domain was weighted properly;
    (9) Whether the weighted domain scores were properly summed to 
arrive at the Total Performance Score; and,
    (10) Whether the hospital's open/closed status (including mergers 
and acquisitions) is properly specified in CMS' systems.
    (b) Appeals must be submitted within 30 days of CMS' decision to 
deny a corrections request under Sec.  412.163 or within 30 days of the 
conclusion of the review and corrections period, as applicable, and must 
contain the following information:
    (1) Hospital's CMS Certification Number (CCN).
    (2) Hospital name.
    (3) Hospital's basis for requesting an appeal. This must identify 
the hospital's specific reason(s) for appealing the hospital's Total 
Performance Score or performance assessment with respect to the 
performance standards.
    (4) CEO contact information, including name, email address, 
telephone number, and mailing address (must include the physical 
address, not just the post office box).
    (5) QualityNet security official contact information, including 
name, email address, telephone number, and mailing address (must include 
the physical address, not just the post office box).
    (c) If a hospital is dissatisfied with CMS' decision on an appeal 
request submitted under paragraph (b) of this section, the hospital may 
request an independent CMS review of that decision.
    (d) Limitations on review. There is no administrative or judicial 
review of the following:
    (1) The methodology used to determine the amount of the value-based 
incentive payment under section 1886(o)(6) of the Act and the 
determination of such amount.
    (2) The determination of the amount of funding available for value-
based incentive payments under section 1886(o)(7)(A) of the Act and the 
payment reduction under section 1886(o)(7)(B)(i) of the Act.
    (3) The establishment of the performance standards under section 
1886(o)(3) of the Act and the performance period under section 
1886(o)(4) of the Act.
    (4) The measures specified under section 1886(b)(3)(B)(viii) of the 
Act and the measures selected under section 1886(o)(2) of the Act.
    (5) The methodology developed under section 1886(o)(5) of the Act 
that is used to calculate hospital performance scores and the 
calculation of such scores.
    (6) The validation methodology that is specified under section 
1886(b)(3)(B)(viii)(XI) of the Act.

[50 FR 12741, Mar. 29, 1985, as amended at 78 FR 75196, Dec. 10, 2013; 
86 FR 45520, Aug. 13, 2021]



Sec.  412.168  Special rule for FY 2022.

    (a) This section sets forth the scoring and payment methodology for 
the fiscal year 2022 Hospital VBP Program.

[[Page 700]]

    (b) CMS calculates a measure rate for all measures selected under 
Sec.  412.164(a) for fiscal year 2022 but only applies Sec.  412.165(a) 
to the measures included in the Clinical Outcomes Domain for that fiscal 
year, which are the following:
    (1) Hospital 30-Day, All-Cause, Risk-Standardized Mortality Rate 
Following Acute Myocardial Infarction (AMI) Hospitalization (MORT-30-
AMI).
    (2) Hospital 30-Day, All-Cause, Risk-Standardized Mortality Rate 
Following Heart Failure (HF) Hospitalization (MORT-30-HF).
    (3) Hospital 30-Day, All-Cause, Risk-Standardized Mortality Rate 
Following Pneumonia Hospitalization (MORT-30-PN (updated cohort)).
    (4) Hospital 30-Day, All-Cause, Risk-Standardized Mortality Rate 
Following Chronic Obstructive Pulmonary Disease (COPD) Hospitalization 
(MORT-30-COPD).
    (5) Hospital 30-Day, All-Cause, Risk-Standardized Mortality Rate 
Following Coronary Artery Bypass Graft (CABG) Surgery (MORT-30-CABG).
    (6) Hospital-Level Risk-Standardized Complication Rate Following 
Elective Primary Total Hip Arthroplasty (THA) and/or Total Knee 
Arthroplasty (TKA) (COMP-HIP-KNEE).
    (c) CMS calculates a domain score for the measures described in 
paragraph (b)(1) of this section for hospitals that report the minimum 
number of measures in the Clinical Outcomes Domain.
    (d) CMS does not award a Total Performance Score to any hospital.
    (e) The total amount available for value-based incentive payments 
for fiscal year 2022 is equal to the total amount of base-operating DRG 
payment reductions for that fiscal year, as estimated by the Secretary.
    (f) CMS awards value-based incentive payment percentages (as defined 
in Sec.  412.160) for all hospitals to ensure that each hospital 
receives an incentive payment amount equal to the amount of the 
reduction made to its base-operating DRG payment amounts.

[86 FR 45520, Aug. 13, 2021]



Sec.  412.169  [Reserved]

  Payment Adjustments Under the Hospital-Acquired Condition Reduction 
                                 Program



Sec.  412.170  Definitions for the Hospital-Acquired Condition 
Reduction Program.

    As used in this section and Sec.  412.172, the following definitions 
apply:
    Applicable hospital is a hospital described in section 1886(d)(1)(B) 
of the Act (including a hospital in Maryland that is paid under the 
waiver under section 1814(b)(3) of the Act and that, absent the waiver 
specified by section 1814(b)(3) of the Act, would have been paid under 
the hospital inpatient prospective payment system) as long as the 
hospital meets the criteria specified under Sec.  412.172(e).
    Applicable period is, unless otherwise specified by the Secretary, 
with respect to a fiscal year, the 2-year period (specified by the 
Secretary) from which data are collected in order to calculate the total 
hospital-acquired condition score under the Hospital-Acquired Condition 
Reduction Program.
    (1) The applicable period for FY 2022--
    (i) For the CMS PSI 90 measure, is the 24-month period from July 1, 
2018 through June 30, 2020; and
    (ii) For the CDC NHSN HAI measures, is the 24-month period from 
January 1, 2019 through December 31, 2020.
    (2) Beginning with the FY 2023 program year, the applicable period 
is the 24-month period advanced by 1-year from the prior fiscal year's 
period from which data are collected in order to calculate the total 
hospital-acquired condition score under the Hospital-Acquired Condition 
Reduction Program, unless otherwise specified by the Secretary.
    CDC NHSN HAI stands for Centers for Disease Control and Prevention 
National Healthcare Safety Network healthcare-associated infection 
measures.
    CMS PSI 90 stands for Patient Safety and Adverse Events Composite 
for Selected Indicators (modified version of PSI 90).
    Hospital-acquired condition is a condition as described in section

[[Page 701]]

1886(d)(4)(D)(iv) of the Act and any other condition determined 
appropriate by the Secretary that an individual acquires during a stay 
in an applicable hospital, as determined by the Secretary.

[78 FR 50967, Aug. 19, 2013, as amended at 81 FR 57268, Aug. 22, 2016; 
85 FR 59022, Sept. 18, 2020]



Sec.  412.172  Payment adjustments under the Hospital-Acquired Condition 
Reduction Program.

    (a) Scope. This section sets forth the requirements for determining 
the payment adjustments under the Hospital-Acquired Condition Reduction 
Program for hospitals that meet the criteria described under paragraph 
(e) of this section.
    (b) Payment adjustment. With respect to all discharges from an 
applicable hospital occurring during FY 2015 or a subsequent year, the 
amount of payment under this section, or section 1814(b)(3) of the Act 
as applicable, for such discharges during the fiscal year will be equal 
to 99 percent of the amount of payment that would otherwise apply to 
these discharges under this section or section 1814(b)(3) of the Act 
(determined after the application of the payment adjustment under the 
Hospital Readmissions Reduction Program under Sec.  412.154 and the 
adjustment made under the Hospital Value-Based Purchasing Program under 
Sec.  412.162 and section 1814(l)(4) of the Act but without regard to 
section 1886(p) of the Act).
    (c) [Reserved]
    (d) Risk adjustment. In carrying out the provisions of paragraph (e) 
of this section, CMS will establish and apply an appropriate risk-
adjustment methodology.
    (e) Criteria for applicable hospitals. (1) General. With respect to 
a subsection (d) hospital, CMS will identify the top quartile of all 
subsection (d) hospitals with respect to hospital-acquired conditions as 
measured during the applicable period.
    (2) Use of total hospital-acquired condition scores. CMS will use 
total hospital-acquired condition scores to identify applicable 
hospitals. CMS will identify the 25 percent of hospitals with the 
highest total scores.
    (3) Methodology for calculating total hospital-acquired condition 
scores. CMS will calculate the total hospital-acquired condition scores 
by weighing the selected measures according to the established 
methodology.
    (f) Reporting of hospital-specific information. CMS will make 
information available to the public regarding hospital-acquired 
condition rates of all hospitals under the Hospital-Acquired Condition 
Reduction Program.
    (1) CMS will provide each hospital with confidential hospital-
specific reports and discharge level information used in the calculation 
of its total hospital-acquired condition score.
    (2) Hospitals will have a period of 30 days after the receipt of the 
information provided under paragraph (f)(1) of this section to review 
and submit corrections for the hospital-acquired condition program 
scores for each condition that is used to calculate the total hospital-
acquired condition score for the fiscal year.
    (3) The administrative claims data used to calculate a hospital's 
total hospital-acquired condition score for a condition for a fiscal 
year are not subject to review and correction under paragraph (f)(2) of 
this section.
    (4) CMS posts the total hospital-acquired condition score, the 
domain score, and the score on each measure for each hospital on the 
Hospital Compare website or successor website.
    (g) Limitations on review. There is no administrative or judicial 
review under Sec.  412.170 and this section for the following:
    (1) The criteria describing applicable hospitals.
    (2) The applicable period.
    (3) The specification of hospital-acquired conditions.
    (4) The provision of reports to hospitals and the information made 
available to the public.

[78 FR 50967, Aug. 19, 2013, as amended at 79 FR 50355, Aug. 22, 2014; 
84 FR 42614, Aug. 16, 2019; 86 FR 45520, Aug. 13, 2021]



Sec.  412.190  Overall Hospital Quality Star Rating.

    (a) Purpose. (1) The Overall Hospital Quality Star Rating (Overall 
Star Rating) is a summary of certain publicly reported hospital measure 
data for the

[[Page 702]]

benefit of stakeholders, such as patients, consumers, and hospitals.
    (2) The guiding principles of the Overall Star Rating are as 
follows. In developing and maintaining the Overall Star Ratings, we 
strive to:
    (i) Use scientifically valid methods that are inclusive of hospitals 
and measure information and able to accommodate underlying measure 
changes;
    (ii) Align with Hospital Compare or its successor website and CMS 
programs;
    (iii) Provide transparency of the methods for calculating the 
Overall Star Rating; and
    (iv) Be responsive to stakeholder input.
    (b) Data included in Overall Star Rating--(1) Source of data. The 
Overall Star Rating is calculated based on measure data collected and 
publicly reported on Hospital Compare or its successor site under the 
following CMS hospital inpatient and outpatient programs:
    (i) Hospital Inpatient Quality Reporting (IQR) Program--section 
1886(b)(3)(B)(viii)(VII) of the Act.
    (ii) Hospital-Acquired Condition Reduction Program--section 
1886(p)(6)(A) of the Act.
    (iii) Hospital Value-based Purchasing Program--section 
1886(o)(10)(A) of the Act.
    (iv) Hospital Readmissions Reduction Program--section 1886(q)(6)(A) 
of the Act.
    (v) Hospital Outpatient Quality Reporting (OQR) Program--section 
1833(t)(17)(e) of the Act.
    (2) Hospitals included in Overall Star Rating. Subsection (d) 
hospitals subject to the CMS quality programs specified in paragraph 
(b)(1) of this section that also have their data publicly reported on 
one of CMS' websites are included in the Overall Star Rating.
    (3) Critical Access Hospitals. Critical Access Hospitals (CAHs) that 
wish to be voluntarily included in the Overall Star Rating must have 
elected to--
    (i) Voluntarily submit quality measures included in and as specified 
under CMS hospital programs; and
    (ii) Publicly report their quality measure data on Hospital Compare 
or its successor site.
    (c) Frequency of publication and data used. The Overall Star Rating 
are published once annually using data publicly reported on Hospital 
Compare or its successor website from a quarter within the prior year.
    (d) Methodology--(1) Selection of measures. Measures are selected 
from those publicly reported on Hospital Compare or its successor 
website through certain CMS quality programs under paragraph (b)(1) of 
this section.
    (i) From this group of measures, measures falling into one or more 
of the exclusions in paragaphs (d)(1)(i)(A) through (E) of this section 
will be removed from consideration:
    (A) Measures that 100 hospitals or less publicly report. These 
measures would not produce reliable measure group scores based on too 
few hospitals;
    (B) Measures that cannot be standardized to a single, common scale 
and otherwise not amenable to inclusion in a summary score calculation 
alongside process and outcome measures or measures that cannot be 
combined in a meaningful way. This includes measures that cannot be as 
easily combined with other measures captured on a continuous scale with 
more granular data;
    (C) Non-directional measures for which it is unclear whether a 
higher or lower score is better. These measures cannot be standardized 
to be combined with other measures and form an aggregate measure group 
score;
    (D) Measures not required for reporting on Hospital Compare or its 
successor websites through CMS programs; or
    (E) Measures that overlap with another measure in terms of cohort or 
outcome, including component measures that are part of an already-
included composite measure.
    (ii) [Reserved]
    (2) Measure score standardization. All measure scores are 
standardized by calculating Z-scores so that all measures are on a 
single, common scale to be consistent in terms of direction (that is, 
higher scores are better) and numerical magnitude. This is calculated by 
subtracting the national mean measure score from each hospital's measure 
score and dividing the difference by the measure standard deviation in 
order to standardize measures.

[[Page 703]]

    (3) Grouping measures. Measures are grouped into one of the five 
clinical groups as follows:
    (i) Mortality.
    (ii) Safety of Care.
    (iii) Readmission.
    (iv) Patient Experience.
    (v) Timely and Effective Care.
    (4) Calculate measure group scores. A score is calculated for each 
measure group for which a hospital has measure data using a simple 
average of measure scores, as follows:
    (i) Each measure group score is standardized by calculating Z-scores 
for each measure group so that all measure group scores are centered 
near zero with a standard deviation of one.
    (ii) We take 100 percent divided by the number of measures reported 
in a measure group to determine the percentage of each measure's weight.
    (iii) The measure weight is then multiplied by the standardized 
measure score to calculate the measure's weighted score.
    (iv) Then, all of the individual measure weighted scores within a 
measure group are added together to calculate the measure group score.
    (5) Reporting thresholds. In order to receive an Overall Star 
Rating, a hospital must report at least three measures within at least 
three measure groups, one of which must specifically be the Mortality or 
Safety of Care outcome group.
    (6) Hospital summary score. A summary score is calculated by 
multiplying the standardized measure group scores by the assigned 
measure group weights and then summing the weighted measure group 
scores.
    (i) Standard measure group weighting. (A) Each of the Mortality, 
Safety of Care, Readmission, and Patient Experience groups are weighted 
22 percent; and
    (B) The Timely and Effective Care group is weighted 12 percent.
    (ii) Reweighting. (A) Hospitals may have too few cases to report 
particular measures and, in those cases, may not report enough measures 
in one or more measure groups.
    (B) When a hospital does not have enough measures in one or more 
measure groups due to too few cases CMS may re-distribute one or more of 
the missing measure group's weight proportionally across the remaining 
measure groups by subtracting the standard weight percentage of the 
group or groups with insufficient measures from 100 percent; and then 
dividing the resulting percentage across the remaining measure groups, 
giving new re-proportioned weights.
    (7) Peer grouping. Hospitals are assigned to one of three peer 
groups based on the number of measure groups for which they report at 
least three measures: three, four, or five measure groups.
    (8) Star ratings assignment. Hospitals in each peer group are then 
assigned between one and five stars where one star is the lowest and 
five stars is the highest using k-means clustering to complete 
convergence.
    (e) Preview period prior to publication. CMS provides hospitals the 
opportunity to preview their Overall Star Rating prior to publication. 
Hospitals have at least 30 days to preview their results, and if 
necessary, can reach out to CMS with questions.
    (f) Suppression of Overall Star Rating--(1) Subsection (d) 
hospitals. CMS may consider suppressing Overall Star Rating for 
subsection (d) hospitals only under extenuating circumstances that 
affect numerous hospitals (as in, not an individualized or localized 
issue) as determined by CMS, or when CMS is at fault, including but not 
limited to when:
    (i) There is an Overall Star Rating calculation error by CMS;
    (ii) There is a systemic error at the CMS quality program level that 
substantively affects the Overall Star Rating calculation; or
    (iii) If a Public Health Emergency, as defined in Sec.  400.200 of 
this chapter, substantially affects the underlying measure data.
    (2) CAHs. (i) CAHs may request to withhold their Overall Star Rating 
from publication on Hospital Compare or its successor website so long as 
the request for withholding is made, at the latest, during the Overall 
Star Rating preview period.
    (ii) CAHs may request to have their Overall Star Rating withheld 
from publication on Hospital Compare or its successor website, as well 
as their data

[[Page 704]]

from the public input file, so long as the request is made during the 
CMS quality program-level 30-day confidential preview period for the 
Hospital Compare refresh data used to calculate the Overall Star 
Ratings.

[85 FR 86300, Dec. 29, 2020]

Subpart J [Reserved]



 Subpart K_Prospective Payment System for Inpatient Operating Costs for 
                    Hospitals Located in Puerto Rico

    Source: 52 FR 33058, Sept. 1, 1987, unless otherwise noted.



Sec.  412.200  General provisions.

    Beginning with discharges occurring on or after October 1, 1987, 
hospitals located in Puerto Rico are subject to the rules governing the 
prospective payment system for inpatient operating costs. Except as 
provided in this subpart, the provisions of subparts A, B, C, F, G, and 
H of this part apply to hospitals located in Puerto Rico. Except for 
Sec.  412.60, which deals with DRG classification and weighting factors, 
or as otherwise specified, the provisions of subparts D and E, which 
describe the methodology used to determine prospective payment rates for 
inpatient operating costs for hospitals, do not apply to hospitals 
located in Puerto Rico. Instead, the methodology for determining 
prospective payment rates for inpatient operating costs for these 
hospitals is set forth in Sec. Sec.  412.204 through 412.212.

[83 FR 41704, Aug. 17 2018]



Sec.  412.204  Payment to hospitals located in Puerto Rico.

    (a) FY 1988 through FY 1997. For discharges occurring on or after 
October 1, 1987 and before October 1, 1997, payments for inpatient 
operating costs to hospitals located in Puerto Rico that are paid under 
the prospective payment system are equal to the sum of--
    (1) 75 percent of the Puerto Rico prospective payment rate for 
inpatient operating costs, as determined under Sec.  412.208 or Sec.  
412.210; and
    (2) 25 percent of a national prospective payment rate for inpatient 
operating costs, as determined under Sec.  412.212.
    (b) FY 1998 through March 31, 2004. For discharges occurring on or 
after October 1, 1997 and before April 1, 2004, payments for inpatient 
operating costs to hospitals located in Puerto Rico that are paid under 
the prospective payment system are equal to the sum of--
    (1) 50 percent of the Puerto Rico prospective payment rate for 
inpatient operating costs, as determined under Sec.  412.208 or Sec.  
412.210; and
    (2) 50 percent of a national prospective payment rate for inpatient 
operating costs, as determined under Sec.  412.212.
    (c) Period of April 1, 2004 through September 31, 2004. For 
discharges occurring on or after April 1, 2004 and before October 1, 
2004, payment for inpatient operating costs to hospitals located in 
Puerto Rico that are paid under the prospective payment system are equal 
to the sum of--
    (1) 37.5 percent of the Puerto Rico prospective payment rate for 
inpatient operating costs, as determined under Sec.  412.208 or Sec.  
412.210; and
    (2) 62.5 percent of the national prospective payment rate for 
inpatient operating costs, as determined under Sec.  412.212.
    (d) FY 2005 through December 31, 2015. For discharges occurring on 
or after October 1, 2004 and before January 1, 2016, payments for 
inpatient operating costs to hospitals located in Puerto Rico that are 
paid under the prospective payment system are equal to the sum of--
    (1) 25 percent of the Puerto Rico prospective payment rate for 
inpatient operating costs, as determined under Sec.  412.208 or Sec.  
412.211; and
    (2) 75 percent of a national prospective payment rate for inpatient 
operating costs, as determined under Sec.  412.212.
    (e) January 1, 2016 and thereafter. For discharges occurring on or 
after January 1, 2016, payments for inpatient operating costs to 
hospitals located in Puerto Rico that are paid under the prospective 
payment system are equal to 100 percent of a national prospective

[[Page 705]]

payment rate for inpatient operating costs, as determined under Sec.  
412.212.

[62 FR 46030, Aug. 29, 1997, as amended at 69 FR 49247, Aug. 11, 2004; 
81 FR 57268, Aug. 22, 2016]



Sec.  412.208  Puerto Rico rates for Federal fiscal year 1988.

    (a) General rule. CMS determines the Puerto Rico adjusted DRG 
prospective payment rate for inpatient operating costs for each 
inpatient hospital discharge occurring in Federal fiscal year 1988 for a 
prospective payment hospital. These rates are determined as described in 
paragraphs (b) through (i) of this section.
    (b) Determining target amounts. For each hospital subject to the 
prospective payment system for inpatient operating costs, CMS determines 
the Medicare target amount, as described in Sec.  413.40(c) of this 
chapter, for the hospital's cost reporting period beginning in fiscal 
year 1987. Revisions in the target amounts made subsequent to 
establishment of the standardized amounts under paragraph (d) of this 
section do not affect the standardized amounts.
    (c) Updating the target amounts for fiscal year 1988. CMS updates 
each target amount determined under paragraph (b) of this section for 
fiscal year 1988 by prorating the applicable percentage increase (as 
defined in Sec.  412.63(f) of this chapter) for fiscal year 1988 to the 
midpoint of fiscal year 1988 (April 1, 1988).
    (d) Standardizing amounts. CMS standardizes the amount updated under 
paragraph (c) of this section for each hospital by--
    (1) Adjusting for variations in case mix among hospitals;
    (2) Excluding an estimate of indirect medical education costs;
    (3) Adjusting for area variations in hospital wage levels; and
    (4) Excluding an estimate of the payments for hospitals that serve a 
disproportionate share of low-income patients.
    (e) Computing urban and rural averages. CMS computes separate 
discharge-weighted averages of the standardized amounts determined under 
paragraph (d) of this section for urban and rural hospitals in Puerto 
Rico.
    (f) Geographic classification. (1) For purposes of this paragraph 
(e) of this section, the following definitions apply:
    (i) The term urban area means a Metropolitan Statistical Area (MSA), 
as defined by the Executive Office of Management and Budget.
    (ii) The term large urban area means an MSA with a population of 
more than 1,000,000.
    (iii) The term rural area means any area outside an urban area.
    (2) A hospital classified as rural is deemed to be urban and 
receives the urban Puerto Rico payment amount if the county in which it 
is located meets the following criteria:
    (i) At least 95 percent of the perimeter of the rural county is 
contiguous with urban counties.
    (ii) The county was reclassified from an urban area to a rural area 
after April 20, 1983, as described in Sec.  412.62(f)(1)(iv).
    (iii) At least 15 percent of employed workers in the county commute 
to the central county of one of the adjacent MSAs.
    (g) Reducing for value of outlier payments. CMS reduces each of the 
average standardized amounts determined under paragraphs (c) through (e) 
of this section by a proportion equal to the proportion (estimated by 
CMS) of the total amount of payments based on DRG prospective payment 
rates that are additional payments to hospitals located in Puerto Rico 
for outlier cases under subpart F of this part.
    (h) Computing Puerto Rico rates established under the prospective 
payment system for inpatient operating costs for urban and rural 
hospitals. For each discharge classified within a DRG, CMS establishes a 
Puerto Rico prospective payment rate, as follows:
    (1) For hospitals located in an urban area, the rate equals the 
product of--
    (i) The average standardized amount (computed under paragraphs (c) 
through (g) of this section) for hospitals located in an urban area; and
    (ii) The weighting factor determined under Sec.  412.60(b) for that 
DRG.
    (2) For hospitals located in a rural area, the rate equals the 
product of--
    (i) The average standardized amount (computed under paragraphs (c)

[[Page 706]]

through (g) of this section) for hospitals located in a rural area; and
    (ii) The weighting factor determined under Sec.  412.60(b) for that 
DRG.
    (i) Adjusting for different area wage levels. CMS adjusts the 
proportion (as estimated by CMS from time to time) of Puerto Rico rates 
computed under paragraph (h) of this section that are attributable to 
wages and labor-related costs, for area differences in hospital wage 
levels, by a factor (established by CMS) reflecting the relative 
hospital wage level in the geographic area (that is, urban or rural area 
as determined under the provisions of paragraph (f) of this section) of 
the hospital compared to the national average hospital wage level.

[52 FR 33058, Sept. 1, 1987; 52 FR 35350, Sept. 18, 1987, as amended at 
53 FR 38533, Sept. 30, 1988; 57 FR 39825, Sept. 1, 1992]



Sec.  412.210  Puerto Rico rates for Federal fiscal years 1989 through 2003.

    (a) General rule. (1) CMS determines the Puerto Rico adjusted 
prospective payment rate for inpatient operating costs for each 
inpatient hospital discharge occurring in Federal fiscal years 1989 
through 2003 that involves inpatient hospital services of a hospital in 
Puerto Rico subject to the prospective payment system for which payment 
may be made under Medicare Part A.
    (2) The rate is determined for hospitals located in large urban, 
other urban, or rural areas within Puerto Rico, as described in 
paragraphs (b) through (e) of this section.
    (b) Geographic classifications. (1) For purposes of this section, 
the definitions set forth in Sec.  412.208(f)(1) apply.
    (2) For discharges occurring on or after October 1, 1988, a hospital 
located in a rural county adjacent to one or more urban areas is deemed 
to be located in an urban area and receives the Federal payment amount 
for the urban area to which the greatest number of workers in the county 
commute if the rural county would otherwise be considered part of an 
urban area, under the standards for designating MSAs if the commuting 
rates used in determining outlying counties were determined on the basis 
of the aggregate number of resident workers who commute to (and, if 
applicable under the standards, from) the central county or central 
counties of all adjacent MSAs.

These EOMB standards are set forth in the notice of final standards for 
classification of MSAs published in the Federal Register on January 3, 
1980 (45 FR 956), and available from CMS, East High Rise Building, Room 
132, 6325 Security Boulevard, Baltimore, Maryland 21207.
    (3) For discharges occurring on or after October 1, 1988, for 
hospitals that consist of two or more separately located inpatient 
hospital facilities, the national adjusted prospective payment rate for 
inpatient operating costs is based on the geographic location of the 
hospital at which the discharge occurs.
    (c) Updating previous standardized amounts. CMS computes separate 
average standardized amounts for hospitals in large urban, other urban, 
and rural areas within Puerto Rico equal to the respective average 
standardized amount computed for fiscal year 1988 under Sec.  
412.208(e)--
    (1) Increased by the applicable percentage changes determined under 
Sec.  412.63 (g) and (h); and
    (2) Reduced by a proportion equal to the proportion (estimated by 
CMS) of the total amount of prospective payments that are additional 
payment amounts to hospitals located in Puerto Rico attributable to 
outlier cases under subpart F of this part.
    (d) Computing Puerto Rico rates for large urban, other urban, and 
rural hospitals. For each discharge classified within a DRG, CMS 
establishes for the fiscal year a Puerto Rico prospective payment rate 
for inpatient operating costs as follows:
    (1) For hospitals located in a large urban or other urban area in 
Puerto Rico, the rate equals the product of--
    (i) The average standardized amount (computed under paragraph (c) of 
this section) for the fiscal year for hospitals located in a large urban 
or other urban area; and
    (ii) The weighting factor determined under Sec.  412.60(b) for that 
DRG.
    (2) For hospitals located in a rural area in Puerto Rico, the rate 
equals the product of--
    (i) The average standardized amount (computed under paragraph (c) of 
this

[[Page 707]]

section) for the fiscal year for hospitals located in a rural area; and
    (ii) The weighting factor (determined under Sec.  412.60(b)) for 
that DRG.
    (e) Adjusting for different area wage levels. CMS adjusts the 
proportion (as estimated by CMS from time to time) of Puerto Rico rates 
computed under paragraph (d) of this section that is attributable to 
wages and labor-related costs for area differences in hospital wage 
levels by a factor (established by CMS) reflecting the relative hospital 
wage level in the geographic area (that is, urban or rural area as 
determined under the provisions of paragraph (b) of this section) of the 
hospital compared to the Peurto Rico average hospital wage level.

[52 FR 33058, Sept. 1, 1987, as amended at 53 FR 38533, Sept. 30, 1988; 
57 FR 39825, Sept. 1, 1992; 62 FR 46030, Aug. 29, 1997; 69 FR 49247, 
Aug. 11, 2004]



Sec.  412.211  Puerto Rico rates for Federal fiscal year 2004 
and subsequent fiscal years.

    (a) General rule. CMS determines the Puerto Rico adjusted 
prospective payment rate for inpatient operating costs for each 
inpatient hospital discharge occurring in Federal fiscal year 2004 and 
subsequent fiscal years that involves inpatient hospital services of a 
hospital in Puerto Rico subject to the prospective payment system for 
which payment may be made under Medicare Part A.
    (b) Geographic classifications. (1) For purposes of this section, 
the following definitions apply:
    (i) The term urban area means a Metropolitan Statistical Area (MSA) 
as defined by the Executive Office of Management and Budget.
    (ii) The term rural area means any area outside of an urban area.
    (2) For discharges occurring on or after October 1, 2004, a hospital 
located in a rural county adjacent to one or more urban areas is deemed 
to be located in an urban area and receives the Federal payment amount 
for the urban area to which the greater number of workers in the county 
commute if the rural county would otherwise be considered part of an 
urban area, under the standards for designating MSAs if the commuting 
rates used in determining outlying counties were determined on the basis 
of the aggregate number of resident workers who commute to (and, if 
applicable under the standards, from) the central county or central 
counties of all adjacent MSAs. These EOMB standards are set forth in the 
notice of final revised standards for classification of MSAs published 
in the Federal Register on December 27, 2000 (65 FR 82228), announced by 
EOMB on June 6, 2003, and available from CMS, 7500 Security Boulevard, 
Baltimore, Maryland 21244.
    (c) Computing the standardized amount. CMS computes a Puerto Rico 
standardized amount that is applicable to all hospitals located in all 
areas. The applicable percentage change for updating the Puerto Rico 
specific standardized amount is as follows:
    (1) For fiscal year 2004 through fiscal year 2009, increased by the 
applicable percentage change specified in Sec.  412.64(d)(1)(ii)(A).
    (2) For fiscal year 2010, increased by the market basket index for 
prospective payment hospitals (as defined in Sec.  413.40(a) of this 
subchapter) for hospitals in all areas.
    (3) For fiscal year 2011, increased by the applicable percentage 
change specified in Sec.  412.64(d)(1)(iii).
    (4) For fiscal year 2012 and subsequent fiscal years, the applicable 
percentage increase specified in Sec.  412.64(d).
    (d) Computing Puerto Rico Federal rates for inpatient operating 
costs for hospitals located in all areas. For each discharge classified 
within a DRG, CMS establishes for the fiscal year a Puerto Rico 
prospective payment rate for inpatient operating costs equal to the 
product of--
    (1) The average standardized amount for the fiscal year for 
hospitals located in all areas; and
    (2) The weighting factor determined under Sec.  412.60(b) for that 
DRG.
    (e) Adjusting for different area wage levels. CMS adjusts the 
proportion of the Puerto Rico rate for inpatient operating costs that 
are attributable to wages and labor-related costs for area differences 
in hospital wage levels by a factor (established by CMS based on survey 
data) reflecting the relative level of hospital wages and wage-related 
costs in the geographic area (that

[[Page 708]]

is, urban or rural area as determined under the provisions of paragraph 
(b) of this section) of the hospital compared to the Puerto Rico average 
level of hospital wages and wage-related costs. The adjustment specified 
in this paragraph (e) also takes into account the earnings and paid 
hours of employment by occupational category.
    (1) The wage index is updated annually.
    (2) CMS determines the proportion of the Puerto Rico rate that is 
attributable to wages and labor-related costs from time to time, 
employing a methodology that is described in the annual update of the 
prospective payment system for payment of inpatient hospital operating 
costs published in the Federal Register.
    (3) For discharges occurring on or after October 1, 2004, CMS 
employs 62 percent as the proportion of the rate that is adjusted for 
the relative level of hospital wages and wage-related costs, unless 
employing that percentage would result in lower payments for the 
hospital than employing the proportion determined under the methodology 
described in paragraph (e)(2) of this section.
    (f) Adjusting the wage index to account for commuting patterns of 
hospital workers--(1) General criteria. For discharges occurring on or 
after October 1, 2004, CMS adjusts the hospital wage index for hospitals 
located in qualifying areas to recognize the commuting patterns of 
hospital employees. A qualifying area is an area that meets all of the 
following criteria:
    (i) Hospital employees in the area commute to work in an MSA (or 
MSAs) with a wage index (or wage indices) higher than the wage index of 
the area.
    (ii) At least 10 percent of the county's hospital employees commute 
to an MSA (or MSAs) with a higher wage index (or wage indices).
    (iii) The 3-year average hourly wage of the hospital(s) in the area 
equals or exceeds the 3-year average hourly wage of all hospitals in the 
MSA or rural area in which the county is located.
    (2) Amount of adjustment. A hospital located in an area that meets 
the criteria under paragraphs (f)(1)(i) through (f)(1)(iii) of this 
section will receive an increase in its wage index that is equal to a 
weighted average of the difference between the prereclassified wage 
index of the MSA (or MSAs) with the higher wage index (or wage indices) 
and the prereclasssified wage index of the qualifying area, weighted by 
the overall percentage of the hospital employees residing in the 
qualifying area who are employed in any MSA with a higher wage index.
    (3) Process for determining the adjustment. (i) CMS will use the 
most accurate data available, as determined by CMS, to determine the 
out-migration percentage for each area.
    (ii) CMS will include, in its annual proposed and final notices of 
updates to the hospital inpatient prospective payment system, a listing 
of qualifying areas and the hospitals that are eligible to receive the 
adjustment to their wage indexes for commuting hospital employees, and 
the wage index increase applicable to each qualifying area.
    (iii) Any wage index adjustment made under this paragraph (f) is 
effective for a period of 3 fiscal years, except that hospitals in a 
qualifying county may elect to waive the application of the wage index 
adjustment. A hospital may waive the application of the wage index 
adjustment by notifying CMS in writing within 45 days of the date of 
public display of the annual notice of proposed rulemaking for the 
hospital inpatient prospective payment system at the Office of the 
Federal Register.
    (iv) A hospital in a qualifying area that receives a wage index 
adjustment under this paragraph (f) is not eligible for reclassification 
under Subpart L of this part.

[69 FR 49248, Aug. 11, 2004, as amended at 75 FR 50414, Aug. 16, 2010; 
76 FR 51783, Aug. 18, 2011; 82 FR 38512, Aug. 14, 2017]



Sec.  412.212  National rate.

    (a) General rule. For purposes of payment to hospitals located in 
Puerto Rico, the national prospective payment rate for inpatient 
operating costs is determined as described in paragraphs (b) through (d) 
of this section.
    (b) Computing Puerto Rico standardized amounts. (1) For Federal 
fiscal years before FY 2004, CMS computes a discharge-weighted average 
of the--

[[Page 709]]

    (i) National urban adjusted standardized amount determined under 
Sec.  412.63(j)(1); and
    (ii) National rural adjusted average standardized amount determined 
under Sec.  412.63(j)(2)(i).
    (2) For fiscal years 2004 and subsequent fiscal years, CMS computes 
a discharge-weighted average of the national adjusted standardized 
amount determined under Sec.  412.64(e).
    (c) Computing a national rate. For each discharge classified within 
a DRG, the national rate equals the product of--
    (1) The national average standardized amount computed under 
paragraph (b) of this section; and
    (2) The weighting factor (determined under Sec.  412.60(b)) for that 
DRG.
    (d) Adjusting for different area wage levels. CMS adjusts the 
proportion (as estimated by CMS from time to time) of the national rate 
computed under paragraph (c) of this section that is attributable to 
wages and labor-related costs for area differences in hospital wage 
levels by a factor (established by CMS) reflecting the relative hospital 
wage level in the geographic area of the hospital compared to the 
national average hospital wage level.

[52 FR 33058, Sept. 1, 1987, as amended at 53 FR 38533, Sept. 30, 1988; 
57 FR 39825, Sept. 1, 1992; 69 FR 49248, Aug. 11, 2004]



Sec.  412.220  Special treatment of certain hospitals located in Puerto Rico.

    Subpart G of this part sets forth rules for special treament of 
certain facilities under the prospective payment system for inpatient 
operating costs. The following sections in subpart G of this part do not 
apply to hospitals located in Puerto Rico:
    (a) Section 412.92, sole community hospitals.
    (b) Section 412.96, referral centers.

[52 FR 33058, Sept. 1, 1987, as amended at 57 FR 39825, Sept. 1, 1992]



      Subpart L_The Medicare Geographic Classification Review Board

    Source: 55 FR 36766, Sept. 6, 1990, unless otherwise noted.

                Criteria and Conditions for Redesignation



Sec.  412.230  Criteria for an individual hospital seeking redesignation 
to another rural area or an urban area.

    (a) General--(1) Purposes. Except as specified in paragraph (a)(5)--
    (i) For fiscal years prior to fiscal year 2005, an individual 
hospital may be redesignated from a rural area to an urban area, from a 
rural area to another rural area, or from an urban area to another urban 
area for the purposes of using the other area's standardized amount for 
inpatient operating costs, the wage index value, or both.
    (ii) Effective for fiscal year 2005 and subsequent fiscal years, an 
individual hospital may be redesignated from an urban area to another 
urban area, from a rural area to another rural area, or from a rural 
area to another urban area for the purposes of using the other area's 
wage index value.
    (iii) An urban hospital that has been granted redesignation as rural 
under Sec.  412.103 is considered to be located in the rural area of the 
state for the purposes of this section.
    (2) Proximity. Except as provided in paragraph (a)(3) of this 
section, to be redesignated to another rural area or an urban area, a 
hospital must demonstrate a close proximity to the area to which it 
seeks redesignation by meeting the criteria in paragraph (b) of this 
section, and submitting data requested under paragraph (c) of this 
section.
    (3) Special rules for sole community hospitals and rural referral 
centers. To be redesignated under the special rules in this paragraph, a 
hospital must be approved as a sole community hospital or a rural 
referral center as of the date of the MGCRB's review.
    (i) A hospital that is approved as a rural referral center or a sole 
community hospital, or both, does not have to demonstrate a close 
proximity to the area to which it seeks redesignation.
    (ii) If a hospital that is approved as a rural referral center or a 
sole community hospital, or both, qualifies for urban redesignation, it 
is redesignated to the urban area that is closest to the hospital or to 
the hospital's geographic

[[Page 710]]

home area. If the hospital is closer to another rural area than to any 
urban area, it may seek redesignation to either the closest rural area 
or the closest urban area.
    (iii) If a sole community hospital or rural referral center loses 
its special status as a result of redesignation, the hospital is 
considered to retain its special status for the purpose of applicability 
of the special rules in paragraph (a)(3) of this section.
    (iv) A hospital that is redesignated under paragraph (a)(3) of this 
section may not be redesignated in the same fiscal year under paragraph 
(a)(2) of this section.
    (4) Application of criteria. In applying the numeric criteria 
contained in paragraphs (b)(1) and (2) and (d)(1)(iii) and (iv) of this 
section, rounding of numbers to meet the mileage or qualifying 
percentage standards is not permitted.
    (5) Limitations on redesignation. The following limitations apply to 
redesignation:
    (i) An individual hospital may not be redesignated to another area 
for purposes of the wage index if the pre-reclassified average hourly 
wage for that area is lower than the pre-reclassified average hourly 
wage for the area in which the hospital is located. An urban hospital 
that has been granted redesignation as rural under Sec.  412.103 is 
considered to be located in the rural area of the state for the purposes 
of this paragraph (a)(5)(i).
    (ii) A hospital may not be redesignated to more than one area, 
except for an urban hospital that has been granted redesignation as 
rural under Sec.  412.103 and receives an additional reclassification by 
the MGCRB.
    (iii) Beginning with wage index reclassification applications for FY 
2003, if a hospital is already reclassified to a given geographic area 
for wage index purposes for a 3-year period, and submits an application 
for reclassification to the same area for either the second or third 
year of the 3-year period, that application will not be approved.
    (b) Proximity criteria. A hospital demonstrates a close proximity 
with the area to which it seeks redesignation if one of the following 
conditions applies:
    (1) The distance from the hospital to the area is no more than 15 
miles for an urban hospital and no more than 35 miles for a rural 
hospital.
    (2) At least 50 percent of the hospital's employees reside in the 
area.
    (c) Appropriate proximity data. For redesignation to an area, the 
hospital must submit appropriate data relating to its proximity to that 
area.
    (1) To demonstrate proximity to the area, the hospital must submit 
evidence of the shortest route over improved roads to the area and the 
distance of that route.
    (2) For employee address data, the hospital must submit current 
payroll records that include information that establishes the home 
addresses by zip code of its employees.
    (d) Use of urban or other rural area's wage index--(1) Criteria for 
use of area's wage index. Except as provided in paragraphs (d)(3) and 
(d)(4) of this section, to use an area's wage index, a hospital must 
demonstrate the following:
    (i) The hospital's incurred wage costs are comparable to hospital 
wage costs in an urban or other rural area;
    (ii) The hospital has the necessary geographic relationship as 
specified in paragraphs (a) and (b) of this section;
    (iii) One of the following conditions apply:
    (A) With respect to redesignations for Federal fiscal years 1994 
through 2001, the hospital's average hourly wage is at least 108 percent 
of the average hourly wage of hospitals in the area in which the 
hospital is located;
    (B) With respect to redesignations for Federal fiscal years 2002 
through 2005, the hospital's average hourly wage is, in the case of a 
hospital located in a rural area, at least 106 percent and in the case 
of a hospital located in an urban area, at least 108 percent of the 
average hourly wage of hospitals in the area in which the hospital is 
located; or
    (C) With respect to redesignations for Federal fiscal year 2006 and 
subsequent years, the hospital's average hourly wage is, in the case of 
a hospital located in a rural area, at least 106 percent and in the case 
of a hospital located in an urban area, at least 108 percent of the 
average hourly wage of all other hospitals in the area in which the 
hospital is located;

[[Page 711]]

    (iv) One of the following conditions apply:
    (A) For redesignations effective before fiscal year 1999, the 
hospital's average hourly wage weighted for occupational categories is 
at least 90 percent of the average hourly wages of hospitals in the area 
to which it seeks redesignation.
    (B) With respect to redesignations for fiscal year 1994 through 
2001, the hospital's average hourly wage is equal to at least 84 percent 
of the average hourly wage of hospitals in the area to which it seeks 
redesignation.
    (C) With respect to redesignations for fiscal years 2002 through 
2009, the hospital's average hourly wage is equal to, in the case of a 
hospital located in a rural area, at least 82 percent, and in the case 
of a hospital located in an urban area, at least 84 percent of the 
average hourly wage of hospitals in the area to which it seeks 
redesignation.
    (D) With respect to redesignations for fiscal year 2010, the 
hospital's average hourly wage is equal to, in the case of a hospital 
located in a rural area, at least 84 percent, and in the case of a 
hospital located in an urban area, at least 86 percent of the average 
hourly wage of hospitals in the area to which it seeks redesignation.
    (E) With respect to redesignations for fiscal year 2011 and later 
fiscal years, the hospital's average hourly wage is equal to, in the 
case of a hospital located in a rural area, at least 82 percent, and in 
the case of a hospital located in an urban area, at least 84 percent of 
the average hourly wage of hospitals in the area to which it seeks 
redesignation.
    (2) Appropriate wage data. For a wage index change, the hospital 
must submit appropriate wage data as follows:
    (i) For redesignations effective through FY 2002:
    (A) For hospital-specific data, the hospital must provide data from 
the CMS hospital wage survey used to construct the wage index in effect 
for prospective payment purposes during the fiscal year prior to the 
fiscal year for which the hospital requests reclassification.
    (B) For data for other hospitals, the hospital must provide data 
concerning the average hourly wage in the area in which the hospital is 
located and the average hourly wage in the area to which the hospital 
seeks reclassification. The wage data are taken from the CMS hospital 
wage survey used to construct the wage index in effect for prospective 
payment purposes during the fiscal year prior to the fiscal year for 
which the hospital requests reclassification.
    (ii) For redesignations effective beginning FY 2003:
    (A) For hospital-specific data, the hospital must provide a weighted 
3-year average of its average hourly wages using data from the CMS 
hospital wage survey used to construct the wage index in effect for 
prospective payment purposes.
    (1) For the limited purpose of qualifying for geographic 
reclassification based on wage data from cost reporting periods 
beginning prior to FY 2000, a hospital may request that its wage data be 
revised if the hospital is in an urban area that was subject to the 
rural floor for the period during which the wage data the hospital 
wishes to revise were used to calculate its wage index.
    (2) Once a hospital has accumulated at least 1 year of wage data in 
the applicable 3-year average hourly wage period used by the MGCRB, the 
hospital is eligible to apply for reclassification based on those data.
    (B) For data for other hospitals, the hospital must provide a 
weighted 3-year average of the average hourly wage in the area in which 
the hospital is located and a weighted 3-year average of the average 
hourly wage in the area to which the hospital seeks reclassification. 
The wage data are taken from the CMS hospital wage survey used to 
construct the wage index in effect for prospective payment purposes.
    (iii) For applications submitted for reclassifications effective in 
FYs 2006 through 2008, a campus of a multicampus hospital may seek 
reclassification only to a CBSA in which another campus(es) is located. 
If the campus is seeking reclassification to a CBSA in which another 
campus(es) is located, as part of its reclassification request, the 
requesting entity must submit the composite wage data for the entire

[[Page 712]]

multicampus hospital as its hospital-specific data.
    (iv) For purposes of this paragraph (d)(2), if a new owner does not 
accept assignment of the existing hospital's provider agreement in 
accordance with Sec.  489.18 of this chapter, the hospital will be 
treated as a new provider with a new provider number. In this case, the 
wage data associated with the previous hospital's provider number cannot 
be used in calculating the new hospital's 3-year average hourly wage. 
Once a new hospital has accumulated at least 1 year of wage data, it is 
eligible to apply for reclassification on the basis of those data.
    (v) For applications submitted for reclassification effective in FY 
2009 and thereafter, a campus of a multicampus hospital that is located 
in a geographic area different from the area associated with the 
provider number of the entire multicampus hospital may seek 
reclassification to another CBSA using the composite wage data of the 
entire multicampus hospital as its hospital-specific data.
    (3) Rural referral center exceptions. (i) If a hospital was ever 
approved as a rural referral center, it does not have to demonstrate 
that it meets the average hourly wage criterion set forth in paragraph 
(d)(1)(iii) of this section.
    (ii) If a hospital was ever approved as a rural referral center, it 
is required to meet only the criterion that applies to rural hospitals 
under paragraph (d)(1)(iv) of this section, regardless of its actual 
location in an urban or rural area.
    (4) Special dominating hospital exception. The requirements of 
paragraph (d)(1)(i) and (d)(1)(iii) of this section do not apply if a 
hospital meets the following criteria:
    (i) Its average hourly wage is at least 108 percent of the average 
hourly wage of all other hospitals in the area in which the hospital is 
located.
    (ii) It pays at least 40 percent of the adjusted uninflated wages in 
the MSA.
    (iii) It was approved for redesignation under this paragraph (d) for 
each year from fiscal year 1992 through fiscal year 1997.
    (5) Single hospital MSA exception. The requirements of paragraph 
(d)(1)(iii) of this section do not apply if a hospital is the single 
hospital in its MSA with published 3-year average hourly wage data 
included in the current fiscal year inpatient prospective payment system 
final rule.

[55 FR 36766, Sept. 6, 1990]

    Editorial Note: For Federal Register citations affecting Sec.  
412.230, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.  412.232  Criteria for all hospitals in a rural county seeking 
urban redesignation.

    (a) Criteria. For all hospitals in a rural county to be redesignated 
to an urban area, the following conditions must be met:
    (1) The county in which the hospitals are located--
    (i) For fiscal years prior to fiscal year 2006, must be adjacent to 
the MSA or NECMA to which they seek redesignation.
    (ii) For fiscal years beginning with fiscal year 2006, must be 
adjacent to the MSA to which they seek redesignation.
    (2) All hospitals in a rural county must apply for redesignation as 
a group.
    (3) The hospitals must demonstrate that the rural county in which 
they are located currently meets the criteria for metropolitan character 
under paragraph (b) of this section and the wage criteria under 
paragraph (c) of this section.
    (4) The hospital may be redesignated only if one of the following 
conditions is met:
    (i) The prereclassified average hourly wage for the area to which 
they seek redesignation is higher than the prereclassified average 
hourly wage for the area in which they are currently located.
    (ii) For fiscal years prior to fiscal year 2006, the standardized 
amount for the area to which they seek redesignation is higher than the 
standardized amount for the area in which they are located.
    (b) Metropolitan character. (1) For fiscal years prior to FY 2005, 
the group of hospitals must demonstrate that the

[[Page 713]]

county in which the hospitals are located meets the standards for 
redesignation to an MSA or an NECMA as an outlying county that were 
published in the Federal Register on March 30, 1990 (55 FR 12154) using 
Bureau of the Census data or Bureau of Census estimates made after 1990.
    (2) For fiscal years beginning with FY 2005, the group of hospitals 
must demonstrate that the county in which the hospitals are located 
meets the standards for redesignation to an MSA as an outlying county 
using the most recent OMB standards for delineating statistical areas 
adopted by CMS and the most recent Census Bureau data.
    (c) Wage criteria. In applying the following numeric criteria, 
rounding of numbers to meet the qualifying percentages is not permitted.
    (1) Aggregate hourly wage for fiscal years before fiscal year 2010--
(i) Aggregate hourly wage. With respect to redesignations effective 
beginning fiscal year 1999 and before fiscal year 2010, the aggregate 
average hourly wage for all hospitals in the rural county must be equal 
to at least 85 percent of the average hourly wage in the adjacent urban 
area.
    (ii) Aggregate hourly wage weighted for occupational mix. For 
redesignations effective before fiscal year 1999, the aggregate hourly 
wage for all hospitals in the rural county, weighed for occupational 
categories, is at least 90 percent of the average hourly wage in the 
adjacent urban area.
    (2) Aggregate hourly wage for fiscal year 2010. With respect to 
redesignations effective for fiscal year 2010, the aggregate average 
hourly wage for all hospitals in the rural county must be equal to at 
least 86 percent of the average hourly wage in the adjacent urban area.
    (3) Aggregate hourly wage for fiscal year 2011 and later fiscal 
years. With respect to redesignations effective for fiscal year 2011 and 
later fiscal years, the aggregate average hourly wage for all hospitals 
in the rural county must be equal to at least 85 percent of the average 
hourly wage in the adjacent urban area.
    (d) Appropriate data--(1) Metropolitan character. (i) To meet the 
criteria in paragraph (b) of this section, the hospitals may submit 
data, estimates, or projections, made by the Bureau of the Census 
concerning population density or growth, or changes in designation of 
urban areas.
    (ii) The MGCRB only considers data developed by the Bureau of the 
Census.
    (2) Appropriate wage data. The hospitals must submit appropriate 
data as follows:
    (i) For redesignations effective through FY 2002:
    (A) For hospital-specific data, the hospitals must provide data from 
the CMS wage survey used to construct the wage index in effect for 
prospective payment purposes during the fiscal year prior to the fiscal 
year for which the hospitals request reclassification.
    (B) For data for other hospitals, the hospitals must provide the 
following:
    (1) The average hourly wage in the adjacent area, which is taken 
from the CMS hospital wage survey used to construct the wage index in 
effect for prospective payment purposes during the fiscal year prior to 
the fiscal year for which the hospitals request reclassification.
    (2) Occupational-mix data to demonstrate the average occupational 
mix for each employment category in the adjacent area. Occupational-mix 
data can be obtained from surveys conducted by the American Hospital 
Association.
    (ii) For redesignations effective beginning FY 2003:
    (A) For hospital-specific data, the hospital must provide a weighted 
3-year average of its average hourly wages using data from the CMS 
hospital wage survey used to construct the wage index in effect for 
prospective payment purposes.
    (B) For data for other hospitals, the hospital must provide a 
weighted 3-year average of the average hourly wage in the area in which 
the hospital is located and a weighted 3-year average of the average 
hourly wage in the area to which the hospital seeks reclassification. 
The wage data are taken from the CMS hospital wage survey used to 
construct the wage index in effect for prospective payment purposes.
    (iii) For redesignations effective beginning FY 2009, the wage data 
of an individual campus of a multicampus

[[Page 714]]

hospital will be determined by allocating, on the basis of full-time 
equivalent staff or discharges, the wage data of the entire multicampus 
hospital between or among the individual campuses of the multicampus 
hospital. The provision of this paragraph (d)(2)(iii) applies only in 
the case where an individual campus is located in a geographic area 
different from the area associated with the provider number of the 
entire multicampus hospital.

[55 FR 36766, Sept. 6, 1990, as amended at 57 FR 39826, Sept. 1, 1992; 
58 FR 46339, Sept. 1, 1993; 59 FR 45399, Sept. 1, 1994; 60 FR 45849, 
Sept. 1, 1995; 62 FR 46031, Aug. 29, 1997; 66 FR 39934, Aug. 1, 2001; 69 
FR 49249, Aug. 11, 2004; 69 FR 60252, Oct. 7, 2004; 72 FR 47412, Aug. 
22, 2007; 73 FR 48756, Aug. 19, 2008; 75 FR 50415, Aug. 16, 2010; 79 FR 
50355, Aug. 22, 2014]



Sec.  412.234  Criteria for all hospitals in an urban county seeking 
redesignation to another urban area.

    (a) General criteria. For all prospective payment hospitals in an 
.urban county to be redesignated to another urban area, the following 
conditions must be met:
    (1) All hospitals in an urban county must apply for redesignation as 
a group.
    (2) The county in which the hospitals are located must be adjacent 
to the urban area to which they seek redesignation.
    (3)(i) For Federal fiscal years before fiscal year 2006, the 
counties in which the hospitals are located must be part of the 
Consolidated Metropolitan Statistical Area (CMSA) that includes the 
urban area to which they seek redesignation.
    (ii) For Federal fiscal year 2006, hospitals located in counties 
that are in the same Combined Statistical Area (CSA) (under the MSA 
definitions announced by the OMB on June 6, 2003) as the urban area to 
which they seek redesignation; or in the same Consolidated Metropolitan 
Statistical Area (CMSA) (under the standards published by the OMB on 
March 30, 1990) as the urban area to which they seek designation qualify 
as meeting the proximity requirements for reclassification to the urban 
area to which they seek redesignation.
    (iii) For Federal fiscal year 2007, hospitals located in counties 
that are in the same Combined Statistical Area (CSA) (under the MSA 
definitions announced by the OMB on June 6, 2003) as the urban area to 
which they seek redesignation qualify as meeting the proximity 
requirement for reclassification to the urban area to which they seek 
redesignation.
    (iv) For Federal fiscal year 2008 and thereafter, hospitals located 
in counties that are in the same Combined Statistical Area (CSA) or 
Core-Based Statistical Area (CBSA) (under the most recent OMB standards 
for delineating statistical areas adopted by CMS and the most recent 
Census Bureau data) as the urban area to which they seek redesignation 
qualify as meeting the proximity requirement for reclassification to the 
urban area to which they seek redesignation.
    (4) The hospital may be redesignated only if one of the following 
conditions is met:
    (i) The prereclassified average hourly wage for the area to which 
they seek redesignation is higher than the prereclassified average 
hourly wage for the area in which they are currently located.
    (ii) For fiscal years prior to fiscal year 2005, the standardized 
amount for the area to which they seek redesignation is higher than the 
standardized amount for the area in which they are located.
    (b) Wage criteria. In applying the following numeric criteria, 
rounding of numbers to meet the qualifying percentages is not permitted.
    (1) Aggregate hourly wage for fiscal years before fiscal year 2010--
(i) Aggregate hourly wage. With respect to redesignations effective 
beginning fiscal year 1999 and before fiscal year 2010, the aggregate 
average hourly wage for all hospitals in the urban county must be at 
least 85 percent of the average hourly wage in the urban area to which 
the hospitals in the county seek reclassification.
    (ii) Aggregate hourly wage weighted for occupational mix. For 
redesignations effective before fiscal year 1999, the aggregate hourly 
wage for all hospitals in the county, weighed for occupational 
categories, is at least 90 percent of the average hourly wage in the 
adjacent urban area.

[[Page 715]]

    (2) Aggregate hourly wage for fiscal year 2010. With respect to 
redesignations effective for fiscal year 2010, the aggregate average 
hourly wage for all hospitals in the urban county must be at least 86 
percent of the average hourly wage in the urban area to which the 
hospitals in the county seek reclassification.
    (3) Aggregate hourly wage for fiscal year 2011 and later fiscal 
years. With respect to redesignations effective for fiscal year 2011 and 
later fiscal years, the aggregate average hourly wage for all hospitals 
in the urban county must be at least 85 percent of the average hourly 
wage in the urban area to which the hospitals in the county seek 
reclassification.
    (c) Appropriate wage data. (1) The hospitals must submit appropriate 
wage data as provided for in Sec.  412.230(d)(2).
    (2) For redesignations effective beginning FY 2009, the appropriate 
wage data of an individual campus located in a geographic area different 
from the area associated with the provider number of the entire 
multicampus hospital are the wage data described in Sec.  
412.232(d)(2)(iii).

[56 FR 25488, June 4, 1991, as amended at 57 FR 39826, Sept. 1, 1992; 58 
FR 46339, Sept. 1, 1993; 60 FR 45849, Sept. 1, 1995; 62 FR 46031, Aug. 
29, 1997; 69 FR 49249, Aug. 11, 2004; 70 FR 47487, Aug. 12, 2005; 71 FR 
48140, Aug. 18, 2006; 72 FR 47412, Aug. 22, 2007; 73 FR 48756, Aug. 19, 
2008; 75 FR 50415, Aug. 16, 2010; 79 FR 50355, Aug. 22, 2014]



Sec.  412.235  Criteria for all hospitals in a State seeking a statewide 
wage index redesignation.

    (a) General criteria. For all prospective payment system hospitals 
in a State to be redesignated to a statewide wage index, the following 
conditions must be met:
    (1) All prospective payment system hospitals in the State must apply 
as a group for reclassification to a statewide wage index through a 
signed single application.
    (2) All prospective payment system hospitals in the State must agree 
to the reclassification to a statewide wage index through a signed 
affidavit on the application.
    (3) All prospective payment system hospitals in the State must 
agree, through an affidavit, to withdrawal of an application or to 
termination of an approved statewide wage index reclassification.
    (4) All hospitals in the State must waive their rights to any wage 
index classification that they would otherwise receive absent the 
statewide wage index classification, including a wage index that any of 
the hospitals might have received through individual geographic 
reclassification.
    (5) New hospitals that open within the State prior to the deadline 
for submitting an application for a statewide wage index 
reclassification (September 1), regardless of whether a group 
application has already been filed, must agree to the use of the 
statewide wage index as part of the group application. New hospitals 
that open within the State after the deadline for submitting a statewide 
wage index reclassification application or during the approved 
reclassification period will be considered a party to the statewide wage 
index application and reclassification.
    (b) Effect on payments. (1) An individual hospital within the State 
may receive a wage index that could be higher or lower under the 
statewide wage index reclassification in comparison to its otherwise 
redesignated wage index.
    (2) Any new prospective payment system hospital that opens in the 
State during the effective period of an approved statewide wage index 
reclassification will be designated to receive the statewide wage index 
for the duration of that period.
    (c) Terms of the decision. (1) A decision by the MGCRB on an 
application for a statewide wage index reclassification will be 
effective for 3 years beginning with discharges occurring on the first 
day (October 1) of the second Federal fiscal year following the Federal 
fiscal year in which the hospitals filed a complete application.
    (2) The procedures and timeframes specified in Sec.  412.273 apply 
to withdrawals of applications for redesignation to a statewide wage 
index and terminations of approved statewide wage index 
reclassifications, including the requirement that, to withdraw an 
application or terminate an approved reclassification, the request must 
be made in writing by all hospitals that

[[Page 716]]

are party to the application, except hospitals reclassified into the 
State for purposes of receiving the statewide wage index.

[66 FR 39935, Aug. 1, 2001]

                       Composition and Procedures



Sec.  412.246  MGCRB members.

    (a) Composition. The Medicare Geographical Classification Review 
Board (MGCRB) consists of five members, including a Chairman, all of 
whom are appointed by the Secretary. The members include two members who 
are representative of prospective payment system hospitals located in 
rural areas, and at least one individual who is knowledgeable in 
analyzing the costs of inpatient hospital services.
    (b) Term of office. The term of office for an MGCRB member may not 
exceed 3 years. A member may serve more than one term. The Secretary may 
terminate a member's tenure prior to its full term.

[55 FR 36766, Sept. 6, 1990, as amended at 61 FR 46224, Aug. 30, 1996; 
61 FR 51217, Oct. 1, 1996]



Sec.  412.248  Number of members needed for a decision or a hearing.

    (a) A quorum. A quorum, consisting of at least a majority of the 
MGCRB members, one of whom is representative of rural hospitals if 
possible, is required for making MGCRB decisions.
    (b) Number of members for a hearing. If less than a quorum is 
present for an oral hearing, the chairman with the consent of the 
hospital may allow those members present to conduct the hearing and to 
prepare a recommended decision, which is then submitted to a quorum.



Sec.  412.250  Sources of MGCRB's authority.

    (a) Compliance. The MGCRB, in issuing decisions under section 
1886(d)(10)(C) of the Act, complies with all the provisions of title 
XVIII and related provisions of the Act and implementing regulations, 
including the criteria and conditions located at Sec.  412.230 through 
Sec.  412.236, issued by the Secretary under the authority of section 
1886(d)(10)(D) of the Act; and CMS Rulings issued under the authority of 
the Administrator.
    (b) Affords great weight. The MGCRB affords great weight to other 
interpretive rules, general statements of policy and rules of agency 
organization, procedure, and practice established by CMS.

[55 FR 36766, Sept. 6, 1990, as amended at 56 FR 25488, June 4, 1991]



Sec.  412.252  Applications.

    (a) By one hospital. An individual prospective payment system 
hospital seeking redesignation to a different rural or urban area has 
the right to submit an application to the MGCRB.
    (b) By a group of hospitals. A group of hospitals has the right to 
submit an application to the MGCRB requesting redesignation of all 
prospective payment hospitals in a county if all prospective payment 
hospitals located in a county agree to the request.

[55 FR 36766, Sept. 6, 1990, as amended at 69 FR 49250, Aug. 11, 2004]



Sec.  412.254  Proceedings before MGCRB.

    (a) On-the-record decision. The MGCRB will ordinarily issue an on-
the-record decision without conducting an oral hearing. The MGCRB will 
issue a decision based upon all documents, data, and other written 
evidence and comments submitted timely to the MGCRB by the parties.
    (b) Oral hearing. The MGCRB may hold an oral hearing on its own 
motion or if a party demonstrates to the MGCRB's satisfaction that an 
oral hearing is necessary.



Sec.  412.256  Application requirements.

    (a) Written application. A request for reclassification must be in 
writing and must constitute a complete application in accordance with 
paragraph (b) of this section.
    (1) An application must be submitted to the MGCRB according to the 
method prescribed by the MGCRB.
    (2) A complete application must be received not later than the first 
day of the 13-month period preceding the Federal fiscal year for which 
reclassification is requested.

[[Page 717]]

    (3) The filing date of an application is the date the application is 
received by the MGCRB.
    (b) Criteria for a complete application. An application is complete 
if the application from an individual hospital or from all hospitals in 
a county includes the following information:
    (1) The Federal fiscal year for which the hospital is applying for 
redesignation.
    (2) Which criteria constitute the basis of the request for 
reclassification.
    (3) An explanation of how the hospital or hospitals meet the 
relevant criteria in Sec. Sec.  412.230 through 412.236, including any 
necessary data to support the application.
    (c) Opportunity to complete a submitted application. (1) The MGCRB 
will review an application within 15 days of receipt to determine if the 
application is complete. If the MGCRB determines that an application is 
incomplete, the MGCRB will notify the hospital, with a copy to CMS, 
within the 15 day period, that it has determined that the application is 
incomplete and may dismiss the application if a complete application is 
not filed by September 1.
    (2) At the request of the hospital, the MGCRB may, for good cause, 
grant a hospital that has submitted an application by September 1, an 
extension beyond September 1 to complete its application.
    (d) Appeal of MGCRB dismissal. (1) The hospital may appeal the MGCRB 
dismissal to the Administrator within 15 days of the date of the notice 
of dismissal.
    (2) Within 20 days of receipt of the hospital's request for appeal, 
the Administrator will affirm the dismissal or reverse the dismissal and 
remand the case to the MGCRB to determine whether reclassification is 
appropriate.
    (e) Notification of complete application. When the MGCRB determines 
that the hospital's application contains all the necessary elements for 
a complete application, it notifies the hospital in writing, with a copy 
to CMS, that the application is complete and that the case may proceed 
to an MGCRB decision.

[55 FR 36766, Sept. 6, 1990, as amended at 56 FR 25488, June 4, 1991; 62 
FR 46031, Aug. 29, 1997; 63 FR 26357, May 12, 1998; 64 FR 41541, July 
30, 1999; 81 FR 57268, Aug. 22, 2016; 84 FR 42614, Aug. 16, 2019]



Sec.  412.258  Parties to MGCRB proceeding.

    (a) The party or parties to an MGCRB proceeding are the hospital or 
group of hospitals requesting a change in geographic designation.
    (b) CMS has 30 days from the date of receipt of notice of a complete 
application to submit written comments and recommendations (with a copy 
to the hospital) for consideration by the MGCRB.
    (c) The hospital has 15 days from the date of receipt of CMS's 
comments to submit written comments to the MGCRB, with a copy to CMS, 
for the purpose of responding to CMS's comments.



Sec.  412.260  Time and place of the oral hearing.

    If the MGCRB decides that an oral hearing is necessary, it sets the 
time and place for the hearing and notifies the parties in writing, with 
a copy to CMS, not less than 10 days before the time scheduled for the 
hearing. The MGCRB may reschedule, adjourn, postpone, or reconvene the 
hearing provided that reasonable written notice is given to the parties, 
with a copy to CMS.



Sec.  412.262  Disqualification of an MGCRB member.

    (a) Grounds for disqualification. An MGCRB member may not 
participate in any decision in a case in which he or she may be 
prejudiced or partial with respect to a party or has any other interest 
in the case.
    (b) Request for disqualification. If a party believes that an MGCRB 
member should not participate in a decision, the party submits the 
objection in writing to the MGCRB at its earliest opportunity, 
explaining the grounds for the request. CMS may also submit such a 
suggestion to the MGCRB.
    (c) Consideration by the MGCRB member. The MGCRB member will 
consider

[[Page 718]]

the objection and, at his or her discretion, either will proceed or 
withdraw.
    (d) Consideration by the MGCRB If the member does not withdraw, a 
party may petition the MGCRB for withdrawal and the MGCRB will consider 
the objection and rule on whether the member may participate in the 
decision before it decides the case.



Sec.  412.264  Evidence and comments in MGCRB proceeding.

    (a) Submission by the parties. Before a decision is issued and 
during an oral hearing, the parties may present evidence or comments to 
the MGCRB regarding the matters at issue in the case.
    (b) Content of evidence and comments. The MGCRB may receive evidence 
and comments without regard for the rules of evidence applicable to 
court procedures.
    (c) Ex parte communications. (1) The members of the MGCRB and its 
staff may not consult or be consulted by an individual representing the 
interests of an applicant hospital or by any other individual on any 
matter in issue before the MGCRB without notice to the hospital or CMS. 
If such communication occurs, the MGCRB will disclose it to the hospital 
or CMS, as appropriate, and make it part of the record after the 
hospital or CMS has had an opportunity to comment. MGCRB members and 
staff may not consider any information outside the record about matters 
concerning a hospital's application for reclassification.
    (2) The provisions in paragraph (c)(1) of this section do not apply 
to the following:
    (i) Communications among MGCRB members and staff.
    (ii) Communications concerning the MGCRB's administrative functions 
or procedures.
    (iii) Requests from the MGCRB to a party or CMS for a document.
    (iv) Material that the MGCRB includes in the record after notice and 
an opportunity to comment.
    (d) MGCRB rulings on evidence and comments. The MGCRB rules upon the 
admissibility of evidence and comments and excludes irrelevant, 
immaterial, or unduly repetitious evidence and comments.



Sec.  412.266  Availability of wage data.

    A hospital may obtain the average hourly wage data necessary to 
prepare its application to the MGCRB from Federal Register documents 
published in accordance with the provisions of Sec.  412.8(b).

[60 FR 45849, Sept. 1, 1995]



Sec.  412.268  Subpoenas.

    (a) In general. When reasonably necessary for the full presentation 
of a case, and only after a pre-decision request for information or data 
has failed to produce the necessary evidence, either upon its own motion 
or upon the request of a party, the MGCRB may issue subpoenas for the 
attendance and testimony of witnesses, for an oral hearing or the 
production of books, records, correspondence, papers, or other documents 
that are relevant and material to any matter at issue.
    (b) Content of request. The request must designate which witnesses 
or documents are to be produced, and describe addresses or locations 
with sufficient particularly to permit these witnesses or documents to 
be found. The request for a subpoena must state the pertinent facts that 
the party expects to establish by the requested witnesses or documents 
and whether these facts could be established by other evidence without 
the use of a subpoena.
    (c) Issuance. Subpoenas are issued as provided in section 205(d) of 
the Act.
    (d) Payment for subpoena cost. CMS pays for the cost of issuing 
subpoenas and the fees and mileage of any witness who is subpoenaed, as 
provided in section 205(d) of the Act.



Sec.  412.270  Witnesses.

    Witnesses at an oral hearing testify under oath or affirmation, 
unless excused by the MGCRB for cause. The MGCRB may examine the 
witnesses and may allow the parties or their representatives to also 
examine any witnesses called.



Sec.  412.272  Record of proceedings before the MGCRB.

    A complete record of the proceedings before the MGCRB is made in all 
cases. The record will not be closed until a decision has been issued by 
the

[[Page 719]]

MGCRB. A transcription of an oral hearing will be made at a party's 
request, at the expense of the requesting party.



Sec.  412.273  Withdrawing an application, terminating an approved 
3-year reclassification, or canceling a previous withdrawal or termination.

    (a) Definitions. For purposes of this section, the following 
definitions apply.
    Termination refers to the termination of an already existing 3-year 
MGCRB reclassification where such reclassification has already been in 
effect for 1 or 2 years, and there are 1 or 2 years remaining on the 3-
year reclassification. A termination is effective only for the full 
fiscal year(s) remaining in the 3-year period at the time the request is 
received. Requests for terminations for part of a fiscal year are not 
considered.
    Withdrawal refers to the withdrawal of a 3-year MGCRB 
reclassification that has not yet gone into effect or where the MGCRB 
has not yet issued a decision on the application.
    (b) General rule. The MGCRB allows a hospital, or group of 
hospitals, to withdraw its application or to terminate an already 
existing 3-year reclassification, in accordance with this section.
    (c) Timing. (1) A request for withdrawal must be received by the 
MGCRB--
    (i) At any time before the MGCRB issues a decision on the 
application; or
    (ii) After the MGCRB issues a decision, provided that the request 
for withdrawal is received by the MCGRB within 45 days of the date that 
CMS' annual notice of proposed rulemaking is issued in the Federal 
Register concerning changes to the inpatient hospital prospective 
payment system and proposed payment rates for the fiscal year for which 
the application has been filed.
    (2) A request for termination must be received by the MGCRB within 
45 days of the date that CMS' annual notice of proposed rulemaking is 
issued in the Federal Register concerning changes to the inpatient 
hospital prospective payment system and proposed payment rates for the 
fiscal year for which the termination is to apply.
    (d) Reapplication within the approved 3-year period, cancellations 
of terminations and withdrawals, and prohibition on overlapping 
reclassification approvals--(1) Cancellation of terminations or 
withdrawals. Subject to the provisions of this section, a hospital (or 
group of hospitals) may cancel a withdrawal or termination in a 
subsequent year and request the MGCRB to reinstate the wage index 
reclassification for the remaining fiscal year(s) of the 3-year period. 
(Withdrawals may be cancelled only in cases where the MGCRB issued a 
decision on the geographic reclassification request.)
    (2) Timing and process of cancellation request. Cancellation 
requests must be received in writing by the MGCRB no later than the 
deadline for submitting reclassification applications for the following 
fiscal year, as specified in Sec.  412.256(a)(2).
    (3) Reapplications. A hospital may apply for reclassification to a 
different area (that is, an area different from the one to which it was 
originally reclassified for the 3-year period). If the application is 
approved, the reclassification will be effective for 3 years. Once a 3-
year reclassification becomes effective, a hospital may no longer cancel 
a withdrawal or termination of another 3-year reclassification, 
regardless of whether the withdrawal or termination request is made 
within 3 years from the date of the withdrawal or termination.
    (4) Termination of existing 3-year reclassification. In a case in 
which a hospital with an existing 3-year wage index reclassification 
applies to be reclassified to another area, its existing 3-year 
reclassification will be terminated when a second 3-year wage index 
reclassification goes into effect for payments for discharges on or 
after the following October 1.
    (e) Written request only. A request to withdraw an application must 
be made in writing to the MGCRB by all hospitals that are party to the 
application. A request to terminate an approved reclassification must be 
made in writing to the MGCRB by an individual hospital or by an 
individual hospital that is party to a group classification.

[[Page 720]]

    (f) Appeal of the MGCRB's denial of a hospital's request for 
withdrawal or termination, or for cancellation of a withdrawal or 
termination. (1) A hospital may file an appeal of the MGCRB's denial of 
its request for withdrawal or termination, or of the MGCRB's denial of 
its request for a cancellation of such withdrawal or termination, to the 
Administrator. The appeal must be received within 15 days of the date of 
the notice of the denial.
    (2) Within 20 days of receipt of the hospital's request for appeal, 
the Administrator affirms or reverses the denial.

[75 FR 50415, Aug. 16, 2010, as amended at 82 FR 38512, Aug. 14, 2017]



Sec.  412.274  Scope and effect of an MGCRB decision.

    (a) Scope of decision. The MGCRB may affirm or change a hospital's 
geographic designation. The MGCRB's decision is based upon the evidence 
of record, including the hospital's application and other evidence 
obtained or received by the MGCRB.
    (b) Effective date and term of the decision. (1) For 
reclassifications prior to fiscal year 2005, a standardized amount 
classification change is effective for 1 year beginning with discharges 
occurring on the first day (October 1) of the second Federal fiscal year 
following the Federal fiscal year in which the complete application is 
filed and ending effective at the end of that Federal fiscal year (the 
end of the next September 30).
    (2) A wage index classification change is effective for 3 years 
beginning with discharges occurring on the first day (October 1) of the 
second Federal fiscal year in which the complete application is filed.

[55 FR 36766, Sept. 6, 1990, as amended at 62 FR 46031, Aug. 29, 1997; 
66 FR 39935, Aug. 1, 2001; 69 FR 49250, Aug. 11, 2004]



Sec.  412.276  Timing of MGCRB decision and its appeal.

    (a) Timing. The MGCRB notifies the parties in writing, with a copy 
to CMS, and issues a decision within 180 days after the first day of the 
13-month period preceding the Federal fiscal year for which a hospital 
has filed a complete application. The hospital has 15 days from the date 
of the decision to request Administrator review.
    (b) Appeal. The decision of the MGCRB is final and binding upon the 
parties unless it is reviewed by the Administrator and the decision is 
changed by the Administrator in accordance with Sec.  412.278.

[55 FR 36766, Sept. 6, 1990, as amended at 64 FR 41541, July 30, 1999]



Sec.  412.278  Administrator's review.

    (a) Hospitals requests for review. A hospital or group of hospitals 
dissatisfied with the MGCRB's decision regarding its geographic 
designation may request the Administrator to review the MGCRB decision. 
(A hospital or group of hospitals may also request that the 
Administrator review the MGCRB's dismissal of an application as untimely 
filed or incomplete, as provided in Sec.  412.256(d).)
    (b) Procedures for hospital's request for review.(1) The hospital's 
request for review must be in writing and sent to the Administrator, in 
care of the Office of the Attorney Advisor, in the manner directed by 
the Office of the Attorney Advisor. The request must be received by the 
Administrator within 15 days after the date the MGCRB issues its 
decision. The hospital must also submit an electronic copy of its 
request for review to CMS's Hospital and Ambulatory Policy Group.
    (2) The request for review may contain proposed findings of fact and 
conclusions of law, exceptions to the MGCRB's decision, and supporting 
reasons therefor.
    (3) Within 15 days of receipt of the hospital's request for review, 
CMS may submit to the Administrator, in writing, with a copy to the 
party, comments and recommendations concerning the hospital's 
submission.
    (4) Within 10 days of receipt of CMS's submission, the hospital may 
submit in writing, with a copy to CMS, a response to the Administrator.
    (c) Discretionary review by the Administrator. (1) The Administrator 
may, at his or her discretion, review any final decision of the MGCRB.
    (2) The Administrator promptly notifies the hospital that he or she 
has decided to review a decision of the MGCRB. The notice of review 
indicates

[[Page 721]]

the particular issues to be considered and includes copies of any 
comments submitted to the Administrator by CMS staff concerning the 
MGCRB decision.
    (3) Within 15 days of the receipt of the Administrator's notice of 
review, the hospital may submit a response in writing to the 
Administrator, with a copy of CMS.
    (d) Criteria for discretionary review. In deciding whether to review 
an MGCRB decision, the Administrator normally considers whether it 
appears that any of the following situations apply:
    (1) The MGCRB made an erroneous interpretation of law, regulation, 
or CMS Ruling.
    (2) The MGCRB's decision is not supported by substantial evidence.
    (3) The case presents a significant policy issue having a basis in 
law and regulations, and review is likely to lead to issuance of a CMS 
Ruling or other directive needed to clarify a provision in the law or 
regulations.
    (4) The decision of the MGCRB requires clarification, amplication, 
or an alternative legal basis.
    (5) The MGCRB has incorrectly extended its authority to a degree not 
provided for by law, regulation, or CMS Ruling.
    (e) Communication procedures. All communications between CMS staff 
and the Administrator concerning the Administrator's review of an MGCRB 
decision must be in writing. As specified in paragraphs (b) and (c) of 
this section, copies of comments by CMS staff are sent to applicant 
hospitals within 15 days of receipt of a hospital's request for review, 
or, in cases in which the Administrator decides to review a case at his 
or her discretion, are included with the Administrator's notice of 
review. In the event there are additional communications between CMS 
staff and the Administrator concerning MGCRB decisions reviewed by the 
Administrator under paragraphs (b) or (c) of this section, CMS furnishes 
copies of the communications to the hospital or group of hospitals.
    (f) Administrator's decision. (1) The Administrator may not receive 
or consider any new evidence and must issue a decision based only upon 
the record as it appeared before the MGCRB and comments submitted under 
paragraphs (b)(2), (b)(3), (b)(4), (c)(2), and (c)(3) of this section.
    (2) The Administrator issues a decision in writing to the party with 
a copy to CMS--
    (i) Not later than 90 days following receipt of the party's request 
for review, except the Administrator may, at his or her discretion, for 
good cause shown, toll such 90 days; or
    (ii) Not later than 105 days following issuance of the MGCRB 
decision in the case of review at the discretion of the Administrator, 
except the Administrator may, at his or her discretion, for good cause 
shown, toll such 105 days.
    (3) The Administrator's decision issued under Sec.  412.278 (a) or 
(c) is the final Departmental decision, unless it is amended under Sec.  
412.278(g). The final Departmental decision is not subject to judicial 
review.
    (4) The Administrator's decision is not subject to judicial review.
    (g) Amendment of Administrator decision--(1) Hospital's request for 
amendment. The hospital may request the Administrator to amend the 
decision for the limited purpose of correcting mathematical or 
computational errors, or to correct the decision if the evidence that 
was considered in making the decision clearly shows on its face that an 
error was made. The following procedure is followed:
    (i) The hospital's request for amendment must be received by the 
Administrator within 10 days after the date the Administrator issues a 
decision. The request for amendment must be in writing, with a copy to 
CMS.
    (ii) The Administrator promptly reviews the hospital's request and 
amends the decision, if necessary, within 5 days following receipt of 
the hospital's request for amendment.
    (2) Discretionary review by the Administrator. Within 15 days 
following the issuance of the Administrator's decision, the 
Administrator, at his or her discretion, may amend the decision to 
correct mathematical or computational errors, or to correct the decision 
if the evidence that was considered in making the decision clearly shows 
on its face that an error was made. The Administrator's amended decision 
is

[[Page 722]]

final and is not subject to judicial review.

[55 FR 36766, Sept. 6, 1990, as amended at 56 FR 25489, June 4, 1991; 57 
FR 39826, Sept. 1, 1992; 68 FR 45471, Aug. 1, 2003; 70 FR 47487, Aug. 
12, 2005; 85 FR 59023, Sept. 18, 2020; 86 FR 45520, Aug. 13, 2021]



Sec.  412.280  Representation.

    (a) General. A party may be represented by legal counsel or by any 
other person appointed to act as its representative at any proceeding 
before the MGCRB or the Administrator.
    (b) Rights of a representative. A representative appointed by a 
party may accept or give on behalf of the party any request or notice 
connected with any proceeding before the MGCRB or the Administrator. A 
representative is entitled to present evidence and argument as to facts 
and law in any MGCRB proceeding affecting the party represented and to 
obtain information to the same extent as the party represented. Notice 
of any action or decision sent to the representative of a party has the 
same effect as if it had been sent to the party itself.



  Subpart M_Prospective Payment System for Inpatient Hospital Capital 
                                  Costs

    Source: 56 FR 43449, Aug. 30, 1991, unless otherwise noted.

                           General Provisions



Sec.  412.300  Scope of subpart and definition.

    (a) Purpose. This subpart implements section 1886(g)(1)(A) of the 
Act by establishing a prospective payment system for inpatient hospital 
capital-related costs. Under this system, payment is made on the basis 
described in Sec.  412.304 through Sec.  412.374 for inpatient hospital 
capital-related costs furnished by hospitals subject to the prospective 
payment system under subpart B of this part.
    (b) Definition. For purposes of this subpart, a new hospital means a 
hospital that has operated (under previous or present ownership) for 
less than 2 years. The following hospitals are not new hospitals:
    (1) A hospital that builds new or replacement facilities at the same 
or another location even if coincidental with a change of ownership, a 
change in management, or a lease arrangement.
    (2) A hospital that closes and subsequently reopens.
    (3) A hospital that has been in operation for more than 2 years but 
has participated in the Medicare program for less than 2 years.
    (4) A hospital that changes its status from a hospital that is 
excluded from the prospective payment systems to a hospital that is 
subject to the capital prospective payment systems.

[56 FR 43449, Aug. 30, 1991, as amended at 57 FR 39827, Sept. 1, 1992]



Sec.  412.302  Introduction to capital costs.

    (a) New capital costs. New capital costs are allowable Medicare 
inpatient hospital capital-related costs under subpart G of part 413 of 
this chapter that are related to assets that were first put in use for 
patient care after December 31, 1990 (except for such costs deemed to be 
old capital costs based on prior obligations as described in paragraph 
(c) of this section) and those allowable capital-related costs related 
to assets in use prior to December 31, 1990 that are excluded from the 
definition of old capital costs described in paragraphs (b) (2) through 
(5) of this section, or are betterment or improvement costs related to 
those old capital assets.
    (b) Old capital costs. Except as provided in paragraph (c) of this 
section with respect to capital obligations that qualify for recognition 
as old capital, old capital costs are allowable capital-related costs 
for land and depreciable assets that were put in use for patient care on 
or before December 31, 1990. However, for a new hospital as defined in 
Sec.  412.300(b), old capital costs are defined as those allowable 
capital-related costs for land and depreciable assets that were put in 
use for patient care on or before the later of December 31, 1990 or the 
last day of the hospital's base year cost reporting period under Sec.  
412.328(a)(2). Old capital costs include the following:
    (1) Allowable depreciation on assets based on the useful life 
guidelines used

[[Page 723]]

to determine depreciation expense in the hospital's base period.
    (2) Allowable capital-related interest expense. Except as provided 
below, the amount of allowable capital-related interest expense that 
will be recognized as old capital is limited to the amount the hospital 
was legally obligated to pay as of December 31, 1990. Any allowable 
interest expense in excess of this limitation will be recognized as new 
capital.
    (i) An increase in interest expense is recognized if the increase is 
due to periodic fluctuations of rates in variable interest rate loans or 
at the time of conversion from a variable rate loan to a fixed rate loan 
when no other changes in the terms of the loan are made.
    (ii) If the terms of a debt instrument are revised after December 
31, 1990, the amount of interest that will be recognized as old capital 
during the transition cannot exceed the amount that would have been 
recognized during the same period prior to the revision of the debt 
instrument.
    (iii) If short-term financing was used to acquire old capital assets 
and the debt is extended or ``rolled-over'', a portion of the extended 
debt will be recognized as old capital. The portion will equal the ratio 
of the net book value as of the beginning of the applicable cost 
reporting period for depreciable assets that were in use in the base 
year, to the net book value as of the beginning of the base year cost 
reporting period for those assets. The net book value for the base year 
will not be adjusted to exclude assets that have been fully depreciated 
or removed from service since the base year. If the debt is related to 
specific assets, the ratio will be determined based on the values for 
those assets. The ratio will exclude assets that were acquired with 
other identifiable debt instruments. For purposes of this paragraph, 
short term financing is a debt that becomes due in no later than the 
earlier of 5 years or half of the average useful life of the assets to 
which the debt is related.
    (iv) If old capital indebtedness is commingled with new capital 
debt, the allowable interest expense will be apportioned to old capital 
costs based on the ratio of the portion of the loan principal related to 
old capital indebtedness to the total loan principal.
    (v) Investment income, excluding income from funded depreciation 
accounts, is used to reduce old capital interest expense based on the 
ratio of total old capital interest expense to total allowable interest 
expense in each cost reporting period.
    (3) Allowable capital-related lease and rental costs for land and 
depreciable assets that were obligated as of December 31, 1990.
    (i) Lease renewals up to the annual lease payment level obligated as 
of December 31, 1990 are recognized provided the same asset remains in 
use, the asset has a useful life of at least 3 years, and the annual 
lease payment is $1,000 or more for each item or service.
    (ii) If a hospital-owned asset is sold or given to another party and 
that same asset is then leased back by the hospital, the amount of 
allowable capital-related costs recognized as old capital costs is 
limited to the amount allowed for that asset in the last cost reporting 
period that it was owned by the hospital.
    (iii) If an entire hospital is leased without assumption of the 
hospital's asset costs after December 31, 1990, the amount of allowable 
capital-related costs recognized as old capital costs is limited to the 
amount allowed for old capital costs in the base year or the last cost 
reporting period these costs were recognized under this subpart, 
whichever is later.
    (4) The portion of allowable costs for other capital-related 
expenses (including but not limited to, taxes, insurance, license and 
royalty fees on depreciable assets) resulting from applying the ratio of 
the hospital's gross old asset value to total asset value in each cost 
reporting period.
    (5) The appropriate portion of the capital-related costs of related 
organizations under Sec.  413.17 that would be recognized as old capital 
costs if these costs had been incurred directly by the hospital.
    (6) Obligated capital costs that are recognized as old capital costs 
in accordance with paragraph (c) of this section.
    (7) If a hospital had nonreimbursable costs applicable to an old 
capital asset

[[Page 724]]

as of December 31, 1990 that subsequently become allowable inpatient 
capital-related costs, the allowable costs for such an asset that are 
attributable to inpatient hospital services are recognized as old 
capital costs if a portion of the asset was in use for inpatient 
hospital care on December 31, 1990 and the costs meet all other 
provisions for recognition of old capital costs contained in this 
section.
    (c) Obligated capital costs--(1) General rule. Under the conditions 
described below, capital-related costs attributable to assets that are 
put in use after December 31, 1990 may be recognized as old capital 
costs. Any allowable capital-related costs for these assets that are not 
recognized as old capital costs are recognized as new capital costs.
    (i) Fixed assets. The costs of capital-related items and services 
defined in subpart G of part 413 for which there was a contractual 
obligation entered into by a hospital or related party with an outside, 
unrelated party for the construction, reconstruction, lease, rental, or 
financing of a fixed asset may be recognized as old capital costs if all 
the following conditions are met:
    (A) The obligation must arise from a binding written agreement that 
was executed on or before December 31, 1990 and that obligates the 
hospital on or before December 31, 1990.
    (B) The capital asset must be put in use for patient care before 
October 1, 1994 except as provided in paragraph (c)(1)(iv) of this 
section.
    (C) The hospital notifies the intermediary of the existence of 
obligated capital costs as provided in paragraph (c)(1)(v) of this 
section.
    (D) The amount that is recognized as old capital cost is limited to 
the lesser of the actual allowable costs when the asset is put in use or 
the estimated costs of the capital expenditure at the time it was 
obligated as provided in paragraph (c)(1)(vi) of this section.
    (ii) Moveable equipment. Moveable equipment is recognized as old 
capital only if all of the conditions specified in paragraphs (c)(1)(i) 
(B) through (D) of this section are met and one of the following 
conditions is met:
    (A) There was a binding contractual agreement that was executed on 
or before December 31, 1990 and obligates the hospital on or before 
December 31, 1990 for the lease or purchase of the item of equipment on 
or before December 31, 1990.
    (B) There was a binding contractual agreement that was executed on 
or before December 31, 1990 and obligates the hospital on or before 
December 31, 1990 for financing the acquisition of the equipment; the 
item of equipment costs at least $100,000; and the item was specifically 
listed in an equipment purchase plan approved by the Board of Directors 
on or before December 31, 1990.
    (iii) Agreements not recognized. Agreements for planning, design or 
feasibility that do not commit the hospital to undertake a project are 
not recognized as obligating capital expenditures for purposes of this 
subsection.
    (iv) Extension of deadline. CMS may extend the deadline in paragraph 
(c)(1)(i)(B) of this section, under which an asset must be put in use 
for patient care before October 1, 1994, to no later than September 30, 
1996 for extraordinary circumstances beyond the hospital's control. 
Extraordinary circumstances include, but are not limited to, a 
construction strike or atypically severe weather that significantly 
delayed completion of a construction project. Normal construction delays 
do not constitute extraordinary circumstances.
    (A) The hospital must submit its request for an extended deadline 
with documentation of the extraordinary circumstances by the later of 
January 1, 1993 or 180 days after the extraordinary circumstance.
    (B) The intermediary reviews the request and verifies the hospital's 
documentation, and forwards the request to CMS within 60 days. Within 90 
days, CMS notifies the intermediary of its decision and, if an extension 
is granted, of the revised deadline for putting the asset in use for 
patient care service.
    (v) The hospital must submit to its intermediary the binding 
agreement and supporting documents that relate to the obligated capital 
expenditure by the later of October 1, 1992, or within 90 days after the 
start of the hospital's first cost reporting period beginning on

[[Page 725]]

or after October 1, 1991. This documentation must include a project 
description (including details of any phased construction or financing) 
and an estimate of costs that were prepared no later than December 31, 
1990.
    (vi) Cost limitation--(A) Leases, rentals or purchases. The amount 
of obligated capital costs recognized as old capital costs cannot exceed 
the amount specified in the lease, rental, or purchase agreement. If 
moveable equipment is recognized as old capital under paragraph 
(c)(1)(ii)(B) of this section, the amount recognized as old capital 
costs cannot exceed the estimated cost identified in the equipment 
purchase plan approved by the hospital's Board of Directors.
    (B) Construction contracts. The amount of obligated capital costs 
recognized as old capital costs cannot exceed the estimated construction 
costs for the project as of December 31, 1990. Additional costs will be 
recognized as old capital costs only if the additional costs are 
directly attributable to changes in life safety codes or other building 
requirements established by government ordinance that occurred after the 
project was obligated.
    (C) Financing costs. The amount of obligated interest expense that 
will be recognized as old capital costs cannot exceed the amount for 
which the hospital was legally obligated as of December 31, 1990 or, in 
the case of financing that is arranged after December 31, 1990 for a 
capital acquisition that was legally obligated as of December 31, 1990, 
the amount specified in a detailed financing plan approved by the 
hospital's Board of Directors prior to January 1, 1991.
    (vii) Determining old capital costs. (A) The intermediary determines 
whether the applicable criteria are met for recognition of obligated 
capital costs as old capital costs and the maximum allowable cost that 
will be recognized as old capital costs.
    (B) The intermediary advises the hospital of its determination by 
the later of the end of the hospital's first cost reporting period 
subject to the capital prospective payment system or 9 months after the 
receipt of the hospital's notification under paragraph (c)(1)(v) of this 
section.
    (C) The actual amount that will be recognized as old capital costs 
is based on the lesser of the allowable costs for the asset when it is 
put into patient use or the amounts determined under paragraph 
(c)(1)(vi) of this section.
    (viii) Multi-phase project. If the hospital has a multi-phase 
capital project, the provisions of paragraphs (c)(1) (i) through (vii) 
of this section apply independently to each phase of the project.
    (2) Lengthy certificate-of-need process. (i) If a hospital does not 
meet the criteria under paragraph (c)(1)(i) or paragraph (c)(1)(ii) of 
this section, but meets all of the following criteria, the estimated 
cost for the project as of December 31, 1990 may be recognized as old 
capital costs:
    (A) The hospital is required under State law to obtain preapproval 
of the capital project or acquisition by a designated State or local 
planning authority in the State in which it is located.
    (B) The hospital filed an initial application for a certificate of 
need on or before December 31, 1989 that includes a detailed description 
of the project and its estimated cost and had not received approval or 
disapproval on or before September 30, 1990. If the hospital received 
conditional approval on or before September 30, 1990, the hospital's 
intermediary assesses the nature of the conditions. The hospital will be 
considered to have received approval for the project as of September 30, 
1990 if the intermediary determines that the hospital received 
sufficient approval for the project to proceed without significant 
delay.
    (C) The hospital expended the lesser of $750,000 or 10 percent of 
the estimated cost of the project on or before December 31, 1990; and
    (D) The hospital put the asset into patient use on or before the 
later of September 30, 1996 or 4 years from the date the certificate of 
need was approved.
    (ii) The provisions of paragraphs (c)(1) (iv) through (viii) of this 
section apply to projects that meet the criteria in paragraph (c)(2)(i) 
of this section.
    (3) Construction in process. (i) If a hospital that initiates 
construction on a capital project does not meet the requirements of 
paragraphs (c)(1)(i) or (ii) or (c)(2)(i) of this section, the

[[Page 726]]

project costs may be recognized as old capital costs if all the 
following conditions are met:
    (A) The hospital received any required certificate of need approval 
on or before December 31, 1990.
    (B) The hospital's Board of Directors formally authorized the 
project with a detailed description of its scope and costs on or before 
December 31, 1990.
    (C) The estimated cost of the project as of December 31, 1990 
exceeds 5 percent of the hospital's total patient revenues during its 
base year.
    (D) The capitalized cost that had been incurred for the project as 
of December 31, 1990 exceeded the lesser of $750,000 or 10 percent of 
the estimated project cost.
    (E) The hospital began actual construction or renovation 
(``groundbreaking'') on or before March 31, 1991.
    (F) The project is completed before October 1, 1994.
    (ii) The provisions of paragraphs (c)(1) (iv) through (viii) of this 
section apply to projects that meet the criteria in paragraph (c)(3)(i) 
of this section.
    (d) Consistency in cost reporting--(1) General rule. For cost 
reporting periods beginning on or after October 1, 1991, and before 
October 1, 2001, the hospital must follow consistent cost finding 
methods for classifying and allocating capital-related costs, except as 
otherwise provided in paragraph (d)(4) of this section.
    (2) Old capital costs. Unless there is a change of ownership, the 
hospital must continue the same cost finding methods for old capital 
costs, including its practices for the direct assignment of capital-
related costs and its cost allocation bases, that were in effect in the 
hospital's last cost reporting period ending on or before October 1, 
1991. If there is a change of ownership, the new owners may request that 
the intermediary approve a change in order to be consistent with their 
established cost finding practices.
    (3) New capital costs. If a hospital desires to change its cost 
finding methods for new capital costs, the request for change must be 
made in writing to the intermediary prior to the beginning of the cost 
reporting period for which the change is to apply. The request must 
include justification as to why the change will result in more accurate 
and more appropriate cost finding. The intermediary will not approve the 
change unless it determines that there is reasonable justification for 
the change.
    (4) Hospitals may elect the simplified cost allocation methodology 
under the terms and conditions provided in the instructions for CMS Form 
2552.

[56 FR 43449, Aug. 30, 1991, as amended at 57 FR 3016, Jan. 27, 1992; 57 
FR 39827, Sept. 1, 1992; 57 FR 46510, Oct. 9, 1992; 59 FR 45399, Sept. 
1, 1994; 61 FR 46224, Aug. 30, 1996; 61 FR 51217, Oct. 1, 1996]



Sec.  412.304  Implementation of the capital prospective payment system.

    (a) General rule. As described in Sec. Sec.  412.312 through 
412.370, effective with cost reporting periods beginning on or after 
October 1, 1991, CMS pays an amount determined under the capital 
prospective payment system for each inpatient hospital discharge as 
defined in Sec.  412.4. This amount is in addition to the amount payable 
under the prospective payment system for inpatient hospital operating 
costs as determined under subpart D of this part.
    (b) Cost reporting periods beginning on or after October 1, 1991 and 
before October 1, 2001. For cost reporting periods beginning on or after 
October 1, 1991 and before October 1, 2001, the capital payment amount 
is based on either a combination of payments for old capital costs and 
new capital costs or a fully prospective rate, as determined under Sec.  
412.324 through Sec.  412.348.
    (c) Cost reporting periods beginning on or after October 1, 2001--
(1) General. Except as provided in paragraph (c)(2) of this section, for 
cost reporting periods beginning on or after October 1, 2001, the 
capital payment amount is based solely on the Federal rate determined 
under Sec. Sec.  412.308(a) and (b) and updated under Sec.  412.308(c).
    (2) Payment to new hospitals. For cost reporting periods beginning 
on or after October 1, 2002--
    (i) A new hospital, as defined under Sec.  412.300(b), is paid 85 
percent of its allowable Medicare inpatient hospital capital-related 
costs through its cost report ending at least 2 years after the

[[Page 727]]

hospital accepts its first patient, unless the new hospital elects to be 
paid under the capital prospective payment system based on 100 percent 
of the Federal rate.
    (A) If the new hospital elects to be paid based on 100 percent of 
the Federal rate, the new hospital must submit a written request to the 
fiscal intermediary by the later of December 1, 2002 or 60 days before 
the beginning of its cost reporting period.
    (B) Once a new hospital elects to be paid based on 100 percent of 
the Federal rate, it may not revert to payment at 85 percent of its 
allowable Medicare inpatient hospital capital-related costs.
    (ii) For the third year and subsequent years, the hospital is paid 
based on the Federal rate as described under Sec.  412.312.
    (d) Interim payments. Interim payments are made to the hospital as 
provided in Sec.  412.116.

[56 FR 43449, Aug. 30, 1991, as amended at 67 FR 50113, Aug. 1, 2002; 70 
FR 47487, Aug. 12, 2005]

 Basic Methodology for Determining the Federal Rate for Capital-Related 
                                  Costs



Sec.  412.308  Determining and updating the Federal rate.

    (a) FY 1992 national average cost per discharge. CMS determines the 
FY 1992 estimated national average cost per discharge by updating the 
discharge weighted national average Medicare inpatient hospital capital-
related cost per discharge for FY 1989 by the estimated increase in 
Medicare inpatient hospital capital costs per discharge.
    (b) Standard Federal rate. The standard Federal rate is used to 
determine the Federal rate for each fiscal year in accordance with the 
formula specified in paragraph (c) of this section.
    (1) CMS determines the standard Federal rate by adjusting the FY 
1992 updated national average cost per discharge by a factor so that 
estimated aggregate payments based on the standard Federal rate adjusted 
by the payment adjustments described in Sec.  412.312(b) equal estimated 
aggregate payments based solely on the national average cost per 
discharge.
    (2) Effective FY 1994, the standard Federal rate used to determine 
the Federal rate each year under paragraph (c) of this section is 
reduced by 7.4 percent.
    (3) Effective FY 1996, the standard Federal rate used to determine 
the Federal rate each year under paragraph (c) of this section is 
reduced by 0.28 percent to account for the effect of the revised policy 
for payment of transfers under Sec.  412.4(d).
    (4) Effective FY 1998, the unadjusted standard Federal capital 
payment rate in effect on September 30, 1997, used to determine the 
Federal rate each year under paragraph (c) of this section is reduced by 
15.68 percent.
    (5) For discharges occurring on or after October 1, 1997 through 
September 30, 2002, the unadjusted standard Federal capital payment rate 
as in effect on September 30, 1997, used to determine the Federal rate 
each year under paragraph (c) of this section is further reduced by 2.1 
percent.
    (6) For discharges occurring on or after October 1, 2002, the 2.1 
percent reduction provided for under paragraph (b)(5) of this section is 
eliminated from the unadjusted standard Federal rate in effect on 
September 30, 2002, used to determine the Federal rate each year under 
paragraph (c) of this section.
    (c) The Federal rate. CMS determines the Federal rate each year by 
adjusting the standard Federal rate by the following factors.
    (1) Update factor. After FY 1992, CMS updates the standard Federal 
rate as follows:
    (i) FY 1993 through FY 1995. For FY 1993 through FY 1995, the 
standard Federal rate is updated based on a moving two-year average of 
actual increases in capital-related costs per discharge for the period 
three and four years before the fiscal year in question, excluding the 
portion of the increase attributable to changes in case mix.
    (ii) Effective FY 1996. Effective FY 1996, the standard Federal rate 
is updated based on an analytical framework. The framework includes a 
capital input price index, which measures the annual change in the 
prices associated with capital-related costs during the year. CMS 
adjusts the capital input price index rate of change to take into

[[Page 728]]

account forecast errors, changes in the case mix index, the effect of 
changes to DRG classification and relative weights, and allowable 
changes in the intensity of hospital services.
    (2) Outlier payment adjustment factor. CMS reduces the updated 
standard Federal rate by an adjustment factor equal to the estimated 
additional payments under the Federal rate for outlier cases under 
subpart F of this part, determined as a proportion of total capital 
payments under the Federal rate.
    (3) Exceptions payment adjustment factor. CMS reduces the updated 
standard Federal rate by an adjustment factor equal to the estimated 
additional payments for exceptions under Sec.  412.348 determined as a 
proportion of total payments under the hospital-specific rate and 
Federal rate.
    (4) Budget neutrality adjustment factor. (i) For FY 1992 through FY 
1995, CMS adjusts the updated standard Federal rate by a budget 
neutrality factor determined under Sec.  412.352.
    (ii) CMS makes an adjustment to the Federal rate so that estimated 
aggregate payments for the fiscal year based on the Federal rate after 
any changes resulting from the annual reclassification and recalibration 
of the DRG weight in accordance with Sec.  412.60(e) and in the 
geographic adjustment factors described in Sec.  412.312(b)(2) equal 
estimated aggregate payments based on the Federal rate that would have 
been made without such changes.

[56 FR 43449, Aug. 30, 1991; 57 FR 3016, Jan. 27, 1992, as amended at 58 
FR 46339, Sept. 1, 1993; 59 FR 45399, Sept. 1, 1994; 60 FR 45849, Sept. 
1, 1995; 62 FR 46031, Aug. 29, 1997; 67 FR 50113, Aug. 1, 2002]



Sec.  412.312  Payment based on the Federal rate.

    (a) General. The payment amount for each discharge based on the 
Federal rate determined under Sec.  412.308(c) is determined under the 
following formula: [Federal rate x DRG weight x Geographic adjustment 
factor x Large urban add-on x (1 + Capital disproportionate share 
adjustment factor + capital indirect medical education adjustment 
factor) x (for hospitals located in Alaska and Hawaii, a cost-of-living 
adjustment factor)] + (Any applicable outlier payment).
    (b) Payment adjustments--(1) DRG weights. The relative resource 
requirements of the discharge are taken into account by applying the DRG 
weighting factor that is assigned to the discharge under Sec.  412.60.
    (2) Geographic adjustment factors--(i) Local cost variation. A 
geographic adjustment factor is applied that takes into account 
geographic variation in costs.
    (ii) Large urban add-on. An additional adjustment is made for 
hospitals located in a large urban area to reflect the higher costs 
incurred by hospitals located in those areas. For purposes of the 
payment adjustment under this paragraph, the definition of large urban 
area set forth at Sec.  412.63(c)(6) continues to be in effect for 
discharges occurring on or after September 30, 2004.
    (iii) Cost-of-living adjustment. An additional adjustment is made 
for hospitals located in Alaska and Hawaii to account for the higher 
cost-of-living in those States.
    (3) Disproportionate share adjustment. For hospitals with at least 
100 beds located in an urban area and serving low-income patients, a 
disproportionate share adjustment factor is applied that reflects the 
higher costs attributable to furnishing services to low income patients.
    (4) Indirect medical education adjustment. An additional adjustment 
is made based on the ratio of residents to the average daily patient 
census of the hospital to account for the indirect costs of medical 
education.
    (c) Additional payment for outlier cases. Payment is made for day 
outlier cases as provided for in Sec.  412.82 and for cost outlier cases 
if both capital-related and operating-related costs exceed the cost 
outlier threshold as provided for in Sec.  412.84.
    (d) Payment for transfer cases. Payment is made for transfer cases 
as provided for in Sec.  412.4.
    (e) Payment for extraordinary circumstances. For cost reporting 
periods beginning on or after October 1, 2001--
    (1) Payment for extraordinary circumstances is made as provided for 
in Sec.  412.348(f).
    (2) Although no longer independently in effect, the minimum payment 
levels

[[Page 729]]

established under Sec.  412.348(c) continue to be used in the 
calculation of exception payments for extraordinary circumstances, 
according to the formula in Sec.  412.348(f).
    (3) Although no longer independently in effect, the offsetting 
amounts established under Sec.  412.348(e) continue to be used in the 
calculation of exception payments for extraordinary circumstances. 
However, for cost reporting periods beginning during FY 2005 and 
subsequent fiscal years, the offsetting amounts in Sec.  412.348(e) are 
determined based on the lesser of--
    (i) The preceding 10-year period; or
    (ii) The period of time under which the hospital is subject to the 
prospective payment system for capital-related costs.
    (f) Payment adjustment for certain clinical trial or expanded access 
use immunotherapy cases. For discharges occurring on or after October 1, 
2020, in determining the payment amount under this section for certain 
clinical trial or expanded access use immunotherapy cases as described 
in Sec.  412.85(b), the DRG weighting factor described in paragraph 
(b)(1) of this section is adjusted as described in Sec.  412.85(c).

[56 FR 43449, Aug. 30, 1991, as amended at 67 FR 50113, Aug. 1, 2002; 69 
FR 49250, Aug. 11, 2004; 69 FR 60252, Oct. 7, 2004; 85 FR 59023, Sept. 
18, 2020]



Sec.  412.316  Geographic adjustment factors.

    (a) Local cost variation. CMS adjusts for local cost variation based 
on the hospital wage index value that is applicable to the hospital 
under subpart D of this part. The adjustment factor equals the hospital 
wage index value applicable to the hospital raised to the .6848 power 
and is applied to 100 percent of the Federal rate.
    (b) Large urban location. For discharges occurring on or before 
September 30, 2007, CMS provides an additional payment to a hospital 
located in a large urban area equal to 3.0 percent of what would 
otherwise be payable to the hospital based on the Federal rate.
    (1) For discharges occurring on or before September 30, 2004, the 
payment adjustment under this section is based on a hospital's location 
for the purpose of receiving payment under Sec.  412.63(a). The term 
``large urban area'' is defined under Sec.  412.63(c)(6).
    (2) For discharges occurring on or after October 1, 2004, and before 
October 1, 2007, the definition of large urban areas under Sec.  
412.63(c)(6) continues be in effect for purposes of the payment 
adjustment under this section, based on the geographic classification 
under Sec.  412.64, except as provided for in paragraph (b)(3) of this 
section.
    (3) For purposes of this section, the geographic classifications 
specified under Sec.  412.64 apply, except that, effective for 
discharges occurring on or after October 1, 2006, and before October 1, 
2007, for an urban hospital that is reclassified as rural as set forth 
in Sec.  412.103, the geographic classification is rural.
    (c) Cost-of-living adjustment. CMS provides an additional payment to 
a hospital located in Alaska and Hawaii equal to [0.3152 x (the cost-of-
living adjustment factor used to determine payments under subpart D of 
this part - 1)] percent.

[56 FR 43449, Aug. 30, 1991, Aug. 11, 2004, as amended at 69 FR 49250, 
Aug. 11, 2004; 71 FR 48140, Aug. 18, 2006; 72 FR 47412, Aug. 22, 2007]



Sec.  412.320  Disproportionate share adjustment factor.

    (a) Criteria for classification. A hospital is classified as a 
``disproportionate share hospital'' for the purposes of capital 
prospective payments if either of the following conditions is met:
    (1) The hospital is located in an urban area, has 100 or more beds 
as determined in accordance with Sec.  412.105(b), and serves low-income 
patients as determined under Sec.  412.106(b).
    (i) For discharges occurring on or before September 30, 2004, the 
payment adjustment under this section is based on a hospital's location, 
for the purpose of receiving payment, under Sec.  412.63(a).
    (ii) For discharges occurring on or after October 1, 2004, the 
payment adjustment under this section is based on the geographic 
classifications specified under Sec.  412.64, except as provided for in 
paragraph (a)(1)(iii) of this section.
    (iii) For purposes of this section, the geographic classifications 
specified

[[Page 730]]

under Sec.  412.64 apply, except that, effective for discharges 
occurring on or after October 1, 2006, for an urban hospital that is 
reclassified as rural as set forth in Sec.  412.103, the geographic 
classification is rural.
    (2) The hospital meets the criteria in Sec.  412.106(c)(2).
    (b) Payment adjustment factor. (1) If a hospital meets the criteria 
in paragraph (a)(1) of this section for a disproportionate share 
hospital for purposes of capital prospective payments, the 
disproportionate share payment adjustment factor equals [e raised to the 
power of (.2025 x the hospital's disproportionate patient percentage as 
determined under Sec.  412.106(b)(5)), -1], where e is the natural 
antilog of 1.
    (2) If a hospital meets the criteria in Sec.  412.106(c)(2) for 
purposes of hospital inpatient operating prospective payments, the 
disproportionate share adjustment factor is the factor that results from 
deeming the hospital to have the same disproportionate share patient 
percentage that would yield its operating disproportionate share 
adjustment.

[56 FR 43449, Aug. 30, 1991; 57 FR 3016, Jan. 27, 1992, as amended at 58 
FR 46339, Sept. 1, 1993; 69 FR 49250, Aug. 11, 2004; 71 FR 48140, Aug. 
18, 2006]



Sec.  412.322  Indirect medical education adjustment factor.

    (a) Basic data. CMS determines the following for each hospital:
    (1) The hospital's number of full-time equivalent residents as 
determined under Sec.  412.105(f).
    (2) The hospital's average daily census is determined by dividing 
the total number of inpatient days in the acute inpatient area of the 
hospital by the number of days in the cost reporting period.
    (3) The measurement of teaching activity is the ratio of the 
hospital's full-time equivalent residents to average daily census. This 
ratio cannot exceed 1.5.
    (b) Payment adjustment factor. The indirect teaching adjustment 
factor equals [e (raised to the power of .2822 x the ratio of residents 
to average daily census)-1].
    (c)-(d) [Reserved]

[56 FR 43449, Aug. 30, 1991, as amended at 63 FR 26357, May 12, 1998; 63 
FR 41004, July 31, 1998; 72 FR 47412, Aug. 22, 2007; 74 FR 43998, Aug. 
27, 2009]

  Determination of Transition Period Payment Rates for Capital-Related 
                                  Costs



Sec.  412.324  General description.

    (a) Hospitals under Medicare in FY 1991. During the ten-year 
transition period, payments to a hospital with a hospital-specific rate 
below the Federal rate are based on the fully prospective payment 
methodology under Sec.  412.340 or for a hospital with a hospital-
specific rate above the Federal rate, the hold-harmless payment 
methodology under Sec.  412.344.
    (b) New hospitals. (1) A new hospital, as defined under Sec.  
412.300(b), is paid 85 percent of its allowable Medicare inpatient 
hospital capital-related costs through its cost reporting period ending 
at least 2 years after the hospital accepts its first patient.
    (2) For the third year through the remainder of the transition 
period, the hospital is paid based on the fully prospective payment 
methodology or the hold-harmless payment methodology using the base 
period determined under Sec.  412.328(a)(2).
    (3) If the hospital is paid under the hold-harmless methodology 
described in Sec.  412.344, the hold-harmless payment for old capital 
costs described in Sec.  412.344(a)(1) is payable for up to and 
including 8 years and may continue beyond the first cost reporting 
period beginning on or after October 1, 2000.
    (c) Hospitals with 52-53 week fiscal years ending September 25 
through September 29. For purposes of this subpart, a hospital with a 
52-53 week fiscal year period beginning September 26 through September 
30, 1992 is deemed to have the same beginning date for all cost 
reporting periods beginning before October 1, 2000 (unless the hospital 
later changes its cost reporting period).

[56 FR 43449, Aug. 30, 1991; 57 FR 3016, Jan. 27, 1992]

[[Page 731]]



Sec.  412.328  Determining and updating the hospital-specific rate.

    (a) Base-year cost reporting period--(1) Last 12 month cost 
reporting period ending on or before December 31, 1990. For each 
hospital, the intermediary uses the hospital's latest 12-month or longer 
cost reporting period ending on or before December 31, 1990 as the base 
period to determine a hospital's hospital-specific rate.
    (2) New hospitals. The base-year cost reporting period for a new 
hospital is its 12-month cost reporting period (or a combination of cost 
reporting periods covering at least 12 months) that begins at least 1 
year after the hospital accepts its first patient.
    (3) Other hospitals. For other than a new hospital as defined in 
Sec.  412.300(b), if a hospital does not have a 12-month cost reporting 
period or does not have adequate Medicare utilization to file a cost 
report in a period ending on or before December 31, 1990, the hospital-
specific rate is based on the hospital's old capital costs (per 
discharge) in its first 12-month cost reporting period (or combination 
of cost reporting periods covering at least 12 months) ending after 
December 31, 1990.
    (b) Base-year costs per discharge--(1) Base period allowable 
inpatient capital costs per discharge--(i) Determination. The 
intermediary determines the base period allowable inpatient capital 
costs per discharge for the hospital by dividing the hospital's total 
allowable Medicare inpatient hospital capital-related cost in the base 
period by the number of Medicare discharges in the base period.
    (ii) Disposal of assets in the base year. When a depreciable asset 
has been disposed of in the base year, only that portion of the gain or 
loss that is allocated to the base-year cost reporting period is 
reflected in the hospital-specific rate.
    (iii) Disposal of assets subsequent to the base year. If an asset 
for which the Medicare program had recognized depreciation during the 
base year is disposed of subsequent to the base year, the hospital-
specific rate will not be revised to recognize the portion of the gain 
or loss allocated to the base year.
    (2) Discharges. For the purpose of determining a hospital's base 
period capital costs per discharge, a discharge includes discharges as 
defined in Sec.  412.4(a) and transfers as defined in Sec.  412.4(b)(2), 
adjusted by the transfer adjustment factor that is determined under 
paragraph (b)(3) of this section.
    (3) Transfer adjustment factor. (i) For base year cost reporting 
periods ending on or before December 31, 1990, CMS uses the base year 
MEDPAR data received as of June 30, 1991 to develop an adjustment to 
discharges to account for transfers. CMS divides the length of stay for 
each transfer case by the geometric mean length of stay for the DRG (but 
in no case using a number greater than 1.0) and assigns each nontransfer 
case a value of 1.0. To determine the transfer adjustment factor, CMS 
adds together the adjusted discharges and divides the result by total 
discharges including transfers.
    (ii) For base year cost reporting periods ending after December 31, 
1990 but beginning before October 1, 1991, CMS determines a transfer 
adjustment factor as described in paragraph (b)(3)(i) of this section 
for a hospital using the applicable base year MEDPAR data on file as of 
the December 31 or June 30 occurring at least 6 months after the close 
of the approved base year.
    (iii) For base year cost reporting periods beginning on or after 
October 1, 1991, the intermediary determines the transfer adjustment 
factor in place of CMS as described in paragraph (b)(3)(i) of this 
section based on the most recent billing data available as of the date 
of the final determination of the hospital-specific rate.
    (c) Case-mix adjustment--(1) Determining transfer-adjusted case mix 
value. Step 1: For base year cost reporting periods ending on or before 
December 31, 1990, CMS uses the base year MEDPAR data received as of 
June 30, 1991 to determine the hospital's transfer-adjusted case-mix 
value. For base year cost reporting periods ending after December 31, 
1990 and beginning before October 1, 1991, CMS determines a transfer-
adjusted case-mix value for a hospital using the applicable base year 
MEDPAR data on file as of the December 31 or June 30 occurring at least 
6 months after the close of the base year. For base year cost reporting 
periods beginning on or after October 1, 1991,

[[Page 732]]

the intermediary determines the transfer-adjusted case-mix value based 
on the most recent billing data available as of the date of the final 
determination of the hospital-specific rate. CMS or the intermediary, as 
appropriate, multiplies the DRG weight for each case by one of the 
following factors:
    (i) If the case is not a transfer, the factor equals 1.0.
    (ii) If the case is a transfer, the factor equals the lesser of 1.0 
or the ratio of the length of stay for the case divided by the geometric 
mean length of stay for the DRG.

Step 2: The products derived for all cases under Step 1 are added 
together and the result is divided by the adjusted discharges used to 
calculate the transfer adjustment factor determined under paragraph 
(b)(3) of this section.
    (2) Adjusting base period capital costs per discharge by the 
hospital's transfer-adjusted case-mix value. The intermediary divides 
the base period capital costs per discharge for each hospital as 
determined in paragraph (b) of this section by the hospital's transfer-
adjusted case mix value for the cost reporting period determined under 
paragraph (c)(1) of this section.
    (d) Updating to FY 1992. The intermediary updates the case-mix 
adjusted base period costs per discharge to FY 1992 based on the 
national average increase in Medicare inpatient capital costs per 
discharge as estimated by CMS, excluding the portion of the increase in 
capital costs per discharge attributable to changes in case mix.
    (e) Hospital-specific rate. The intermediary determines the 
hospital-specific rate each year by adjusting the amount determined 
under paragraph (d) of this section by the following factors:
    (1) Update factor. After FY 1992, the intermediary updates the 
hospital-specific rate in accordance with Sec.  412.308(c)(1).
    (2) Exceptions payment adjustment factor. For FY 1992 through FY 
2001, the intermediary reduces the updated amount determined in 
paragraph (d) of this section by an adjustment factor equal to the 
estimated additional payments for capital-related costs for exceptions 
under Sec.  412.348, determined as a proportion of the total amount of 
payments under the hospital-specific rate and Federal rate.
    (3) Budget neutrality adjustment factor. For FY 1992 through FY 
1995, the intermediary adjusts the updated amount determined in 
paragraph (d) of this section by a budget neutrality adjustment factor 
determined under Sec.  412.352.
    (4) Payment for transfer cases. Effective FY 1996, the intermediary 
reduces the updated amount determined in paragraph (d) of this section 
by 0.28 percent to account for the effect of the revised policy for 
payment of transfers under Sec.  412.4(d).
    (5) Reduction of rate: FY 1998. Effective FY 1998, the unadjusted 
hospital-specific rate as in effect on September 30, 1997 described in 
paragraph (e)(1) of this section is reduced by 15.68 percent.
    (6) Reduction of rate: FY 1998 through FY 2002. For discharges 
occurring on or after October 1, 1997 through September 30, 2002, the 
unadjusted hospital-specific rate in effect on September 30, 1997, 
described in paragraph (e)(1) of this section is further reduced by 2.1 
percent.
    (f) Redetermination of hospital-specific rate--(1) General. (i) Upon 
request by a hospital, the intermediary redetermines the hospital-
specific rate to reflect an increase in old capital costs as determined 
in a cost reporting period subsequent to the base year. An increase in 
Medicare old capital cost per discharge that is related solely to a 
decline in utilization is not recognized as an increase in old capital 
costs for purposes of this section. New capital costs are excluded from 
the redetermination of the hospital-specific rate.
    (ii) The hospital may request redetermination for any cost reporting 
period beginning subsequent to the base period but no later than the 
later of the hospital's cost reporting period beginning in FY 1994 or 
the cost reporting period beginning after obligated capital that is 
recognized as old capital under Sec.  412.302(b) is put in use.
    (iii) The hospital must request a redetermination in writing no 
later than the date the cost report must be filed with the hospital's 
intermediary for the first cost reporting period beginning on or after 
October 1, 1991 or the cost reporting period that will serve as the new 
base period, whichever is later.

[[Page 733]]

The hospital's redetermination request must include the cost report for 
the new base period and an estimate of the revised hospital-specific 
rate indicating that the new rate exceeds the hospital's current 
hospital-specific rate.
    (2) Determination of old capital costs. The intermediary determines 
the hospital's old capital costs for the subsequent cost reporting 
period that will serve as the new base period. The intermediary includes 
the costs of obligated capital that are recognized as old capital costs 
under Sec.  412.302(b), excludes the costs of assets disposed of 
subsequent to the initial base year, and reflects changes in allowable 
old capital costs occurring subsequent to the initial base period.
    (3) Redetermined hospital-specific rate. The intermediary 
redetermines the hospital-specific rate based on the old capital costs 
that are determined under paragraph (f)(2) of this section for the new 
base period. The intermediary--
    (i) Divides the hospital's old capital costs for the new base period 
by the number of Medicare discharges in that cost reporting period 
(consistent with paragraph (b) of this section);
    (ii) Divides the old capital costs per discharge by the hospital's 
transfer adjusted case-mix value for the new base period (consistent 
with paragraph (c) of this section);
    (iii) Applies an update factor, if appropriate, to account for 
inflation occurring subsequent to the new base year, an exceptions 
payment adjustment factor, and a budget neutrality adjustment factor 
(consistent with paragraphs (d) and (e) of this section).
    (4) Denial by intermediary. If the intermediary determines, after 
audit, that the revised hospital-specific rate is lower than the current 
hospital-specific rate, it advises the hospital that its request is 
denied and explains the basis for the denial.
    (5) Implementation date. The redetermined hospital-specific rate 
applies to discharges occurring on or after the beginning date of the 
new base period.
    (g) Review and revision of the hospital-specific rate--(1) Interim 
determination. The intermediary makes an interim determination of the 
hospital-specific rate based on the best data available and notifies the 
hospital at least 30 days before the beginning of the hospital's first 
cost reporting period beginning on or after October 1, 1991.
    (2) Final determination. (i) The intermediary makes a final 
determination of the hospital-specific rate based on the final 
settlement of the base period cost report.
    (ii) The final determination of the hospital-specific rate is 
effective retroactively to the beginning of the hospital's first cost 
reporting period beginning on or after October 1, 1991 or, in the case 
of a redetermination of the hospital-specific rate under Sec.  
412.328(f), to the beginning of the new base period.
    (iii) The final determination of the hospital-specific rate is 
subject to administrative and judicial review in accordance with subpart 
R of part 405 of this chapter, governing provider reimbursement 
determinations and appeals.
    (iv) The intermediary adjusts the hospital-specific rate to reflect 
any revisions that result from administrative or judicial review of the 
final determination of hospital-specific rate. The revised determination 
is effective retroactively to the same extent as in paragraph (g)(2)(ii) 
of this section.

[56 FR 43449, Aug. 30, 1991; 57 FR 3016, 3017, Jan. 27, 1992; 57 FR 
39828, Sept. 1, 1992; 60 FR 45849, Sept. 1, 1995; 62 FR 46031, Aug. 29, 
1997]



Sec.  412.331  Determining hospital-specific rates in cases of 
hospital merger, consolidation, or dissolution.

    (a) New hospital merger or consolidation. If, after a new hospital 
accepts its first patient but before the end of its base year, it merges 
with one or more existing hospitals, and two or more separately located 
hospital campuses are maintained, the hospital-specific rate and payment 
determination for the merged entity are determined as follows--
    (1) Post-merger base year payment methodology. The new campus is 
paid based on reasonable costs until the end of its base year. The 
existing campus remains on its previous payment methodology until the 
end of the new campus' base year. Effective with the first cost 
reporting period beginning after the end of the new campus' base year,

[[Page 734]]

the intermediary determines a hospital-specific rate applicable to the 
new campus in accordance with Sec.  412.328, and then determines a 
revised hospital-specific rate for the merged entity in accordance with 
paragraph (a)(2) of this section.
    (2) Revised hospital-specific rate. Using each hospital's base 
period data, the intermediary determines a combined average discharge-
weighted hospital-specific rate.
    (3) Post-base year payment determination. To determine the 
applicable payment methodology under Sec.  412.336 and for payment 
purposes under Sec.  412.340 or Sec.  412.344, the discharge-weighted 
hospital-specific rate determined by the intermediary is compared to the 
Federal rate. The revised payment methodology is effective on the first 
day of the cost reporting period beginning after the end of the new 
campus' base year.
    (b) Hospital merger or consolidation. If, after the base year, two 
or more hospitals merge or consolidate into one hospital as provided for 
under Sec.  413.134(k) of this chapter and the provisions of paragraph 
(a) of this section do not apply, the intermediary determines a revised 
hospital-specific rate applicable to the combined facility under Sec.  
412.328, which is effective beginning with the date of merger or 
consolidation. The following rules apply to the revised hospital-
specific rate and payment determination:
    (1) Revised hospital-specific rate. Using each hospital's base 
period data, the intermediary determines a combined average discharge 
weighted hospital-specific rate.
    (2) Payment determination. The discharge-weighted hospital-specific 
rate determined by the intermediary is compared to the Federal rate to 
establish the appropriate payment methodology under Sec.  412.336 and 
for payment purposes under Sec. Sec.  412.340 or 412.344. The revised 
payment methodology is effective as of the date of merger or 
consolidation.
    (3) Old capital cost determination. The capital-related costs 
related to the assets of each merged or consolidated hospital as of 
December 31, 1990 are recognized as old capital costs during the 
transition period. If the hospital is paid under the hold-harmless 
methodology after merger or consolidation, only that original base year 
old capital is eligible for hold-harmless payments.
    (c) Hospital dissolution. If a hospital separates into two or more 
hospitals that are subject to capital payments under this subpart after 
the base year, the intermediary determines new hospital-specific rates 
for each separate hospital under the provisions of Sec.  412.328 
effective as of the date of the dissolution. The new hospital-specific 
rates are determined as follows:
    (1) Hospital-specific rate--(i) Adequate base year data. The 
intermediary determines whether the base year capital-related cost data 
and necessary statistical records are adequate to reconstruct the cost 
and other data required under Sec.  412.328 from the former hospital's 
financial records to determine the hospital-specific rates for each 
facility. If the data are adequate, the intermediary uses the former 
hospital's base period to determine the hospital-specific rate for each 
separate hospital.
    (ii) Inadequate original base year data. If the intermediary 
determines that the base period data for the former hospital is 
inadequate to establish separate hospital-specific rates, the 
intermediary establishes a new base period for each hospital. The new 
base period is each hospital's first 12-month or longer cost reporting 
period (or combination of cost reporting periods covering at least 12 
months) immediately following separation of the hospitals. The 
intermediary determines the hospital-specific rate for each hospital 
using the new base period under Sec.  412.328.
    (2) Payment determinations. The intermediary applies the payment 
methodology provisions of Sec.  412.336. The revised payment 
determination is effective as of the date of the hospital's dissolution.
    (3) Old capital cost determination. In determining the old capital 
costs for each hospital, the amount recognized as old capital is limited 
to the allowable capital-related costs attributable to assets that were 
in use for patient care as of December 31, 1990, and the hospitals are 
subject to all other transition period rules of this subpart.

[57 FR 39828, Sept. 1, 1992, as amended at 63 FR 41004, July 31, 1998]

[[Page 735]]



Sec.  412.332  Payment based on the hospital-specific rate.

    The payment amount for each discharge (as defined in Sec.  412.4(a)) 
based on the hospital-specific rate determined under Sec.  412.328 (e) 
or (f) is determined by multiplying the applicable hospital-specific 
rate by the DRG weighting factor applicable to the discharge under Sec.  
412.60 and the applicable hospital-specific rate percentage for the 
pertinent cost reporting period under Sec.  412.340.



Sec.  412.336  Transition period payment methodologies.

    (a) General. For discharges occurring in cost reporting periods 
beginning on or after October 1, 1991 and before October 1, 2001, a 
hospital is paid under one of two payment methodologies described in 
Sec. Sec.  412.340 and 412.344. Except as provided under paragraph (b) 
of this section, a hospital is paid under the same methodology 
throughout the transition period.
    (1) Hospital-specific rate below the Federal rate. A hospital with a 
hospital-specific rate below the Federal rate (after taking into account 
the estimated effect of the payment adjustments and outlier payments) is 
paid under the fully prospective payment methodology as described in 
Sec.  412.340.
    (2) Hospital-specific rate above the Federal rate. A hospital with a 
hospital-specific rate that is above the Federal rate (after taking into 
account the estimated effect of the payment adjustments and outlier 
payments) is paid under the hold-harmless payment methodology as 
described in Sec.  412.344.
    (b) Special rule for revised hospital-specific rate. If a hospital 
with a hospital-specific rate below the Federal rate requests that its 
hospital-specific rate be redetermined, the redetermined hospital-
specific rate is compared to the Federal rate that is applicable to the 
new base period (after taking into account the estimated effect of the 
payment adjustments and outlier payments). If the redetermined hospital-
specific rate is higher than the Federal rate, the hospital is paid 
under the hold-harmless methodology effective with the beginning of the 
new base period and continuing throughout the remainder of the 
transition.
    (c) Interim and final determinations of applicable payment 
methodology--(1) Interim determination. The intermediary makes an 
interim determination of the applicable payment methodology based on the 
best data available and notifies the hospital of its determination at 
least 30 days before the beginning of the hospital's first cost 
reporting period beginning on or after October 1, 1991.
    (2) Final determination. (i) The intermediary makes a final 
determination of the applicable payment methodology based on its final 
determination of the hospital's hospital-specific rate. The final 
determination of the applicable payment methodology is effective 
retroactively to the beginning of the hospital's first cost reporting 
period beginning on or after October 1, 1991.
    (ii) If the hospital-specific rate is redetermined in accordance 
with Sec.  412.328(f), the intermediary makes a new determination of the 
applicable payment methodology. The new determination is effective 
retroactively to the beginning of the new base period.
    (iii) If the hospital-specific rate is revised under Sec.  
412.328(g) as a result of administrative or judicial review, the 
intermediary makes a new determination of the applicable payment 
methodology. The new determination is effective retroactively to the 
beginning of the hospital's first cost reporting period beginning on or 
after October 1, 1991 or to the beginning of the new base period.
    (d) Special Rule for Redetermination of Hospital Payment 
Methodology. For cost reporting periods beginning on or after October 1, 
1993, the intermediary redetermines the hospital payment methodologies 
to take into account the reduction to the standard Federal rate provided 
in Sec.  412.308(b)(2):
    (1) For a hospital paid under the fully prospective payment 
methodology in the last hospital cost reporting period beginning before 
October 1, 1993, the intermediary compares the hospital's FY 1994 
hospital-specific rate with the hospital's FY 1994 Federal rate (after 
taking into account the estimated effect of the payment adjustments and 
outlier payments).
    (i) A hospital with a FY 1994 hospital-specific rate that is above 
the FY 1994

[[Page 736]]

adjusted Federal rate is paid under the hold-harmless payment 
methodology described in Sec.  412.344.
    (ii) Subject to the provisions of Sec.  412.328(f), a hospital with 
a FY 1994 hospital-specific rate that is below the FY 1994 adjusted 
Federal rate continues to be paid under the fully prospective payment 
methodology as described in Sec.  412.340.
    (iii) The intermediary notifies the hospital of the new 
determination of the hospital's payment methodology within 90 days of 
the hospital's first cost reporting period beginning on or after October 
1, 1993. The new determination is effective to the beginning of the 
hospital's first cost reporting period beginning on or after October 1, 
1993.
    (2) A hospital paid under the hold-harmless payment methodology in 
the last cost reporting period beginning before October 1, 1993, will 
continue to be paid in accordance with the provisions of Sec.  412.344.

[56 FR 43449, Aug. 30, 1991; 57 FR 3017, Jan. 27, 1992, as amended at 58 
FR 46340, Sept. 1, 1993]



Sec.  412.340  Fully prospective payment methodology.

    A hospital paid under the fully prospective payment methodology 
receives a payment per discharge based on a proportion of the hospital-
specific rate and the Federal rate as follows:

------------------------------------------------------------------------
                                                              Hospital-
                                                  Federal      specific
 Cost reporting periods beginning on or after:      rate         rate
                                                 percentage   percentage
------------------------------------------------------------------------
October 1, 1991...............................           10           90
October 1, 1992...............................           20           80
October 1, 1993...............................           30           70
October 1, 1994...............................           40           60
October 1, 1995...............................           50           50
October 1, 1996...............................           60           40
October 1, 1997...............................           70           30
October 1, 1998...............................           80           20
October 1, 1999...............................           90           10
October 1, 2000...............................          100            0
------------------------------------------------------------------------



Sec.  412.344  Hold-harmless payment methodology.

    (a) General. A hospital paid under the hold-harmless payment 
methodology receives a payment per discharge based on the higher of:
    (1) 85 percent of reasonable costs for old capital costs (100 
percent for sole community hospitals) plus an amount for new capital 
costs based on a proportion of the Federal rate. The proportion is equal 
to the ratio of the hospital's Medicare inpatient costs for new capital 
to total Medicare inpatient capital costs; or
    (2) 100 percent of the Federal rate.
    (3) Exceptions. (i) A hospital that would receive higher payment 
under paragraph (a)(1) of this section may elect payment based on 100 
percent of the Federal rate under paragraph (a)(2) of this section.
    (ii) A hospital that does not maintain records that are adequate to 
identify its old capital costs is deemed to have elected payment per 
discharge based on 100 percent of the Federal rate.
    (b) Continued basis of payment. A hospital paid based on 100 percent 
of the Federal rate during the later of its cost reporting period 
beginning in FY 1994 or its first cost reporting period beginning after 
obligated capital that is recognized as old capital under Sec.  
412.302(b) is put in use continues to be paid on that basis in 
subsequent cost reporting periods during the transition period and does 
not receive a reasonable cost payment for old capital costs under 
paragraph (a)(1) of this section.
    (c) Basis of determination. The determination under paragraph (a) of 
this section regarding which payment alternative is applicable is made 
without regard to additional payments under the exceptions process under 
Sec.  412.348.
    (d) Interim and final payment determinations. (1) Using the best 
data available, the intermediary makes an interim payment determination 
under paragraph (a) of this section concerning the applicable payment 
alternative, and, in the case of payment under paragraph (a)(1) of this 
section, the payment amounts for old and new capital. The intermediary 
notifies the hospital of its determination at least 30 days before the 
beginning of the hospital's first cost reporting period beginning on or 
after October 1, 1991. The intermediary may revise its determination 
based on additional information submitted by the hospital and make 
appropriate adjustments retroactively.
    (2) The final determination of the amount payable under paragraph 
(a) of this section is based on final settlement of the Medicare cost 
report for the applicable cost reporting period

[[Page 737]]

and is effective retroactively to the beginning of that cost reporting 
period. This final determination is subject to administrative and 
judicial review in accordance with subpart R of part 405 of this 
chapter, governing provider reimbursement determinations and appeals.

[56 FR 43449, Aug. 30, 1991; 57 FR 3017, Jan. 27, 1992]



Sec.  412.348  Exception payments.

    (a) Definitions. As used in this section--
    Annual operating expenses. Annual operating expenses means the sum 
of net expenses for all reimbursable cost centers for a 12 month cost 
reporting period. Annual operating expenses are obtained from the 
Medicare cost report.
    Average age of fixed assets. The average age of fixed assets is the 
ratio of accumulated depreciation for buildings and fixed equipment to 
current depreciation expense for buildings and fixed equipment. The 
average age of fixed assets is determined from information on the 
Medicare cost report.
    Fixed assets. Fixed assets mean buildings and fixed equipment.
    (b) Criterion for additional payment during the transition period. 
An additional payment is made to a hospital paid under either the fully 
prospective payment methodology or the hold-harmless payment methodology 
as determined under paragraph (c) of this section for cost reporting 
periods beginning on or after October 1, 1991 and before October 1, 
2001.
    (c) Minimum payment level by class of hospital. (1) CMS establishes 
a minimum payment level by class of hospital. The minimum payment level 
for a hospital will equal a fixed percentage of the hospital's capital-
related costs. The minimum payment levels may be no greater than the 
percentages of allowable capital-related costs that follow:
    (i) 90 percent for sole community hospitals.
    (ii) 80 percent for hospitals located in an urban area for purposes 
of Sec.  412.63(a) with at least 100 beds, as determined under Sec.  
412.105(b), that have a disproportionate share patient percentage of at 
least 20.2 percent as determined under Sec.  412.106(b), and for 
hospitals located in an urban area for purposes of Sec.  412.63(a) with 
at least 100 beds that qualify for disproportionate share payments under 
Sec.  412.106(c)(2).
    (iii) 70 percent for all other hospitals.
    (2) When it is necessary to adjust the minimum payment levels set by 
class of hospitals specified in paragraphs (c)(1)(i) and (g)(6) of this 
section, CMS will adjust those levels for each class of hospitals in one 
percentage point increments as necessary to satisfy the requirement 
specified in paragraph (h) of this section that total estimated payments 
under the exception process not exceed 10 percent of the total estimated 
capital prospective payments (exclusive of hold-harmless payments for 
old capital) for the same fiscal year.
    (d) Additional payments. A hospital is entitled to an additional 
payment if its capital payments for the cost reporting period would 
otherwise be less than the applicable minimum payment level. The 
additional payment equals the difference between the applicable minimum 
payment level and the capital payments that the hospital would otherwise 
receive minus any offset amount determined under paragraph (e)(2) of 
this section.
    (e) Determining a hospital's exception payment amount--(1) 
Cumulative comparison. For each cost reporting period beginning before 
October 1, 2001, the hospital's exception payment is determined by 
comparing the cumulative payments made to the hospital under the capital 
prospective payment system to the cumulative minimum payment levels 
applicable to the hospital for each cost reporting period subject to the 
prospective payment system.
    (2) Offsetting amounts. Any amount by which the hospital's 
cumulative payments exceed its cumulative minimum payment levels is 
deducted from the additional payment that would otherwise be payable for 
a cost reporting period.
    (f) Additional payment exception for extraordinary circumstances. 
(1) A hospital may request an additional payment if the hospital incurs 
unanticipated capital expenditures in excess of $5 million (net of 
proceeds from other payment sources such as insurance, litigation

[[Page 738]]

decisions and other State, local or Federal government funding programs) 
due to extraordinary circumstances beyond the hospital's control. 
Extraordinary circumstances include, but are not limited to, a flood, 
fire, or earthquake.
    (2) A hospital must apply to its CMS Regional Office by the later of 
October 1, 1992 or 180 days after the extraordinary circumstance causing 
the unanticipated expenditures for a determination by CMS of whether the 
hospital is eligible for an additional payment based on the nature of 
the circumstances and the amount of financial loss documented by the 
hospital.
    (3) Except for sole community hospitals, the additional payment is 
based on a minimum payment amount of 85 percent for Medicare's share of 
allowable capital-related costs attributable to the extraordinary 
circumstances. For sole community hospitals, the minimum payment amount 
is 100 percent.
    (4) The minimum payment level applicable under paragraph (c)(1) of 
this section is adjusted to take into account the 85 percent minimum 
payment level (100 percent for sole community hospitals) under paragraph 
(f)(3) of this section for the unanticipated capital-related costs. The 
additional payment for the cost reporting period equals the difference 
between the adjusted minimum payment level and the capital payments the 
hospital would otherwise receive less any offset amount determined under 
paragraph (e)(2) of this section.
    (g) Special exceptions process. For eligible hospitals that meet a 
project need requirement, a project size requirement, and, in the case 
of certain urban hospitals, meet an excess capacity test, an additional 
payment may be made for up to 10 years beyond the end of the capital 
prospective payment system transition period.
    (1) Eligible hospitals. The following classes of hospitals are 
eligible to receive exceptions payments under this special exceptions 
provision:
    (i) Sole community hospitals.
    (ii) Hospitals located in an urban area under Sec.  412.63(a) with 
at least 100 beds, as determined under Sec.  412.105(b), that either 
have a disproportionate share of at least 20.2 percent as determined 
under Sec.  412.106(b) or qualify for disproportionate share payments 
under Sec.  412.106(c)(2).
    (iii) Hospitals with a combined inpatient Medicare and Medicaid 
utilization of at least 70 percent.
    (2) Project need requirement. A hospital must show that it has 
obtained any required approval from a State or local planning authority. 
If a hospital is not required to obtain approval from a planning 
authority, it must satisfy the age of asset test specified in paragraph 
(g)(3) of this section and, in the case of an urban hospital, the excess 
capacity test under paragraph (g)(4) of this section.
    (3) Age of assets test. A hospital must show that its average age of 
fixed assets is at or above the 75th percentile for the hospital's first 
cost reporting period beginning on or after October 1, 1991.
    (4) Excess capacity test for urban hospitals. Urban hospitals that 
are not required to receive approval from a State or local planning 
authority must demonstrate that either--
    (i) The overall average occupancy rate in its metropolitan 
statistical area is at least 80 percent; or
    (ii) After completion of the project, its capacity is no more than 
80 percent of its prior capacity (in terms of bed size).
    (5) Project size requirement. A hospital must complete, during the 
period from the beginning of its first cost reporting period beginning 
on or after October 1, 1991 to the end of its last cost reporting period 
beginning before October 1, 2001, a project whose costs for replacement 
and/or renovation of fixed assets related to patient care are at least:
    (i) $200 million; or
    (ii) 100 percent of its operating cost during the first 12 month 
cost reporting period beginning on or after October 1, 1991.
    (6) Minimum payment level. (i) The minimum payment level for 
qualifying hospitals will be 70 percent.
    (ii) CMS will adjust the minimum payment level in one percentage 
point increments as necessary to satisfy the requirement specified in 
paragraph (h) of this section that total estimated payments under the 
exceptions process

[[Page 739]]

not exceed 10 percent of the total estimated capital prospective payment 
system payments for the same fiscal year.
    (7) Limitation on the period for exception payments. A qualifying 
hospital may receive an exceptions payment for up to 10 years from the 
year in which it completes a project for replacement or renovation of 
capital assets that meets project need and project size requirements 
(and, if applicable, excess capacity test), provided that it completes 
the project no later than the end of the hospital's last cost reporting 
period beginning before October 1, 2001. A project is considered to be 
completed when the assets are put into use for patient care.
    (8) Determining a hospital's exception payment amount--(i) 
Cumulative comparison. For each cost reporting period, the hospital's 
exception payment is determined by comparing the cumulative payments 
made to the hospital under the capital prospective payment system to the 
cumulative minimum payment levels applicable to the hospital for each 
cost reporting period subject to the prospective payment system.
    (ii) Offsetting amounts. Offsetting amounts are applied in the 
following order--(A) Any amount by which the hospital's cumulative 
payments exceed its cumulative minimum payment levels is deducted from 
the additional payment that would otherwise be payable for a cost 
reporting period.
    (B) Any amount by which the hospital's current year Medicare 
inpatient operating and capital prospective payment system payments 
(excluding, if applicable, 75 percent of the hospital's operating 
prospective payment system disproportionate share payments) exceed its 
Medicare inpatient operating and capital costs is deducted from the 
additional payment that would otherwise be payable for the cost 
reporting period. For purposes of calculating the offset, the costs and 
payments for services that are not subject to the hospital inpatient 
prospective payment system are excluded.
    (9) Notification requirement. Eligible hospitals must submit 
documentation to the intermediary indicating the completion date of a 
project that meets the project need requirement under paragraph (g)(2) 
of this section, the project size requirement under paragraph (g)(5) of 
this section, and, in the case of certain urban hospitals, an excess 
capacity test under paragraph (g)(4) of this section, by the later of 
October 1, 2001 or within 3 months of the end of the hospital's last 
cost reporting period beginning before October 1, 2001, during which a 
qualifying project was completed.
    (h) Limit on exception payments. Total estimated payments under the 
exception process may not exceed 10 percent of the total estimated 
capital prospective payments (exclusive of hold-harmless payments for 
old capital) for the same fiscal year.

