[Title 42 CFR ]
[Code of Federal Regulations (annual edition) - October 1, 2022 Edition]
[From the U.S. Government Publishing Office]



[[Page i]]

          

          Title 42

Public Health


________________________

Parts 430 to 481

                         Revised as of October 1, 2022

          Containing a codification of documents of general 
          applicability and future effect

          As of October 1, 2022
                    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 
          (Continued)                                                3
  Finding Aids:
      Table of CFR Titles and Chapters........................     735
      Alphabetical List of Agencies Appearing in the CFR......     755
      List of CFR Sections Affected...........................     765

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

                     Cite this Code: CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus, 42 CFR 430.0 refers 
                       to title 42, part 430, 
                       section 0.

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

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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 
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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 
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HOW TO USE THE CODE OF FEDERAL REGULATIONS

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[[Page vi]]

Many agencies have begun publishing numerous OMB control numbers as 
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    Office of the Federal Register
    October 1, 2022







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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, 2022.

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

[[Page 1]]



                         TITLE 42--PUBLIC HEALTH




                  (This book contains parts 430 to 481)

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

chapter iv--Centers for Medicare & Medicaid Services, 
  Department of Health and Human Services (Continued).......         430

[[Page 3]]



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




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


  Editorial Note: Nomenclature changes to chapter IV appear at 66 FR 
39452, July 31, 2001; 67 FR 36540, May 24, 2002; 69 FR 18803, Apr. 9, 
2004; and 77 FR 29028, July 16, 2012.

                SUBCHAPTER C--MEDICAL ASSISTANCE PROGRAMS
Part                                                                Page
430             Grants to States for Medical Assistance 
                    Programs................................           5
431             State organization and general 
                    administration..........................          22
432             State personnel administration..............          77
433             State fiscal administration.................          81
434             Contracts...................................         128
435             Eligibility in the States, District of 
                    Columbia, the Northern Mariana Islands, 
                    and American Samoa......................         131
436             Eligibility in Guam, Puerto Rico, and the 
                    Virgin Islands..........................         217
438             Managed care................................         250
440             Services: General provisions................         337
441             Services: Requirements and limits applicable 
                    to specific services....................         371
442             Standards for payment to nursing facilities 
                    and intermediate care facilities for 
                    Individuals with Intellectual 
                    Disabilities............................         444
447             Payments for services.......................         450
455             Program integrity: Medicaid.................         508

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456             Utilization control.........................         530
    SUBCHAPTER D--STATE CHILDREN'S HEALTH INSURANCE PROGRAMS (SCHIPS)
457             Allotments and grants to States.............         568
   SUBCHAPTER E--PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)
460             Programs of all-inclusive care for the 
                    elderly (PACE)..........................         646
             SUBCHAPTER F--QUALITY IMPROVEMENT ORGANIZATIONS
475             Quality improvement organizations...........         691
476             Quality improvement organization review.....         694
478             Reconsiderations and appeals................         713
480             Acquisition, protection, and disclosure of 
                    quality improvement organization 
                    information.............................         719
481

[Reserved]

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                SUBCHAPTER C_MEDICAL ASSISTANCE PROGRAMS





PART 430_GRANTS TO STATES FOR MEDICAL ASSISTANCE PROGRAMS-
-Table of Contents



               Subpart A_Introduction; General Provisions

Sec.
430.0 Program description.
430.1 Scope of subchapter C.
430.2 Other applicable Federal regulations.
430.3 Appeals under Medicaid.
430.5 Definitions.

                          Subpart B_State Plans

430.10 The State plan.
430.12 Submittal of State plans and plan amendments.
430.14 Review of State plan material.
430.15 Basis and authority for action on State plan material.
430.16 Timing and notice of action on State plan material.
430.18 Administrative review of action on State plan material.
430.20 Effective dates of State plans and plan amendments.
430.25 Waivers of State plan requirements.

Subpart C_Grants; Reviews and Audits; Withholding for Failure To Comply; 
   Deferral and Disallowance of Claims; Reduction of Federal Medicaid 
                                Payments

430.30 Grants procedures.
430.32 Program reviews.
430.33 Audits.
430.35 Withholding of payment for failure to comply with Federal 
          requirements.
430.38 Judicial review.
430.40 Deferral of claims for FFP.
430.42 Disallowance of claims for FFP.
430.45 Reduction of Federal Medicaid payments.
430.48 Repayment of Federal funds by installments.

Subpart D_Hearings on Conformity of State Medicaid Plans and Practice to 
                          Federal Requirements

430.60 Scope.
430.62 Records to be public.
430.63 Filing and service of papers.
430.64 Suspension of rules.
430.66 Designation of presiding officer for hearing.
430.70 Notice of hearing or opportunity for hearing.
430.72 Time and place of hearing.
430.74 Issues at hearing.
430.76 Parties to the hearing.
430.80 Authority of the presiding officer.
430.83 Rights of parties.
430.86 Discovery.
430.88 Evidence.
430.90 Exclusion from hearing for misconduct.
430.92 Unsponsored written material.
430.94 Official transcript.
430.96 Record for decision.
430.100 Posthearing briefs.
430.102 Decisions following hearing.
430.104 Decisions that affect FFP.

    Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302).

    Source: 53 FR 36571, Sept. 21, 1988, unless otherwise noted.



               Subpart A_Introduction; General Provisions



Sec.  430.0  Program description.

    Title XIX of the Social Security Act, enacted in 1965, authorizes 
Federal grants to States for medical assistance to low-income persons 
who are age 65 or over, blind, disabled, or members of families with 
dependent children or qualified pregnant women or children. The program 
is jointly financed by the Federal and State governments and 
administered by States. Within broad Federal rules, each State decides 
eligible groups, types and range of services, payment levels for 
services, and administrative and operating procedures. Payments for 
services are made directly by the State to the individuals or entities 
that furnish the services.



Sec.  430.1  Scope of subchapter C.

    The regulations in subchapter C set forth State plan requirements, 
standards, procedures, and conditions for obtaining Federal financial 
participation (FFP). Each part (or subpart of section) in the subchapter 
describes the specific statutory basis for the regulation. However, 
where the basis is the Secretary's general authority to issue 
regulations for any program under the Act (section 1102 of the Act), or 
his general authority to prescribe State plan requirements needed for 
proper and efficient administration of the

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plan (section 1902(a)(4)), those statutory provisions are simply cited 
without further description.



Sec.  430.2  Other applicable Federal regulations.

    Other regulations applicable to State Medicaid programs include the 
following:
    (a) 5 CFR part 900, subpart F, Administration of the Standards for a 
Merit System of Personnel Administration.
    (b) The following HHS Regulations in 45 CFR subtitle A:

Part 16--Procedures of the Departmental Appeals Board.
Part 75--Uniform Administrative Requirements, Cost Principles, and Audit 
Requirements for HHS Awards.
Part 80--Nondiscrimination Under Programs Receiving Federal Assistance 
Through the Department of Health and Human Services: Effectuation of 
Title VI of the Civil Rights Act of 1964.
Part 81--Practice and Procedure for Hearings Under 45 CFR part 80.
Part 84--Nondiscrimination on the Basis of Handicap in Programs and 
Activities Receiving or Benefiting From Federal Financial Assistance.
Part 95--General Administration--grant programs (public assistance and 
medical assistance).

[53 FR 36571, Sept. 21, 1988, as amended at 56 FR 8845, Mar. 1, 1991; 81 
FR 3011, Jan. 20, 2016]



Sec.  430.3  Appeals under Medicaid.

    Three distinct types of disputes may arise under Medicaid.
    (a) Compliance with Federal requirements. Disputes that pertain to 
whether a State's plan or proposed plan amendments, or its practice 
under the plan meet or continue to meet Federal requirements are subject 
to the hearing provisions of subpart D of this part.
    (b) FFP in Medicaid expenditures. Disputes that pertain to 
disallowances of FFP in Medicaid expenditures (mandatory grants) are 
heard by the Departmental Appeals Board (the Board) in accordance with 
procedures set forth in 45 CFR part 16.
    (c) Discretionary grants disputes. Disputes pertaining to 
discretionary grants, such as grants for special demonstration projects 
under sections 1110 and 1115 of the Act, which may be awarded to a 
Medicaid agency, are also heard by the Board. 45 CFR part 16, appendix 
A, lists all the types of disputes that the Board hears.

[53 FR 36571, Sept. 21, 1988, as amended at 56 FR 8845, Mar. 1, 1991]



Sec.  430.5  Definitions.

    As used in this subchapter, unless the context indicates otherwise--
    Contractor means any entity that contracts with the State agency, 
under the State plan, in return for a payment, to process claims, to 
provide or pay for medical services, or to enhance the State agency's 
capability for effective administration of the program.
    Representative has the meaning given the term by each State 
consistent with its laws, regulations, and policies.

[67 FR 41094, June 14, 2002]



                          Subpart B_State Plans



Sec.  430.10  The State plan.

    The State plan is a comprehensive written statement submitted by the 
agency describing the nature and scope of its Medicaid program and 
giving assurance that it will be administered in conformity with the 
specific requirements of title XIX, the regulations in this Chapter IV, 
and other applicable official issuances of the Department. The State 
plan contains all information necessary for CMS to determine whether the 
plan can be approved to serve as a basis for Federal financial 
participation (FFP) in the State program.



Sec.  430.12  Submittal of State plans and plan amendments.

    (a) Format. A State plan for Medicaid consists of a standardized 
template, issued and updated by CMS, that includes both basic 
requirements and individualized content that reflects the 
characteristics of the State's program. The Secretary will periodically 
update the template and format specifications for State plans and plan 
amendments through a process consistent with the requirements of the 
Paperwork Reduction Act.
    (b) Governor's review--(1) Basic rules. Except as provided in 
paragraph (b)(2) of this section--

[[Page 7]]

    (i) The Medicaid agency must submit the State plan and State plan 
amendments to the State Governor or his designee for review and comment 
before submitting them to the CMS regional office.
    (ii) The plan must provide that the Governor will be given a 
specific period of time to review State plan amendments, long-range 
program planning projections, and other periodic reports on the Medicaid 
program, excluding periodic statistical, budget and fiscal reports.
    (iii) Any comments from the Governor must be submitted to CMS with 
the plan or plan amendment.
    (2) Exceptions. (i) Submission is not required if the Governor's 
designee is the head of the Medicaid agency.
    (ii) Governor's review is not required for preprinted plan 
amendments that are developed by CMS if they provide absolutely no 
options for the State.
    (c) Plan amendments. (1) The plan must provide that it will be 
amended whenever necessary to reflect--
    (i) Changes in Federal law, regulations, policy interpretations, or 
court decisions; or
    (ii) Material changes in State law, organization, or policy, or in 
the State's operation of the Medicaid program. For changes related to 
advance directive requirements, amendments must be submitted as soon as 
possible, but no later than 60 days from the effective date of the 
change to State law concerning advance directives.
    (2) Prompt submittal of amendments is necessary--
    (i) So that CMS can determine whether the plan continues to meet the 
requirements for approval; and
    (ii) To ensure the availability of FFP in accordance with Sec.  
430.20.

[53 FR 36571, Sept. 21, 1988, as amended at 60 FR 33293, June 27, 1995; 
81 FR 86447, Nov. 30, 2016]



Sec.  430.14  Review of State plan material.

    CMS regional staff reviews State plans and plan amendments, 
discusses any issues with the Medicaid agency, and consults with central 
office staff on questions regarding application of Federal policy.



Sec.  430.15  Basis and authority for action on State plan material.

    (a) Basis for action. (1) Determinations as to whether State plans 
(including plan amendments and administrative practice under the plans) 
originally meet or continue to meet the requirements for approval are 
based on relevant Federal statutes and regulations.
    (2) Guidelines are furnished to assist in the interpretation of the 
regulations.
    (b) Approval authority. The Regional Administrator exercises 
delegated authority to approve the State plan and plan amendments on the 
basis of policy statements and precedents previously approved by the 
Administrator.
    (c) Disapproval authority. (1) The Administrator retains authority 
for determining that proposed plan material is not approvable or that 
previously approved material no longer meets the requirements for 
approval.
    (2) The Administrator does not make a final determination of 
disapproval without first consulting the Secretary.



Sec.  430.16  Timing and notice of action on State plan material.

    (a) Timing. (1) A State plan or plan amendment will be considered 
approved unless CMS, within 90 days after receipt of the plan or plan 
amendment in the regional office, sends the State--
    (i) Written notice of disapproval; or
    (ii) Written notice of any additional information it needs in order 
to make a final determination.
    (2) If CMS requests additional information, the 90-day period for 
CMS action on the plan or plan amendment begins on the day it receives 
that information.
    (b) Notice of final determination. (1) The Regional Administrator or 
the Administrator notifies the Medicaid agency of the approval of a 
State plan or plan amendment.
    (2) Only the Administrator gives notice of disapproval of a State 
plan or plan amendment.

[[Page 8]]



Sec.  430.18  Administrative review of action on State plan material.

    (a) Request for reconsideration. Any State dissatisfied with the 
Administrator's action on plan material under Sec.  430.15 may, within 
60 days after receipt of the notice provided under Sec.  430.16(b), 
request that the Administrator reconsider the issue of whether the plan 
or plan amendment conforms to the requirements for approval.
    (b) Notice and timing of hearing. (1) Within 30 days after receipt 
of the request, the Administrator notifies the State of the time and 
place of the hearing.
    (2) The hearing takes place not less than 30 days nor more than 60 
days after the date of the notice, unless the State and the 
Administrator agree in writing on an earlier or later date.
    (c) Hearing procedures. The hearing procedures are set forth in 
subpart D of this part.
    (d) Decision. A decision affirming, modifying, or reversing the 
Administrator's original determination is made in accordance with Sec.  
430.102.
    (e) Effect of hearing decision. (1) Denial of Federal funds, if 
required by the Administrator's original determination, will not be 
delayed pending a hearing decision.
    (2) However, if the Administrator determines that his or her 
original decision was incorrect, CMS pays the State a lump sum equal to 
any funds incorrectly denied.



Sec.  430.20  Effective dates of State plans and plan amendments.

    For purposes of FFP, the following rules apply:
    (a) New plans. The effective date of a new plan--
    (1) May not be earlier than the first day of the quarter in which an 
approvable plan is submitted to the regional office; and
    (2) With respect to expenditures for medical assistance, may not be 
earlier than the first day on which the plan is in operation on a 
statewide basis.
    (b) Plan amendment. (1) For a plan amendment that provides 
additional services to individuals eligible under the approved plan, 
increases the payment amounts for services already included in the plan, 
or makes additional groups eligible for services provided under the 
approved plan, the effective date is determined in accordance with 
paragraph (a) of this section.
    (2) For a plan amendment that changes the State's payment method and 
standards, the rules of Sec.  447.256 of this chapter apply.
    (3) For other plan amendments, the effective date may be a date 
requested by the State if CMS approves it.

[53 FR 36571, Sept. 21, 1988, as amended at 56 FR 8845, Mar. 1, 1991]



Sec.  430.25  Waivers of State plan requirements.

    (a) Scope of section. This section describes the purpose and effect 
of waivers, identifies the requirements that may be waived and the other 
regulations that apply to waivers, and sets forth the procedures that 
CMS follows in reviewing and taking action on waiver requests.
    (b) Purpose of waivers. Waivers are intended to provide the 
flexibility needed to enable States to try new or different approaches 
to the efficient and cost-effective delivery of health care services, or 
to adapt their programs to the special needs of particular areas or 
groups of beneficiaries. Waivers allow exceptions to State plan 
requirements and permit a State to implement innovative programs or 
activities on a time-limited basis, and subject to specific safeguards 
for the protection of beneficiaries and the program. Detailed rules for 
waivers are set forth in subpart B of part 431, subpart A of part 440, 
and subpart G of part 441 of this chapter.
    (c) Effect of waivers. (1) Waivers under section 1915(b) allow a 
State to take the following actions:
    (i) Implement a primary care case-management system or a specialty 
physician system.
    (ii) Designate a locality to act as central broker in assisting 
Medicaid beneficiaries to choose among competing health care plans.
    (iii) Share with beneficiaries (through provision of additional 
services) cost-savings made possible through the beneficiaries' use of 
more cost-effective medical care.

[[Page 9]]

    (iv) Limit beneficiaries' choice of providers (except in emergency 
situations and with respect to family planning services) to providers 
that fully meet reimbursement, quality, and utilization standards, which 
are established under the State plan and are consistent with access, 
quality, and efficient and economical furnishing of care.
    (2) A waiver under section 1915(c) of the Act allows a State to 
include as ``medical assistance'' under its plan home and community 
based services furnished to beneficiaries who would otherwise need 
inpatient care that is furnished in a hospital, SNF, ICF, or ICF/IID, 
and is reimbursable under the State plan.
    (3) A waiver under section 1916 (a)(3) or (b)(3) of the Act allows a 
State to impose a deduction, cost-sharing or similar charge of up to 
twice the ``nominal charge'' established under the plan for outpatient 
services, if--
    (i) The outpatient services are received in a hospital emergency 
room but are not emergency services; and
    (ii) The State has shown that Medicaid beneficiaries have actually 
available and accessible to them alternative services of nonemergency 
outpatient services.
    (d) Requirements that are waived. In order to permit the activities 
described in paragraph (c) of this section, one or more of the title XIX 
requirements must be waived, in whole or in part.
    (1) Under section 1915(b) of the Act, and subject to certain 
limitations, any of the State plan requirements of section 1902 of the 
Act may be waived to achieve one of the purposes specified in that 
section.
    (2) Under section 1915(c) of the Act, the following requirements may 
be waived:
    (i) Statewideness--section 1902(a)(1).
    (ii) Comparability of services--section 1902(a)(10)(B).
    (iii) Income and resource rules--section 1902(a)(10)(C)(i)(III).
    (3) Under section 1916 of the Act, paragraphs (a)(3) and (b)(3) 
require that any cost-sharing imposed on beneficiaries be nominal in 
amount, and provide an exception for nonemergency services furnished in 
a hospital emergency room if the conditions of paragraph (c)(3) of this 
section are met.
    (e) Submittal of waiver request. The State Governor, the head of the 
Medicaid agency, or an authorized designee may submit the waiver 
request.
    (f) Review of waiver requests. (1) This paragraph applies to initial 
waiver requests and to requests for renewal or amendment of a previously 
approved waiver.
    (2) CMS regional and central office staff review waiver requests and 
submit a recommendation to the Administrator, who--
    (i) Has the authority to approve or deny waiver requests; and
    (ii) Does not deny a request without first consulting the Secretary.
    (3) A waiver request is considered approved unless, within 90 days 
after the request is received by CMS, the Administrator denies the 
request, or the Administrator or the Regional Administrator sends the 
State a written request for additional information necessary to reach a 
final decision. If additional information is requested, a new 90-day 
period begins on the day the response to the additional information 
request is received by the addressee.
    (g) Basis for approval--(1) Waivers under section 1915 (b) and (c). 
The Administrator approves waiver requests if the State's proposed 
program or activity meets the requirements of the Act and the 
regulations at Sec.  431.55 or subpart G of part 441 of this chapter.
    (2) Waivers under section 1916. The Administrator approves a waiver 
under section 1916 of the Act if the State shows, to CMS's satisfaction, 
that the Medicaid beneficiaries have available and accessible to them 
sources, other than a hospital emergency room, where they can obtain 
necessary nonemergency outpatient services.
    (h) Effective date and duration of waivers--(1) Effective date. 
Waivers receive a prospective effective date determined, with State 
input, by the Administrator. The effective date is specified in the 
letter of approval to the State.
    (2) Duration of waivers--(i) Home and community-based services under 
section 1915(c) of the Act. (A) The initial waiver is for a period of 3 
years and may be renewed thereafter for periods of 5 years.

[[Page 10]]

    (B) For waivers that include individuals who are dually eligible for 
Medicare and Medicaid, 5-year initial approval periods may be granted at 
the discretion of the Secretary for waivers meeting all necessary 
programmatic, financial and quality requirements, and in a manner 
consistent with the interests of beneficiaries and the objectives of the 
Medicaid program.
    (ii) Waivers under section 1915(b) of the Act. (A) The initial 
waiver is for a period of 2 years and may be renewed for additional 
periods of up to 2 years as determined by the Administrator.
    (B) For waivers that include individuals who are dually eligible for 
Medicare and Medicaid, 5-year initial and renewal approval periods may 
be granted at the discretion of the Secretary for waivers meeting all 
necessary programmatic, financial and quality requirements, and in a 
manner consistent with the interests of beneficiaries and the objectives 
of the Medicaid program.
    (iii) Waivers under section 1916 of the Act. The initial waiver is 
for a period of 2 years and may be renewed for additional periods of up 
to 2 years as determined by the Administrator.
    (3) Renewal of waivers. (i) A renewal request must be submitted at 
least 90 days (but not more than 120 days) before a currently approved 
waiver expires, to provide adequate time for CMS review.
    (ii) If a renewal request for a section 1915(c) waiver proposes a 
change in services provided, eligible population, service area, or 
statutory sections waived, the Administrator may consider it a new 
waiver, and approve it for a period of three years.

[56 FR 8846, Mar. 1, 1991, as amended at 79 FR 3028, Jan. 16, 2014]



Subpart C_Grants; Reviews and Audits; Withholding for Failure To Comply; 
   Deferral and Disallowance of Claims; Reduction of Federal Medicaid 
                                Payments



Sec.  430.30  Grants procedures.

    (a) General provisions. (1) Once CMS has approved a State plan, it 
makes quarterly grant awards to the State to cover the Federal share of 
expenditures for services, training, and administration.
    (2) The amount of the quarterly grant is determined on the basis of 
information submitted by the State agency (in quarterly estimate and 
quarterly expenditure reports) and other pertinent documents.
    (b) Quarterly estimates. The Medicaid agency must submit Form CMS-37 
(Medicaid Program Budget Report; Quarterly Distribution of Funding 
Requirements) to the central office (with a copy to the regional office) 
45 days before the beginning of each quarter.
    (c) Expenditure reports. (1) The State must submit Form CMS-64 
(Quarterly Medicaid Statement of Expenditures for the Medical Assistance 
Program) to the central office (with a copy to the regional office) not 
later than 30 days after the end of each quarter.
    (2) This report is the State's accounting of actual recorded 
expenditures. The disposition of Federal funds may not be reported on 
the basis of estimates.
    (d) Grant award--(1) Computation by CMS. Regional office staff 
analyzes the State's estimates and sends a recommendation to the central 
office. Central office staff considers the State's estimates, the 
regional office recommendations and any other relevant information, 
including any adjustments to be made under paragraph (d)(2) of this 
section, and computes the grant.
    (2) Content of award. The grant award computation form shows the 
estimate of expenditures for the ensuring quarter, and the amounts by 
which that estimate is increased or decreased because of an 
underestimate or overestimate for prior quarters, or for any of the 
following reasons:
    (i) Penalty reductions imposed by law.
    (ii) Accounting adjustments.
    (iii) Deferrals or disallowances.
    (iv) Interest assessments.
    (v) Mandated adjustments such as those required by section 1914 of 
the Act.
    (3) Effect of award. The grant award authorizes the State to draw 
Federal funds as needed to pay the Federal share of disbursements.

[[Page 11]]

    (4) Drawing procedure. The draw is through a commercial bank and the 
Federal Reserve system against a continuing letter of credit certified 
to the Secretary of the Treasury in favor of the State payee. (The 
letter of credit payment system was established in accordance with 
Treasury Department regulations--Circular No. 1075.)
    (e) General administrative requirements. With the following 
exceptions, the provisions of 45 CFR 75, which establish uniform 
administrative requirements and cost principles, apply to all grants 
made to States under this subpart:
    (1) Cost sharing or matching, 45 CFR 75.306; and
    (2) Financial reporting, 45 CFR 75.341.

[53 FR 36571, Sept. 21, 1988, as amended at 77 FR 31507, May 29, 2012; 
81 FR 3011, Jan. 20, 2016]



Sec.  430.32  Program reviews.

    (a) Review of State and local administration. In order to determine 
whether the State is complying with the Federal requirements and the 
provisions of its plan, CMS reviews State and local administration 
through analysis of the State's policies and procedures, on-site review 
of selected aspects of agency operation, and examination of samples of 
individual case records.
    (b) Quality control program. The State itself is required to carry 
out a continuing quality control program as set forth in part 431, 
subpart P, of this chapter.
    (c) Action on review findings. If Federal or State reviews reveal 
serious problems with respect to compliance with any Federal 
requirement, the State must correct its practice accordingly.



Sec.  430.33  Audits.

    (a) Purpose. The Department's Office of Inspector General (OIG) 
periodically audits State operations in order to determine whether--
    (1) The program is being operated in a cost-efficient manner; and
    (2) Funds are being properly expended for the purposes for which 
they were appropriated under Federal and State law and regulations.
    (b) Reports. (1) The OIG releases audit reports simultaneously to 
State officials and the Department's program officials.
    (2) The reports set forth OIG opinion and recommendations regarding 
the practices it reviewed, and the allowability of the costs it audited.
    (3) Cognizant officials of the Department make final determinations 
on all audit findings.
    (c) Action on audit exceptions--(1) Concurrence or clearance. The 
State agency has the opportunity of concurring in the exceptions or 
submitting additional facts that support clearance of the exceptions.
    (2) Appeal. Any exceptions that are not disposed of under paragraph 
(c)(1) of this section are included in a disallowance letter that 
constitutes the Department's final decision unless the State requests 
reconsideration by the Administrator or the Departmental Appeals Board. 
(Specific rules are set forth in Sec.  430.42.)
    (3) Adjustment. If the decision by the Board requires an adjustment 
of FFP, either upward or downward, a subsequent grant award promptly 
reflects the amount of increase or decrease.