[59 FR 45399, Sept. 1, 1994, as amended at 62 FR 46031, Aug. 29, 1997; 
66 FR 39936, Aug. 1, 2001]



Sec.  412.352  Budget neutrality adjustment.

    For FY 1992 through FY 1995, CMS will determine an adjustment to the 
hospital-specific rate and the Federal rate proportionately so that the 
estimated aggregate payments under this subpart for inpatient hospital 
capital costs each fiscal year will equal 90 percent of what CMS 
estimates would have been paid for capital-related costs on a reasonable 
cost basis under Sec.  413.130 of this chapter.

                 Special Rules for Puerto Rico Hospitals



Sec.  412.370  General provisions for hospitals located in Puerto Rico.

    Except as provided in Sec.  412.374, hospitals located in Puerto 
Rico are subject to the rules in this subpart governing the prospective 
payment system for inpatient hospital capital-related costs.



Sec.  412.374  Payments to hospitals located in Puerto Rico.

    (a) FY 1998 through FY 2004. Payments for capital-related costs to 
hospitals located in Puerto Rico that are paid under the prospective 
payment system are equal to the sum of the following:
    (1) 50 percent of the Puerto Rico capital rate based on data from 
Puerto

[[Page 740]]

Rico hospitals only, which is determined in accordance with procedures 
for developing the Federal rate; and
    (2) 50 percent of the Federal rate, as determined under Sec.  
412.308.
    (b) FY 2005 through FY 2016. For discharges occurring on or after 
October 1, 2004 and on or before September 30, 2016, payments for 
capital-related costs to hospitals located in Puerto Rico that are paid 
under the prospective payment system are equal to the sum of the 
following:
    (1) 25 percent of the Puerto Rico capital rate based on data from 
Puerto Rico hospitals only, which is determined in accordance with 
procedures for developing the Federal rate; and
    (2) 75 percent of the Federal rate, as determined under Sec.  
412.308.
    (c) Effective for fiscal year 1998, the Puerto Rico capital rate 
described in paragraph (a) of this section in effect on September 30, 
1997, is reduced by 15.68 percent.
    (d) For discharges occurring on or after October 1, 1997 through 
September 30, 2002, the Puerto Rico capital rate described in paragraph 
(a) of this section in effect on September 30, 1997 is further reduced 
by 2.1 percent.
    (e) FY 2017 and subsequent fiscal years. For discharges occurring on 
or after October 1, 2016, payments for capital-related costs to 
hospitals located in Puerto Rico that are paid under the prospective 
payment system are based on 100 percent of the Federal rate, as 
determined under Sec.  412.308.

[62 FR 46032, Aug. 29, 1997, as amended at 69 FR 49250, Aug. 11, 2004; 
81 FR 57268, Aug. 22, 2016]



Subpart N_Prospective Payment System for Inpatient Hospital Services of 
                    Inpatient Psychiatric Facilities

    Source: 69 FR 66977, Nov. 15, 2004, unless otherwise noted.



Sec.  412.400  Basis and scope of subpart.

    (a) Basis. This subpart implements section 124 of Public Law 106-
113, which provides for the implementation of a per diem-based 
prospective payment system for inpatient hospital services of inpatient 
psychiatric facilities.
    (b) Scope. This subpart sets forth the framework for the prospective 
payment system for the inpatient hospital services of inpatient 
psychiatric facilities, including the methodology used for the 
development of the Federal per diem rate, payment adjustments, 
implementation issues, and related rules. Under this system, for cost 
reporting periods beginning on or after January 1, 2005, payment for the 
operating and capital-related costs of inpatient hospital services 
furnished by inpatient psychiatric facilities to Medicare Part A fee-
for-service beneficiaries is made on the basis of prospectively 
determined payment amount applied on a per diem basis.



Sec.  412.402  Definitions.

    As used in this subpart--
    Closure of an IPF means closure of a hospital as defined in Sec.  
413.79(h)(1)(i) by an IPF meeting the requirements of Sec.  412.404(b) 
for the purposes of accounting for indirect teaching costs.
    Closure of an IPF's residency training program means closure of a 
hospital residency training program as defined in Sec.  413.79(h)(1)(ii) 
by an IPF meeting the requirements of Sec.  412.404(b) for the purposes 
of accounting for indirect teaching costs.
    Comorbidity means all specific patient conditions that are secondary 
to the patient's primary diagnosis and that coexist at the time of 
admission, develop subsequently, or that affect the treatment received 
or the length of stay or both. Diagnoses that relate to an earlier 
episode of care that have no bearing on the current hospital stay are 
excluded.
    Displaced resident means a displaced resident as defined in Sec.  
413.79(h)(1)(iii) for the purposes of accounting for indirect teaching 
costs.
    Federal per diem base rate means the payment based on the average 
routine operating, ancillary, and capital-related cost of 1 day of 
hospital inpatient services in an inpatient psychiatric facility.
    Federal per diem payment amount means the Federal per diem base rate 
with all applicable adjustments.
    Fixed dollar loss threshold amount means a dollar amount which, when 
added to the Federal payment amount

[[Page 741]]

for a case, the estimated costs of a case must exceed in order for the 
case to qualify for an outlier payment.
    Inpatient psychiatric facilities means hospitals that meet the 
requirements as specified in Sec. Sec.  412.22, 412.23(a), 482.60, 
482.61, and 482.62, and units that meet the requirements as specified in 
Sec. Sec.  412.22, 412.25, and 412.27.
    Inpatient psychiatric facilities prospective payment system rate 
year means--
    (1) Through June 30, 2011, the 12-month period of July 1 through 
June 30.
    (2) Beginning July 1, 2011, the 15-month period of July 1, 2011 
through September 30, 2012.
    (3) Beginning October 1, 2012, the 12-month period of October 1 
through September 30, referred to as Fiscal Year (FY).
    Interrupted stay means a Medicare inpatient is discharged from an 
inpatient psychiatric facility and is admitted to any inpatient 
psychiatric facility within 3 consecutive calendar days following 
discharge. The 3 consecutive calendar days begins with the day of 
discharge from the inpatient psychiatric facility and ends on midnight 
of the third day.
    New graduate medical education program means a medical education 
program that receives initial accreditation by the appropriate 
accrediting body or begins training residents on or after November 15, 
2004.
    Outlier payment means an additional payment beyond the Federal per 
diem payment amount for cases with unusually high costs.
    Principal diagnosis means the condition established after study to 
be chiefly responsible for occasioning the admission of the patient to 
the inpatient psychiatric facility. Principal diagnosis is also referred 
to as the primary diagnosis.
    Qualifying emergency department means an emergency department that 
is staffed and equipped to furnish a comprehensive array of emergency 
services and meeting the definitions of a dedicated emergency department 
as specified in Sec.  489.24(b) of this chapter and the definition of 
``provider-based status'' as specified in Sec.  413.65 of this chapter.
    Rural area means for cost reporting periods beginning January 1, 
2005, with respect to discharges occurring during the period covered by 
such cost reports but before July 1, 2006, an area as defined in Sec.  
412.62(f)(1)(iii). For discharges occurring on or after July 1, 2006, 
rural area means an area as defined in Sec.  412.64(b)(1)(ii)(C).
    Urban area means for cost reporting periods beginning on or after 
January 1, 2005, with respect to discharges occurring during the period 
covered by such cost reports but before July 1, 2006, an area as defined 
in Sec.  412.62(f)(1)(ii). For discharges occurring on or after July 1, 
2006, urban area means an area as defined in Sec.  412.64(b)(1)(ii)(A) 
and Sec.  412.64(b)(1)(ii)(B).

[69 FR 66977, Nov. 15, 2004; 70 FR 19728, Apr. 1, 2005, as amended at 71 
FR 27086, May 9, 2006; 76 FR 26465, May 6, 2011; 83 FR 38619, Aug. 6, 
2018; 86 FR 42678, Aug. 4, 2021]



Sec.  412.404  Conditions for payment under the prospective payment system 
for inpatient hospital services of psychiatric facilities.

    (a) General requirements. (1) Effective for cost reporting periods 
beginning on or after January 1, 2005, an inpatient psychiatric facility 
must meet the conditions of this section to receive payment under the 
prospective payment system described in this subpart for inpatient 
hospital services furnished to Medicare Part A fee-for-service 
beneficiaries.
    (2) If an inpatient psychiatric facility fails to comply fully with 
these conditions, CMS may, as appropriate--
    (i) Withhold (in full or in part) or reduce Medicare payment to the 
inpatient psychiatric facility until the facility provides adequate 
assurances of compliance; or
    (ii) Classify the inpatient psychiatric facility as an inpatient 
hospital that is subject to the conditions of subpart C of this part and 
is paid under the prospective payment system as specified in Sec.  
412.1(a)(1).
    (b) Inpatient psychiatric facilities subject to the prospective 
payment system. Subject to the special payment provisions of Sec.  
412.22(c), an inpatient psychiatric facility must meet the general 
criteria set forth in Sec.  412.22. In order to

[[Page 742]]

be excluded from the hospital inpatient prospective payment system as 
specified in Sec.  412.1(a)(1), a psychiatric hospital must meet the 
criteria set forth in Sec. Sec.  412.23(a), 482.60, 482.61, and 482.62 
and psychiatric units must meet the criteria set forth in Sec.  412.25 
and Sec.  412.27.
    (c) Limitations on charges to beneficiaries--(1) Prohibited charges. 
Except as permitted in paragraph (c)(2) of this section, an inpatient 
psychiatric facility may not charge a beneficiary for any services for 
which payment is made by Medicare, even if the facility's cost of 
furnishing services to that beneficiary are greater than the amount the 
facility is paid under the prospective payment system.
    (2) Permitted charges. An inpatient psychiatric facility receiving 
payment under this subpart for a covered hospital stay (that is, a stay 
that included at least one covered day) may charge the Medicare 
beneficiary or other person only the applicable deductible and 
coinsurance amounts under Sec. Sec.  409.82, 409.83, and 409.87 of this 
chapter and for items or services as specified under Sec.  489.20(a) of 
this chapter.
    (d) Furnishing of inpatient hospital services directly or under 
arrangement. (1) Subject to the provisions of Sec.  412.422, the 
applicable payments made under this subpart are payment in full for all 
inpatient hospital services, as specified in Sec.  409.10 of this 
chapter. Hospital inpatient services do not include the following:
    (i) Physicians' services that meet the requirements of Sec.  
415.102(a) of this chapter for payment on a fee schedule basis.
    (ii) Physician assistant services, as specified in section 
1861(s)(2)(K)(i) of the Act.
    (iii) Nurse practitioners and clinical nurse specialist services, as 
specified in section 1861(s)(2)(K)(ii) of the Act.
    (iv) Certified nurse midwife services, as specified in section 
1861(gg) of the Act.
    (v) Qualified psychologist services, as specified in section 
1861(ii) of the Act.
    (vi) Services of a certified registered nurse anesthetist, as 
specified in section 1861(bb) of the Act and defined in Sec.  410.69 of 
this subchapter.
    (2) CMS does not pay providers or suppliers other than inpatient 
psychiatric facilities for services furnished to a Medicare beneficiary 
who is an inpatient of the inpatient psychiatric facility, except for 
services described in paragraphs (d)(1)(i) through (d)(1)(vi) of this 
section
    (3) The inpatient psychiatric facility must furnish all necessary 
covered services to a Medicare beneficiary who is an inpatient of the 
inpatient psychiatric facility, either directly or under arrangements 
(as specified in Sec.  409.3 of this chapter).
    (e) Reporting and recordkeeping requirements. All inpatient 
psychiatric facilities participating in the prospective payment system 
under this subpart must meet the recordkeeping and cost reporting 
requirements as specified in Sec. Sec.  412.27(c), 413.20, 413.24, and 
482.61 of this chapter.

[69 FR 66977, Nov. 15, 2004, as amended at 76 FR 26465, May 6, 2011]



Sec.  412.405  Preadmission services as inpatient operating costs 
under the inpatient psychiatric facility prospective payment system.

    The prospective payment system includes payment for inpatient 
operating costs of preadmission services if the inpatient operating 
costs are for--
    (a) Preadmission services otherwise payable under Medicare Part B 
furnished to a beneficiary on the date of the beneficiary's inpatient 
admission, and during the calendar day immediately preceding the date of 
the beneficiary's inpatient admission, to the inpatient psychiatric 
facility that meet the following conditions:
    (1) The services are furnished by the inpatient psychiatric facility 
or by an entity wholly owned or wholly operated by the inpatient 
psychiatric facility. An entity is wholly owned by the inpatient 
psychiatric facility if the inpatient psychiatric facility is the sole 
owner of the entity. An entity is wholly operated by an inpatient 
psychiatric facility if the inpatient psychiatric facility has exclusive 
responsibility for conducting and overseeing the entity's routine 
operations, regardless of whether the inpatient psychiatric facility 
also has policymaking authority over the entity.
    (2) The services are diagnostic (including clinical diagnostic 
laboratory tests).

[[Page 743]]

    (3) The services are nondiagnostic when furnished on the date of the 
beneficiary's inpatient admission, the services are nondiagnostic when 
furnished on the calendar day preceding the date of the beneficiary's 
inpatient admission and the hospital does not demonstrate that such 
services are unrelated to the beneficiary's inpatient admission, and are 
not one of the following:
    (i) Ambulance services.
    (ii) Maintenance renal dialysis services.
    (b) The preadmission services are furnished on or after June 25, 
2010.

[75 FR 50415, Aug. 16, 2010]



Sec.  412.422  Basis of payment.

    (a) Method of Payment. (1) Under the inpatient psychiatric facility 
prospective payment system, inpatient psychiatric facilities receive a 
predetermined Federal per diem base rate for inpatient hospital services 
furnished to Medicare Part A fee-for-service beneficiaries.
    (2) The Federal per diem payment amount is based on the Federal per 
diem base rate plus applicable adjustments as specified in Sec.  
412.424.
    (3) During the transition period, payment is based on a blend of the 
Federal per diem payment amount as specified in Sec.  412.424, and the 
facility-specific payment rate as specified in Sec.  412.426.
    (b) Payment in full. (1) The payment made under this subpart 
represents payment in full (subject to applicable deductibles and 
coinsurance as specified in subpart G of part 409 of this chapter) for 
inpatient operating and capital-related costs associated with furnishing 
Medicare covered services in an inpatient psychiatric facility, but not 
the cost of an approved medical education program as specified in Sec.  
413.75 through Sec.  413.85 of this chapter.
    (2) In addition to the Federal per diem payment amounts, inpatient 
psychiatric facilities receive payment for bad debts of Medicare 
beneficiaries, as specified in Sec.  413.89 of this chapter.

[69 FR 66977, Nov. 15, 2004; 70 FR 19728, Apr. 1, 2005, as amended at 76 
FR 26465, May 6, 2011]



Sec.  412.424  Methodology for calculating the Federal per diem payment amount.

    (a) Data sources. (1) To calculate the Federal per diem base rate 
(as specified in paragraph (b) of this section for inpatient psychiatric 
facilities, as specified in paragraph (b) of this section, CMS uses the 
following data sources:
    (2) The best Medicare data available to estimate the average 
inpatient operating and capital-related costs per day made as specified 
in part 413 of this chapter.
    (i) Patient and facility cost report data capturing routine and 
ancillary costs.
    (ii) An appropriate wage index to adjust for wage differences.
    (iii) An increase factor to adjust for the most recent estimate of 
increases in the prices of an appropriate market basket of goods and 
services provided by inpatient psychiatric facilities.
    (b) Determining the average per diem cost of inpatient psychiatric 
facilities for FY 2002. CMS determines the average inpatient operating, 
ancillary, and capital-related per diem cost for which payment is made 
to each inpatient psychiatric facility, using the available data 
described in paragraph (a) of this section.
    (c) Determining the Federal per diem base rate for cost reporting 
periods beginning on or after January 1, 2005 through June 30, 2006--(1) 
General. Payment under the inpatient psychiatric facility prospective 
payment system is based on a standardized per diem payment referred to 
as the Federal per diem base rate. The Federal per diem base rate is the 
adjusted cost for 1 day of inpatient hospital services in an inpatient 
psychiatric facility in a base year as described in paragraph (b) of 
this section. The adjusted cost per day is adjusted in accordance with 
paragraphs (c)(2) through (c)(5) of this section.
    (2) Update of the average per diem cost. CMS applies the increase 
factor described in paragraph (a)(2)(iii) of this section to the updated 
average per diem cost to the midpoint of the January 1, 2005 through 
June 30, 2006, under the update methodology described in section 
1886(b)(3)(B)(ii) of the Act.
    (3) Budget neutrality. (i) CMS adjusts the updated average per diem 
cost so

[[Page 744]]

that the aggregate payments in the first 18 months (for January 1, 2005 
through June 30, 2006) under the inpatient psychiatric facility 
prospective payment system are estimated to equal the amount that would 
have been made to the inpatient psychiatric facilities under part 413 of 
this chapter if the inpatient psychiatric facility prospective payment 
system described in this subpart were not implemented.
    (ii) CMS evaluates the accuracy of the budget-neutrality adjustment 
within the first 5 years after implementation of the inpatient 
psychiatric facility prospective payment system. CMS may make a one-time 
prospective adjustment to the Federal per diem base rate to account for 
significant differences between the historical data on cost-based TEFRA 
payments (the basis of the budget-neutrality adjustment at the time of 
implementation) and estimates of TEFRA payments based on actual data 
from the first year of the prospective payment system.
    (4) Outlier payments. CMS determines a reduction factor equal to the 
estimated proportion of outlier payments described in paragraph 
(d)(3)(i) of this section.
    (5) Standardization. CMS determines a reduction factor to reflect 
estimated increases in the Federal per diem base rate as defined in 
Sec.  412.402 resulting from the facility-level and patient-level 
adjustments described in paragraph (d) of this section.
    (6) Computation of the Federal per diem base rate. The Federal per 
diem base rate is computed as follows:
    (i) For cost reporting periods beginning on or after January 1, 2005 
and on or before June 30, 2006, the Federal per diem base rate is 
computed in accordance with paragraph (c) of this section.
    (ii) For inpatient psychiatric facilities beginning on or after July 
1, 2006, the Federal per diem base rate will be the Federal per diem 
base rate for the previous year, updated by an increase factor described 
in paragraph (a)(2)(iii) of this section.
    (d) Determining the Federal per diem payment amount. The Federal per 
diem payment amount is the product of the Federal per diem base rate 
established under paragraph (c) of this section, the facility-level 
adjustments applicable to the inpatient psychiatric facility, patient-
level adjustments and other policy adjustments applicable to the case.
    (1) Facility-level adjustments--(i) Adjustment for wages. CMS 
adjusts the labor portion of the Federal per diem base rate to account 
for geographic differences in the area wage levels using an appropriate 
wage index. The application of the wage index is made on the basis of 
the location of the inpatient psychiatric facility in an urban or rural 
area as defined in Sec.  412.402.
    (ii) Rural location. CMS adjusts the Federal per diem base rate for 
inpatient psychiatric facilities located in a rural area as defined in 
Sec.  412.402.
    (iii) Teaching adjustment. CMS adjusts the Federal per diem base 
rate by a factor to account for indirect teaching costs.
    (A) An inpatient psychiatric facility's teaching adjustment is based 
on the ratio of the number of full-time equivalent residents training in 
the inpatient psychiatric facility divided by the facility's average 
daily census.
    (B) Residents with less than full-time status and residents rotating 
through the inpatient psychiatric facility for less than a full year 
will be counted in proportion to the time they spend in the inpatient 
psychiatric facility.
    (C) Except as described in paragraph (d)(1)(iii)(D) of this section, 
the actual number of current year full-time equivalent residents used in 
calculating the teaching adjustment is limited to the number of full-
time equivalent residents in the inpatient psychiatric facility's most 
recently filed cost report filed with its fiscal intermediary before 
November 15, 2004 (base year).
    (D) If the inpatient psychiatric facility first begins training 
residents in a new approved graduate medical education program after 
November 15, 2004, the number of full-time equivalent residents 
determined under paragraph (d)(1)(iii)(C) of this section may be 
adjusted using the method described in Sec.  413.79(e)(1)(i) and (ii) of 
this chapter.
    (E) The teaching adjustment is made on a claim basis as an interim 
payment, and the final payment in full for the claim is made during the 
final settlement of the cost report.

[[Page 745]]

    (F) Closure of an IPF or IPF residency training program--(1) Closure 
of an IPF. For cost reporting periods beginning on or after July 1, 
2011, an IPF may receive a temporary adjustment to its FTE cap to 
reflect displaced residents added because of another IPF's closure if 
the IPF meets the following criteria:
    (i) The IPF is training additional displaced residents from an IPF 
that closed on or after July 1, 2011.
    (ii) No later than 60 days after the IPF begins to train the 
displaced residents, the IPF submits a request to its Medicare 
contractor for a temporary adjustment to its cap, documents that the IPF 
is eligible for this temporary adjustment by identifying the displaced 
residents who have come from the closed IPF and have caused the IPF to 
exceed its cap, and specifies the length of time the adjustment is 
needed.
    (2) Closure of an IPF's residency training program. If an IPF that 
closes its residency training program on or after July 1, 2011, agrees 
to temporarily reduce its FTE cap according to the criteria specified in 
paragraph (d)(1)(iii)(F)(2)(ii) of this section, another IPF(s) may 
receive a temporary adjustment to its FTE cap to reflect displaced 
residents added because of the closure of the residency training program 
if the criteria specified in paragraph (d)(1)(iii)(F)(2)(i) of this 
section are met.
    (i) Receiving IPF(s). For cost reporting periods beginning on or 
after July 1, 2011, an IPF may receive a temporary adjustment to its FTE 
cap to reflect displaced residents added because of the closure of 
another IPF's residency training program if the IPF is training 
additional displaced residents from the residency training program of an 
IPF that closed a program; and if no later than 60 days after the IPF 
begins to train the displaced residents, the IPF submits to its Medicare 
Contractor a request for a temporary adjustment to its FTE cap, 
documents that it is eligible for this temporary adjustment by 
identifying the displaced residents who have come from another IPF's 
closed program and have caused the IPF to exceed its cap, specifies the 
length of time the adjustment is needed, and submits to its Medicare 
contractor a copy of the FTE reduction statement by the hospital that 
closed its program, as specified in paragraph (d)(1)(iii)(F)(2)(ii) of 
this section.
    (ii) IPF that closed its program. An IPF that agrees to train 
displaced residents who have been displaced by the closure of another 
IPF's program may receive a temporary FTE cap adjustment only if the 
hospital with the closed program temporarily reduces its FTE cap based 
on the FTE of displaced residents in each program year training in the 
program at the time of the program's closure. This yearly reduction in 
the FTE cap will be determined based on the number of those displaced 
residents who would have been training in the program during that year 
had the program not closed. No later than 60 days after the displaced 
residents who were in the closed program begin training at another 
hospital, the hospital with the closed program must submit to its 
Medicare contractor a statement signed and dated by its representative 
that specifies that it agrees to the temporary reduction in its FTE cap 
to allow the IPF training the displaced residents to obtain a temporary 
adjustment to its cap; identifies the displaced residents who were in 
training at the time of the program's closure; identifies the IPFs to 
which the displaced residents are transferring once the program closes; 
and specifies the reduction for the applicable program years.
    (iv) Inpatient psychiatric facilities located in Alaska and Hawaii. 
CMS adjusts the non-labor portion of the Federal per diem base rate to 
reflect the higher cost of living of inpatient psychiatric facilities 
located in Alaska and Hawaii.
    (v) Adjustment for IPF with qualifying emergency departments. (A) 
CMS adjusts the Federal per diem base rate to account for the costs 
associated with maintaining a qualifying emergency department. A 
qualifying emergency department is staffed and equipped to furnish a 
comprehensive array of emergency services (medical and psychiatric) and 
meets the requirements of Sec. Sec.  489.24(b) and 413.65 of this 
chapter.
    (B) Where the inpatient psychiatric facility is part of an acute 
care hospital that has a qualifying emergency department as described in 
paragraph

[[Page 746]]

(d)(1)(v)(A) of this section and an individual patient is discharged to 
the inpatient psychiatric facility from that acute care hospital, CMS 
would not apply the emergency adjustment.
    (vi) Applicable percentage change for fiscal year 2014 payment 
determination and for subsequent years. (A) In the case of an inpatient 
psychiatric facility that is paid under the prospective payment system 
in Sec.  412.1(a)(2) that does not submit quality data to CMS, in the 
form and manner and at a time specified by CMS, the applicable annual 
update to a Federal standard rate is reduced by 2.0 percentage points.
    (B) Any reduction in the applicable annual update to a Federal 
standard rate will apply only to the fiscal year involved and will not 
be taken into account in computing the annual payment update for a 
subsequent year.
    (2) Patient-level adjustments. The inpatient psychiatric facility 
must identify a principal psychiatric diagnosis as specified in Sec.  
412.27(a) for each patient. CMS adjusts the Federal per diem base rate 
by a factor to account for the diagnosis-related group assignment 
associated with the principal diagnosis, as specified by CMS.
    (i) Age. CMS adjusts the Federal per diem base rate to account for 
patient age based on age groupings specified by CMS.
    (ii) Diagnosis-related group assignment. The inpatient psychiatric 
facility must identify a principal diagnosis as specified in Sec.  
412.27(a) for each patient. CMS adjusts the Federal per diem base rate 
by a factor to account for the CMS inpatient psychiatric facility 
prospective payment system recognized diagnosis-related group assignment 
associated with each patient's principal diagnosis.
    (iii) [Reserved]
    (iv) Comorbidities. CMS adjusts the Federal per diem base rate by a 
factor to account for certain comorbidities as specified by CMS.
    (v) Variable per diem adjustments. CMS adjusts the Federal per diem 
base rate by factors as specified by CMS to account for the cost of each 
day of inpatient psychiatric care relative to the cost of the median 
length of stay.
    (3) Other adjustments. (i) Outlier payments. CMS provides an outlier 
payment if an inpatient psychiatric facility's estimated total cost for 
a case exceeds a fixed dollar loss threshold amount for an inpatient 
psychiatric facility as defined in Sec.  412.402 plus the Federal 
payment amount for the case.
    (A) The fixed dollar loss threshold amount is adjusted for the 
inpatient psychiatric facility's adjustments for wage area, teaching, 
rural locations, and cost of living adjustment for facilities located in 
Alaska and Hawaii.
    (B) The outlier payment equals a percentage of the difference 
between the IPF's estimated cost for the case and the adjusted threshold 
amount specified by CMS for each day of the inpatient stay.
    (C) For discharges occurring in cost reporting periods beginning on 
or after January 1, 2005, outlier payments are subject to the 
adjustments specified at Sec. Sec.  412.84(i) and 412.84(m) of this 
part, except that national urban and rural median cost-to-charge ratios 
would be used instead of statewide average cost-to-charge ratios.
    (ii) Stop-loss payments. CMS will provide additional payments during 
the transition period, specified in Sec.  412.426(a)(1) through (3), to 
an inpatient psychiatric facility to ensure that aggregate payments 
under the prospective payment system are at least 70 percent of the 
amount the inpatient psychiatric facility would have received under 
reasonable cost reimbursement had the prospective payment system not 
been implemented.
    (iii) Special payment provision for interrupted stays. If a patient 
is discharged from an inpatient psychiatric facility and is admitted to 
the same or another inpatient psychiatric facility within 3 consecutive 
calendar days following the discharge, the case is considered to be 
continuous for the purposes listed below. The 3 consecutive calendar 
days begins with the day of discharge from the inpatient psychiatric 
facility and ends on midnight of day 3.
    (A) Determining the appropriate variable per diem adjustment, as 
specified in paragraph (d)(2)(v) of this section, applicable to the 
case.
    (B) Determining whether the total cost for a case meets the criteria 
for outlier payments, as specified in paragraph (d)(3)(i)(C) of this 
section.

[[Page 747]]

    (iv) Payment for electroconvulsive therapy treatments. CMS provides 
an additional payment to reflect the cost of electroconvulsive therapy 
treatments received by a patient during an inpatient psychiatric 
facility stay in a manner specified by CMS.

[69 FR 66977, Nov. 15, 2004; 70 FR 16729, Apr. 1, 2005, as amended at 71 
FR 27086, May 9, 2006; 76 FR 26465, May 6, 2011; 77 FR 53678, Aug. 31, 
2012; 86 FR 42678, Aug. 4, 2021]



Sec.  412.426  Transition period.

    (a) Duration of transition period and composition of the blended 
transition payment. Except as provided in paragraph (c) of this section, 
for cost reporting periods beginning on or after January 1, 2005 through 
December 31, 2007, an inpatient psychiatric facility receives a payment 
comprised of a blend of the estimated Federal per diem payment amount, 
as specified in Sec.  412.424(d) of this subpart and a facility-specific 
payment as specified under paragraph (b) of this section.
    (1) For cost reporting periods beginning on or after January 1, 2005 
and before January 1, 2006, payment is based on 75 percent of the 
facility-specific payment and 25 percent is based on the Federal per 
diem payment amount.
    (2) For cost reporting periods beginning on or after January 1, 2006 
and before January 1, 2007, payment is based on 50 percent of the 
facility-specific payment and 50 percent is based on the Federal per 
diem payment amount.
    (3) For cost reporting periods beginning on or after January 1, 2007 
and before January 1, 2008, payment is based on 25 percent of the 
facility-specific payment and 75 percent is based on the Federal per 
diem payment amount.
    (4) For cost reporting periods beginning on or after January 1, 
2008, payment is based entirely on the Federal per diem payment amount.
    (b) Calculation of the facility-specific payment. The facility-
specific payment is equal to the estimated payment for each cost 
reporting period in the transition period that would have been made 
without regard to this subpart. The facility's Medicare fiscal 
intermediary calculates the facility-specific payment for inpatient 
operating costs and capital costs in accordance with part 413 of this 
chapter.
    (c) Treatment of new inpatient psychiatric facilities. New inpatient 
psychiatric facilities, are facilities that under present or previous 
ownership or both have their first cost reporting period as an IPF 
beginning on or after January 1, 2005. New IPFs are paid based on 100 
percent of the Federal per diem payment amount.

[69 FR 66977, Nov. 15, 2004; 70 FR 16729, Apr. 1, 2005, as amended at 71 
FR 27087, May 9, 2006; 76 FR 26466, May 6, 2011]



Sec.  412.428  Publication of changes to the inpatient psychiatric facility 
prospective payment system.

    CMS will issue annually in the Federal Register information 
pertaining to changes to the inpatient psychiatric facility prospective 
payment system. This information includes:
    (a) A description of the methodology and data used to calculate the 
federal per diem base payment amount for the subsequent fiscal year.
    (b)(1) For discharges occurring on or after January 1, 2005 but 
before July 1, 2006, the update, described in Sec.  412.424(a)(2)(iii), 
for the federal portion of the inpatient psychiatric facility's payments 
is based on the 1997-based excluded hospital with capital market basket 
under the applicable percentage increase methodology described in 
section 1886(b)(3)(B)(ii) of the Act for each year.
    (2)(i) For discharges occurring on or after July 1, 2006 but before 
October 1, 2015, the update for the federal portion of the inpatient 
psychiatric facility's payment is based on the rehabilitation, 
psychiatric, and long-term care market basket.
    (ii) For discharges occurring on or after October 1, 2015, the 
update of the inpatient psychiatric facility's payment is based on the 
inpatient psychiatric facility market basket.
    (3) For discharges occurring on or after January 1, 2005 but before 
October 1, 2005, the update, described in Sec.  412.424(a)(2)(iii), for 
the reasonable cost portion of the inpatient psychiatric facility's 
payment is based on the 1997-based excluded hospital with capital market 
basket under the updated methodology described in section 
1886(b)(3)(B)(ii) of the Act for each year.

[[Page 748]]

    (4) For discharges occurring on or after October 1, 2005 but before 
July 1, 2008, the update for the reasonable cost portion of the 
inpatient psychiatric facility's payment is based on the 2002-based 
excluded hospital market basket.
    (c) The best available hospital wage index and information regarding 
whether an adjustment to the Federal per diem base rate is needed to 
maintain budget neutrality.
    (d) Updates to the fixed dollar loss threshold amount in order to 
maintain the appropriate outlier percentage.
    (e) Describe the ICD-10-CM coding changes and DRG classification 
changes discussed in the annual update to the hospital inpatient 
prospective payment system regulations.
    (f) Update the electroconvulsive therapy adjustment by a factor 
specified by CMS.
    (g) Update the national urban and rural cost to charge ratio median 
and ceilings. CMS will apply the national cost to charge ratio to--
    (1) New inpatient psychiatric facilities that have not submitted 
their first Medicare cost report.
    (2) Inpatient psychiatric facilities whose operating or capital cost 
to charge ratio is in excess of 3 standard deviations above the 
corresponding national geometric mean.
    (3) Other inpatient psychiatric facilities for which the fiscal 
intermediary obtains inaccurate or incomplete data with which to 
calculate either an operating or capital cost to charge ratio or both.
    (h) Update the cost of living adjustment factor if appropriate.

[69 FR 66977, Nov. 15, 2004, as amended at 71 FR 27087, May 9, 2006; 80 
FR 46726, Aug. 5, 2015; 83 FR 38619, Aug. 6, 2018]



Sec.  412.432  Method of payment under the inpatient psychiatric facility 
prospective payment system.

    (a) General rule. Subject to the exceptions in paragraphs (b) and 
(c) of this section, an inpatient psychiatric facility receives payment 
under this subpart for inpatient operating cost and capital-related 
costs for each inpatient stay following submission of a bill.
    (b) Periodic interim payments (PIP). (1) Criteria for receiving PIP.
    (i) An inpatient psychiatric facility receiving payment under this 
subpart may receive PIP for Part A services under the PIP method subject 
to the provisions of Sec.  413.64(h) of this chapter.
    (ii) To be approved for PIP, the inpatient psychiatric facility must 
meet the qualifying requirements in Sec.  413.64(h)(3) of this chapter.
    (iii) A hospital that is receiving periodic interim payments also 
receives payment under this subpart for applicable services furnished by 
its excluded psychiatric unit.
    (iv) As provided in Sec.  413.64(h)(5) of this chapter, intermediary 
approval is conditioned upon the intermediary's best judgment as to 
whether payment can be made under the PIP method without undue risk of 
resulting in an overpayment to the provider.
    (2) Frequency of payment. For facilities approved for PIP, the 
intermediary estimates the annual inpatient psychiatric facility's 
Federal per diem prospective payments, net of estimated beneficiary 
deductibles and coinsurance, and makes biweekly payments equal to \1/26\ 
of the total estimated amount of payment for the year. If the inpatient 
psychiatric facility has payment experience under the prospective 
payment system, the intermediary estimates PIP based on that payment 
experience, adjusted for projected changes supported by substantiated 
information for the current year. Each payment is made 2 weeks after the 
end of a biweekly period of service as specified in Sec.  413.64(h)(6) 
of this chapter. The interim payments are reviewed at least twice during 
the reporting period and adjusted if necessary. Fewer reviews may be 
necessary if an inpatient psychiatric facility receives interim payments 
for less than a full reporting period. These payments are subject to 
final settlement.
    (3) Termination of PIP. (i) Request by the inpatient psychiatric 
facility. Subject to the provisions of paragraph (b)(1)(iii) of this 
section, an inpatient psychiatric facility receiving PIP may convert to 
receiving prospective payments on a non-PIP basis at any time.
    (ii) Removal by the intermediary. An intermediary terminates PIP if 
the inpatient psychiatric facility no longer

[[Page 749]]

meets the requirements of Sec.  413.64(h) of this chapter.
    (c) Interim payments for Medicare bad debts and for costs of an 
approved education program and other costs paid outside the prospective 
payment system. For Medicare bad debts and for costs of an approved 
education program and other costs paid outside the prospective payment 
system, the intermediary determines the interim payments by estimating 
the reimbursable amount for the year based on the previous year's 
experience, adjusted for projected changes supported by substantiated 
information for the current year, and makes biweekly payments equal to 
\1/26\ of the total estimated amount. Each payment is made 2 weeks after 
the end of the biweekly period of service as specified in Sec.  
413.64(h)(6) of this chapter. The interim payments are reviewed at least 
twice during the reporting period and adjusted if necessary. Fewer 
reviews may be necessary if an inpatient psychiatric facility receives 
interim payments for less than a full reporting period. These payments 
are subject to final cost settlement.
    (d) Outlier payments. Additional payments for outliers are not made 
on an interim basis. Outlier payments are made based on the submission 
of a discharge bill and represents final payment subject to the cost 
report settlement specified in Sec.  412.84(i) and Sec.  412.84(m) of 
this part.
    (e) Accelerated payments--(1) General rule. Upon request, an 
accelerated payment may be made to an inpatient psychiatric facility 
that is receiving payment under this subpart and is not receiving PIP 
under paragraph (b) of this section if the inpatient psychiatric 
facility is experiencing financial difficulties because of the 
following:
    (i) There is a delay by the intermediary in making payment to the 
inpatient psychiatric facility.
    (ii) Due to an exceptional situation, there is a temporary delay in 
the inpatient psychiatric facility's preparation and submittal of bills 
to the intermediary beyond the normal billing cycle.
    (2) Approval of accelerated payment. An inpatient psychiatric 
facility's request for an accelerated payment must be approved by the 
intermediary and CMS.
    (3) Amount of accelerated payment. The amount of the accelerated 
payment is computed as a percent of the net payment for unbilled or 
unpaid covered services.
    (4) Recovery of accelerated payment. Recovery of the accelerated 
payment is made by recoupment as inpatient psychiatric facility bills 
are processed or by direct payment by the inpatient psychiatric 
facility.

[69 FR 66977, Nov. 15, 2004, as amended at 76 FR 26465, May 6, 2011]



Sec.  412.434  Reconsideration and appeals procedures of Inpatient Psychiatric 
Facilities Quality Reporting (IPFQR) Program decisions.

    (a) An inpatient psychiatric facility may request reconsideration of 
a decision by CMS that the inpatient psychiatric facility has not met 
the requirements of the IPFQR Program for a particular fiscal year. An 
inpatient psychiatric facility must submit a reconsideration request to 
CMS no later than 30 days from the date identified on the IPFQR Program 
Annual Payment Update Notification Letter provided to the inpatient 
psychiatric facility.
    (b) A reconsideration request must contain the following 
information:
    (1) The inpatient psychiatric facility's CMS Certification Number 
(CCN);
    (2) The name of the inpatient psychiatric facility;
    (3) Contact information for the inpatient psychiatric facility's 
chief executive officer and QualityNet security official, including each 
individual's name, email address, telephone number, and physical mailing 
address;
    (4) A summary of the reason(s), as set forth in the IPFQR Program 
Annual Payment Update Notification Letter, that CMS concluded the 
inpatient psychiatric facility did not meet the requirements of the 
IPFQR Program;
    (5) A detailed explanation of why the inpatient psychiatric facility 
believes that it complied with the requirements of the IPFQR Program for 
the applicable fiscal year; and

[[Page 750]]

    (6) Any evidence that supports the inpatient psychiatric facility's 
reconsideration request, such as emails and other documents.
    (c) An inpatient psychiatric facility that is dissatisfied with a 
decision made by CMS on its reconsideration request may file an appeal 
with the Provider Reimbursement Review Board under part 405, subpart R 
of this chapter.

[77 FR 53678, Aug. 31, 2012, as amended at 86 FR 42678, Aug. 4, 2021]



    Subpart O_Prospective Payment System for Long-Term Care Hospitals

    Source: 67 FR 56049, Aug. 30, 2002, unless otherwise noted.



Sec.  412.500  Basis and scope of subpart.

    (a) Basis. This subpart implements the following:
    (1) Section 123 of Public Law 106-113, which provides for the 
implementation of a prospective payment system for long-term care 
hospitals described in section 1886(d)(1)(B)(iv) of the Act.
    (2) Section 307 of Public Law 106-554, which states that the 
Secretary shall examine and may provide for appropriate adjustments to 
that system, including adjustments to DRG weights, area wage 
adjustments, geographic reclassification, outliers, updates, and 
disproportionate share adjustments consistent with section 1886(d)(5)(F) 
of the Act.
    (3) Section 114 of Public Law 110-173, which contains several 
provisions regarding long-term care hospitals, including the--
    (i) Amendment of section 1886 of the Act to add a new subsection (m) 
that references section 123 of Public Law 106-113 and section 307(b) of 
Public Law 106-554 for the establishment and implementation of a 
prospective payment system for payments under title XVIII for inpatient 
hospital services furnished by a long-term care hospital described in 
section 1886(d)(1)(B)(iv) of the Act; and
    (ii) Revision of the standard Federal rate for RY 2008.
    (4) Section 4302(a) of Public Law 111-5, which amended sections 
114(c) and (d) of Public Law 110-173 relating to several moratoria on 
the establishment of new long-term care hospitals and satellite 
facilities and on the increase in the number of beds in existing long-
term care hospitals and satellite facilities under the long-term care 
hospital prospective payment system.
    (5) Sections 3106(a) and 10312(a) of Public Law 111-148, which 
extended certain payment rules and moratoria under the long-term care 
hospital prospective payment system by further amending sections 114(c) 
and (d) of Public Law 110-173.
    (6) Section 1206 of Public Law 113-67, which further extended 
certain payment rules and moratoria under the long-term care hospital 
prospective payment system by amending sections 114(c) and (d) of Public 
Law 110-173, and which:
    (i) Added a new section 1886(m)(6) to the Act to establish a site 
neutral payment amount for long-term care hospital discharges that fail 
to meet the applicable criteria in cost reporting periods beginning on 
or after October 1, 2015; and
    (ii) Requires the Secretary's review of the payment rates and 
regulations governing long-term care hospitals established under section 
1886(d)(1)(B)(iv)(II) of the Act and application of payment adjustments 
based on that review.
    (7) Section 411 of Public Law 114-10 which revises the annual update 
to the LTCH PPS standard Federal payment rate in FY 2018.
    (8) Public Law 114-255 which at--
    (i) Section 15004 amended the moratorium on increasing beds in 
existing LTCHs and LTCH satellite facilities and amended high cost 
outlier payment requirements;
    (ii) Section 15006 amended moratoria on certain payment policies;
    (iii) Section 15007 amended the average length of stay requirements;
    (iv) Section 15009 temporally excepted certain spinal cord specialty 
hospitals from the site neutral payment rate; and
    (v) Section 15010 temporally excepted certain wound care discharges 
from certain LTCHs from the site neutral payment rate.

[[Page 751]]

    (9) Section 51005(a) of Public Law 115-123 which extended the 
blended payment rate for the site neutral payment rate cases to apply to 
discharges occurring in cost reporting periods beginning in FYs 2018 and 
2019.
    (10) Section 51005(b) of Public Law which reduces the IPPS 
comparable amount for the site neutral payment rate cases by 4.6 percent 
for FYs 2018 through 2026.
    (b) Scope. This subpart sets forth the framework for the prospective 
payment system for long-term care hospitals, including the methodology 
used for the development of payment rates and associated adjustments and 
related rules. Under this system, for cost reporting periods beginning 
on or after October 1, 2002, payment for the operating and capital-
related costs of inpatient hospital services furnished by long-term care 
hospitals is made on the basis of prospectively determined rates and 
applied on a per discharge basis.

[67 FR 56049, Aug. 30, 2002, as amended at 73 FR 24879, May 6, 2008; 79 
FR 50355, Aug. 22, 2014; 82 FR 38512, Aug. 14, 2017; 83 FR 41704, Aug. 
17, 2018]



Sec.  412.503  Definitions.

    As used in this subpart--
    CMS stands for the Centers for Medicare & Medicaid Services.
    Discharge. A Medicare patient in a long-term care hospital is 
considered discharged when--
    (1) For purposes of the long-term care hospital qualification 
calculation, as described in Sec.  412.23(e)(3), the patient is formally 
released;
    (2) For purposes of payment, as described in Sec.  412.521(b), the 
patient stops receiving Medicare-covered long-term care services; or
    (3) The patient dies in the long-term care facility.
    Long-term care hospital prospective payment system fiscal year 
means, beginning October 1, 2010, the 12-month period of October 1 
through September 30.
    Long-term care hospital prospective payment system payment year 
means the general term that encompasses both the definition of ``long-
term care hospital prospective payment system rate year'' and ``long-
term care hospital prospective payment system fiscal year'' specified in 
this section.
    Long-term care hospital prospective payment system rate year means--
    (1) From July 1, 2003 and ending on or before June 30, 2008, the 12-
month period of July 1 through June 30.
    (2) From July 1, 2008 and ending on September 30, 2009, the 15-month 
period of July 1, 2008 through September 30, 2009.
    (3) From October 1, 2009 through September 30, 2010, the 12-month 
period of October 1 through September 30.
    LTC-DRG stands for the diagnosis-related group used to classify 
patient discharges from a long-term care hospital based on clinical 
characteristics and average resource use, for prospective payment 
purposes. Effective October 1, 2007, long-term care hospital patient 
discharges occurring on or after October 1, 2007, are classified by a 
severity-adjusted patient classification system, the MS-LTC-DRGs. Any 
reference to the term ``LTC-DRG'' shall be considered a reference to the 
term ``MS-LTC-DRG'' when applying the provisions of this subpart for 
policy descriptions and payment calculations for discharges from a long-
term care hospital occurring on or after October 1, 2007.
    MSA means a Metropolitan Statistical Area, as defined by the 
Executive Office of Management and Budget.
    MSA-dominant area means an MSA in which an MSA-dominant hospital is 
located.
    MSA-dominant hospital means a hospital that has discharged more than 
25 percent of the total subsection (d) hospital Medicare discharges in 
the MSA (not including discharges paid by a Medicare Advantage plan) in 
which the hospital is located.
    MS-LTC-DRG stands for the severity-adjusted diagnosis-related group 
used to classify patient discharges from a long-term care hospital based 
on clinical characteristics and average resource use, for prospective 
payment purposes for discharges from a long-term care hospital occurring 
on or after October 1, 2007.
    Outlier payment means an additional payment beyond the long-term 
care hospital standard Federal payment rate or the site neutral payment 
rate (including, when applicable, the blended payment rate), as 
applicable, for cases with unusually high costs.

[[Page 752]]

    QIO (formerly PRO or Peer Review Organization) stands for the 
Quality Improvement Organization.
    Rural area means--(1) For cost reporting periods beginning on or 
after October 1, 2002, with respect to discharges occurring during the 
period covered by such cost reports but before July 1, 2005, an area 
defined in Sec.  412.62(f)(1)(iii);
    (2) For discharges occurring on or after July 1, 2005, and before 
July 1, 2008, an area as defined in Sec.  412.64(b)(1)(ii)(C); and
    (3) For discharges occurring on or after July 1, 2008, any area 
outside an urban area.
    Subsection (d) hospital means, for purposes of Sec.  412.522, a 
hospital defined in section 1886(d)(1)(B) of the Social Security Act and 
includes any hospital that is located in Puerto Rico and that would be a 
subsection (d) hospital as defined in section 1886(d)(1)(B) of the 
Social Security Act if it were located in one of the 50 States.
    Urban area means--(1) For cost reporting periods beginning on or 
after October 1, 2002, with respect to discharges occurring during the 
period covered by such cost reports but before July 1, 2005, an area 
defined in Sec.  412.62(f)(1)(ii);
    (2) For discharges occurring on or after July 1, 2005, and before 
July 1, 2008, an urban area means an area as defined in Sec.  
412.64(b)(1)(ii)(A) and (B); and
    (3) For discharges occurring on or after July 1, 2008, a 
Metropolitan Statistical Area, as defined by the Executive Office of 
Management and Budget.

[67 FR 56049, Aug. 30, 2002, as amended at 72 FR 47412, Aug. 22, 2007; 
73 FR 26838, May 9, 2008; 75 FR 50416, Aug. 16, 2010; 80 FR 49767, Aug. 
17, 2015; 81 FR 57268, Aug. 22, 2016]



Sec.  412.505  Conditions for payment under the prospective payment system 
for long-term care hospitals.

    (a) Long-term care hospitals subject to the prospective payment 
system. To be eligible to receive payment under the prospective payment 
system specified in this subpart, a long-term care hospital must meet 
the criteria to be classified as a long-term care hospital set forth in 
Sec.  412.23(e) for exclusion from the acute care hospital inpatient 
prospective payment systems specified in Sec.  412.1(a)(1). This 
condition is subject to the special payment provisions of Sec.  
412.22(c), the provisions on change in hospital status of Sec.  
412.22(d), the provisions related to hospitals-within-hospitals under 
Sec.  412.22(e), and the provisions related to satellite facilities 
under Sec.  412.22(h).
    (b) General requirements. (1) Effective for cost reporting periods 
beginning on or after October 1, 2002, a long-term care hospital must 
meet the conditions for payment of this section, Sec.  412.22(e)(3) and 
(h)(6), if applicable, and Sec.  412.507 through Sec.  412.511 to 
receive payment under the prospective payment system described in this 
subpart for inpatient hospital services furnished to Medicare 
beneficiaries.
    (2) If a long-term care hospital fails to comply fully with these 
conditions for payment with respect to inpatient hospital services 
furnished to one or more Medicare beneficiaries, CMS may withhold (in 
full or in part) or reduce Medicare payment to the hospital.

[67 FR 56049, Aug. 30, 2002, as amended at 71 FR 48140, Aug. 19, 2006]



Sec.  412.507  Limitation on charges to beneficiaries.

    (a) Prohibited charges. Except as provided in paragraph (b) of this 
section, a long-term care hospital may not charge a beneficiary for any 
covered services for which payment is made by Medicare, even if the 
hospital's costs of furnishing services to that beneficiary are greater 
than the amount the hospital is paid under the prospective payment 
system.
    (1) If Medicare has paid at the full LTCH prospective payment system 
standard Federal payment rate, that payment applies to the hospital's 
costs for services furnished until the high-cost outlier threshold is 
met.
    (2) If Medicare pays less than the full LTCH prospective payment 
system standard Federal payment rate and payment was not made at the 
site neutral payment rate (including, when applicable, the blended 
payment rate), that payment only applies to the hospital's costs for 
those costs or days used to calculate the Medicare payment.

[[Page 753]]

    (3) For cost reporting periods beginning on or after October 1, 
2016, for Medicare payments to a long-term care hospital described in 
Sec.  412.23(e)(2)(ii), that payment only applies to the hospital's 
costs for those costs or days used to calculate the Medicare payment.
    (4) If Medicare has paid at the full site neutral payment rate, that 
payment applies to the hospital's costs for services furnished until the 
high-cost outlier is met.
    (b) Permitted charges. (1) A long-term care hospital that receives a 
payment at the full LTCH prospective payment system standard Federal 
payment rate or the site neutral payment rate may only charge the 
Medicare beneficiary for the applicable deductible and coinsurance 
amounts under Sec. Sec.  409.82, 409.83, and 409.87 of this chapter, and 
for items and services as specified under Sec.  489.20(a) of this 
chapter.
    (2) A long-term care hospital that receives a payment at less than 
the full LTCH prospective payment system standard Federal payment rate 
for a short-stay outlier case, in accordance with Sec.  412.529 (which 
would not include any discharge paid at the site neutral payment rate), 
may only charge the Medicare beneficiary for the applicable deductible 
and coinsurance amounts under Sec. Sec.  409.82, 409.83, and 409.87 of 
this chapter, for items and services as specified under Sec.  489.20(a) 
of this chapter, and for services provided during the stay that were not 
the basis for the short-stay adjusted payment.
    (3) For cost reporting periods beginning on or after October 1, 
2016, a long-term care hospital described in Sec.  412.23(e)(2)(ii) may 
only charge the Medicare beneficiary for the applicable deductible and 
coinsurance amounts under Sec. Sec.  409.82, 409.83, and 409.87 of this 
chapter, for items and services as specified under Sec.  489.20(a) of 
this chapter, and for services provided during the stay for which 
benefit days were not available and that were not the basis for adjusted 
LTCH prospective payment system payment amount under Sec.  412.526.

[80 FR 49767, Aug. 17, 2015, as amended at 81 FR 57268, Aug. 22, 2016]



Sec.  412.508  Medical review requirements.

    (a) Admission and quality review. A long-term care hospital must 
have an agreement with a QIO to have the QIO review, on an ongoing 
basis, the following:
    (1) The medical necessity, reasonableness, and appropriateness of 
hospital admissions and discharges.
    (2) The medical necessity, reasonableness, and appropriateness of 
inpatient hospital care for which additional payment is sought under the 
outlier provisions of Sec. Sec.  412.523(d)(1) and 412.525(a).
    (3) The validity of the hospital's diagnostic and procedural 
information.
    (4) The completeness, adequacy, and quality of the services 
furnished in the hospital.
    (5) Other medical or other practices with respect to beneficiaries 
or billing for services furnished to beneficiaries.
    (b) Physician acknowledgement. Payment under the long-term care 
hospital prospective payment system is based in part on each patient's 
principal and secondary diagnoses and major procedures performed, as 
evidenced by the physician's entries in the patient's medical record. 
The hospital must assure that physicians complete an acknowledgement 
statement to this effect in accordance with paragraphs (b)(1) and (b)(2) 
of this section.
    (1) Content of physician acknowledgement statement. When a claim is 
submitted, the hospital must have on file a signed and dated 
acknowledgement from the attending physician that the physician has 
received the following notice:

    Notice to physicians: Medicare payment to hospitals is based in part 
on each patient's principal and secondary diagnoses and the major 
procedures performed on the patient, as attested to by the patient's 
attending physician by virtue of his or her signature in the medical 
record. Anyone who misrepresents, falsifies, or conceals essential 
information required for payment of Federal funds, may be subject to 
fine, imprisonment, or civil penalty under applicable Federal laws.

    (2) Completion of acknowledgement. The acknowledgement must be 
completed by the physician at the time

[[Page 754]]

that the physician is granted admitting privileges at the hospital, or 
before or at the time the physician admits his or her first patient. 
Existing acknowledgements signed by physicians already on staff remain 
in effect as long as the physician has admitting privileges at the 
hospital.
    (c) Denial of payment as a result of admissions and quality review. 
(1) If CMS determines, on the basis of information supplied by a QIO, 
that a hospital has misrepresented admissions, discharges, or billing 
information, or has taken an action that results in the unnecessary 
admission or unnecessary multiple admissions of an individual entitled 
to benefits under Part A, or other inappropriate medical or other 
practices with respect to beneficiaries or billing for services 
furnished to beneficiaries, CMS may, as appropriate--
    (i) Deny payment (in whole or in part) under Part A with respect to 
inpatient hospital services provided for an unnecessary admission or 
subsequent readmission of an individual; or
    (ii) Require the hospital to take other corrective action necessary 
to prevent or correct the inappropriate practice.
    (2) When payment with respect to admission of an individual patient 
is denied by a QIO under paragraph (c)(1) of this section, and liability 
is not waived in accordance with Sec. Sec.  411.400 through 411.402 of 
this chapter, notice and appeals are provided under procedures 
established by CMS to implement the provisions of section 1155 of the 
Act, Right to Hearing and Judicial Review.
    (3) A determination under paragraph (c)(1) of this section, if it is 
related to a pattern of inappropriate admissions and billing practices 
that has the effect of circumventing the prospective payment system, is 
referred to the Department's Office of Inspector General for handling in 
accordance with Sec.  1001.201 of this title.

[67 FR 56049, Aug. 30, 2002, as amended at 71 FR 48140, Aug. 19, 2006]



Sec.  412.509  Furnishing of inpatient hospital services directly 
or under arrangement.

    (a) Subject to the provisions of Sec.  412.521(b), the applicable 
payments made under this subpart are payment in full for all inpatient 
hospital services, as defined in Sec.  409.10 of this chapter. Inpatient 
hospital services do not include the following:
    (1) Physicians' services that meet the requirements of Sec.  
415.102(a) of this subchapter for payment on a fee schedule basis.
    (2) Physician assistant services, as defined in section 
1861(s)(2)(K)(i) of the Act.
    (3) Nurse practitioners and clinical nurse specialist services, as 
defined in section 1861(s)(2)(K)(ii) of the Act.
    (4) Certified nurse midwife services, as defined in section 1861(gg) 
of the Act.
    (5) Qualified psychologist services, as defined in section 1861(ii) 
of the Act.
    (6) Services of an anesthetist, as defined in Sec.  410.69 of this 
subchapter.
    (b) Medicare does not pay any provider or supplier other than the 
long-term care hospital for services furnished to a Medicare beneficiary 
who is an inpatient of the hospital except for services described in 
paragraphs (a)(1) through (a)(6) of this section.
    (c) The long-term care hospital must furnish all necessary covered 
services to the Medicare beneficiary who is an inpatient of the hospital 
either directly or under arrangements (as defined in Sec.  409.3 of this 
subchapter).



Sec.  412.511  Reporting and recordkeeping requirements.

    A long-term care hospital participating in the prospective payment 
system under this subpart must meet the requirement of Sec. Sec.  
412.22(e)(3) and 412.22(h)(6) to report co-located status, if 
applicable, and the recordkeeping and cost reporting requirements of 
Sec. Sec.  413.20 and 413.24 of this subchapter.

[71 FR 48140, Aug. 18, 2006]



Sec.  412.513  Patient classification system.

    (a) Classification methodology. CMS classifies specific inpatient 
hospital discharges from long-term care hospitals by long-term care 
diagnosis-related groups (LTC-DRGs) to ensure that each hospital 
discharge is appropriately assigned based on essential data abstracted 
from the inpatient bill for that discharge.

[[Page 755]]

    (b) Assignment of discharges to LTC-DRGs. (1) The classification of 
a particular discharge is based, as appropriate, on the patient's age, 
sex, principal diagnosis (that is, the diagnosis established after study 
to be chiefly responsible for causing the patient's admission to the 
hospital), secondary diagnoses, procedures performed, and the patient's 
discharge status.
    (2) Each discharge from a long-term care hospital is assigned to 
only one LTC-DRG (related, except as provided in paragraph (b)(3) of 
this section, to the patient's principal diagnosis), regardless of the 
number of conditions treated or services furnished during the patient's 
stay.
    (3) When the discharge data submitted by a hospital show a surgical 
procedure unrelated to a patient's principal diagnosis, the bill is 
returned to the hospital for validation and reverification. The LTC-DRG 
classification system provides a LTC-DRG, and an appropriate weighting 
factor, for those cases for which none of the surgical procedures 
performed are related to the principal diagnosis.
    (c) Review of LTC-DRG assignment. (1) A hospital has 60 days after 
the date of the notice of the initial assignment of a discharge to a 
LTC-DRG to request a review of that assignment. The hospital may submit 
additional information as a part of its request.
    (2) The intermediary reviews that hospital's request and any 
additional information and decides whether a change in the LTC-DRG 
assignment is appropriate. If the intermediary decides that a different 
LTC-DRG should be assigned, the case will be reviewed by the appropriate 
QIO as specified in Sec.  476.71(c)(2) of this chapter.
    (3) Following the 60-day period described in paragraph (c)(1) of 
this section, the hospital may not submit additional information with 
respect to the DRG assignment or otherwise revise its claim.



Sec.  412.515  LTC-DRG weighting factors.

    For each LTC-DRG, CMS assigns an appropriate weight that reflects 
the estimated relative cost of hospital resources used within that group 
compared to discharges classified within other groups.



Sec.  412.517  Revision of LTC-DRG group classifications and weighting factors.

    (a) CMS adjusts the classifications and weighting factors annually 
to reflect changes in--
    (1) Treatment patterns;
    (2) Technology;
    (3) Number of discharges; and
    (4) Other factors affecting the relative use of hospital resources.
    (b) Beginning in FY 2008, the annual changes to the LTC-DRG 
classifications and recalibration of the weighting factors described in 
paragraph (a) of this section are made in a budget neutral manner such 
that estimated aggregate LTCH PPS payments are not affected.
    (c) Beginning in FY 2016, the annual recalibration of the weighting 
factors described in paragraph (a) of this section is determined using 
long-term care hospital discharges described in Sec.  412.522(a)(2) (or 
that would have been described in such section had the application of 
the site neutral payment rate been in effect at the time of the 
discharge).

[67 FR 56049, Aug. 30, 2002, as amended at 72 FR 26991, May 11, 2007; 80 
FR 49768, Aug. 17, 2015]



Sec.  412.521  Basis of payment.

    (a) Method of payment. (1) Under the prospective payment system, 
long-term care hospitals receive a predetermined payment amount per 
discharge for inpatient services furnished to Medicare beneficiaries.
    (2) Except as provided for in Sec.  412.526, the amount of payment 
under the prospective payment system is based on either the long-term 
care hospital prospective payment system standard Federal payment rate 
established in accordance with Sec.  412.523, including adjustments 
described in Sec.  412.525, or the site neutral payment rate established 
in accordance with Sec.  412.522(c), or, if applicable during a 
transition period, the blend of the LTCH PPS standard Federal payment 
rate and the applicable site neutral payment rate described in Sec.  
412.522(c)(3).
    (b) Payment in full. (1) The payment made under this subpart 
represents payment in full (subject to applicable deductibles and 
coinsurance described

[[Page 756]]

in subpart G of part 409 of this subchapter) for covered inpatient 
operating costs as described in Sec. Sec.  412.2(c)(1) through (c)(4) of 
this part and Sec.  412.540 and capital-related costs described in 
subpart G of part 413 of this subchapter associated with furnishing 
Medicare covered services in long-term care hospitals.
    (2) In addition to payment based on prospective payment rates, long-
term care hospitals may receive payments separate from payments under 
the prospective payment system for the following:
    (i) The costs of approved medical education programs described in 
Sec. Sec.  413.75 through 413.83, 413.85, and 413.87 of this subchapter.
    (ii) Bad debts of Medicare beneficiaries, as provided in Sec.  
413.89 of this subchapter.
    (iii) A payment amount per unit for blood clotting factor provided 
to Medicare inpatients who have hemophilia.
    (iv) Anesthesia services furnished by hospital employed nonphysician 
anesthetists or obtained under arrangements, as specified in Sec.  
412.113(c)(2).
    (v) The costs of photocopying and mailing medical records requested 
by a QIO, in accordance with Sec.  476.78(c) of this chapter.
    (c) Payment by workers' compensation, automobile medical, no-fault 
or liability insurance or an employer group health plan primary to 
Medicare. If workers' compensation, automobile medical, no-fault, or 
liability insurance or an employer group health plan that is primary to 
Medicare pays in full or in part, payment is determined in accordance 
with the guidelines specified in Sec.  412.120(b).
    (d) Effect of change of ownership on payments under the prospective 
payment system. When a hospital's ownership changes, as described in 
Sec.  489.18 of this chapter, the following rules apply:
    (1) Payment for the operating and capital-related costs of inpatient 
hospital services for each patient, including outlier payments as 
provided in Sec.  412.525 and payments for hemophilia clotting factor 
costs as provided in paragraph (b)(2)(iii) of this section, are made to 
the entity that is the legal owner on the date of discharge. Payments 
are not prorated between the buyer and seller.
    (i) The owner on the date of discharge is entitled to submit a bill 
for all inpatient hospital services furnished to a beneficiary 
regardless of when the beneficiary's coverage began or ended during a 
stay, or of how long the stay lasted.
    (ii) Each bill submitted must include all information necessary for 
the intermediary to compute the payment amount, whether or not some of 
that information is attributable to a period during which a different 
party legally owned the hospital.
    (2) Other payments for the direct costs of approved medical 
education programs, bad debts, anesthesia services furnished by hospital 
employed nonphysician anesthetists, and costs of photocopying and 
mailing medical records to the QIO as provided for under paragraphs 
(b)(2)(i), (ii), (iv), and (v) of this section are made to each owner or 
operator of the hospital (buyer and seller) in accordance with the 
principles of reasonable cost reimbursement.
    (e) Special payment provisions for patients in acute care hospitals 
that change classification status to LTCH status during a patient stay. 
(1) If a patient is admitted to an acute care hospital and then the 
acute care hospital meets the criteria at Sec.  412.23(e) to be paid as 
a LTCH during the course of the patient's hospitalization, Medicare 
considers all the days of the patient stay in the facility (days prior 
to and after the designation of LTCH status) to be a single episode of 
LTCH care. Payment for the entire patient stay (days prior to and after 
the designation of LTCH status) will include the day and cost data for 
that patient at both the acute care hospital and the LTCH in determining 
the payment to the LTCH under this subpart. The requirements of this 
paragraph (e)(1) apply only to a patient stay in which a patient is in 
an acute care hospital and that hospital is designated as a LTCH on or 
after October 1, 2004.
    (2) The days of the patient's stay prior to and after the hospital's 
designation as a LTCH as specified in

[[Page 757]]

paragraph (e)(1) of this section are included for purposes of 
determining the beneficiary's length of stay.

[67 FR 56049, Aug. 30, 2002, as amended at 68 FR 34162, June 6, 2003; 69 
FR 49250, Aug. 11, 2004; 70 FR 47487, Aug. 12, 2005; 75 FR 50416, Aug. 
16, 2010; 79 FR 50355, Aug. 22, 2014; 80 FR 49768, Aug. 17, 2015]



Sec.  412.522  Application of site neutral payment rate.

    (a) General. For discharges in cost reporting periods beginning on 
or after October 1, 2015--
    (1) Except as provided for in paragraph (b) of this section, all 
discharges are paid based on the site neutral payment rate as determined 
under the provisions of paragraph (c) of this section.
    (2) Discharges that meet the criteria for exclusion from site 
neutral payment rate specified in paragraph (b) of this section are paid 
based on the standard Federal prospective payment rate established under 
Sec.  412.523.
    (b) Criteria for exclusion from the site neutral payment rate--(1) 
General criteria--(i) Basis and scope. A discharge that meets the 
following criteria is excluded from the site neutral payment rate 
specified under this section.
    (A) The discharge from the long-term care hospital does not have a 
principal diagnosis relating to a psychiatric diagnosis or to 
rehabilitation based on the LTC-DRG assignment of the discharge under 
Sec.  412.513; and
    (B) The admission to the long-term care hospital was immediately 
preceded by a discharge from a subsection (d) hospital and meets either 
the intensive care unit criterion specified in paragraph (b)(1)(ii) of 
this section or the ventilator criterion specified in paragraph 
(b)(1)(iii) of this section. In order for an admission to a long-term 
care hospital to be considered immediately preceded for purposes of this 
section, the patient discharged from the subsection (d) hospital must be 
directly admitted to the long-term care hospital.
    (ii) Intensive care unit criterion. In addition to meeting the 
requirements of paragraph (b)(1)(i) of this section, the discharge from 
the subsection (d) hospital that immediately preceded the admission to 
the long-term care hospital includes at least 3 days in an intensive 
care unit (as defined in Sec.  413.53(d) of this chapter), as evidenced 
by at least one of the revenue center codes on the claim for the 
discharge that indicate such services were provided for the requisite 
number of days during the stay.
    (iii) Ventilator criterion. In addition to meeting the requirements 
of paragraph (b)(1)(i) of this section, the discharge from the long-term 
care hospital is assigned to a LTC-DRG based on the patient's receipt of 
ventilator services of at least 96 hours, as evidenced by the procedure 
code on the discharge bill indicating such services were provided during 
the stay.
    (2) Special criteria--(i) Definitions. For purposes of this 
paragraph (b)(2) the following definitions are applicable:
    Severe wound means a wound which is a stage 3 wound, stage 4 wound, 
unstageable wound, non-healing surgical wound, infected wound, fistula, 
osteomyelitis or wound with morbid obesity as identified by the 
applicable code on the claim from the long-term care hospital.
    Wound means an injury, usually involving division of tissue or 
rupture of the integument or mucous membrane with exposure to the 
external environment.
    (ii) Discharges for severe wounds. A discharge that occurs on or 
after April 21, 2016 and before January 1, 2017 for a patient that was 
treated for a severe wound that meets the all of following criteria is 
excluded from the site neutral payment rate specified under this 
section:
    (A) The severe wound meets the definition specified in paragraph 
(b)(2)(i) of this section.
    (B) The discharge is from a long term care hospital that is--
    (1) Described in Sec.  412.23(e)(2)(i) and meets the criteria of 
Sec.  412.22(f); and
    (2) Located in a rural area (as defined at Sec.  412.503) or 
reclassified as rural by meeting the requirements set forth in Sec.  
412.103.
    (3) Temporary exception for certain severe wound discharges.--(i) 
Definitions. For purposes of this paragraph (b)(3) the following 
definitions are applicable:
    Severe wound means a wound which is a stage 3 wound, stage 4 wound,

[[Page 758]]

unstageable wound, non-healing surgical wound, fistula, as identified by 
the applicable code on the claim from the long-term care hospital.
    Wound means an injury, usually involving division of tissue or 
rupture of the integument or mucous membrane with exposure to the 
external environment.
    (ii) Discharges for severe wounds. A discharge that occurs in a cost 
reporting period beginning during fiscal year 2018 for a patient who was 
treated for a severe wound that meets all of the following criteria is 
excluded from the site neutral payment rate specified under this 
section:
    (A) The severe wound meets the definition specified in paragraph 
(b)(3)(i) of this section.
    (B) The discharge is from a long-term care hospital that is 
described in Sec.  412.23(e)(2)(i) and meets the criteria of Sec.  
412.22(f); and
    (C) The discharge is classified under MS-LTC-DRG 539, 540, 602, or 
603.
    (4) Temporary exception for certain spinal cord specialty hospitals. 
For discharges in cost reporting periods beginning in fiscal years 2018 
and 2019, the site neutral payment rate specified under this section 
does not apply if such discharge is from a long-term care hospital that 
meets each of the following requirements:
    (i) The hospital was a not-for-profit long-term care hospital on 
June 1, 2014, as determined by cost report data;
    (ii) Of the discharges in calendar year 2013 from the long-term care 
hospital for which payment was made under subpart O, at least 50 percent 
were classified under MS-LTC-DRGs 28, 29, 52, 57, 551, 573, and 963; and
    (iii) The long-term care hospital discharged inpatients (including 
both individuals entitled to, or enrolled for, benefits under Medicare 
Part A and individuals not so entitled or enrolled) during fiscal year 
2014 who had been admitted from at least 20 of the 50 States determined 
by the States of residency of such inpatients.
    (c) Site neutral payment rate--(1) General. Subject to the 
provisions of paragraph (c)(2) of this section, the site neutral payment 
rate is the lower of--
    (i) The inpatient hospital prospective payment system comparable per 
diem amount determined under Sec.  412.529(d)(4), including any 
applicable outlier payments specified in Sec.  412.525(a); or
    (ii) 100 percent of the estimated cost of the case determined under 
the provisions of Sec.  412.529(d)(2). The provisions for cost-to-charge 
ratios at Sec.  412.529(f)(4)(i) through (iii) apply to the calculation 
of the estimated cost of the case under this paragraph.
    (iii) For discharges occurring in fiscal years 2018 through 2026, 
the amount in paragraph (c)(1)(i) of this section is reduced by 4.6 
percent.
    (2) Adjustments. CMS adjusts the payment rate determined under 
paragraph (c)(1) of this section to account for--
    (i) Outlier payments, by applying a reduction factor equal to the 
estimated proportion of outlier payments under Sec.  412.525(a) payable 
for discharges from a long-term care hospital described in paragraph 
(a)(1) of this section to total estimated payments under the long-term 
care hospital prospective payment system to discharges from a long-term 
care hospital described in paragraph (a)(1) of this section. The 
adjustment under this paragraph (c)(2)(i) does not include the portion 
of the blended payment rate described in paragraph (c)(3)(ii) of this 
section.
    (ii) A 3-day or less interruption of a stay and a greater than 3-day 
interruption of a stay, as provided for in Sec.  412.531. For purposes 
of the application of the provisions of Sec.  412.531 to discharges from 
a long-term care hospital described under paragraph (a)(1) of this 
section, the long-term care hospital prospective payment system standard 
Federal payment-related terms, such as ``LTC-DRG payment,'' ``full 
Federal LTC-DRG prospective payment,'' and ``Federal prospective 
payment,'' mean the site neutral payment rate calculated under paragraph 
(c) of this section.
    (iii) The special payment provisions for long-term care hospitals-
within-hospitals and satellite facilities of long-term care hospitals 
specified in Sec.  412.534.

[[Page 759]]

    (iv) The special payment provisions for long-term care hospitals and 
satellite facilities of long-term care hospitals that discharged 
Medicare patients admitted from a hospital not located in the same 
building or on the same campus as the long-term care hospital or 
satellite facility of the long-term care hospital, as provided in Sec.  
412.536.
    (3) Transition. For discharges occurring in cost reporting periods 
beginning on or after October 1, 2015 and on or before September 30, 
2019, payment for discharges under paragraph (c)(1) of this section are 
made using a blended payment rate, which is determined as--
    (i) 50 percent of the site neutral payment rate amount for the 
discharge as determined under paragraph (c)(1) of this section; and
    (ii) 50 percent of the standard Federal prospective payment rate 
amount for the discharge as determined under Sec.  412.523.
    (d) Discharge payment percentage. (1) For purposes of this section, 
the discharge payment percentage is a ratio, expressed as a percentage, 
of Medicare discharges that meet the criteria for exclusion from the 
site neutral payment rate as described under paragraph (a)(2) of this 
section to total Medicare discharges paid under this subpart during the 
cost reporting period.
    (2) CMS will inform each long-term care hospital of its discharge 
payment percentage, as determined under paragraph (d)(1) of this 
section, for each cost reporting period beginning on or after October 1, 
2015.
    (3) For cost reporting periods beginning on or after October 1, 
2019, if a long-term care hospital's discharge payment percentage for 
the cost reporting period is not at least 50 percent, discharges in all 
cost reporting periods beginning after the notification described under 
paragraph (d)(2) of this section will be paid under the payment 
adjustment described in paragraph (d)(4) of this section until 
reinstated under paragraph (d)(5) or (6) of this section.
    (4) For cost reporting periods subject to the payment adjustment 
under paragraph (d)(3) of this section, the payment for all discharges 
consists of--
    (i) An amount equivalent to the hospital inpatient prospective 
payment system amount as determined under Sec.  412.529(d)(4)(i)(A) and 
(d)(4)(ii) and (iii); and
    (ii) If applicable, an additional payment for high cost outlier 
cases based on the fixed-loss amount established for the hospital 
inpatient prospective payment system in effect at the time of the LTCH 
discharge.
    (5) For full reinstatement--
    (i) When the discharge payment percentage for a cost reporting 
period is calculated to be at least 50 percent, any payment adjustment 
described in paragraph (d)(4) of this section will be discontinued for 
cost reporting periods beginning on or after the notification described 
under paragraph (d)(2) of this section.
    (ii) A long-term care hospital reinstated under paragraph (d)(5)(i) 
of this section will be subject to the payment adjustment under 
paragraph (d)(4) of this section if, after being reinstated, it again 
meets the criteria in paragraph (d)(3) of this section.
    (6) For special probationary reinstatement--
    (i) A hospital that would be subject to the payment adjustment under 
paragraph (d)(4) of this section for a cost reporting period will have 
application of the payment adjustment delayed for that period if, for 
the period of at least 5 consecutive months of the 6 months immediately 
preceding the cost reporting period, the discharge payment percentage is 
calculated to be at least 50 percent.
    (ii) For any cost reporting period to which the payment adjustment 
under paragraph (d)(4) of this section would have applied but for a 
delay under paragraph (d)(6)(i) of this section, the payment adjustment 
under paragraph (d)(4) of this section will be applied to all discharges 
in the cost reporting period if the discharge payment percentage for the 
cost reporting period is not calculated to be at least 50 percent.

[80 FR 49768, Sept. 1, 2015, as amended at 81 FR 23438, Apr. 21, 2016; 
81 FR 57269, Aug. 22, 2016; 82 FR 38512, Aug. 14, 2017; 83 FR 41704, 
Aug. 17, 2018; 84 FR 42614, Aug. 16, 2019]

[[Page 760]]



Sec.  412.523  Methodology for calculating the Federal prospective 
payment rates.

    (a) Data used. To calculate the initial prospective payment rates 
for inpatient hospital services furnished by long-term care hospitals, 
CMS uses--
    (1) The best Medicare data available; and
    (2) A rate of increase factor to adjust for the most recent estimate 
of increases in the prices of an appropriate market basket of goods and 
services included in covered inpatient long-term care hospital services.
    (b) Determining the average costs per discharge for FY 2003. CMS 
determines the average inpatient operating and capital-related costs per 
discharge for which payment is made to each inpatient long-term care 
hospital using the available data under paragraph (a)(1) of this 
section. The cost per discharge is adjusted to FY 2003 by a rate of 
increase factor, described in paragraph (a)(2) of this section, under 
the update methodology described in section 1886(b)(3)(B)(ii) of the Act 
for each year.
    (c) Determining the Federal prospective payment rates--(1) General. 
The Federal prospective payment rates will be established using a 
standard payment amount referred to as the standard Federal rate. The 
standard Federal rate is a standardized payment amount based on average 
costs from a base year that reflects the combined aggregate effects of 
the weighting factors and other adjustments.
    (2) Update the cost per discharge. CMS applies the increase factor 
described in paragraph (a)(2) of this section to each hospital's cost 
per discharge determined under paragraph (b) of this section to compute 
the cost per discharge for FY 2003. Based on the updated cost per 
discharge, CMS estimates the payments that would have been made to each 
hospital for FY 2003 under Part 413 of this chapter without regard to 
the prospective payment system implemented under this subpart.
    (3) Computation of the standard Federal rate. Subject to the 
provisions of paragraph (c)(4) of this section, the standard Federal 
rate is computed as follows:
    (i) For FY 2003. Based on the updated costs per discharge and 
estimated payments for FY 2003 determined in paragraph (c)(2) of this 
section, CMS computes a standard Federal rate for FY 2003 that reflects, 
as appropriate, the adjustments described in paragraph (d) of this 
section. The FY 2003 standard Federal rate is effective for discharges 
occurring in cost reporting periods beginning on or after October 1, 
2002 through June 30, 2003.
    (ii) For long-term care hospital prospective payment system rate 
years beginning on or after July 1, 2003 and ending on or before June 
30, 2006. The standard Federal rate for long-term care hospital 
prospective payment system rate years beginning on or after July 1, 2003 
and ending on or before June 30, 2006 is the standard Federal rate for 
the previous long-term care hospital prospective payment system rate 
year, updated by the increase factor described in paragraph (a)(2) of 
this section, and adjusted, as appropriate, as described in paragraph 
(d) of this section. For the rate year from July 1, 2003 through June 
30, 2004, the updated and adjusted standard Federal rate is offset by a 
budget neutrality factor to account for updating the FY 2003 standard 
Federal rate on July 1 rather than October 1.
    (iii) For long-term care hospital prospective payment system rate 
year beginning July 1, 2006 and ending June 30, 2007. The standard 
Federal rate for long-term care hospital prospective payment system rate 
year beginning July 1, 2006 and ending June 30, 2007 is the standard 
Federal rate for the previous long-term care hospital prospective 
payment system rate year updated by zero percent. The standard Federal 
rate is adjusted, as appropriate, as described in paragraph (d) of this 
section.
    (iv) For long-term care hospital prospective payment system rate 
year beginning July 1, 2007 and ending June 30, 2008. (A) The standard 
Federal rate for long-term care hospital prospective payment system rate 
year beginning July 1, 2007 and ending June 30, 2008 is the same as the 
standard Federal rate for the previous long-term care hospital 
prospective payment system rate year. The standard Federal rate is 
adjusted, as appropriate, as described in paragraph (d) of this section.

[[Page 761]]

    (B) With respect to discharges occurring on or after July 1, 2007 
and before April 1, 2008, payments are based on the standard Federal 
rate in paragraph (c)(3)(iii) of this section updated by 0.71 percent.
    (v) For long-term care hospital prospective payment system rate year 
beginning July 1, 2008 and ending September 30, 2009. The standard 
Federal rate for long-term care hospital prospective payment system rate 
year beginning July 1, 2008 and ending September 30, 2009 is the 
standard Federal rate for the previous long-term care hospital 
prospective payment system rate year updated by 2.7 percent. The 
standard Federal rate is adjusted, as appropriate, as described in 
paragraph (d) of this section.
    (vi) For long-term care hospital prospective payment system rate 
year beginning October 1, 2009 and ending September 30, 2010. (A) The 
standard Federal rate for long-term care hospital prospective payment 
system rate year beginning October 1, 2009 and ending September 30, 2010 
is the standard Federal rate for the previous long-term care hospital 
prospective payment system rate year updated by 1.74 percent. The 
standard Federal rate is adjusted, as appropriate, as described in 
paragraph (d) of this section.
    (B) With respect to discharges occurring on or after October 1, 2009 
and before April 1, 2010, payments are based on the standard Federal 
rate in paragraph (c)(3)(v) of this section updated by 2.0 percent.
    (vii) For long-term care hospital prospective payment system fiscal 
year beginning October 1, 2010, and ending September 30, 2011. The 
standard Federal rate for the long-term care hospital prospective 
payment system fiscal year beginning October 1, 2010, and ending 
September 30, 2011, is the standard Federal rate for the previous long-
term care hospital prospective payment system rate year updated by -0.49 
percent. The standard Federal rate is adjusted, as appropriate, as 
described in paragraph (d) of this section.
    (viii) For long-term care hospital prospective payment system fiscal 
year beginning October 1, 2011, and ending September 30, 2012. The 
standard Federal rate for the long-term care hospital prospective 
payment system beginning October 1, 2011, and ending September 30, 2012, 
is the standard Federal rate for the previous long-term care hospital 
prospective payment system fiscal year updated by 1.8 percent. The 
standard Federal rate is adjusted, as appropriate, as described in 
paragraph (d) of this section.
    (ix) For long-term care hospital prospective payment system fiscal 
year beginning October 1, 2012, and ending September 30, 2013. (A) The 
standard Federal rate for the long-term care hospital prospective 
payment system beginning October 1, 2012, and ending September 30, 2013, 
is the standard Federal rate for the previous long-term care hospital 
prospective payment system fiscal year updated by 1.8 percent, and 
further adjusted, as appropriate, as described in paragraph (d) of this 
section.
    (B) With respect to discharges occurring on or after October 1, 2012 
and before December 29, 2012, payments are based on the standard Federal 
rate in paragraph (c)(3)(ix)(A) of this section without regard to the 
adjustment provided for under paragraph (d)(3)(ii) of this section.
    (x) For long-term care hospital prospective payment system fiscal 
year beginning October 1, 2013, and ending September 30, 2014. The 
standard Federal rate for the long-term care hospital prospective 
payment system beginning October 1, 2013, and ending September 30, 2014, 
is the standard Federal rate for the previous long-term care hospital 
prospective payment system fiscal year updated by 1.7 percent, and 
further adjusted, as appropriate, as described in paragraph (d) of this 
section.
    (xi) For long-term care hospital prospective payment system fiscal 
year beginning October 1, 2014, and ending September 30, 2015. The 
standard Federal rate for the long-term care hospital prospective 
payment system beginning October 1, 2014, and ending September 30, 2015, 
is the standard Federal rate for the previous long-term care hospital 
prospective payment system fiscal year updated by 2.2 percent, and 
further adjusted, as appropriate, as described in paragraph (d) of this 
section.

[[Page 762]]

    (xii) For long-term care hospital prospective payment system fiscal 
year beginning October 1, 2015, and ending September 30, 2016. The LTCH 
PPS standard Federal payment rate for the long-term care hospital 
prospective payment system beginning October 1, 2015, and ending 
September 30, 2016, is the standard Federal payment rate for the 
previous long-term care hospital prospective payment system fiscal year 
updated by 1.7 percent, and further adjusted, as appropriate, as 
described in paragraph (d) of this section.
    (xiii) For long-term care hospital prospective payment system fiscal 
year beginning October 1, 2016, and ending September 30, 2017. The LTCH 
PPS standard Federal payment rate for the long-term care hospital 
prospective payment system beginning October 1, 2016, and ending 
September 30, 2017, is the standard Federal payment rate for the 
previous long-term care hospital prospective payment system fiscal year 
updated by 1.75 percent and further adjusted, as appropriate, as 
described in paragraph (d) of this section.
    (xiv) For long-term care hospital prospective payment system fiscal 
year beginning October 1, 2017, and ending September 30, 2018. The LTCH 
PPS standard Federal payment rate for the long-term care hospital 
prospective payment system beginning October 1, 2017, and ending 
September 30, 2018, is the standard Federal payment rate for the 
previous long-term care hospital prospective payment system fiscal year 
updated by 1.0 percent and further adjusted, as appropriate, as 
described in paragraph (d) of this section.
    (xv) For long-term care hospital prospective payment system fiscal 
year beginning October 1, 2018, and ending September 30, 2019. The LTCH 
PPS standard Federal payment rate for the long-term care hospital 
prospective payment system beginning October 1, 2018, and ending 
September 30, 2019, is the standard Federal payment rate for the 
previous long-term care hospital prospective payment system fiscal year 
updated by 1.35 percent and further adjusted, as appropriate, as 
described in paragraph (d) of this section.
    (xvi) For long-term care prospective payment system fiscal year 
beginning October 1, 2019, and ending September 30, 2020. The long-term 
care hospital prospective payment system standard Federal payment rate 
for the long-term care hospital prospective payment system beginning 
October 1, 2019 and ending September 30, 2020 is the standard Federal 
payment rate for the previous long-term care prospective payment system 
fiscal year updated by 2.5 percent and further adjusted, as appropriate, 
as described in paragraph (d) of this section.
    (xvii) For long-term care prospective payment system fiscal year 
2021 and subsequent fiscal years. The long-term care hospital 
prospective payment system standard Federal payment rate for a long-term 
care hospital prospective payment system fiscal year is the standard 
Federal payment rate for the previous long-term care prospective payment 
system fiscal year updated by the percentage increase in the market 
basket index (as determined by CMS) less a multifactor productivity 
adjustment (as determined by CMS), and further adjusted, as appropriate, 
as described in paragraph (d) of this section.
    (4) For fiscal year 2014 and subsequent fiscal years--
    (i) In the case of a long-term care hospital that does not submit 
quality reporting data to CMS in the form and manner and at a time 
specified by the Secretary, the annual update to the standard Federal 
rate specified in paragraph (c)(3) of this section is further reduced by 
2.0 percentage points.
    (ii) Any reduction of the annual update to the standard Federal rate 
under paragraph (c)(4)(i) of this section will apply only to the fiscal 
year involved and will not be taken into account in computing the annual 
update to the standard Federal rate for a subsequent fiscal year.
    (5) Determining the Federal prospective payment rate for each LTC-
DRG. The Federal prospective payment rate for each LTC-DRG is the 
product of the weighting factors described in Sec.  412.515 and the 
standard Federal rate described in paragraph (c)(3) of this section.
    (d) Adjustments to the standard Federal rate. The standard Federal 
rate described in paragraph (c)(3) of this section will be adjusted 
for--

[[Page 763]]

    (1) Outlier payments. CMS adjusts the LTCH PPS standard Federal 
payment rate by a reduction factor of 8 percent, the estimated 
proportion of outlier payments under Sec.  412.525(a) payable for 
discharges described in Sec.  412.522(a)(2) (notwithstanding the 
provisions of Sec.  412.525(a)(2)(ii) for FY 2018 and subsequent years.
    (2) Budget neutrality. CMS adjusts the Federal prospective payment 
rates for FY 2003 so that aggregate payments under the prospective 
payment system are estimated to equal the amount that would have been 
paid to long-term care hospitals under part 413 of this subchapter 
without regard to the prospective payment system implemented under this 
subpart, excluding the effects of section 1886(b)(2)(E) and (b)(3)(J) of 
the Act.
    (3)(i) General. The Secretary reviews payments under this 
prospective payment system and may make a one-time prospective 
adjustment to the long-term care hospital prospective payment system 
rates no earlier than December 29, 2012, so that the effect of any 
significant difference between the data used in the original 
computations of budget neutrality for FY 2003 and more recent data to 
determine budget neutrality for FY 2003 is not perpetuated in the 
prospective payment rates for future years.
    (ii) Adjustment to the standard Federal rate. The standard Federal 
rate determined in paragraph (c)(3) of this section is permanently 
adjusted by 3.75 percent to account for the estimated difference between 
projected aggregate payments in FY 2003 made under the prospective 
payment system implemented under this subpart and the projected 
aggregate payments that would have been made in FY 2003 under Part 413 
of this chapter without regard to the implementation of the prospective 
payment system implemented under this subpart, excluding the effects of 
sections 1886(b)(2)(E) and (b)(3)(J) of the Act. This adjustment is 
transitioned over 3 years beginning in FY 2013.
    (iii) Special rule for certain discharges occurring during FY 2013. 
The adjustment applied under paragraph (d)(3)(ii) of this section is not 
applicable when making payments under this subpart for discharges 
occurring on or after October 1, 2012, and on or before December 28, 
2012.
    (4) Changes to the adjustment for area wage levels. Beginning in FY 
2012, CMS adjusts the standard Federal rate by a factor that accounts 
for the estimated effect of any adjustments or updates to the area wage 
level adjustment under Sec.  412.525(c)(1) on estimated aggregate LTCH 
PPS payments.
    (5) Adjustment for changes to the short-stay outlier policy. The 
standard Federal rate determined under paragraph (c)(3) of this section 
is permanently adjusted by a one-time factor so that estimated aggregate 
payments to LTCH PPS standard Federal rate cases in FY 2018 are 
projected to equal estimated aggregate payments that would have been 
paid for such cases without regard to the change in the short-stay 
outlier policy for FY 2018 under Sec.  412.529(c)(4).
    (6) Adjustment for the elimination of the limitation on long-term 
care hospital admissions from referring hospitals. The standard Federal 
payment rate determined in paragraph (c)(3) of this section is adjusted 
as follows:
    (i) For discharges occurring on or after October 1, 2018 and before 
October 1, 2019, by a one-time factor so that estimated aggregate 
payments to LTCH PPS standard Federal rate cases in FY 2019, and the 
portion of estimated aggregate payments to site neutral cases that are 
paid based on the LTCH PPS standard Federal rate in FY 2019, are 
projected to equal estimated aggregate payments that would have been 
paid for such cases without regard to the elimination of the limitation 
on long-term care hospital admissions from referring hospitals. This 
adjustment only applies to the fiscal year involved and will not be 
taken into account in computing the standard Federal payment rate for a 
subsequent fiscal year.
    (ii) For discharges occurring on or after October 1, 2019 and before 
October 1, 2020, by a one-time factor so that estimated aggregate 
payments to LTCH PPS standard Federal rate cases in FY 2020, and the 
portion of estimated aggregate payments to site neutral payment rate 
cases that are paid based on the LTCH PPS standard Federal rate in FY 
2020, are projected to equal estimated aggregate payments that would

[[Page 764]]

have been paid for such cases without regard to the elimination of the 
limitation on long-term care hospital admissions from referring 
hospitals. This adjustment only applies to the fiscal year involved and 
will not be taken into account in computing the standard Federal payment 
rate for a subsequent fiscal year.
    (iii) For discharges occurring on or after October 1, 2020, by a 
permanent, one-time factor so that estimated aggregate payments to LTCH 
PPS standard Federal rate cases in FY 2021 are projected to equal 
estimated aggregate payments that would have been paid for such cases 
without regard to the elimination of the limitation on long-term care 
hospital admissions from referring hospitals.
    (e) Calculation of the adjusted Federal prospective payment. For 
each discharge, a long-term care hospital's Federal prospective payment 
is computed on the basis of the Federal prospective payment rate 
multiplied by the relative weight of the LTC-DRG assigned for that 
discharge. A hospital's Federal prospective payment rate will be 
adjusted, as appropriate, to account for outliers and other factors as 
specified in Sec.  412.525.

[67 FR 56049, Aug. 30, 2002]

    Editorial Note: For Federal Register citations affecting Sec.  
412.523, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.  412.525  Adjustments to the Federal prospective payment.

    (a) Adjustments for high-cost outliers. (1) CMS provides for an 
additional payment to a long-term care hospital if its estimated costs 
for a patient exceed the applicable long-term care hospital prospective 
payment system payment plus an applicable fixed-loss amount. For each 
long-term care hospital prospective payment system payment year, CMS 
annually establishes a fixed-loss amount that is the maximum loss that a 
long-term care hospital would incur under the long-term care hospital 
prospective payment system for a case with unusually high costs before 
receiving an additional payment.
    (2)(i) The fixed loss-amount for discharges from a long-term care 
hospital described under Sec.  412.522(a)(2) is determined for the long-
term care hospital prospective payment system payment year, using the 
LTC-DRG relative weights that are in effect at the start of the 
applicable long-term care hospital prospective payment system payment 
year.
    (ii) For FY 2018 and subsequent years, the fixed-loss amount for 
long-term care hospital discharges described under Sec.  412.522(a)(2) 
is determined such that the estimated proportion of outlier payments 
under paragraph (a) of this section payable for such discharges is 
projected to be equal to 99.6875 of 8 percent.
    (3) The additional payment equals 80 percent of the difference 
between the estimated cost of the patient's care (determined by 
multiplying the hospital-specific cost-to-charge ratio by the Medicare 
allowable covered charge) and the sum of the applicable long-term care 
hospital prospective payment system payment and the applicable fixed-
loss amount.
    (4)(i) For discharges occurring on or after October 1, 2002 and 
before August 8, 2003, no reconciliations will be made to outlier 
payments upon cost report settlement to account for differences between 
the estimated cost-to-charge ratio and the actual cost-to-charge ratio 
of the case.
    (ii) For discharges occurring on or after August 8, 2003, and before 
October 1, 2006, high-cost outlier payments are subject to the 
provisions of Sec.  412.84(i)(1), (i)(3), and (i)(4) and (m) for 
adjustments of cost-to-charge ratios.
    (iii) For discharges occurring on or after October 1, 2003, and 
before October 1, 2006, high-cost outlier payments are subject to the 
provisions of Sec.  412.84(i)(2) for adjustments to cost-to-charge 
ratios.
    (iv) For discharges occurring on or after October 1, 2006, high-cost 
outlier payments are subject to the following provisions:
    (A) CMS may specify an alternative to the cost-to-charge ratio 
otherwise applicable under paragraph (a)(4)(iv)(B) of this section. A 
hospital may also request that its fiscal intermediary use a different 
(higher or lower) cost-to-

[[Page 765]]

charge ratio based on substantial evidence presented by the hospital. A 
request must be approved by the CMS Regional Office.
    (B) The cost-to-charge ratio applied at the time a claim is 
processed is based on either the most recent settled cost report or the 
most recent tentatively settled cost report, whichever is from the 
latest cost reporting period.
    (C) The fiscal intermediary may use a statewide average cost-to-
charge ratio, which CMS establishes annually, if it is unable to 
determine an accurate cost-to-charge ratio for a hospital in one of the 
following circumstances:
    (1) A new hospital that has not yet submitted its first Medicare 
cost report. (For this purpose, a new hospital is defined as an entity 
that has not accepted assignment of an existing hospital's provider 
agreement in accordance with Sec.  489.18 of this chapter.)
    (2) A hospital whose cost-to-charge ratio is in excess of 3 standard 
deviations above the corresponding national geometric mean cost-to-
charge ratio. CMS establishes and publishes this mean annually.
    (3) Any other hospital for which data to calculate a cost-to-charge 
ratio are not available.
    (D) Any reconciliation of outlier payments is based on the cost-to-
charge ratio calculated based on a ratio of costs to charges computed 
from the relevant cost report and charge data determined at the time the 
cost report coinciding with the discharge is settled.
    (E) At the time of any reconciliation under paragraph (a)(4)(iv)(D) 
of this section, outlier payments may be adjusted to account for the 
time value of any underpayments or overpayments. Any adjustment is based 
upon a widely available index to be established in advance by the 
Secretary, and is applied from the midpoint of the cost reporting period 
to the date of reconciliation.
    (5) For purposes of this paragraph (a)--
    (i) Applicable long-term care hospital prospective payment system 
payment means--
    (A) The site neutral payment rate established under Sec.  412.522(c) 
for long-term care hospital discharges described under Sec.  
412.522(a)(1);
    (B) The standard Federal prospective payment rates established under 
Sec.  412.523 for long-term care hospital discharges described under 
Sec.  412.522(a)(2); or
    (C) The standard Federal prospective payment rates established under 
Sec.  412.523 for discharges occurring on or after October 1, 2015, in a 
long-term care hospital cost reporting period that begins before October 
1, 2015.
    (ii) Applicable fixed-loss amount means--
    (A) For long-term care hospital discharges described under Sec.  
412.522(a)(1), the fixed-loss amount established for such cases as 
provided at Sec.  412.522(c)(2)(i);
    (B) For long-term care hospital discharges described under Sec.  
412.522(a)(2), the fixed-loss amount established for such cases as 
provided at Sec.  412.523(e); or
    (C) For discharges occurring on or after October 1, 2015 in a long-
term care hospital cost reporting period that begins before October 1, 
2015, the fixed-loss amount payable to discharges described under Sec.  
412.522(a)(2) as set forth in paragraph (a)(5)(ii)(B) of this section.
    (b) Adjustments for Alaska and Hawaii. CMS adjusts the Federal 
prospective payment for the effects of a higher cost of living for 
hospitals located in Alaska and Hawaii.
    (c) Adjustments for area wage levels. (1) The labor portion of a 
long-term care hospital's Federal prospective payment is adjusted to 
account for geographical differences in the area wage levels using an 
appropriate wage index (established by CMS), which reflects the relative 
level of hospital wages and wage-related costs in the geographic area 
(that is, urban or rural area as determined in accordance with the 
definitions set forth in Sec.  412.503) of the hospital compared to the 
national average level of hospital wages and wage-related costs. The 
appropriate wage index that is established by CMS is updated annually. 
The labor portion of a long-term care hospital's Federal prospective 
payment is established by CMS and is updated annually.
    (2) Beginning in FY 2012, any adjustments or updates to the area 
wage level adjustment under this paragraph (c) will be made in a budget 
neutral

[[Page 766]]

manner such that estimated aggregate LTCH PPS payments are not affected.
    (d) Special payment provisions. CMS adjusts the Federal prospective 
payment to account for--
    (1) Short-stay outliers, as provided for in Sec.  412.529.
    (2) A 3-day or less interruption of a stay and a greater than 3-day 
interruption of a stay, as provided for in Sec.  412.531.
    (3) [Reserved]
    (4) Long-term care hospitals-within-hospitals and satellites of 
long-term care hospitals as provided in Sec.  412.534.
    (5) Long-term care hospitals and satellites of long-term care 
hospitals that discharged Medicare patients admitted from a hospital not 
located in the same building or on the same campus as the long-term care 
hospital or satellite of the long-term care hospital, as provided in 
Sec.  412.536.

[67 FR 56049, Aug. 30, 2002, as amended at 68 FR 34163, June 6, 2003; 68 
FR 34515, June 9, 2003; 69 FR 25721, May 7, 2004; 70 FR 24222, May 6, 
2005; 71 FR 48140, Aug. 18, 2006; 73 FR 26839, May 9, 2008; 74 FR 43998, 
Aug. 27, 2009; 75 FR 50416, Aug. 16, 2010; 76 FR 51783, Aug. 18, 2011; 
79 FR 50356, Aug. 22, 2014; 80 FR 49769, Aug. 17, 2015; 81 FR 57269, 
Aug. 22, 2016; 82 FR 38513, Aug. 14, 2017; 83 FR 41705, Aug. 17, 2018]



Sec.  412.526  Payment provisions for a ``subclause (II)'' 
long-term care hospital.

    (a) Definition. A ``subclause (II)'' long-term care hospital is a 
hospital that qualifies as an LTCH under section 1886(d)(1)(B)(iv)(II) 
of the Act.
    (b) Method of payment. (1) For cost reporting periods beginning on 
or after October 1, 2003 and before September 30, 2014, payment to a 
``subclause (II)'' long-term care hospital is made under the prospective 
payment system specified in Sec.  412.1(a)(4) and Subpart O of this 
part.
    (2) For cost reporting periods beginning on or after October 1, 
2014, payment to a ``subclause (II)'' long-term care hospital is made 
under the prospective payment system specified in Sec.  412.1(a)(4) and 
under Subpart O of this part, as adjusted. The adjusted payment amount 
is determined based on reasonable cost, as described at Sec.  
412.526(c).
    (c) Determining the adjusted payment for Medicare inpatient 
operating and capital-related costs under the reasonable cost-based 
reimbursement rules. Medicare inpatient operating costs are paid based 
on reasonable cost, subject to a ceiling. The ceiling is the aggregate 
upper limit on the amount of a hospital's net Medicare inpatient 
operating costs that the program will recognize for payment purposes, as 
determined under paragraph (c)(1) of this section.
    (1) Ceiling. For each cost reporting period, the ceiling is 
determined by multiplying the updated target amount, as defined in 
paragraph (c)(2) of this section, for that period by the number of 
Medicare discharges paid under this subpart during that period.
    (2) Target amounts. (i) For cost reporting periods beginning during 
Federal fiscal year 2015, the target amount equals the hospital's target 
amount determined under Sec.  413.40(c)(4) for its cost reporting period 
beginning during Federal fiscal year 2000, updated by the applicable 
annual rate-of-increase percentages specified in Sec.  413.40(c)(3) to 
the subject period.
    (ii) For subsequent cost reporting periods, the target amount equals 
the hospital's target amount for the previous cost reporting period 
updated by the applicable annual rate-of-increase percentage specified 
in Sec.  413.40(c)(3) for the subject cost reporting period.
    (3) Payment for inpatient operating costs. For cost reporting 
periods subject to this section, the hospital's Medicare allowable net 
inpatient operating costs for that period (as defined at Sec.  
413.40(a)(3)) are paid on a reasonable cost basis, subject to that 
hospital's ceiling (as determined under paragraph (c)(1) of this 
section) for that period.
    (4) Payment for inpatient capital-related costs. Medicare allowable 
net inpatient capital costs are paid on a reasonable cost basis, in 
accordance with the regulations under Part 413 of this chapter.
    (5) Adjustments for extraordinary circumstances--(i) General rules. 
(A) CMS may adjust the ceiling determined under paragraph (c)(1) of this 
section for one or more cost reporting periods when unusual inpatient 
operating costs have resulted in the hospital exceeding its ceiling 
imposed under this section

[[Page 767]]

due to extraordinary circumstances beyond the hospital's control. These 
circumstances include, but are not limited to, strikes, fire, 
earthquakes, floods, or similar unusual occurrences with substantial 
cost effects.
    (B) When the hospital requests an adjustment, CMS makes an 
adjustment only to the extent that the hospital's operating costs are 
reasonable, attributable to the circumstances specified separately, 
identified by the hospital, and verified by the Medicare administrative 
contractor.
    (ii) Process for adjustment requests. The provisions of Sec. Sec.  
413.40(e)(1) through (e)(5) of this subchapter are applicable to 
extraordinary circumstances adjustment requests under this section.

[79 FR 50356, Aug. 22, 2014]



Sec.  412.529  Special payment provision for short-stay outliers.

    (a) Short-stay outlier defined. ``Short-stay outlier'' means a 
discharge with a covered length of stay in a long-term care hospital 
that is up to and including five-sixths of the geometric average length 
of stay for each LTC-DRG.
    (b) Adjustment to payment. CMS adjusts the hospital's Federal 
prospective payment to account for any case that is determined to be a 
short-stay outlier, as defined in paragraph (a) of this section, under 
the methodology specified in paragraph (c) of this section.
    (c) Method for determining the payment amount--(1) Discharges 
occurring before July 1, 2006. For discharges from long-term care 
hospitals described under Sec.  412.23(e)(2)(i), occurring before July 
1, 2006, the LTCH prospective payment system adjusted payment amount for 
a short-stay outlier case is the least of the following amounts:
    (i) One hundred and twenty (120) percent of the LTC-DRG specific per 
diem amount determined under paragraph (d)(1) of this section.
    (ii) One hundred and twenty (120) percent of the estimated cost of 
the case determined under paragraph (d)(2) of this section.
    (iii) The Federal prospective payment for the LTC-DRG determined 
under paragraph (d)(3) of this section.
    (2) Discharges occurring on or after July 1, 2006 and before July 1, 
2007 and discharges occurring on or after December 29, 2007 and before 
December 29, 2012. For discharges from long-term care hospitals 
described under Sec.  412.23(e)(2)(i) occurring on or after July 1, 2006 
and before July 1, 2007 and discharges occurring on or after December 
29, 2007 and before December 29, 2012, the LTCH prospective payment 
system adjusted payment amount for a short-stay outlier case is the 
least of the following amounts:
    (i) One hundred and twenty (120) percent of the LTC-DRG specific per 
diem amount determined under paragraph (d)(1) of this section.
    (ii) One hundred (100) percent of the estimated cost of the case 
determined under paragraph (d)(2) of this section.
    (iii) The Federal prospective payment for the LTC-DRG as determined 
under paragraph (d)(3) of this section.
    (iv) An amount payable under subpart O computed as a blend of an 
amount comparable to the hospital inpatient prospective payment system 
per diem amount determined under paragraph (d)(4)(i) of this section and 
the 120 percent of the LTC-DRG specific per diem payment amount 
determined under paragraph (d)(1) of this section.
    (A) The blend percentage applicable to the 120 percent of the LTC-
DRG specific per diem payment amount determined under paragraph (d)(1) 
of this section is determined by dividing the covered length-of-stay of 
the case by the lesser of five-sixths of the geometric average length of 
stay of the LTC-DRG or 25 days, not to exceed 100 percent.
    (B) The blend percentage of the amount determined under paragraph 
(d)(4)(i) of this section is determined by subtracting the percentage 
determined in paragraph (A) from 100 percent.
    (3) Discharges occurring on or after July 1, 2007 and before 
December 29, 2007 and discharges occurring on or after December 29, 2012 
and on or before September 30, 2017. For discharges from long-term care 
hospitals described under Sec.  412.23(e)(2)(i) occurring on or after 
July 1, 2007, and on or before December 29, 2007 and discharges 
occurring on or after December 29, 2012, and on or before September 30, 
2017, the

[[Page 768]]

LTCH prospective payment system adjusted payment amount for a short-stay 
outlier case is adjusted by either of the following:
    (i) If the covered length of stay of the case assigned to a 
particular LTC-DRG is less than or equal to one standard deviation from 
the geometric ALOS of the same DRG under the inpatient prospective 
payment system (the IPPS-comparable threshold), the LTCH prospective 
payment system adjusted payment amount for such a case is the least of 
the following amounts:
    (A) One hundred and twenty (120) percent of the LTC-DRG specific per 
diem amount determined under paragraph (d)(1) of this section.
    (B) One hundred (100) percent of the estimated cost of the case 
determined under paragraph (d)(2) of this section.
    (C) The Federal prospective payment for the LTC-DRG as determined 
under paragraph (d)(3) of this section.
    (D) An amount payable under subpart O of this part comparable to the 
hospital inpatient prospective payment system per diem amount determined 
under paragraph (d)(4) of this section.
    (ii) If the covered length of stay of the case assigned to a 
particular LTC-DRG is greater than one standard deviation from the 
geometric ALOS of the same DRG under the inpatient prospective payment 
system (the IPPS-comparable threshold), the LTCH prospective payment 
system adjusted payment amount for such a case is determined under 
paragraph (c)(2) of this section.
    (4) Discharges occurring on or after October 1, 2017. For discharges 
occurring on or after October 1, 2017, short-stay outlier payments are 
determined according to paragraph (c)(2)(iv) of this section.
    (d) Calculation of alternative payment amounts--(1) Determining the 
LTC-DRG per diem amount. CMS calculates the LTC-DRG per diem amount for 
short-stay outliers for each LTC-DRG by dividing the product of the 
standard Federal payment rate and the LTC-DRG relative weight by the 
geometric average length of stay of the specific LTC-DRG multiplied by 
the covered days of the stay.
    (2) Determining the estimated cost of a case. To determine the 
estimated cost of a case, CMS multiplies the hospital-specific cost-to-
charge ratio by the Medicare allowable charges for the case.
    (3) Determining the Federal prospective payment for the LTC-DRG. CMS 
calculates the Federal prospective payment for the LTC-DRG by 
multiplying the adjusted standard Federal payment rate by the LTC-DRG 
relative weight.
    (4) Determining the amount comparable to the hospital inpatient 
prospective payment system per diem amount--(i) General. Under subpart 
O, CMS calculates--
    (A) An amount comparable to what would otherwise be paid under the 
hospital inpatient prospective payment system based on the sum of the 
applicable operating inpatient prospective payment system standardized 
amount and the capital inpatient prospective payment system Federal rate 
in effect at the time of the LTCH discharge.
    (B) An amount comparable to the hospital inpatient prospective 
payment system per diem amount for each DRG that is determined by 
dividing the amount that would otherwise be paid under the hospital 
inpatient prospective payment system computed under paragraph (A) of 
this section by the hospital inpatient prospective payment system 
geometric average length of stay of the specific DRG multiplied by the 
covered days of the stay.
    (C) The payment amount specified under paragraph (d)(4)(i)(B) of 
this section may not exceed the full amount comparable to what would 
otherwise be paid under the hospital inpatient prospective payment 
system determined under paragraph (d)(4)(i)(A) of this section.
    (ii) Hospital inpatient prospective payment system operating 
standardized amount. The hospital inpatient prospective payment system 
operating standardized amount--
    (A) Is adjusted for the applicable hospital inpatient prospective 
payment system DRG weighting factors.
    (B) Is adjusted for different area wage levels based on the 
geographic classifications set forth at Sec.  412.503 and the applicable 
hospital inpatient prospective payment system labor-related share, using 
the applicable hospital inpatient prospective payment system wage index 
value for nonreclassified

[[Page 769]]

hospitals. For LTCHs located in Alaska and Hawaii, this amount is also 
adjusted by the applicable hospital inpatient prospective payment system 
cost of living adjustment factors.
    (C) Includes, where applicable, adjustments for indirect medical 
education costs and the costs of serving a disproportionate share of 
low-income patients.
    (iii) Hospital inpatient prospective payment system capital Federal 
rate. The hospital inpatient prospective payment system capital Federal 
rate--
    (A) Is adjusted for the applicable inpatient prospective payment 
system DRG weighting factors.
    (B) Is adjusted for the applicable geographic adjustment factors, 
including local cost variation based on the geographic classifications 
set forth at Sec.  412.503 and the applicable full hospital inpatient 
prospective payment system wage index value for nonreclassified 
hospitals and, applicable large urban location cost of living adjustment 
factors for LTCHs in Alaska and Hawaii, if applicable.
    (C) Includes, where applicable, adjustments for indirect medical 
education costs and the costs of serving a disproportionate share of 
low-income patients.
    (e) Short-stay outlier payments to long-term care hospitals 
described under Sec.  412.23(e)(2)(ii).
    (1) For discharges occurring on or after October 1, 2002, through 
June 30, 2003, the LTCH prospective payment system adjusted payment 
amount for a short-stay outlier case is the least of the following 
amounts:
    (i) 120 percent of the LTC-DRG specific per diem amount determined 
under paragraph (d)(1) of this section;
    (ii) 120 percent of the estimated cost of the case determined under 
paragraph (d)(2) of this section; or
    (iii) The Federal prospective payment for the LTC-DRG determined 
under paragraph (d)(3) of this section.
    (2) For discharges occurring on or after July 1, 2003, subject to 
the provisions of paragraph (e)(2)(v) of this section, the adjusted 
payment amount for a short-stay outlier is determined under the formulas 
set forth in paragraphs (e)(1)(i) through (iv) of this section with the 
following substitutions:
    (i) For the first year of the transition period, as specified at 
Sec.  412.533(a)(1), the 120 percent specified for the LTC-DRG specific 
per diem amount and the 120 percent of the cost of the case in the 
formula under paragraphs (e)(1)(i) and (e)(1)(ii) of this section are 
substituted with 195 percent.
    (ii) For the second year of the transition period, as specified at 
Sec.  412.533(a)(2), the 120 percent specified for the LTC-DRG specific 
per diem amount and the 120 percent of the cost of the case in the 
formula under paragraphs (e)(1)(i) and (e)(1)(ii) of this section are 
substituted with 193 percent.
    (iii) For the third year of the transition period, as specified at 
Sec.  412.533(a)(3), the 120 percent specified for the LTC-DRG specific 
per diem amount and the 120 percent of the cost of the case in the 
formula under paragraphs (e)(1)(i) and (e)(1)(ii) of this section are 
substituted with 165 percent.
    (iv) For the fourth year of the transition period, as specified at 
Sec.  412.533(a)(4), the 120 percent specified for the LTC-DRG specific 
per diem amount and 120 percent of the cost of the case in the formula 
under paragraphs (e)(1)(i) and (e)(1)(ii) of this section are 
substituted with 136 percent.
    (v) For discharges occurring in cost reporting periods beginning on 
or after October 1, 2006 (beginning with the fifth year of the 
transition period), as specified at Sec.  412.533(a)(5), short-stay 
outlier payments are made based on the least of the following amounts:
    (A) 120 percent of the LTC-DRG specific per diem amount determined 
under paragraph (d)(1) of this section;
    (B) 120 percent of the estimated cost of the case determined under 
paragraph (d)(2) of this section; or
    (C) The Federal prospective payment for the LTC-DRG determined under 
paragraph (d)(3) of this section.
    (f) Reconciliation of short-stay payments. Payments for discharges 
occurring before October 1, 2017 are reconciled in accordance with one 
of the following:
    (1) Discharges occurring on or after October 1, 2002, and before 
August 8, 2003. For discharges occurring on or after October 1, 2002, 
and before August 8, 2003, no reconciliations are made to short-stay 
outlier payments upon cost

[[Page 770]]

report settlement to account for differences between cost-to-charge 
ratio and the actual cost-to-charge ratio of the case.
    (2) Discharges occurring on or after August 8, 2003, and before 
October 1, 2006. For discharges occurring on or after August 8, 2003, 
and before October 1, 2006, short-stay outlier payments are subject to 
the provisions of Sec.  412.84(i)(1), (i)(3), and (i)(4) and (m) for 
adjustments of cost-to-charge ratios.
    (3) Discharges occurring on or after October 1, 2003, and before 
October 1, 2006. For discharges occurring on or after October 1, 2003, 
and before October 1, 2006, short-stay outlier payments are subject to 
the provisions of Sec.  412.84(i)(2) for adjustments to cost-to-charge 
ratios.
    (4) Discharges occurring on or after October 1, 2006. For discharges 
occurring on or after October 1, 2006, short-stay outlier payments are 
subject to the following provisions:
    (i) CMS may specify an alternative to the cost-to-charge ratio 
otherwise applicable under paragraph (f)(4)(ii) of this section. A 
hospital may also request that its fiscal intermediary use a different 
(higher or lower) cost-to-charge ratio based on substantial evidence 
presented by the hospital. This request must be approved by the 
appropriate CMS Regional Office.
    (ii) The cost-to-charge ratio applied at the time a claim is 
processed is based on either the most recent settled cost report or the 
most recent tentatively settled cost report, whichever is from the 
latest cost reporting period.
    (iii) The fiscal intermediary may use a statewide average cost-to-
charge ratio, which CMS establishes annually, if it is unable to 
determine an accurate cost-to-charge ratio for a hospital in one of the 
following circumstances:
    (A) A new hospital that has not yet submitted its first Medicare 
cost report. (For this purpose, a new hospital is defined as an entity 
that has not accepted assignment of an existing hospital's provider 
agreement in accordance with Sec.  489.18 of this chapter.)
    (B) A hospital whose cost-to-charge ratio is in excess of 3 standard 
deviations above the corresponding national geometric mean. CMS 
establishes and publishes this mean annually.
    (C) Any other hospital for which data to calculate a cost-to-charge 
ratio are not available.
    (iv) Any reconciliation of outlier payments is based on the cost-to-
charge ratio calculated based on a ratio of costs to charges computed 
from the relevant cost report and charge data determined at the time the 
cost report coinciding with the discharge is settled.
    (v) At the time of any reconciliation under paragraph (f)(4)(iv) of 
this section, outlier payments may be adjusted to account for the time 
value of any underpayments or overpayments. Any adjustment is based upon 
a widely available index to be established in advance by the Secretary, 
and is applied from the midpoint of the cost reporting period to the 
date of reconciliation.

[67 FR 56049, Aug. 30, 2002, as amended at 68 FR 34163, June 6, 2003; 68 
FR 34515, June 9, 2003; 71 FR 27899, May 12, 2006; 71 FR 48141, Aug. 18, 
2006; 72 FR 26991, May 11, 2007; 73 FR 24880, May 6, 2008; 73 FR 26839, 
May 9, 2008; 75 FR 50416, Aug. 16, 2010; 77 FR 53679, Aug. 31, 2012; 82 
FR 38513, Aug. 14, 2017]



Sec.  412.531  Special payment provisions when an interruption of a stay 
occurs in a long-term care hospital.

    (a) Definitions--(1) A 3-day or less interruption of stay defined. 
``A 3-day or less interruption of stay'' means a stay at a long-term 
care hospital during which a Medicare inpatient is discharged from the 
long-term care hospital to an acute care hospital, IRF, SNF, or the 
patient's home and readmitted to the same long-term care hospital within 
3 days of the discharge from the long-term care hospital. The 3-day or 
less period begins with the date of discharge from the long-term care 
hospital and ends not later than midnight of the third day.
    (2) A greater than 3-day interruption of stay defined. ``A greater 
than 3-day or less interruption of stay'' means A stay in a long-term 
care hospital during which a Medicare inpatient is discharged from the 
long-term care hospital to an acute care hospital, an IRF, or a SNF for 
a period of greater than 3 days but within the applicable fixed-day 
period specified in paragraphs

[[Page 771]]

(a)(2)(i) through (a)(2)(iii) of this section before being readmitted to 
the same long-term care hospital.
    (i) For a discharge to an acute care hospital, the applicable fixed 
day period is between 4 and 9 consecutive days. The counting of the days 
begins on the date of discharge from the long-term care hospital and 
ends on the 9th date after the discharge.
    (ii) For a discharge to an IRF, the applicable fixed day period is 
between 4 and 27 consecutive days. The counting of the days begins on 
the day of discharge from the long-term care hospital and ends on the 
27th day after discharge.
    (iii) For a discharge to a SNF, the applicable fixed day period is 
between 4 and 45 consecutive days. The counting of the days begins on 
the day of discharge from the long-term care hospital and ends on the 
45th day after the discharge.
    (b) Methods of determining payments. (1) For purposes of determining 
a Federal prospective payment--
    (i) Determining the length of stay. In determining the length of 
stay of a patient at a long-term care hospital for payment purposes 
under this paragraph (b)--
    (A) Except as specified in paragraphs (b)(1)(i)(B) and (b)(1)(i)(C) 
of this section, the number of days that a beneficiary spends away from 
the long-term care hospital during a 3-day or less interruption of stay 
under paragraph (a)(1) of this section is not included in determining 
the length of stay of the patient at the long-term care hospital when 
there is no outpatient or inpatient medical treatment or care provided 
at an acute care hospital or an IRF, or SNF services during the 
interruption that is considered a covered service delivered to the 
beneficiary.
    (B) The number of days that a beneficiary spends away from a long-
term care hospital during a 3-day or less interruption of stay under 
paragraph (a)(1) of this section are counted in determining the length 
of stay of the patient at the long-term care hospital if the beneficiary 
receives inpatient or outpatient medical care or treatment provided by 
an acute care hospital or IRF, or SNF services during the interruption. 
In the case where these services are provided during some, but not all 
days of a 3-day or less interruption, Medicare will include all days of 
the interruption in the long-term care hospitals day-count.
    (C) Surgical DRG exception to the 3-day or less interruption of stay 
policy.
    (1) The number of days that a beneficiary spends away from a long-
term care hospital during a 3-day or less interruption of stay under 
paragraph (a)(1) of this section during which the beneficiary receives a 
procedure grouped to a surgical DRG under the hospital inpatient 
prospective payment system in an acute care hospital during the 2005 and 
2006 LTCH prospective payment system rate years are not included in 
determining the length of stay of the patient at the long-term care 
hospital.
    (2) For discharges occurring on or after July 1 2006, the number of 
days that a beneficiary spends away from a long-term care hospital 
during a 3-day or less interruption of stay under paragraph (a)(1) of 
this section during which the beneficiary receives a procedure grouped 
to a surgical DRG under the hospital inpatient prospective payment 
system in an acute care hospital are included in determining the length 
of stay of the patient at the long-term care hospital.
    (D) The number of days that a beneficiary spends away from a LTCH 
during a greater than 3-day interruption of stay, as defined in 
paragraph (a)(2) of this section, is not included in determining the 
length of stay at the LTCH.
    (ii) Determining how payment is made. (A) Subject to the provisions 
of paragraphs (b)(1)(ii)(A)(1) and (b)(1)(ii)(A)(2) of this section, for 
a 3-day or less interruption of stay under paragraph (a)(1) of this 
section, the entire stay is paid as a single discharge from the long-
term care hospital. CMS makes only one LTC-DRG payment for all portions 
of a long-term care stay.
    (1) For a 3-day or less interruption of stay under paragraph (a)(1) 
of this section in which a long-term care hospital discharges a patient 
to an acute care hospital and the patient's treatment during the 
interruption is grouped into a surgical DRG under the acute care 
inpatient hospital prospective payment system, for the LTCH 2005 and 
2006 rate

[[Page 772]]

years, CMS also makes a separate payment to the acute care hospital for 
the surgical DRG discharge in accordance with paragraph (b)(1)(i)(C) of 
this section.
    (2) For discharges occurring on or after July 1, 2006, for a 3-day 
or less interruption of stay under paragraph (a)(1) of this section in 
which a long-term care hospital discharges a patient to an acute care 
hospital and the patient's treatment during the interruption is grouped 
into a surgical DRG under the acute care hospital inpatient prospective 
payment system, the services must be provided under arrangements in 
accordance with Sec.  412.509(c). CMS does not make a separate payment 
to the acute care hospital for the surgical treatment. The LTC-DRG 
payment made to the long-term care hospital is considered payment in 
full as specified in Sec.  412.521(b).
    (3) For a 3-day or less interruption of stay under paragraph (a)(1) 
of this section during which the patient receives inpatient or 
outpatient treatment or services at an acute care hospital or IRF, or 
SNF services, that are not otherwise excluded under Sec.  412.509(a), 
the services must be provided under arrangements in accordance with 
Sec.  412.509(c). CMS does not make a separate payment to the acute care 
hospital, IRF, or SNF for these services. The LTC-DRG payment made to 
the long-term care hospital is considered payment in full as specified 
in Sec.  412.521(b).
    (B) For a greater than 3-day interruption of stay under paragraph 
(a)(2) of this section, CMS will make only one LTC-DRG payment for all 
portions of a long-term care stay. CMS also separately pays the acute 
care hospital, the IRF, or the SNF in accordance with their respective 
payment systems, as specified in paragraph (c) of this section.
    (iii) Basis for the prospective payment. Payment to the long-term 
care hospital is based on the patient's LTC-DRG that is determined in 
accordance with Sec.  412.513(b).
    (2) If the total number of days of a patient's length of stay in a 
long-term care hospital prior to and following a 3-day or less 
interruption of stay under paragraphs (b)(1)(i)(A), (B), or (C) of this 
section or a greater than 3-day interruption of stay under paragraph 
(b)(1)(i)(D) of this section is up to and including five-sixths of the 
geometric average length of stay of the LTC-DRG, CMS will make a Federal 
prospective payment for a short-stay outlier in accordance with Sec.  
412.529(c).
    (3) If the total number of days of a patient's length of stay in a 
long-term care hospital prior to and following a 3-day or less 
interruption of stay under paragraphs (b)(1)(i)(A), (B), or (C) of this 
section or a greater than 3-day interruption of stay under paragraph 
(b)(1)(i)(D) of this section exceeds five-sixths of the geometric 
average length of stay for the LTC-DRG, CMS will make one full Federal 
LTC-DRG prospective payment for the case. An additional payment will be 
made if the patient's stay qualifies as a high-cost outlier, as set 
forth in Sec.  412.525(a).
    (4) Notwithstanding the provisions of paragraph (a) of this section, 
if a patient who has been discharged from a long-term care hospital to 
another facility and is readmitted to the long-term care hospital for 
additional treatment or services in the long-term care hospital 
following the stay at the other facility, the subsequent admission to 
the long-term care hospital is considered a new stay, even if the case 
is determined to fall into the same LTC-DRG, and the long-term care 
hospital will receive two separate Federal prospective payments if one 
of the following conditions are met:
    (i) The patient has a length of stay in the acute care hospital that 
exceeds 9 days from the day of discharge from the long-term care 
hospital;
    (ii) The patient has a length of stay in the IRF that exceeds 27 
days from the day of discharge from the long-term care hospital; or
    (iii) The patient has a length of stay in the SNF that exceeds 45 
days from the day of discharge from the long-term care hospital.
    (c) Payments to an acute care hospital, an IRF, or a SNF during an 
interruption of a stay. (1) Payment to the acute care hospital for the 
acute care hospital stay following discharge from the long-term care 
hospital will be paid in accordance with the acute care hospital

[[Page 773]]

inpatient prospective payment systems specified in Sec.  412.1(a)(1).
    (2) Payment to an IRF for the IRF stay following a discharge from 
the long-term care hospital will be paid in accordance with the IRF 
prospective payment system specified in Sec.  412.624 of subpart P of 
this part.
    (3) Payment to a SNF for the SNF stay following a discharge from the 
long-term care hospital will be paid in accordance with the SNF 
prospective payment system specified in subpart J of part 413 of this 
subchapter.

[67 FR 56049, Aug. 30, 2002, as amended at 69 FR 25721, May 7, 2004; 70 
FR 24222, May 6, 2005; 71 FR 27900, May 12, 2006]



Sec.  412.533  Transition payments.

    (a) Duration of transition periods. Except for a long-term care 
hospital that makes an election under paragraph (c) of this section or 
for a long-term care hospital that is defined as new under Sec.  
412.23(e)(4), for cost reporting periods beginning on or after October 
1, 2002, and before October 1, 2006, a long-term care hospital receives 
a payment comprised of a blend of the adjusted Federal prospective 
payment as determined under Sec.  412.523, and the payment determined 
under the cost-based reimbursement rules under Part 413 of this 
subchapter.
    (1) For cost reporting periods beginning on or after October 1, 2002 
and before October 1, 2003, payment is based on 20 percent of the 
Federal prospective payment rate and 80 percent of the cost-based 
reimbursement rate.
    (2) For cost reporting periods beginning on or after October 1, 2003 
and before October 1, 2004, payment is based on 40 percent of the 
Federal prospective payment rate and 60 percent of the cost-based 
reimbursement rate.
    (3) For cost reporting periods beginning on or after October 1, 2004 
and before October 1, 2005, payment is based on 60 percent of the 
Federal prospective payment rate and 40 percent of the cost-based 
reimbursement rate.
    (4) For cost reporting periods beginning on or after October 1, 2005 
and before October 1, 2006, payment is based on 80 percent of the 
Federal prospective payment rate and 20 percent of the cost-based 
reimbursement rate.
    (5) For cost reporting periods beginning on or after October 1, 
2006, payment is based entirely on the adjusted Federal prospective 
payment rate.
    (b) Adjustments based on reconciliation of cost reports. The cost-
based percentage of the provider's total Medicare payment under 
paragraphs (a)(1) through (a)(4) of this section are subject to 
adjustments based on reconciliation of cost reports.
    (c) Election not to be paid under the transition period methodology. 
A long-term care hospital may elect to be paid based on 100 percent of 
the Federal prospective rate at the start of any of its cost reporting 
periods during the 5-year transition periods specified in paragraph (a) 
of this section. Once a long-term care hospital elects to be paid based 
on 100 percent of the Federal prospective payment rate, it may not 
revert to the transition blend.
    (1) General requirement. A long-term care hospital must notify its 
fiscal intermediary of its intent to elect to be paid based on 100 
percent of the Federal prospective rate at the start of any of its cost 
reporting periods during the 5-year transition period specified in 
paragraph (a) of this section.
    (2) Notification requirement to make election. (i) The request by 
the long-term care hospital to make the election under paragraph (c)(1) 
of this section must be made in writing to the Medicare fiscal 
intermediary.
    (ii) For cost reporting periods that begin on or after October 1, 
2002 through November 30, 2002, the fiscal intermediary must receive the 
notification of the election before November 1, 2002.
    (iii) For cost reporting periods that begin on or after December 1, 
2002 through September 30, 2006, the fiscal intermediary must receive 
the notification of the election on or before the 30th day before the 
applicable cost reporting period begins.
    (iv) The fiscal intermediary must receive the notification by the 
dates specified in paragraphs (c)(2)(ii) and (c)(2)(iii) of this 
section, regardless of any postmarks or anticipated delivery dates. 
Requests received, postmarked, or delivered by other means after the 
dates specified in paragraphs (c)(2)(ii) and (c)(2)(iii) of this section 
will not be

[[Page 774]]

accepted. If the date specified in paragraphs (c)(2)(ii) and (c)(2)(iii) 
of this section falls on a day that the postal service or other delivery 
sources are not open for business, the long-term care hospital is 
responsible for allowing sufficient time for the delivery of the 
notification before the deadline.
    (v) If a long-term care hospital's notification is not received by 
the dates specified in paragraphs (c)(2)(ii) and (c)(2)(iii) of this 
section, payment will be based on the transition period rates specified 
in paragraphs (a)(1) through (a)(5) of this section.
    (d) Payments to new long-term care hospitals. A new long-term care 
hospital, as defined in Sec.  412.23(e)(4), will be paid based on 100 
percent of the standard Federal rate, as described in Sec.  412.523, 
with no transition payments, as described in Sec.  412.533(a)(1) through 
(a)(5).



Sec.  412.534  Special payment provisions for long-term care 
hospitals-within-hospitals and satellites of long-term care hospitals, 
effective for discharges occurring in cost reporting periods beginning on 
or before September 30, 2016.

    (a) Scope. Except as provided in paragraph (h), the policies set 
forth in this section apply to discharges occurring in cost reporting 
periods beginning on or after October 1, 2004 from long-term care 
hospitals as described in Sec.  412.23(e)(2)(i) meeting the criteria in 
Sec.  412.22(e)(2), or satellite facilities of long-term care hospitals 
that meet the criteria in Sec.  412.22(h).
    (b) Patients admitted from hospitals not located in the same 
building or on the same campus as the long-term care hospital or long-
term care hospital satellite--(1) For cost reporting periods beginning 
on or after October 1, 2004 and before July 1, 2007. Payments to the 
long-term care hospital as described in Sec.  412.23(e)(2)(i) meeting 
the criteria in Sec.  412.22(e)(2) for patients admitted to the long-
term care hospital or to a long-term care hospital satellite facility as 
described in Sec.  412.23(e)(2)(i) that meets the criteria of Sec.  
412.22(h) from another hospital that is not the co-located hospital are 
made under the rules in this subpart with no adjustment under this 
section.
    (2) For cost reporting periods beginning on or after July 1, 2007. 
For cost reporting periods beginning on or after July 1, 2007, payments 
to one of the following long-term care hospitals or long-term care 
hospital satellites are subject to the provisions of Sec.  412.536 of 
this subpart:
    (i) A long-term care hospital as described in Sec.  412.23(e)(2)(i) 
of this part that meets the criteria of Sec.  412.22(e) of this part.
    (ii) Except as provided in paragraph (h) of this section, a long-
term care hospital as described in Sec.  412.23(e)(2)(i) of this part 
that meets the criteria of Sec.  412.22(f) of this part.
    (iii) A long-term care hospital satellite facility as described in 
Sec.  412.23(e)(2)(i) of this part that meets the criteria in Sec.  
412.22(h) or Sec.  412.22(h)(3)(i) of this part.
    (c) Patients admitted from the hospital located in the same building 
or on the same campus as the long-term care hospital or satellite 
facility. Except for a long-term care hospital or a long-term care 
hospital satellite facility that meets the requirements of paragraphs 
(d) or (e) of this section, payments to the long-term care hospital for 
patients admitted to it or to its long-term care hospital satellite 
facility from the co-located hospital are made under either of the 
following:
    (1) For cost reporting periods beginning on or after October 1, 2004 
and before October 1, 2007 and for cost reporting periods beginning on 
or after October 1, 2016. (i) Except as provided in paragraphs (c)(3), 
(g), and (h) of this section, for any cost reporting period beginning on 
or after October 1, 2004 and before October 1, 2007, and for cost 
reporting periods beginning on or after October 1, 2016 in which the 
long-term care hospital or its satellite facility has a discharged 
Medicare inpatient population of whom no more than 25 percent were 
admitted to the hospital or its satellite facility from the co-located 
hospital, payments are made under the rules at Sec. Sec.  412.500 
through 412.541 with no adjustment under this section.
    (ii) Except as provided in paragraph (g) or (h) of this section, for 
any cost reporting period beginning on or after October 1, 2004 and 
before October 1, 2007 and for cost reporting periods beginning on or 
after October 1, 2013 in which the long-term care hospital or

[[Page 775]]

satellite facility has a discharged Medicare inpatient population of 
whom more than 25 percent were admitted to the hospital or satellite 
facility from the co-located hospital, payments for the patients who are 
admitted from the co-located hospital and who cause the long-term care 
hospital or satellite facility to exceed the 25 percent threshold for 
discharged patients who have been admitted from the co-located hospital 
are the lesser of the amount otherwise payable under this subpart or the 
amount payable under this subpart that is equivalent, as set forth in 
paragraph (f) of this section, to the amount that would be determined 
under the rules at Sec.  412.1(a). Payments for the remainder of the 
long-term care hospital's or satellite facility's patients are made 
under the rules in this subpart at Sec. Sec.  412.500 through 412.541 
with no adjustment under this section.
    (iii) In determining the percentage of patients admitted to the 
long-term care hospital or its satellite from the co-located hospital 
under paragraphs (c)(1)(i) and (c)(1)(ii) of this section, patients on 
whose behalf an outlier payment was made to the co-located hospital are 
not counted towards the 25 percent threshold.
    (2) For cost reporting periods beginning on or after October 1, 2007 
and before October 1, 2016. (i) Except for a long-term care hospital or 
a long-term care hospital satellite facility subject to paragraph (g) or 
(h) of this section, payments are determined using the methodology 
specified in paragraph (c)(1) of this section.
    (ii) Payments for a long-term care hospital or long-term care 
hospital satellite facility subject to paragraph (g) of this section are 
determined using the methodology specified in paragraph (c)(1) of this 
section except that 25 percent is substituted with 50 percent.
    (3) For a long-term care hospital satellite facility described in 
Sec.  412.22(h)(3)(i), for cost reporting periods beginning on or after 
July 1, 2007 and before July 1, 2016, payments will be determined using 
the methodology specified in paragraph (c)(1) of this section, except 
that the applicable percentage threshold for Medicare discharges is 50 
percent.
    (d) Special treatment of rural hospitals--(1) For cost reporting 
periods beginning on or after October 1, 2004 and before October 1, 2007 
and for cost reporting periods beginning on or after October 1, 2016. 
(i) Subject to paragraphs (g) and (h) of this section, in the case of a 
long-term care hospital or satellite facility that is located in a rural 
area as defined in Sec.  412.503 and is co-located with another hospital 
for any cost reporting period beginning on or after October 1, 2004 and 
before October 1, 2007 and for any cost reporting period beginning on or 
after October 1, 2016 in which the long-term care hospital or long-term 
care satellite facility has a discharged Medicare inpatient population 
of whom more than 50 percent were admitted to the long-term care 
hospital or satellite facility from the co-located hospital, payments 
for the patients who are admitted from the co-located hospital and who 
cause the long-term care hospital or satellite facility to exceed the 50 
percent threshold for discharged patients who were admitted from the co-
located hospital are the lesser of the amount otherwise payable under 
this subpart or the amount payable under this subpart that is 
equivalent, as set forth in paragraph (f) of this section, to the amount 
that were otherwise payable under Sec.  412.1(a). Payments for the 
remainder of the long-term care hospital's or long-term care hospital 
satellite facility's patients are made under the rules in this subpart 
at Sec. Sec.  412.500 through 412.541 with no adjustment under this 
section.
    (ii) In determining the percentage of patients admitted from the co-
located hospital under paragraph (d)(1)(i) of this section, patients on 
whose behalf outlier payment was made at the co-located hospital are not 
counted toward the 50 percent threshold.
    (2) For cost reporting periods beginning on or after October 1, 
2007, and before October 1, 2016. (i) Except for a long-term care 
hospital or a long-term care hospital satellite facility subject to 
paragraph (g) or (h) of this section, payments are determined using the 
methodology specified in paragraph (d)(1) of this section.
    (ii) Payments for long-term care hospitals and long-term care 
hospital satellite facilities subject to paragraph (g)

[[Page 776]]

of this section are determined using the methodology specified in 
paragraph (d)(1) of this section except that 50 percent is substituted 
with 75 percent.
    (3) For cost reporting periods beginning on or after July 1, 2007 
and before July 1, 2016, payment for a long-term care hospital satellite 
facility described in Sec.  412.22(h)(3)(i) will be determined using the 
methodology specified in paragraph (c)(1) of this section, except that 
the applicable percentage threshold for Medicare discharges is 75 
percent.
    (e) Special treatment of urban single or MSA-dominant hospitals--(1) 
For cost reporting periods beginning on or after October 1, 2004 and 
before October 1, 2007 and for cost reporting periods beginning on or 
after October 1, 2016. (i) Subject to paragraphs (g) and (h) of this 
section, in the case of a long-term care hospital or a long-term care 
hospital satellite facility that is co-located with the only other 
hospital in the MSA or with a MSA-dominant hospital as defined in 
paragraph (e)(1)(iv) of this section, for any cost reporting period 
beginning on or after October 1, 2004, and before October 1, 2007 and 
for any cost reporting periods beginning on or after October 1, 2016, in 
which the long-term care hospital or long-term care hospital satellite 
facility has a discharged Medicare inpatient population of whom more 
than the percentage calculated under paragraph (e)(1)(ii) of this 
section were admitted to the hospital from the co-located hospital, 
payments for the patients who are admitted from the co-located hospital 
and who cause the long-term care hospital to exceed the applicable 
threshold for discharged patients who have been admitted from the co-
located hospital are the lesser of the amount otherwise payable under 
this subpart or the amount under this subpart that is equivalent, as set 
forth in paragraph (f) of this section, to the amount that otherwise 
would be determined under Sec.  412.1(a). Payments for the remainder of 
the long-term care hospital's or satellite facility's patients are made 
under the rules in this subpart with no adjustment under this section.
    (ii) For purposes of paragraph (e)(1)(i) of this section, the 
percentage used is the percentage of total Medicare discharges in the 
Metropolitan Statistical Area in which the hospital is located that are 
from the co-located hospital for the cost reporting period for which the 
adjustment was made, but in no case is less than 25 percent or more than 
50 percent.
    (iii) In determining the percentage of patients admitted from the 
co-located hospital under paragraph (e)(1)(i) of this section, patients 
on whose behalf outlier payment was made at the co-located hospital are 
not counted toward the applicable threshold.
    (iv) For purposes of this paragraph, an ``MSA-dominant hospital'' is 
a hospital that has discharged more than 25 percent of the total 
hospital Medicare discharges in the MSA in which the hospital is 
located.
    (2) For cost reporting periods beginning on or after October 1, 2007 
and before October 1, 2016. (i) Except for a long-term care hospital or 
a long-term care hospital satellite facility subject to paragraph (g) or 
(h) of this section, payments are determined using the methodology 
specified in paragraph (e)(1) of this section.
    (ii) Payments for a long-term care hospital or long-term care 
hospital satellite facilities subject to paragraph (g) of this section 
are determined using the methodology specified in paragraph (e)(1) of 
this section except that the percentage of Medicare discharges that may 
be admitted from the co-located hospital without being subject to the 
payment adjustment at paragraph (e)(1) of this section is 75 percent.
    (3) For cost reporting periods beginning on or after July 1, 2007 
and before July 1, 2016, payments for a long-term care hospital 
satellite facility described in Sec.  412.22(h)(3)(i) will be determined 
using the methodology specified in paragraph (c)(1) of this section, 
except that the applicable percentage threshold for Medicare discharges 
is 75 percent.
    (f) Calculation of rates--(1) Calculation of LTCH prospective 
payment system amount. CMS calculates an amount payable under subpart O 
equivalent to an amount that would otherwise be paid under the hospital 
inpatient prospective payment system based on the

[[Page 777]]

sum of the applicable hospital inpatient prospective payment system 
operating standardized amount and capital Federal rate in effect at the 
time of the LTCH discharge.
    (2) Operating inpatient prospective payment system standardized 
amount. The hospital inpatient prospective payment system operating 
standardized amount--
    (i) Is adjusted for the applicable hospital inpatient prospective 
payment system DRG weighting factors;
    (ii) Is adjusted for different area wage levels based on the 
geographic classifications set forth at Sec.  412.503 and the applicable 
hospital inpatient prospective payment system labor-related share, using 
the applicable hospital inpatient prospective payment system wage index 
value for non-reclassified hospitals. For LTCHs located in Alaska and 
Hawaii, this amount is also adjusted by the applicable hospital 
inpatient prospective payment system cost of living adjustment factors;
    (iii) Includes, where applicable, adjustments for indirect medical 
education costs and the costs of serving a disproportionate share of 
low-income patients.
    (3) Hospital inpatient prospective payment system capital Federal 
rate. The hospital inpatient prospective payment system capital Federal 
rate--
    (i) Is adjusted for the applicable hospital inpatient prospective 
payment system DRG weighting factors;
    (ii) Is adjusted by the applicable geographic adjustment factors, 
including local cost variation based on the applicable geographic 
classifications set forth at Sec.  412.503 and the applicable full 
hospital inpatient prospective payment system wage index value for 
nonreclassified hospitals, applicable large urban location and cost of 
living adjustment factors for LTCHs for Alaska and Hawaii, if 
applicable;
    (iii) Includes, where applicable, capital inpatient prospective 
payment system adjustments for indirect medical education costs and the 
costs of serving a disproportionate share of low-income patients.
    (4) High cost outlier. An additional payment for high cost outlier 
cases is based on the fixed loss amount established for the hospital 
inpatient prospective payment system.
    (g) Transition period for long-term care hospitals and satellite 
facilities paid under this subpart. Except as specified in paragraph 
(h)(2), in the case of a long-term care hospital or a satellite facility 
that is paid under the provisions of this subpart on October 1, 2004 or 
of a hospital that is paid under the provisions of this subpart and 
whose qualifying period under Sec.  412.23(e) began on or before October 
1, 2004, the amount paid is calculated as specified below:
    (1) For each discharge during the first cost reporting period 
beginning on or after October 1, 2004, and before October 1, 2005, the 
amount paid is the amount payable under this subpart with no adjustment 
under this section but the hospital may not exceed the percentage of 
patients admitted from the host during its FY 2004 cost reporting 
period.
    (2) For each discharge during the cost reporting period beginning on 
or after October 1, 2005, and before October 1, 2006, the percentage 
that may be admitted from the host with no payment adjustment may not 
exceed the lesser of the percentage of patients admitted from the host 
during its FY 2004 cost reporting period or 75 percent.
    (3) For each discharge during the cost reporting period beginning on 
or after October 1, 2006, and before October 1, 2007, the percentage 
that may be admitted from the host with no payment adjustment may not 
exceed the lesser of the percentage of patients admitted from the host 
during its FY 2004 cost reporting period or 50 percent.
    (4) For each discharge during cost reporting periods beginning on or 
after October 1, 2007, the percentage that may be admitted from the host 
with no payment adjustment may not exceed 25 percent or the applicable 
percentage determined under paragraph (d) or (e) of this section.
    (h) Effective date of policies in this section for certain co-
located long-term care hospitals and satellite facilities of long-term 
care hospitals. Except as specified in paragraph (h)(4) of this section, 
the policies set forth in this paragraph (h) apply to Medicare patient 
discharges

[[Page 778]]

that were admitted from a hospital located in the same building or on 
the same campus as a long-term care hospital described in Sec.  
412.23(e)(2)(i) that meets the criteria in Sec.  412.22(f) and a 
satellite facility of a long-term care hospital as described under Sec.  
412.22(h)(3)(i) for discharges occurring in cost reporting periods 
beginning on or after July 1, 2007.
    (1) Except as specified in paragraph (h)(4) of this section, in the 
case of a long-term care hospital or long-term care hospital satellite 
facility that is described under this paragraph (h), the thresholds 
applied at paragraphs (c), (d), and (e) of this section are not less 
than the following percentages:
    (i) For cost reporting periods beginning on or after July 1, 2007 
and before July 1, 2008, the lesser of 75 percent of the total number of 
Medicare discharges that were admitted to the long-term care hospital or 
long-term care hospital satellite facility from its co-located hospital 
during the cost reporting period or the percentage of Medicare 
discharges that had been admitted to the long-term care hospital or 
satellite from that co-located hospital during the long-term care 
hospital's or satellite's RY 2005 cost reporting period.
    (ii) For cost reporting periods beginning on or after July 1, 2008 
and before July 1, 2009, the lesser of 50 percent of the total number of 
Medicare discharges that were admitted to the long-term care hospital or 
the long-term care hospital satellite facility from its co-located 
hospital or the percentage of Medicare discharges that had been admitted 
from that co-located hospital during the long-term care hospital's or 
satellite's RY 2005 cost reporting period.
    (iii) For cost reporting periods beginning on or after July 1, 2009, 
25 percent of the total number of Medicare discharges that were admitted 
to the long-term care hospital or satellite from its co-located hospital 
during the cost reporting period.
    (2) In determining the percentage of Medicare discharges admitted 
from the co-located hospital under this paragraph, patients on whose 
behalf a Medicare high cost outlier payment was made at the co-located 
referring hospital are not counted toward this threshold.
    (3) Except as specified in paragraph (h)(4) of this section, for 
cost reporting periods beginning on or after July 1, 2007, payments to 
long term care hospitals described in Sec.  412.23(e)(2)(i) that meet 
the criteria in Sec.  412.22(f) and satellite facilities of long-term 
care hospitals described at Sec.  412.22(h)(3)(i) are subject to the 
provisions of Sec.  412.536 for discharges of Medicare patients who are 
admitted from a hospital not located in the same building or on the same 
campus as the LTCH or LTCH satellite facility.
    (4) For a long-term care hospital described in Sec.  412.23(e)(2)(i) 
that meets the criteria in Sec.  412.22(f), the policies set forth in 
this paragraph (h) and in Sec.  412.536 do not apply for discharges 
occurring in cost reporting periods beginning on or after July 1, 2007.
    (5) For a long-term care hospital or a satellite facility that, as 
of December 29, 2007, was co-located with an entity that is a provider-
based, off-campus location of a subsection (d) hospital which did not 
provide services payable under section 1886(d) of the Act at the off-
campus location, the policies set forth in this paragraph (h) and in 
Sec.  412.536 do not apply for discharges occurring in cost reporting 
periods beginning on or after July 1, 2007 and before July 1, 2016.