[53 FR 36571, Sept. 21, 1988, as amended at 56 FR 8846, Mar. 1, 1991; 77 
FR 31507, May 29, 2012]



Sec.  430.35  Withholding of payment for failure to comply with Federal
requirements.

    (a) Basis for withholding. CMS withholds payments to the State, in 
whole or in part, only if, after giving the agency reasonable notice and 
opportunity for a hearing in accordance with subpart D of this part, the 
Administrator finds--
    (1) That the plan no longer complies with the provisions of section 
1902 of the Act; or
    (2) That in the administration of the plan there is failure to 
comply substantially with any of those provisions.

(Hearings under subpart D are generally not called until a reasonable 
effort has been made to resolve the issues through conferences and 
discussions. These may be continued even if a date and place have been 
set for the hearing.)
    (b) Noncompliance of the plan. A question of noncompliance of a 
State plan may arise from an unapprovable

[[Page 12]]

change in the approved State plan or the failure of the State to change 
its approved plan to conform to a new Federal requirement for approval 
of State plans.
    (c) Noncompliance in practice. A question of noncompliance in 
practice may arise from the State's failure to actually comply with a 
Federal requirement, regardless of whether the plan itself complies with 
that requirement.
    (d) Notice and implementation of withholding. If the Administrator 
makes a finding of noncompliance under paragraph (a) of this section, 
the following rules apply:
    (1) The Administrator notifies the State:
    (i) That no further payments will be made to the State (or that 
payments will be made only for those portions or aspects of the program 
that are not affected by the noncompliance); and
    (ii) That the total or partial withholding will continue until the 
Administrator is satisfied that the State's plan and practice are, and 
will continue to be, in compliance with Federal requirements.
    (2) CMS withholds payments, in whole or in part, until the 
Administrator is satisfied regarding the State's compliance.



Sec.  430.38  Judicial review.

    (a) Right to judicial review. Any State dissatisfied with the 
Administrator's final determination on approvability of plan material 
(Sec.  430.18) or compliance with Federal requirements (Sec.  430.35) 
has a right to judicial review.
    (b) Petition for review. (1) The State must file a petition for 
review with the U.S. Court of Appeals for the circuit in which the State 
is located, within 60 days after it is notified of the determination.
    (2) The clerk of the court will file a copy of the petition with the 
Administrator and the Administrator will file in the court the record of 
the proceedings on which the determination was based.
    (c) Court action. (1) The court is bound by the Administrator's 
findings of fact if they are supported by substantial evidence.
    (2) The court has jurisdiction to affirm the Administrator's 
decision, to set it aside in whole or in part, or, for good cause, to 
remand the case for additional evidence.
    (d) Response to remand. (1) If the court remands the case, the 
Administrator may make new or modified findings of fact and may modify 
his or her previous determination.
    (2) The Administrator will certify to the court the transcript and 
record of the further proceedings.
    (e) Review by the Supreme Court. The judgment of the appeals court 
is subject to review by the U.S. Supreme Court upon certiorari or 
certification, as provided in 28 U.S.C. 1254.



Sec.  430.40  Deferral of claims for FFP.

    (a) Requirements for deferral. Payment of a claim or any portion of 
a claim for FFP is deferred only if--
    (1) The Administrator or current Designee questions its allowability 
and needs additional information to resolve the question; and
    (2) CMS takes action to defer the claim (by excluding the claimed 
amount from the grant award) within 60 days after the receipt of a 
Quarterly Statement of Expenditures (prepared in accordance with CMS 
instructions) that includes that claim.
    (b) Notice of deferral and State's responsibility. (1) Within 15 
days of the action described in paragraph (a)(2) of this section, the 
current Designee sends the State a written notice of deferral that--
    (i) Identifies the type and amount of the deferred claim and 
specifies the reason for deferral; and
    (ii) Requests the State to make available all the documents and 
materials the regional office then believes are necessary to determine 
the allowability of the claim.
    (2) It is the responsibility of the State to establish the 
allowability of a deferred claim.
    (c) Handling of documents and materials. (1) Within 60 days (or 
within 120 days if the State requests an extension) after receipt of the 
notice of deferral, the State must make available to the regional 
office, in readily reviewable form, all requested documents and 
materials except any that it identifies as not being available.

[[Page 13]]

    (2) Regional office staff usually initiates review within 30 days 
after receipt of the documents and materials.
    (3) If the current Designee finds that the materials are not in 
readily reviewable form or that additional information is needed, he or 
she promptly notifies the State that it has 15 days to submit the 
readily reviewable or additional materials.
    (4) If the State does not provide the necessary materials within 15 
days, the current Designee disallows the claim.
    (5) The current Designee has 90 days, after all documentation is 
available in readily reviewable form, to determine the allowability of 
the claim.
    (6) If the current Designee cannot complete review of the material 
within 90 days, CMS pays the claim, subject to a later determination of 
allowability.
    (d) Effect of decision to pay a deferred claim. Payment of a 
deferred claim under paragraph (c)(6) of this section does not preclude 
a subsequent disallowance based on the results of an audit or financial 
review. (If there is a subsequent disallowance, the State may request 
reconsideration as provided in paragraph (e)(2) of this section.)
    (e) Notice and effect of decision on allowability. (1) The 
Administrator or current Designee gives the State written notice of his 
or her decision to pay or disallow a deferred claim.
    (2) If the decision is to disallow, the notice informs the State of 
its right to reconsideration in accordance with 45 CFR part 16.

[53 FR 36571, Sept. 21, 1988, as amended at 77 FR 31507, May 29, 2012]



Sec.  430.42  Disallowance of claims for FFP.

    (a) Notice of disallowance and of right to reconsideration. When the 
Administrator or current Designee determines that a claim or portion of 
claim is not allowable, he or she promptly sends the State a 
disallowance letter that includes the following, as appropriate:
    (1) The date or dates on which the State's claim for FFP was made.
    (2) The time period during which the expenditures in question were 
made or claimed to have been made.
    (3) The date and amount of any payment or notice of deferral.
    (4) A statement of the amount of FFP claimed, allowed, and 
disallowed and the manner in which these amounts were computed.
    (5) Findings of fact on which the disallowance determination is 
based or a reference to other documents previously furnished to the 
State or included with the notice (such as a report of a financial 
review or audit) which contain the findings of fact on which the 
disallowance determination is based.
    (6) Pertinent citations to the law, regulations, guides and 
instructions supporting the action taken.
    (7) A request that the State make appropriate adjustment in a 
subsequent expenditure report.
    (8) Notice of the State's right to request reconsideration of the 
disallowance and the time allowed to make the request.
    (9) A statement indicating that the disallowance letter is the 
Department's final decision unless the State requests reconsideration 
under paragraph (b)(2) or (f)(2) of this section.
    (b) Reconsideration of a disallowance. (1) The Administrator will 
reconsider Medicaid disallowance determinations.
    (2) To request reconsideration of a disallowance, a State must 
complete the following:
    (i) Submit the following within 60 days after receipt of the 
disallowance letter:
    (A) A written request to the Administrator that includes the 
following:
    (1) A copy of the disallowance letter.
    (2) A statement of the amount in dispute.
    (3) A brief statement of why the disallowance should be reversed or 
revised, including any information to support the State's position with 
respect to each issue.
    (4) Additional information regarding factual matters or policy 
considerations.
    (B) A copy of the written request to the Regional Office.
    (C) Send all requests for reconsideration via registered or 
certified mail to establish the date the reconsideration was received by 
CMS.
    (ii) In all cases, the State has the burden of documenting the 
allowability of its claims for FFP.

[[Page 14]]

    (iii) Additional information regarding the legal authority for the 
disallowance will not be reviewed in the reconsideration but may be 
presented in any appeal to the Departmental Appeals Board under 
paragraph (f)(2) of this section.
    (3) A State may request to retain the FFP during the reconsideration 
of the disallowance under section 1116(e) of the Act, in accordance with 
Sec.  433.38 of this subchapter.
    (4) The State is not required to request reconsideration before 
seeking review from the Departmental Appeals Board.
    (5) The State may also seek reconsideration, and following the 
reconsideration decision, request a review from the Board.
    (6) If the State elects reconsideration, the reconsideration process 
must be completed or withdrawn before requesting review by the Board.
    (c) Procedures for reconsideration of a disallowance. (1) Within 60 
days after receipt of the disallowance letter, the State shall, in 
accordance with (b)(2) of this section, submit in writing to the 
Administrator any relevant evidence, documentation, or explanation and 
shall simultaneously submit a copy thereof to the Regional Office.
    (2) After consideration of the policies and factual matters 
pertinent to the issues in question, the Administrator shall, within 60 
days from the date of receipt of the request for reconsideration, issue 
a written decision or a request for additional information as described 
in paragraph (c)(3) of this section.
    (3) At the Administrator's option, CMS may request from the State 
any additional information or documents necessary to make a decision. 
The request for additional information must be sent via registered or 
certified mail to establish the date the request was sent by CMS and 
received by the State.
    (4) Within 30 days after receipt of the request for additional 
information, the State must submit to the Administrator, with a copy to 
the Regional Office in readily reviewable form, all requested documents 
and materials.
    (i) If the Administrator finds that the materials are not in readily 
reviewable form or that additional information is needed, he or she 
shall notify the State via registered or certified mail that it has 15 
business days from the date of receipt of the notice to submit the 
readily reviewable or additional materials.
    (ii) If the State does not provide the necessary materials within 15 
business days from the date of receipt of such notice, the Administrator 
shall affirm the disallowance in a final reconsideration decision issued 
within 15 days from the due date of additional information from the 
State.
    (5) If additional documentation is provided in readily reviewable 
form under the paragraph (c)(4) of this section, the Administrator shall 
issue a written decision, within 60 days from the due date of such 
information.
    (6) The final written decision shall constitute final CMS 
administrative action on the reconsideration and shall be (within 15 
business days of the decision) mailed to the State agency via registered 
or certified mail to establish the date the reconsideration decision was 
received by the State.
    (7) If the Administrator does not issue a decision within 60 days 
from the date of receipt of the request for reconsideration or the date 
of receipt of the requested additional information, the disallowance 
shall be deemed to be affirmed upon reconsideration.
    (8) No section of this regulation shall be interpreted as waiving 
the Department's right to assert any provision or exemption under the 
Freedom of Information Act.
    (d) Withdrawal of a request for reconsideration of a disallowance. 
(1) A State may withdraw the request for reconsideration at any time 
before the notice of the reconsideration decision is received by the 
State without affecting its right to submit a notice of appeal to the 
Board. The request for withdrawal must be in writing and sent to the 
Administrator, with a copy to the Regional Office, via registered or 
certified mail.
    (2) Within 60 days after CMS' receipt of a State's withdrawal 
request, a State may, in accordance with (f)(2) of this section, submit 
a notice of appeal to the Board.
    (e) Implementation of decisions for reconsideration of a 
disallowance. (1) After

[[Page 15]]

undertaking a reconsideration, the Administrator may affirm, reverse, or 
revise the disallowance and shall issue a final written reconsideration 
decision to the State in accordance with paragraph (c)(4) of this 
section.
    (2) If the reconsideration decision requires an adjustment of FFP, 
either upward or downward, a subsequent grant award will be issued in 
the amount of such increase or decrease.
    (3) Within 60 days after the receipt of a reconsideration decision 
from CMS a State may, in accordance with paragraph (f)(2) of this 
section, submit a notice of appeal to the Board.
    (f) Appeal of Disallowance. (1) The Departmental Appeals Board 
reviews disallowances of FFP under title XIX.
    (2) A State that wishes to appeal a disallowance to the Board must:
    (i) Submit a notice of appeal to the Board at the address given on 
the Departmental Appeals Board's web site within 60 days after receipt 
of the disallowance letter.
    (A) If a reconsideration of a disallowance was requested, within 60 
days after receipt of the reconsideration decision; or
    (B) If reconsideration of a disallowance was requested and no 
written decision was issued, within 60 days from the date the decision 
on reconsideration of the disallowance was due to be issued by CMS.
    (ii) Include all of the following:
    (A) A copy of the disallowance letter.
    (B) A statement of the amount in dispute.
    (C) A brief statement of why the disallowance is wrong.
    (3) The Board's decision of an appeal under paragraph (f)(2) of this 
section shall be the final decision of the Secretary and shall be 
subject to reconsideration by the Board only upon a motion by either 
party that alleges a clear error of fact or law and is filed during the 
60-day period that begins on the date of the Board's decision or to 
judicial review in accordance with paragraph (f)(2)(i) of this section.
    (g) Appeals procedures. The appeals procedures are those set forth 
in 45 CFR part 16 for Medicaid and for many other programs administered 
by the Department.
    (1) In all cases, the State has the burden of documenting the 
allowability of its claims for FFP.
    (2) The Board shall conduct a thorough review of the issues, taking 
into account all relevant evidence, including such documentation as the 
State may submit and the Board may require.
    (h) Implementation of decisions. (1) The Board may affirm the 
disallowance, reverse the disallowance, modify the disallowance, or 
remand the disallowance to CMS for further consideration.
    (2) The Board will issue a final written decision to the State 
consistent with 45 CFR part 16.
    (3) If the appeal decision requires an adjustment of FFP, either 
upward or downward, a subsequent grant award will be issued in the 
amount of increase or decrease.

[53 FR 36571, Sept. 21, 1988, as amended at 56 FR 8846, Mar. 1, 1991; 77 
FR 31507, May 29, 2012]



Sec.  430.45  Reduction of Federal Medicaid payments.

    (a) Methods of reduction. CMS may reduce Medicaid payments to a 
State as required under the Act by reducing--
    (1) The Federal Medical Assistance Percentage;
    (2) The amount of State expenditures subject to FFP;
    (3) The rates of FFP; or
    (4) The amount otherwise payable to the State.
    (b) Right to reconsideration. A state that receives written final 
notice of a reduction under paragraph (a) of this section has a right to 
reconsideration. The provisions of Sec.  430.42 (b) and (c) apply.
    (c) Other applicable rules. Other rules regarding reduction of 
Medicaid payments are set forth in parts 433 and 447 of this chapter.



Sec.  430.48  Repayment of Federal funds by installments.

    (a) Basic conditions. When Federal payments have been made for 
claims that are later found to be unallowable, the State may repay the 
Federal funds by installments if all of the following conditions are 
met:
    (1) The amount to be repaid exceeds 0.25 percent of the estimated or 
actual

[[Page 16]]

annual State share for the Medicaid program.
    (2) The State has given the Regional Office written notice, before 
total repayment was due, of its intent to repay by installments.
    (b) Annual State share determination. CMS determines whether the 
amount to be repaid exceeds 0.25 percent of the annual State share as 
follows:
    (1) If the Medicaid program is ongoing, CMS uses the annual 
estimated State share of Medicaid expenditures for the current year, as 
shown on the State's latest Medicaid Program Budget Report (CMS-37). The 
current year is the year in which the State requests the repayment by 
installments.
    (2) If the Medicaid program has been terminated by Federal law or by 
the State, CMS uses the actual State share that is shown on the State's 
CMS-64 Quarterly Expense Report for the last four quarters filed.
    (c) Standard Repayment amounts, schedules, and procedures--(1) 
Repayment amount. The repayment amount may not include any amount 
previously approved for installment repayment.
    (2) Repayment schedule. The maximum number of quarters allowed for 
the standard repayment schedule is 12 quarters (3 years), except as 
provided in paragraphs (c)(4) and (e) of this section.
    (3) Quarterly repayment amounts. (i) The quarterly repayment amounts 
for each of the quarters in the repayment schedule will be the larger of 
the repayment amount divided by 12 quarters or the minimum repayment 
amount;
    (ii) The minimum quarterly repayment amounts for each of the 
quarters in the repayment schedule is 0.25 percent of the estimated 
State share of the current annual expenditures for Medicaid;
    (iii) The repayment period may be less than 12 quarters when the 
minimum repayment amount is required.
    (4) Extended schedule. (i) The repayment schedule may be extended 
beyond 12 quarterly installments if the total repayment amount exceeds 
100 percent of the estimated State share of the current annual 
expenditures;
    (ii) The quarterly repayment amount will be 8\1/3\ percent of the 
estimated State share of the current annual expenditures until fully 
repaid.
    (5) Repayment process. (i) Repayment is accomplished through 
deposits into the State's Payment Management System (PMS) account;
    (ii) A State may choose to make payment by Automated Clearing House 
(ACH) direct deposit, by check, or by Fedwire transfer.
    (6) Reductions. If the State chooses to repay amounts representing 
higher percentages during the early quarters, any corresponding 
reduction in required minimum percentages is applied first to the last 
scheduled payment, then to the next to the last payment, and so forth as 
necessary.
    (d) Alternate repayment amounts, schedules, and procedures for 
States experiencing economic distress immediately prior to the repayment 
period--(1) Repayment amount. The repayment amount may not include 
amounts previously approved for installment repayment if a State 
initially qualifies for the alternate repayment schedule at the onset of 
an installment repayment period.
    (2) Qualifying period of economic distress. (i) A State will qualify 
to avail itself of the alternate repayment schedule if it demonstrates 
the State is experiencing a period of economic distress;
    (ii) A period of economic distress is one in which the State 
demonstrates distress for at least each of the previous 6 months, ending 
the month prior to the date of the State's written request for an 
alternate repayment schedule, as determined by a negative percent change 
in the monthly Philadelphia Federal Reserve Bank State coincident index.
    (3) Repayment schedule. The maximum number of quarters allowed for 
the alternate repayment schedule is 12 quarters (3 years), except as 
provided in paragraph (d)(5) of this section.
    (4) Quarterly repayment amounts. (i) The quarterly repayment amounts 
for each of the first 8 quarters in the repayment schedule will be the 
smaller of the repayment amount divided by 12 quarters or the maximum 
quarterly repayment amount;
    (ii) The maximum quarterly repayment amounts for each of the first 8 
quarters in the repayment schedule is

[[Page 17]]

0.25 percent of the annual State share determination as defined in 
paragraph (b) of this section;
    (iii) For the remaining 4 quarters, the quarterly repayment amount 
equals the remaining balance of the overpayment amount divided by the 
remaining 4 quarters.
    (5) Extended schedule. (i) For a State that initiated its repayment 
under an alternate payment schedule for economic distress, the repayment 
schedule may be extended beyond 12 quarterly installments if the total 
repayment amount exceeds 100 percent of the estimated State share of 
current annual expenditures;
    (A) In these circumstances, paragraph (d)(3) of this section is 
followed for repayment of the amount equal to 100 percent of the 
estimated State share of current annual expenditures.
    (B) The remaining amount of the repayment is in quarterly amounts 
equal to 8\1/3\ percent of the estimated State share of current annual 
expenditures until fully repaid.
    (ii) Upon request by the State, the repayment schedule may be 
extended beyond 12 quarterly installments if the State has qualifying 
periods of economic distress in accordance with paragraph (d)(2) of this 
section during the first 8 quarters of the alternate repayment schedule.
    (A) To qualify for additional quarters, the States must demonstrate 
a period of economic distress in accordance with paragraph (d)(2) of 
this section for at least 1 month of a quarter during the first 8 
quarters of the alternate repayment schedule.
    (B) For each quarter (of the first 8 quarters of the alternate 
payment schedule) identified as qualified period of economic distress, 
one quarter will be added to the remaining 4 quarters of the original 12 
quarter repayment period.
    (C) The total number of quarters in the alternate repayment schedule 
shall not exceed 20 quarters.
    (6) Repayment process. (i) Repayment is accomplished through 
deposits into the State's Payment Management System (PMS) account;
    (ii) A State may choose to make payment by Automated Clearing House 
(ACH) direct deposit, by check, or by Fedwire transfer.
    (7) If the State chooses to repay amounts representing higher 
percentages during the early quarters, any corresponding reduction in 
required minimum percentages is applied first to the last scheduled 
payment, then to the next to the last payment, and so forth as 
necessary.
    (e) Alternate repayment amounts, schedules, and procedures for 
States entering into distress during a standard repayment schedule--(1) 
Repayment amount. The repayment amount may include amounts previously 
approved for installment repayment if a State enters into a qualifying 
period of economic distress during an installment repayment period.
    (2) Qualifying period of economic distress. (i) A State will qualify 
to avail itself of the alternate repayment schedule if it demonstrates 
the State is experiencing economic distress;
    (ii) A period of economic distress is one in which the State 
demonstrates distress for each of the previous 6 months, that begins on 
the date of the State's request for an alternate repayment schedule, as 
determined by a negative percent change in the monthly Philadelphia 
Federal Reserve Bank State coincident index.
    (3) Repayment schedule. The maximum number of quarters allowed for 
the alternate repayment schedule is 12 quarters (3 years), except as 
provided in paragraph (e)(5) of this section.
    (4) Quarterly repayment amounts. (i) The quarterly repayment amounts 
for each of the first 8 quarters in the repayment schedule will be the 
smaller of the repayment amount divided by 12 quarters or the maximum 
repayment amount;
    (ii) The maximum quarterly repayment amounts for each of the first 8 
quarters in the repayment schedule is 0.25 percent of the annual State 
share determination as defined in paragraph (b) of this section;
    (iii) For the remaining 4 quarters, the quarterly repayment amount 
equals the remaining balance of the overpayment amount divided by the 
remaining 4 quarters.
    (5) Extended schedule. (i) For a State that initiated its repayment 
under the

[[Page 18]]

standard payment schedule and later experienced periods of economic 
distress and elected an alternate repayment schedule, the repayment 
schedule may be extended beyond 12 quarterly installments if the total 
repayment amount of the remaining balance of the standard schedule, 
exceeds 100 percent of the estimated State share of the current annual 
expenditures;
    (ii) In these circumstances, paragraph (d)(3) of this section is 
followed for repayment of the amount equal to 100 percent of the 
estimated State share of current annual expenditures;
    (iii) The remaining amount of the repayment is in quarterly amounts 
equal to 8\1/3\ percent of the estimated State share of the current 
annual expenditures until fully repaid.
    (6) Repayment process. (i) Repayment is accomplished through 
deposits into the State's Payment Management System (PMS) account;
    (ii) A State may choose to make payment by Automated Clearing House 
(ACH) direct deposit, by check, or by Fedwire transfer.
    (7) If the State chooses to repay amounts representing higher 
percentages during the early quarters, any corresponding reduction in 
required minimum percentages is applied first to the last scheduled 
payment, then to the next to the last payment, and so forth as 
necessary.

[77 FR 31509, May 29, 2012]



Subpart D_Hearings on Conformity of State Medicaid Plans and Practice to 
                          Federal Requirements



Sec.  430.60  Scope.

    (a) This subpart sets forth the rules for hearings to States that 
appeal a decision to disapprove State plan material (under Sec.  430.18) 
or to withhold Federal funds (under Sec.  430.35), because the State 
plan or State practice in the Medicaid program is not in compliance with 
Federal requirements.
    (b) Nothing in this subpart is intended to preclude or limit 
negotiations between CMS and the State, whether before, during, or after 
the hearing to resolve the issues that are, or otherwise would be, 
considered at the hearing. Such negotiations and resolution of issues 
are not part of the hearing, and are not governed by the rules in this 
subpart except as expressly provided.



Sec.  430.62  Records to be public.

    All pleadings, correspondence, exhibits, transcripts of testimony, 
exceptions, briefs, decisions, and other documents filed in the docket 
in any proceeding may be inspected and copied in the office of the CMS 
Docket Clerk. Inquiries may be made to the Docket Clerk, Hearing Staff, 
Bureau of Eligibility, Reimbursment and Coverage, 300 East High Rise, 
6325 Security Boulevard, Baltimore, Maryland, 21207. Telephone: (301) 
594-8261.



Sec.  430.63  Filing and service of papers.

    (a) Filing. All papers in the proceedings are filed with the CMS 
Docket Clerk, in an original and two copies. Originals only of exhibits 
and transcripts of testimony need be filed.
    (b) Service. All papers in the proceedings are served on all parties 
by personal delivery or by mail. Service on the party's designated 
attorney is considered service upon the party.



Sec.  430.64  Suspension of rules.

    Upon notice to all parties, the Administrator or the presiding 
officer may modify or waive any rule in this subpart upon determination 
that no party will be unduly prejudiced and the ends of justice will 
thereby be served.



Sec.  430.66  Designation of presiding officer for hearing.

    (a) The presiding officer at a hearing is the Administrator or his 
designee.
    (b) The designation of the presiding officer is in writing. A copy 
of the designation is served on all parties.



Sec.  430.70  Notice of hearing or opportunity for hearing.

    The Administrator mails the State a notice of hearing or opportunity 
for hearing that--
    (a) Specifies the time and place for the hearing;
    (b) Specifies the issues that will be considered;
    (c) Identifies the presiding officer; and

[[Page 19]]

    (d) Is published in the Federal Register.



Sec.  430.72  Time and place of hearing.

    (a) Time. The hearing is scheduled not less than 30 nor more than 60 
days after the date of notice to the State. The scheduled date may be 
changed by written agreement between CMS and the State.
    (b) Place. The hearing is conducted in the city in which the CMS 
regional office is located or in another place fixed by the presiding 
officer in light of the circumstances of the case, with due regard for 
the convenience and necessity of the parties or their representatives.



Sec.  430.74  Issues at hearing.

    The list of issues specified in the notice of hearing may be 
augmented or reduced as provided in this section.
    (a) Additional issues. (1) Before a hearing under Sec.  430.35, the 
Administrator may send written notice to the State listing additional 
issues to be considered at the hearing. That notice is published in the 
Federal Register.
    (2) If the notice of additional issues is furnished to the State 
less than 20 days before the scheduled hearing date, postponement is 
granted if requested by the State or any other party. The new date may 
be 20 days after the date of the notice, or a later date agreed to by 
the presiding officer.
    (b) New or modified issues. If, as a result of negotiations between 
CMS and the State, the submittal of plan amendment, a change in the 
State program, or other actions by the State, any issue is resolved in 
whole or in part, but new or modified issues are presented, as specified 
by the presiding officer, the hearing proceeds on the new or modified 
issues.
    (c) Issues removed from consideration--(1) Basis for removal. If at 
any time before, during, or after the hearing, the presiding officer 
finds that the State has come into compliance with Federal requirements 
on any issue or part of an issue, he or she removes the appropriate 
issue or part of an issue from consideration. If all issues are removed, 
the hearing is terminated.
    (2) Notice to parties. Before removing any issue or part of an issue 
from consideration, the presiding officer provides all parties other 
than CMS and the State with--
    (i) A statement of the intent to remove and the reasons for removal; 
and
    (ii) A copy of the proposed State plan provision on which CMS and 
the State have agreed.
    (3) Opportunity for written comment. The notified parties have 15 
days to submit, for consideration by the presiding officer, and for the 
record, their views as to, or any information bearing upon, the merits 
of the proposed plan provision and the merits of the reasons for 
removing the issue from consideration.
    (d) Remaining issues. The issues considered at the hearing are 
limited to those issues of which the State is notified as provided in 
Sec.  430.70 and paragraph (a) of this section, and new or modified 
issues described in paragraph (b) of this section. They do not include 
issues or parts of issues removed in accordance with paragraph (c) of 
this section.



Sec.  430.76  Parties to the hearing.

    (a) CMS and the State. CMS and the State are parties to the hearing.
    (b) Other individuals--(1) Basis for participation. Other 
individuals or groups may be recognized as parties if the issues to be 
considered at the hearing have caused them injury and their interest is 
within the zone of interests to be protected by the governing Federal 
statute.
    (2) Petition for participation. Any individual or group wishing to 
participate as a party must, within 15 days after notice of hearing is 
published in the Federal Register, file with the CMS Docket Clerk, a 
petition that concisely states--
    (i) Petitioner's interest in the proceeding;
    (ii) Who will appear for petitioner;
    (iii) The issues on which petitioner wishes to participate; and
    (iv) Whether petitioner intends to present witnesses.

The petitioner must also serve a copy of the petition on each party of 
record at that time.
    (3) Comments on petition. Any party may, within 5 days of receipt of 
the copy of the petition, file comments on it.

[[Page 20]]

    (4) Action on petition. (i) The presiding officer promptly 
determines whether each petitioner has the requisite interest in the 
proceedings and approves or denies participation accordingly.
    (ii) If petitions are made by more than one individual or group with 
common interests, the presiding officer may--
    (A) Request all those petitioners to designate a single 
representative; or
    (B) Recognize one or more of those petitioners to represent all of 
them.
    (iii) The presiding officer gives each petitioner written notice of 
the decision and, if the decision is to deny, briefly states the grounds 
for denial.
    (c) Amicus curiae (friend of the court)--(1) Petition for 
participation. Any person or organization that wishes to participate as 
amicus curiae must, before the hearing begins, file with the CMS Docket 
Clerk, a petition that concisely states--
    (i) The petitioners' interest in the hearing;
    (ii) Who will represent the petitioner; and
    (iii) The issues on which the petitioner intends to present 
argument.
    (2) Action on amicus curiae petition. The presiding officer may 
grant the petition if he or she finds that the petitioner has a 
legitimate interest in the proceedings, that such participation will not 
unduly delay the outcome and may contribute materially to the proper 
disposition of the issues.
    (3) Nature of amicus participation. An amicus curiae is not a party 
to the hearing but may participate by--
    (i) Submitting a written statement of position to the presiding 
officer before the beginning of the hearing;
    (ii) Presenting a brief oral statement at the hearing, at the point 
in the proceedings specified by the presiding officer; and
    (iii) Submitting a brief or written statement when the parties 
submit briefs.

The amicus curiae must serve copies of any briefs or written statements 
on all parties.



Sec.  430.80  Authority of the presiding officer.

    (a) The presiding officer has the duty to conduct a fair hearing, to 
avoid delay, maintain order, and make a record of the proceedings. He or 
she has the authority necessary to accomplish those ends, including but 
not limited to authority to take the following actions:
    (1) Change the date, time, and place of the hearing after due notice 
to the parties. This includes authority to postpone or adjourn the 
hearing in whole or in part. In a hearing on disapproval of a State 
plan, or State plan amendments, changes in the date of the hearing are 
subject to the time limits imposed by section 1116(a)(2) of the Act.
    (2) Hold conferences to settle or simplify the issues, or to 
consider other matters that may aid in the expeditious disposition of 
the issues.
    (3) Regulate participation of parties and amici curiae and require 
parties and amici curiae to state their position with respect to the 
various issues in the proceeding.
    (4) Administer oaths and affirmations.
    (5) Rule on motions and other procedural items, including issuance 
of protective orders or other relief to a party against whom discovery 
is sought.
    (6) Regulate the course of the hearing and conduct of counsel.
    (7) Examine witnesses.
    (8) Receive, rule on, exclude or limit evidence or discovery.
    (9) Fix the time for filing motions, petitions, briefs, or other 
items.
    (10) If the presiding officer is the Administrator, make a final 
decision.
    (11) If the presiding officer is a designee of the Administrator, 
certify the entire record including recommended findings and proposed 
decision to the Administrator.
    (12) Take any action authorized by the rules in this subpart or in 
conformance with the provisions of 5 U.S.C. 551 through 559.
    (b) The presiding officer does not have authority to compel by 
subpoena the production of witnesses, papers, or other evidence.
    (c) If the presiding officer is a designee of the Administrator, his 
or her authority pertains to the issues of compliance by a State with 
Federal requirements, and does not extend to the question of whether, in 
case of any

[[Page 21]]

noncompliance, Federal payments will be denied in respect to the entire 
State plan or only for certain categories under, or parts of, the State 
plan affected by the noncompliance.



Sec.  430.83  Rights of parties.

    All parties may:
    (a) Appear by counsel or other authorized representative, in all 
hearing proceedings.
    (b) Participate in any prehearing conference held by the presiding 
officer.
    (c) Agree to stipulations as to facts which will be made a part of 
the record.
    (d) Make opening statements at the hearing.
    (e) Present relevant evidence on the issues at the hearing.
    (f) Present witnesses who then must be available for cross-
examination by all other parties.
    (g) Present oral arguments at the hearing.
    (h) Submit written briefs, proposed findings of fact, and proposed 
conclusions of law, after the hearing.



Sec.  430.86  Discovery.

    CMS and any party named in the notice issued under Sec.  430.70 has 
the right to conduct discovery (including depositions) against opposing 
parties. Rules 26-37 of the Federal Rules of Civil Procedures apply to 
such proceedings; there will be no fixed rule on priority of discovery. 
Upon written motion, the presiding officer promptly rules upon any 
objection to discovery action initiated under this section. The 
presiding officer also has the power to grant a protective order or 
relief to any party against whom discovery is sought and to restrict or 
control discovery so as to prevent undue delay in the conduct of the 
hearing. Upon the failure of any party to make discovery, the presiding 
officer may issue any order and impose any sanction (other than contempt 
orders) authorized by Rule 37 of the Federal Rules of Civil Procedure.



Sec.  430.88  Evidence.

    (a) Evidentiary purpose. The hearing is directed to receiving 
factual evidence and expert opinion testimony related to the issues 
involved in the proceeding. Argument is not received in evidence. It 
must be presented in statements, memoranda, or briefs, as determined by 
the presiding officer. Brief opening statements, concerning the party's 
position and what he or she intends to prove, may be made at hearings.
    (b) Testimony. Testimony is given orally under oath or affirmation 
by witnesses at the hearing. Witnesses are available at the hearing for 
cross-examination by all parties.
    (c) Stipulations and exhibits. Two or more parties may agree to 
stipulations of fact. Those stipulations, and any exhibit proposed by 
any party, are exchanged before the hearing if the presiding officer so 
requires.
    (d) Rules of evidence. (1) Technical rules of evidence do not apply 
to hearings conducted under this subpart. However, rules or principles 
designed to ensure production of the most credible evidence available 
and to subject testimony to test by cross-examination are applied by the 
presiding officer when reasonably necessary.
    (2) A witness may be cross-examined on any matter material to the 
proceeding without regard to the scope of his or her direct examination.
    (3) The presiding officer may exclude irrelevant, immaterial, or 
unduly repetitious evidence.
    (4) All documents and other evidence offered or taken for the record 
are open to examination by the parties and an opportunity is given to 
refute facts and arguments advanced on either side of the issues.



Sec.  430.90  Exclusion from hearing for misconduct.

    The presiding officer may immediately exclude from the hearing any 
person who--
    (a) Uses disrespectful, disorderly, or contumacious language or 
engages in contemptuous behavior;
    (b) Refuses to comply with directions; or
    (c) Uses dilatory tactics.



Sec.  430.92  Unsponsored written material.

    Letters expressing views or urging action and other unsponsored 
written material regarding matters in issue in

[[Page 22]]

a hearing are placed in the correspondence section of the docket of the 
proceeding. These data are not considered part of the evidence or record 
in the hearing.



Sec.  430.94  Official transcript.

    (a) Filing. The official transcripts of testimony, together with any 
stipulations, briefs, or memoranda of law, are filed with CMS.
    (b) Availability of transcripts. CMS designates an official reporter 
for each hearing. Transcripts of testimony in hearings may be obtained 
from the official reporter by the parties and the public at rates not in 
excess of the maximum rates fixed by the contract between CMS and the 
reporter.
    (c) Correction of transcript. Upon notice to all parties, the 
presiding officer may authorize corrections that affect substantive 
matters in the transcript.



Sec.  430.96  Record for decision.

    The transcript of testimony, exhibits, and all papers and requests 
filed in the proceedings, except the correspondence section of the 
docket, including rulings and any recommended or initial decision 
constitute the exclusive record for decision.



Sec.  430.100  Posthearing briefs.

    The presiding officer fixes the time for filing posthearing briefs, 
which may contain proposed findings of fact and conclusions of law. The 
presiding officer may also permit reply briefs.



Sec.  430.102  Decisions following hearing.

    (a) Administrator presides. If the presiding officer is the 
Administrator, he or she issues the hearing decision within 60 days 
after expiration of the period for submission of posthearing briefs.
    (b) Administrator's designee presides. If the presiding officer is 
other than the Administrator, the procedure is as follows:
    (1) Upon expiration of the period allowed for submission of 
posthearing briefs, the presiding officer certifies the entire record, 
including his or her recommended findings and proposed decision, to the 
Administrator. The Administrator serves a copy of the recommended 
findings and proposed decision upon all parties and amici, if any.
    (2) Any party may, within 20 days, file with the Administrator 
exceptions to the recommended findings and proposed decision and a 
supporting brief or statement.
    (3) The Administrator reviews the recommended decision and, within 
60 days of its issuance, issues his or her own decision.
    (c) Effect of Administrator's decision. The decision of the 
Administrator under this section is the final decision of the Secretary 
and constitutes ``final agency action'' within the meaning of 5 U.S.C. 
704 and a ``final determination'' within the meaning of section 
1116(a)(3) of the Act and Sec.  430.38. The Administrator's decision is 
promptly served on all parties and amici.



Sec.  430.104  Decisions that affect FFP.

    (a) Scope of decisions. If the Administrator concludes that 
withholding of FFP is necessary because a State is out of compliance 
with Federal requirements, in accordance with Sec.  430.35, the decision 
also specifies--
    (1) Whether no further payments will be made to the State or whether 
payments will be limited to parts of the program not affected by the 
noncompliance; and
    (2) The effective date of the decision to withhold.
    (b) Consultation. The Administrator may ask the parties for 
recommendations or briefs or may hold conferences of the parties on the 
question of further payments to the State.
    (c) Effective date of decision. The effective date of a decision to 
withhold Federal funds will not be earlier than the date of the 
Administrator's decision and will not be later than the first day of the 
next calendar quarter. The provisions of this section may not be waived 
under Sec.  430.64.



PART 431_STATE ORGANIZATION AND GENERAL ADMINISTRATION--Table of Contents



Sec.
431.1 Purpose.

                      Subpart A_Single State Agency

431.10 Single State agency.
431.11 Organization for administration.
431.12 Medical care advisory committee.
431.15 Methods of administration.

[[Page 23]]

431.16 Reports.
431.17 Maintenance of records.
431.18 Availability of agency program manuals.
431.20 Advance directives.

              Subpart B_General Administrative Requirements

431.40 Basis and scope.
431.50 Statewide operation.
431.51 Free choice of providers.
431.52 Payments for services furnished out of State.
431.53 Assurance of transportation.
431.54 Exceptions to certain State plan requirements.
431.55 Waiver of other Medicaid requirements.
431.56 Special waiver provisions applicable to American Samoa and the 
          Northern Mariana Islands.
431.60 Beneficiary access to and exchange of data.
431.70 Access to published provider directory information.

        Subpart C_Administrative Requirements: Provider Relations

431.105 Consultation to medical facilities.
431.107 Required provider agreement.
431.108 Effective date of provider agreements.
431.110 Participation by Indian Health Service facilities.
431.115 Disclosure of survey information and provider or contractor 
          evaluation.
431.120 State requirements with respect to nursing facilities.

             Subpart D_Appeals Process for NFs and ICFs/IID

431.151 Scope and applicability.
431.152 State plan requirements.
431.153 Evidentiary hearing.
431.154 Informal reconsideration for ICFs/IID.

        Subpart E_Fair Hearings for Applicants and Beneficiaries

                           General Provisions

431.200 Basis and purpose.
431.201 Definitions.
431.202 State plan requirements.
431.205 Provision of hearing system.
431.206 Informing applicants and beneficiaries.

                                 Notice

431.210 Content of notice.
431.211 Advance notice.
431.213 Exceptions from advance notice.
431.214 Notice in cases of probable fraud.

                            Right to Hearing

431.220 When a hearing is required.
431.221 Request for hearing.
431.222 Group hearings.
431.223 Denial or dismissal of request for a hearing.
431.224 Expedited appeals.

                               Procedures

431.230 Maintaining services.
431.231 Reinstating services.
431.232 Adverse decision of local evidentiary hearing.
431.233 State agency hearing after adverse decision of local evidentiary 
          hearing.
431.240 Conducting the hearing.
431.241 Matters to be considered at the hearing.
431.242 Procedural rights of the applicant or beneficiary.
431.243 Parties in cases involving an eligibility determination.
431.244 Hearing decisions.
431.245 Notifying the applicant or beneficiary of a State agency 
          decision.
431.246 Corrective action.

                     Federal Financial Participation

431.250 Federal financial participation.

   Subpart F_Safeguarding Information on Applicants and beneficiaries

431.300 Basis and purpose.
431.301 State plan requirements.
431.302 Purposes directly related to State plan administration.
431.303 State authority for safeguarding information.
431.304 Publicizing safeguarding requirements.
431.305 Types of information to be safeguarded.
431.306 Release of information.
431.307 Distribution of information materials.

                  Subpart G_Section 1115 Demonstrations

431.400 Basis and purpose.
431.404 Definitions.
431.408 State public notice process.
431.412 Application procedures.
431.416 Federal public notice and approval process.
431.420 Monitoring and compliance.
431.424 Evaluation requirements.
431.428 Reporting requirements.

Subparts H-L [Reserved]

                 Subpart M_Relations With Other Agencies

431.610 Relations with standard-setting and survey agencies.

[[Page 24]]

431.615 Relations with State health and vocational rehabilitation 
          agencies and title V grantees.
431.620 Agreement with State mental health authority or mental 
          institutions.
431.621 State requirements with respect to nursing facilities.
431.625 Coordination of Medicaid with Medicare part B.
431.630 Coordination of Medicaid with QIOs.
431.635 Coordination of Medicaid with Special Supplemental Food Program 
          for Women, Infants, and Children (WIC).

   Subpart N_State Programs for Licensing Nursing Home Administrators

431.700 Basis and purpose.
431.701 Definitions.
431.702 State plan requirement.
431.703 Licensing requirement.
431.704 Nursing homes designated by other terms.
431.705 Licensing authority.
431.706 Composition of licensing board.
431.707 Standards.
431.708 Procedures for applying standards.
431.709 Issuance and revocation of license.
431.710 Provisional licenses.
431.711 Compliance with standards.
431.712 Failure to comply with standards.
431.713 Continuing study and investigation.
431.714 Waivers.
431.715 Federal financial participation.

Subpart O [Reserved]

                        Subpart P_Quality Control

           Medicaid Eligibility Quality Control (MEQC) Program

431.800 Basis and scope.
431.804 Definitions.
431.806 State requirements.
431.808 Protection of beneficiary rights.
431.810 Basic elements of the Medicaid Eligibility Quality Control 
          (MEQC) Program.
431.812 Review procedures.
431.814 Pilot planning document.
431.816 Case review completion deadlines and submittal of reports.
431.818 Access to records.
431.820 Corrective action under the MEQC program.

   Medicaid Quality Control (MQC) Claims Processing Assessment System

431.830 Basic elements of the Medicaid quality control (MQC) claims 
          processing assessment system.
431.832 Reporting requirements for claims processing assessment systems.
431.834 Access to records: Claims processing assessment systems.
431.836 Corrective action under the MQC claims processing assessment 
          systems.

Subpart Q_Requirements for Estimating Improper Payments in Medicaid and 
                                  CHIP

431.950 Purpose.
431.954 Basis and scope.
431.958 Definitions and use of terms.
431.960 Types of payment errors.
431.970 Information submission and systems access requirements.
431.972 Claims sampling procedures.
431.992 Corrective action plan.
431.998 Difference resolution and appeal process.
431.1002 Recoveries.
431.1010 Disallowance of Federal financial participation for erroneous 
          State payments (for PERM review years ending after July 1, 
          2020).

    Authority: 42 U.S.C. 1302.

    Source: 43 FR 45188, Sept. 29, 1978, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 431 appear at 75 FR 
48852, Aug. 11, 2010.



Sec.  431.1  Purpose.

    This part establishes State plan requirements for the designation, 
organization, and general administrative activities of a State agency 
responsible for operating the State Medicaid program, directly or 
through supervision of local administering agencies.



                      Subpart A_Single State Agency



Sec.  431.10  Single State agency.

    (a) Basis, purpose, and definitions. (1) This section implements 
section 1902(a)(4) and (5) of the Act.
    (2) For purposes of this part--
    Appeals decision means a decision made by a hearing officer 
adjudicating a fair hearing under subpart E of this part.
    Exchange has the meaning given to the term in 45 CFR 155.20.
    Exchange appeals entity has the meaning given to the term ``appeals 
entity,'' as defined in 45 CFR 155.500.
    Medicaid agency is the single State agency for the Medicaid program.
    (b) Designation and certification. A State plan must--
    (1) Specify a single State agency established or designated to 
administer or supervise the administration of the plan; and
    (2) Include a certification by the State Attorney General, citing 
the

[[Page 25]]

legal authority for the single State agency to--
    (i) Administer or supervise the administration of the plan; and
    (ii) Make rules and regulations that it follows in administering the 
plan or that are binding upon local agencies that administer the plan.
    (3) The single State agency is responsible for determining 
eligibility for all individuals applying for or receiving benefits in 
accordance with regulations in part 435 of this chapter and for fair 
hearings filed in accordance with subpart E of this part.
    (c) Delegations. (1) Subject to the requirement in paragraph (c)(2) 
of this section, the Medicaid agency--
    (i)(A) May, in the approved state plan, delegate authority to 
determine eligibility for all or a defined subset of individuals to--
    (1) The single State agency for the financial assistance program 
under title IV-A (in the 50 States or the District of Columbia), or 
under title I or XVI (AABD), in Guam, Puerto Rico, or the Virgin 
Islands;
    (2) The Federal agency administering the supplemental security 
income program under title XVI of the Act; or
    (3) The Exchange.
    (B) Must in the approved state plan specify to which agency, and the 
individuals for which, authority to determine eligibility is delegated.
    (ii) Delegate authority to conduct fair hearings under subpart E of 
this part for denials of eligibility for individuals whose income 
eligibility is determined based on the applicable modified adjusted 
gross income standard described in Sec.  435.911(c) of this chapter, to 
an Exchange or Exchange appeals entity, provided that individuals who 
have requested a fair hearing of such a denial are given a choice to 
have their fair hearing instead conducted by the Medicaid agency.
    (2) The Medicaid agency may delegate authority to make eligibility 
determinations or to conduct fair hearings under this section only to a 
government agency which maintains personnel standards on a merit basis.
    (3) The Medicaid agency--
    (i) Must ensure that any agency to which eligibility determinations 
or appeals decisions are delegated--
    (A) Complies with all relevant Federal and State law, regulations 
and policies, including, but not limited to, those related to the 
eligibility criteria applied by the agency under part 435 of this 
chapter; prohibitions against conflicts of interest and improper 
incentives; and safeguarding confidentiality, including regulations set 
forth at subpart F of this part.
    (B) Informs applicants and beneficiaries how they can directly 
contact and obtain information from the agency; and
    (ii) Must exercise appropriate oversight over the eligibility 
determinations and appeals decisions made by such agencies to ensure 
compliance with paragraphs (c)(2) and (c)(3)(i) of this section and 
institute corrective action as needed, including, but not limited to, 
rescission of the authority delegated under this section.
    (iii) If authority to conduct fair hearings is delegated to the 
Exchange or Exchange appeals entity under paragraph (c)(1)(ii) of this 
section, the agency may establish a review process whereby the agency 
may review fair hearing decisions made under that delegation, but that 
review will be limited to the proper application of federal and state 
Medicaid law and regulations, including sub-regulatory guidance and 
written interpretive policies, and must be conducted by an impartial 
official not directly involved in the initial determination.
    (d) Agreement with Federal, State or local entities making 
eligibility determinations or appeals decisions. The plan must provide 
for written agreements between the Medicaid agency and the Exchange or 
any other State or local agency that has been delegated authority under 
paragraph (c)(1)(i) of this section to determine Medicaid eligibility 
and for written agreements between the agency and the Exchange or 
Exchange appeals entity that has been delegated authority to conduct 
Medicaid fair hearings under paragraph (c)(1)(ii) of this section. Such 
agreements must be available to the Secretary upon request and must 
include provisions for:
    (1) The relationships and respective responsibilities of the 
parties, including but not limited to the respective

[[Page 26]]

responsibilities to effectuate the fair hearing rules in subpart E of 
this part;
    (2) Quality control and oversight by the Medicaid agency, including 
any reporting requirements needed to facilitate such control and 
oversight;
    (3) Assurances that the entity to which authority to determine 
eligibility or conduct fair hearings will comply with the provisions set 
forth in paragraph (c)(3) of this section.
    (4) For appeals, procedures to ensure that individuals have notice 
and a full opportunity to have their fair hearing conducted by either 
the Exchange or Exchange appeals entity or the Medicaid agency.
    (e) Authority of the single State agency. The Medicaid agency may 
not delegate, to other than its own officials, the authority to 
supervise the plan or to develop or issue policies, rules, and 
regulations on program matters.

[44 FR 17930, Mar. 23, 1979, as amended at 77 FR 17202, Mar. 23, 2012; 
78 FR 42300, July 15, 2013]



Sec.  431.11  Organization for administration.

    (a) Basis and purpose. This section, based on section 1902(a)(4) of 
the Act, prescribes the general organization and staffing requirements 
for the Medicaid agency and the State plan.
    (b) Description of organization. (1) The plan must include a 
description of the organization and functions of the Medicaid agency.
    (2) When submitting a state plan amendment related to the 
designation, authority, organization or functions of the Medicaid 
agency, the Medicaid agency must provide an organizational chart 
reflecting the key components of the Medicaid agency and the functions 
each performs.
    (c) Eligibility determined or fair hearings decided by other 
entities. If eligibility is determined or fair hearings decided by 
Federal or State entities other than the Medicaid agency or by local 
agencies under the supervision of other State agencies, the plan must 
include a description of the staff designated by those other entities 
and the functions they perform in carrying out their responsibilities.

[44 FR 17931, Mar. 23, 1979, as amended at 77 FR 17203, Mar. 23, 2012; 
78 FR 42301, July 15, 2013]



Sec.  431.12  Medical care advisory committee.

    (a) Basis and purpose. This section, based on section 1902(a)(4) of 
the Act, prescribes State plan requirements for establishment of a 
committee to advise the Medicaid agency about health and medical care 
services.
    (b) State plan requirement. A State plan must provide for a medical 
care advisory committee meeting the requirements of this section to 
advise the Medicaid agency director about health and medical care 
services.
    (c) Appointment of members. The agency director, or a higher State 
authority, must appoint members to the advisory committee on a rotating 
and continuous basis.
    (d) Committee membership. The committee must include--
    (1) Board-certified physicians and other representatives of the 
health professions who are familiar with the medical needs of low-income 
population groups and with the resources available and required for 
their care;
    (2) Members of consumers' groups, including Medicaid beneficiaries, 
and consumer organizations such as labor unions, cooperatives, consumer-
sponsored prepaid group practice plans, and others; and
    (3) The director of the public welfare department or the public 
health department, whichever does not head the Medicaid agency.
    (e) Committee participation. The committee must have opportunity for 
participation in policy development and program administration, 
including furthering the participation of beneficiary members in the 
agency program.
    (f) Committee staff assistance and financial help. The agency must 
provide the committee with--
    (1) Staff assistance from the agency and independent technical 
assistance as needed to enable it to make effective recommendations; and
    (2) Financial arrangements, if necessary, to make possible the 
participation of beneficiary members.