[69 FR 49251, Aug. 11, 2004, as amended at 69 FR 78529, Dec. 30, 2004; 
71 FR 27900, May 12, 2006; 72 FR 26992, May 11, 2007; 73 FR 26839, May 
9, 2008; 73 FR 29709, May 22, 2008; 74 FR 43998, Aug. 27, 2009; 75 FR 
50416, Aug. 16, 2010; 77 FR 53679, Aug. 31, 2012; 77 FR 63752, Oct. 17, 
2012; 79 FR 50356, Aug. 22, 2014]



Sec.  412.535  Publication of the Federal prospective payment rates.

    Except as specified in paragraph (b), CMS publishes information 
pertaining to the long-term care hospital prospective payment system 
effective for each annual update in the Federal Register.
    (a) For the period beginning on or after July 1, 2003 and ending on 
June 30, 2008, information on the unadjusted Federal payment rates and a 
description of the methodology and data used to calculate the payment 
rates are published on or before May 1 prior to the

[[Page 779]]

start of each long-term care hospital prospective payment system rate 
year which begins July 1, unless for good cause it is published after 
May 1, but before June 1.
    (b) For the period beginning on July 1, 2008 and ending on September 
30, 2009, information of the unadjusted Federal payment rates and a 
description of the methodology and data used to calculate the payment 
rates are published on or before May 1 prior to the start of the long-
term care hospital prospective payment system rate year which begins 
July 1, unless for good cause it is published after May 1, but before 
June 1.
    (c) For the period beginning on or after October 1, 2009, 
information on the unadjusted Federal payment rates and a description of 
the methodology and data used to calculate the payment rates are 
published on or before August 1 prior to the start of the Federal fiscal 
year which begins October 1, unless for good cause it is published after 
August 1, but before September 1.
    (d) Information on the LTC-DRG classification and associated 
weighting factors is published on or before August 1 prior to the 
beginning of each Federal fiscal year.

[68 FR 34163, June 6, 2003, as amended at 73 FR 26839, May 9, 2008]



Sec.  412.536  Special payment provisions for long-term care hospitals 
and satellites of long-term care hospitals that discharge Medicare patients 
admitted from a hospital not located in the same building or on the same 
campus as the long-term care hospital or satellite of the long-term care 
hospital, effective for discharges occurring on or before September 30, 2016 
or in cost reporting periods beginning on or before June 30, 2016.

    (a) Scope. (1) Except as specified in paragraph (a)(2) of this 
section, for cost reporting periods beginning on or after July 1, 2007, 
the policies set forth in this section apply to discharges from the 
following:
    (i) Long-term care hospitals as described in Sec.  412.23(e)(2)(i) 
that meet the criteria in Sec.  412.22(e).
    (ii) Long-term care hospitals as described in Sec.  412.23(e)(2)(i) 
and that meet the criteria in Sec.  412.22(f).
    (iii) [Reserved]
    (iv) Long-term care hospitals as described in Sec.  412.23(e)(5).
    (2) For cost reporting periods beginning on or after July 1, 2007 
and before July 1, 2016, the policies set forth in this section are not 
applicable to discharges from:
    (i) A long-term care hospital described in Sec.  412.23(e)(5) of 
this part; or
    (ii) [Reserved]
    (iii) A long-term care hospital or satellite facility, that as of 
December 29, 2007, was co-located with an entity that is a provider-
based, off-campus location of a subsection (d) hospital which did not 
provide services payable under section 1886(d) of the Act at the off-
campus location.
    (b) For cost reporting periods beginning on or after July 1, 2007, 
payments for discharges of Medicare patients admitted from a hospital 
not located in the same building or on the same campus as the long-term 
care hospital or long-term care hospital satellite facility will be made 
under either paragraph (b)(1) or paragraph (b)(2) of this section.
    (1) Except as provided in paragraphs (c), (d) and subject to 
paragraph (f) of this section, for any cost reporting period beginning 
on or after July 1, 2007 in which a long-term care hospital or a long-
term care hospital satellite facility has a discharged Medicare 
inpatient population of whom no more than 25 percent were admitted to 
the long-term care hospital or the satellite facility from any 
individual hospital not co-located with the long-term care hospital or 
with the satellite of a long-term care hospital, payments for the 
Medicare discharges admitted from that hospital are made under the rules 
at Sec.  412.500 through Sec.  412.541 in this subpart with no 
adjustment under this section.
    (2) Except as provided in paragraph (c) and (d) and subject to 
paragraph (f) of this section, for any cost reporting period beginning 
on or after July 1, 2007 in which a long-term care hospital or long-term 
care hospital satellite facility has a discharged Medicare inpatient 
population of whom more than 25 percent were admitted to the long-term 
care hospital or satellite facility from any individual hospital not co-
located with the long-term care hospital or

[[Page 780]]

with the satellite of a long-term care hospital, payment for the 
Medicare discharges who cause the long-term care hospital or satellite 
facility to exceed the 25 percent threshold for discharged patients who 
have been admitted from that referring hospital is the lesser of the 
amount otherwise payable under this subpart or the amount payable under 
this subpart that is equivalent, as set forth in paragraph (e) of this 
section, to the amount that would be determined under the rules at 
subpart A, Sec.  412.1(a). Payments for the remainder of the long-term 
care hospital's or satellite facility's patients admitted from that 
referring hospital are made under the rules in this subpart at 
Sec. Sec.  412.500 through 412.541 with no adjustment under this 
section.
    (3) In determining the percentage of Medicare discharges admitted to 
the long-term care hospital or long-term care hospital satellite 
facility from any referring hospital not co-located with the long-term 
care hospital or with the satellite of a long-term care hospital, under 
paragraphs (b)(1) and (b)(2) of this section, patients on whose behalf a 
Medicare high cost outlier payment was made to the referring hospital 
are not counted towards the 25 percent threshold from that referring 
hospital.
    (c) Special treatment of rural hospitals. (1) Subject to paragraph 
(f) of this section, in the case of a long-term care hospital or long-
term care hospital satellite facility that is located in a rural area as 
defined in Sec.  412.503 that has a discharged Medicare inpatient 
population of whom more than 50 percent were admitted to the long-term 
care hospital or long-term care hospital satellite facility from a 
hospital not co-located with the long-term care hospital or with the 
satellite of a long-term care hospital, payment for the Medicare 
discharges who are admitted from that hospital and who cause the long-
term care hospital or satellite facility to exceed the 50 percent 
threshold for Medicare discharges is determined at the lesser of the 
amount otherwise payable under this subpart or the amount payable under 
this subpart that is equivalent, as set forth in paragraph (e) of this 
section, to the amount that is otherwise payable under subpart A, Sec.  
412.1(a). Payments for the remainder of the long-term care hospital's or 
long-term care hospital satellite facility's Medicare discharges 
admitted from that referring hospital are made under the rules in this 
subpart at Sec. Sec.  412.500 through 412.541 with no adjustment under 
this section.
    (2) In determining the percentage of Medicare discharges admitted 
from the referring hospital under paragraph (c)(1) of this section, 
patients on whose behalf a Medicare high cost outlier payment was made 
at the referring hospital are not counted toward the 50 percent 
threshold.
    (d) Special treatment of urban single or MSA dominant hospitals. (1) 
Subject to paragraph (f) of this section, in the case of a long-term 
care hospital or long-term care hospital satellite facility that admits 
Medicare patients from the only other hospital in the MSA or from a 
referring MSA dominant hospital as defined in paragraph (d)(4) of this 
section, that are not co-located with the long-term care hospital or 
with the satellite of a long-term care hospital for any cost reporting 
period beginning on or after July 1, 2007, in which the long-term care 
hospital or satellite facility has a discharged Medicare inpatient 
population of whom more than the percentage calculated under paragraph 
(d)(2) of this section were admitted to the hospital from the single or 
MSA-dominant referring hospital, payment for the Medicare discharges who 
are admitted from the referring hospital and who cause the long-term 
care hospital or long-term care hospital satellite facility to exceed 
the applicable threshold for Medicare discharges who have been admitted 
from the referring hospital is the lesser of the amount otherwise 
payable under this subpart or the amount under this subpart that is 
equivalent, as set forth in paragraph (e) of this section, to the amount 
that otherwise would be determined under subpart A, Sec.  412.1(a). 
Payments for the remainder of the long-term care hospital's or satellite 
facility's Medicare discharges admitted from that referring hospital are 
made under the rules in this subpart at Sec. Sec.  412.500 through 
412.541 with no adjustment under this section.

[[Page 781]]

    (2) For purposes of paragraph (d)(1) of this section, the percentage 
threshold is equal to the percentage of total Medicare discharges in the 
Metropolitan Statistical Area (MSA) in which the hospital is located 
that are from the referring hospital, but in no case is less than 25 
percent or more than 50 percent.
    (3) In determining the percentage of patients admitted from the 
referring hospital under paragraph (d)(1) of this section, patients on 
whose behalf a Medicare outlier payment was made at the referring 
hospital are not counted toward the applicable threshold.
    (4) For purposes of this paragraph, an ``MSA-dominant hospital'' is 
a hospital that has discharged more than 25 percent of the total 
hospital Medicare discharges in the MSA in which the hospital is 
located.
    (e) Calculation of adjusted payment--(1) Calculation of adjusted 
long-term care hospital prospective payment system amount. CMS 
calculates an amount payable under subpart O equivalent to an amount 
that would otherwise be paid under the hospital inpatient prospective 
payment system at subpart A, Sec.  412.1(a). The amount is based on the 
sum of the applicable hospital inpatient prospective payment system 
operating standardized amount and capital Federal rate in effect at the 
time of the long-term care hospital discharge.
    (2) Operating inpatient prospective payment system standardized 
amount. The hospital inpatient prospective payment system operating 
standardized amount--
    (i) Is adjusted for the applicable hospital inpatient prospective 
payment system DRG weighting factors;
    (ii) Is adjusted for different area wage levels based on the 
geographic classifications defined at Sec.  412.503 and the applicable 
hospital inpatient prospective payment system labor-related share, using 
the applicable hospital inpatient prospective payment system wage index 
value for nonreclassified hospitals. For long-term care hospitals 
located in Alaska and Hawaii, this amount is also adjusted by the 
applicable hospital inpatient prospective payment system cost of living 
adjustment factors;
    (iii) Includes, where applicable, adjustments for indirect medical 
education costs and for the costs of serving a disproportionate share of 
low-income patients.
    (3) Hospital inpatient prospective payment system capital Federal 
rate. The hospital inpatient prospective payment system capital Federal 
rate--
    (i) Is adjusted for the applicable hospital inpatient prospective 
payment system DRG weighting factors;
    (ii) Is adjusted by the applicable geographic adjustment factors, 
including local cost variation based on the applicable geographic 
classifications set forth at Sec.  412.503 and the applicable full 
hospital inpatient prospective payment system wage index value for non-
reclassified hospitals, applicable large urban location and cost of 
living adjustment factors for long-term care hospitals for Alaska and 
Hawaii, if applicable;
    (iii) Includes, where applicable, capital inpatient prospective 
payment system adjustments for indirect medical education costs and the 
costs of serving a disproportionate share of low-income patients.
    (4) High cost outlier. An additional payment for high cost outlier 
cases is based on the applicable fixed loss amount established for the 
hospital inpatient prospective payment system.
    (f) Transition period for long-term care hospitals and satellites 
paid under this section. In the case of a long-term care hospital or 
satellite of a long-term care hospital that is paid under the provisions 
of this section, the thresholds applied under paragraphs (b), (c) and 
(d) of this section will not be less than the percentages specified 
below:
    (1) For cost reporting periods beginning on or after July 1, 2007 
and before July 1, 2008, the lesser of 75 percent of the total number of 
Medicare discharges that were admitted to the long-term care hospital or 
satellite facility of a long-term care hospital from all referring 
hospitals not co-located with the long-term care hospital or with the 
satellite facility of a long-term care hospital during the cost 
reporting period or the percentage of Medicare discharges that had been 
admitted to the long-term care hospital or satellite of a long-term care 
hospital

[[Page 782]]

from that referring hospital during the long-term care hospital's or 
satellite's RY 2005 cost reporting period.
    (2) For cost reporting periods beginning on or after July 1, 2008 
and before July 1, 2009, the lesser of 50 percent of the total number of 
Medicare discharges that were admitted to the long-term care hospital or 
to the satellite facility of a long-term care hospital from all 
referring hospitals not co-located with the long-term care hospital or 
with the satellite facility of a long-term care hospital during the cost 
reporting period or the percentage of Medicare discharges that had been 
admitted from that referring hospital during the long-term care 
hospital's or satellite's RY 2005 cost reporting period.
    (3) For cost reporting periods beginning on or after July 1, 2009, 
25 percent of the total number of Medicare discharges that were admitted 
to the long-term care hospital or to the satellite facility of a long-
term care hospital from all referring hospitals not co-located with the 
long-term care hospital or with the satellite facility of a long-term 
care hospital to the long-term care hospital during the cost reporting 
period.
    (4) In determining the percentage of Medicare discharges admitted 
from the referring hospital under this paragraph, patients on whose 
behalf a Medicare high cost outlier payment was made at the referring 
hospital are not counted toward this threshold.

[72 FR 26993, May 11, 2007, as amended at 73 FR 26840, May 9, 2008; 73 
FR 29711, May 22, 2008; 74 FR 44000, Aug. 27, 2009; 75 FR 50416, Aug. 
16, 2010; 77 FR 53680, Aug. 31, 2012; 77 FR 63752, Oct. 17, 2012; 79 FR 
50357, Aug. 22, 2014]



Sec.  412.538  [Reserved]



Sec.  412.540  Method of payment for preadmission services 
under the long-term care hospital prospective payment system.

    The prospective payment system includes payment for inpatient 
operating costs of preadmission services that are--
    (a) Otherwise payable under Medicare Part B;
    (b) Furnished to a beneficiary on the date of the beneficiary's 
inpatient admission, and during the calendar day immediately preceding 
the date of the beneficiary's inpatient admission, to the long-term care 
hospital, or to an entity wholly owned or wholly operated by the long-
term care hospital; and
    (1) An entity is wholly owned by the long-term care hospital if the 
long-term care hospital is the sole owner of the entity.
    (2) An entity is wholly operated by a long-term care hospital if the 
long-term care hospital has exclusive responsibility for conducting and 
overseeing the entity's routine operations, regardless of whether the 
long-term care hospital also has policymaking authority over the entity.
    (c) Related to the inpatient stay. A preadmission service is related 
if--
    (1) It is diagnostic (including clinical diagnostic laboratory 
tests); or
    (2) It is nondiagnostic when furnished on the date of the 
beneficiary's inpatient admission; or
    (3) On or after June 25, 2010, it is nondiagnostic when furnished on 
the calendar day preceding the date of the beneficiary's inpatient 
admission and the hospital does not attest that such service is 
unrelated to the beneficiary's inpatient admission.
    (d) Not one of the following--
    (1) Ambulance services.
    (2) Maintenance renal dialysis services.

[75 FR 50416, Aug. 16, 2010]



Sec.  412.541  Method of payment under the long-term care hospital 
prospective payment system.

    (a) General rule. Subject to the exceptions in paragraphs (b) and 
(c) of this section, long-term care hospitals receive payment under this 
subpart for inpatient operating costs and capital-related costs for each 
discharge only following submission of a discharge bill.
    (b) Periodic interim payments--(1) Criteria for receiving periodic 
interim payments. (i) A long-term care hospital receiving payment under 
this subpart may receive periodic interim payments (PIP) for Part A 
services under the PIP method subject to the provisions of Sec.  
413.64(h) of this subchapter.
    (ii) To be approved for PIP, the long-term care hospital must meet 
the

[[Page 783]]

qualifying requirements in Sec.  413.64(h)(3) of this subchapter.
    (iii) As provided in Sec.  413.64(h)(5) of this subchapter, 
intermediary approval is conditioned upon the intermediary's best 
judgment as to whether payment can be made under the PIP method without 
undue risk of the PIP resulting in an overpayment to the provider.
    (2) Frequency of payment. (i) For long-term care hospitals approved 
for PIP and paid solely under Federal prospective payment system rates 
under Sec. Sec.  412.533(a)(5) and 412.533(c), the intermediary 
estimates the long-term care hospital's Federal prospective payments net 
after estimated beneficiary deductibles and coinsurance and makes 
biweekly payments equal to \1/26\ of the total estimated amount of 
payment for the year.
    (ii) For long-term care hospitals approved for PIP and paid using 
the blended payment schedule specified in Sec.  412.533(a) for cost 
reporting periods beginning on or after October 1, 2002, and before 
October 1, 2006, the intermediary estimates the hospital's portion of 
the Federal prospective payments net and the hospital's portion of the 
reasonable cost-based reimbursement payments net, after beneficiary 
deductibles and coinsurance, in accordance with the blended transition 
percentages specified in Sec.  412.533(a), and makes biweekly payments 
equal to \1/26\ of the total estimated amount of both portions of 
payments for the year.
    (iii) If the long-term care hospital has payment experience under 
the long-term care hospital prospective payment system, the intermediary 
estimates PIP based on that payment experience, adjusted for projected 
changes supported by substantiated information for the current year.
    (iv) Each payment is made 2 weeks after the end of a biweekly period 
of service as described in Sec.  413.64(h)(6) of this subchapter.
    (v) The interim payments are reviewed at least twice during the 
reporting period and adjusted if necessary. Fewer reviews may be 
necessary if a hospital receives interim payments for less than a full 
reporting period. These payments are subject to final settlement.
    (3) Termination of PIP. (i) Request by the hospital. Subject to 
paragraph (b)(1)(iii) of this section, a long-term care hospital 
receiving PIP may convert to receiving prospective payments on a non-PIP 
basis at any time.
    (ii) Removal by the intermediary. An intermediary terminates PIP if 
the long-term care hospital no longer meets the requirements of Sec.  
413.64(h) of this subchapter.
    (c) Interim payments for Medicare bad debts and for Part A costs not 
paid under the prospective payment system. For Medicare bad debts and 
for the costs of an approved education program, blood clotting factors, 
anesthesia services furnished by hospital-employed nonphysician 
anesthetists or obtained under arrangement, and photocopying and mailing 
medical records to a QIO, which are costs paid outside the prospective 
payment system, the intermediary determines the interim payments by 
estimating the reimbursable amount for the year based on the previous 
year's experience, adjusted for projected changes supported by 
substantiated information for the current year, and makes biweekly 
payments equal to \1/26\ of the total estimated amount. Each payment is 
made 2 weeks after the end of the biweekly period of service as 
described in Sec.  413.64(h)(6) of this subchapter. The interim payments 
are reviewed at least twice during the reporting period and adjusted if 
necessary. Fewer reviews may be necessary if a long-term care hospital 
receives interim payments for less than a full reporting period. These 
payments are subject to final cost settlement.
    (d) Special interim payment for unusually long lengths of stay--(1) 
First interim payment. A hospital that is not receiving periodic interim 
payments under paragraph (b) of this section may request an interim 
payment 60 days after a Medicare beneficiary has been admitted to the 
hospital. Payment for the interim bill is determined as if the bill were 
a final discharge bill and includes any outlier payment determined as of 
the last day for which services have been billed.
    (2) Additional interim payments. A hospital may request additional 
interim payments at intervals of at least 60

[[Page 784]]

days after the date of the first interim bill submitted under paragraph 
(d)(1) of this section. Payment for these additional interim bills, as 
well as the final bill, is determined as if the bill were the final bill 
with appropriate adjustments made to the payment amount to reflect any 
previous interim payment made under the provisions of this paragraph.
    (e) Outlier payments. Additional payments for outliers are not made 
on an interim basis. The outlier payments are made based on the 
submission of a discharge bill and represent final payment.
    (f) Accelerated payments--(1) General rule. Upon request, an 
accelerated payment may be made to a long-term care hospital that is 
receiving payment under this subpart and is not receiving PIP under 
paragraph (b) of this section if the hospital is experiencing financial 
difficulties because of the following:
    (i) There is a delay by the intermediary in making payment to the 
long-term care hospital.
    (ii) Due to an exceptional situation, there is a temporary delay in 
the hospital's preparation and submittal of bills to the intermediary 
beyond its normal billing cycle.
    (2) Approval of payment. A request by a long-term care hospital for 
an accelerated payment must be approved by the intermediary and by CMS.
    (3) Amount of payment. The amount of the accelerated payment is 
computed as a percentage of the net payment for unbilled or unpaid 
covered services.
    (4) Recovery of payment. Recovery of the accelerated payment is made 
by recoupment as long-term care hospital bills are processed or by 
direct payment by the long-term care hospital.

[67 FR 56049, Aug. 30, 2002, as amended at 68 FR 10988, Mar. 7, 2003; 71 
FR 48141, Aug. 18, 2006]



Sec.  412.560  Requirements under the Long-Term Care Hospital Quality 
Reporting Program (LTCH QRP).

    (a) Participation in the LTCH QRP. A long-term-care hospital must 
begin submitting data on measures specified under sections 
1886(m)(5)(D), 1899B(c)(1), and 1899B(d)(1) of the Act, and standardized 
patient assessment data required under section 1899B(b)(1) of the Act, 
under the LTCH QRP by no later than the first day of the calendar 
quarter subsequent to 30 days after the date on its CMS Certification 
Number (CCN) notification letter.
    (b) Data submission requirements and payment impact. (1) Except as 
provided in paragraph (c) of this section, a long-term care hospital 
must submit to CMS data on measures specified under sections 
1886(m)(5)(D), 1899B(c)(1) and 1899B(d)(1) of the Act, and standardized 
patient assessment data required under section 1899B(b)(1) of the Act. 
Such data must be submitted in a form and manner, and at a time, 
specified by CMS.
    (2) A long-term care hospital that does not submit data in 
accordance with sections 1886(m)(5)(C) and 1886(m)(5)(F) of the Act with 
respect to a given fiscal year will have its annual update to the 
standard Federal rate for discharges for the long-term care hospital 
during the fiscal year reduced by 2 percentage points.
    (3) CMS may remove a quality measure from the LTCH QRP based on one 
or more of the following factors:
    (i) Measure performance among long-term care hospitals is so high 
and unvarying that meaningful distinctions in improvements in 
performance can no longer be made.
    (ii) Performance or improvement on a measure does not result in 
better patient outcomes.
    (iii) A measure does not align with current clinical guidelines or 
practice.
    (iv) The availability of a more broadly applicable (across settings, 
populations, or conditions) measure for the particular topic.
    (v) The availability of a measure that is more proximal in time to 
desired patient outcomes for the particular topic.
    (vi) The availability of a measure that is more strongly associated 
with desired patient outcomes for the particular topic.
    (vii) Collection or public reporting of a measure leads to negative 
unintended consequences other than patient harm.
    (viii) The costs associated with a measure outweigh the benefit of 
its continued use in the program.
    (c) Exception and extension request requirements. Upon request by a 
long-term care hospital, CMS may grant an

[[Page 785]]

exception or extension with respect to the measures data and 
standardized patient assessment data reporting requirements, for one or 
more quarters, in the event of certain extraordinary circumstances 
beyond the control of the long-term care hospital, subject to the 
following:
    (1) A long-term care hospital that wishes to request an exception or 
extension with respect to measures data and standardized patient 
assessment data reporting requirements must submit its request to CMS 
within 90 days of the date that the extraordinary circumstances 
occurred.
    (2) A long-term care hospital must submit its request for an 
exception or extension to CMS via email. Email is the only form that may 
be used to submit to CMS a request for an exception or an extension.
    (3) The email request for an exception or extension must contain the 
following information:
    (i) The CCN for the long-term care hospital.
    (ii) The business name of the long-term care hospital.
    (iii) The business address of the long-term care hospital.
    (iv) Contact information for the long-term care hospital's chief 
executive officer or designated personnel, including the name, telephone 
number, title, email address, and physical mailing address. (The mailing 
address may not be a post office box.)
    (v) A statement of the reason for the request for the exception or 
extension.
    (vi) Evidence of the impact of the extraordinary circumstances, 
including, but not limited to, photographs, newspaper articles, and 
other media.
    (vii) The date on which the long-term care hospital will be able to 
again submit measures data and standardized patient assessment data 
under the LTCH QRP and a justification for the proposed date.
    (4) CMS may grant an exception or extension to a long-term care 
hospital that has not been requested by the long-term care hospital if 
CMS determines that--
    (i) An extraordinary circumstance affects an entire region or 
locale; or
    (ii) A systemic problem with one of CMS' data collection systems 
directly affected the ability of the long-term care hospital to submit 
measures data and standardized patient assessment data.
    (d) Reconsiderations of noncompliance decisions-- (1) Written letter 
of non-compliance decision. Long-term care hospitals that do not meet 
the requirement in paragraph (b) of this section for a program year will 
receive a notification of non-compliance sent through at least one of 
the following methods: The CMS designated data submission system, the 
United States Postal Service, or via an email from the MAC.
    (2) Request for reconsideration of noncompliance decision. A long-
term care hospital may request a reconsideration of CMS' decision of 
noncompliance no later than 30 calendar days from the date of the 
written notification of noncompliance. The reconsideration request by 
the long-term care hospital must be submitted to CMS via email and must 
contain the following information:
    (i) The CCN for the long-term care hospital.
    (ii) The business name of the long-term care hospital.
    (iii) The business address of the long-term care hospital.
    (iv) Contact information for the long-term care hospital's chief 
executive officer or designated personnel, including each individual's 
name, title, email address, telephone number, and physical mailing 
address. (The physical address may not be a post office box.)
    (v) CMS's identified reason(s) for the noncompliance decision from 
the written notification of noncompliance.
    (vi) The reason for requesting reconsideration of CMS' noncompliance 
decision.
    (vii) Accompanying documentation that demonstrates compliance of the 
long-term care hospital with the LTCH QRP requirements. This 
documentation must be submitted electronically at the same time as the 
reconsideration request as an attachment to the email.
    (3) CMS decision on reconsideration request. CMS will notify long-
term care

[[Page 786]]

hospitals, in writing, of its final decision regarding any 
reconsideration request through at least one of the following methods: 
The CMS designated data submission system, the United States Postal 
Service, or via an email from the MAC.
    (e) Appeals of reconsideration requests. A long-term care hospital 
that is dissatisfied with a decision made by CMS on its reconsideration 
request may file an appeal with the Provider Reimbursement Review Board 
under part 405, subpart R, of this chapter.
    (f) Data completion thresholds. (1) Long-term care hospitals must 
meet or exceed two separate data completeness thresholds: One threshold 
set at 80 percent for completion of measures data and standardized 
patient assessment data collected using the LTCH CARE Data Set submitted 
through the CMS designated data submission system; and a second 
threshold set at 100 percent for measures data collected and submitted 
using the CDC NHSN.
    (2) The thresholds in paragraph (f)(1) of this section apply to all 
data that must be submitted under paragraph (b) of this section.
    (3) A long-term care hospital must meet or exceed both thresholds in 
paragraph (f)(1) of this section to avoid receiving a 2 percentage point 
reduction to its annual payment update for a given fiscal year, 
beginning with the FY 2019 LTCH QRP.

[80 FR 49769, Aug. 17, 2015, as amended at 81 FR 57270, Aug. 22, 2016; 
82 FR 38513, Aug. 14, 2017; 83 FR 41705, Aug. 17, 2018; 84 FR 42615, 
Aug. 16, 2019]



Subpart P_Prospective Payment for Inpatient Rehabilitation Hospitals and 
                          Rehabilitation Units

    Source: 66 FR 41388, Aug. 7, 2001, unless otherwise noted.



Sec.  412.600  Basis and scope of subpart.

    (a) Basis. This subpart implements section 1886(j) of the Act, which 
provides for the implementation of a prospective payment system for 
inpatient rehabilitation hospitals and rehabilitation units (in this 
subpart referred to as ``inpatient rehabilitation facilities'').
    (b) Scope. This subpart sets forth the framework for the prospective 
payment system for inpatient rehabilitation facilities, including the 
methodology used for the development of payment rates and associated 
adjustments, the application of a transition phase, and related rules. 
Under this system, for cost reporting periods beginning on or after 
January 1, 2002, payment for the operating and capital costs of 
inpatient hospital services furnished by inpatient rehabilitation 
facilities to Medicare Part A fee-for-service beneficiaries is made on 
the basis of prospectively determined rates and applied on a per 
discharge basis.



Sec.  412.602  Definitions.

    As used in this subpart--
    Assessment reference date means the specific calendar day in the 
patient assessment process that sets the designated endpoint of the 
common patient observation period, with most patient assessment items 
usually referring back in time from this endpoint.
    CMS stands for the Centers for Medicare & Medicaid Services.
    Comorbidity means a specific patient condition that is secondary to 
the patient's principal diagnosis that is the primary reason for the 
inpatient rehabilitation stay.
    Discharge. A Medicare patient in an inpatient rehabilitation 
facility is considered discharged when--
    (1) The patient is formally released from the inpatient 
rehabilitation facility; or
    (2) The patient dies in the inpatient rehabilitation facility.
    Encode means entering data items into the fields of the computerized 
patient assessment software program.
    Functional-related groups refers to the distinct groups under which 
inpatients are classified using proxy measurements of inpatient 
rehabilitation relative resource usage.
    Interrupted stay means a stay at an inpatient rehabilitation 
facility during which a Medicare inpatient is discharged from the 
inpatient rehabilitation facility and returns to the same inpatient 
rehabilitation facility within

[[Page 787]]

3 consecutive calendar days. The duration of the interruption of the 
stay of 3 consecutive calendar days begins with the day of discharge 
from the inpatient rehabilitation facility and ends on midnight of the 
third day.
    Outlier payment means an additional payment beyond the standard 
Federal prospective payment for cases with unusually high costs.
    Patient assessment instrument refers to a document that contains 
clinical, demographic, and other information on a patient.
    Rural area means: For cost-reporting periods beginning on or after 
January 1, 2002, with respect to discharges occurring during the period 
covered by such cost reports but before October 1, 2005, an area as 
defined in Sec.  412.62(f)(1)(iii). For discharges occurring on or after 
October 1, 2005, rural area means an area as defined in Sec.  
412.64(b)(1)(ii)(C).
    Transfer means the release of a Medicare inpatient from an inpatient 
rehabilitation facility to another inpatient rehabilitation facility, a 
short-term, acute-care prospective payment hospital, a long-term care 
hospital as described in Sec.  412.23(e), or a nursing home that 
qualifies to receive Medicare or Medicaid payments.
    Urban area means: For cost-reporting periods beginning on or after 
January 1, 2002, with respect to discharges occurring during the period 
covered by such cost reports but before October 1, 2005, an area as 
defined in Sec.  412.62(f)(1)(ii). For discharges occurring on or after 
October 1, 2005, urban area means an area as defined in Sec. Sec.  
412.64(b)(1)(ii)(A) and 412.64(b)(1)(ii)(B).

[66 FR 41388, Aug. 7, 2001, as amended at 67 FR 44077, July 1, 2002; 68 
FR 45699, Aug. 1, 2003; 70 FR 47952, Aug. 15, 2005]



Sec.  412.604  Conditions for payment under the prospective payment system 
for inpatient rehabilitation facilities.

    (a) General requirements. (1) Effective for cost reporting periods 
beginning on or after January 1, 2002, an inpatient rehabilitation 
facility must meet the conditions of this section to receive payment 
under the prospective payment system described in this subpart for 
inpatient hospital services furnished to Medicare Part A fee-for-service 
beneficiaries.
    (2) If an inpatient rehabilitation facility fails to comply fully 
with these conditions with respect to inpatient hospital services 
furnished to one or more Medicare Part A fee-for-service beneficiaries, 
CMS or its Medicare fiscal intermediary may, as appropriate--
    (i) Withhold (in full or in part) or reduce Medicare payment to the 
inpatient rehabilitation facility until the facility provides adequate 
assurances of compliance; or
    (ii) Classify the inpatient rehabilitation facility as an inpatient 
hospital that is subject to the conditions of subpart C of this part and 
is paid under the prospective payment systems specified in Sec.  
412.1(a)(1).
    (b) Inpatient rehabilitation facilities subject to the prospective 
payment system. Subject to the special payment provisions of Sec.  
412.22(c), an inpatient rehabilitation facility must meet the general 
criteria set forth in Sec.  412.22 and the criteria to be classified as 
a rehabilitation hospital or rehabilitation unit set forth in Sec. Sec.  
412.23(b), 412.25, and 412.29 for exclusion from the inpatient hospital 
prospective payment systems specified in Sec.  412.1(a)(1).
    (c) Completion of patient assessment instrument. For each Medicare 
Part A fee-for-service patient admitted to or discharged from an IRF on 
or after January 1, 2002, the inpatient rehabilitation facility must 
complete a patient assessment instrument in accordance with Sec.  
412.606. IRFs must also complete a patient assessment instrument in 
accordance with Sec.  412.606 for each Medicare Part C (Medicare 
Advantage) patient admitted to or discharged from an IRF on or after 
October 1, 2009.
    (d) Limitation on charges to beneficiaries--(1) Prohibited charges. 
Except as provided in paragraph (d)(2) of this section, an inpatient 
rehabilitation facility may not charge a beneficiary for any services 
for which payment is made by Medicare, even if the facility's costs of 
furnishing services to that beneficiary are greater than the amount the 
facility is paid under the prospective payment system.
    (2) Permitted charges. An inpatient rehabilitation facility 
receiving payment

[[Page 788]]

under this subpart for a covered hospital stay (that is, a stay that 
includes at least one covered day) may charge the Medicare beneficiary 
or other person only for the applicable deductible and coinsurance 
amounts under Sec. Sec.  409.82, 409.83, and 409.87 of this subchapter 
and for items or services as specified under Sec.  489.20(a) of this 
chapter.
    (e) Furnishing of inpatient hospital services directly or under 
arrangement. (1) Subject to the provisions of Sec.  412.622(b), the 
applicable payments made under this subpart are payment in full for all 
inpatient hospital services, as defined in Sec.  409.10 of this 
subchapter. Inpatient hospital services do not include the following:
    (i) Physicians' services that meet the requirements of Sec.  
415.102(a) of this subchapter for payment on a fee schedule basis.
    (ii) Physician assistant services, as defined in section 
1861(s)(2)(K)(i) of the Act.
    (iii) Nurse practitioner and clinical nurse specialist services, as 
defined in section 1861(s)(2)(K)(ii) of the Act.
    (iv) Certified nurse midwife services, as defined in section 
1861(gg) of the Act.
    (v) Qualified psychologist services, as defined in section 1861(ii) 
of the Act.
    (vi) Services of an anesthetist, as defined in Sec.  410.69 of this 
chapter.
    (2) Medicare does not pay any provider or supplier other than the 
inpatient rehabilitation facility for services furnished to a Medicare 
beneficiary who is an inpatient of the inpatient rehabilitation 
facility, except for services described in paragraphs (e)(1)(i) through 
(e)(1)(vi) of this section.
    (3) The inpatient rehabilitation facility must furnish all necessary 
covered services to the Medicare beneficiary either directly or under 
arrangements (as defined in Sec.  409.3 of this subchapter).
    (f) The prospective payment system includes payment for inpatient 
operating costs of preadmission services that are--
    (1) Otherwise payable under Medicare Part B;
    (2) Furnished to a beneficiary on the date of the beneficiary's 
inpatient admission, and during the calendar day immediately preceding 
the date of the beneficiary's inpatient admission, to the inpatient 
rehabilitation facility, or to an entity wholly owned or wholly operated 
by the inpatient rehabilitation facility; and
    (i) An entity is wholly owned by the inpatient rehabilitation 
facility if the inpatient rehabilitation facility is the sole owner of 
the entity.
    (ii) An entity is wholly operated by an inpatient rehabilitation 
facility if the inpatient rehabilitation facility has exclusive 
responsibility for conducting and overseeing the entity's routine 
operations, regardless of whether the inpatient rehabilitation facility 
also has policymaking authority over the entity.
    (3) Related to the inpatient stay. A preadmission service is related 
if--
    (i) It is diagnostic (including clinical diagnostic laboratory 
tests); or
    (ii) It is nondiagnostic when furnished on the date of the 
beneficiary's inpatient admission; or
    (iii) On or after June 25,, 2010, it is nondiagnostic when furnished 
on the calendar day preceding the date of the beneficiary's inpatient 
admission and the hospital does not attest that such service is 
unrelated to the beneficiary's inpatient admission.
    (4) Not one of the following--
    (i) Ambulance services.
    (ii) Maintenance renal dialysis services.
    (g) Reporting and recordkeeping requirements. All inpatient 
rehabilitation facilities participating in the prospective payment 
system under this subpart must meet the recordkeeping and cost reporting 
requirements of Sec. Sec.  413.20 and 413.24 of this subchapter.

[66 FR 41388, Aug. 7, 2001, as amended at 67 FR 44077, July 1, 2002; 68 
FR 45699, Aug. 1, 2003; 74 FR 39810, Aug. 7, 2009; 75 FR 50417, Aug. 16, 
2010]



Sec.  412.606  Patient assessments.

    (a) Patient assessment instrument. An inpatient rehabilitation 
facility must use the CMS inpatient rehabilitation facility patient 
assessment instrument to assess Medicare Part A fee-for-service and 
Medicare Part C (Medicare Advantage) inpatients who--
    (1) Are admitted on or after January 1, 2002; or

[[Page 789]]

    (2) Were admitted before January 1, 2002, and are still inpatients 
as of January 1, 2002.
    (b) Comprehensive assessments. (1) A clinician of the inpatient 
rehabilitation facility must perform a comprehensive, accurate, 
standardized, and reproducible assessment of each Medicare Part A fee-
for-service inpatient using the inpatient rehabilitation facility 
patient assessment instrument specified in paragraph (b) of this section 
as part of his or her patient assessment in accordance with the schedule 
described in Sec.  412.610. IRFs must also complete a patient assessment 
instrument in accordance with Sec.  412.606 for each Medicare Part C 
(Medicare Advantage) patient admitted to or discharged from an IRF on or 
after October 1, 2009.
    (2) A clinician employed or contracted by an inpatient 
rehabilitation facility who is trained on how to perform a patient 
assessment using the inpatient rehabilitation facility patient 
assessment instrument specified in paragraph (b) of the section must 
record appropriate and applicable data accurately and completely for 
each item on the patient assessment instrument.
    (3) The assessment process must include--
    (i) Direct patient observation and communication with the patient; 
and
    (ii) When appropriate and to the extent feasible, patient data from 
the patient's physician(s), family, someone personally knowledgeable 
about the patient's clinical condition or capabilities, the patient's 
clinical record, and other sources.

[66 FR 41388, Aug. 7, 2001, as amended at 74 FR 39810, Aug. 7, 2009; 83 
FR 38573, Aug. 6, 2018]



Sec.  412.608  Patients' rights regarding the collection of patient 
assessment data.

    (a) Before performing an assessment using the inpatient 
rehabilitation facility patient assessment instrument, a clinician of 
the inpatient rehabilitation facility must give a Medicare inpatient--
    (1) The form entitled ``Privacy Act Statement--Health Care 
Records''; and
    (2) The simplified plain language description of the Privacy Act 
Statement--Health Care Records which is a form entitled ``Data 
Collection Information Summary for Patients in Inpatient Rehabilitation 
Facilities.''
    (b) The inpatient rehabilitation facility must document in the 
Medicare inpatient's clinical record that the Medicare inpatient has 
been given the documents specified in paragraph (a) of this section.
    (c) By giving the Medicare inpatient the forms specified in 
paragraph (a) of this section the inpatient rehabilitation facility will 
inform the Medicare patient of--
    (1) Their privacy rights under the Privacy Act of 1974 and 45 CFR 
5b.4(a)(3); and
    (2) The following rights:
    (i) The right to be informed of the purpose of the collection of the 
patient assessment data;
    (ii) The right to have the patient assessment information collected 
be kept confidential and secure;
    (iii) The right to be informed that the patient assessment 
information will not be disclosed to others, except for legitimate 
purposes allowed by the Federal Privacy Act and Federal and State 
regulations;
    (iv) The right to refuse to answer patient assessment questions; and
    (v) The right to see, review, and request changes on his or her 
patient assessment.
    (d) The patient rights specified in this section are in addition to 
the patient rights specified in Sec.  82.13 of this chapter.

[68 FR 45699, Aug. 1, 2003]



Sec.  412.610  Assessment schedule.

    (a) General. For each Medicare Part A fee-for-service or Medicare 
Part C (Medicare Advantage) inpatient, an inpatient rehabilitation 
facility must complete a patient assessment instrument as specified in 
Sec.  412.606 that covers a time period that is in accordance with the 
assessment schedule specified in paragraph (c) of this section.
    (b) Starting the assessment schedule day count. The first day that 
the Medicare Part A fee-for-service or Medicare Part C (Medicare 
Advantage) inpatient is furnished Medicare-covered services

[[Page 790]]

during his or her current inpatient rehabilitation facility hospital 
stay is counted as day one of the patient assessment schedule.
    (c) Assessment schedules and references dates. The inpatient 
rehabilitation facility must complete a patient assessment instrument 
upon the Medicare Part A fee-for-service or Medicare Part C (Medicare 
Advantage) patient's admission and discharge as specified in paragraphs 
(c)(1) and (c)(2) of this section.
    (1) Admission assessment--(i) General rule. The admission 
assessment--
    (A) Time period is a span of time that covers calendar days 1 
through 3 of the patient's current Medicare Part A fee-for-service or 
Medicare Part C (Medicare Advantage) hospitalization;
    (B) Has an admission assessment reference date that is the third 
calendar day of the span of time specified in paragraph (c)(1)(i)(A) of 
this section; and
    (C) Must be completed by the calendar day that follows the admission 
assessment reference day.
    (ii) Exception to the general rule. We may specify in the patient 
assessment instrument item-by-item guide and in other issued 
instructions, items that have a different admission assessment time 
period to most appropriately capture patient information for payment and 
quality of care monitoring objectives.
    (2) Discharge assessment--(i) General rule. The discharge 
assessment--
    (A) Time period is a span of time that covers 3 calendar days, and 
is the discharge assessment reference date itself specified in paragraph 
(c)(2)(ii) of this section and the 2 calendar days prior to the 
discharge assessment reference date; and
    (B) Must be completed on the 5th calendar day that follows the 
discharge assessment reference date specified in paragraph (c)(2)(ii) of 
this section with the discharge assessment reference date itself being 
counted as the first day of the 5 calendar day time span.
    (ii) Discharge assessment reference date. The discharge assessment 
reference date is the actual day that the first of either of the 
following two events occurs:
    (A) The patient is discharged from the inpatient rehabilitation 
facility; or
    (B) The patient stops being furnished Medicare Part A fee-for-
service or Medicare Part C (Medicare Advantage) inpatient rehabilitation 
services.
    (iii) Exception to the general rule. We may specify in the patient 
assessment instrument item-by-item guide and in other issued 
instructions, items that have a different discharge assessment time 
period to most appropriately capture patient information for payment and 
quality of care monitoring objectives.
    (d) Encoding dates. The admission and discharge patient assessments 
must be encoded by the 7th calendar day from the completion dates 
specified in paragraph (c) of this section.
    (e) Accuracy of the patient assessment data. The encoded patient 
assessment data must accurately reflect the patient's clinical status at 
the time of the patient assessment.
    (f) Patient assessment instrument record retention. An inpatient 
rehabilitation facility must maintain all patient assessment data sets 
completed on Medicare Part A fee-for-service patients within the 
previous 5 years and Medicare Part C (Medicare Advantage) patients 
within the previous 10 years either in a paper format in the patient's 
clinical record or in an electronic computer file format that the 
inpatient rehabilitation facility can easily obtain and produce upon 
request to CMS or its contractors.

[66 FR 41388, Aug. 7, 2001, as amended at 67 FR 44077, July 1, 2002; 68 
FR 45699, Aug. 1, 2003; 74 FR 39810, Aug. 7, 2009]



Sec.  412.612  Coordination of the collection of patient assessment data.

    (a) Responsibilities of the clinician. A clinician of an inpatient 
rehabilitation facility who has participated in performing the patient 
assessment must have responsibility for--
    (1) The accuracy and thoroughness of the specific data recorded by 
that clinician on the patient's assessment instrument; and
    (2) The accuracy of the assessment reference date inserted on the 
patient assessment instrument completed under Sec.  412.610(c).

[[Page 791]]

    (b) Penalty for falsification. (1) Under Medicare, an individual who 
knowingly and willfully--
    (i) Completes a material and false statement in a patient assessment 
is subject to a civil money penalty of not more than $1,000 as adjusted 
annually under 45 CFR part 102 for each assessment; or
    (ii) Causes another individual to complete a material and false 
statement in a patient assessment is subject to a civil money penalty of 
not more than $5,000 as adjusted annually under 45 CFR part 102 for each 
assessment.
    (2) Clinical disagreement does not constitute a material and false 
statement.

[66 FR 41388, Aug. 7, 2001, as amended at 81 FR 61562, Sept. 6, 2016]



Sec.  412.614  Transmission of patient assessment data.

    (a) Data format. General rule. The inpatient rehabilitation facility 
must encode and transmit data for each Medicare Part A fee-for-service 
and Medicare Part C (Medicare Advantage) inpatient--
    (1) Using the computerized version of the patient assessment 
instrument available from us; or
    (2) Using a computer program(s) that conforms to our standard 
electronic record layout, data specifications, and data dictionary, 
includes the required patient assessment instrument data set, and meets 
our other specifications.
    (b) How to transmit data. The inpatient rehabilitation facility 
must--
    (1) Electronically transmit complete, accurate, and encoded data 
from the patient assessment instrument for each Medicare Part A fee-for-
service and Medicare Part C (Medicare Advantage) inpatient to our 
patient data system in accordance with the data format specified in 
paragraph (a) of this section; and
    (2) Transmit data using electronic communications software that 
provides a direct telephone connection from the inpatient rehabilitation 
facility to the our patient data system.
    (c) Transmission dates. The inpatient rehabilitation facility must 
transmit both the admission patient assessment and the discharge patient 
assessments at the same time to the our patient data system by the 7th 
calendar day in the period beginning with the applicable patient 
assessment instrument encoding date specified in Sec.  412.610(d).
    (d) Failure to submit complete and timely IRF-PAI data, as required 
under paragraph (c) of this section--(1) Medicare Part-A fee-for-
service. (i) A given Medicare Part-A fee-for-service IRF claim will not 
be accepted and processed for payment until a corresponding IRF-PAI has 
been received and accepted by CMS.
    (ii) [Reserved]
    (2) Medicare Part C (Medicare Advantage) data. Failure of the 
inpatient rehabilitation facility to transmit all of the required 
patient assessment instrument data for its Medicare Part C (Medicare 
Advantage) patients to our patient data system in accordance with the 
transmission timeline in paragraph (c) of this section will result in a 
forfeiture of the facility's ability to have any of its Medicare Part C 
(Medicare Advantage) data used in the calculations for determining the 
facility's compliance with the regulations in Sec.  412.23(b)(2).
    (e) Exemption to the consequences for transmitting the IRF-PAI data 
late for Medicare Part C (Medicare Advantage) patients. CMS may waive 
the consequences of failure to submit complete and timely IRF-PAI data 
specified in paragraph (d) of this section when, due to an extraordinary 
situation that is beyond the control of an inpatient rehabilitation 
facility, the inpatient rehabilitation facility is unable to transmit 
the patient assessment data in accordance with paragraph (c) of this 
section. Only CMS can determine if a situation encountered by an 
inpatient rehabilitation facility is extraordinary and qualifies as a 
situation for waiver of the forfeiture specified in paragraph (d)(2) of 
this section. An extraordinary situation may be due to, but is not 
limited to, fires, floods, earthquakes, or similar unusual events that 
inflect extensive damage to an inpatient facility. An extraordinary 
situation may be one that produces a data transmission problem that is 
beyond the control of the inpatient rehabilitation facility, as well as 
other situations determined by CMS to be beyond

[[Page 792]]

the control of the inpatient rehabilitation facility. An extraordinary 
situation must be fully documented by the inpatient rehabilitation 
facility.

[66 FR 41388, Aug. 7, 2001, as amended at 68 FR 45699, Aug. 1, 2003; 74 
FR 39811, Aug. 7, 2009; 82 FR 36304, Aug. 3, 2017]



Sec.  412.616  Release of information collected using the patient 
assessment instrument.

    (a) General. An inpatient rehabilitation facility may release 
information from the patient assessment instrument only as specified in 
Sec.  482.24(b)(3) of this chapter.
    (b) Release to the inpatient rehabilitation facility's agent. An 
inpatient rehabilitation facility may release information that is 
patient-identifiable to an agent only in accordance with a written 
contract under which the agent agrees not to use or disclose the 
information except for the purposes specified in the contract and only 
to the extent the facility itself is permitted to do so under paragraph 
(a) of this section.



Sec.  412.618  Assessment process for interrupted stays.

    For purposes of the patient assessment process, if a Medicare Part A 
fee-for-service or Medicare Part C (Medicare Advantage) patient has an 
interrupted stay, as defined under Sec.  412.602, the following applies:
    (a) Assessment requirements. (1) The initial case-mix group 
classification from the admission assessment remains in effect (that is, 
no new admission assessment is performed).
    (2) When the patient has completed his or her entire rehabilitation 
episode stay, a discharge assessment must be performed.
    (b) Recording and encoding of data. The clinician must record the 
interruption of the stay on the patient assessment instrument.
    (c) If the interruption in the stay occurs during the admission 
assessment time period, the assessment reference date, completion date, 
and encoding date for the admission assessment are advanced by the same 
number of calendar days as the length of the patient's interruption in 
the stay.

[66 FR 41388, Aug. 7, 2001, as amended at 67 FR 44077, July 1, 2002; 74 
FR 39811, Aug. 7, 2009]



Sec.  412.620  Patient classification system.

    (a) Classification methodology. (1) A patient classification system 
is used to classify patients in inpatient rehabilitation facilities into 
mutually exclusive case-mix groups.
    (2) For purposes of this subpart, case-mix groups are classes of 
Medicare patient discharges by functional-related groups that are based 
on a patient's impairment, age, comorbidities, functional capabilities, 
and other factors that may improve the ability of the functional-related 
groups to estimate variations in resource use.
    (3) Data from admission assessments under Sec.  412.610(c)(1) are 
used to classify a Medicare patient into an appropriate case-mix group.
    (4) Data from the discharge assessment under Sec.  412.610(c)(2) are 
used to determine the weighting factors under paragraph (b)(4) of this 
section.
    (b) Weighting factors--(1) General. An appropriate weight is 
assigned to each case-mix group that measures the relative difference in 
facility resource intensity among the various case-mix groups.
    (2) Short-stay outliers. We will determine a weighting factor or 
factors for patients that are discharged and not transferred (as defined 
in Sec.  412.602) within a number of days from admission as specified by 
us.
    (3) Patients who expire. We will determine a weighting factor or 
factors for patients who expire within a number of days from admission 
as specified by us.
    (4) Comorbidities. We will determine a weighting factor or factors 
to account for the presence of a comorbidity, as defined in Sec.  
412.602, that is relevant to resource use in the classification system.
    (c) Revision of case-mix group classifications and weighting 
factors. We may periodically adjust the case-mix groups and weighting 
factors to reflect changes in--
    (1) Treatment patterns;
    (2) Technology;
    (3) Number of discharges; and

[[Page 793]]

    (4) Other factors affecting the relative use of resources.



Sec.  412.622  Basis of payment.

    (a) Method of payment. (1) Under the prospective payment system, 
inpatient rehabilitation facilities receive a predetermined amount per 
discharge for inpatient services furnished to Medicare Part A fee-for-
service beneficiaries.
    (2) The amount of payment under the prospective payment system is 
based on the Federal payment rate, including adjustments described in 
Sec.  412.624 and, if applicable, during a transition period, on a blend 
of the Federal payment rate and the facility-specific payment rate 
described in Sec.  412.626.
    (3) IRF coverage criteria. In order for an IRF claim to be 
considered reasonable and necessary under section 1862(a)(1) of the Act, 
there must be a reasonable expectation that the patient meets all of the 
following requirements at the time of the patient's admission to the 
IRF--
    (i) Except for care furnished to patients in a freestanding IRF 
hospital solely to relieve acute care hospital capacity in a state (or 
region, as applicable) that is experiencing a surge during the Public 
Health Emergency, as defined in Sec.  400.200 of this chapter, requires 
the active and ongoing therapeutic intervention of multiple therapy 
disciplines (physical therapy, occupational therapy, speech-language 
pathology, or prosthetics/orthotics therapy), one of which must be 
physical or occupational therapy.
    (ii) Except during the emergency period described in section 
1135(g)(1)(B) of the Act, generally requires and can reasonably be 
expected to actively participate in, and benefit from, an intensive 
rehabilitation therapy program. Under current industry standards, this 
intensive rehabilitation therapy program generally consists of at least 
3 hours of therapy (physical therapy, occupational therapy, speech-
language pathology, or prosthetics/orthotics therapy) per day at least 5 
days per week. In certain well-documented cases, this intensive 
rehabilitation therapy program might instead consist of at least 15 
hours of intensive rehabilitation therapy per week. Benefit from this 
intensive rehabilitation therapy program is demonstrated by measurable 
improvement that will be of practical value to the patient in improving 
the patient's functional capacity or adaptation to impairments. The 
required therapy treatments must begin within 36 hours from midnight of 
the day of admission to the IRF.
    (iii) Except for care furnished to patients in a freestanding IRF 
hospital solely to relieve acute care hospital capacity in a state (or 
region, as applicable) that is experiencing a surge during the Public 
Health Emergency, as defined in Sec.  400.200 of this chapter, is 
sufficiently stable at the time of admission to the IRF to be able to 
actively participate in the intensive rehabilitation therapy program 
that is described in paragraph (a)(3)(ii) of this section.
    (iv) Except for care furnished to patients in a freestanding IRF 
hospital solely to relieve acute care hospital capacity in a state (or 
region, as applicable) that is experiencing a surge during the Public 
Health Emergency, as defined in Sec.  400.200 of this chapter, requires 
physician supervision by a rehabilitation physician. The requirement for 
medical supervision means that the rehabilitation physician must conduct 
face-to-face visits with the patient at least 3 days per week throughout 
the patient's stay in the IRF to assess the patient both medically and 
functionally, as well as to modify the course of treatment as needed to 
maximize the patient's capacity to benefit from the rehabilitation 
process, except that during a Public Health Emergency, as defined in 
Sec.  400.200 of this chapter, such visits may be conducted using 
telehealth services (as defined in section 1834(m)(4)(F) of the Act). 
Beginning with the second week of admission to the IRF, a non-physician 
practitioner who is determined by the IRF to have specialized training 
and experience in inpatient rehabilitation may conduct 1 of the 3 
required face-to-face visits with the patient per week, provided that 
such duties are within the non-physician practitioner's scope of 
practice under applicable state law.
    (4) Documentation. Except for care furnished to patients in a 
freestanding IRF hospital solely to relieve acute

[[Page 794]]

care hospital capacity in a state (or region, as applicable) that is 
experiencing a surge during the Public Health Emergency, as defined in 
Sec.  400.200 of this chapter, to document that each patient for whom 
the IRF seeks payment is reasonably expected to meet all of the 
requirements in paragraph (a)(3) of this section at the time of 
admission, the patient's medical record at the IRF must contain the 
following documentation--
    (i) A comprehensive preadmission screening that meets all of the 
following requirements--
    (A) It is conducted by a licensed or certified clinician(s) 
designated by a rehabilitation physician within the 48 hours immediately 
preceding the IRF admission. A preadmission screening that includes all 
of the required elements, but that is conducted more than 48 hours 
immediately preceding the IRF admission, will be accepted as long as an 
update is conducted in person or by telephone to update the patient's 
medical and functional status within the 48 hours immediately preceding 
the IRF admission and is documented in the patient's medical record.
    (B) It includes a detailed and comprehensive review of each 
patient's condition and medical history, including the patient's level 
of function prior to the event or condition that led to the patient's 
need for intensive rehabilitation therapy, expected level of 
improvement, and the expected length of time necessary to achieve that 
level of improvement; an evaluation of the patient's risk for clinical 
complications; the conditions that caused the need for rehabilitation; 
the treatments needed (that is, physical therapy, occupational therapy, 
speech-language pathology, or prosthetics/orthotics); and anticipated 
discharge destination.
    (C) It serves as the basis for the initial determination of whether 
or not the patient meets the requirements for an IRF admission to be 
considered reasonable and necessary in paragraph (a)(3) of this section.
    (D) It is used to inform a rehabilitation physician who reviews and 
documents his or her concurrence with the findings and results of the 
preadmission screening prior to the IRF admission.
    (E) It is retained in the patient's medical record at the IRF.
    (ii) An individualized overall plan of care for the patient that 
meets all of the following requirements--
    (A) It is developed by a rehabilitation physician with input from 
the interdisciplinary team within 4 days of the patient's admission to 
the IRF.
    (B) It is retained in the patient's medical record at the IRF.
    (5) Interdisciplinary team approach to care. Except for care 
furnished to patients in a freestanding IRF hospital solely to relieve 
acute care hospital capacity in a state (or region, as applicable) that 
is experiencing a surge during the Public Health Emergency, as defined 
in Sec.  400.200 of this chapter, in order for an IRF claim to be 
considered reasonable and necessary under section 1862(a)(1) of the Act, 
the patient must require an interdisciplinary team approach to care, as 
evidenced by documentation in the patients' medical record of weekly 
interdisciplinary team meetings that meet all of the following 
requirements--
    (i) The team meetings are led by a rehabilitation physician and 
further consist of a registered nurse with specialized training or 
experience in rehabilitation; a social worker or case manager (or both); 
and a licensed or certified therapist from each therapy discipline 
involved in treating the patient. All team members must have current 
knowledge of the patient's medical and functional status. The 
rehabilitation physician may lead the interdisciplinary team meeting 
remotely via a mode of communication such as video or telephone 
conferencing.
    (ii) The team meetings occur at least once per week throughout the 
duration of the patient's stay to implement appropriate treatment 
services; review the patient's progress toward stated rehabilitation 
goals; identify any problems that could impede progress towards those 
goals; and, where necessary, reassess previously established goals in 
light of impediments, revise the treatment plan in light of new goals, 
and monitor continued progress toward those goals.
    (iii) The results and findings of the team meetings, and the 
concurrence by the rehabilitation physician with those

[[Page 795]]

results and findings, are retained in the patient's medical record.
    (b) Payment in full. (1) The payment made under this subpart 
represents payment in full (subject to applicable deductibles and 
coinsurance as described in subpart G of part 409 of this subchapter) 
for inpatient operating and capital-related costs associated with 
furnishing Medicare covered services in an inpatient rehabilitation 
facility, but not for the cost of an approved medical education program 
described in Sec. Sec.  413.75 and 413.85 of this chapter.
    (2) In addition to payments based on prospective payment rates, 
inpatient rehabilitation facilities receive payments for the following:
    (i) Bad debts of Medicare beneficiaries, as provided in Sec.  413.89 
of this chapter; and
    (ii) A payment amount per unit for blood clotting factor provided to 
Medicare inpatients who have hemophilia.
    (c) Definitions. As used in this section--
    Rehabilitation physician means a licensed physician who is 
determined by the IRF to have specialized training and experience in 
inpatient rehabilitation.
    State (or region, as applicable) that is experiencing a surge means 
a state (or region, as applicable) that is in phase 1 of the President's 
Guidelines for Opening Up America Again (https://www.whitehouse.gov/
openingamerica/), specifically, a state (or region, as applicable) that 
satisfies all of the following, as determined by applicable state and 
local officials:
    (i) All vulnerable individuals continue to shelter in place.
    (ii) Individuals continue social distancing.
    (iii) Individuals avoid socializing in groups of more than 10.
    (iv) Non-essential travel is minimized.
    (v) Visits to senior living facilities and hospitals are prohibited.
    (vi) Schools and organized youth activities remain closed.
    Week means a period of 7 consecutive calendar days beginning with 
the date of admission to the IRF.

[66 FR 41388, Aug. 7, 2001, as amended at 70 FR 47952, Aug. 15, 2005; 74 
FR 39811, Aug. 7, 2009; 83 FR 38573,Aug. 6, 2018; 84 FR 39172, Aug. 8, 
2019; 85 FR 19287, Apr. 6, 2020; 85 FR 27622, May 8, 2020; 85 FR 48462, 
Aug. 10, 2020; 85 FR 59023, Sept. 18, 2020]



Sec.  412.624  Methodology for calculating the Federal 
prospective payment rates.

    (a) Data used. To calculate the prospective payment rates for 
inpatient hospital services furnished by inpatient rehabilitation 
facilities, we use--
    (1) The most recent Medicare data available, as of the date of 
establishing the inpatient rehabilitation facility prospective payment 
system, to estimate payments for inpatient operating and capital-related 
costs made under part 413 of this subchapter;
    (2) An appropriate wage index to adjust for area wage differences;
    (3) An increase factor to adjust for the most recent estimate of 
increases in the prices of an appropriate market basket of goods and 
services included in covered inpatient rehabilitation services; and
    (4) Patient assessment data described in Sec.  412.606 and other 
data that account for the relative resource utilization of different 
patient types.
    (b) Determining the average costs per discharge for fiscal year 
2001. We determine the average inpatient operating and capital costs per 
discharge for which payment is made to each inpatient rehabilitation 
facility using the available data specified under paragraph (a)(1) of 
this section. The cost per discharge is adjusted to fiscal year 2001 by 
an increase factor, described in paragraph (a)(3) of this section, under 
the update methodology described in section 1886(b)(3)(B)(ii) of the Act 
for each year through the midpoint of fiscal year 2001.
    (c) Determining the Federal prospective payment rates--(1) General. 
The Federal prospective payment rates will be established using a 
standard payment amount referred to as the standard payment conversion 
factor. The standard payment conversion factor is a standardized payment 
amount based on

[[Page 796]]

average costs from a base year that reflects the combined aggregate 
effects of the weighting factors, various facility and case level 
adjustments, and other adjustments.
    (2) Update the cost per discharge. CMS applies the increase factor 
described in paragraph (a)(3) of this section to the facility's cost per 
discharge determined under paragraph (b) of this section to compute the 
cost per discharge for fiscal year 2002. Based on the updated cost per 
discharge, CMS estimates the payments that would have been made to the 
facility for fiscal year 2002 under part 413 of this chapter without 
regard to the prospective payment system implemented under this subpart.
    (3) Computation of the standard payment conversion factor. The 
standard payment conversion factor is computed as follows:
    (i) For fiscal year 2002. Based on the updated costs per discharge 
and estimated payments for fiscal year 2002 determined in paragraph 
(c)(2) of this section, CMS computes a standard payment conversion 
factor for fiscal year 2002, as specified by CMS, that reflects, as 
appropriate, the adjustments described in paragraph (d) of this section.
    (ii) For fiscal years after 2002. The standard payment conversion 
factor for fiscal years after 2002 will be the standardized payments for 
the previous fiscal year updated by the increase factor described in 
paragraph (a)(3) of this section, including adjustments described in 
paragraph (d) of this section as appropriate.
    (4) Applicable increase factor for FY 2014 and for subsequent FY. 
Subject to the provisions of paragraphs (c)(4)(i) and (c)(4)(ii) of this 
section, the applicable increase factor for FY 2014 and for subsequent 
years for updating the standard payment conversion factor is the 
increase factor described in paragraph (a)(3) of this section, including 
adjustments described in paragraph (d) of this section as appropriate.
    (i) In the case of an IRF that is paid under the prospective payment 
system specified in Sec.  412.1(a)(3) that does not submit quality data 
to CMS in accordance with Sec.  412.634, the applicable increase factor 
specified in paragraph (a)(3) of this section, after application of 
subparagraphs (C)(iii) and (D) of section 1886(j)(3) of the Act, is 
reduced by 2 percentage points.
    (ii) Any reduction of the increase factor will apply only to the 
fiscal year involved and will not be taken into account in computing the 
applicable increase factor for a subsequent fiscal year.
    (iii) The 2 percentage point reduction described in paragraph 
(c)(4)(i) of this section may result in the applicable increase factor 
specified in paragraph (a)(3) of this section being less than 0.0 for a 
fiscal year, and may result in payment rates under the prospective 
payment system specified in Sec.  412.1(a)(3) for a fiscal year being 
less than such payment rates for the preceding fiscal year.
    (5) Determining the Federal prospective payment rate for each case-
mix group. The Federal prospective payment rates for each case-mix group 
is the product of the weighting factors described in Sec.  412.620(b) 
and the standard payment conversion factor described in paragraph (c)(3) 
of this section.
    (d) Adjustments to the standard payment conversion factor. The 
standard payment conversion factor described in paragraph (c)(3) of this 
section will be adjusted for the following:
    (1) Outlier payments. CMS determines a reduction factor equal to the 
estimated proportion of additional outlier payments described in 
paragraph (e)(5) of this section.
    (2) Budget neutrality. CMS adjusts the Federal prospective payment 
rates for fiscal year 2002 so that aggregate payments under the 
prospective payment system, excluding any additional payments associated 
with elections not to be paid under the transition period methodology 
under Sec.  412.626(b), are estimated to equal the amount that would 
have been made to inpatient rehabilitation facilities under part 413 of 
this chapter without regard to the prospective payment system 
implemented under this subpart.
    (3) Coding and classification changes. CMS adjusts the standard 
payment conversion factor for a given year if CMS determines that 
revisions in case-mix classifications or weighting factors for a 
previous fiscal year (or estimates that those revisions for a future

[[Page 797]]

fiscal year) did result in (or would otherwise result in) a change in 
aggregate payments that are a result of changes in the coding or 
classification of patients that do not reflect real changes in case-mix.
    (4) Payment adjustment for Federal fiscal year 2006 and applicable 
Federal fiscal years. CMS adjusts the standard payment conversion factor 
based on any updates to the adjustments specified in paragraph (e)(2), 
(3), (4) and (6), of this section, and to any revision specified in 
Sec.  412.620(c) by a factor as specified by the Secretary.
    (e) Calculation of the adjusted Federal prospective payment. For 
each discharge, an inpatient rehabilitation facility's Federal 
prospective payment is computed on the basis of the Federal prospective 
payment rate that is in effect for its cost reporting period that begins 
in a Federal fiscal year specified under paragraph (c) of this section. 
A facility's Federal prospective payment rate will be adjusted, as 
appropriate, to account for area wage levels, payments for outliers and 
transfers, and for other factors as follows:
    (1) Adjustment for area wage levels. The labor portion of a 
facility's Federal prospective payment is adjusted to account for 
geographical differences in the area wage levels using an appropriate 
wage index. The application of the wage index is made on the basis of 
the location of the facility in an urban or rural area as defined in 
Sec.  412.602. Adjustments or updates to the wage data used to adjust a 
facility's Federal prospective payment rate under paragraph (e)(1) of 
this section will be made in a budget neutral manner. CMS determines a 
budget neutral wage adjustment factor, based on any adjustment or update 
to the wage data, to apply to the standard payment conversion factor.
    (2) Adjustments for low-income patients. We adjust the Federal 
prospective payment, on a facility basis, for the proportion of low-
income patients that receive inpatient rehabilitation services as 
determined by us.
    (3) Adjustments for rural areas. We adjust the Federal prospective 
payment by a factor, as specified by us for facilities located in rural 
areas, as defined in Sec.  412.602.
    (4) Adjustments for teaching hospitals. For discharges on or after 
October 1, 2005, CMS adjusts the Federal prospective payment on a 
facility basis by a factor as specified by CMS for facilities that are 
teaching institutions or units of teaching institutions. This adjustment 
is made on a claim basis as an interim payment and the final payment in 
full for the claim is made during the final settlement of the cost 
report.
    (5) Adjustment for high-cost outliers. CMS provides for an 
additional payment to an inpatient rehabilitation facility if its 
estimated costs for a patient exceed a fixed dollar amount (adjusted for 
area wage levels and factors to account for treating low-income 
patients, for rural location, and for teaching programs) as specified by 
CMS. The additional payment equals 80 percent of the difference between 
the estimated cost of the patient and the sum of the adjusted Federal 
prospective payment computed under this section and the adjusted fixed 
dollar amount. Effective for discharges occurring on or after October 1, 
2003, additional payments made under this section will be subject to the 
adjustments at Sec.  412.84(i), except that CMS calculates a single 
overall (combined operating and capital) cost-to-charge ratio and 
national averages that will be used instead of statewide averages. 
Effective for discharges occurring on or after October 1, 2003, 
additional payments made under this section will also be subject to 
adjustments at Sec.  412.84(m), except that CMS calculates a single 
overall (combined operating and capital) cost-to-charge ratio.
    (6) Adjustments for certain facilities geographically redesignated 
in FY 2006--(i) General. For a facility defined as an urban facility 
under Sec.  412.602 in FY 2006 that was previously defined as a rural 
facility in FY 2005 as the term rural was defined in FY 2005 under Sec.  
412.602 and whose payment, after applying the adjustment under this 
paragraph, will be lower only because of being defined as an urban 
facility in FY 2006 and it no longer qualified for the rural adjustment 
under Sec.  412.624(e)(3) in FY 2006, CMS will adjust the facility's 
payment using the following method:
    (A) For discharges occurring on or after October 1, 2005, and on or 
before

[[Page 798]]

September 30, 2006, the facility's payment will be increased by an 
adjustment of two thirds of its prior FY 2005 19.14 percent rural 
adjustment.
    (B) For discharges occurring on or after October 1, 2006, and on or 
before September 30, 2007, the facility's payment will be increased by 
an adjustment of one third of its FY 2005 19.14 percent rural 
adjustment.
    (ii) Exception. For discharges occurring on or after October 1, 2005 
and on or before September 30, 2007, facilities whose payments, after 
applying the adjustment under this paragraph (e)(7)(i) of this section, 
will be higher because of being defined as an urban facility in FY 2006 
and no longer being qualified for the rural adjustment under Sec.  
412.624(e)(3) in FY 2006, CMS will adjust the facility's payment by a 
portion of the applicable additional adjustment described in paragraph 
(e)(6)(i)(A) and (B) of this section as determined by us.
    (f) Special payment provision for patients that are transferred. (1) 
A facility's Federal prospective payment will be adjusted to account for 
a discharge of a patient who--
    (i) Is transferred from the inpatient rehabilitation facility to 
another site of care, as defined in Sec.  412.602; and
    (ii) Stays in the facility for a number of days that is less than 
the average length of stay for nontransfer cases in the case-mix group 
to which the patient is classified.
    (2) We calculate the adjusted Federal prospective payment for 
patients who are transferred in the following manner:
    (i) By dividing the Federal prospective payment by the average 
length of stay for nontransfer cases in the case-mix group to which the 
patient is classified to equal the payment per day.
    (ii) By multiplying the payment per day under paragraph (f)(2)(i) of 
this section by the number of days the patient stayed in the facility 
prior to being discharged to equal the per day payment amount.
    (iii) By multiplying the payment per day under paragraph (f)(2)(i) 
by 0.5 to equal an additional one half day payment for the first day of 
the stay before the discharge.
    (iv) By adding the per day payment amount under paragraph (f)(2)(ii) 
and the additional one-half day payment under paragraph (f)(2)(iii) to 
equal the unadjusted payment amount.
    (v) By applying the adjustment described in paragraphs (e)(1), (2), 
(3), (4), and (6) of this section to the unadjusted payment amount 
determined in paragraph (f)(2)(iv) of this section to equal the adjusted 
transfer payment amount and making a payment in accordance with 
paragraph (e)(5) of this section, if applicable.
    (g) Special payment provision for interrupted stays. When a patient 
in an inpatient rehabilitation facility has one or more interruptions in 
the stay, as defined in Sec.  412.602 and as indicated on the patient 
assessment instrument in accordance with Sec.  412.618(b), we will make 
payments in the following manner:
    (1) Patient is discharged and returns on the same day. Payment for a 
patient who is discharged and returns to the same inpatient 
rehabilitation facility on the same day will be the adjusted Federal 
prospective payment under paragraph (e) of this section that is based on 
the patient assessment data specified in Sec.  412.618(a)(1). Payment 
for a patient who is discharged and returns to the same inpatient 
rehabilitation facility on the same day will only be made to the 
inpatient rehabilitation facility.
    (2) Patient is discharged and does not return by the end of the same 
day. Payment for a patient who is discharged and does not return on the 
same day but does return to the same inpatient rehabilitation facility 
by or on midnight of the third day, defined as an interrupted stay under 
Sec.  412.602, will be--
    (i) The adjusted Federal prospective payment under paragraph (e) of 
this section that is based on the patient assessment data specified in 
Sec.  412.618(a)(1) made to the inpatient rehabilitation facility; and
    (ii) If the reason for the interrupted patient stay is to receive 
inpatient acute care hospital services, an amount

[[Page 799]]

based on the prospective payment systems described in Sec.  412.1(a)(1) 
made to the acute care hospital.

[66 FR 41388, Aug. 7, 2001, as amended at 67 FR 44077, July 1, 2002; 68 
FR 45700, Aug. 1, 2003; 70 FR 47952, Aug. 15, 2005; 71 FR 48408, Aug. 
18, 2006; 72 FR 44312, Aug. 7, 2007; 76 FR 47892, Aug. 5, 2011; 82 FR 
36305, Aug. 3, 2017; 83 FR 38573, Aug. 6, 2018]



Sec.  412.626  Transition period.

    (a) Duration of transition period and proportion of the blended 
transition rate. (1) Except for a facility that makes an election under 
paragraph (b) of this section, for cost reporting periods beginning on 
or after January 1, 2002 and before October 1, 2002, an inpatient 
rehabilitation facility receives a payment comprised of a blend of the 
adjusted Federal prospective payment, as determined under Sec.  
412.624(e) or Sec.  412.624(f) and a facility-specific payment as 
determined under paragraph (a)(2) of this section.
    (i) For cost reporting periods beginning on or after January 1, 2002 
and before October 1, 2002, payment is based on 33\1/3\ percent of the 
facility-specific payment and 66\2/3\ percent of the adjusted FY 2002 
Federal prospective payment.
    (ii) For cost reporting periods beginning on or after October 1, 
2002, payment is based entirely on the adjusted Federal prospective 
payment.
    (2) Calculation of the facility-specific payment. The facility-
specific payment is equal to the payment for each cost reporting period 
in the transition period that would have been made without regard to 
this subpart. The facility's Medicare fiscal intermediary calculates the 
facility-specific payment for inpatient operating costs and capital-
related costs in accordance with part 413 of this chapter.
    (b) Election not to be paid under the transition period methodology. 
An inpatient rehabilitation facility may elect a payment that is based 
entirely on the adjusted Federal prospective payment for cost reporting 
periods beginning before fiscal year 2003 without regard to the 
transition period percentages specified in paragraph (a)(1)(i) of this 
section.
    (1) General requirement. An inpatient rehabilitation facility will 
be required to request the election under this paragraph (b) within 30 
days of its first cost reporting period for which payment is based on 
the inpatient rehabilitation facility prospective payment system for 
cost reporting periods beginning on or after January 1, 2002 and before 
October 1, 2002.
    (2) Notification requirement to make election. The request by the 
inpatient rehabilitation facility to make the election under this 
paragraph (b) must be made in writing to the Medicare fiscal 
intermediary. The intermediary must receive the request on or before the 
30th day before the applicable cost reporting period begins, regardless 
of any postmarks or anticipated delivery dates. Requests received, 
postmarked, or delivered by other means after the 30th day before the 
cost reporting period begins will not be approved. If the 30th day 
before the cost reporting period begins falls on a day that the postal 
service or other delivery sources are not open for business, the 
inpatient rehabilitation facility is responsible for allowing sufficient 
time for the delivery of the request before the deadline. If an 
inpatient rehabilitation facility's request is not received timely or is 
otherwise not approved, payment will be based on the transition period 
rate specified in paragraph (a)(1)(i) of this section.

[66 FR 41388, Aug. 7, 2001, as amended at 67 FR 44077, July 1, 2002]



Sec.  412.628  Publication of the Federal prospective payment rates.

    We publish information pertaining to the inpatient rehabilitation 
facility prospective payment system effective for each fiscal year in 
the Federal Register. This information includes the unadjusted Federal 
payment rates, the patient classification system and associated 
weighting factors, and a description of the methodology and data used to 
calculate the payment rates. This information is published on or before 
August 1 prior to the beginning of each fiscal year.



Sec.  412.630  Limitation on review.

    Administrative or judicial review under sections 1869 or 1878 of the 
Act, or otherwise, is prohibited with regard

[[Page 800]]

to the establishment of the methodology to classify a patient into the 
case-mix groups and the associated weighting factors, the Federal per 
discharge payment rates, additional payments for outliers and special 
payments, and the area wage index.

[78 FR 47934, Aug. 6, 2013]



Sec.  412.632  Method of payment under the inpatient rehabilitation facility 
prospective payment system.

    (a) General rule. Subject to the exceptions in paragraphs (b) and 
(c) of this section, an inpatient rehabilitation facility receives 
payment under this subpart for inpatient operating costs and capital-
related costs for each discharge only following submission of a 
discharge bill.
    (b) Periodic interim payments--(1) Criteria for receiving periodic 
interim payments. (i) An inpatient rehabilitation facility receiving 
payment under this subpart may receive periodic interim payments (PIP) 
for Part A services under the PIP method subject to the provisions of 
Sec.  413.64(h) of this subchapter.
    (ii) To be approved for PIP, the inpatient rehabilitation facility 
must meet the qualifying requirements in Sec.  413.64(h)(3) of this 
subchapter.
    (iii) Payments to a rehabilitation unit are made under the same 
method of payment as the hospital of which it is a part as described in 
Sec.  412.116.
    (iv) As provided in Sec.  413.64(h)(5) of this chapter, intermediary 
approval is conditioned upon the intermediary's best judgment as to 
whether payment can be made under the PIP method without undue risk of 
its resulting in an overpayment to the provider.
    (2) Frequency of payment. For facilities approved for PIP, the 
intermediary estimates the inpatient rehabilitation facility's Federal 
prospective payments net of estimated beneficiary deductibles and 
coinsurance and makes biweekly payments equal to \1/26\ of the total 
estimated amount of payment for the year. If the inpatient 
rehabilitation facility has payment experience under the prospective 
payment system, the intermediary estimates PIP based on that payment 
experience, adjusted for projected changes supported by substantiated 
information for the current year. Each payment is made 2 weeks after the 
end of a biweekly period of service as described in Sec.  413.64(h)(6) 
of this subchapter. The interim payments are reviewed at least twice 
during the reporting period and adjusted if necessary. Fewer reviews may 
be necessary if an inpatient rehabilitation facility receives interim 
payments for less than a full reporting period. These payments are 
subject to final settlement.
    (3) Termination of PIP. (i) Request by the inpatient rehabilitation 
facility. Subject to the provisions of paragraph (b)(1)(iii) of this 
section, an inpatient rehabilitation facility receiving PIP may convert 
to receiving prospective payments on a non-PIP basis at any time.
    (ii) Removal by the intermediary. An intermediary terminates PIP if 
the inpatient rehabilitation facility no longer meets the requirements 
of Sec.  413.64(h) of this chapter.
    (c) Interim payments for Medicare bad debts and for Part A costs not 
paid under the prospective payment system. For Medicare bad debts and 
for costs of an approved education program and other costs paid outside 
the prospective payment system, the intermediary determines the interim 
payments by estimating the reimbursable amount for the year based on the 
previous year's experience, adjusted for projected changes supported by 
substantiated information for the current year, and makes biweekly 
payments equal to \1/26\ of the total estimated amount. Each payment is 
made 2 weeks after the end of a biweekly period of service as described 
in Sec.  413.64(h)(6) of this chapter. The interim payments are reviewed 
at least twice during the reporting period and adjusted if necessary. 
Fewer reviews may be necessary if an inpatient rehabilitation facility 
receives interim payments for less than a full reporting period. These 
payments are subject to final cost settlement.
    (d) Outlier payments. Additional payments for outliers are not made 
on an interim basis. The outlier payments are made based on the 
submission of a discharge bill and represent final payment.

[[Page 801]]

    (e) Accelerated payments--(1) General rule. Upon request, an 
accelerated payment may be made to an inpatient rehabilitation facility 
that is receiving payment under this subpart and is not receiving PIP 
under paragraph (b) of this section if the inpatient rehabilitation 
facility is experiencing financial difficulties because of the 
following:
    (i) There is a delay by the intermediary in making payment to the 
inpatient rehabilitation facility.
    (ii) Due to an exceptional situation, there is a temporary delay in 
the inpatient rehabilitation facility's preparation and submittal of 
bills to the intermediary beyond its normal billing cycle.
    (2) Approval of payment. An inpatient rehabilitation facility's 
request for an accelerated payment must be approved by the intermediary 
and us.
    (3) Amount of payment. The amount of the accelerated payment is 
computed as a percentage of the net payment for unbilled or unpaid 
covered services.
    (4) Recovery of payment. Recovery of the accelerated payment is made 
by recoupment as inpatient rehabilitation facility bills are processed 
or by direct payment by the inpatient rehabilitation facility.



Sec.  412.634  Requirements under the Inpatient Rehabilitation Facility (IRF) 
Quality Reporting Program (QRP).

    (a) Participation.(1) For the FY 2018 payment determination and 
subsequent years, an IRF must begin reporting data under the IRF QRP 
requirements no later than the first day of the calendar quarter 
subsequent to 30 days after the date on its CMS Certification Number 
(CCN) notification letter, which designates the IRF as operating in the 
CMS designated data submission system.
    (2) [Reserved]
    (b) Submission requirements. (1) IRFs must submit to CMS data on 
measures specified under sections 1886(j)(7)(D), 1899B(c)(1), 
1899B(d)(1) of the Act, and standardized patient assessment data 
required under section 1899B(b)(1) of the Act, as applicable. Such data 
must be submitted in the form and manner, and at a time, specified by 
CMS.
    (2) CMS may remove a quality measure from the IRF QRP based on one 
or more of the following factors:
    (i) Measure performance among IRFs is so high and unvarying that 
meaningful distinctions in improvements in performance can no longer be 
made;
    (ii) Performance or improvement on a measure does not result in 
better patient outcomes;
    (iii) A measure does not align with current clinical guidelines or 
practice;
    (iv) The availability of a more broadly applicable (across settings, 
populations, or conditions) measure for the particular topic;
    (v) The availability of a measure that is more proximal in time to 
desired patient outcomes for the particular topic;
    (vi) The availability of a measure that is more strongly associated 
with desired patient outcomes for the particular topic;
    (vii) The collection or public reporting of a measure leads to 
negative unintended consequences other than patient harm;
    (viii) The costs associated with a measure outweigh the benefit of 
its continued use in the program.
    (c) Exception and Extension Requirements. (1) An IRF may request and 
CMS may grant exceptions or extensions to the measures data or 
standardized patient assessment data reporting requirements, for one or 
more quarters, when there are certain extraordinary circumstances beyond 
the control of the IRF.
    (2) An IRF must request an exception or extension within 90 days of 
the date that the extraordinary circumstances occurred.
    (3) Exception and extension requests must be submitted to CMS from 
the IRF by sending an email to [email protected] 
containing all of the following information:
    (i) IRF CMS Certification Number (CCN).
    (ii) IRF Business Name.
    (iii) IRF Business Address.
    (iv) CEO or CEO-designated personnel contact information including 
name, telephone number, title, email address, and mailing address. (The 
address must be a physical address, not a post office box.)

[[Page 802]]

    (v) IRF's reason for requesting the exception or extension.
    (vi) Evidence of the impact of extraordinary circumstances, 
including, but not limited to, photographs, newspaper, and other media 
articles.
    (vii) Date when the IRF believes it will be able to again submit IRF 
QRP data and a justification for the proposed date.
    (4) CMS may grant exceptions or extensions to IRFs without a request 
if it is determined that one or more of the following has occurred:
    (i) An extraordinary circumstance affects an entire region or 
locale.
    (ii) A systemic problem with one of CMS's data collection systems 
directly affected the ability of an IRF to submit data.
    (5) Email is the only form of submission that will be accepted. Any 
reconsideration requests received through another channel will not be 
considered as a valid exception or extension request.
    (d) Reconsideration. (1) IRFs that do not meet the requirement in 
paragraph (b) of this section for a program year will receive a written 
notification of non-compliance through at least one of the following 
methods: The CMS designated data submission system, the United States 
Postal Service, or via an email from the Medicare Administrative 
Contractor (MAC).
    (2) Reconsideration requests must be submitted to CMS by sending an 
email to [email protected] containing all of the 
following information:
    (i) IRF CCN.
    (ii) IRF Business Name.
    (iii) IRF Business Address.
    (iv) CEO or CEO-designated personnel contact information including 
name, telephone number, title, email address, and mailing address. (The 
address must be a physical address, not a post office box.)
    (v) CMS identified reason(s) for non-compliance from the non-
compliance letter.
    (vi) Reason(s) for requesting reconsideration.
    (3) The request for reconsideration must be accompanied by 
supporting documentation demonstrating compliance. This documentation 
must be submitted electronically as an attachment to the reconsideration 
request email. Any request for reconsideration that does not contain 
sufficient evidence of compliance with the IRF QRP requirements will be 
denied.
    (4) Email is the only form of submission that will be accepted. Any 
reconsideration requests received through another channel will not be 
considered as a valid exception or extension request.
    (5) CMS will notify IRFs, in writing, of its final decision 
regarding any reconsideration request through at least one of the 
following methods: CMS designated data submission system, the United 
States Postal Service, or via an email from the Medicare Administrative 
Contractor (MAC).
    (e) Appeals. (1) An IRF may appeal the decision made by CMS on its 
reconsideration request by filing with the Provider Reimbursement Review 
Board (PRRB) under 42 CFR part 405, subpart R.
    (2) [Reserved]
    (f) Data Completion Thresholds. (1) IRFs must meet or exceed two 
separate data completeness thresholds: One threshold set at 95 percent 
for completion of required quality measures data and standardized 
patient assessment data collected using the IRF-PAI submitted through 
the CMS designated data submission system; and a second threshold set at 
100 percent for measures data collected and submitted using the CDC 
NHSN.
    (2) These thresholds (95 percent for completion of required quality 
measures data and standardized patient assessment data on the IRF-PAI; 
100 percent for CDC NHSN data) will apply to all measures and 
standardized patient assessment data requirements adopted into the IRF 
QRP.
    (3) An IRF must meet or exceed both thresholds to avoid receiving a 
2 percentage point reduction to their annual payment update for a given 
fiscal year, beginning with FY 2016 and for all subsequent payment 
updates.

[80 FR 47138, Aug. 6, 2015, as amended at 81 FR 52140, Aug. 5, 2016; 82 
FR 36305, Aug. 3, 2017; 83 FR 38573, Aug. 6, 2018; 84 FR 39172, Aug. 8, 
2019]

[[Page 803]]



 PART 413_PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR END	STAGE 
 RENAL DISEASE SERVICES; PROSPECTIVELY DETERMINED PAYMENT RATES 
 FOR SKILLED NURSING FACILITIES; PAYMENT FOR ACUTE KIDNEY INJURY DIALYSIS--
 Table of Contents



                Subpart A_Introduction and General Rules

Sec.
413.1 Introduction.
413.5 Cost reimbursement: General.
413.9 Cost related to patient care.
413.13 Amount of payment if customary charges for services furnished are 
          less than reasonable costs.
413.17 Cost to related organizations.

                Subpart B_Accounting Records and Reports

413.20 Financial data and reports.
413.24 Adequate cost data and cost finding.

                 Subpart C_Limits on Cost Reimbursement

413.30 Limitations on payable costs.
413.35 Limitations on coverage of costs: Charges to beneficiaries if 
          cost limits are applied to services.
413.40 Ceiling on the rate of increase in hospital inpatient costs.

                         Subpart D_Apportionment

413.50 Apportionment of allowable costs.
413.53 Determination of cost of services to beneficiaries.
413.56 [Reserved]

                     Subpart E_Payments to Providers

413.60 Payments to providers: General.
413.64 Payments to providers: Specific rules.
413.65 Requirements for a determination that a facility or an 
          organization has provider-based status.
413.70 Payment for services of a CAH.
413.74 Payment to a foreign hospital.

                 Subpart F_Specific Categories of Costs

413.75 Direct GME payments: General requirements.
413.76 Direct GME payments: Calculation of payments for GME costs.
413.77 Direct GME payments: Determination of per resident amounts.
413.78 Direct GME payments: Determination of the total number of FTE 
          residents.
413.79 Direct GME payments: Determination of the weighted number of FTE 
          residents.
413.80 Direct GME payments: Determination of weighting factors for 
          foreign medical graduates.
413.81 Direct GME payments: Application of community support and 
          redistribution of costs in determining FTE resident counts.
413.82 Direct GME payments: Special rules for States that formerly had a 
          waiver from Medicare reimbursement principles.
413.83 Direct GME payments: Adjustment of a hospital's target amount or 
          prospective payment hospital-specific rate.
413.85 Cost of approved nursing and allied health education activities.
413.87 Payments for Medicare + Choice nursing and allied health 
          education programs.
413.88 Incentive payments under plans for voluntary reduction in number 
          of medical residents.
413.89 Bad debts, charity, and courtesy allowances.
413.90 Research costs.
413.92 Costs of surety bonds.
413.94 Value of services of nonpaid workers.
413.98 Purchase discounts and allowances, and refunds of expenses.
413.100 Special treatment of certain accrued costs.
413.102 Compensation of owners.
413.106 Reasonable cost of physical and other therapy services furnished 
          under arrangements.
413.114 Payment for posthospital SNF care furnished by a swing-bed 
          hospital.
413.118 Payment for facility services related to covered ASC surgical 
          procedures performed in hospitals on an outpatient basis.
413.122 Payment for hospital outpatient radiology services and other 
          diagnostic procedures.
413.123 Payment for screening mammography performed by hospitals on an 
          outpatient basis.
413.124 Reduction to hospital outpatient operating costs.
413.125 Payment for home health agency services.

                     Subpart G_Capital-Related Costs

413.130 Introduction to capital-related costs.
413.134 Depreciation: Allowance for depreciation based on asset costs.
413.139 Depreciation: Optional allowance for depreciation based on a 
          percentage of operating costs.
413.144 Depreciation: Allowance for depreciation on fully depreciated or 
          partially depreciated assets.
413.149 Depreciation: Allowance for depreciation on assets financed with 
          Federal or public funds.
413.153 Interest expense.

[[Page 804]]

413.157 Return on equity capital of proprietary providers.

Subpart H_Payment for End-Stage Renal Disease (ESRD) Services and Organ 
                            Procurement Costs

413.170 Scope.
413.171 Definitions.
413.172 Principles of prospective payment.
413.174 Prospective rates for hospital-based and independent ESRD 
          facilities.
413.176 Amount of payments.
413.177 Quality incentive program payment.
413.178 ESRD quality incentive program.
413.180 Procedures for requesting exceptions to payment rates.
413.182 Criteria for approval of exception requests.
413.184 Payment exception: Pediatric patient mix.
413.186 Payment exception: Self-dialysis training costs.
413.194 Appeals.
413.195 Limitation on review.
413.196 Notification of changes in rate-setting methodologies and 
          payment rates.
413.198 Recordkeeping and cost reporting requirements for outpatient 
          maintenance dialysis.
413.200 Payment of independent organ procurement organizations and 
          histocompatibility laboratories.
413.202 Organ procurement organization (OPO) cost for kidneys sent to 
          foreign countries or transplanted in patients other than 
          Medicare beneficiaries.
413.203 Transplant center costs for organs sent to foreign countries or 
          transplanted in patients other than Medicare beneficiaries.
413.210 Conditions for payment under the end-stage renal disease (ESRD) 
          prospective payment system.
413.215 Basis of payment.
413.217 Items and services included in the ESRD prospective payment 
          system.
413.220 Methodology for calculating the per-treatment base rate under 
          the ESRD prospective payment system effective January 1, 2011.
413.230 Determining the per treatment payment amount.
413.231 Adjustment for wages.
413.232 Low-volume adjustment.
413.233 Rural facility adjustment.
413.234 Drug designation process.
413.235 Patient-level adjustments.
413.236 Transitional add-on payment adjustment for new and innovative 
          equipment and supplies.
413.237 Outliers.
413.239 Transition period.
413.241 Pharmacy arrangements.

Subpart I_Prospectively Determined Payment Rates for Low-Volume Skilled 
 Nursing Facilities, for Cost Reporting Periods Beginning Prior to July 
                                 1, 1998

413.300 Basis and scope.
413.302 Definitions.
413.304 Eligibility for prospectively determined payment rates.
413.308 Rules governing election of prospectively determined payment 
          rates.
413.310 Basis of payment.
413.312 Methodology for calculating rates.
413.314 Determining payment amounts: Routine per diem rate.
413.316 Determining payment amounts: Ancillary services.
413.320 Publication of prospectively determined payment rates or 
          amounts.
413.321 Simplified cost reports for SNFs.

      Subpart J_Prospective Payment for Skilled Nursing Facilities

413.330 Basis and scope.
413.333 Definitions.
413.335 Basis of payment.
413.337 Methodology for calculating the prospective payment rates.
413.338 Skilled nursing facility value-based purchasing program.
413.340 Transition period.
413.343 Resident assessment data.
413.345 Publication of Federal prospective payment rates.
413.348 Limitation on review.
413.350 Periodic interim payments for skilled nursing facilities 
          receiving payment under the skilled nursing facility 
          prospective payment system for Part A services.
413.355 Additional payment: QIO reimbursement for cost of sending 
          records electronically or by photocopy and mailing.
413.360 Requirements under the Skilled Nursing Facility (SNF) Quality 
          Reporting Program (QRP).

        Subpart K_Payment for Acute Kidney Injury (AKI) Dialysis

413.370 Scope.
413.371 Definition.
413.372 AKI dialysis payment rate.
413.373 Other adjustments to the AKI dialysis payment rate
413.374 Renal dialysis services included in the AKI dialysis payment 
          rate
413.375 Notification of changes in rate-setting methodologies and 
          payment rates.

    Authority: 42 U.S.C. 1302, 1395d(d), 1395f(b), 1395g, 1395l(a), (i), 
and (n), 1395x(v), 1395hh, 1395rr, 1395tt, and 1395ww.

[[Page 805]]


    Source: 51 FR 34793, Sept. 30, 1986, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 413 appear at 76 FR 
50537, August 22, 2014.



                Subpart A_Introduction and General Rules



Sec.  413.1  Introduction.

    (a) Basis, scope, and applicability--(1) Statutory basis--(i) Basic 
provisions. (A) Section 1815 of the Act requires that the Secretary make 
interim payments to providers and periodically determine the amount that 
should be paid under Part A of Medicare to each provider for the 
services it furnishes.
    (B) Section 1814(b) of the Act (for Part A) and section 1833(a) (for 
Part B) provide for payment on the basis of the lesser of a provider's 
reasonable costs or customary charges.
    (C) Section 1861(v) of the Act defines ``reasonable cost''.
    (ii) Additional provisions. (A) Section 1138(b) of the Act specifies 
the conditions for Medicare payment for organ procurement costs.
    (B) Section 1814(j) of the Act provides for exceptions to the 
``lower of costs or charges'' provisions.
    (C) Sections 1815(a) and 1833(e) of the Act provide the Secretary 
with authority to request information from providers to determine the 
amount of Medicare payment due providers.
    (D) Section 1833(a)(4) and (i)(3) of the Act provide for payment of 
a blended amount for certain surgical services furnished in a hospital's 
outpatient department.
    (E) Section 1833(n) of the Act provides for payment of a blended 
amount for outpatient hospital diagnostic procedures such as radiology.
    (F) Section 1834(c)(1)(C) of the Act establishes the method for 
determining Medicare payment for screening mammograms performed by 
hospitals.
    (G) Section 1834(g) of the Act provides that payment for critical 
access hospital (CAH) outpatient services is the reasonable costs of the 
CAH in providing these services, as determined in accordance with 
section 1861(v)(1)(A) of the Act and the applicable principles of cost 
reimbursement in this part and in part 415 of this chapter.
    (H) Section 1881 of the Act authorizes payment for services 
furnished to ESRD patients.
    (I) Section 1883 of the Act provides for payment for post-hospital 
SNF care furnished by a rural hospital that has swing-bed approval.
    (J) Sections 1886(a) and (b) of the Act impose a ceiling on the rate 
of increase in hospital inpatient costs.
    (K) Section 1886(h) of the Act provides for payment to a hospital 
for the services of interns and residents in approved teaching programs 
on the basis of a ``per resident'' amount.
    (2) Scope. This part sets forth regulations governing Medicare 
payment for services furnished to beneficiaries by--
    (i) Hospitals and critical access hospitals (CAHs);
    (ii) Skilled nursing facilities (SNFs);
    (iii) Home health agencies (HHAs);
    (iv) End-stage renal disease (ESRD) facilities;
    (v) Organ procurement agencies (OPAs) and histocompatibility 
laboratories.
    (3) Applicability. The payment principles and related policies set 
forth in this part are binding on CMS and its fiscal contractors, on the 
Provider Reimbursement Review Board, and on the entities listed in 
paragraph (a)(2) of this section.
    (b) Reasonable cost reimbursement. Except as provided under 
paragraphs (c) through (h) of this section, Medicare is generally 
required, under section 1814(b) of the Act (for services covered under 
Part A) and under section 1833(a)(2) of the Act (for services covered 
under Part B) to pay for services furnished by providers on the basis of 
reasonable costs as defined in section 1861(v) of the Act, or the 
provider's customary charges for those services, if lower. Regulations 
implementing section 1861(v) are found generally in this part beginning 
at Sec.  413.5.
    (c) Outpatient maintenance dialysis and related services. Section 
1881 of the Act authorizes special rules for the coverage of and payment 
for services furnished to ESRD patients. Sections 413.170 and 413.174 
implement various provisions of section 1881. In particular, Sec.  
413.170 establishes a prospective payment method for outpatient

[[Page 806]]

maintenance dialysis services that applies both to hospital-based and 
independent ESRD facilities, and under which Medicare pays for both home 
and infacility dialysis services furnished on or after August 1, 1983.
    (d) Payment for inpatient hospital services. (1) For cost reporting 
periods beginning before October 1, 1983, the amount paid for inpatient 
hospital services is determined on a reasonable cost basis.
    (2) Payment to short-term general hospitals located in the 50 States 
and the District of Columbia for the operating costs of hospital 
inpatient services for cost reporting periods beginning on or after 
October 1, 1983, and for the capital-related costs of inpatient services 
for cost reporting periods beginning on or after October 1, 1991, are 
determined prospectively on a per discharge basis under part 412 of this 
chapter except as follows:
    (i) Payment for capital-related costs for cost reporting periods 
beginning before October 1, 1991, medical education costs, kidney 
acquisition costs, and the costs of certain anesthesia services, is 
described in Sec.  412.113 of this chapter.
    (ii) Payment to children's hospitals that are excluded from the 
prospective payment systems under subpart B of part 412 of this chapter, 
and hospitals outside the 50 States and the District of Columbia is on a 
reasonable cost basis, subject to the provisions of Sec.  413.40.
    (iii) Payment to hospitals subject to a State reimbursement control 
system is described in paragraph (e) of this section.
    (iv) For cost reporting periods beginning before January 1, 2005, 
payment to psychiatric hospitals (as well as separate psychiatric units 
(distinct parts) of short-term general hospitals) that are excluded 
under subpart B of part 412 of this chapter from the prospective payment 
system is on a reasonable cost basis, subject to the provisions of Sec.  
413.40.
    (v) For cost reporting periods beginning on or after January 1, 
2005, payment to inpatient psychiatric facilities that meet the 
conditions of Sec.  412.404 of this chapter, is made under the 
prospective payment system described in subpart N of part 412 of this 
chapter.
    (vi) For cost reporting periods beginning before January 1, 2002, 
payment to rehabilitation hospitals (as well as separate rehabilitation 
units (distinct parts) of short-term general hospitals), that are 
excluded under subpart B of part 412 of this subchapter from the 
prospective payment systems is made on a reasonable cost basis, subject 
to the provisions of Sec.  413.40.
    (vii) For cost reporting periods beginning on or after January 1, 
2002, payment to rehabilitation hospitals (as well as separate 
rehabilitation units (distinct parts) of short-term general hospitals) 
that meet the conditions of Sec.  412.604 of this chapter is based on 
prospectively determined rates under subpart P of part 412 of this 
subchapter.
    (viii) For cost reporting periods beginning before October 1, 2002, 
payment to long-term care hospitals that are excluded under subpart B of 
Part 412 of this subchapter from the prospective payment systems is on a 
reasonable cost basis, subject to the provisions of Sec.  413.40.
    (ix) For cost reporting periods beginning on or after October 1, 
2002, payment to the long-term hospitals that meet the condition for 
payment of Sec. Sec.  412.505 through 412.511 of this subchapter is 
based on prospectively determined rates under subpart O of Part 412 of 
this subchapter.
    (e) State reimbursement control systems. Beginning October 1, 1983, 
Medicare reimbursement for inpatient hospital services may be made in 
accordance with a State reimbursement control system rather than under 
the Medicare reimbursement principles set forth in this part, if the 
State system is approved by CMS. Regulations implementing this 
alternative reimbursement authority are set forth in subpart C of part 
403 of this chapter.
    (f) Services of qualified nonphysician anesthetists. For cost 
reporting periods, or any part of a cost reporting period, beginning on 
or after January 1, 1989, costs incurred for the services of qualified 
nonphysician anesthetists are not paid on a reasonable cost basis unless 
the provisions of Sec.  412.113(c)(2) of this chapter apply. These 
services are paid under the special rules set forth in Sec.  405.553 of 
this chapter.

[[Page 807]]

    (g) Payment for services furnished in SNFs. (1) Except as specified 
in paragraph (g)(2)(ii) of this section, the amount paid for services 
furnished in cost reporting periods beginning before July 1, 1998, is 
determined on a reasonable cost basis or, where applicable, in 
accordance with the prospectively determined payment rates for low-
volume SNFs established under section 1888(d) of the Act, as set forth 
in subpart I of this part.
    (2) The amount paid for services (other than those described in 
Sec.  411.15(p)(2) of this chapter)--
    (i) That are furnished in cost reporting periods beginning on or 
after July 1, 1998, to a resident who is in a covered Part A stay, is 
determined in accordance with the prospectively determined payment rates 
for SNFs established under section 1888(e) of the Act, as set forth in 
subpart J of this part.
    (ii) That are furnished on or after July 1, 1998, to a resident who 
is not in a covered Part A stay, is determined in accordance with any 
applicable Part B fee schedule or, for a particular item or service to 
which no fee schedule applies, by using the existing payment methodology 
utilized under Part B for such item or service.
    (h) Payment for services furnished by HHAs. The amount paid for home 
health services as defined in section 1861(m) of the Act (except durable 
medical equipment and the covered osteoporosis drug as provided for in 
that section) that are furnished beginning on or after October 1, 2000 
to an eligible beneficiary under a home health plan of care is 
determined according to the prospectively determined payment rates for 
HHAs set forth in part 484, subpart E of this chapter.

[51 FR 34793, Sept. 30, 1986]

    Editorial Note: For Federal Register citations affecting Sec.  
413.1, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.  413.5  Cost reimbursement: General.

    (a) In formulating methods for making fair and equitable 
reimbursement for services rendered beneficiaries of the program, 
payment is to be made on the basis of current costs of the individual 
provider, rather than costs of a past period or a fixed negotiated rate. 
All necessary and proper expenses of an institution in the production of 
services, including normal standby costs, are recognized. Furthermore, 
the share of the total institutional cost that is borne by the program 
is related to the care furnished beneficiaries so that no part of their 
cost would need to be borne by other patients. Conversely, costs 
attributable to other patients of the institution are not to be borne by 
the program. Thus, the application of this approach, with appropriate 
accounting support, will result in meeting actual costs of services to 
beneficiaries as such costs vary from institution to institution. 
However, payments to providers of services for services furnished 
Medicare beneficiaries are subject to the provisions of Sec. Sec.  
413.13 and 413.30.
    (b) Putting these several points together, certain tests have been 
evolved for the principles of reimbursement and certain goals have been 
established that they should be designed to accomplish. In general 
terms, these are the tests or objectives:
    (1) That the methods of reimbursement should result in current 
payment so that institutions will not be disadvantaged, as they 
sometimes are under other arrangements, by having to put up money for 
the purchase of goods and services well before they receive 
reimbursement.
    (2) That, in addition to current payment, there should be 
retroactive adjustment so that increases in costs are taken fully into 
account as they actually occurred, not just prospectively.
    (3) That there be a division of the allowable costs between the 
beneficiaries of this program and the other patients of the provider 
that takes account of the actual use of services by the beneficiaries of 
this program and that is fair to each provider individually.
    (4) That there be sufficient flexibility in the methods of 
reimbursement to be used, particularly at the beginning of the program, 
to take account of the great differences in the present state of 
development of recordkeeping.
    (5) That the principles should result in the equitable treatment of 
both nonprofit organizations and profit-making organizations.

[[Page 808]]

    (6) That there should be a recognition of the need of hospitals and 
other providers to keep pace with growing needs and to make 
improvements.
    (c) As formulated herein, the principles given recognition to such 
factors as depreciation, interest, bad debts, educational costs, 
compensation of owners, and an allowance for a reasonable return on 
equity capital (in the case of certain proprietary providers). With 
respect to allowable costs some items of inclusion and exclusion are:
    (1) An appropriate part of the net cost of approved educational 
activities will be included.
    (2) Costs incurred for research purposes, over and above usual 
patient care, will not be included.
    (3) [Reserved]
    (4) The value of services provided by nonpaid workers, as members of 
an organization (including services of members of religious orders) 
having an agreement with the provider to furnish such services, is 
includable in the amount that would be paid others for similar work.
    (5) Discounts and allowances received on the purchase of goods or 
services are reductions of the cost to which they relate.
    (6) Bad debts growing out of the failure of a beneficiary to pay the 
deductible, or the coinsurance, will be reimbursed (after bona fide 
efforts at collection).
    (7) Charity and courtesy allowances are not includable, although 
``fringe benefit'' allowances for employees under a formal plan will be 
includable as part of their compensation.
    (8) A reasonable allowance of compensation for the services of 
owners in profitmaking organizations will be allowed providing their 
services are actually performed in a necessary function.
    (9) Reasonable cost of physicians' direct medical and surgical 
services (including supervision of interns and residents in the care of 
individual patients) furnished in a teaching hospital may be reimbursed 
as a provider cost (as described in Sec.  415.162 of this chapter) if 
elected as provided for in Sec.  415.160 of this chapter.
    (d) In developing these principles of reimbursement for the Medicare 
program, all of the considerations inherent in allowances for 
depreciation were studied. The principles, as presented, provide options 
to meet varied situations. Depreciation will essentially be on an 
historical cost basis but since many institutions do not have adequate 
records of old assets, the principles provide an optional allowance in 
lieu of such depreciation for assets acquired before 1966. For assets 
acquired after 1965, the historical cost basis must be used. All assets 
actually in use for production of services for Medicare beneficiaries 
will be recognized even though they may have been fully or partially 
depreciated for other purposes. Assets financed with public funds may be 
depreciated. Although funding of depreciation is not required, there is 
an incentive for it since income from funded depreciation is not 
considered as an offset which must be taken to reduce the interest 
expense that is allowable as a program cost.
    (e) A return on the equity capital of proprietary facilities, as 
described in Sec.  413.157, is an allowance in addition to the 
reasonable cost of covered services furnished to beneficiaries.
    (f) Renal dialysis items and services furnished under the ESRD 
provision are reimbursed and reported under Sec. Sec.  413.170 and 
413.174 respectively. For special rules concerning health maintenance 
organizations (HMOs), and providers of services and other health care 
facilities that are owned or operated by an HMO, or related to an HMO by 
common ownership or control, see Sec. Sec.  417.242(b)(14) and 
417.250(c) of this chapter.

[51 FR 34793, Sept. 30, 1986; 51 FR 37398, Oct. 22, 1986, as amended at 
52 FR 21225, June 4, 1987; 52 FR 23398, June 19, 1987; 57 FR 39829, 
Sept. 1, 1992; 60 FR 63189, Dec. 8, 1995; 61 FR 63748, Dec. 2, 1996]



Sec.  413.9  Cost related to patient care.

    (a) Principle. All payments to providers of services must be based 
on the reasonable cost of services covered under Medicare and related to 
the care of beneficiaries. Reasonable cost includes all necessary and 
proper costs incurred in furnishing the services, subject to principles 
relating to specific items of revenue and cost. However, for cost 
reporting periods beginning after December 31, 1973, payments

[[Page 809]]

to providers of services are based on the lesser of the reasonable cost 
of services covered under Medicare and furnished to program 
beneficiaries or the customary charges to the general public for such 
services, as provided for in Sec.  413.13.
    (b) Definitions--(1) Reasonable cost. Reasonable cost of any 
services must be determined in accordance with regulations establishing 
the method or methods to be used, and the items to be included. The 
regulations in this part take into account both direct and indirect 
costs of providers of services. The objective is that under the methods 
of determining costs, the costs with respect to individuals covered by 
the program will not be borne by individuals not so covered, and the 
costs with respect to individuals not so covered will not be borne by 
the program. These regulations also provide for the making of suitable 
retroactive adjustments after the provider has submitted fiscal and 
statistical reports. The retroactive adjustment will represent the 
difference between the amount received by the provider during the year 
for covered services from both Medicare and the beneficiaries and the 
amount determined in accordance with an accepted method of cost 
apportionment to be the actual cost of services furnished to 
beneficiaries during the year.
    (2) Necessary and proper costs. Necessary and proper costs are costs 
that are appropriate and helpful in developing and maintaining the 
operation of patient care facilities and activities. They are usually 
costs that are common and accepted occurrences in the field of the 
provider's activity.
    (c) Application. (1) It is the intent of Medicare that payments to 
providers of services should be fair to the providers, to the 
contributors to the Medicare trust funds, and to other patients.
    (2) The costs of providers' services vary from one provider to 
another and the variations generally reflect differences in scope of 
services and intensity of care. The provision in Medicare for payment of 
reasonable cost of services is intended to meet the actual costs, 
however widely they may vary from one institution to another. This is 
subject to a limitation if a particular institution's costs are found to 
be substantially out of line with other institutions in the same area 
that are similar in size, scope of services, utilization, and other 
relevant factors.
    (3) The determination of reasonable cost of services must be based 
on cost related to the care of Medicare beneficiaries. Reasonable cost 
includes all necessary and proper expenses incurred in furnishing 
services, such as administrative costs, maintenance costs, and premium 
payments for employee health and pension plans. It includes both direct 
and indirect costs and normal standby costs. However, if the provider's 
operating costs include amounts not related to patient care, 
specifically not reimbursable under the program, or flowing from the 
provision of luxury items or services (that is, those items or services 
substantially in excess of or more expensive than those generally 
considered necessary for the provision of needed health services), such 
amounts will not be allowable. The reasonable cost basis of 
reimbursement contemplates that the providers of services would be 
reimbursed the actual costs of providing quality care however widely the 
actual costs may vary from provider to provider and from time to time 
for the same provider.

[51 FR 34795, Sept. 30, 1986; 51 FR 37398, Oct. 22, 1986]



Sec.  413.13  Amount of payment if customary charges for services furnished 
are less than reasonable costs.

    (a) Definitions. As used in this section--
    Customary charges means the regular rates that providers charge both 
beneficiaries and other paying patients for the services furnished to 
them.
    Fair compensation means the reasonable cost of covered services.
    Nominal charge means a charge equal to 60 percent or less of the 
reasonable cost of a service.
    Public provider means a provider operated by a Federal, State, 
county, city, or other local government agency or instrumentality.
    Reasonable cost means cost actually incurred, to the extent that 
cost is necessary for the efficient delivery of the service, and subject 
to the exclusions

[[Page 810]]

specified in paragraph (d) of this section.
    (b) Application of the lesser of costs or charges (LCC) principle--
(1) General rule. Except as provided in paragraph (c) of this section, 
CMS pays providers the lesser of the reasonable cost or the customary 
charges for services furnished to Medicare beneficiaries. Reasonable 
cost and customary charges are compared separately for Part A services 
and Part B services.
    (2) Example. (i) A provider's reasonable cost for covered services 
furnished to Medicare beneficiaries during a cost reporting period is 
$125,000.
    (ii) The provider's customary charges for those services is 
$110,000.
    (iii) CMS pays the provider $110,000 less the deductible and 
coinsurance amounts for which the beneficiaries are responsible.
    (c) Exceptions to the LCC principle--(1) Providers not subject to 
the LCC principle. CMS pays the following providers the fair 
compensation for the services they furnish:
    (i) CORFs.
    (ii) Public providers that furnish services free of charge or at a 
nominal charge.
    (iii) Any provider that requests payment of fair compensation and 
can demonstrate to its contractor that a significant portion of its 
patients are low income and that its charges are less than costs because 
its customary practice is to charge patients on the basis of their 
ability to pay.
    (2) Services not subject to the LCC principle. The following 
services are not subject to the LCC principle:
    (i) Part A inpatient hospital services. Inpatient hospital services 
are not subject to the LCC principle if they are subject to either of 
the following:
    (A) The prospective payment system under part 412 of this chapter.
    (B) The rate of increase limits set forth in Sec.  413.40.
    (ii) Facility services related to ambulatory surgical procedures 
performed in outpatient hospital departments. Facility services related 
to ambulatory surgical procedures performed in hospital outpatient 
departments are subject to the payment methodology set forth in Sec.  
413.118.
    (iii) Services furnished by a critical access hospital (CAH). 
Inpatient and outpatient services furnished by a CAH are subject to the 
payment methodology set forth in Sec.  413.70.
    (iv) Hospital outpatient radiology services. Hospital outpatient 
radiology services are subject to the payment methodology set forth in 
Sec.  413.122.
    (v) Other diagnostic procedures performed by a hospital on an 
outpatient basis. Other outpatient diagnostic procedures are subject to 
the payment methodology set forth in Sec.  413.122.
    (vi) Skilled nursing facility services. Skilled nursing facility 
services subject to the payment methodology set forth in Sec. Sec.  
413.330 et seq.
    (d) Exclusions from reasonable cost. For purposes of comparison with 
customary charges under this section, reasonable cost does not include 
the following:
    (1) Payments made to a provider as reimbursement for bad debts 
arising from noncollection of Medicare deductible and coinsurance 
amounts, as provided in Sec.  413.89.
    (2) Amounts that represent the recovery of excess depreciation 
resulting from termination from the Medicare program or a decrease in 
Medicare utilization applicable to prior cost reporting periods, as 
provided in Sec.  413.134.
    (3) Amounts that result from disposition of depreciable assets, 
applicable to prior cost reporting periods, as provided in Sec.  
413.134.
    (4) Payments to funds for the donated services of teaching 
physicians, as provided in Sec.  413.85.
    (5) Except as provided in paragraph (f)(2)(iii) of this section for 
making nominal charge determinations in special situations, graduate 
medical education costs.
    (e) Reductions in customary charges. Customary charges are reduced 
in proportion to the ratio of the aggregate amount actually collected 
from charge-paying non-Medicare patients to the amount that would have 
been realized had customary charges been paid, if the provider--
    (1) Did not actually impose charges on most of the patients liable 
for payment for its services on a charge basis; or

[[Page 811]]

    (2) Failed to make a reasonable effort to collect those charges.
    (f) Nominal charge determinations. In determining whether a 
provider's customary charges equal 60 percent or less of its reasonable 
costs, the following rules apply:
    (1) General rule. The determination is based on charges actually 
billed to charge-paying, non-Medicare patients, and (except for clinical 
diagnostic laboratory tests that are paid under section 1833(h) of the 
Act) is made separately for Part A services and Part B services.
    (2) Determination in special situations. (i) Charges based on 
ability to pay. For providers that have a sliding scale or discounted 
charges based on patients' ability to pay, the determination--
    (A) Is based on charges billed to all charge-paying patients;
    (B) Uses the ratio of the sliding scale charges to the provider's 
full customary charges; and
    (C) Applies the ratio to the discounted charges to equate those 
charges to customary charges.
    (ii) HHA services. In determining nominal charges for HHAs, all Part 
A and Part B services, with the exception of DME, are considered 
together.
    (iii) Graduate medical education. When making the nominal charge 
determination, graduate medical education payments (or the provider's 
reasonable costs for that education, if supported by appropriate data) 
are included in reasonable costs.

[65 FR 8661, Feb. 22, 2000, as amended at 70 FR 47487, Aug. 12, 2005]



Sec.  413.17  Cost to related organizations.

    (a) Principle. Except as provided in paragraph (d) of this section, 
costs applicable to services, facilities, and supplies furnished to the 
provider by organizations related to the provider by common ownership or 
control are includable in the allowable cost of the provider at the cost 
to the related organization. However, such cost must not exceed the 
price of comparable services, facilities, or supplies that could be 
purchased elsewhere.
    (b) Definitions--(1) Related to the provider. Related to the 
provider means that the provider to a significant extent is associated 
or affiliated with or has control of or is controlled by the 
organization furnishing the services, facilities, or supplies.
    (2) Common ownership. Common ownership exists if an individual or 
individuals possess significant ownership or equity in the provider and 
the institution or organization serving the provider.
    (3) Control. Control exists if an individual or an organization has 
the power, directly or indirectly, significantly to influence or direct 
the actions or policies of an organization or institution.
    (c) Application. (1) Individuals and organizations associate with 
others for various reasons and by various means. Some deem it 
appropriate to do so to assure a steady flow of supplies or services, to 
reduce competition, to gain a tax advantage, to extend influence, and 
for other reasons. These goals may be accomplished by means of ownership 
or control, by financial assistance, by management assistance, and other 
ways.
    (2) If the provider obtains items of services, facilities, or 
supplies from an organization, even though it is a separate legal 
entity, and the organization is owned or controlled by the owner(s) of 
the provider, in effect the items are obtained from itself. An example 
would be a corporation building a hospital or a nursing home and then 
leasing it to another corporation controlled by the owner. Therefore, 
reimbursable cost should include the costs for these items at the cost 
to the supplying organization. However, if the price in the open market 
for comparable services, facilities, or supplies is lower than the cost 
to the supplier, the allowable cost to the provider may not exceed the 
market price.
    (d) Exception. (1) An exception is provided to this general 
principle if the provider demonstrates by convincing evidence to the 
satisfaction of the contractor, that--
    (i) The supplying organization is a bona fide separate organization;
    (ii) A substantial part of its business activity of the type carried 
on with the provider is transacted with others than the provider and 
organizations related to the supplier by common ownership

[[Page 812]]

or control and there is an open, competitive market for the type of 
services, facilities, or supplies furnished by the organization;
    (iii) The services, facilities, or supplies are those that commonly 
are obtained by institutions such as the provider from other 
organizations and are not a basic element of patient care ordinarily 
furnished directly to patients by such institutions; and
    (iv) The charge to the provider is in line with the charge for such 
services, facilities, or supplies in the open market and no more than 
the charge made under comparable circumstances to others by the 
organization for such services, facilities, or supplies.
    (2) In such cases, the charge by the supplier to the provider for 
such services, facilities, or supplies is allowable as cost.

[51 FR 34793, Sept. 30, 1986, as amended at 81 FR 57270, Aug. 22, 2016]



                Subpart B_Accounting Records and Reports



Sec.  413.20  Financial data and reports.

    (a) General. The principles of cost reimbursement require that 
providers maintain sufficient financial records and statistical data for 
proper determination of costs payable under the program. Standardized 
definitions, accounting, statistics, and reporting practices that are 
widely accepted in the hospital and related fields are followed. Changes 
in these practices and systems will not be required in order to 
determine costs payable under the principles of reimbursement. 
Essentially the methods of determining costs payable under Medicare 
involve making use of data available from the institution's basis 
accounts, as usually maintained, to arrive at equitable and proper 
payment for services to beneficiaries.
    (b) Frequency of cost reports. Cost reports are required from 
providers on an annual basis with reporting periods based on the 
provider's accounting year. In the interpretation and application of the 
principles of reimbursement, the fiscal contractors will be an important 
source of consultative assistance to providers and will be available to 
deal with questions and problems on a day-to-day basis.
    (c) Recordkeeping requirements for new providers. A newly 
participating provider of services (as defined in Sec.  400.202 of this 
chapter) must make available to its selected contractor for examination 
its fiscal and other records for the purpose of determining such 
provider's ongoing recordkeeping capability and inform the contractor of 
the date its initial Medicare cost reporting period ends. This 
examination is intended to assure that--
    (1) The provider has an adequate ongoing system for furnishing the 
records needed to provide accurate cost data and other information 
capable of verification by qualified auditors and adequate for cost 
reporting purposes under section 1815 of the Act; and
    (2) No financial arrangements exist that will thwart the commitment 
of the Medicare program to reimburse providers the reasonable cost of 
services furnished beneficiaries. The data and information to be 
examined include cost, revenue, statistical, and other information 
pertinent to reimbursement including, but not limited to, that described 
in paragraph (d) of this section and in Sec.  413.24.
    (d) Continuing provider recordkeeping requirements. (1) The provider 
must furnish such information to the contractor as may be necessary to--
    (i) Assure proper payment by the program, including the extent to 
which there is any common ownership or control (as described in Sec.  
413.17(b)(2) and (3)) between providers or other organizations, and as 
may be needed to identify the parties responsible for submitting program 
cost reports;
    (ii) Receive program payments; and
    (iii) Satisfy program overpayment determinations.
    (2) The provider must permit the contractor to examine such records 
and documents as are necessary to ascertain information pertinent to the 
determination of the proper amount of program payments due. These 
records include, but are not limited to, matters pertaining to--
    (i) Provider ownership, organization, and operation;
    (ii) Fiscal, medical, and other recordkeeping systems;

[[Page 813]]

    (iii) Federal income tax status;
    (iv) Asset acquisition, lease, sale, or other action;
    (v) Franchise or management arrangements;
    (vi) Patient service charge schedules;
    (vii) Costs of operation;
    (viii) Amounts of income received by source and purpose; and
    (ix) Flow of funds and working capital.
    (3)(i) The provider must furnish the contractor, upon request, 
copies of patient service charge schedules and changes thereto as they 
are put into effect; and
    (ii) The contractor evaluates the charge schedules as specified in 
paragraph (d)(3)(i) of this section to determine the extent to which 
they may be used for determining program payment.
    (e) Suspension of program payments to a provider. If an contractor 
determines that a provider does not maintain or no longer maintains 
adequate records for the determination of reasonable cost under the 
Medicare program, payments to such provider will be suspended until the 
contractor is assured that adequate records are maintained. Before 
suspending payments to a provider, the contractor will, in accordance 
with the provisions in Sec.  405.372(a) of this chapter, send written 
notice to such provider of its intent to suspend payments. The notice 
will explain the basis for the contractor's determination with respect 
to the provider's records and will identify the provider's recordkeeping 
deficiencies. The provider must be given the opportunity, in accordance 
with Sec.  405.372(b) of this chapter, to submit a statement (including 
any pertinent evidence) as to why the suspension must not be put into 
effect.

[51 FR 34793, Sept. 30, 1986, as amended at 61 FR 63749, Dec. 2, 1996; 
85 FR 59023, Sept. 18, 2020; 86 FR 45521, Aug. 13, 2021]



Sec.  413.24  Adequate cost data and cost finding.

    (a) Principle. Providers receiving payment on the basis of 
reimbursable cost must provide adequate cost data. This must be based on 
their financial and statistical records which must be capable of 
verification by qualified auditors. The cost data must be based on an 
approved method of cost finding and on the accrual basis of accounting, 
except for--
    (1) Governmental institutions which operate on a cash basis method 
of accounting. Cost data based on such basis of accounting will be 
acceptable, subject to appropriate treatment of capital expenditures.
    (2) Costs of qualified defined benefit pension plans shall be 
reported on a cash basis method of accounting, as described at Sec.  
413.100(c)(2)(vii)(D) for cost reporting periods beginning on or after 
October 1, 2011.
    (b) Definitions--(1) Cost finding. Cost finding is the process of 
recasting the data derived from the accounts ordinarily kept by a 
provider to ascertain costs of the various types of services furnished. 
It is the determination of these costs by the allocation of direct costs 
and proration of indirect costs.
    (2) Accrual basis of accounting. As used in this part, the term 
accrual basis of accounting means that revenue is reported in the period 
in which it is earned, regardless of when it is collected; and an 
expense is reported in the period in which it is incurred, regardless of 
when it is paid. (See Sec.  413.100 regarding limitations on allowable 
accrued costs in situations in which the related liabilities are not 
liquidated timely.)
    (c) Adequacy of cost information. Adequate cost information must be 
obtained from the provider's records to support payments made for 
services furnished to beneficiaries. The requirement of adequacy of data 
implies that the data be accurate and in sufficient detail to accomplish 
the purposes for which it is intended. Adequate data capable of being 
audited is consistent with good business concepts and effective and 
efficient management of any organization, whether it is operated for 
profit or on a nonprofit basis. It is a reasonable expectation on the 
part of any agency paying for services on a cost-reimbursement basis. In 
order to provide the required cost data and not impair comparability, 
financial and statistical records should be maintained in a manner 
consistent from one period to another. However, a proper

[[Page 814]]

regard for consistency need not preclude a desirable change in 
accounting procedures if there is reason to effect such change.
    (d) Cost finding methods. After the close of the accounting period, 
providers must use one of the following methods of cost finding to 
determine the actual costs of services furnished during that period. 
(These provisions do not apply to SNFs that elect and qualify for 
prospectively determined payment rates under subpart I of this part for 
cost reporting periods beginning on or after October 1, 1986. For the 
special rules that are applicable to those SNFs, see Sec.  413.321.) For 
cost reporting periods beginning after December 31, 1971, providers 
using the departmental method of cost apportionment must use the step-
down method described in paragraph (d)(1) of this section or an ``other 
method'' described in paragraph (d)(2) of this section. For cost 
reporting periods beginning after December 31, 1971, providers using the 
combination method of cost apportionment must use the modified cost 
finding method described in paragraph (d)(3) of this section. Effective 
for cost reporting periods beginning on or after October 1, 1980, HHAs 
not based in hospitals or SNFs must use the step-down method described 
in paragraph (d)(1) of this section. (HHAs based in hospitals or SNFs 
must use the method applicable to the parent institution.) However, an 
HHA not based in a hospital or SNF that received less than $35,000 in 
Medicare payment for the immediately preceding cost reporting period, 
and for whom this payment represented less than 50 percent of the total 
operating cost of the agency, may use a simplified version of the step-
down method, as specified in instructions for the cost report issued by 
CMS.
    (1) Step-down method. This method recognizes that services furnished 
by certain nonrevenue-producing departments or centers are utilized by 
certain other nonrevenue-producing centers as well as by the revenue-
producing centers. All costs of nonrevenue-producing centers are 
allocated to all centers that they serve, regardless of whether or not 
these centers produce revenue. The cost of the nonrevenue-producing 
center serving the greatest number of other centers, while receiving 
benefits from the least number of centers, is apportioned first. 
Following the apportionment of the cost of the nonrevenue-producing 
center, that center will be considered ``closed'' and no further costs 
are apportioned to that center. This applies even though it may have 
received some service from a center whose cost is apportioned later. 
Generally, if two centers furnish services to an equal number of centers 
while receiving benefits from an equal number, that center which has the 
greatest amount of expense should be allocated first.
    (2) Other methods--(i) The double-apportionment method. The double-
apportionment method may be used by a provider upon approval of the 
contractor. This method also recognizes that the nonrevenue-producing 
departments or centers furnish services to other nonrevenue-producing 
centers as well as to revenue-producing centers. A preliminary 
allocation of the costs of non-revenue-producing centers is made. These 
centers or departments are not ``closed'' after this preliminary 
allocation. Instead, they remain ``open,'' accumulating a portion of the 
costs of all other centers from which services are received. Thus, after 
the first or preliminary allocation, some costs will remain in each 
center representing services received from other centers. The first or 
preliminary allocation is followed by a second or final apportionment of 
expenses involving the allocation of all costs remaining in the 
nonrevenue-producing functions directly to revenue-producing centers.
    (ii) More sophisticated methods. A more sophisticated method 
designed to allocate costs more accurately may be used by the provider 
upon approval of the contractor. However, having elected to use the 
double-apportionment method, the provider may not thereafter use the 
step-down method without approval of the contractor. Written request for 
the approval must be made on a prospective basis and must be submitted 
before the end of the fourth month of the prospective reporting period. 
Likewise, once having elected to use a more sophisticated method, the 
provider may not thereafter use either the double-apportionment or step-
down

[[Page 815]]

methods without similar request and approval.
    (3) Modified cost finding for providers using the Combination Method 
for reporting periods beginning after December 31, 1971. This method 
differs from the step-down method in that services furnished by 
nonrevenue-producing departments or centers are allocated directly to 
revenue-producing departments or centers even though these services may 
be utilized by other nonrevenue-producing departments or centers. In the 
application of this method the cost of nonrevenue-producing centers 
having a common basis of allocation are combined and the total 
distributed to revenue-producing centers. All nonrevenue-producing 
centers having significant percentages of cost in relation to total 
costs will be allocated this way. The combined total costs of remaining 
nonrevenue-producing costs centers will be allocated to revenue-
producing cost centers in the proportion that each bears to total costs, 
direct and indirect, already allocated. The bases which are to be used 
and the centers which are to be combined for allocation are not optional 
but are identified and incorporated in the cost report forms developed 
for this method. Providers using this method must use the program cost 
report forms devised for it. Alternative forms may not be used without 
prior approval by CMS based upon a written request by the provider 
submitted through the contractor.
    (4) Temporary method for initial period. If the provider is unable 
to use either cost-finding method when it first participates in the 
program, it may apply to the contractor for permission to use some other 
acceptable method that would accurately identify costs by department or 
center, and appropriately segregate inpatient and outpatient costs. Such 
other method may be used for cost reports covering periods ending before 
January 1, 1968.
    (5) Simplified optional reimbursement method for small, rural 
hospitals with distinct parts for cost reporting periods beginning on or 
after July 20, 1982. (i) A rural hospital with a Medicare-certified 
distinct part SNF may elect to be reimbursed for services furnished in 
its hospital general routine service area and distinct part SNF using 
the reimbursement method specified in Sec.  413.53 for swing-bed 
hospitals, if it meets the following conditions:
    (A) The institution is located in a rural area as defined in Sec.  
482.58 of this chapter.
    (B) On the first day of the cost reporting period, the hospital and 
distinct part SNF have fewer than 50 beds in total (with the exception 
of beds for newborns and beds in intensive care type inpatient units).
    (ii) In applying the optional reimbursement method, only those beds 
located in the hospital general routine service area and in the distinct 
part SNF certified by Medicare are combined into a single cost center 
for purposes of cost finding.
    (iii) The reasonable cost of the routine extended care services is 
determined in accordance with Sec.  413.114(c). The reasonable cost of 
the hospital general routine services is determined in accordance with 
Sec.  413.53(a)(2).
    (iv) The hospital must make its election to use the optional swing-
bed reimbursement method in writing to the contractor before the 
beginning of the hospital's cost reporting year. The hospital must make 
any request to revoke the election in writing before the beginning of 
the affected cost reporting period.
    (v) The contractor must approve requests to terminate use of the 
optional swing-bed reimbursement method. If a hospital terminates use of 
this optional method, no further elections may be made by the facility 
to use the optional method.
    (6) Provider-based entities and departments: Preventing duplication 
of cost. In some situations, the main provider in a provider-based 
complex may purchase services for a provider-based entity or for a 
department of the provider through a contract for services (for example, 
a management contract), directly assigning the costs to the provider-
based entity or department and reporting the costs directly in the cost 
center for that entity or department. In any situation in which costs 
are directly assigned to a cost center, there is a risk of excess cost 
in that cost center resulting from the directly assigned costs plus a 
share of overhead improperly allocated to the cost center which

[[Page 816]]

duplicates the directly assigned costs. This duplication could result in 
improper Medicare payment to the provider. Where a provider has 
purchased services for a provider-based entity or for a provider 
department, like general service costs of the provider (for example, 
like costs in the administrative and general cost center) must be 
separately identified to ensure that they are not improperly allocated 
to the entity or the department. If the like costs of the main provider 
cannot be separately identified, the costs of the services purchased 
through a contract must be reclassified to the main provider and 
allocated among the main provider's benefiting cost centers.

    Example: A provider-based complex is composed of a hospital and a 
hospital-based rural health clinic (RHC). The hospital furnishes the 
entirety of its own administrative and general costs internally. The 
RHC, however, is managed by an independent contractor through a 
management contract. The management contract provides a full array of 
administrative and general services, with the exception of patient 
billing. The hospital directly assigns the costs of the RHC's management 
contract to the RHC cost center (for example, Form CMS 2552-96, 
Worksheet A, Line 71). A full allocation of the hospital's 
administrative and general costs to the RHC cost center would duplicate 
most of the RHC's administrative and general costs. However, an 
allocation of the hospital's cost (included in hospital administrative 
and general costs) of its patient billing function to the RHC would be 
appropriate. Therefore, the hospital must include the costs of the 
patient billing function in a separate cost center to be allocated to 
the benefiting cost centers, including the RHC cost center. The 
remaining hospital administrative and general costs would be allocated 
to all cost centers, excluding the RHC cost center. If the hospital is 
unable to isolate the costs of the patient billing function, the costs 
of the RHC's management contract must be reclassified to the hospital 
administrative and general cost center to be allocated among all cost 
centers, as appropriate.

    (7) Costs of services furnished to free-standing entities. The costs 
that a provider incurs to furnish services to free-standing entities 
with which it is associated are not allowable costs of that provider. 
Any costs of services furnished to a free-standing entity must be 
identified and eliminated from the allowable costs of the servicing 
provider, to prevent Medicare payment to that provider for those costs. 
This may be done by including the free-standing entity on the cost 
report as a nonreimbursable cost center for the purpose of allocating 
overhead costs to that entity. If this method would not result in an 
accurate allocation of costs to the entity, the provider must develop 
detailed work papers showing how the cost of services furnished by the 
provider to the entity were determined. These costs are removed from the 
applicable cost centers of the servicing provider.
    (e) Accounting basis. The cost data submitted must be based on the 
accrual basis of accounting which is recognized as the most accurate 
basis for determining costs. However, governmental institutions that 
operate on a cash basis of accounting may submit cost data on the cash 
basis subject to appropriate treatment of capital expenditures.
    (f) Cost reports. For cost reporting purposes, the Medicare program 
requires each provider of services to submit periodic reports of its 
operations that generally cover a consecutive 12-month period of the 
provider's operations. Amended cost reports to revise cost report 
information that has been previously submitted by a provider may be 
permitted or required as determined by CMS.
    (1) Cost reports--Terminated providers and changes of ownership. A 
provider that voluntarily or involuntarily ceases to participate in the 
Medicare program or experiences a change of ownership must file a cost 
report for that period under the program beginning with the first day 
not included in a previous cost reporting period and ending with the 
effective date of termination of its provider agreement or change of 
ownership.
    (2) Due dates for cost reports. (i) Cost reports are due on or 
before the last day of the fifth month following the close of the period 
covered by the report. For cost reports ending on a day other than the 
last day of the month, cost reports are due 150 days after the last day 
of the cost reporting period.
    (ii) Extensions of the due date for filing a cost report may be 
granted by the

[[Page 817]]

contractor only when a provider's operations are significantly adversely 
affected due to extraordinary circumstances over which the provider has 
no control, such as flood or fire.
    (3) Changes in cost reporting periods. A provider may change its 
cost reporting period if a change in ownership is experienced or if 
the--
    (i) Provider requests the change in writing from its contractor;
    (ii) Contractor receives the request at least 120 days before the 
close of the new reporting period requested by the provider; and
    (iii) Contractor determines that good cause for the change exists. 
Good cause would not be found to exist if the effect is to change the 
initial date that a hospital would be affected by the rate of increase 
ceiling (see Sec.  413.40), or be paid under the prospective payment 
systems (see part 412 of this chapter).
    (4) Electronic submission of cost reports. (i) As used in this 
paragraph, ``provider'' means a hospital, skilled nursing facility, home 
health agency, hospice, organ procurement organization, 
histocompatibility laboratory, rural health clinic, federally qualified 
health center, community mental health center, or end-stage renal 
disease facility.
    (ii) Effective for cost reporting periods beginning on or after 
October 1, 1989 for hospitals, cost reporting periods ending on or after 
February 1, 1997 for skilled nursing facilities and home health 
agencies, cost reporting periods ending on or after December 31, 2004 
for hospices, and end-stage renal disease facilities, and cost reporting 
periods ending on or after March 31, 2005 for organ procurement 
organizations, histocompatibility laboratories, rural health clinics, 
Federally qualified health centers, and community mental health centers, 
a provider is required to submit cost reports in a standardized 
electronic format. The provider's electronic program must be capable of 
producing the CMS standardized output file in a form that can be read by 
the contractor's automated system. This electronic file, which must 
contain the input data required to complete the cost report and to pass 
specified edits, must be forwarded to the contractor for processing 
through its system.
    (iii) The contractor stores the provider's as-filed electronic cost 
report and may not alter that file for any reason. The contractor makes 
a ``working copy'' of the as-filed electronic cost report to be used, as 
necessary, throughout the settlement process (that is, desk review, 
processing audit adjustments, and final settlement). The provider's 
electronic program must be able to disclose if any changes have been 
made to the as-filed electronic cost report after acceptance by the 
contractor. If the as-filed electronic cost report does not pass all 
specified edits, the contractor must return it to the provider for 
correction. For purposes of the requirements in paragraph (f)(2) of this 
section concerning due dates, an electronic cost report is not 
considered to be filed until it is accepted by the contractor.
    (iv)(A) Effective as specified in paragraphs (f)(4)(iv)(A)(1) 
through (4) and except as provided in paragraph (f)(4)(iv)(C) of this 
section, a provider must submit a hard copy of a settlement summary, if 
applicable, which is a statement of certain worksheet totals found 
within the electronic file, and the certification statement described in 
paragraph (f)(4)(iv)(B) of this section signed by its administrator or 
chief financial officer certifying the accuracy of the electronic file 
or the manually prepared cost report.
    (1) For hospitals, effective for cost reporting periods ending on or 
after September 30, 1994;
    (2) For skilled nursing facilities and home health agencies, 
effective for cost reporting periods ending on or after February 1, 
1997;
    (3) For hospices and end-stage renal disease facilities, effective 
for cost reporting periods ending on or after December 31, 2004; and
    (4) For organ procurement organizations, histocompatibility 
laboratories, rural health clinics, Federally qualified health centers, 
and community mental health centers, effective for cost reporting 
periods ending on or after March 31, 2005.
    (B) The following certification statement must immediately precede 
the dated original signature, or electronic signature as set forth in 
paragraph (f)(4)(iv)(C)(1) of this section, of the

[[Page 818]]

provider's administrator or chief financial officer:
    MISREPRESENTATION OR FALSIFICATION OF ANY INFORMATION CONTAINED IN 
THIS COST REPORT MAY BE PUNISHABLE BY CRIMINAL, CIVIL AND ADMINISTRATIVE 
ACTION, FINE AND/OR IMPRISONMENT UNDER FEDERAL LAW. FURTHERMORE, IF 
SERVICES IDENTIFIED IN THIS REPORT WERE PROVIDED OR PROCURED THROUGH THE 
PAYMENT DIRECTLY OR INDIRECTLY OF A KICKBACK OR WERE OTHERWISE ILLEGAL, 
CRIMINAL, CIVIL AND ADMINISTRATIVE ACTION, FINES AND/OR IMPRISONMENT MAY 
RESULT.
    I hereby certify that I have read the above certification statement 
and that I have examined the accompanying electronically filed or 
manually submitted cost report and the Balance Sheet and Statement of 
Revenue and Expenses prepared by ____ (Provider Name(s) and Number(s)) 
for the cost reporting period beginning ___ and ending ___ and that to 
the best of my knowledge and belief, this report and statement are true, 
correct, complete and prepared from the books and records of the 
provider in accordance with applicable instructions, except as noted. I 
further certify that I am familiar with the laws and regulations 
regarding the provision of health care services, and that the services 
identified in this cost report were provided in compliance with such 
laws and regulations.
    (C) Effective for cost reporting periods ending on or after December 
31, 2017--(1) A provider that is required to file an electronic cost 
report may elect to electronically submit the settlement summary, if 
applicable, and the certification statement with an electronic signature 
of the provider's administrator or chief financial officer. The 
following checkbox for electronic signature and submission will 
immediately follow the certification statement as set forth in paragraph 
(f)(4)(iv)(B) of this section and must be checked if electronic 
signature and submission is elected.
    [squ] I have read and agree with the above certification statement. 
I certify that I intend my electronic signature on this certification 
statement to be the legally binding equivalent of my original signature.
    (2) A provider that is required to file an electronic cost report 
but does not elect to electronically submit the certification statement 
with an electronic signature, must submit a hard copy of the settlement 
summary, if applicable, and a certification statement with an original 
signature of the provider's administrator or chief financial officer as 
set forth in paragraphs (f)(4)(iv)(A) and (B) of this section.
    (v) A provider may request a delay or waiver of the electronic 
submission requirement in paragraph (f)(4)(ii) of this section if this 
requirement would cause a financial hardship or if the provider 
qualifies as a low or no Medicare utilization provider. The provider 
must submit a written request for delay or waiver with necessary 
supporting documentation to its contractor no later than 30 days after 
the end of its cost reporting period. The contractor reviews the request 
and forwards it, with a recommendation for approval or denial, to CMS 
central office within 30 days of receipt of the request. CMS central 
office either approves or denies the request and notifies the contractor 
within 60 days of receipt of the request.
    (5) An acceptable cost report submission is defined as follows:
    (i) The provider must accurately complete and submit the required 
cost reporting forms, including all necessary signatures and supporting 
documents. For providers claiming costs on their cost reports that are 
allocated from a home office or chain organization, the Home Office Cost 
statement must be submitted by the home office or chain organization as 
set forth in paragraph (f)(5)(i)(E) of this section. A cost report is 
rejected for lack of supporting documentation if it does not include the 
following, except as provided in paragraph (f)(5)(i)(E) of this section:
    (A) Teaching hospitals. For teaching hospitals, effective for cost 
reporting periods beginning on or after October 1, 2021, the Intern and 
Resident Information System (IRIS) data which must contain the same 
total counts of direct GME FTE residents (unweighted and weighted) and 
IME FTE residents as

[[Page 819]]

the total counts of direct GME FTE and IME FTE residents reported in the 
provider's cost report.
    (B) Bad debt--Effective for cost reporting periods beginning on or 
after October 1, 2018, for providers claiming Medicare bad debt 
reimbursement, a detailed bad debt listing that corresponds to the 
amount of bad debt claimed in the provider's cost report.
    (C) DSH eligible hospitals--Effective for cost reporting periods 
beginning on or after October 1, 2018, for hospitals claiming a 
disproportionate share hospital payment adjustment, a detailed listing 
of the hospital's Medicaid eligible days that corresponds to the 
Medicaid eligible days claimed in the hospital's cost report. If the 
hospital submits an amended cost report that changes its Medicaid 
eligible days, the hospital must submit an amended listing or an 
addendum to the original listing of the hospital's Medicaid eligible 
days that corresponds to the Medicaid eligible days claimed in the 
hospital's amended cost report.
    (D) Charity care and uninsured discounts--Effective for cost 
reporting periods beginning on or after October 1, 2018, for DSH 
eligible hospitals reporting charity care and/or uninsured discounts, a 
detailed listing of charity care and/or uninsured discounts that 
corresponds to the amounts claimed in the DSH eligible hospital's cost 
report.
    (E) Home office cost allocation. (1) Same fiscal year end. Effective 
for cost reporting periods beginning on or after October 1, 2018, for 
providers claiming costs on their cost report that are allocated from a 
home office or chain organization with the same fiscal year end, a Home 
Office Cost Statement completed and submitted by the home office or 
chain organization to its chain provider's servicing contractor that 
corresponds to the amounts allocated from the home office or chain 
organization to the provider's cost report.
    (2) Differing fiscal year end. Effective for cost reporting periods 
beginning on or after October 1, 2018, for providers claiming costs on 
their cost report that are allocated from a home office or chain 
organization with a different fiscal year end, a Home Office Cost 
Statement completed and submitted by the home office or chain 
organization to its chain provider's servicing contractor that 
corresponds to some portion of the amounts allocated from the home 
office or chain organization to the provider's cost report.
    (ii) For providers that are required to file electronic cost 
reports--In addition to the requirements of paragraphs (f)(4) and 
(f)(5)(i) of this section, the provider must submit its cost reports in 
an electronic cost report format in conformance with the requirements 
contained in the Electronic Cost Report (ECR) Specifications Manual 
(unless the provider has received an exemption from CMS).
    (iii) The contractor makes a determination of acceptability within 
30 days of receipt of the provider's cost report. If the cost report is 
considered unacceptable, the contractor returns the cost report with a 
letter explaining the reasons for the rejection. When the cost report is 
rejected, it is deemed an unacceptable submission and treated as if a 
report had never been filed.
    (g) Exception from full cost reporting for lack of program 
utilization. If a provider does not furnish any covered services to 
Medicare beneficiaries during a cost reporting period, it is not 
required to submit a full cost report. It must, however, submit an 
abbreviated cost report, as prescribed by CMS.
    (h) Waiver of full or simplified cost reporting for low program 
utilization. (1) If the provider has had low utilization of covered 
services by Medicare beneficiaries (as determined by the contractor) and 
has received correspondingly low interim payments for the cost reporting 
period, the contractor may waive a full cost report or the simplified 
cost report described in Sec.  413.321 if it decides that it can 
determine, without a full or simplified report, the reasonable cost of 
covered services provided during that period.
    (2) If a full or simplified cost report is waived, the provider must 
submit within the same time period required for full or simplified cost 
reports:
    (i) The cost reporting forms prescribed by CMS for this situation; 
and
    (ii) Any other financial and statistical data the contractor 
requires.
    (i) [Reserved]
    (j) Substantive reimbursement requirement of an appropriate cost 
report claim--

[[Page 820]]

(1) General requirement. In order for a provider to receive or 
potentially qualify for reimbursement for a specific item for its cost 
reporting period, the provider's cost report, whether determined on an 
as submitted, as amended, or as adjusted basis (as prescribed in 
paragraph (j)(3) of this section), must include an appropriate claim for 
the specific item, by either--
    (i) Claiming full reimbursement in the provider's cost report for 
the specific item in accordance with Medicare policy, if the provider 
seeks payment for the item that it believes comports with program 
policy; or
    (ii) Self-disallowing the specific item in the provider's cost 
report, if the provider seeks payment that it believes may not be 
allowable or may not comport with Medicare policy (for example, if the 
provider believes the contractor lacks the authority or discretion to 
award the reimbursement the provider seeks for the item), by following 
the procedures (set forth in paragraph (j)(2) of this section) for 
properly self-disallowing the specific item in the provider's cost 
report as a protested amount.
    (2) Self-disallowance procedures. In order to properly self-disallow 
a specific item, the provider must--
    (i) Include an estimated reimbursement amount for each specific 
self-disallowed item in the protested amount line (or lines) of the 
provider's cost report; and
    (ii) Attach a separate work sheet to the provider's cost report for 
each specific self-disallowed item, explaining why the provider self-
disallowed each specific item (instead of claiming full reimbursement in 
its cost report for the specific item) and describing how the provider 
calculated the estimated reimbursement amount for each specific self-
disallowed item.
    (3) Procedures for determining whether there is an appropriate cost 
report claim. Whether the provider's cost report for its cost reporting 
period includes an appropriate claim for a specific item (as prescribed 
in paragraph (j)(1) of this section) must be determined by reference to 
the cost report that the provider submits originally to, and was 
accepted by, the contractor for such period, provided that none of the 
following exceptions applies:
    (i) If the provider submits an amended cost report for its cost 
reporting period and such amended cost report is accepted by the 
contractor, then whether there is an appropriate cost report claim for 
the specific item must be determined by reference to such amended cost 
report, provided that neither of the exceptions set forth in paragraphs 
(j)(3)(ii) and (iii) of this section applies;
    (ii) If the contractor adjusts the provider's cost report, as 
submitted originally by the provider and accepted by the contractor or 
as amended by the provider and accepted by the contractor, whichever is 
applicable, with respect to the specific item, then whether there is an 
appropriate cost report claim for the specific item must be determined 
by reference to the provider's cost report, as such cost report claim is 
adjusted for the specific item in the final contractor determination (as 
defined in Sec.  405.1801(a) of this chapter) for the provider's cost 
reporting period, provided that the exception set forth in paragraph 
(j)(3)(iii) of this section does not apply;
    (iii) If the contractor reopens either the final contractor 
determination for the provider's cost reporting period (pursuant to 
Sec.  405.1885 of this chapter) or a revised final contractor 
determination for such period (issued pursuant to Sec.  405.1889 of this 
chapter) and the contractor adjusts the provider's cost report with 
respect to the specific item, then whether there is an appropriate cost 
report claim for the specific item must be determined by reference to 
the provider's cost report, as such cost report claim is adjusted for 
the specific item in the most recent revised final contractor 
determination for such period.
    (4) Reimbursement effects of contractor's determination of whether 
there is an appropriate cost report claim. If the contractor determines 
that the provider's cost report included an appropriate claim for a 
specific item (as specified in paragraphs (j)(1), (2), and (3) of this 
section) and that all the other substantive reimbursement requirements 
for the specific item are also satisfied, the final contractor 
determination (as

[[Page 821]]

defined in Sec.  405.1801(a) of this chapter) must include reimbursement 
for the specific item to the extent permitted by Medicare policy. If the 
contractor determines that the provider made an appropriate cost report 
claim for a specific item but the contractor disagrees with material 
aspects of the provider's claim for the specific item, the contractor 
must make appropriate adjustments to the provider's cost report and 
include reimbursement for the specific item in the final contractor 
determination in accordance with such cost report adjustments and to the 
extent permitted by program policy. If the contractor determines that 
the provider did not make an appropriate cost report claim for a 
specific item, the final contractor determination must not include any 
reimbursement for the specific item, regardless of whether the other 
substantive reimbursement requirements for the specific item are or are 
not satisfied.
    (5) Administrative review of whether there is an appropriate cost 
report claim. If the provider files an administrative appeal (pursuant 
to Part 405, Subpart R of this chapter) seeking reimbursement for a 
specific item and any party to such appeal questions whether the 
provider's cost report included an appropriate claim for the specific 
item under appeal (as specified in paragraphs (j)(1), (2), (3), and (4) 
of this section), the reviewing entity (as defined in Sec.  405.1801(a) 
of this chapter) must follow the procedures prescribed in Sec.  405.1873 
of this chapter (if the appeal was filed originally with the Board), or 
the procedures set forth in Sec.  405.1832 of this chapter (if the 
appeal was filed initially with the contractor), for review of whether 
the substantive reimbursement requirement of an appropriate cost report 
claim for the specific item under appeal is satisfied. The reviewing 
entity must follow the procedures set forth in paragraph (j)(3) of this 
section in determining whether the provider's cost report included an 
appropriate claim for the specific item under appeal. The reviewing 
entity may permit reimbursement for the specific item under appeal 
solely to the extent authorized by Sec.  405.1873(f) of this chapter (if 
the appeal was filed originally with the Board) or by Sec.  405.1832(f) 
of this chapter (if the appeal was filed initially with the contractor).

[51 FR 34793, Sept. 30, 1986]

    Editorial Note: For Federal Register citations affecting Sec.  
413.24, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



                 Subpart C_Limits on Cost Reimbursement



Sec.  413.30  Limitations on payable costs.

    (a) Introduction--(1) Scope. This section implements section 
1861(v)(1)(A) of the Act by setting forth the general rules under which 
CMS may establish limits on SNF and HHA costs recognized as reasonable 
in determining Medicare program payments. It also sets forth rules 
governing exemptions and exceptions to limits established under this 
section that CMS may make as appropriate in considering special needs or 
situations of particular providers.
    (2) General principle. Reimbursable provider costs may not exceed 
the costs CMS estimates to be necessary for the efficient delivery of 
needed health care services. CMS may establish estimated cost limits for 
direct or indirect overall costs or for costs of specific services or 
groups of services. CMS imposes these limits prospectively and may 
calculate them on a per admission, per discharge, per diem, per visit, 
or other basis.
    (b) Procedure for establishing limits. (1) In establishing limits 
under this section, CMS may classify SNFs and HHAs by factors that CMS 
finds appropriate and practical, including the following:
    (i) Type of services furnished.
    (ii) Geographical area where services are furnished, allowing for 
grouping of noncontiguous areas having similar demographic and economic 
characteristics.
    (iii) Size of institution.
    (iv) Nature and mix of services furnished.
    (v) Type and mix of patients treated.
    (2) CMS bases its estimates of the costs necessary for efficient 
delivery of health services on cost reports or other data providing 
indicators of current

[[Page 822]]

costs. CMS adjusts current and past period data to arrive at estimated 
costs for the prospective periods to which limits are applied.
    (3) Before the beginning of a cost period to which revised limits 
will be applied, CMS publishes a notice in the Federal Register, 
establishing cost limits and explaining the basis on which they are 
calculated.
    (4) In establishing limits under paragraph (b)(1) of this section, 
CMS may find it inappropriate to apply particular limits to a class of 
SNFs or HHAs due to the characteristics of the SNF or HHA class, the 
data on which CMS bases those limits, or the method by which CMS 
determines the limits. In these cases, CMS may exclude that class of 
SNFs or HHAs from the limits, explaining the basis of the exclusion in 
the notice setting forth the limits for the appropriate cost reporting 
periods.
    (c) Requests regarding applicability of cost limits. For cost 
reporting periods beginning before July 1, 1998, a SNF may request an 
exception or exemption to the cost limits imposed under this section. An 
HHA may request only an exception to the cost limits. The SNF or HHA 
must make its request to its contractor within 180 days of the date on 
the contractor's notice of program reimbursement.
    (1) Home health agencies. The contractor makes a recommendation on 
the HHA's request to CMS, which makes the decision. CMS responds to the 
request within 180 days from the date CMS receives the request from the 
contractor. The contractor notifies the HHA of CMS's decision. The time 
required by CMS to review the request is considered good cause for the 
granting of an extension of the time limit for requesting an contractor 
hearing or a Provider Reimbursement Review Board (Board) hearing as 
specified in Sec. Sec.  405.1813 and 405.1836 of this chapter, 
respectively.
    (2) Skilled nursing facility exception. The contractor makes the 
final determination on the SNF's exception request and notifies the SNF 
of its determination within 90 days from the date that the contractor 
receives the request from the SNF. If the contractor determines that the 
SNF did not provide adequate documentation from which a proper 
determination can be made, the contractor notifies the SNF that the 
request is denied. The contractor also notifies the SNF that it has 45 
days from the date on the contractor's denial letter to submit a new 
exception request with the complete documentation and that otherwise, 
the denial is the final determination. The time required by the 
contractor to review the request is considered good cause for the 
granting of an extension of the time limit for requesting an contractor 
hearing or a Board hearing as specified in Sec. Sec.  405.1813 and 
405.1836 of this chapter, respectively.
    (d) Exemptions. Exemptions from the limits imposed under this 
section may be granted to a new SNF with cost reporting periods 
beginning before July 1, 1998 as stated in Sec.  413.1(g)(1). The 
contractor makes a recommendation on the provider's request to CMS, 
which makes the decision. A new SNF is a provider of inpatient services 
that has operated as a SNF (or the equivalent) for which it is certified 
for Medicare, under present and previous ownership, for less than 3 full 
years. An exemption granted under this paragraph expires at the end of 
the SNF's first cost reporting period beginning at least 2 years after 
the provider accepts its first inpatient.
    (e) Exceptions. Limits established under this section may be 
adjusted upward for a SNF or HHA under the circumstances specified in 
paragraphs (e)(1) through (e)(5) of this section. An adjustment is made 
only to the extent that the costs are reasonable, attributable to the 
circumstances specified, separately identified by the SNF or HHA, and 
verified by the contractor.
    (1) Atypical services. The SNF or HHA can show that the--
    (i) Actual cost of services furnished by a SNF or HHA exceeds the 
applicable limit because the services are atypical in nature and scope, 
compared to the services generally furnished by SNFs or HHAs similarly 
classified; and
    (ii) Atypical services are furnished because of the special needs of 
the patients treated and are necessary in the efficient delivery of 
needed health care.
    (2) Extraordinary circumstances. The SNF or HHA can show that it 
incurred

[[Page 823]]

higher costs due to extraordinary circumstances beyond its control. 
These circumstances include, but are not limited to, strikes, fire, 
earthquake, flood, or other unusual occurrences with substantial cost 
effects.
    (3) Areas with fluctuating populations. The SNF meets the following 
conditions:
    (i) Is located in an area (for example, a resort area) that has a 
population that varies significantly during the year.
    (ii) Is furnishing similar services in an area for which the 
appropriate health planning agency has determined does not have a 
surplus of beds or similar services and has certified that the beds or 
similar services furnished by the SNF are necessary.
    (iii) Meets occupancy or capacity standards established by the 
Secretary.
    (4) Medical and paramedical education. The SNF or HHA can 
demonstrate that, if compared to other SNFs or HHAs in its group, it 
incurs increased costs for services covered by limits under this section 
because of its operation of an approved education program specified in 
Sec.  413.85.
    (5) Unusual labor costs. The SNF or HHA has a percentage of labor 
costs that varies more than 10 percent from that included in the 
promulgation of the limits.
    (f) Operational review. Any SNF or HHA that applies for an exception 
to the limits established under paragraph (e) of this section must agree 
to an operational review at the discretion of CMS. The findings from 
this review may be the basis for recommendations for improvements in the 
efficiency and economy of the SNF's or the HHA's operations. If 
recommendations are made, any future exceptions are contingent on the 
SNF's or HHA's implementation of these recommendations.

[64 FR 42612, Aug. 5, 1999; 65 FR 60104, Oct. 10, 2000, as amended at 67 
FR 48802, July 26, 2002; 73 FR 30267, May 23, 2008; 73 FR 49357, Aug. 
21, 2008]



Sec.  413.35  Limitations on coverage of costs: Charges to beneficiaries 
if cost limits are applied to services.

    (a) Principle. A provider of services that customarily furnishes an 
individual items or services that are more expensive than the items or 
services determined to be necessary in the efficient delivery of needed 
health services described in Sec.  413.30, may charge an individual 
entitled to benefits under Medicare for such more expensive items or 
services even though not requested by the individual. The charge, 
however, may not exceed the amount by which the cost of (or, if less, 
the customary charges for) such more expensive items or services 
furnished by such provider in the second cost reporting period 
immediately preceding the cost reporting period in which such charges 
are imposed exceeds the applicable limit imposed under the provisions of 
Sec.  413.30. This charge may be made only if--
    (1) The contractor determines that the charges have been calculated 
properly in accordance with the provisions of this section;
    (2) The services are not emergency services as defined in paragraph 
(d) of this section;
    (3) The admitting physician has no direct or indirect financial 
interest in such provider;
    (4) CMS has provided notice to the public through notice in a 
newspaper of general circulation servicing the provider's locality and 
such other notice as the Secretary may require, of any charges the 
provider is authorized to impose on individuals entitled to benefits 
under Medicare on account of costs in excess of the costs determined to 
be necessary in the efficient delivery of needed health services under 
Medicare; and
    (5) The provider has, in the manner described in paragraph (e) of 
this section, identified such charges to such individual or person 
acting on his behalf as charges to meet the costs in excess of the costs 
determined to be necessary in the efficient delivery of needed health 
services under Medicare.
    (b) Provider request to charge beneficiaries for costs in excess of 
limits. (1) If a provider's actual costs (or, if less, the customary 
charges) in the second preceding cost period exceed the prospective 
limits established for such costs, the contractor will, at the 
provider's request, validate in advance the charges that may be made to 
the beneficiaries for the excess.

[[Page 824]]

    (2) If a provider does not have a second preceding cost period and 
is a new provider as defined in Sec.  413.30(e), the provider, subject 
to validation by the contractor, will estimate the current cost of the 
service to which a limit is being applied. Such amount will be adjusted 
to an amount equivalent to costs in the second preceding year by use of 
a factor to be developed based on estimates of cost increases during the 
preceding two years and published by SSA or CMS. The amount thus derived 
will be used in lieu of the second preceding cost period amount in 
determining the charge to the beneficiary.
    (3) To obtain consideration of such a request, the provider must 
submit to the contractor a statement indicating the chagre for which it 
is seeking validation and providing the data and method used to 
determine the amount. Such statement should include the--
    (i) Provider's name and number;
    (ii) Identity of class and prospective cost limit for the class in 
which the provider has been included;
    (iii) Amount of charge and cost period in which the charge is to be 
imposed;
    (iv) Cost and customary charge for items and services furnished to 
beneficiaries; and
    (v) Cost period ending date of the second reporting period 
immediately preceding the cost period in which the charge is to be 
imposed. The contractor may request such additional information as it 
finds necessary with respect to the request.
    (c) Provider charges--(1) Establishing the charges. If the actual 
cost incurred (or, if less, the customary charges) in the prior period 
determined under paragraph (a) of this section exceeds the limits 
applicable to the pertinent period, the provider may charge the 
beneficiary to the extent costs in the second preceding cost reporting 
period (or the equivalent when there is no second preceding period) 
exceed the current cost limits. (Data from the most recently submitted 
appropriate cost report will be used in determining the actual cost.) 
For example, if a limit of $58 per day is applied to the cost of general 
routine services for the provider's cost reporting period starting in 
calendar year 1975 and if the provider's actual general routine cost in 
the second preceding reporting period, that is, the reporting period 
starting in calendar year 1973, was $60 per day, the provider (after 
first having obtained contractor validation and subject to the 
considerations and requirements specified in paragraph (a) of this 
section) may charge Medicare Part A beneficiaries up to $2 per day for 
general routine services.
    (2) Adjusting cost. Program reimbursement for the costs to which 
limits imposed under Sec.  413.30 are applied in any cost reporting 
period will not exceed the lesser of the provider's actual cost or the 
limits imposed under Sec.  413.30. If program reimbursement for items or 
services to which such limits are applied plus the charges to 
beneficiaries for such items or services imposed under this section 
exceed the provider's actual cost for such items or services, program 
payment to the provider will be reduced to the extent program payment 
plus charges to the beneficiaries exceed actual cost. If the provider's 
actual cost for general routine services in 1975 was $57,000, the cost 
limit was $58,000, and billed charges to Medicare Part A beneficiaries 
were $2,000, the provider would receive $55,000 from the program 
($57,000 actual cost minus the $2,000 in charges to the beneficiaries).
    (d) Definition of emergency services. For purposes of paragraph 
(a)(2) of this section, emergency services are those hospital services 
that are necessary to prevent the death or serious impairment of the 
health of the individual, and which, because of the threat to the life 
or health of the individual, necessitate the use of the most accessible 
hospital (as determined under Sec.  424.106 of this chapter) available 
and equipped to furnish such services. If an individual has been 
admitted to such hospital as an inpatient because of an emergency, the 
emergency will be deemed to continue until it is safe from a medical 
standpoint to move the individual to another hospital or other 
institution or to discharge him.
    (e) Identification of charges to individual. For purposes of 
paragraph (a)(5) of this section, a provider must give or send to the 
individual or his representative, a schedule of all items and services 
that the individual might need and

[[Page 825]]

for which the provider imposes charges under this section, and the 
charge for each. Such schedule must specify that the charges are 
necessary to meet the costs in excess of the costs determined to be 
necessary in the efficient delivery of needed health services under 
Medicare and include such other information as CMS considers necessary 
to protect the individual's rights under this section. The provider, in 
arranging for the individual's admission, first service, or start of 
care, must give or send this schedule to the individual or his 
representative when arrangements are being made for such services or if 
this is not feasible, as soon thereafter as is practicable but no later 
than at the initiation of services.

[51 FR 34793, Sept. 30, 1986, as amended at 53 FR 6648, Mar. 20, 1988; 
60 FR 45849, Sept. 1, 1995]



Sec.  413.40  Ceiling on the rate of increase in hospital inpatient costs.

    (a) Introduction--(1) Scope. This section implements section 1886(b) 
of the Act, establishing a ceiling on the rate of increase in operating 
costs per case for hospital inpatient services furnished to Medicare 
beneficiaries that will be recognized as reasonable for purposes of 
determining the amount of Medicare payment. This rate-of-increase 
ceiling applies to hospital cost reporting periods beginning on or after 
October 1, 1982. This section also sets forth rules governing exemptions 
from and adjustments to the ceiling.
    (2) Applicability. (i) This section is not applicable to--
    (A) Hospitals reimbursed in accordance with section 1814(b)(3) of 
the Act or under State reimbursement control systems that have been 
approved under section 1886(c) of the Act and subpart C of part 403 of 
this chapter; or
    (B) Hospitals that are paid under the prospective payment systems 
for inpatient hospital services in accordance with section 1886 (d) and 
(g) of the Act and part 412 of this chapter.
    (C) Psychiatric hospitals and psychiatric units that are paid under 
the prospective payment system for inpatient psychiatric facilities 
described in subpart N of part 412 of this chapter for cost reporting 
periods beginning on or after January 1, 2005.
    (D) Rehabilitation hospitals and rehabilitation units that are paid 
under the prospective payment system for inpatient hospital services in 
accordance with section 1886(j) of the Act and subpart P of part 412 of 
this subchapter for cost reporting periods beginning on or after January 
1, 2002.
    (E) Long-term care hospitals, as defined in section 
1886(d)(1)(B)(iv) of the Act, that are paid based on 100 percent of the 
Federal prospective payment rate for inpatient hospital services in 
accordance with section 123 of Public Law 106-113 and section 307 of 
Public Law 106-554 and Sec.  412.533(b) and (c) of subpart O of part 412 
of this subchapter for cost reporting periods beginning on or after 
October 1, 2002.
    (ii) For cost reporting periods beginning on or after October 1, 
1983, this section applies to--
    (A) Hospitals excluded from the prospective payment systems 
described in Sec.  412.1(a)(1) of this subchapter;
    (B) Psychiatric and rehabilitation units excluded from the 
prospective payment systems, as specified in Sec.  412.1(a)(1) of this 
chapter and in accordance with Sec.  412.25 through Sec.  412.30 of this 
chapter, except as limited by paragraphs (a)(2)(iii) and (a)(2)(iv) of 
this section with respect to psychiatric and rehabilitation hospitals 
and psychiatric and rehabilitation units as specified in Sec. Sec.  
412.22, 412.23, 412.25, 412.27, 412.29 and 412.30 of this chapter.
    (C) Long-term care hospitals excluded from the prospective payment 
systems described in Sec.  412.1(a)(1) of this subchapter and in 
accordance with Sec.  412.23 of this subchapter, except as limited by 
paragraph (a)(2)(v) of this section with respect to long-term care 
hospitals specified in Sec.  412.23(e) of this subchapter.
    (iii) For cost reporting periods beginning on or after October 1, 
1983 and before January 1, 2005 this section applies to psychiatric 
hospitals and psychiatric units that are excluded from the prospective 
payment systems as specified in Sec.  412.1(a)(1) of this chapter and 
paid under the prospective payment system as specified in Sec.  
412.1(a)(2) of this chapter.

[[Page 826]]

    (iv) For cost reporting periods beginning on or after October 1, 
1983 and before January 1, 2002, this section applies to rehabilitation 
hospitals and rehabilitation units that are excluded from the 
prospective payment systems described in Sec.  412.1(a)(1) of this 
subchapter.
    (v) For cost reporting periods beginning on or after October 1, 1983 
and before October 1, 2002, this section applies to long-term care 
hospitals that are excluded from the prospective payment systems 
described in Sec.  412.1(a)(1) of this subchapter. For cost reporting 
periods beginning on or after October 1, 2002, and before October 1, 
2006, this section also applies to long-term care hospitals, subject to 
paragraph (a)(2)(i)(D) of this section.
    (3) Definitions. As used in this section--
    Ceiling is the aggregate upper limit on the amount of a hospital's 
net Medicare inpatient operating costs that the program will recognize 
for payment purposes. For each cost reporting period, the ceiling is 
determined by multiplying the updated target amount, as defined in this 
paragraph, for that period by the number of Medicare discharges during 
that period. For a hospital-within-a-hospital, as described in Sec.  
412.22(e) of this chapter, the number of Medicare discharges in a cost 
reporting period does not include discharges of a patient to another 
hospital in the same building on or on the same campus, if--
    (A) The patient is subsequently readmitted to the hospital-within-a-
hospital directly from the other hospital; and
    (B) The hospital-within-a-hospital has discharged to the other 
hospital and subsequently readmitted more than 5 percent (that is, in 
excess of 5.0 percent) of the total number of Medicare inpatients 
discharged from the hospital-within-a-hospital in that cost reporting 
period.
    Date of discharge is the earliest of the following dates:
    (A) The date the patient has exhausted Medicare Part A hospital 
inpatient benefits (including the election to use lifetime reserve days) 
during his or her spell of illness.
    (B) The date the patient is formally released as specified in Sec.  
412.4(a)(1) of this chapter.
    (C) The date the patient is transferred to another facility.
    (D) The date the patient dies.
    Market basket index is CMS's projection of the annual percentage 
increase in hospital inpatient operating costs. The market basket index 
is a wage and price index that incorporates weighted indicators of 
changes in wages and prices that are representative of the mix of goods 
and services included in the most common categories of hospital 
inpatient operating costs subject to the ceiling, as described in 
paragraph (c)(1) of this section.
    Net inpatient operating costs include the costs of certain 
preadmission services as specified in Sec.  413.40(c)(2), the costs of 
routine services, ancillary services, and intensive care services (as 
defined in Sec.  413.53(b)) incurred by a hospital in furnishing covered 
inpatient services to Medicare beneficiaries. Net inpatient operating 
costs exclude capital-related costs as described in Sec.  413.130, the 
costs of approved medical education programs as described in Sec. Sec.  
413.75 through 413.83 and 413.85, and heart, kidney, and liver 
acquisition costs incurred by approved transplantation centers. These 
costs are identified and excluded from inpatient operating costs before 
the application of the ceiling.
    Rate-of-increase percentage is the percentage by which each 
hospital's target amount from the preceding Federal fiscal year is 
increased.
    Target amount is the per discharge (case) limitation, derived from 
the hospital's allowable net Medicare inpatient operating costs in the 
hospital's base year, and updated for each subsequent hospital cost 
reporting period by the appropriate annual rate-of-increase percentage.
    Update adjustment percentage is the percentage by which a hospital's 
allowable inpatient operating service costs for the 12-month cost 
reporting period beginning in Federal fiscal year 1990 exceeds the 
hospital's ceiling for that period.
    Update factor is the decimal equivalent of the rate-of-increase 
percentage. The update factor is the value by which

[[Page 827]]

a hospital's target amount for the preceding year is multiplied in order 
to determine the target amount for the following year. For example, if 
the rate-of-increase percentage for a year is 2.7 percent, the update 
factor for that year is 1.027.
    (b) Cost reporting periods subject to the rate-of-increase ceiling--
(1) Base period. Each hospital's target amount is based on its allowable 
net inpatient operating costs per case from the cost reporting period of 
at least 12 months immediately preceding the first cost reporting period 
subject to the rate-of-increase ceiling established under this section. 
If the immediately preceding cost reporting period is a short reporting 
period (fewer than 12 months), the first period of at least 12 months 
subsequent to that short period is the base period.
    (i) The target amount established under this provision remains 
applicable to a hospital or excluded hospital unit, as described in 
Sec. Sec.  412.25 through 412.30 of this chapter, despite intervening 
cost reporting periods during which the hospital or excluded hospital 
unit is not subject to the ceiling as a result of other provisions of 
the law or regulations, or nonparticipation in the Medicare program, 
unless the hospital or excluded hospital unit qualifies as a new 
hospital or excluded part hospital unit under the provisions of 
paragraph (f) of this section.
    (ii) The base period for a newly established excluded unit is the 
first cost reporting period of at least 12 months following the unit's 
certification to participate in the Medicare program.
    (iii) When the operational structure of a hospital or unit changes 
(that is, a freestanding hospital becomes an excluded unit or an 
excluded unit becomes a freestanding hospital, or an entity of a 
multicampus hospital becomes a newly created hospital or unit or a 
hospital or unit becomes a part of a multicampus hospital), the base 
period for the hospital or unit that changed its operational structure 
is the first cost reporting period of at least 12 months effective with 
the revised Medicare certification classification.
    (iv) Request for rebased target amount for the cost reporting period 
beginning on or after October 1, 1997 and on or before September 30, 
1998. Except for qualified long-term care hospitals as defined in 
paragraph (b)(1)(v) of this section, each hospital or unit under present 
or previous ownership that received payment under section 1886(b) of the 
Act during cost reporting periods beginning before October 1, 1990, may 
submit a request to its contractor to rebase its target amount. The 
request must be received by the contractor by the later of November 1, 
1997 or 60 days before the beginning of its cost reporting period 
beginning during fiscal year 1998. The rebased target amount for the 
cost reporting period beginning during fiscal year 1998 is determined as 
follows:
    (A) Determine the hospital's inpatient operating costs per case for 
each of the five most recent settled cost reports as of August 5, 1997.
    (B) For each of the five cost reports, update the operating costs 
per case by the applicable update factors up to the hospital's cost 
reporting period beginning during FY 1998.
    (C) Exclude the highest and lowest of the five updated amounts 
determined under paragraph (b)(1)(iv)(B) of this section.
    (D) Compute the average for the remaining three updated amounts for 
operating cost per case.
    (v) Request by qualified long-term care hospital. A qualified long-
term care hospital may file a request to its contractor for a rebased FY 
1998 target amount. The request must be received by the contractor by 
the later of November 1, 1997 or 60 days before the beginning of its 
cost reporting period beginning during fiscal year 1998. The rebased FY 
1998 target amount is the hospital's FY 1996 inpatient operating costs 
updated to FY 1997. A qualified long-term care hospital means a long-
term care hospital that meets the following two conditions for its two 
most recent settled cost reports as of August 5, 1997:
    (A) Its Medicare inpatient operating costs exceed 115 percent of the 
ceiling.
    (B) The hospital would have had a disproportionate patient 
percentage (as defined in Sec.  412.106) equal to or greater than 70 
percent if it were a prospective payment hospital.

[[Page 828]]

    (2) Periods subject to the ceiling. The ceiling established under 
this section applies to all cost reporting periods that--
    (i) Begin on or after October 1, 1982; and
    (ii) Immediately follow the base period established under paragraph 
(b)(1) of this section unless the exception in paragraph (b)(3) of this 
section is applicable.
    (3) Periods of other than 12 months. The ceiling established under 
this section does not apply to cost reporting periods of fewer than 12 
months that occur in conjunction with a change in operation of the 
facility, as defined in paragraph (b)(1)(iii) of this section, as a 
result of changes in ownership, merger, or consolidation. However, the 
ceiling applies to cost reporting periods of fewer than 12 months that 
result solely from the approval of a hospital's request for a change in 
accounting cycle, as specified in Sec.  413.24(f)(3).
    (c) Costs subject to the ceiling--(1) Applicability. The ceiling 
established under this section applies to net operating costs incurred 
by a hospital in furnishing inpatient hospital services to Medicare 
beneficiaries.
    (2) Preadmission services otherwise payable under Medicare Part B 
furnished to a beneficiary on the date of the beneficiary's admission to 
the hospital and during the calendar day immediately preceding the date 
of the beneficiary's admission to the hospital that meet the condition 
specified in paragraph (c)(2)(i) of this section and at least one of the 
conditions specified in paragraphs (c)(2)(ii) through (c)(2)(iv):
    (i) The services are furnished by the hospital or any entity wholly 
owned or operated by the hospital. An entity is wholly owned by the 
hospital if the hospital is the sole owner of the entity. An entity is 
wholly operated by a hospital if the hospital has exclusive 
responsibility for conducting and overseeing the entity's routine 
perations, regardless of whether the hospital also has policymaking 
authority over the entity.
    (ii) For services furnished after January 1, 1991, the services are 
diagnostic (including clinical diagnostic laboratory tests).
    (iii) For services furnished on or after October 1, 1991 through 
June 24, 2010, the services are furnished in connection with the 
principal diagnosis that requires the beneficiary to be admitted as an 
inpatient and are not the following:
    (A) Ambulance services.
    (B) Maintenance renal dialysis services.
    (iv) Nondiagnostic services furnished on or after June 25, 2010, 
other than ambulance services and maintenance renal dialysis services, 
that are furnished on the date of the beneficiary's inpatient admission 
or on the calendar day immediately preceding the date of the 
beneficiary's inpatient admission and the hospital does not attest that 
such services are unrelated to the beneficiary's inpatient admission.
    (3) Rate-of-increase percentages and update factors. The applicable 
rate-of-increase percentages and update factors are determined as 
follows:
    (i) Federal fiscal year 1986. The applicable rate-of-increase 
percentage for cost reporting periods beginning on or after October 1, 
1985 and before September 30, 1986 is five twenty-fourths of one 
percent, and the update factor is 1.00208333. For purposes of 
determining the target amount for cost reporting periods beginning on or 
after October 1, 1986, the applicable percentage increase for cost 
reporting periods beginning during Federal fiscal year 1986 is deemed to 
have been one-half percent, and the update factor is 1.005.
    (ii) Federal fiscal year 1987. The applicable rate-of-increase 
percentage for cost reporting periods beginning on or after October 1, 
1986 and before September 30, 1987 is 1.15 percent; the update factor is 
1.0115.
    (iii) Federal fiscal year 1988. The applicable rate-of-increase 
percentage for cost reporting periods beginning on or after October 1, 
1987 and before October 1, 1988 is 2.3238 percent; the update factor is 
1.023238. For purposes of updating the target amount for cost reporting 
periods beginning on or after October 1, 1988, the rate-of-increase 
percentage for cost reporting periods beginning during FY 1988 is deemed 
to have been 2.7 percent; the update factor is deemed to have been 
1.027.

[[Page 829]]

    (iv) Federal fiscal year 1989 through Federal fiscal year 1993. The 
applicable rate-of-increase percentage for cost reporting periods 
beginning on or after October 1, 1988, and before October 1, 1993, is 
the percentage increase projected by the hospital market basket index 
(as defined in paragraph (a)(3) of this section).
    (v) Federal fiscal year 1994 through Federal fiscal year 1997. The 
applicable rate-of-increase percentage for cost reporting periods 
beginning on or after October 1, 1993, and before October 1, 1998, is 
the market basket percentage increase minus the lesser of, 1 percentage 
point, or the percentage point difference between 10 percent and the 
hospital's ``update adjustment percentage'' (as defined in paragraph 
(a)(3) of this section); for hospitals with an ``update adjustment 
percentage'' of at least 10 percent, the applicable rate-of-increase 
percentage is the market basket percentage increase. The ``update 
adjustment percentage'' is increased in each Federal fiscal year by the 
sum of the hospital's applicable reductions applied to the market basket 
percentage increase for previous Federal fiscal years.
    (vi) Federal fiscal year 1998. The applicable rate-of-increase 
percentage for cost reporting periods beginning on or after October 1, 
1997 is 0 percent.
    (vii) Federal fiscal year 1999 through Federal fiscal year 2002. The 
applicable rate-of-increase percentage for cost reporting periods 
beginning on or after October 1, 1998, and before October 1, 2002, based 
n data from the most recent available cost report, is:
    (A) The percentage increase in the market basket, if inpatient 
operating costs are equal to or exceed the ceiling amount by 10 percent 
or more of the ceiling.
    (B) The percentage increase in the market basket minus .25 
percentage points for each percentage point by which inpatient operating 
costs are less than 10 percent over the ceiling (but not less than 0), 
if inpatient operating costs exceed the ceiling by less than 10 percent 
of the ceiling.
    (C) The greater of the percentage increase in the market basket 
minus 2.5 percentage points or 0 percent, if inpatient operating costs 
are equal to or less than the ceiling but greater than 66.7 percent of 
the ceiling.
    (D) 0 percent, if inpatient operating costs do not exceed 66.7 
percent of the ceiling.
    (viii) Federal fiscal year 2003 and following. The applicable rate-
of-increase percentage for cost reporting periods beginning on or after 
October 1, 2002, is the percentage increase projected by the hospital 
market basket index.
    (4) Target amounts. The contractor will establish a target amount 
for each hospital. The target amount for a cost reporting period is 
determined as follows:
    (i) Except as provided in paragraph (c)(4)(iv) of this section, and 
subject to the provisions of paragraph (c)(4)(iii) of this section, for 
the first cost reporting period to which this ceiling applies, the 
target amount equals the hospital's allowable net inpatient operating 
costs per case for the hospital's base period increased by the update 
factor for the subject period.
    (ii) Subject to the provisions of paragraph (c)(4)(iii) of this 
section, for subsequent cost reporting periods, the target amount equals 
the hospital's target amount for the previous cost reporting period 
increased by the update factor for the subject cost reporting period, 
unless the provisions of paragraph (c)(5)(ii) of this section apply.
    (iii) For cost reporting periods beginning on or after October 1, 
1997 through September 30, 2002, in the case of a psychiatric hospital 
or unit, rehabilitation hospital or unit, or long-term care hospital, 
the target amount is the lower of the amounts specified in paragraph 
(c)(4)(iii)(A) or paragraph (c)(4)(iii)(B) of this section.
    (A) The hospital-specific target amount.
    (1) In the case of all hospitals and units, except long-term care 
hospitals for cost reporting periods beginning during FY 2001, the 
hospital-specific target amount is the net allowable costs in a base 
period increased by the applicable update factors .
    (2) In the case of long-term care hospitals, for cost reporting 
periods beginning during FY 2001, the hospital-specific target amount is 
the net allowable costs in a base period increased by

[[Page 830]]

the applicable update factors multiplied by 1.25.
    (B) One of the following for the applicable cost reporting period--
    (1) For cost reporting periods beginning during fiscal year 1998, 
the 75th percentile of target amounts for hospitals in the same class 
(psychiatric hospital or unit, rehabilitation hospital or unit, or long-
term care hospital) for cost reporting periods ending during FY 1996, 
increased by the applicable market basket percentage up to the first 
cost reporting period beginning on or after October 1, 1997.
    (2) For cost reporting periods beginning during fiscal year 1999, 
the amount determined under paragraph (c)(4)(iii)(B)(1) of this section, 
increased by the market basket percentage up through the subject period, 
subject to the provisions of paragraph (c)(4)(iv) of this section.
    (3) For cost reporting periods beginning during fiscal year 2000--
    (i) The labor-related portion and the nonlabor-related portion of 
the wage-neutralized 75th percentile of target amounts for hospitals in 
the same class (psychiatric hospital or unit, rehabilitation hospital or 
unit, or long-term care hospital) for cost reporting periods ending 
during FY 1996, are increased by the applicable market basket percentage 
up to the first cost reporting period beginning on or after October 1, 
1999.
    (ii) The labor-related portion of the wage-neutralized 75th 
percentile target amounts under paragraph (c)(4)(iii)(B)(4)(i) of this 
section is wage adjusted by multiplying it by the hospital's FY 2000 
hospital inpatient prospective payment system wage index.
    (iii) The wage-adjusted 75th percentile target amounts for hospitals 
in the same class is determined by adding the nonlabor-related portion 
of the wage-neutralized 75th percentile target amounts under paragraph 
(c)(4)(iii)(B)(3)(i) of this section and the hospital's wage-adjusted 
labor-related portion of the wage-neutralized 75th percentile target 
amounts determined under paragraph (c)(4)(iii)(B)(3)(ii) of this 
section, subject to the provisions of paragraph (c)(4)(iv) of this 
section.
    (4) For cost reporting periods beginning during fiscal years 2001 
and 2002--
    (i) The amounts determined under paragraph (c)(4)(iii)(B)(3)(i) of 
this section are: increased by the market basket percentage up through 
the subject period; or in the case of a long-term care hospital for cost 
reporting periods beginning during FY 2001, the amounts determined under 
paragraph (c)(4)(iii)(B)(3)(i) of this section, increased by the market 
basket percentage up through the subject period and further increased by 
2 percent.
    (ii) The labor-related portion of the wage-neutralized 75th 
percentile target amounts under paragraph (c)(4)(iii)(B)(4)(i) of this 
section is wage-adjusted by multiplying by the hospital's FY 2001 
hospital inpatient prospective payment system wage index, for cost 
reporting periods beginning during fiscal year 2001 and the hospital's 
FY 2002 hospital inpatient prospective payment system wage index for 
cost reporting periods beginning during fiscal year 2002.
    (iii) The wage-adjusted 75th percentile target amounts for hospitals 
in the same class are determined by adding the nonlabor-related portion 
of the wage-neutralized 75th percentile target amounts under paragraph 
(c)(4)(iii)(B)(4)(i) of this section and the hospital's wage-adjusted 
labor-related portion of the wage-neutralized 75th percentile target 
amounts determined under paragraph (c)(4)(iii)(B)(4)(ii) of this 
section, subject to the provisions of paragraph (c)(4)(iv) of this 
section.
    (iv) For purposes of the limits on target amounts established under 
paragraph (c)(4)(iii) of this section, each hospital or unit that 
qualifies for exclusion as a member of only one class of excluded 
facility (psychiatric hospital or unit, rehabilitation hospital or unit, 
or long-term care hospital) will be subject to the limit applicable to 
that class. If a hospital or unit qualifies to be classified in more 
than one way under the exclusion criteria in subpart B of part 412 of 
this chapter, the hospital's or unit's target amount may not exceed the 
lowest applicable limit.
    (v) In the case of a hospital that received payments under paragraph 
(f)(2)(ii) of this section as a newly created hospital or unit, to 
determine the

[[Page 831]]

hospital's target amount for the hospital's third 12-month cost 
reporting period, the payment amount determined under paragraph 
(f)(2)(ii)(A) of this section for the preceding cost reporting period is 
updated to the third cost reporting period.
    (5) Applicable update factor. (i) The applicable update factor is 
derived from the prospectively determined rate-of-increase percentage 
published by CMS. The update factor for each Federal fiscal year is 
applied prospectively to the target amount for each cost reporting 
period beginning during the Federal fiscal year.
    (ii) In the case of cost reporting periods of less than 12 months, 
the target amount determined for a hospital's first cost reporting 
period beginning in a Federal fiscal year applies to subsequent periods 
beginning in the same Federal fiscal year.
    (d) Application of the target amount in determining the amount of 
payment--(1) General process. (i) At the end of each cost reporting 
period subject to this section, the hospital's contractor will compare a 
hospital's allowable net inpatient operating costs with that hospital's 
ceiling (as defined in paragraph (a)(3) of this section) for that 
period.
    (ii) The hospital's actual allowable costs will be determined 
without regard to the lesser of cost or charges provisions of Sec.  
413.13, and in accordance with the provisions of paragraphs (d)(2) or 
(d)(3) of this section, as applicable.
    (2) Net inpatient operating costs are less than or equal to the 
ceiling. (i) For cost reporting periods beginning on or after October 1, 
1997, if a hospital's allowable net inpatient operating costs do not 
exceed the hospital's ceiling, payment to the hospital will be 
determined on the basis of the lower of the--
    (A) Net inpatient operating costs plus 15 percent of the difference 
between inpatient operating costs and the ceiling; or
    (B) Net inpatient operating costs plus 2 percent of the ceiling.
    (ii) For psychiatric hospitals and units, for cost reporting periods 
beginning on or after October 1, 2000 and before October 1, 2001, if a 
hospital's allowable net inpatient operating costs do not exceed the 
hospital's ceiling, payment to the hospital will be determined on the 
basis of the lower of the--
    (A) Net inpatient operating costs plus 15 percent of the difference 
between inpatient operating costs and the ceiling; or
    (B) Net inpatient costs plus 3 percent of the ceiling.
    (3) Net inpatient operating costs are greater than the ceiling. For 
cost reporting periods beginning on or after October 1, 1997--
    (i) If a hospital's allowable net inpatient operating costs do not 
exceed 110 percent of the ceiling (or the adjusted ceiling, if 
applicable), payment will be the ceiling (or the adjusted ceiling, if 
applicable);
    (ii) If a hospital's allowable net inpatient operating costs are 
greater than 110 percent of the ceiling (or the adjusted ceiling, if 
applicable), payment will be the ceiling (or the adjusted ceiling, if 
applicable) plus the lesser of:
    (A) 50 percent of the allowable net inpatient operating costs in 
excess of 110 percent of the ceiling (or the adjusted ceiling, if 
applicable); or
    (B) 10 percent of the ceiling (or the adjusted ceiling, if 
applicable).
    (4) Continuous improvement bonus payments. (i) For cost reporting 
periods beginning on or after October 1, 1997, eligible hospitals (as 
defined in paragraph (d)(5) of this section) receive payments in 
addition to those in paragraph (d)(2) of this section, as applicable. 
These payments are equal to the lesser of--
    (A) 50 percent of the amount by which the operating costs are less 
than the expected costs for the period; or
    (B) 1 percent of the ceiling.
    (ii) For cost reporting periods beginning on or after October 1, 
2000, and before September 30, 2001, eligible psychiatric hospitals and 
units and long-term care hospitals (as defined in paragraph (d)(5) of 
this section) receive payments in addition to those in paragraph (d)(2) 
of this section, as applicable. These payments are equal to the lesser 
of--
    (A) 50 percent of the amount by which the operating costs are less 
than the expected costs for the period; or
    (B) 1.5 percent of the ceiling.

[[Page 832]]

    (iii) For cost reporting periods beginning on or after October 1, 
2001, and before September 30, 2002, eligible psychiatric hospitals and 
units and long-term care hospitals receive payments in addition to those 
in paragraph (d)(5) of this section, as applicable. These payments are 
equal to the lesser of--
    (A) 50 percent of the amount by which the operating costs are less 
than the expected costs for the periods; or
    (B) 2 percent of the ceiling.
    (5) Eligibility requirements for continuous improvement bonus 
payments. To qualify, a hospital must have been paid as a prospective 
payment excluded hospital for at least three full cost reporting periods 
prior to the applicable period, and the hospital's operating costs per 
discharge for the period must be less than the least of the following:
    (i) The hospital's target amount.
    (ii) The hospital's trended costs.
    (A) For a hospital for which its cost reporting period ending during 
fiscal year 1996 was its third or subsequent full cost reporting period, 
trended costs are the lesser of the allowable inpatient operating costs 
per discharge or the target amount for the cost reporting period ending 
in fiscal year 1996, increased in a compounded manner for each 
succeeding fiscal year by the market basket percentage increase;
    (B) For all other hospitals, trended costs are the allowable 
inpatient operating costs per discharge for its third full cost 
reporting period increased in a compounded manner for each succeeding 
fiscal year by the market basket increase.
    (iii) The hospital's expected costs. The hospital's expected costs 
are the lesser of its allowable inpatient operating costs per discharge 
or the target amount for the previous cost reporting period, updated by 
the market basket percentage increase for the fiscal year.
    (e) Hospital requests regarding adjustments to the payment allowed 
under the rate-of-increase ceiling--(1) Timing of application. A 
hospital may request an adjustment to the rate-of-increase ceiling 
imposed under this section. The hospital's request must be received by 
the hospital's contractor no later than 180 days after the date on the 
contractor's initial notice of amount of program reimbursement (NPR) for 
the cost reporting period for which the hospital requests an adjustment.
    (2) Contractor recommendation. Unless CMS has authorized the 
contractor to make the decision, the contractor makes a recommendation 
on the hospital's request to CMS, which makes the decision. CMS issues a 
decision to the contractor no later than 180 days after receipt of the 
completed application and the contractor's recommendation.
    (3) Contractor decision. If CMS has authorized the contractor to 
make the decision, the contractor issues a decision no later than 180 
days after receipt of the completed application.
    (4) Notification and review. (i) The contractor notifies the 
hospital of the decision, including a full explanation of the grounds 
for the decision. A decision issued under paragraph (e)(2) or (e)(3) of 
this section is considered final unless the hospital submits additional 
information and requests a review of the decision no later than 180 days 
after the date on the contractor's notice of the decision.
    (ii) The final decision is subject to review under the provider 
reimbursement determination and appeal procedures in subpart R of part 
405 of this chapter, provided the hospital has received an NPR for the 
cost reporting period in question, and the NPR disallows costs for which 
the hospital had requested an adjustment (see the definitions in Sec.  
405.1801(a) of this chapter and the provisions regarding a provider's 
right to a Board hearing in Sec.  405.1835 of this chapter).
    (5) Extending the time limit for review of NPR. The time required to 
review the request is considered good cause for the granting of an 
extension of the time limit for requesting an contractor hearing or a 
Board hearing as specified in Sec. Sec.  405.1813 and 405.1836 of this 
chapter, respectively.
    (6) Applicability. The provisions in paragraphs (e)(1) through 
(e)(5) of this section apply to a hospital's initial request for an 
adjustment and to a request for a review of the original decision based 
on additional data.
    (f) Comparison to the target amount for new hospitals and units--(1) 
New hospitals and units--(i) New hospitals. For purposes of this 
section, a new hospital

[[Page 833]]

is a provider of hospital inpatient services that--
    (A) Has operated as the type of hospital for which CMS granted it 
approval to participate in the Medicare program, under present or 
previous ownership (or both), for less than 2 full years; and
    (B) Has provided the type of hospital inpatient services for which 
CMS granted it approval to participate in the Medicare program, for less 
than 2 years.
    (ii) New units. A newly established unit that is excluded from the 
prospective payments system under the provisions of Sec. Sec.  412.25 
through 412.30 of this chapter does not qualify for the exemption 
afforded to a new hospital under paragraph (f)(2)(i) of this section 
unless the unit is located in an acute care hospital that, if it were 
subject to the provisions of this section, would qualify as a new 
hospital under paragraph (f)(1)(i) of this section.
    (2) Comparison--(i) Exemptions. (A) A new children's hospital is 
exempt from the rate-of-increase ceiling imposed under this section. The 
exemption begins when the hospital accepts its first patient and ends at 
the end of the first cost reporting period ending at least 2 years after 
the hospital accepts its first patient. The first cost reporting period 
of at least 12 months beginning at least 1 year after the hospital 
accepts its first patient is the base year, in accordance with paragraph 
(b) of this section.
    (B) Within 180 days of the date a hospital is excluded from the 
prospective payment system, the contractor determines whether the 
hospital is exempt from the rate-of-increase ceiling. The contractor 
notifies the hospital of its determination and the hospital's base 
period.
    (C) A decision issued under paragraph (f)(2)(ii)(B) of this section 
is considered final unless the hospital submits additional information 
and requests a review of the decision no later than 180 days after the 
date on the contractor's notice of the decision. The final decision is 
subject to review under subpart R of part 405 of this chapter, provided 
the hospital has received a notice of program reimbursement (NPR) for 
the cost reporting period in question and the NPR does not reflect an 
exemption (see the definitions in Sec.  405.1801(a) of this chapter and 
the provisions regarding a provider's right to a Board hearing in Sec.  
405.1835 of this chapter).
    (ii) Median target amount. (A) For cost reporting periods beginning 
on or after October 1, 1997, the amount of payment for a new psychiatric 
hospital or unit, a new rehabilitation hospital or unit, or a new long-
term care hospital that was not paid as an excluded hospital prior to 
October 1, 1997, is the lower of the hospital's net inpatient operating 
cost per case or 110 percent of the national median of the target 
amounts for the class of excluded hospitals and units (psychiatric, 
rehabilitation, long-term care) as adjusted for differences in wage 
levels and updated to the first cost reporting period in which the 
hospital receives payment. The second cost reporting period is subject 
to the same target amount as the first cost reporting period.
    (B) The national median of the target amounts is the FY 1996 median 
target amount--
    (1) Adjusted to account for differences in area wage levels;
    (2) Updated by the market basket percentage increase to the fiscal 
year in which the hospital first received payments as an excluded 
provider.
    (3) Risk-basis HMOs. Items or services that are furnished to 
beneficiaries enrolled in an HMO by a hospital that is either owned or 
operated by a risk-basis HMO or related to a risk-basis HMO by common 
ownership or control are exempt from the rate-of-increase ceiling (see 
the definition of an entity with a risk sharing contract in Sec.  
417.401 of this chapter).
    (g) Adjustments--(1) General rules. (i) CMS adjusts the amount of 
the operating costs considered in establishing the rate-of-increase 
ceiling for one or more cost reporting periods, including both periods 
subject to the ceiling and the hospital's base period, under the 
circumstances specified in paragraphs (g)(2), (g)(3), and (g)(4) of this 
section.
    (ii) When the hospital requests an adjustment, CMS makes an 
adjustment only to the extent that the hospital's operating costs are 
reasonable, attributable to the circumstances specified

[[Page 834]]

separately, identified by the hospital, and verified by the contractor.
    (iii) When the hospital requests an adjustment, CMS makes an 
adjustment only if the hospital's operating costs exceed the rate-of-
increase ceiling imposed under this section.
    (iv) In the case of a psychiatric hospital or unit, rehabilitation 
hospital or unit, or long-term care hospital, the amount of payment 
under paragraph (g)(3) of this section may not exceed the payment amount 
based on the target amount determined under paragraph (c)(4)(iii) of 
this section.
    (v) In the case of a hospital or unit that received a revised FY 
1998 target amount under the rebasing provisions of paragraph (b)(1)(iv) 
of this section, the amount of an adjustment payment for a cost 
reporting period is based on a comparison of the hospital's operating 
costs for the cost reporting period to the average costs and statistics 
for the cost reporting periods used to determine the FY 1998 rebased 
target amount.
    (2) Extraordinary circumstances. CMS may make an adjustment to take 
into account unusual costs (in either a cost reporting period subject to 
the ceiling or the hospital's base period) due to extraordinary 
circumstances beyond the hospital's control. These circumstances 
include, but are not limited to, strikes, fire, earthquakes, floods, or 
similar unusual occurrences with substantial cost effects.
    (3) Comparability of cost reporting periods--(i) Adjustment for 
distortion. CMS may make an adjustment to take into account factors that 
would result in a significant distortion in the operating costs of 
inpatient hospital services between the base year and the cost reporting 
period subject to the limits.
    (ii) Factors. The adjustments described in paragraph (g)(3)(i) of 
this section, include, but are not limited to, adjustments to take into 
account:
    (A) FICA taxes (if the hospital did not incur costs for FICA taxes 
in its base period).
    (B) Services billed under part B of Medicare during the base period, 
but paid under part A during the subject cost reporting period.
    (C) Malpractice insurance costs (if malpractice costs were not 
included in the base year operating costs).
    (D) Increases in service intensity or length of stay attributable to 
changes in the type of patient served.
    (E) A change in the inpatient hospital services that a hospital 
provides, and that are customarily provided directly by similar 
hospitals, such as an addition or discontinuation of services or 
treatment programs.
    (F) The manipulation of discharges to increase reimbursement.
    (iii) Adjusting operating costs. Without a formal request from a 
hospital, CMS may adjust the amount of operating costs determined under 
paragraph (c)(1) of this section to take into account certain 
adjustments. These adjustments include, but are not limited to, 
adjustments under paragraphs (g)(3)(ii)(A), (B), (C), (E), and (F) of 
this section.
    (4) Significant wage increase. (i) Criteria. CMS may make an 
adjustment to take into account a significant increase in wages 
occurring between the base period and the cost reporting period subject 
to the ceiling if there is a significant increase in the average hourly 
wage for the geographic area in which the hospital is located 
(determined by reference to the wage index for prospective payment 
hospitals without regard to geographic reclassifications under sections 
1886(d)(8) and (10) of the Act). For this purpose, there is a 
significant wage increase if the wage index value based on wage survey 
data collected for the cost reporting period subject to the ceiling is 
at least 8.0 percent higher than the wage index value based on survey 
data collected for the base year cost reporting period. If survey data 
are not available for the cost reporting periods used in the comparison, 
the wage index value based on the latest available survey data collected 
prior to that cost reporting period is used.
    (ii) Amount of the adjustment. The adjustment for a significant wage 
increase equals the amount by which the lesser of the following 
calculations exceeds 108 percent of the increase in the national average 
hourly earnings for hospital workers:

[[Page 835]]

    (A) The rate of increase in the average hourly wage in the 
geographic area (determined by applying the applicable increase in the 
area wage index value to the rate of increase in the national average 
hourly earnings for hospital workers).
    (B) The rate of increase in the hospital's average hourly wage.
    (5) Adjustment limitations. For cost reporting periods beginning on 
or after October 1, 1993, and before October 1, 2003, the payment 
reductions under paragraph (c)(3)(v) through (c)(3)(vii) of this section 
will not be considered when determining adjustments under this 
paragraph.
    (h) [Reserved]
    (i) Assignment of a new base period--(1) General rule. (i) Effective 
with cost reporting periods beginning on or after April 1, 1990, CMS may 
assign a new base period to establish a revised ceiling if the new base 
period is more representative of the reasonable and necessary cost of 
furnishing inpatient services and all the following conditions apply:
    (A) The actual allowable inpatient costs of the hospital in the cost 
reporting period that would be affected by the revised ceiling exceed 
the target amount established under paragraph (c) of this section.
    (B) The hospital documents that the higher costs are the result of 
substantial and permanent changes in furnishing patient care services 
since the base period. In making this determination, CMS takes into 
consideration the following factors:
    (1) Changes in the services provided by the hospital.
    (2) Changes in applicable technologies and medical practices.
    (3) Differences in the severity of illness among patients or types 
of patients served.
    (C) The adjustments described in paragraph (g) of this section would 
not result in recognition of the reasonable and necessary costs of 
providing inpatient services.
    (ii) The revised ceiling is based on the necessary and proper costs 
incurred during the new base period.
    (A) Increases in overhead costs (for example, administrative and 
general costs and housekeeping costs) are not taken into consideration 
unless the hospital documents that these increases result from 
substantial and permanent changes in furnishing patient care services.
    (B) In determining whether wage increases are necessary and proper, 
CMS takes into consideration whether increases in wages and wage-related 
costs for hospitals in the labor market area exceed the national average 
increase.
    (2) New base period. The new base period is the first cost reporting 
period that is 12 months or longer that reflects the substantial and 
permanent change.
    (3) New applicable rate-of-increase percentages and update factors. 
The revised target amount resulting from the assignment of a new base 
period is increased by the applicable rate-of-increase percentages 
(update factors) described in paragraph (c)(3) of this section.
    (j) Reduction to capital-related costs. For psychiatric hospital and 
units, rehabilitation hospitals and units, and long-term care hospitals, 
the amount otherwise payable for capital-related costs for hospital 
inpatient services is reduced by 15 percent for portions of cost 
reporting periods occurring on or after October 1, 1997 through 
September 30, 2002.

[58 FR 46340, Sept. 1, 1993]

    Editorial Note: For Federal Register citations affecting Sec.  
413.40, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



                         Subpart D_Apportionment



Sec.  413.50  Apportionment of allowable costs.

    (a) Consistent with prevailing practice in which third-party 
organizations pay for health care on a cost basis, reimbursement under 
the Medicare program involves a determination of--
    (1) Each provider's allowable costs for producing services; and
    (2) The share of these costs which is to be borne by Medicare. The 
provider's costs are to be determined in accordance with the principles 
reviewed in the preceding discussion relating to allowable costs. The 
share to be borne by

[[Page 836]]

Medicare is to be determined in accordance with principles relating to 
apportionment of cost.
    (b) In the study and consideration devoted to the method of 
apportioning costs, the objective has been to adopt methods for use 
under Medicare that would, to the extent reasonably possible, result in 
the program's share of a provider's total allowable costs being the same 
as the program's share of the provider's total services. This result is 
essential for carrying out the statutory directive that the program's 
payments to providers should be such that the costs of covered services 
for beneficiaries would not be passed on to nonbeneficiaries, nor would 
the cost of services for nonbeneficiaries be borne by the program.
    (c) A basic factor bearing upon apportionment of costs is that 
Medicare beneficiaries are not a cross section of the total population. 
Nor will they constitute a cross section of all patients receiving 
services from most of the providers that participate in the program. 
Available evidence shows that the use of services by persons age 65 and 
over differs significantly from other groups. Consequently, the 
objective sought in the determination of the Medicare share of a 
provider's total costs means that the methods used for apportionment 
must take into account the differences in the amount of services 
received by patients who are beneficiaries and other patients serviced 
by the provider.
    (d) The method of cost reimbursement most widely used at the present 
time by third-party purchasers of inpatient hospital care apportions a 
provider's total costs among groups served on the basis of the relative 
number of days of care used. This method, commonly referred to as 
average-per-diem cost, does not take into account, variations in the 
amount of service which a day of care may represent and thereby assumes 
that the patients for whom payment is made on this basis are average in 
their use of service.
    (e) In considering the average-per-diem method of apportioning cost 
for use under the program, the difficulty encountered is that the 
preponderance of presently available evidence strongly indicates that 
the over-age 65 patient is not typical from the standpoint of average-
per-diem cost. On the average this patient stays in the hospital twice 
as long and therefore the ancillary services that he uses are averaged 
over the longer period of time, resulting in an average-per-diem cost 
for the aged alone, significantly below the average-per-diem for all 
patients.
    (f) Moreover, the relative use of services by aged patients as 
compared to other patients differs significantly among institutions. 
Consequently, considerations of equity among institutions are involved 
as well as that of effectiveness of the apportionment method under the 
program in accomplishing the objective of paying each provider fully, 
but only for services to beneficiaries.
    (g) A further consideration of long-range importance is that the 
relative use of services by aged and other patients can be expected to 
change, possibly to a significant extent in future years. The ability of 
apportionment methods used under the program to reflect such change is 
an element of flexibility which has been regarded as important in the 
formulation of the cost reimbursement principles.
    (h) An alternative to the relative number of days of care as a basis 
for apportioning costs is the relative amount of charges billed by the 
provider for services to patients. The amount of charges is the basis 
upon which the cost of hospital care is distributed among patients who 
pay directly for the services they receive. Payment for services on the 
basis of charges applies generally under insurance programs in which 
individuals are indemnified for incurred expenses, a form of health 
insurance widely held throughout the United States. Also, charges to 
patients are commonly a factor in determining the amount of payment to 
hospitals under insurance programs providing service benefits, many of 
which pay ``costs or charges, whichever is less'' and some of which pay 
exclusively on the basis of charges. In all of these instances, the 
provider's own charge structure and method of itemizing services for the 
purpose of assessing charges is utilized as a measure of the amount of 
services received

[[Page 837]]

and as the basis for allocating responsibility for payment among those 
receiving the provider's services.
    (i) An increasing number of third-party purchasers who pay for 
services on the basis of cost are developing methods that utilize 
charges to measure the amount of services for which they have 
responsibility for payment. In this approach, the amount of charges for 
such services as a proportion of the provider's total charges to all 
patients is used to determine the proportion of the provider's total 
costs for which the third-party purchaser assumes responsibility. The 
approach is subject to numerous variations. It can be applied to the 
total of charges for all services combined or it can be applied to 
components of the provider's activities for which the amount of costs 
and charges are ascertained through a breakdown of data from the 
provider's accounting records.
    (j) For the application of the approach to components, which 
represent types of services, the breakdown of total costs is 
accomplished by ``cost-finding'' techniques under which indirect costs 
and nonrevenue activities are allocated to revenue producing components 
for which charges are made as services are furnished.



Sec.  413.53  Determination of cost of services to beneficiaries.

    (a) Principle. Total allowable costs of a provider will be 
apportioned between program beneficiaries and other patients so that the 
share borne by the program is based upon actual services received by 
program beneficiaries. The methods of apportionment are defined as 
follows:
    (1) Departmental method--(i) Methodology. Except as provided in 
paragraph (a)(1)(ii) of this section with respect to the treatment of 
the private room cost differential for cost reporting periods starting 
on or after October 1, 1982, the ratio of beneficiary charges to total 
patient charges for the services of each ancillary department is applied 
to the cost of the department; to this is added the cost of routine 
services for program beneficiaries, determined on the basis of a 
separate average cost per diem for general routine patient care areas as 
defined in paragraph (b) of this section, taking into account, in 
hospitals, a separate average cost per diem for each intensive care 
unit, coronary care unit, and other intensive care type inpatient 
hospital units.
    (ii) Exception: Indirect cost of private rooms. For cost reporting 
periods starting on or after October 1, 1982, except with respect to a 
hospital receiving payment under part 412 of this chapter (relating to 
the prospective payment system), the additional cost of furnishing 
services in private room accommodations is apportioned to Medicare only 
if these accommodations are furnished to program beneficiaries, and are 
medically necessary. To determine routine service cost applicable to 
beneficiaries--
    (A) Multiply the average cost per diem (as defined in paragraph (b) 
of this section) by the total number of Medicare patient days (including 
private room days whether or not medically necessary);
    (B) Add the product of the average per diem private room cost 
differential (as defined in paragraph (b) of this section) and the 
number of medically necessary private room days used by beneficiaries; 
and
    (C) Effective October 1, 1990, do not include private rooms 
furnished for SNF-type and NF-type services under the swing-bed 
provision in the number of days in paragraphs (a)(1)(ii)(A) and (B) of 
this section.
    (2) Carve-out out method. (i) The carve-out out method is used to 
allocate hospital inpatient general routine service costs in a 
participating swing-bed hospital, as defined in Sec.  413.114(b). Under 
this method, effective for services furnished on or after October 1, 
1990, the reasonable costs attributable to the inpatient routine SNF-
type and NF-type services furnished to all classes of patients are 
subtracted from total inpatient routine service costs before computing 
the average cost per diem for inpatient routine hospital care.
    (ii) The cost per diem attributable to the routine SNF-type services 
covered by Medicare is based on the regional Medicare swing-bed SNF rate 
in effect for a given calendar year, as described in Sec.  413.114(c). 
The Medicare SNF rate applies only to days covered and paid

[[Page 838]]

as Medicare days. When Medicare coverage runs out, the Medicare rate no 
longer applies.
    (iii) The cost per diem attributable to all non-Medicare swing-bed 
days is based on the average statewide Medicaid NF rate for the prior 
calendar year, adjusted to approximate the average NF rate for the 
current calendar year.
    (iv) The sum of total Medicare SNF-type days multiplied by the cost 
per diem attributable to Medicare SNF-type services and the total NF-
type days multiplied by the cost per diem attributable to all non-
Medicare days is subtracted from total inpatient general routine service 
costs. The cost per diem for inpatient routine hospital care is computed 
based on the remaining inpatient routine service costs.
    (3) Cost per visit by type-of-service method--HHAs. For cost 
reporting periods beginning on or after October 1, 1980, all HHAs must 
use the cost per visit by type-of-service method of apportioning costs 
between Medicare and non-Medicare beneficiaries. Under this method, the 
total allowable cost of all visits for each type of service is divided 
by the total number of visits for that type of service. Next, for each 
type of service, the number of Medicare covered visits is multiplied by 
the average cost per visit just computed. This represents the cost 
Medicare will recognize as the cost for that service, subject to cost 
limits published by CMS (see Sec.  413.30).
    (b) Definitions. As used in this section--
    Ancillary services means the services for which charges are 
customarily made in addition to routine services.
    Apportionment means an allocation or distribution of allowable cost 
between the beneficiaries of the Medicare program and other patients.
    Average cost per diem for general routine services means the 
following:
    (1) For cost reporting periods beginning on or after October 1, 
1982, subject to the provisions on swing-bed hospitals, the average cost 
of general routine services net of the private room cost differential. 
The average cost per diem is computed by the following methodology:
    (i) Determine the total private room cost differential by 
multiplying the average per diem private room cost differential 
determined in paragraph (c) of this section by the total number of 
private room patient days.
    (ii) Determine the total inpatient general routine service costs net 
of the total private room cost differential by subtracting the total 
private room cost differential from total inpatient general routine 
service costs.
    (iii) Determine the average cost per diem by dividing the total 
inpatient general routine service cost net of private room cost 
differential by all inpatient general routine days, including total 
private room days.
    (2) For swing-bed hospitals, the amount computed by--
    (i) Subtracting the routine costs associated with Medicare SNF-type 
days and non-Medicare NF-type days from the total allowable inpatient 
cost for routine services (excluding the cost of services provided in 
intensive care units, coronary care units, and other intensive care type 
inpatient hospital units and nursery costs); and
    (ii) Dividing the remainder (excluding the total private room cost 
differential) by the total number of inpatient hospital days of care 
(excluding Medicare SNF-type days and non-Medicare NF-type days of care, 
days of care in intensive care units, coronary care units, and other 
intensive care type inpatient hospital units; and newborn days; but 
including total private room days).
    Average cost per diem for hospital intensive care type units means 
the amount computed by dividing the total allowable costs for routine 
services in each of these units by the total number of inpatient days of 
care furnished in each of these units.
    Average per diem private room cost differential means the difference 
in the average per diem cost of furnishing routine services in a private 
room and in a semi-private room. (This differential is not applicable to 
hospital intensive care type units.) (The method for computing this 
differential is described in paragraph (c) of this section.)
    Charges means the regular rates for various services that are 
charged to

[[Page 839]]

both beneficiaries and other paying patients who receive the services. 
Implicit in the use of charges as the basis for apportionment is the 
objective that charges for services be related to the cost of the 
services.
    Intensive care type inpatient hospital unit means a hospital unit 
that furnishes services to critically ill inpatients. Examples of 
intensive care type units include, but are not limited to, intensive 
care units, trauma units, coronary care units, pulmonary care units, and 
burn units. Excluded as intensive care type units are postoperative 
recovery rooms, postanesthesia recovery rooms, maternity labor rooms, 
and subintensive or intermediate care units. (The unit must also meet 
the criteria of paragraph (d) of this section.)
    Nursing facility (NF)-type services, formerly known as ICF and SNF-
type services, are routine services furnished by a swing-bed hospital to 
Medicaid and other non-Medicare patients. Under the Medicaid program, 
effective October 1, 1990, facilities are no longer certified as SNFs or 
ICFs but instead are certified only as NFs and can provide services as 
defined in section 1919(a)(1) of the Act.
    Skilled nursing facility (SNF)-type services are routine services 
furnished by a swing-bed hospital that would constitute extended care 
services if furnished by an SNF. SNF-type services include routine SNF 
services furnished in the distinct part SNF of a hospital complex that 
is combined with the hospital general routine service area cost center 
under Sec.  413.24(d)(5). Effective October 1, 1990, only Medicare 
covered services are included in the definition of SNF-type services.
    Ratio of beneficiary charges to total charges on a departmental 
basis means the ratio of charges to beneficiaries of the Medicare 
program for services of a revenue-producing department or center to the 
charges to all patients for that center during an accounting period. 
After each revenue-producing center's ratio is determined, the cost of 
services furnished to beneficiaries of the Medicare program is computed 
by applying the individual ratio for the center to the cost of the 
related center for the period.
    Routine services means the regular room, dietary, and nursing 
services, minor medical and surgical supplies, and the use of equipment 
and facilities for which a separate charge is not customarily made.
    (c) Method for computing the average per diem private room cost 
differential. Compute the average per diem private room cost 
differential as follows:
    (1) Determine the average per diem private room charge differential 
by subtracting the average per diem charge for all semi-private room 
accommodations from the average per diem charge for all private room 
accommodations. The average per diem charge for private room 
accommodations is determined by dividing the total charges for private 
room accommodations by the total number of days of care furnished in 
private room accommodations. The average per diem charge for semi-
private accommodations is determined by dividing the total charges for 
semi-private room accommodations by the total number of days of care 
furnished in semi-private accommodations.
    (2) Determine the inpatient general routine cost to charge ratio by 
dividing total inpatient general routine service cost by the total 
inpatient general routine service charges.
    (3) Determine the average per diem private room cost differential by 
multiplying the average per diem private room charge differential 
determined in paragraph (c)(1) of this section by the ratio determined 
in paragraph (c)(2) of this section.
    (d) Criteria for identifying intensive care type units. For purposes 
of determining costs under this section, a unit will be identified as an 
intensive care type inpatient hospital unit only if the unit--
    (1) Is in a hospital;
    (2) Is physically and identifiably separate from general routine 
patient care areas, including subintensive or intermediate care units, 
and ancillary service areas. There cannot be a concurrent sharing f 
nursing staff between an intensive care type unit and units or areas 
furnishing different levels or

[[Page 840]]

types of care. However, two or more intensive care type units that 
concurrently share nursing staff can be reimbursed as one combined 
intensive care type unit if all other criteria are met. Float nurses 
(nurses who work in different units on an as-needed basis) can be 
utilized in the intensive care type unit. If a float nurse works in two 
different units during the same eight hour shift, then the costs must be 
allocated to the appropriate units depending upon the time spent in 
those units. The hospital must maintain adequate records to support the 
allocation. If such records are not available, then the costs must be 
allocated to the general routine services cost areas;
    (3) Has specific written policies that include criteria for 
admission to, and discharge from, the unit;
    (4) Has registered nursing care available on a continuous 24-hour 
basis with at least one registered nurse present in the unit at all 
times;
    (5) Maintains a minimum nurse-patient ratio of one nurse to two 
patients per patient day. Included in the calculation of this nurse-
patient ratio are registered nurses, licensed vocational nurses, 
licensed practical nurses, and nursing assistants who provide patient 
care. Not included are general support personnel such as ward clerks, 
custodians, and housekeeping personnel; and
    (6) Is equipped, or has available for immediate use, life-saving 
equipment necessary to treat the critically ill patients for which it is 
designed. This equipment may include, but is not limited to, respiratory 
and cardiac monitoring equipment, respirators, cardiac defibrillators, 
and wall or canister oxygen and compressed air.
    (e) Application--(1) Departmental method; Cost reporting periods 
beginning on or after October 1, 1982. (i) The following example 
illustrates how costs would be determined, using only inpatient data, 
for cost reporting periods beginning on or after October 1, 1982, based 
on apportionment of--
    (A) The average cost per diem for general routine services (subject 
to the private room differential provisions of paragraph (a)(1)(iii) of 
this section);
    (B) The average cost per diem for each intensive care type unit;
    (C) The ratio of beneficiary charges to total charges applied to 
cost by department.

                                                   Hospital Y
----------------------------------------------------------------------------------------------------------------
                                                                             Ratio of
                                                 Charges to                beneficiary                 Cost of
                  Department                      program        Total      charges to   Total cost  beneficiary
                                               beneficiaries    charges       total                    services
                                                                             charges
----------------------------------------------------------------------------------------------------------------
                                                                            Percent
                                              ------------------------------------------------------------------
Operating rooms..............................       $20,000       $70,000      28\4/7\      $77,000      $22,000
Delivery rooms...............................             0        12,000            0       30,000            0
Pharmacy.....................................        20,000        60,000      33\1/3\       45,000       15,000
X-ray........................................        24,000       100,000           24       75,000       18,000
Laboratory...................................        40,000       140,000      28\4/7\       98,000       28,000
Others.......................................         6,000        30,000           20       25,000        5,000
                                              ------------------------------------------------------------------
      Total..................................       110,000       412,000  ...........      350,000       88,000
----------------------------------------------------------------------------------------------------------------


----------------------------------------------------------------------------------------------------------------
                                                    Total                    Average     Program in    Cost of
                                                  inpatient    Total cost    cost per     patient    beneficiary
                                                     days                      diem         days       services
----------------------------------------------------------------------------------------------------------------
General routine................................       30,000     $630,000          $21        8,000     $168,000
Coronary care unit.............................          500       20,000           40          200        8,000
Intensive care unit............................        3,000      108,000           36        1,000       36,000
                                                ----------------------------------------------------------------
                                                      33,500      758,000  ...........        9,200      212,000
                                                ----------------------------------------------------------------
      Total....................................  ...........  ...........  ...........  ...........      300,000
----------------------------------------------------------------------------------------------------------------


[[Page 841]]

    (ii) The following illustrates how apportionment based on an average 
cost per diem for general routine services is determined.

                                                   Hospital E
----------------------------------------------------------------------------------------------------------------
                                                                       Private        Semi-private
                              Facts                                accommodations    accommodations      Total
----------------------------------------------------------------------------------------------------------------
Total charges...................................................           $20,000          $175,000    $195,000
Total days......................................................               100             1,000       1,100
Programs days...................................................                70               400         470
Medically necessary for program beneficiaries...................                20  ................          20
    Total general routine service costs.........................  ................  ................    165,000
Average private room per diem charge ($20,000 private room charges / 100 days)......................    \1\ $200
Average semi-private room per diem charge ($175,000 semi-private charge / 1,000 days)...............   \1\ $175
----------------------------------------------------------------------------------------------------------------
\1\ Per diem.
 Average per diem private room cost differential.
1. Average per diem private room charge differential ($200 private room per diem--$175, semi-private room per
  diem), $25.
2. Inpatient general routine cost/charge ratio ($165,000 total costs / $195,000 total charges), 0.8461538.
3. Average per diem private room cost differential ($25 charge differential x .8461538 cost/charge ratio),
  $21.15.
 Average cost per diem for inpatient general routine services.
4. Total private room cost differential ($21.15 average per diem cost differential x 100 private room days),
  $2,115.
5. Total inpatient general routine service costs net of private room cost differential ($165,000 total routine
  cost -$2,115 private room cost differential), $162,885.
6. Average cost per diem for inpatient general routine services ($162,885 routine cost net of private room cost
  differential / 1,100 patient days), $148.08.
 Medicare general routine service cost.
7. Total routine per diem cost applicable to Medicare ($148.08 average cost per diem x 470 Medicare private and
  semi-private patient days), $69,598.
8. Total private room cost differential applicable to Medicare ($21.15 average per diem private room cost
  differential x 20 medically necessary private room days), $423.
9. Medicare inpatient general routine service cost ($423 Medicare private room cost differential + $69,598
  Medicare cost of general routine inpatient services), $70,021.

    (2) Carve out method. The following illustrates how apportionment is 
determined in a hospital reimbursed under the carve out method (subject 
to the private room differential provisions of paragraph (a)(1)(ii) of 
this section):

                               Hospital K
  [Determination of cost of routine SNF-type and ICF-type services and
                 general routine hospital services \1\]
------------------------------------------------------------------------
                                                   Days of care
                                        --------------------------------
                 Facts                    General
                                          routine    SNF-type   ICF-type
                                          hospital
------------------------------------------------------------------------
Total days of care.....................      2,000        400        100
Medicare days of care..................        600        300
Average Medicaid rate..................        N/A        $35        $20
  Total inpatient general routine service costs: $250,000...............
------------------------------------------------------------------------


Calculation of cost of routine SNF-type services applicable to Medicare:
      $35 x 300 = $10,500
Calculation of cost of general routine hospital services:
    Cost of SNF-type services: $35 x 400....................     $14,000
    Cost of ICF-type services: $20 x 100....................       2,000
                                                             -----------
      Total.................................................     $16,000
Average cost per diem of general routine hospital services:
  $250,000 - $16,000 / 2,000 days = $117
Medicare general routine hospital cost:
    $117 x 600 = $70,200
Total Medicare reasonable cost for general routine inpatient days:
      $10,500 + $70,200 = $80,700
 


[51 FR 34793, Sept. 30, 1986, as amended at 59 FR 45401, Sept. 1, 1994; 
61 FR 51616, Oct. 3, 1996; 61 FR 58631, Nov. 18, 1996]



Sec.  413.56  [Reserved]



                     Subpart E_Payments to Providers



Sec.  413.60  Payments to providers: General.

    (a) The fiscal contractors will establish a basis for interim 
payments to each provider. This may be done by one of several methods. 
If an contractor is already paying the provider on a cost basis, the 
contractor may adjust its rate of payment to an estimate of the result 
under the Medicare principles of reimbursement. If no organization is 
paying the provider on a cost basis, the contractor may obtain the 
previous year's financial statement from the provider and, by applying 
the principles of reimbursement, compute or approximate an appropriate 
rate of payment. The interim payment may be related to the last year's 
average per diem, or to charges, or to any other ready basis of 
approximating costs.
    (b) At the end of the period, the actual apportionment, based on the 
cost finding and apportionment methods selected by the provider, 
determines the

[[Page 842]]

Medicare reimbursement for the actual services provided to beneficiaries 
during the period.
    (c) Basically, therefore, interim payments to providers will be made 
for services throughout the year, with final settlement on a retroactive 
basis at the end of the accounting period. Interim payments will be made 
as often as possible and in no event less frequently than once a month. 
The retroactive payments will take fully into account the costs that 
were actually incurred and settle on an actual, rather than on an 
estimated basis.



Sec.  413.64  Payments to providers: Specific rules.

    (a) Reimbursement on a reasonable cost basis. Providers of services 
paid on the basis of the reasonable cost of services furnished to 
beneficiaries will receive interim payments approximating the actual 
costs of the provider. These payments will be made on the most 
expeditious schedule administratively feasible but not less often than 
monthly. A retroactive adjustment based on actual costs will be made at 
the end of a reporting period.
    (b) Amount and frequency of payment. Medicare states that providers 
of services will be paid the reasonable cost of services furnished to 
beneficiaries. Since actual costs of services cannot be determined until 
the end of the accounting period, the providers must be paid on an 
estimated cost basis during the year. While Medicare provides that 
interim payments will be made no less often than monthly, contractors 
are expected to make payments on the most expeditious basis 
administratively feasible. Whatever estimated cost basis is used for 
determining interim payments during the year, the intent is that the 
interim payments shall approximate actual costs as nearly as is 
practicable so that the retroactive adjustment based on actual costs 
will be as small as possible.
    (c) Interim payments during initial reporting period. At the 
beginning of the program or when a provider first participates in the 
program, it will be necessary to establish interim rates of payment to 
providers of services. Once a provider has filed a cost report under the 
Medicare program, the cost report may be used as a basis for determining 
the interim rate of reimbursement for the following period. However, 
since initially there is no previous history of cost under the program, 
the interim rate of payment must be determined by other methods, 
including the following:
    (1) If the contractor is already paying the provider on a cost or 
cost-related basis, the contractor will adjust its rate of payment to 
the program's principles of reimbursement. This rate may be either an 
amount per inpatient day, or a percent of the provider's charges for 
services furnished to the program's beneficiaries.
    (2) If an organization other than the contractor is paying the 
provider for services on a cost or cost-related basis, the contractor 
may obtain from that organization or from the provider itself the rate 
of payment being used and other cost information as may be needed to 
adjust that rate of payment to give recognition to the program's 
principles of reimbursement.
    (3) It no organization is paying the provider on a cost or cost-
related basis, the contractor will obtain the previous year's financial 
statement from the provider. By analysis of such statement in light of 
the principles of reimbursement, the contractor will compute an 
appropriate rate of payment.
    (4) After the initial interim rate has been set, the provider may at 
any time request, and be allowed, an appropriate increase in the 
computed rate, upon presentation of satisfactory evidence to the 
contractor that costs have increased. Likewise, the contractor may 
adjust the interim rate of payment if it has evidence that actual costs 
may fall significantly below the computed rate.
    (d) Interim payments for new providers. (1) Newly-established 
providers will not have cost experience on which to base a determination 
of an interim rate of payment. In such cases, the contractor will use 
the following methods to determine an appropriate rate:
    (i) If there is a provider or providers comparable in substantially 
all relevant factors to the provider for which the rate is needed, the 
contractor will base an interim rate of payment on the costs of the 
comparable provider.
    (ii) If there are no substantially comparable providers from whom 
data are

[[Page 843]]

available, the contractor will determine an interim rate of payment 
based on the budgeted or projected costs of the provider.
    (2) Under either method, the contractor will review the provider's 
cost experience after a period of three months. If need for an 
adjustment is indicated, the interim rate of payment will be adjusted in 
line with the provider's cost experience.
    (e) Interim payments after initial reporting period. Interim rates 
of payment for services provided after the initial reporting period will 
be established on the basis of the cost report filed for the previous 
year covering Medicare services. The current rate will be determined--
whether on a per diem or percentage of charges basis--using the previous 
year's costs of covered services and making any appropriate adjustments 
required to bring, as closely as possible, the current year's rate of 
interim payment into agreement with current year's costs. This interim 
rate of payment may be adjusted by the contractor during an accounting 
period if the provider submits appropriate evidence that its actual 
costs are or will be significantly higher than the computed rate. 
Likewise, the contractor may adjust the interim rate of payment if it 
has evidence that actual costs may fall significantly below the computed 
rate.
    (f) Retroactive adjustment. (1) Medicare provides that providers of 
services will be paid amounts determined to be due, but not less often 
than monthly, with necessary adjustments due to previously made 
overpayments or underpayments. Interim payments are made on the basis of 
estimated costs. Actual costs reimbursable to a provider cannot be 
determined until the cost reports are filed and costs are verified. 
Therefore, a retroactive adjustment will be made at the end of the 
reporting period to bring the interim payments made to the provider 
during the period into agreement with the reimbursable amount payable to 
the provider for the services furnished to program beneficiaries during 
that period.
    (2) In order to reimburse the provider as quickly as possible, an 
initial retroactive adjustment will be made as soon as the cost report 
is received. For this purpose, the costs will be accepted as reported, 
unless there are obvious errors or inconsistencies, subject to later 
audit. When an audit is made and the final liability of the program is 
determined, a final adjustment will be made.
    (3) To determine the retroactive adjustment, the amount of the 
provider's total allowable cost apportioned to the program for the 
reporting year is computed. This is the total amount of reimbursement 
the provider is due to receive from the program and the beneficiaries 
for covered services furnished during the reporting period. The total of 
the interim payments made by the program in the reporting year and the 
deductibles and coinsurance amounts receivable from beneficiaries is 
computed. The difference between the reimbursement due and the payments 
made is the amount of the retroactive adjustment.
    (g) Accelerated payments to providers. Upon request, an accelerated 
payment may be made to a provider of services that is not receiving 
periodic interim payments under paragraph (h) of this section if the 
provider has experienced financial difficulties due to a delay by the 
contractor in making payments or in exceptional situations, in which the 
provider has experienced a temporary delay in preparing and submitting 
bills to the contractor beyond its normal billing cycle. Any such 
payment must be approved first by the contractor and then by CMS. The 
amount of the payment is computed as a percentage of the net 
reimbursement for unbilled or unpaid covered services. Recovery of the 
accelerated payment may be made by recoupment as provider bills are 
processed or by direct payment.
    (h) Periodic interim payment method of reimbursement--(1) Covered 
services furnished before July 1, 1987. In addition to the regular 
methods of interim payment on individual provider billings for covered 
services, the periodic interim payment (PIP) method is available for 
Part A hospital and SNF inpatient services.
    (2) Covered services furnished on or after July 1, 1987. Effective 
with claims received on or after July l, 1987, or as

[[Page 844]]

otherwise specified, the periodic interim payment (PIP) method is 
available for the following:
    (i) Part A inpatient services furnished in hospitals that are 
excluded from the prospective payment systems, as specified in Sec.  
412.1(a)(1) of this chapter under subpart B of part 412 of this 
subchapter, or are paid under the prospective payment systems described 
in subpart N, O, and P of part 412 of this chapter.
    (ii) Part A services furnished in hospitals receiving payment in 
accordance with a demonstration project authorized under section 402(a) 
of Public Law 90-248 (42 U.S.C. 1395b-1) or section 222(a) of Public Law 
92-603 (42 U.S.C. 1395b-1 (note)), or a State reimbursement control 
system approved under section 1886(c) of the Act and subpart C of part 
403 of this chapter, if that type of payment is specifically approved by 
CMS as an integral part of the demonstration or control system. If that 
type of payment is not an integral part of the demonstration or control 
system, PIP is available for the hospital under paragraph (h)(1)(i) of 
this section for hospitals excluded from the prospective payment systems 
or under Sec.  412.116(b) of this chapter for prospective payment 
hospitals.
    (iii) Part A SNF services furnished in cost reporting periods 
beginning before July 1, 1998. (For services furnished in subsequent 
cost reporting periods, see Sec.  413.350 regarding periodic interim 
payments for skilled nursing facilities).
    (iv) Part A services furnished in hospitals paid under the 
prospective payment system, including distinct part psychiatric or 
rehabilitation units, as described in Sec.  412.116(b) of this chapter.
    (v) Services furnished in a hospice as specified in part 418 of this 
chapter. Payment on a PIP basis is described in Sec.  418.307 of this 
chapter.
    (vi) Effective for payments made on or after July 1, 2004, inpatient 
CAH services furnished by a CAH as specified in Sec.  413.70. Payment on 
a PIP basis is described in Sec.  413.70(d).
    (3) Any participating provider furnishing the services described in 
paragraphs (h)(1) and (h)(2) of this section that establishes to the 
satisfaction of the contractor that it meets the following requirements 
may elect to be reimbursed under the PIP method, beginning with the 
first month after its request that the contractor finds administratively 
feasible:
    (i) The provider's estimated total Medicare reimbursement for 
inpatient services is at least $25,000 a year computed under the PIP 
formula or, in the case of an HHA, either its estimated--
    (A) Total Medicare reimbursement for Part A and Part B services is 
at least $25,000 a year computed under the PIP formula; or
    (B) Medicare reimbursement computed under the PIP formula is at 
least 50 percent of estimated total allowable cost.
    (ii) The provider has filed at least one completed Medicare cost 
report accepted by the contractor as providing an accurate basis for 
computation of program payment (except in the case of a provider 
requesting reimbursement under the PIP method upon first entering the 
Medicare program).
    (iii) The provider has the continuing capability of maintaining in 
its records the cost, charge, and statistical data needed to accurately 
complete a Medicare cost report on a timely basis.
    (4) [Reserved]
    (5) The contractor's approval of a provider's request for 
reimbursement under the PIP method will be conditioned upon the 
contractor's best judgment as to whether payment can be made to the 
provider under the PIP method without undue risk of its resulting in an 
overpayment because of greatly varying or substantially declining 
Medicare utilization, inadequate billing practices, or other 
circumstances. The contractor may terminate PIP reimbursement to a 
provider at any time it determines that the provider no longer meets the 
qualifying requirements or that the provider's experience under the PIP 
method shows that proper payment cannot be made under this method.
    (6) Payment will be made biweekly under the PIP method unless the 
provider requests a longer fixed interval (not to exceed one month) 
between payments. The payment amount will be computed by the contractor 
to approximate, on the average, the cost of covered inpatient or home 
health services furnished by the provider during

[[Page 845]]

the period for which the payment is to be made, and each payment will be 
made two weeks after the end of such period of services. Upon request, 
the contractor will, if feasible, compute the provider's payments to 
recognize significant seasonal variation in Medicare utilization of 
services on a quarterly basis starting with the beginning of the 
provider's reporting year.
    (7) A provider's PIP amount may be appropriately adjusted at any 
time if the provider presents or the contractor otherwise obtains 
evidence relating to the provider's costs or Medicare utilization that 
warrants such adjustment. In addition, the contractor will recompute the 
payment immediately upon completion of the desk review of a provider's 
cost report and also at regular intervals not less often than quarterly. 
The contractor may make a retroactive lump sum interim payment to a 
provider, based upon an increase in its PIP amount, in order to bring 
past interim payments for the provider's current cost reporting period 
into line with the adjusted payment amount. The objective of contractor 
monitoring of provider costs and utilization is to assure payments 
approximating, as closely as possible, the reimbursement to be 
determined at settlement for the cost reporting period. A significant 
factor in evaluating the amount of the payment in terms of the 
realization of the projected Medicare utilization of services is the 
timely submittal to the contractor of completed admission and billing 
forms. All providers must complete billings in detail under this method 
as under regular interim payment procedures.
    (i) Bankruptcy or insolvency of provider. If on the basis of 
reliable evidence, the contractor has a valid basis for believing that, 
with respect to a provider, proceedings have been or will shortly be 
instituted in a State or Federal court for purposes of determining 
whether such provider is insolvent or bankrupt under an appropriate 
State or Federal law, any payments to the provider will be adjusted by 
the contractor, notwithstanding any other regulation or program 
instruction regarding the timing or manner of such adjustments, to a 
level necessary to insure that no overpayment to the provider is made.
    (j) Interest payments resulting from judicial review--(1) 
Application. If a provider of services seeks judicial review by a 
Federal court (see Sec.  405.1877 of this chapter) of a decision 
furnished by the Provider Reimbursement Review Board or subsequent 
reversal, affirmation, or modification by the Secretary, the amount of 
any award of such Federal court will be increased by interest payable by 
the party against whom the judgment is made (see Sec.  413.153 for 
treatment of interest). The interest begins to accrue on the first day 
of the first month following the 180-day period described in Sec.  
405.1835(a)(3)(i) or (a)(3)(ii) of this chapter, as applicable.
    (2) Amount due. Section 1878(f) of the Act, 42 U.S.C. 1395oo(f), 
authorizes a court to award interest in favor of the prevailing party on 
any amount due as a result of the court's decision. If the contractor 
withheld any portion of the amount in controversy prior to the date the 
provider seeks judicial review by a Federal court, and the Medicare 
program is the prevailing party, interest is payable by the provider 
only on the amount not withheld. Similarly, if the Medicare program 
seeks to recover amounts previously paid to a provider, and the provider 
is the prevailing party, interest on the amounts previously paid to a 
provider is not payable by the Medicare program since that amount had 
been paid and is not due the provider.
    (3) Rate. The amount of interest to be paid is equal to the rate of 
return on equity capital (see Sec.  413.157) in effect for the month in 
which the civil action is commenced.

    Example: An contractor made a final determination on the amount of 
Medicare program reimbursement on June 15, 1974, and the provider 
appealed that determination to the Provider Reimbursement Review Board. 
The Board heard the appeal and rendered a decision adverse to the 
provider. On October 28, 1974, the provider commenced civil action to 
have such decision reviewed. The rate of return on equity capital for 
the month of October 1974 was 11.625 percent. The period for

[[Page 846]]

which interest is computed begins on January 1, 1975, and the interest 
beginning January 1, 1975, would be at the rate of 11.625 percent per 
annum.

[51 FR 34793, Sept. 30, 1986, as amended at 51 FR 42238, Nov. 24, 1986; 
53 FR 1628, Jan. 21, 1988; 57 FR 39830, Sept. 1, 1992; 59 FR 36713, July 
19, 1994; 64 FR 41682, July 30, 1999; 65 FR 41211, July 3, 2000; 66 FR 
41394, Aug. 7, 2001; 67 FR 56056, Aug. 30, 2002; 69 FR 49252, Aug. 11, 
2004; 69 FR 66981, Nov. 15, 2004; 73 FR 30267, May 23, 2008]



Sec.  413.65  Requirements for a determination that a facility 
or an organization has provider-based status.

    (a) Scope and definitions. (1) Scope. (i) This section applies to 
all facilities for which provider-based status is sought, including 
remote locations of hospitals, as defined in paragraph (a)(2) of this 
section and satellite facilities as defined in Sec. Sec.  412.22(h)(1) 
and 412.25(e)(1) of this chapter, other than facilities described in 
paragraph (a)(1)(ii) of this section.
    (ii) The determinations of provider-based status for payment 
purposes described in this section are not made as to whether the 
following facilities are provider-based:
    (A) Ambulatory surgical centers (ASCs).
    (B) Comprehensive outpatient rehabilitation facilities (CORFs).
    (C) Home health agencies (HHAs).
    (D) Skilled nursing facilities (SNFs) (determinations for SNFs are 
made in accordance with the criteria set forth in Sec.  483.5 of this 
chapter).
    (E) Hospices.
    (F) Inpatient rehabilitation units that are excluded from the 
inpatient PPS for acute hospital services.
    (G) Independent diagnostic testing facilities furnishing only 
services paid under a fee schedule, such as facilities that furnish only 
screening mammography services (as defined in section 1861(jj) of the 
Act), facilities that furnish only clinical diagnostic laboratory tests, 
other than those clinical diagnostic laboratories operating as parts of 
CAHs on or after October 1, 2010, or facilities that furnish only some 
combination of these services.
    (H) Facilities, other than those operating as parts of CAHs, 
furnishing only physical, occupational, or speech therapy to ambulatory 
patients, throughout any period during which the annual financial cap 
amount on payment for coverage of physical, occupational, or speech 
therapy, as described in section 1833(g)(2) of the Act, is suspended by 
legislation.
    (I) ESRD facilities (determinations for ESRD facilities are made 
under Sec.  413.174 of this chapter).
    (J) Departments of providers that perform functions necessary for 
the successful operation of the providers but do not furnish services of 
a type for which separate payment could be claimed under Medicare or 
Medicaid (for example, laundry or medical records departments).
    (K) Ambulances.
    (L) Rural health clinics (RHCs) affiliated with hospitals having 50 
or more beds.
    (2) Definitions. In this subpart E, unless the context indicates 
otherwise--
    Campus means the physical area immediately adjacent to the 
provider's main buildings, other areas and structures that are not 
strictly contiguous to the main buildings but are located within 250 
yards of the main buildings, and any other areas determined on an 
individual case basis, by the CMS regional office, to be part of the 
provider's campus.
    Department of a provider means a facility or organization that is 
either created by, or acquired by, a main provider for the purpose of 
furnishing health care services of the same type as those furnished by 
the main provider under the name, ownership, and financial and 
administrative control of the main provider, in accordance with the 
provisions of this section. A department of a provider comprises both 
the specific physical facility that serves as the site of services of a 
type for which payment could be claimed under the Medicare or Medicaid 
program, and the personnel and equipment needed to deliver the services 
at that facility. A department of a provider may not by itself be 
qualified to participate in Medicare as a provider under Sec.  489.2 of 
this chapter, and the Medicare conditions of participation do not apply 
to a department as an independent entity. For purposes of this part, the 
term ``department of a provider'' does not include an RHC or, except as 
specified

[[Page 847]]

in paragraph (n) of this section, an FQHC.
    Free-standing facility means an entity that furnishes health care 
services to Medicare beneficiaries and that is not integrated with any 
other entity as a main provider, a department of a provider, remote 
location of a hospital, satellite facility, or a provider-based entity.
    Main provider means a provider that either creates, or acquires 
ownership of, another entity to deliver additional health care services 
under its name, ownership, and financial and administrative control.
    Provider-based entity means a provider of health care services, or 
an RHC as defined in Sec.  405.2401(b) of this chapter, that is either 
created by, or acquired by, a main provider for the purpose of 
furnishing health care services of a different type from those of the 
main provider under the ownership and administrative and financial 
control of the main provider, in accordance with the provisions of this 
section. A provider-based entity comprises both the specific physical 
facility that serves as the site of services of a type for which payment 
could be claimed under the Medicare or Medicaid program, and the 
personnel and equipment needed to deliver the services at that facility. 
A provider-based entity may, by itself, be qualified to participate in 
Medicare as a provider under Sec.  489.2 of this chapter, and the 
Medicare conditions of participation do apply to a provider-based entity 
as an independent entity.
    Provider-based status means the relationship between a main provider 
and a provider-based entity or a department of a provider, remote 
location of a hospital, or satellite facility, that complies with the 
provisions of this section.
    Remote location of a hospital means a facility or an organization 
that is either created by, or acquired by, a hospital that is a main 
provider for the purpose of furnishing inpatient hospital services under 
the name, ownership, and financial and administrative control of the 
main provider, in accordance with the provisions of this section. A 
remote location of a hospital comprises both the specific physical 
facility that serves as the site of services for which separate payment 
could be claimed under the Medicare or Medicaid program, and the 
personnel and equipment needed to deliver the services at that facility. 
The Medicare conditions of participation do not apply to a remote 
location of a hospital as an independent entity. For purposes of this 
part, the term ``remote location of a hospital'' does not include a 
satellite facility as defined in Sec. Sec.  412.22(h)(1) and 
412.25(e)(1) of this chapter.
    (b) Provider-based determinations. (1) A facility or organization is 
not entitled to be treated as provider-based simply because it or the 
main provider believe it is provider-based.
    (2) If a facility was treated as provider-based in relation to a 
hospital or CAH on October 1, 2000, it will continue to be considered 
provider-based in relation to that hospital or CAH until the start of 
the hospital's first cost reporting period beginning on or after July 1, 
2003. The requirements, limitations, and exclusions specified in 
paragraphs (d), (e), (f), (h), and (i) of this section will not apply to 
that hospital or CAH until the start of the hospital's first cost 
reporting period beginning on or after July 1, 2003. For purposes of 
this paragraph (b)(2), a facility is considered as provider-based on 
October 1, 2000 if, on that date, it either had a written determination 
from CMS that it was provider-based, or was billing and being paid as a 
provider-based department or entity of the hospital.
    (3)(i) Except as specified in paragraphs (b)(2) and (b)(5) of this 
section, if a potential main provider seeks a determination of provider-
based status for a facility that is located on the campus of the 
potential main provider, the provider would be required to submit an 
attestation stating that the facility meets the criteria in paragraph 
(d) of this section and, if it is a hospital, also attest that it will 
fulfill the obligations of hospital outpatient departments and hospital-
based entities described in paragraph (g) of this section. The provider 
seeking such a determination would also be required to maintain 
documentation of the basis for its attestations and to make that 
documentation available to CMS and to CMS contractors upon request. If

[[Page 848]]

the facility is operated as a joint venture, the provider would also 
have to attest that it will comply with the requirements of paragraph 
(f) of this section.
    (ii) If the facility is not located on the campus of the potential 
main provider, the provider seeking a determination would be required to 
submit an attestation stating that the facility meets the criteria in 
paragraphs (d) and (e) of this section, and if the facility is operated 
under a management contract, the requirements of paragraph (h) of this 
section. If the potential main provider is a hospital, the hospital also 
would be required to attest that it will fulfill the obligations of 
hospital outpatient departments and hospital-based entities described in 
paragraph (g) of this section. The provider would be required to supply 
documentation of the basis for its attestations to CMS at the time it 
submits its attestations.
    (iii) Whenever a provider submits an attestation of provider-based 
status for an on-campus facility or organization, as described in 
paragraph (b)(3)(i) of this section, CMS will send the provider written 
acknowledgment of receipt of the attestation, review the attestation for 
completeness, consistency with the criteria in this section, and 
consistency with information in the possession of CMS at the time the 
attestation is received, and make a determination as to whether the 
facility or organization is provider-based.
    (iv) Whenever a provider submits an attestation of provider-based 
status for an off-campus facility or organization, as described in 
paragraph (b)(3)(ii) of this section, CMS will send the provider written 
acknowledgment of receipt of the attestation, review the attestation for 
completeness, consistency with the criteria in this section, consistency 
with the documentation submitted with the attestation and consistency 
with information in the possession of CMS at the time the attestation is 
received, and make a determination as to whether the facility or 
organization is provider-based.
    (4) A facility that is not located on the campus of a hospital and 
that is used as a site where physician services of the kind ordinarily 
furnished in physician offices are furnished is presumed as a free-
standing facility, unless CMS determines the facility has provider-based 
status.
    (5) A facility that has requested provider-based status in relation 
to a hospital or CAH on or after October 1, 2000 and before October 1, 
2002 will be treated as provider-based in relation to the hospital or 
CAH from the first date on or after October 1, 2000 on which the 
facility was licensed (to the extent required by the State), staffed and 
equipped to treat patients until the date on which CMS determines that 
the facility does not qualify for provider-based status.
    (c) Reporting of material changes in relationships. A main provider 
that has had one or more facilities or organizations considered 
provider-based also may report to CMS any material change in the 
relationship between it and any provider-based facility or organization, 
such as a change in ownership of the facility or organization or entry 
into a new or different management contract that would affect the 
provider-based status of the facility or organization.
    (d) Requirements applicable to all facilities or organizations. Any 
facility or organization for which provider-based status is sought, 
whether located on or off the campus of a potential main provider, must 
meet all of the following requirements to be determined by CMS to have 
provider-based status:
    (1) Licensure. The department of the provider, the remote location 
of a hospital, or the satellite facility and the main provider are 
operated under the same license, except in areas where the State 
requires a separate license for the department of the provider, the 
remote location of a hospital, or the satellite facility, or in States 
where State law does not permit licensure of the provider and the 
prospective department of the provider, the remote location of a 
hospital, or the satellite facility under a single license. If a State 
health facilities' cost review commission or other agency that has 
authority to regulate the rates charged by hospitals or other providers 
in a State finds that a particular facility or organization is not part 
of a provider, CMS

[[Page 849]]

will determine that the facility or organization does not have provider-
based status.
    (2) Clinical services. The clinical services of the facility or 
organization seeking provider-based status and the main provider are 
integrated as evidenced by the following:
    (i) Professional staff of the facility or organization have clinical 
privileges at the main provider.
    (ii) The main provider maintains the same monitoring and oversight 
of the facility or organization as it does for any other department of 
the provider.
    (iii) The medical director of the facility or organization seeking 
provider-based status maintains a reporting relationship with the chief 
medical officer or other similar official of the main provider that has 
the same frequency, intensity, and level of accountability that exists 
in the relationship between the medical director of a department of the 
main provider and the chief medical officer or other similar official of 
the main provider, and is under the same type of supervision and 
accountability as any other director, medical or otherwise, of the main 
provider.
    (iv) Medical staff committees or other professional committees at 
the main provider are responsible for medical activities in the facility 
or organization, including quality assurance, utilization review, and 
the coordination and integration of services, to the extent practicable, 
between the facility or organization seeking provider-based status and 
the main provider.
    (v) Medical records for patients treated in the facility or 
organization are integrated into a unified retrieval system (or cross 
reference) of the main provider.
    (vi) Inpatient and outpatient services of the facility or 
organization and the main provider are integrated, and patients treated 
at the facility or organization who require further care have full 
access to all services of the main provider and are referred where 
appropriate to the corresponding inpatient or outpatient department or 
service of the main provider.
    (3) Financial integration. The financial operations of the facility 
or organization are fully integrated within the financial system of the 
main provider, as evidenced by shared income and expenses between the 
main provider and the facility or organization. The costs of a facility 
or organization that is a hospital department are reported in a cost 
center of the provider, costs of a provider-based facility or 
organization other than a hospital department are reported in the 
appropriate cost center or cost centers of the main provider, and the 
financial status of any provider-based facility or organization is 
incorporated and readily identified in the main provider's trial 
balance.
    (4) Public awareness. The facility or organization seeking status as 
a department of a provider, a remote location of a hospital, or a 
satellite facility is held out to the public and other payers as part of 
the main provider. When patients enter the provider-based facility or 
organization, they are aware that they are entering the main provider 
and are billed accordingly.
    (5) Obligations of hospital outpatient departments and hospital-
based entities. In the case of a hospital outpatient department or a 
hospital-based entity, the facility or organization must fulfill the 
obligations of hospital outpatient departments and hospital-based 
entities described in paragraph (g) of this section.
    (e) Additional requirements applicable to off-campus facilities or 
organizations. Except as described in paragraphs (b)(2) and (b)(5) of 
this section, any facility or organization for which provider-based 
status is sought that is not located on the campus of a potential main 
provider must meet both the requirements in paragraph (d) of this 
section and all of the following additional requirements, in order to be 
determined by CMS to have provider-based status.
    (1) Operation under the ownership and control of the main provider. 
The facility or organization seeking provider-based status is operated 
under the ownership and control of the main provider, as evidenced by 
the following:
    (i) The business enterprise that constitutes the facility or 
organization is 100 percent owned by the main provider.
    (ii) The main provider and the facility or organization seeking 
status as a

[[Page 850]]

department of the main provider, a remote location of a hospital, or a 
satellite facility have the same governing body.
    (iii) The facility or organization is operated under the same 
organizational documents as the main provider. For example, the facility 
or organization seeking provider-based status must be subject to common 
bylaws and operating decisions of the governing body of the main 
provider where it is based.
    (iv) The main provider has final responsibility for administrative 
decisions, final approval for contracts with outside parties, final 
approval for personnel actions, final responsibility for personnel 
policies (such as fringe benefits or code of conduct), and final 
approval for medical staff appointments in the facility or organization.
    (2) Administration and supervision. The reporting relationship 
between the facility or organization seeking provider-based status and 
the main provider must have the same frequency, intensity, and level of 
accountability that exists in the relationship between the main provider 
and one of its existing departments, as evidenced by compliance with all 
of the following requirements:
    (i) The facility or organization is under the direct supervision of 
the main provider.
    (ii) The facility or organization is operated under the same 
monitoring and oversight by the provider as any other department of the 
provider, and is operated just as any other department of the provider 
with regard to supervision and accountability. The facility or 
organization director or individual responsible for daily operations at 
the entity--
    (A) Maintains a reporting relationship with a manager at the main 
provider that has the same frequency, intensity, and level of 
accountability that exists in the relationship between the main provider 
and its existing departments; and
    (B) Is accountable to the governing body of the main provider, in 
the same manner as any department head of the provider.
    (iii) The following administrative functions of the facility or 
organization are integrated with those of the provider where the 
facility or organization is based: billing services, records, human 
resources, payroll, employee benefit package, salary structure, and 
purchasing services. Either the same employees or group of employees 
handle these administrative functions for the facility or organization 
and the main provider, or the administrative functions for both the 
facility or organization and the entity are--
    (A) Contracted out under the same contract agreement; or
    (B) Handled under different contract agreements, with the contract 
of the facility or organization being managed by the main provider.
    (3) Location. The facility or organization meets the requirements in 
paragraph (e)(3)(i), (e)(3)(ii), (e)(3)(iii), (e)(3)(iv), (e)(3)(v), or, 
in the case of an RHC, paragraph (e)(3)(vi) of this section, and the 
requirements in paragraph (e)(3)(vii) of this section.
    (i) The facility or organization is located within a 35-mile radius 
of the campus of the hospital or CAH that is the potential main 
provider.
    (ii) The facility or organization is owned and operated by a 
hospital or CAH that has a disproportionate share adjustment (as 
determined under Sec.  412.106 of this chapter) greater than 11.75 
percent or is described in Sec.  412.106(c)(2) of this chapter 
implementing section 1886(d)(5)(F)(i)(II) of the Act and is--
    (A) Owned or operated by a unit of State or local government;
    (B) A public or nonprofit corporation that is formally granted 
governmental powers by a unit of State or local government; or
    (C) A private hospital that has a contract with a State or local 
government that includes the operation of clinics located off the main 
campus of the hospital to assure access in a well-defined service area 
to health care services for low-income individuals who are not entitled 
to benefits under Medicare (or medical assistance under a Medicaid State 
plan).
    (iii) The facility or organization demonstrates a high level of 
integration with the main provider by showing that it meets all of the 
other provider-based criteria and demonstrates that it

[[Page 851]]

serves the same patient population as the main provider, by submitting 
records showing that, during the 12-month period immediately preceding 
the first day of the month in which the application for provider-based 
status is filed with CMS, and for each subsequent 12-month period--
    (A) At least 75 percent of the patients served by the facility or 
organization reside in the same zip code areas as at least 75 percent of 
the patients served by the main provider; or
    (B) At least 75 percent of the patients served by the facility or 
organization who required the type of care furnished by the main 
provider received that care from that provider (for example, at least 75 
percent of the patients of an RHC seeking provider-based status received 
inpatient hospital services from the hospital that is the main 
provider).
    (iv) If the facility or organization is unable to meet the criteria 
in paragraph (e)(3)(iii)(A) or paragraph (e)(3)(iii)(B) of this section 
because it was not in operation during all of the 12-month period 
described in paragraph (e)(3)(iii) of this section, the facility or 
organization is located in a zip code area included among those that, 
during all of the 12-month period described in paragraph (e)(3)(iii) of 
this section, accounted for at least 75 percent of the patients served 
by the main provider.
    (v) The facility or organization meets all of the following 
criteria:
    (A) The facility or organization is seeking provider-based status 
with respect to a hospital that meets the criteria in Sec.  412.23(d) 
for reimbursement under Medicare as a children's hospital;
    (B) The facility or organization meets the criteria for identifying 
intensive care type units set forth in the Medicare reasonable cost 
reimbursement regulations under Sec.  413.53(d).
    (C) The facility or organization accepts only patients who are 
newborn infants who require intensive care on an inpatient basis.
    (D) The hospital in which the facility or organization is physically 
located is in a rural area as defined in Sec.  412.64(b)(1)(ii)(C) of 
this chapter.
    (E) The facility or organization is located within a 100-mile radius 
of the children's hospital that is the potential main provider.
    (F) The facility or organization is located at least 35 miles from 
the nearest other neonatal intensive care unit.
    (G) The facility or organization meets all other requirements for 
provider-based status under this section.
    (vi) Both of the following criteria are met:
    (A) The facility or organization is an RHC that is otherwise 
qualified as a provider-based entity of a hospital that has fewer than 
50 beds, as determined under Sec.  412.105(b) of this chapter; and
    (B) The hospital with which the facility or organization has a 
provider-based relationship is located in a rural area, as defined in 
Sec.  412.64(b)(1)(ii)(C) of this subchapter.
    (vii) A facility or organization may qualify for provider-based 
status under this section only if the facility or organization and the 
main provider are located in the same State or, when consistent with the 
laws of both States, in adjacent States.
    (f) Provider-based status for joint ventures. In order for a 
facility or organization operated as a joint venture to be considered 
provider-based, the facility or organization must--
    (1) Be partially owned by at least one provider'
    (2) Be located on the main campus of a provider who is a partial 
owner;
    (3) Be provider-based to that one provider whose campus on which the 
facility or organization is located; and
    (4) Also meet all the requirements applicable to all provider-based 
facilities and organizations in paragraph (d) of this section. For 
example, where a provider has jointly purchased or jointly created a 
facility under joint venture arrangements with one or more other 
providers, and the facility is not located on the campus of the provider 
or the campus of any other provider engaged in the joint venture 
arrangement, no party to the joint venture arrangement can claim the 
facility as provider-based.
    (g) Obligations of hospital outpatient departments and hospital-
based entities. To qualify for provider-based status in relation to a 
hospital, a facility or organization must comply with the following 
requirements:

[[Page 852]]

    (1) The following departments must comply with the antidumping rules 
of Sec. Sec.  489.20(l), (m), (q), and (r) and 489.24 of this chapter:
    (i) Any facility or organization that is located on the main 
hospital campus and is treated by Medicare under this section as a 
department of the hospital; and
    (ii) Any facility or organization that is located off the main 
hospital campus that is treated by Medicare under this section as a 
department of the hospital and is a dedicated emergency department, as 
defined in Sec.  489.24(b) of this chapter.
    (2) Physician services furnished in hospital outpatient departments 
or hospital-based entities (other than RHCs) must be billed with the 
correct site-of-service so that appropriate physician and practitioner 
payment amounts can be determined under the rules of Part 414 of this 
chapter.
    (3) Hospital outpatient departments must comply with all the terms 
of the hospital's provider agreement.
    (4) Physicians who work in hospital outpatient departments or 
hospital-based entities are obligated to comply with the non-
discrimination provisions in Sec.  489.10(b) of this chapter.
    (5) Hospital outpatient departments (other than RHCs) must treat all 
Medicare patients, for billing purposes, as hospital outpatients. The 
department must not treat some Medicare patients as hospital outpatients 
and others as physician office patients.
    (6) In the case of a patient admitted to the hospital as an 
inpatient after receiving treatment in the hospital outpatient 
department or hospital-based entity, payments for services in the 
hospital outpatient department or hospital-based entity are subject to 
the payment window provisions applicable to PPS hospitals and to 
hospitals and units excluded from PPS set forth at Sec.  412.2(c)(5) of 
this chapter and at Sec.  413.40(c)(2), respectively.
    (7) When a Medicare beneficiary is treated in a hospital outpatient 
department that is not located on the main provider's campus, the 
treatment is not required to be provided by the antidumping rules in 
Sec.  489.24 of this chapter, and the beneficiary will incur a 
coinsurance liability for an outpatient visit to the hospital as well as 
for the physician service, the following requirements must be met:
    (i) The hospital must provide written notice to the beneficiary, 
before the delivery of services, of--
    (A) The amount of the beneficiary's potential financial liability; 
or
    (B) If the exact type and extent of care needed are not known, an 
explanation that the beneficiary will incur a coinsurance liability to 
the hospital that he or she would not incur if the facility were not 
provider-based, an estimate based on typical or average charges for 
visits to the facility, and a statement that the patient's actual 
liability will depend upon the actual services furnished by the 
hospital.
    (ii) The notice must be one that the beneficiary can read and 
understand.
    (iii) If the beneficiary is unconscious, under great duress, or for 
any other reason unable to read a written notice and understand and act 
on his or her own rights, the notice must be provided, before the 
delivery of services, to the beneficiary's authorized representative.
    (iv) In cases where a hospital outpatient department provides 
examination or treatment that is required to be provided by the 
antidumping rules of Sec.  489.24 of this chapter, notice, as described 
in this paragraph (g)(7), must be given as soon as possible after the 
existence of an emergency has been ruled out or the emergency condition 
has been stabilized.
    (8) Hospital outpatient departments must meet applicable hospital 
health and safety rules for Medicare-participating hospitals in part 482 
of this chapter.
    (h) Management contracts. A facility or organization that is not 
located on the campus of the potential main provider and otherwise meets 
the requirements of paragraphs (d) and (e) of this section, but is 
operated under management contracts, must also meet all of the following 
criteria:
    (1) The main provider (or an organization that also employs the 
staff of the main provider and that is not the management company) 
employs the staff of the facility or organization who are directly 
involved in the delivery of patient care, except for management

[[Page 853]]

staff and staff who furnish patient care services of a type that would 
be paid for by Medicare under a fee schedule established by regulations 
at part 414 of this chapter. Other than staff that may be paid under 
such a Medicare fee schedule, the main provider may not utilize the 
services of ``leased'' employees (that is, personnel who are actually 
employed by the management company but provide services for the provider 
under a staff leasing or similar agreement) that are directly involved 
in the delivery of patient care.
    (2) The administrative functions of the facility or organization are 
integrated with those of the main provider, as determined under criteria 
in paragraph (e)(2)(iii) of this section.
    (3) The main provider has significant control over the operations of 
the facility or organization as determined under criteria in paragraph 
(e)(2)(ii) of this section.
    (4) The management contract is held by the main provider itself, not 
by a parent organization that has control over both the main provider 
and the facility or organization.
    (i) Furnishing all services under arrangement. A facility or 
organization may not qualify for provider-based status if all patient 
care services furnished at the facility or organization are furnished 
under arrangements.
    (j) Inappropriate treatment of a facility or organization as 
provider-based--(1) Determination and review. If CMS learns that a 
provider has treated a facility or organization as provider-based and 
the provider did not request a determination of provider-based status 
from CMS under paragraph (b)(3) of this section and CMS determines that 
the facility or organization did not meet the requirements for provider-
based status under paragraphs (d) through (i) of this section, as 
applicable (or, in any period before the effective date of these 
regulations, the provider-based requirements in effect under Medicare 
program regulations or instructions), CMS will--
    (i) Issue notice to the provider in accordance with paragraph (j)(3) 
of this section, adjust the amount of future payments to the provider 
for services of the facility or organization in accordance with 
paragraph (j)(4) of this section, and continue payments to the provider 
for services of the facility or organization only in accordance with 
paragraph (j)(5) of this section; and
    (ii) Except as otherwise provided in paragraphs (b)(2), (b)(5), or 
(j)(2) of this section, recover the difference between the amount of 
payments that actually was made and the amount of payments that CMS 
estimates should have been made, in the absence of compliance with the 
provider-based requirements, to that provider for services at the 
facility or organization for all cost reporting periods subject to 
reopening in accordance with Sec. Sec.  405.1885 and 405.1889 of this 
chapter.
    (2) Exception for good faith effort. CMS will not recover any 
payments for any period before the beginning of the hospital's first 
cost reporting period beginning on or after January 10, 2001, if, during 
all of that period--
    (i) The requirements regarding licensure and public awareness in 
paragraphs (d)(1) and (d)(4) of this section were met;
    (ii) All facility services were billed as if they had been furnished 
by a department of a provider, a remote location of a hospital, a 
satellite facility, or a provider-based entity of the main provider; and
    (iii) All professional services of physicians and other 
practitioners were billed with the correct site-of-service indicator, as 
described in paragraph (g)(2) of this section.
    (3) Notice to provider. If CMS determines that a facility or 
organization was inappropriately treated as provider-based, CMS will 
issue written notice to the provider that payments for past cost 
reporting periods may be reviewed and recovered as described in 
paragraph (j)(1)(ii) of this section, and that future payments for 
services in or of the facility or organization will be adjusted as 
described in paragraph (j)(4) of this section.
    (4) Adjustment of payments. If CMS determines that a facility or 
organization was inappropriately treated as provider-based, CMS will 
adjust future payments to the provider or the facility or organization, 
or both, to estimate the amounts that would be paid for the same 
services furnished by a freestanding facility.

[[Page 854]]

    (5) Continuation of payment. (i) The notice of denial of provider-
based status sent to the provider will ask the provider to notify CMS in 
writing, within 30 days of the date the notice is issued, of whether the 
provider intends to seek a determination of provider-based status for 
the facility or organization under this section or whether the facility 
or organization (or, where applicable, the practitioners who staff the 
facility or organization) will be seeking to enroll and meet other 
requirements to bill for services in a freestanding facility.
    (ii) If the provider indicates that it will not be seeking a 
determination for the facility or organization under this section or 
that the facility or organization or its practitioners will not be 
seeking to enroll, or if CMS does not receive a response within 30 days 
of the date the notice was issued, all payment under this paragraph 
(j)(5) will end as of the 30th day after the date of notice.
    (iii) If the provider indicates that it will be seeking a 
determination for the facility or organization under this section or 
that the facility or organization or its practitioners will be seeking 
to meet enrollment and other requirements for billing for services in a 
freestanding facility, payment for services of the facility or 
organization will continue, at the adjusted amounts described in 
paragraph (j)(4) of this section, for as long as is required for all 
billing requirements to be met (but not longer than 6 months) if the 
provider or the facility or organization or its practitioners--
    (A) Submits, as applicable, a complete request for a determination 
of provider-based status or a complete enrollment application and 
provide all other required information within 90 days after the date of 
notice; and
    (B) Furnishes all other information needed by CMS to make a 
determination regarding provider-based status or process the enrollment 
application, as applicable, and verifies that other billing requirements 
are met.
    (v) If the necessary applications or information are not provided, 
CMS will terminate all payment to the provider, facility, or 
organization as of the date CMS issues notice that necessary 
applications or information have not been submitted.
    (k) Temporary treatment as provider-based. If a provider submits a 
complete attestation of compliance with the requirements for provider-
based status for a facility or organization that has not previously been 
found by CMS to have been inappropriately treated as provider-based 
under paragraph (j) of this section, the provider may bill and be paid 
for services of the facility or organization as provider-based from the 
date it submits the attestation and any required supporting 
documentation until the date that CMS determines that the facility or 
organization does not meet the provider-based rules. If CMS subsequently 
determines that the requirements for provider-based status are not met, 
CMS will recover the difference between the amount of payments that 
actually was made since the date the complete attestation of compliance 
with provider-based requirements was submitted and the amount of 
payments that CMS estimates should have been made in the absence of 
compliance with the provider-based requirements. For purposes of this 
paragraph (k), a complete attestation of compliance with provider-based 
requirements is one that includes all information needed to permit CMS 
to make a determination under paragraph (b)(3) of this section.
    (l) Correction of errors. (1) If CMS determines that a facility or 
organization that had previously been determined to be provider-based 
under this section no longer qualifies for provider-based status, and 
the failure to qualify for provider-based status resulted from a 
material change in the relationship between the provider and the 
facility or organization that the provider did report to CMS under 
paragraph (c) of this section, treatment of the facility or organization 
as provider-based ceases with the date that CMS determines that the 
facility or organization no longer qualifies for provider-based status.
    (2) If CMS determines that a facility or organization that had 
previously been determined to be provider-based under this section no 
longer qualifies for provider-based status, and if the failure to 
qualify for provider-based

[[Page 855]]

status resulted from a material change in the relationship between the 
provider and the facility or organization that the provider did not 
report to CMS under paragraph (c) of this section, CMS will take the 
actions with respect to notice to the provider, adjustment of payments, 
and continuation of payment described in paragraphs (j)(3), (j)(4), and 
(j)(5) of this section, and will recover past payments to the provider 
to the extent described in paragraph (j)(1)(ii) of this section.
    (m) Status of Indian Health Service and Tribal facilities and 
organizations. Facilities and organizations operated by the Indian 
Health Services and Tribes will be considered to be departments of 
hospitals operated by the Indian Health Service or Tribes if they 
furnish only services that are billed, using the CCN of the main 
provider and with the consent of the main provider, as if they had been 
furnished by a department of a hospital operated by the Indian Health 
Service or a Tribe and they are:
    (1) Owned and operated by the Indian Health Service;
    (2) Owned by the Tribe but leased from the Tribe by the IHS under 
the Indian Self-Determination Act (Pub. L. 93-638) in accordance with 
applicable regulations and policies of the Indian Health Service in 
consultation with Tribes: or
    (3) Owned by the Indian Health Service but leased and operated by 
the Tribe under the Indian Self-Determination Act (Pub. L. 93-638) in 
accordance with applicable regulations and policies of the Indian Health 
Service in consultation with Tribes.
    (n) FQHCs and ``look alikes.'' A facility that has, since April 7, 
1995, furnished only services that were billed as if they had been 
furnished by a department of a provider will continue to be treated, for 
purposes of this section, as a department of the provider without regard 
to whether it complies with the criteria for provider-based status in 
this section, if the facility--
    (1) Received a grant on or before April 7, 2000 under section 330 of 
the Public Health Service Act and continues to receive funding under 
such a grant, or is receiving funding from a grant made on or before 
April 7, 2000 under section 330 of the Public Health Service Act under a 
contract with the beneficiary of such a grant, and continues to meet the 
requirements to receive a grant under section 330 of the Public Health 
Service Act; or
    (2) Based on the recommendation of the Public Health Service, was 
determined by CMS on or before April 7, 2000 to meet the requirements 
for receiving a grant under section 330 of the Public Health Service 
Act, and continues to meet such requirements.
    (o) Effective date of provider-based status--(1) General rule. 
Provider-based status for a facility or organization is effective on the 
earliest date all of the requirements of this part have been met.
    (2) Inappropriate treatment as provider-based or not reporting 
material change. Effective for any period on or after October 1, 2002 
(or, in the case of facilities or organizations described in paragraph 
(b)(2) of this section, for cost reporting periods starting on or after 
July 1, 2003), if a facility or organization is found by CMS to have 
been inappropriately treated as provider-based under paragraph (j) of 
this section for those periods, or previously was determined by CMS to 
be provider-based but no longer qualifies as provider-based because of a 
material change occurring during those periods that was not reported to 
CMS under paragraph (c) of this section, CMS will not treat the facility 
or organization as provider-based for payment purposes until CMS has 
determined, based on documentation submitted by the provider, that the 
facility or organization meets all requirements for provider-based 
status under this part

[65 FR 18538, Apr. 7, 2000, as amended at 65 FR 58920, Oct. 3, 2000; 66 
FR 1599, Jan. 9, 2001; 66 FR 59920, Nov. 30, 2001; 67 FR 50114, Aug. 1, 
2002; 68 FR 46070, Aug. 4, 2003; 68 FR 53261, Sept. 9, 2003; 70 FR 
47487, Aug. 12, 2005; 74 FR 44000, Aug. 27, 2009; 82 FR 38515, Aug. 14, 
2017]



Sec.  413.70  Payment for services of a CAH.

    (a) Payment for inpatient services furnished by a CAH (other than 
services of distinct part units). (1) Effective for cost reporting 
periods beginning on or after January 1, 2004, payment for inpatient 
services of a CAH, other than services of a distinct part unit of the 
CAH and

[[Page 856]]

other than the items included in the incentive payment described in 
paragraph (a)(5) of this section and subject to the adjustments 
described in paragraph (a)(6) of this section, is 101 percent of the 
reasonable costs of the CAH in providing CAH services to its inpatients, 
as determined in accordance with section 1861(v)(1)(A) of the Act and 
the applicable principles of cost reimbursement in this part and in part 
415 of this chapter, except that the following payment principles are 
excluded when determining payment for CAH inpatient services:
    (i) Lesser of cost or charges;
    (ii) Ceilings on hospital operating costs;
    (iii) Reasonable compensation equivalent (RCE) limits for physician 
services to providers; and
    (iv) The payment window provisions for preadmission services, 
specified in Sec.  412.2(c)(5) of this subchapter and Sec.  413.40(c)(2) 
of this part.
    (2) Except as specified in paragraph (a)(3) of this section, payment 
to a CAH for inpatient services does not include any costs of physician 
services or other professional services to CAH inpatients, and is 
subject to the Part A hospital deductible and coinsurance, as determined 
under subpart G of part 409 of this chapter.
    (3) If a CAH meets the criteria in Sec.  412.113(c) of this 
subchapter for pass-through of costs of anesthesia services furnished by 
qualified nonphysician anesthetists employed by the CAH or obtained 
under arrangements, payment to the CAH for the costs of those services 
is made in accordance with Sec.  412.113(c).
    (4) Payment for inpatient services of distinct part psychiatric or 
rehabilitation units is described in paragraph (e) of this section.
    (5) A qualifying CAH receives an incentive payment for the 
reasonable costs of purchasing certified EHR technology in a cost 
reporting period during a payment year as determined under Sec.  495.106 
of this chapter in lieu of payment for such reasonable costs under 
paragraph (a)(1) of this section.
    (6)(i) For cost reporting periods beginning in or after FY 2015, if 
a CAH is not a qualifying CAH for the applicable EHR reporting period, 
as defined in Sec. Sec.  495.4 and 495.106(a) of this chapter, then 
notwithstanding the percentage applicable in paragraph (a)(1) of this 
section, the reasonable costs of the CAH in providing CAH services to 
its inpatients are adjusted by the following applicable percentage:
    (A) For cost reporting periods beginning in FY 2015, 100.66 percent.
    (B) For cost reporting periods beginning in FY 2016, 100.33 percent.
    (C) For cost reporting periods beginning in FY 2017 and each 
subsequent fiscal year, 100 percent.
    (ii) The Secretary may on a case-by-case basis, exempt a CAH that is 
not a qualifying CAH from the application of the payment adjustment 
under paragraph (a)(6)(i) of this section if the Secretary determines 
that compliance with the requirement for being a meaningful user would 
result in a significant hardship for the CAH. In order to be considered 
for an exception, a CAH must submit an application demonstrating that it 
meets one or more of the criteria specified in this paragraph (a)(6) for 
the applicable payment adjustment year no later than November 30 after 
the close of the applicable EHR reporting period, or a later date 
specified by CMS. The Secretary may grant an exception for one or more 
of the following:
    (A) During any 90-day period from the beginning of the cost 
reporting period that begins in the fiscal year before the payment 
adjustment year to November 30 after the end of the payment adjustment 
year, or a later date specified by CMS, the hospital was located in an 
area without sufficient Internet access to comply with the meaningful 
use objectives requiring Internet connectivity, and faced insurmountable 
barriers to obtaining such Internet connectivity.
    (B) A CAH that faces extreme and uncontrollable circumstances that 
prevent it from becoming a meaningful EHR user during the payment 
adjustment year.
    (C) The CAH is new in the payment adjustment year and has not 
previously operated (under previous or present ownership). This 
exception expires beginning with the first Federal fiscal year that 
begins on or after the hospital has had at least one 12-month

[[Page 857]]

(or longer) cost reporting period after they accept their first 
Medicare-covered patient. For the purposes of this exception, the 
following CAHs are not considered new CAHs:
    (1) A CAH that builds new or replacement facilities at the same or 
another location even if coincidental with a change of ownership, a 
change in management, or a lease arrangement.
    (2) A CAH that closes and subsequently reopens.
    (3) A CAH that has been converted from an eligible hospital as 
defined at Sec.  495.4 of this chapter.
    (iii) Exception for decertified EHR technology. Beginning with the 
fiscal year 2018 payment adjustment year, the Secretary shall exempt a 
CAH that is not a qualifying CAH from the application of the payment 
adjustment under paragraph (a)(6)(i) of this section if the Secretary 
determines that compliance with the requirement for being a meaningful 
EHR user is not possible because the certified EHR technology used by 
the CAH has been decertified under ONC's Health IT Certification 
Program. In order to be considered for an exception, a CAH must submit 
an application, in the manner specified by CMS, demonstrating that the 
certified EHR technology was decertified during the 12-month period 
preceding the applicable EHR reporting period for the payment adjustment 
year, or during the applicable EHR reporting period for the payment 
adjustment year, and that the CAH made a good faith effort to obtain 
another certified EHR technology for that EHR reporting period. 
Applications requesting this exception must be submitted by November 30 
after the end of the applicable payment adjustment year, or a later date 
specified by CMS.
    (iv) Exceptions granted under paragraphs (a)(6)(ii) and (iii) of 
this section are subject to annual renewal, but in no case may a CAH be 
granted such an exception for more than 5 years.
    (7) There is no administrative or judicial review under section 
s1869 and 1878 of the Actor otherwise of the following:
    (i) The methodology and standards for determining the amount of 
payment under paragraph (a)(5) of this section, including the 
calculation of reasonable costs under Sec.  495.106(c) of this chapter.
    (ii) The methodology and standards for determining the amount of 
payment adjustments made under paragraph (a)(6).
    (iii) The methodology and standards for determining a CAH to be a 
qualifying CAH under Sec.  495.106 of this chapter.
    (iv) The methodology and standards for determining if the hardship 
exemption applies to a CAH under paragraph (a)(6)(ii) of this section.
    (v) The specification of the cost reporting periods, payment years, 
or fiscal years as applied under this paragraph.
    (b) Payment for outpatient services furnished by CAH--(1) General. 
(i) Unless the CAH elects to be paid for services to its outpatients 
under the method specified in paragraph (b)(3) of this section, the 
amount of payment for outpatient services of a CAH is determined under 
paragraph (b)(2) of this section.
    (ii) Except as specified in paragraph (b)(6) of this section, 
payment to a CAH for outpatient services does not include any costs of 
physician services or other professional services to CAH outpatients.
    (2) Reasonable costs for facility services. (i) Effective for cost 
reporting periods beginning on or after January 1, 2004, payment for 
outpatient services of a CAH is 101 percent of the reasonable costs of 
the CAH in providing CAH services to its outpatients, as determined in 
accordance with section 1861(v)(1)(A) of the Act and the applicable 
principles of cost reimbursement in this part and in part 415 of this 
chapter, except that the following payment principles are excluded when 
determining payment for CAH outpatient services:
    (A) Lesser of cost or charges; and
    (B) RCE limits.
    (ii) Payment to a CAH under paragraph (b)(2) of this section does 
not include any costs of physician services or other professional 
services to CAH outpatients and, other than for clinical diagnostic 
laboratory tests, is subject to the Part B deductible and coinsurance 
amounts as determined under Sec. Sec.  410.152(k), 410.160, and 410.161 
of this chapter.