[[Page 27]]

    (g) Federal financial participation. FFP is available at 50 percent 
in expenditures for the committee's activities.



Sec.  431.15  Methods of administration.

    A State plan must provide for methods of administration that are 
found by the Secretary to be necessary for the proper and efficient 
operation of the plan.

(Sec. 1902(a)(4) of the Act)

[44 FR 17931, Mar. 23, 1979]



Sec.  431.16  Reports.

    A State plan must provide that the Medicaid agency will--
    (a) Submit all reports required by the Secretary;
    (b) Follow the Secretary's instructions with regard to the form and 
content of those reports; and
    (c) Comply with any provisions that the Secretary finds necessary to 
verify and assure the correctness of the reports.

[44 FR 17931, Mar. 23, 1979]



Sec.  431.17  Maintenance of records.

    (a) Basis and purpose. This section, based on section 1902(a)(4) of 
the Act, prescribes the kinds of records a Medicaid agency must 
maintain, the retention period, and the conditions under which microfilm 
copies may be substituted for original records.
    (b) Content of records. A State plan must provide that the Medicaid 
agency will maintain or supervise the maintenance of the records 
necessary for the proper and efficient operation of the plan. The 
records must include--
    (1) Individual records on each applicant and beneficiary that 
contain information on--
    (i) Date of application;
    (ii) Date of and basis for disposition;
    (iii) Facts essential to determination of initial and continuing 
eligibility;
    (iv) Provision of medical assistance;
    (v) Basis for discontinuing assistance;
    (vi) The disposition of income and eligibility verification 
information received under Sec. Sec.  435.940 through 435.960 of this 
subchapter; and
    (2) Statistical, fiscal, and other records necessary for reporting 
and accountability as required by the Secretary.
    (c) Retention of records. The plan must provide that the records 
required under paragraph (b) of this section will be retained for the 
periods required by the Secretary.
    (d) Conditions for optional use of microfilm copies. The agency may 
substitute certified microfilm copies for the originals of 
substantiating documents required for Federal audit and review, if the 
conditions in paragraphs (d)(1) through (4) of this section are met.
    (1) The agency must make a study of its record storage and must show 
that the use of microfilm is efficient and economical.
    (2) The microfilm system must not hinder the agency's supervision 
and control of the Medicaid program.
    (3) The microfilm system must--
    (i) Enable the State to audit the propriety of expenditures for 
which FFP is claimed; and
    (ii) Enable the HHS Audit Agency and CMS to properly discharge their 
respective responsibilities for reviewing the manner in which the 
Medicaid program is being administered.
    (4) The agency must obtain approval from the CMS regional office 
indicating--
    (i) The system meets the conditions of paragraphs (d)(2) and (3) of 
this section; and
    (ii) The microfilming procedures are reliable and are supported by 
an adequate retrieval system.

[44 FR 17931, Mar. 23, 1979, as amended at 51 FR 7210, Feb. 28, 1986]



Sec.  431.18  Availability of agency program manuals.

    (a) Basis and purpose. This section, based on section 1902(a)(4) of 
the Act, prescribes State plan requirements for facilitating access to 
Medicaid rules and policies by individuals outside the State Medicaid 
agency.
    (b) State plan requirements. A State plan must provide that the 
Medicaid agency meets the requirements of paragraphs (c) through (g) of 
this section.
    (c) Availability in agency offices. (1) The agency must maintain, in 
all its offices, copies of its current rules and

[[Page 28]]

policies that affect the public, including those that govern 
eligibility, provision of medical assistance, covered services, and 
beneficiary rights and responsibilities.
    (2) These documents must be available upon request for review, 
study, and reproduction by individuals during regular working hours of 
the agency.
    (d) Availability through other entities. The agency must provide 
copies of its current rules and policies to--
    (1) Public and university libraries;
    (2) The local or district offices of the Bureau of Indian Affairs;
    (3) Welfare and legal services offices; and
    (4) Other entities that--
    (i) Request the material in order to make it accessible to the 
public;
    (ii) Are centrally located and accessible to a substantial number of 
the beneficiary population they serve; and
    (iii) Agree to accept responsibility for filing all amendments or 
changes forwarded by the agency.
    (e) Availability in relation to fair hearings. The agency must make 
available to an applicant or beneficiary, or his representative, a copy 
of the specific policy materials necessary--
    (1) To determine whether to request a fair hearing; or
    (2) To prepare for a fair hearing.
    (f) Availability for other purposes. The agency must establish rules 
for making program policy materials available to individuals who request 
them for other purposes.
    (g) Charges for reproduction. The agency must make copies of its 
program policy materials available without charge or at a charge related 
to the cost of reproduction.

[44 FR 17931, Mar. 23, 1979]



Sec.  431.20  Advance directives.

    (a) Basis and purpose. This section, based on section 1902(a) (57) 
and (58) of the Act, prescribes State plan requirements for the 
development and distribution of a written description of State law 
concerning advance directives.
    (b) A State Plan must provide that the State, acting through a State 
agency, association, or other private nonprofit entity, develop a 
written description of the State law (whether statutory or as recognized 
by the courts of the State) concerning advance directives, as defined in 
Sec.  489.100 of this chapter, to be distributed by Medicaid providers 
and health maintenance organizations (as specified in section 
1903(m)(1)(A) of the Act) in accordance with the requirements under part 
489, subpart I of this chapter. Revisions to the written descriptions as 
a result of changes in State law must be incorporated in such 
descriptions and distributed as soon as possible, but no later than 60 
days from the effective date of the change in State law, to Medicaid 
providers and health maintenance organizations.

[57 FR 8202, Mar. 6, 1992, as amended at 60 FR 33293, June 27, 1995]



              Subpart B_General Administrative Requirements

    Source: 56 FR 8847, Mar. 1, 1991, unless otherwise noted.



Sec.  431.40  Basis and scope.

    (a) This subpart sets forth State plan requirements and exceptions 
that pertain to the following administrative requirements and provisions 
of the Act:
    (1) Statewideness--section 1902(a)(1);
    (2) Proper and efficient administration--section 1902(a)(4);
    (3) Comparability of services--section 1902(a)(10) (B)-(E);
    (4) Payment for services furnished outside the State--section 
1902(a)(16);
    (5) Free choice of providers--section 1902(a)(23);
    (6) Special waiver provisions applicable to American Samoa and the 
Northern Mariana Islands--section 1902(j); and
    (7) Exceptions to, and waiver of, State plan requirements--sections 
1915 (a)-(c) and 1916 (a)(3) and (b)(3).
    (b) Other applicable regulations include the following:
    (1) Section 430.25 Waivers of State plan requirements.
    (2) Section 440.250 Limits on comparability of services.



Sec.  431.50  Statewide operation.

    (a) Statutory basis. Section 1902(a)(1) of the Act requires a State 
plan to be

[[Page 29]]

in effect throughout the State, and section 1915 permits certain 
exceptions.
    (b) State plan requirements. A State plan must provide that the 
following requirements are met:
    (1) The plan will be in operation statewide through a system of 
local offices, under equitable standards for assistance and 
administration that are mandatory throughout the State.
    (2) If administered by political subdivisions of the State, the plan 
will be mandatory on those subdivisions.
    (3) The agency will ensure that the plan is continuously in 
operation in all local offices or agencies through--
    (i) Methods for informing staff of State policies, standards, 
procedures, and instructions;
    (ii) Systematic planned examination and evaluation of operations in 
local offices by regularly assigned State staff who make regular visits; 
and
    (iii) Reports, controls, or other methods.
    (c) Exceptions. (1) ``Statewide operation'' does not mean, for 
example, that every source of service must furnish the service State-
wide. The requirement does not preclude the agency from contracting with 
a comprehensive health care organization (such as an HMO or a rural 
health clinic) that serves a specific area of the State, to furnish 
services to Medicaid beneficiaries who live in that area and chose to 
receive services from that HMO or rural health clinic. beneficiaries who 
live in other parts of the State may receive their services from other 
sources.
    (2) Other allowable exceptions and waivers are set forth in 
Sec. Sec.  431.54 and 431.55.

[56 FR 8847, Mar. 1, 1991; 56 FR 23022, May 20, 1991]



Sec.  431.51  Free choice of providers.

    (a) Statutory basis. This section is based on sections 1902(a)(23), 
1902(e)(2), and 1915(a) and (b) and 1932(a)(3) of the Act.
    (1) Section 1902(a)(23) of the Act provides that beneficiaries may 
obtain services from any qualified Medicaid provider that undertakes to 
provide the services to them.
    (2) Section 1915(a) of the Act provides that a State shall not be 
found out of compliance with section 1902(a)(23) solely because it 
imposes certain specified allowable restrictions on freedom of choice.
    (3) Section 1915(b) of the Act authorizes waiver of the section 
1902(a)(23) freedom of choice of providers requirement in certain 
specified circumstances, but not with respect to providers of family 
planning services.
    (4) Section 1902(a)(23) of the Act provides that a beneficiary 
enrolled in a primary care case management system or Medicaid managed 
care organization (MCO) may not be denied freedom of choice of qualified 
providers of family planning services.
    (5) Section 1902(e)(2) of the Act provides that an enrollee who, 
while completing a minimum enrollment period, is deemed eligible only 
for services furnished by or through the MCO or PCCM, may, as an 
exception to the deemed limitation, seek family planning services from 
any qualified provider.
    (6) Section 1932(a) of the Act permits a State to restrict the 
freedom of choice required by section 1902(a)(23), under specified 
circumstances, for all services except family planning services.
    (b) State plan requirements. A State plan, except the plan for 
Puerto Rico, the Virgin Islands, or Guam, must provide as follows:
    (1) Except as provided under paragraph (c) of this section and part 
438 of this chapter, a beneficiary may obtain Medicaid services from any 
institution, agency, pharmacy, person, or organization that is--
    (i) Qualified to furnish the services; and
    (ii) Willing to furnish them to that particular beneficiary.

This includes an organization that furnishes, or arranges for the 
furnishing of, Medicaid services on a prepayment basis.
    (2) A beneficiary enrolled in a primary care case-management system, 
a Medicaid MCO, or other similar entity will not be restricted in 
freedom of choice of providers of family planning services.
    (c) Exceptions. Paragraph (b) of this section does not prohibit the 
agency from--

[[Page 30]]

    (1) Establishing the fees it will pay providers for Medicaid 
services;
    (2) Setting reasonable standards relating to the qualifications of 
providers; or
    (3) Subject to paragraph (b)(2) of this section, restricting 
beneficiaries' free choice of providers in accordance with one or more 
of the exceptions set forth in Sec.  431.54, or under a waiver as 
provided in Sec.  431.55; or
    (4) Limiting the providers who are available to furnish targeted 
case management services defined in Sec.  440.169 of this chapter to 
target groups that consist solely of individuals with developmental 
disabilities or with chronic mental illness. This limitation may only be 
permitted so that the providers of case management services for eligible 
individuals with developmental disabilities or with chronic mental 
illness are capable of ensuring that those individuals receive needed 
services.
    (d) Certification requirement--(1) Content of certification. If a 
State implements a project under one of the exceptions allowed under 
Sec.  431.54 (d), (e) or (f), it must certify to CMS that the statutory 
safeguards and requirements for an exception under section 1915(a) of 
the Act are met.
    (2) Timing of certification. (i) For an exception under Sec.  
431.54(d), the State may not institute the project until after it has 
submitted the certification and CMS has made the findings required under 
the Act, and so notified the State.
    (ii) For exceptions under Sec.  431.54 (e) or (f), the State must 
submit the certificate by the end of the quarter in which it implements 
the project.

[56 FR 8847, Mar. 1, 1991, as amended at 67 FR 41094, June 14, 2002; 72 
FR 68091, Dec. 4, 2007]



Sec.  431.52  Payments for services furnished out of State.

    (a) Statutory basis. Section 1902(a)(16) of the Act authorizes the 
Secretary to prescribe State plan requirements for furnishing Medicaid 
to State residents who are absent from the State.
    (b) Payment for services. A State plan must provide that the State 
will pay for services furnished in another State to the same extent that 
it would pay for services furnished within its boundaries if the 
services are furnished to a beneficiary who is a resident of the State, 
and any of the following conditions is met:
    (1) Medical services are needed because of a medical emergency;
    (2) Medical services are needed and the beneficiary's health would 
be endangered if he were required to travel to his State of residence;
    (3) The State determines, on the basis of medical advice, that the 
needed medical services, or necessary supplementary resources, are more 
readily available in the other State;
    (4) It is general practice for beneficiaries in a particular 
locality to use medical resources in another State.
    (c) Cooperation among States. The plan must provide that the State 
will establish procedures to facilitate the furnishing of medical 
services to individuals who are present in the State and are eligible 
for Medicaid under another State's plan.



Sec.  431.53  Assurance of transportation.

    A State plan must--
    (a) Specify that the Medicaid agency will ensure necessary 
transportation for beneficiaries to and from providers; and
    (b) Describe the methods that the agency will use to meet this 
requirement.

[74 FR 31195, June 30, 2009]



Sec.  431.54  Exceptions to certain State plan requirements.

    (a) Statutory basis--(1) Section 1915(a) of the Act provides that a 
State shall not be deemed to be out of compliance with the requirements 
of sections 1902(a)(1), (10), or (23) of the Act solely because it has 
elected any of the exceptions set forth in paragraphs (b) and (d) 
through (f) of this section.
    (2) Section 1915(g) of the Act provides that a State may provide, as 
medical assistance, targeted case management services under the plan 
without regard to the requirements of sections 1902(a)(1) and 
1902(a)(10)(B) of the Act.
    (3) Section 1915(i) of the Act provides that a State may provide, as 
medical assistance, home and community-based services under an approved 
State plan amendment that meets certain requirements, without regard to 
the requirements of sections 1902(a)(10)(B) and

[[Page 31]]

1902(a)(10)(C)(i)(III) of the Act, with respect to such services.
    (b) Additional services under a prepayment system. If the Medicaid 
agency contracts on a prepayment basis with an organization that 
provides services additional to those offered under the State plan, the 
agency may restrict the provision of the additional services to 
beneficiaries who live in the area served by the organization and wish 
to obtain services from it.
    (c) [Reserved]
    (d) Special procedures for purchase of medical devices and 
laboratory and X-ray tests. The Medicaid agency may establish special 
procedures for the purchase of medical devices or laboratory and X-ray 
tests (as defined in Sec.  440.30 of this chapter) through a competitive 
bidding process or otherwise, if the State assures, in the certification 
required under Sec.  431.51(d), and CMS finds, as follows:
    (1) Adequate services or devices are available to beneficiaries 
under the special procedures.
    (2) Laboratory services are furnished through laboratories that meet 
the following requirements:
    (i) They are independent laboratories, or inpatient or outpatient 
hospital laboratories that provide services for individuals who are not 
hospital patients, or physician laboratories that process at least 100 
specimens for other physicians during any calendar year.
    (ii) They meet the requirements of subpart M of part 405 or part 482 
of this chapter.
    (iii) Laboratories that require an interstate license under 42 CFR 
part 74 are licensed by CMS or receive an exemption from the licensing 
requirement by the College of American Pathologists. (Hospital and 
physician laboratories may participate in competitive bidding only with 
regard to services to non-hospital patients and other physicians' 
patients, respectively.)
    (3) Any laboratory from which a State purchases services under this 
section has no more than 75 percent of its charges based on services to 
Medicare beneficiaries and Medicaid beneficiaries.
    (e) Lock-in of beneficiaries who over-utilize Medicaid services. If 
a Medicaid agency finds that a beneficiary has utilized Medicaid 
services at a frequency or amount that is not medically necessary, as 
determined in accordance with utilization guidelines established by the 
State, the agency may restrict that beneficiary for a reasonable period 
of time to obtain Medicaid services from designated providers only. The 
agency may impose these restrictions only if the following conditions 
are met:
    (1) The agency gives the beneficiary notice and opportunity for a 
hearing (in accordance with procedures established by the agency) before 
imposing the restrictions.
    (2) The agency ensures that the beneficiary has reasonable access 
(taking into account geographic location and reasonable travel time) to 
Medicaid services of adequate quality.
    (3) The restrictions do not apply to emergency services furnished to 
the beneficiary.
    (f) Lock-out of providers. If a Medicaid agency finds that a 
Medicaid provider has abused the Medicaid program, the agency may 
restrict the provider, through suspension or otherwise, from 
participating in the program for a reasonable period of time.
    Before imposing any restriction, the agency must meet the following 
conditions:
    (1) Give the provider notice and opportunity for a hearing, in 
accordance with procedures established by the agency.
    (2) Find that in a significant number or proportion of cases, the 
provider has:
    (i) Furnished Medicaid services at a frequency or amount not 
medically necessary, as determined in accordance with utilization 
guidelines established by the agency; or
    (ii) Furnished Medicaid services of a quality that does not meet 
professionally recognized standards of health care.
    (3) Notify CMS and the general public of the restriction and its 
duration.
    (4) Ensure that the restrictions do not result in denying 
beneficiaries reasonable access (taking into account geographic 
location: and reasonable travel time) to Medicaid services of adequate 
quality, including emergency services.

[[Page 32]]

    (g) Targeted case management services. The requirements of Sec.  
431.50(b) relating to the statewide operation of a State plan and Sec.  
440.240 of this chapter related to comparability of services do not 
apply with respect to targeted case management services defined in Sec.  
440.169 of this chapter.
    (h) State plan home and community-based services. The requirements 
of Sec.  440.240 of this chapter related to comparability of services do 
not apply with respect to State plan home and community-based services 
defined in Sec.  440.182 of this chapter.

[56 FR 8847, Mar. 1, 1991, as amended at 72 FR 68091, Dec. 4, 2007; 79 
FR 3028, Jan. 16, 2014]



Sec.  431.55  Waiver of other Medicaid requirements.

    (a) Statutory basis. Section 1915(b) of the Act authorizes the 
Secretary to waive most requirements of section 1902 of the Act to the 
extent he or she finds proposed improvements or specified practices in 
the provision of services under Medicaid to be cost effective, 
efficient, and consistent with the objectives of the Medicaid program. 
Sections 1915 (f) and (h) prescribe how such waivers are to be approved, 
continued, monitored, and terminated. Section 1902(p)(2) of the Act 
conditions FFP in payments to an entity under a section 1915(b)(1) 
waiver on the State's provision for exclusion of certain entities from 
participation.
    (b) General requirements. (1) General requirements for submittal of 
waiver requests, and the procedures that CMS follows for review and 
action on those requests are set forth in Sec.  430.25 of this chapter.
    (2) In applying for a waiver to implement an approvable project 
under paragraph (c), (d), (e), or (f) of this section, a Medicaid agency 
must document in the waiver request and maintain data regarding:
    (i) The cost-effectiveness of the project;
    (ii) The effect of the project on the accessibility and quality of 
services;
    (iii) The anticipated impact of the project on the State's Medicaid 
program and;
    (iv) Assurances that the restrictions on free choice of providers do 
not apply to family planning services.
    (3) No waiver under this section may be granted for a period longer 
than 2 years, unless the agency requests a continuation of the waiver.
    (4) CMS monitors the implementation of waivers granted under this 
section to ensure that requirements for such waivers are being met.
    (i) If monitoring demonstrates that the agency is not in compliance 
with the requirements for a waiver under this section, CMS gives the 
agency notice and opportunity for a hearing.
    (ii) If, after a hearing, CMS finds an agency to be out of 
compliance with the requirements of a waiver, CMS terminates the waiver 
and gives the agency a specified date by which it must demonstrate that 
it meets the applicable requirements of section 1902 of the Act.
    (5) The requirements of section 1902(s) of the Act, with regard to 
adjustments in payments for inpatient hospital services furnished to 
infants who have not attained age 1 and to children who have not 
attained age 6 and who receive these services in disproportionate share 
hospitals, may not be waived under a section 1915(b) waiver.
    (c) Case-management system. (1) Waivers of appropriate requirements 
of section 1902 of the Act may be authorized for a State to implement a 
primary care case-management system or specialty physician services 
system.
    (i) Under a primary care case-management system the agency assures 
that a specific person or persons or agency will be responsible for 
locating, coordinating, and monitoring all primary care or primary care 
and other medical care and rehabilitative services on behalf of a 
beneficiary. The person or agency must comply with the requirements set 
forth in part 438 of this chapter for primary care case management 
contracts and systems.
    (ii) A specialty physician services system allows States to restrict 
beneficiaries of specialty services to designated providers of such 
services, even in the absence of a primary care case-management system.
    (2) A waiver under this paragraph (c) may not be approved unless the 
State's request assures that the restrictions--

[[Page 33]]

    (i) Do not apply in emergency situations; and
    (ii) Do not substantially impair access to medically necessary 
services of adequate quality.
    (d) Locality as central broker. Waivers of appropriate requirements 
of section 1902 of the Act may be authorized for a State to allow a 
locality to act as a central broker to assist beneficiaries in selecting 
among competing health care plans. States must ensure that access to 
medically necessary services of adequate quality is not substantially 
impaired.
    (1) A locality is any defined jurisdiction, e.g., district, town, 
city, borough, county, parish, or State.
    (2) A locality may use any agency or agent, public or private, 
profit or nonprofit, to act on its behalf in carrying out its central 
broker function.
    (e) Sharing of cost savings. (1) Waivers of appropriate requirements 
of section 1902 of the Act may be authorized for a State to share with 
beneficiaries the cost savings resulting from the beneficiaries' use of 
more cost-effective medical care.
    (2) Sharing is through the provision of additional services, 
including--
    (i) Services furnished by a plan selected by the beneficiary; and
    (ii) Services expressly offered by the State as an inducement for 
beneficiaries to participate in a primary care case-management system, a 
competing health care plan or other system that furnishes health care 
services in a more cost-effective manner.
    (f) Restriction of freedom of choice--(1) Waiver of appropriate 
requirements of section 1902 of the Act may be authorized for States to 
restrict beneficiaries to obtaining services from (or through) qualified 
providers or practitioners that meet, accept, and comply with the State 
reimbursement, quality and utilization standards specified in the 
State's waiver request.
    (2) An agency may qualify for a waiver under this paragraph (f) only 
if its applicable State standards are consistent with access, quality 
and efficient and economic provision of covered care and services and 
the restrictions it imposes--
    (i) Do not apply to beneficiaries residing at a long-term care 
facility when a restriction is imposed unless the State arranges for 
reasonable and adequate beneficiary transfer.
    (ii) Do not discriminate among classes of providers on grounds 
unrelated to their demonstrated effectiveness and efficiency in 
providing those services; and
    (iii) Do not apply in emergency circumstances.
    (3) Demonstrated effectiveness and efficiency refers to reducing 
costs or slowing the rate of cost increase and maximizing outputs or 
outcomes per unit of cost.
    (4) The agency must make payments to providers furnishing services 
under a freedom of choice waiver under this paragraph (f) in accordance 
with the timely claims payment standards specified in Sec.  447.45 of 
this chapter for health care practitioners participating in the Medicaid 
program.
    (g) [Reserved]
    (h) Waivers approved under section 1915(b)(1) of the Act--(1) Basic 
rules. (i) An agency must submit, as part of it's waiver request, 
assurance that the entities described in paragraph (h)(2) of this 
section will be excluded from participation under an approved waiver.
    (ii) FFP is available in payments to an entity that furnishes 
services under a section 1915(b)(1) waiver only if the agency excludes 
from participation any entity described in paragraph (h)(2) of this 
section.
    (2) Entities that must be excluded. The agency must exclude an 
entity that meets any of the following conditions:
    (i) Could be excluded under section 1128(b)(8) of the Act as being 
controlled by a sanctioned individual.
    (ii) Has a substantial contractual relationship (direct or indirect) 
with an individual convicted of certain crimes, as described in section 
1128(b)(8)(B) of the Act.
    (iii) Employs or contracts directly or indirectly with one of the 
following:
    (A) Any individual or entity that, under section 1128 or section 
1128A of the Act, is precluded from furnishing health care, utilization 
review, medical social services, or administrative services.
    (B) Any entity described in paragraph (h)(2)(i) of this section.

[[Page 34]]

    (3) Definitions. As used in this section, substantial contractual 
relationship means any contractual relationship that provides for one or 
more of the following services:
    (i) The administration, management, or provision of medical 
services.
    (ii) The establishment of policies, or the provision of operational 
support, for the administration, management, or provision of medical 
services.

[56 FR 8847, Mar. 1, 1991, as amended at 59 FR 4599, Feb. 1, 1994; 59 FR 
36084, July 15, 1994; 67 FR 41094, June 14, 2002]



Sec.  431.56  Special waiver provisions applicable to American Samoa and
the Northern Mariana Islands.