[[Page 858]]

    (iii) [Reserved]
    (3) Election to be paid reasonable costs for facility services plus 
fee schedule for professional services. (i) A CAH may elect to be paid 
for outpatient services in any cost reporting period beginning on or 
after July 1, 2004 under the method described in paragraphs (b)(3)(ii) 
and (b)(3)(iii) of this section.
    (A)(1) For cost reporting periods beginning before October 1, 2010. 
The election must be made in writing, made on an annual basis, and 
delivered to the contractor or MAC servicing the CAH at least 30 days 
before the start of the cost reporting period for which the election is 
made. An election, once made for a cost reporting period, remains in 
effect for all of that period.
    (2) For cost reporting periods beginning on or after October 1, 
2010. If a CAH had elected the method specified in paragraph (b)(3)(i) 
of this section in its most recent cost reporting period beginning prior 
to October 1, 2010, that election remains in effect for all of that 
period and for all subsequent cost reporting periods, unless the CAH 
submits a termination request to the contractor or MAC servicing the CAH 
at least 30 days before the start of the next cost reporting period. 
However, for cost reporting periods beginning in October 2010 and 
November 2010, if a CAH wishes to terminate its previous election, the 
CAH must submit a termination request to the contractor or MAC servicing 
the CAH prior to December 1, 2010. If a CAH had no election in effect in 
its most recent preceding cost reporting period and chooses to elect the 
method specified in paragraph (b)(3)(i) of this section on or after 
October 1, 2010, the election must be made in writing and delivered to 
the contractor or MAC servicing the CAH at least 30 days before the 
start of the first cost reporting period for which the election is made. 
Once the election is made, it remains in effect for all of that period 
and for all subsequent cost reporting periods unless the CAH submits a 
termination request to the contractor or MAC servicing the CAH at least 
30 days before the start of the next cost reporting period.
    (B) An election of the payment method specified under paragraph 
(b)(3)(i) of this section applies to all services furnished to 
outpatients by a physician or other practitioner who has reassigned his 
or her rights to bill for those services to the CAH in accordance with 
subpart F of part 424 of this chapter. If a physician or other 
practitioner does not reassign his or her billing rights to the CAH in 
accordance with subpart F of part 424 of this chapter, payment for the 
physician's or practitioner's services furnished to CAH outpatients will 
be made on a fee schedule or other applicable basis as specified in 
subpart B of part 414 of this subchapter.
    (C) In the case of a CAH that made an election under this section 
before November 1, 2003, for a cost reporting period beginning before 
December 1, 2003, the rules in paragraph (b)(3)(i)(B) of this section 
are applicable to cost reporting periods beginning on or after July 1, 
2001.
    (D) An election made under paragraph (b)(3)(i) of this section is 
effective as provided for under paragraph (b)(3)(i)(A) or paragraph 
(b)(3)(i)(C) of this section and does not apply to an election that was 
terminated prior to the start of the cost reporting period for which it 
would otherwise apply.
    (ii) If the CAH elects payment under this method, payment to the CAH 
for each outpatient visit will be the sum of the following:
    (A) Effective for cost reporting periods beginning on or after 
January 1, 2004, for facility services not including any services for 
which payment may be made under paragraph (b)(3)(ii)(B) of this section, 
101 percent of the reasonable costs of the services as determined under 
paragraph (b)(2)(i) of this section; and
    (B) For professional services that are furnished by a physician or 
other practitioner who has reassigned his or her rights to bill for 
those services to the CAH in accordance with part 424, subpart F of this 
chapter, and that would otherwise be payable to the physician or other 
practitioner if the rights to bill for them had not been reassigned, 115 
percent of the amounts that otherwise would be paid for the service if 
the CAH had not elected payment under this method. Effective for primary 
care services furnished by primary care practitioners (as defined in 
Sec.  414.80(a))

[[Page 859]]

and major surgical procedures furnished by general surgeons in health 
professional shortage areas (as defined in Sec.  414.2) furnished on or 
after January 1, 2011 and before January 1, 2016, incentive payments 
specified under Sec.  414.80 and Sec.  414.67(b), respectively, of this 
title must not be included in determining payment made under this 
paragraph.
    (iii) Payment to a CAH, other than for clinical diagnostic 
laboratory tests, is subject to the Part B deductible and coinsurance 
amounts, as determined under Sec. Sec.  410.152(k), 410.160, and 410.161 
of this chapter.
    (4) Costs of certain emergency room on-call providers. (i) Effective 
for cost reporting periods beginning on or after October 1, 2001, the 
reasonable costs of outpatient CAH services under paragraph (b) of this 
section may include amounts for reasonable compensation and related 
costs for an emergency room physician who is on call but who is not 
present on the premises of the CAH involved, is not otherwise furnishing 
physicians' services, and is not on call at any other provider or 
facility. Effective for costs incurred for services furnished on or 
after January 1, 2005, the payment amount of 101 percent of the 
reasonable costs of outpatient CAH services may also include amounts for 
reasonable compensation and related costs for the following emergency 
room providers who are on call but who are not present on the premises 
of the CAH involved, are not otherwise furnishing physicians' services, 
and are not on call at any other provider or facility: physician 
assistants, nurse practitioners, and clinical nurse specialists.
    (ii) For purposes of this paragraph (b)(4)--
    (A) ``Amounts for reasonable compensation and related costs'' means 
all allowable costs of compensating emergency room physicians, physician 
assistants, nurse practitioners, and clinical nurse specialists who are 
on call to the extent that the costs are found to be reasonable under 
the rules specified in paragraph (b)(2) of this section and the 
applicable sections of part 413. Costs of compensating these specified 
medical emergency room staff are allowable only if the costs are 
incurred under written contracts that require the physician, physician 
assistant, nurse practitioner, or clinical nurse specialist to come to 
the CAH when the physician's or other practitioner's presence is 
medically required.
    (B) Effective for costs incurred on or after January 1, 2005, an 
``emergency room physician, physician assistant, nurse practitioner, or 
clinical nurse specialist who is on call'' means a doctor of medicine or 
osteopathy, a physician assistant, a nurse practitioner, or a clinical 
nurse specialist, with training or experience in emergency care who is 
immediately available by telephone or radio contact, and is available 
onsite within the timeframes specified in Sec.  485.618(d) of this 
chapter.
    (5) Costs of ambulance services. (i)(A) Effective for services 
furnished on or after December 21, 2000 and on or before December 31, 
2003, payment for ambulance services furnished by a CAH or an entity 
that is owned and operated by a CAH is the reasonable costs of the CAH 
or the entity in furnishing those services, but only if the CAH or the 
entity is the only provider or supplier of ambulance services located 
within a 35-mile drive of the CAH or the entity.
    (B) Effective for cost reporting periods beginning on or after 
January 1, 2004 and on or before September 30, 2011, payment for 
ambulance services furnished by a CAH or an entity that is owned and 
operated by a CAH is 101 percent of the reasonable costs of the CAH or 
the entity in furnishing those services, but only if the CAH or the 
entity is the only provider or supplier of ambulance services located 
within a 35-mile drive of the CAH or the entity.
    (C) Effective for cost reporting periods beginning on or after 
October 1, 2011 and on or before September 30, 2019, payment for 
ambulance services furnished by a CAH or an entity that is owned and 
operated by a CAH is 101 percent of the reasonable costs of the CAH or 
the entity in furnishing those services, but only if the CAH or the 
entity is the only provider or supplier of ambulance services located 
within a 35-mile drive of the CAH. If there is no provider or supplier 
of ambulance services located within a 35-mile drive of the CAH and 
there is an entity that is owned and operated by a CAH that is

[[Page 860]]

more than a 35-mile drive from the CAH, payment for ambulance services 
furnished by that entity is 101 percent of the reasonable costs of the 
entity in furnishing those services, but only if the entity is the 
closest provider or supplier of ambulance services to the CAH.
    (D) Effective for cost reporting periods beginning on or after 
October 1, 2019, payment for ambulance services furnished by a CAH or by 
a CAH-owned and operated entity is 101 percent of the reasonable costs 
of the CAH or the entity in furnishing those services, but only if the 
CAH or the entity is the only provider or supplier of ambulance services 
located within a 35-mile drive of the CAH, excluding ambulance providers 
or suppliers that are not legally authorized to furnish ambulance 
services to transport individuals to or from the CAH. If there is no 
provider or supplier of ambulance services located within a 35-mile 
drive of the CAH and there is an entity that is owned and operated by a 
CAH that is more than a 35-mile drive from the CAH, payment for 
ambulance services furnished by that entity is 101 percent of the 
reasonable costs of the entity in furnishing those services, but only if 
the entity is the closest provider or supplier of ambulance services to 
the CAH.
    (ii) For purposes of paragraph (b)(5) of this section, the distance 
between the CAH or the entity and the other provider or supplier of 
ambulance services will be determined as the shortest distance in miles 
measured over improved roads between the CAH or the entity and the site 
at which the vehicles of the closest provider or supplier of ambulance 
services are garaged. An improved road for this purpose is any road that 
is maintained by a local, State, or Federal government entity and is 
available for use by the general public. An improved road will be 
considered to include the paved surface up to the front entrance of the 
hospital and the front entrance of the garage.
    (6) If a CAH meets the criteria in Sec.  412.113(c) of this 
subchapter for pass-through of costs of anesthesia services furnished by 
nonphysician anesthetists employed by the CAH or obtained under 
arrangement, payment to the CAH for the costs of those services is made 
in accordance with Sec.  412.113(c) of this chapter.
    (7) Payment for clinical diagnostic laboratory tests included as 
outpatient CAH services. (i) Payment for clinical diagnostic laboratory 
tests is not subject to the Medicare Part B deductible and coinsurance 
amounts.
    (ii) Subject to the provisions of paragraphs (b)(7)(iii) through 
(b)(7)(vi) of this section, payment to a CAH for clinical diagnostic 
laboratory tests will be made at 101 percent of reasonable costs of the 
services as determined in accordance paragraph (b)(2)(i) of this 
section.
    (iii) For services furnished before July 1, 2009, payment to a CAH 
for clinical diagnostic laboratory tests will be made under paragraph 
(b)(7)(ii) of this section only if the individual is an outpatient of 
the CAH, as defined in Sec.  410.2 of this chapter, and is physically 
present in the CAH at the time the specimen is collected.
    (iv) Except as provided in paragraphs (b)(7)(iii) and (b)(7)(v) of 
this section, payment to a CAH for clinical diagnostic laboratory tests 
will be made under paragraph (b)(7)(ii) of this section only if the 
individual is an outpatient of the CAH, as defined in Sec.  410.2 of 
this chapter, without regard to whether the individual is physically 
present in the CAH at the time the specimen is collected and at least 
one of the following conditions is met:
    (A) The individual is receiving outpatient services in the CAH on 
the same day the specimen is collected; or
    (B) The specimen is collected by an employee of the CAH.
    (v) Notwithstanding paragraph (b)(7)(iv) of this section, payment 
for outpatient clinical diagnostic laboratory tests will not be made 
under paragraph (b)(7)(ii) of this section if the billing rules under 
Sec.  411.15(p) of this chapter apply.
    (vi) Payment for clinical diagnostic laboratory tests for which 
payment may not be made under paragraph (b)(7)(iii) or paragraph 
(b)(7)(iv) of this section will be made in accordance with the 
provisions of sections 1833(a)(1)(D) and 1833(a)(2)(D) of the Act.

[[Page 861]]

    (c) Final payment based on cost report. Final payment to the CAH for 
CAH facility services to inpatients and outpatients furnished during a 
cost reporting is based on a cost report for that period, as required 
under Sec.  413.20(b).
    (d) Periodic interim payments. Subject to the provisions of Sec.  
413.64(h), a CAH receiving payments under this section may elect to 
receive periodic interim payments (PIP) for Part A inpatient CAH 
services, effective for payments made on or after July l, 2004. Payment 
is made biweekly under the PIP method unless the CAH requests a longer 
fixed interval (not to exceed one month) between payments. The biweekly 
interim payment amount is based on the total estimated Medicare payment 
(after estimated beneficiary deductibles and coinsurance) for the cost 
reporting period. Each payment is made 2 weeks after the end of a 
biweekly period of service, as described in Sec.  413.64(h)(6). These 
PIP provisions are further described in Sec.  413.64(h)(6). Under 
certain circumstances that are described in Sec.  413.64(g), a CAH that 
is not receiving PIP may request an accelerated payment.
    (e) Payment for service of distinct part psychiatric and 
rehabilitation units of CAHS. Payment for inpatient services of distinct 
part psychiatric units of CAHs--
    (1) For cost reporting periods beginning before January 1, 2005, 
payment is made on a reasonable cost basis, subject to the provisions of 
Sec.  413.40.
    (2) For cost reporting periods beginning on or after January 1, 
2005, payment is made in accordance with regulations governing inpatient 
psychiatric facilities at subpart N (Sec.  412.400 through Sec.  
412.432) of Part 412 of this subchapter.
    (3) Payment for inpatient services of distinct part rehabilitation 
units of CAHs is made in accordance with regulations governing the 
inpatient rehabilitation facilities prospective payment system at 
subpart P (Sec.  412.600 through Sec.  412.632) of part 412 of this 
subchapter.

[65 FR 47109, Aug. 1, 2000]

    Editorial Note: For Federal Register citations affecting Sec.  
413.70, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.  413.74  Payment to a foreign hospital.

    (a) Principle. Section 1814(f) of the Act provides for the payment 
of emergency and nonemergency inpatient hospitals services furnished by 
foreign hospitals to Medicare beneficiaries. Subpart H of part 424 of 
this chapter, together with this section, specifies the conditions for 
payment.
    (b) Amount of payment. Effective with admissions on or after January 
1, 1980, the reasonable cost for services covered under the Medicare 
program furnished to beneficiaries by a foreign hospital will be equal 
to 100 percent of the hospital's customary charges (as defined in Sec.  
413.13(b)) for the services.
    (c) Submittal of claims. The hospital must establish its customary 
charges for the services by submitting an itemized bill with each claim 
it files in accordance with its election under Sec.  424.104 of this 
chapter.
    (d) Exchange rate. Payment to the hospital will be subject to the 
official exchange rate on the date the patient is discharged and to the 
applicable deductible and coinsurance amounts described in Sec. Sec.  
409.80 through 409.83.

[51 FR 34793, Sept. 30, 1986, as amended at 51 FR 41351, Nov. 14, 1986; 
53 FR 6648, Mar. 2, 1988; 53 FR 12945, Apr. 20, 1988; 71 FR 48141, Aug. 
18, 2006]



                 Subpart F_Specific Categories of Costs



Sec.  413.75  Direct GME payments: General requirements.

    (a) Statutory basis and scope--(1) Basis. This section and 
Sec. Sec.  413.76 through 413.83 implement section 1886(h) of the Act by 
establishing the methodology for Medicare payment of the cost of direct 
graduate medical educational activities.
    (2) Scope. This section and Sec. Sec.  413.76 through 413.83 apply 
to Medicare payments to hospitals and hospital-based providers for the 
costs of approved residency programs in medicine, osteopathy, dentistry, 
and podiatry for cost reporting periods beginning on or after July 1, 
1985.
    (b) Definitions. For purposes of this section and Sec. Sec.  413.76 
through 413.83, the following definitions apply:

[[Page 862]]

    All or substantially all of the costs for the training program in 
the nonhospital setting means--
    (1) Effective on or after January 1, 1999 and for cost reporting 
periods beginning before July 1, 2007, the residents' salaries and 
fringe benefits (including travel and lodging where applicable) and the 
portion of the cost of teaching physicians' salaries and fringe benefits 
attributable to direct graduate medical education (GME); and
    (2) Effective for cost reporting periods beginning on or after July 
1, 2007 and before July 1, 2010, at least 90 percent of the total of the 
costs of the residents' salaries and fringe benefits (including travel 
and lodging where applicable) and the portion of the cost of teaching 
physicians' salaries attributable to nonpatient care direct GME 
activities.
    Approved geriatric program means a fellowship program of one or more 
years in length that is approved by one of the national organizations 
listed in Sec.  415.152 of this chapter under that respective 
organization's criteria for geriatric fellowship programs.
    Approved medical residency program means a program that meets one of 
the following criteria:
    (1) Is approved by one of the national organizations listed in Sec.  
415.152 of this chapter.
    (2) May count towards certification of the participant in a 
specialty or subspecialty listed in the current edition of either of the 
following publications:
    (i) The Directory of Graduate Medical Education Programs published 
by the American Medical Association, and available from American Medical 
Association, Department of Directories and Publications, 515 North State 
Street, Chicago, Illinois 60610; or
    (ii) The Annual Report and Reference Handbook published by the 
American Board of Medical Specialties, and available from American Board 
of Medical Specialties, One Rotary Center, Suite 805, Evanston, Illinois 
60201.
    (3) Is approved by the Accreditation Council for Graduate Medical 
Education (ACGME) as a fellowship program in geriatric medicine.
    (4) Is a program that would be accredited except for the accrediting 
agency's reliance upon an accreditation standard that requires an entity 
to perform an induced abortion or require, provide, or refer for 
training in the performance of induced abortions, or make arrangements 
for such training, regardless of whether the standard provides 
exceptions or exemptions.
    Base period means a cost reporting period that began on or after 
October 1, 1983 but before October 1, 1984.
    Community support means funding that is provided by the community 
and generally includes all non-Medicare sources of funding (other than 
payments made for furnishing services to individual patients), including 
State and local government appropriations. Community support does not 
include grants, gifts, and endowments of the kind that are not to be 
offset in accordance with section 1134 of the Act.
    CPI-U stands for the Consumer Price Index for All Urban Consumers as 
compiled by the Bureau of Labor Statistics.
    Emergency Medicare GME affiliated group means at least one home 
hospital and one or more host hospitals, as those terms are defined 
below, that meet the requirements at Sec.  413.79(f)(6). For purposes of 
an emergency Medicare GME affiliated group, the following definitions 
apply:
    (1) Home hospital means a hospital that--
    (i) Is located in section 1135 emergency area;
    (ii) Had its inpatient bed occupancy decreased by 20 percent or more 
as the result of a section 1135 emergency period so that it is unable to 
train the number of residents it originally intended to train in that 
academic year; and
    (iii) Needs to send the displaced residents to train at a host 
hospital.
    (2) Host hospital means a hospital training residents displaced from 
a home hospital.
    (i) In-State host hospital means a host hospital located in the same 
State as a home hospital.
    (ii) Out-of-State host hospital means a host hospital located in a 
different State from the home hospital.
    (3) Section 1135 emergency area or section 1135 emergency period 
mean, respectively, a geographic area in which, or a period during 
which, there exists--

[[Page 863]]

    (i) An emergency or disaster declared by the President pursuant to 
the National Emergencies Act or the Robert T. Stafford Disaster Relief 
and Emergency Assistance Act; and
    (ii) A public health emergency declared by the Secretary pursuant to 
section 319 of the Public Health Service Act.
    Foreign medical graduate means a resident who is not a graduate of a 
medical, osteopathy, dental, or podiatry school, respectively, 
accredited or approved as meeting the standards necessary for 
accreditation by one of the following organizations:
    (1) The Liaison Committee on Medical Education of the American 
Medical Association.
    (2) The American Osteopathic Association.
    (3) The Commission on Dental Accreditation.
    (4) The Council on Podiatric Medical Education.
    FMGEMS stands for the Foreign Medical Graduate Examination in the 
Medical Sciences (Part I and Part II).
    FTE stands for full-time equivalent.
    GME stands for graduate medical education.
    Medicare GME affiliated group means--
    (1) Two or more hospitals that are located in the same urban or 
rural area (as those terms are defined in subpart D of Part 412 of this 
subchapter) or in a contiguous area and meet the rotation requirements 
in Sec.  413.79(f)(2).
    (2) Two or more hospitals that are not located in the same or in a 
contiguous urban or rural area, but meet the rotation requirement in 
Sec.  413.79(f)(2), and are jointly listed--
    (i) As the sponsor, primary clinical site, or major participating 
institution for one or more programs as these terms are used in the most 
current publication of the Graduate Medical Education Directory; or
    (ii) As the sponsor or is listed under ``affiliations and outside 
rotations'' for one or more programs in operation in Opportunities, 
Directory of Osteopathic Postdoctoral Education Programs.
    (3) Two or more hospitals that are under common ownership and, 
effective for all Medicare GME affiliation agreements beginning July 1, 
2003, meet the rotation requirement in Sec.  413.79(f)(2).
    Medicare GME affiliation agreement means a written, signed, and 
dated agreement by responsible representatives of each respective 
hospital in a Medicare GME affiliated group, as defined in this section, 
that specifies--
    (1) The term of the Medicare GME affiliation agreement (which, at a 
minimum is 1 year), beginning on July 1 of a year;
    (2) Each participating hospital's direct and indirect GME FTE caps 
in effect prior to the Medicare GME affiliation;
    (3) The total adjustment to each hospital's FTE caps in each year 
that the Medicare GME affiliation agreement is in effect, for both 
direct GME and IME, that reflects a positive adjustment to one 
hospital's direct and indirect FTE caps that is offset by a negative 
adjustment to the other hospital's (or hospitals') direct and indirect 
FTE caps of at least the same amount;
    (4) The adjustment to each participating hospital's FTE counts 
resulting from the FTE resident's (or residents') participation in a 
shared rotational arrangement at each hospital participating in the 
Medicare GME affiliated group for each year the Medicare GME affiliation 
agreement is in effect. This adjustment to each participating hospital's 
FTE count is also reflected in the total adjustment to each hospital's 
FTE caps (in accordance with paragraph (3) of this definition); and
    (5) The names of the participating hospitals and their Medicare 
provider numbers.
    Medicare patient load means, with respect to a hospital's cost 
reporting period, the total number of hospital inpatient days during the 
cost reporting period that are attributable to patients for whom payment 
is made under Medicare Part A divided by total hospital inpatient days. 
In calculating inpatient days, inpatient days in any distinct part of 
the hospital furnishing a hospital level of care are included and 
nursery days are excluded.
    Nonprovider setting that is primarily engaged in furnishing patient 
care means a nonprovider setting in which the primary activity is the 
care and treatment of patients.

[[Page 864]]

    Orientation activities means activities that are principally 
designed to prepare an individual for employment as a resident in a 
particular setting, or for participation in a particular specialty 
program and patient care activities associated with that particular 
specialty program.
    Patient care activities means the care and treatment of particular 
patients, including services for which a physician or other practitioner 
may bill, and orientation activities as defined in this section.
    Primary care resident is a resident who is enrolled in an approved 
medical residency training program in family medicine, general internal 
medicine, general pediatrics, preventive medicine, geriatric medicine or 
osteopathic general practice. Effective for cost reporting periods 
beginning on or after October 1, 2010, primary care resident is a 
resident who is formally accepted, enrolled, and participating in an 
approved medical residency training program in family medicine, general 
internal medicine, general pediatrics, preventive medicine, geriatric 
medicine or osteopathic general practice.
    Redistribution of costs occurs when a hospital counts FTE residents 
in medical residency programs and the costs of the program had 
previously been incurred by an educational institution.
    Resident means an intern, resident, or fellow who participates in an 
approved medical residency program, including programs in osteopathy, 
dentistry, and podiatry, as required in order to become certified by the 
appropriate specialty board. Effective for cost reporting periods 
beginning on or after October 1, 2010, resident means an intern, 
resident, or fellow who is formally accepted, enrolled, and 
participating in an approved medical residency program, including 
programs in osteopathy, dentistry, and podiatry, as required in order to 
become certified by the appropriate specialty board.
    Rural track FTE limitation means the maximum number of residents (as 
specified in Sec.  413.79(k)) training in a rural track residency 
program that an urban hospital may include in its FTE count and that is 
in addition to the number of FTE residents already included in the 
hospital's FTE cap.
    Rural track or integrated rural track means an approved medical 
residency training program established by an urban hospital in which 
residents train for a portion of the program at the urban hospital and 
then rotate for a portion of the program to a rural hospital(s) or a 
rural nonhospital site(s).
    Shared rotational arrangement means a residency training program 
under which a resident(s) participates in training at two or more 
hospitals in that program.
    (c) Payment for GME costs--General rule. Beginning with cost 
reporting periods starting on or after July 1, 1985, hospitals, 
including hospital-based providers, are paid for the costs of approved 
GME programs as described in Sec. Sec.  413.76 through 413.83.
    (d) Documentation requirements. To include a resident in the FTE 
count for a particular cost reporting period, the hospital must furnish 
the following information. The information must be certified by an 
official of the hospital and, if different, an official responsible for 
administering the residency program.
    (1) The name and social security number of the resident.
    (2) The type of residency program in which the individual 
participates and the number of years the resident has completed in all 
types of residency programs.
    (3) The dates the resident is assigned to the hospital and any 
hospital-based providers.
    (4) The dates the resident is assigned to other hospitals, or other 
freestanding providers, and any nonprovider setting during the cost 
reporting period, if any.
    (5) The name of the medical, osteopathic, dental, or podiatric 
school from which the resident graduated and the date of graduation.
    (6) If the resident is an FMG, documentation concerning whether the 
resident has satisfied the requirements of this section.

[[Page 865]]

    (7) The name of the employer paying the resident's salary.

[69 FR 49254, Aug. 11, 2004, as amended at 70 FR 47489, Aug. 12, 2005; 
71 FR 18666, Apr. 12, 2006; 71 FR 48141, Aug. 18, 2006; 72 FR 26995, May 
11, 2007; 72 FR 47412, Aug. 22, 2007; 72 FR 66931, Nov. 27, 2007; 75 FR 
50418, Aug. 16, 2010; 75 FR 72262, Nov. 24, 2010; 79 FR 50357, Aug. 22, 
2014]



Sec.  413.76  Direct GME payments: Calculation of payments for GME costs.

    A hospital's Medicare payment for the costs of an approved residency 
program is calculated as follows:
    (a) Step one. The hospital's updated per resident amount (as 
determined under Sec.  413.77) is multiplied by the actual number of FTE 
residents (as determined under Sec.  413.79). This result is the 
aggregate approved amount for the cost reporting period.
    (b) Step two. The product derived in step one is multiplied by the 
hospital's Medicare patient load.
    (c) Step three. For portions of cost reporting periods occurring on 
or after January 1, 1998, the product derived in step one is multiplied 
by the proportion of the hospital's inpatient days attributable to 
individuals who are enrolled under a risk-sharing contract with an 
eligible organization under section 1876 of the Act and who are entitled 
to Medicare Part A or with a Medicare + Choice organization under Title 
XVIII, Part C of the Act. This amount is multiplied by an applicable 
payment percentage equal to--
    (1) 20 percent for 1998;
    (2) 40 percent for 1999;
    (3) 60 percent in 2000;
    (4) 80 percent in 2001; and
    (5) 100 percent in 2002 and subsequent years.
    (d) Step four. Effective for portions of cost reporting periods 
occurring on or after January 1, 2000, the product derived from step 
three is reduced by a percentage equal to the ratio of the Medicare + 
Choice nursing and allied health payment ``pool'' for the current 
calendar year as described at Sec.  413.87(f), to the projected total 
Medicare + Choice direct GME payments made to all hospitals for the 
current calendar year.
    (e) Step five. (1) For portions of cost reporting periods beginning 
on or after January 1, 1998 and before January 1, 2000, add the results 
of steps two and three.
    (2) Effective for portions of cost reporting periods beginning on or 
after January 1, 2000, add the results of steps two and four.
    (f) Step six. The product derived in step two is apportioned between 
Part A and Part B of Medicare based on the ratio of Medicare's share of 
reasonable costs excluding GME costs attributable to each part as 
determined through the Medicare cost report.

[69 FR 49254, Aug. 11, 2004]



Sec.  413.77  Direct GME payments: Determination of per resident amounts.

    (a) Per resident amount for the base period. (1) Except as provided 
in paragraph (d) of this section, the contractor determines a base-
period per resident amount for each hospital as follows:
    (i) Determine the allowable GME costs for the cost reporting period 
beginning on or after October 1, 1983 but before October 1, 1984. In 
determining these costs, GME costs allocated to the nursery cost center, 
research and other nonreimbursable cost centers, and hospital-based 
providers that are not participating in Medicare are excluded and GME 
costs allocated to distinct-part hospital units and hospital-based 
providers that participate in Medicare are included.
    (ii) Divide the costs calculated in paragraph (a)(1)(i) of this 
section by the average number of FTE residents working in all areas of 
the hospital complex (including those areas whose costs were excluded 
under paragraph (a)(1)(i) of this section) for its cost reporting period 
beginning on or after October 1, 1983 but before October 1, 1984.
    (2) In determining the base-period per resident amount under 
paragraph (a)(1) of this section, the contractor--
    (i) Verifies the hospital's base-period GME costs and the hospital's 
average number of FTE residents;
    (ii) Excludes from the base-period GME costs any nonallowable or 
misclassified costs, including those previously allowed under Sec.  
412.113(b)(3) of this chapter; and
    (iii) Upon a hospital's request, includes GME costs that were 
misclassified as operating costs during

[[Page 866]]

the hospital's prospective payment base year and were not allowable 
under Sec.  412.113(b)(3) of this chapter during the GME base period. 
These costs may be included only if the hospital requests an adjustment 
of its prospective payment hospital-specific rate or target amount as 
described in Sec.  413.82(a) of this chapter.
    (3) If the hospital's cost report for its GME base period is no 
longer subject to reopening under Sec.  405.1885 of this chapter, the 
contractor may modify the hospital's base-period costs solely for 
purposes of computing the per resident amount.
    (4) If the contractor modifies a hospital's base-period GME costs as 
described in paragraph (a)(2)(ii) of this section, the hospital may 
request an adjustment of its prospective payment hospital-specific rate 
or target amount as described in Sec.  413.82(a) of this chapter.
    (5) The contractor notifies each hospital that either had direct GME 
costs or received indirect education payment in its cost reporting 
period beginning on or after October 1, 1984, and before October 1, 
1985, of its base-period average per resident amount. A hospital may 
appeal this amount within 180 days of the date of that notice.
    (b) Per resident amount for cost reporting periods beginning on or 
after July 1, 1985, and before July 1, 1986. For cost reporting periods 
beginning on or after July 1, 1985, and before July 1, 1986, a 
hospital's base-period per resident amount is adjusted as follows:
    (1) If a hospital's base period began on or after October 1, 1983, 
and before July 1, 1984, the amount is adjusted by the percentage change 
in the CPI-U that occurred between the hospital's base period and the 
first cost reporting period to which the provisions of this section 
apply. The adjusted amount is then increased by one percent.
    (2) If a hospital's base period began on or after July 1, 1984 and 
before October 1, 1984, the amount is increased by one percent.
    (c) Per resident amount for cost reporting periods beginning on or 
after July 1, 1986. Subject to the provisions of paragraph (d) of this 
section, for cost reporting periods beginning on or after July 1, 1986, 
a hospital's base-period per resident amount is adjusted as follows:
    (1) Except as provided in paragraph (c)(2) of this section, each 
hospital's per resident amount for the previous cost reporting is 
adjusted by the projected change in the CPI-U for the 12-month cost 
reporting period. This adjustment is subject to revision during the 
settlement of the cost report to reflect actual changes in the CPI-U 
that occurred during the cost reporting period.
    (2) For cost reporting periods beginning on or after October 1, 1993 
through September 30, 1995, each hospital's per resident amount for the 
previous cost reporting period will not be adjusted for any resident 
FTEs who are not either a primary care resident or an obstetrics and 
gynecology resident.
    (d) Per resident amount for cost reporting periods beginning on or 
after October 1, 2000 and ending on or before September 30, 2013. For 
cost reporting periods beginning on or after October 1, 2000 and ending 
on or before September 30, 2013, a hospital's per resident amount for 
each fiscal year is adjusted in accordance with the following 
provisions:
    (1) General provisions. For purposes of this Sec.  413.77--
    (i) Weighted average per resident amount. The weighted average per 
resident amount is established as follows:
    (A) Using data from hospitals' cost reporting periods ending during 
FY 1997, CMS calculates each hospital's single per resident amount by 
adding each hospital's primary care and nonprimary care per resident 
amounts, weighted by its respective FTEs, and dividing by the sum of the 
FTEs for primary care and nonprimary care residents.
    (B) Each hospital's single per resident amount calculated under 
paragraph (d)(1)(i)(A) of this section is standardized by the 1999 
geographic adjustment factor for the physician fee schedule area (as 
determined under Sec.  414.26 of this chapter) in which the hospital is 
located.
    (C) CMS calculates an average of all hospitals' standardized per 
resident amounts that are determined under paragraph (d)(1)(i)(B) of 
this section. The resulting amount is the weighted average per resident 
amount.

[[Page 867]]

    (ii) Primary care/obstetrics and gynecology and nonprimary care per 
resident amounts. A hospital's per resident amount is an amount 
inclusive of any CPI-U adjustments that the hospital may have received 
since the hospital's base year, including any CPI-U adjustments the 
hospital may have received because the hospital trains primary care/
obstetrics and gynecology residents and nonprimary care residents as 
specified under paragraph (c)(2) of this section.
    (2) Adjustment beginning in FY 2001 and ending in FY 2013. For cost 
reporting periods beginning on or after October 1, 2000, and ending on 
or before September 30, 2013, a hospital's per resident amount is 
adjusted in accordance with paragraphs (d)(2)(i) through (d)(2)(iv) of 
this section, in that order:
    (i) Updating the weighted average per resident amount for inflation. 
The weighted average per resident amount (as determined under paragraph 
(d)(1)(i) of this section) is updated by the estimated percentage 
increase in the CPI-U during the period beginning with the month that 
represents the midpoint of the cost reporting periods ending during FY 
1997 (that is, October 1, 1996) and ending with the midpoint of the 
hospital's cost reporting period that begins in FY 2001.
    (ii) Adjusting for locality. The updated weighted average per 
resident amount determined under paragraph (d)(2)(i) of this section 
(the national average per resident amount) is adjusted for the locality 
of each hospital by multiplying the national average per resident amount 
by the 1999 geographic adjustment factor for the physician fee schedule 
area in which each hospital is located, established in accordance with 
Sec.  414.26 of this chapter.
    (iii) Determining necessary revisions to the per resident amount. 
The locality-adjusted national average per resident amount, as 
calculated in accordance with paragraph (d)(2)(ii) of this section, is 
compared to the hospital's per resident amount and is revised, if 
appropriate, according to the following three categories:
    (A) Floor. (1) For cost reporting periods beginning on or after 
October 1, 2000, and before October 1, 2001, if the hospital's per 
resident amount would otherwise be less than 70 percent of the locality-
adjusted national average per resident amount for FY 2001 (as determined 
under paragraph (d)(2)(ii) of this section), the per resident amount is 
equal to 70 percent of the locality-adjusted national average per 
resident amount for FY 2001.
    (2) For cost reporting periods beginning on or after October 1, 
2001, and before October 1, 2002, if the hospital's per resident amount 
would otherwise be less than 85 percent of the locality-adjusted 
national average per resident amount for FY 2002 (as determined under 
paragraph (d)(2)(ii) of this section), the per resident amount is equal 
to 85 percent of the locality-adjusted national average per resident 
amount for FY 2002.
    (3) For subsequent cost reporting periods beginning on or after 
October 1, 2002, the hospital's per resident amount is updated using the 
methodology specified under paragraph (c)(1) of this section.
    (B) Ceiling. If the hospital's per resident amount is greater than 
140 percent of the locality-adjusted national average per resident 
amount, the per resident amount is adjusted as follows for FY 2001 
through FY 2013:
    (1) FY 2001. For cost reporting periods beginning on or after 
October 1, 2000 and on or before September 30, 2001, if the hospital's 
FY 2000 per resident amount exceeds 140 percent of the FY 2001 locality-
adjusted national average per resident amount (as calculated under 
paragraph (d)(2)(ii) of this section), subject to the provision stated 
in paragraph (d)(2)(iii)(B)(5) of this section, the hospital's per 
resident amount is frozen at the FY 2000 per resident amount and is not 
updated for FY 2001 by the CPI-U factor.
    (2) FY 2002. For cost reporting periods beginning on or after 
October 1, 2001, and on or before September 30, 2002, if the hospital's 
FY 2001 per resident amount exceeds 140 percent of the FY 2002 locality-
adjusted national average per resident amount, subject to the provision 
stated in paragraph (d)(2)(iii)(B)(5) of this section, the hospital's 
per resident amount is frozen at the FY 2001 per resident amount and is 
not updated for FY 2002 by the CPI-U factor.

[[Page 868]]

    (3) FY 2003. For cost reporting periods beginning on or after 
October 1, 2002, and on or before September 30, 2003, if the hospital's 
per resident amount for the previous cost reporting period is greater 
than 140 percent of the locality-adjusted national average per resident 
amount for that same previous cost reporting period (for example, for 
cost reporting periods beginning in FY 2003, compare the hospital's per 
resident amount from the FY 2002 cost report to the hospital's locality-
adjusted national average per resident amount from FY 2002), subject to 
the provision stated in paragraph (d)(2)(iii)(B)(5) of this section, the 
hospital's per resident amount is adjusted using the methodology 
specified in paragraph (c)(1) of this section, except that the CPI-U 
applied for a 12-month period is reduced (but not below zero) by 2 
percentage points.
    (4) FY 2004 through FY 2013. For cost reporting periods beginning on 
or after October 1, 2003, and on or before September 30, 2013, if the 
hospital's preceding year per resident amount exceeds 140 percent of the 
current year's locality-adjusted national average per resident amount 
(as calculated under paragraph (d)(2)(ii) of this section), subject to 
the provision stated in paragraph (d)(2)(iii)(B)(5) of this section, the 
hospital-specific per resident amount is frozen for the current year at 
the preceding year's hospital-specific per resident amount and is not 
updated by the CPI-U factor.
    (5) General rule for hospitals that exceed the ceiling. For cost 
reporting periods beginning on or after October 1, 2000, and on or 
before September 30, 2013, if a hospital's per resident amount exceeds 
140 percent of the hospital's locality-adjusted national average per 
resident amount and it is adjusted under any of the criteria under 
paragraphs (d)(2)(iii)(B)(1) through (d)(2)(iii)(B)(3) of this section, 
the current year per resident amount cannot be reduced below 140 percent 
of the locality-adjusted national average per resident amount.
    (C) Per resident amounts greater than or equal to the floor and less 
than or equal to the ceiling. For cost reporting periods beginning on or 
after October 1, 2000 and on or before September 30, 2013, if a 
hospital's per resident amount is greater than or equal to 70 percent 
and less than or equal to 140 percent of the hospital's locality-
adjusted national average per resident amount for each respective fiscal 
year, the hospital's per resident amount is updated using the 
methodology specified in paragraph (c)(1) of this section.
    (e) Exceptions--(1) Base period for certain hospitals. If a hospital 
did not have any approved medical residency training programs or did not 
participate in Medicare during the base period, but either condition 
changes in a cost reporting period beginning on or after July 1, 1985, 
the contractor establishes a per resident amount for the hospital using 
the information from the first cost reporting period during which the 
hospital participates in Medicare and the residents are on duty during 
the first month of that period. Effective for cost reporting periods 
beginning on or after October 1, 2006, if a hospital did not have any 
approved medical residency training programs or did not participate in 
Medicare during the base period, but either condition changes in a cost 
reporting period beginning on or after October 1, 2006, and the 
residents are not on duty during the first month of that period, the 
contractor establishes a per resident amount for the hospital using the 
information from the first cost reporting period immediately following 
the cost reporting period during which the hospital participates in 
Medicare and residents began training at the hospital. The per resident 
amount is based on the lower of the amount specified in paragraph 
(e)(1)(i) or paragraph (e)(1)(ii) of this section, subject to the 
provisions of paragraph (e)(1)(iii) of this section. Any GME costs 
incurred by the hospital during the cost reporting period prior to the 
base period used for calculating the PRA are reimbursed on a reasonable 
cost basis.
    (i) The hospital's actual cost per resident incurred in connection 
with the GME program(s) based on the cost and resident data from the 
hospital's base year cost reporting period as established in paragraph 
(e)(1) of this section.
    (ii) Except as specified in paragraph (e)(1)(iii)of this section--

[[Page 869]]

    (A) For base periods that begin before October 1, 2002, the updated 
weighted mean value of per resident amounts of all hospitals located in 
the same geographic wage area, as that term is used in the prospective 
payment system under Part 412 of this chapter.
    (B) For base periods beginning on or after October 1, 2002, the 
updated weighted mean value of per resident amounts of all hospitals 
located in the same geographic wage area is calculated using all per 
resident amounts (including primary care and obstetrics and gynecology 
and nonprimary care) and FTE resident counts from the most recently 
settled cost reports of those teaching hospitals.
    (iii) If, under paragraph (e)(1)(ii)(A) or paragraph (e)(1)(ii)(B) 
of this section, there are fewer than three existing teaching hospitals 
with per resident amounts that can be used to calculate the weighted 
mean value per resident amount, for base periods beginning on or after 
October 1, 1997, the per resident amount equals the updated weighted 
mean value of per resident amounts of all hospitals located in the same 
census region as that term is used in subpart D of part 412 of this 
subchapter.
    (2) Short or long base-period cost reporting periods. If a 
hospital's base-period cost reporting period reflects GME costs for a 
period that is shorter than 50 weeks or longer than 54 weeks, the 
contractor converts the allowable costs for the base period into a daily 
figure. The daily figure is then multiplied by 365 or 366, as 
appropriate, to derive the approved per resident amount for a 12-month 
base-period cost reporting period. If a hospital has two cost reporting 
periods beginning in the base period, the later period serves as the 
base-period cost reporting period.
    (3) Short or long cost reporting periods beginning on or after July 
1, 1985. If a hospital's cost reporting period is shorter than 50 weeks 
or longer than 54 weeks, the hospital's contractor should contact CMS 
Central Office to receive a special CPI-U adjustment factor.
    (f) Residency match. Effective for portions of cost reporting 
periods beginning on or after October 1, 2004, with respect to a 
resident who matches simultaneously for a first year of training in a 
primary care specialty, and for an additional year(s) of training in a 
nonprimary care specialty, the per resident amount that is used to 
determine direct GME payment with respect to that resident is the 
nonprimary care per resident amount for the first year of training in 
the primary care specialty and for the duration of the resident's 
training in the nonprimary care specialty.
    (g) Special use of locality-adjusted national average per resident 
amount. Effective for portions of cost reporting periods beginning on or 
after July 1, 2005, for a hospital that counts additional residents as a 
result of an increase in its FTE resident cap under Sec.  413.79(c)(4) 
direct GME payments attributable to those additional FTE residents are 
calculated using the locality-adjusted national average per resident 
amount, as determined under paragraph (d)(2)(ii) of this section. The 
hospital will receive direct GME payments based on the sum of the 
following two direct GME calculations:
    (1) A calculation using the per resident amount(s) as determined 
under paragraph (d) of this section and the hospital's number of FTE 
residents that is not attributable to an FTE resident cap increase under 
Sec.  413.79(c)(4); and
    (2) A calculation using the locality-adjusted national average per 
resident amount, as determined under paragraph (d)(2)(ii) of this 
section, inflated to the hospital's current cost reporting period, and 
the hospital's number of FTE residents that is attributable to the 
increase in the hospital's FTE resident cap under Sec.  413.79(c)(4).
    (h) Hospital mergers. Effective for cost reporting periods beginning 
on or after October 1, 2006, when multiple hospitals merge, a primary 
care and obstetrics and gynecology weighted average per resident amount 
and a nonprimary care weighted average per resident amount is 
calculated, if applicable, for the surviving hospital, using FTE 
resident data and per resident amount data from the most recently 
settled cost reports of the respective hospitals prior to the merger.

[69 FR 49254, Aug. 11, 2004, as amended at 69 FR 60252, Oct. 7, 2004; 70 
FR 47489, Aug. 12, 2005; 71 FR 48142, Aug. 18, 2006]

[[Page 870]]



Sec.  413.78  Direct GME payments: Determination of the total number 
of FTE residents.

    Subject to the weighting factors in Sec. Sec.  413.79 and 413.80, 
and subject to the provisions of Sec.  413.81, the count of FTE 
residents is determined as follows:
    (a) Residents in an approved program working in all areas of the 
hospital complex may be counted.
    (b) No individual may be counted as more than one FTE. A hospital 
cannot claim the time spent by residents training at another hospital, 
except as provided in paragraph (i) of this section. Except as provided 
in paragraphs (c), (d), and (e) of this section, if a resident spends 
time in more than one hospital or in a nonprovider setting, the resident 
counts as partial FTE based on the proportion of time worked at the 
hospital to the total time worked. A part-time resident counts as a 
partial FTE based on the proportion of allowable time worked compared to 
the total time necessary to fill a full-time internship or residency 
slot.
    (c) On or after July 1, 1987, and for portions of cost reporting 
periods occurring before January 1, 1999, the time residents spend in 
nonprovider settings such as freestanding clinics, nursing homes, and 
physicians' offices in connection with approved programs is not excluded 
in determining the number of FTE residents in the calculation of a 
hospital's resident count if the following conditions are met--
    (1) The resident spends his or her time in patient care activities, 
as defined in Sec.  413.75(b).
    (2) There is a written agreement between the hospital and the 
outside entity that states that the resident's compensation for training 
time spent outside of the hospital setting is to be paid by the 
hospital.
    (d) For portions of cost reporting periods occurring on or after 
January 1, 1999, and before October 1, 2004, the time residents spend in 
nonprovider settings such as freestanding clinics, nursing homes, and 
physicians' offices in connection with approved programs may be included 
in determining the number of FTE residents in the calculation of a 
hospital's resident count if the following conditions are met--
    (1) The resident spends his or her time in patient care activities, 
as defined in Sec.  413.75(b).
    (2) The written agreement between the hospital and the nonhospital 
site must indicate that the hospital will incur the cost of the 
resident's salary and fringe benefits while the resident is training in 
the nonhospital site and the hospital is providing reasonable 
compensation to the nonhospital site for supervisory teaching 
activities. The agreement must indicate the compensation the hospital is 
providing to the nonhospital site for supervisory teaching activities.
    (3) The hospital must incur all or substantially all of the costs 
for the training program in the nonhospital setting in accordance with 
the definition in Sec.  413.75(b).
    (4) The hospital is subject to the principles of community support 
and redistribution of costs as specified in Sec.  413.81.
    (e) For portions of cost reporting periods occurring on or after 
October 1, 2004, and for cost reporting periods beginning before July 1, 
2007, the time residents spend in nonprovider settings such as 
freestanding clinics, nursing homes, and physicians' offices in 
connection with approved programs may be included in determining the 
number of FTE residents in the calculation of a hospital's resident 
count if the following conditions are met:
    (1) The resident spends his or her time in patient care activities, 
as defined in Sec.  413.75(b).
    (2) The hospital must incur all or substantially all of the costs of 
the training program in a nonhospital setting(s) (in accordance with the 
definition under Sec.  413.75(b)).
    (3) The hospital must comply with one of the following:
    (i) The hospital must pay all or substantially all of the costs of 
the training program in a nonhospital setting(s) attributable to 
training that occurs during a month by the end of the third month 
following the month in which the training in the nonhospital site 
occurred.
    (ii) There is a written agreement between the hospital and the 
nonhospital site that states that the hospital will incur the cost of 
the resident's salary

[[Page 871]]

and fringe benefits while the resident is training in the nonhospital 
site and the hospital is providing reasonable compensation to the 
nonhospital site for supervisory teaching activities. The agreement must 
indicate the compensation the hospital is providing to the nonhospital 
site for supervisory teaching activities.
    (iii) If the hospital has in place an emergency Medicare GME 
affiliation agreement in accordance with Sec.  413.79(f)(6), during the 
period covered by the emergency Medicare GME affiliation agreement--
    (A) The hospital must pay all or substantially all of the costs of 
the training program in a nonhospital setting(s) attributable to 
training that occurs during a month by the end of the sixth month 
following the month in which the training in the nonhospital site 
occurred. For the costs that would otherwise be required to be paid by 
the hospital during the period of August 29, 2005 through November 1, 
2007, the participating hospital must pay the costs by April 29, 2008; 
or
    (B) There is a written agreement that specifies that the hospital is 
incurring the cost of the resident's salary and fringe benefits while 
the resident is training in the nonhospital site and the hospital is 
providing reasonable compensation to the nonhospital site for 
supervisory teaching activities. The agreement must indicate the 
compensation the hospital is providing to the nonhospital site for 
supervisory teaching activities. The written agreement must be submitted 
to the contractor by 180 days after the training at the nonhospital site 
begins. For written agreements that would otherwise be required to be 
submitted prior to the date the resident(s) begin training at the 
nonhospital site during the period of August 29, 2005 through November 
1, 2007, the written agreement must be submitted to the CMS contractor 
by April 29, 2008.
    (4) The hospital is subject to the principles of community support 
and redistribution of costs as specified in Sec.  413.81.
    (f) For cost reporting periods beginning on or after July 1, 2007, 
and before July 1, 2010, the time residents spend in nonprovider 
settings such as freestanding clinics, nursing homes, and physicians' 
offices in connection with approved programs may be included in 
determining the number of FTE residents in the calculation of a 
hospital's resident count if the following conditions are met--
    (1) The resident spends his or her time in patient care activities 
as defined at Sec.  413.75(b), except that for cost reporting periods 
beginning on or after July 1, 2009, the time spent training in 
nonpatient care activities, such as didactic conferences and seminars, 
but excluding research not associated with the treatment or diagnosis of 
a particular patient, in a nonprovider setting that is primarily engaged 
in furnishing patient care activities, as defined at Sec.  413.75(b), 
also may be counted.
    (2) The hospital must incur all or substantially all of the costs 
for the training program in the nonhospital setting(s) (in accordance 
with the definition under Sec.  413.75(b)).
    (3) The hospital must comply with one of the following:
    (i) The hospital must pay for all or substantially all of the costs 
for the training program in a nonhospital setting(s) attributable to 
training that occurs during a month by the end of the third month 
following the month in which the training in the nonhospital site 
occurred.
    (ii) There is a written agreement in place between the hospital and 
the nonhospital site before the training begins that states that the 
hospital will incur at least 90 percent of the total of the costs of the 
resident's salary and fringe benefits (and travel and lodging where 
applicable) while the resident is training in the nonhospital site and 
the portion of the cost of the teaching physician's salary attributable 
to nonpatient care direct GME activities. The written agreement must 
specify the total cost of the training program at the nonhospital site, 
and the amount the hospital will incur (at least 90 percent of the 
total), and must indicate the portion of the amount the hospital will 
incur that reflects residents' salaries and fringe benefits (and travel 
and lodging where applicable), and the portion of this amount that 
reflects teaching physician compensation. Hospitals

[[Page 872]]

may modify the amounts specified in the written agreement by the end of 
the academic year (that is, June 30) to reflect that at least 90 percent 
of the costs of the training program in the nonhospital site has been 
incurred.
    (iii) If the hospital has in place an emergency Medicare GME 
affiliation agreement in accordance with Sec.  413.79(f)(6), during the 
period covered by the emergency Medicare GME affiliation agreement--
    (A) The hospital must pay all or substantially all of the costs of 
the training program in a nonhospital setting(s) attributable to 
training that occurs during a month by the end of the sixth month after 
the month in which the training in the nonhospital site occurs. For the 
costs that would otherwise be required to be incurred by the hospital 
during the period of August 29, 2005 through November 1, 2007, the 
participating hospital must incur the costs by April 29, 2008; or
    (B) There is a written agreement that specifies that the hospital 
will incur at least 90 percent of the total of the costs of the 
resident's salary and fringe benefits (and travel and lodging where 
applicable) while the resident is training in the nonhospital site and 
the portion of the cost of the teaching physician's salary attributable 
to nonpatient care direct GME activities. The written agreement must 
specify the total cost of the training program at the nonhospital site, 
and the amount the hospital will incur (at least 90 percent of the 
total), and must indicate the portion of the amount the hospital will 
incur that reflects residents' salaries and fringe benefits (and travel 
and lodging where applicable), and the portion of this amount that 
reflects teaching physician compensation. The written agreement must be 
submitted to the contractor by 180 days after the training at the 
nonhospital site begins. Hospitals may modify the amounts specified in 
the written agreement by the end of the academic year (that is, June 30) 
to reflect that at least 90 percent of the costs of the training program 
in the nonhospital site has been incurred. For written agreements that 
would otherwise be required to be submitted prior to the date the 
training begins in the nonhospital site during the period of August 29, 
2005 through November 1, 2007, the hospital must submit the written 
agreement to its contractor by April 29, 2008.
    (4) The hospital is subject to the principles of community support 
and redistribution of costs as specified in Sec.  413.81.
    (g) For cost reporting periods beginning on or after July 1, 2010, 
the time residents spend in nonprovider settings such as freestanding 
clinics, nursing homes, and physicians' offices in connection with 
approved programs may be included in determining the number of FTE 
residents in the calculation of a hospital's resident count if the 
following conditions are met--
    (1) The resident spends his or her time--
    (i) In patient care activities as defined at Sec.  413.75(b); or
    (ii) In nonpatient care activities, such as didactic conferences and 
seminars, but excluding research not associated with the treatment or 
diagnosis of a particular patient, in a nonprovider setting that is 
primarily engaged in furnishing patient care activities, as defined at 
Sec.  413.75(b).
    (2) The hospital or hospitals must incur the costs of the salaries 
and fringe benefits of the resident during the time the resident spends 
in the nonprovider setting. If more than one hospital incurs these 
costs, either directly or through a third party, the hospitals must 
count a proportional share of the time that residents train at the 
nonprovider setting(s) as recorded in a written agreement between the 
hospitals.
    (i) Hospitals must have a reasonable basis for establishing that 
proportion of the cost and the FTE time that each will incur and count.
    (ii) If hospitals already arrange payment to the nonprovider site 
via a written agreement as described in paragraph (g)(3)(ii) of this 
section, the proportion may be recorded in that agreement.
    (iii) If hospitals choose to pay the nonprovider site concurrently 
as described in paragraph (g)(3)(i) of this section, the hospitals must 
record the proportion of cost and FTE time they are incurring and 
counting in a written agreement between the hospitals.

[[Page 873]]

    (3) The hospital or hospitals must comply with one of the following:
    (i) The hospital or hospitals must incur the costs of the salaries 
and fringe benefits of the resident during the time the resident spends 
in the nonprovider setting by the end of the third month following the 
month in which the training in the nonprovider site occurred.
    (ii) There is a written agreement between the hospital or hospitals 
and the outside entity that states that the residents' salaries and 
fringe benefits (including travel and lodging where applicable) during 
the time the resident spends in the nonprovider setting is to be paid by 
the hospital(s). Hospitals may modify the amounts specified in the 
written agreement by the end of the academic year (that is, June 30) to 
reflect that the costs of the training program in the nonprovider site 
have been incurred.
    (4) The hospital is subject to the principles of community support 
and redistribution of costs as specified in Sec.  413.81.
    (5) For cost reporting periods beginning on or after July 1, 2010, a 
hospital must maintain and make available records of the FTE count 
determined for direct GME purposes under this section that its residents 
spend in nonprovider sites, in order to compare that time to the time 
spent by its residents in nonprovider sites in the base year of cost 
reporting periods beginning on or after July 1, 2009, and before June 
30, 2010. The hospital must supply the CMS contractor with the data for 
each of its primary care programs on a program-specific basis, and with 
data for its nonprimary care programs on an overall basis.
    (6) The provisions of paragraphs (g)(1)(ii), (g)(2), (g)(3), and 
(g)(5) of this section shall not be applied in a manner that requires 
reopening of any settled cost reports as to which there is not a 
jurisdictionally proper appeal pending as of March 23, 2010, on direct 
GME or IME payments. Cost reporting periods beginning before July 1, 
2010 are not governed by paragraph (g) of this section.
    (h) Effective for cost reporting periods beginning on or after 
January 1, 1983, the time spent by a resident in an approved medical 
residency program on vacation, sick leave, or other approved leave that 
does not prolong the total time the resident is participating in the 
approved program beyond the normal duration of the program is countable. 
This provision cannot be applied in a manner that would require the 
reopening of settled cost reports, except those cost reports on which 
there is a jurisdictionally proper appeal pending on direct GME or IME 
payments as of March 23, 2010.
    (i) For the time frame that the Public Health Emergency (as defined 
in Sec.  400.200 of this chapter) associated with COVID-19 was in 
effect, a sending hospital can include FTE residents training at another 
hospital in its FTE count if all of the following conditions are met.
    (1) The sending hospital sends the resident to the other hospital in 
response to the COVID-19 pandemic.
    (2) The time spent by the resident training at the other hospital is 
in lieu of time that would have been spent in approved training at the 
sending hospital.
    (3) The time that the resident spent training immediately prior to 
and/or subsequent to the time frame that the Public Health Emergency (as 
defined in Sec.  400.200 of this chapter) associated with COVID-19 was 
in effect is included in the FTE count for the sending hospital.

[69 FR 49254, Aug. 11, 2004, as amended at 71 FR 48142, Aug. 18, 2006; 
72 FR 26995, May 11, 2007; 72 FR 66931, Nov. 27, 2007; 75 FR 72262, Nov. 
24, 2010; 78 FR 50968, Aug. 19, 2013; 79 FR 50357, Aug. 22, 2014; 85 FR 
27623, May 8, 2020]



Sec.  413.79  Direct GME payments: Determination of the weighted number 
of FTE residents.

    Subject to the provisions in Sec.  413.80, CMS determines a 
hospital's number of FTE residents by applying a weighting factor to 
each resident and then summing the resulting numbers that represent each 
resident. The weighting factor is determined as follows:
    (a) Initial residency period. Generally, for purposes of this 
section, effective July 1, 1995, an initial residency period is defined 
as the minimum number of years required for board eligibility.
    (1) Prior to July 1, 1995, the initial residency period equals the 
minimum

[[Page 874]]

number of years required for board eligibility in a specialty or 
subspecialty plus 1 year. An initial residency period may not exceed 5 
years in order to be counted toward determining FTE status except in the 
case of a resident in an approved geriatric program whose initial 
residency period may last up to 2 additional years.
    (2) Effective October 1, 2003, for a resident who trains in an 
approved geriatric program that requires the residents to complete 2 
years of training to initially become board eligible in the geriatric 
specialty, the 2 years spent in the geriatrics program are treated as 
part of the resident's initial residency period.
    (3) Effective July 1, 2000, for residency programs that began 
before, on, or after November 29, 1999, the period of board eligibility 
and the initial residency period for a resident in an approved child 
neurology program is the period of board eligibility for pediatrics plus 
2 years.
    (4) Effective August 10, 1993, residents or fellows in an approved 
preventive medicine residency or fellowship program also may be counted 
as a full FTE resident for up to 2 additional years beyond the initial 
residency period limitations.
    (5) For combined residency programs, an initial residency period is 
defined as the time required for individual certification in the longer 
of the programs. If the resident is enrolled in a combined medical 
residency training program in which all of the individual programs (that 
are combined) are for training primary care residents (as defined in 
Sec.  413.75(b)) or obstetrics and gynecology residents, the initial 
residency period is the time required for individual certification in 
the longer of the programs plus 1 year.
    (6) For residency programs other than those specified in paragraphs 
(a)(2) through (a)(4) of this section, the initial residency period is 
the minimum number of years of formal training necessary to satisfy the 
requirements for initial board eligibility in the particular specialty 
for which the resident is training, as specified in the most recently 
published edition of the Graduate Medical Education Directory.
    (7) For residency programs in osteopathy, dentistry, and podiatry, 
the minimum requirement for certification in a specialty or subspecialty 
is the minimum number of years of formal training necessary to satisfy 
the requirements of the appropriate approving body listed in Sec.  
415.152 of this chapter.
    (8) For residency programs in geriatric medicine, accredited by the 
appropriate approving body listed in Sec.  415.152 of this chapter, 
these programs are considered approved programs on the later of--
    (i) The starting date of the program within a hospital; or
    (ii) The hospital's cost reporting periods beginning on or after 
July 1, 1985.
    (9) The time spent in residency programs that do not lead to 
certification in a specialty or subspecialty, but that otherwise meet 
the definition of approved programs, as described in Sec.  413.75(b), is 
counted toward the initial residency period limitation.
    (10) Effective for portions of cost reporting periods beginning on 
or after October 1, 2004, if a hospital can document that a resident 
simultaneously matched for one year of training in a particular 
specialty program, and for a subsequent year(s) of training in a 
different specialty program, the resident's initial residency period 
will be determined based on the period of board eligibility for the 
specialty associated with the program for which the resident matched for 
the subsequent year(s) of training. Effective for portions of cost 
reporting periods beginning on or after October 1, 2005, if a hospital 
can document that a particular resident, prior to beginning the first 
year of residency training, matched in a specialty program for which 
training would begin at the conclusion of the first year of training, 
that resident's initial residency period will be determined in the 
resident's first year of training based on the period of board 
eligibility associated with the specialty program for which the resident 
matched for subsequent training year(s).
    (b) Weighting factor. (1) If the resident is in an initial residency 
period, the weighting factor is one.
    (2) If the resident is not in an initial residency period, the 
weighting factor

[[Page 875]]

is 1.00 during the period beginning on or after July 1, 1985 and before 
July 1, 1986, .75 during the period beginning on or after July 1, 1986 
and before July 1, 1987, and .50 thereafter without regard to the 
hospital's cost reporting period.
    (c) Unweighted FTE counts--(1) Definitions. As used in this 
paragraph (c):
    (i) Otherwise applicable resident cap refers to a hospital's FTE 
resident cap that is determined for a particular cost reporting period 
under paragraph (c)(2) of this section.
    (ii)(A) For purposes of paragraph (c)(3) of this section, reference 
resident level refers to a hospital's resident level in the applicable 
reference period specified under paragraph (c)(3) of this section.
    (B) For purposes of paragraph (m) of this section, reference 
resident level means with respect to a hospital, the highest resident 
level for any of the three most recent cost reporting periods ending 
before March 23, 2010, for which a cost report has been either settled 
or submitted (subject to audit) to the Medicare contractor by March 23, 
2010.
    (iii) Resident level refers to the number of unweighted allopathic 
and osteopathic FTE residents who are training in a hospital in a 
particular cost reporting period.
    (2) Determination of the FTE resident cap. Subject to the provisions 
of paragraphs (c)(3) through (c)(6) and (m) through (o) of this section 
and Sec.  413.81, for purposes of determining direct GME payment--
    (i) For cost reporting periods beginning on or after October 1, 
1997, a hospital's resident level may not exceed the hospital's 
unweighted FTE count (or, effective for cost reporting periods beginning 
on or after April 1, 2000, 130 percent of the unweighted FTE count for a 
hospital located in a rural area) for these residents for the most 
recent cost reporting period ending on or before December 31, 1996.
    (ii) If a hospital's number of FTE residents in a cost reporting 
period beginning on or after October 1, 1997, and before October 1, 
2001, exceeds the limit described in this section, the hospital's total 
weighted FTE count (before application of the limit) will be reduced in 
the same proportion that the number of FTE residents for that cost 
reporting period exceeds the number of FTE residents for the most recent 
cost reporting period ending on or before December 31, 1996.
    (iii) If the hospital's number of FTE residents in a cost reporting 
period beginning on or after October 1, 2001 exceeds the limit described 
in this section, the hospital's weighted FTE count (before application 
of the limit) for primary care and obstetrics and gynecology residents 
and nonprimary care residents, respectively, will be reduced in the same 
proportion that the number of FTE residents for that cost reporting 
period exceeds the number of FTE residents for the most recent cost 
reporting period ending on or before December 31, 1996.
    (iv) Hospitals that are part of the same Medicare GME affiliated 
group or the same emergency Medicare GME affiliated group (as described 
under Sec.  413.75(b)) may elect to apply the limit on an aggregate 
basis as described under paragraph (f) of this section.
    (v) The contractor may make appropriate modifications to apply the 
provisions of this paragraph (c) of this section based on the equivalent 
of a 12-month cost reporting period.
    (3) Determination of the reduction to the FTE resident cap due to 
unused FTE resident slots under section 422 of Public Law 108-173. If a 
hospital's reference resident level is less than its otherwise 
applicable FTE resident cap as determined under paragraph (c)(2) of this 
section or paragraph (e) of this section in the reference cost reporting 
period (as described under paragraph (c)(3)(ii) of this section), for 
portions of cost reporting periods beginning on or after July 1, 2005, 
the hospital's otherwise applicable FTE resident cap is reduced by 75 
percent of the difference between the otherwise applicable FTE resident 
cap and the reference resident level. Under this provision--
    (i) Exemption for certain rural hospitals. A rural hospital, as 
defined at subpart D of part 412 of this subchapter, with less than 250 
beds (as determined at Sec.  412.105(b)) in its most recent cost 
reporting period ending on or before September 30, 2002, is exempt from 
any reduction to the otherwise

[[Page 876]]

applicable FTE resident cap limit under paragraph (c)(3) of this 
section.
    (ii) Reference cost reporting periods.
    (A) To determine a hospital's reference resident level, CMS uses one 
of the following periods:
    (1) A hospital's most recent cost reporting period ending on or 
before September 30, 2002, for which a cost report has been settled or 
if the cost report has not been settled, the as-submitted cost report 
(subject to audit); or
    (2) A hospital's cost reporting period that includes July 1, 2003 if 
the hospital submits a timely request to CMS to increase its resident 
level due to an expansion of an existing program and that expansion is 
not reflected on the hospital's most recent settled cost report. An 
expansion of an existing program means that, except for expansions due 
to newly approved programs under paragraph (c)(3)(ii)(A)(3) of this 
section, the number of unweighted allopathic and osteopathic FTE 
residents in any cost reporting period after the hospital's most recent 
settled cost report, up to and including the hospital's cost report that 
includes July 1, 2003, is greater than the number of unweighted 
allopathic and osteopathic FTE residents in programs that were existing 
at that hospital during the hospital's most recent settled cost report.
    (3) A hospital may submit a timely request that CMS adjust the 
resident level for purposes of determining any reduction under paragraph 
(c)(3) of this section for the following purposes:
    (i) In the hospital's reference cost reporting period under 
paragraph (c)(3)(ii)(A)(1) of this section, to include the number of FTE 
residents for which a new program was accredited by the appropriate 
allopathic or osteopathic accrediting body (listed under Sec.  415.152 
of this chapter) before January 1, 2002, if the program was not in 
operation during the reference cost reporting period under paragraph 
(c)(3)(ii)(A)(1); or
    (ii) In the hospital's reference cost reporting period under 
paragraph (c)(3)(ii)(A)(2) of this section, to include the number of FTE 
residents for which a new program was accredited by the appropriate 
allopathic or osteopathic accrediting body (listed under Sec.  415.152 
of this chapter) before January 1, 2002, if the program was not in 
operation during the cost reporting period that includes July 1, 2003, 
and if the hospital also qualifies to use its cost report under 
paragraph (c)(3)(ii)(A)(2) of this section due to an expansion of an 
existing program.
    (B) If the cost report that is used to determine a hospital's 
otherwise applicable FTE resident cap in the reference period is not 
equal to 12 months, the contractor may make appropriate modifications to 
apply the provisions of paragraph (c)(3)(i)(A) of this section based on 
the equivalent of a 12-month cost reporting period.
    (iii) If the new program described in paragraph (c)(3)(ii)(A)(3)(i) 
or paragraph (c)(3)(ii)(A)(ii) was accredited for a range of residents, 
the hospital may request that its reference resident level in its 
applicable reference cost reporting period under paragraph 
(c)(3)(ii)(A)(1) or (c)(3)(ii)(A)(2) of this section be adjusted to 
reflect the maximum number of accredited slots applicable to that 
hospital.
    (iv) Consideration of Medicare GME affiliated group agreements. For 
hospitals that are members of the same affiliated group for the program 
year July 1, 2003 through June 30, 2004, in determining whether a 
hospital's otherwise applicable resident FTE resident cap is reduced 
under paragraph (c)(3) of this section, CMS treats these hospitals as a 
group. Using information from the hospitals' cost reports that include 
July 1, 2003, if the hospitals' aggregate FTE resident counts are equal 
to or greater than the aggregate otherwise applicable FTE resident cap 
for the affiliated group, then no reductions are made under paragraph 
(c)(3) of this section to the hospitals' otherwise applicable FTE 
resident caps. If the hospitals' aggregate FTE resident count is below 
the aggregate otherwise applicable FTE resident cap, then CMS determines 
on a hospital-specific basis whether the individual hospital's FTE 
resident count is less than its otherwise applicable resident cap (as 
adjusted by affiliation agreement(s)) in the hospital's cost report that 
includes July 1, 2003. If the hospital's FTE resident count is in excess 
of its otherwise

[[Page 877]]

applicable FTE resident cap, the hospital will not have its otherwise 
applicable FTE resident cap reduced under paragraph (c)(3) of this 
section. Hospitals in the affiliated group that have FTE resident counts 
below their individual otherwise applicable FTE resident caps are 
subject to a pro rata reduction in their otherwise applicable FTE 
resident caps that is equal, in total, to 75 percent of the difference 
between the aggregate FTE cap and the aggregate FTE count for the 
affiliated group. The pro rata reduction to the individual hospital's 
otherwise applicable resident cap is calculated by dividing the 
difference between the hospital's individual otherwise applicable FTE 
resident cap and the hospital's FTE resident count by the total amount 
by which all of the hospitals' individual FTE resident counts are below 
their otherwise affiliated FTE resident caps, multiplying the quotient 
by the difference between the aggregate FTE resident cap and the 
aggregate FTE resident counts for the affiliated group, and multiplying 
that result by 75 percent.
    (4) Determination of an increase in the otherwise applicable 
resident cap under section 422 of Public Law 108-173. For portions of 
cost reporting periods beginning on or after July 1, 2005, a hospital 
may receive an increase in its otherwise applicable FTE resident cap up 
to an additional 25 FTEs (as determined by CMS) if the hospital meets 
the requirements and qualifying criteria of section 1886(h)(7) of the 
Act and implementing instructions issued by CMS and if the hospital 
submits an application to CMS within the timeframe specified by CMS.
    (5) Special rules for hospitals that participate in demonstration 
projects or voluntary resident reduction plans for purposes of section 
422 of Public Law 108-173. (i) If a hospital was participating in a 
demonstration project under section 402 of Public Law 90-248 or the 
voluntary reduction plan under Sec.  413.88 for a greater period of time 
than the time period that elapsed since it withdrew from participation 
(or if it completed its participation) in the demonstration program or 
the voluntary reduction plan, for purposes of determining a possible 
reduction to the FTE resident caps under paragraph (c)(3) of this 
section, CMS compares the higher of the hospital's base number of 
residents (after subtracting any dental and podiatric FTE residents) or 
the hospital's reference resident level to the hospital's otherwise 
applicable resident cap determined under paragraph (c)(2) of this 
section.
    (ii) If a hospital participated in the demonstration project or the 
voluntary resident reduction plan for a period of time that is less than 
the time that elapsed since it withdraw from participation in the 
demonstration project or the voluntary reduction plan, the special rules 
in paragraph (c)(5)(i) do not apply, and the hospital is subject to the 
procedures applicable to all other hospitals for determining possible 
reductions to the FTE resident caps under paragraph (c)(3) of this 
section.
    (iii) CMS will not redistribute residency positions that are 
attributable to a hospital's participation in a demonstration project or 
a voluntary resident reduction plan to other hospitals that seek to 
increase their FTE resident caps under paragraph (c)(4) of this section.
    (6) FTE resident caps for rural hospitals that are redesignated as 
urban. A rural hospital redesignated as urban after September 30, 2004, 
as a result of the most recent census data and implementation of the new 
MSA definitions announced by OMB on June 6, 2003, may retain the 
increases to its FTE resident cap that it received under paragraphs 
(c)(2)(i), (e)(1)(iii), and (e)(3) of this section while it was located 
in a rural area. Effective October 1, 2014, if a rural hospital is 
redesignated as urban due to the most recent OMB standards for 
delineating statistical areas adopted by CMS, the redesignated urban 
hospital may retain any existing increases to its FTE resident cap that 
it had received prior to when the redesignation became effective. 
Effective October 1, 2014, if a rural hospital is redesignated as urban 
due to the most recent OMB standards for delineating statistical areas 
adopted by CMS, the redesignated urban hospital may receive an increase 
to its FTE resident cap for a new program, in accordance with paragraph 
(e) of this section, if it received a letter of accreditation for the 
new

[[Page 878]]

program and/or started training residents in the new program prior to 
the redesignation becoming effective.
    (d) Weighted FTE counts. Subject to the provisions of Sec.  413.81, 
for purposes of determining direct GME payment--
    (1) For the hospital's first cost reporting period beginning on or 
after October 1, 1997, the hospital's weighted FTE count is equal to the 
average of the weighted FTE count for the payment year cost reporting 
period and the preceding cost reporting period.
    (2) For cost reporting periods beginning on or after October 1, 
1998, and before October 1, 2001, the hospital's weighted FTE count is 
equal to the average of the weighted FTE count for the payment year cost 
reporting period and the preceding two cost reporting periods.
    (3) For cost reporting periods beginning on or after October 1, 
2001, the hospital's weighted FTE count for primary care and obstetrics 
and gynecology residents is equal to the average of the weighted primary 
care and obstetrics and gynecology counts for the payment year cost 
reporting period and the preceding two cost reporting periods, and the 
hospital's weighted FTE count for nonprimary care residents is equal to 
the average of the weighted nonprimary care FTE counts for the payment 
year cost reporting period and the preceding two cost reporting periods.
    (4) The contractor may make appropriate modifications to apply the 
provisions of this paragraph (d) based on the equivalent of 12-month 
cost reporting periods.
    (5) (i) For new programs started prior to October 1, 2012, if a 
hospital qualifies for an adjustment to the limit established under 
paragraph (c)(2) of this section for new medical residency programs 
created under paragraph (e) of this section, the count of the residents 
participating in new medical residency training programs above the 
number included in the hospital's FTE count for the cost reporting 
period ending during calendar year 1996 is added after applying the 
averaging rules in this paragraph (d), for a period of years. Residents 
participating in new medical residency training programs are included in 
the hospital's FTE count before applying the averaging rules after the 
period of years has expired. For purposes of this paragraph (d), for 
each new program started, the period of years equals the minimum 
accredited length for each new program. The period of years begins when 
the first resident begins training in each new program.
    (ii) For new programs started on or after October 1, 2012, for 
hospitals for which the FTE cap may be adjusted in accordance with Sec.  
413.79(e), FTE residents participating in new medical residency training 
programs are excluded from the hospital's FTE count before applying the 
averaging rules during the cost reporting periods prior to the beginning 
of the applicable hospital's cost reporting period that coincides with 
or follows the start of the sixth program year of the first new program 
started, for hospitals for which the FTE may be adjusted in accordance 
with Sec.  413.79(e)(1), and prior to the beginning of the applicable 
hospital's cost reporting period that coincides with or follows the 
start of the sixth program year of the each individual new program 
started, for hospitals for which the FTE cap may be adjusted in 
accordance with Sec.  413.79(e)(3). Beginning with the applicable 
hospital's cost reporting period that coincides with or follows the 
start of the sixth program year of the first new program started for 
hospitals for which the FTE cap may be adjusted in accordance with Sec.  
413.79(e)(1), and beginning with the applicable hospital's cost 
reporting period that coincides with or follows the start of the sixth 
program year of the each individual new program started for hospitals 
for which the FTE cap may be adjusted in accordance with Sec.  
413.79(e)(3), FTE residents participating in new medical residency 
training programs are included in the hospital's FTE count before 
applying the averaging rules.
    (6)(i) Subject to the provisions of paragraph (h) of this section, 
FTE residents who are displaced by the closure of either another 
hospital or another hospital's program are added to the FTE count after 
applying the averaging rules in this paragraph (d), for the receiving 
hospital for the duration

[[Page 879]]

of the time that the displaced residents are training at the receiving 
hospital.
    (ii) If a hospital receives a permanent increase in its FTE resident 
cap under paragraph (o)(1) of this section due to redistribution of 
slots from a closed hospital, the displaced FTE residents that the 
hospital receives are added to the FTE count after applying the 
averaging rules only in the first cost reporting period in which the 
receiving hospital trains the displaced FTE residents. In subsequent 
cost reporting periods, the displaced FTE residents are included in the 
receiving hospital's rolling average calculation.
    (7) Subject to the provisions under paragraph (k) of this section, 
effective for cost reporting periods beginning on or after April 1, 
2000, FTE residents in a rural track program at an urban hospital are 
included in the urban hospital's rolling average calculation described 
in this paragraph (d).
    (e) New medical residency training programs. If a hospital 
establishes a new medical residency training program as defined in 
paragraph (l) of this section on or after January 1, 1995, the 
hospital's FTE cap described under paragraph (c) of this section may be 
adjusted as follows:
    (1) If a hospital had no allopathic or osteopathic residents in its 
most recent cost reporting period ending on or before December 31, 1996, 
and it begins training residents in a new medical residency training 
program(s) for the first time on or after January 1, 1995, but before 
October 1, 2012, the hospital's unweighted FTE resident cap under 
paragraph (c) of this section may be adjusted for new residency training 
programs based on the sum of the products of the highest number of FTE 
residents in any program year during the third year of the first new 
program's existence and the number of years in which residents are 
expected to complete the program based on the minimum accredited length 
for each type of program. The adjustment to the cap may not exceed the 
number of accredited slots available to the hospital for the new 
program. If a hospital had no allopathic or osteopathic residents in its 
most recent cost reporting period ending on or before December 31, 1996, 
and it begins training residents in a new medical residency training 
program(s) for the first time on or after October 1, 2012, the 
hospital's unweighted FTE resident cap under paragraph (c) of this 
section may be adjusted for new residency training programs based on the 
sum of the products of the highest number of FTE residents in any 
program year during the fifth year of the first new program's existence 
and the number of years in which residents are expected to complete the 
program based on the minimum accredited length for each type of program. 
The adjustment to the cap may not exceed the number of accredited slots 
available to the hospital for the new program.
    (i) If a hospital begins training residents in a new medical 
residency training program(s) for the first time on or after January 1, 
1995, but before October 1, 2012, and if the residents are spending 
portions of a program year (or years) at one hospital and the remainder 
of the program at another hospital(s), the adjustment to each qualifying 
hospital's cap for a new medical residency training program(s) is equal 
to the sum of the products of the highest number of FTE residents in any 
program year during the third year of the first new program's existence 
and the number of years in which residents are expected to complete the 
program based on the minimum accredited length for each type of program 
and the number of years the residents are training at each respective 
hospital. If a hospital begins training residents in a new medical 
residency training program(s) for the first time on or after October 1, 
2012, and if the residents are spending portions of a program (or years) 
at one hospital and the remainder of the program at another hospital(s), 
the adjustment to each qualifying hospital's cap for new residency 
training program (s) is equal to the sum of the products of three 
factors (limited to the number of accredited slots for each program):
    (A) The highest total number of FTE residents trained in any program 
year during the fifth year of the first new program's existence at all 
of the hospitals to which the residents in the program rotate;

[[Page 880]]

    (B) The number of years in which residents are expected to complete 
the program, based on the minimum accredited length for each type of 
program.
    (C) The ratio of the number of FTE residents in the new program that 
trained at the hospital over the entire 5-year period to the total 
number of FTE residents that trained at all hospitals over the entire 5-
year period.
    (ii) If a hospital begins training residents in a new medical 
residency training program(s) for the first time on or after January 1, 
1995, but before October 1, 2012, prior to the implementation of the 
hospital's adjustment to its FTE cap beginning with the fourth year of 
the hospital's first new residency program(s), the hospital's cap may be 
temporarily adjusted during each of the first 3 years of the hospital's 
first new residency program using the actual number of residents 
participating in the new program. The adjustment may not exceed the 
number of accredited slots available to the hospital for each program 
year. If a hospital begins training residents in a new medical residency 
training program(s) for the first time on or after October 1, 2012, 
prior to the implementation of the hospital's adjustment to its FTE cap 
beginning with the sixth year of the hospital's first new residency 
program(s), the hospital's cap may be adjusted temporarily during each 
of the first 5 years of the hospital's first new residency program using 
the actual number of FTE residents participating in the new program. The 
adjustment may not exceed the number of accredited slots available to 
the hospital for each program year.
    (iii) If a hospital begins training residents in a new medical 
residency training program for the first time on or after January 1, 
1995, but before October 1, 2012, the cap will not be adjusted for new 
programs established more than 3 years after residents begin training in 
the first new program, or if a hospital begins training residents in a 
new medical residency training program for the first time on or after 
October 1, 2012, the cap will not be adjusted for new programs 
established more than 5 years after residents begin training in the 
first new program.
    (iv)(A) Effective for Medicare GME affiliation agreements entered 
into on or after October 1, 2005, exceptas provided in paragraph 
(e)(1)(iv)(B) of this section, an urban hospital that qualifies for an 
adjustment to its FTE cap under paragraph (e)(1) of this section is 
permitted to be part of a Medicare GME affiliated group for purposes of 
establishing an aggregate FTE cap only if the adjustment that results 
from the affiliation is an increase to the urban hospital's FTE cap.
    (B) Effective for Medicare GME affiliation agreements entered into 
on or after July 1, 2019, an urban hospital that qualifies for an 
adjustment to its FTE cap under paragraph (e)(1) of this section is 
permitted to be part of a Medicare GME affiliated group for purposes of 
establishing an aggregate FTE cap and receive an adjustment that is a 
decrease to the urban hospital's FTE cap, provided the Medicare GME 
affiliated group meets one of the following conditions:
    (1) The Medicare GME affiliated group consists solely of two or more 
urban hospitals that qualify for adjustments to their FTE caps under 
paragraph (e)(1) of this section.
    (2) The Medicare GME affiliated group includes an urban hospital(s) 
that received FTE cap(s) under paragraph (c)(2)(i) of this section or 
Sec.  412.105(f)(1)(iv)(A) of this subchapter, or both. This Medicare 
GME affiliated group must be established effective with a July 1 date 
(the residency training year) that is at least 5 years after the start 
of the cost reporting period that coincides with or follows the start of 
the sixth program year of the first new program for which the hospital's 
FTE cap was adjusted in accordance with paragraph (e)(1) of this section 
or Sec.  412.105(f)(1)(v)(C) or (D) of this subchapter, or both.
    (v) A rural hospital that qualifies for an adjustment to its FTE cap 
under paragraph (e)(1) of this section is permitted to be part of a 
Medicare GME affiliated group for purposes of establishing an aggregate 
FTE cap.
    (2) If a hospital had allopathic or osteopathic residents in its 
most recent cost reporting period ending on or before December 31, 1996, 
the hospital's unweighted FTE cap may be adjusted

[[Page 881]]

for a new medical residency training program(s) established on or after 
January 1, 1995, and on or before August 5, 1997. The adjustment to the 
hospital's FTE resident cap for new residency training programs is based 
on the sum of the product of the highest number of FTE residents in any 
program year during the third year of the newly established program and 
the number of years in which residents are expected to complete each 
program based on the minimum accredited length for the type of program.
    (i) If the residents are spending portions of a program year (or 
years) at one hospital and the remainder of the program at another 
hospital(s), the adjustment to each respective hospital's cap for each 
program is equal to the product of the highest number of FTE residents 
in any program year during the third year of each program's existence 
and the number of years in which residents are expected to complete the 
program based on the minimum accredited length for each type of program 
and the number of years the residents are training at each respective 
hospital.
    (ii) Prior to the implementation of the hospital's adjustment to its 
FTE cap beginning with the fourth year of the hospital's residency 
program, the hospital's cap may be temporarily adjusted during each of 
the first 3 years of the hospital's new residency program, using the 
actual number of FTE residents in the new programs. The adjustment may 
not exceed the number of accredited slots available to the hospital for 
each program year.
    (3) If a rural hospital participates in new medical residency 
training programs, regardless of whether the rural hospital had 
allopathic or osteopathic residents in its most recent cost reporting 
period ending on or before December 31, 1996, the hospital's unweighted 
FTE cap may be adjusted in the same manner described in paragraph (e)(2) 
of this section to reflect the increase for residents training in a new 
medical residency training program(s) established after August 5, 1997 
and before October 1, 2012. If a rural hospital participates in new 
medical residency training programs on or after October 1, 2012, the 
hospital's unweighted FTE cap is adjusted in accordance with paragraph 
(e)(1) of this section, except that the adjustment is based on the sum 
of the products of the highest number of FTE residents in any program 
year during the fifth year of each new program's existence and the 
number of years in which residents are expected to complete the program 
based on the minimum accredited length for each type of program.
    (4) A hospital seeking an adjustment to its FTE cap must provide 
documentation to its fiscal contractor justifying the adjustment.
    (5) The cap will not be adjusted for expansion of existing or 
previously existing programs.
    (f) Medicare GME affiliated group. A hospital may receive a 
temporary adjustment to its FTE cap, which is subject to the averaging 
rules under paragraph (d) of this section, to reflect residents added or 
subtracted because the hospital is participating in a Medicare GME 
affiliated group (as defined under Sec.  413.75(b)). Under this 
provision--
    (1) Except as provided in paragraph (f)(6) of this section, each 
hospital in the Medicare GME affiliated group must submit the Medicare 
GME affiliation agreement, as defined under Sec.  413.75(b) of this 
section, to the CMS contractor or MAC servicing the hospital and send a 
copy to the CMS Central Office no later than July 1 of the residency 
program year during which the Medicare GME affiliation agreement will be 
in effect.
    (2) Each hospital in the Medicare GME affiliated group must have a 
shared rotational arrangement, as defined in Sec.  413.75(b), with at 
least one other hospital within the Medicare GME affiliated group, and 
all of the hospitals within the Medicare GME affiliated group must be 
connected by a series of such shared rotational arrangements.
    (3) During the shared rotational arrangements under a Medicare GME 
affiliation agreement, as defined in Sec.  413.75(b), more than one of 
the hospitals in the Medicare GME affiliated group must count the 
proportionate amount of the time spent by the resident(s) in its FTE 
resident counts. No resident may be counted in the aggregate as more 
than one FTE.

[[Page 882]]

    (4) The net effect of the adjustments (positive or negative) on the 
Medicare GME affiliated hospitals' aggregate FTE cap for each Medicare 
GME affiliation agreement must not exceed zero.
    (5) If the Medicare GME affiliation agreement terminates for any 
reason, the FTE cap of each hospital in the Medicare GME affiliated 
group will revert to the individual hospital's pre-affiliation FTE cap 
that is determined under the provisions of paragraph (c) of this 
section.
    (6) Effective October 1, 2009, a hospital that is new after July 1 
and begins training residents for the first time after the July 1 start 
date of an academic year may receive a temporary adjustment to its FTE 
resident cap to reflect its participation in an existing Medicare GME 
affiliated group by submitting the Medicare GME affiliation agreement, 
as defined under Sec.  413.75(b), to the CMS contractor or MAC servicing 
the hospital and sending a copy to the CMS Central Office by the earlier 
of June 30 of the residency program year during which the Medicare GME 
affiliation agreement will be in effect or the end of the first cost 
reporting period during which the hospital begins training residents. 
The Medicare GME affiliation agreement must specify the effective period 
for the agreement, which may begin no earlier than the date the 
affiliation agreement is submitted to CMS. Each of the other hospitals 
participating in the Medicare GME affiliated group must submit an 
amended Medicare GME affiliation agreement that reflects the 
participation of the new hospital to the CMS contractor or MAC servicing 
the hospital and send a copy to the CMS Central Office no later than 
June 30 of the residency program year during which the Medicare GME 
affiliation agreement will be in effect. For purposes of this paragraph, 
a new hospital is one for which a new Medicare provider agreement takes 
effect in accordance with Sec.  489.13 of this chapter.
    (7) Emergency Medicare GME affiliated group. Effective on or after 
August 29, 2005, home and host hospitals as defined in Sec.  413.75(b) 
may form an emergency Medicare GME affiliated group by meeting the 
requirements provided in this section. The emergency Medicare GME 
affiliation agreements may be made effective beginning on or after the 
first day of a section 1135 emergency period, and must terminate no 
later than at the conclusion of 4 academic years following the academic 
year during which the section 1135 emergency period began.
    (i) Requirements for submission of emergency Medicare GME 
affiliation agreements. Each hospital in the emergency Medicare GME 
affiliated group must submit an emergency Medicare GME affiliation 
agreement that is written, signed, and dated by responsible 
representatives of each participating hospital in the manner specified 
in paragraph (ii) and includes the following information:
    (A) List each participating hospital and its provider number; and 
indicate whether each hospital is a home or host hospital.
    (B) Specify the effective period of the emergency Medicare GME 
affiliation agreement (which must, in any event, terminate at the 
conclusion of four academic years following the academic year in which 
the section 1135 emergency period began).
    (C) List each participating hospital's IME and direct GME FTE caps 
in effect before the emergency Medicare GME affiliation agreement 
(including any adjustments to those caps in effect as a result of other 
Medicare GME affiliation agreements but not including any slots gained 
under Sec.  413.79(c)(4)).
    (D) Specify the total adjustment to each participating hospital's 
FTE caps in each academic year that the emergency Medicare GME 
affiliation agreement is in effect, for both direct GME and IME, that 
reflects a positive adjustment to the host hospital's direct and 
indirect FTE caps that is offset by a negative adjustment to the home 
hospital's (or hospitals') direct and indirect FTE caps of at least the 
same amount subject to the following--
    (1) The sum total of adjustments to all the participating hospitals' 
FTE caps under the emergency Medicare GME affiliation agreement may not 
exceed the aggregate adjusted FTE caps of the hospitals participating in 
the emergency Medicare GME affiliated group.

[[Page 883]]

    (2) A home hospital's IME and direct GME FTE cap reductions in an 
emergency Medicare GME affiliation agreement are limited to the home 
hospital's IME and direct GME FTE resident caps at Sec.  413.79(c) or 
Sec.  413.79(f)(1) through (f)(5), that is, as adjusted by any and all 
existing affiliation agreements as applicable.
    (3) For emergency Medicare GME affiliation agreements for the third 
or fourth academic years subsequent to the year in which the section 
1135 emergency period began and involving an out-of-State host hospital, 
the positive adjustment to the out-of-State host hospital's direct and 
indirect FTE caps pursuant to the agreement shall reflect only FTE 
residents that were actually displaced from a home hospital immediately 
following the emergency.
    (E) Attach copies of all existing Medicare GME affiliation 
agreements and emergency Medicare GME affiliation agreements in which 
the hospital is participating at the time the emergency Medicare GME 
affiliation agreement is executed.
    (ii) Deadline for submission of the emergency Medicare GME 
affiliation agreement. Each participating home and host hospital must 
submit an emergency Medicare GME affiliation agreement to CMS and submit 
a copy to the CMS contractor/MAC by the applicable due date.
    (A) For emergency Medicare GME affiliation agreements that would 
otherwise be required to be submitted by June 30, 2006, or July 1, 2006, 
each participating host and home hospital must submit an emergency 
Medicare GME affiliation agreement to CMS and submit a copy to its CMS 
contractor/MAC on or before October 9, 2006.
    (B) Except for emergency Medicare GME affiliation agreements 
specified in paragraph (f)(6)(ii)(A) of this section, for emergency 
Medicare GME affiliation agreements that would otherwise be required to 
be submitted prior to October 1, 2008, the following due dates are 
applicable:
    (1) First year. The later of 180 days after the section 1135 
emergency period begins or by June 30 of the academic year in which the 
section 1135 emergency was declared; or
    (2) Subsequent academic years. The later of 180 days after the 
section 1135 emergency period begins, or by July 1 of each academic 
year.
    (C) For emergency Medicare GME affiliation agreements that would 
otherwise be required to be submitted after October 1, 2008, the 
following due dates are applicable:
    (1) First year. By 180 days after the end of the academic year in 
which the section 1135 emergency was declared;
    (2) Second academic year. By 180 days after the end of the next 
academic year following the academic year in which the section 1135 
emergency was declared; or
    (3) Subsequent academic years. By July 1 of each academic year.
    (iii) Exemption from the Shared Rotational Arrangement Requirement. 
During the effective period of the emergency Medicare GME affiliation 
agreement, hospitals in the emergency Medicare GME affiliated group are 
not required to participate in a shared rotational arrangement as 
defined at Sec.  413.75(b).
    (iv) Host Hospital Exception from the Rolling Average for the Period 
from August 29, 2005 to June 30, 2006. To determine the FTE resident 
count for a host hospital that is training residents in excess of its 
cap, a two step process will be applied. First, subject to the limit at 
paragraph (f)(6)(i)(D) of this section, a host hospital is to exclude 
the displaced FTE residents that are counted by a host hospital in 
excess of the hospital's cap pursuant to an emergency Medicare GME 
affiliation agreement from August 29, 2005, to June 30, 2006, from the 
current year's FTE resident count before applying the three-year rolling 
averaging rules under paragraph (d) of this section to calculate the 
average FTE resident count. Second, the displaced FTE residents that are 
counted by the host hospital in excess of the host hospital's cap 
pursuant to an emergency Medicare GME affiliation agreement from August 
29, 2005, to June 30, 2006, are added to the hospital's 3-year rolling 
average FTE resident count to determine the host hospital's FTE resident 
count for payment purposes.

[[Page 884]]

    (g) Newly constructed hospitals. A hospital that began construction 
of its facility prior to August 5, 1997, and sponsored new medical 
residency training programs on or after January 1, 1995, and on or 
before August 5, 1997, that either received initial accreditation by the 
appropriate accrediting body or temporarily trained residents at another 
hospital(s) until the facility was completed, may receive an adjustment 
to its FTE cap.
    (1) The newly constructed hospital's FTE cap is equal to the lesser 
of--
    (i) The product of the highest number of residents in any program 
year during the third year of the newly established program and the 
number of years in which residents are expected to complete the programs 
based on the minimum accredited length for each type of program; or
    (ii) The number of accredited slots available to the hospital for 
each year of the programs.
    (2) If the new medical residency training programs sponsored by the 
newly constructed hospital have been in existence for 3 years or more by 
the time the residents begin training at the newly constructed hospital, 
the newly constructed hospital's cap will be based on the number of 
residents training in the third year of the programs begun at the 
temporary training site.
    (3) If the new medical residency training programs sponsored by the 
newly constructed hospital have been in existence for less than 3 years 
by the time the residents begin training at the newly constructed 
hospital, the newly constructed hospital's cap will be based on the 
number of residents training at the newly constructed hospital in the 
third year of the programs (including the years at the temporary 
training site).
    (4) A hospital that qualifies for an adjustment to its FTE cap under 
this paragraph (g) may be part of an affiliated group for purposes of 
establishing an aggregate FTE cap.
    (5) The provisions of this paragraph (g) are applicable during 
portions of cost reporting periods occurring on or after October 1, 
1999.
    (h) Closure of hospital or hospital residency program--(1) 
Definitions. For purposes of this section--
    (i) Closure of a hospital means the hospital terminates its Medicare 
agreement under the provisions of Sec.  489.52 of this chapter.
    (ii) Closure of a hospital residency training program means the 
hospital ceases to offer training for residents in a particular approved 
medical residency training program.
    (iii) Displaced resident means a resident who--
    (A) Leaves a program after the hospital or program closure is 
publicly announced, but before the actual hospital or program closure;
    (B) Is assigned to and training at planned rotations at another 
hospital who will be unable to return to his/her rotation at the closing 
hospital or program;
    (C) Is accepted into a GME program at the closing hospital or 
program but has not yet started training at the closing hospital or 
program;
    (D) Is physically training in the hospital on the day prior to or 
day of program or hospital closure; or
    (E) Is on approved leave at the time of the announcement of closure 
or actual closure, and therefore, cannot return to his/her rotation at 
the closing hospital or program.
    (2) Closure of a hospital. A hospital may receive a temporary 
adjustment to its FTE cap to reflect residents added because of another 
hospital's closure if the hospital meets the following criteria:
    (i) The hospital is training additional residents from a hospital 
that closed on or after July 1, 1996.
    (ii) No later than 60 days after the hospital begins to train the 
residents, the hospital submits a request to its contractor for a 
temporary adjustment to its FTE cap, documents that the hospital is 
eligible for this temporary adjustment by identifying the residents who 
have come from the closed hospital and have caused the hospital to 
exceed its cap, and specifies the length of time the adjustment is 
needed.
    (3) Closure of a hospital's residency training program. If a 
hospital that closes its residency training program

[[Page 885]]

voluntarily agrees to temporarily reduce its FTE cap according to the 
criteria specified in paragraph (h)(3)(ii) of this section, another 
hospital(s) may receive a temporary adjustment to its FTE cap to reflect 
residents added because of the closure of the residency training program 
if the criteria specified in paragraph (h)(3)(i) of this section are 
met.
    (i) Receiving hospital(s). A hospital may receive a temporary 
adjustment to its FTE cap to reflect residents added because of the 
closure of another hospital's residency training program if--
    (A) The hospital is training additional residents from the residency 
training program of a hospital that closed a program; and
    (B) No later than 60 days after the hospital begins to train the 
residents, the hospital submits to its contractor a request for a 
temporary adjustment to its FTE cap, documents that it is eligible for 
this temporary adjustment by identifying the residents who have come 
from another hospital's closed program and have caused the hospital to 
exceed its cap, specifies the length of time the adjustment is needed, 
and submits to its contractor a copy of the FTE reduction statement by 
the hospital that closed its program, as specified in paragraph 
(h)(3)(ii)(B) of this section.
    (ii) Hospital that closed its program(s). A hospital that agrees to 
train residents who have been displaced by the closure of another 
hospital's program may receive a temporary FTE cap adjustment only if 
the hospital with the closed program--
    (A) Temporarily reduces its FTE cap based on the FTE residents in 
each program year training in the program at the time of the program's 
closure. This yearly reduction in the FTE cap will be determined based 
on the number of those residents who would have been training in the 
program during that year had the program not closed; and
    (B) No later than 60 days after the residents who were in the closed 
program begin training at another hospital, submit to its contractor a 
statement signed and dated by its representative that specifies that it 
agrees to the temporary reduction in its FTE cap to allow the hospital 
training the displaced residents to obtain a temporary adjustment to its 
cap; identifies the residents who were in training at the time of the 
program's closure; identifies the hospitals to which the residents are 
transferring once the program closes; and specifies the reduction for 
the applicable program years.
    (i) Additional FTEs for residents on maternity or disability leave 
or other approved leave of absence. Effective for cost reporting periods 
beginning on or after November 29, 1999, a hospital may receive an 
adjustment to its FTE cap of up to three additional resident FTEs, if 
the hospital meets the following criteria:
    (1) The additional residents are residents of a primary care program 
that would have been counted by the hospital as residents for purposes 
of the hospital's FTE cap but for the fact that the additional residents 
were on maternity or disability leave or a similar approved leave of 
absence during the hospital's most recent cost reporting period ending 
on or before December 31, 1996;
    (2) The leave of absence was approved by the residency program 
director to allow the residents to be absent from the program and return 
to the program after the leave of absence; and
    (3) No later than 6 months after August 1, 2000, the hospital 
submits to the contractor a request for an adjustment to its FTE cap, 
and provides contemporaneous documentation of the approval of the leave 
of absence by the residency director, specific to each additional 
resident that is to be counted for purposes of the adjustment.
    (j) Residents previously trained at VA hospitals. For cost reporting 
periods beginning on or after October 1, 1997, a non-Veterans Affairs 
(VA) hospital may receive a temporary adjustment to its FTE cap to 
reflect residents who had previously trained at a VA hospital and were 
subsequently transferred to the non-VA hospital, if that hospital meets 
the following criteria:
    (1) The transferred residents had been training previously at a VA 
hospital in a program that would have lost its accreditation by the 
ACGME if the residents continued to train at the VA hospital;

[[Page 886]]

    (2) The residents were transferred to the hospital from the VA 
hospital on or after January 1, 1997, and before July 31, 1998; and
    (3) The hospital submits a request to its contractor for a temporary 
adjustment to its FTE cap, documents that it is eligible for this 
temporary adjustment by identifying the residents who have come from the 
VA hospital, and specifies the length of time those residents will be 
trained at the hospital.
    (k) Residents training in rural track programs. Subject to the 
provisions of Sec.  413.81, an urban hospital that establishes a new 
residency program, or has an existing residency program, with a rural 
track (or an integrated rural track) may include in its FTE count 
residents in those rural tracks, in addition to the residents subject to 
its FTE cap specified under paragraph (c) of this section. An urban 
hospital with a rural track residency program may count residents in 
those rural tracks up to a rural track FTE limitation if the hospital 
complies with the conditions specified in paragraphs (k)(2) through 
(k)(7) of this section.
    (1) If an urban hospital rotates residents to a separately 
accredited rural track program at a rural hospital(s) for two-thirds of 
the duration of the program for cost reporting periods beginning on or 
after April 1, 2000, and before October 1, 2003, or for more than one-
half of the duration of the program for cost reporting periods beginning 
on or after October 1, 2003, the urban hospital may include those 
residents in its FTE count for the time the rural track residents spend 
at the urban hospital. The urban hospital may include in its FTE count 
those residents in the rural track training at the urban hospital, not 
to exceed its rural track FTE limitation, determined as follows:
    (i) For rural track programs started prior to October 1, 2012, for 
the first 3 years of the rural track's existence, the rural track FTE 
limitation for each urban hospital will be the actual number of FTE 
residents, subject to the rolling average at paragraph (d)(7) of this 
section, training in the rural track at the urban hospital. For rural 
track programs started on or after October 1, 2012, prior to the start 
of the urban hospital's cost reporting period that coincides with or 
follows the start of the sixth program year of the rural track's 
existence, the rural track FTE limitation for each urban hospital will 
be the actual number of FTE residents, subject to the rolling average at 
paragraph (d)(7) of this section, training in the rural track at the 
urban hospital.
    (ii) For rural track programs started prior to October 1, 2012, 
beginning with the fourth year of the rural track's existence, the rural 
track FTE limitation is equal to the product of the highest number of 
residents, in any program year, who during the third year of the rural 
track's existence are training in the rural track at the urban hospital 
and are designated at the beginning of their training to be rotated to 
the rural hospital(s) for at least two-thirds of the duration of the 
program for cost reporting periods beginning on or after April 1, 2000, 
and before October 1, 2002, or for more than one-half of the duration of 
the program effective for cost reporting periods beginning on or after 
October 1, 2003, and the number of years those residents are training at 
the urban hospital. For rural track programs started on or after October 
1, 2012, beginning with the start of the urban hospital's cost reporting 
period that coincides with or follows the start of the sixth program 
year of the rural track's existence, the rural track FTE limitation is 
calculated in accordance with paragraph (e)(1) of this section.
    (2) If an urban hospital rotates residents to a separately 
accredited rural track program at a rural nonprovider site(s) for two-
thirds of the duration of the program for cost reporting periods 
beginning on or after April 1, 2000, and before October 1, 2003, or for 
more than one-half of the duration of the program for cost reporting 
periods beginning on or after October 1, 2003, the urban hospital may 
include those residents in its FTE count, subject to the requirements 
under Sec.  413.78(d) through (g). The urban hospital may include in its 
FTE count those residents in the rural track, not to exceed its rural 
track FTE limitation, determined as follows:
    (i) For rural track programs started prior to October 1, 2012, for 
the first 3 years of the rural track's existence, the rural track FTE 
limitation for each

[[Page 887]]

urban hospital will be the actual number of FTE residents, subject to 
the rolling average specified in paragraph (d)(7) of this section, 
training in the rural track at the urban hospital and the rural 
nonprovider site(s). For rural track programs started on or after 
October 1, 2012, prior to the start of the urban hospital's cost 
reporting period that coincides with or follows the start of the sixth 
program year of the rural track's existence, the rural track FTE 
limitation for each urban hospital will be the actual number of FTE 
residents, subject to the rolling average specified in paragraph (d)(7) 
of this section, training in the rural track at the urban hospital and 
the rural nonprovider site(s).
    (ii)(A) For rural track programs started prior to October 1, 2012, 
beginning with the fourth year of the rural track's existence, the rural 
track FTE limitation is equal to the product of--
    (1) The highest number of residents in any program year who, during 
the third year of the rural track's existence, are training in the rural 
track at--
    (i) The urban hospital and are designated at the beginning of their 
training to be rotated to a rural nonprovider site(s) for at least two-
thirds of the duration of the program for cost reporting periods 
beginning on or after April 1, 2000 and before October 1, 2003, or for 
more than one-half of the duration of the program for cost reporting 
periods beginning on or after October 1, 2003; and
    (ii) The rural nonprovider site(s); and
    (2) The number of years in which the residents are expected to 
complete each program based on the minimum accredited length for the 
type of program.
    (B) For rural track programs started on or after October 1, 2012, 
beginning with the start of the urban hospital's cost reporting period 
that coincides with or follows the start of the sixth program year of 
the rural track's existence, the rural track FTE limitation is 
calculated in accordance with paragraph (e)(1) of this section.
    (3) For rural track programs started prior to October 1, 2012, if an 
urban hospital rotates residents in the rural track program to a rural 
hospital(s) for less than two-thirds of the duration of the program for 
cost reporting periods beginning on or after April 1, 2000, and before 
October 1, 2003, or for one-half or less than one-half of the duration 
of the program for cost reporting periods beginning on or after October 
1, 2003, the rural hospital may not include those residents in its FTE 
count (if the rural track is not a new program under paragraph (e)(3) of 
this section, or if the rural hospital's FTE count exceeds that 
hospital's FTE cap), nor may the urban hospital include those residents 
when calculating its rural track FTE limitation. For rural track 
programs started on or after October 1, 2012, if an urban hospital 
rotates residents in the rural track program to a rural hospital(s) for 
one-half or less than one-half of the duration of the program, the rural 
hospital may not include those residents in its FTE count (if the rural 
track is not a new program under paragraph (e)(3) of this section, or if 
the rural hospital's FTE count exceeds that hospital's FTE cap), nor may 
the urban hospital include those residents when calculating its rural 
track FTE limitation.
    (4)(i) For rural track programs started prior to October 1, 2012, if 
an urban hospital rotates residents in the rural track program to a 
rural nonprovider site(s) for less than two-thirds of the duration of 
the program for cost reporting periods beginning on or after April 1, 
2000 and before October 1, 2003, or for one-half or less than one-half 
of the duration of the program for cost reporting periods beginning on 
or after October 1, 2003, the urban hospital may include those residents 
in its FTE count, subject to the requirements under Sec.  413.78(d) 
through (g), as applicable. The urban hospital may include in its FTE 
count those residents in the rural track, not to exceed its rural track 
limitation, determined as follows:
    (A) For the first 3 years of the rural track's existence, the rural 
track FTE limitation for the urban hospital will be the actual number of 
FTE residents, subject to the rolling average specified in paragraph 
(d)(7) of this section, training in the rural track at the rural 
nonprovider site(s).

[[Page 888]]

    (B) Beginning with the fourth year of the rural track's existence, 
the rural track FTE limitation is equal to the product of--
    (1) The highest number of residents in any program year who, during 
the third year of the rural track's existence, are training in the rural 
track at the rural nonprovider site(s) or are designated at the 
beginning of their training to be rotated to the rural nonprovider 
site(s) for a period that is less than two-thirds of the duration of the 
program for cost reporting periods beginning on or after April 1, 2002, 
and before October 1, 2003, or for one-half or less than one-half of the 
duration of the program for cost reporting periods beginning on or after 
October 1, 2003; and
    (2) The length of time in which the residents are training at the 
rural nonprovider site(s) only.
    (ii) For rural track programs started on or after October 1, 2012, 
if an urban hospital rotates residents in the rural track program to a 
rural nonprovider site(s) for one-half or less than one-half of the 
duration of the program, the urban hospital may include those residents 
in its FTE count, subject to the requirements under Sec.  413.78(g). The 
urban hospital may include in its FTE count those residents in the rural 
track, not to exceed its rural track limitation, determined as follows:
    (A) Prior to the start of the urban hospital's cost reporting period 
that coincides with or follows the start of the sixth program year of 
the rural track's existence, the rural track FTE limitation for the 
urban hospital will be the actual number of FTE residents, subject to 
the rolling average specified in paragraph (d)(7) of this section, 
training in the rural track at the rural nonprovider site(s).
    (B) Beginning with the start of the urban hospital's cost reporting 
period that coincides with or follows the start of the sixth program 
year of the rural track's existence, the rural track FTE limitation is 
equal to the product of--
    (1) The highest number of residents in any program year who, during 
the fifth year of the rural track's existence, are training in the rural 
track at the rural nonprovider site(s) or are designated at the 
beginning of their training to be rotated to the rural nonprovider 
site(s) for a period that is for one-half or less than one-half of the 
duration of the program; and
    (2) The ratio of the length of time in which the residents are 
training at the rural nonprovider site(s) only to the total duration of 
the program.
    (5) All urban hospitals that wish to count FTE residents in rural 
tracks, not to exceed their respective rural track FTE limitation, must 
also comply with all of the following conditions:
    (i) An urban hospital may not include in its rural track FTE 
limitation or (assuming the urban hospital's FTE count exceeds its FTE 
cap) FTE count residents who are training in a rural track residency 
program that were already included as part of the hospital's FTE cap.
    (ii) The hospital must base its count of residents in a rural track 
on written contemporaneous documentation that each resident enrolled in 
a rural track program at the hospital intends to rotate for a portion of 
the residency program to a rural area.
    (iii) All residents that are included by the hospital as part of its 
rural track FTE count (not to exceed its rural track FTE limitation) 
must train in the rural area. However, where a resident begins to train 
in the rural track program at the urban hospital but leaves the program 
before completing the total required portion of training in the rural 
area, the urban hospital may count the time the resident trained in the 
urban hospital if another resident fills the vacated FTE slot and 
completes the training in the rural portion of the rural track program. 
An urban hospital may not receive GME payment for the time the resident 
trained at the urban hospital if another resident fills the vacated FTE 
slot and first begins to train at the urban hospital.
    (6) If CMS finds that residents who are included by the urban 
hospital as part of its FTE count did not actually complete the training 
in the rural area, CMS will reopen the urban hospital's cost report 
within the 3-year reopening period as specified in Sec.  405.1885 of 
this

[[Page 889]]

chapter and adjust the hospital's Medicare GME payments (and, where 
applicable, the hospital's rural track FTE limitation).
    (7)(i) Effective prior to October 1, 2014, if an urban hospital had 
established a rural track training program under the provisions of this 
paragraph (k) with a hospital located in a rural area and that rural 
area subsequently becomes an urban area due to the most recent census 
data and implementation of the new labor market area definitions 
announced by OMB on June 6, 2003, the urban hospital may continue to 
adjust its FTE resident limit in accordance with this paragraph (k) for 
the rural track programs established prior to the adoption of such new 
labor market area definitions. In order to receive an adjustment to its 
FTE resident cap for a new rural track residency program, the urban 
hospital must establish a rural track program with hospitals that are 
designated rural based on the most recent geographical location 
delineations adopted by CMS.
    (ii)(A) For rural track programs started prior to October 1, 2012, 
effective October 1, 2014, if an urban hospital started a rural track 
training program under the provisions of this paragraph (k) with a 
hospital located in a rural area and, during the 3-year period that is 
used to calculate the urban hospital's rural track FTE limit, that rural 
area subsequently becomes an urban area due to the most recent OMB 
standards for delineating statistical areas adopted by CMS and the most 
recent Census Bureau data, the urban hospital may continue to adjust its 
FTE resident limit in accordance with this paragraph (k) and subject to 
paragraph (k)(7)(iii) of this section for the rural track programs 
started prior to the adoption of such new OMB standards for delineating 
statistical areas.
    (B) For rural track programs started on or after October 1, 2012, 
effective October 1, 2014, if an urban hospital started a rural track 
training program under the provisions of this paragraph (k) with a 
hospital located in a rural area and, during the 5-year period that is 
used to calculate the urban hospital's rural track FTE limit, that rural 
area subsequently becomes an urban area due to the most recent OMB 
standards for delineating statistical areas adopted by CMS and the most 
recent Census Bureau data, the urban hospital may continue to adjust its 
FTE resident limit in accordance with this paragraph (k) and subject to 
paragraph (k)(7)(iii) of this section for the rural track programs 
started prior to the adoption of such new OMB standards for delineating 
statistical areas.
    (iii)(A) For rural track programs started prior to October 1, 2012, 
effective October 1, 2014, if an urban hospital started a rural track 
training program under the provisions of this paragraph (k) with a 
hospital located in a rural area and that rural area subsequently 
becomes an urban area due to the most recent OMB standards for 
delineating statistical areas adopted by CMS and the most recent Census 
Bureau data, regardless of whether the redesignation of the rural 
hospital occurs during the 3-year period that is used to calculate the 
urban hospital's rural track FTE limit, or after the 3-year period used 
to calculate the urban hospital's rural track FTE limit, the urban 
hospital may continue to adjust its FTE resident limit in accordance 
with this paragraph (k) based on the rural track programs started prior 
to the change in the hospital's geographic designation. In order for the 
urban hospital to receive or use the adjustment to its FTE resident cap 
for training FTE residents in the rural track residency program that was 
started prior to the most recent OMB standards for delineating 
statistical areas adopted by CMS, one of the following two conditions 
must be met by the end of a period that begins when the most recent OMB 
standards for delineating statistical areas are adopted by CMS and 
continues through the end of the second residency training year 
following the date the most recent OMB delineations are adopted by CMS: 
The hospital that has been redesignated from rural to urban must 
reclassify as rural under Sec.  412.103 of this chapter, for purposes of 
IME only; or the urban hospital must find a new site that is 
geographically rural consistent with the most recent geographical 
location delineations adopted by CMS. In order to receive an adjustment 
to its FTE resident cap for

[[Page 890]]

an additional new rural track residency program, the urban hospital must 
participate in a rural track program with sites that are geographically 
rural based on the most recent geographical location delineations 
adopted by CMS.
    (B) For rural track programs started on or after October 1, 2012, 
effective October 1, 2014, if an urban hospital started a rural track 
training program under the provisions of this paragraph (k) with a 
hospital located in a rural area and that rural area subsequently 
becomes an urban area due to the most recent OMB standards for 
delineating statistical areas adopted by CMS and the most recent Census 
Bureau data, regardless of whether the redesignation of the rural 
hospital occurs during the 5-year period that is used to calculate the 
urban hospital's rural track FTE limit, or after the 5-year period used 
to calculate the urban hospital's rural track FTE limit, the urban 
hospital may continue to adjust its FTE resident limit in accordance 
with this paragraph (k) based on the rural track programs started prior 
to the change in the hospital's geographic designation. In order for the 
urban hospital to receive or use the adjustment to its FTE resident cap 
for training FTE residents in the rural track residency program that was 
started prior to the most recent OMB standards for delineating 
statistical areas adopted by CMS, one of the following two conditions 
must be met by the end of a period that begins when the most recent OMB 
standards for delineating statistical areas are adopted by CMS and 
continues through the end of the second residency training year 
following the date the most recent OMB delineations are adopted by CMS: 
The hospital that has been redesignated from rural to urban must 
reclassify as rural under Sec.  412.103 of this chapter, for purposes of 
IME only; or the urban hospital must find a new site that is 
geographically rural consistent with the most recent geographical 
location delineations adopted by CMS. In order to receive an adjustment 
to its FTE resident cap for an additional new rural track residency 
program, the urban hospital must participate in a rural track program 
with sites that are geographically rural based on the most recent 
geographical location delineations adopted by CMS.
    (l) For purposes of this section, a new medical residency training 
program means a medical residency that receives initial accreditation by 
the appropriate accrediting body or begins training residents on or 
after January 1, 1995.
    (m) Determination of the reduction to the FTE resident cap due to 
unused FTE resident slots under section 5503 of Public Law 111-148. If a 
hospital's reference resident level, as defined under paragraph 
(c)(1)(ii)(B) of this section is less than its otherwise applicable FTE 
resident cap as determined under paragraph (c)(2) of this section or 
paragraph (e) of this section in the reference cost reporting period (as 
described under paragraph (m)(6) of this section), for portions of cost 
reporting periods beginning on or after July 1, 2011, the hospital's 
otherwise applicable FTE resident cap is reduced by 65 percent of the 
difference between the otherwise applicable FTE resident cap and the 
reference resident level. The reduction shall take into account the 
hospital's FTE resident cap as reduced under paragraph (c)(3) of this 
section. Under this provision--
    (1) Exemption for certain rural hospitals. A rural hospital, as 
defined at subpart D of part 412 of this subchapter, with fewer than 250 
beds (as determined at Sec.  412.105(b)) in its most recent cost 
reporting period ending on or before March 23, 2010, for which a cost 
report has been either settled or submitted (subject to audit) to the 
Medicare contractor by March 23, 2010, is exempt from any reduction to 
its otherwise applicable FTE resident cap under paragraph (m) of this 
section.
    (2) Exemption for certain hospitals that participate in 
demonstration projects or voluntary residency reduction plans. A 
hospital that was participating in a demonstration project under section 
402 of Public Law 90-248 or the voluntary reduction plan under Sec.  
413.88, is exempt from any reduction to its otherwise applicable FTE 
resident cap under paragraph (m) of this section if, by January 21, 
2011, it submits a plan to CMS for filling all of its unused FTE 
resident slots by not later than March 23, 2012.

[[Page 891]]

    (3) Exemption for a hospital described at section 1886(h)(4)(H)(v) 
of the Act. A hospital described at section 1886(h)(4)(H)(v) of the Act, 
is exempt from any reduction to its otherwise applicable FTE resident 
cap under paragraph (m) of this section.
    (4) Exemptions for certain other hospitals. A hospital training at 
or above its otherwise applicable FTE resident cap as determined under 
paragraph (c)(2) of this section for all three most recent cost 
reporting periods ending prior to March 23, 2010, for which a cost 
report has been either settled or submitted (subject to audit) to the 
Medicare contractor by March 23, 2010, is exempt from any reduction to 
its otherwise applicable FTE resident cap under paragraph (m) of this 
section.
    (5) New teaching hospital. A new teaching hospital that does not 
have an otherwise applicable FTE resident cap as determined under 
paragraph (e)(1) of this section for all three most recent cost 
reporting periods ending prior to March 23, 2010, for which a cost 
report has been either settled or submitted (subject to audit) to the 
Medicare contractor by March 23, 2010, is exempt from any reduction to 
its otherwise applicable FTE resident cap under paragraph (m) of this 
section.
    (6) Reference cost reporting period. (i) To determine a hospital's 
reference resident level, CMS determines, for a hospital's three most 
recent cost reporting periods ending before March 23, 2010, for which a 
cost report has been either settled or submitted (subject to audit) to 
the Medicare contractor by March 23, 2010, the cost reporting period 
with the highest resident level.
    (ii) If the cost report that is used to determine a hospital's 
otherwise applicable FTE resident cap in the reference period is not 
equal to 12 months, the Medicare contractor may make appropriate 
modifications to apply the provisions of paragraph (m) of this section 
based on the equivalent of a 12-month cost reporting period.
    (7) Consideration for members of Medicare GME affiliated groups. For 
a hospital that is a member of a Medicare GME affiliated group at any 
point during any of the hospital's three most recent cost reporting 
periods ending before March 23, 2010 for which a cost report has been 
settled or has been submitted to Medicare contractor by March 23, 2010, 
in determining whether a hospital's otherwise applicable resident FTE 
resident cap is reduced under paragraph (m) of this section, the 
Medicare contractor determines a hospital's reference cost reporting 
period by finding the cost reporting period that results in the smallest 
difference between the reference resident level and the otherwise 
applicable resident limit.
    (i) If the reference resident level is less than the otherwise 
applicable resident limit in that reference cost reporting period, the 
Medicare contractor must then determine if the hospital was a member of 
a Medicare GME affiliated group as of the July 1 that occurs during that 
reference cost reporting period.
    (ii) If the hospital was a member of a Medicare GME affiliated group 
as of the July 1 that occurs during that reference cost report, the 
Medicare contractor does all of the following:
    (A) Treat the members of the Medicare GME affiliated group as a 
group for that reference cost reporting period, for the purpose of 
determining a reduction to the particular hospital's FTE resident cap.
    (B) Determine for each hospital in the Medicare GME affiliated group 
respectively the FTE resident cap and FTE resident count (IME and direct 
GME separately).
    (C) Add each hospital's FTE resident caps (IME and direct GME 
separately) to determine the aggregate FTE resident cap.
    (D) Add each hospital's FTE resident count (IME and direct GME 
separately) to determine the aggregate FTE resident count.
    (iii) If the aggregate FTE resident count is equal to or exceeds the 
aggregate FTE resident cap, then the Medicare contractor would make no 
reduction to the particular hospital's otherwise applicable FTE resident 
cap under paragraph (m) of this section, and no further steps are 
necessary for that hospital.
    (iv) If the hospitals' aggregate FTE resident count is less than the 
aggregate FTE resident cap, then the Medicare contractor would determine 
on a

[[Page 892]]

hospital-specific basis whether the particular hospital's FTE resident 
count is less than its otherwise applicable FTE resident cap (as 
adjusted by affiliation agreement(s)) in the hospital's reference cost 
report.
    (v) If the hospital's FTE resident count exceeds its otherwise 
applicable FTE resident cap, the hospital will not have its otherwise 
applicable FTE resident cap reduced under paragraph (m) of this section.
    (vi) If the particular hospital's FTE resident count is less than 
its otherwise applicable FTE resident cap, the Medicare contractor 
determines a pro rata cap reduction amount that is equal, in total, to 
65 percent of the difference between the aggregate FTE resident cap and 
the aggregate FTE resident count for the Medicare GME affiliated group.
    (A) The pro rata cap reduction to the particular hospital's 
otherwise applicable FTE resident cap is calculated by dividing the 
difference between the hospital's otherwise applicable FTE resident cap 
and the hospital's FTE resident count, by the total amount by which all 
of the hospitals' individual FTE resident counts are below their 
affiliated FTE resident caps, multiplying the quotient by the difference 
between the aggregate FTE resident cap and the aggregate FTE resident 
counts for the Medicare GME affiliated group, and multiplying that 
result by 65 percent.
    (B) The final reduction takes into account the hospital's FTE 
resident cap as reduced under the provisions of paragraph (c)(3) of this 
section.
    (n) Determination of an increase in the otherwise applicable 
resident cap under section 5503 of Public Law 111-148. (1) For portions 
of cost reporting periods beginning on or after July 1, 2011, a hospital 
may receive an increase in its otherwise applicable FTE resident cap (as 
determined by CMS) of not more than 75 additional FTEs if the hospital 
meets the requirements and qualifying criteria of section 1886(h)(8) of 
the Act and implementing instructions issued by CMS and if the hospital 
submits an application to CMS within the timeframe specified by CMS.
    (2) A hospital that receives an increase in the otherwise applicable 
FTE resident cap under paragraph (n)(1) of this section must ensure, 
during the 5-year period beginning on July 1, 2011 and ending on June 
30, 2016, that--
    (i) The number of FTE primary care residents, as defined in Sec.  
413.75(b), excluding any additional positions under this paragraph, is 
not less than the average number of FTE primary care residents (as so 
determined) during the three most recent cost reporting periods ending 
prior to March 23, 2010 (and submitted to the Medicare contractor by 
March 23, 2010); and not less than 75 percent of the positions 
attributable to such increase are in a primary care or general surgery 
residency programs.
    (ii) If a hospital receives an increase in the otherwise applicable 
FTE resident cap under paragraph (n)(1) of this section, and does not 
use all of that increase in its final (12-month or partial) cost report 
of the 5-year period beginning July 1, 2011 and ending June 30, 2016, 
the Medicare contractor will remove the applicable unused slots, and the 
hospital's increase in the otherwise applicable FTE resident cap 
received under paragraph (n)(1) of this section will be reduced for 
portions of cost reporting periods on or after July 1, 2016. The number 
of applicable unused slots is equal to the difference between the 
increase in the otherwise applicable FTE resident cap and the applicable 
slots used. In determining the applicable slots used, the following 
amounts are added, as relevant:
    (A) If a hospital uses the increase in the otherwise applicable FTE 
resident cap under paragraph (n)(1) of this section to expand an 
existing program(s), the used slots are equal to the lesser of the 
number of slots used for an expansion(s) in the fourth 12-month cost 
report or the final cost report.
    (B) If a hospital uses the increase in the otherwise applicable FTE 
resident cap under paragraph (n)(1) of this section to start a new 
program(s), the used slots are equal to the number of slots used for a 
new program(s) in the final cost report.
    (C) The portion, if any, of the increase in the otherwise applicable 
FTE resident cap under paragraph (n)(1) of this section used for cap 
relief, subject to the requirements in paragraph (n)(2)(i) of this 
section.

[[Page 893]]

    (iii) CMS may determine whether a hospital has met the requirements 
under paragraphs (n)(2)(i) and (n)(2)(ii) of this section during the 5-
year period of July 1, 2011, through June 30, 2016, in such manner and 
at such time as CMS determines appropriate, including at the end of such 
5-year period.
    (iv) In a case where the Medicare contractor determines that a 
hospital did not meet the requirements under paragraphs (n)(2)(i), 
(n)(2)(ii), and (n)(2)(iii) of this section in a cost reporting period 
within the 5-year time period, the Medicare contractor will reduce the 
otherwise applicable FTE resident cap of the hospital by the amount by 
which such limit was increased under paragraph (n)(1) of this section 
from the earliest cost reporting period that is reopenable in which it 
would be determined that the hospital did not meet the requirements.
    (o) Determination of an increase in the FTE resident cap due to 
slots redistributed from a closed hospital. (1) Except in the case of 
the closure of the hospital with Medicare Provider Number 05-0578, in 
the instance of a hospital closure, as defined at paragraph (h)(1)(i) of 
this section, the FTE resident cap of the closed hospital would be 
redistributed, and a hospital that meets the requirements and qualifying 
criteria of section 1886(h)(4)(H)(vi) of the Act and implementing 
instructions issued by CMS, including submission of a timely application 
to CMS, may receive an increase in its FTE resident cap, as determined 
by CMS.
    (2)(i) Except in the case of the closure of the hospital with 
Medicare Provider Number 05-0578, in redistributing the FTE resident cap 
of a closed hospital, consideration shall be given to ensure that there 
is no duplication of FTE slots between FTE slots redistributed under 
this paragraph and temporary adjustments to FTE resident caps provider 
under paragraph (h)(2) of this section.
    (ii) The provisions of this paragraph (o) will not be applied in a 
manner that will require the reopening of settled cost reports, except 
where the provider has a jurisdictionally proper appeal pending on 
direct GME or IME payments as of March 23, 2010.

[69 FR 49254, Aug. 11, 2004]

    Editorial Note: For Federal Register citations affecting Sec.  
413.79, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.  413.80  Direct GME payments: Determination of weighting factors 
for foreign medical graduates.

    (a) The weighting factor for a foreign medical graduate is 
determined under the provisions of Sec.  413.79 if the foreign medical 
graduate--
    (1) Has passed FMGEMS; or
    (2) Before July 1, 1986, received certification from, or passed an 
examination of, the Educational Committee for Foreign Medical Graduates.
    (b) Before July 1, 1986, the weighting factor for a foreign medical 
graduate is 1.0 times the weight determined under the provisions of 
Sec.  413.79. On or after July 1, 1986, and before July 1, 1987, the 
weighting factor for a graduate of a foreign medical school who was in a 
residency program both before and after July 1, 1986 but who does not 
meet the requirements set forth in paragraph (a) of this section is .50 
times the weight determined under the provisions of Sec.  413.79.
    (c) On or after July 1, 1987, these foreign medical graduates are 
not counted in determining the number of FTE residents.
    (d) During the cost reporting period in which a foreign medical 
graduate passes FMGEMS, the weighting factor for that resident is 
determined under the provisions of Sec.  413.79 for the part of the cost 
reporting period beginning with the month the resident passes the test.
    (e) On or after September 1, 1989, the National Board of Medical 
Examiners Examination, Parts I and II, may be substituted for FMGEMS for 
purposes of the determination made under paragraphs (a) and (d) of this 
section.
    (f) On or after June 1, 1992, the United States Medical Licensing 
Examination may be substituted for the FMGEMS for purposes of the 
determination made under paragraphs (a) and (d) of this section. On or 
after July 1, 1993, only the results of steps I and II of the United 
States Medical Licensing Examination

[[Page 894]]

will be accepted for purposes of making this determination.

[69 FR 49254, Aug. 11, 2004]



Sec.  413.81  Direct GME payments: Application of community support 
and redistribution of costs in determining FTE resident counts.

    (a) For purposes of determining direct GME payments, the following 
principles apply:
    (1) Community support. If the community has undertaken to bear the 
costs of medical education through community support, the costs are not 
considered GME costs to the hospital for purposes of Medicare payment.
    (2) Redistribution of costs. The costs of training residents that 
constitute a redistribution of costs from an educational institution to 
the hospital are not considered GME costs to the hospital for purposes 
of Medicare payment.
    (b) Application. A hospital must continuously incur costs of direct 
GME of residents training in a particular program at a training site 
since the date the residents first began training in that program in 
order for the hospital to count the FTE residents in accordance with the 
provisions of Sec. Sec.  413.78, 413.79 (c) through (e), and 413.79(k). 
This rule also applies to providers that are paid for direct GME in 
accordance with Sec.  405.2468 of this chapter, Sec.  422.270 of this 
subchapter, and Sec.  413.70.
    (c)(1) Effective date. Subject to the provisions of paragraph (c)(2) 
of this section, payments made in accordance with determinations made 
under the provisions of paragraphs (a) and (b) of this section will be 
effective for portions of cost reporting periods occurring on or after 
October 1, 2003.
    (2) Applicability for certain hospitals. With respect to an FTE 
resident who begins training in a residency program on or before October 
1, 2003, and with respect to whom there has been a redistribution of 
costs or community support determined under the provisions of paragraphs 
(a) and (b) of this section, the hospital may continue to count the FTE 
resident until the resident has completed training in that program, or 
until 3 years after the date the resident began training in that 
program, whichever comes first.

[69 FR 49254, Aug. 11, 2004]



Sec.  413.82  Direct GME payments: Special rules for States that formerly had 
a waiver from Medicare reimbursement principles.

    (a) Effective for cost reporting periods beginning on or after 
January 1, 1986, hospitals in States that, prior to becoming subject to 
the prospective payment system, had a waiver for the operation of a 
State reimbursement control system under section 1886(c) of the Act, 
section 402 of the Social Security Amendments of 1967 (42 U.S.C. 1395b-1 
or section 222(a) of the Social Security Amendment of 1972 (42 U.S.C. 
1395b-1 (note)) are permitted to change the order in which they allocate 
administrative and general costs to the order specified in the 
instructions for the Medicare cost report.
    (b) For hospitals making this election, the base-period costs for 
the purpose of determining the per resident amount are adjusted to take 
into account the change in the order by which they allocate 
administrative and general costs to interns and residents in approved 
program cost centers.
    (c) Per resident amounts are determined for the base period and 
updated as described in Sec.  413.77. For cost reporting periods 
beginning on or after January 1, 1986, payment is made based on the 
methodology described in Sec.  413.76.

[69 FR 49254, Aug. 11, 2004]



Sec.  413.83  Direct GME payments: Adjustment of a hospital's target amount 
or prospective payment hospital-specific rate.

    (a) Misclassified operating costs--(1) General rule. If a hospital 
has its base-period GME costs reduced under Sec.  413.77(a) of this 
section because those costs included misclassified operating costs, the 
hospital may request that the contractor review the classification of 
the affected costs in its rate-of-increase ceiling or prospective 
payment base year for purposes of adjusting the hospital's target amount 
or hospital-specific rate. For those cost reports that are not subject 
to reopening under Sec.  405.1885 of this chapter, the

[[Page 895]]

hospital's reopening request must explicitly state that the review is 
limited to this one issue.
    (2) Request for review. The hospital must request review of the 
classification of its rate-of-increase ceiling or prospective payment 
base year costs no later than 180 days after the date of the notice by 
the contractor of the hospital's base-period average per resident 
amount. A hospital's request for review must include sufficient 
documentation to demonstrate to the contractor that adjustment of the 
hospital's hospital-specific rate or target amount is warranted.
    (3) Effect of contractor's review. If the contractor, upon review of 
the hospital's costs, determines that the hospital's hospital-specific 
rate or target amount should be adjusted, the adjustment of the 
hospital-specific rate or the target amount is effective for the 
hospital's cost reporting periods subject to the prospective payment 
system or the rate-of-increase ceiling that are still subject to 
reopening under Sec.  405.1885 of this chapter.
    (b) Misclassification of GME costs--(1) General rule. If costs that 
should have been classified as GME costs were treated as operating costs 
during both the GME base period and the rate-of-increase ceiling base 
year or prospective payment base year and the hospital wishes to receive 
benefit for the appropriate classification of these costs as GME costs 
in the GME base period, the hospital must request that the contractor 
review the classification of the affected costs in the rate-of-increase 
ceiling or prospective payment base year for purposes of adjusting the 
hospital's target amount or hospital-specific rate. For those cost 
reports that are not subject to reopening under Sec.  405.1885 of this 
chapter, the hospital's reopening request must explicitly state that the 
review is limited to this one issue.
    (2) Request for review. The hospital must request review of the 
classification of its costs no later than 180 days after the date of the 
contractor's notice of the hospital's base-period average per resident 
amount. A hospital's request for review must include sufficient 
documentation to demonstrate to the contractor that modification of the 
adjustment of the hospital's hospital-specific rate or target amount is 
warranted.
    (3) Effect of contractor's review. If the contractor, upon review of 
the hospital's costs, determines that the hospital's hospital-specific 
rate or target amount should be adjusted, the adjustment of the 
hospital-specific rate and the adjustment of the target amount is 
effective for the hospital's cost reporting periods subject to the 
prospective payment system or the rate-of-increase ceiling that are 
still subject to reopening under Sec.  405.1885 of this chapter.

[69 FR 49254, Aug. 11, 2004]



Sec.  413.85  Cost of approved nursing and allied health education activities.

    (a) Statutory basis. This section implements section 1861(v)(1)(A) 
of the Act and section 4004(b) of the Omnibus Budget Reconciliation Act 
of 1990 (Public Law 101-508) by establishing the methodology for 
Medicare payment of the costs of approved nursing and allied health 
education activities.
    (b) Scope. (1) This section sets forth the rules for determining 
Medicare payments to hospitals for the costs of nursing and allied 
health education activities.
    (2) This section does not address Medicare payments for the direct 
and indirect costs of graduate medical education (that is, approved 
residency programs in medicine, osteopathy, dentistry, and podiatry). 
Medicare payment for these costs is determined as provided in Sec.  
412.105 of this subchapter and Sec. Sec.  413.75 through 413.83.
    (3) The rules under this section do not apply to activities that are 
specified in paragraph (h) of this section and identified as normal 
operating costs.
    (c) Definitions. For purposes of this section, the following 
definitions apply:
    Approved educational activities means formally organized or planned 
programs of study of the type that:
    (1) Are operated by providers as specified in paragraph (f) of this 
section;
    (2) Enhance the quality of health care at the provider; and
    (3) Meet the requirements of paragraph (e) of this section for State 
licensure or accreditation.

[[Page 896]]

    Classroom instruction costs are those costs associated with formal, 
didactic instruction on a specific topic or subject in a class that 
meets at regular, scheduled intervals over a specific time period (for 
example, semester or quarter), and for which a student receives a grade.
    Clinical training costs means costs of training for the acquisition 
and use of the skills of a nursing or allied health profession or trade 
in the actual environment in which these skills will be used by the 
student upon graduation. Clinical training may involve occasional or 
periodic meetings to discuss or analyze cases, critique performance, or 
discuss specific skills or techniques; it involves no classroom 
instruction.
    Community support means funding that is provided by the community 
and generally includes all non-Medicare sources of funding (other than 
payments made for furnishing services to individual patients), including 
State and local government appropriations. Community support does not 
include grants, gifts, and endowments of the kind that are not to be 
offset in accordance with section 1134 of the Act.
    Redistribution of costs means an attempt by a provider to increase 
the amount, or to expand the types, of the costs of educational 
activities that are allowed for Medicare payment purposes by claiming 
costs that previously were not claimed by the provider and were 
considered costs of an educational institution. For example, costs for a 
school of nursing or allied health education or a medical school that 
were incurred by an educational institution and were not allowable to 
the provider in its prospective payment or rate-of-increase limit base 
year cost report, or graduate medical education per resident amount 
calculated under Sec. Sec.  413.75 through 413.83, are not allowable 
costs in subsequent fiscal years.
    (d) General payment rules. (1) Payment for a provider's net cost of 
nursing and allied health education activities is determined on a 
reasonable cost basis, subject to the following conditions and 
limitations:
    (i) An approved educational activity--
    (A) Is recognized by a national approving body or State licensing 
authority as specified in paragraph (e) of this section;
    (B) Meets the criteria specified in paragraph (f) of this section 
for identification as an operator of an approved education program.
    (C) Enhance the quality of health care at the provider.
    (ii) The cost for certain nonprovider-operated programs are 
reimbursable on a reasonable cost basis if the programs meet the 
criteria specified in paragraph (g)(2) of this section.
    (iii) The costs of certain nonprovider-operated programs at wholly 
owned subsidiary educational institutions are reimbursable on a 
reasonable cost basis if the provisions of paragraph (g)(3) of this 
section are met.
    (2) Determination of net cost. (i) Subject to the provisions of 
paragraph (d)(2)(iii) of this section, the net cost of approved 
educational activities is determined by deducting the revenues that a 
provider receives from tuition and student fees from the provider's 
total allowable educational costs that are directly related to approved 
educational activities.
    (ii) A provider's total allowable educational costs are those costs 
incurred by the provider for trainee stipends, compensation of teachers, 
and other costs of the activities as determined under the Medicare cost-
finding principles in Sec.  413.24. These costs do not include patient 
care costs, costs incurred by a related organization, or costs that 
constitute a redistribution of costs from an educational institution to 
a provider or costs that have been or are currently being provided 
through community support.
    (iii) The net costs of approved certified registered nurse 
anesthetist (CRNA) education programs that are determined on a 
reasonable cost basis are subject to the additional condition that 
allowable compensation costs for faculty members who are CRNAs are 
limited to the compensation costs for administrative activities related 
to the educational program, the compensation costs directly related to 
hours spent in classroom instruction, and the costs related to the 
clinical training of students for which the CRNA may not receive payment 
under the CRNA fee

[[Page 897]]

schedule. No pass-through compensation costs are allowable for the time 
a CRNA spends in the clinical training of a student anesthetist during a 
surgical procedure in the operating room for which the CRNA may receive 
payment under the CRNA fee schedule. As specified at Sec.  414.46 of 
this chapter, if the CRNA continuously supervises the services of a 
single student nurse anesthetist, or where the medical direction rules 
allow a CRNA to bill for the service, payment can be made under the CRNA 
fee schedule.
    (iv) Net costs are subject to apportionment for Medicare utilization 
as described in Sec.  413.50.
    (e) Approved nursing and allied health education programs. CMS will 
consider an activity an approved nursing and allied health education 
program if the program is a planned program of study that is licensed by 
State law, or if licensing is not required, is accredited by the 
recognized national professional organization for the particular 
activity. Such national accrediting bodies include, but are not limited 
to, the Commission on Accreditation of Allied Health Education Programs, 
the National League of Nursing Accrediting Commission, the Association 
for Clinical Pastoral Education Inc., and the American Dietetic 
Association.
    (f) Criteria for identifying programs operated by a provider. (1) 
Except as provided in paragraph (f)(2) of this section, for cost 
reporting periods beginning on or after October 1, 1983, in order to be 
considered the operator of an approved nursing or allied health 
education program, a provider must meet all of the following 
requirements:
    (i) Directly incur the training costs.
    (ii) Have direct control of the program curriculum. (A provider may 
enter into an agreement with an educational institution to furnish basic 
academic courses required for completion of the program, but the 
provider must provide all of the courses relating to the theory and 
practice of the nursing or allied health profession involved that are 
required for the degree, diploma, or certificate awarded at the 
completion of the program.)
    (iii) Control the administration of the program, including 
collection of tuition (where applicable), control the maintenance of 
payroll records of teaching staff or students, or both (where 
applicable), and be responsible for day-to-day program operation. (A 
provider may contract with another entity to perform some administrative 
functions, but the provider must maintain control over all aspects of 
the contracted functions.)
    (iv) Employ the teaching staff.
    (v) Provide and control both classroom instruction and clinical 
training (where classroom instruction is a requirement for program 
completion), subject to the parenthetical sentence in paragraph 
(f)(1)(ii) of this section.
    (2) Absent evidence to the contrary, the provider that issues the 
degree, diploma, or other certificate upon successful completion of an 
approved education program is assumed to meet all of the criteria set 
forth in paragraph (f)(1) of this section and to be the operator of the 
program.
    (g) Payment for certain nonprovider-operated programs--(1) Payment 
rule. Costs incurred by a provider, or by an educational institution 
that is related to the provider by common ownership or control (that is, 
a related organization as defined in Sec.  413.17(b)), for the clinical 
training of students enrolled in an approved nursing or allied health 
education program that is not operated by the provider, are paid on a 
reasonable cost basis if the conditions specified in paragraph (g)(2) of 
this section are met.
    (2) Criteria for identification of nonprovider-operated education 
programs. Payment for the incurred costs of educational activities 
identified in paragraph (g)(1) of this section will be made if the 
following conditions are met:
    (i) The clinical training must occur on the premises of the 
provider, that is, in the hospital itself or in the physical area 
immediately adjacent to the provider's main buildings, or in other areas 
and structures that are not strictly contiguous to the main buildings 
but are located within 250 yards of the main buildings.
    (ii) The provider must have claimed and been paid for clinical 
training costs on a reasonable cost basis during the most recent cost 
reporting period that ended on or before October 1, 1989. This condition 
is met if a notice of program reimbursement (NPR) was issued

[[Page 898]]

for that cost reporting period by November 5, 1990, and the clinical 
training costs were included as pass-through costs. If an NPR was not 
issued by that date, or an NPR was issued but did not treat the clinical 
training costs as pass-through costs, the condition is met if--
    (A) The contractor included the clinical training costs in the 
allowable costs used to determine the interim rate for the most recent 
cost reporting period ending on or before October 1, 1989; or
    (B) The provider claimed the clinical training costs as pass-through 
costs when the cost report for the most recent cost reporting period 
ending on or before October 1, 1989, was initially submitted.
    (iii) In any cost reporting period, the percentage of total 
allowable provider cost attributable to allowable clinical training cost 
does not exceed the percentage of total cost for clinical training in 
the provider's most recent cost reporting period ending on or before 
October 1, 1989.
    (iv) The students in the educational program must provide a benefit 
to the provider through the provision of clinical services to patients 
of the provider.
    (v) The clinical training costs must be incurred by the provider or 
by an educational institution related to the provider by common control 
or ownership as defined in Sec.  413.17(b) (``Cost to related 
organizations.'') Costs incurred by a third-party, regardless of its 
relationship to either the provider or the educational institution, are 
not allowed.
    (vi) The costs incurred by a provider does not exceed the costs the 
provider would have incurred if it was the sole operator of the program.
    (3) Special rule: Payment for certain nonprovider-operated programs 
at wholly owned subsidiary educational institutions. (i) Effective for 
portions of cost reporting periods occurring on or after October 1, 
2003, a provider that incurs costs for a nursing or allied health 
education program(s) where those program(s) had originally been 
provider-operated according to the criteria at paragraph (f) of this 
section, and then operation of the program(s) was transferred to a 
wholly owned subsidiary educational institution in order to meet 
accreditation standards prior to October 1, 2003, and where the provider 
has continuously incurred the costs of both the classroom and clinical 
training portions of the program(s) at the educational institution, may 
receive reasonable cost payment for such a program(s) according to the 
specifications under paragraphs (g)(3)(ii) and (g)(3)(iii) of this 
section.
    (ii) Payment for the incurred costs of educational activities 
identified in paragraph (g)(3)(i) of this section will be made on a 
reasonable cost basis if a provider, as described in paragraph (g)(3)(i) 
of this section, received Medicare reasonable cost payment for those 
nursing and allied health education program(s) both prior and subsequent 
to the date the provider transferred operation of the program(s) to its 
wholly owned subsidiary educational institution (and ceased to be a 
provider-operated program(s) according to the criteria under paragraph 
(f) of this section).
    (iii) The provider that meets the requirements in paragraphs 
(g)(3)(i) and (g)(3)(ii) of this section will be eligible to receive 
payment under this paragraph for: (A) the clinical training costs 
incurred for the program(s) as described in paragraph (g)(3)(i) of this 
section; and (B) classroom costs, but only those costs incurred by the 
provider for the courses that were included in the programs.
    (h) Cost of educational activities treated as normal operating 
costs. The costs of the following educational activities incurred by a 
provider but not operated by that provider are recognized only as normal 
operating costs and paid in accordance with the reimbursement principles 
specified in Part 412 of this subchapter. They include:
    (1) Orientation and on-the-job training.
    (2) Part-time education for bona fide full-time employees at 
properly accredited academic or technical institutions (including other 
providers) devoted to undergraduate or graduate work.
    (3) Educational seminars, workshops, and continuing education 
programs in which the employees or trainees participate that enhance the 
quality of medical care or operating efficiency of

[[Page 899]]

the provider and, effective October 1, 2003, do not lead to the ability 
to practice and begin employment in a nursing or allied health 
specialty.
    (4) Maintenance of a medical library.
    (5) Training of a patient or patient's family in the use of medical 
appliances or other treatments.
    (6) Except as provided in paragraph (g) of this section, clinical 
training and classroom instruction of students enrolled in an 
educational program that is not operated by the provider. The following 
are clinical training and classroom instruction costs that are allowable 
as normal operating costs:
    (i) Costs incurred in the clinical training of students, including 
the clinical training or clerkship of undergraduate medical school 
students that takes place in a provider.
    (ii) Classroom instruction costs incurred by a provider that meet 
the following criteria:
    (A) The provider's support does not constitute a redistribution of 
nonprovider costs to the provider. The support must be in addition to 
the costs already being incurred by the nonprovider-operated program. If 
the nonprovider entity reduces its costs due to receiving provider 
support, this reduction constitutes a redistribution of costs from an 
educational institution to a patient care institution and is a 
nonallowable provider cost.
    (B) The provider receives a benefit for the support it furnishes.
    (C) The cost of the provider's support is less than the cost the 
provider would incur were it to operate the program.
    (7) Other activities that do not involve the actual operation of an 
approved educational program.

[66 FR 3374, Jan. 12, 2001, as amended at 66 FR 14342, Mar. 12, 2001; 68 
FR 45471, Aug. 1, 2003; 69 FR 49254, Aug. 11, 2004; 71 FR 48142, Aug. 
18, 2006; 75 FR 50418, Aug. 16, 2010]



Sec.  413.87  Payments for Medicare + Choice nursing and allied health 
education programs.

    (a) Statutory basis. This section implements section 1886(l) of the 
Act, which provides for additional payments to hospitals that operate 
and receive Medicare reasonable cost reimbursement for approved nursing 
and allied health education programs and the methodology for determining 
the additional payments.
    (b) Scope. This section sets forth the rules for determining an 
additional payment amount to hospitals that receive payments for the 
costs of operating approved nursing or allied health education programs 
under Sec.  413.85.
    (c) Qualifying conditions for payment. (1) For portions of cost 
reporting periods occurring on or after January 1, 2000 and before 
January 1, 2001, a hospital that operates and receives payment for a 
nursing or allied health education program under Sec.  413.85 may 
receive an additional payment amount associated with Medicare + Choice 
utilization. The hospital may receive the additional payment amount, 
which is calculated in accordance with the provisions of paragraph (d) 
of this section, if both of the conditions specified in paragraphs 
(c)(1)(i) and (c)(1)(ii) of this section are met.
    (i) The hospital must have received Medicare reasonable cost payment 
for an approved nursing or allied health education program under Sec.  
413.85 in its cost reporting period(s) ending in the fiscal year that is 
2 years prior to the current calendar year. (For example, if the current 
year is calendar year 2000, the fiscal year that is 2 years prior to 
calendar year 2000 is FY 1998.) For a hospital that first establishes a 
nursing or allied health education program after FY 1998 and receives 
reasonable cost payment for the program as specified under Sec.  413.85 
after FY 1998, the hospital is eligible to receive an additional payment 
amount in a calendar year that is 2 years after the respective fiscal 
year so long as the hospital also meets the condition under paragraph 
(c)(1(ii) of this section.
    (ii) The hospital must be receiving reasonable cost payment for an 
approved nursing or allied health education program under Sec.  413.85 
in the current calendar year.
    (2) For portions of cost reporting periods occurring on or after 
January 1, 2001, in addition to meeting the conditions specified in 
paragraphs (c)(1)(i) and (c)(1)(ii) of this section, the hospital must 
have had a Medicare + Choice utilization greater than zero in its cost 
reporting period(s) ending in

[[Page 900]]

the fiscal year that is 2 years prior to the current calendar year.
    (d) Calculating the additional payment amount for portions of cost 
reporting periods occurring on or after January 1, 2000 and before 
January 1, 2001. For portions of cost reporting periods occurring on or 
after January 1, 2000 and before January 1, 2001, subject to the 
provisions of Sec.  413.76(d)(4) relating to calculating a proportional 
reduction in Medicare + Choice direct GME payments, the additional 
payment amount specified in paragraph (c) of this section is calculated 
according to the following steps:
    (1) Step one. Each calendar year, determine the hospital's total 
nursing and allied health education program payments from its cost 
reporting period(s) ending in the fiscal year that is 2 years prior to 
the current calendar year.
    (2) Step two. Determine the ratio of the hospital's payments from 
step one to the total of all nursing and allied health education program 
payments across all hospitals for all cost reporting periods ending in 
the fiscal year that is 2 years prior to the current calendar year.
    (3) Step three. Multiply the ratio calculated in step two by the 
Medicare + Choice nursing and allied health payment ``pool'' determined 
in accordance with paragraph (f) of this section for the current 
calendar year. The resulting product is each respective hospital's 
additional payment amount.
    (e) Calculating the additional payment amount for portions of cost 
reporting periods occurring on or after January 1, 2001. For portions of 
cost reporting periods occurring on or after January 1, 2001, subject to 
the provisions of Sec.  413.76(d) relating to calculating a proportional 
reduction in Medicare + Choice direct GME payments, the additional 
payment amount specified in paragraph (c) of this section is calculated 
according to the following steps:
    (1) Step one. Each calendar year, determine for each eligible 
hospital the total--
    (i) Medicare payments received for approved nursing or allied health 
education programs based on data from the settled cost reports for the 
period(s) ending in the fiscal year that is 2 years prior to the current 
calendar year; and
    (ii) Inpatient days for that same cost reporting period.
    (iii) Medicare + Choice inpatient days for that same cost reporting 
period.
    (2) Step two. Using the data from step one, determine the ratio of 
the individual hospital's total nursing or allied health payments, to 
its total inpatient days. Multiply this ratio by the hospital's total 
Medicare + Choice inpatient days.
    (3) Step three. CMS will determine, using the best available data, 
for all eligible hospitals the total of all--
    (i) Nursing and allied health education program payments made to all 
hospitals for all cost reporting periods ending in the fiscal year that 
is 2 years prior to the current calendar year;
    (ii) Inpatient days from those same cost reporting periods; and
    (iii) Medicare + Choice inpatient days for those same cost reporting 
periods.
    (4) Step four. Using the data from step three, CMS will determine 
the ratio of the total of all nursing and allied health education 
program payments made to all hospitals for all cost reporting periods 
ending in the fiscal year that is 2 years prior to the current calendar 
year, to the total of all inpatient days from those same cost reporting 
periods. CMS will multiply this ratio by the total of all Medicare + 
Choice inpatient days for those same cost reporting periods.
    (5) Step 5. Calculate the ratio of the product determined in step 
two to the product determined in step four.
    (6) Step 6. Multiply the ratio calculated in step five by the amount 
determined in accordance with paragraph (f) of this section for the 
current calendar year. The resulting product is each respective 
hospital's additional payment amount.
    (f) Calculation of the payment ``pool.'' (1) Subject to paragraph 
(f)(3) of this section, each calendar year, CMS will calculate a 
Medicare + Choice nursing and allied health payment ``pool'' according 
to the following steps:
    (i) Determine the ratio of projected total Medicare + Choice direct 
GME payments made in accordance with the provisions of Sec.  413.76(c) 
across all hospitals in the current calendar year to

[[Page 901]]

projected total direct GME payments made across all hospitals in the 
current calendar year.
    (ii) Multiply the ratio calculated in paragraph (f)(1)(i) of this 
section by projected total Medicare nursing and allied health education 
reasonable cost payments made to all hospitals in the current calendar 
year.
    (2) The resulting product of the steps under paragraphs (f)(1)(i) 
and (f)(1)(ii) of this section is the Medicare + Choice nursing and 
allied health payment ``pool'' for the current calendar year.
    (3) The payment pool may not exceed $60 million in any calendar 
year.

[65 FR 47051, Aug. 1, 2000, as amended at 66 FR 32195, June 13, 2001; 69 
FR 49265, Aug. 11, 2004; 70 FR 47489, Aug. 12, 2005]



Sec.  413.88  Incentive payments under plans for voluntary reduction 
in number of medical residents.

    (a) Statutory basis. This section implements section 1886(h)(6) of 
the Act, which establishes a program under which incentive payments may 
be made to qualifying entities that develop and implement approved plans 
to voluntarily reduce the number of residents in medical residency 
training.
    (b) Qualifying entity defined. ``Qualifying entity'' means:
    (1) An individual hospital that is operating one or more approved 
medical residency training programs as defined in Sec.  413.75(b) of 
this chapter; or
    (2) Two or more hospitals that are operating approved medical 
residency training programs as defined in Sec.  413.75(b) of this 
chapter and that submit a residency reduction application as a single 
entity.
    (c) Conditions for payments. (1) A qualifying entity must submit an 
application for a voluntary residency reduction plan that meets the 
requirements and conditions of this section in order to receive 
incentive payments for reducing the number of residents in its medical 
residency training programs.
    (2) The incentive payments will be determined as specified under 
paragraph (g) of this section.
    (d) Requirements for voluntary plans. In order for a qualifying 
entity to receive incentive payments under a voluntary residency 
reduction plan, the qualifying entity must submit an application that 
contains the following information, documents, and agreements--
    (1) A description of the operation of a plan for reducing the full-
time equivalent (FTE) residents in its approved medical residency 
training programs, consistent with the percentage reduction requirements 
specified in paragraphs (g)(2) and (g)(3) of this section;
    (2) An election of the period of residency training years during 
which the reductions will occur. The reductions must be fully 
implemented by not later than the fifth residency training year in which 
the plan is effective;
    (3) FTE counts for the base number of residents, as defined in 
paragraph (g)(1) of this section, with a breakdown of the number of 
primary care residents compared to the total number of residents; and 
the direct and indirect FTE counts of the entity on June 30, 1997. For 
joint applicants, these counts must be provided individually and 
collectively;
    (4) Data on the annual and cumulative targets for reducing the 
number of FTE residents and the ratios of the number of primary care 
residents to the total number of residents for the base year and for 
each year in the 5-year reduction period. For joint applicants, these 
data must be provided individually and collectively;
    (5) An agreement to not reduce the proportion of its primary care 
residents to its total number of residents below the proportion that 
exists in the base year, as specified in paragraph (g)(1) of this 
section;
    (6) An agreement to comply with data submission requirements deemed 
necessary by CMS to make annual incentive payments during the 5-year 
residency reduction plan, and to fully cooperate with additional audit 
and monitoring activities deemed necessary by CMS;
    (7) For a qualifying entity that is a member of an affiliated group 
as defined in Sec.  413.75(b), a statement that all members of the group 
agree to an aggregate FTE cap that reflects--
    (i) The reduction in the qualifying entity's FTE count as specified 
in the plan during each year of the plan; and
    (ii) The 1996 FTE count of the other hospital(s) in the affiliated 
group.

[[Page 902]]

    (8) A statement indicating voluntary participation in the plan under 
the terms of this section, signed by each hospital that is part of the 
applying entity.
    (e) Deadline for applications. A qualifying entity must submit an 
application that meets the requirements of paragraph (d) of this section 
at least one day prior to the first day of the period to which the plan 
would be effective but no later than November 1, 1999. The application 
must be submitted to the contractor, with a copy to CMS.
    (f) Effective dates of plans. Residency reduction plans that are 
submitted to the contractor on or after September 17, 1999 but on or 
before November 1, 1999, may be effective for portions of cost reporting 
periods beginning no earlier than the day after the date of the 
application.
    (g) Residency reduction requirements--(1) Base number of residents 
defined. (i) ``Base number of residents'' means the lesser of--
    (A) The number of FTE residents in all approved medical residency 
training programs of the qualifying entity (before application of 
weighting factors under Sec.  413.79) for the most recent residency 
training year ending June 30, 1996; or
    (B) The number of FTE residents in all approved medical residency 
training programs of the qualifying entity (before application of 
weighting factors under Sec.  413.79) for any subsequent residency 
training year that ends before the date the entity submits its plan to 
the contractor and CMS.
    (ii) The residency training year used to determine the base number 
of residents is the ``base year'' for determining reduction 
requirements.
    (iii) The qualifying entity's base number of residents may not be 
adjusted to reflect adjustments that may otherwise be made to the 
entity's FTE caps for new medical residency training programs.
    (2) Qualifying entity consisting of individual hospital. The base 
number of FTE residents in all the approved medical residency training 
programs operated by or through a qualifying entity consisting of an 
individual hospital must be reduced as follows:
    (i) If the base number of residents exceeds 750, residents, by at 
least 20 percent of the base number.
    (ii) If the base number of residents exceeds 600 but is less than or 
equal to 750 residents--
    (A) By 150 residents; or
    (B) By 20 percent, if the qualifying entity increases the number of 
primary care residents included in the base number by at least 20 
percent.
    (iii) If the base number of residents is 600 or less residents--
    (A) By 25 percent; or
    (B) By 20 percent, if the qualifying entity increases the number of 
primary care residents included in the base number of residents by at 
least 20 percent.
    (3) Qualifying entity consisting of two or more hospitals. The base 
number of FTE residents in the aggregate for all the approved medical 
residency training programs operated by or through a qualifying entity 
consisting of two or more hospitals must be reduced--
    (i) By 25 percent; or
    (ii) By 20 percent, if the qualifying entity increases the number of 
primary care residents included in the base number of residents by at 
least 20 percent.
    (4) Treatment of rotating residents. A qualifying entity will not be 
eligible for incentive payments for a reduction in the base number of 
residents if the reduction is a result of the entity rotating residents 
to another hospital that is not a part of its voluntary residency 
reduction plan.
    (5) Updates to annual and cumulative targets (i) Except as provided 
in paragraph (g)(5)(ii) of this section an entity with an approved 
voluntary residency reduction plan may not change the annual and 
cumulative reduction targets that are specified in its plan in 
accordance with paragraphs (g)(2) and (g)(3) of this section.
    (ii) An entity may update annual reduction targets specified in its 
plan only if--
    (A) It has failed to meet a specified annual target for a plan year 
in the 5-year period; and
    (B) It wishes to adjust future annual targets for the remaining 
years of the plan in order to comply with its cumulative target.

[[Page 903]]

    (iii) An updated plan allowed under paragraph (g)(5)(ii) of this 
section must be submitted prior to the beginning of each July 1 medical 
residency training year during the plan years.
    (h) Computation of incentive payment amount. (1) Incentive payments 
to qualifying entities that meets the requirements and conditions of 
paragraphs (d) and (g) of this section will be computed as follows:
    (i) Step 1. Determine the amount (if any) by which the payment 
amount that would have been made under Sec.  413.76 if there had been a 
5-percent reduction in the number of FTE residents in the approved 
medical education training programs of the hospital as of June 30, 1997, 
exceeds the amount of payment that would have been made under Sec.  
413.76 in each year under the voluntary residency reduction plan, taking 
into account the reduction in the number of FTE residents under the 
plan.
    (ii) Step 2. Determine the amount (if any) by which the payment 
amount that would have been made under Sec.  412.105 of this chapter if 
there had been a 5-percent reduction in the number of FTE residents in 
the approved medical education training programs of the hospital as of 
June 30, 1997, exceeds the payment amount made under Sec.  412.105 of 
this chapter in each year under the voluntary residency reduction plan, 
taking into account the actual reduction in the number of FTE residents.
    (iii) Step 3. Determine the amount (if any) by which the payment 
amount that would have been made under Sec.  412.322 of this chapter if 
there had been a 5-percent reduction in the number of FTE residents in 
the approved medical education training programs of the hospital as of 
June 30, 1997, exceeds the payment amount made under Sec.  412.322 of 
this chapter in each year under the voluntary residency reduction plan, 
taking into account the actual reduction in the number of FTE residents.
    (iv) Step 4. Multiply the sum of the amounts determined under 
paragraph (h)(i), (ii), and (iii) of this section by the applicable hold 
harmless percentages specified in paragraph (i) of this section.
    (2) The determination of the amounts under paragraph (h)(1) of this 
section for any year is based on the applicable Medicare statutory 
provisions in effect on the application deadline date for the voluntary 
reduction plan specified under paragraph (e) of this section.
    (i) Applicable hold-harmless percentage. The applicable hold-
harmless percentages for each year in which the residency reduction plan 
is in effect are as follows:
    (1) 100 percent for the first and second residency training years;
    (2) 75 percent for the third year;
    (3) 50 percent for the fourth year; and
    (4) 25 percent for the fifth year.
    (j) Payments to qualifying entities. Annual incentive payments 
through cost reports will be made to each hospital that is or is part of 
a qualifying entity over the 5-year reduction period if the qualifying 
entity meets the annual and cumulative reduction targets specified in 
its voluntary reduction plan.
    (k) Penalty for noncompliance--(1) Nonpayment. No incentive payment 
may be made to a qualifying entity for a residency training year if the 
qualifying entity has failed to reduce the number of FTE residents 
according to its voluntary residency reduction plan.
    (2) Repayment of incentive amounts. The qualifying entity is liable 
for repayment of the total amount of incentive payments it has received 
if the qualifying entity--
    (i) Fails to reduce the base number of residents by the percentages 
specified in paragraphs (g)(2) and (g)(3) of this section by the end of 
the fifth residency training year; or
    (ii) Increases the number of FTE residents above the number of 
residents permitted under the voluntary residency reduction plan as of 
the completion date of the plan.
    (l) Postplan determination of FTE caps for qualifying entities--(1) 
No penalty imposed. Upon completion of a voluntary residency reduction 
plan, if no penalty is imposed, the qualifying entity's 1996 FTE count 
is permanently adjusted to equal the unweighted FTE count used for 
direct GME payments for the last residency training year in which a 
qualifying entity participates.

[[Page 904]]

    (2) Penalty imposed. Upon completion of the voluntary residency 
reduction plan--
    (i) During repayment period. If a penalty is imposed under paragraph 
(k)(2) of this section, during the period of repayment, the qualifying 
entity's FTE count is as specified in paragraph (l)(1) of this section.
    (ii) After repayment period. Once the penalty repayment is 
completed, the qualifying entity's FTE reverts back to its original 1996 
FTE cap.

[64 FR 44855, Aug. 18, 1999, as amended at 69 FR 49265, Aug. 11, 2004]



Sec.  413.89  Bad debts, charity, and courtesy allowances.

    (a) Principle. Bad debts, charity, and courtesy allowances are 
deductions from revenue and are not to be included in allowable cost. 
However, subject to the limitations described under paragraph (h) of 
this section and the exception for services described under paragraph 
(i) of this section, bad debts attributable to the deductibles and 
coinsurance amounts are reimbursable under the program.
    (b) Definitions--(1) Bad debts. (i) For cost reporting periods 
beginning before October 1, 2020:
    (A) ``Bad debts'' are amounts considered to be uncollectible from 
accounts and notes receivable that were created or acquired in providing 
services.
    (B) ``Accounts receivable'' and ``notes receivable'' are 
designations for claims arising from the furnishing of services, and are 
collectible in money in the relatively near future.
    (ii) For cost reporting periods beginning on or after October 1, 
2020, ``bad debts'' are amounts considered to be uncollectible from 
patient accounts that were created or acquired in providing services and 
are categorized as implicit price concessions for cost reporting 
purposes and are recorded in the provider's accounting records as a 
component of net patient revenue.
    (2) Charity allowances. Charity allowances are reductions in charges 
made by the provider of services because of the indigence or medical 
indigence of the patient. Cost of free care (uncompensated services) 
furnished under a Hill-Burton obligation are considered as charity 
allowances.
    (3) Courtesy allowances. Courtesy allowances indicate a reduction in 
charges in the form of an allowance to physicians, clergy, members of 
religious orders, and others as approved by the governing body of the 
provider, for services received from the provider. Employee fringe 
benefits, such as hospitalization and personnel health programs, are not 
considered to be courtesy allowances.
    (c) Normal accounting treatment: Reduction in revenue. (1) For cost 
reporting periods beginning before October 1, 2020:
    (i) Bad debts, charity, and courtesy allowances represent reductions 
in revenue. The failure to collect charges for services furnished does 
not add to the cost of providing the services as these costs have 
already been incurred in the production of the services.
    (ii) Medicare bad debts must not be written off to a contractual 
allowance account but must be charged to an expense account for 
uncollectible accounts.
    (2) For cost reporting periods beginning on or after October 1, 
2020:
    (i) Bad debts, also known as ``implicit price concessions,'' 
charity, and courtesy allowances represent reductions in revenue. The 
failure to collect charges for services furnished does not add to the 
cost of providing the services as these costs have already been incurred 
in the production of the services.
    (ii) Medicare bad debts must not be written off to a contractual 
allowance account but must be recorded as an implicit price concession 
that results in a reduction in revenue.
    (d) Requirements for Medicare. Under Medicare, costs of covered 
services furnished beneficiaries are not to be borne by individuals not 
covered by the Medicare program, and conversely, costs of services 
provided for other than beneficiaries are not to be borne by the 
Medicare program. Uncollected revenue related to services furnished to 
beneficiaries of the program generally means the provider has not 
recovered the cost of services covered by that revenue. The failure of 
beneficiaries to pay the deductible and coinsurance amounts could result 
in the related costs of covered services being borne by other than 
Medicare beneficiaries. To

[[Page 905]]

assure that such covered service costs are not borne by others, the 
costs attributable to the deductible and coinsurance amounts that remain 
unpaid are added to the Medicare share of allowable costs. Bad debts 
arising from other sources are not allowable costs.
    (e) Criteria for allowable bad debt. A bad debt must meet the 
following criteria to be allowable:
    (1) The debt must be related to covered services and derived from 
deductible and coinsurance amounts.
    (2) The provider must be able to establish that reasonable 
collection efforts were made.
    (i) Non-indigent beneficiary. A non-indigent beneficiary is a 
beneficiary who has not been determined to be categorically or medically 
needy by a State Medicaid Agency to receive medical assistance from 
Medicaid, nor have they been determined to be indigent by the provider 
for Medicare bad debt purposes. To be considered a reasonable collection 
effort for non-indigent beneficiaries, all of the following are 
applicable:
    (A) A provider's collection effort or the effort of a collection 
agency acting on the provider's behalf, or both, to collect Medicare 
deductible or coinsurance amounts must consist of all of the following:
    (1) Be similar to the collection effort put forth to collect 
comparable amounts from non-Medicare patients.
    (2) For cost reporting periods beginning before October 1, 2020, 
involve the issuance of a bill to the beneficiary or the party 
responsible for the beneficiary's personal financial obligations on or 
shortly after discharge or death of the beneficiary.
    (3) For cost reporting periods beginning on or after October 1, 
2020, involve the issuance of a bill to the beneficiary or the party 
responsible for the beneficiary's personal financial obligations on or 
before 120 days after the latter of one of the following:
    (i) The date of the Medicare remittance advice that results from 
processing the claim for services furnished to the beneficiary and 
generates the beneficiary's cost sharing amounts.
    (ii) The date of the remittance advice from the beneficiary's 
secondary payer, if any.
    (iii) The date of the notification that the beneficiary's secondary 
payer does not cover the service furnished to the beneficiary.
    (4) Include other actions such as subsequent billings, collection 
letters, and telephone calls, emails, text messages, or personal 
contacts with this party.
    (5)(i) Last at least 120 days after paragraph (e)(2)(i)(A)(2) or (3) 
of this section is met before being written off as uncollectible under 
paragraph (e)(3) of this section.
    (ii) Start a new 120-day collection period each time a payment is 
received within a 120-day collection period.
    (6) Maintaining and, upon request, furnishing verifiable 
documentation to its contractor that includes all of the following:
    (i) The provider's bad debt collection policy which describes the 
collection process for Medicare and non-Medicare patients.
    (ii) The patient account history documents which show the dates of 
various collection actions such as the issuance of bills to the 
beneficiary, follow-up collection letters, reports of telephone calls 
and personal contact, etc.
    (iii) The beneficiary's file with copies of the bill(s) and follow-
up notices.
    (B) A provider that uses a collection agency to perform its 
collection effort must do all of the following:
    (1) Reduce the beneficiary's account receivable by the gross amount 
collected.
    (2) Include any fee charged by the collection agency as an 
administrative cost.
    (3) Before claiming the unpaid amounts as a Medicare bad debt, cease 
all collection efforts, including the collection agency efforts, and 
ensure that the collection accounts have been returned to the provider 
from the agency.
    (ii) Indigent non-dual eligible beneficiary. An indigent non-dual 
eligible beneficiary is a beneficiary who is determined to be indigent 
or medically indigent by the provider and is not eligible for Medicaid 
as categorically or medically needy.
    (A) To determine a beneficiary to be an indigent non-dual eligible 
beneficiary, the provider--

[[Page 906]]

    (1) Must not use a beneficiary's declaration of their inability to 
pay their medical bills or deductibles and coinsurance amounts as sole 
proof of indigence or medical indigence;
    (2) Must take into account the analysis of both the beneficiary's 
assets (only those convertible to cash and unnecessary for the 
beneficiary's daily living) and income;
    (3) May consider extenuating circumstances that would affect the 
determination of the beneficiary's indigence or medical indigence which 
may include an analysis of both the beneficiary's liabilities and 
expenses, if indigence is unable to be determined under paragraph 
(e)(ii)(A)(2) of this section;
    (4) Must determine that no source other than the beneficiary would 
be legally responsible for the beneficiary's medical bill, such as a 
legal guardian or State Medicaid program; and
    (5) Must maintain and, upon request, furnish its contractor its 
indigence policy describing the method by which indigence or medical 
indigence is determined and all the verifiable beneficiary specific 
documentation which supports the provider's determination of each 
beneficiary's indigence or medical indigence.
    (B) Once indigence is determined the bad debt may be deemed 
uncollectible without applying a collection effort under paragraph 
(e)(2)(i)(A) or (B) of this section.
    (iii) Indigent dual-eligible beneficiaries (including qualified 
Medicare beneficiaries). Providers may deem Medicare beneficiaries 
indigent or medically indigent when such individuals have also been 
determined eligible for Medicaid under a State's Title XIX Medicaid 
program as either categorically needy individuals or medically needy 
individuals. To be considered a reasonable collection effort for dual-
eligible beneficiaries:
    (A) When a State permits a Medicare provider's Medicaid enrollment 
for the purposes of processing a beneficiary's claim, to determine the 
State's liability for the beneficiary's Medicare cost sharing, the 
provider--
    (1) Must determine whether the State's Title XIX Medicaid Program 
(or a local welfare agency, if applicable) is responsible to pay all or 
a portion of the beneficiary's Medicare deductible or coinsurance 
amounts;
    (2) Must submit a bill to its Medicaid/Title XIX agency (or to its 
local welfare agency) to determine the State's cost sharing obligation 
to pay all or a portion of the applicable Medicare deductible and 
coinsurance;
    (3) Must submit the Medicaid remittance advice received from the 
State to its Medicare contractor;
    (4) Must reduce allowable Medicare bad debt by any amount that the 
State is obligated to pay, either by statute or under the terms of its 
approved Medicaid State plan, regardless of whether the State actually 
pays its obligated amount to the provider; and
    (5) May include the Medicare deductible or coinsurance amount, or 
any portion thereof that the State is not obligated to pay, and which 
remains unpaid by the beneficiary, as an allowable Medicare bad debt.
    (B) When, through no fault of the provider, a provider does not 
receive a Medicaid remittance advice because the State does not permit a 
Medicare provider's Medicaid enrollment for the purposes of processing a 
beneficiary's claim, or because the State does not generate a Medicaid 
remittance advice, the provider--
    (1) Must submit to its contractor, all of the following auditable 
and verifiable documentation:
    (i) The State's Medicaid notification stating that the State has no 
legal obligation to pay the provider for the beneficiary's Medicare cost 
sharing.
    (ii) A calculation of the amount the State owes the provider for 
Medicare cost sharing.
    (iii) Verification of the beneficiary's eligibility for Medicaid for 
the date of service;
    (2) Must reduce allowable Medicare bad debt by any amount the State 
is obligated to pay, regardless of whether the State actually pays its 
obligated amount to the provider; and
    (3) May include the Medicare deductible or coinsurance amount, or 
any portion thereof that the State is not obligated to pay, and which 
remains unpaid by the beneficiary, as an allowable Medicare bad debt.

[[Page 907]]

    (3) The debt was actually uncollectible when claimed as worthless.
    (4) Sound business judgment established that there was no likelihood 
of recovery at any time in the future.
    (f) Reporting period for writing off bad debts and reporting of 
recoveries of bad debts reimbursed in prior periods. For cost reporting 
periods beginning before, on, or after October 1, 2020, the deductible 
and coinsurance amounts uncollected from beneficiaries are to be written 
off and recognized as allowable bad debts in the cost reporting period 
in which the accounts are deemed to be worthless.
    (1) Any payment on the account made by the beneficiary or a 
responsible party, after the write-off date but before the end of the 
cost reporting period, must be used to reduce the final bad debt for the 
account claimed in that cost report.
    (2) In some cases an amount written off as a bad debt and reimbursed 
by the program in a prior cost reporting period may be recovered in a 
subsequent period.
    (i) In situations described in this paragraph (f)(2), the recovered 
amount must be used to reduce the provider's reimbursable costs in the 
period in which the amount is recovered.
    (ii) The amount of reduction in the period of recovery (as specified 
in paragraph (f)(2)(i) of this section) must not exceed the actual 
amount reimbursed by the program for the related bad debt in the 
applicable prior cost reporting period.
    (g) Charity allowances. Charity allowances have no relationship to 
beneficiaries of the Medicare program and are not allowable costs. These 
charity allowances include the costs of uncompensated services furnished 
under a Hill-Burton obligation. (Note: In accordance with section 106(b) 
of Pub. L. 97-248 (enacted September 3, 1982), this sentence is 
effective with respect to any costs incurred under Medicare except that 
it does not apply to costs which have been allowed prior to September 3, 
1982, pursuant to a final court order affirmed by a United States Court 
of Appeals.) The cost to the provider of employee fringe-benefit 
programs is an allowable element of reimbursement.
    (h) Limitations on bad debts--(1) Hospitals. In determining 
reasonable costs for hospitals, the amount of allowable bad debt (as 
defined in paragraph (e) of this section) is reduced:
    (i) For cost reporting periods beginning during fiscal year 1998, by 
25 percent;
    (ii) For cost reporting periods beginning during fiscal year 1999, 
by 40 percent;
    (iii) For cost reporting periods beginning during fiscal year 2000, 
by 45 percent; and
    (iv) For cost reporting periods beginning during fiscal years 2001 
through 2012, by 30 percent.
    (v) For cost reporting periods beginning during a subsequent fiscal 
year, by 35 percent.
    (2) Skilled nursing facilities and swing bed hospitals. For the 
purposes of this paragraph (h)(2), a dual eligible individual is defined 
as an individual that is entitled to benefits under Part A of Medicare 
and is determined eligible by the State for medical assistance under 
Title XIX of the Act as described under paragraph (2) of the definition 
of a ``full-benefit dual eligible individual'' at Sec.  423.772 of this 
chapter. In determining reasonable costs for a skilled nursing facility 
and for post-hospital SNF care furnished in a swing bed hospital, as 
defined in Sec.  413.114(b), the amount of allowable bad debt (as 
defined in paragraph (e) of this section) is reduced:
    (i) For non-dual eligible individuals--(A) For cost reporting 
periods beginning during fiscal years 2006 through 2012, by 30 percent, 
for a patient in a skilled nursing facility.
    (B) For cost reporting periods beginning during a subsequent fiscal 
year, by 35 percent, for a patient in a skilled nursing facility or 
receiving post-hospital SNF care in a swing bed hospital.
    (ii) For dual eligible individuals--(A) For cost reporting periods 
beginning during fiscal year 2013, by 12 percent, for a patient in a 
skilled nursing facility or a patient receiving post-hospital SNF care 
in a swing bed hospital.
    (B) For cost reporting periods beginning during fiscal year 2014, by 
24 percent, for a patient in a skilled nursing

[[Page 908]]

facility or a patient receiving post-hospital SNF care in a swing bed 
hospital.
    (C) For cost reporting periods beginning during a subsequent fiscal 
year, by 35 percent, for a patient in a skilled nursing facility or a 
patient receiving post-hospital SNF care in a swing bed hospital.
    (3) End-stage renal dialysis facilities. In determining reasonable 
costs for an end-stage renal dialysis facility, the amount of allowable 
bad debt (as defined in paragraph (e) of this section) is:
    (i) For cost reporting periods beginning before October 1, 2012, 
reimbursed up to the facility's costs.
    (ii) For cost reporting periods beginning on or after October 1, 
2012 and before January 1, 2013, reduced by 12 percent with the 
resulting amount reimbursed up to the facility's costs.
    (iii) For cost reporting periods beginning on or after January 1, 
2013 and before October 1, 2013, reduced by 12 percent.
    (iv) For cost reporting periods beginning during fiscal year 2014, 
reduced by 24 percent.
    (v) For cost reporting periods beginning during a subsequent fiscal 
year, reduced by 35 percent.
    (4) All other providers. In determining reasonable costs for all 
other providers, suppliers and other entities not described elsewhere in 
paragraph (h) of this section that are eligible to receive reimbursement 
for bad debts under this section, the amount of allowable bad debts (as 
defined in paragraph (e) of this section) is reduced:
    (i) For cost reporting periods beginning during fiscal year 2013, by 
12 percent.
    (ii) For cost reporting periods beginning during fiscal year 2014, 
by 24 percent.
    (iii) For cost reporting periods beginning during a subsequent 
fiscal year, by 35 percent.
    (i) Exceptions applicable to bad debt reimbursement. (1) Bad debts 
arising from covered services paid under a reasonable charge-based 
methodology or a fee schedule are not reimbursable under the program.
    (2) For end-stage renal dialysis services furnished on or after 
January 1, 2011 and paid for under the end-stage renal dialysis 
prospective payment system described in Sec.  413.215, bad debts arising 
from covered items or services that, prior to January 1, 2011 were paid 
under a reasonable charge-based methodology or a fee schedule, including 
but not limited to drugs, laboratory tests, and supplies are not 
reimbursable under the program.

[51 FR 34793, Sept. 30, 1986, as amended at 57 FR 33898, July 31, 1992; 
60 FR 63189, Dec. 8, 1995; 63 FR 41005, July 31, 1998; 66 FR 32195, June 
13, 2001. Redesignated at 69 FR 49254, Aug. 11, 2004, and amended at 71 
FR 48142, Aug. 18, 2006; 71 FR 69785, Dec. 1, 2006; 75 FR 49198, Aug. 
12, 2010; 77 FR 67350, Nov. 9, 2012; 85 FR 59023, Sept. 18, 2020]



Sec.  413.90  Research costs.

    (a) Principle. Costs incurred for research purposes, over and above 
usual patient care, are not includable as allowable costs.
    (b) Application. (1) There are numerous sources of financing for 
health-related research activities. Funds for this purpose are provided 
under many Federal programs and by other tax-supported agencies. Also, 
many foundations, voluntary health agencies, and other private 
organizations, as well as individuals, sponsor or contribute to the 
support of medical and related research. Funds available from such 
sources are generally ample to meet basic medical and hospital research 
needs. A further consideration is that quality review should be assured 
as a condition of governmental support for research. Provisions for such 
review would introduce special difficulties in the Medicare programs.
    (2) If research is conducted in conjunction with, and as a part of, 
the care of patients, the costs of usual patient care and studies, 
analyses, surveys, and related activities to serve the provider's 
administrative and program needs are allowable costs in the 
determination of payment under Medicare.

[51 FR 34793, Sept. 30, 1986, as amended at 61 FR 63748, Dec. 2, 1996]



Sec.  413.92  Costs of surety bonds.

    Costs incurred by a provider to obtain a surety bond required by 
part 489, subpart F of this chapter are not included as allowable costs.

[63 FR 310, Jan. 5, 1998]

[[Page 909]]



Sec.  413.94  Value of services of nonpaid workers.

    (a) Principle. The value of services in positions customarily held 
by full-time employees performed on a regular, scheduled basis by 
individuals as nonpaid members of organizations under arrangements 
between such organizations and a provider for the performance of such 
services without direct remuneration from the provider to such 
individuals is allowable as an operating expense for the determination 
of allowable cost subject to the limitation contained in paragraph (b) 
of this section. The amounts allowed are not to exceed those paid others 
for similar work. Such amounts must be identifiable in the records of 
the institutions as a legal obligation for operating expenses.
    (b) Limitations: Services of nonpaid workers. The services must be 
performed on a regular, scheduled basis in positions customarily held by 
full-time employees and necessary to enable the provider to carry out 
the functions of normal patient care and operation of the institution. 
The value of services of a type for which providers generally do not 
remunerate individuals performing such services is not allowable as a 
reimbursable cost under the Medicare program. For example, donated 
services of individuals in distributing books and magazines to patients, 
or in serving in a provider canteen or cafeteria or in a provider gift 
shop, would not be reimbursable.
    (c) Application. The following illustrates how a provider would 
determine an amount to be allowed under this principle: The prevailing 
salary for a lay nurse working in Hospital A is $5,000 for the year. The 
lay nurse receives no maintenance or special perquisites. A sister 
working as a nurse engaged in the same activities in the same hospital 
receives maintenance and special perquisites which cost the hospital 
$2,000 and are included in the hospital's allowable operating costs. The 
hospital would then include in its records an additional $3,000 to bring 
the value of the services rendered to $5,000. The amount of $3,000 would 
be allowable if the provider assumes obligation for the expense under a 
written agreement with the sisterhood or other religious order covering 
payment by the provider for the services.



Sec.  413.98  Purchase discounts and allowances, and refunds of expenses.

    (a) Principle. Discounts and allowances received on purchases of 
goods or services are reductions of the costs to which they relate. 
Similarly, refunds of previous expense payments are reductions of the 
related expense.
    (b) Definitions--(1) Discounts. Discounts, in general, are 
reductions granted for the settlement of debts.
    (2) Allowances. Allowances are deductions granted for damage, delay, 
shortage, imperfection, or other causes, excluding discounts and 
returns.
    (3) Refunds. Refunds are amounts paid back or a credit allowed on 
account of an overcollection.
    (c) Normal accounting treatment--Reduction of costs. All discounts, 
allowances, and refunds of expenses are reductions in the cost of goods 
or services purchased and are not income. If they are received in the 
same accounting period in which the purchases were made or expenses were 
incurred, they will reduce the purchases or expenses of that period. 
However, if they are received in a later accounting period, they will 
reduce the comparable purchases or expenses in the period in which they 
are received.
    (d) Application. (1) Purchase discounts have been classified as 
cash, trade, or quantity discounts. Cash discounts are reductions 
granted for the settlement of debts before they are due. Trade discounts 
are reductions from list prices granted to a class of customers before 
consideration of credit terms. Quantity discounts are reductions from 
list prices granted because of the size of individual or aggregate 
purchase transactions. Whatever the classification of purchase 
discounts, like treatment in reducing allowable costs is required. In 
the past, purchase discounts were considered as financial management 
income. However, modern accounting theory holds that income is not 
derived from a purchase but rather from a sale or an exchange and that 
purchase discounts are reductions in the cost of whatever was purchased. 
The true cost of the goods or services is the net

[[Page 910]]

amount actually paid for them. Treating purchase discounts as income 
would result in an overstatement of costs to the extent of the discount.
    (2) As with discounts, allowances, and rebates received from 
purchases of goods or services, refunds of previous expense payments are 
clearly reductions in costs and must be reflected in the determination 
of allowable costs. This treatment is equitable and is in accord with 
that generally followed by other governmental programs and third-party 
payment organizations paying on the basis of cost.



Sec.  413.100  Special treatment of certain accrued costs.

    (a) Principle. As described in Sec.  413.24(b)(2), under the accrual 
basis of accounting, revenue is reported in the period in which it is 
earned and expenses are reported in the period in which they are 
incurred. In the case of accrued costs described in this section, for 
Medicare payment purposes the costs are allowable in the year in which 
the costs are accrued and claimed for Medicare payment only under the 
conditions set forth in paragraph (c) of this section.
    (b) Definitions--(1) All-inclusive paid days off benefit. An all-
inclusive paid days off benefit replaces other vacation and sick pay 
plans. It is a formal plan under which, based on actual hours worked, 
all employees accrue vested leave or payment in lieu of vested leave for 
any combination of types of leave, such as illness, medical 
appointments, holidays, and vacations.
    (2) Self-insurance. Self-insurance is a means by which a provider 
independently or as part of a group undertakes the risk of protecting 
itself against anticipated liabilities by providing funds in an amount 
equal to anticipated liabilities, rather than by purchasing insurance 
coverage.
    (c) Recognition of accrued costs--(1) General. Although Medicare 
recognizes, in the year of accrual, the accrual of costs for which a 
provider has not actually expended funds during the current cost 
reporting period, for purposes of payment Medicare does not recognize 
the accrual of costs unless the related liabilities are liquidated 
timely.
    (2) Requirements for liquidation of liabilities. For accrued costs 
to be recognized for Medicare payment in the year of the accrual, the 
requirements set forth below must be met with respect to the liquidation 
of related liabilities. If liquidation does not meet these requirements, 
the cost is disallowed, generally in the year of accrual, except as 
specified in paragraph (c)(2)(ii) of this section.
    (i) A short-term liability. (A) Except as provided in paragraph 
(c)(2)(i)(B) of this section, a short-term liability, including the 
current portion of a long-term liability (for example, mortgage interest 
payments due to be paid in the current year), must be liquidated within 
1 year after the end of the cost reporting period in which the liability 
is incurred.
    (B) If, within the 1-year time limit, the provider furnishes to the 
contractor sufficient written justification (based upon documented 
evidence) for nonpayment of the liability , the contractor may grant an 
extension for good cause. The extension may not exceed 3 years beyond 
the end of the cost reporting year in which the liability was incurred.
    (ii) Vacation pay and all-inclusive paid days off. (A) If the 
provider's vacation policy, or its policy for all-inclusive paid days 
off, is consistent for all employees, liquidation of the liability must 
be made within the period provided for by that policy.
    (B) If the provider's vacation policy, or its policy for all-
inclusive paid days off, is not consistent for all employees, 
liquidation of the liability must be made within 2 years after the close 
of the cost reporting period in which the liability is accrued.
    (C) If payment is not made within the required time period or if 
benefits are forfeited by the employee, an adjustment to disallow the 
accrued cost is made in the current period (that is, the latest year in 
which payment should have been made or the year in which the benefits 
are forfeited) rather than in the period in which the cost was accrued 
and claimed for Medicare payment. However, an contractor may choose to 
require the adjustment in the period in which the cost was accrued and 
claimed for Medicare payment if

[[Page 911]]

the cost report for that period is open or can be reopened as provided 
in Sec.  405.1885 of this chapter, and if the contractor believes the 
adjustment is more appropriate in that period.
    (iii) Sick pay. (A) If sick leave is vested and funded in a deferred 
compensation plan, liabilities related to the contributions to the fund 
must be liquidated, generally within 1 year after the end of the cost 
reporting period in which the liability is incurred. If, within the 1-
year time limit, the provider furnishes to the contractor sufficient 
written justification (based upon documented evidence) for nonpayment of 
the liability, the contractor may grant an extension for good cause. The 
extension may not exceed 3 years beyond the end of the cost reporting 
year in which the liability was incurred. Contributions to the deferred 
compensation plan must be reduced to reflect estimated forfeitures. 
Actual forfeitures above or below estimated forfeitures must be used to 
adjust annual contributions to the fund.
    (B) If the sick leave plan grants employees the nonforfeitable right 
to demand cash payment for unused sick leave at the end of each year, 
sick pay is includable in allowable costs, without funding, in the cost 
reporting period in which it is earned.
    (C) Sick pay paid on any basis other than that specified in 
paragraphs (c)(2)(iii) (A) or (B) of this section can be claimed for 
Medicare payment only on a cash basis for the year in which the benefits 
are paid.
    (iv) Compensation of owners. Accrued liability related to 
compensation of owners other than sole proprietors and partners must be 
liquidated within 75 days after the close of the cost reporting period 
in which the liability occurs.
    (v) Nonpaid workers. Obligations incurred under a legally-
enforceable agreement to remunerate an organization of nonpaid workers 
must be discharged no later than the end of the provider's cost 
reporting period following the period in which the services were 
furnished.
    (vi) FICA and other payroll taxes--(A) General rule. The provider's 
share of FICA and other payroll taxes that the provider becomes 
obligated to remit to governmental agencies is included in allowable 
costs only during the cost reporting period in which payment (upon which 
the payroll taxes are based) is actually made to the employee. For 
example, payroll taxes applicable to vacation benefits are not to be 
accrued in the period in which the vacation benefits themselves are 
accrued but rather are allowable only in the period in which the 
employee takes the vacation.
    (B) Exception. If payment would be made to an employee during a cost 
reporting period but for the fact the regularly scheduled payment date 
is after the end of the period, costs of accrued payroll taxes related 
to the portion of payroll accrued through the end of the period, but 
paid to the employee after the beginning of the new period, are 
allowable costs in the year of accrual, subject to the liquidation 
requirements specified in paragraph (c)(2)(i) of this section.
    (vii) Deferred compensation. (A) Reasonable provider payments made 
under unfunded deferred compensation plans are included in allowable 
costs only during the cost reporting period in which actual payment is 
made to the participating employee.
    (B) Accrued liability related to contributions to a funded deferred 
compensation plan must be liquidated within 1 year after the end of the 
cost reporting period in which the liability is incurred. An extension, 
not to exceed 3 years beyond the end of the cost reporting year in which 
the liability was incurred, may be granted by the contractor for good 
cause if the provider, within the 1-year time limit, furnishes to the 
contractor sufficient written justification for non-payment of the 
liability.
    (C) Postretirement benefit plans (including those addressed in 
Statement of Financial Accounting Standards No. 106 (December 1990)) are 
deferred compensation arrangements and thus are subject to the 
provisions of this section regarding deferred compensation and to 
applicable program instructions for determining Medicare payment for 
deferred compensation.
    (D) Exception: Qualified defined benefit pension plans, which are 
funded deferred compensation arrangements,

[[Page 912]]

shall be reported on a cash accounting basis as follows:
    (1) The allowable pension cost shall be equal to the amount of 
actual pension contributions funded during the hospital's current 
Medicare cost reporting period, plus any contributions funded in a prior 
period and carried forward, subject to the limit under paragraph 
(c)(2)(vii)(D)(2) of this section.
    (2) Except as provided in paragraph (c)(2)(vii)(D)(3) of this 
section, the allowable pension cost shall not exceed 150 percent of the 
average contribution(s) funded during the three consecutive Medicare 
cost reporting periods that produce the highest average contribution(s), 
out of the five most recent Medicare cost reporting periods (ending with 
the current cost reporting period). Contributions in excess of the limit 
may be carried forward to future period(s). In the case of a newly 
adopted pension plan, the 5-year look-back period and/or the 3-year 
averaging period will be limited to the number of cost reporting periods 
the provider sponsored a qualified defined benefit pension plan.
    (3) A waiver of the limit imposed under paragraph (c)(2)(vii)(D)(2) 
of this section may be granted for a specific Medicare cost reporting 
period for all or a portion of the contributions in excess of the limit 
imposed under paragraph (c)(2)(vii)(D)(2) of this section if it is 
determined that such excess costs are reasonable and necessary for that 
period.
    (viii) Self-insurance. Accrued liability related to contributions to 
a self-insurance program that are systematically made to a funding 
agency and that cover malpractice and comprehensive general liability, 
unemployment compensation, workers' compensation insurance losses, or 
employee health benefits, must be liquidated within 75 days after the 
close of the cost reporting period.

[60 FR 33136, June 27, 1995, as amended at 64 FR 51909, Sept. 27, 1999; 
77 FR 53682, Aug. 31, 2012]



Sec.  413.102  Compensation of owners.

    (a) Principle. A reasonable allowance of compensation for services 
of owners is an allowable cost provided that the services are actually 
performed in a necessary function.
    (b) Definitions--(1) Compensation. Compensation means the total 
benefit received by the owner for the services he furnishes to the 
institution. It includes the following items:
    (i) Salary amounts paid for managerial, administrative, 
professional, and other services.
    (ii) Amounts paid by the institution for the personal benefit of the 
proprietor.
    (iii) The cost of assets and services that the proprietor receives 
from the institution.
    (iv) Deferred compensation.
    (2) Reasonableness. Reasonableness requires that the compensation 
allowance--
    (i) Be such an amount as would ordinarily be paid for comparable 
services by comparable institutions; and
    (ii) Depend upon the facts and circumstances of each case.
    (3) Necessary. Necessary requires that the function be--
    (i) Such that had the owner not furnished the services, the 
institution would have had to employ another person to perform the 
services; and
    (ii) Pertinent to the operation and sound conduct of the 
institution.
    (c) Application. (1) Owners of provider organizations often furnish 
services as managers, administrators, or in other capacities. In such 
cases, it is equitable that reasonable compensation for the services 
furnished to be an allowable cost. To do otherwise would disadvantage 
such owners in comparison with corporate providers or providers 
employing persons to perform similar services.
    (2) Ordinarily, compensation paid to proprietors is a distribution 
of profits. However, if a proprietor furnishes necessary services for 
the institution, the institution is in effect employing his services, 
and a reasonable compensation for these services is an allowable cost. 
In corporate providers, the salaries of owners who are also employees 
are subject to the same requirements of reasonableness. If the services 
are furnished on less than a full-time basis, the allowable compensation 
should reflect an amount proportionate to a

[[Page 913]]

full-time basis. Reasonableness of compensation may be determined by 
reference to, or in comparison with, compensation paid for comparable 
services and responsibilities in comparable institutions; or it may be 
determined by other appropriate means.



Sec.  413.106  Reasonable cost of physical and other therapy services 
furnished under arrangements.

    (a) Principle. The reasonable cost of the services of physical, 
occupational, speech, and other therapists, and services of other health 
specialists (other than physicians), furnished under arrangements (as 
defined in section 1861(w) of the Act) with a provider of services, a 
clinic, a rehabilitation agency or a public health agency, may not 
exceed an amount equivalent to the prevailing salary and additional 
costs that would reasonably have been incurred by the provider or other 
organization had such services been performed by such person in an 
employment relationship, plus the cost of other reasonable expenses 
incurred by such person in furnishing services under such an 
arrangement. However, if the services of a therapist are required on a 
limited part-time basis, or to perform intermittent services, payment 
may be made on the basis of a reasonable rate per unit of service, even 
though this rate may be greater per unit of time than salary-related 
amounts, if the greater payment is, in the aggregate, less than the 
amount that would have been paid had a therapist been employed on a 
full-time or regular part-time salaried basis. Pursuant to section 17(a) 
of Public Law 93-233 (87 Stat. 967), the provisions of this section are 
effective for cost reporting periods beginning after March, 1975.
    (b) Definitions--(1) Prevailing salary. The prevailing salary is the 
hourly salary rate based on the 75th percentile of salary ranges paid by 
providers in the geographical area, by type of therapy, to therapists 
working full time in an employment relationship.
    (2) Fringe benefit and expense factor. The standard fringe benefit 
and expense factor is an amount that takes account of fringe benefits, 
such as vacation pay, insurance premiums, pension payments, allowances 
for job-related training, meals, etc., generally received by an employee 
therapist, as well as expenses, such as maintaining an office, 
appropriate insurance, etc., an individual not working as an employee 
might incur in furnishing services under arrangements.
    (3) Adjusted hourly salary equivalency amount. The adjusted hourly 
salary equivalency amount is the prevailing hourly salary rate plus the 
standard fringe benefit and expense factor. This amount is determined on 
a periodic basis for appropriate geographical areas.
    (4) Travel allowance. A standard travel allowance is an amount that 
is recognized, in addition to the adjusted hourly salary equivalency 
amount.
    (5) Limited part-time or intermittent services. Therapy services are 
considered to be on a limited part-time or intermittent basis if the 
provider or other organization furnishing the services under 
arrangements requires the services of a therapist or therapists on an 
average of less than 15 hours per week. This determination is made by 
dividing the total hours of services furnished during the cost reporting 
period by the number of weeks in which the services were furnished in 
the cost reporting period regardless of the number of days in each week 
in which services were performed.
    (6) Guidelines. Guidelines are the amounts published by CMS 
reflecting the application of paragraphs (b) (1) through (4) of this 
section to an individual therapy service and a geographical area. Other 
statistically valid data may be used to establish guidelines for a 
geographical area, provided that the study designs, questionnaires and 
instructions, as well as the resultant survey data for determining the 
guidelines are submitted to and approved in advance by CMS. Such data 
must be arrayed so as to permit the determination of the 75th percentile 
of the range of salaries paid to full-time employee therapists.
    (7) Administrative responsibility. Administrative responsibility is 
the performance of those duties that normally fall within the purview of 
a department head or other supervisor. This term does not apply to 
directing aides or

[[Page 914]]

other assistants in furnishing direct patient care.
    (c) Application. (1) Under this provision, CMS will establish 
criteria for use in determining the reasonable cost of physical, 
occupational, speech, and other therapy services and the services of 
other health specialists (other than physicians) furnished by 
individuals under arrangements with a provider of services, a clinic, a 
rehabilitation agency, or public health agency. It is recognized that 
providers have a wide variety of arrangements with such individuals. 
These individuals may be independent practitioners or employees of 
organizations furnishing various health care specialists. This provision 
does not require change in the substance of these arrangements.
    (2) If therapy services are performed under arrangements at a 
provider site on a full-time or regular part-time basis, the reasonable 
cost of such services may not exceed the amount determined by taking 
into account the total number of hours of services furnished by the 
therapist, the adjusted hourly salary equivalency amount appropriate for 
the particular therapy in the geographical area in which the services 
are furnished and a standard travel allowance.
    (3) If therapy services are performed under arrangements on a 
limited part-time or intermittent basis at the provider site, the 
reasonable cost of such services is evaluated on a reasonable rate per 
unit of service basis, except that payment for these services, in the 
aggregate, during the cost reporting period, may not exceed the amount 
that would be determined to be reasonable under paragraph (c)(2) of this 
section, had a therapist furnished the provider or other organization 
furnishing the services under arrangements 15 hours of service per week 
on a regular part-time basis for the weeks in which services were 
furnished by the non-employee therapist.
    (4) If an HHA furnishes services under arrangements at the patient's 
residence or in other situations in which therapy services are not 
performed at the provider's site, the reasonable cost of such services 
is evaluated as follows:
    (i) Time records available. If time records of HHA visits are 
maintained by the provider, the reasonable cost of such services is 
evaluated on a unit-of-time basis, by taking into account the total 
number of hours of service furnished by the therapist, the adjusted 
hourly salary equivalency amount appropriate for the particular therapy 
in the geographical area in which the services are furnished, and a 
standard travel allowance for each visit. However, if the travel time of 
the therapist is accurately recorded by the therapist, and approved and 
maintained by the provider, the reasonable cost of such services may be 
evaluated, at the option of the provider, by taking into account the 
total number of hours of service furnished by the therapist, including 
travel time, and the adjusted hourly salary equivalency amount 
appropriate for the particular therapy in the geographical area in which 
the services are furnished. This option does not apply to services 
furnished by HHAs under arrangements with providers other than HHAs.
    (ii) No time records available. If time records are unavailable or 
found to be inaccurate, each HHA visit is considered the equivalent of 
one hour of service. In such cases, the reasonable cost of such services 
is determined by taking into account the number of visits made by the 
therapist under arrangements with such agency, the adjusted hourly 
salary equivalency amount appropriate for the particular therapy in the 
geographical area in which the services are furnished, and a standard 
travel allowance.
    (iii) Limited part-time or intermittent services. If under paragraph 
(c)(4) (i) or (ii) of this section, the provider required therapy 
services on an average of less than 15 hours per week, the services are 
considered limited part-time or intermittent services, and the 
reasonable cost of such services is evaluated on a reasonable rate per 
unit of service basis as described in paragraph (c)(3) of this section.
    (5) If therapy services are performed in situations where 
compensation to a therapist employed by the provider is based, at least 
in part, on a fee-for-service or on a percentage of income (or 
commission), the guidelines will apply. The entire compensation will be 
subject to the guidelines in cases where

[[Page 915]]

the nature of the arrangements is most like an under ``arrangement'' 
situation, although technically the provider may treat the therapists as 
employees. The intent of this section is to prevent an employment 
relationship from being used to circumvent the guidelines.
    (6) These provisions are applicable to individual therapy services 
or disciplines by means of separate guidelines by geographical area and 
apply to costs incurred after issuance of the guidelines but no earlier 
than the beginning of the provider's cost reporting period described in 
paragraph (a) of this section. Until a guideline is issued for a 
specific therapy or discipline, costs are evaluated so that such costs 
do not exceed what a prudent and cost-conscious buyer would pay for the 
given service.
    (d) Notice of guidelines to be imposed. Prior to the beginning of a 
period to which a guideline will be applied, a notice will be published 
in the Federal Register establishing the guideline amounts to be applied 
to each geographical area by type of therapy.
    (e) Additional allowances. (1) If a therapist supervises other 
therapists or has administrative responsibility for operating a 
provider's therapy department, a reasonable allowance may be added to 
the adjusted hourly salary equivalency amount by the contractor based on 
its knowledge of the differential between therapy supervisors' and 
therapists' salaries in similar provider settings in the area.
    (2) If a therapist performing services under arrangements furnishes 
equipment and supplies used in furnishing therapy services, the 
guideline amount may be supplemented by the cost of the equipment and 
supplies, provided the cost does not exceed the amount the provider, as 
a prudent and cost-conscious buyer, would have been able to include as 
allowable cost.
    (f) Exceptions. The following exceptions may be granted but only 
upon the provider's demonstration that the conditions indicated are 
present:
    (1) Exception because of unique circumstances or special labor 
market conditions. An exception may be granted under this section by the 
contractor if a provider demonstrates that the costs for therapy 
services established by the guideline amounts are inappropriate to a 
particular provider because of some unique circumstances or special 
labor market conditions in the area.
    (2) Exception for services furnished by risk-basis HMO providers. 
For special rules concerning services furnished to an HMO's enrollees 
who are Medicare beneficiaries by a provider owned or operated by a 
risk-basis HMO (see Sec.  417.201(b) of this chapter) or related to a 
risk-basis HMO by common ownership or control (see Sec.  417.250(c) of 
this chapter).
    (3) Exception for inpatient hospital services. Effective with cost 
reporting periods beginning on or after October 1, 1983, the costs of 
therapy services furnished under arrangements to a hospital inpatient 
are excepted from the guidelines issued under this section if such costs 
are subject to the provisions of Sec.  413.40 or part 412 of this 
chapter. The contractor will grant the exception without request from 
the provider.
    (g) Appeals. A request by a provider for a hearing on the 
determination of an contractor concerning the therapy costs determined 
to be allowable based on the provisions of this section, including a 
determination with respect to an exception under paragraph (f) of this 
section, is made to the contractor only after submission of its cost 
report and receipt of the notice of amount of program reimbursement 
reflecting such determination, in accordance with the provisions of 
subpart R of part 405 of this chapter.

[51 FR 34793, Sept. 30, 1986, as amended at 63 FR 5139, Jan. 30, 1998]



Sec.  413.114  Payment for posthospital SNF care furnished by 
a swing-bed hospital.

    (a) Purpose and basis. This section implements section 1883 of the 
Act, which provides for payment for posthospital SNF care furnished by 
rural hospitals and CAHs having a swing-bed approval.
    (1) Services furnished in cost reporting periods beginning prior to 
July 1, 2002. Posthospital SNF care furnished in general routine 
inpatient beds in rural hospitals and CAHs is paid in accordance with 
the special rules in paragraph (c) of this section for determining the 
reasonable cost of this care.

[[Page 916]]

When furnished by rural and CAH swing-bed hospitals approved after March 
31, 1988 with more than 49 beds (but fewer than 100), these services 
must also meet the additional payment requirements set forth in 
paragraph (d) of this section.
    (2) Services furnished in cost reporting periods beginning on and 
after July 1, 2002. Posthospital SNF care furnished in general routine 
inpatient beds in rural hospitals (other than CAHs) is paid in 
accordance with the provisions of the prospective payment system for 
SNFs described in subpart J of this part, except that for purposes of 
this paragraph, the requirements of Sec.  413.343(a) must be met using 
the specific assessment instrument and data designated by CMS for this 
purpose. Posthospital SNF care furnished in general routine inpatient 
beds in CAHs is paid based on reasonable cost for cost reporting periods 
beginning on and after July l, 2002 and before January 1, 2004, and is 
paid based on 101 percent of reasonable cost for cost reporting periods 
beginning on and after January 1, 2004, in accordance with the 
provisions of subparts A through G of this part (other than paragraphs 
(c) and (d) of this section).
    (b) Definitions. For purposes of this section--
    Availability date means with respect to a posthospital SNF care 
patient in a swing-bed hospital, the later of--
    (i) Any date on which a bed is available for the patient in a 
Medicare-participating SNF located within the hospital's geographic 
region;
    (ii) The date that a hospital learns that a bed is available in a 
Medicare-participating SNF; or
    (iii) If the notice is prospective, the date that a bed will become 
available in a Medicare-participating SNF.
    Geographic region means an area that includes the SNFs with which a 
hospital has traditionally arranged transfers and all other SNFs within 
the same proximity to the hospital. In the case of a hospital without 
existing transfer practices upon which to base a determination, the 
geographic region is an area that includes all the SNFs within 50 miles 
(as defined in Sec.  412.92(c)(1) of this chapter) of the hospital 
unless the hospital can demonstrate that the SNFs are inaccessible to 
its patients. In the event of a dispute as to whether an SNF is within a 
hospital's geographic region or the SNF is inaccessible to hospital 
patients, the CMS Regional Office makes a determination.
    Swing-bed hospital means a hospital or CAH participating in Medicare 
that has an approval from CMS to provide posthospital SNF care as 
defined in Sec.  409.20 of this chapter, and meets the requirements 
specified in Sec.  482.58 or Sec.  485.645 of this chapter, 
respectively.
    (c) Special rules for determining the reasonable cost of 
posthospital SNF care furnished in cost reporting periods beginning 
prior to July 1, 2002. The reasonable cost of posthospital SNF care 
furnished by a swing-bed hospital is determined as follows:
    (1) The reasonable cost of routine SNF services is based on the 
average Medicare rate per patient day for routine services provided in 
freestanding SNFs in the region where the swing-bed hospital is located. 
The rates are calculated using the regions as defined in section 
1886(d)(2)(D) of the Social Security Act. The rates are based on the 
most recent year for which settled cost reporting period data are 
available, increased in a compounded manner, using the increase 
applicable to the SNF routine cost limits, up to and including the 
calendar year for which the rates are in effect. If the current Medicare 
swing-bed rate for routine extended care services furnished by a swing-
bed hospital during a calendar year is less than the rate for the prior 
calendar year, payment is made based on the prior calendar year's rate.
    (2) The reasonable cost of ancillary services furnished as 
posthospital SNF care is determined in the same manner as the reasonable 
cost of other ancillary services furnished by the hospital in accordance 
with Sec.  413.53(a)(1).
    (d) Additional requirements--(1) General rule. For services 
furnished in cost reporting periods beginning prior to July 1, 2002, in 
order for Medicare payment to be made to a swing-bed hospital with more 
than 49 beds (but fewer than 100), the following payment requirements 
must be met:
    (i) If there is an available SNF bed in the geographic region, a 
posthospital

[[Page 917]]

SNF care patient must be transferred within 5 days (excluding weekends 
and holidays) of the availability date, unless the patient's physician 
certifies within the 5-day period that transfer is not medically 
appropriate.
    (ii) The number of patient days for posthospital SNF care in a cost 
reporting period does not exceed 15 percent of the product of the number 
of days in the period and the average number of licensed beds in the 
hospital in the period. In those States that do not license their 
hospital beds, the hospitals must use the total number of hospital beds 
reported on their most recent Certificate of Need (CON), excluding 
bassinets. If during the cost reporting period, there is an increase or 
decrease in the number of ``licensed'' beds, the number of ``licensed'' 
beds for each part of the period is to be multiplied by the number of 
days for which that number of ``licensed'' beds was available. After 
totalling the results, compute 15 percent of the total available 
``licensed'' bed days to determine the payment limitation.
    (2) Payment restrictions. (i) The hospital must not seek payment for 
posthospital SNF care after the end of the 5 day period (excluding 
weekends and holidays) beginning on the availability date of a SNF bed 
unless the patient's physician has certified, within that 5 day period, 
that the transfer of the patient to the SNF was not medically 
appropriate.
    (ii) The hospital must not seek payment for posthospital SNF care in 
a cost reporting period to the extent that they exceed 15 percent of the 
product of the number of days in the period and the average number of 
licensed beds in the period. In those States that do not license 
hospital beds, the hospital must use the average number of hospital beds 
reported on its most recent CON, excluding bassinets.
    (3) Payment exception. Payment will continue to be made during the 
cost reporting period in which the 15 percent limit specified in 
paragraph (d)(1)(ii) of this section is reached for those patients who 
are receiving posthospital SNF care at the time the hospital reaches the 
limit.

[51 FR 34793, Sept. 30, 1986, as amended at 54 FR 37274, Sept. 7, 1989; 
56 FR 54545, Oct. 22, 1991; 58 FR 30671, May 26, 1993; 61 FR 51616, Oct. 
3, 1996; 62 FR 46037, Aug. 29, 1997; 66 FR 39600, July 31, 2001; 69 FR 
49265, Aug. 11, 2004; 79 FR 27153, May 12, 2014; 85 FR 47633, Aug. 5, 
2020]



Sec.  413.118  Payment for facility services related to covered ASC 
surgical procedures performed in hospitals on an outpatient basis.

    (a) Basis and scope. This section implements section 1833(a)(4) and 
(i)(3) of the Act and establishes the method for determining Medicare 
payments for services related to covered ambulatory surgical center 
(ASC) procedures performed in a hospital on an outpatient basis. It does 
not apply to services furnished by an ASC operated by a hospital that 
has an agreement with CMS to be paid in accordance with Sec.  416.30 of 
this chapter. (For regulations governing ASCs see part 416 of this 
chapter.)
    (b) Definitions. For purposes of this section--
    Facility services are those items and services, as specified in 
Sec.  416.61 of this chapter, that are furnished by a hospital on an 
outpatient basis in connection with covered ASC surgical procedures, as 
described in Sec.  416.65 of this chapter.
    Standard overhead amount means an amount equal to the prospectively 
determined payment rate that would be paid for the procedure if it had 
been furnished by an ASC in the same geographic area.
    (c) Payment principle. The aggregate amount of payments for facility 
services, furnished in a hospital on an outpatient basis, that are 
related to covered ASC surgical procedures (covered under Sec.  416.65 
of this chapter) is equal to the lesser of--
    (1) The hospital's reasonable cost or customary charges, as 
determined in accordance with Sec.  413.13, reduced by deductibles and 
coinsurance; or
    (2) The blended payment amount as described in paragraph (d) of this 
section, which is based on hospital-specific cost and charge data and 
rates paid to free-standing ASCs.

[[Page 918]]

    (d) Blended payment amount. (1) For cost reporting periods beginning 
on or after October 1, 1987 but before October 1, 1988, the blended 
payment amount is equal to the sum of--
    (i) 75 percent of the hospital-specific amount (the lesser of the 
hospital's reasonable cost or customary charges, reduced by deductibles 
and coinsurance); and
    (ii) 25 percent of the ASC payment amount (that is, 80 percent of 
the result obtained by subtracting the deductibles from the sum of the 
standard overhead amounts.)
    (2) For the period of time beginning with the first day of a 
hospital's cost reporting period that begins on or after October 1, 1988 
and ends on December 31, 1990, the blended payment amount is equal to 50 
percent of the hospital-specific amount and 50 percent of the ASC 
payment amount.
    (3) For portions of cost reporting periods beginning on or after 
January 1, 1991, the blended payment amount is equal to 42 percent of 
the hospital-specific amount and 58 percent of the ASC payment amount.
    (4) For cost reporting periods beginning on or after October 1, 1988 
and before January 1, 1995, the blended payment amount is equal to the 
sum of 75 percent of the hospital-specific amount and 25 percent of the 
ASC payment amount for a hospital that makes an application to its 
contractor and meets the following requirements.
    (i) More than 60 percent of the hospital's inpatient hospital 
discharges, as described in Sec.  412.60 of this chapter, occurring 
during its cost reporting period beginning on or after October 1, 1986 
and before October 1, 1987, are classified in diagnosis related groups 
36 through 74.
    (ii) During its cost reporting period beginning on or after October 
1, 1986 and before October 1, 1987, more than 30 percent of the 
hospital's total revenues is derived from outpatient services.
    (5) For portions of cost reporting periods beginning on or after 
October 1, 1997, for purposes of calculating the blended payment amount 
under paragraph (d)(4) of this section, the ASC payment amount is the 
sum of the standard overhead amounts reduced by deductibles and 
coinsurance as defined in section 1866(a)(2)(ii) of the Act.
    (e) Aggregation of cost, charges, and the blended amount. For 
purposes of determining the correct payment amount under paragraphs (c) 
and (d) of this section, all reasonable costs and customary charges 
attributable to facility services furnished during a cost reporting 
period are aggregated and treated separately from the reasonable costs 
and customary charges attributable to all other services furnished in 
the hospital.

[52 FR 36773, Oct. 1, 1987; 52 FR 37715, Oct. 8, 1987, as amended at 55 
FR 33699, Aug. 17, 1990; 55 FR 34797, Aug. 24, 1990; 57 FR 36017, Aug. 
12, 1992; 57 FR 45113, Sept. 30, 1992; 65 FR 18541, Apr. 7, 2000]



Sec.  413.122  Payment for hospital outpatient radiology services 
and other diagnostic procedures.

    (a) Basis and purpose. (1) This section implements section 1833(n) 
of the Act and establishes the method for determining Medicare payments 
for radiology services and other diagnostic procedures performed by a 
hospital on an outpatient basis.
    (2) For purposes of this section--
    (i) Radiology services include diagnostic and therapeutic radiology, 
nuclear medicine, CAT scan procedures, magnetic resonance imaging, 
ultrasound and other imaging services; and
    (ii) Other diagnostic procedures are those identified by CMS, and do 
not include diagnostic radiology procedures or diagnostic laboratory 
tests.
    (b) Payment for hospital outpatient radiology services. (1) The 
aggregate payment for hospital outpatient radiology services furnished 
on or after October 1, 1988 is equal to the lesser of the following:
    (i) The hospital's reasonable cost or customary charges, as 
determined in accordance with Sec.  413.13, reduced by the applicable 
Part B annual deductible and coinsurance amounts.
    (ii) The blended payment amount described in paragraph (b)(2) of 
this section.
    (2) The blended payment amount for hospital outpatient radiology 
services furnished on or after October 1, 1988,

[[Page 919]]

but before October 1, 1989, is equal to the sum of--
    (i) 65 percent of the hospital-specific amount (the hospital's 
reasonable cost or customary charges, whichever is less, reduced by the 
applicable Part B annual deductible and coinsurance amounts); and
    (ii) 35 percent of a prevailing charge or fee schedule amount that 
is calculated as 80 percent of the amount determined by subtracting the 
applicable Part B annual deductible from 62 percent of the prevailing 
charges (or for services furnished on or after January 1, 1989, the fee 
schedule amount established) for the same services when furnished by 
participating physicians in their offices in the same locality.
    (3) For hospital outpatient radiology services furnished on or after 
October 1, 1989, the blended payment amount is equal to the sum of 50 
percent of the hospital-specific amount and 50 percent of the fee 
schedule amount.
    (4) For hospital outpatient radiology services furnished on or after 
January 1, 1991, the blended payment amount is equal to the sum of 42 
percent of the hospital-specific amount and 58 percent of the fee 
schedule amount.
    (5) For hospital outpatient radiology services furnished on or after 
October 1, 1997, the blended payment amount is equal to the sum of--
    (i) 42 percent of the hospital-specific amount; and
    (ii) 58 percent of the fee schedule amount calculated as 62 percent 
of the sum of the fee schedule amounts payable for the same services 
when furnished by participating physicians in their offices in the same 
locality, less deductible and coinsurance as defined in section 
1866(a)(2)(A)(ii) of the Act.
    (c) Payment for other diagnostic procedures. (1) The aggregate 
payment for other diagnostic procedures performed by a hospital on an 
outpatient basis on or after October 1, 1989 is equal to the lesser of 
the following:
    (i) The hospital's reasonable cost or customary charges, as 
determined in accordance with Sec.  414.13, reduced by the applicable 
Part B annual deductible and coinsurance amounts.
    (ii) The blended payment described in paragraph (c)(2) of this 
section.
    (2) The blended payment amount for other diagnostic procedures 
furnished on or after October 1, 1989, but before October 1, 1990, is 
equal to the sum of--
    (i) 65 percent of the hospital-specific amount (the hospital's 
reasonable cost or customary charges, whichever is less, reduced by the 
applicable Part B annual deductible and coinsurance amounts); and
    (ii) 35 percent of a prevailing charge amount that is calculated as 
80 percent of the amount determined by subtracting the applicable Part B 
annual deductible from 42 percent of the prevailing charges for the same 
services furnished by participating physicians in their offices in the 
same locality.
    (3) For other diagnostic procedures performed by a hospital on or 
after October 1, 1990, the blended payment is equal to 50 percent of the 
hospital-specific amount and 50 percent of the prevailing charge amount.
    (4) For other diagnostic services furnished on or after October 1, 
1997, the blended payment amount is equal to the sum of--
    (i) 50 percent of the hospital-specific amount; and
    (ii) 50 percent of the fee schedule amount calculated as 42 percent 
of the sum of the fee schedule amounts payable for the same services 
when furnished by participating physicians in their offices in the same 
locality less deductible and coinsurance as defined in section 
1866(a)(2)(A)(ii) of the Act.

[56 FR 8842, Mar. 1, 1991, as amended at 57 FR 36017, Aug. 12, 1992; 65 
FR 18542, Apr. 7, 2000]



Sec.  413.123  Payment for screening mammography performed by hospitals 
on an outpatient basis.

    (a) Basis and scope. This section implements section 1834(c)(1)(C) 
of the Act and establishes the method for determining Medicare payment 
for screening mammographies performed by hospitals.
    (b) Payment to hospitals for outpatient services. Payment to 
hospitals for screening mammography services performed on an outpatient 
basis is determined in accordance with the technical component billing 
requirements in Sec.  405.534(d) of this chapter.

[55 FR 53522, Dec. 31, 1990, as amended at 59 FR 49834, Sept. 30, 1994]

[[Page 920]]



Sec.  413.124  Reduction to hospital outpatient operating costs.

    (a) Except for sole community hospitals, as defined in Sec.  412.92 
of this chapter, and critical access hospitals, the reasonable costs of 
outpatient hospital services (other than capital-related costs of these 
services) are reduced by 5.8 percent for services furnished during 
portions of cost reporting periods occurring on or after October 1, 1990 
and until the first date that the prospective payment system under part 
419 of this chapter is implemented.
    (b) For purposes of determining the blended payment amounts of 
ambulatory surgical center approved surgical procedures performed in the 
hospital outpatient setting under Sec.  413.118 and hospital outpatient 
radiology services and other diagnostic procedures under Sec.  413.122, 
the reduction is applicable only to the hospital-specific portion of the 
blended payment amounts.

[57 FR 36017, Aug. 12, 1992, as amended at 59 FR 26960, May 25, 1994; 62 
FR 46037, Aug. 29, 1997; 65 FR 18542, Apr. 07, 2000]



Sec.  413.125  Payment for home health agency services.

    (a) For additional rules on the allowability of certain costs 
incurred by home health agencies, see Sec. Sec.  409.46 and 409.49(b) of 
this chapter.
    (b) The reasonable cost of outpatient rehabilitation services 
furnished by a home health agency to homebound patients who are not 
entitled to home health benefits may not exceed the amounts payable 
under the physician fee schedule for comparable services effective 
January 1, 1999.

[59 FR 65497, Dec. 20, 1994, as amended at 63 FR 58910, Nov. 2, 1998]



                     Subpart G_Capital-Related Costs



Sec.  413.130  Introduction to capital-related costs.

    (a) General rule. Capital-related costs and an allowance for return 
on equity are limited to the following:
    (1) Net depreciation expense as determined under Sec. Sec.  413.134, 
413.144, and 413.149, adjusted by gains and losses realized from the 
disposal of depreciable assets under Sec.  413.134(f).
    (2) Taxes on land or depreciable assets used for patient care.
    (3) Leases and rentals, including license and royalty fees, for the 
use of depreciable assets or land, as described in paragraph (b) of this 
section.
    (4) The costs of betterments and improvements as described in 
paragraph (c) of this section.
    (5) The costs of minor equipment that are capitalized, rather than 
expensed, as described in paragraph (d) of this section.
    (6) Insurance expense on depreciable assets, as described in 
paragraph (e) of this section.
    (7) Interest expense as determined under Sec.  413.153, subject to 
the qualifications of paragraph (f) of this section.
    (8) For certain proprietary providers, return on equity capital, as 
determined under Sec.  413.157.
    (9) The capital-related costs of related organizations (as described 
in Sec.  413.17), as determined in accordance with paragraph (g) of this 
section.
    (10) Debt issuance costs, debt discounts, and debt redemption costs, 
if the associated debt was incurred to acquire land or depreciable 
assets used for patient care or to refinance existing debt for which the 
original purpose was to acquire land or depreciable assets used for 
patient care.
    (11) The apportionment of the capital-related costs of jointly owned 
assets among the owners must be on a basis that reflects the relative 
use by each owner, rather than the ownership share or the amount of time 
the asset is located at each owners site.
    (b) Leases and rentals. (1) Subject to the qualifications of 
paragraphs (b) (2), (4), (5), and (8) of this section, leases and 
rentals, including licenses and royalty fees, are includable in capital-
related costs if they relate to the use of assets that would be 
depreciable if the provider owned them outright or they relate to land, 
which is neither depreciable nor amortizable if owned outright. The 
terms ``leases'' and ``rentals of assets'' signify that a provider has 
possession, use, and enjoyment of the assets.
    (2) For sale and leaseback agreements for hospitals and SNFs entered 
into before October 23, 1992 and for sale and leaseback agreements for 
other

[[Page 921]]

providers entered into at any time, a provider may include incurred 
rental charges in its capital-related costs, as specified in a sale and 
leaseback agreement with a nonrelated purchaser (including shared 
service organizations not related within the meaning of Sec.  413.17) 
involving plant facilities or equipment only if the following conditions 
are met:
    (i) The rental charges are reasonable based on the following--
    (A) Consideration of rental charges of comparable facilities and 
market conditions in the area;
    (B) The type, expected life, condition, and value of the facilities 
or equipment rented; and
    (C) Other provisions of the rental agreements.
    (ii) Adequate alternative facilities or equipment that would serve 
the purpose are not or were not available at lower cost.
    (iii) The leasing was based on economic and technical 
considerations.
    (3) If the conditions of paragraph (b)(2) of this section are not 
met, the amount a provider may include in its capital-related costs as 
rental or lease expense under a sale and leaseback agreement may not 
exceed the amount that the provider would have included in its capital-
related costs had the provider retained legal title to the facilities or 
equipment, such as interest on mortgage, taxes, depreciation, and 
insurance costs.
    (4) For sale and leaseback agreements for hospitals and SNFs entered 
into on or after October 23, 1992, the amount a provider may include in 
its capital-related costs as rental or lease expense may not exceed the 
amount that the provider would have included in its capital-related 
costs had the provider retained legal title to the facilities or 
equipment, such as interest expense on mortgages, taxes, depreciation, 
and insurance costs (the costs of ownership). This limitation applies 
both on an annual basis and over the useful life of the asset.
    (i) If in the early years of the lease, the annual rental or lease 
costs are less than the annual costs of ownership, but in the later 
years of the lease the annual rental or lease costs are more than the 
annual costs of ownership, in the years that the annual rental or lease 
costs are more than the annual costs of ownership, the provider may 
include in capital-related costs annually the actual amount of rental or 
lease costs. The aggregate rental or lease costs included in capital-
related costs may not exceed the aggregate costs of ownership that would 
have been included in capital-related costs over the useful life of the 
asset had the provider retained legal title to the asset.
    (ii) If in the early years of the lease, the annual rental or lease 
costs exceed the annual costs of ownership, but in the later years of 
the lease the annual rental or lease costs are less than the annual 
costs of ownership, the provider may carry forward amounts of rental or 
lease costs that were not included in capital-related costs in the early 
years of the lease due to the costs of ownership limitation, and include 
these amounts in capital-related costs in the years of the lease when 
the annual rental or lease costs are less than the annual costs of 
ownership.
    (iii) In any given year the amount of actual annual rental or lease 
costs plus the amount carried forward to that year may not exceed the 
amount of the costs of ownership for that year.
    (iv) In the aggregate, the amount of rental or lease costs included 
in capital-related costs may not exceed the amount of the costs of 
ownership that the provider could have included in capital-related costs 
had the provider retained legal title to the asset.
    (5) For lease purchase transactions entered into before October 23, 
1992, a lease that meets the following conditions establishes a virtual 
purchase:
    (i) The rental charge exceeds rental charges of comparable 
facilities or equipment in the area.
    (ii) The term of the lease is less than the useful life of the 
facilities or equipment.
    (iii) The provider has the option to renew the lease at a 
significantly reduced rental, or the provider has the right to purchase 
the facilities or equipment at a price that appears to be significantly 
less than what the fair market value of the facilities or equipment 
would be at the time acquisition by the provider is permitted.

[[Page 922]]

    (6)(i) If a lease is a virtual purchase under paragraph (b)(5) of 
this section, the rental charge is includable in capital-related costs 
only to the extent that it does not exceed the amount that the provider 
would have included in capital-related costs if it had legal title to 
the asset (the cost of ownership), such as straight-line depreciation, 
insurance, and interest. A provider may not include in its capital-
related costs accelerated depreciation in this situation.
    (ii) The difference between the amount of rent paid and the amount 
of rent allowed as capital-related costs is considered a deferred charge 
and is capitalized as part of the historical cost of the asset when the 
asset is purchased.
    (iii) If an asset is returned to the owner, instead of being 
purchased, the deferred charge may be included in capital-related costs 
in the year the asset is returned.
    (iv) If the term of the lease is extended for an additional period 
of time at a reduced lease cost and the option to purchase still exists, 
the deferred charge may be included in capital-related costs to the 
extent of increasing the reduced rental to an amount not in excess of 
the cost of ownership.
    (v) If the term of the lease is extended for an additional period of 
time at a reduced lease cost and the option to purchase no longer 
exists, the deferred charge may be included in the capital-related costs 
to the extent of increasing the reduced rental to a fair rental value.
    (7) Amounts included in lease or rental payments for repair or 
maintenance agreements are excluded from capital-related costs. If no 
amount is identified in the lease or rental agreement for maintenance, 
the entire lease payment is considered a capital-related cost subject to 
the provisions of paragraph (b)(1) of this section.
    (8) For lease purchase transactions entered into on or after October 
23, 1992, a lease that meets any one of the following conditions 
establishes a virtual purchase:
    (i) The lease transfers title of the facilities or equipment to the 
lessee during the lease term.
    (ii) The lease contains a bargain purchase option.
    (iii) The lease term is at least 75 percent of the useful life of 
the facilities or equipment. This provision is not applicable if the 
lease begins in the last 25 percent of the useful life of the facilities 
or equipment.
    (iv) The present value of the minimum lease payments (payments to be 
made during the lease term including bargain purchase option, guaranteed 
residual value, and penalties for failure to renew) equals at least 90 
percent of the fair market value of the leased property. This provision 
is not applicable if the lease begins in the last 25 percent of the 
useful life of the facilities or equipment. Present value is computed 
using the lessee's incremental borrowing rate, unless the interest rate 
implicit in the lease is known and is less than the lessee's incremental 
borrowing rate, in which case the interest rate implicit in the lease is 
used.
    (9)(i) If a lease establishes a virtual purchase under paragraph 
(b)(8) of this section, the rental charge is includable in capital-
related costs to the extent that it does not exceed the amount that the 
provider would have included in capital-related costs if it had legal 
title to the asset (the cost of ownership). The cost of ownership 
includes straight-line depreciation, insurance, and interest. For 
purposes of computing the limitation on allowable rental cost in this 
paragraph, a provider may not include accelerated depreciation.
    (ii) The difference between the amount of rent paid and the amount 
of rent allowed as capital-related costs is considered a deferred charge 
and is capitalized as part of the historical cost of the asset when the 
asset is purchased.
    (iii) If an asset is returned to the owner instead of being 
purchased, the deferred charge may be included in capital-related costs 
in the year the asset is returned.
    (iv) If the term of the lease is extended for an additional period 
of time at a reduced lease cost and the option to purchase still exists, 
the deferred charge may be included in capital-related costs to the 
extent of increasing

[[Page 923]]

the reduced rental to an amount not in excess of the cost of ownership.
    (v) If the term of the lease is extended for an additional period of 
time at a reduced lease cost and the option to purchase no longer 
exists, the deferred charge may be included in capital-related costs to 
the extent of increasing the reduced rental to a fair rental value.
    (vi) If the lessee becomes the owner of the leased asset (either by 
operation of the lease or by other means), the amount considered as 
depreciation, for the purpose of having computed the limitation on 
rental charges in paragraph (b)(9)(i) of this section, must be used in 
calculating the limitation on adjustments for the purpose of determining 
any gain or loss under Sec.  413.134(f) upon disposal of an asset.
    (c) Betterments and improvements. (1) Betterments and improvements 
are changes which extend the estimated useful life of an asset at least 
two years beyond its original estimated useful life, or increase the 
productivity of an asset significantly over its original productivity.
    (2) A provider must capitalize and prorate the costs of betterments 
and improvements over the remaining estimated useful life of the asset, 
as modified by the betterment or improvement.
    (d) Minor equipment. A provider must include in its capital-related 
costs the costs of minor equipment that are capitalized rather than 
charged off to expense if--
    (1) The net book value of minor equipment at the time the provider 
enters the program is prorated over three years (that is, one-third of 
the net book value is written off each year), and new purchases are also 
prorated over a 3-year period; or
    (2) The cost of minor equipment is prorated over their actual useful 
lives.
    (e) Insurance. (1) A provider must include in its capital-related 
costs the costs of insurance on depreciable assets used for patient care 
or insurance that provides for the payment of capital-related costs 
during business interruption.
    (2) If an insurance policy also provides protection for other than 
the replacement of depreciable assets or to pay capital-related costs in 
the case of business interruption insurance, only that portion of the 
premium related to the replacement of depreciable assets or to pay 
capital-related costs in the case of business interruption insurance is 
includable in capital-related costs.
    (f) Debt premiums and debt discounts. Debt premiums or debt discount 
are applied as adjustments to capital-related costs if the associated 
debt is incurred for acquiring land or depreciable assets used for 
patient care or for refinancing existing debt for which the original 
purpose was to acquire land or depreciable assets used for patient care.
    (g) Interest expense. (1) A provider must include in its capital-
related costs interest expense, as described in Sec.  413.153, if such 
expense is incurred in--
    (i) Acquiring land or depreciable assets (either through purchase or 
lease) used for patient care; or
    (ii) Refinancing existing debt, if the original purpose of the 
refinanced debt was to acquire land or depreciable assets used for 
patient care.
    (2) If investment income offset is required under Sec.  
413.153(b)(2)(iii), only that portion of investment income that bears 
the same relationship to total investment income, as the portion of 
capital-related interest expense bears to total interest expense, is 
offset against capital-related costs.
    (h) Costs of supplying organizations--(1) Supplying organizations 
related to the provider. (i) If the supplying organization is related to 
the provider within the meaning of Sec.  413.17, except as provided in 
paragraph (g)(1)(ii) of this section, a provider's capital-related costs 
include the capital-related costs of the supplying organization.
    (ii) If the costs of the services, facilities or supplies being 
furnished exceed the open market price, or if the provisions of Sec.  
413.17(d) apply, no part of the cost to the provider of the services, 
facilities, or supplies are considered capital-related costs, unless the 
services, facilities, or supplies would otherwise be considered capital-
related.
    (2) Supplying organizations not related to the provider. If the 
supplying organization is not related to the provider within the meaning 
of Sec.  413.17, no part of the charge to the provider may be

[[Page 924]]

considered a capital-related cost (unless the services, facilities, or 
supplies are capital-related in nature) unless--
    (i) The capital-related equipment is leased or rented (as described 
in paragraph (b) of this section) by the provider;
    (ii) The capital-related equipment is located on the provider's 
premises, or is located offsite and is on real estate owned, leased or 
rented by the provider; and
    (iii) The capital-related portion of the charge is separately 
specified in the charge to the provider.
    (i) Costs excluded from capital-related costs. The following costs 
are not capital-related costs. To the extent that they are allowable, 
they must be included in determining each provider's operating costs:
    (1) Costs incurred for the repair or maintenance of equipment or 
facilities.
    (2) Amounts included in rentals or lease payments for repair or 
maintenance agreements.
    (3) Interest expense incurred to borrow working capital (for 
operating expenses).
    (4) General liability insurance or any other form of insurance to 
provide protection other than for the replacement of depreciable assets 
or to pay capital-related costs in the case of business interruption.
    (5) Taxes other than those assessed on the basis of some valuation 
of land or depreciable assets used for patient care. (Taxes not related 
to patient care, such as income taxes, are not allowable, and are 
therefore not included among either capital-related or operating costs.)
    (6) The costs of minor equipment that are charged off to expense 
rather than capitalized as described in paragraph (d) of this section.
    (7) The costs incurred for maintenance and repair insurance 
agreements (commonly referred to as maintenance agreements).
    (j) Reduction to capital-related costs. (1) Except for sole 
community hospitals and critical access hospitals, the amount of 
capital-related costs of all hospital outpatient services is reduced 
by--
    (i) 15 percent for portions of cost reporting periods occurring on 
or after October 1, 1989, through September 30, 1991; and
    (ii) 10 percent for portions of cost reporting periods occurring on 
or after October 1, 1991 and until the first date that the prospective 
payment system under part 419 of this chapter is implemented.
    (2) For purposes of determining the blended payment amounts for 
hospital outpatient services under Sec. Sec.  413.118 and 413.122, the 
reduction is applicable only to the hospital-specific portion of the 
blended amounts.

[51 FR 34793, Sept. 30, 1986, as amended at 52 FR 21225, June 4, 1987; 
56 FR 43456, Aug. 30, 1991; 57 FR 3017, Jan. 27, 1992; 57 FR 36017, Aug. 
12, 1992; 57 FR 43917, Sept. 23, 1992; 58 FR 17528, Apr. 5, 1993; 59 FR 
26960, May 25, 1994; 62 FR 46037, Aug. 29, 1997; 65 FR 18542, Apr. 7, 
2000]



Sec.  413.134  Depreciation: Allowance for depreciation based on asset costs.

    (a) Principle. An appropriate allowance for depreciation on 
buildings and equipment used in the provision of patient care is an 
allowable cost. The depreciation must be--
    (1) Identifiable and recorded in the provider's accounting records;
    (2) Based on the historical cost of the asset, except as specified 
in paragraph (j) of this section regarding donated assets; and
    (3) Prorated over the estimated useful life of the asset using--
    (i) The straight-line method; or
    (ii) Accelerated depreciation under a declining balance method (not 
to exceed double the straight-line rate) or the sum-of-the-years' digits 
method in the following situations:
    (A) Depreciable assets for which accelerated depreciation was used 
for Medicare purposes before August 1, 1970, including those assets for 
which a timely request to change from straight-line depreciation to 
accelerated depreciation was received by an contractor before August 1, 
1970;
    (B) Depreciable assets acquired before August 1, 1970, if no 
election to use straight-line or accelerated depreciation was in effect 
on August 1, 1970, and the provider was participating in the program on 
August 1, 1970;
    (C) Depreciable assets of a provider if construction of such 
depreciable asset began before February 5, 1970, and the

[[Page 925]]

provider was participating in the program on February 5, 1970; or
    (D) Depreciable assets of a provider if a valid written contract was 
entered into by a provider participating in the program before February 
5, 1970, for construction, acquisition, or for the permanent financing 
thereof, and such contract was binding on a provider on February 5, 
1970, and at all times thereafter; or
    (iii) A declining balance method, not to exceed 150 percent of the 
straight-line rate, for a depreciable asset acquired after July 31, 
1970; however, this declining balance method may be used only if the 
cash flow from depreciation on the total assets of the institution 
during the reporting period, including straight-line depreciation on the 
assets in question, is insufficient (assuming funding of available 
capital not required currently for amortization and assuming reasonable 
interest income on such funds) to supply the funds required to meet the 
reasonable principal amortization schedules on the capital debts related 
to the provider's total depreciable assets. For each depreciable asset 
for which a provider requests authorization to use a declining balance 
method for Medicare reimbursement purposes, but not to exceed 150 
percent of the straight-line rate, the provider must demonstrate to the 
contractor's satisfaction that the required cash flow need exists. For 
each depreciable asset in which a provider justifies the use of 
accelerated depreciation, the contractor must give written approval for 
the use of a depreciation method other than straight-line before basing 
any interim payment on this accelerated depreciation or making its 
reasonable cost determination which includes an allowance for such 
depreciation.
    (b) General rules--(1) Historical cost. Historical cost is the cost 
incurred by the present owner in acquiring the asset.
    (i) All providers--(A) Depreciable assets acquired after July 31, 
1970 and before December 1, 1997. For depreciable assets acquired after 
July 31, 1970 and before December 1, 1997, and for a hospital or an SNF, 
acquired before July 18, 1984, the historical cost may not exceed the 
lower of current reproduction cost adjusted for straight-line 
depreciation over the life of the asset to the time of the purchase or 
the fair market value of the asset at the time of its purchase.
    (B) Depreciable assets acquired on or after December 1, 1997. For 
depreciable assets acquired on or after December 1, 1997, the historical 
cost of the asset that will be recognized under this program must not 
exceed the historical cost less depreciation allowed to the owner of 
record as of August 5, 1997 (or if an asset did not exist as of August 
5, 1997, the first owner of record after August 5, 1997). For this 
paragraph (b)(1)(i)(B), the following apply:
    (1) An asset that was not in existence as of August 5, 1997 includes 
an asset that physically existed but was not owned by a provider 
participating in the Medicare program as of that date.
    (2) The acquisition cost to the owner of record is subject to the 
limitation on historical costs described in paragraphs (g) (1), (2), and 
(3) of this section, and is reduced by any depreciation taken by the 
owner of record. The limitation on historical cost is also applied to 
the purchase of land, which is a capital asset that is neither 
depreciable nor amortizable under any circumstances. (See Sec. Sec.  
413.153(d) and 413.157(b) for application of the limitation to the cost 
of land for purposes of determining the allowable interest expense.)
    (3) Acquisition cost to the owner of record includes the costs of 
betterment or improvements that extend the estimated useful life of an 
asset at least 2 years beyond its original estimated useful life or that 
increase the productivity of an asset significantly over its original 
productivity.
    (4) For assets acquired prior to a provider's entrance into the 
Medicare program, the acquisition cost to the owner of record is the 
historical cost when acquired, rather than when the provider entered the 
program.
    (5) For assets subject to the optional depreciation allowance as 
described in Sec.  413.139, the acquisition cost to the owner of record 
is the historical cost established for those assets when the provider 
changed to actual depreciation as described in Sec.  413.139(e). If the 
provider did not change to actual depreciation, as described in Sec.  
413.139(e), for optional allowance assets, the acquisition cost to the 
owner of record is

[[Page 926]]

based on the provider's recorded historical cost of the asset when 
acquired. If the provider has no historical cost records for optional 
allowance assets, the acquisition cost to the owner of record is 
established by appraisal.
    (6) The historical cost of an asset acquired on or after July 18, 
1984 may not include costs attributable to the negotiation or settlement 
of the sale or purchase (by acquisition, merger, or consolidation) of 
any capital asset for which any payment was previously made under the 
Medicare program. The costs to be excluded include, but are not limited 
to, appraisal costs (except those incurred at the request of the 
contractor under paragraph (f)(2)(iv) of this section), legal fees, 
accounting and administrative costs, travel costs, and the costs of 
feasibility studies.
    (ii) Hospitals and SNFs only. (A) For assets acquired on or after 
July 18, 1984 and before December 1, 1997 and not subject to an 
enforceable agreement entered into before July 18, 1984, historical cost 
may not exceed the lowest of the following:
    (1) The allowable acquisition cost of the asset to the owner of 
record as of July 18, 1984 (or, in the case of an asset not in existence 
as of July 18, 1984, the first owner of record of the asset after that 
date);
    (2) The acquisition cost of the asset to the new owner; or
    (3) The fair market value of the asset on the date of acquisition.
    (B) For purposes of applying paragraph (b)(1)(ii)(A) of this 
section, an asset not in existence as of July 18, 1984 includes any 
asset that physically existed, but was not owned by a hospital or SNF 
participating in the Medicare program as of July 18, 1984.
    (C) The acquisition cost to the owner of record is subject to any 
limitation on historical costs described in paragraphs (b)(1)(i) or 
(g)(1) and (2) of this section, and is not reduced by any depreciation 
taken by the owner of record. This limitation on historical cost is also 
applied to the purchase of land, a capital asset that is neither 
depreciable nor amortizable under any circumstances. (See Sec. Sec.  
413.153(d) and 413.157(b) for application of the limitation to the cost 
of land for purposes of determining allowable interest expense and 
return on equity capital or proprietary providers.)
    (D) Acquisition cost to the owner of record includes the costs of 
betterments or improvements that extend the estimated useful life of an 
asset at least two years beyond its original estimated useful life or 
increase the productivity of an asset significantly over its original 
productivity.
    (E) For assets acquired prior to a hospital's or SNF's entrance into 
the Medicare program, the acquisition cost to the owner of record is the 
historical cost of the asset when acquired, rather than when the 
hospital or SNF entered the program.
    (F) For assets subject to the optional depreciation allowance as 
described in Sec.  413.139, the acquisition cost to the owner of record 
is the historical cost established for those assets when the hospital or 
SNF changed to actual depreciation as described in Sec.  413.139(e). If 
the hospital or SNF did not change to actual depreciation, as described 
in Sec.  413.139(e), for optional allowance assets, the acquisition cost 
to the owner of record is established by reference to the hospital's or 
SNF's recorded historical cost of the asset when acquired. If the 
hospital or SNF has no historical cost records for optional allowance 
assets, the acquisition cost to the owner of record is established by 
appraisal.
    (G) The historical cost of an asset acquired on or after July 18, 
1984 may not include costs attributable to the negotiation or settlement 
of the sale or purchase (by acquisition, merger, or consolidation) of 
any capital asset for which any payment was previously made under the 
Medicare program. The costs to be excluded include, but are not limited 
to, appraisal costs (except those incurred at the request of the 
contractor under paragraph (f)(2)(iv) of this section), legal fees, 
accounting and administrative costs, travel costs, and the costs of 
feasibility studies.
    (iii) Hospital-based providers other than SNFs and SNF-based 
providers. For changes of ownership that involve assets of a hospital-
based provider other than a SNF, or assets of a SNF-based provider, the 
provisions of paragraph (b)(1)(ii) of this section are not applicable. A 
reasonable allocation of the purchase price must be made, so that the

[[Page 927]]

hospital-based provider other than a SNF, or a SNF-based provider, is 
not affected by the limitations described in paragraph (b)(1)(ii) of 
this section. The historical cost of assets of providers other than 
hospitals and SNFs is governed by paragraph (b)(1)(i) of this section.
    (2) Fair market value. Fair market value is the price that the asset 
would bring by bona fide bargaining between well-informed buyers and 
sellers at the date of acquisition. Usually the fair market price is the 
price that bona fide sales have been consummated for assets of like 
type, quality, and quantity in a particular market at the time of 
acquisition.
    (3) The straight-line method. Under the straight-line method of 
depreciation, the cost or other basis (for example, fair market value in 
the case of donated assets) of the asset, less its estimated salvage 
value, if any, is determined first. Then this amount is distributed in 
equal amounts over the period of the estimated useful life of the asset.
    (4) Declining balance method. Under the declining balance method, 
the annual depreciation allowance is computed by multiplying the 
undepreciated cost of the asset each year by a uniform rate up to double 
the straight-line rate or 150 percent, as the case may be (see paragraph 
(a)(3) of this section for limitations on use of accelerated methods of 
depreciation).
    (5) Sum-of-the-years' digits method. Under the sum-of-the-years' 
digits method, the annual depreciation allowance is computed by 
multiplying the depreciable cost basis (cost less salvage value) by a 
constantly decreasing fraction. The numerator of the fraction is 
represented by the remaining years of useful life of the asset at the 
beginning of each year, and the denominator is always represented by the 
sum of the years' digits of useful life at the time of acquisition.
    (6) Current reproduction cost. Current reproduction cost is the cost 
at current prices, in a particular locality or market area, of 
reproducing an item of property or a group of assets. Where depreciable 
assets are concerned, this means the reasonable cost to have built, 
reproduce in kind, or, in the case of equipment or similar assets, to 
purchase in the competitive market.
    (7) Useful life. The estimated useful life of a depreciable asset is 
its normal operating or service life to the provider, subject to the 
provisions in paragraph (b)(7)(i) of this section. Factors to be 
considered in determining useful life include normal wear and tear; 
obsolescence due to normal economic and technological changes; climatic 
and other local conditions; and the provider's policy for repairs and 
replacement.
    (i) Initial selection of useful life. In selecting a proper useful 
life for computing depreciation under the Medicare program, providers 
must use the useful life guidelines published by CMS. If CMS has not 
published applicable useful life guidelines, providers must use--
    (A) The edition of the American Hospital Association useful life 
guidelines, as specified in CMS Medicare program manuals; or
    (B) A different useful life specifically requested by the provider 
and approved by the contractor. A different useful life may be approved 
by the contractor if the provider's request is properly supported by 
acceptable factors that affect the determination of useful life. 
However, such factors as an expected early sale, retirement, demolition 
or abandonment of an asset, or termination of the provider from the 
Medicare program may not be used.
    (ii) Application of guidelines. The provisions concerning the 
selection of useful life guidelines described in paragraph (b)(7)(i) of 
this section apply to assets acquired on or after January 1, 1981. For 
assets acquired before January 1, 1981, providers must use the useful 
life guidelines published by the American Hospital Association in its 
1973 edition of Chart of Accounts for Hospitals, or those published by 
the Internal Revenue Service, or those approved for use by contractors 
as provided in paragraph (b)(7)(i)(B) of this section.
    (iii) Changing useful life. A change in the estimated useful life 
may be made if clear and convincing evidence justifies a redetermination 
of the useful life used by the provider. Such a change must be approved 
by the contractor in

[[Page 928]]

writing, and the factors cited in paragraphs (b)(7) and (b)(7)(i) of 
this section are applicable in making such redeterminations of useful 
life. If the request is approved, the change is effective with the 
reporting period immediately following the period in which the 
provider's request is submitted for approval.
    (8) Donated asset. An asset is considered donated when the provider 
acquires the asset without making payment in the form of cash, new debt, 
assumed debt, property or services. Except as provided in paragraph 
(j)(3) of this section, if a provider makes payment in any form to 
acquire an asset, the payment is considered the purchase price for the 
purpose of determining allowable historical cost.
    (9) Net book value. The net book value of an asset is the 
depreciable basis used for the Medicare program by the asset's last 
participating owner less depreciation recognized under the Medicare 
program.
    (c) Recording of depreciation. Appropriate recording of depreciation 
includes the identification of the depreciable assets in use, the 
assets' historical costs, the assets' dates of acquisition, the method 
of depreciation, estimated useful lives, and the assets' accumulated 
depreciation.
    (d) Depreciation methods--(1) General. Proration of the cost of an 
asset over its useful life is allowed on the straight-line method, or, 
when permitted under paragraph (a)(3) of this section, the declining 
balance or the sum-of-the-years' digits methods. One method may be used 
on a single asset or group of assets and another method on others. In 
applying the declining balance or sum-of-the-years' digits method to an 
asset that is not new, the undepreciated cost of the asset is treated as 
the cost of a new asset in computing depreciation.
    (2) Change in method. Prior to August 1, 1970, a provider may change 
from the straight-line method to an accelerated method or vice versa, 
upon advance approval from the contractor on a prospective basis with 
the request being made before the end of the first month of the 
prospective reporting period. Only one such change with respect to a 
particular asset may be made by a provider. Effective with August 1, 
1970, a provider may only change from an accelerated method or optional 
method (see Sec.  413.139) to the straight-line method. Such a change 
may be made without contractor approval and the basis for depreciation 
is the undepreciated cost reduced by the salvage value. Thereafter, once 
straight-line depreciation is selected for a particular asset, an 
accelerated method may not be established for that asset.
    (3) Recovery of accelerated depreciation--(i) General. If a provider 
who has used an accelerated method of depreciation for any of its assets 
terminates participation in the program, or if the Medicare proportion 
of its allowable costs decreases so that cumulatively substantially more 
depreciation was paid than would have been paid using the straight-line 
method of depreciation, the excess of reimbursable cost determined by 
using accelerated depreciation methods and paid under the program over 
the reimbursable cost that would have been determined and paid under the 
program by using the straight-line method of depreciation, will be 
recovered as an offset to current reimbursement due or, if the provider 
has terminated participation in the program, as an overpayment. In this 
determination of excess payment, recognition will be given to the 
effects the adjustment to straight-line depreciation would have on the 
return on equity capital and on the allowance in lieu of specific 
recognition of other costs in the respective years.
    (ii) Transaction between related organizations--(A) General. If the 
termination of the provider agreement is due to a change in provider 
ownership, as defined in Sec.  489.18 of this chapter, resulting from a 
transaction between related organizations, as defined in Sec.  413.17, 
and the criteria in paragraph (b) of this section are met, the excess of 
reimbursable cost, as determined in paragraph (d)(3)(i) of this section 
may not be recovered if there is a continuation of participation by the 
facility in the Medicare program.
    (B) Criteria. The following criteria must be met if the recovery of 
excess reimbursable cost is not to be made:

[[Page 929]]

    (1) The termination of the provider agreement is due to a change in 
ownership of the provider resulting from a transaction between related 
organizations.
    (2) The successor provider continues to participate in the Medicare 
program.
    (3) Control and the extent of the financial interest of the owners 
of the provider before and after the termination remain the same; that 
is, the successor owners acquire the same per-centage of control or 
financial investment as the transferors had.
    (4) All assets and liabilities of the terminated provider are 
transferred to the related successor participating provider.
    (C) Effect of transaction. In transactions meeting the criteria 
specified in paragraph (d)(3)(ii)(B) of this section, the provision 
concerning recovery of excess reimbursable cost (Sec.  413.134(d)(3)(i)) 
is not applied, and the transaction is treated as follows:
    (1) The successor provider must record the historical cost and 
accumulated depreciation and the method of depreciation recognized under 
the Medicare program, and these are considered as incurred by the 
successor provider for Medicare purposes.
    (2) The Medicare program's utilization of the terminated provider is 
considered as having been incurred by the successor provider for 
Medicare purposes.
    (3) The equity capital of the terminated provider as of the closing 
of its final cost reporting period must be wholly contained in the 
equity capital of the successor provider as of the beginning of its 
first cost reporting period.
    (e) Funding of depreciation. Although funding of depreciation is not 
required, it is strongly recommended that providers use this mechanism 
as a means of conserving funds for replacement of depreciable assets. 
Funded depreciation account funds must be placed in readily marketable 
investments of the type that assures the availability and conservation 
of the funds. Additions to the funded depreciation account must remain 
in the account for at least 6 months to be considered valid funding 
transactions.
    (1) Incentive. As an incentive for funding, investment income on 
funded depreciation is not treated as a reduction of allowable interest 
expense provided such investment income is deposited in, and becomes 
part of, the funded depreciation account at the time of receipt by the 
provider. Investment income earned on deposits before the 6-month period 
elapses are not offset unless the deposits are withdrawn for an improper 
purpose during this period. If a provider transfers assets of the funded 
depreciation account to a related organization (for example, pooling of 
several chain organization providers' funded depreciation accounts at 
the chain home office for investment purposes), these assets shall be 
treated as the provider's funds and are subject to all the requirements 
specified in paragraph (e) of this section.
    (2) Availability of funded depreciation. (i) CMS considers funded 
depreciation available for use in the acquisition or replacement of 
depreciable assets related to patient care unless the funded 
depreciation funds have been committed by contract for the acquisition 
of depreciable assets related to the furnishing of patient care or for 
other capital purposes related to patient care.
    (ii) Borrowing for a purpose for which funded depreciation account 
funds should have been used makes the borrowing unnecessary to the 
extent that funded depreciation account funds were available at the time 
of the borrowing. Available funds in the funded depreciation account, to 
the extent of the unnecessary borrowing, are called ``tainted'' funds. 
Interest expense incurred on borrowing for a capital purpose is not an 
allowable cost to the extent that funded depreciation account funds were 
available at the time of the borrowing.
    (iii) A provider can remove the ``unnecessary'' characterization of 
borrowing, and thereby cure tainted funded depreciation, by using the 
tainted funds for a proper purpose described in paragraph (e)(3)(i) of 
this section. However, any funded depreciation that existed at the time 
of the unnecessary borrowing and is not classified as tainted must be 
used before any of the tainted funds.

[[Page 930]]

    (iv) When only a portion of the borrowing is considered unnecessary 
under paragraph (e)(2)(ii) of this section, subsequent repayments of 
such borrowing from general funds are applied first to the allowable 
portion of the borrowing and then, when all of the allowable borrowing 
is repaid, to the unallowable portion of the borrowing. When funds from 
the funded depreciation account are used for the repayment of the 
unnecessary borrowing, an equivalent amount of tainted funds is cured 
without regard to the provisions of paragraphs (e)(2)(ii) and 
(e)(3)(i)(C) of this section. Similarly, where general funds are used to 
pay for the unallowable borrowing after the necessary borrowing has been 
repaid, an equivalent amount of tainted funded depreciation is cured 
without regard to the provisions of paragraphs (e)(2)(ii) and 
(e)(3)(i)(C) of this section.
    (3) Withdrawals of funded depreciation--(i) Proper withdrawals. (A) 
Withdrawals from funded depreciation are considered proper if made 
either for the acquisition or replacement of depreciable assets related 
to the furnishing of patient care or for other capital purposes related 
to patient care.
    (B) First-in, first-out basis. Proper withdrawals from funded 
depreciation are made on a first-in, first-out basis.
    (C) Exception. If CMS determines that a borrowing is unnecessary 
because of the existence of available funded depreciation, and 
additional deposits have been made to funded depreciation after the 
occurrence of the unnecessary borrowing, withdrawals made after the date 
of the additional deposits are deemed to be made on a last-in, first-out 
basis.
    (ii) Improper withdrawals. (A) Withdrawals from funded depreciation 
that do not meet the requirements for proper withdrawals under the 
provisions in paragraph (e)(3)(i)(A) of this section are considered 
improper withdrawals.
    (B) Improper withdrawals from funded depreciation are made on a 
last-in, first-out basis. If improper withdrawals are made, interest 
expense is reduced in accordance with section Sec.  413.153(c)(3).
    (C) Improper withdrawals will result in the offset of otherwise 
allowable interest expense under the offset provisions in Sec.  
413.153(c)(3).
    (4) Loans from funded depreciation. (i) When the general fund of the 
provider borrows from the funded depreciation to obtain working capital 
for normal operating expenses to furnish patient care, interest incurred 
by the general fund is an allowable operating cost only if the interest 
expense is supported by documents that evidence that the funds were 
borrowed and that payment of interest and repayment of the funds are 
required, is separately identified in the provider's accounting records, 
and meets the necessary and proper tests described in Sec. Sec.  
413.153(b)(2) and (b)(3). However, if the general fund of the provider 
borrows from the funded depreciation account to acquire depreciable 
assets used in furnishing patient care, or for other capital purposes 
related to patient care, interest expense paid by the general fund to 
the funded depreciation account is not an allowable cost. Providers are 
expected to use the funded depreciation for these purposes.
    (ii) Loans from funded depreciation to the general fund are 
considered investments of funded depreciation, but do not have to meet 
the readily marketable test described in paragraph (e) of this section. 
Loans made from funded depreciation are subject to the requirement that 
funded depreciation must be available for the acquisition of depreciable 
assets used to furnish patient care, or for other capital purposes 
related to patient care. Costs incurred to secure lines of credit from 
lending institutions to ensure such availability are not allowable 
costs.
    (iii) Funding of depreciation from general funds will not be 
recognized to the extent of any outstanding loans from the funded 
depreciation account to the general fund. Deposits from the general fund 
into the funded depreciation account must be first applied to reduce any 
loans outstanding from the funded depreciation to the general fund. When 
the loans are repaid in full, general funds deposited in the funded 
depreciation account are considered as repayments of the general fund. 
Therefore, any subsequent interest expense of the general fund paid to 
the funded

[[Page 931]]

depreciation fund is not an allowable cost.
    (iv) A provider may loan its funded depreciation to a related 
organization for any purpose subject to the following conditions:
    (A) Authorization for such a loan by the provider's appropriate 
managing body of the provider, such as Board of Trustees or Board of 
Directors, must be on file.
    (B) The funded depreciation loaned must remain available, as 
specified in paragraph (e)(2) of this section, to the provider making 
the loan. Costs incurred for lines of credit to assure such availability 
are not allowable costs. During the period of time that the loan is 
outstanding, if the provider making the loan resorts to outside 
borrowing for a purpose for which its funded depreciation should have 
been used, interest expense on an amount of the outside borrowing up to 
the amount of the funded depreciation that should have been available 
would be disallowed as unnecessary.
    (C) Such loans shall be considered investments of the provider's 
funded depreciation, but the requirement that funded depreciation be 
invested in readily marketable investments as required in paragraph (e) 
of this section is waived for such loans.
    (D) The funded depreciation account must earn interest on such loans 
at a rate that does not exceed the rate that would be charged for a 
comparable loan from an independent lending institution. This investment 
income will not be used to reduce the provider's interest expense if all 
the other conditions in paragraph (e) of this section are met. If the 
entity borrowing the funds is another provider participating in the 
Medicare program, the interest expense incurred on such loans would be 
allowable if the loan meets all of the interest expense requirements 
specified in Sec.  413.153. (For purposes of Sec.  413.153(b)(3)(ii), 
such loans are not considered to be with a related lender.)
    (f) Gains and losses on disposal of assets--(1) General. Depreciable 
assets may be disposed of through sale, scrapping, trade-in, exchange, 
demolition, abandonment, condemnation, fire, theft, or other casualty.
    (i) Disposal of an asset before December 1, 1997. If disposal of a 
depreciable asset, including the sale or scrapping of an asset before 
December 1, 1997, results in a gain or loss, an adjustment is necessary 
in the provider's allowable cost.
    (A) The amount of a gain included in the determination of allowable 
cost is limited to the amount of depreciation previously included in 
Medicare allowable costs.
    (B) The amount of a loss to be included is limited to the 
undepreciated basis of the asset permitted under the program.
    (C) The treatment of the gain or loss depends upon the manner of 
disposition of the asset, as specified in paragraphs (f)(2) through (6) 
of this section.
    (D) The gain or loss on the disposition of depreciable assets has no 
retroactive effect on a proprietary provider's equity capital for years 
prior to the year of disposition.
    (ii) Disposal of an asset on or after December 1, 1997. No gain or 
loss is recognized on either the sale or scrapping of an asset that 
occurs on or after December 1, 1997, regardless of whether the asset is 
sold incident to a provider's change of ownership, or otherwise sold or 
scrapped as an asset of a Medicare participating provider. Gains or 
losses on dispositions other than sales or scrapping are recognized to 
the same extent as prior to December 1, 1997.
    (2) Bona fide sale or scrapping before December 1, 1997. For the 
bona fide sale or scrapping of depreciable assets before December 1, 
1997, the following apply:
    (i) Except as specified in paragraph (f)(3) of this section, gains 
and losses realized from the bona fide sale or scrapping of depreciable 
assets are included in the determination of allowable cost only if the 
sale or scrapping occurs while the provider is participating in 
Medicare. The extent to which such gains and losses are included is 
calculated by prorating the basis for depreciation of the asset in 
accordance with the proportion of the asset's useful life for which the 
provider participated in Medicare. For purposes of this paragraph 
(f)(2)(i), scrapping refers to the physical removal from the provider's 
premises of

[[Page 932]]

tangible personal properties that are no longer useful for their 
intended purpose and are only salable for their scrap or junk value.
    (ii) If the total amount of gains or losses realized from bona fide 
sales or scrapping does not exceed $5,000 within the cost reporting 
period or if the provider's cumulative utilization under the Medicare 
program is less than 5 percent, the net amount of gains or losses 
realized from sale or scrapping will be allowed as a depreciation 
adjustment in the period of disposal. For purposes of this paragraph 
(f)(2)(ii), the provider's cumulative Medicare utilization precentage is 
determined by comparing the cumulative total of the Medicare inpatient 
days for all reporting periods in which depreciation on the asset 
disposed of was claimed under the Medicare program to the cumulative 
total of inpatient days of the participating provider for the same 
reporting periods.
    (iii) If the conditions specified in paragraph (f)(2)(ii) of this 
section are not met, the adjustment to reimbursable cost in the 
reporting period of asset disposition is calculated as follows:
    (A) The total amount of gains or losses shall be allocated to all 
reporting periods under the Medicare program, based on the ratio of the 
depreciation allowed on the assets in each reporting period to the total 
depreciation allowed under the Medicare program.
    (B) The results of this allocation are multiplied by the ratio of 
Medicare reimbursable cost to total allowable cost for each reporting 
period.
    (C) The results of this multiplication are then added.
    (D) Effective for cost reporting periods beginning on or after 
October 1, 1991, no adjustment will be made for the portion of gains or 
losses allocated to inpatient hospital services for which the hospital 
was paid under the fully prospective payment methodology as described in 
Sec.  412.340 of this chapter or under the hold-harmless methodology 
based on the Federal rate as described in Sec.  412.344(a)(1) of this 
chapter for new capital costs or in Sec.  412.344(a)(2) of this chapter.
    (iv) If a provider sells more than one asset for a lump sum sales 
price, the gain or loss on the sale of each depreciable asset must be 
determined by allocating the lump sum sales price among all the assets 
sold, in accordance with the fair market value of each asset as it was 
used by the provider at the time of sale. If the buyer and seller cannot 
agree on an allocation of the sales price, or if they do agree but there 
is insufficient documentation of the current fair market value of each 
asset, the contractor for the selling provider will require an appraisal 
by an independent appraisal expert to establish the fair market value of 
each asset and will make an allocation of the sales price in accordance 
with the appraisal.
    (3) Sale within 1 year after termination. Gains and losses realized 
from a bona fide sale of depreciable assets within 1 year immediately 
following the date on which the provider terminates participation in the 
Medicare program are also included in the determination of allowable 
cost, in accordance with the procedure specified in paragraph (f)(2) of 
this section. However, if several assets are sold for a lump sum sales 
price, the determination of fair market value must be based on the 
appraised value of the assets as they were last used by the provider 
while participating in the Medicare program.
    (4) Exchange, trade-in or donation. Gains or losses realized from 
the exchange, trade-in, or donation of depreciable assets are not 
included in the determination of allowable cost. When the disposition of 
an asset is by means of exchange or trade-in, the historical cost of the 
new asset is the sum of the undepreciated cost of the asset disposed of 
and the additional cash or other assets transferred (or to be 
transferred) to acquire the new asset. However, if the asset disposed of 
was acquired by the provider before its participation in the Medicare 
program and the sum of the undepreciated cost and the cash or other 
assets transferred (or to be transferred) exceed the list price or fair 
market value of the new asset, the historical cost of the new asset is 
limited to the lower of its list price or fair market value.

[[Page 933]]

    (5) Demolition or abandonment. (i) For purposes of this section, the 
term ``abandonment'' means the permanent retirement of an asset for any 
future purpose, not merely the provider's ceasing to use the asset for 
patient care purposes. To claim an abandonment under the Medicare 
program, the provider must have relinquished all rights, title, claim, 
and possession of the asset with the intention of never reclaiming it or 
resuming its ownership, possession, or enjoyment.
    (ii) If losses resulting from the demolition or abandonment of 
depreciable assets do not exceed $5,000 within the cost-reporting 
period, the losses are to be allowed in the period of disposal.
    (iii) If losses exceed $5,000 and, at the date of disposition, the 
demolished or abandoned assets are at least 80 percent depreciated as 
computed under the straight-line method, such losses are includable in 
the determination of allowable cost under the Medicare program in the 
period of disposal and the procedure provided in paragraph (f)(2)(iii) 
of this section must be used in determining the adjustment to 
reimbursable cost.
    (iv) Losses in excess of $5,000 resulting from the demolition or 
abandonment of assets, which at the date of disposition are not 80 
percent depreciated as computed under the straight-line method, must be 
capitalized as a deferred charge and amortized as follows:
    (A) If the State Health Planning and Development Agency (SHPDA) 
designated under section 1521 of the Public Health Service Act approves 
the demolition or abandonment of a depreciable asset as being consistent 
with the health systems plan of the health service area in which the 
provider is located, the net loss realized shall be capitalized as a 
deferred charge and amortized over the remaining life of the demolished 
or abandoned asset, or at the rate of $5,000 per year, whichever is 
greater. If no SHPDA exists or if such agency is unable or unwilling to 
perform this function, the provider must submit a request for approval 
to the contractor. The contractor, after reviewing this request and 
before issuing the approval, will submit the request along with its 
recommendation to the appropriate Regional Office for its approval.
    (B) If a provider fails to obtain approval as specified in paragraph 
(f)(5)(iv)(A) of this section, a loss is not allowable unless the 
demolished or abandoned asset is replaced. If the asset is replaced, the 
loss resulting from the unapproved demolition or abandonment must be 
capitalized as a deferred charge and amortized over the estimated useful 
life of the replacement asset or at the rate of $5,000 per year, 
whichever is greater.
    (v) If a loss resulting from the demolition or abandonment is 
deferred and amortized and the provider terminates its participation in 
the Medicare program or ceases to use a replacement asset in the 
provision of patient care services, the unamortized deferred charge 
remaining at that time must not be included in determining allowable 
cost under the Medicare program.
    (vi) Losses on demolition must include the demolition cost incurred 
by the provider for razing and removal of the asset, less any salvage 
value recovered by the provider. However, if a provider demolishes a 
depreciable asset for the purpose of preparing land for future sale, the 
net demolition cost incurred by the provider (razing and removal costs 
less salvage recovered) is considered a capital expenditure and added to 
the historical basis of the land.
    (vii) If a provider purchases land on which there is a building, no 
depreciation will be allowed under the Medicare program unless the 
building is used in providing patient care. If the building is 
demolished, the entire purchase price and demolition cost shall be 
considered the historical cost of the land. If the building is used for 
patient care, but demolished within 5 years of purchase, the entire 
purchase price, less allowed depreciation, plus demolition cost will be 
considered the historical cost of the land.
    (6) Involuntary conversion. (i) Losses resulting from the 
involuntary conversion of depreciable assets, such as condemnation, 
fire, theft, or other casualty, are generally included in the 
determination of allowable cost on a deferred basis if the asset is 
restored or replaced. However, losses resulting

[[Page 934]]

from a provider's imprudent management of its depreciable assets, such 
as the failure to obtain proper insurance coverage, are not included in 
the determination of allowable cost.
    (ii) The net allowable loss from involuntary conversion must consist 
of the undepreciated cost of unrecovered book value of the asset, less 
amounts received from insurance proceeds gifts, and grants received from 
local, State, or Federal government, or any other source as a result of 
the involuntary conversion.
    (iii) If the asset is replaced and the net allowable loss in any 
cost-reporting period does not exceed $5,000, the entire amount must be 
included in allowable cost in the period in which the loss is incurred. 
If the asset is replaced and the net allowable loss in any cost-
reporting period exceeds $5,000, the loss must be capitalized as a 
deferred charge and amortized over the useful life of the replacement or 
restored asset. If a replaced or restored asset ceases to be used in the 
provision of patient care services or the provider terminates its 
participation in the Medicare program, the unamortized deferred charge 
remaining at that time will not be included in determining allowable 
cost under the Medicare program.
    (iv) If the provider fails to replace or restore an involuntarily 
converted asset, the loss is not included in determining allowable cost. 
However, if the provider intends to replace or restore the asset but is 
unable to do so because the designated SHPDA finds such replacement or 
restoration to be inconsistent with the health systems plan of the 
provider's health service area, the loss is allowable so long as the 
provider continues to participate in Medicare. In this case, the loss 
must be capitalized as a deferred charge and amortized over the 
remaining life of the involuntarily converted asset, or at the rate of 
$5,000 per year, whichever is greater.
    (v) If a gain is realized from an involuntary conversion of 
depreciable assets, the net amount realized reduces the basis of the 
restored or replacement asset. If the asset is not restored or replaced, 
the gain is to be treated in accordance with paragraph (f)(2) of this 
section.
    (7) Effect on equity capital. The unrecovered loss entered on the 
books of the provider as a deferred charge, in accordance with 
paragraphs (f) (5) and (6) of this section, is not includable in the 
computation of equity capital under Sec.  413.157.
    (8) Sale of replacement or restored assets. If a provider sells a 
replacement or restored asset while participating in the Medicare 
program or within 1 year immediately following the date on which it 
terminates its participation in the Medicare program, the unrecovered 
loss entered on the books of the provider as a deferred charge in 
accordance with paragraphs (f) (5) and (6) of this section will not be 
included in determining the gain or loss realized from the sale of the 
replacement or restored asset. However, if the sale of such asset is 
made to a related organization, as defined in Sec.  413.17, and the 
purchasing organization continues as a provider in the Medicare program, 
the remaining deferred charge representing the unrecovered depreciable 
basis of the demolished, abandoned or destroyed asset must continue to 
be amortized over the remaining expected useful life of the replacement 
or restored asset. If the sale is made to an unrelated organization, 
further amortization of the deferred charge is not allowed.
    (g) Establishment of cost basis on purchase of facility as an 
ongoing operation--(1) Assets acquired after July 1, 1966 and before 
August 1, 1970. The cost basis for the assets of a facility purchased as 
an ongoing operation after July 1, 1966, and before August 1, 1970, is 
the lowest of the--
    (i) Total price paid for the facility by the purchaser, as allocated 
to the individual assets of the facility;
    (ii) Total fair market value of the facility at the time of the 
sale, as allocated to the individual assets; or
    (iii) Combined fair market value of the individually identified 
assets at the time of the sale.
    (2) Assets acquired after July 31, 1970 and, for hospitals and SNFs, 
before July 18, 1984. For depreciable assets acquired after July 31, 
1970 and, for hospitals and SNFs, before July 18, 1984, in addition to 
the limitations specified in paragraph (g)(1) of this section, the

[[Page 935]]

cost basis of the depreciable assets may not exceed the current 
reproduction cost depreciated on a straight-line basis over the life of 
the asset to the time of the sale.
    (3) Assets acquired by hospitals and SNFs on or after July 18, 1984 
and not subject to an enforceable agreement entered into before that 
date. Subject to paragraphs (b)(1)(ii) (B) through (G) and (b)(1)(iii) 
of this section, historical cost may not exceed the lowest of the 
following:
    (i) The allowable acquisition cost of the asset to the owner of 
record as of July 18, 1984 (or, in the case of an asset not in existence 
as of July 18, 1984, the first owner of record of the asset);
    (ii) The acquisition cost to the new owner; or
    (iii) The fair market value of the asset on the date of acquisition.
    (4) Assets acquired by all providers on or after December 1, 1997. 
Subject to the provisions of paragraph (b)(1)(i)(A) of this section, the 
historical cost may not exceed the historical cost of the asset, as 
recognized under the Medicare program, less depreciation allowed, to the 
owner of record as of August 5, 1997 (or for an asset not in existence 
as of August 5, 1997, the first owner of record after August 5, 1997).
    (5) Transactions other than bona fide. If the purchaser cannot 
demonstrate that the sale was bona fide, in addition to the limitations 
specified in paragraph (g)(1), (2), and (3) of this section, the 
purchaser's cost basis may not exceed the seller's cost basis, less 
accumulated depreciation.
    (h) Sale and leaseback agreements and other lease transactions. (1) 
For sale and leaseback agreements for all providers, and for sale and 
leaseback agreements for hospitals and SNFs entered into before October 
23, 1992, a provider may include in its allowable costs incurred rental 
charges, as specified in a sale and leaseback agreement with a 
nonrelated purchaser involving plant facilities or equipment, only if--
    (i) The rental charges are reasonable based on consideration of 
rental charges of comparable facilities and market conditions in the 
area; the type, expected life, condition, and value of the facilities or 
equipment rented; and other provisions of the rental agreement;
    (ii) Adequate alternate facilities or equipment that would serve the 
purpose are not or were not available at lower cost; and
    (iii) The leasing was based on economic and technical 
considerations.
    (2) If the conditions of paragraph (h)(1) of this section are not 
met, the amount a provider may include in its allowable costs as rental 
or lease expense under a sale and leaseback agreement may not exceed the 
amount that the provider would have included in its allowable costs had 
the provider retained legal title to the facilities or equipment such as 
interest expense on mortgages, taxes, depreciation, and insurance costs.
    (3) For hospitals and SNFs entering into sale and leaseback 
agreements on or after October 23, 1992, the amount a provider may 
include in its allowable costs as rental or lease expense may not exceed 
the amount that the provider would have included in its allowable costs 
had the provider retained legal title to the facilities or equipment, 
such as interest expense on mortgages, taxes, depreciation, and 
insurance costs (the costs of ownership). This limitation applies both 
on an annual basis and over the useful life of the asset.
    (i) If in the early years of the lease, the annual rental or lease 
costs are less than the annual costs of ownership, but in the later 
years of the lease the annual rental or lease costs are more than the 
annual costs of ownership, in the years that the annual rental or lease 
costs are more than the costs of ownership the provider may include in 
allowable costs annually the actual amount of rental or lease costs. The 
aggregate rental or lease costs included in allowable costs may not 
exceed the aggregate costs of ownership that would have been included in 
allowable costs over the useful life of the asset had the provider 
retained legal title to the asset.
    (ii) If in the early years of the lease, the annual rental or lease 
costs exceed the annual costs of ownership, but in the later years of 
the lease the annual rental or lease costs are less than the annual 
costs of ownership, the provider

[[Page 936]]

may carry forward amounts of rental or lease costs that were not 
included in allowable costs in the early years of the lease due to the 
costs of ownership limitation, and include these amounts in allowable 
costs in the years of the lease when the annual rental or lease costs 
are less than the annual costs of ownership. In any given year the 
amount of actual annual rental or lease costs plus the amount carried 
forward to that year may not exceed the amount of the costs of ownership 
for that year.
    (iii) In the aggregate, the amount of rental or lease costs included 
in allowable costs may not exceed the amount of the costs of ownership 
that the provider could have included in allowable costs had the 
provider retained legal title to the asset.
    (4) For lease transactions of all providers entered into before 
October 23, 1992, a lease that meets the following conditions 
establishes a virtual purchase:
    (i) The rental charge exceeds rental charges of comparable 
facilities or equipment in the area.
    (ii) The term of the lease is less than the useful life of the 
facilities or equipment.
    (iii) The provider has the option to renew the lease at a 
significantly reduced rental, or the provider has the right to purchase 
the facilities or equipment at a price that appears to be significantly 
less than what the fair market value of the facilities or equipment 
would be at the time acquisition by the provider is permitted.
    (5)(i) If a lease is a virtual purchase under paragraph (h)(4) of 
this section, the rental charge is includable in allowable costs only to 
the extent that it does not exceed the amount that the provider would 
have included in allowable costs if it had legal title to the asset (the 
cost of ownership), such as straight-line depreciation, insurance, and 
interest. For purposes of computing the limitation on allowable rental 
cost in this paragraph, a provider may not include accelerated 
depreciation.
    (ii) The difference between the amount of rent paid and the amount 
of rent allowed as rental expense is considered a deferred charge and 
must be capitalized as part of the historical cost of the asset when the 
asset is purchased.
    (iii) If an asset is returned to the owner instead of being 
purchased, the deferred charge may be expensed in the year the asset is 
returned.
    (iv) If the term of the lease is extended for an additional period 
of time at a reduced lease cost and the option to purchase still exists, 
the deferred charge may be expensed to the extent of increasing the 
reduced rental to an amount not in excess of the cost of ownership.
    (v) If the term of the lease is extended for an additional period of 
time at a reduced lease cost and the option to purchase no longer 
exists, the deferred charge may be expensed to the extent of increasing 
the reduced rental to a fair rental value.
    (6) For lease transactions entered into on or after October 23, 
1992, a lease that meets any one of the following conditions establishes 
a virtual purchase:
    (i) The lease transfers title of the facilities or equipment to the 
lessee during the lease term.
    (ii) The lease contains a bargain purchase option.
    (iii) The lease term is 75 percent or more of the useful life of the 
facilities or equipment. This provision is not applicable if the lease 
begins in the last 25 percent of the useful life of the facilities or 
equipment.
    (iv) The present value of the minimum lease payments (that is, 
payments to be made during the lease term, including bargain purchase 
option, guaranteed residual value, or penalties for failure to renew) 
equals 90 percent or more of the fair market value of the leased 
property. This provision is not applicable if the lease begins in the 
last 25 percent of the useful life of the facilities or equipment. The 
present value is computed using the lessee's incremental borrowing rate, 
unless the interest rate implicit in the lease is known and is less than 
the lessee's incremental borrowing rate, in which case, the interest 
rate implicit in the lease is used.
    (7)(i) If a lease is a virtual purchase under paragraph (h)(6) of 
this section,

[[Page 937]]

the rental charge is includable in allowable costs only to the extent 
that it does not exceed the amount that the provider would have included 
in allowable costs if it had legal title to the asset (the costs of 
ownership), such as straight-line depreciation, insurance, and interest. 
For purposes of computing the limitation on allowable rental cost as 
described in this paragraph, a provider may not include accelerated 
depreciation in its allowable costs.
    (ii) The difference between the amount of rent paid and the amount 
of rent allowed as rental expense is considered a deferred charge and is 
capitalized as part of the historical cost of the asset when the asset 
is purchased.
    (iii) If an asset is returned to the owner instead of being 
purchased, the deferred charge may be expensed in the year the asset is 
returned.
    (iv) If the term of the lease is extended for an additional period 
of time at a reduced lease cost and the option to purchase still exists, 
the deferred charge may be expensed to the extent of increasing the 
reduced rental to an amount not in excess of the cost of ownership.
    (v) If the term of the lease is extended for an additional period of 
time at a reduced lease cost and the option to purchase no longer 
exists, the deferred charge may be expensed to the extent of increasing 
the reduced rental to a fair rental value.
    (vi) If the lessee becomes the owner of the leased asset (either by 
operation of the lease or by other means), the amount considered as 
depreciation, for the purpose of having computed the limitation 
expressed in paragraph (h)(7)(i) of this section, must be used in 
calculating the limitation on adjustments to depreciation for the 
purpose of determining any gain or loss upon disposal of an asset under 
paragraph (f) of this section.
    (i) Intergovernmental transfer of facilities. The basis for 
depreciation of assets transferred under appropriate legal authority 
from one governmental entity to another is as follows:
    (1) The historical cost incurred by the present owner in acquiring 
the asset under a bona fide sale. The historical cost may not exceed the 
lower of current reproduction cost adjusted for straight-line 
depreciation over the life of the asset to the time of the purchase of 
fair market value at the time of the purchase.
    (2) The fair market value at the time of donation under a bona fide 
donation of the asset (subject to the limitations set forth under 
paragraph (i) of this section). An asset is considered donated when a 
governmental entity acquires the asset without assuming the functions 
for which the transferor used the asset or making any payment for it in 
the form of cash, property, or services.
    (3) If neither paragraph (h) (1) nor (2) of this section applies, 
for example, the transfer was solely to facilitate administration or to 
reallocate jurisdictional responsibility, or the transfer constituted a 
taking over in whole or in part of the function of one governmental 
entity by another governmental entity, the basis for depreciation is--
    (i) With respect to an asset on which the transferor has claimed 
depreciation under the Medicare program, the transferor's basis under 
the Medicare program prior to the transfer. The method of depreciation 
used by the transferee may be the same as that used by the transferor, 
or the transferee may change the method, as permitted under paragraph 
(d)(2) of this section; or
    (ii) With respect to an asset on which the transferor has not 
claimed depreciation under the Medicare program, the cost incurred by 
the transferor in acquiring the asset (not to exceed the basis that 
would have been recognized had the transferor participated in the 
Medicare program) less depreciation calculated on the straight-line 
basis over the life of the asset to the time of transfer.
    (j) Basis of assets donated to a provider--(1) Assets not used or 
depreciated under the Medicare program. If an asset has never been used 
or depreciated under the Medicare program and is donated to a provider, 
the basis for the purpose of calculating depreciation and equity capital 
(if applicable) is the fair market value of the asset at the time of 
donation.
    (2) Assets used or depreciated under the Medicare program. If an 
asset has been

[[Page 938]]

used or depreciated under the Medicare program and is donated to a 
provider, the basis for the purpose of calculating depreciation and 
equity capital (if applicable) is the lesser of--
    (i) The fair market value at the time of donation; or
    (ii) The net book value in the hands of the owner last participating 
in the Medicare program.
    (3) Transfers of State hospitals to nonprofit corporations without 
monetary consideration. If a State transfers a hospital to a nonprofit 
corporation without monetary consideration on or after July 18, 1984, 
the depreciable basis of the assets to the new owner is the net book 
value of the assets as recorded on the State's books at the time of the 
transfer. For purposes of this section, monetary consideration includes 
cash, new debt, and assumed debt.
    (k) Transactions involving a provider's capital stock--(1) 
Acquisition of capital stock of a provider. If the capital stock of a 
provider is acquired, the provider's assets may not be revalued. For 
example, if Corporation A purchases the capital stock of Corporation B, 
the provider, Corporation B continues to be the provider after the 
purchase and Corporation A is merely the stockholder. Corporation B's 
assets may not be revalued.
    (2) Statutory merger. A statutory merger is a combination of two or 
more corporations under the corporation laws of the State, with one of 
the corporations surviving. The surviving corporation acquires the 
assets and liabilities of the merged corporation(s) by operation of 
State law. The effect of a statutory merger upon Medicare reimbursement 
is as follows:
    (i) Statutory merger between unrelated parties. If the statutory 
merger is between two or more corporations that are unrelated (as 
specified in Sec.  413.17), the assets of the merged corporation(s) 
acquired by the surviving corporation may be revalued in accordance with 
paragraph (g) of this section. If the merged corporation was a provider 
before the merger, then it is subject to the provisions of paragraphs 
(d)(3) and (f) of this section concerning recovery of accelerated 
depreciation and the realization of gains and losses. The basis of the 
assets owned by the surviving corporation are unaffected by the 
transaction. An example of this type of transaction is one in which 
Corporation A, a nonprovider, and Corporation B, the provider, are 
combined by a statutory merger, with Corporation A being the surviving 
corporation. In such a case the assets of Corporation B acquired by 
Corporation A may be revalued in accordance with paragraph (g) of this 
section.
    (ii) Statutory merger between related parties. If the statutory 
merger is between two or more related corporations (as specified in 
Sec.  413.17), no revaluation of assets is permitted for those assets 
acquired by the surviving corporation. An example of this type of 
transaction is one in which Corporation A purchase the capital stock of 
Corporation B, the provider. Immediately after the acquisition of the 
capital stock of Corporation B, there is a statutory merger of 
Corporation B and Corporation A, with Corporation A being the surviving 
corporation. Under these circumstances, at the time of the merger the 
transaction is one between related parties and is not a basis for 
revaluation of the provider's assets.
    (3) Consolidation. A consolidation is the combination of two or more 
corporations resulting in the creation of a new corporate entity. If at 
least one of the original corporations is a provider, the effect of a 
consolidation upon Medicare reimbursement for the provider is as 
follows:
    (i) Consolidation between unrelated parties. If the consolidation is 
between two or more corporations that are unrelated (as specified in 
Sec.  413.17), the assets of the provider corporation(s) may be revalued 
in accordance with paragraph (g) of this section.
    (ii) Consolidation between related parties. If the consolidation is 
between two or more related corporations (as specified in Sec.  413.17), 
no revaluation of provider assets is permitted.

[51 FR 34793, Sept. 30, 1986, as amended at 56 FR 43456, Aug. 30, 1991; 
57 FR 3017, Jan. 27, 1992; 57 FR 39830, Sept. 1, 1992; 57 FR 43919, 
Sept. 23, 1992; 58 FR 17528, Apr. 5, 1993; 59 FR 45401, Sept. 1, 1994; 
63 FR 1382, Jan. 9, 1998; 65 FR 8662, Feb. 22, 2000; 82 FR 38515, Aug. 
14, 2017]

[[Page 939]]



Sec.  413.139  Depreciation: Optional allowance for depreciation based on 
a percentage of operating costs.