    (a) Statutory basis. Section 1902(j) of the Act provides for waiver 
of all but three of the title XIX requirements, in the case of American 
Samoa and the Northern Mariana Islands.
    (b) Waiver provisions. American Samoa or the Northern Mariana 
Islands may request, and CMS may approve, a waiver of any of the title 
XIX requirements except the following:
    (1) The Federal medical assistance percentage specified in section 
1903 of the Act and Sec.  433.10(b) of this chapter.
    (2) The limit imposed by section 1108(c) of the Act on the amount of 
Federal funds payable to American Samoa or the Northern Mariana Islands 
for care and services that meet the section 1905(a) definition for 
Medicaid assistance.
    (3) The requirement that payment be made only with respect to 
expenditure made by American Samoa or the Northern Mariana Islands for 
care and services that meet the section 1905(a) definition of medical 
assistance.



Sec.  431.60  Beneficiary access to and exchange of data.

    (a) Application Programming Interface to support Medicaid 
beneficiaries. A State must implement and maintain a standards-based 
Application Programming Interface (API) that permits third-party 
applications to retrieve, with the approval and at the direction of a 
current beneficiary or the beneficiary's personal representative, data 
specified in paragraph (b) of this section through the use of common 
technologies and without special effort from the beneficiary.
    (b) Accessible content. A State must make the following information 
accessible to its current beneficiaries or the beneficiary's personal 
representative through the API described in paragraph (a) of this 
section:
    (1) Data concerning adjudicated claims, including claims data for 
payment decisions that may be appealed, were appealed, or are in the 
process of appeal, and provider remittances and beneficiary cost-sharing 
pertaining to such claims, no later than one (1) business day after a 
claim is processed;
    (2) Encounter data no later than one (1) business day after 
receiving the data from providers, other than MCOs, PIHPs, and PAHPs, 
compensated on the basis of capitation payments;
    (3) Clinical data, including laboratory results, if the State 
maintains any such data, no later than one (1) business day after the 
data is received by the State; and
    (4) Information about covered outpatient drugs and updates to such 
information, including, where applicable, preferred drug list 
information, no later than one (1) business day after the effective date 
of any such information or updates to such information.
    (c) Technical requirements. A State implementing an API under 
paragraph (a) of this section:
    (1) Must implement, maintain, and use API technology conformant with 
45 CFR 170.215;
    (2) Must conduct routine testing and monitoring, and update as 
appropriate, to ensure the API functions properly, including assessments 
to verify that the API is fully and successfully implementing privacy 
and security features such as, but not limited to, those required to 
comply with HIPAA privacy and security requirements in 45 CFR parts 160 
and 164, 42 CFR parts 2 and 3, and other applicable law protecting the 
privacy and security of individually identifiable data;
    (3) Must comply with the content and vocabulary standards 
requirements in paragraphs (c)(3)(i) and (ii) of this section, as 
applicable to the data type or data element, unless alternate standards 
are required by other applicable law:

[[Page 35]]

    (i) Content and vocabulary standards at 45 CFR 170.213 where such 
standards are applicable to the data type or element, as appropriate; 
and
    (ii) Content and vocabulary standards at 45 CFR part 162 and Sec.  
423.160 of this chapter where required by law, or where such standards 
are applicable to the data type or element, as appropriate.
    (4) May use an updated version of any standard or all standards 
required under paragraph (c)(1) or (3) of this section, where:
    (i) Use of the updated version of the standard is required by other 
applicable law, or
    (ii) Use of the updated version of the standard is not prohibited 
under other applicable law, provided that:
    (A) For content and vocabulary standards other than those at 45 CFR 
170.213, the Secretary has not prohibited use of the updated version of 
a standard for purposes of this section or 45 CFR part 170;
    (B) For standards at 45 CFR 170.213 and 45 CFR 170.215, the National 
Coordinator has approved the updated version for use in the ONC Health 
IT Certification Program; and
    (C) Use of the updated version of a standard does not disrupt an end 
user's ability to access the data described in paragraph (b) of this 
section through the API described in paragraph (a) of this section.
    (d) Documentation requirements for APIs. For each API implemented in 
accordance with paragraph (a) of this section, a State must make 
publicly accessible, by posting directly on its website or via publicly 
accessible hyperlink(s), complete accompanying documentation that 
contains, at a minimum the information listed in this paragraph. For the 
purposes of this section, ``publicly accessible'' means that any person 
using commonly available technology to browse the internet could access 
the information without any preconditions or additional steps, such as a 
fee for access to the documentation; a requirement to receive a copy of 
the material via email; a requirement to register or create an account 
to receive the documentation; or a requirement to read promotional 
material or agree to receive future communications from the organization 
making the documentation available;
    (1) API syntax, function names, required and optional parameters 
supported and their data types, return variables and their types/
structures, exceptions and exception handling methods and their returns;
    (2) The software components and configurations an application must 
use in order to successfully interact with the API and process its 
response(s); and
    (3) All applicable technical requirements and attributes necessary 
for an application to be registered with any authorization server(s) 
deployed in conjunction with the API.
    (e) Denial or discontinuation of access to the API. A State may deny 
or discontinue any third-party application's connection to the API 
required under paragraph (a) of this section if the State:
    (1) Reasonably determines, consistent with its security risk 
analysis under 45 CFR part 164 subpart C, that allowing an application 
to connect or remain connected to the API would present an unacceptable 
level of risk to the security of protected health information on the 
State's systems; and
    (2) Makes this determination using objective, verifiable criteria 
that are applied fairly and consistently across all applications and 
developers through which beneficiaries seek to access their electronic 
health information as defined at 45 CFR 171.102, including but not 
limited to criteria that may rely on automated monitoring and risk 
mitigation tools.
    (f) Beneficiary resources regarding privacy and security. The State 
must provide in an easily accessible location on its public website and 
through other appropriate mechanisms through which it ordinarily 
communicates with current and former beneficiaries seeking to access 
their health information held by the State Medicaid agency, educational 
resources in non-technical, simple and easy-to-understand language 
explaining at a minimum:
    (1) General information on steps the individual may consider taking 
to help protect the privacy and security of their health information, 
including factors to consider in selecting an application including 
secondary uses of

[[Page 36]]

data, and the importance of understanding the security and privacy 
practices of any application to which they will entrust their health 
information; and
    (2) An overview of which types of organizations or individuals are 
and are not likely to be HIPAA covered entities, the oversight 
responsibilities of the Office for Civil Rights (OCR) and the Federal 
Trade Commission (FTC), and how to submit a complaint to:
    (i) The HHS Office for Civil Rights (OCR); and
    (ii) The Federal Trade Commission (FTC).
    (g) Data availability. (1) The State must comply with the 
requirements in paragraph (a) through (f) of this section beginning 
January 1, 2021 with regard to data:
    (i) With a date of service on or after January 1, 2016; and
    (ii) That are maintained by the State.
    (2) [Reserved]

[85 FR 25634, May 1, 2020]



Sec.  431.70  Access to published provider directory information.

    (a) The State must implement and maintain a publicly accessible, 
standards-based Application Programming Interface (API) that is 
conformant with the technical requirements at Sec.  431.60(c), excluding 
the security protocols related to user authentication and authorization 
and any other protocols that restrict the availability of this 
information to particular persons or organizations, the documentation 
requirements at Sec.  431.60(d), and is accessible via a public-facing 
digital endpoint on the State's website.
    (b) The API must provide a complete and accurate directory of--
    (1) The State's provider directory information specified in section 
1902(a)(83) of the Act, updated no later than 30 calendar days after the 
State receives provider directory information or updates to provider 
directory information.
    (2) [Reserved]
    (c) This section is applicable beginning January 1, 2021.

[85 FR 25635, May 1, 2020]



        Subpart C_Administrative Requirements: Provider Relations



Sec.  431.105  Consultation to medical facilities.

    (a) Basis and purpose. This section implements section 1902(a)(24) 
of the Act, which requires that the State plan provide for consultative 
services by State agencies to certain institutions furnishing Medicaid 
services.
    (b) State plan requirements. A State plan must provide that health 
agencies and other appropriate State agencies furnish consultative 
services to hospitals, nursing homes, home health agencies, clinics, and 
laboratories in order to assist these facilities to--
    (1) Qualify for payments under the maternal and child health and 
crippled children's program (title V of the Act), Medicaid or Medicare;
    (2) Establish and maintain fiscal records necessary for the proper 
and efficient administration of the Act; and
    (3) Provide information needed to determine payments due under the 
Act for services furnished to beneficiaries.
    (c) State plan option: Consultation to other facilities. The plan 
may provide that health agencies and other appropriate State agencies 
furnish consultation to other types of facilities if those facilities 
are specified in the plan and provide medical care to individuals 
receiving services under the programs specified in paragraph (b) of this 
section.



Sec.  431.107  Required provider agreement.

    (a) Basis and purpose. This section sets forth State plan 
requirements, based on sections 1902(a)(4), 1902(a)(27), 1902(a)(57), 
and 1902(a)(58) of the Act, that relate to the keeping of records and 
the furnishing of information by all providers of services (including 
individual practitioners and groups of practitioners).
    (b) Agreements. A State plan must provide for an agreement between 
the Medicaid agency and each provider or organization furnishing 
services under the plan in which the provider or organization agrees to:
    (1) Keep any records necessary to disclose the extent of services 
the provider furnishes to beneficiaries;

[[Page 37]]

    (2) On request, furnish to the Medicaid agency, the Secretary, or 
the State Medicaid fraud control unit (if such a unit has been approved 
by the Secretary under Sec.  455.300 of this chapter), any information 
maintained under paragraph (b)(1) of this section and any information 
regarding payments claimed by the provider for furnishing services under 
the plan;
    (3) Comply with the disclosure requirements specified in part 455, 
subpart B of this chapter; and
    (4) Comply with the advance directives requirements for hospitals, 
nursing facilities, providers of home health care and personal care 
services, hospices, and HMOs specified in part 489, subpart I, and Sec.  
417.436(d) of this chapter.
    (5)(i) Furnish to the State agency its National Provider Identifier 
(NPI) (if eligible for an NPI); and
    (ii) Include its NPI on all claims submitted under the Medicaid 
program.

[44 FR 41644, July 17, 1979, as amended at 57 FR 8202, Mar. 6, 1992; 75 
FR 24449, May 5, 2010]



Sec.  431.108  Effective date of provider agreements.

    (a) Applicability--(1) General rule. Except as provided in paragraph 
(a)(2) of this section, this section applies to Medicaid provider 
agreements with entities that, as a basis for participation in 
Medicaid--
    (i) Are subject to survey and certification by CMS or the State 
survey agency; or
    (ii) Are deemed to meet Federal requirements on the basis of 
accreditation by an accrediting organization whose program has CMS 
approval at the time of accreditation survey and accreditation decision.
    (2) Exception. A Medicaid provider agreement with a laboratory is 
effective only while the laboratory has in effect a valid CLIA 
certificate issued under part 493 of this chapter, and only for the 
specialty and subspecialty tests it is authorized to perform.
    (b) All requirements are met on the date of survey. The agreement is 
effective on the date the onsite survey (including the Life Safety Code 
survey if applicable) is completed, if on that date the provider meets--
    (1) All applicable Federal requirements as set forth in this 
chapter; and
    (2) Any other requirements imposed by the State for participation in 
the Medicaid program. (If the provider has a time-limited agreement, the 
new agreement is effective on the day following expiration of the 
current agreement.)
    (c) All requirements are not met on the date of survey. If on the 
date the survey is completed the provider fails to meet any of the 
requirements specified in paragraph (b) of this section, the following 
rules apply:
    (1) An NF provider agreement is effective on the date on which--
    (i) The NF is found to be in substantial compliance as defined in 
Sec.  488.301 of this chapter; and
    (ii) CMS or the State survey agency receives from the NF, if 
applicable, an approvable waiver request.
    (2) For an agreement with any other provider, the effective date is 
the earlier of the following:
    (i) The date on which the provider meets all requirements.
    (ii) The date on which a provider is found to meet all conditions of 
participation but has lower level deficiencies, and CMS or the State 
survey agency receives from the provider an acceptable plan of 
correction for the lower level deficiencies, or an approvable waiver 
request, or both. (The date of receipt is the effective date of the 
agreement, regardless of when CMS approves the plan of correction or 
waiver request, or both.)
    (d) Accredited provider requests participation in the Medicaid 
program--(1) General rule. If a provider is currently accredited by a 
national accrediting organization whose program had CMS approval at the 
time of accreditation survey and accreditation decision, and on the 
basis of accreditation, CMS has deemed the provider to meet Federal 
requirements, the effective date depends on whether the provider is 
subject to requirements in addition to those included in the accrediting 
organization's approved program.
    (i) Provider subject to additional requirements. For a provider that 
is subject to additional requirements, Federal or State, or both, the 
effective date is the date on which the provider

[[Page 38]]

meets all requirements, including the additional requirements.
    (ii) Provider not subject to additional requirements. For a provider 
that is not subject to additional requirements, the effective date is 
the date of the provider's initial request for participation if on that 
date the provider met all Federal requirements.
    (2) Special rule: Retroactive effective date. If the provider meets 
the requirements of paragraphs (d)(1) and (d)(1)(i) or (d)(1)(ii) of 
this section, the effective date may be retroactive for up to one year, 
to encompass dates on which the provider furnished, to a Medicaid 
beneficiary, covered services for which it has not been paid.

[62 FR 43935, Aug. 18, 1997]



Sec.  431.110  Participation by Indian Health Service facilities.

    (a) Basis. This section is based on section 1902(a)(4) of the Act, 
proper and efficient administration; 1902(a)(23), free choice of 
provider; and 1911, reimbursement of Indian Health Service facilities.
    (b) State plan requirements. A State plan must provide that an 
Indian Health Service facility meeting State requirements for Medicaid 
participation must be accepted as a Medicaid provider on the same basis 
as any other qualified provider. However, when State licensure is 
normally required, the facility need not obtain a license but must meet 
all applicable standards for licensure. In determining whether a 
facility meets these standards, a Medicaid agency or State licensing 
authority may not take into account an absence of licensure of any staff 
member of the facility.



Sec.  431.115  Disclosure of survey information and provider or contractor
evaluation.

    (a) Basis and purpose. This section implements--
    (1) Section 1902(a)(36) of the Act, which requires a State plan to 
provide that the State survey agency will make publicly available the 
findings from surveys of health care facilities, laboratories, agencies, 
clinics, or organizations; and
    (2) Section 1106(d) of the Act, which places certain restrictions on 
the Medicaid agency's disclosure of contractor and provider evaluations.
    (b) Definition of State survey agency. The State survey agency 
referred to in this section means the agency specified under section 
1902(a)(9) of the Act as responsible for establishing and maintaining 
health standards for private or public institutions in which Medicaid 
beneficiaries may receive services.
    (c) State plan requirements. A State plan must provide that the 
requirements of this section and Sec.  488.325 of this chapter are met.
    (d) Disclosure procedure. The Medicaid agency must have a procedure 
for disclosing pertinent findings obtained from surveys made by the 
State survey agency to determine if a health care facility, laboratory, 
agency, clinic or health care organization meets the requirements for 
participation in the Medicaid program.
    (e) Documents subject to disclosure. Documents subject to disclosure 
include--
    (1) Survey reports, except for Joint Commission on the Accreditation 
of Hospitals reports prohibited from disclosure under Sec.  
422.426(b)(2) of this chapter;
    (2) Official notifications of findings based on survey reports:
    (3) Pertinent parts of written documents furnished by the health 
care provider to the survey agency that relate to the reports and 
findings; and
    (4) Ownership and contract information as specified in Sec.  455.104 
of this subchapter.
    (f) Availability for inspection and copy of statements listing 
deficiencies. The disclosure procedure must provide that the State 
survey agency will--
    (1) Make statements of deficiencies based on the survey reports 
available for inspection and copying in both the public assistance 
office and the Social Security Administration district office serving 
the area where the provider is located; and
    (2) Submit to the Regional Medicaid Director, through the Medicaid 
agency, a plan for making those findings available in other public 
assistance offices in standard metropolitian statistical areas where 
this information would be helpful to persons likely to use the health 
care provider's services.

[[Page 39]]

    (g) When documents must be made available. The disclosure procedure 
must provide that the State survey agency will--
    (1) Retain in the survey agency office and make available upon 
request survey reports and current and accurate ownership information; 
and
    (2) Make available survey reports, findings, and deficiency 
statements immediately upon determining that a health care provider is 
eligible to begin or continue participation in the Medicaid program, or 
within 90 days after completion of the survey, whichever occurs first.
    (h) Evaluation reports on providers and contractors. (1) If the 
Secretary sends the following reports to the Medicaid agency, the agency 
must meet the requirements of paragraphs (h) (2) and (3) of this section 
in releasing them:
    (i) Individual contractor performance reviews and other formal 
performance evaluations of carriers, intermediaries, and State agencies, 
including the reports of followup reviews;
    (ii) Comparative performance evaluations of those contractors, 
including comparisons of either overall performance or of any particular 
aspect of contractor operations; and
    (iii) Program validation survey reports and other formal performance 
evaluations of providers, including the reports of followup reviews.
    (2) The agency must not make the reports public until--
    (i) The contractor or provider has had a reasonable opportunity, not 
to exceed 30 days, to comment on them; and
    (ii) Those comments have been incorporated in the report.
    (3) The agency must ensure that the reports contain no 
identification of individual patients, individual health care 
practitioners or other individuals.

[43 FR 45188, Sept. 29, 1978, as amended at 44 FR 41644, July 17, 1979; 
59 FR 56232, Nov. 10, 1994]



Sec.  431.120  State requirements with respect to nursing facilities.

    (a) State plan requirements. A State plan must--
    (1) Provide that the requirements of subpart D of part 483 of this 
chapter are met; and
    (2) Specify the procedures and rules that the State follows in 
carrying out the specified requirements, including review and approval 
of State-operated programs.
    (3) To an NF or ICF/IID that is dissatisfied with a determination as 
to the effective date of its provider agreement.
    (b) Basis and scope of requirements. The requirements set forth in 
part 483 of this chapter pertain to the following aspects of nursing 
facility services and are required by the indicated sections of the Act.
    (1) Nurse aide training and competency programs, and evaluation of 
nurse aide competency (1919(e)(1) of the Act).
    (2) Nurse aide registry (1919(e)(2) of the Act).

[56 FR 48918, Sept. 26, 1991, as amended at 62 FR 43935, Aug. 18, 1997]



             Subpart D_Appeals Process for NFs and ICFs/IID

    Source: 44 FR 9753, Feb. 15, 1979, unless otherwise noted.



Sec.  431.151  Scope and applicability.

    (a) General rules. This subpart sets forth the appeals procedures 
that a State must make available as follows:
    (1) To a nursing facility (NF) that is dissatisfied with a State's 
finding of noncompliance that has resulted in one of the following 
adverse actions:
    (i) Denial or termination of its provider agreement.
    (ii) Imposition of a civil money penalty or other alternative 
remedy.
    (2) To an intermediate care facility for Individuals with 
Intellectual Disabilities (ICF/IID) that is dissatisfied with a State's 
finding of noncompliance that has resulted in the denial, termination, 
or nonrenewal of its provider agreement.
    (3) To an NF or ICF/IID that is dissatisfied with a determination as 
to the effective date of its provider agreement.
    (b) Special rules. This subpart also sets forth the special rules 
that apply

[[Page 40]]

in particular circumstances, the limitations on the grounds for appeal, 
and the scope of review during a hearing.

[61 FR 32348, June 24, 1996, as amended at 62 FR 43935, Aug. 18, 1997]



Sec.  431.152  State plan requirements.

    The State plan must provide for appeals procedures that, as a 
minimum, satisfy the requirements of Sec. Sec.  431.153 and 431.154.

[59 FR 56232, Nov. 10, 1994, as amended at 61 FR 32348, June 24, 1996]



Sec.  431.153  Evidentiary hearing.

    (a) Right to hearing. Except as provided in paragraph (b) of this 
section, and subject to the provisions of paragraphs (c) through (j) of 
this section, the State must give the facility a full evidentiary 
hearing for any of the actions specified in Sec.  431.151.
    (b) Limit on grounds for appeal. The following are not subject to 
appeal:
    (1) The choice of sanction or remedy.
    (2) The State monitoring remedy.
    (3) [Reserved]
    (4) The level of noncompliance found by a State except when a 
favorable final administrative review decision would affect the range of 
civil money penalty amounts the State could collect.
    (5) A State survey agency's decision as to when to conduct an 
initial survey of a prospective provider.
    (c) Notice of deficiencies and impending remedies. The State must 
give the facility a written notice that includes:
    (1) The basis for the decision; and
    (2) A statement of the deficiencies on which the decision was based.
    (d) Request for hearing. The facility or its legal representative or 
other authorized official must file written request for hearing within 
60 days of receipt of the notice of adverse action.
    (e) Special rules: Denial, termination or nonrenewal of provider 
agreement--(1) Appeal by an ICF/IID. If an ICF/IID requests a hearing on 
denial, termination, or nonrenewal of its provider agreement--
    (i) The evidentiary hearing must be completed either before, or 
within 120 days after, the effective date of the adverse action; and
    (ii) If the hearing is made available only after the effective date 
of the action, the State must, before that date, offer the ICF/IID an 
informal reconsideration that meets the requirements of Sec.  431.154.
    (2) Appeal by an NF. If an NF requests a hearing on the denial or 
termination of its provider agreement, the request does not delay the 
adverse action and the hearing need not be completed before the 
effective date of the action.
    (f) Special rules: Imposition of remedies. If a State imposes a 
civil money penalty or other remedies on an NF, the following rules 
apply:
    (1) Basic rule. Except as provided in paragraph (f)(2) of this 
section (and notwithstanding any provision of State law), the State must 
impose all remedies timely on the NF, even if the NF requests a hearing.
    (2) Exception. The State may not collect a civil money penalty until 
after the 60-day period for request of hearing has elapsed or, if the NF 
requests a hearing, until issuance of a final administrative decision 
that supports imposition of the penalty.
    (g) Special rules: Dually participating facilities. If an NF is also 
participating or seeking to participate in Medicare as an SNF, and the 
basis for the State's denial or termination of participation in Medicaid 
is also a basis for denial or termination of participation in Medicare, 
the State must advise the facility that--
    (1) The appeals procedures specified for Medicare facilities in part 
498 of this chapter apply; and
    (2) A final decision entered under the Medicare appeals procedures 
is binding for both programs.
    (h) Special rules: Adverse action by CMS. If CMS finds that an NF is 
not in substantial compliance and either terminates the NF's Medicaid 
provider agreement or imposes alternative remedies on the NF (because 
CMS's findings and proposed remedies prevail over those of the State in 
accordance with Sec.  488.452 of this chapter), the NF is entitled only 
to the appeals procedures set forth in part 498 of this chapter, instead 
of the procedures specified in this subpart.

[[Page 41]]

    (i) Required elements of hearing. The hearing must include at least 
the following:
    (1) Opportunity for the facility--
    (i) To appear before an impartial decision-maker to refute the 
finding of noncompliance on which the adverse action was based;
    (ii) To be represented by counsel or other representative; and
    (iii) To be heard directly or through its representative, to call 
witnesses, and to present documentary evidence.
    (2) A written decision by the impartial decision-maker, setting 
forth the reasons for the decision and the evidence on which the 
decision is based.
    (j) Limits on scope of review: Civil money penalty cases. In civil 
money penalty cases--
    (1) The State's finding as to a NF's level of noncompliance must be 
upheld unless it is clearly erroneous; and
    (2) The scope of review is as set forth in Sec.  488.438(e) of this 
chapter.

[61 FR 32348, June 24, 1996, as amended at 62 FR 43935, Aug. 18, 1997; 
64 FR 39937, July 23, 1999]



Sec.  431.154  Informal reconsideration for ICFs/IID.

    The informal reconsideration must, at a minimum, include--
    (a) Written notice to the facility of the denial, termination or 
nonrenewal and the findings upon which it was based;
    (b) A reasonable opportunity for the facility to refute those 
findings in writing, and
    (c) A written affirmation or reversal of the denial, termination, or 
nonrenewal.

[44 FR 9753, Feb. 15, 1979, as amended at 59 FR 56233, Nov. 10, 1994; 61 
FR 32349, June 24, 1996]



        Subpart E_Fair Hearings for Applicants and Beneficiaries

    Source: 44 FR 17932, Mar. 29, 1979, unless otherwise noted.

                           General Provisions



Sec.  431.200  Basis and scope.

    This subpart--
    (a) Implements section 1902(a)(3) of the Act, which requires that a 
State plan provide an opportunity for a fair hearing to any person whose 
claim for assistance is denied or not acted upon promptly;
    (b) Prescribes procedures for an opportunity for a hearing if the 
State agency or non-emergency transportation PAHP (as defined in Sec.  
438.9(a) of this chapter) takes action, as stated in this subpart, to 
suspend, terminate, or reduce services, or of an adverse benefit 
determination by an MCO, PIHP or PAHP under subpart F of part 438 of 
this chapter; and
    (c) Implements sections 1919(f)(3) and 1919(e)(7)(F) of the Act by 
providing an appeals process for any person who--
    (1) Is subject to a proposed transfer or discharge from a nursing 
facility; or
    (2) Is adversely affected by the pre-admission screening or the 
annual resident review that are required by section 1919(e)(7) of the 
Act.
    (d) Implements section 1943(b)(3) of the Act and section 1413 of the 
Affordable Care Act to permit coordinated hearings and appeals among 
insurance affordability programs.

[67 FR 41094, June 14, 2002, as amended at 81 FR 27852, May 6, 2016; 81 
FR 86448, Nov. 30, 2016]



Sec.  431.201  Definitions.