    (a) Principle. With respect to all assets acquired before 1966, the 
provider, at its option, may choose an allowance for depreciation based 
on a percentage of operating costs. The operating costs to be used are 
the provider's 1965 operating costs or the provider's current year's 
allowable costs, whichever are the lower. The percentage to be applied 
is 5 percent starting with the year 1966-67, with such percentage being 
uniformly reduced by one-half percent each succeeding year. The 
allowance based on operating costs is in addition to regular 
depreciation on assets acquired after 1965; however, if the optional 
allowance is selected, the combined amount of such allowance on pre-1966 
assets and the straight-line depreciation on assets acquired after 1965 
(including the estimated depreciation on assets held on a rental basis 
during the current year) may not exceed 6 percent of the provider's 
allowable cost for the current year.
    (b) Definitions--(1) Operating costs. Operating costs are the total 
costs incurred by the provider in operating the institution or facility.
    (2) Allowable costs. Allowable costs are the costs of a provider 
that are includable under the principles for cost reimbursement. Through 
application of apportionment methods to the total amount of such 
allowable costs, the share of a provider's total cost that is 
attributable to covered services for beneficiaries is determined.
    (c) Application. If a provider has inadequate historical cost 
records for pre-1966 depreciable assets, the provider may elect to 
receive an allowance for depreciation on such assets based on a 
percentage of operating costs. The optional allowance for depreciation 
for such assets may be used, however, whether or not a provider has 
records of the cost of pre-1966 depreciable assets currently in use.
    (d) Allowance based on a percentage of operating costs. (1) The 
allowance for depreciation based on a percentage of operating costs is 
to be computed by applying a specified percentage to a base amount equal 
to the provider's 1965 total operating costs, without adjustments to 
these principles or the current year's allowable operating costs, 
whichever is lower. The percentage to be applied is five for the 
reporting period that starts before or during 1966-67, four and one-half 
for the reporting period that begins during 1967-68, and continues to 
decline annually by equal amounts to become zero in 1976-77.
    (2) If used as a base for determining the optional allowance for 
depreciation, neither the 1965 operating costs nor the current year's 
allowable costs are to include any actual depreciation, estimated 
depreciation on rented depreciable-type assets, allowance in lieu of 
specific recognition of other costs, or return on equity capital. Such 
exclusions are to be made only for the purpose of computing the 
allowance for depreciation based on operating costs. For other purposes, 
the excluded amounts are recognized in determining allowable costs and 
for computing the costs of services furnished to Medicare beneficiaries 
during the reporting period.
    (e) Change to actual depreciation. (1) A provider that elects this 
allowance may at any time before 1976 change to actual depreciation on 
all pre-1966 depreciable assets. In such case, this option is eliminated 
and the provider can no longer elect to receive an allowance for 
depreciation based on a percentage of operating costs.
    (2) If the provider desires to change to actual depreciation but 
either has no historical cost records or has incomplete records, the 
determination of historical cost may be made through appropriate means 
involving expert consultation with the determination being subject to 
review and approval by the contractor.
    (f) Determination of optional allowance based on percentage of 
operating costs illustrated. The following illustrates how the provider 
would determine the optional allowance for depreciation based on 
operating costs.

    Example No. 1. The provider keeps its records on a calendar year 
basis. The current year's actual allowable cost and the actual operating 
cost for 1965 do not include any actual depreciation or rentals on 
depreciable-type assets. The current year's allowable cost also does not 
include any allowance in

[[Page 940]]

lieu of specific recognition of other costs or return on equity capital.

                                Year 1966
Current year's allowable cost.............................    $1,100,000
                                                           =============
Operating cost for 1965 \1\...............................    $1,000,000
Percent for determining the allowance.....................             5
                                                           -------------
      Allowance...........................................       $50,000
 
\1\ 1965 Operating cost was used in computing the allowance for
  depreciation based on a percentage of operating costs because it was
  lower than 1966 allowable cost.


                                Year 1967
Current year's allowable cost.............................    $1,200,000
                                                           =============
Operating cost for 1965 \1\...............................    $1,000,000
Percent for determining the allowance \2\.................             5
                                                           -------------
      Allowance...........................................       $50,000
 
\1\ 1965 Operating cost was used in computing the allowance for
  depreciation based on a percentage of operating costs because it was
  lower than 1967 allowable cost.
\2\ Since the reporting period began during the year 1966-1967 (July 1,
  1966-June 30, 1967) 5 percent is the percentage to be used.


                                Year 1968
Operating cost for 1965...................................    $1,000,000
                                                           =============
Current year's allowable cost \1\.........................      $900,000
Percent for determining the allowance \2\.................        4\1/2\
                                                           -------------
      Allowance...........................................       $40,500
 
\1\ The current year's allowable cost was used in computing the
  allowance for depreciation based on percentage of operating costs
  because it was lower than 1965 operating cost.
\2\ Since the reporting period began during the year 1967-1968 (July 1,
  1967-June 30, 1968) 4\1/2\ percent is the percentage to be used.

    Example No. 2. When the provider pays rent for depreciable-type 
assets rented prior to 1966, the estimated depreciation on such assets 
must be deducted from the allowance. The following illustration 
demonstrates how the allowance is determined.
    The provider keeps its records on a calendar year basis. The current 
year's actual allowable cost and the actual operating cost for 1965 did 
not include any actual depreciation, allowance in lieu of specific 
recognition of other costs, or return on equity capital. However, such 
costs have been adjusted to exclude estimated depreciation on rented 
depreciable-type assets.

                                Year 1966
Adjusted current year's allowable cost....................    $1,100,000
                                                           =============
Adjusted operating cost for 1965 \1\......................    $1,000,000
Percent for determining the allowance.....................             5
                                                           -------------
      Allowance...........................................       $50,000
Less estimated depreciation for depreciable-type assets           $3,000
 rented prior to 1966 on which rental is paid in 1966.....
                                                           -------------
      Adjusted allowance..................................       $47,000
 
\1\ 1965 operating cost was used in computing the allowance for
  depreciation based on a percentage of operating costs because it was
  lower than 1966 allowable cost.


    (g) Limitation on depreciation if optional allowance is used. This 
optional allowance only is subject to a limitation based on the 
provider's total allowable operating cost for the current year. To 
determine this limitation, compute the sum of the actual depreciation 
claimed, the allowance based on a percentage of operating costs, and the 
estimated straight-line depreciation on depreciable-type assets rented 
after 1965. If this sum exceeds six percent of the provider's current 
year's allowable cost (exclusive of any actual depreciation claimed, 
estimated depreciation on rented depreciable-type assets, allowance in 
lieu of specific recognition of other costs, and return on equity 
capital), the allowance for depreciation based on a percentage of 
operating costs is reduced by the amount of excess. In applying this 
limitation, if the actual depreciation claimed is on an accelerated 
basis, it must be converted to a straight-line basis only for use in 
calculating this limitation. It is presumed that pre-1966 assets will 
not be retired at a greater than normal rate, and the limitation of six 
percent, as it affects the availability of the allowance, is designed as 
a safeguard if the presumption is not borne out. If the provider does 
not elect to use the optional allowance, the combined allowance for 
depreciation based on costs of pre-1966 assets and those subsequently 
acquired is not subject to the six percent limitation.

    Example No. 1. The following illustration demonstrates how this 
limitation would be determined.

                                Year 1966
  [The provider keeps its records on a calendar year basis. The current
year's actual allowable cost and the actual operating cost for 1965 have
been adjusted to exclude actual depreciation, the estimated depreciation
    on rented depreciable-type assets, allowance in lieu of specific
       recognition of other costs, and return on equity capital.]
Adjusted operating cost for 1965..........................    $1,000,000
Percent for determining the allowance.....................             5
In 1966 assets were acquired which produce a straight-line       $18,000
 depreciation of..........................................
Estimated depreciation on assets rented in 1966...........        $2,000
Adjusted allowable operating cost for 1966................    $1,100,000
 
   calculation of allowance for depreciation based on a percentage of
                             operating costs
 
                      Gross allowance
 
5 percent times adjusted 1965 operating costs ($1,000,000)       $50,000
Estimated depreciation on assets rented in 1966...........         2,000

[[Page 941]]

 
Straight-line depreciation on post-1965 assets............        18,000
                                                           -------------
      Total...............................................        70,000
6 percent of adjusted 1966 allowable operating cost.......        66,000
                                                           -------------
      Reduction in allowance..............................         4,000
                                                           =============
Allowance.................................................        50,000
Reduction.................................................         4,000
                                                           -------------
      Adjusted allowance..................................        46,000
                                                           =============
      Total depreciation allowance for 1966 ($18,000              64,000
       actual depreciation plus $46,000 allowance based on
       operating cost)....................................
 

    Assume in this illustration that the provider had elected to use the 
declining balance method in computing its allowable depreciation and the 
rental expense for depreciable-type assets was $3,500. In that case, it 
would include in its 1966 allowable cost not only the $46,000 allowance 
based on operating costs but also $36,000 (in this instance 2 x 
straight-line rate is used) in actual depreciation and the rental 
expense of $3,500--or a total of $85,500 covering all its depreciable 
assets.



Sec.  413.144  Depreciation: Allowance for depreciation on fully depreciated 
or partially depreciated assets.

    (a) Principle. Depreciation on assets being used by a provider at 
the time it enters into the Medicare program is allowed. This principle 
applies even though such assets may be fully or partially depreciated on 
the provider's books.
    (b) Application. Depreciation is allowable on assets being used at 
the time the provider enters into the program. This applies even though 
such assets may be fully depreciated on the provider's books or fully 
depreciated with respect to other third-party payers. So long as an 
asset is being used, its useful life is considered not to have ended, 
and consequently the asset is subject to depreciation based upon a 
revised estimate of the asset's useful life as determined by the 
provider and approved by the contractor. Correction of prior years' 
depreciation to reflect revision of estimated useful life should be made 
in the first year of participation in the program unless the provider 
has used the optional method (Sec.  413.139), in which case the 
correction should be made at the time of discontinuing the use of that 
method. If an asset has become fully depreciated under Medicare, further 
depreciation is not appropriate or allowable, even though the asset may 
continue in use.
    (c) Example of an allowance for a fully-depreciated asset. For 
example, if a 50-year-old building is in use at the time the provider 
enters into the program, depreciation is allowable on the building even 
though it has been fully depreciated on the provider's books. Assuming 
that a reasonable estimate of the asset's continued life is 20 years (70 
years from the date of acquisition), the provider may claim depreciation 
over the next 20 years--if the asset is in use that long--or a total 
depreciation of as much as twenty-seventieths of the asset's historical 
cost.
    (d) Corrections to depreciation. If the asset is disposed of before 
the expiration of its estimated useful life, the depreciation would be 
adjusted to the actual useful life. Likewise, a provider may not have 
fully depreciated other assets it is using and finds that it has 
incorrectly estimated the useful lives of those assets. In such cases, 
the provider may use the corrected useful lives in determining the 
amount of depreciation, provided such corrections have been approved by 
the contractor.



Sec.  413.149  Depreciation: Allowance for depreciation on assets financed 
with Federal or public funds.

    (a) Principle. Depreciation is allowed on assets financed with Hill-
Burton or other Federal or public funds.
    (b) Application. Like other assets (including other donated 
depreciable assets), assets financed with Hill-Burton or other Federal 
or public funds become a part of the provider institution's plant and 
equipment to be used in furnishing services. It is the function of 
payment of depreciation to provide funds that make it possible to 
maintain the assets and preserve the capital employed in the production 
of services. Therefore, irrespective of the source of financing of an 
asset, if it is used in the providing of services for beneficiaries of 
the program, payment for depreciation of the asset is, in fact,

[[Page 942]]

a cost of the production of those services. Moreover, recognition of 
this cost is necessary to maintain productive capacity for the future. 
An incentive for funding of depreciation is provided in these principles 
by the provision that investment income on funded depreciation is not 
treated as a reduction of allowable interest expense under Sec.  
413.153(a).



Sec.  413.153  Interest expense.

    (a)(1) Principle. Necessary and proper interest on both current and 
capital indebtedness is an allowable cost. However, interest costs are 
not allowable if incurred as a result of--
    (i) Judicial review by a Federal court (as described in Sec.  
413.64(j));
    (ii) An interest assessment on a determined overpayment (as 
described in Sec.  405.377 of this chapter); or
    (iii) Interest on funds borrowed to repay an overpayment (as 
described in Sec.  413.64(j) or Sec.  405.378 of this chapter), up to 
the amount of the overpayment, unless the provider had made a prior 
commitment to borrow funds for other purposes (for example, capital 
improvements).
    (2) Exception. In those cases of administrative or judicial 
reversal, interest paid on funds borrowed to repay an overpayment is an 
allowable cost, in accordance with this section.
    (b) Definitions--(1) Interest. Interest is the cost incurred for the 
use of borrowed funds. Interest on current indebtedness is the cost 
incurred for funds borrowed for a relatively short term. This is usually 
for such purposes as working capital for normal operating expenses. 
Interest on capital indebtedness is the cost incurred for funds borrowed 
for capital purposes, such as acquisition of facilities and equipment, 
and capital improvements. Generally, loans for capital purposes are 
long-term loans.
    (2) Necessary. Necessary interest is interest that meets the 
following requirements:
    (i) It is incurred on a loan made to satisfy a financial need of the 
provider. Loans that result in excess funds or investments are not 
considered necessary.
    (ii) It is incurred on a loan made for a purpose reasonably related 
to patient care.
    (iii) It is reduced by investment income except income from--
    (A) Gifts, grants, and endowments, whether held separately or pooled 
with other funds;
    (B) Funded depreciation that meets the program's qualifying 
criteria;
    (C) The provider's qualified pension funds;
    (D) The provider's deferred compensation funds that meet the 
program's qualifying criteria; and
    (E) The provider's self-insurance trust funds that meet the 
program's qualifying criteria.
    (iv) It is not reduced by interest received as a result of judicial 
review by a Federal court (as described in Sec.  413.64(j)).
    (3) Proper. Proper requires that interest be--
    (i) Incurred at a rate not in excess of what a prudent borrower 
would have had to pay in the money market existing at the time the loan 
was made; and
    (ii) Paid to a lender not related through control or ownership, or 
personal relationship to the borrowing organization. However, interest 
is allowable if paid on loans from the provider's donor-restricted 
funds, the funded depreciation account, or the provider's qualified 
pension fund.
    (4) Zero coupon bonds. Zero coupon bonds are issued by government 
agencies, corporations, and banks at a price substantially below the 
face value. The difference between the purchase price and the face value 
reflects the actual amount of interest and is neither a discount nor an 
adjustment to the interest rate as with other bonds. Interest is paid at 
maturity when the bond is redeemed at face value.
    (c) Borrower-lender relationship. (1) Except as described in 
paragraph (c)(2) of this section, to be allowable, interest expense must 
be incurred on indebtedness established with lenders or lending 
organizations not related through control, ownership, or personal 
relationship to the borrower. Presence of any of these factors could 
affect the ``bargaining'' process that usually accompanies the making of 
a loan, and

[[Page 943]]

could thus be suggestive of an agreement on higher rates of interest or 
of unnecessary loans. Loans should be made under terms and conditions 
that a prudent borrower would make in armslength transactions with 
lending institutions. The intent of this provision is to assure that 
loans are legitimate and needed, and that the interest rate is 
reasonable. Thus, interest paid by the provider to partners, 
stockholders, or related organizations of the provider would not be 
allowable. If the owner uses his own funds in a business, it is 
reasonable to treat the funds as invested funds or capital, rather than 
borrowed funds. Therefore, if interest on loans by partners, 
stockholders, or related organizations is disallowed as a cost solely 
because of the relationship factor, the principal of such loans is 
treated as invested funds in the computation of the provider's equity 
capital under Sec.  413.157.
    (2) Exceptions to the general rule regarding interest on loans from 
controlled sources of funds are made in the following circumstances. 
Interest on loans to providers by partners, stockholders, or related 
organizations made prior to July 1, 1966, is allowable as cost, provided 
that the terms and conditions of payment of such loans have been 
maintained in effect without modification subsequent to July 1, 1966. If 
the general fund of a provider ``borrows'' from a donor-restricted fund 
and pays interest to the restricted fund, this interest expense is an 
allowable cost. The same treatment is accorded interest paid by the 
general fund on money ``borrowed'' from the funded depreciation account 
of the provider or from the provider's qualified pension fund. In 
addition, if a provider operated by members of a religious order borrows 
from the order, interest paid to the order is an allowable cost.
    (3) If funded depreciation is used for purposes other than 
improvement, replacement, or expansion of facilities or equipment 
related to patient care, allowable interest expense is reduced to adjust 
for offsets not made in prior years for earnings on funded depreciation. 
A similar treatment is accorded deposits in the provider's qualified 
pension fund if such deposits are used for other than the purpose for 
which the fund was established.
    (d) Loans not reasonably related to patient care. (1) The following 
types of loans are not considered to be for a purpose reasonably related 
to patient care:
    (i) For loans made to finance acquisition of a facility, that 
portion of the cost that exceeds--
    (A) Historical cost as determined under Sec.  413.134(b); or
    (B) The cost basis determined under Sec.  413.134(g); and
    (ii) Loans made to finance capital stock acquisitions, mergers, or 
consolidations for which revaluation of assets is not allowed under 
Sec.  413.134(k).
    (2) In determining whether a loan was made for the purpose of 
acquiring a facility, we apply any owner's investment or funds first to 
the tangible assets, then to the intangible assets other than goodwill, 
and lastly to the goodwill. If the owner's investment or funds are not 
sufficient to cover the cost allowed for tangible assets, we apply funds 
borrowed to finance the acquisition to the portion of the allowed cost 
of the tangible assets not covered by the owner's investment, then to 
the intangible assets other than goodwill, and lastly to the goodwill. 
Repayments of the funds borrowed are applied first to the borrowing 
related to the tangible assets, then to the borrowing related to the 
intangible assets other than goodwill, and lastly to the borrowing 
related to the goodwill.
    (3) When a provider borrows funds, but only some of the funds are 
necessary, repayments of the loan (principal and interest portions) are 
applied first to pay for the necessary portion of the loan. Only after 
all of the necessary portion of the loan (principal and interest) has 
been repaid are any repayments applied to the unnecessary portion of the 
loan. Repayments toward non-allowable borrowing pertaining to assets or 
activities not related to patient care are considered investments, and 
the provisions of paragraph (b)(2)(iii) of this section are applied.
    (e) Zero coupon bonds--(1) Interest on bonds issued on or after 
August 15, 1996. For zero coupon bonds issued on or after August 15, 
1996, interest expense

[[Page 944]]

incurred to provide funds for patient care-related costs is an allowable 
expense, and interest income earned for investment purposes is an 
allowable offset, in the cost reporting period in which the interest 
accrues.
    (2) Interest income offset. Interest income from zero coupon bonds 
must be offset against allowable interest expense as prescribed in 
paragraph (b)(2) of this section and in Sec.  413.130(g)(2). If zero 
coupon bonds are purchased with the proceeds of an advanced refunding of 
debt, offset of the investment income is required under Sec.  
413.153(b)(2)(iii), but the investment income is not prorated under 
Sec.  413.130(g)(2).
    (3) Use of effective interest method. (i) Interest expense and 
interest income from zero coupon bonds that are reported as they accrue 
must be amortized using the effective interest method. This method 
recognizes the actual accrual of interest expense or income for each 
interest computation period (as specified by the bond instrument) 
throughout the life of the bond.
    (ii) A constant effective yield rate is determined and applied to 
the book value (outstanding loan balance including prior accrued 
interest) of the bond at the beginning of each period to determine the 
total interest for the period.
    (iii) If the interest computation period involves portions of more 
than one cost reporting period, the amount of interest for that 
computation period shall be apportioned to each cost reporting period.
    (iv) An example of the computation of interest using the effective 
interest method follows:

                                  Facts

    Life of zero coupon bond: 15 years.
    Value at maturity: $50,000.
    Bondholder pays $6,996 for the bond.
    Annual interest rate is 13.5506% compounded semi-annually.
    From the table below, interest for the first year would be $980.11 
($474.00 plus $506.11).

------------------------------------------------------------------------
                                                                Col. 4
                                      Col 2 Book              Book value
                                         value      Col. 3      end of
       Col 1 Six-month periods         beginning   Effective    period
                                       of period   interest*  (columns 2
                                                                 + 3)
------------------------------------------------------------------------
1                                      $6,996.00     $474.00   $7,470.00
2                                       7,470.00      506.11    7,976.11
3                                       7,976.11      540.40    8,516.51
4                                       8,516.51      577.02    9,093.53
29                                     43,855.94    2,971.37   46,827.31
30                                     46,827.31    3,172.69  50,000.00
------------------------------------------------------------------------
*Computed by multiplying the book value at the beginning of each period
  (Column 2) by 6.7753% (the annual interest rate of 13.5506% 2 =
  6.7753%).


[51 FR 34793, Sept. 30, 1986, as amended at 56 FR 43457, Aug. 30, 1991; 
59 FR 45402, Sept. 1, 1994; 61 FR 37014, July 16, 1996; 61 FR 63748, 
63479, Dec. 2, 1996; 65 FR 8662, Feb. 22, 2000]



Sec.  413.157  Return on equity capital of proprietary providers.

    (a) Definitions. For purposes of this section--
    Proprietary provider means a provider that is organized and operated 
with the expectation of earning a profit for its owners (as 
distinguished from a provider that is organized and operated on a 
nonprofit basis). Proprietary providers may be sole proprietorships, 
partnerships, or corporations. Effective for cost reporting periods 
beginning on or after July 6, 1987, the term applies only to proprietary 
hospitals and SNFs.
    (b) General rule. A reasonable return on equity capital invested and 
used in the provision of patient care is paid as an allowance in 
addition to the reasonable cost of covered services furnished to 
beneficiaries by proprietary providers.
    (1) Rate of return applicable to proprietary providers for cost 
reporting periods beginning before July 6, 1987. Except as provided in 
paragraphs (b)(2), (b)(3), and (b)(4) of this section, the amount 
allowable on an annual basis, for cost reporting periods beginning 
before July 6, 1987, is determined by multiplying the provider's equity 
capital by a percentage equal to one and one-half times the average of 
the rates of interest on special issues of public debt obligations 
issued for purchase by the Medicare Part A Trust Fund for each of the 
months during the provider's reporting period or portion thereof covered 
under the program.
    (2) Rate of return for inpatient hospital services furnished by 
proprietary hospitals. The rate used in determining the return for 
inpatient hospital services is

[[Page 945]]

a percentage of the average of the rates of interest described in 
paragraph (b)(1) of this section. The percentages applicable to 
inpatient hospital services are as follows:
    (i) 150 percent for cost reporting periods beginning before April 
20, 1983.
    (ii) 100 percent for cost reporting periods beginning on or after 
April 20, 1983 and before October 1, 1986.
    (iii) 75 percent for cost reporting periods beginning on or after 
October 1, 1986 and before October 1, 1987.
    (iv) 50 percent for cost reporting periods beginning on or after 
October 1, 1987 and before October 1, 1988.
    (v) 25 percent for cost reporting periods beginning on or after 
October 1, 1988 and before October 1, 1989.
    (vi) Zero percent for cost reporting periods beginning on or after 
October 1, 1989.
    (3) Rate of return related to proprietary SNFs. (i) For cost 
reporting periods beginning on or after October 1, 1985, the rate used 
in determining the return for SNF services furnished before October 1, 
1993, is a percentage equal to the average of the rates of interest 
described in paragraph (b)(1) of this section.
    (ii) There is no allowance for return for SNF services furnished on 
or after October 1, 1993.
    (4) Rate of return related to outpatient hospital services. (i) For 
cost reporting periods beginning on or after October 1, 1985, the rate 
used in determining the return for outpatient hospital services 
furnished before January 1, 1988 is a percentage equal to the average of 
the rates of interest described in paragraph (b)(1) of this section.
    (ii) There is no allowance for return for outpatient hospital 
services furnished on or after January 1, 1988.
    (5) Rate of return for proprietary services of all nonhospital and 
non-SNF providers. (i) For cost reporting periods beginning on or after 
October 1, 1985, but before July 6, 1987, the rate used in determining 
the return for services of all nonhospital and non-SNF providers is a 
percentage equal to the average of the rates of interest described in 
paragraph (b)(1) of this section.
    (ii) For cost reporting periods beginning on or after July 6, 1987, 
there is no allowance for return on equity capital for nonhospital and 
non-SNF providers.
    (c) Application--(1) Computation of equity capital. For purposes of 
computing the allowable return, the provider's equity capital means--
    (i) The provider's investment in plant, property, and equipment 
related to patient care (net of depreciation) and funds deposited by a 
provider who leases plant, property, or equipment related to patient 
care and is required by the terms of the lease to deposit such funds 
(net of noncurrent debt related to such investment or deposited funds); 
and
    (ii) Net working capital maintained for necessary and proper 
operation of patient care activities. However, debt representing loans 
from partners, stockholders, or related organizations on which interest 
payments would be allowable as costs but for the provisions of Sec.  
413.153(b)(3)(ii), is not subtracted in computing the amount of equity 
capital in order that the proceeds from such loans be treated as part of 
the provider's equity capital. In computing the amount of equity capital 
upon which a return is allowable, investment in facilities is recognized 
on the basis of the historical cost, or other basis, used for 
depreciation and other purposes under Part A of Medicare.
    (2) Acquisitions after July 1970. With respect to a facility or any 
tangible assets of a facility acquired on or after August 1, 1970, the 
excess of the price paid for such facility or such tangible assets over 
the historical cost, as defined in Sec.  413.134(b), or the cost basis, 
as determined under Sec.  413.134(g) (whichever is appropriate), is not 
includable in equity capital, and loans made to finance such excess 
portion of the cost of such acquisitions (see Sec.  413.153(d)) are 
excluded in computing equity capital.
    (3) Acquisitions prior to August 1970. With respect to a facility or 
any tangible assets of a facility acquired before August 1970, the 
excess of the price paid for such facility or assets over the fair 
market value of tangible assets at the time of purchase is includable in 
equity capital to the extent that it is reasonable except that the 
cumulative allowable return for such excess may not exceed 100 percent 
of such excess. For purposes of this section, the cumulative allowable 
return means the sum

[[Page 946]]

of the allowable rate of return on equity capital for all months 
starting from August 1, 1970. For example, if the allowable rates of 
return on equity capital for a provider are 9 percent for the first year 
(and such year started August 1, 1970), 8.5 percent for the second year, 
and 10.5 percent for the third year, the cumulative allowable return at 
the end of the third year would be 28 percent. After the cumulative 
allowable return equals 100 percent, the inclusion in equity capital of 
the excess is no longer allowable.
    (4) Computation of return on equity capital. For purposes of 
computing the allowable return, the amount of equity capital is the 
average investment during the reporting period. The rate of return 
allowed, as derived from time to time based upon interest rates in 
accordance with this principle, is determined by CMS and communicated 
through contractors. Return on investment as an element of allowable 
costs is subject to apportionment in the same manner as other elements 
of allowable costs.

    Example of calculation of cumulative allowable return. X purchased a 
provider on July 1, 1969, paying $100,000 in excess f the fair market 
value of the assets acquired. Provider X files its cost report on a 
calendar-year basis. The allowable rate of return on equity capital for 
August 1, 1970-December 31, 1970 (4.538 percent), is obtained by 
multiplying the allowable rate of return for the period ending December 
31, 1970 (10.891) by \5/12\ (a fraction of which the numerator is the 
number of months from August 1, 1970, to the end of the cost-reporting 
period and the denominator is the number of months in the cost-reporting 
period). The cumulative allowable return for Provider X for the period 
August 1, 1970-December 31, 1973, (32.367 percent) is computed as 
follows:

------------------------------------------------------------------------
                                                                Rate of
                                                               return on
                  Cost reporting year ending                     equity
                                                                capital
                                                               (percent)
------------------------------------------------------------------------
Dec. 31, 1970................................................      4.538
Dec. 31, 1971................................................      8.969
Dec. 31, 1972................................................      8.891
Dec. 31, 1973................................................      9.969
                                                              ----------
      Total..................................................     32.367
------------------------------------------------------------------------


(The $100,000 paid in excess of the fair market value of the assets 
acquired is included in equity capital until the sum of the allowable 
rate of return on equity capital equals 100 percent. Of course, no 
portion of the $100,000 may be amortized as an allowable cost or is 
otherwise allowable for any program reimbursement purposes other than 
for determining the provider's equity capital.

[51 FR 34793, Sept. 30, 1986, as amended at 52 FR 21225, June 4, 1987; 
52 FR 23398, June 19, 1987; 52 FR 32921, Sept. 1, 1987; 53 FR 12017, 
Apr. 12, 1988; 57 FR 39830, Sept. 1, 1992; 59 FR 26960, May 25, 1994]



Subpart H_Payment for End-Stage Renal Disease (ESRD) Services and Organ 
                            Procurement Costs

    Source: 62 FR 43668, Aug. 15, 1997, unless otherwise noted.



Sec.  413.170  Scope.

    This subpart implements sections 1881(b)(2), (b)(4), (b)(7), and 
(b)(12) through (b)(14) of the Act by--
    (a) Setting forth the principles and authorities under which CMS is 
authorized to establish a prospective payment system for outpatient 
maintenance dialysis services in or under the supervision of an ESRD 
facility that meets the conditions of coverage in part 494 of this 
chapter and as defined in Sec.  413.171(c).
    (b) Providing procedures and criteria under which a pediatric ESRD 
facility (an ESRD facility with at least a 50 percent pediatric patient 
mix as specified in Sec.  413.184 of this subpart) may receive an 
exception to its prospective payment rate prior to January 1, 2011; and
    (c) Establishing procedures that a facility must follow to appeal 
its payment amount under the prospective payment system.

[62 FR 43668, Aug. 15, 1997, as amended at 70 FR 70330, Nov. 21, 2005; 
73 FR 20474, Apr. 15, 2008; 75 FR 49198, Aug. 12, 2010]



Sec.  413.171  Definitions.

    For purposes of this subpart, the following definitions apply:
    Base rate. The average payment amount per-treatment, standardized to 
remove the effects of case-mix and area wage levels and further reduced 
for budget neutrality and the outlier percentage. The base rate is the 
amount to which the patient-specific case-mix

[[Page 947]]

adjustments and any ESRD facility adjustments, if applicable, are 
applied.
    Composite Rate Services. Items and services used in the provision of 
outpatient maintenance dialysis for the treatment of ESRD and included 
in the composite payment system established under section 1881(b)(7) and 
the basic case-mix adjusted composite payment system established under 
section 1881(b)(12) of the Act.
    ESRD facility. An ESRD facility is an independent facility or a 
hospital-based provider of services (as described in Sec.  413.174(b) 
and (c) of this chapter), including facilities that have a self-care 
dialysis unit that furnish only self-dialysis services as defined in 
Sec.  494.10 of this chapter and meets the supervision requirements 
described in part 494 of this chapter, and that furnishes institutional 
dialysis services and supplies under Sec.  410.50 and Sec.  410.52 of 
this chapter.
    New ESRD facility. A new ESRD facility is an ESRD facility (as 
defined above) that is certified for Medicare participation on or after 
January 1, 2011.
    Pediatric ESRD Patient. A pediatric ESRD patient is defined as an 
individual less than 18 years of age who is receiving renal dialysis 
services.
    Renal dialysis services. Effective January 1, 2011, the following 
items and services are considered ``renal dialysis services,'' and paid 
under the ESRD prospective payment system under section 1881(b)(14) of 
the Act:
    (1) Items and services included in the composite rate for renal 
dialysis services as of December 31, 2010;
    (2) Erythropoiesis stimulating agents and any oral form of such 
agents that are furnished to individuals for the treatment of ESRD;
    (3) Other drugs and biologicals that are furnished to individuals 
for the treatment of ESRD and for which payment was (prior to January 1, 
2011) made separately under Title XVIII of the Act (including drugs and 
biologicals with only an oral form),
    (4) Diagnostic laboratory tests and other items and services not 
described in paragraph (1) of this definition that are furnished to 
individuals for the treatment of ESRD.
    (5) Renal dialysis services do not include those services that are 
not essential for the delivery of maintenance dialysis.
    Separately billable items and services. Items and services used in 
the provision of outpatient maintenance dialysis for the treatment of 
individuals with ESRD that were or would have been, prior to January 1, 
2011, separately payable under Title XVIII of the Act and not included 
in the payment systems established under section 1881(b)(7) and section 
1881(b)(12) of the Act.

[75 FR 49198, Aug. 12, 2010]



Sec.  413.172  Principles of prospective payment.

    (a) Payment for renal dialysis services as defined in Sec.  413.171 
and home dialysis services as defined in Sec.  413.217 of this chapter 
are based on payment rates set prospectively by CMS.
    (b) All approved ESRD facilities must accept the prospective payment 
rates established by CMS as payment in full for covered renal dialysis 
services as defined in Sec.  413.171 or home dialysis services. Approved 
ESRD facility means--
    (1) Any independent ESRD facility or hospital-based provider of 
services (as defined in Sec.  413.174(b) and Sec.  413.174(c) of this 
part) that has been approved by CMS to participate in Medicare as an 
ESRD supplier; or
    (2) Any approved independent facility with a written agreement with 
the Secretary. Under the agreement, the independent ESRD facility 
agrees--
    (i) To maintain compliance with the conditions for coverage set 
forth in part 494 of this chapter and to report promptly to CMS any 
failure to do so; and
    (ii) Not to charge the beneficiary or any other person for items and 
services for which the beneficiary is entitled to have payment made 
under the provisions of this part.
    (c) CMS publishes the methodology used to establish payment rates 
and the changes specified in Sec.  413.196(b) in the Federal Register.

[62 FR 43668, Aug. 15, 1997, as amended at 73 FR 20474, Apr. 15, 2008; 
75 FR 49198, Aug. 12, 2010]

[[Page 948]]



Sec.  413.174  Prospective rates for hospital-based and independent 
ESRD facilities.

    (a) Establishment of rates. CMS establishes prospective payment 
rates for ESRD facilities using a methodology that--
    (1) Differentiates between hospital-based providers of services and 
independent ESRD facilities for items and services furnished prior to 
January 1, 2009;
    (2) Does not differentiate between hospital-based providers of 
services and independent ESRD facilities for items and services 
furnished on or after January 1, 2009; and
    (3) Requires the labor share be based on the labor share otherwise 
applied to independent ESRD facilities when applying the geographic 
index to hospital-based ESRD providers of services, on or after January 
1, 2009.
    (b) Determination of independent facility. For purposes of rate-
setting and payment under this section, CMS considers any facility that 
does not meet all of the criteria of a hospital-based facility to be an 
independent facility. A determination under this paragraph (b) is an 
initial determination under Sec.  498.3 of this chapter.
    (c) Determination of hospital-based facility. A determination under 
this paragraph (c) is an initial determination under Sec.  498.3 of this 
chapter. CMS determines that a facility is hospital-based if the--
    (1) Facility and hospital are subject to the bylaws and operating 
decisions of a common governing board. This governing board, which has 
final administrative responsibility, approves all personnel actions, 
appoints medical staff, and carries out similar management functions;
    (2) Facility's director or administrator is under the supervision of 
the hospital's chief executive officer and reports through him or her to 
the governing board;
    (3) Facility personnel policies and practices conform to those of 
the hospital;
    (4) Administrative functions of the facility (for example, records, 
billing, laundry, housekeeping, and purchasing) are integrated with 
those of the hospital; and
    (5) Facility and hospital are financially integrated, as evidenced 
by the cost report, which reflects allocation of overhead to the 
facility through the required step-down methodology.
    (d) Nondetermination of hospital-based facility. In determining 
whether a facility is hospital-based, CMS does not consider--
    (1) An agreement between a facility and a hospital concerning 
patient referral;
    (2) A shared service arrangement between a facility and a hospital; 
or
    (3) The physical location of a facility on the premises of a 
hospital.
    (e) Add-on amounts. If all the physicians furnishing services to 
patients in an ESRD facility elect the initial method of payment (as 
described in Sec.  414.313(c) of this chapter), the prospective rate (as 
described in paragraph (a) of this section) paid to that facility is 
increased by an add-on amount as described in Sec.  414.313.
    (f) Additional payment for separately billable drugs and 
biologicals. Prior to January 1, 2011, CMS makes additional payment 
directly to an ESRD facility for certain ESRD-related drugs and 
biologicals furnished to ESRD patients.
    (1) Only on an assignment basis, directly to the facility which must 
accept, as payment in full, the amount that CMS determines;
    (2) Subject to the Part B deductible and coinsurance;
    (3) For drugs furnished prior to January 1, 2006, payment is made to 
hospital-based ESRD providers of services on a reasonable cost basis. 
Effective January 1, 2006, and prior to January 1, 2011, payment for 
drugs furnished by a hospital-based ESRD provider of service is based on 
the methodology specified in Sec.  414.904 of this chapter.
    (4) For drugs furnished prior to January 1, 2006, payment is made to 
independent ESRD facilities based on the methodology specified in Sec.  
405.517 of this chapter. Effective January 1, 2006, and prior to January 
1, 2011, payment for drugs and biological furnished by independent ESRD 
facilities is based on the methodology specified in Sec.  414.904 of 
this chapter.
    (5) Effective January 1, 2011, except as provided below, payment to 
an ESRD facility for renal dialysis service

[[Page 949]]

drugs and biologicals as defined in Sec.  413.171, furnished to ESRD 
patients on or after January 1, 2011 is incorporated within the 
prospective payment system rates established by CMS in Sec.  413.230 and 
separate payment will no longer be provided.
    (6) Effective January 1, 2025, payment to an ESRD facility for renal 
dialysis service drugs and biologicals with only an oral form furnished 
to ESRD patients is incorporated within the prospective payment system 
rates established by CMS in Sec.  413.230 and separate payment will no 
longer be provided.

[62 FR 43668, Aug. 15, 1997, as amended at 70 FR 70330, Nov. 21, 2005; 
73 FR 69935, Nov. 19, 2008; 75 FR 49198, Aug. 12, 2010; 78 FR 72252, 
Dec. 2, 2013; 79 FR 66262, Nov. 6, 2014; 80 FR 69076, Nov. 6, 2015]



Sec.  413.176  Amount of payments.

    For items and services, for which payment is made under section 
1881(b)(7), section 1881(b)(12), and section 1881(b)(14) of the Act:
    (a) If the beneficiary has incurred the full deductible applicable 
under Part B of Medicare before the dialysis treatment, Medicare pays 
the ESRD facility 80 percent of its prospective rate.
    (b) If the beneficiary has not incurred the full deductible 
applicable under Part B of Medicare before the dialysis treatment, CMS 
subtracts the amount applicable to the deductible from the ESRD 
facility's prospective rate and pays the facility 80 percent of the 
remainder, if any.

[75 FR 49199, Aug. 12, 2010]



Sec.  413.177  Quality incentive program payment.

    (a) With respect to renal dialysis services as defined under Sec.  
413.171, in the case of an ESRD facility that does not earn enough 
points under the program described at Sec.  413.178 to meet or exceed 
the minimum total performance score (as defined at Sec.  413.178(a)(8)) 
established by CMS for a payment year (as defined at Sec.  
413.178(a)(10)), payments otherwise made to the facility under Sec.  
413.230 for renal dialysis services during the payment year will be 
reduced by up to 2 percent as follows:
    (1) For every 10 points that the total performance score (as defined 
at Sec.  413.178(a)(14)) earned by the ESRD facility falls below the 
minimum total performance score, the payments otherwise made will be 
reduced by 0.5 percent.
    (2) [Reserved]
    (b) Any payment reduction will apply only to the payment year 
involved and will not be taken into account in computing the single 
payment amount under this subpart for services provided in a subsequent 
payment year.

[76 FR 646, Jan. 5, 2011, as amended at 83 FR 57068, Nov. 14, 2018]



Sec.  413.178  ESRD quality incentive program.

    (a) Definitions. As used in this section:
    (1) Achievement threshold means the 15th percentile of national ESRD 
facility performance on a clinical measure during the baseline period 
for a payment year.
    (2) Baseline period means, with respect to a payment year, the time 
period used to calculate the performance standards, benchmark, 
improvement threshold and achievement threshold that apply to each 
clinical measure for that payment year.
    (3) Benchmark means, with respect to a payment year, the 90th 
percentile of national ESRD facility performance on a clinical measure 
during the baseline period that applies to the measure for that payment 
year.
    (4) Clinical measure means a measure that is scored for a payment 
year using the methodology described in paragraphs (e)(1)(i) through (v) 
of this section.
    (5) End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP) 
means the program authorized under section 1881(h) of the Social 
Security Act.
    (6) ESRD facility means an ESRD facility as defined in Sec.  
413.171.
    (7) Improvement threshold means an ESRD facility's performance on a 
clinical measure during the baseline period that applies to the measure 
for a payment year.
    (8) Minimum total performance score (mTPS) means, with respect to a 
payment year, the total performance score that an ESRD facility would 
receive if, during the baseline period, it performed at the 50th 
percentile of national ESRD facility performance on

[[Page 950]]

all clinical measures and the median of national ESRD facility 
performance on all reporting measures.
    (9) Payment reduction means the reduction, as specified by CMS, to 
each payment that would otherwise be made to an ESRD facility under 
Sec.  413.230 for a calendar year based on the TPS earned by the ESRD 
facility for the corresponding payment year that is lower than the mTPS 
score established for that payment year.
    (10) Payment year means the calendar year for which a payment 
reduction, if applicable, is applied to the payments otherwise made to 
an ESRD facility under Sec.  413.230.
    (11) Performance period means the time period during which data are 
collected for the purpose of calculating an ESRD facility's performance 
on measures with respect to a payment year.
    (12) Performance standards are, for a clinical measure, the 
performance levels used to award points to an ESRD facility based on its 
performance on the measure, and are, for a reporting measure, the levels 
of data submission and completion of other actions specified by CMS that 
are used to award points to an ESRD facility on the measure.
    (13) Reporting measure means a measure that is scored for a payment 
year using the methodology described in paragraph (e)(1)(vi) of this 
section.
    (14) Total performance score (TPS) means the numeric score ranging 
from 0 to 100 awarded to each ESRD facility based on its performance 
under the ESRD QIP with respect to a payment year.
    (b) Applicability of the ESRD QIP. The ESRD QIP applies to ESRD 
facilities as defined at Sec.  413.171 beginning the first day of the 
month that is 4 months after the facility CMS Certification Number (CCN) 
effective date.
    (c) ESRD QIP measure selection. CMS specifies measures for the ESRD 
QIP for a payment year and groups the measures into domains. The 
measures for a payment year include, but are not limited to:
    (1) Measures on anemia management that reflect the labeling approved 
by the Food and Drug Administration for such management.
    (2) Measures on dialysis adequacy.
    (3) To the extent feasible, a measure (or measures) of patient 
satisfaction.
    (4) To the extent feasible, measures on iron management, bone 
mineral metabolism, and vascular access (including for maximizing the 
placement of arterial venous fistula).
    (5) Beginning with the 2016 payment year, measures specific to the 
conditions treated with oral-only drugs and that are, to the extent 
feasible, outcomes-based.
    (d) Data submission requirement. (1) Except as provided in paragraph 
(d)(3) and (4) of this section, and for a payment year, facilities must 
submit to CMS data on each measure specified by CMS under paragraph (c) 
of this section. Facilities must submit these data in the form, manner, 
and at a time specified by CMS.
    (2) For purposes of paragraph (d)(1) of this section, the baseline 
period that applies to the 2023 payment year is calendar year 2019 for 
purposes of calculating the achievement threshold, benchmark and minimum 
total performance score, and calendar year 2020 for purposes of 
calculating the improvement threshold, and the performance period that 
applies to the 2023 payment year is calendar year 2021. Beginning with 
the 2024 payment year, the performance period and corresponding baseline 
periods are each advanced 1 year for each successive payment year.
    (3) A facility may request and CMS may grant exceptions to the 
reporting requirements under paragraph (d)(1) of this section for one or 
more calendar days, when there are certain extraordinary circumstances 
beyond the control of the facility.
    (4) A facility may request an exception within 90 days of the date 
that the extraordinary circumstances occurred by submitting the 
Extraordinary Circumstances Exception request form, which is available 
on the QualityNet website (https://www.qualitynet.org/), to CMS via 
email to the ESRD QIP mailbox at [email protected]. Facilities must 
provide the following information on the form:
    (i) Facility CCN.
    (ii) Facility name.
    (iii) CEO name and contact information.

[[Page 951]]

    (iv) Additional contact name and contact information.
    (v) Reason for requesting an exception.
    (vi) Dates affected.
    (vii) Date the facility will start submitting data again, with 
justification for this date.
    (viii) Evidence of the impact of the extraordinary circumstances, 
including but not limited to photographs, newspaper, and other media 
articles.
    (5) CMS will not consider an exception request unless the facility 
requesting such exception has complied with the requirements in 
paragraph (d)(4) of this section.
    (6) CMS may grant exceptions to facilities without a request if it 
determines that one or more of the following has occurred:
    (i) An extraordinary circumstance affects an entire region or 
locale.
    (ii) An unresolved issue with a CMS data system affected the ability 
of a facility to submit data in accordance with paragraph (d)(1) of this 
section and CMS was unable to provide the facility with an alternative 
method of data submission.
    (7) With the exception of first and second quarter 2020 ESRD QIP 
data for which CMS granted an exception under paragraph (d)(6) of this 
section, a facility that has been granted an exception to the data 
submission requirements under paragraph (d)(6) of this section may 
notify CMS that it will continue to submit data under paragraph (d)(1) 
of this section by sending an email signed by the CEO or another 
designated contact to the ESRD QIP mailbox at [email protected]. Upon 
receipt of an email under this clause, CMS will notify the facility in 
writing that CMS is withdrawing the exception it previously granted to 
the facility. With respect to fourth quarter 2019 ESRD QIP data for 
which CMS granted an exception under paragraph (d)(6) of this section, a 
facility is deemed to have met the requirements of this paragraph if the 
facility actually submitted the data by the March 31, 2020 submission 
deadline but did not notify CMS that it would do so.
    (e) Performance scoring under the ESRD QIP. (1) CMS will award 
points to an ESRD facility based on its performance on each clinical 
measure for which the ESRD facility reports the applicable minimum 
number of cases during the performance period for a payment year, and 
based on the degree to which the ESRD facility submits data and 
completes other actions specified by CMS for a reporting measure during 
the performance period for a payment year.
    (i) CMS will award from 1 to 9 points for achievement on a clinical 
measure to each ESRD facility whose performance on that measure during 
the applicable performance period meets or exceeds the achievement 
threshold but is less than the benchmark specified for that measure.
    (ii) CMS will award 0 points for achievement on a clinical measure 
to each ESRD facility whose performance on that measure during the 
applicable performance period falls below the achievement threshold 
specified for that measure.
    (iii) CMS will award from 0 to 9 points for improvement on a 
clinical measure to each ESRD facility whose performance on that measure 
during the applicable performance period meets or exceeds the 
improvement threshold but is less than the benchmark specified for that 
measure.
    (iv) CMS will award 0 points for improvement on a clinical measure 
to each ESRD facility whose performance on that measure during the 
applicable performance period is below the improvement threshold 
specified for that measure.
    (v) CMS will award 10 points to each ESRD facility whose performance 
on a clinical measure during the applicable performance period meets or 
exceeds the benchmark specified for that measure.
    (vi) CMS will award from 0 to 10 points to each ESRD facility on a 
reporting measure based on the degree to which, during the applicable 
performance period, the ESRD facility reports data and completes other 
actions specified by CMS with respect to that measure.
    (2) CMS calculates the TPS for an ESRD facility for a payment year 
as follows:
    (i) CMS calculates a domain score for each domain based on the total 
number

[[Page 952]]

of points the ESRD facility has earned under paragraph (e)(1) of this 
section for each measure in the domain and the weight that CMS has 
assigned to each measure.
    (ii) CMS weights each domain score in accordance with the domain 
weight that CMS has established for the payment year.
    (iii) The sum of the weighted domain scores is the ESRD facility's 
TPS for the payment year.
    (f) Public availability of ESRD QIP performance information. (1) CMS 
will make information available to the public regarding the performance 
of each ESRD facility under the ESRD QIP on the Dialysis Facility 
Compare website, including the facility's TPS and scores on individual 
measures.
    (2) Prior to making the information described in paragraph (f)(1) of 
this section available to the public, CMS will provide ESRD facilities 
with an opportunity to review that information, technical assistance to 
help them understand how their performance under the ESRD QIP was 
scored, and an opportunity to request and receive responses to questions 
that they have about the ESRD QIP.
    (3) CMS will provide each ESRD facility with a performance score 
certificate on an annual basis that describes the TPS achieved by the 
facility with respect to a payment year. The performance score 
certificate must be posted by the ESRD facility within 15 business days 
of the date that CMS issues the certificate to the ESRD facility, with 
the content unaltered, in an area of the facility accessible to 
patients.
    (g) Limitation on review. There is no administrative or judicial 
review of the following:
    (1) The determination of the amount of the payment reduction under 
section 1881(h)(1) of the Act.
    (2) The specification of measures under section 1881(h)(2) of the 
Act.
    (3) The methodology developed under section 1881(h)(3) of the Act 
that is used to calculate TPSs and performance scores for individual 
measures.
    (4) The establishment of the performance standards and the 
performance period under section 1881(h)(4) of the Act.

[83 FR 57068, Nov. 14, 2018, as amended at 84 FR 60803, Nov. 8, 2019; 85 
FR 54872, Sept. 2, 2020]



Sec.  413.180  Procedures for requesting exceptions to payment rates.

    (a) Outpatient maintenance dialysis payments. All payments for 
outpatient maintenance dialysis furnished at or by facilities are made 
on the basis of prospective payment rates.
    (b) Criteria for requesting an exception. If a pediatric ESRD 
facility projects on the basis of prior year costs and utilization 
trends that it has an allowable cost per treatment higher than its 
prospective rate set under Sec.  413.174, and if these excess costs are 
attributable to one or more of the factors in Sec.  413.182, the 
facility may request, in accordance with paragraph (e) of this section, 
that CMS approve an exception to that rate and set a higher prospective 
payment rate.
    (c) Application of deductible and coinsurance. The higher payment 
rate is subject to the application of deductible and coinsurance in 
accordance with Sec.  413.176.
    (d) Payment rate exception request. Effective October 1, 2002, CMS 
may approve exceptions to a pediatric ESRD facility's updated 
prospective payment rate, if the pediatric ESRD facility did not have an 
approved exception rate as of October 1, 2002. A pediatric ESRD facility 
may request an exception to its payment rate at any time after it is in 
operation for at least 12 consecutive months.
    (e) Documentation for a payment rate exception request. If the 
facility is requesting an exception to its payment rate, it must submit 
to CMS its most recently completed cost report as required under Sec.  
413.198 and whatever statistics, data, and budgetary projections as 
determined by CMS to be needed to adjudicate each type of exception. CMS 
may audit any cost report or other information submitted. The materials 
submitted to CMS must--
    (1) Separately identify elements of cost contributing to costs per 
treatment in excess of the facility's payment rate;

[[Page 953]]

    (2) Show that the facility's costs, including those costs that are 
not directly attributable to the exception criteria, are allowable and 
reasonable under the reasonable cost principles set forth in this part;
    (3) Show that the elements of excessive cost are specifically 
attributable to one or more conditions specified in Sec.  413.182;
    (4) Specify the amount of additional payment per treatment the 
facility believes is required for it to recover its justifiable excess 
costs; and
    (5) Specify that the facility has compared its most recently 
completed cost report with cost reports from (at least 2) prior years. 
The facility must explain any material statistical data or cost changes, 
or both, and include an explanation with the documentation supporting 
the exception request.
    (f) Completion of requirements and criteria. The facility must 
demonstrate to CMS's satisfaction that the requirements of this section 
and the criteria in Sec.  413.182 are fully met. The burden of proof is 
on the facility to show that one or more of the criteria are met and 
that the excessive costs are justifiable under the reasonable cost 
principles set forth in this part.
    (g) Approval of an exception request. An exception request is deemed 
approved unless it is disapproved within 60 working days after it is 
filed with its contractor.
    (h) Determination of an exception request. In determining the 
facility's payment rate under the exception process, CMS excludes all 
costs that are not reasonable or allowable under the reasonable cost 
principles set forth in this part.
    (i) Period of approval: Payment exception request. A prospective 
exception payment rate approved by CMS applies for the period from the 
date the complete exception request was filed with its contractor until 
30 days after the contractor's receipt of the facility's letter 
notifying the contractor of the facility's request to give up its 
exception rate and be subject to the basic case-mix adjusted composite 
payment rate methodology. ESRD facilities electing to retain their 
nonpediatric or pediatric exception rates (including self-dialysis 
training) do not need to notify their contractors. Once a facility 
notifies its contractor in writing that it cannot retain its current 
exception rate, that decision cannot be subsequently reversed.
    (j) Denial of an exception request. CMS denies exception requests 
submitted without the documentation specified in Sec.  413.182 and the 
applicable regulations cited there.
    (k) Criteria for refiling a denied exception request. A pediatric 
ESRD facility that was denied an exception request may immediately file 
another exception request. Any subsequent exception request must address 
and document the issues cited in CMS' denial letter.
    (l) Periods of exceptions. (1) Prior to December 31, 2000, an ESRD 
facility may receive an exception to its composite payment rate for 
isolated essential facilities, self dialysis training costs, atypical 
service intensity (patient mix) and pediatric facilities.
    (2) Effective December 31, 2000, an ESRD facility not subject to 
paragraph (l)(3), is no longer granted any new exception to the 
composite payment rate as defined in Sec.  413.180(1).
    (3) Effective April 1, 2004 through September 27, 2004, and on an 
annual basis, an ESRD facility with at least 50 percent pediatric 
patient mix as specified in Sec.  413.184 of this part, that did not 
have an exception rate in effect as of October 1, 2002, may apply for an 
exception to its composite payment rate.
    (4) For ESRD facilities that are paid a blended rate for renal 
dialysis services provided during the transition described in Sec.  
413.239 of this part, any existing exceptions for isolated essential 
facilities, self dialysis training costs, atypical service intensity 
(patient mix) and pediatric facilities are used as the payment amount in 
place of the composite rate, and will be terminated for ESRD services 
furnished on or after January 1, 2014.
    (5) For ESRD facilities that, in accordance with Sec.  413.239(b) of 
this part, elect to be paid for renal dialysis services provided during 
the transition based on 100 percent of the payment amount determined 
under Sec.  413.220, any existing exceptions for isolated essential 
facilities, self dialysis training costs, atypical service intensity 
(patient mix) and pediatric facilities are

[[Page 954]]

terminated for ESRD services furnished on or after January 1, 2011.

[62 FR 43668, Aug. 15, 1997, as amended at 70 FR 70331, Nov. 21, 2005; 
75 FR 49199, Aug. 12, 2010]



Sec.  413.182  Criteria for approval of exception requests.

    (a) CMS may approve exceptions to a pediatric ESRD facility's 
prospective payment rate if the pediatric ESRD facility did not have an 
approved exception rate as of October 1, 2002.
    (b) The pediatric ESRD facility must demonstrate, by convincing 
objective evidence, that its total per treatment costs are reasonable 
and allowable under the relevant cost reimbursement principles of part 
413 and that its per treatment costs in excess of its payment rate are 
directly attributable to any of the following criteria:
    (1) Pediatric patient mix, as specified in Sec.  413.184.
    (2) Self-dialysis training costs in pediatric facilities, as 
specified in Sec.  413.186.

[70 FR 70331, Nov. 21, 2005]



Sec.  413.184  Payment exception: Pediatric patient mix.

    (a) Qualifications. To qualify for an exception to its prospective 
payment rate based on its pediatric patient mix a facility must 
demonstrate that--
    (1) At least 50 percent of its patients are individuals under 18 
years of age;
    (2) Its nursing personnel costs are allocated properly between each 
mode of care;
    (3) The additional nursing hours per treatment are not the result of 
an excess number of employees;
    (4) Its pediatric patients require a significantly higher staff-to-
patient ratio than typical adult patients; and
    (5) These services, procedures, or supplies and their per treatment 
costs are clearly prudent and reasonable when compared to those of 
pediatric facilities with a similar patient mix.
    (b) Documentation. (1) A pediatric ESRD facility must submit a 
listing of all outpatient dialysis patients (including all home 
patients) treated during the most recently completed and filed cost 
report (in accordance with cost reporting requirements under Sec.  
413.198) showing--
    (i) Age of patients and percentage of patients under the age of 18;
    (ii) Individual patient diagnosis;
    (iii) Home patients and ages;
    (iv) In-facility patients, staff-assisted, or self-dialysis;
    (v) Diabetic patients; and
    (vi) Patients isolated because of contagious disease.
    (2) The facility also must--
    (i) Submit documentation on costs of nursing personnel (registered 
nurses, licensed practical nurses, technicians, and aides) incurred 
during the most recently completed fiscal year cost report showing--
    (A) Amount each employee was paid;
    (B) Number of personnel;
    (C) Amount of time spent in the dialysis unit; and
    (D) Staff-to-patient ratio based on total hours, with an analysis of 
productive and nonproductive hours.
    (ii) Submit documentation on supply costs incurred during the most 
recently completed fiscal or calendar year cost report showing--
    (A) By modality, a complete list of supplies used routinely in a 
dialysis treatment;
    (B) The make and model number of each dialyzer and its component 
cost; and
    (C) That supplies are prudently purchased (for example, that bulk 
discounts are used when available).
    (iii) Submit documentation on overhead costs incurred during the 
most recently completed fiscal or calendar year cost reporting year 
showing--
    (A) The basis of the higher overhead costs;
    (B) The impact on the specific cost components; and
    (C) The effect on per treatment costs.

[62 FR 43668, Aug. 15, 1997, as amended at 70 FR 70331, Nov. 21, 2005]



Sec.  413.186  Payment exception: Self-dialysis training costs 
in pediatric facilities.

    (a) Qualification. To qualify for an exception to the prospective 
payment rate based on self-dialysis training costs, the pediatric ESRD 
facility must establish that it incurs per treatment costs for 
furnishing self-dialysis and home dialysis training that exceed the

[[Page 955]]

facility's payment rate for the training sessions.
    (b) Justification. To justify its exception request, a facility 
must--
    (1) Separately identify those elements contributing to its costs in 
excess of the composite training rate; and
    (2) Demonstrate that its per treatment costs are reasonable and 
allowable.
    (c) Criteria for determining proper cost reporting. CMS considers 
the pediatric ESRD facility's total costs, cost finding and 
apportionment, including its allocation of costs, to determine if costs 
are properly reported by treatment modality.
    (d) Limitation of exception requests. Exception requests for a 
higher training rate are limited to those cost components relating to 
training such as technical staff, medical supplies, and the special 
costs of education (manuals and education materials). These requests may 
include overhead and other indirect costs to the extent that these costs 
are directly attributable to the additional training costs.
    (e) Documentation. The pediatric ESRD facility must provide the 
following information to support its exception request:
    (1) A copy of the facility's training program.
    (2) Computation of the facility's cost per treatment for maintenance 
sessions and training sessions including an explanation of the cost 
difference between the two modalities.
    (3) Class size and patients' training schedules.
    (4) Number of training sessions required, by treatment modality, to 
train patients.
    (5) Number of patients trained for the current year and the prior 2 
years on a monthly basis.
    (6) Projection for the next 12 months of future training candidates.
    (7) The number and qualifications of staff at training sessions.
    (f) Accelerated training exception. (1) A pediatric ESRD facility 
may bill Medicare for a dialysis training session only when a patient 
receives a dialysis treatment (normally 3 times a week for 
hemodialysis). Continuous cycling peritoneal dialysis (CCPD) and 
continuous ambulatory peritoneal dialysis (CAPD) are daily treatment 
modalities; ESRD facilities are paid the equivalent of three 
hemodialysis treatments for each week that CCPD and CAPD treatments are 
provided.
    (2) If a pediatric ESRD facility elects to train all its patients 
using a particular treatment modality more often than during each 
dialysis treatment and, as a result, the number of billable training 
dialysis sessions is less than the number of actual training sessions, 
the facility may request a composite rate exception, limited to the 
lesser of the--
    (i) Facility's projected training cost per treatment; or
    (ii) Cost per treatment the facility receives in training a patient 
if it had trained patients only during a dialysis treatment, that is, 
three times per week.
    (3) An ESRD facility may bill a maximum of 25 training sessions per 
patient for hemodialysis training and 15 sessions for CCPD and CAPD 
training.
    (4) In computing the payment amount under an accelerated training 
exception, CMS uses a minimum number of training sessions per patient 
(15 for hemodialysis and 5 for CAPD and CCPD) when the facility actually 
provides fewer than the minimum number of training sessions.
    (5) To justify an accelerated training exception request, an ESRD 
facility must document that a significant number of training sessions 
for a particular modality are provided during a shorter but more 
condensed period.
    (6) The facility must submit with the exception request a list of 
patients, by modality, trained during the most recent cost report 
period. The list must include each beneficiary's--
    (i) Name;
    (ii) Age; and
    (iii) Training status (completed, not completed, being retrained, or 
in the process of being trained).
    (7) The total treatments from the patient list must be the same as 
the total treatments reported on the cost report filed with the request.

[70 FR 70331, Nov. 21, 2005]



Sec.  413.194  Appeals.

    (a) Appeals under section 1878 of the Act. (1) A facility that 
disputes the

[[Page 956]]

amount of its allowable Medicare bad debts reimbursed by CMS under Sec.  
413.89(h)(3) may request review by the contractor or the Provider 
Reimbursement Review Board (PRRB) in accordance with subpart R to part 
405 of this chapter.
    (2) A facility must request and obtain a final agency decision prior 
to seeking judicial review of a dispute regarding the amount of 
allowable Medicare bad debts.
    (b) Other appeals. (1) A facility that has requested higher payment 
per treatment in accordance with Sec.  413.180 may request review from 
the contractor or the PRRB if CMS has denied the request in whole or in 
part. In such a case, the procedure in subpart R of part 405 of this 
chapter is followed to the extent that it is applicable.
    (2) The PRRB has the authority to review the action taken by CMS on 
the facility's requests. However, the PRRB's decision is subject to 
review by the Administrator under Sec.  405.1875 of this chapter.
    (3) A facility must request and obtain a final agency decision, in 
accordance with paragraph (b)(1) of this section, prior to seeking 
judicial review of the denial, in whole or in part, of the exception 
request.
    (c) Procedure. (1) The facility must request review within 180 days 
of the date of the decision on which review is sought.
    (2) The facility may not submit to the reviewing entity, whether it 
is the contractor or the PRRB, any additional information or cost data 
that had not been submitted to CMS at the time CMS evaluated the 
exception request.
    (d) Determining amount in controversy. For purposes of determining 
PRRB jurisdiction under subpart R of part 405 of this chapter for the 
appeals described in paragraph (b) of this section--
    (1) The amount in controversy per treatment is determined by 
subtracting the amount of program payment from the amount the facility 
requested under Sec.  413.180; and
    (2) The total amount in controversy is calculated by multiplying the 
amount in controversy per treatment by the projected number of 
treatments for the exception request period.

[62 FR 43668, Aug. 15, 1997, as amended at 81 FR 77965, Nov. 4, 2016]



Sec.  413.195  Limitation on Review.

    Administrative or judicial review under section 1869 of the Act, 
section 1878 of the Act, or otherwise of the following is prohibited: 
The determination of payment amounts under section 1881(b)(14)(A) of the 
Act, the establishment of an appropriate unit of payment under section 
1881(b)(14)(C) of the Act, the identification of renal dialysis services 
included in the bundled payment, the adjustments under section 
1881(b)(14)(D) of the Act, the application of the phase-in under section 
1881(b)(14)(E) of the Act, and the establishment of the market basket 
percentage increase factors under section 1881(b)(14)(F) of the Act.

[75 FR 49199, Aug. 12, 2010]



Sec.  413.196  Notification of changes in rate-setting methodologies 
and payment rates.

    (a) CMS or the facility's contractor notifies each facility of 
changes in its payment rate. This notice includes changes in individual 
facility payment rates resulting from corrections or revisions of 
particular geographic labor cost adjustment factors.
    (b) Changes in payment rates resulting from incorporation of updated 
cost data or general revisions of geographic labor cost adjustment 
factors are announced by notice published in the Federal Register 
without opportunity for prior comment. Revisions of the rate-setting 
methodology are published in the Federal Register in accordance with the 
Department's established rulemaking procedures.
    (c) Effective for items and services furnished on or after January 
1, 2011 and before January 1, 2012, CMS adjusts the composite rate 
portion of the basic case-mix adjusted composite payment system 
described in Sec.  413.220 by the ESRD bundled market basket percentage 
increase factor.
    (d) Effective for items and services furnished on or after January 
1, 2012, CMS updates on an annual basis the following:

[[Page 957]]

    (1) The per-treatment base rate and the composite rate portion of 
the basic case-mix adjusted composite payment system described in Sec.  
413.220 by the ESRD bundled market basket percentage increase factor 
minus a productivity adjustment factor.
    (2) The wage index using the most current hospital wage data.
    (3) The fixed dollar loss amount as defined in Sec.  413.237 of this 
part to ensure that outlier payments continue to be 1.0 percent of total 
payments to ESRD facilities.

[62 FR 43668, Aug. 15, 1997, as amended at 75 FR 49199, Aug. 12, 2010]



Sec.  413.198  Recordkeeping and cost reporting requirements 
for outpatient maintenance dialysis.

    (a) Purpose and Scope. This section implements section 
1881(b)(2)(B)(i) of the Act by specifying recordkeeping and cost 
reporting requirements for ESRD facilities under part 494 of this 
chapter. The records and reports will enable CMS to determine the costs 
incurred in furnishing outpatient maintenance dialysis as defined in 
Sec.  413.170(a).
    (b) Recordkeeping and reporting requirements. (1) Each facility must 
keep adequate records and submit the appropriate CMS-approved cost 
report in accordance with Sec. Sec.  413.20 and 413.24, which provide 
rules on financial data and reports, and adequate cost data and cost 
finding, respectively.
    (2) The cost reimbursement principles set forth in this part 
(beginning with Sec.  413.134, Depreciation, and excluding the 
principles listed in paragraph (b)(4) of this section), apply in the 
determination and reporting of the allowable cost incurred in furnishing 
outpatient maintenance dialysis treatments to patients dialyzing in the 
facility, or incurred by the facility in furnishing home dialysis 
service, supplies, and equipment.
    (3) Allowable cost is the reasonable cost related to dialysis 
treatments. Reasonable cost includes all necessary and proper expenses 
incurred by the facility in furnishing the dialysis treatments, such as 
administrative costs, maintenance costs, and premium payments for 
employee health and pension plans. It includes both direct and indirect 
costs and normal standby costs. Reasonable cost does not include costs 
that--
    (i) Are not related to patient care for outpatient maintenance 
dialysis;
    (ii) Are for services or items specifically not reimbursable under 
the program;
    (iii) Flow from the provision of luxury items or servicess (items or 
services substantially in excess of or more expensive than those 
generally considered necessary for the provision of needed health 
services); or
    (iv) Are found to be substantially out of line with other 
institutions in the same area that are similar in size, scope of 
services, utilization, and other relevant factors.
    (4) The following principles of this part do not apply in 
determining adjustments to allowable costs as reported by ESRD 
facilities:
    (i) Section 413.157, Return on equity capital of proprietary 
providers;
    (ii) Section 413.200, Reimbursement of OPAs and histocompatibility 
laboratories;
    (iii) Section 413.9, Cost related to patient care (except for the 
principles stated in paragraph (b)(3) of this section); and
    (iv) Sections 413.64, Payments to providers, and Sec. Sec.  413.13, 
413.30, 413.35, 413.40, 413.74, and Sec. Sec.  415.55 through 415.70, 
Sec.  415.162, and Sec.  415.164 of this chapter, Principles of 
reimbursement for services by hospital-based physicians.

[62 FR 43668, Aug. 15, 1997, as amended at 73 FR 20474, Apr. 15, 2008]



Sec.  413.200  Payment of independent organ procurement organizations 
and histocompatibility laboratories.

    (a) Principle. Covered services furnished after September 30, 1978 
by organ procurement organizations (OPOs) and histocompatibility 
laboratories in connection with kidney acquisition and transplantation 
will be reimbursed under the principles for determining reasonable cost 
contained in this part. Services furnished by freestanding OPOs and 
histocompatibility laboratories, that have an agreement with the 
Secretary in accordance with paragraph (c) of this section, will be 
reimbursed by making an interim payment to the transplant hospitals 
using

[[Page 958]]

these services and by making a retroactive adjustment, directly with the 
OPO or laboratory, based upon a cost report filed by the OPO or 
laboratory. (The reasonable costs of services furnished by hospital 
based OPOs or laboratories will be reimbursed in accordance with the 
principles contained in Sec. Sec.  413.60 and 413.64.)
    (b) Definitions. For purposes of this section:
    Freestanding refers to an OPO or a histocompatibility laboratory 
that is not--
    (1) Subject to the control of the hospital with respect to the 
hiring, firing, training, and paying of employees; and
    (2) Considered as a department of the hospital for insurance 
purposes (including malpractice insurance, general liability insurance, 
worker's compensation insurance, and employee retirement insurance).
    Histocompatibility laboratory means a laboratory meeting the 
standards and providing the services for kidneys or other organs set 
forth in Sec.  413.2171(d) of this chapter.
    OPO means an organization defined in Sec.  486.302 of this chapter.
    (c) Agreements with independent OPOs and laboratories. (1) Any 
freestanding OPO or histocompatibility laboratory that wishes to have 
the cost of its pretransplant services reimbursed under the Medicare 
program must file an agreement with CMS under which the OPO or 
laboratory agrees--
    (i) To file a cost report in accordance with Sec.  413.24(f) within 
5 months after the end of each fiscal year;
    (ii) To permit CMS to designate an contractor to determine the 
interim reimbursement rate payable to the transplant hospitals for 
services provided by the OPO or laboratory and to make a determination 
of reasonable cost based upon the cost report filed by the OPO or 
laboratory;
    (iii) To provide such budget or cost projection information as may 
be required to establish an initial interim reimbursement rate;
    (iv) To pay to CMS amounts that have been paid by CMS to transplant 
hospitals and that are determined to be in excess of the reasonable cost 
of the services provided by the OPO or laboratory; and
    (v) Not to charge any individual for items or services for which 
that individual is entitled to have payment made under section 1861 of 
the Act.
    (2) The initial cost report due from an OPO or laboratory is for its 
first fiscal year during any portion of which it had an agreement with 
the Secretary under paragraphs (c) (1) and (2) of this section. The 
initial cost report covers only the period covered by the agreement.
    (d) Interim reimbursement. (1) Hospitals eligible to receive 
Medicare reimbursement for renal transplantation will be paid for the 
pretransplantation services of a freestanding OPO or histocompatibility 
laboratory that has an agreement with the Secretary under paragraph (c) 
of this section, on the basis of an interim rate established by an 
contractor for that OPO or laboratory.
    (2) The interim rate will be based on the average cost per service 
incurred by an OPO or laboratory, during its previous fiscal year, 
associated with procuring a kidney for transplantation. This interim 
rate may be adjusted if necessary for anticipated cost changes. If there 
is not adequate cost data to determine the initial interim rate, it will 
be determined according to the OPO's or laboratory's estimate of its 
projected costs for the fiscal year.
    (3) Payments made on the basis of the interim rate will be 
reconciled directly with the OPO or laboratory after the close of its 
fiscal year, in accordance with paragraph (e) of this section.
    (4) Information on the interim rate for all freestanding OPOs and 
histocompatibility laboratories shall be disseminated to all transplant 
hospitals and contractors.
    (e) Retroactive adjustment--(1) Cost reports. Information provided 
in cost reports by freestanding OPOs and histocompatibility laboratories 
must meet the requirements for cost data and cost finding specified in 
paragraphs (a) through (e) of Sec.  413.24. These cost reports must 
provide a complete accounting of the cost incurred by the agency or 
laboratory in providing covered services, the total number of Medicare 
beneficiaries who received those services, and any other data necessary 
to

[[Page 959]]

enable the contractor to make a determination of the reasonable cost of 
covered services provided to Medicare beneficiaries.
    (2) Audit and adjustment. A cost report submitted by a freestanding 
OPO or histocompatibility laboratory will be reviewed by the contractor 
and a new interim reimbursement rate for the succeeding fiscal year will 
be established based upon this review. A retroactive adjustment in the 
amount paid under the interim rate will be made in accordance with Sec.  
413.64(f). If the determination of reasonable cost reveals an 
overpayment or underpayment resulting from the interim reimbursement 
rate paid to transplant hospitals, a lump sum adjustment will be made 
directly between that contractor and the OPO or laboratory.
    (f) For services furnished on or after April 1, 1988, no payment may 
be made for services furnished by an OPO that does not meet the 
requirements of part 486, subpart G of this chapter.
    (g) Appeals. Any OPO or histocompatibility laboratory that disagrees 
with a contractor's cost determination under this section is entitled to 
an contractor hearing, in accordance with the procedures contained in 
Sec. Sec.  405.1811 through 405.1833, if the amount in controversy is 
$1,000 or more.

[62 FR 43668, Aug. 15, 1997, as amended at 71 FR 31046, May 31, 2006; 81 
FR 57272, Aug. 22, 2016]



Sec.  413.202  Organ procurement organization (OPO) cost for kidneys 
sent to foreign countries or transplanted in patients other than 
Medicare beneficiaries.

    An OPO's total costs for all kidneys is reduced by the costs 
associated with procuring kidneys sent to foreign transplant centers or 
transplanted in patients other than Medicare beneficiaries. OPOs, as 
defined in Sec.  486.302 of this chapter, must separate costs for 
procuring kidneys that are sent to foreign transplant centers and 
kidneys transplanted in patients other than Medicare beneficiaries from 
Medicare allowable costs prior to final settlement by the Medicare 
fiscal contractors. Medicare costs are based on the ratio of the number 
of usable kidneys transplanted into Medicare beneficiaries to the total 
number of usable kidneys applied to reasonable costs. Certain long-
standing arrangements that existed before March 3, 1988 (for example, an 
OPO that procures kidneys at a military transplant hospital for 
transplant at that hospital), will be deemed to be Medicare kidneys for 
cost reporting statistical purposes. The OPO must submit a request to 
the contractor for review and approval of these arrangements.

[62 FR 43668, Aug. 15, 1997, as amended at 71 FR 31046, May 31, 2006]



Sec.  413.203  Transplant center costs for organs sent to foreign countries 
or transplanted in patients other than Medicare beneficiaries.

    (a) A transplant center's total costs for all organs is reduced by 
the costs associated with procuring organs sent to foreign transplant 
centers or transplanted in patients other than Medicare beneficiaries. 
Organs are defined in Sec.  486.302 (only covered organs will be paid 
for on a reasonable cost basis).
    (b) Transplant center hospitals must separate costs for procuring 
organs that are sent to foreign transplant centers and organs 
transplanted in patients other than Medicare beneficiaries from Medicare 
allowable costs prior to final cost settlement by the Medicare fiscal 
contractors.
    (c) Medicare costs are based on the ratio of the number of usable 
organs transplanted into Medicare beneficiaries to the total number of 
usable organs applied to reasonable costs.



Sec.  413.210  Conditions for payment under the end-stage renal disease (ESRD) 
prospective payment system.

    Except as noted in Sec.  413.174(f), items and services furnished on 
or after January 1, 2011, under section 1881(b)(14)(A) of the Act and as 
identified in Sec.  413.217 of this part, are paid under the ESRD 
prospective payment system described in Sec.  413.215 through Sec.  
413.235 of this part.
    (a) Qualifications for payment. To qualify for payment, ESRD 
facilities must meet the conditions for coverage in part 494 of this 
chapter.

[[Page 960]]

    (b) Payment for items and services. CMS will not pay any entity or 
supplier other than the ESRD facility for covered items and services 
furnished to a Medicare beneficiary. The ESRD facility must furnish all 
covered items and services defined in Sec.  413.217 of this part either 
directly or under arrangements.

[75 FR 49199, Aug. 12, 2010]



Sec.  413.215  Basis of payment.

    (a) Except as otherwise provided under Sec.  413.235 or Sec.  
413.174(f) of this part, effective January 1, 2011, ESRD facilities 
receive a predetermined per treatment payment amount described in Sec.  
413.230 of this part, for renal dialysis services, specified under 
section 1881(b)(14) of the Act and as defined in Sec.  413.217 of this 
part, furnished to Medicare Part B fee-for-service beneficiaries.
    (b) In addition to the per-treatment payment amount, as described in 
paragraph (a) of this section, the ESRD facility may receive payment for 
bad debts of Medicare beneficiaries as specified in Sec.  413.89(h)(3).

[75 FR 49200, Aug. 12, 2010, as amended at 81 FR 77965, Nov. 4, 2016]



Sec.  413.217  Items and services included in the ESRD prospective 
payment system.

    The following items and services are included in the ESRD 
prospective payment system effective January 1, 2011:
    (a) Renal dialysis services as defined in Sec.  413.171; and
    (b) Home dialysis services, support, and equipment as identified in 
Sec.  410.52 of this chapter.

[75 FR 49200, Aug. 12, 2010]



Sec.  413.220  Methodology for calculating the per-treatment base rate 
under the ESRD prospective payment system effective January 1, 2011.

    (a) Data sources. The methodology for determining the per treatment 
base rate under the ESRD prospective payment system utilized:
    (1) Medicare data available to estimate the average cost and 
payments for renal dialysis services.
    (2) ESRD facility cost report data capturing the average cost per 
treatment.
    (3) The lowest per patient utilization calendar year as identified 
from Medicare claims is calendar year 2007.
    (4) Wage index values used to adjust for geographic wage levels 
described in Sec.  413.231 of this part.
    (5) An adjustment factor to account for the most recent estimate of 
increases in the prices of an appropriate market basket of goods and 
services provided by ESRD facilities.
    (b) Determining the per treatment base rate for calendar year 2011. 
Except as noted in Sec.  413.174(f), the ESRD prospective payment system 
combines payments for the composite rate items and services as defined 
in Sec.  413.171 of this part and the items and services that, prior to 
January 1, 2011, were separately billable items and services, as defined 
in Sec.  413.171 of this part, into a single per treatment base rate 
developed from 2007 claims data. The steps to calculating the per-
treatment base rate for 2011 are as follows:
    (1) Per patient utilization in CY 2007, 2008, or 2009. CMS removes 
the effects of enrollment and price growth from total expenditures for 
2007, 2008 or 2009 to determine the year with the lowest per patient 
utilization.
    (2) Update of per treatment base rate to 2011. CMS updates the per-
treatment base rate under the ESRD prospective payment system in order 
to reflect estimated per treatment costs in 2011.
    (3) Standardization. CMS applies a reduction factor to the per 
treatment base rate to reflect estimated increases resulting from the 
facility-level and patient-level adjustments applicable to the case as 
described in Sec.  413.231 through Sec.  413.235 of this part.
    (4) Outlier percentage. CMS reduces the per treatment base rate by 1 
percent to account for the proportion of the estimated total payments 
under the ESRD prospective payment system that are outlier payments as 
described in Sec.  413.237 of this part.
    (5) Budget neutrality. CMS adjusts the per treatment base rate so 
that the aggregate payments in 2011 are estimated to be 98 percent of 
the amount that would have been made under title XVIII of the Social 
Security Act if the

[[Page 961]]

ESRD prospective payment system described in section 1881(b)(14) of the 
Act were not implemented.
    (6) First 4 Years of the ESRD prospective payment system. During the 
first 4 years of ESRD prospective payment system (January 1, 2011 to 
December 31, 2013), CMS adjusts the per-treatment base rate in 
accordance with Sec.  413.239(d).

[75 FR 49200, Aug. 12, 2010]



Sec.  413.230  Determining the per treatment payment amount.

    The per-treatment payment amount is the sum of:
    (a) The per treatment base rate established in Sec.  413.220, 
adjusted for wages as described in Sec.  413.231, and adjusted for 
facility-level and patient-level characteristics described in Sec. Sec.  
413.232 and 413.235 of this part;
    (b) Any outlier payment under Sec.  413.237;
    (c) Any training adjustment add-on under Sec.  413.235(c);
    (d) Any transitional drug add-on payment adjustment under Sec.  
413.234(c); and
    (e) Any transitional add-on payment adjustment for new and 
innovative equipment and supplies under Sec.  413.236(d).

[75 FR 49200, Aug. 12, 2010, as amended at 84 FR 60803, Nov. 8, 2019]



Sec.  413.231  Adjustment for wages.

    (a) CMS adjusts the labor-related portion of the base rate to 
account for geographic differences in the area wage levels using an 
appropriate wage index (established by CMS) which reflects the relative 
level of hospital wages and wage-related costs in the geographic area in 
which the ESRD facility is located.
    (b) The application of the wage index is made on the basis of the 
location of the ESRD facility in an urban or rural area as defined in 
this paragraph (b).
    (1) Urban area means a Metropolitan Statistical Area or a 
Metropolitan division (in the case where a Metropolitan Statistical Area 
is divided into Metropolitan Divisions), as defined by OMB.
    (2) Rural area means any area outside an urban area.

[75 FR 49200, Aug. 12, 2010]



Sec.  413.232  Low-volume adjustment.

    (a) CMS adjusts the base rate for low-volume ESRD facilities, as 
defined in paragraph (b) of this section.
    (b) A low-volume facility is an ESRD facility that, as determined 
based on the documentation submitted pursuant to paragraph (g) of this 
section:
    (1) Furnished less than 4,000 treatments in each of the 3 cost 
reporting years (based on as-filed or final settled 12-consecutive month 
cost reports, whichever is most recent, except as specified in paragraph 
(g)(4) of this section) preceding the payment year; and
    (2) Has not opened, closed, or received a new provider number due to 
a change in ownership (except where the change in ownership results in a 
change in facility type) in the 3 cost reporting years (based on as-
filed or final settled 12-consecutive month cost reports, whichever is 
most recent) preceding the payment year.
    (c) For the purpose of determining the number of treatments under 
paragraph (b)(1) of this section, the number of treatments considered 
furnished by the ESRD facility shall equal the aggregate number of 
treatments furnished by the ESRD facility and the number of treatments 
furnished by other ESRD facilities that are both:
    (1) Under common ownership with, and
    (2) Five (5) road miles or less from the ESRD facility in question.
    (d) Common ownership means the same individual, individuals, entity, 
or entities, directly, or indirectly, own 5 percent or more of each ESRD 
facility.
    (e) Except as provided in paragraph (f) of this section and unless 
extraordinary circumstances justify an exception, to receive the low-
volume adjustment an ESRD facility must provide an attestation 
statement, by November 1st of each year preceding the payment year, to 
its Medicare Administrative Contractor (MAC) that the facility meets all 
the criteria established in this section, except that:
    (1) For payment year 2012, the attestation must be provided by 
January 3, 2012;
    (2) For payment year 2015, the attestation must be provided by 
December 31, 2014;

[[Page 962]]

    (3) For payment year 2016, the attestation must be provided by 
December 31, 2015; and
    (4) For payment year 2021, the attestation must be provided by 
December 31, 2020.
    (f) The low-volume adjustment applies only for dialysis treatments 
provided to adults (18 years or older).
    (g) To receive the low-volume adjustment, an ESRD facility must 
include in their attestation provided pursuant to paragraph (e) of this 
section a statement that the ESRD facility meets the definition of a 
low-volume facility in paragraph (b) of this section. To determine 
eligibility for the low-volume adjustment, the MAC on behalf of CMS 
relies upon as filed or final settled 12-consecutive month cost reports, 
except as specified in paragraph (g)(4) of this section, for the 3 cost 
reporting years preceding the payment year to verify the number of 
treatments, except that:
    (1) In the case of a hospital-based ESRD facility as defined in 
Sec.  413.174(c), the MAC relies upon the attestation submitted pursuant 
to paragraph (e) of this section and may consider other supporting data 
in addition to the total treatments reported in each of the 12-
consecutive month cost reports for the 3 cost reporting years preceding 
the payment year to verify the number of treatments that were furnished 
by the individual hospital-based ESRD facility seeking the adjustment; 
and
    (2) In the case of an ESRD facility that has undergone a change of 
ownership wherein the ESRD facility's Medicare billing number does not 
change or changes due to a reclassification of facility type, the MAC 
relies upon the attestation and if the change results in two non-
standard cost reporting periods (less than or greater than 12 
consecutive months) does one of the following for the 3 cost reporting 
years preceding the payment year to verify the number of treatments:
    (i) Combines the two non-standard cost reporting periods of less 
than 12 months to equal a full 12-consecutive month period; and/or
    (ii) Combines the two non-standard cost reporting periods that in 
combination may exceed 12-consecutive months and prorates the data to 
equal a full 12-consecutive month period.
    (3) In the case of an ESRD facility that has changed its cost 
reporting period, the MAC relies on the attestation and does one or both 
of the following for the 3-cost reporting years preceding the payment 
year to verify the number of treatments:
    (i) Combines the two non-standard cost reporting periods of less 
than 12 months to equal a full 12-consecutive month period; and/or
    (ii) Combines the two non-standard cost reporting periods that in 
combination may exceed 12-consecutive months and prorates the data to 
equal a full 12-consecutive month period.
    (4) For payment years 2021, 2022, and 2023, the attestation 
specified in paragraph (e)(4) of this section must indicate that the 
ESRD facility meets all the criteria specified in this section, except 
that, for a facility that would not otherwise meet the number of 
treatments criterion specified in paragraph (b)(1) of this section 
because of the COVID-19 PHE, the facility may attest that it furnished 
less than 2,000 treatments in any six months during the cost-reporting 
period ending in 2020. For any facility that so attests--
    (i) The facility must also attest that it furnished treatments equal 
to or in excess of 4,000 in the payment year due to temporary patient 
shifting as a result of the COVID-19 PHE; and
    (ii) The MAC relies on the attestation and multiplies the total 
number of treatments for the 6-month period by 2.
    (h) When an ESRD facility provides an attestation in accordance with 
paragraph (e) of this section, for the third eligibility year, the MAC 
verifies the as-filed cost report and takes one of the following 
actions:
    (1) If the MAC determines an ESRD facility meets the definition of a 
low-volume facility as described in paragraph (b) of this section, CMS 
adjusts the low-volume facility's base rate for the entire payment year; 
or
    (2) If the MAC determines an ESRD facility does not meet the 
definition of a low-volume facility as described in paragraph (b) of 
this section, the MAC

[[Page 963]]

reprocesses claims and recoups low-volume adjustments paid during the 
payment year.

[75 FR 49200, Aug. 12, 2010, as amended at 76 FR 70314, Nov. 10, 2011; 
79 FR 66262, Nov. 6, 2014; 80 FR 69076, Nov. 6, 2015; 83 FR 57069, Nov. 
23, 2018; 85 FR 71485, Nov. 9, 2020]



Sec.  413.233  Rural facility adjustment.

    CMS adjusts the base rate for facilities in rural areas, as defined 
in Sec.  413.231(b)(2).

[80 FR 69077, Nov. 6, 2015]



Sec.  413.234  Drug designation process.

    (a) Definitions. For purposes of this section, the following 
definitions apply:
    ESRD PPS functional category. A distinct grouping of drugs or 
biological products, as determined by CMS, whose end action effect is 
the treatment or management of a condition or conditions associated with 
ESRD.
    New renal dialysis drug or biological product. An injectable, 
intravenous, oral or other form or route of administration drug or 
biological product that is used to treat or manage a condition(s) 
associated with ESRD. It must be approved by the Food and Drug 
Administration (FDA) on or after January 1, 2020, under section 505 of 
the Federal Food, Drug, and Cosmetic Act or section 351 of the Public 
Health Service Act, commercially available, have an HCPCS application 
submitted in accordance with the official Level II HCPCS coding 
procedures, and designated by CMS as a renal dialysis service under 
Sec.  413.171. Oral-only drugs are excluded until January 1, 2025.
    Oral-only drug. A drug or biological product with no injectable 
equivalent or other form of administration other than an oral form.
    (b) Drug designation process. New renal dialysis drugs or biological 
products are included in the ESRD PPS bundled payment using the 
following drug designation process:
    (1) If the new renal dialysis drug or biological product is used to 
treat or manage a condition for which there is an ESRD PPS functional 
category, the new renal dialysis drug or biological product is 
considered included in the ESRD PPS bundled payment and the following 
steps occur:
    (i) The new renal dialysis drug or biological product is added to an 
existing ESRD PPS functional category.
    (ii) Except as provided in paragraph (e) of this section, the new 
renal dialysis drug or biological product is paid for using the 
transitional drug add-on payment adjustment described in paragraph 
(c)(1) of this section.
    (2) If the new renal dialysis drug or biological product is used to 
treat or manage a condition for which there is not an ESRD PPS 
functional category, the new renal dialysis drug or biological product 
is not considered included in the ESRD PPS bundled payment and the 
following steps occur:
    (i) An existing ESRD PPS functional category is revised or a new 
ESRD PPS functional category is added for the condition that the new 
renal dialysis drug or biological product is used to treat or manage;
    (ii) The new renal dialysis drug or biological product is paid for 
using the transitional drug add-on payment adjustment described in 
paragraph (c)(2) of this section; and
    (iii) The new renal dialysis drug or biological product is added to 
the ESRD PPS bundled payment following payment of the transitional drug 
add-on payment adjustment.
    (c) Transitional drug add-on payment adjustment. A new renal 
dialysis drug or biological product is paid for using a transitional 
drug add-on payment adjustment, which is based on 100 percent of average 
sales price (ASP). If ASP is not available then the transitional drug 
add-on payment adjustment is based on 100 percent of wholesale 
acquisition cost (WAC) and, when WAC is not available, the payment is 
based on the drug manufacturer's invoice. Notwithstanding the provisions 
in paragraphs (c)(1) and (2) of this section, if CMS does not receive a 
full calendar quarter of ASP data for a new renal dialysis drug or 
biological product within 30 days of the last day of the 3rd calendar 
quarter after we begin applying the transitional drug add-on payment 
adjustment for the product, CMS will no longer apply the transitional 
drug add-on payment adjustment for that

[[Page 964]]

product beginning no later than 2-calendar quarters after we determine a 
full calendar quarter of ASP data is not available. If CMS stops 
receiving the latest full calendar quarter of ASP data for a new renal 
dialysis drug or biological product during the applicable time period 
specified in paragraph (c)(1) or (2) of this section, CMS will no longer 
apply the transitional drug add-on payment adjustment for the product 
beginning no later than 2-calendar quarters after CMS determines that 
the latest full calendar quarter of ASP data is not available.
    (1) A new renal dialysis drug or biological product that is 
considered included in the ESRD PPS base rate is paid the transitional 
drug add-on payment adjustment for 2 years.
    (i) Following payment of the transitional drug add-on payment 
adjustment the ESRD PPS base rate will not be modified.
    (ii) [Reserved]
    (2) A new renal dialysis drug or biological product that is not 
considered included in the ESRD PPS base rate is paid the transitional 
drug add-on payment adjustment until sufficient claims data for rate 
setting analysis for the new renal dialysis drug or biological product 
is available, but not for less than 2 years.
    (i) Following payment of the transitional drug add-on payment 
adjustment the ESRD PPS base rate will be modified, if appropriate, to 
account for the new renal dialysis drug or biological in the ESRD PPS 
bundled payment.
    (ii) [Reserved]
    (d) Oral-only drug determination. An oral-only drug is no longer 
considered oral-only if an injectable or other form of administration of 
the oral-only drug is approved by the Food and Drug Administration.
    (e) Exclusion criteria for the transitional drug add-on payment 
adjustment. A new renal dialysis drug used to treat or manage a 
condition for which there is an ESRD PPS functional category is not 
eligible for payment using the transitional drug add-on payment 
adjustment described in paragraph (c)(1) of this section if the drug is 
approved by FDA under section 505(j) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) or the new drug application (NDA) for the drug 
is classified by FDA as Type 3, 5, 7, or 8, Type 3 in combination with 
Type 2 or Type 4, or Type 5 in combination with Type 2, or Type 9 when 
the parent NDA is a Type 3, 5, 7 or 8 as described in paragraphs (e)(1) 
through (7) of this section, respectively:
    (1) Type 3 NDA--New Dosage Form.
    (i) A Type 3 NDA is for a new dosage form of an active ingredient 
that has been approved or marketed in the United States (U.S.) by the 
same or another applicant but in a different dosage form. The indication 
for the drug product does not need to be the same as that of the already 
marketed drug product. Once a new dosage form has been approved for an 
active ingredient, subsequent applications for the same dosage form and 
active ingredient should be classified as a Type 5 NDA, as described in 
paragraph (e)(2) of this section.
    (ii) [Reserved]
    (2) Type 5 NDA--New Formulation or Other Differences.
    (i) A Type 5 NDA is for a product, other than a new dosage form, 
that differs from a product already approved or marketed in the U.S. 
because of one of the following:
    (A) The product involves changes in inactive ingredients that 
require either bioequivalence studies or clinical studies for approval 
and is submitted as an original NDA rather than as a supplement by the 
applicant of the approved product;
    (B) The product is a duplicate of a drug product by another 
applicant (same active ingredient, same dosage form, same or different 
indication, or same combination), and
    (1) Requires bioequivalence testing (including bioequivalence 
studies with clinical endpoints), but is not eligible for submission as 
a section 505(j) of the FD&C Act application; or
    (2) Requires safety or effectiveness testing because of novel 
inactive ingredients; or
    (3) Requires full safety or effectiveness testing because it is:
    (i) Subject to exclusivity held by another applicant, or
    (ii) A product of biotechnology and its safety and/or effectiveness 
are not

[[Page 965]]

assessable through bioequivalence testing, or
    (iii) A crude natural product, or
    (iv) Ineligible for submission under section 505(j) of the FD&C Act 
because it differs in bioavailability (for example, products with 
different release patterns); or
    (4) The applicant has a right of reference to the application.
    (C) The product contains an active ingredient or active moiety that 
has been previously approved or marketed in the U.S. only as part of a 
combination. This applies to active ingredients previously approved or 
marketed as part of a physical or chemical combination, or as part of a 
mixture derived from recombinant deoxyribonucleic acid technology or 
natural sources.
    (D) The product is a combination product that differs from a 
previously marketed combination by the removal of one or more active 
ingredients or by substitution of a new ester or salt or other 
noncovalent derivative of an active ingredient for one or more of the 
active ingredients. In the latter case, the NDA would be classified as a 
combination of a Type 2 NDA as described in paragraph (e)(5)(i) of this 
section, with a Type 5 NDA as described in paragraph (e)(2) of this 
section.
    (E) The product contains a different strength of one or more active 
ingredients in a previously approved or marketed combination. A Type 5 
NDA, as described in paragraph (e)(2) of this section, would generally 
be submitted by an applicant other than the holder of the approved 
application for the approved product. A similar change in an approved 
product by the applicant of the approved product would usually be 
submitted as a supplemental application.
    (F) The product differs in bioavailability (for example, 
superbioavailable or different controlled-release pattern) and, 
therefore, is ineligible for submission as an abbreviated new drug 
application (ANDA) under section 505(j) of the FD&C Act.
    (G) The product involves a new plastic container that requires 
safety studies beyond limited confirmatory testing (see 21 CFR 310.509, 
Parenteral drug products in plastic containers).
    (ii) [Reserved]
    (3) Type 7 NDA--Previously Marketed But Without an Approved NDA.
    (i) A Type 7 NDA is for a drug product that contains an active 
moiety that has not been previously approved in an application, but has 
been marketed in the U.S. This classification applies only to the first 
NDA approved for a drug product containing this (these) active 
moiety(ies). Type 7 NDAs include, but are not limited to:
    (A) The first post-1962 application for an active moiety marketed 
prior to 1938.
    (B) The first application for an active moiety first marketed 
between 1938 and 1962 that is identical, related or similar (IRS) to a 
drug covered by a Drug Efficacy Study Implementation notice. Regulation 
at 21 CFR 310.6(b)(1) states that an identical, related, or similar drug 
includes other brands, potencies, dosage forms, salts, and esters of the 
same drug moiety as well as any of drug moiety related in chemical 
structure or known pharmacological properties.
    (C) The first application for an IRS drug product first marketed 
after 1962.
    (D) The first application for an active moiety that was first 
marketed without an NDA after 1962.
    (ii) [Reserved]
    (4) Type 8 NDA--Prescription to Over-the-Counter (OTC).
    (i) A Type 8 NDA is for a drug product intended for OTC marketing 
that contains an active ingredient that has been approved previously or 
marketed in the U.S. only for dispensing by prescription (OTC switch). A 
Type 8 NDA may provide for a different dosing regimen, different 
strength, different dosage form, or different indication from the 
product approved previously for prescription sale.
    (ii) If the proposed OTC switch will apply to all indications, uses, 
and strengths of an approved prescription dosage form (leaving no 
prescription-only products of that particular dosage form on the 
market), the application holder should submit the change as a supplement 
to the approved application. If the applicant intends to switch only 
some indications, uses, or strengths of the dosage form to OTC status 
(while continuing to market

[[Page 966]]

other indications, uses, or strengths of the dosage form for 
prescription-only sale), the applicant should submit a new NDA for the 
OTC products, which would be classified as a Type 8 NDA.
    (5) Combination of Type 3 NDA. Type 3 NDA, as described in paragraph 
(e)(1) of this section, in combination with a Type 2 NDA, as described 
in paragraph (e)(5)(i) of this section, or in combination with a Type 4 
NDA, as described in paragraph (e)(5)(ii) of this section;
    (i) Type 2 NDA--New Active Ingredient.
    (A) A Type 2 NDA is for a drug product that contains a new active 
ingredient, but not a new molecular entity (NME). A new active 
ingredient includes those products whose active moiety has been 
previously approved or marketed in the U.S., but whose particular ester, 
salt, or noncovalent derivative of the unmodified parent molecule has 
not been approved by FDA or marketed in the U.S., either alone, or as 
part of a combination product. Similarly, if any ester, salt, or 
noncovalent derivative has been marketed first, the unmodified parent 
molecule would also be considered a new active ingredient, but not an 
NME. The indication for the drug product does not need to be the same as 
that of the already marketed product containing the same active moiety.
    (B) If the active ingredient is a single enantiomer and a racemic 
mixture containing that enantiomer has been previously approved by FDA 
or marketed in the U.S., or if the active ingredient is a racemic 
mixture containing an enantiomer that has been previously approved by 
FDA or marketed in the U.S., the NDA will be classified as a Type 2 NDA.
    (ii) Type 4 NDA--New Combination.
    (A) A Type 4 NDA is for a new drug-drug combination of two or more 
active ingredients. An application for a new drug-drug combination 
product may have more than one classification code if at least one 
component of the combination is an NME or a new active ingredient. The 
new product may be a physical or chemical (for example, covalent ester 
or noncovalent derivative) combination of two or more active moieties.
    (B) A new physical combination may be two or more active ingredients 
combined into a single dosage form, or two or more drugs packaged 
together with combined labeling. When at least one of the active 
moieties is classified as an NME, the NDA is classified as a combination 
of a Type 1 NDA, as described in paragraph (e)(5)(ii)(B)(1) of this 
section, with a Type 4 NDA, as described in paragraph (e)(5)(ii) of this 
section. When none of the active moieties is an NME, but at least one is 
a new active ingredient, the NDA is classified as a combination of a 
Type 2 NDA, as described in paragraph (e)(5)(i) of this section, with a 
Type 4 NDA, as described in paragraph (e)(5)(ii) of this section.
    (1) Type 1 NDA--New Molecular Entity.
    (i) A Type 1 NDA is for a drug product that contains an NME. An NME 
is an active ingredient that contains no active moiety that has been 
previously approved by FDA in an application submitted under section 505 
of the FD&C Act or has been previously marketed as a drug in the U.S. A 
pure enantiomer or a racemic mixture is an NME only when neither has 
been previously approved or marketed.
    (ii) An NDA for a drug product containing an active moiety that has 
been marketed as a drug in the U.S., but never approved in an 
application submitted under section 505 of the FD&C Act, would be 
considered a Type 7 NDA as described in paragraph (e)(3) of this 
section, not a Type 1 NDA.
    (iii) An NDA for a drug-drug combination product containing an 
active moiety that is an NME in combination with another active moiety 
that had already been approved by FDA would be classified as a new 
combination containing an NME (that is, Type 1,4 NDA, as described in 
paragraph (e)(5)(ii) of this section). For example, a drug-drug 
combination can include a fixed-combination drug product or a co-
packaged drug product with two or more active moieties.
    (iv) An active moiety in a radiopharmaceutical (or radioactive drug 
product) which has not been approved by the FDA or marketed in the U.S. 
is classified as an NME.

[[Page 967]]

    (v) In addition, if a change in isotopic form results in an active 
moiety that has never been approved by the FDA or marketed in the U.S., 
the active ingredient is classified as an NME.
    (C) An NDA for an active ingredient that is a chemical combination 
of two or more previously approved or marketed active moieties that are 
linked by an ester bond is classified as a combination of a Type 2 NDA 
as described in paragraph (e)(5)(i) of this section, with a Type 4 NDA 
as described in paragraph (e)(5)(ii) of this section, if the active 
moieties have not been previously marketed or approved as a physical 
combination. If the physical combination has been previously marketed or 
approved, however, such a product would no longer be considered a new 
combination and the NDA would thus be classified as a Type 2 NDA, as 
described in paragraph (e)(5)(i) of this section.
    (6) Combination of Type 5 NDA. Type 5 NDA, as described in paragraph 
(e)(2) of this section, in combination with a Type 2 NDA, as described 
in paragraph (e)(5)(i) of this section.
    (7) Type 9 NDA when the parent NDA is a Type 3, Type 5, Type 7, or a 
Type 8. A Type 9 NDA, as described in paragraph (e)(7)(i) of this 
section when the parent NDA is a Type 3 NDA as described in paragraph 
(e)(1) of this section or a Type 5 NDA as described in paragraph (e)(2) 
of this section or Type 7 NDA as described in paragraph (e)(3) of this 
section or a Type 8 NDA as described in paragraph (e)(4) of this 
section.
    (i) Type 9 NDA--New Indication or Claim, Drug Not to be Marketed 
under Type 9 NDA after Approval.
    (A) A Type 9 NDA is for a new indication or claim for a drug product 
that is currently being reviewed under a different NDA (the ``parent 
NDA''), and the applicant does not intend to market this drug product 
under the Type 9 NDA after approval. Generally, a Type 9 NDA is 
submitted as a separate NDA so as to be in compliance with the guidance 
for industry on Submitting Separate Marketing Applications and Clinical 
Data for Purposes of Assessing User Fees.
    (B) When the Type 9 NDA is submitted, it will be given the same NDA 
classification as the pending NDA. When one application is approved, the 
other will be reclassified as Type 9 regardless of whether it was the 
first or second NDA actually submitted. After the approval of a Type 9 
NDA, FDA will ``administratively close'' the Type 9 NDA and thereafter 
only accept submissions to the ``parent'' NDA.
    (ii) [Reserved]
    (f) Methodology for modifying the ESRD PPS base rate to account for 
the costs of calcimimetics in the ESRD PPS bundled payment. Beginning 
January 1, 2021, payment for calcimimetics is included in the ESRD PPS 
base rate using the following data sources and methodology:
    (1) The methodology specified in paragraph (f)(2) of this section 
for determining the average per treatment payment amount for 
calcimimetics that is added to the ESRD PPS base rate uses the following 
data sources:
    (i) Total units of oral and injectable calcimimetics and total 
number of paid hemodialysis-equivalent dialysis treatments furnished, as 
derived from Medicare ESRD facility claims, that is, the 837-
institutional form with bill type 072X, for the third and fourth 
quarters of calendar year 2018 and for the full calendar year 2019.
    (ii) The weighted average ASP based on the most recent 
determinations by CMS.
    (2) CMS uses the following methodology to calculate the average per 
treatment payment amount for calcimimetics that is added to the ESRD PPS 
base rate:
    (i) Determines utilization of oral and injectable calcimimetics by 
aggregating the total units of oral and injectable calcimimetics in 
paragraph (f)(1) of this section.
    (ii) Determines a price for each form of the drug by calculating 100 
percent of the values from the most recent calendar quarter ASP 
calculations available to the public for the oral and injectable 
calcimimetic.
    (iii) Calculates the total calcimimetic expenditure amount by 
multiplying the utilization of the oral and injectable calcimimetics 
determined in paragraph (f)(2)(i) of this section by their respective 
prices determined in paragraph (f)(2)(ii) of this section and adding the 
expenditure amount for both forms.

[[Page 968]]

    (iv) Calculates the average per treatment payment amount by dividing 
the total calcimimetic expenditure amount determined in paragraph 
(f)(2)(iii) of this section by the total number of paid hemodialysis-
equivalent dialysis treatments in the third and fourth quarter of 
calendar year 2018 and the full calendar year 2019.
    (v) Calculates the amount added to the ESRD PPS base rate by 
reducing the average per treatment payment amount determined in 
paragraph (f)(2)(iv) of this section by 1 percent to account for the 
outlier policy under Sec.  413.237.

[80 FR 69077, Nov. 6, 2015, as amended at 83 FR 57070, Nov. 14, 2018; 84 
FR 60803, Nov. 8, 2019; 85 FR 71485, Nov. 9, 2020]



Sec.  413.235  Patient-level adjustments.

    Adjustments to the per-treatment base rate may be made to account 
for variation in case-mix. These adjustments reflect patient 
characteristics that result in higher costs for ESRD facilities.
    (a) CMS adjusts the per treatment base rate for adults to account 
for patient age, body surface area, low body mass index, onset of 
dialysis (new patient), and co-morbidities, as specified by CMS.
    (b) CMS adjusts the per treatment base rate for pediatric patients 
in accordance with section 1881(b)(14) (D)(iv)(I) of the Act, to account 
for patient age and treatment modality.
    (c) CMS provides a wage-adjusted add-on per treatment adjustment for 
home and self-dialysis training.

[75 FR 49201, Aug. 12, 2010]



Sec.  413.236  Transitional add-on payment adjustment for new and innovative 
equipment and supplies.

    (a) Basis and definitions. (1) Effective January 1, 2020, this 
section establishes an add-on payment adjustment to support ESRD 
facilities in the uptake of new and innovative renal dialysis equipment 
and supplies under the ESRD prospective payment system under the 
authority of section 1881(b)(14)(D)(iv) of the Social Security Act.
    (2) For purposes of this section, the following definitions apply:
    Capital-related asset. Asset that an ESRD facility has an economic 
interest in through ownership (regardless of the manner in which it was 
acquired) and is subject to depreciation. Equipment obtained by the ESRD 
facility through operating leases are not considered capital-related 
assets.
    Depreciation. The amount that represents a portion of the capital-
related asset's cost and that is allocable to a period of operation.
    Home dialysis machines. Hemodialysis machines and peritoneal 
dialysis cyclers in their entirety (meaning that one new part of a 
machine does not make the entire capital-related asset new) that receive 
FDA marketing authorization for home use and when used in the home for a 
single patient.
    Particular calendar year. The year in which the payment adjustment 
specified in paragraph (d) of this section would take effect.
    Straight-line depreciation method. A method in accounting in which 
the annual allowance is determined by dividing the cost of the capital-
related asset by the years of useful life.
    Useful life. The estimated useful life of a capital-related asset is 
its expected useful life to the ESRD facility, not necessarily the 
inherent useful or physical life.
    (b) Eligibility criteria. CMS provides for a transitional add-on 
payment adjustment for new and innovative equipment and supplies (as 
specified in paragraph (d) of this section) to an ESRD facility for 
furnishing a covered equipment or supply only if the item:
    (1) Has been designated by CMS as a renal dialysis service under 
Sec.  413.171;
    (2) Is new, meaning within 3 years beginning on the date of the Food 
and Drug Administration (FDA) marketing authorization;
    (3) Is commercially available by January 1 of the particular 
calendar year, meaning the year in which the payment adjustment would 
take effect;
    (4) Has a complete Healthcare Common Procedure Coding System (HCPCS) 
Level II code application submitted, in accordance with the HCPCS Level 
II coding procedures on the CMS website, by the HCPCS Level II code

[[Page 969]]

application deadline for biannual Coding Cycle 2 for durable medical 
equipment, orthotics, prosthetics and supplies (DMEPOS) items and 
services as specified in the HCPCS Level II coding guidance on the CMS 
website prior to the particular calendar year;
    (5) Is innovative, meaning it meets the criteria specified in Sec.  
412.87(b)(1) of this chapter; and
    (6) Is not a capital-related asset, except for capital-related 
assets that are home dialysis machines.
    (c) Announcement of determinations and deadline for consideration of 
new renal dialysis equipment or supply applications. CMS will consider 
whether a new renal dialysis supply or equipment meets the eligibility 
criteria specified in paragraph (b) of this section and announce the 
results in the Federal Register as part of its annual updates and 
changes to the ESRD prospective payment system. CMS will only consider a 
complete application received by CMS by February 1 prior to the 
particular calendar year. FDA marketing authorization for the equipment 
or supply must occur by the HCPCS Level II code application deadline for 
biannual Coding Cycle 2 for DMEPOS items and services as specified in 
the HCPCS Level II coding guidance on the CMS website prior to the 
particular calendar year.
    (d) Transitional add-on payment adjustment for new and innovative 
equipment and supplies. A new and innovative renal dialysis equipment or 
supply will be paid for using a transitional add-on payment adjustment 
for new and innovative equipment and supplies based on 65 percent of the 
MAC-determined price, as specified in paragraph (e) of this section. For 
capital-related assets that are home dialysis machines, payment is based 
on 65 percent of the pre-adjusted per treatment amount, as specified in 
paragraph (f)(1)(ii) of this section.
    (1) The transitional add-on payment adjustment for new and 
innovative equipment and supplies is paid for 2-calendar years.
    (2) Following payment of the transitional add-on payment adjustment 
for new and innovative equipment and supplies, the ESRD PPS base rate 
will not be modified and the new and innovative renal dialysis equipment 
or supply will be an eligible outlier service as provided in Sec.  
413.237, except a capital-related asset that is a home dialysis machine 
will not be an eligible outlier service as provided in Sec.  413.237.
    (e) Pricing of new and innovative renal dialysis equipment and 
supplies. (1) The Medicare Administrative Contractors (MACs) on behalf 
of CMS will establish prices for new and innovative renal dialysis 
equipment and supplies that meet the eligibility criteria specified in 
paragraph (b) of this section using verifiable information from the 
following sources of information, if available:
    (i) The invoice amount, facility charges for the item, discounts, 
allowances, and rebates;
    (ii) The price established for the item by other MACs and the 
sources of information used to establish that price;
    (iii) Payment amounts determined by other payers and the information 
used to establish those payment amounts; and
    (iv) Charges and payment amounts required for other equipment and 
supplies that may be comparable or otherwise relevant.
    (2) [Reserved]
    (f) Pricing of new and innovative renal dialysis equipment and 
supplies that are capital-related assets that are home dialysis 
machines. (1) The MACs calculate a pre-adjusted per treatment amount, 
using the prices they establish under paragraph (e) of this section for 
a capital-related asset that is a home dialysis machine, as defined in 
paragraph (a)(2) of this section, as follows:
    (i) Calculate an annual allowance to determine the amount that 
represents the portion of the cost allocable to 1 year, using the 
straight-line depreciation method, by dividing the MAC-determined price 
by its useful life of 5 years.
    (ii) Calculate a per treatment amount for use in calculating the 
pre-adjusted per treatment amount by dividing the annual allowance, as 
determined in paragraph (f)(1)(i) of this section, by the expected 
number of treatments.
    (iii) Calculate a pre-adjusted per treatment amount to determine the

[[Page 970]]

amount that is adjusted by the 65 percent under paragraph (d) of this 
section, by subtracting the average per treatment offset amount (as 
determined using the data sources and methodology specified in 
paragraphs (f)(2) and (3) of this section, respectively, of this 
section) from the per treatment amount (as determined in paragraph 
(f)(1)(ii) of this section) to account for the costs already paid 
through the ESRD PPS base rate for current home dialysis machines that 
ESRD facilities already own.
    (2) The methodology specified in paragraph (f)(3) of this section 
for determining the average per treatment offset amount uses the 
following data sources:
    (i) Dialysis machine and equipment cost, total cost across all 
dialysis modalities, the number of hemodialysis-equivalent home dialysis 
treatment counts, and the number of hemodialysis-equivalent total 
treatment counts are obtained from renal facility cost reports (CMS form 
265-11) and hospital cost reports (CMS form 2552-10) using calendar 
years 2017-2019 cost reports.
    (A) Dialysis machine and equipment costs are obtained by summing 
lines 8.01 through 17.02 from Worksheet B, Column 4 for renal facility 
cost reports, and by summing lines 2 through 11 from Worksheet I-2 for 
hospital cost reports.
    (B) Total cost across all dialysis modalities are obtained by 
summing lines 8.01 through 17.02 from Worksheet C, Column 2 for renal 
facility cost reports, and by summing lines 1 through 10 from Worksheet 
I-4, Column 2 for the hospital cost reports.
    (C) Hemodialysis-equivalent total treatment counts are obtained by 
summing lines 8.01 through 17.02 from Worksheet C, Column 1 for renal 
facility cost reports, and by summing lines 1 through 10 from Worksheet 
I-4, Column 1 for the hospital cost reports.
    (D) Hemodialysis-equivalent home dialysis treatment counts are 
obtained by summing lines 14.01 through 17.02 from Worksheet C, Column 1 
for renal facility cost reports, and by summing lines 7 through 10 from 
Worksheet I-4, Column 1 for the hospital cost reports. In both renal 
facility and hospital cost reports, home Continuous Ambulatory 
Peritoneal Dialysis and home Continuous Cyclic Peritoneal Dialysis are 
reported as patient weeks, so a conversion factor of 3 is applied to 
obtain hemodialysis-equivalent treatment counts.
    (ii) [Reserved]
    (3) CMS uses the following methodology to calculate the average per 
treatment offset amount for home dialysis machines that is subtracted 
from the per treatment amount as determined in paragraph (f)(1)(ii) of 
this section to determine the pre-adjusted per treatment amount 
specified in paragraph (f)(1)(iii) of this section:
    (i) Calculates annualized values for calendar year 2018 at the ESRD 
facility level for the metrics specified in paragraph (f)(2)(i) of this 
section by dividing the numbers of days the cost report spanned to 
compute a per-day metric, then multiplying the resulting value by the 
number of days in 2018 the cost report covered to compute the metrics 
attributable to the period covered by the cost report in 2018. Next, for 
ESRD facilities with multiple cost reports covering 2018 the resulting 
metrics are aggregated. Finally, each ESRD facility's aggregated metrics 
are annualized to cover the full calendar year 2018. The annualization 
factor for an ESRD facility is the total number of days in 2018 divided 
by the total days in 2018 covered by the ESRD facility's cost report(s).
    (ii) Calculates an estimated home dialysis machine and equipment 
cost for each ESRD facility by multiplying the annualized dialysis 
machine and equipment cost determined in paragraph (f)(3)(i) of this 
section by the ESRD facility's hemodialysis-equivalent home dialysis 
treatment percentage. The hemodialysis-equivalent home dialysis 
treatment percentage for each facility is calculated by dividing 
annualized hemodialysis-equivalent home treatment count determined in 
paragraph (f)(3)(i) of this section by annualized hemodialysis-
equivalent treatment count across all modalities determined in paragraph 
(f)(3)(i) of this section.
    (iii) Calculates an average home dialysis machine and equipment cost 
per home dialysis treatment for calendar

[[Page 971]]

year 2018 by dividing the sum of the estimated home dialysis machine and 
equipment cost in paragraph (f)(3)(ii) of this section across all ESRD 
facilities by the sum of annualized hemodialysis-equivalent home 
treatment counts determined in paragraph (f)(3)(i) of this section 
across all facilities.
    (iv) Calculates the amount subtracted from the pre-adjusted 
treatment amount determined in paragraph (f)(1)(iii) of this section by 
inflating the average home dialysis machine and equipment cost per home 
dialysis treatment for calendar year 2018 determined in paragraph 
(f)(3)(iii) to calendar year 2021. The average home dialysis machine and 
equipment cost per home dialysis treatment for calendar year 2018 is 
inflated to calendar year 2021 by multiplying this value by the payment 
rate update factor required under section 1881(b)(14)(F)(i) of the 
Social Security Act for calendar years 2019, 2020, and 2021. This value 
is then divided by a scaling factor to be converted to the ESRD PPS 
payment scale. The scaling factor is calculated by dividing the calendar 
year 2018 total cost per treatment inflated to calendar year 2021 by the 
average ESRD PPS payment per treatment projected for calendar year 2021.
    (v) Effective January 1, 2022, CMS annually updates the amount 
determined in paragraph (f)(3)(iv) of this section by the ESRD bundled 
market basket percentage increase factor minus the productivity 
adjustment factor.

[84 FR 60805, Nov. 8, 2019, as amended at 85 FR 71486, Nov. 9, 2020]



Sec.  413.237  Outliers.

    (a) The following definitions apply to this section.
    (1) ESRD outlier services are the following items and services that 
are included in the ESRD PPS bundle:
    (i) Renal dialysis drugs and biological products that were or would 
have been, prior to January 1, 2011, separately billable under Medicare 
Part B.
    (ii) Renal dialysis laboratory tests that were or would have been, 
prior to January 1, 2011, separately billable under Medicare Part B.
    (iii) Renal dialysis medical/surgical supplies, including syringes, 
used to administer renal dialysis drugs and biological products that 
were or would have been, prior to January 1, 2011, separately billable 
under Medicare Part B.
    (iv) Renal dialysis drugs and biological products that were or would 
have been, prior to January 1, 2011, covered under Medicare Part D, 
including renal dialysis oral-only drugs effective January 1, 2025.
    (v) Renal dialysis equipment and supplies, except for capital-
related assets that are home dialysis machines (as defined in Sec.  
413.236(a)(2)), that receive the transitional add-on payment adjustment 
as specified in Sec.  413.236, after the payment period has ended.
    (vi) As of January 1, 2012, the laboratory tests that comprise the 
Automated Multi-Channel Chemistry panel are excluded from the definition 
of outlier services.
    (2) Adult predicted ESRD outlier services Medicare allowable payment 
(MAP) amount means the predicted per-treatment case-mix adjusted amount 
for ESRD outlier services furnished to an adult beneficiary by an ESRD 
facility.
    (3) Pediatric predicted ESRD outlier services Medicare allowable 
payment (MAP) amount means the predicted per-treatment case-mix adjusted 
amount for ESRD outlier services furnished to a pediatric beneficiary by 
an ESRD facility.
    (4) Adult fixed dollar loss amount is the amount by which an ESRD 
facility's imputed per-treatment MAP amount for furnishing ESRD outlier 
services to an adult beneficiary must exceed the adult predicted ESRD 
outlier services MAP amount to be eligible for an outlier payment.
    (5) Pediatric fixed dollar loss amount is the amount by which an 
ESRD facility's imputed per-treatment MAP amount for furnishing ESRD 
outlier services to a pediatric beneficiary must exceed the pediatric 
predicted ESRD outlier services MAP amount to be eligible for an outlier 
payment.
    (6) Outlier Percentage: This term has the meaning set forth in Sec.  
413.220(b)(4).
    (b) Eligibility for outlier payments--(1) Adult beneficiaries. An 
ESRD facility will receive an outlier payment for a treatment furnished 
to an adult beneficiary if the ESRD facility's per-treatment imputed MAP 
amount for ESRD

[[Page 972]]

outlier services exceeds the adult predicted ESRD outlier services MAP 
amount plus the adult fixed dollar loss amount. To calculate the ESRD 
facility's per-treatment imputed MAP amount for an adult beneficiary, 
CMS divides the ESRD facility's monthly imputed MAP amount of providing 
ESRD outlier services to the adult beneficiary by the number of dialysis 
treatments furnished to the adult beneficiary in the relevant month. A 
beneficiary is considered an adult beneficiary if the beneficiary is 18 
years old or older.
    (2) Pediatric beneficiaries. An ESRD facility will receive an 
outlier payment for a treatment furnished to a pediatric beneficiary if 
the ESRD facility's per-treatment imputed MAP amount for ESRD outlier 
services exceeds the pediatric predicted ESRD outlier services MAP 
amount plus the pediatric fixed dollar loss amount. To calculate the 
ESRD facility's per-treatment imputed MAP amount for a pediatric 
beneficiary, CMS divides the ESRD facility's monthly imputed MAP amount 
of providing ESRD outlier services to the pediatric beneficiary by the 
number of dialysis treatments furnished to the pediatric beneficiary in 
the relevant month. A beneficiary is considered a pediatric beneficiary 
if the beneficiary is under 18 years old.
    (c) Outlier payment amount: CMS pays 80 percent of the difference 
between:
    (1) The ESRD facility's per-treatment imputed MAP amount for the 
ESRD outlier services, and
    (2) The adult or pediatric predicted ESRD outlier services MAP 
amount plus the adult or pediatric fixed dollar loss amount, as 
applicable.

[75 FR 49201, Aug. 12, 2010, as amended at 76 FR 70314, Nov. 10, 2011; 
78 FR 72252, Dec. 2, 2013; 79 FR 66262, Nov. 6, 2014; 80 FR 69077, Nov. 
6, 2015; 84 FR 60806, Nov. 8, 2019; 85 FR 71487, Nov. 9, 2020]



Sec.  413.239  Transition period.

    (a) Duration of transition period and composition of the blended 
transition payment. ESRD facilities not electing under paragraph (b) of 
this section to be paid based on the payment amount determined under 
Sec.  413.230 of this part, will be paid a per-treatment payment amount 
for renal dialysis services (as defined in Sec.  413.171 of this part) 
and home dialysis, provided during the transition as follows--
    (1) For services provided on and after January 1, 2011 through 
December 31, 2011, a blended rate equal to the sum of:
    (i) 75 percent of the payment amount determined under the ESRD 
payment methodology in effect prior to January 1, 2011 in accordance 
with section 1881(b)(12) of the Act and items and services separately 
paid under Part B; and
    (ii) 25 percent of the payment amount determined in accordance with 
section 1881(b)(14) of the Act;
    (2) For services provided on and after January 1, 2012 through 
December 31, 2012, a blended rate equal to the sum of:
    (i) 50 percent of the payment amount determined under the ESRD 
payment methodology in effect prior to January 1, 2011 in accordance 
with section 1881(b)(12) of the Act and items and services separately 
paid under Part B; and
    (ii) 50 percent of the payment rate determined in accordance with 
section 1881(b)(14) of the Act;
    (3) For services provided on and after January 1, 2013 through 
December 31, 2013, a blended rate equal to the sum of:
    (i) 25 percent of the payment amount determined under the ESRD 
payment methodology in effect prior to January 1, 2011 in accordance 
with section 1881(b) (12) of the Act and items and services separately 
paid under Part B; and
    (ii) 75 percent of the payment amount determined in accordance with 
section 1881(b)(14) of the Act;
    (4) For services provided on and after January 1, 2014, 100 percent 
of the payment amount determined in accordance with section 1881(b)(14) 
of the Act.
    (b) One-time election. Except as provided in paragraph (b)(2) of 
this section, ESRD facilities may make a one-time election to be paid 
for renal dialysis services provided during the transition based on 100 
percent of the payment amount determined under Sec.  413.215 of this 
part, rather than based on the payment amount determined under paragraph 
(a) of this section.

[[Page 973]]

    (1) Except as provided in paragraph (b)(3) of this section, the 
election must be received by each ESRD facility's Medicare 
administrative contractor (MAC) by November 1, 2010. Requests received 
by the MAC after November 1, 2010, will not be accepted regardless of 
postmarks, or delivered dates. MACs will establish the manner in which 
an ESRD facility will indicate their intention to be excluded from the 
transition and paid entirely based on payment under the ESRD PPS. Once 
the election is made, it may not be rescinded.
    (2) If the ESRD facility fails to submit an election, or the ESRD 
facility's election is not received by their MAC by November 1, 2010, 
payments to the ESRD facility for items and services provided during the 
transition will be based on the payment amounts determined under 
paragraph (a) of this section.
    (3) ESRD facilities that become certified for Medicare participation 
and begin to provide renal dialysis services, as defined in Sec.  
413.171 of this part, between November 1, 2010 and December 31, 2010, 
must notify their designated MAC of their election choice at the time of 
enrollment.
    (c) Treatment of new ESRD facilities. For renal dialysis services as 
defined in Sec.  413.171, furnished during the transition period, new 
ESRD facilities as defined in Sec.  413.171, are paid based on the per-
treatment payment amount determined under Sec.  413.215 of this part.
    (d) Transition budget-neutrality adjustment. During the transition, 
CMS adjusts all payments, including payments under this section, under 
the ESRD prospective payment system so that the estimated total amount 
of payment equals the estimated total amount of payments that would 
otherwise occur without such a transition.

[75 FR 49201, Aug. 12, 2010]



Sec.  413.241  Pharmacy arrangements.

    Effective January 1, 2011, an ESRD facility that enters into an 
arrangement with a pharmacy to furnish renal dialysis service drugs and 
biologicals must ensure that the pharmacy has the capability to provide 
all classes of renal dialysis service drugs and biologicals to patients 
in a timely manner.

[75 FR 49202, Aug. 12, 2010]



Subpart I_Prospectively Determined Payment Rates for Low-Volume Skilled 
 Nursing Facilities, for Cost Reporting Periods Beginning Prior to July 
                                 1, 1998

    Source: 60 FR 37594, July 21, 1995, unless otherwise noted.



Sec.  413.300  Basis and scope.

    (a) Basis. This subpart implements section 1888(d) of the Act, which 
provides for optional prospectively determined payment rates for 
qualified SNFs.
    (b) Scope. This subpart sets forth the eligibility criteria an SNF 
must meet to qualify, the process governing election of prospectively 
determined payment rates, and the basis and methodology for determining 
prospectively determined payment rates.



Sec.  413.302  Definitions.

    For purposes of this subpart--
    Area wage level means the average wage per hour for all 
classifications of employees as reported by health care facilities 
within a specified area.
    Census region means one of the 9 census divisions, comprising the 50 
States and the District of Columbia, established by the Bureau of the 
Census for statistical and reporting purposes.
    Routine capital-related costs means the capital-related costs, 
allowable for Medicare purposes (as described in subpart G of this 
part), that are allocated to the SNF participating inpatient routine 
service cost center as reported on the Medicare cost report.
    Routine operating costs means the cost of regular room, dietary, and 
nursing services, and minor medical and surgical supplies for which a 
separate charge is not customarily made. It does not include the costs 
of ancillary services, capital-related costs, or, where appropriate, 
return on equity.
    Rural area means any area outside an urban area in a census region.
    Urban area means--

[[Page 974]]

    (1) Prior to October 1, 2004, a Metropolitan Statistical Area (MSA), 
or New England County Metropolitan Area (NECMA), as defined by the 
Office of Management and Budget, or a New England county deemed to be an 
urban area as listed in Sec.  412.62(f)(1)(ii)(B) of this chapter.
    (2) Effective October 1, 2004, a Metropolitan Statistical Area 
(MSA), as defined by the Office of Management and Budget, or a New 
England county deemed to be an urban area as specified under Sec.  
412.64.

[60 FR 37594, July 21, 1995, as amended at 69 FR 49265, Aug. 11, 2004]



Sec.  413.304  Eligibility for prospectively determined payment rates.

    (a) General rule. An SNF is eligible to receive a prospectively 
determined payment rate for a cost reporting period if it had fewer than 
1,500 Medicare covered inpatient days as reported on a Medicare cost 
report in its immediately preceding cost reporting period. This 
criterion applies even if the SNF received a prospectively determined 
payment rate during the preceding cost reporting period.
    (b) Less than a full cost reporting period. If the cost reporting 
period that precedes an SNF's request for prospectively determined 
payment is not a full cost reporting period, the SNF is eligible to 
receive prospectively determined payment rates only if the average daily 
Medicare census for the period (Medicare inpatient days divided by the 
total number of days in the cost reporting period) is not greater than 
4.1.
    (c) Newly-participating SNFs. An SNF is eligible to receive 
prospectively determined payment rates for its first cost reporting 
period for which it is approved to participate in Medicare.



Sec.  413.308  Rules governing election of prospectively determined 
payment rates.

    (a) Requirements. An SNF must notify its contractor at least 30 
calendar days before the beginning of the cost reporting period for 
which it requests to receive such payment that it elects prospectively 
determined payment rates. A separate request must be made for each cost 
reporting period for which an SNF seeks prospectively determined 
payment. A newly participating SNF with no preceding cost reporting 
period must make its election within 30 days of its notification of 
approval to participate in Medicare.
    (b) Contractor notice. After evaluating an SNF's request for 
prospectively determined payment rates, the contractor notifies the SNF 
in writing as to whether the SNF meets any of the eligibility criteria 
described in Sec.  413.304 and the timely election requirements under 
Sec.  413.308(a). The contractor must notify the SNF of its initial and 
final determinations within 10 working days after it receives all the 
data necessary to make each determination. The contractor's 
determination is limited to one cost reporting period.
    (c) Prohibition against revocation. An SNF may not revoke its 
request after it has received the initial determination of eligibility 
from the contractor and the cost reporting period has begun.
    (d) Revocation by contractor. If an SNF is given tentative approval 
to receive a prospectively determined payment rate, and, after the start 
of the applicable cost reporting period, the contractor determines that 
the SNF does not meet the eligibility criteria, the contractor must 
revoke the prospectively determined payment option.



Sec.  413.310  Basis of payment.

    (a) Method of payment. Under the prospectively determined payment 
rate system, a qualified SNF receives a per diem payment of a 
predetermined rate for inpatient services furnished to Medicare 
beneficiaries. Each SNF's routine per diem payment rate is determined 
according to the methodology described in Sec.  413.312 and is based on 
various components of SNF costs.
    (b) Payment in full. The payment rate represents payment in full for 
routine services as described in Sec.  413.314 (subject to applicable 
coinsurance as described in subpart G of part 409 of this title), and 
for routine capital costs. Payment is made in lieu of payment on a 
reasonable cost basis for routine services and for routine capital 
costs.

[[Page 975]]



Sec.  413.312  Methodology for calculating rates.

    (a) Data used. (1) To calculate the prospectively determined payment 
rates, CMS uses:
    (i) The SNF cost data that were used to develop the applicable 
routine service cost limits;
    (ii) A wage index to adjust for area wage differences; and
    (iii) The most recent projections of increases in the costs from the 
SNF market basket index.
    (2) In the annual schedule of rates published in the Federal 
Register under the authority of Sec.  413.320, CMS announces the wage 
index and the annual percentage increases in the market basket used in 
the calculation of the rates.
    (b) Calculation of per diem rate--(1) Routine operating component of 
rate--(i) Adjusting cost report data. The SNF market basket index is 
used to adjust the routine operating cost from the SNF cost report to 
reflect cost increases occurring between cost reporting periods 
represented in the data collected and the midpoint of the initial cost 
reporting period to which the payment rates apply.
    (ii) Calculating a per diem cost. For each SNF, an adjusted routine 
operating per diem cost is computed by dividing the adjusted routine 
operating cost (see paragraph (b)(1)(i) of this section) by the SNF's 
total patient days.
    (iii) Adjusting for wage levels. (A) The SNF's adjusted per diem 
routine operating cost calculated under paragraph (b)(1)(ii) of this 
section is then divided into labor-related and nonlabor-related 
portions.
    (B) The labor-related portion is obtained by multiplying the SNF's 
adjusted per diem routine operating cost by a percentage that represents 
the labor-related portion of cost from the market basket. This 
percentage is published when the revised rates are published as 
described in Sec.  413.320.
    (C) The labor-related portion of each SNF's per diem cost is divided 
by the wage index applicable to the SNF's geographic location to arrive 
at the adjusted labor-related portion of routine cost.
    (iv) Group means. SNFs are grouped by urban or rural location by 
census region. Separate means of adjusted labor-related and nonlabor 
routine operating costs for each SNF group are established in accordance 
with the SNF's region and urban or rural location. For each group, the 
mean labor-related and mean nonlabor-related per diem routine operating 
costs are multiplied by 105 percent.
    (2) Computation of routine capital-related cost. (i) The SNF routine 
capital-related cost for both direct and indirect capital costs 
allocated to routine services, as reported on the Medicare cost report, 
is obtained for each SNF in the data base.
    (ii) For each SNF, the per diem capital-related cost is calculated 
by dividing the SNF's routine capital costs by its inpatient days.
    (iii) SNFs are grouped by urban and rural location by census region, 
and mean per diem routine capital-related cost is determined for each 
group.
    (iv) Each group mean per diem capital-related cost is multiplied by 
105 percent.
    (3) Computation of return on owner's equity for services furnished 
before October 1, 1993. (i) Each proprietary SNF's Medicare return on 
equity is obtained from its cost report and the portion attributable to 
the routine service cost is determined as described in Sec.  413.157.
    (ii) For each proprietary SNF, per diem return on equity is 
calculated by dividing the routine cost related return on equity 
determined under paragraph (b)(3)(i) of this section by the SNF's total 
Medicare inpatient days.
    (iii) Separate group means are computed for per diem return on 
equity of proprietary SNFs, based on regional and urban or rural 
classification.
    (iv) Each group mean is multiplied by 105 percent.



Sec.  413.314  Determining payment amounts: Routine per diem rate.

    (a) General rule. An SNF that elects to be paid under the 
prospectively determined payment rate system, and qualifies for such 
payment, is paid a per diem rate for inpatient routine services. This 
rate is adjusted to reflect area wage differences and the cost reporting 
period beginning date (if necessary) and is subject to the limitation

[[Page 976]]

specified in paragraph (d) of this section.
    (b) Per diem rate. The prospectively determined payment rate for 
each urban and rural area in each census region is comprised of the 
following:
    (1) A routine operating component, which is divided into:
    (i) A labor-related portion adjusted by the appropriate wage index; 
and
    (ii) A nonlabor-related portion.
    (2) A routine capital-related cost portion.
    (3) For proprietary SNFs only, a portion that is based on the return 
on owner's equity related to routine cost, applicable only for services 
furnished before October 1, 1993.
    (c) Adjustment for cost reporting period. (1) If a facility has a 
cost reporting period beginning after the beginning of the Federal 
fiscal year, the contractor increases the labor-related and nonlabor-
related portions of the prospective payment rate that would otherwise 
apply to the SNF by an adjustment factor. Each factor represents the 
projected increase in the market basket index for a specific 12-month 
period. The factors are used to account for inflation in costs for cost 
reporting periods beginning after October 1. Adjustment factors are 
published in the annual notice of prospectively determined payment rates 
described in Sec.  413.320.
    (2) If a facility uses a cost reporting period that is not 12 months 
in duration, the contractor must obtain a special adjustment factor from 
CMS for the specific period.
    (d) Limitation of prospectively determined payment rate. The per 
diem prospectively determined payment rate for an SNF, excluding 
capital-related costs and excluding return on equity for services 
furnished prior to October 1, 1993, may not exceed the individual SNF's 
routine service cost limit. Under Sec.  413.30, the routine service cost 
limit is the limit determined without regard to exemptions, exceptions, 
or retroactive adjustments, and is the actual limit in effect when the 
provider elects to be paid a prospectively determined payment rate.



Sec.  413.316  Determining payment amounts: Ancillary services.

    Ancillary services are paid on the basis of reasonable cost in 
accordance with section 1861(v)(1) of the Act and Sec.  413.53.



Sec.  413.320  Publication of prospectively determined payment rates 
or amounts.

    At least 90 days before the beginning of a Federal fiscal year to 
which revised prospectively determined payment rates are to be applied, 
CMS publishes a notice in the Federal Register:
    (a) Establishing the prospectively determined payment rates for 
routine services; and
    (b) Explaining the basis on which the prospectively determined 
payment rates are calculated.



Sec.  413.321  Simplified cost report for SNFs.

    SNFs electing to be paid under the prospectively determined payment 
rate system may file a simplified cost report. The cost report contains 
a simplified method of cost finding to be used in lieu of cost methods 
described in Sec.  413.24(d). This method is specified in the 
instructions for Form CMS-2540S, contained in sections 3000-3027.3 of 
Part 2 of the Provider Reimbursement Manual. This form may not be used 
by hospital-based SNFs or SNFs that are part of a health care complex. 
Those SNFs must file a cost report that reflects the shared services and 
administrative costs of the hospital and any other related facilities in 
the health care complex.



      Subpart J_Prospective Payment for Skilled Nursing Facilities

    Source: 63 FR 26309, May 12, 1998, unless otherwise noted.



Sec.  413.330  Basis and scope.

    (a) Basis. This subpart implements section 1888(e) of the Act, which 
provides for the implementation of a prospective payment system for SNFs 
for cost reporting periods beginning on or after July 1, 1998.

[[Page 977]]

    (b) Scope. This subpart sets forth the framework for the prospective 
payment system for SNFs, including the methodology used for the 
development of payment rates and associated adjustments, the application 
of a transition phase, and related rules.



Sec.  413.333  Definitions.

    As used in this subpart--
    Case-mix index means a scale that measures the relative difference 
in resource intensity among different groups in the resident 
classification system.
    Market basket index means an index that reflects changes over time 
in the prices of an appropriate mix of goods and services included in 
covered skilled nursing services.
    Resident classification system means a system for classifying SNF 
residents into mutually exclusive groups based on clinical, functional, 
and resource-based criteria. For purposes of this subpart, this term 
refers to the current version of the resident classification system, as 
set forth in the annual publication of Federal prospective payment rates 
described in Sec.  413.345.
    Rural area means, for services provided on or after July 1, 1998, 
but before October 1, 2005, an area as defined in Sec.  
412.62(f)(1)(iii) of this chapter. For services provided on or after 
October 1, 2005, rural area means an area as defined in Sec.  
412.64(b)(1)(ii)(C) of this chapter.
    Urban area means, for services provided on or after July 1, 1998, 
but before October 1, 2005, an area as defined in Sec.  412.62(f)(1)(ii) 
of this chapter. For services provided on or after October 1, 2005, 
urban area means an area as defined in Sec. Sec.  412.64(b)(1)(ii)(A) 
and 412.64(b)(1)(ii)(B) of this chapter.

[63 FR 26309, May 12, 1998; 63 FR 53307, Oct. 5, 1998, as amended at 73 
FR 46440, Aug. 8, 2008; 82 FR 36633, Aug. 4, 2017]



Sec.  413.335  Basis of payment.

    (a) Method of payment. Under the prospective payment system, SNFs 
receive a per diem payment of a predetermined rate for inpatient 
services furnished to Medicare beneficiaries. The per diem payments are 
made on the basis of the Federal payment rate described in Sec.  413.337 
and, during a transition period, on the basis of a blend of the Federal 
rate and the facility-specific rate described in Sec.  413.340. These 
per diem payment rates are determined according to the methodology 
described in Sec. Sec.  413.337 and 413.340.
    (b) Payment in full. (1) The payment rates represent payment in full 
(subject to applicable coinsurance as described in subpart G of part 409 
of this chapter) for all costs (routine, ancillary, and capital-related) 
associated with furnishing inpatient SNF services to Medicare 
beneficiaries other than costs associated with approved educational 
activities as described in Sec.  413.85.
    (2) In addition to the Federal per diem payment amounts, SNFs 
receive payment for bad debts of Medicare beneficiaries, as specified in 
Sec.  413.89 of this part.

[63 FR 26309, May 12, 1998, as amended at 73 FR 46440, Aug. 8, 2008]



Sec.  413.337  Methodology for calculating the prospective payment rates.

    (a) Data used. (1) To calculate the prospective payment rates, CMS 
uses--
    (i) Medicare data on allowable costs from freestanding and hospital-
based SNFs for cost reporting periods beginning in fiscal year 1995. 
SNFs that received ``new provider'' exemptions under Sec.  413.30(e)(2) 
are excluded from the data base used to compute the Federal payment 
rates. In addition, allowable costs related to exceptions payments under 
Sec.  413.30(f) are excluded from the data base used to compute the 
Federal payment rates;
    (ii) An appropriate wage index to adjust for area wage differences;
    (iii) The most recent projections of increases in the costs from the 
SNF market basket index;
    (iv) Resident assessment and other data that account for the 
relative resource utilization of different resident types; and
    (v) Medicare Part B SNF claims data reflecting amounts payable under 
Part B for covered SNF services (other than those services described in 
Sec.  411.15(p)(2) of this chapter) furnished during SNF cost reporting 
periods beginning in fiscal year 1995 to individuals who were residents 
of SNFs and receiving Part A covered services.