    For purposes of this subpart:
    Action means a termination, suspension of, or reduction in covered 
benefits or services, or a termination, suspension of, or reduction in 
Medicaid eligibility or an increase in beneficiary liability, including 
a determination that a beneficiary must incur a greater amount of 
medical expenses in order to establish income eligibility in accordance 
with Sec.  435.121(e)(4) or Sec.  435.831 of this chapter or is subject 
to an increase in premiums or cost-sharing charges under subpart A of 
part 447 of this chapter. It also means a determination by a skilled 
nursing facility or nursing facility to transfer or discharge a resident 
and an adverse determination by a State with regard to the preadmission 
screening and resident review requirements of section 1919(e)(7) of the 
Act.
    Adverse determination means a determination made in accordance with 
sections 1919(b)(3)(F) or 1919(e)(7)(B) of the Act that the individual 
does not require the level of services provided by a

[[Page 42]]

nursing facility or that the individual does or does not require 
specialized services.
    Date of action means the intended date on which a termination, 
suspension, reduction, transfer or discharge becomes effective. It also 
means the date of the determination made by a State with regard to the 
preadmission screening and annual resident review requirements of 
section 1919(e)(7) of the Act.
    De novo hearing means a hearing that starts over from the beginning.
    Evidentiary hearing means a hearing conducted so that evidence may 
be presented.
    Joint fair hearing request means a request for a Medicaid fair 
hearing which is included in an appeal request submitted to an Exchange 
or Exchange appeals entity under 45 CFR 155.520 or other insurance 
affordability program or appeals entity, in accordance with the signed 
agreement between the agency and an Exchange or Exchange appeals entity 
or other program or appeals entity described in Sec.  435.1200(b)(3) of 
this chapter .
    Local evidentiary hearing means a hearing held on the local or 
county level serving a specified portion of the State.
    Notice means a written statement that meets the requirements of 
Sec.  431.210.
    Request for a hearing means a clear expression by the applicant or 
beneficiary, or his authorized representative, that he wants the 
opportunity to present his case to a reviewing authority.
    Send means deliver by mail or in electronic format consistent with 
Sec.  435.918 of this chapter.
    Service authorization request means a managed care enrollee's 
request for the provision of a service.

[44 FR 17932, Mar. 29, 1979, as amended at 57 FR 56505, Nov. 30, 1992; 
67 FR 41095, June 14, 2002; 78 FR 42301, July 15, 2013; 81 FR 86448, 
Nov. 30, 2016]



Sec.  431.202  State plan requirements.

    A State plan must provide that the requirements of Sec. Sec.  
431.205 through 431.246 of this subpart are met.



Sec.  431.205  Provision of hearing system.

    (a) The Medicaid agency must be responsible for maintaining a 
hearing system that meets the requirements of this subpart.
    (b) The State's hearing system must provide for--
    (1) A hearing before--
    (i) The Medicaid agency; or
    (ii) For the denial of eligibility for individuals whose income 
eligibility is determined based on the applicable modified adjusted 
gross income standard described inSec.  435.911(c) of this chapter, the 
Exchange or Exchange appeals entity to which authority to conduct fair 
hearings has been delegated under Sec.  431.10(c)(1)(ii), provided that 
individuals who have requested a fair hearing are given the choice to 
have their fair hearing conducted instead by the Medicaid agency; at 
state option the Exchange or Exchange appeals entity decision may be 
subject to review by the Medicaid agency in accordance with Sec.  
431.10(c)(3)(iii); or
    (2) An evidentiary hearing at the local level, with a right of 
appeal to the Medicaid agency.
    (c) The agency may offer local hearings in some political 
subdivisions and not in others.
    (d) The hearing system must meet the due process standards set forth 
in Goldberg v. Kelly, 397 U.S. 254 (1970), and any additional standards 
specified in this subpart.
    (e) The hearing system must be accessible to persons who are limited 
English proficient and persons who have disabilities, consistent with 
Sec.  435.905(b) of this chapter.
    (f) The hearing system must comply with the United States 
Constitution, the Social Security Act, title VI of the Civil Rights Act 
of 1964, section 504 of the Rehabilitation Act of 1973, the Americans 
with Disabilities Act of 1990, the Age Discrimination Act of 1975, and 
section 1557 of the Affordable Care Act and implementing regulations.

[44 FR 17932, Mar. 29, 1979, as amended at 78 FR 42301, July 15, 2013; 
81 FR 86448, Nov. 30, 2016]

[[Page 43]]



Sec.  431.206  Informing applicants and beneficiaries.

    (a) The agency must issue and publicize its hearing procedures.
    (b) The agency must, at the time specified in paragraph (c) of this 
section, inform every applicant or beneficiary in writing--
    (1) Of his or her right to a fair hearing and right to request an 
expedited fair hearing;
    (2) Of the method by which he may obtain a hearing;
    (3) That he may represent himself or use legal counsel, a relative, 
a friend, or other spokesman; and
    (4) Of the time frames in which the agency must take final 
administrative action, in accordance with Sec.  431.244(f).
    (c) The agency must provide the information required in paragraph 
(b) of this section--(1) At the time that the individual applies for 
Medicaid;
    (2) At the time the agency denies an individual's claim for 
eligibility, benefits or services; or denies a request for exemption 
from mandatory enrollment in an Alternative Benefit Plan; or takes other 
action, as defined at Sec.  431.201; or whenever a hearing is otherwise 
required in accordance with Sec.  431.220(a);
    (3) At the time a skilled nursing facility or a nursing facility 
notifies a resident in accordance with Sec.  483.15 of this chapter that 
he or she is to be transferred or discharged; and
    (4) At the time an individual receives an adverse determination by 
the State with regard to the preadmission screening and annual resident 
review requirements of section 1919(e)(7) of the Act.
    (d) If, in accordance with Sec.  431.10(c)(1)(ii), the agency has 
delegated authority to the Exchange or Exchange appeals entity to 
conduct the fair hearing, the agency must inform the individual in 
writing that--
    (1) He or she has the right to have his or her hearing before the 
agency, instead of the Exchange or the Exchange appeals entity; and
    (2) The method by which the individual may make such election;
    (e) The information required under this subpart must be accessible 
to individuals who are limited English proficient and to individuals 
with disabilities, consistent with Sec.  435.905(b) of this chapter, and 
may be provided in electronic format in accordance with Sec.  435.918 of 
this chapter.

[44 FR 17932, Mar. 29, 1979, as amended at 57 FR 56505, Nov. 30, 1992; 
58 FR 25784, Apr. 28, 1993; 78 FR 42301, July 15, 2013; 81 FR 68847, 
Oct. 4, 2016; 81 FR 86448, Nov. 30, 2016]

                                 Notice



Sec.  431.210  Content of notice.

    A notice required under Sec.  431.206 (c)(2), (c)(3), or (c)(4) of 
this subpart must contain--
    (a) A statement of what action the agency, skilled nursing facility, 
or nursing facility intends to take and the effective date of such 
action;
    (b) A clear statement of the specific reasons supporting the 
intended action;
    (c) The specific regulations that support, or the change in Federal 
or State law that requires, the action;
    (d) An explanation of--
    (1) The individual's right to request a local evidentiary hearing if 
one is available, or a State agency hearing; or
    (2) In cases of an action based on a change in law, the 
circumstances under which a hearing will be granted; and
    (e) An explanation of the circumstances under which Medicaid is 
continued if a hearing is requested.

[44 FR 17932, Mar. 29, 1979, as amended at 57 FR 56505, Nov. 30, 1992; 
81 FR 86448, Nov. 30, 2016]



Sec.  431.211  Advance notice.

    The State or local agency must send a notice at least 10 days before 
the date of action, except as permitted under Sec. Sec.  431.213 and 
431.214.

[78 FR 42301, July 15, 2013]



Sec.  431.213  Exceptions from advance notice.

    The agency may send a notice not later than the date of action if--
    (a) The agency has factual information confirming the death of a 
beneficiary;
    (b) The agency receives a clear written statement signed by a 
beneficiary that--
    (1) He no longer wishes services; or
    (2) Gives information that requires termination or reduction of 
services and indicates that he understands that

[[Page 44]]

this must be the result of supplying that information;
    (c) The beneficiary has been admitted to an institution where he is 
ineligible under the plan for further services;
    (d) The beneficiary's whereabouts are unknown and the post office 
returns agency mail directed to him indicating no forwarding address 
(See Sec.  431.231 (d) of this subpart for procedure if the 
beneficiary's whereabouts become known);
    (e) The agency establishes the fact that the beneficiary has been 
accepted for Medicaid services by another local jurisdiction, State, 
territory, or commonwealth;
    (f) A change in the level of medical care is prescribed by the 
beneficiary's physician;
    (g) The notice involves an adverse determination made with regard to 
the preadmission screening requirements of section 1919(e)(7) of the 
Act; or
    (h) The date of action will occur in less than 10 days, in 
accordance with Sec.  483.15(b)(4)(ii) and (b)(8), which provides 
exceptions to the 30 days notice requirements of Sec.  483.15(b)(4)(i) 
of this chapter.

[44 FR 17932, Mar. 29, 1979, as amended at 57 FR 56505, Nov. 30, 1992; 
58 FR 25784, Apr. 28, 1993; 78 FR 42301, July 15, 2013; 81 FR 68847, 
Oct. 4, 2016]



Sec.  431.214  Notice in cases of probable fraud.

    The agency may shorten the period of advance notice to 5 days before 
the date of action if--
    (a) The agency has facts indicating that action should be taken 
because of probable fraud by the beneficiary; and
    (b) The facts have been verified, if possible, through secondary 
sources.

                            Right to Hearing



Sec.  431.220  When a hearing is required.

    (a) The State agency must grant an opportunity for a hearing to the 
following:
    (1) Any individual who requests it because he or she believes the 
agency has taken an action erroneously, denied his or her claim for 
eligibility or for covered benefits or services, or issued a 
determination of an individual's liability, or has not acted upon the 
claim with reasonable promptness including, if applicable--
    (i) An initial or subsequent decision regarding eligibility;
    (ii) A determination of the amount of medical expenses that an 
individual must incur in order to establish eligibility in accordance 
with Sec.  435.121(e)(4) or Sec.  435.831 of this chapter; or
    (iii) A determination of the amount of premiums and cost sharing 
charges under subpart A of part 447 of this chapter;
    (iv) A change in the amount or type of benefits or services; or
    (v) A request for exemption from mandatory enrollment in an 
Alternative Benefit Plan.
    (2) Any resident who requests it because he or she believes a 
skilled nursing facility or nursing facility has erroneously determined 
that he or she must be transferred or discharged.
    (3) Any individual who requests it because he or she believes the 
State has made an erroneous determination with regard to the 
preadmission and annual resident review requirements of section 
1919(e)(7) of the Act.
    (4) Any MCO, PIHP, or PAHP enrollee who is entitled to a hearing 
under subpart F of part 438 of this chapter.
    (5) Any enrollee in a non-emergency medical transportation PAHP (as 
that term is defined in Sec.  438.9 of this chapter) who has an action 
as stated in this subpart.
    (6) Any enrollee who is entitled to a hearing under subpart B of 
part 438 of this chapter.
    (b) The agency need not grant a hearing if the sole issue is a 
Federal or State law requiring an automatic change adversely affecting 
some or all beneficiaries.

[44 FR 17932, Mar. 29, 1979, as amended at 57 FR 56505, Nov. 30, 1992; 
67 FR 41095, June 14, 2002; 67 FR 65505, Oct. 25, 2002; 81 FR 27853, May 
6, 2016; 81 FR 86448, Nov. 30, 2016]



Sec.  431.221  Request for hearing.

    (a)(1) The agency must establish procedures that permit an 
individual, or an authorized representative as defined at Sec.  435.923 
of this chapter, to--
    (i) Submit a hearing request via any of the modalities described in 
Sec.  435.907(a) of this chapter, except that

[[Page 45]]

the requirement to establish procedures for submission of a fair hearing 
request described in Sec.  435.907(a)(1), (2) and (5) of this chapter 
(relating to submissions via Internet Web site, telephone and other 
electronic means) is effective no later than the date described in Sec.  
435.1200(i) of this chapter; and
    (ii) Include in a hearing request submitted under paragraph 
(a)(1)(i) of this section, a request for an expedited fair hearing.
    (2) [Reserved]
    (b) The agency may not limit or interfere with the applicant's or 
beneficiary's freedom to make a request for a hearing.
    (c) The agency may assist the applicant or beneficiary in submitting 
and processing his request.
    (d) The agency must allow the applicant or beneficiary a reasonable 
time, not to exceed 90 days from the date that notice of action is 
mailed, to request a hearings.

[44 FR 17932, Mar. 29, 1979, as amended at 81 FR 86448, Nov. 30, 2016]



Sec.  431.222  Group hearings.

    The agency--
    (a) May respond to a series of individual requests for hearing by 
conducting a single group hearing;
    (b) May consolidate hearings only in cases in which the sole issue 
involved is one of Federal or State law or policy;
    (c) Must follow the policies of this subpart and its own policies 
governing hearings in all group hearings; and
    (d) Must permit each person to present his own case or be 
represented by his authorized representative.



Sec.  431.223  Denial or dismissal of request for a hearing.

    The agency may deny or dismiss a request for a hearing if--
    (a) The applicant or beneficiary withdraws the request. The agency 
must accept withdrawal of a fair hearing request via any of the 
modalities available per Sec.  431.221(a)(1)(i). For telephonic hearing 
withdrawals, the agency must record the individual's statement and 
telephonic signature. For telephonic, online and other electronic 
withdrawals, the agency must send the affected individual written 
confirmation, via regular mail or electronic notification in accordance 
with the individual's election under Sec.  435.918(a) of this chapter.
    (b) The applicant or beneficiary fails to appear at a scheduled 
hearing without good cause.

[44 FR 17932, Mar. 29, 1979, as amended at 81 FR 86449, Nov. 30, 2016]



Sec.  431.224  Expedited appeals.

    (a) General rule. (1) The agency must establish and maintain an 
expedited fair hearing process for individuals to request an expedited 
fair hearing, if the agency determines that the time otherwise permitted 
for a hearing under Sec.  431.244(f)(1) could jeopardize the 
individual's life, health or ability to attain, maintain, or regain 
maximum function.
    (2) The agency must take final administrative action within the 
period of time permitted under Sec.  431.244(f)(3) if the agency 
determines that the individual meets the criteria for an expedited fair 
hearing in paragraph (a)(1) of this section.
    (b) Notice. The agency must notify the individual whether the 
request is granted or denied as expeditiously as possible. Such notice 
must be provided orally or through electronic means in accordance with 
Sec.  435.918 of this chapter, if consistent with the individual's 
election under such section; if oral notice is provided, the agency must 
follow up with written notice, which may be through electronic means if 
consistent with the individual's election under Sec.  435.918.

[81 FR 86449, Nov. 30, 2016]

                               Procedures



Sec.  431.230  Maintaining services.

    (a) If the agency sends the 10-day or 5-day notice as required under 
Sec.  431.211 or Sec.  431.214 of this subpart, and the beneficiary 
requests a hearing before the date of action, the agency may not 
terminate or reduce services until a decision is rendered after the 
hearing unless--
    (1) It is determined at the hearing that the sole issue is one of 
Federal or State law or policy; and

[[Page 46]]

    (2) The agency promptly informs the beneficiary in writing that 
services are to be terminated or reduced pending the hearing decision.
    (b) If the agency's action is sustained by the hearing decision, the 
agency may institute recovery procedures against the applicant or 
beneficiary to recoup the cost of any services furnished the 
beneficiary, to the extent they were furnished solely by reason of this 
section.

[44 FR 17932, Mar. 29, 1979, as amended at 45 FR 24882, Apr. 11, 1980; 
78 FR 42302, July 15, 2013]



Sec.  431.231  Reinstating services.

    (a) The agency may reinstate services if a beneficiary requests a 
hearing not more than 10 days after the date of action.
    (b) The reinstated services must continue until a hearing decision 
unless, at the hearing, it is determined that the sole issue is one of 
Federal or State law or policy.
    (c) The agency must reinstate and continue services until a decision 
is rendered after a hearing if--
    (1) Action is taken without the advance notice required under Sec.  
431.211 or Sec.  431.214 of this subpart;
    (2) The beneficiary requests a hearing within 10 days from the date 
that the individual receives the notice of action. The date on which the 
notice is received is considered to be 5 days after the date on the 
notice, unless the beneficiary shows that he or she did not receive the 
notice within the 5-day period; and
    (3) The agency determines that the action resulted from other than 
the application of Federal or State law or policy.
    (d) If a beneficiary's whereabouts are unknown, as indicated by the 
return of unforwardable agency mail directed to him, any discontinued 
services must be reinstated if his whereabouts become known during the 
time he is eligible for services.

[44 FR 17932, Mar. 29, 1979, as amended at 78 FR 42302, July 15, 2013]



Sec.  431.232  Adverse decision of local evidentiary hearing.

    If the decision of a local evidentiary hearing is adverse to the 
applicant or beneficiary, the agency must--
    (a) Inform the applicant or beneficiary of the decision;
    (b) Inform the applicant or beneficiary in writing that he or she 
has a right to appeal the decision to the State agency within 10 days 
after the individual receives the notice of the adverse decision. The 
date on which the notice is received is considered to be 5 days after 
the date on the notice, unless the individual shows that he or she did 
not receive the notice within the 5-day period; and
    (c) Inform the applicant or beneficiary of his right to request that 
his appeal be a de novo hearing; and
    (d) Discontinue services after the adverse decision.

[44 FR 17932, Mar. 29, 1979, as amended at 81 FR 86449, Nov. 30, 2016]



Sec.  431.233  State agency hearing after adverse decision of local
evidentiary hearing.

    (a) Unless the applicant or beneficiary specifically requests a de 
novo hearing, the State agency hearing may consist of a review by the 
agency hearing officer of the record of the local evidentiary hearing to 
determine whether the decision of the local hearing officer was 
supported by substantial evidence in the record.
    (b) A person who participates in the local decision being appealed 
may not participate in the State agency hearing decision.



Sec.  431.240  Conducting the hearing.

    (a) All hearings must be conducted--
    (1) At a reasonable time, date, and place;
    (2) Only after adequate written notice of the hearing; and
    (3) By one or more impartial officials or other individuals who have 
not been directly involved in the initial determination of the action in 
question.
    (b) If the hearing involves medical issues such as those concerning 
a diagnosis, an examining physician's report, or a medical review team's 
decision, and if the hearing officer considers it

[[Page 47]]

necessary to have a medical assessment other than that of the individual 
involved in making the original decision, such a medical assessment must 
be obtained at agency expense and made part of the record.
    (c) A hearing officer must have access to agency information 
necessary to issue a proper hearing decision, including information 
concerning State policies and regulations.

[44 FR 17932, Mar. 29, 1979, as amended at 78 FR 42302, July 15, 2013]



Sec.  431.241  Matters to be considered at the hearing.

    The hearing must cover--
    (a) Any matter described in Sec.  431.220(a)(1) for which an 
individual requests a fair hearing.
    (b) A decision by a skilled nursing facility or nursing facility to 
transfer or discharge a resident; and
    (c) A State determination with regard to the preadmission screening 
and annual resident review requirements of section 1919(e)(7) of the 
Act.

[57 FR 56505, Nov. 30, 1992, as amended at 81 FR 86449, Nov. 30, 2016]]



Sec.  431.242  Procedural rights of the applicant or beneficiary.

    The applicant or beneficiary, or his representative, must be given 
an opportunity to--
    (a) Examine at a reasonable time before the date of the hearing and 
during the hearing:
    (1) The content of the applicant's or beneficiary's case file and 
electronic account, as defined in Sec.  435.4 of this chapter; and
    (2) All documents and records to be used by the State or local 
agency or the skilled nursing facility or nursing facility at the 
hearing;
    (b) Bring witnesses;
    (c) Establish all pertinent facts and circumstances;
    (d) Present an argument without undue interference; and
    (e) Question or refute any testimony or evidence, including 
opportunity to confront and cross-examine adverse witnesses.
    (f) Request an expedited fair hearing.

[44 FR 17932, Mar. 29, 1979, as amended at 57 FR 56506, Nov. 30, 1992; 
81 FR 86449, Nov. 30, 2016]



Sec.  431.243  Parties in cases involving an eligibility determination.

    If the hearing involves an issue of eligibility and the Medicaid 
agency is not responsible for eligibility determinations, the agency 
that is responsible for determining eligibility must participate in the 
hearing.



Sec.  431.244  Hearing decisions.

    (a) Hearing recommendations or decisions must be based exclusively 
on evidence introduced at the hearing.
    (b) The record must consist only of--
    (1) The transcript or recording of testimony and exhibits, or an 
official report containing the substance of what happened at the 
hearing;
    (2) All papers and requests filed in the proceeding; and
    (3) The recommendation or decision of the hearing officer.
    (c) The applicant or beneficiary must have access to the record at a 
convenient place and time.
    (d) In any evidentiary hearing, the decision must be a written one 
that--
    (1) Summarizes the facts; and
    (2) Identifies the regulations supporting the decision.
    (e) In a de novo hearing, the decision must--
    (1) Specify the reasons for the decision; and
    (2) Identify the supporting evidence and regulations.
    (f) The agency must take final administrative action as follows:
    (1) Ordinarily, within 90 days from:
    (i) The date the enrollee filed an MCO, PIHP, or PAHP appeal, not 
including the number of days the enrollee took to subsequently file for 
a State fair hearing; or
    (ii) For all other fair hearings, the date the agency receives a 
request for a fair hearing in accordance with Sec.  431.221(a)(1).
    (2) As expeditiously as the enrollee's health condition requires, 
but no later than 3 working days after the agency receives, from the 
MCO, PIHP, or PAHP, the case file and information for any appeal of a 
denial of a service

[[Page 48]]

that, as indicated by the MCO, PIHP, or PAHP--
    (i) Meets the criteria for expedited resolution as set forth in 
Sec.  438.410(a) of this chapter, but was not resolved within the 
timeframe for expedited resolution; or
    (ii) Was resolved within the timeframe for expedited resolution, but 
reached a decision wholly or partially adverse to the enrollee.
    (3) In the case of individuals granted an expedited fair hearing in 
accordance with Sec.  431.224(a)--
    (i) For a claim related to eligibility described in Sec.  
431.220(a)(1), or any claim described in Sec.  431.220(a)(2) (relating 
to a nursing facility) or Sec.  431.220(a)(3) (related to preadmission 
and annual resident review), as expeditiously as possible and, effective 
no later than the date described in Sec.  435.1200(i) of this chapter, 
no later than 7 working days after the agency receives a request for 
expedited fair hearing; or
    (ii) For a claim related to services or benefits described in Sec.  
431.220(a)(1) as expeditiously as possible and, effective no later than 
the date described in Sec.  435.1200(i) of this chapter, within the time 
frame in paragraph (f)(2) of this section.
    (iii) For a claim related to services or benefits described in Sec.  
431.220(a)(4), (5) or (6), in accordance with the time frame in 
paragraph (f)(2) of this section.
    (4)(i) The agency must take final administrative action on a fair 
hearing request within the time limits set forth in this paragraph 
except in unusual circumstances when--
    (A) The agency cannot reach a decision because the appellant 
requests a delay or fails to take a required action; or
    (B) There is an administrative or other emergency beyond the 
agency's control.
    (ii) The agency must document the reasons for any delay in the 
appellant's record.
    (g) The public must have access to all agency hearing decisions, 
subject to the requirements of subpart F of this part for safeguarding 
of information.

[44 FR 17932, Mar. 29, 1979, as amended at 67 FR 41095, June 14, 2002; 
81 FR 27853, May 6, 2016; 81 FR 86449, Nov. 30, 2016]



Sec.  431.245  Notifying the applicant or beneficiary of a State agency 
decision.

    The agency must notify the applicant or beneficiary in writing of--
    (a) The decision; and
    (b) His right to request a State agency hearing or seek judicial 
review, to the extent that either is available to him.



Sec.  431.246  Corrective action.

    The agency must promptly make corrective payments, retroactive to 
the date an incorrect action was taken, and, if appropriate, provide for 
admission or readmission of an individual to a facility if--
    (a) The hearing decision is favorable to the applicant or 
beneficiary; or
    (b) The agency decides in the applicant's or beneficiary's favor 
before the hearing.

[57 FR 56506, Nov. 30, 1992]

                     Federal Financial Participation



Sec.  431.250  Federal financial participation.

    FFP is available in expenditures for--
    (a) Payments for services continued pending a hearing decision;
    (b) Payments made--
    (1) To carry out hearing decisions; and
    (2) For services provided within the scope of the Federal Medicaid 
program and made under a court order.
    (c) Payments made to take corrective action prior to a hearing;
    (d) Payments made to extend the benefit of a hearing decision or 
court order to individuals in the same situation as those directly 
affected by the decision or order;
    (e) Retroactive payments under paragraphs (b), (c), and (d) of this 
section in accordance with applicable Federal policies on corrective 
payments; and
    (f) Administrative costs incurred by the agency for--
    (1) Transportation for the applicant or beneficiary, his 
representative, and witnesses to and from the hearing;
    (2) Meeting other expenses of the applicant or beneficiary in 
connection with the hearing;

[[Page 49]]

    (3) Carrying out the hearing procedures, including expenses of 
obtaining the additional medical assessment specified in Sec.  431.240 
of this subpart; and
    (4) Hearing procedures for Medicaid and non-Medicaid individuals 
appealing transfers, discharges and determinations of preadmission 
screening and annual resident reviews under part 483, subparts C and E 
of this chapter.

[44 FR 17932, Mar. 29, 1979, as amended at 45 FR 24882, Apr. 11, 1980; 
57 FR 56506, Nov. 30, 1992]



   Subpart F_Safeguarding Information on Applicants and Beneficiaries

    Source: 44 FR 17934, Mar. 29, 1979, unless otherwise noted.



Sec.  431.300  Basis and purpose.

    (a) Section 1902(a)(7) of the Act requires that a State plan must 
provide safeguards that restrict the use or disclosure of information 
concerning applicants and beneficiaries to purposes directly connected 
with the administration of the plan. This subpart specifies State plan 
requirements, the types of information to be safeguarded, the conditions 
for release of safeguarded information, and restrictions on the 
distribution of other information.
    (b) For purposes of this subpart, information concerning an 
applicant or beneficiary includes information on a non-applicant, as 
defined in Sec.  435.4 of this subchapter.
    (c) Section 1137 of the Act, which requires agencies to exchange 
information to verify the income and eligibility of applicants and 
beneficiaries (see Sec.  435.940 through Sec.  435.965 of this 
subchapter), requires State agencies to have adequate safeguards to 
assure that--
    (1) Information exchanged by the State agencies is made available 
only to the extent necessary to assist in the valid administrative needs 
of the program receiving the information, and information received under 
section 6103(l)(7) of the Internal Revenue Code is exchanged only with 
agencies authorized to receive that information under that section of 
the Code; and
    (2) The information is adequately stored and processed so that it is 
protected against unauthorized disclosure for other purposes.
    (d) Section 1943 of the Act and section 1413 of the Affordable Care 
Act.

[51 FR 7210, Feb. 28, 1986, as amended at 77 FR 17203, Mar. 23, 2012]



Sec.  431.301  State plan requirements.

    A State plan must provide, under a State statute that imposes legal 
sanctions, safeguards meeting the requirements of this subpart that 
restrict the use or disclosure of information concerning applicants and 
beneficiaries to purposes directly connected with the administration of 
the plan.



Sec.  431.302  Purposes directly related to State plan administration.

    Purposes directly related to plan administration include--
    (a) Establishing eligibility;
    (b) Determining the amount of medical assistance;
    (c) Providing services for beneficiaries; and
    (d) Conducting or assisting an investigation, prosecution, or civil 
or criminal proceeding related to the administration of the plan.



Sec.  431.303  State authority for safeguarding information.

    The Medicaid agency must have authority to implement and enforce the 
provisions specified in this subpart for safeguarding information about 
applicants and beneficiaries.



Sec.  431.304  Publicizing safeguarding requirements.

    (a) The agency must publicize provisions governing the confidential 
nature of information about applicants and beneficiaries, including the 
legal sanctions imposed for improper disclosure and use.
    (b) The agency must provide copies of these provisions to applicants 
and beneficiaries and to other persons and agencies to whom information 
is disclosed.



Sec.  431.305  Types of information to be safeguarded.

    (a) The agency must have criteria that govern the types of 
information

[[Page 50]]

about applicants and beneficiaries that are safeguarded.
    (b) This information must include at least--
    (1) Names and addresses;
    (2) Medical services provided;
    (3) Social and economic conditions or circumstances;
    (4) Agency evaluation of personal information;
    (5) Medical data, including diagnosis and past history of disease or 
disability; and
    (6) Any information received for verifying income eligibility and 
amount of medical assistance payments (see Sec.  435.940 through Sec.  
435.965 of this subchapter). Income information received from SSA or the 
Internal Revenue Service must be safeguarded according to the 
requirements of the agency that furnished the data, including section 
6103 of the Internal Revenue Code, as applicable.
    (7) Any information received in connection with the identification 
of legally liable third party resources under Sec.  433.138 of this 
chapter.
    (8) Social Security Numbers.

[44 FR 17934, Mar. 29, 1979, as amended at 51 FR 7210, Feb. 28, 1986; 52 
FR 5975, Feb. 27, 1987; 77 FR 17203, Mar. 23, 2012]



Sec.  431.306  Release of information.

    (a) The agency must have criteria specifying the conditions for 
release and use of information about applicants and beneficiaries.
    (b) Access to information concerning applicants or beneficiaries 
must be restricted to persons or agency representatives who are subject 
to standards of confidentiality that are comparable to those of the 
agency.
    (c) The agency must not publish names of applicants or 
beneficiaries.
    (d) The agency must obtain permission from a family or individual, 
whenever possible, before responding to a request for information from 
an outside source, unless the information is to be used to verify 
income, eligibility and the amount of medical assistance payment under 
section 1137 of this Act and Sec. Sec.  435.940 through 435.965 of this 
chapter.

If, because of an emergency situation, time does not permit obtaining 
consent before release, the agency must notify the family or individual 
immediately after supplying the information.
    (e) The agency's policies must apply to all requests for information 
from outside sources, including governmental bodies, the courts, or law 
enforcement officials.
    (f) If a court issues a subpoena for a case record or for any agency 
representative to testify concerning an applicant or beneficiary, the 
agency must inform the court of the applicable statutory provisions, 
policies, and regulations restricting disclosure of information.
    (g) Before requesting information from, or releasing information to, 
other agencies to verify income, eligibility and the amount of 
assistance under Sec.  435.940 through Sec.  435.965 of this subchapter, 
the agency must execute data exchange agreements with those agencies, as 
specified in Sec.  435.945(i) of this subchapter.
    (h) Before requesting information from, or releasing information to, 
other agencies to identify legally liable third party resources under 
Sec.  433.138(d) of this chapter, the agency must execute data exchanges 
agreements, as specified in Sec.  433.138(h)(2) of this chapter.

[44 FR 17934, Mar. 29, 1979, as amended at 51 FR 7210, Feb. 28, 1986; 52 
FR 5975, Feb. 27, 1987; 77 FR 17203, Mar. 23, 2012]



Sec.  431.307  Distribution of information materials.

    (a) All materials distributed to applicants, beneficiaries, or 
medical providers must--
    (1) Directly relate to the administration of the Medicaid program;
    (2) Have no political implications except to the extent required to 
implement the National Voter Registration Act of 1993 (NVRA) Pub. L. 
103-931; for States that are exempt from the requirements of NVRA, voter 
registration may be a voluntary activity so long as the provisions of 
section 7(a)(5) of NVRA are observed;
    (3) Contain the names only of individuals directly connected with 
the administration of the plan; and
    (4) Identify those individuals only in their official capacity with 
the State or local agency.

[[Page 51]]

    (b) The agency must not distribute materials such as ``holiday'' 
greetings, general public announcements, partisan voting information and 
alien registration notices.
    (c) The agency may distribute materials directly related to the 
health and welfare of applicants and beneficiaries, such as 
announcements of free medical examinations, availability of surplus 
food, and consumer protection information.
    (d) Under NVRA, the agency must distribute voter information and 
registration materials as specified in NVRA.

[44 FR 17934, Mar. 29, 1979, as amended at 61 FR 58143, Nov. 13, 1996]



                  Subpart G_Section 1115 Demonstrations

    Source: 77 FR 11696, Feb. 27, 2012, unless otherwise noted.



Sec.  431.400  Basis and purpose.

    (a) Basis. This subpart implements provisions in section 1115(d) of 
the Act, which requires all of the following:
    (1) The establishment of application requirements for Medicaid and 
CHIP demonstration projects that provide for:
    (i) A process for public notice and comment at the State level, 
including public hearings, sufficient to ensure a meaningful level of 
public input and that does not impose requirements that are in addition 
to, or duplicative of, requirements imposed under the Administrative 
Procedure Act, or requirements that are unreasonable or unnecessarily 
burdensome with respect to State compliance.
    (ii) Requirements relating to all of the following:
    (A) The goals of the program to be implemented or renewed under the 
demonstration project.
    (B) Expected State and Federal costs and coverage projections of the 
State demonstration project.
    (C) Specific plans of the State to ensure the demonstration project 
will be in compliance with titles XIX or XXI of the Act.
    (2) A process for public notice and comment after a demonstration 
application is received by the Secretary that is sufficient to ensure a 
meaningful level of public input.
    (3) A process for the submission of reports to the Secretary by a 
State relating to the implementation of a demonstration project.
    (4) Periodic evaluation of demonstration projects by the Secretary.
    (b) Purpose. This subpart sets forth a process for application and 
review of Medicaid and CHIP demonstration projects that provides for 
transparency and public participation.



Sec.  431.404  Definitions.

    For the purposes of this subpart:
    Demonstration means any experimental, pilot, or demonstration 
project which the Secretary approves under the authority of section 1115 
of the Act because, in the judgment of the Secretary, it is likely to 
assist in promoting the statutory objectives of the Medicaid or CHIP 
program.
    Indian Health Program means a program as defined at section 4(12) of 
the Indian Health Care Improvement Act, (Pub. L. 94-437).
    Public notice means a notice issued by a government agency or 
legislative body that contains sufficient detail to notify the public at 
large of a proposed action, consistent with the provisions of Sec.  
431.408 of this subpart.



Sec.  431.408  State public notice process.

    (a) General. A State must provide at least a 30-day public notice 
and comment period regarding applications for a demonstration project, 
or an extension of an existing demonstration project that the State 
intends to submit to CMS for review and consideration.
    (1) Public notice and comment period. Prior to submitting an 
application to CMS for a new demonstration project or an extension of a 
previously approved demonstration project, the State must provide at 
least a 30-day public notice and comment period, and the public notice 
shall include all of the following information:
    (i) A comprehensive description of the demonstration application or 
extension to be submitted to CMS that contains a sufficient level of 
detail to

[[Page 52]]

ensure meaningful input from the public, including:
    (A) The program description, goals, and objectives to be implemented 
or extended under the demonstration project, including a description of 
the current or new beneficiaries who will be impacted by the 
demonstration.
    (B) To the extent applicable, the proposed health care delivery 
system and the eligibility requirements, benefit coverage and cost 
sharing (premiums, co-payments, and deductibles) required of individuals 
that will be impacted by the demonstration, and how such provisions vary 
from the State's current program features.
    (C) An estimate of the expected increase or decrease in annual 
enrollment, and in annual aggregate expenditures, including historic 
enrollment or budgetary data, if applicable. This includes a financial 
analysis of any changes to the demonstration requested by the State in 
its extension request.
    (D) The hypothesis and evaluation parameters of the demonstration.
    (E) The specific waiver and expenditure authorities that the State 
believes to be necessary to authorize the demonstration.
    (ii) The locations and Internet address where copies of the 
demonstration application are available for public review and comment.
    (iii) Postal and Internet email addresses where written comments may 
be sent and reviewed by the public, and the minimum 30-day time period 
in which comments will be accepted.
    (iv) The location, date, and time of at least two public hearings 
convened by the State to seek public input on the demonstration 
application.
    (2) Statement of public notice and public input procedures. (i) The 
State shall publish its public notice process, public input process, 
planned hearings, the demonstration application(s), and a link to the 
relevant Medicaid demonstration page(s) on the CMS Web site in a 
prominent location on either the main page of the public Web site of the 
State agency responsible for making applications for demonstrations or 
on a demonstration-specific Web page that is linked in a readily 
identifiable way to the main page of the State agency's Web site. The 
State must maintain and keep current the public Web site throughout the 
entire public comment and review process.
    (ii) The State shall also publish an abbreviated public notice which 
must include a summary description of the demonstration, the location 
and times of the two or more public hearings, and an active link to the 
full public notice document on the State's Web site in the State's 
administrative record in accordance with the State's Administrative 
Procedure Act, provided that such notice is provided at least 30 days 
prior to the submission of the demonstration application to CMS or in 
the newspapers of widest circulation in each city with a population of 
100,000, or more, provided that such notice is provided at least 30 days 
prior to the submission of the demonstration application to CMS, or 
both.
    (iii) The State must also utilize additional mechanisms, such as an 
electronic mailing list, to notify interested parties of the 
demonstration application(s).
    (3) Public hearings. At least 20 days prior to submitting an 
application for a new demonstration project or extension of an existing 
demonstration project to CMS for review, the State must have conducted 
at least two public hearings, on separate dates and at separate 
locations, regarding the State's demonstration application at which 
members of the public throughout the State have an opportunity to 
provide comments. The State must use telephonic and/or Web conference 
capabilities for at least one of the two required public hearings to 
ensure statewide accessibility to the public hearing unless it can 
document it has afforded the public throughout the State the opportunity 
to provide comment, such as holding the two public hearings in 
geographically distinct areas of the State. The State must use at least 
two of the following public forums:
    (i) The Medical Care Advisory Committee that operates in accordance 
with Sec.  431.12 of this subpart; or
    (ii) A commission or other similar process, where meetings are open 
to members of the public; or
    (iii) A State legislative process, which would afford an interested 
party

[[Page 53]]

the opportunity to learn about the contents of the demonstration 
application, and to comment on its contents; or
    (iv) Any other similar process for public input that would afford an 
interested party the opportunity to learn about the contents of the 
demonstration application, and to comment on its contents.
    (b) Tribal consultation and seeking advice from Indian health 
providers and urban Indian organizations. A State with Federally-
recognized Indian tribes, Indian health programs, and/or urban Indian 
health organizations shall include a process to consult with the Indian 
tribes, and seek advice from Indian Health programs and urban Indian 
health organizations in the State, prior to submission of an application 
to CMS for a new demonstration project, or an extension of a previously 
approved demonstration project, that has or would have a direct effect 
on Indians, tribes, on Indian health programs, or on urban Indian health 
organizations.
    (1) For initial applications and applications extending existing 
demonstration projects that have a direct effect on Indians, tribes, 
Indian health programs, and urban Indian health organizations in the 
State, the State must demonstrate that it has conducted consultation 
activities with tribes and sought advice from Indian health programs and 
urban Indian health organizations prior to submission of such 
application.
    (2) Consultation with Federally-recognized Indian tribes and 
solicitation of advice from affected Indian health providers and urban 
Indian organizations must be conducted in accordance with the 
consultation process outlined in the July 17, 2001 letter or the State's 
formal tribal consultation agreement or process and the process for 
seeking advice from Indian Health providers must be conducted as 
outlined in the State's approved Medicaid State Plan.
    (3) Documentation of the State's consultation activities must be 
included in the demonstration application, which must describe the 
notification process, the entities involved in the consultation(s), the 
date(s) and location(s) of the consultation(s), issues raised, and the 
potential resolution for such issues.



Sec.  431.412  Application procedures.

    (a) Initial demonstration application content. (1) Applications for 
initial approval of a demonstration will not be considered complete 
unless they comply with the public notice process set forth in Sec.  
431.408(a) of this subpart, and include the following:
    (i) A comprehensive program description of the demonstration, 
including the goals and objectives to be implemented under the 
demonstration project.
    (ii) A description of the proposed health care delivery system, 
eligibility requirements, benefit coverage and cost sharing (premiums, 
copayments, and deductibles) required of individuals who will be 
impacted by the demonstration to the extent such provisions would vary 
from the State's current program features and the requirements of the 
Act.
    (iii) An estimate of the expected increase or decrease in annual 
enrollment, and in annual aggregate expenditures, including historic 
enrollment or budgetary data, if applicable.
    (iv) Current enrollment data, if applicable, and enrollment 
projections expected over the term of the demonstration for each 
category of beneficiary whose health care coverage is impacted by the 
demonstration.
    (v) Other program features that the demonstration would modify in 
the State's Medicaid and CHIP programs.
    (vi) The specific waiver and expenditure authorities that the State 
believes to be necessary to authorize the demonstration.
    (vii) The research hypotheses that are related to the 
demonstration's proposed changes, goals, and objectives, a plan for 
testing the hypotheses in the context of an evaluation, and, if a 
quantitative evaluation design is feasible, the identification of 
appropriate evaluation indicators.
    (viii) Written documentation of the State's compliance with the 
public notice requirements set forth in Sec.  431.408 of this subpart, 
with a report of the issues raised by the public during the comment 
period, which shall be no less than 30 days, and how the State 
considered those comments when developing the demonstration application.

[[Page 54]]

    (2) CMS may request, or the State may propose application 
modifications, as well as additional information to aid in the review of 
the application. If an application modification substantially changes 
the original demonstration design, CMS may, at its discretion, direct an 
additional 30-day public comment period.
    (3) This section does not preclude a State from submitting to CMS a 
pre-application concept paper or from conferring with CMS about its 
intent to seek a demonstration prior to submitting a completed 
application.
    (b) Demonstration application procedures. A State application for 
approval of a new demonstration project or an extension of an existing 
demonstration project must be submitted to CMS as both printed and 
electronic documents. Electronic documents must be submitted in a format 
that will be accessible to individuals with disabilities.
    (1) Consistent with Sec.  431.416(a) of this subpart, within 15 days 
of receipt of a complete application, CMS will send the State a written 
notice informing the State of receipt of the submitted application, the 
date in which the Secretary received the State's demonstration 
application and the start date of the 30-day Federal public notice 
process set forth in Sec.  431.416 of this subpart. The written notice--
    (i) Is provided for purposes of initiating the Federal-level public 
comment period and does not preclude a determination that, based on 
further review, further information is required to supplement or support 
the application, or that the application cannot be approved because a 
required element is missing or insufficient.
    (ii) Does not prevent a State from modifying its application or 
submitting any supplementary information it determines necessary to 
support CMS' review of its application.
    (2) Within 15 days of receipt of a demonstration application that 
CMS determines is incomplete, CMS will send the State a written notice 
of the elements missing from the application.
    (3) CMS will publish on its Web site at regular intervals the status 
of all State submissions, including information received from the State 
while the State works with CMS to meet the demonstration application 
process set forth in this section.
    (c) Demonstration extension request. A request to extend an existing 
demonstration under sections 1115(a), (e), and (f) of the Act will be 
considered only if it is submitted at least 12 months prior to the 
expiration date of the demonstration when requesting an extension under 
section 1115(e) of the Act or 6 months prior to the expiration date of 
the demonstration when requesting an extension under section 1115(a) or 
(f) of the Act, unless a longer time frame is specified in the Special 
Terms and Conditions for the original demonstration. An extension 
application, including an extension for the purpose of phasing out a 
demonstration, must be sent from the Governor of the State to the 
Secretary.
    (1) Changes to existing demonstration. If an extension application 
includes substantial changes to the existing demonstration, CMS may, at 
its discretion, treat the application as an application for a new 
demonstration.
    (2) Demonstration extension application. An application to extend an 
existing demonstration will be considered complete, for purposes of 
initiating the Federal-level public notice period, when the State 
provides the following:
    (i) A historical narrative summary of the demonstration project, 
which includes the objectives set forth at the time the demonstration 
was approved, evidence of how these objectives have or have not been 
met, and the future goals of the program.
    (ii) If changes are requested, a narrative of the changes being 
requested along with the objective of the change and the desired 
outcomes.
    (iii) A list and programmatic description of the waivers and 
expenditure authorities that are being requested for the extension 
period, or a statement that the State is requesting the same waiver and 
expenditure authorities as those approved in the current demonstration.
    (iv) Summaries of External Quality Review Organization (EQRO) 
reports, managed care organization (MCO) and State quality assurance 
monitoring, and any other documentation of the quality of and access to 
care provided

[[Page 55]]

under the demonstration, such as the CMS Form 416 EPSDT/CHIP report.
    (v) Financial data demonstrating the State's historical and 
projected expenditures for the requested period of the extension, as 
well as cumulatively over the lifetime of the demonstration. This 
includes a financial analysis of changes to the demonstration requested 
by the State.
    (vi) An evaluation report of the demonstration, inclusive of 
evaluation activities and findings to date, plans for evaluation 
activities during the extension period, and if changes are requested, 
identification of research hypotheses related to the changes and an 
evaluation design for addressing the proposed revisions.
    (vii) Documentation of the State's compliance with the public notice 
process set forth in Sec.  431.408 of this subpart, including the post-
award public input process described in Sec.  431.420(c) of this 
subpart, with a report of the issues raised by the public during the 
comment period and how the State considered the comments when developing 
the demonstration extension application.
    (3) CMS may request, or the State may propose application 
modifications, as well as additional information to aid in the review of 
an application to extend a demonstration. If an application modification 
substantially changes the original demonstration design, CMS may, at its 
discretion, direct an additional 30-day public comment period.
    (4) Upon application from the State, the Secretary may extend 
existing demonstration projects on a temporary basis for the period 
during which a successor demonstration is under review, without regard 
to the date when the application was submitted.
    (d) Approvals. Approval of a new demonstration or a demonstration 
extension will generally be prospective only and Federal Financial 
Participation (FFP) will not be available for changes to the 
demonstration that have not been approved by CMS.



Sec.  431.416  Federal public notice and approval process.

    (a) General. Within 15 days of receipt of a complete application 
from the State for a new demonstration project or an extension of a 
previously approved demonstration project, CMS will:
    (1) Send the State a written notice informing the State of receipt 
of the demonstration application, the date in which the Secretary 
received the State's demonstration application, the start dates of the 
30-day Federal public notice process, and the end date of the 45-day 
minimum Federal decision-making period.
    (2) Publish the written notice acknowledging receipt of the State's 
completed application on its Web site within the same 15-day timeframe.
    (b) Public comment period. Upon notifying a State of a completed 
application, CMS will solicit public comment regarding such 
demonstration application for 30 days by doing the following:
    (1) Publishing the following on the CMS Web site:
    (i) The written notice of CMS receipt of the State's complete 
demonstration application.
    (ii) Demonstration applications, including supporting information 
submitted by the State as part of the complete application, and 
associated concept papers, as applicable.
    (iii) The proposed effective date of the demonstration.
    (iv) Addresses to which inquiries and comments from the public may 
be directed to CMS by mail or email.
    (2) Notifying interested parties through a mechanism, such an 
electronic mailing list, that CMS will create for this purpose.
    (c) Public disclosure. CMS will publish on its Web site, at regular 
intervals, appropriate information, which may include, but is not 
limited to the following:
    (1) Relevant status update(s);
    (2) A listing of the issues raised through the public notice 
process.
    (d) Publishing of comments. (1) CMS will publish written comments 
electronically through its Web site or an alternative Web site.
    (2) CMS will review and consider all comments received by the 
deadline, but will not provide written responses to public comments. 
While comments may be submitted after the deadline, CMS cannot assure 
that these comments will be considered.

[[Page 56]]

    (e) Approval of a demonstration application. (1) CMS will not render 
a final decision on a demonstration application until at least 45 days 
after notice of receipt of a completed application, to receive and 
consider public comments.
    (2) CMS may expedite this process under the exception to the normal 
public notice process provisions in Sec.  431.416(g) of this subpart.
    (f) Administrative record. (1) CMS will maintain, and publish on its 
public Web site, an administrative record that may include, but is not 
limited to the following:
    (i) The demonstration application from the State.
    (ii) The State's disaster exemption request and CMS' response, if 
applicable.
    (iii) Written public comments sent to the CMS and any CMS responses.
    (iv) If an application is approved, the final special terms and 
conditions, waivers, expenditure authorities, and award letter sent to 
the State.
    (v) If an application is denied, the disapproval letter sent to the 
State.
    (vi) The State acceptance letter, as applicable.
    (vii) Specific requirements related to the approved and agreed upon 
terms and conditions, such as implementation reviews, evaluation design, 
quarterly progress reports, annual reports, and interim and/or final 
evaluation reports.
    (viii) Notice of the demonstration's suspension or termination, if 
applicable.
    (2) To ensure that the public has access to all documentation 
related to the demonstration project, including the aforementioned 
items, we will also provide a link to the State's public Web site.
    (g) Exemption from the normal public notice process. (1) CMS may 
waive, in whole or in part, the Federal and State public notice 
procedures to expedite a decision on a proposed demonstration or 
demonstration extension request that addresses a natural disaster, 
public health emergency, or other sudden emergency threats to human 
lives.
    (2) The Secretary may exempt a State from the normal public notice 
process or the required time constraints imposed in this section or 
Sec.  431.408(a) of this subpart when the State demonstrates to CMS the 
existence of unforeseen circumstances resulting from a natural disaster, 
public health emergency, or other sudden emergency that directly 
threatens human lives that warrant an exception to the normal public 
notice process.
    (i) The State is expected to discharge its basic responsibilities in 
submitting demonstration applications to the Secretary as required in 
Sec.  431.412 of this subpart.
    (ii) Such applications will be posted on the CMS Web site.
    (3) A State must establish (or meet) all of the following criteria 
to obtain such an exemption from the normal public notice process 
requirements:
    (i) The State acted in good faith, and in a diligent, timely, and 
prudent manner.
    (ii) The circumstances constitute an emergency and could not have 
been reasonably foreseen.
    (iii) Delay would undermine or compromise the purpose of the 
demonstration and be contrary to the interests of beneficiaries.
    (4) CMS will publish on its Web site any disaster exemption 
determinations within 15 days of approval, as well as the revised 
timeline for public comment or post-award processes, if applicable.



Sec.  431.420  Monitoring and compliance.