[[Page 978]]

    (b) Methodology for calculating the per diem Federal payment rates--
(1) Determining SNF costs. In calculating the initial unadjusted Federal 
rates applicable for services provided during the period beginning July 
1, 1998 through September 30, 1999, CMS determines each SNF's costs by 
summing its allowable costs for the cost reporting period beginning in 
fiscal year 1995 and its estimate of Part B payments (described in 
paragraphs (a)(1)(i) and (a)(1)(v) of this section).
    (2) Use of market basket index. The SNF market basket index is used 
to adjust the SNF cost data to reflect cost increases occurring between 
cost reporting periods represented in the data and the initial period 
(beginning July 1, 1998 and ending September 30, 1999) to which the 
payment rates apply. For each year, the cost data are updated by a 
factor equivalent to the annual market basket index percentage minus 1 
percentage point.
    (3) Calculation of the per diem cost. For each SNF, the per diem 
cost is computed by dividing the cost data for each SNF by the 
corresponding number of Medicare days.
    (4) Standardization of data for variation in area wage levels and 
case-mix. The cost data described in paragraph (b)(2) of this section 
are standardized to remove the effects of geographic variation in wage 
levels and facility variation in case-mix. The cost data are 
standardized for geographic variation in wage levels using the wage 
index. The cost data are standardized for facility variation in case-mix 
using the case-mix indices and other data that indicate facility case-
mix.
    (5) Calculation of unadjusted Federal payment rates. CMS calculates 
the national per diem unadjusted payment rates by urban and rural 
classification in the following manner:
    (i) By computing the average per diem standardized cost of 
freestanding SNFs weighted by Medicare days.
    (ii) By computing the average per diem standardized cost of 
freestanding and hospital-based SNFs combined weighted by Medicare days.
    (iii) By computing the average of the amounts determined under 
paragraphs (b)(5)(i) and (b)(5)(ii) of this section.
    (c) Calculation of adjusted Federal payment rates for case-mix and 
area wage levels. The Federal rate is adjusted to account for facility 
case-mix using a resident classification system and associated case-mix 
indices that account for the relative resource utilization of different 
patient types. This classification system utilizes the resident 
assessment instrument completed by SNFs as described at Sec.  483.20 of 
this chapter, according to the assessment schedule described in Sec.  
413.343(b). The Federal rate is also adjusted to account for geographic 
differences in area wage levels using an appropriate wage index.
    (d) Annual updates of Federal unadjusted payment rates. CMS updates 
the unadjusted Federal payment rates on a fiscal year basis.
    (1) Update formula. The unadjusted Federal payment rate shall be 
updated as follows:
    (i) For the initial period beginning on July 1, 1998, and ending on 
September 30, 1999, the unadjusted Federal payment rate is equal to the 
rate computed under paragraph (b)(5)(iii) of this section increased by a 
factor equal to the SNF market basket index percentage change for such 
period minus 1.0 percentage point.
    (ii) For fiscal year 2000, the unadjusted Federal payment rate is 
equal to the rate computed for the initial period described in paragraph 
(d)(1)(i) of this section increased by a factor equal to the SNF market 
basket index percentage change for that period minus 1.0 percentage 
point.
    (iii) For fiscal year 2001, the unadjusted Federal payment rate is 
equal to the rate computed for the previous fiscal year increased by a 
factor equal to the SNF market basket index percentage change for the 
fiscal year.
    (iv) For fiscal years 2002 and 2003, the unadjusted Federal payment 
rate is equal to the rate computed for the previous fiscal year 
increased by a factor equal to the SNF market basket index percentage 
change for the fiscal year involved minus 0.5 percentage points.
    (v) For each subsequent fiscal year, the unadjusted Federal payment 
rate is equal to the rate computed for the previous fiscal year 
increased by a factor equal to the SNF market basket index percentage 
change for the fiscal year

[[Page 979]]

involved, except as provided in paragraphs (d)(1)(vi) and (vii) of this 
section.
    (vi) For fiscal year 2018, the unadjusted Federal payment rate is 
equal to the rate computed for the previous fiscal year increased by a 
SNF market basket index percentage change of 1 percent (after 
application of paragraphs (d)(2) and (3) of this section).
    (vii) For fiscal year 2019, the unadjusted Federal payment rate is 
equal to the rate computed for the previous fiscal year increased by a 
SNF market basket index percentage change of 2.4 percent (after 
application of paragraphs (d)(2) and (3) of this section).
    (2) Forecast error adjustment. Beginning with fiscal year 2004, an 
adjustment to the annual update of the previous fiscal year's rate will 
be computed to account for forecast error. The initial adjustment (in 
fiscal year 2004) to the update of the previous fiscal year's rate will 
take into account the cumulative forecast error between fiscal years 
2000 and 2002. Subsequent adjustments in succeeding fiscal years will 
take into account the forecast error from the most recently available 
fiscal year for which there is final data. The forecast error adjustment 
applies whenever the difference between the forecasted and actual 
percentage change in the SNF market basket index exceeds the following 
threshold:
    (i) 0.25 percentage points for fiscal years 2004 through 2007; and
    (ii) 0.5 percentage points for fiscal year 2008 and subsequent 
fiscal years.
    (3) Multifactor productivity (MFP) adjustment. For fiscal year 2012 
and each subsequent fiscal year, the SNF market basket index percentage 
change for the fiscal year (as modified by any applicable forecast error 
adjustment under paragraph (d)(2) of this section) shall be reduced by 
the MFP adjustment described in section 1886(b)(3)(B)(xi)(II) of the 
Act. The reduction of the market basket index percentage change by the 
MFP adjustment may result in the market basket index percentage change 
being less than zero for a fiscal year, and may result in the unadjusted 
Federal payment rates for a fiscal year being less than such payment 
rates for the preceding fiscal year.
    (4) Penalty for failure to report quality data. For fiscal year 2018 
and subsequent fiscal years--
    (i) In the case of a SNF that does not meet the requirements in 
Sec.  413.360, for a fiscal year, the SNF market basket index percentage 
change for the fiscal year (as specified in paragraph (d)(1)(v) of this 
section, as modified by any applicable forecast error adjustment under 
paragraph (d)(2) of this section, reduced by the MFP adjustment 
specified in paragraph (d)(3) of this section, and as specified for FY 
2018 in section 1888(e)(5)(B)(iii) of the Act), is further reduced by 
2.0 percentage points.
    (ii) The application of the 2.0 percentage point reduction specified 
in paragraph (d)(4)(i) of this section to the SNF market basket index 
percentage change may result in such percentage being less than zero for 
a fiscal year, and may result in payment rates for that fiscal year 
being less than such payment rates for the preceding fiscal year.
    (iii) Any 2.0 percentage point reduction applied pursuant to 
paragraph (d)(4)(i) of this section will apply only to the fiscal year 
involved and will not be taken into account in computing the payment 
amount for a subsequent fiscal year.
    (e) Pursuant to section 101 of the Medicare, Medicaid, and SCHIP 
Balanced Budget Refinement Act of 1999 (BBRA) as revised by section 314 
of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection 
Act of 2000 (BIPA), using the best available data, the Secretary will 
issue a new regulation with a newly refined case-mix classification 
system to better account for medically complex patients. Upon issuance 
of the new regulation, the temporary increases in payment for certain 
high cost patients will no longer be applicable.
    (f) Adjustments to payment rates under the SNF Value-Based 
Purchasing Program. Beginning with payment for services furnished on 
October 1, 2018, the adjusted Federal per diem rate (as defined in Sec.  
413.338(a)(2)) otherwise applicable to a SNF for the fiscal year is 
reduced by the applicable percent (as defined in Sec.  413.338(a)(3)). 
The resulting

[[Page 980]]

amount is then adjusted by the value-based incentive payment amount (as 
defined in Sec.  413.338(a)(14)) based on the SNF's performance score 
for that fiscal year under the SNF Value-Based Purchasing Program, as 
calculated under Sec.  413.338.

[63 FR 26309, May 12, 1998, as amended at 66 FR 39600, July 31, 2001; 68 
FR 46070, Aug. 4, 2003; 76 FR 48539, Aug. 8, 2011; 82 FR 36633, Aug. 4, 
2017; 83 FR 39289, Aug. 8, 2018]



Sec.  413.338  Skilled nursing facility value-based purchasing program.

    (a) Definitions. As used in this section:
    (1) Achievement threshold (or achievement performance standard) 
means the 25th percentile of SNF performance on the SNF readmission 
measure during the baseline period for a fiscal year.
    (2) Adjusted Federal per diem rate means the payment made to SNFs 
under the skilled nursing facility prospective payment system (as 
described under section 1888(e)(4)(G) of the Act).
    (3) Applicable percent means for FY 2019 and subsequent fiscal 
years, 2.0 percent.
    (4) Baseline period means the time period used to calculate the 
achievement threshold, benchmark and improvement threshold that apply 
for a fiscal year.
    (5) Benchmark means, for a fiscal year, the arithmetic mean of the 
top decile of SNF performance on the SNF readmission measure during the 
baseline period for that fiscal year.
    (6) Logistic exchange function means the function used to translate 
a SNF's performance score on the SNF readmission measure into a value-
based incentive payment percentage.
    (7) Improvement threshold (or improvement performance standard) 
means an individual SNF's performance on the SNF readmission measure 
during the applicable baseline period.
    (8) Performance period means the time period during which 
performance on the SNF readmission measure is calculated for a fiscal 
year.
    (9) Performance standards are the levels of performance that SNFs 
must meet or exceed to earn points under the SNF VBP Program for a 
fiscal year, and are announced no later than 60 days prior to the start 
of the performance period that applies to the SNF readmission measure 
for that fiscal year. Beginning with the performance standards that 
apply to FY 2021, if CMS discovers an error in the performance standard 
calculations subsequent to publishing their numerical values for a 
fiscal year, CMS will update the numerical values to correct the error. 
If CMS subsequently discovers one or more other errors with respect to 
the same fiscal year, CMS will not further update the numerical values 
for that fiscal year.
    (10) Ranking means the ordering of SNFs based on each SNF's 
performance score under the SNF VBP Program for a fiscal year.
    (11) SNF readmission measure means, prior to October 1, 2019, the 
all-cause all-condition hospital readmission measure (SNFRM) or the all-
condition risk-adjusted potentially preventable hospital readmission 
rate (SNFPPR) specified by CMS for application in the SNF Value-Based 
Purchasing Program. Beginning October 1, 2019, the term SNF readmission 
measure means the all-cause all-condition hospital readmission measure 
(SNFRM) or the all-condition risk-adjusted potentially preventable 
hospital readmission rate (Skilled Nursing Facility Potentially 
Preventable Readmissions after Hospital Discharge measure) specified by 
CMS for application in the SNF Value-Based Purchasing Program.
    (12) Performance score means the numeric score ranging from 0 to 100 
awarded to each SNF based on its performance under the SNF VBP Program 
for a fiscal year.
    (13) SNF Value-Based Purchasing (VBP) Program means the program 
required under section 1888(h) of the Social Security Act.
    (14) Value-based incentive payment amount is the portion of a SNF's 
adjusted Federal per diem rate that is attributable to the SNF VBP 
Program.
    (15) Value-based incentive payment adjustment factor is the number 
that will be multiplied by the adjusted Federal per diem rate for 
services furnished by a SNF during a fiscal year, based on its 
performance score for that fiscal year, and after such rate is reduced 
by the applicable percent.

[[Page 981]]

    (16) Low-volume SNF means a SNF with fewer than 25 eligible stays 
included in the SNF readmission measure denominator during the 
performance period for a fiscal year.
    (17) Eligible stay means, for purposes of the SNF readmission 
measure, an index SNF admission that would be included in the 
denominator of that measure.
    (b) Applicability of the SNF VBP Program. The SNF VBP Program 
applies to SNFs, including facilities described in section 
1888(e)(7)(B).
    (c) Process for reducing the adjusted Federal per diem rate and 
applying the value-based incentive payment adjustment factor under the 
SNF VBP Program--(1) General. CMS will make value-based incentive 
payments to each SNF based on its performance score for a fiscal year 
under the SNF VBP Program under the requirements and conditions 
specified in this paragraph.
    (2) Value-based incentive payment amount--(i) Total amount available 
for a fiscal year. The total amount available for value-based incentive 
payments for a fiscal year is at least 60 percent of the total amount of 
the reduction to the adjusted SNF PPS payments for that fiscal year, as 
estimated by CMS, and will be increased as appropriate for each fiscal 
year to account for the assignment of a performance score to low-volume 
SNFs under paragraph (d)(3) of this section.
    (ii) Calculation of the value-based incentive payment amount. The 
value-based incentive payment amount is calculated by multiplying the 
adjusted Federal per diem rate by the value- based incentive payment 
adjustment factor, after the adjusted Federal per diem rate has been 
reduced by the applicable percent.
    (iii) Calculation of the value-based incentive payment adjustment 
factor. The value-based incentive payment adjustment factor is 
calculated by estimating Medicare spending under the skilled nursing 
facility prospective payment system to estimate the total amount 
available for value-based incentive payments, ordering SNFs by their SNF 
performance scores, then assigning an adjustment factor value for each 
performance score subject to the limitations set by the exchange 
function.
    (iv) Reporting of adjustment to SNF payments. CMS will inform each 
SNF of the value-based incentive payment adjustment factor that will be 
applied to its adjusted Federal per diem rate for services furnished 
during a fiscal year at least 60 days prior to the start of that fiscal 
year.
    (d) Performance scoring under the SNF VBP Program. (1) CMS will 
award points to SNFs based on their performance on the SNF readmission 
measure applicable to a fiscal year during the performance period 
applicable to that fiscal year as follows:
    (i) CMS will award from 1 to 99 points for achievement to each SNF 
whose performance meets or exceeds the achievement threshold but is less 
than the benchmark.
    (ii) CMS will award from 0 to 90 points for improvement to each SNF 
whose performance exceeds the improvement threshold but is less than the 
benchmark.
    (iii) CMS will award 100 points to a SNF whose performance meets or 
exceeds the benchmark.
    (iv) CMS will not award points for improvement to a SNF that has 
fewer than 25 eligible stays during the baseline period.
    (2) The highest of the SNF's achievement, improvement and benchmark 
score will be the SNF's performance score for the fiscal year.
    (3) If CMS determines that a SNF is a low-volume SNF with respect to 
a fiscal year, CMS will assign a performance score to the SNF for the 
fiscal year that, when used to calculate the value-based incentive 
payment amount (as defined in paragraph (a)(14) of this section), 
results in a value-based incentive payment amount that is equal to the 
adjusted Federal per diem rate (as defined in paragraph (a)(2) of this 
section) that would apply to the SNF for the fiscal year without 
application of Sec.  413.337(f).
    (4)(i) A SNF may request and CMS may grant exceptions to the SNF 
Value-Based Purchasing Program's requirements under this section for one 
or more calendar months when there

[[Page 982]]

are certain extraordinary circumstances beyond the control of the SNF.
    (ii) A SNF may request an exception within 90 days of the date that 
the extraordinary circumstances occurred in the form and manner 
specified by CMS on the SNF VBP website at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/
SNF-VBP/Extraordinary- Circumstance- Exception-. The request must 
include a completed Extraordinary Circumstances Request form (available 
on https://qualitynet.cms.gov/) and any available evidence of the impact 
of the extraordinary circumstances on the care that the SNF furnished to 
patients including, but not limited to, photographs and media articles.
    (iii) Except as provided in paragraph (d)(4)(iv) of this section, 
CMS will not consider an exception request unless the SNF requesting 
such exception has complied fully with the requirements in this 
paragraph (d).
    (iv) CMS may grant exceptions to SNFs without a request if it 
determines that an extraordinary circumstance affects an entire region 
or locale.
    (v) CMS will calculate a SNF performance score for a fiscal year for 
a SNF for which it has granted an exception request that does not 
include its performance on the SNF readmission measure during the 
calendar months affected by the extraordinary circumstance.
    (e) Confidential feedback reports and public reporting.
    (1) CMS will provide quarterly confidential feedback reports to SNFs 
on their performance on the SNF readmission measure. Beginning with the 
baseline period and performance period quality measure quarterly reports 
issued on or after October 1, 2021, which contain the baseline period 
and performance period measure rates, respectively, SNFs will have 30 
days following the date CMS provides each of these reports to review and 
submit corrections to the SNF readmission measure rates contained in 
that report. The administrative claims data used to calculate a SNF's 
readmission measure rates are not subject to review and correction under 
this paragraph (e)(1). All correction requests must be accompanied by 
appropriate evidence showing the basis for the correction to the SNF 
readmission measure rates.
    (2) Beginning not later than 60 days prior to each fiscal year, CMS 
will provide SNF performance score reports to SNFs on their performance 
under the SNF VBP Program for a fiscal year. SNFs will have the 
opportunity to review and submit corrections to their SNF performance 
scores and ranking contained in these reports for 30 days following the 
date that CMS provides the reports. Any such correction requests must be 
accompanied by appropriate evidence showing the basis for the 
correction.
    (3) CMS will publicly report the information described in paragraphs 
(e)(1) and (2) of this section on the Nursing Home Compare website or a 
successor website. Beginning with information publicly reported on or 
after October 1, 2019, the following exceptions apply:
    (i) If CMS determines that a SNF has fewer than 25 eligible stays 
during the baseline period for a fiscal year but has 25 or more eligible 
stays during the performance period for that fiscal year, CMS will not 
publicly report the SNF's baseline period SNF readmission measure rate 
and improvement score for that fiscal year;
    (ii) If CMS determines that a SNF is a low-volume SNF with respect 
to a fiscal year and assigns a performance score to the SNF under 
paragraph (d)(3) of this section, CMS will not publicly report the SNF's 
performance period SNF readmission measure rate, achievement score or 
improvement score for the fiscal year; and
    (iii) If CMS determines that a SNF has zero eligible cases during 
the performance period with respect to a fiscal year, CMS will not 
publicly report any information for that SNF for that fiscal year.
    (f) Limitations on review. There is no administrative or judicial 
review of the following:
    (1) The methodology used to determine the value-based incentive 
payment percentage and the amount of the value-based incentive payment 
under section 1888(h)(5) of the Act.

[[Page 983]]

    (2) The determination of the amount of funding available for value-
based incentive payments under section 1888(h)(5)(C)(ii)(III) of the Act 
and the payment reduction under section 1888(h)(6) of the Act.
    (3) The establishment of the performance standards under section 
1888(h)(3) of the Act and the performance period.
    (4) The methodology developed under section 1888(h)(4) of the Act 
that is used to calculate SNF performance scores and the calculation of 
such scores.
    (5) The ranking determinations under section 1888(h)(4)(B) of the 
Act.
    (g) Special rules for the FY 2022 SNF VBP Program. (1) CMS will 
calculate a SNF readmission measure rate for each SNF based on its 
performance on the SNF readmission measure during the performance period 
specified by CMS for fiscal year 2022, but CMS will not calculate a 
performance score for any SNF using the methodology described in 
paragraphs (d)(1) and (2) of this section. CMS will instead assign a 
performance score of zero to each SNF, with the exception of those SNFs 
qualifying for the low-volume scoring adjustment described in paragraph 
(d)(3) of this section.
    (2) CMS will calculate the value-based incentive payment adjustment 
factor for each SNF using a performance score of zero and will then 
calculate the value-based incentive payment amount for each SNF using 
the methodology described in paragraph (c)(2)(ii) of this section. CMS 
will then apply low-volume scoring adjustment described in paragraph 
(d)(3) of this section.
    (3) CMS will provide confidential feedback reports to SNFs on their 
performance on the SNF readmission measure in accordance with paragraphs 
(e)(1) and (2) of this section.
    (4) CMS will publicly report SNF performance on the SNF readmission 
measure in accordance with paragraph (e)(3) of this section.

[82 FR 36633, Aug. 4, 2017, as amended at 83 FR 39289, Aug. 8, 2018; 85 
FR 47633, Aug. 5, 2020; 86 FR 42524, Aug. 4, 2021]



Sec.  413.340  Transition period.

    (a) Duration of transition period and proportions for the blended 
transition rate. Beginning with an SNF's first cost reporting period 
beginning on or after July 1, 1998, there is a transition period 
covering three cost reporting periods. During this transition phase, 
SNFs receive a payment rate comprising a blend of the adjusted Federal 
rate and a facility-specific rate. For the first cost reporting period 
beginning on or after July 1, 1998, payment is based on 75 percent of 
the facility-specific rate and 25 percent of the Federal rate. For the 
subsequent cost reporting period, the rate is comprised of 50 percent of 
the facility-specific rate and 50 percent of the Federal rate. In the 
final cost reporting period of the transition, the rate is comprised of 
25 percent of the facility-specific rate and 75 percent of the Federal 
rate. For all subsequent cost reporting periods, payment is based 
entirely on the Federal rate.
    (b) Calculation of facility-specific rate for the first cost 
reporting period. The facility-specific rate is computed based on the 
SNF's Medicare allowable costs from its fiscal year 1995 cost report 
plus an estimate of the amounts payable under Part B for covered SNF 
services (other than those services described in Sec.  411.15(p)(2) of 
this chapter) furnished during fiscal year 1995 to individuals who were 
residents of SNFs and receiving Part A covered services. Allowable costs 
associated with exceptions, as described in Sec.  413.30(f), are 
included in the calculation of the facility-specific rate. Allowable 
costs associated with exemptions, as described in Sec.  413.30(e)(2), 
are included in the calculation of the facility-specific rate but only 
to the extent that they do not exceed 150 percent of the routine cost 
limit. Low Medicare volume SNFs that were paid a prospectively 
determined rate under Sec.  413.300 for their cost reporting period 
beginning in fiscal year 1995 will utilize that rate as the basis for 
the allowable costs of routine (operating and capital-related) expenses 
in determining the facility-specific rate. Each SNF's allowable costs 
are updated to the first cost reporting period to which the payment 
rates apply using annual factors equal to the SNF market basket 
percentage minus 1 percentage point.
    (c) SNFs participating in the Multistate Nursing Home Case-Mix and 
Quality

[[Page 984]]

Demonstration. SNFs that participated in the Multistate Nursing Home 
Case-Mix and Quality Demonstration in a cost reporting period that began 
in calendar year 1997 will utilize their allowable costs from that cost 
reporting period, including prospective payment amounts determined under 
the demonstration payment methodology.
    (d) Update of facility-specific rates for subsequent cost reporting 
periods. The facility-specific rate for a cost reporting period that is 
subsequent to the first cost reporting period is equal to the facility-
specific rate for the first cost reporting period (described in 
paragraph (a) of this section) updated by the market basket index.
    (1) For a subsequent cost reporting period beginning in fiscal years 
1998 and 1999, the facility-specific rate is equal to the facility-
specific rate for the previous cost reporting period updated by the 
applicable market basket index percentage minus one percentage point.
    (2) For a subsequent cost reporting period beginning in fiscal year 
2000, the facility-specific rate is equal to the facility-specific rate 
for the previous cost reporting period updated by the applicable market 
basket index percentage.
    (e) SNFs excluded from the transition period. SNFs that received 
their first payment from Medicare, under present or previous ownership, 
on or after October 1, 1995, are excluded from the transition period, 
and payment is made according to the Federal rates only.



Sec.  413.343  Resident assessment data.

    (a) Submission of resident assessment data. SNFs are required to 
submit the resident assessment data described at Sec.  483.20 of this 
chapter in the manner necessary to administer the payment rate 
methodology described in Sec.  413.337. This provision includes the 
frequency, scope, and number of assessments required.
    (b) Assessment schedule. In accordance with the methodology 
described in Sec.  413.337(c) related to the adjustment of the Federal 
rates for case-mix, SNFs must submit assessments according to an 
assessment schedule. This schedule must include performance of an 
initial Medicare assessment with an assessment reference date that is 
set for no later than the 8th day of posthospital SNF care, and such 
other interim payment assessments as the SNF determines are necessary to 
account for changes in patient care needs.
    (c) Noncompliance with assessment schedule. CMS pays a default rate 
for the Federal rate when a SNF fails to comply with the assessment 
schedule in paragraph (b) of this section. The default rate is paid for 
the days of a patient's care for which the SNF is not in compliance with 
the assessment schedule.

[63 FR 26309, May 12, 1998, as amended at 64 FR 41682, July 30, 1999; 84 
FR 38832, Aug. 7, 2019]



Sec.  413.345  Publication of Federal prospective payment rates.

    CMS publishes information pertaining to each update of the Federal 
payment rates in the Federal Register. This information includes the 
standardized Federal rates, the resident classification system that 
provides the basis for case-mix adjustment, and the factors to be 
applied in making the area wage adjustment. This information is 
published before May 1 for the fiscal year 1998 and before August 1 for 
the fiscal years 1999 and after.

[82 FR 36634, Aug. 4, 2017]



Sec.  413.348  Limitation on review.

    Judicial or administrative review under sections 1869 or 1878 of the 
Act or otherwise is prohibited with regard to the establishment of the 
Federal rates. This prohibition includes the methodology used in the 
computation of the Federal standardized payment rates, the case-mix 
methodology, and the development and application of the wage index. This 
prohibition on judicial and administrative review also extends to the 
methodology used to establish the facility-specific rates but not to 
determinations related to reasonable cost in the fiscal year 1995 cost 
reporting period used as the basis for these rates.

[[Page 985]]



Sec.  413.350  Periodic interim payments for skilled nursing facilities 
receiving payment under the skilled nursing facility prospective 
payment system for Part A services.

    (a) General rule. Subject to the exceptions in paragraphs (b) and 
(c) of this section, SNFs receiving payment under the PPS for Part A 
services do not receive interim payments during the cost reporting year, 
and receive payment only following submission of a bill. Paragraph (d) 
of this section provides for accelerated payments in certain 
circumstances.
    (b) Periodic interim payments. (1) An SNF receiving payment under 
the prospective payment system may receive periodic interim payments 
(PIP) for Part A SNF services under the PIP method subject to the 
provisions of Sec.  413.64(h). To be approved for PIP, the SNF must meet 
the qualifying requirements in Sec.  413.64(h)(3). Moreover, as provided 
in Sec.  413.64(h)(5), contractor approval is conditioned upon the 
contractor's best judgment as to whether payment can be made under the 
PIP method without undue risk of its resulting in an overpayment to the 
provider.
    (2) Frequency of payment. The contractor estimates an SNF's 
prospective payments net of estimated beneficiary coinsurance and makes 
biweekly payments equal to \1/26\ of the total estimated amount of 
payment for the year. If an SNF has payment experience under the 
prospective payment system, the contractor estimates PIP based on that 
payment experience, adjusted for projected changes supported by 
substantiated information for the current year. Each payment is made 2 
weeks after the end of a biweekly period of service as described in 
Sec.  413.64(h)(6). The interim payments are reviewed at least twice 
during the reporting period and adjusted if necessary. Fewer reviews may 
be necessary if an SNF receives interim payments for less than a full 
reporting period. These payments are subject to final settlement.
    (3) Termination of PIP--(i) Request by the SNF. An SNF receiving PIP 
may convert to receiving prospective payments on a non-PIP basis at any 
time.
    (ii) Removal by the contractor. An contractor terminates PIP if the 
SNF no longer meets the requirements of Sec.  413.64(h).
    (c) Interim payments for Medicare bad debts and for Part A costs not 
paid under the prospective payment system. For Medicare bad debts and 
for costs of an approved education program and other costs paid outside 
the prospective payment system, the contractor determines the interim 
payments by estimating the reimbursable amount for the year based on the 
previous year's experience, adjusted for projected changes supported by 
substantiated information for the current year, and makes biweekly 
payments equal to \1/26\ of the total estimated amount. Each payment is 
made 2 weeks after the end of a biweekly period of service as described 
in Sec.  413.64(h)(6). The interim payments are reviewed at least twice 
during the reporting period and adjusted if necessary. Fewer reviews may 
be necessary if an SNF receives interim payments for less than a full 
reporting period. These payments are subject to final cost settlement.
    (d) Accelerated payments--(1) General rule. Upon request, an 
accelerated payment may be made to an SNF that is receiving payment 
under the prospective payment system and is not receiving PIP under 
paragraph (b) of this section if the SNF is experiencing financial 
difficulties because of the following:
    (i) There is a delay by the contractor in making payment to the SNF.
    (ii) Due to an exceptional situation, there is a temporary delay in 
the SNF's preparation and submittal of bills to the contractor beyond 
its normal billing cycle.
    (2) Approval of payment. An SNF's request for an accelerated payment 
must be approved by the contractor and CMS.
    (3) Amount of payment. The amount of the accelerated payment is 
computed as a percentage of the net payment for unbilled or unpaid 
covered services.
    (4) Recovery of payment. Recovery of the accelerated payment is made 
by recoupment as SNF bills are processed or by direct payment by the 
SNF.

[64 FR 41682, July 30, 1999]

[[Page 986]]



Sec.  413.355  Additional payment: QIO reimbursement for cost 
of sending records electronically or by photocopy and mailing.

    An additional payment is made to a skilled nursing facility in 
accordance with Sec.  476.78 of this chapter for the costs of sending 
requested patient records to the QIO in electronic format, by facsimile, 
or by photocopying and mailing.

[85 FR 59025, Sept. 18, 2020]



Sec.  413.360  Requirements under the Skilled Nursing Facility (SNF) 
Quality Reporting Program (QRP).

    (a) Participation start date. Beginning with the FY 2018 program 
year, a SNF must begin reporting data in accordance with paragraph (b) 
of this section no later than the first day of the calendar quarter 
subsequent to 30 days after the date on its CMS Certification Number 
(CCN) notification letter, which designates the SNF as operating in the 
CMS designated data submission system. For purposes of this section, a 
program year is the fiscal year in which the market basket percentage 
described in Sec.  413.337(d) is reduced by two percentage points if the 
SNF does not report data in accordance with paragraph (b) of this 
section.
    (b) Data submission requirement. (1) Except as provided in paragraph 
(c) of this section, and for a program year, SNFs must submit to CMS 
data on measures specified under sections 1899B(c)(1) and 1899B(d)(1) of 
the Social Security Act and standardized resident assessment data in 
accordance with section 1899B(b)(1) of the Social Security Act, in the 
form and manner, and at a time, specified by CMS.
    (2) CMS will consider a SNF to have complied with paragraph (b)(1) 
of this section for a program year if the SNF reports: 100 percent of 
the required data elements on at least 80 percent of the MDS assessments 
submitted for that program year.
    (3) CMS may remove a quality measure from the SNF QRP based on one 
or more of the following factors:
    (i) Measure performance among SNFs is so high and unvarying that 
meaningful distinctions in improvements in performance can no longer be 
made.
    (ii) Performance or improvement on a measure does not result in 
better resident outcomes.
    (iii) A measure does not align with current clinical guidelines or 
practice.
    (iv) The availability of a more broadly applicable (across settings, 
populations, or conditions) measure for the particular topic.
    (v) The availability of a measure that is more proximal in time to 
desired resident outcomes for the particular topic.
    (vi) The availability of a measure that is more strongly associated 
with desired resident outcomes for the particular topic.
    (vii) Collection or public reporting of a measure leads to negative 
unintended consequences other than resident harm.
    (viii) The costs associated with a measure outweigh the benefit of 
its continued use in the program.
    (c) Exception and extension requests. (1) A SNF may request and CMS 
may grant exceptions or extensions to the reporting requirements under 
paragraph (b) of this section for one or more quarters, when there are 
certain extraordinary circumstances beyond the control of the SNF.
    (2) A SNF may request an exception or extension within 90 days of 
the date that the extraordinary circumstances occurred by sending an 
email to [email protected] that contains all of the 
following information:
    (i) SNF CMS Certification Number (CCN).
    (ii) SNF Business Name.
    (iii) SNF Business Address.
    (iv) CEO or CEO-designated personnel contact information including 
name, telephone number, title, email address, and mailing address. (The 
address must be a physical address, not a post office box.)
    (v) SNF's reason for requesting the exception or extension.
    (vi) Evidence of the impact of extraordinary circumstances, 
including, but not limited to, photographs, newspaper, and other media 
articles.
    (vii) Date when the SNF believes it will be able to again submit SNF 
QRP data and a justification for the proposed date.

[[Page 987]]

    (3) Except as provided in paragraph (c)(4) of this section, CMS will 
not consider an exception or extension request unless the SNF requesting 
such exception or extension has complied fully with the requirements in 
this paragraph (c).
    (4) CMS may grant exceptions or extensions to SNFs without a request 
if it determines that one or more of the following has occurred:
    (i) An extraordinary circumstance affects an entire region or 
locale.
    (ii) A systemic problem with one of CMS's data collection systems 
directly affected the ability of a SNF to submit data in accordance with 
paragraph (b) of this section.
    (d) Reconsideration.
    (1) SNFs that do not meet the requirements in paragraph (b) of this 
section for a program year will receive a notification of non-compliance 
sent through at least one of the following methods: The CMS designated 
data submission system, the United States Postal Service, or via an 
email from the Medicare Administrative Contractor (MAC). A SNF may 
request reconsideration no later than 30 calendar days after the date 
identified on the letter of non-compliance.
    (2) Reconsideration requests must be submitted to CMS by sending an 
email to [email protected] containing all of the 
following information:
    (i) SNF CCN.
    (ii) SNF Business Name.
    (iii) SNF Business Address.
    (iv) CEO or CEO-designated personnel contact information including 
name, telephone number, title, email address, and mailing address. (The 
address must be a physical address, not a post office box.)
    (v) CMS identified reason(s) for non-compliance stated in the non-
compliance letter.
    (vi) Reason(s) for requesting reconsideration, including all 
supporting documentation.
    (3) CMS will not consider a reconsideration request unless the SNF 
has complied fully with the requirements in paragraph (d)(2) of this 
section.
    (4) CMS will notify SNFs, in writing, of its final decision 
regarding any reconsideration request through at least one of the 
following methods: CMS designated data submission system, the United 
States Postal Service, or via email from the CMS Medicare Administrative 
Contractor (MAC).
    (e) Appeals. A SNF that is dissatisfied with CMS' decision on a 
request for reconsideration may file an appeal with the Provider 
Reimbursement Review Board (PRRB) under 42 CFR part 405, subpart R.

[82 FR 36634, Aug. 4, 2017, as amended at 83 FR 39290, Aug. 8, 2018; 84 
FR 38832, Aug. 7, 2019]



        Subpart K_Payment for Acute Kidney Injury (AKI) Dialysis

    Source: 81 FR 77965, Nov. 4, 2016, unless otherwise noted.



Sec.  413.370  Scope.

    This subpart implements section 1834(r) of the Act by setting forth 
the principles and authorities under which CMS is authorized to 
establish a payment amount for renal dialysis services furnished to 
beneficiaries with an acute kidney injury in or under the supervision of 
an ESRD facility that meets the conditions of coverage in part 494 of 
this chapter and as defined in Sec.  413.171.



Sec.  413.371  Definition.

    For purposes of the subpart, the following definition applies:
    Individual with acute kidney injury. The term individual with acute 
kidney injury means an individual who has acute loss of renal function 
and does not receive renal dialysis services for which payment is made 
under section 1881(b)(14) of the Act.



Sec.  413.372  AKI dialysis payment rate.

    The amount of payment for AKI dialysis services shall be the base 
rate for renal dialysis services determined for such year under section 
1881(b)(14), that is, the ESRD base rate as set forth in Sec.  413.220, 
updated by the ESRD bundled market basket percentage increase factor 
minus a productivity adjustment as set forth in Sec.  413.196(d)(1), 
adjusted for wages as set forth in Sec.  413.231, and adjusted by any 
other

[[Page 988]]

amounts deemed appropriate by the Secretary under Sec.  413.373.



Sec.  413.373  Other adjustments to the AKI dialysis payment rate

    The payment rate for AKI dialysis may be adjusted by the Secretary 
(on a budget neutral basis for payments under section 1834(r)) by any 
other adjustment factor under subparagraph (D) of section 1881(b)(14) of 
the Act.



Sec.  413.374  Renal dialysis services included in the AKI 
dialysis payment rate

    (a) The AKI dialysis payment rate applies to renal dialysis services 
(as defined in subparagraph (B) of section 1881(b)(14) of the Act) 
furnished under Part B by a renal dialysis facility or provider of 
services paid under section 1881(b)(14) of the Act.
    (b) Other items and services furnished to beneficiaries with AKI 
that are not considered to be renal dialysis services as defined in 
Sec.  413.171, but that are related to their dialysis treatment as a 
result of their AKI, would be separately payable, that is, drugs, 
biologicals, laboratory services, and supplies that ESRD facilities are 
certified to furnish and that would otherwise be furnished to a 
beneficiary with AKI in a hospital outpatient setting.



Sec.  413.375  Notification of changes in rate-setting methodologies 
and payment rates.

    (a) Changes to the methodology for payment for renal dialysis 
services furnished to beneficiaries with AKI as well as any adjustments 
to the AKI payment rate other than wage index will be adopted through 
notice and comment rulemaking.
    (b) Annual updates in the AKI dialysis payment rate as described in 
Sec.  413.372 that do not include those changes described in paragraph 
(a) of this section are announced by notice published in the Federal 
Register without opportunity for public comment.
    (c) Effective for cost reporting periods beginning on or after 
January 1, 2017, on an annual basis CMS updates the AKI dialysis payment 
rate.

[[Page 989]]



                              FINDING AIDS




  --------------------------------------------------------------------

  A list of CFR titles, subtitles, chapters, subchapters and parts and 
an alphabetical list of agencies publishing in the CFR are included in 
the CFR Index and Finding Aids volume to the Code of Federal Regulations 
which is published separately and revised annually.

  Table of CFR Titles and Chapters
  Alphabetical List of Agencies Appearing in the CFR
  List of CFR Sections Affected

[[Page 991]]



                    Table of CFR Titles and Chapters




                     (Revised as of October 1, 2021)

                      Title 1--General Provisions

         I  Administrative Committee of the Federal Register 
                (Parts 1--49)
        II  Office of the Federal Register (Parts 50--299)
       III  Administrative Conference of the United States (Parts 
                300--399)
        IV  Miscellaneous Agencies (Parts 400--599)
        VI  National Capital Planning Commission (Parts 600--699)

                    Title 2--Grants and Agreements

            Subtitle A--Office of Management and Budget Guidance 
                for Grants and Agreements
         I  Office of Management and Budget Governmentwide 
                Guidance for Grants and Agreements (Parts 2--199)
        II  Office of Management and Budget Guidance (Parts 200--
                299)
            Subtitle B--Federal Agency Regulations for Grants and 
                Agreements
       III  Department of Health and Human Services (Parts 300--
                399)
        IV  Department of Agriculture (Parts 400--499)
        VI  Department of State (Parts 600--699)
       VII  Agency for International Development (Parts 700--799)
      VIII  Department of Veterans Affairs (Parts 800--899)
        IX  Department of Energy (Parts 900--999)
         X  Department of the Treasury (Parts 1000--1099)
        XI  Department of Defense (Parts 1100--1199)
       XII  Department of Transportation (Parts 1200--1299)
      XIII  Department of Commerce (Parts 1300--1399)
       XIV  Department of the Interior (Parts 1400--1499)
        XV  Environmental Protection Agency (Parts 1500--1599)
     XVIII  National Aeronautics and Space Administration (Parts 
                1800--1899)
        XX  United States Nuclear Regulatory Commission (Parts 
                2000--2099)
      XXII  Corporation for National and Community Service (Parts 
                2200--2299)
     XXIII  Social Security Administration (Parts 2300--2399)
      XXIV  Department of Housing and Urban Development (Parts 
                2400--2499)
       XXV  National Science Foundation (Parts 2500--2599)
      XXVI  National Archives and Records Administration (Parts 
                2600--2699)

[[Page 992]]

     XXVII  Small Business Administration (Parts 2700--2799)
    XXVIII  Department of Justice (Parts 2800--2899)
      XXIX  Department of Labor (Parts 2900--2999)
       XXX  Department of Homeland Security (Parts 3000--3099)
      XXXI  Institute of Museum and Library Services (Parts 3100--
                3199)
     XXXII  National Endowment for the Arts (Parts 3200--3299)
    XXXIII  National Endowment for the Humanities (Parts 3300--
                3399)
     XXXIV  Department of Education (Parts 3400--3499)
      XXXV  Export-Import Bank of the United States (Parts 3500--
                3599)
     XXXVI  Office of National Drug Control Policy, Executive 
                Office of the President (Parts 3600--3699)
    XXXVII  Peace Corps (Parts 3700--3799)
     LVIII  Election Assistance Commission (Parts 5800--5899)
       LIX  Gulf Coast Ecosystem Restoration Council (Parts 5900--
                5999)

                        Title 3--The President

         I  Executive Office of the President (Parts 100--199)

                           Title 4--Accounts

         I  Government Accountability Office (Parts 1--199)

                   Title 5--Administrative Personnel

         I  Office of Personnel Management (Parts 1--1199)
        II  Merit Systems Protection Board (Parts 1200--1299)
       III  Office of Management and Budget (Parts 1300--1399)
        IV  Office of Personnel Management and Office of the 
                Director of National Intelligence (Parts 1400--
                1499)
         V  The International Organizations Employees Loyalty 
                Board (Parts 1500--1599)
        VI  Federal Retirement Thrift Investment Board (Parts 
                1600--1699)
      VIII  Office of Special Counsel (Parts 1800--1899)
        IX  Appalachian Regional Commission (Parts 1900--1999)
        XI  Armed Forces Retirement Home (Parts 2100--2199)
       XIV  Federal Labor Relations Authority, General Counsel of 
                the Federal Labor Relations Authority and Federal 
                Service Impasses Panel (Parts 2400--2499)
       XVI  Office of Government Ethics (Parts 2600--2699)
       XXI  Department of the Treasury (Parts 3100--3199)
      XXII  Federal Deposit Insurance Corporation (Parts 3200--
                3299)
     XXIII  Department of Energy (Parts 3300--3399)
      XXIV  Federal Energy Regulatory Commission (Parts 3400--
                3499)
       XXV  Department of the Interior (Parts 3500--3599)
      XXVI  Department of Defense (Parts 3600--3699)

[[Page 993]]

    XXVIII  Department of Justice (Parts 3800--3899)
      XXIX  Federal Communications Commission (Parts 3900--3999)
       XXX  Farm Credit System Insurance Corporation (Parts 4000--
                4099)
      XXXI  Farm Credit Administration (Parts 4100--4199)
    XXXIII  U.S. International Development Finance Corporation 
                (Parts 4300--4399)
     XXXIV  Securities and Exchange Commission (Parts 4400--4499)
      XXXV  Office of Personnel Management (Parts 4500--4599)
     XXXVI  Department of Homeland Security (Parts 4600--4699)
    XXXVII  Federal Election Commission (Parts 4700--4799)
        XL  Interstate Commerce Commission (Parts 5000--5099)
       XLI  Commodity Futures Trading Commission (Parts 5100--
                5199)
      XLII  Department of Labor (Parts 5200--5299)
     XLIII  National Science Foundation (Parts 5300--5399)
       XLV  Department of Health and Human Services (Parts 5500--
                5599)
      XLVI  Postal Rate Commission (Parts 5600--5699)
     XLVII  Federal Trade Commission (Parts 5700--5799)
    XLVIII  Nuclear Regulatory Commission (Parts 5800--5899)
      XLIX  Federal Labor Relations Authority (Parts 5900--5999)
         L  Department of Transportation (Parts 6000--6099)
       LII  Export-Import Bank of the United States (Parts 6200--
                6299)
      LIII  Department of Education (Parts 6300--6399)
       LIV  Environmental Protection Agency (Parts 6400--6499)
        LV  National Endowment for the Arts (Parts 6500--6599)
       LVI  National Endowment for the Humanities (Parts 6600--
                6699)
      LVII  General Services Administration (Parts 6700--6799)
     LVIII  Board of Governors of the Federal Reserve System 
                (Parts 6800--6899)
       LIX  National Aeronautics and Space Administration (Parts 
                6900--6999)
        LX  United States Postal Service (Parts 7000--7099)
       LXI  National Labor Relations Board (Parts 7100--7199)
      LXII  Equal Employment Opportunity Commission (Parts 7200--
                7299)
     LXIII  Inter-American Foundation (Parts 7300--7399)
      LXIV  Merit Systems Protection Board (Parts 7400--7499)
       LXV  Department of Housing and Urban Development (Parts 
                7500--7599)
      LXVI  National Archives and Records Administration (Parts 
                7600--7699)
     LXVII  Institute of Museum and Library Services (Parts 7700--
                7799)
    LXVIII  Commission on Civil Rights (Parts 7800--7899)
      LXIX  Tennessee Valley Authority (Parts 7900--7999)
       LXX  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 8000--8099)
      LXXI  Consumer Product Safety Commission (Parts 8100--8199)
    LXXIII  Department of Agriculture (Parts 8300--8399)

[[Page 994]]

     LXXIV  Federal Mine Safety and Health Review Commission 
                (Parts 8400--8499)
     LXXVI  Federal Retirement Thrift Investment Board (Parts 
                8600--8699)
    LXXVII  Office of Management and Budget (Parts 8700--8799)
      LXXX  Federal Housing Finance Agency (Parts 9000--9099)
   LXXXIII  Special Inspector General for Afghanistan 
                Reconstruction (Parts 9300--9399)
    LXXXIV  Bureau of Consumer Financial Protection (Parts 9400--
                9499)
    LXXXVI  National Credit Union Administration (Parts 9600--
                9699)
     XCVII  Department of Homeland Security Human Resources 
                Management System (Department of Homeland 
                Security--Office of Personnel Management) (Parts 
                9700--9799)
    XCVIII  Council of the Inspectors General on Integrity and 
                Efficiency (Parts 9800--9899)
      XCIX  Military Compensation and Retirement Modernization 
                Commission (Parts 9900--9999)
         C  National Council on Disability (Parts 10000--10049)
        CI  National Mediation Board (Parts 10100--10199)
       CII  U.S. Office of Special Counsel (Parts 10200--10299)

                      Title 6--Domestic Security

         I  Department of Homeland Security, Office of the 
                Secretary (Parts 1--199)
         X  Privacy and Civil Liberties Oversight Board (Parts 
                1000--1099)

                         Title 7--Agriculture

            Subtitle A--Office of the Secretary of Agriculture 
                (Parts 0--26)
            Subtitle B--Regulations of the Department of 
                Agriculture
         I  Agricultural Marketing Service (Standards, 
                Inspections, Marketing Practices), Department of 
                Agriculture (Parts 27--209)
        II  Food and Nutrition Service, Department of Agriculture 
                (Parts 210--299)
       III  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 300--399)
        IV  Federal Crop Insurance Corporation, Department of 
                Agriculture (Parts 400--499)
         V  Agricultural Research Service, Department of 
                Agriculture (Parts 500--599)
        VI  Natural Resources Conservation Service, Department of 
                Agriculture (Parts 600--699)
       VII  Farm Service Agency, Department of Agriculture (Parts 
                700--799)
      VIII  Agricultural Marketing Service (Federal Grain 
                Inspection Service, Fair Trade Practices Program), 
                Department of Agriculture (Parts 800--899)

[[Page 995]]

        IX  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Fruits, Vegetables, Nuts), Department 
                of Agriculture (Parts 900--999)
         X  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Milk), Department of Agriculture 
                (Parts 1000--1199)
        XI  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Miscellaneous Commodities), Department 
                of Agriculture (Parts 1200--1299)
       XIV  Commodity Credit Corporation, Department of 
                Agriculture (Parts 1400--1499)
        XV  Foreign Agricultural Service, Department of 
                Agriculture (Parts 1500--1599)
       XVI  [Reserved]
      XVII  Rural Utilities Service, Department of Agriculture 
                (Parts 1700--1799)
     XVIII  Rural Housing Service, Rural Business-Cooperative 
                Service, Rural Utilities Service, and Farm Service 
                Agency, Department of Agriculture (Parts 1800--
                2099)
        XX  [Reserved]
       XXV  Office of Advocacy and Outreach, Department of 
                Agriculture (Parts 2500--2599)
      XXVI  Office of Inspector General, Department of Agriculture 
                (Parts 2600--2699)
     XXVII  Office of Information Resources Management, Department 
                of Agriculture (Parts 2700--2799)
    XXVIII  Office of Operations, Department of Agriculture (Parts 
                2800--2899)
      XXIX  Office of Energy Policy and New Uses, Department of 
                Agriculture (Parts 2900--2999)
       XXX  Office of the Chief Financial Officer, Department of 
                Agriculture (Parts 3000--3099)
      XXXI  Office of Environmental Quality, Department of 
                Agriculture (Parts 3100--3199)
     XXXII  Office of Procurement and Property Management, 
                Department of Agriculture (Parts 3200--3299)
    XXXIII  Office of Transportation, Department of Agriculture 
                (Parts 3300--3399)
     XXXIV  National Institute of Food and Agriculture (Parts 
                3400--3499)
      XXXV  Rural Housing Service, Department of Agriculture 
                (Parts 3500--3599)
     XXXVI  National Agricultural Statistics Service, Department 
                of Agriculture (Parts 3600--3699)
    XXXVII  Economic Research Service, Department of Agriculture 
                (Parts 3700--3799)
   XXXVIII  World Agricultural Outlook Board, Department of 
                Agriculture (Parts 3800--3899)
       XLI  [Reserved]
      XLII  Rural Business-Cooperative Service and Rural Utilities 
                Service, Department of Agriculture (Parts 4200--
                4299)

[[Page 996]]

         L  Rural Business-Cooperative Service, and Rural 
                Utilities Service, Department of Agriculture 
                (Parts 5000--5099)

                    Title 8--Aliens and Nationality

         I  Department of Homeland Security (Parts 1--499)
         V  Executive Office for Immigration Review, Department of 
                Justice (Parts 1000--1399)

                 Title 9--Animals and Animal Products

         I  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 1--199)
        II  Agricultural Marketing Service (Fair Trade Practices 
                Program), Department of Agriculture (Parts 200--
                299)
       III  Food Safety and Inspection Service, Department of 
                Agriculture (Parts 300--599)

                           Title 10--Energy

         I  Nuclear Regulatory Commission (Parts 0--199)
        II  Department of Energy (Parts 200--699)
       III  Department of Energy (Parts 700--999)
         X  Department of Energy (General Provisions) (Parts 
                1000--1099)
      XIII  Nuclear Waste Technical Review Board (Parts 1300--
                1399)
      XVII  Defense Nuclear Facilities Safety Board (Parts 1700--
                1799)
     XVIII  Northeast Interstate Low-Level Radioactive Waste 
                Commission (Parts 1800--1899)

                      Title 11--Federal Elections

         I  Federal Election Commission (Parts 1--9099)
        II  Election Assistance Commission (Parts 9400--9499)

                      Title 12--Banks and Banking

         I  Comptroller of the Currency, Department of the 
                Treasury (Parts 1--199)
        II  Federal Reserve System (Parts 200--299)
       III  Federal Deposit Insurance Corporation (Parts 300--399)
        IV  Export-Import Bank of the United States (Parts 400--
                499)
         V  [Reserved]
        VI  Farm Credit Administration (Parts 600--699)
       VII  National Credit Union Administration (Parts 700--799)
      VIII  Federal Financing Bank (Parts 800--899)
        IX  [Reserved]
         X  Bureau of Consumer Financial Protection (Parts 1000--
                1099)

[[Page 997]]

        XI  Federal Financial Institutions Examination Council 
                (Parts 1100--1199)
       XII  Federal Housing Finance Agency (Parts 1200--1299)
      XIII  Financial Stability Oversight Council (Parts 1300--
                1399)
       XIV  Farm Credit System Insurance Corporation (Parts 1400--
                1499)
        XV  Department of the Treasury (Parts 1500--1599)
       XVI  Office of Financial Research, Department of the 
                Treasury (Parts 1600--1699)
      XVII  Office of Federal Housing Enterprise Oversight, 
                Department of Housing and Urban Development (Parts 
                1700--1799)
     XVIII  Community Development Financial Institutions Fund, 
                Department of the Treasury (Parts 1800--1899)

               Title 13--Business Credit and Assistance

         I  Small Business Administration (Parts 1--199)
       III  Economic Development Administration, Department of 
                Commerce (Parts 300--399)
        IV  Emergency Steel Guarantee Loan Board (Parts 400--499)
         V  Emergency Oil and Gas Guaranteed Loan Board (Parts 
                500--599)

                    Title 14--Aeronautics and Space

         I  Federal Aviation Administration, Department of 
                Transportation (Parts 1--199)
        II  Office of the Secretary, Department of Transportation 
                (Aviation Proceedings) (Parts 200--399)
       III  Commercial Space Transportation, Federal Aviation 
                Administration, Department of Transportation 
                (Parts 400--1199)
         V  National Aeronautics and Space Administration (Parts 
                1200--1299)
        VI  Air Transportation System Stabilization (Parts 1300--
                1399)

                 Title 15--Commerce and Foreign Trade

            Subtitle A--Office of the Secretary of Commerce (Parts 
                0--29)
            Subtitle B--Regulations Relating to Commerce and 
                Foreign Trade
         I  Bureau of the Census, Department of Commerce (Parts 
                30--199)
        II  National Institute of Standards and Technology, 
                Department of Commerce (Parts 200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  Foreign-Trade Zones Board, Department of Commerce 
                (Parts 400--499)
       VII  Bureau of Industry and Security, Department of 
                Commerce (Parts 700--799)

[[Page 998]]

      VIII  Bureau of Economic Analysis, Department of Commerce 
                (Parts 800--899)
        IX  National Oceanic and Atmospheric Administration, 
                Department of Commerce (Parts 900--999)
        XI  National Technical Information Service, Department of 
                Commerce (Parts 1100--1199)
      XIII  East-West Foreign Trade Board (Parts 1300--1399)
       XIV  Minority Business Development Agency (Parts 1400--
                1499)
        XV  Office of the Under-Secretary for Economic Affairs, 
                Department of Commerce (Parts 1500--1599)
            Subtitle C--Regulations Relating to Foreign Trade 
                Agreements
        XX  Office of the United States Trade Representative 
                (Parts 2000--2099)
            Subtitle D--Regulations Relating to Telecommunications 
                and Information
     XXIII  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                2300--2399) [Reserved]

                    Title 16--Commercial Practices

         I  Federal Trade Commission (Parts 0--999)
        II  Consumer Product Safety Commission (Parts 1000--1799)

             Title 17--Commodity and Securities Exchanges

         I  Commodity Futures Trading Commission (Parts 1--199)
        II  Securities and Exchange Commission (Parts 200--399)
        IV  Department of the Treasury (Parts 400--499)

          Title 18--Conservation of Power and Water Resources

         I  Federal Energy Regulatory Commission, Department of 
                Energy (Parts 1--399)
       III  Delaware River Basin Commission (Parts 400--499)
        VI  Water Resources Council (Parts 700--799)
      VIII  Susquehanna River Basin Commission (Parts 800--899)
      XIII  Tennessee Valley Authority (Parts 1300--1399)

                       Title 19--Customs Duties

         I  U.S. Customs and Border Protection, Department of 
                Homeland Security; Department of the Treasury 
                (Parts 0--199)
        II  United States International Trade Commission (Parts 
                200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  U.S. Immigration and Customs Enforcement, Department 
                of Homeland Security (Parts 400--599) [Reserved]

[[Page 999]]

                     Title 20--Employees' Benefits

         I  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 1--199)
        II  Railroad Retirement Board (Parts 200--399)
       III  Social Security Administration (Parts 400--499)
        IV  Employees' Compensation Appeals Board, Department of 
                Labor (Parts 500--599)
         V  Employment and Training Administration, Department of 
                Labor (Parts 600--699)
        VI  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 700--799)
       VII  Benefits Review Board, Department of Labor (Parts 
                800--899)
      VIII  Joint Board for the Enrollment of Actuaries (Parts 
                900--999)
        IX  Office of the Assistant Secretary for Veterans' 
                Employment and Training Service, Department of 
                Labor (Parts 1000--1099)

                       Title 21--Food and Drugs

         I  Food and Drug Administration, Department of Health and 
                Human Services (Parts 1--1299)
        II  Drug Enforcement Administration, Department of Justice 
                (Parts 1300--1399)
       III  Office of National Drug Control Policy (Parts 1400--
                1499)

                      Title 22--Foreign Relations

         I  Department of State (Parts 1--199)
        II  Agency for International Development (Parts 200--299)
       III  Peace Corps (Parts 300--399)
        IV  International Joint Commission, United States and 
                Canada (Parts 400--499)
         V  United States Agency for Global Media (Parts 500--599)
       VII  U.S. International Development Finance Corporation 
                (Parts 700--799)
        IX  Foreign Service Grievance Board (Parts 900--999)
         X  Inter-American Foundation (Parts 1000--1099)
        XI  International Boundary and Water Commission, United 
                States and Mexico, United States Section (Parts 
                1100--1199)
       XII  United States International Development Cooperation 
                Agency (Parts 1200--1299)
      XIII  Millennium Challenge Corporation (Parts 1300--1399)
       XIV  Foreign Service Labor Relations Board; Federal Labor 
                Relations Authority; General Counsel of the 
                Federal Labor Relations Authority; and the Foreign 
                Service Impasse Disputes Panel (Parts 1400--1499)
        XV  African Development Foundation (Parts 1500--1599)
       XVI  Japan-United States Friendship Commission (Parts 
                1600--1699)
      XVII  United States Institute of Peace (Parts 1700--1799)

[[Page 1000]]

                          Title 23--Highways

         I  Federal Highway Administration, Department of 
                Transportation (Parts 1--999)
        II  National Highway Traffic Safety Administration and 
                Federal Highway Administration, Department of 
                Transportation (Parts 1200--1299)
       III  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 1300--1399)

                Title 24--Housing and Urban Development

            Subtitle A--Office of the Secretary, Department of 
                Housing and Urban Development (Parts 0--99)
            Subtitle B--Regulations Relating to Housing and Urban 
                Development
         I  Office of Assistant Secretary for Equal Opportunity, 
                Department of Housing and Urban Development (Parts 
                100--199)
        II  Office of Assistant Secretary for Housing-Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 200--299)
       III  Government National Mortgage Association, Department 
                of Housing and Urban Development (Parts 300--399)
        IV  Office of Housing and Office of Multifamily Housing 
                Assistance Restructuring, Department of Housing 
                and Urban Development (Parts 400--499)
         V  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 500--599)
        VI  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 600--699) [Reserved]
       VII  Office of the Secretary, Department of Housing and 
                Urban Development (Housing Assistance Programs and 
                Public and Indian Housing Programs) (Parts 700--
                799)
      VIII  Office of the Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Section 8 Housing Assistance 
                Programs, Section 202 Direct Loan Program, Section 
                202 Supportive Housing for the Elderly Program and 
                Section 811 Supportive Housing for Persons With 
                Disabilities Program) (Parts 800--899)
        IX  Office of Assistant Secretary for Public and Indian 
                Housing, Department of Housing and Urban 
                Development (Parts 900--1699)
         X  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Interstate Land Sales 
                Registration Program) (Parts 1700--1799) 
                [Reserved]
       XII  Office of Inspector General, Department of Housing and 
                Urban Development (Parts 2000--2099)
        XV  Emergency Mortgage Insurance and Loan Programs, 
                Department of Housing and Urban Development (Parts 
                2700--2799) [Reserved]

[[Page 1001]]

        XX  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 3200--3899)
      XXIV  Board of Directors of the HOPE for Homeowners Program 
                (Parts 4000--4099) [Reserved]
       XXV  Neighborhood Reinvestment Corporation (Parts 4100--
                4199)

                           Title 25--Indians

         I  Bureau of Indian Affairs, Department of the Interior 
                (Parts 1--299)
        II  Indian Arts and Crafts Board, Department of the 
                Interior (Parts 300--399)
       III  National Indian Gaming Commission, Department of the 
                Interior (Parts 500--599)
        IV  Office of Navajo and Hopi Indian Relocation (Parts 
                700--899)
         V  Bureau of Indian Affairs, Department of the Interior, 
                and Indian Health Service, Department of Health 
                and Human Services (Part 900--999)
        VI  Office of the Assistant Secretary, Indian Affairs, 
                Department of the Interior (Parts 1000--1199)
       VII  Office of the Special Trustee for American Indians, 
                Department of the Interior (Parts 1200--1299)

                      Title 26--Internal Revenue

         I  Internal Revenue Service, Department of the Treasury 
                (Parts 1--End)

           Title 27--Alcohol, Tobacco Products and Firearms

         I  Alcohol and Tobacco Tax and Trade Bureau, Department 
                of the Treasury (Parts 1--399)
        II  Bureau of Alcohol, Tobacco, Firearms, and Explosives, 
                Department of Justice (Parts 400--799)

                   Title 28--Judicial Administration

         I  Department of Justice (Parts 0--299)
       III  Federal Prison Industries, Inc., Department of Justice 
                (Parts 300--399)
         V  Bureau of Prisons, Department of Justice (Parts 500--
                599)
        VI  Offices of Independent Counsel, Department of Justice 
                (Parts 600--699)
       VII  Office of Independent Counsel (Parts 700--799)
      VIII  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 800--899)
        IX  National Crime Prevention and Privacy Compact Council 
                (Parts 900--999)

[[Page 1002]]

        XI  Department of Justice and Department of State (Parts 
                1100--1199)

                            Title 29--Labor

            Subtitle A--Office of the Secretary of Labor (Parts 
                0--99)
            Subtitle B--Regulations Relating to Labor
         I  National Labor Relations Board (Parts 100--199)
        II  Office of Labor-Management Standards, Department of 
                Labor (Parts 200--299)
       III  National Railroad Adjustment Board (Parts 300--399)
        IV  Office of Labor-Management Standards, Department of 
                Labor (Parts 400--499)
         V  Wage and Hour Division, Department of Labor (Parts 
                500--899)
        IX  Construction Industry Collective Bargaining Commission 
                (Parts 900--999)
         X  National Mediation Board (Parts 1200--1299)
       XII  Federal Mediation and Conciliation Service (Parts 
                1400--1499)
       XIV  Equal Employment Opportunity Commission (Parts 1600--
                1699)
      XVII  Occupational Safety and Health Administration, 
                Department of Labor (Parts 1900--1999)
        XX  Occupational Safety and Health Review Commission 
                (Parts 2200--2499)
       XXV  Employee Benefits Security Administration, Department 
                of Labor (Parts 2500--2599)
     XXVII  Federal Mine Safety and Health Review Commission 
                (Parts 2700--2799)
        XL  Pension Benefit Guaranty Corporation (Parts 4000--
                4999)

                      Title 30--Mineral Resources

         I  Mine Safety and Health Administration, Department of 
                Labor (Parts 1--199)
        II  Bureau of Safety and Environmental Enforcement, 
                Department of the Interior (Parts 200--299)
        IV  Geological Survey, Department of the Interior (Parts 
                400--499)
         V  Bureau of Ocean Energy Management, Department of the 
                Interior (Parts 500--599)
       VII  Office of Surface Mining Reclamation and Enforcement, 
                Department of the Interior (Parts 700--999)
       XII  Office of Natural Resources Revenue, Department of the 
                Interior (Parts 1200--1299)

                 Title 31--Money and Finance: Treasury

            Subtitle A--Office of the Secretary of the Treasury 
                (Parts 0--50)
            Subtitle B--Regulations Relating to Money and Finance

[[Page 1003]]

         I  Monetary Offices, Department of the Treasury (Parts 
                51--199)
        II  Fiscal Service, Department of the Treasury (Parts 
                200--399)
        IV  Secret Service, Department of the Treasury (Parts 
                400--499)
         V  Office of Foreign Assets Control, Department of the 
                Treasury (Parts 500--599)
        VI  Bureau of Engraving and Printing, Department of the 
                Treasury (Parts 600--699)
       VII  Federal Law Enforcement Training Center, Department of 
                the Treasury (Parts 700--799)
      VIII  Office of Investment Security, Department of the 
                Treasury (Parts 800--899)
        IX  Federal Claims Collection Standards (Department of the 
                Treasury--Department of Justice) (Parts 900--999)
         X  Financial Crimes Enforcement Network, Department of 
                the Treasury (Parts 1000--1099)

                      Title 32--National Defense

            Subtitle A--Department of Defense
         I  Office of the Secretary of Defense (Parts 1--399)
         V  Department of the Army (Parts 400--699)
        VI  Department of the Navy (Parts 700--799)
       VII  Department of the Air Force (Parts 800--1099)
            Subtitle B--Other Regulations Relating to National 
                Defense
       XII  Department of Defense, Defense Logistics Agency (Parts 
                1200--1299)
       XVI  Selective Service System (Parts 1600--1699)
      XVII  Office of the Director of National Intelligence (Parts 
                1700--1799)
     XVIII  National Counterintelligence Center (Parts 1800--1899)
       XIX  Central Intelligence Agency (Parts 1900--1999)
        XX  Information Security Oversight Office, National 
                Archives and Records Administration (Parts 2000--
                2099)
       XXI  National Security Council (Parts 2100--2199)
      XXIV  Office of Science and Technology Policy (Parts 2400--
                2499)
     XXVII  Office for Micronesian Status Negotiations (Parts 
                2700--2799)
    XXVIII  Office of the Vice President of the United States 
                (Parts 2800--2899)

               Title 33--Navigation and Navigable Waters

         I  Coast Guard, Department of Homeland Security (Parts 
                1--199)
        II  Corps of Engineers, Department of the Army, Department 
                of Defense (Parts 200--399)
        IV  Great Lakes St. Lawrence Seaway Development 
                Corporation, Department of Transportation (Parts 
                400--499)

[[Page 1004]]

                          Title 34--Education

            Subtitle A--Office of the Secretary, Department of 
                Education (Parts 1--99)
            Subtitle B--Regulations of the Offices of the 
                Department of Education
         I  Office for Civil Rights, Department of Education 
                (Parts 100--199)
        II  Office of Elementary and Secondary Education, 
                Department of Education (Parts 200--299)
       III  Office of Special Education and Rehabilitative 
                Services, Department of Education (Parts 300--399)
        IV  Office of Career, Technical, and Adult Education, 
                Department of Education (Parts 400--499)
         V  Office of Bilingual Education and Minority Languages 
                Affairs, Department of Education (Parts 500--599) 
                [Reserved]
        VI  Office of Postsecondary Education, Department of 
                Education (Parts 600--699)
       VII  Office of Educational Research and Improvement, 
                Department of Education (Parts 700--799) 
                [Reserved]
            Subtitle C--Regulations Relating to Education
        XI  [Reserved]
       XII  National Council on Disability (Parts 1200--1299)

                          Title 35 [Reserved]

             Title 36--Parks, Forests, and Public Property

         I  National Park Service, Department of the Interior 
                (Parts 1--199)
        II  Forest Service, Department of Agriculture (Parts 200--
                299)
       III  Corps of Engineers, Department of the Army (Parts 
                300--399)
        IV  American Battle Monuments Commission (Parts 400--499)
         V  Smithsonian Institution (Parts 500--599)
        VI  [Reserved]
       VII  Library of Congress (Parts 700--799)
      VIII  Advisory Council on Historic Preservation (Parts 800--
                899)
        IX  Pennsylvania Avenue Development Corporation (Parts 
                900--999)
         X  Presidio Trust (Parts 1000--1099)
        XI  Architectural and Transportation Barriers Compliance 
                Board (Parts 1100--1199)
       XII  National Archives and Records Administration (Parts 
                1200--1299)
        XV  Oklahoma City National Memorial Trust (Parts 1500--
                1599)
       XVI  Morris K. Udall Scholarship and Excellence in National 
                Environmental Policy Foundation (Parts 1600--1699)

             Title 37--Patents, Trademarks, and Copyrights

         I  United States Patent and Trademark Office, Department 
                of Commerce (Parts 1--199)
        II  U.S. Copyright Office, Library of Congress (Parts 
                200--299)

[[Page 1005]]

       III  Copyright Royalty Board, Library of Congress (Parts 
                300--399)
        IV  National Institute of Standards and Technology, 
                Department of Commerce (Parts 400--599)

           Title 38--Pensions, Bonuses, and Veterans' Relief

         I  Department of Veterans Affairs (Parts 0--199)
        II  Armed Forces Retirement Home (Parts 200--299)

                       Title 39--Postal Service

         I  United States Postal Service (Parts 1--999)
       III  Postal Regulatory Commission (Parts 3000--3099)

                  Title 40--Protection of Environment

         I  Environmental Protection Agency (Parts 1--1099)
        IV  Environmental Protection Agency and Department of 
                Justice (Parts 1400--1499)
         V  Council on Environmental Quality (Parts 1500--1599)
        VI  Chemical Safety and Hazard Investigation Board (Parts 
                1600--1699)
       VII  Environmental Protection Agency and Department of 
                Defense; Uniform National Discharge Standards for 
                Vessels of the Armed Forces (Parts 1700--1799)
      VIII  Gulf Coast Ecosystem Restoration Council (Parts 1800--
                1899)
        IX  Federal Permitting Improvement Steering Council (Part 
                1900)

          Title 41--Public Contracts and Property Management

            Subtitle A--Federal Procurement Regulations System 
                [Note]
            Subtitle B--Other Provisions Relating to Public 
                Contracts
        50  Public Contracts, Department of Labor (Parts 50-1--50-
                999)
        51  Committee for Purchase From People Who Are Blind or 
                Severely Disabled (Parts 51-1--51-99)
        60  Office of Federal Contract Compliance Programs, Equal 
                Employment Opportunity, Department of Labor (Parts 
                60-1--60-999)
        61  Office of the Assistant Secretary for Veterans' 
                Employment and Training Service, Department of 
                Labor (Parts 61-1--61-999)
   62--100  [Reserved]
            Subtitle C--Federal Property Management Regulations 
                System
       101  Federal Property Management Regulations (Parts 101-1--
                101-99)
       102  Federal Management Regulation (Parts 102-1--102-299)
  103--104  [Reserved]
       105  General Services Administration (Parts 105-1--105-999)

[[Page 1006]]

       109  Department of Energy Property Management Regulations 
                (Parts 109-1--109-99)
       114  Department of the Interior (Parts 114-1--114-99)
       115  Environmental Protection Agency (Parts 115-1--115-99)
       128  Department of Justice (Parts 128-1--128-99)
  129--200  [Reserved]
            Subtitle D--Other Provisions Relating to Property 
                Management
       201  Federal Acquisition Security Council (Part 201)
            Subtitle E [Reserved]
            Subtitle F--Federal Travel Regulation System
       300  General (Parts 300-1--300-99)
       301  Temporary Duty (TDY) Travel Allowances (Parts 301-1--
                301-99)
       302  Relocation Allowances (Parts 302-1--302-99)
       303  Payment of Expenses Connected with the Death of 
                Certain Employees (Part 303-1--303-99)
       304  Payment of Travel Expenses from a Non-Federal Source 
                (Parts 304-1--304-99)

                        Title 42--Public Health

         I  Public Health Service, Department of Health and Human 
                Services (Parts 1--199)
   II--III  [Reserved]
        IV  Centers for Medicare & Medicaid Services, Department 
                of Health and Human Services (Parts 400--699)
         V  Office of Inspector General-Health Care, Department of 
                Health and Human Services (Parts 1000--1099)

                   Title 43--Public Lands: Interior

            Subtitle A--Office of the Secretary of the Interior 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Lands
         I  Bureau of Reclamation, Department of the Interior 
                (Parts 400--999)
        II  Bureau of Land Management, Department of the Interior 
                (Parts 1000--9999)
       III  Utah Reclamation Mitigation and Conservation 
                Commission (Parts 10000--10099)

             Title 44--Emergency Management and Assistance

         I  Federal Emergency Management Agency, Department of 
                Homeland Security (Parts 0--399)
        IV  Department of Commerce and Department of 
                Transportation (Parts 400--499)

[[Page 1007]]

                       Title 45--Public Welfare

            Subtitle A--Department of Health and Human Services 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Welfare
        II  Office of Family Assistance (Assistance Programs), 
                Administration for Children and Families, 
                Department of Health and Human Services (Parts 
                200--299)
       III  Office of Child Support Enforcement (Child Support 
                Enforcement Program), Administration for Children 
                and Families, Department of Health and Human 
                Services (Parts 300--399)
        IV  Office of Refugee Resettlement, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 400--499)
         V  Foreign Claims Settlement Commission of the United 
                States, Department of Justice (Parts 500--599)
        VI  National Science Foundation (Parts 600--699)
       VII  Commission on Civil Rights (Parts 700--799)
      VIII  Office of Personnel Management (Parts 800--899)
        IX  Denali Commission (Parts 900--999)
         X  Office of Community Services, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 1000--1099)
        XI  National Foundation on the Arts and the Humanities 
                (Parts 1100--1199)
       XII  Corporation for National and Community Service (Parts 
                1200--1299)
      XIII  Administration for Children and Families, Department 
                of Health and Human Services (Parts 1300--1399)
       XVI  Legal Services Corporation (Parts 1600--1699)
      XVII  National Commission on Libraries and Information 
                Science (Parts 1700--1799)
     XVIII  Harry S. Truman Scholarship Foundation (Parts 1800--
                1899)
       XXI  Commission of Fine Arts (Parts 2100--2199)
     XXIII  Arctic Research Commission (Parts 2300--2399)
      XXIV  James Madison Memorial Fellowship Foundation (Parts 
                2400--2499)
       XXV  Corporation for National and Community Service (Parts 
                2500--2599)

                          Title 46--Shipping

         I  Coast Guard, Department of Homeland Security (Parts 
                1--199)
        II  Maritime Administration, Department of Transportation 
                (Parts 200--399)
       III  Coast Guard (Great Lakes Pilotage), Department of 
                Homeland Security (Parts 400--499)
        IV  Federal Maritime Commission (Parts 500--599)

[[Page 1008]]

                      Title 47--Telecommunication

         I  Federal Communications Commission (Parts 0--199)
        II  Office of Science and Technology Policy and National 
                Security Council (Parts 200--299)
       III  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                300--399)
        IV  National Telecommunications and Information 
                Administration, Department of Commerce, and 
                National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 400--499)
         V  The First Responder Network Authority (Parts 500--599)

           Title 48--Federal Acquisition Regulations System

         1  Federal Acquisition Regulation (Parts 1--99)
         2  Defense Acquisition Regulations System, Department of 
                Defense (Parts 200--299)
         3  Department of Health and Human Services (Parts 300--
                399)
         4  Department of Agriculture (Parts 400--499)
         5  General Services Administration (Parts 500--599)
         6  Department of State (Parts 600--699)
         7  Agency for International Development (Parts 700--799)
         8  Department of Veterans Affairs (Parts 800--899)
         9  Department of Energy (Parts 900--999)
        10  Department of the Treasury (Parts 1000--1099)
        12  Department of Transportation (Parts 1200--1299)
        13  Department of Commerce (Parts 1300--1399)
        14  Department of the Interior (Parts 1400--1499)
        15  Environmental Protection Agency (Parts 1500--1599)
        16  Office of Personnel Management Federal Employees 
                Health Benefits Acquisition Regulation (Parts 
                1600--1699)
        17  Office of Personnel Management (Parts 1700--1799)
        18  National Aeronautics and Space Administration (Parts 
                1800--1899)
        19  Broadcasting Board of Governors (Parts 1900--1999)
        20  Nuclear Regulatory Commission (Parts 2000--2099)
        21  Office of Personnel Management, Federal Employees 
                Group Life Insurance Federal Acquisition 
                Regulation (Parts 2100--2199)
        23  Social Security Administration (Parts 2300--2399)
        24  Department of Housing and Urban Development (Parts 
                2400--2499)
        25  National Science Foundation (Parts 2500--2599)
        28  Department of Justice (Parts 2800--2899)
        29  Department of Labor (Parts 2900--2999)
        30  Department of Homeland Security, Homeland Security 
                Acquisition Regulation (HSAR) (Parts 3000--3099)
        34  Department of Education Acquisition Regulation (Parts 
                3400--3499)

[[Page 1009]]

        51  Department of the Army Acquisition Regulations (Parts 
                5100--5199) [Reserved]
        52  Department of the Navy Acquisition Regulations (Parts 
                5200--5299)
        53  Department of the Air Force Federal Acquisition 
                Regulation Supplement (Parts 5300--5399) 
                [Reserved]
        54  Defense Logistics Agency, Department of Defense (Parts 
                5400--5499)
        57  African Development Foundation (Parts 5700--5799)
        61  Civilian Board of Contract Appeals, General Services 
                Administration (Parts 6100--6199)
        99  Cost Accounting Standards Board, Office of Federal 
                Procurement Policy, Office of Management and 
                Budget (Parts 9900--9999)

                       Title 49--Transportation

            Subtitle A--Office of the Secretary of Transportation 
                (Parts 1--99)
            Subtitle B--Other Regulations Relating to 
                Transportation
         I  Pipeline and Hazardous Materials Safety 
                Administration, Department of Transportation 
                (Parts 100--199)
        II  Federal Railroad Administration, Department of 
                Transportation (Parts 200--299)
       III  Federal Motor Carrier Safety Administration, 
                Department of Transportation (Parts 300--399)
        IV  Coast Guard, Department of Homeland Security (Parts 
                400--499)
         V  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 500--599)
        VI  Federal Transit Administration, Department of 
                Transportation (Parts 600--699)
       VII  National Railroad Passenger Corporation (AMTRAK) 
                (Parts 700--799)
      VIII  National Transportation Safety Board (Parts 800--999)
         X  Surface Transportation Board (Parts 1000--1399)
        XI  Research and Innovative Technology Administration, 
                Department of Transportation (Parts 1400--1499) 
                [Reserved]
       XII  Transportation Security Administration, Department of 
                Homeland Security (Parts 1500--1699)

                   Title 50--Wildlife and Fisheries

         I  United States Fish and Wildlife Service, Department of 
                the Interior (Parts 1--199)
        II  National Marine Fisheries Service, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 200--299)
       III  International Fishing and Related Activities (Parts 
                300--399)

[[Page 1010]]

        IV  Joint Regulations (United States Fish and Wildlife 
                Service, Department of the Interior and National 
                Marine Fisheries Service, National Oceanic and 
                Atmospheric Administration, Department of 
                Commerce); Endangered Species Committee 
                Regulations (Parts 400--499)
         V  Marine Mammal Commission (Parts 500--599)
        VI  Fishery Conservation and Management, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 600--699)

[[Page 1011]]





           Alphabetical List of Agencies Appearing in the CFR




                     (Revised as of October 1, 2021)

                                                  CFR Title, Subtitle or 
                     Agency                               Chapter

Administrative Conference of the United States    1, III
Advisory Council on Historic Preservation         36, VIII
Advocacy and Outreach, Office of                  7, XXV
Afghanistan Reconstruction, Special Inspector     5, LXXXIII
     General for
African Development Foundation                    22, XV
  Federal Acquisition Regulation                  48, 57
Agency for International Development              2, VII; 22, II
  Federal Acquisition Regulation                  48, 7
Agricultural Marketing Service                    7, I, VIII, IX, X, XI; 9, 
                                                  II
Agricultural Research Service                     7, V
Agriculture, Department of                        2, IV; 5, LXXIII
  Advocacy and Outreach, Office of                7, XXV
  Agricultural Marketing Service                  7, I, VIII, IX, X, XI; 9, 
                                                  II
  Agricultural Research Service                   7, V
  Animal and Plant Health Inspection Service      7, III; 9, I
  Chief Financial Officer, Office of              7, XXX
  Commodity Credit Corporation                    7, XIV
  Economic Research Service                       7, XXXVII
  Energy Policy and New Uses, Office of           2, IX; 7, XXIX
  Environmental Quality, Office of                7, XXXI
  Farm Service Agency                             7, VII, XVIII
  Federal Acquisition Regulation                  48, 4
  Federal Crop Insurance Corporation              7, IV
  Food and Nutrition Service                      7, II
  Food Safety and Inspection Service              9, III
  Foreign Agricultural Service                    7, XV
  Forest Service                                  36, II
  Information Resources Management, Office of     7, XXVII
  Inspector General, Office of                    7, XXVI
  National Agricultural Library                   7, XLI
  National Agricultural Statistics Service        7, XXXVI
  National Institute of Food and Agriculture      7, XXXIV
  Natural Resources Conservation Service          7, VI
  Operations, Office of                           7, XXVIII
  Procurement and Property Management, Office of  7, XXXII
  Rural Business-Cooperative Service              7, XVIII, XLII
  Rural Development Administration                7, XLII
  Rural Housing Service                           7, XVIII, XXXV
  Rural Utilities Service                         7, XVII, XVIII, XLII
  Secretary of Agriculture, Office of             7, Subtitle A
  Transportation, Office of                       7, XXXIII
  World Agricultural Outlook Board                7, XXXVIII
Air Force, Department of                          32, VII
  Federal Acquisition Regulation Supplement       48, 53
Air Transportation Stabilization Board            14, VI
Alcohol and Tobacco Tax and Trade Bureau          27, I
Alcohol, Tobacco, Firearms, and Explosives,       27, II
     Bureau of
AMTRAK                                            49, VII
American Battle Monuments Commission              36, IV
American Indians, Office of the Special Trustee   25, VII
Animal and Plant Health Inspection Service        7, III; 9, I
Appalachian Regional Commission                   5, IX
Architectural and Transportation Barriers         36, XI
   Compliance Board
[[Page 1012]]

Arctic Research Commission                        45, XXIII
Armed Forces Retirement Home                      5, XI; 38, II
Army, Department of                               32, V
  Engineers, Corps of                             33, II; 36, III
  Federal Acquisition Regulation                  48, 51
Benefits Review Board                             20, VII
Bilingual Education and Minority Languages        34, V
     Affairs, Office of
Blind or Severely Disabled, Committee for         41, 51
     Purchase from People Who Are
  Federal Acquisition Regulation                  48, 19
Career, Technical, and Adult Education, Office    34, IV
     of
Census Bureau                                     15, I
Centers for Medicare & Medicaid Services          42, IV
Central Intelligence Agency                       32, XIX
Chemical Safety and Hazard Investigation Board    40, VI
Chief Financial Officer, Office of                7, XXX
Child Support Enforcement, Office of              45, III
Children and Families, Administration for         45, II, III, IV, X, XIII
Civil Rights, Commission on                       5, LXVIII; 45, VII
Civil Rights, Office for                          34, I
Coast Guard                                       33, I; 46, I; 49, IV
Coast Guard (Great Lakes Pilotage)                46, III
Commerce, Department of                           2, XIII; 44, IV; 50, VI
  Census Bureau                                   15, I
  Economic Affairs, Office of the Under-          15, XV
       Secretary for
  Economic Analysis, Bureau of                    15, VIII
  Economic Development Administration             13, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 13
  Foreign-Trade Zones Board                       15, IV
  Industry and Security, Bureau of                15, VII
  International Trade Administration              15, III; 19, III
  National Institute of Standards and Technology  15, II; 37, IV
  National Marine Fisheries Service               50, II, IV
  National Oceanic and Atmospheric                15, IX; 50, II, III, IV, 
       Administration                             VI
  National Technical Information Service          15, XI
  National Telecommunications and Information     15, XXIII; 47, III, IV
       Administration
  National Weather Service                        15, IX
  Patent and Trademark Office, United States      37, I
  Secretary of Commerce, Office of                15, Subtitle A
Commercial Space Transportation                   14, III
Commodity Credit Corporation                      7, XIV
Commodity Futures Trading Commission              5, XLI; 17, I
Community Planning and Development, Office of     24, V, VI
     Assistant Secretary for
Community Services, Office of                     45, X
Comptroller of the Currency                       12, I
Construction Industry Collective Bargaining       29, IX
     Commission
Consumer Financial Protection Bureau              5, LXXXIV; 12, X
Consumer Product Safety Commission                5, LXXI; 16, II
Copyright Royalty Board                           37, III
Corporation for National and Community Service    2, XXII; 45, XII, XXV
Cost Accounting Standards Board                   48, 99
Council on Environmental Quality                  40, V
Council of the Inspectors General on Integrity    5, XCVIII
     and Efficiency
Court Services and Offender Supervision Agency    5, LXX; 28, VIII
     for the District of Columbia
Customs and Border Protection                     19, I
Defense, Department of                            2, XI; 5, XXVI; 32, 
                                                  Subtitle A; 40, VII
  Advanced Research Projects Agency               32, I
  Air Force Department                            32, VII
  Army Department                                 32, V; 33, II; 36, III; 
                                                  48, 51
  Defense Acquisition Regulations System          48, 2
  Defense Intelligence Agency                     32, I

[[Page 1013]]

  Defense Logistics Agency                        32, I, XII; 48, 54
  Engineers, Corps of                             33, II; 36, III
  National Imagery and Mapping Agency             32, I
  Navy, Department of                             32, VI; 48, 52
  Secretary of Defense, Office of                 2, XI; 32, I
Defense Contract Audit Agency                     32, I
Defense Intelligence Agency                       32, I
Defense Logistics Agency                          32, XII; 48, 54
Defense Nuclear Facilities Safety Board           10, XVII
Delaware River Basin Commission                   18, III
Denali Commission                                 45, IX
Disability, National Council on                   5, C; 34, XII
District of Columbia, Court Services and          5, LXX; 28, VIII
     Offender Supervision Agency for the
Drug Enforcement Administration                   21, II
East-West Foreign Trade Board                     15, XIII
Economic Affairs, Office of the Under-Secretary   15, XV
     for
Economic Analysis, Bureau of                      15, VIII
Economic Development Administration               13, III
Economic Research Service                         7, XXXVII
Education, Department of                          2, XXXIV; 5, LIII
  Bilingual Education and Minority Languages      34, V
       Affairs, Office of
  Career, Technical, and Adult Education, Office  34, IV
       of
  Civil Rights, Office for                        34, I
  Educational Research and Improvement, Office    34, VII
       of
  Elementary and Secondary Education, Office of   34, II
  Federal Acquisition Regulation                  48, 34
  Postsecondary Education, Office of              34, VI
  Secretary of Education, Office of               34, Subtitle A
  Special Education and Rehabilitative Services,  34, III
       Office of
Educational Research and Improvement, Office of   34, VII
Election Assistance Commission                    2, LVIII; 11, II
Elementary and Secondary Education, Office of     34, II
Emergency Oil and Gas Guaranteed Loan Board       13, V
Emergency Steel Guarantee Loan Board              13, IV
Employee Benefits Security Administration         29, XXV
Employees' Compensation Appeals Board             20, IV
Employees Loyalty Board                           5, V
Employment and Training Administration            20, V
Employment Policy, National Commission for        1, IV
Employment Standards Administration               20, VI
Endangered Species Committee                      50, IV
Energy, Department of                             2, IX; 5, XXIII; 10, II, 
                                                  III, X
  Federal Acquisition Regulation                  48, 9
  Federal Energy Regulatory Commission            5, XXIV; 18, I
  Property Management Regulations                 41, 109
Energy, Office of                                 7, XXIX
Engineers, Corps of                               33, II; 36, III
Engraving and Printing, Bureau of                 31, VI
Environmental Protection Agency                   2, XV; 5, LIV; 40, I, IV, 
                                                  VII
  Federal Acquisition Regulation                  48, 15
  Property Management Regulations                 41, 115
Environmental Quality, Office of                  7, XXXI
Equal Employment Opportunity Commission           5, LXII; 29, XIV
Equal Opportunity, Office of Assistant Secretary  24, I
     for
Executive Office of the President                 3, I
  Environmental Quality, Council on               40, V
  Management and Budget, Office of                2, Subtitle A; 5, III, 
                                                  LXXVII; 14, VI; 48, 99
  National Drug Control Policy, Office of         2, XXXVI; 21, III
  National Security Council                       32, XXI; 47, II
  Presidential Documents                          3
  Science and Technology Policy, Office of        32, XXIV; 47, II
  Trade Representative, Office of the United      15, XX
     States
[[Page 1014]]

Export-Import Bank of the United States           2, XXXV; 5, LII; 12, IV
Family Assistance, Office of                      45, II
Farm Credit Administration                        5, XXXI; 12, VI
Farm Credit System Insurance Corporation          5, XXX; 12, XIV
Farm Service Agency                               7, VII, XVIII
Federal Acquisition Regulation                    48, 1
Federal Aviation Administration                   14, I
  Commercial Space Transportation                 14, III
Federal Claims Collection Standards               31, IX
Federal Communications Commission                 5, XXIX; 47, I
Federal Contract Compliance Programs, Office of   41, 60
Federal Crop Insurance Corporation                7, IV
Federal Deposit Insurance Corporation             5, XXII; 12, III
Federal Election Commission                       5, XXXVII; 11, I
Federal Emergency Management Agency               44, I
Federal Employees Group Life Insurance Federal    48, 21
     Acquisition Regulation
Federal Employees Health Benefits Acquisition     48, 16
     Regulation
Federal Energy Regulatory Commission              5, XXIV; 18, I
Federal Financial Institutions Examination        12, XI
     Council
Federal Financing Bank                            12, VIII
Federal Highway Administration                    23, I, II
Federal Home Loan Mortgage Corporation            1, IV
Federal Housing Enterprise Oversight Office       12, XVII
Federal Housing Finance Agency                    5, LXXX; 12, XII
Federal Labor Relations Authority                 5, XIV, XLIX; 22, XIV
Federal Law Enforcement Training Center           31, VII
Federal Management Regulation                     41, 102
Federal Maritime Commission                       46, IV
Federal Mediation and Conciliation Service        29, XII
Federal Mine Safety and Health Review Commission  5, LXXIV; 29, XXVII
Federal Motor Carrier Safety Administration       49, III
Federal Permitting Improvement Steering Council   40, IX
Federal Prison Industries, Inc.                   28, III
Federal Procurement Policy Office                 48, 99
Federal Property Management Regulations           41, 101
Federal Railroad Administration                   49, II
Federal Register, Administrative Committee of     1, I
Federal Register, Office of                       1, II
Federal Reserve System                            12, II
  Board of Governors                              5, LVIII
Federal Retirement Thrift Investment Board        5, VI, LXXVI
Federal Service Impasses Panel                    5, XIV
Federal Trade Commission                          5, XLVII; 16, I
Federal Transit Administration                    49, VI
Federal Travel Regulation System                  41, Subtitle F
Financial Crimes Enforcement Network              31, X
Financial Research Office                         12, XVI
Financial Stability Oversight Council             12, XIII
Fine Arts, Commission of                          45, XXI
Fiscal Service                                    31, II
Fish and Wildlife Service, United States          50, I, IV
Food and Drug Administration                      21, I
Food and Nutrition Service                        7, II
Food Safety and Inspection Service                9, III
Foreign Agricultural Service                      7, XV
Foreign Assets Control, Office of                 31, V
Foreign Claims Settlement Commission of the       45, V
     United States
Foreign Service Grievance Board                   22, IX
Foreign Service Impasse Disputes Panel            22, XIV
Foreign Service Labor Relations Board             22, XIV
Foreign-Trade Zones Board                         15, IV
Forest Service                                    36, II
General Services Administration                   5, LVII; 41, 105
  Contract Appeals, Board of                      48, 61
  Federal Acquisition Regulation                  48, 5
  Federal Management Regulation                   41, 102

[[Page 1015]]

  Federal Property Management Regulations         41, 101
  Federal Travel Regulation System                41, Subtitle F
  General                                         41, 300
  Payment From a Non-Federal Source for Travel    41, 304
       Expenses
  Payment of Expenses Connected With the Death    41, 303
       of Certain Employees
  Relocation Allowances                           41, 302
  Temporary Duty (TDY) Travel Allowances          41, 301
Geological Survey                                 30, IV
Government Accountability Office                  4, I
Government Ethics, Office of                      5, XVI
Government National Mortgage Association          24, III
Grain Inspection, Packers and Stockyards          7, VIII; 9, II
     Administration
Great Lakes St. Lawrence Seaway Development       33, IV
     Corporation
Gulf Coast Ecosystem Restoration Council          2, LIX; 40, VIII
Harry S. Truman Scholarship Foundation            45, XVIII
Health and Human Services, Department of          2, III; 5, XLV; 45, 
                                                  Subtitle A
  Centers for Medicare & Medicaid Services        42, IV
  Child Support Enforcement, Office of            45, III
  Children and Families, Administration for       45, II, III, IV, X, XIII
  Community Services, Office of                   45, X
  Family Assistance, Office of                    45, II
  Federal Acquisition Regulation                  48, 3
  Food and Drug Administration                    21, I
  Indian Health Service                           25, V
  Inspector General (Health Care), Office of      42, V
  Public Health Service                           42, I
  Refugee Resettlement, Office of                 45, IV
Homeland Security, Department of                  2, XXX; 5, XXXVI; 6, I; 8, 
                                                  I
  Coast Guard                                     33, I; 46, I; 49, IV
  Coast Guard (Great Lakes Pilotage)              46, III
  Customs and Border Protection                   19, I
  Federal Emergency Management Agency             44, I
  Human Resources Management and Labor Relations  5, XCVII
       Systems
  Immigration and Customs Enforcement Bureau      19, IV
  Transportation Security Administration          49, XII
HOPE for Homeowners Program, Board of Directors   24, XXIV
     of
Housing, Office of, and Multifamily Housing       24, IV
     Assistance Restructuring, Office of
Housing and Urban Development, Department of      2, XXIV; 5, LXV; 24, 
                                                  Subtitle B
  Community Planning and Development, Office of   24, V, VI
       Assistant Secretary for
  Equal Opportunity, Office of Assistant          24, I
       Secretary for
  Federal Acquisition Regulation                  48, 24
  Federal Housing Enterprise Oversight, Office    12, XVII
       of
  Government National Mortgage Association        24, III
  Housing--Federal Housing Commissioner, Office   24, II, VIII, X, XX
       of Assistant Secretary for
  Housing, Office of, and Multifamily Housing     24, IV
       Assistance Restructuring, Office of
  Inspector General, Office of                    24, XII
  Public and Indian Housing, Office of Assistant  24, IX
       Secretary for
  Secretary, Office of                            24, Subtitle A, VII
Housing--Federal Housing Commissioner, Office of  24, II, VIII, X, XX
     Assistant Secretary for
Housing, Office of, and Multifamily Housing       24, IV
     Assistance Restructuring, Office of
Immigration and Customs Enforcement Bureau        19, IV
Immigration Review, Executive Office for          8, V
Independent Counsel, Office of                    28, VII
Independent Counsel, Offices of                   28, VI
Indian Affairs, Bureau of                         25, I, V
Indian Affairs, Office of the Assistant           25, VI
   Secretary
[[Page 1016]]

Indian Arts and Crafts Board                      25, II
Indian Health Service                             25, V
Industry and Security, Bureau of                  15, VII
Information Resources Management, Office of       7, XXVII
Information Security Oversight Office, National   32, XX
     Archives and Records Administration
Inspector General
  Agriculture Department                          7, XXVI
  Health and Human Services Department            42, V
  Housing and Urban Development Department        24, XII, XV
Institute of Peace, United States                 22, XVII
Inter-American Foundation                         5, LXIII; 22, X
Interior, Department of                           2, XIV
  American Indians, Office of the Special         25, VII
       Trustee
  Endangered Species Committee                    50, IV
  Federal Acquisition Regulation                  48, 14
  Federal Property Management Regulations System  41, 114
  Fish and Wildlife Service, United States        50, I, IV
  Geological Survey                               30, IV
  Indian Affairs, Bureau of                       25, I, V
  Indian Affairs, Office of the Assistant         25, VI
       Secretary
  Indian Arts and Crafts Board                    25, II
  Land Management, Bureau of                      43, II
  National Indian Gaming Commission               25, III
  National Park Service                           36, I
  Natural Resource Revenue, Office of             30, XII
  Ocean Energy Management, Bureau of              30, V
  Reclamation, Bureau of                          43, I
  Safety and Environmental Enforcement, Bureau    30, II
       of
  Secretary of the Interior, Office of            2, XIV; 43, Subtitle A
  Surface Mining Reclamation and Enforcement,     30, VII
       Office of
Internal Revenue Service                          26, I
International Boundary and Water Commission,      22, XI
     United States and Mexico, United States 
     Section
International Development, United States Agency   22, II
     for
  Federal Acquisition Regulation                  48, 7
International Development Cooperation Agency,     22, XII
     United States
International Development Finance Corporation,    5, XXXIII; 22, VII
     U.S.
International Joint Commission, United States     22, IV
     and Canada
International Organizations Employees Loyalty     5, V
     Board
International Trade Administration                15, III; 19, III
International Trade Commission, United States     19, II
Interstate Commerce Commission                    5, XL
Investment Security, Office of                    31, VIII
James Madison Memorial Fellowship Foundation      45, XXIV
Japan-United States Friendship Commission         22, XVI
Joint Board for the Enrollment of Actuaries       20, VIII
Justice, Department of                            2, XXVIII; 5, XXVIII; 28, 
                                                  I, XI; 40, IV
  Alcohol, Tobacco, Firearms, and Explosives,     27, II
       Bureau of
  Drug Enforcement Administration                 21, II
  Federal Acquisition Regulation                  48, 28
  Federal Claims Collection Standards             31, IX
  Federal Prison Industries, Inc.                 28, III
  Foreign Claims Settlement Commission of the     45, V
       United States
  Immigration Review, Executive Office for        8, V
  Independent Counsel, Offices of                 28, VI
  Prisons, Bureau of                              28, V
  Property Management Regulations                 41, 128
Labor, Department of                              2, XXIX; 5, XLII
  Benefits Review Board                           20, VII
  Employee Benefits Security Administration       29, XXV
  Employees' Compensation Appeals Board           20, IV
  Employment and Training Administration          20, V
  Federal Acquisition Regulation                  48, 29

[[Page 1017]]

  Federal Contract Compliance Programs, Office    41, 60
       of
  Federal Procurement Regulations System          41, 50
  Labor-Management Standards, Office of           29, II, IV
  Mine Safety and Health Administration           30, I
  Occupational Safety and Health Administration   29, XVII
  Public Contracts                                41, 50
  Secretary of Labor, Office of                   29, Subtitle A
  Veterans' Employment and Training Service,      41, 61; 20, IX
       Office of the Assistant Secretary for
  Wage and Hour Division                          29, V
  Workers' Compensation Programs, Office of       20, I, VI
Labor-Management Standards, Office of             29, II, IV
Land Management, Bureau of                        43, II
Legal Services Corporation                        45, XVI
Libraries and Information Science, National       45, XVII
     Commission on
Library of Congress                               36, VII
  Copyright Royalty Board                         37, III
  U.S. Copyright Office                           37, II
Management and Budget, Office of                  5, III, LXXVII; 14, VI; 
                                                  48, 99
Marine Mammal Commission                          50, V
Maritime Administration                           46, II
Merit Systems Protection Board                    5, II, LXIV
Micronesian Status Negotiations, Office for       32, XXVII
Military Compensation and Retirement              5, XCIX
     Modernization Commission
Millennium Challenge Corporation                  22, XIII
Mine Safety and Health Administration             30, I
Minority Business Development Agency              15, XIV
Miscellaneous Agencies                            1, IV
Monetary Offices                                  31, I
Morris K. Udall Scholarship and Excellence in     36, XVI
     National Environmental Policy Foundation
Museum and Library Services, Institute of         2, XXXI
National Aeronautics and Space Administration     2, XVIII; 5, LIX; 14, V
  Federal Acquisition Regulation                  48, 18
National Agricultural Library                     7, XLI
National Agricultural Statistics Service          7, XXXVI
National and Community Service, Corporation for   2, XXII; 45, XII, XXV
National Archives and Records Administration      2, XXVI; 5, LXVI; 36, XII
  Information Security Oversight Office           32, XX
National Capital Planning Commission              1, IV, VI
National Counterintelligence Center               32, XVIII
National Credit Union Administration              5, LXXXVI; 12, VII
National Crime Prevention and Privacy Compact     28, IX
     Council
National Drug Control Policy, Office of           2, XXXVI; 21, III
National Endowment for the Arts                   2, XXXII
National Endowment for the Humanities             2, XXXIII
National Foundation on the Arts and the           45, XI
     Humanities
National Geospatial-Intelligence Agency           32, I
National Highway Traffic Safety Administration    23, II, III; 47, VI; 49, V
National Imagery and Mapping Agency               32, I
National Indian Gaming Commission                 25, III
National Institute of Food and Agriculture        7, XXXIV
National Institute of Standards and Technology    15, II; 37, IV
National Intelligence, Office of Director of      5, IV; 32, XVII
National Labor Relations Board                    5, LXI; 29, I
National Marine Fisheries Service                 50, II, IV
National Mediation Board                          5, CI; 29, X
National Oceanic and Atmospheric Administration   15, IX; 50, II, III, IV, 
                                                  VI
National Park Service                             36, I
National Railroad Adjustment Board                29, III
National Railroad Passenger Corporation (AMTRAK)  49, VII
National Science Foundation                       2, XXV; 5, XLIII; 45, VI
  Federal Acquisition Regulation                  48, 25
National Security Council                         32, XXI; 47, II

[[Page 1018]]

National Technical Information Service            15, XI
National Telecommunications and Information       15, XXIII; 47, III, IV, V
     Administration
National Transportation Safety Board              49, VIII
Natural Resource Revenue, Office of               30, XII
Natural Resources Conservation Service            7, VI
Navajo and Hopi Indian Relocation, Office of      25, IV
Navy, Department of                               32, VI
  Federal Acquisition Regulation                  48, 52
Neighborhood Reinvestment Corporation             24, XXV
Northeast Interstate Low-Level Radioactive Waste  10, XVIII
     Commission
Nuclear Regulatory Commission                     2, XX; 5, XLVIII; 10, I
  Federal Acquisition Regulation                  48, 20
Occupational Safety and Health Administration     29, XVII
Occupational Safety and Health Review Commission  29, XX
Ocean Energy Management, Bureau of                30, V
Oklahoma City National Memorial Trust             36, XV
Operations Office                                 7, XXVIII
Patent and Trademark Office, United States        37, I
Payment From a Non-Federal Source for Travel      41, 304
     Expenses
Payment of Expenses Connected With the Death of   41, 303
     Certain Employees
Peace Corps                                       2, XXXVII; 22, III
Pennsylvania Avenue Development Corporation       36, IX
Pension Benefit Guaranty Corporation              29, XL
Personnel Management, Office of                   5, I, IV, XXXV; 45, VIII
  Federal Acquisition Regulation                  48, 17
  Federal Employees Group Life Insurance Federal  48, 21
       Acquisition Regulation
  Federal Employees Health Benefits Acquisition   48, 16
       Regulation
  Human Resources Management and Labor Relations  5, XCVII
       Systems, Department of Homeland Security
Pipeline and Hazardous Materials Safety           49, I
     Administration
Postal Regulatory Commission                      5, XLVI; 39, III
Postal Service, United States                     5, LX; 39, I
Postsecondary Education, Office of                34, VI
President's Commission on White House             1, IV
     Fellowships
Presidential Documents                            3
Presidio Trust                                    36, X
Prisons, Bureau of                                28, V
Privacy and Civil Liberties Oversight Board       6, X
Procurement and Property Management, Office of    7, XXXII
Public and Indian Housing, Office of Assistant    24, IX
     Secretary for
Public Contracts, Department of Labor             41, 50
Public Health Service                             42, I
Railroad Retirement Board                         20, II
Reclamation, Bureau of                            43, I
Refugee Resettlement, Office of                   45, IV
Relocation Allowances                             41, 302
Research and Innovative Technology                49, XI
     Administration
Rural Business-Cooperative Service                7, XVIII, XLII
Rural Development Administration                  7, XLII
Rural Housing Service                             7, XVIII, XXXV
Rural Utilities Service                           7, XVII, XVIII, XLII
Safety and Environmental Enforcement, Bureau of   30, II
Science and Technology Policy, Office of, and     32, XXIV; 47, II
     National Security Council
Secret Service                                    31, IV
Securities and Exchange Commission                5, XXXIV; 17, II
Selective Service System                          32, XVI
Small Business Administration                     2, XXVII; 13, I
Smithsonian Institution                           36, V
Social Security Administration                    2, XXIII; 20, III; 48, 23
Soldiers' and Airmen's Home, United States        5, XI
Special Counsel, Office of                        5, VIII
Special Education and Rehabilitative Services,    34, III
   Office of
[[Page 1019]]

State, Department of                              2, VI; 22, I; 28, XI
  Federal Acquisition Regulation                  48, 6
Surface Mining Reclamation and Enforcement,       30, VII
     Office of
Surface Transportation Board                      49, X
Susquehanna River Basin Commission                18, VIII
Tennessee Valley Authority                        5, LXIX; 18, XIII
Trade Representative, United States, Office of    15, XX
Transportation, Department of                     2, XII; 5, L
  Commercial Space Transportation                 14, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 12
  Federal Aviation Administration                 14, I
  Federal Highway Administration                  23, I, II
  Federal Motor Carrier Safety Administration     49, III
  Federal Railroad Administration                 49, II
  Federal Transit Administration                  49, VI
  Great Lakes St. Lawrence Seaway Development     33, IV
       Corporation
  Maritime Administration                         46, II
  National Highway Traffic Safety Administration  23, II, III; 47, IV; 49, V
  Pipeline and Hazardous Materials Safety         49, I
       Administration
  Secretary of Transportation, Office of          14, II; 49, Subtitle A
  Transportation Statistics Bureau                49, XI
Transportation, Office of                         7, XXXIII
Transportation Security Administration            49, XII
Transportation Statistics Bureau                  49, XI
Travel Allowances, Temporary Duty (TDY)           41, 301
Treasury, Department of the                       2, X; 5, XXI; 12, XV; 17, 
                                                  IV; 31, IX
  Alcohol and Tobacco Tax and Trade Bureau        27, I
  Community Development Financial Institutions    12, XVIII
       Fund
  Comptroller of the Currency                     12, I
  Customs and Border Protection                   19, I
  Engraving and Printing, Bureau of               31, VI
  Federal Acquisition Regulation                  48, 10
  Federal Claims Collection Standards             31, IX
  Federal Law Enforcement Training Center         31, VII
  Financial Crimes Enforcement Network            31, X
  Fiscal Service                                  31, II
  Foreign Assets Control, Office of               31, V
  Internal Revenue Service                        26, I
  Investment Security, Office of                  31, VIII
  Monetary Offices                                31, I
  Secret Service                                  31, IV
  Secretary of the Treasury, Office of            31, Subtitle A
Truman, Harry S. Scholarship Foundation           45, XVIII
United States Agency for Global Media             22, V
United States and Canada, International Joint     22, IV
     Commission
United States and Mexico, International Boundary  22, XI
     and Water Commission, United States Section
U.S. Copyright Office                             37, II
U.S. Office of Special Counsel                    5, CII
Utah Reclamation Mitigation and Conservation      43, III
     Commission
Veterans Affairs, Department of                   2, VIII; 38, I
  Federal Acquisition Regulation                  48, 8
Veterans' Employment and Training Service,        41, 61; 20, IX
     Office of the Assistant Secretary for
Vice President of the United States, Office of    32, XXVIII
Wage and Hour Division                            29, V
Water Resources Council                           18, VI
Workers' Compensation Programs, Office of         20, I, VII
World Agricultural Outlook Board                  7, XXXVIII

[[Page 1021]]



List of CFR Sections Affected



All changes in this volume of the Code of Federal Regulations (CFR) that 
were made by documents published in the Federal Register since January 
1, 2016 are enumerated in the following list. Entries indicate the 
nature of the changes effected. Page numbers refer to Federal Register 
pages. The user should consult the entries for chapters, parts and 
subparts as well as sections for revisions.
For changes to this volume of the CFR prior to this listing, consult the 
annual edition of the monthly List of CFR Sections Affected (LSA). The 
LSA is available at www.govinfo.gov. For changes to this volume of the 
CFR prior to 2001, see the ``List of CFR Sections Affected, 1949-1963, 
1964-1972, 1973-1985, and 1986-2000'' published in 11 separate volumes. 
The ``List of CFR Sections Affected 1986-2000'' is available at 
www.govinfo.gov.

                                  2016

42 CFR
                                                                   81 FR
                                                                    Page
Chapter IV
401 Authority citation revised.....................................44479
401.301--401.305 (Subpart D) Added..................................7683
401.607 (c)(2)(i) amended...........................................7684
401.703 (j) through (u) added......................................44479
401.713 (a) revised; (d) added.....................................44479
401.716 Added......................................................44480
401.717 (f) added..................................................44481
401.718 Added......................................................44481
401.719 (b)(3), (4) and (d)(5) added...............................44481
401.721 (a)(7) added...............................................44482
401.722 Added......................................................44482
402.105 (a), (b) introductory text, (c) introductory text, (d)(1), 
        (2) introductory text, (3), (4), (5), (e), (f) 
        introductory text, (g) and (h) amended.....................61561
403.500--403.512 (Subpart E) Removed; interim.......................5918
    Regulation at 81 FR 5918 confirmed.............................35644
403.512 (a) amended; interim........................................3011
403.742 (a)(1), (4) and (5) removed; (a)(2), (3), (6), (7) and (8) 
        redesignated as new (a)(1) through (5); eff. 11-15-16......64021
403.744 (a)(1)(i), (ii), (4), (b)(1) and (c) revised; (a)(5) and 
        (6) added..................................................26896
403.745 Added......................................................26896
403.748 Added; eff. 11-15-16.......................................64021
403.912 (a)(1), (2), (b)(1), (2) and (c)(2) amended................61561
405 Policy statement...............................................51116
    Technical correction.............................68947, 75328, 95890
405.373 (a) introductory text and (b) revised; (f) added...........80551
405.926 (u) added..................................................57267
    (f) amended....................................................68847
405.980 (c)(4) added................................................7684
405.2413 (a)(5) revised............................................80552
405.2415 (a)(5) revised............................................80552
405.2413 (a)(5) revised............................................80552
405.2415 (a)(5) revised............................................80552
407.42 (a)(5) revised..............................................86447
409.50 Revised.....................................................76796
410 Technical correction...........................................95890
410.26 (a)(3) through (7) redesignated as (a)(4) through (8); new 
        (a)(3) added; (b)(5) revised...............................80552
410.79 Added.......................................................80552
    (b) correctly amended; (c)(1)(ii), (iv) and (2)(i) correctly 
revised............................................................81698
411 Technical correction...........................................95890
411.39 (a) amended; (b)(2) removed; (b)(3) redesignated as new 
        (b)(2); (b)(1)(ii), new (2) and (c) revised................30492
411.103 (b)(1) and (2) amended.....................................61561

[[Page 1022]]

411.361 (f) amended................................................61561
411.357 (d)(1)(iv) and (x)(1)(vi)(A) correctly amended.............12030
    (a)(5)(ii)(B), (b)(4)(ii)(B), (l)(3)(ii) and (p)(1)(ii)(B) 
revised............................................................80553
411.372 (a) revised................................................80553
412 Policy statement................................................3727
    Technical correction....................................34908, 59901
    Technical correction.............................68947, 70980, 75328
    Authority citation revised.....................................57267
412.64 (d)(1)(vii) added; (h)(4) introductory text and (vi) 
        introductory text revised..................................57267
412.103 (b)(6) added...............................................57267
412.106 (g)(1)(iii)(C) revised.....................................57267
412.140 (d)(2) revised.............................................57267
412.160 Amended....................................................57268
412.170 Amended....................................................57268
412.204 (d) introductory text revised; (e) added...................57268
412.230 (a)(5)(ii) revised; (a)(5)(iii) removed; (a)(5)(iv) 
        redesignated as new (a)(5)(iii); interim...................23438
412.256 (a)(1) revised.............................................57268
412.374 (b) introductory text revised; (e) added...................57268
412.503 Amended....................................................57268
412.507 (a) revised; (b)(3) added..................................57268
412.522 (b)(1) introductory text, (i), (ii), (2) and (3) 
        redesignated as (b)(1)(i) introductory text, (A), (B), 
        (ii) and (iii); (b)(1) heading and new (2) added; new 
        (b)(1)(i) introductory text heading revised; new 
        (b)(1)(i)(B), (ii) and (iii) amended.......................23438
412.522 (c)(2)(v) added............................................57269
412.523 (c)(3)(xiii) added.........................................57269
412.525 (d)(6) added...............................................57269
412.534 Heading revised............................................57269
412.536 Heading revised............................................57269
412.538 Added......................................................57269
412.560 (c)(1) revised.............................................57270
412.612 (b)(1)(i) and (ii) amended.................................61562
412.634 (c)(2) revised; (f) added..................................52140
413 Technical correction.............................68947, 75328, 94268
    Heading and authority citation revised.........................77965
    Prospective payment system.....................................51970
    Authority citation revised.....................................57270
413.17 (d)(1) introductory text revised............................57270
413.24 (f)(4)(i), (ii) and (iv) revised............................57270
413.79 (k)(1)(i), (ii), (2), (3), (4), (7)(ii) and (iii) revised 
                                                                   57271
413.194 (a)(1) revised.............................................77965
413.200 (c)(1)(i) amended..........................................57273
413.215 (b) revised................................................77965
413.370--413.375 (Subpart K) Added.................................77965

                                  2017

42 CFR
                                                                   82 FR
                                                                    Page
Chapter IV
401.109 Added.......................................................5105
403.912 (a)(1) correctly amended; interim..........................42749
405 Technical correction....................................14639, 46138
    Authority citation revised; eff. 10-1-17.......................38509
405.902 Amended.....................................................5106
405.904 (a)(1) and (2) revised......................................5106
405.906 (b) introductory text amended...............................5106
405.908 Amended.....................................................5106
405.910 (c)(5), (f)(1), (i)(2), (3) and (l) revised; (d)(3) and 
        (m)(4) added................................................5106
405.926 (l) and (m) revised.........................................5107
405.956 (b)(8) amended..............................................5107
405.968 (b)(1) revised..............................................5107
405.970 Heading, (a) introductory text, (b), (c) introductory 
        text, (e)(1), (2)(i) and (ii) revised.......................5107
405.972 Heading revised; (b)(3) and (e) amended.....................5107
405.974 Heading, (b) heading and (3) revised........................5108
405.976 (b)(5)(ii) amended; (b)(7) revised..........................5108
405.978 (a) amended.................................................5108
405.980 Heading, (a)(1)(iii), (iv), (4), (5), (d) heading, (2), 
        (3), (e) heading, (2) and (3) revised.......................5108
405.982 (a) and (b) amended.........................................5108
405.984 (c) amended; (d) and (e) revised............................5108
405.990 (a)(2), (b)(1) introductory text, (i)(A), (B), (ii), (4), 
        (c)(3), (4), (5), (d)(2)(i) and (ii) amended; (d)(1), 
        (i)(1) and (2) revised......................................5108
405.1000 Revised....................................................5109

[[Page 1023]]

405.1002 (a) introductory text, (4) and (b)(1) amended..............5109
405.1004 Heading, (a) introductory text, (1), (4), (b) and (c) 
        revised; (d) added..........................................5109
405.1006 Heading, (d)(1) introductory text, (ii), (2), (e)(1) 
        introductory text, (ii), (iii), (2) introductory text, 
        (ii) and (iii) revised; (d)(3) through (6) added............5109
405.1008 Revised....................................................5110
405.1010 Revised....................................................5110
405.1012 Revised....................................................5111
405.1014 Revised....................................................5112
405.1016 Revised....................................................5113
405.1018 Revised....................................................5113
405.1020 (b), (c), (d), (e)(3), (4), (h), (i) heading, (1), (2), 
        (4) and (5) revised; (g)(3)(vii), (viii) and (j) added......5114
405.1022 Revised....................................................5115
405.1024 (b) and (c) revised........................................5115
405.1026 Revised....................................................5115
405.1028 Revised....................................................5115
405.1030 Revised....................................................5116
405.1032 Revised....................................................5116
405.1034 Revised....................................................5117
405.1036 (b)(1) and (f)(5)(i) through (vi) amended; (d) removed; 
        (g) redesignated as new (d).................................5117
405.1037 (a)(1) and (f) revised; (e)(1), (2) introductory text and 
        (i) through (v) amended.....................................5117
405.1038 Revised....................................................5117
405.1040 Revised....................................................5118
405.1042 Revised....................................................5118
405.1044 Revised....................................................5118
405.1046 Revised....................................................5119
405.1048 Revised....................................................5119
405.1050 Amended....................................................5119
405.1052 Revised....................................................5119
405.1054 Revised....................................................5120
405.1056 Added......................................................5121
405.1058 Added......................................................5121
405.1060 (a)(4), (b) and (c) amended................................5121
405.1062 Heading, (a), (b) and (c) amended..........................5121
405.1063 Revised....................................................5121
405.1064 Removed....................................................5122
405.1100 Revised....................................................5122
405.1102 Revised....................................................5122
405.1104 Removed....................................................5122
405.1106 Revised....................................................5122
405.1108 Heading, (a), (b), (c), (d) introductory text and (1) 
        through (5) amended.........................................5122
405.1110 Revised....................................................5122
405.1112 Revised....................................................5123
405.1114 Introductory text, (b), (c)(1) and (3) amended.............5123
405.1116 Amended....................................................5123
405.1118 Amended....................................................5123
405.1120 Amended....................................................5123
405.1122 Heading, (a) heading, (1), (2), (b) heading, (1), (2), 
        (c)(1), (2), (3) introductory text, (i), (ii), (d)(1), 
        (3), (e)(1) through (6), (f)(1), (2) and (3) amended........5123
405.1124 Amended....................................................5124
405.1126 Heading, (a), (b), (c), (d) heading, (1), (2), (e) 
        heading, (1) and (2) amended................................5124
405.1128 Heading, (a), (b) and (c) amended..........................5124
405.1130 Amended....................................................5124
405.1132 (a) introductory text, (a)(1), (2) and (b) amended.........5124
405.1134 (a), (b)(3) and (c) amended................................5124
405.1136 (a)(1), (2), (c)(2) and (3) amended........................5124
405.1138 Amended....................................................5124
405.1140 Heading, (a)(1), (2), (3), (b) heading, (1), (2), (3), 
        (c) heading, (1), (3), (4) and (d) amended..................5124
405.1204 (c)(4)(iii) and (5) revised................................5124
405.2404 (d) introductory text revised; eff. 10-1-17...............38509
405.2413 (a)(5) revised............................................53358
405.2415 (a)(5) revised............................................53358
405.2442 (a) introductory text and (b) revised; eff. 10-1-17.......38509
409 Technical correction...........................................46163
409.20 (a)(6) correctly amended....................................32258
409.26 (a)(1) correctly amended....................................32258
409.30 Introdutory text revised....................................36633
409.43 (a), (c)(1)(i)(C) and (d) amended............................4578
    Regulation at 82 FR 4578 eff. date delayed to 1-13-18..........31729
409.44 (b)(1) introductory text and (c)(2)(ii) amended..............4578
    Regulation at 82 FR 4578 eff. date delayed to 1-13-18..........31729
409.45 (c)(4) amended...............................................4578
    Regulation at 82 FR 4578 eff. date delayed to 1-13-18..........31729
409.46 (b) amended..................................................4578

[[Page 1024]]

    Regulation at 82 FR 4578 eff. date delayed to 1-13-18..........31729
409.47 (b) introductory text amended................................4578
    Regulation at 82 FR 4578 eff. date delayed to 1-13-18..........31729
410 Technical correction...........................................14639
    Authority citation revised.....................................53358
410.62 (a) introductory text amended................................4578
    Regulation at 82 FR 4578 eff. date delayed to 1-13-18..........31729
410.79 Heading, (a), (c), and (d) revised; (b) amended.............53358
411 Technical correction....................................14639, 46163
411.15 (p)(3)(iii) revised.........................................36633
412 Authority citation revised; eff. 10-1-17.......................38509
    Technical correction...........................................46138
412.22 (e) introductory text and (1)(v) introductory text revised; 
        (i) added; eff. 10-1-17....................................38509
412.23 (e)(2)(ii), (3)(vi) and (7)(iii) revised; eff. 10-1-17......38510
412.64 (d)(1)(vii), (h)(4) introductory text, (vi) introductory 
        text and (i)(3)(iii) revised; (d)(4)(iii) added; eff. 10-
        1-17.......................................................38510
412.87 (b)(2) revised; eff. 10-1-17................................38511
412.90 (j) revised; eff. 10-1-17...................................38511
412.92 (e)(3) introductory text revised; eff. 10-1-17..............38511
412.101 (b)(2) introductory text revised; (e) added; eff. 10-1-17 
                                                                   38511
412.106 (g)(1)(iii)(C)(4) added; eff. 10-1-17......................38511
412.108 (d)(3) introductory text revised; eff. 10-1-17.............38511
412.140 (c)(2) and (d)(2) revised; eff. 10-1-17....................38511
412.211 (f)(3)(iii) revised; eff. 10-1-17..........................38512
412.230 (a)(3) introductory text, (i), (ii) and (d)(3) revised; 
        eff. 10-1-17...............................................38512
412.273 (c)(1)(ii) and (2) revised; eff. 10-1-17...................38512
412.500 (a)(7) and (8) added; eff. 10-1-17.........................38512
412.522 (b)(3) and (4) added; eff. 10-1-17.........................38512
412.523 (d)(1) revised; (c)(3)(xiv) and (d)(5) added; eff. 10-1-17
                                                                   38513
412.525 (a)(2) revised; eff. 10-1-17...............................38513
412.529 (c)(3) introductory text and (f) introductory text 
        revised; (c)(4) added; eff. 10-1-17........................38513
412.538 (a)(1) revised; eff. 10-1-17...............................38513
412.560 Heading, (a), (b) heading, (1), (c) introductory text, 
        (1), (3)(vii), (4)(ii), (d)(i) and (2)(vii) revised; (f) 
        added; eff. 10-1-17........................................38513
412.614 (d) heading, (1) and (e) revised; eff. 10-1-2017...........36304
412.624 (e)(6) removed; (e)(7) redesignated as new (e)(6); (d)(4), 
        new (e)(6)(ii) and (f)(2)(v) amended; eff. 10-1-2017.......36305
412.634 (b)(1), (c)(1), (f)(1) and (2) revised; eff. 10-1-2017.....36305
413 Heading revised................................................36633
    Authority citation revised; eff. 10-1-17.......................38514
    Technical correction....................................46138, 46163
    Policy statement...............................................50738
413.24 (f)(4)(iv) revised; eff. 10-1-17............................38514
413.65 (m) introductory text revised...............................38515
413.70 (a)(6)(iii) redesignated as (a)(6)(iv); new (a)(6)(iii) 
        added; new (a)(6)(iv) revised; eff. 10-1-17................38515
413.134 (f)(1) revised; eff. 10-1-17...............................38515
413.333 Amended....................................................36633
413.337 (d)(4) added...............................................36633
413.338 Added......................................................36633
413.345 Revised....................................................36634
413.360 Added.......................................................3663

                                  2018

42 CFR
                                                                   83 FR
                                                                    Page
Chapter IV
405 Waiver.........................................................42037
405 Authority citation revised.....................................60072
405.924 (a)(5) added...............................................16721
405.2401 (b) amended; interim......................................60072
405.2462 (g) introductory text revised; interim....................60073
405.2464 (a)(1), (b) heading, (1), (c), and (d) revised; (e) 
        added; interim.............................................60073
409 Authority citation revised.....................................56627

[[Page 1025]]

409.43 (c)(2) removed; (c)(3) and (4) redesignated as new (c)(2) 
        and (3); new (c)(2)(ii) and (e)(1)(iii) amended............56627
409.46 (e) added...................................................56627
410 Authority citation revised.....................................60073
410.32 (b)(4) added; interim.......................................60073
410.59 (a)(4) removed; interim.....................................60073
410.60 (a)(4) removed; interim.....................................60073
410.61 (c) revised; interim........................................60073
410.62 (a)(4) removed; interim.....................................60073
410.78 (b)(3)(ix) through (xii) and (4)(iv) added; (b)(4) revised; 
        interim....................................................60073
410.105 (c)(1)(ii) amended; (d) removed; interim...................60073
411 Authority citation revised..............................39289, 60073
    Technical correction...........................................49832
411.15 (p)(3)(iv) amended..........................................39289
411.353 (g)(1) revised; (g)(2) removed; interim....................60074
411.354 (e) added; interim.........................................60074
412 Authority citation revised.......................38573, 38619, 41700
    Technical correction...........................................49836
    Policy statement...............................................42596
412.3 (a) revised..................................................41700
412.4 (c)(4) added.................................................41700
412.22 (h)(2)(iii)(A)(4) added.....................................41700
412.23 (e)(3)(i) revised; (e)(3)(vii) added........................41701
412.25 (a)(1)(ii), (iii), (d), and (e)(2)(iii)(A) revised; 
        (e)(2)(iv) added...........................................41701
412.27 (a) revised.................................................38619
412.64 (d)(1)(vii) and (3) revised.................................41701
412.90 (j) revised.................................................41701
412.92 (a)(1)(ii), (b)(1)(i), (iii)(B), (iv), (v), (3)(i) through 
        (iv), (d)(2) introductory text, (e)(1), (2) introductory 
        text, (i), (3), (i), (ii), and (iii) amended; (a)(4) and 
        (b)(2)(ii)(C) added; (b)(2)(i), (ii) introductory text, 
        (B), and (iv) revised......................................41702
412.96 (d) redesignated as (e); new (d) added......................41702
412.101 (b)(2), (c)(1), (2) introductory text, and (d) revised; 
        (c)(3) added...............................................41702
412.103 (a)(7) added; (b)(6) revised...............................41703
412.105 (f)(1)(vii) amended........................................41703
412.106 (g)(1)(iii)(C)(5) added....................................41703
412.108 (a)(3) added; (a)(1), (b)(4) introductory text, and 
        (c)(2)(iii) introductory text revised; (b)(1), (3), 
        (4)(i), (ii), (iii), (5) through (9), (d)(1), (2) 
        introductory text, (i), (3) introductory text, (i), (ii), 
        and (iii) amended..........................................41703
412.152 Amended....................................................41704
412.164 (a) revised................................................41704
412.200 Revised....................................................41704
412.230 (d)(5) revised.............................................41704
412.402 Amended....................................................38619
412.428 Heading, introductory text, (a), and (b) revised...........38619
412.500 (a)(9) and (10) added......................................41704
412.522 (c)(1)(iii) added; (c)(2)(v) removed; (c)(3) introductory 
        text revised...............................................41704
412.523 (c)(3)(xv) and (d)(6) added................................41704
412.525 (d)(6) removed.............................................41705
412.538 Removed....................................................41705
412.560 (b)(3) added; (d)(1) and (3) revised.......................41705
412.606 (a) removed; (b) and (c) redesignated as new (a) and (b) 
                                                                   38573
412.622 (a)(5)(A), (B), and (C) redesignated as (a)(5)(i), (ii), 
        and (iii); (a)(3)(iv) and new (a)(5)(i) revised............38573
412.624 (c)(4)(i) revised; (c)(4)(iii) added.......................38573
412.634 (b), (d)(1), and (5) revised...............................38573
413 Authority citation revised.....................................39289
    Technical correction.............................49832, 49836, 67082
413.24 (f)(5)(i) revised...........................................41705
413.79 (e)(1)(iv) revised..........................................41706
413.177 (a) revised................................................57068
413.178 Added......................................................57068
413.232 (b) introductory text, (2), (c)(2), (e), and (g)(2) 
        revised; (g)(3) added......................................57069
413.234 (a) amended; (b) and (c) revised; eff. 1-1-20..............57070
413.337 (d)(1)(v) revised; (d)(1)(vi), (vii), and (f) added........39289
413.338 Heading and (c)(2)(i) revised; (a)(16), (17), (d)(1)(iv), 
        (3), and (4) added.........................................39289
413.360 (b)(3) added; (d)(1) and (4) revised.......................39290

[[Page 1026]]

                                  2019

42 CFR
                                                                   84 FR
                                                                    Page
Chapter IV
403 Authority citation revised..............................20757, 51813
403.736 Introductory text and (b) removed; (a) revised; (c) and 
        (d) redesignated as new (b) and (c); eff. 11-29-19.........51813
403.748 (a) introductory text, (4), (b) introductory text, (c) 
        introductory text, (d) introductory text, and (1)(ii) 
        revised; (d)(1)(v) added; eff. 11-29-19....................51813
403.800--403.822 (Subpart H) Heading revised.......................25675
403.902 Amended; interim...........................................63185
403.904 (c)(1), (3) introductory text, (ii), (iii), (8), (e)(2) 
        introductory text, (xiv), (xv), (f)(1) introductory text, 
        (i)(A) introductory text, (1), (3), (5), (iv), (v), 
        (h)(5), (7), and (13) revised; (e)(2)(xi) and (xviii) 
        added; interim.............................................63186
403.908 (g)(2)(ii) introductory text revised; interim..............63187
403.1200--403.1204 (Subpart L) Added...............................20757
405 Authority citation revised..............................19869, 47851
405 Technical correction............................................9460
405.371 (a) introductory text revised; (a)(1) and (2) amended; 
        (a)(4) added...............................................47852
405.425 (i) and (j) revised........................................47852
405.800 (c) added..................................................47852
405.910 (c)(5) and (e)(4) amended..................................19869
405.926 (f) amended................................................19869
    (t) revised....................................................61490
405.944 (b)(2) and (4) amended.....................................19869
405.952 (b)(4)(i) and (d) amended..................................19870
405.964 (b)(2) and (4) amended.....................................19870
405.970 (c)(2) and (d) amended.....................................19870
405.972 (b)(4)(i) and (d) amended..................................19870
405.1006 (d)(4) revised............................................19870
405.1010 (b)(1), (3)(ii), (c)(3)(i), and (ii)(A) revised...........19870
405.1012 (a)(1), (b), and (e)(1) amended...........................19870
405.1014 (a)(1)(i) and (e)(2) amended..............................19870
405.1020 (c)(1) and (i)(5) revised; (e)(5) added...................19870
405.1034 (a)(1) revised............................................19870
405.1046 (a)(2)(ii) amended........................................19871
405.1052 (a)(3), (4)(i), (5), (6), (b)(3)(i), (d), and (e) revised
                                                                   19871
405.1056 (d), (f), and (g) revised.................................19871
405.1110 (a) and (b)(2) amended; (e) added.........................19871
405.1112 (a) amended...............................................19871
405.1114 (c)(1) amended............................................19871
409.27 (c) amended; interim........................................63187
409.30 Introductory text amended...................................38832
409.43 (a) revised.................................................60642
409.44 (c)(2)(iii)(C) revised......................................60642
410 Technical correction............................................9460
410.20 (e) added; interim..........................................63187
410.27 (a)(1)(iv) revised..........................................61490
410.36 (b) revised.................................................60801
410.38 Heading, (a), (c), (d), and (e) revised; (b) amended; (f) 
        and (g) removed............................................60802
410.40 (a) through (f) redesignated as (b) through (g); new (a) 
        added; (b)(1) amended; (e)(2)(i), (3)(i), (iii), (iv), and 
        (v) revised; interim.......................................63187
410.41 Heading and (c)(1) revised; interim.........................63188
410.49 (b)(1)(vii) revised; (b)(1)(viii) added; interim............63188
410.59 (a)(4) and (e)(1)(v) added; (e)(2) introductory text, (i), 
        (v), and (3) revised; interim..............................63188
410.60 (a)(4) and (e)(1)(v) added; (e)(2) introductory text, (i), 
        (ii), (vi), and (3) revised; interim.......................63188
410.67 Added; interim..............................................63189
410.69 (b) amended; interim........................................63190
410.74 (a)(2)(iv) revised; (e) added; interim......................63190
410.75 (f) added; interim..........................................63191
410.76 (f) added; interim..........................................63191
410.77 (e) added; interim..........................................63191
410.105 (d) added; interim.........................................63191
411 Technical correction............................................9460
411.370 (b) introductory text amended; (b)(1), (c) introductory 
        text, (d), and (e) revised; interim........................63191
411.372 (b)(4)(i), (ii), (5), (6), and (8)(ii) revised; (b)(9) 
        removed; (d) added; interim................................63191
411.375 (a) revised; (b) removed; (c) and (d) redesignated as new 
        (b) and (c); interim.......................................63192

[[Page 1027]]

411.379 (a), (b), (d), and (e) revised; interim....................63192
411.380 (c) revised; interim.......................................63192
411.382 Revised; interim...........................................63193
411.384 (b) amended; interim.......................................63193
411.387 Revised; interim...........................................63193
412 Authority citation revised..............................39172, 42611
412 Policy statement........................................26360, 38424
412 Technical correction...........................................53602
412.22 (f)(1) and (2) revised......................................61490
412.64 (d)(1)(viii) added..........................................42611
412.87 (c) redesignated as (e); (b)(1)(i) through (v), new (c), 
        and (d) added; new (e) revised.............................42611
412.88 (a)(2) and (b) revised......................................42612
412.101 (e) revised................................................42613
412.103 (g)(1)(iii), (3), and (4) added; (b)(3) and (g)(2)(iii) 
        revised....................................................42613
412.106 (g)(1)(iii)(C)(6) added....................................42613
412.152 Amended....................................................42613
412.154 (e)(4) redesignated as (e)(6); new (e)(4) and (5) added....42614
412.172 (f)(2) and (4) revised.....................................42614
412.230 (a)(4) revised.............................................42614
412.256 (a)(1) revised.............................................42614
412.522 (d)(3) through (6) added...................................42614
412.523 (c)(3)(xvi) added..........................................42614
412.560 (d)(1), (3), and (f)(1) revised............................42615
412.622 (a)(3)(iv), (4)(i)(A), (iii)(A), and (5)(i) revised; (c) 
        added......................................................39172
412.634 (a)(1), (d)(1), (5), and (f)(1) revised....................39172
413 Authority citation revised.....................................42615
413 Technical correction...........................................53602
413.70 (b)(5)(i)(C) revised; (b)(5)(i)(D) added....................42615
413.178 (d), (e), and (f) redesignated as (e), (f), and (g); 
        (a)(4), (13), (e)(2)(i), and (f)(2) amended; new (d) added
                                                                   60803
413.230 (b) and (c) revised; (d) and (e) added.....................60803
413.234 (a) amended; (b)(1)(ii) and (c) introductory text revised; 
        (e) added..................................................60803
413.236 Added......................................................60805
413.237 (a)(1)(v) redesignated as (a)(1)(vi); new (a)(1)(v) added; 
        (a)(1)(i) through (iv) and (a)(1)(vi) revised..............60806
413.343 (b) revised................................................38832
413.360 (a), (d)(1), and (4) revised...............................38832

                                  2020

42 CFR
                                                                   85 FR
                                                                    Page
Chapter IV
400 Authority citation revised.....................................19285
400.200 Amended; interim...........................................19285
400.200 Amended; interim...........................................85025
402 Policy statement...................................................7
402.105 Regulation at 81 FR 61561 continued........................55385
403 Policy statement...................................................7
403 Technical correction...............................................8
403.902 Correction: amended...........................................10
403.912 Regulation at 81 FR 61561 continued........................55385
405 Technical correction......................................224, 78748
405.1801 (a) amended; (d) introductory text revised................59018
405.1811 (c)(1) amended............................................59018
405.1813 (d) and (e)(1) amended....................................59019
405.1814 (c)(2) amended............................................59019
405.1819 Amended...................................................59019
405.1821 (c)(1) and (3)(iii)(B) amended............................59019
405.1831 (d) amended...............................................59019
405.1834 (e)(3) amended............................................59019
405.1835 (b) introductory text and (d) introductory text amended 
                                                                   59019
405.1836 (d) and (e)(1) amended....................................59019
405.1840 (c)(2) amended............................................59019
405.1843 (a) redesignated as (a)(1); (a)(2) added; new (a)(1) and 
        (d)(2) amended.............................................59019
405.1845 (h)(2)(iii) amended.......................................59019
405.1849 Amended...................................................59019
405.1851 Amended...................................................59019
405.1853 (e)(5)(vi)(A) amended.....................................59019
405.1857 (c)(1) introductory text revised; (c)(4)(iii)(A) amended 
                                                                   59019
405.1868 (d)(1) amended............................................59019
405.1871 (a)(5) amended............................................59019
405.1875 (c)(1)(iv) and (e)(2) amended.............................59019
405.1885 (b)(1) and (2)(i) amended.................................59019
405.2416 (a)(5) added; interim.....................................19285
406 Authority citation revised.....................................25632
406.26 (a)(1)(i) added.............................................25632
407 Authority citation revised.....................................25632
407.40 (c)(4) added................................................25632
409 Technical correction...............................................8

[[Page 1028]]

409.35 (a) revised.................................................47632
409.41 (b) amended; interim........................................27619
409.42 (b) and (c) introductory text amended; interim..............27619
409.43 (a)(3) revised; interim.....................................19285
409.43 (a) introductory text, (1), and (3) revised.................70354
409.43 (a) introductory text and (1) revised; (b), (c) heading, 
        (1) introductory text, (i) introductory text, (d), (e)(1) 
        introductory text, (2), and (f) amended; interim...........27619
409.44 (c)(1) introductory text revised; (c)(1)(i), (2)(i)(D)(1), 
        (F)(3), (iii)(A), and (iv) introductory text amended; 
        interim....................................................27619
409.45 (a), (b)(1) introductory text, (b)(2)(i), (c)(1), and (g) 
        amended; interim...........................................27620
409.46 (a) amended; interim........................................27620
409.46 (e) revised.................................................70354
409.48 (c)(1) amended; interim.....................................27620
409.49 (h) added...................................................70354
409.64 (a)(2)(ii) revised..........................................70354
410 Technical correction..........................................8, 224
410.15 (a) amended; interim........................................85025
410.16 (a) amended.................................................85025
410.27 (a)(1)(iv)(C), (D), and (E) added............................8476
410.27 (a)(1)(iv)(D) and (E) revised; interim......................19285
410.27 (a)(1)(iv)(C) amended; (a)(1)(iv)(D) revised; (a)(1)(iv)(E) 
        removed....................................................86299
410.28 (e)(1) revised; interim.....................................19286
410.32 (b)(3)(ii) revised; interim.................................19286
410.32 (a) introductory text amended; (a)(3) and (b)(2)(viii) 
        added; (b)(1), (2)(iii)(B), (3) introductory text, 
        (d)(2)(i), (ii) introductory text, and (3)(i) introductory 
        text revised; interim......................................27620
410.32 (a)(3) revised; interim.....................................54871
410.32 (b)(1), (2)(iii)(B), and (3)(ii) revised; (b)(2)(ix) added; 
        interim....................................................85026
410.40 (f)(5) added; interim.......................................19286
410.57 (c) added; interim..........................................71197
410.67 (b) amended; interim........................................19286
410.67 (b)(7) amended; interim.....................................27620
410.67 (b) amended; (d)(2)(i)(A) revised; (d)(4)(i)(E) added; 
        interim....................................................85026
410.78 (a)(3)(i) added; (b) introductory text revised; interim.....19286
410.78 (f) revised; interim........................................27621
410.78 (a)(3) and (f) revised; interim.............................85027
410.79 (e) added; interim..........................................19287
410.79 (c)(3)(i), (ii), and (e) revised; interim...................85027
410.152 (l)(1) revised; interim....................................71197
410.160 (b)(2) revised; interim....................................71197
410.170 (b) revised................................................70354
411 Policy statement...................................................7
411 Technical correction...............................................8
411.15 (e)(3) and (4) amended; (e)(5) added; interim...............71197
411.103 Regulation at 81 FR 61561 continued........................55385
411.350 Revised....................................................77656
411.351 Revised....................................................77656
411.352 Revised....................................................77656
411.352 (i) revised; eff 1-1-22....................................77682
411.353 (d) amended................................................72909
411.353 Revised....................................................77656
411.354 Revised....................................................77656
411.355 Revised....................................................77656
411.356 Revised....................................................77656
411.357 Revised....................................................77656
411.361 Regulation at 81 FR 61561 continued........................55385
411.362 (a) amended; (c)(1) and (6) introductory text revised......86299
412 Technical correction...............................224, 52923, 78748
412 Policy statement............................................7, 47042
412.1 (a)(1) revised...............................................59020
412.2 (e)(6) added.................................................59020
412.3 (d)(2) revised...............................................86300
412.29 (e) revised; interim........................................19287
412.29 (d), (e), (h), and (i) revised; interim.....................27621
412.29 (e) revised.................................................48462
412.42 (b)(2)(i) through (iii) and (2) amended.....................72909
412.64 (e)(5) added................................................59020
412.82 (c) amended.................................................59020
412.83 Redesignated from 412.86....................................59020
412.85--412.86 Undesignated center heading added...................59020
412.86 Redesignated as 412.83......................................59020
412.87 (c)(1), (d) introductory text, (1), (e) heading, and (2) 
        revised; (e)(3) added......................................59020

[[Page 1029]]

412.88 (a)(2)(ii)(A) introductory text amended; (a)(2)(ii)(B) 
        introductory text and (b)(2) revised.......................59021
412.92 (c)(3) revised..............................................59021
412.96 (c)(2)(iii) added...........................................59021
412.104 (a) revised................................................59021
412.105 (d)(1) and (f)(1)(iii)(A) revised; interim.................27621
412.105 (f)(1)(ix)(A) amended......................................59021
412.106 (g)(1)(iii)(C)(6) amended; (g)(1)(iii)(C)(7) and (8) added
                                                                   59021
412.113 (e) added..................................................59022
412.115 (c) revised................................................59022
412.152 Amended....................................................59022
412.165 (c) added; interim.........................................27621
412.170 Amended....................................................59022
412.190 Added......................................................86300
412.230 (d)(2)(ii)(A) revised......................................59022
412.278 (b)(1) revised.............................................59023
412.312 (f) added..................................................59023
412.523 (c)(3)(xvii) added.........................................59023
412.612 Regulation at 81 FR 61561 continued........................55385
412.622 (a)(3)(iv) and (4)(ii) introductory text revised; interim 
                                                                   19287
412.622 (a)(3)(i) through (iv), (4) introductory text, and (5) 
        introductory text revised; (c) amended; interim............27622
412.622 (a)(3)(ii), (iv) (4)(i)(B), and (D) revised; (a)(4)(ii) 
        removed; (a)(4)(iii) redesignated as new (a)(4)(ii); (c) 
        amended....................................................48462
412.622 (b)(2)(i) revised..........................................59023
413 Technical correction...........................................78748
413.20 (d)(3) revised..............................................59023
413.78 (b) revised; (i) added; interim.............................27623
413.79 (h)(1)(iii) added...........................................59023
413.89 (b)(1), (c), (e)(2), and (f) revised........................59023
413.114 (c)(2) amended.............................................47633
413.178 (d)(7) revised; interim....................................54872
413.232 (b) introductory text, (1), (e), and (g) introductory text 
        revised; (g)(4) and (h) added..............................71485
413.234 (f) added..................................................71485
413.236 (a), (b) introductory text, (2), (4) through (6), (c), (d) 
        introductory text, and (2) revised; (f) added..............71486
413.237 (a)(1)(i) through (iv) amended; (a)(1)(v) revised..........71487
413.338 (a)(9), (11), (e)(1), and (3) revised......................47633
413.355 Revised....................................................59025

                                  2021

  (Regulations published from January 1, 2021, through October 1, 2021)

42 CFR
                                                                   86 FR
                                                                    Page
Chapter IV
400 Technical correction.....................................5020, 14690
402.105 Regulation at 81 FR 61561 continued to 9-6-22..............50263
403.912 Regulation at 81 FR 61561 continued to 9-6-22..............50263
404 Added...........................................................5753
404 Regulation at 86 FR 5753 eff. date delayed to 3-22-22..........15404
405 Authority citation revised......................................6093
405.201 (b) amended.................................................3009
405.201 Regulation at 86 FR 3009 eff. date delayed to 5-15-21......14542
405.201 Regulation at 86 FR 3009 eff. date delayed to 12-15-21.....26849
405.370 (a) amended.................................................6093
405.601-405.607 (Subpart F) Added...................................3009
405.601--405.607 (Subpart F) Regulation at 86 FR 3009 eff. date 
        delayed to 5-15-21.........................................14542
405.601--405.607 (Subpart F) Regulation at 86 FR 3009 eff. date 
        delayed to 12-15-21........................................26849
410 Technical correction.......................5020, 11428, 14690, 33902
411 Technical correction....................................11428, 33902
411.15 (p)(2)(xiii) through (xvi) revised; (p)(2)(xvii) 
        redesignated as (p)(2)(xviii); new (p)(2)(xvii) added; 
        eff. 10-1-21...............................................42524
411.103 Regulation at 81 FR 61561 continued to 9-6-22..............50263
411.361 Regulation at 81 FR 61561 continued to 9-6-22..............50263
412 Technical correction....................................11428, 33902
412.1 (a)(7) added; (b)(2) revised.................................45518
412.23 (f)(3) added................................................45518
412.24 Added.......................................................45518
412.64 (e)(1)(ii), (4) introductory text, (h)(4) introductory 
        text, and (vi) introductory text amended; (h)(4)(vii) 
        added; (h)(5) revised......................................45519
412.96 (c)(1) introductory text, (h)(1), (i)(1), and (2) revised 
                                                                   45519

[[Page 1030]]

412.103 (g)(3) revised; (g)(4) redesignated as (g)(5); new (g)(4) 
        added......................................................45519
412.106 (g)(1)(iii)(C)(8) revised; (g)(1)(iii)(C)(9) added.........45519
412.140 (a)(1), (2), (c)(2)(i), and (e)(2)(iii) amended............45520
412.154 (f)(4) revised.............................................45520
412.160 Introductory text amended..................................45520
412.163 (d) amended................................................45520
412.164 (b) amended................................................45520
412.165 (c)(2) and (4) amended.....................................45520
412.167 (b)(5) amended.............................................45520
412.168 Added......................................................45520
412.172 (f)(4) revised.............................................45520
412.230 (a)(1)(iii) added; (a)(5)(i) revised; interim..............24739
412.278 (b)(1) amended; (f)(2)(ii) revised.........................45520
412.402 Amended; eff. 10-1-21......................................42678
412.424 (d)(1)(iii)(F) revised; eff. 10-1-21.......................42678
412.434 (b)(3) revised; eff. 10-1-21...............................42678
412.612 Regulation at 81 FR 61562 continued to 9-6-22..............50263
413.20 (d)(3) revised..............................................45521
413.24 (f)(5)(i) introductory text and (A) revised.................45521
413.338 (d)(4)(ii) and (e)(1) revised; (g) added; eff. 10-1-21.....42524


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