    (a) General. (1) Any provision of the Social Security Act that is 
not expressly waived by CMS in its approval of the demonstration project 
are not waived, and States may not stop compliance with any of these 
provisions not expressly waived. Waivers may be limited in scope to the 
extent necessary to achieve a particular purpose or to the extent of a 
particular regulatory requirement implementing the statutory provision.
    (2) States must comply with the terms and conditions of the 
agreement between the Secretary and the State to implement a State 
demonstration project.
    (b) Implementation reviews. (1) The terms and conditions will 
provide that the State will perform periodic reviews

[[Page 57]]

of the implementation of the demonstration.
    (2) CMS will review documented complaints that a State is failing to 
comply with requirements specified in the special terms and conditions 
and implementing waivers of any approved demonstration.
    (3) CMS will promptly share with the State complaints that CMS has 
received and will also provide notification of any applicable monitoring 
and compliance issues.
    (c) Post award. Within 6 months after the implementation date of the 
demonstration and annually thereafter, the State must hold a public 
forum--
    (1) To solicit comments on the progress of a demonstration project.
    (2) At which members of the public have an opportunity to provide 
comments and in such time as to include a summary of the forum in the 
quarterly report associated with the quarter in which the forum was 
held, as well as in its annual report to CMS.
    (3) The public forum to solicit feedback on the progress of a 
demonstration project must occur using one of the following:
    (i) A Medical Care Advisory Committee that operates in accordance 
with Sec.  431.412 of this subpart.
    (ii) A commission or other similar process, where meetings are open 
to members of the public, and would afford an interested party the 
opportunity to learn about the demonstration's progress.
    (iii) The State must publish the date, time, and location of the 
public forum in a prominent location on the State's public Web site, at 
least 30 days prior to the date of the planned public forum.
    (4) [Reserved]
    (d) Terminations and suspensions. (1) The Secretary may suspend or 
terminate a demonstration in whole or in part, any time before the date 
of expiration, whenever it determines that the State has materially 
failed to comply with the terms of the demonstration project.
    (2) The Secretary may also withdraw waivers or expenditure 
authorities based on a finding that the demonstration project is not 
likely to achieve the statutory purposes.
    (3) The terms and conditions for the demonstration will detail any 
notice and appeal rights for the State for a termination, suspension or 
withdrawal of waivers or expenditure authorities.
    (e) Closeout costs. When a demonstration is terminated, suspended, 
or if waivers or expenditure authority are withdrawn, Federal funding is 
limited to normal closeout costs associated with an orderly termination 
of the demonstration or expenditure authority, including service costs 
during any approved transition period, and administrative costs of 
disenrolling participants.
    (f) Federal evaluators. (1) The State must fully cooperate with CMS 
or an independent evaluator selected by CMS to undertake an independent 
evaluation of any component of the demonstration.
    (2) The State must submit all requested data and information to CMS 
or the independent evaluator.



Sec.  431.424  Evaluation requirements.

    (a) General. States are permitted and encouraged to use a range of 
appropriate evaluation strategies (including experimental and other 
quantitative and qualitative designs) in the application of evaluation 
techniques with the approval of CMS.
    (b) Demonstration evaluations. Demonstration evaluations will 
include the following:
    (1) Quantitative research methods. (i) These methods involve the 
empirical investigation of the impact of key programmatic features of 
the demonstration.
    (ii) CMS will consider alternative evaluation designs when 
quantitative designs are technically infeasible or not well suited to 
the change made by the demonstration.
    (2) Approaches that minimize beneficiary impact. The evaluation 
process must minimize burden on beneficiaries and protect their privacy 
in terms of implementing and operating the policy approach to be 
demonstrated while ensuring the impact of the demonstration is measured.
    (c) Evaluation design plan. (1) The State will submit and receive 
CMS approval of a design for an evaluation of the demonstration project 
and publish

[[Page 58]]

this document to the State's public Web site within 30 days of CMS 
approval.
    (2) The draft demonstration evaluation design must include all of 
the following:
    (i) A discussion of the demonstration hypotheses that are being 
tested including monitoring and reporting on the progress towards the 
expected outcomes.
    (ii) The data that will be utilized and the baseline value for each 
measure.
    (iii) The methods of data collection.
    (iv) A description of how the effects of the demonstration will be 
isolated from those other changes occurring in the State at the same 
time through the use of comparison or control groups to identify the 
impact of significant aspects of the demonstration.
    (v) A proposed date by which a final report on findings from 
evaluation activities conducted under the evaluation plan must be 
submitted to CMS.
    (vi) Any other information pertinent to the State's research on the 
policy operations of the demonstration operations.
    (d) Evaluations for demonstration extensions. (1) In the event that 
the State requests to extend the demonstration beyond the current 
approval period under the authority of section 1115(a), (e), or (f) of 
the Act, the State must submit an interim evaluation report as part of 
the State's request for a subsequent renewal of the demonstration.
    (2) State evaluations must be published on the State's public Web 
site within 30 days of submission to CMS.
    (e) Approved evaluation designs. The State must publish the CMS-
approved demonstration evaluation design on the State's public Web site 
within 30 days of CMS approval.
    (f) Federal evaluations. The State must comply with all requirements 
set forth in this subpart.
    (g) Federal public notice. CMS will post, or provide a link to the 
State's public Web site, all evaluation materials, including research 
and data collection, on its Web site for purposes of sharing findings 
with the public within 30 days of receipt of materials.



Sec.  431.428  Reporting requirements.

    (a) Annual reports. The State must submit an annual report to CMS 
documenting all of the following:
    (1) Any policy or administrative difficulties in the operation of 
the demonstration.
    (2) The status of the health care delivery system under the 
demonstration with respect to issues and/or complaints identified by 
beneficiaries.
    (3) The impact of the demonstration in providing insurance coverage 
to beneficiaries and uninsured populations.
    (4) Outcomes of care, quality of care, cost of care and access to 
care for demonstration populations.
    (5) The results of beneficiary satisfaction surveys, if conducted 
during the reporting year, grievances and appeals.
    (6) The existence or results of any audits, investigations or 
lawsuits that impact the demonstration.
    (7) The financial performance of the demonstration.
    (8) The status of the evaluation and information regarding progress 
in achieving demonstration evaluation criteria.
    (9) Any State legislative developments that may impact the 
demonstration.
    (10) The results/impact of any demonstration programmatic area 
defined by CMS that is unique to the demonstration design or evaluation 
hypothesis.
    (11) A summary of the annual post-award public forum, including all 
public comments received regarding the progress of the demonstration 
project.
    (b) Submitting and publishing annual reports. States must submit a 
draft annual report to CMS no later than 90 days after the end of each 
demonstration year, or as specified in the demonstration's STCs. The 
State must publish its draft annual report on its public Web site within 
30 days of submission to CMS.
    (1) Within 60 days of receipt of comments from CMS, the State must 
submit to CMS the final annual report for the demonstration year.
    (2) The final annual report is to be published on the State's public 
Web site within 30 days of approval by CMS.

[[Page 59]]

Subparts H-L [Reserved]



                 Subpart M_Relations With Other Agencies



Sec.  431.610  Relations with standard-setting and survey agencies.

    (a) Basis and purpose. This section implements--
    (1) Section 1902(a)(9) of the Act, concerning the designation of 
State authorities to be responsible for establishing and maintaining 
health and other standards for institutions participating in Medicaid; 
and
    (2) Section 1902(a)(33) of the Act, concerning the designation of 
the State licensing agency to be responsible for determining whether 
institutions and agencies meet requirements for participation in the 
State's Medicaid program.
    (3) Section 1919(g)(1)(A) of the Act, concerning responsibilities of 
the State for certifying the compliance of non-State operated NFs with 
requirements of participation in the State's Medicaid program.
    (b) Designated agency responsible for health standards. A State plan 
must designate, as the State authority responsible for establishing and 
maintaining health standards for private or public institutions that 
provide services to Medicaid beneficiaries, the same State agency that 
is used by the Secretary to determine qualifications of institutions and 
suppliers of services to participate in Medicare (see 42 CFR 405.1902). 
The requirement for establishing and maintaining standards does not 
apply with respect to religious nonmedical institutions as defined in 
Sec.  440.170(b) of this chapter.
    (c) Designated agency responsible for standards other than health 
standards. The plan must designate the Medicaid agency or other 
appropriate State authority or authorities to be responsible for 
establishing and maintaining standards, other than those relating to 
health, for private or public institutions that provide services to 
Medicaid beneficiaries.
    (d) Description and retention of standards. (1) The plan must 
describe the standards established under paragraphs (b) and (c) of this 
section.
    (2) The plan must provide that the Medicaid agency keeps these 
standards on file and makes them available to the Administrator upon 
request.
    (e) Designation of survey agency. The plan must provide that--
    (1) The agency designated in paragraph (b) of this section, or 
another State agency responsible for licensing health institutions in 
the State, determines for the Medicaid agency whether institutions and 
agencies meet the requirements for participation in the Medicaid 
program; and
    (2) The agency staff making the determination under paragraph (e)(1) 
of this section is the same staff responsible for making similar 
determinations for institutions or agencies participating under 
Medicare; and
    (3) The agency designated in paragraph (e)(1) of this section makes 
recommendations regarding the effective dates of provider agreements, as 
determined under Sec.  431.108.
    (f) Written agreement required. The plan must provide for a written 
agreement (or formal written intra-agency arrangement) between the 
Medicaid agency and the survey agency designated under paragraph (e) of 
this section, covering the activities of the survey agency in carrying 
out its responsibilities. The agreement must specify that--
    (1) Federal requirements and the forms, methods and procedures that 
the Administrator designates will be used to determine provider 
eligibility and certification under Medicaid;
    (2) Inspectors surveying the premises of a provider will--
    (i) Complete inspection reports;
    (ii) Note on completed reports whether or not each requirement for 
which an inspection is made is satisfied; and
    (iii) Document deficiencies in reports;
    (3) The survey agency will keep on file all information and reports 
used in determining whether participating facilities meet Federal 
requirements; and
    (4) The survey agency will make the information and reports required 
under paragraph (f)(3) of this section readily accessible to HHS and the 
Medicaid agency as necessary--
    (i) For meeting other requirements under the plan; and

[[Page 60]]

    (ii) For purposes consistent with the Medicaid agency's effective 
administration of the program.
    (g) Responsibilities of survey agency. The plan must provide that, 
in certifying NFs, HHAs, and ICF-IIDs, the survey agency designated 
under paragraph (e) of this section will --
    (1) Review and evaluate medical and independent professional review 
team reports obtained under part 456 of this subchapter as they relate 
to health and safety requirements;
    (2) Have qualified personnel perform on-site inspections 
periodically as appropriate based on the timeframes in the correction 
plan and--
    (i) At least once during each certification period or more 
frequently if there is a compliance question; and
    (ii) For non-State operated NFs, within the timeframes specified in 
Sec.  488.308 of this chapter.
    (3) Have qualified personnel perform on-site inspections--
    (i) At least once during each certification period or more 
frequently if there is a compliance question; and
    (ii) For intermediate care facilities with deficiencies as described 
in Sec. Sec.  442.112 and 442.113 of this subchapter, within 6 months 
after initial correction plan approval and every 6 months thereafter as 
required under those sections.
    (h) FFP for survey responsibilities. (1) FFP is available in 
expenditures that the survey agency makes to carry out its survey and 
certification responsibilities under the agreement specified in 
paragraph (f) of this section.
    (2) FFP is not available in any expenditures that the survey agency 
makes that are attributable to the State's overall responsibilities 
under State law and regulations for establishing and maintaining 
standards.

[43 FR 45188, Sept. 29, 1978, as amended at 45 FR 24883, Apr. 11, 1980; 
53 FR 20494, June 3, 1988; 57 FR 43923, Sept. 23, 1992; 59 FR 56233, 
Nov. 10, 1994; 62 FR 43936, Aug. 18, 1997; 64 FR 67052, Nov. 30, 1999; 
78 FR 72320, Dec. 2, 2013]



Sec.  431.615  Relations with State health and vocational rehabilitation
agencies and title V grantees.

    (a) Basis and purpose. This section implements section 1902(a)(11) 
and (22)(C) of the Act, by setting forth State plan requirements for 
arrangements and agreements between the Medicaid agency and--
    (1) State health agencies;
    (2) State vocational rehabilitation agencies; and
    (3) Grantees under title V of the Act, Maternal and Child Health and 
Crippled Children's Services.
    (b) Definitions. For purposes of this section--
    ``Title V grantee'' means the agency, institution, or organization 
receiving Federal payments for part or all of the cost of any service 
program or project authorized by title V of the Act, including--
    (1) Maternal and child health services;
    (2) Crippled children's services;
    (3) Maternal and infant care projects;
    (4) Children and youth projects; and
    (5) Projects for the dental health of children.
    (c) State plan requirements. A state plan must--
    (1) Describe cooperative arrangements with the State agencies that 
administer, or supervise the administration of, health services and 
vocational rehabilitation services designed to make maximum use of these 
services;
    (2) Provide for arrangements with title V grantees, under which the 
Medicaid agency will utilize the grantee to furnish services that are 
included in the State plan;
    (3) Provide that all arrangements under this section meet the 
requirements of paragraph (d) of this section; and
    (4) Provide, if requested by the title V grantee in accordance with 
the arrangements made under this section, that the Medicaid agency 
reimburse the grantee or the provider for the cost of services furnished 
beneficiaries by or through the grantee.
    (d) Content of arrangements. The arrangements referred to in 
paragraph (c) must specify, as appropriate--
    (1) The mutual objectives and responsibilities or each party to the 
arrangement;
    (2) The services each party offers and in what circumstances;
    (3) The cooperative and collaborative relationships at the State 
level;

[[Page 61]]

    (4) The kinds of services to be provided by local agencies; and
    (5) Methods for--
    (i) Early identification of individuals under 21 in need of medical 
or remedial services;
    (ii) Reciprocal referrals;
    (iii) Coordinating plans for health services provided or arranged 
for beneficiaries;
    (iv) Payment or reimbursement;
    (v) Exchange of reports of services furnished to beneficiaries;
    (vi) Periodic review and joint planning for changes in the 
agreements;
    (vii) Continuous liaison between the parties, including designation 
of State and local liaison staff; and
    (viii) Joint evaluation of policies that affect the cooperative work 
of the parties.
    (e) Federal financial participation. FFP is available in 
expenditures for Medicaid services provided to beneficiaries through an 
arrangement under this section.



Sec.  431.620  Agreement with State mental health authority or mental
institutions.

    (a) Basis and purpose. This section implements section 
1902(a)(20)(A) of the Act, for States offering Medicaid services in 
institutions for mental diseases for beneficiaries aged 65 or older, by 
specifying the terms of the agreement those States must have with other 
State authorities and institutions. (See part 441, subpart C of this 
chapter for regulations implementing section 1902(a)(20) (B) and (C).)
    (b) Definition. For purposes of this section, an ``institution for 
mental diseases'' means an institution primarily engaged in providing 
diagnosis, treatment, or care of persons with mental diseases. This 
includes medical attention, nursing care, and related services.
    (c) State plan requirement. A State plan that includes Medicaid for 
persons aged 65 or older in institutions for mental diseases must 
provide that the Medicaid agency has in effect a written agreement 
with--
    (1) The State authority or authorities concerned with mental 
diseases; and
    (2) Any institution for mental diseases that is not under the 
jurisdiction of those State authorities, and that provides services 
under Medicaid to beneficiaries aged 65 or older.
    (d) Provisions required in an agreement. The agreement must specify 
the respective responsibilities of the agency and the authority or 
institution, including arrangements for--
    (1) Joint planning between the parties to the agreement;
    (2) Development of alternative methods of care;
    (3) Immediate readmission to an institution when needed by a 
beneficiary who is in alternative care;
    (4) Access by the agency to the institution, the beneficiary, and 
the beneficiary's records when necessary to carry out the agency's 
responsibilities;
    (5) Recording, reporting, and exchanging medical and social 
information about beneficiaries; and
    (6) Other procedures needed to carry out the agreement.

[44 FR 17935, Mar. 23, 1979]



Sec.  431.621  State requirements with respect to nursing facilities.

    (a) Basis and purpose. This section implements sections 
1919(b)(3)(F) and 1919(e)(7) of the Act by specifying the terms of the 
agreement the State must have with the State mental health and 
Intellectual Disability authorities concerning the operation of the 
State's preadmission screening and annual resident review (PASARR) 
program.
    (b) State plan requirement. The State plan must provide that the 
Medicaid agency has in effect a written agreement with the State mental 
health and Intellectual Disability authorities that meets the 
requirements specified in paragraph (c) of this section.
    (c) Provisions required in an agreement. The agreement must specify 
the respective responsibilities of the agency and the State mental 
health and Intellectual Disability authorities, including arrangements 
for--(1) Joint planning between the parties to the agreement;
    (2) Access by the agency to the State mental health and Intellectual 
Disability authorities' records when necessary to carry out the agency's 
responsibilities;

[[Page 62]]

    (3) Recording, reporting, and exchanging medical and social 
information about individuals subject to PASARR;
    (4) Ensuring that preadmission screenings and annual resident 
reviews are performed timely in accordance with Sec. Sec.  483.112(c) 
and 483.114(c) of this part;
    (5) Ensuring that, if the State mental health and Intellectual 
Disability authorities delegate their respective responsibilities, these 
delegations comply with Sec.  483.106(e) of this part;
    (6) Ensuring that PASARR determinations made by the State mental 
health and Intellectual Disability authorities are not countermanded by 
the State Medicaid agency, except through the appeals process, but that 
the State mental health and Intellectual Disability authorities do not 
use criteria which are inconsistent with those adopted by the State 
Medicaid agency under its approved State plan;
    (7) Designating the independent person or entity who performs the 
PASARR evaluations for individuals with MI; and
    (8) Ensuring that all requirements of Sec. Sec.  483.100 through 
483.136 are met.

[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993]



Sec.  431.625  Coordination of Medicaid with Medicare part B.

    (a) Basis and purpose. (1) Section 1843(a) of the Act requires the 
Secretary to have entered into an agreement with any State that 
requested that agreement before January 1, 1970, or during calendar year 
1981, under which the State could enroll certain Medicare-eligible 
beneficiaries under Medicare Part B and agree to pay their premiums.
    (2) Section 1902(a)(10) of the Act (in clause (II) following 
subparagraph (D)), allows the State to pay the premium, deductibles, 
cost sharing, and other charges for beneficiaries enrolled under 
Medicare Part B without obligating itself to provide the range of Part B 
benefits to other beneficiaries; and
    (3) Section 1903 (a)(1) and (b) of the Act authorizes FFP for State 
payment of Medicare Part B premiums for certain beneficiaries.
    (4) This section--
    (i) Specifies the exception, relating to Part B coverage, from the 
requirement to provide comparable services to all beneficiaries; and
    (ii) Prescribes FFP rules concerning State payment for Medicare 
premiums and for services that could have been covered under Medicare.
    (5) Section 1902(a)(15) of the Act requires that if a State chooses 
to pay only a portion of deductibles, cost sharing or other charges for 
beneficiaries enrolled under Medicare Part B, the portion that is to be 
paid by a Medicaid beneficiary must be reasonably related to the 
beneficiary's income and resources.
    (b) Exception from obligation to provide comparable services; State 
plan requirement. (1) The State's payment of premiums, deductibles, cost 
sharing, or similar charges under Part B does not obligate it to provide 
the full range of Part B services to beneficiaries not covered by 
Medicare.
    (2) The State plan must specify this exception if it applies.
    (c) Effect of payment of premiums on State liability for cost 
sharing. (1) State payment of Part B premiums on behalf of a Medicaid 
beneficiary does not obligate it to pay on the beneficiary's behalf the 
Part B deductible and coinsurance amounts for those Medicare Part B 
services not covered in the Medicaid State plan.
    (2) If a State pays on a beneficiary's behalf any portion of the 
deductible or cost sharing amounts under Medicare Part B, the portion 
paid by a State must be reasonably related to the beneficiary's income 
and resources.
    (d) Federal financial participation: Medicare Part B premiums--(1) 
Basic rule. Except as provided in paragraph (d)(2) of this section, FFP 
is not available in State expenditures for Medicare Part B premiums for 
Medicaid beneficiaries unless the beneficiaries receive money payments 
under title I, IV-A, X, XIV, XVI (AABD or SSI) of the Act, or State 
supplements as permitted under section 1616(a) of the Act, or as 
required by section 212 of Pub. L. 93-66.
    (2) Exception. FFP is available in expenditures for Medicare Part B 
premiums for the following groups:

[[Page 63]]

    (i) AFDC families required to be covered under Sec. Sec.  435.112 
and 436.116 of this subchapter, those eligible for continued Medicaid 
coverage despite increased income from employment;
    (ii) Beneficiaries required to be covered under Sec. Sec.  435.114, 
435.134, and 436.112 of this subchapter, those eligible for continued 
Medicaid coverage despite increased income from monthly insurance 
benefits under title II of the Act;
    (iii) Beneficiaries required to be covered under Sec.  435.135 of 
this subchapter, those eligible for continued Medicaid coverage despite 
increased income from cost-of-living increases under title II of the 
Act;
    (iv) Beneficiaries of foster care maintenance payments or adoption 
assistance payments who, under Part E of title IV of the Act are 
considered as receiving AFDC;
    (v) Individuals required to be covered under Sec.  435.120 of this 
chapter, that is, blind or disabled individuals who, under section 
1619(b) of the Act, are considered to be receiving SSI;
    (vi) Individuals who, in accordance with Sec. Sec.  435.115 and 
436.114 of this chapter are, for purposes of Medicaid eligibility, 
considered to be receiving AFDC. These are participants in a work 
supplementation program, or individuals denied AFDC because the payment 
would be less than $10;
    (vii) Certain beneficiaries of Veterans Administration pensions 
during the limited time they are, under section 310(b) of Pub. L. 96-
272, considered as receiving SSI, mandatory State supplements, or AFDC;
    (viii) Disabled children living at home to whom the State provides 
Medicaid under section 1902(e)(3) of the Act;
    (ix) Individuals who become ineligible for AFDC because of the 
collection or increased collection of child or spousal support, but, in 
accordance with section 406(h) of the Act, remain eligible for Medicaid 
for four more months; and
    (x) Individuals who become ineligible for AFDC because they are no 
longer eligible for the disregard of earnings of $30 or of $30 plus one-
third of the remainder, but, in accordance with section 402(a)(37) of 
the Act, are considered as receiving AFDC for a period of 9 to 15 
months.
    (3) No FFP is available in State Medicaid expenditures that could 
have been paid for under Medicare Part B but were not because the person 
was not enrolled in Part B. This limit applies to all beneficiaries 
eligible for enrollment under Part B, whether individually or through an 
agreement under section 1843(a) of the Act. However, FFP is available in 
expenditures required by Sec. Sec.  435.914 and 436.901 of this 
subchapter for retroactive coverage of beneficiaries.

[43 FR 45188, Sept. 29, 1978, as amended at 44 FR 17935, Mar. 23, 1979; 
52 FR 47933, Dec. 17, 1987; 53 FR 657, Jan. 11, 1988]



Sec.  431.630  Coordination of Medicaid with QIOs.

    (a) The State plan may provide for the review of Medicaid services 
through a contract with a QIO designated under part 462 of this chapter. 
Medicaid requirements for medical and utilization review are deemed to 
be met for those services or providers subject to review under the 
contract.
    (b) The State plan must provide that the contract with the QIO--
    (1) Meets the requirements of Sec.  434.6(a) of this part;
    (2) Includes a monitoring and evaluation plan by which the State 
ensures satisfactory performance by the QIO;
    (3) Identifies the services and providers subject to QIO review;
    (4) Ensures that the review activities performed by the QIO are not 
inconsistent with QIO review activities of Medicare services and 
includes a description of whether and to what extent QIO determinations 
will be considered conclusive for Medicaid payment purposes.

[50 FR 15327, Apr. 17, 1985]



Sec.  431.635  Coordination of Medicaid with Special Supplemental Food
Program for Women, Infants, and Children (WIC).

    (a) Basis. This section implements sections 1902(a)(11)(C) and 
1902(a) (53) of the Act, which provide for coordination of Medicaid with 
the Special Supplemental Food Program for Women, Infants, and Children 
(WIC) under section 17 of the Child Nutrition Act of 1966.
    (b) Definitions. As used in this section, the terms breastfeeding 
women,

[[Page 64]]

postpartum women, and pregnant women mean women as defined in section 17 
of the Child Nutrition Act of 1966 (42 U.S.C. 1786(b)).
    (c) State plan requirements. A State Plan must provide for--
    (1) Coordinating operation of the Medicaid program with the State's 
operation of the Special Supplemental Food Program for Women, Infants, 
and Children;
    (2) Providing timely written notice of the availability of WIC 
benefits to all individuals in the State who are determined to be 
eligible (including presumptively eligible) for Medicaid and who are:
    (i) Pregnant women;
    (ii) Postpartum women;
    (iii) Breastfeeding women; and
    (iv) Children under the age of 5.
    (3) Referring individuals described under paragraphs (c)(2) (i) 
through (iv) of this section to the local agency responsible for 
administering the WIC program.
    (d) Notification requirements. (1) The agency must give the written 
notice required under paragraph (c) of this section as soon as the 
agency identifies the individual (e.g., at the time of an eligibility 
determination for Medicaid) or immediately thereafter (e.g., at the time 
of notice of eligibility).
    (2) The agency, no less frequently than annually, must also provide 
written notice of the availability of WIC benefits, including the 
location and telephone number of the local WIC agency or instructions 
for obtaining further information about the WIC program, to all Medicaid 
beneficiaries (including those found to be presumptively eligible) who 
are under age 5 or who are women who might be pregnant, postpartum, or 
breastfeeding as described in paragraphs (c)(2) (i) through (iv) of this 
section.
    (3) The agency must effectively inform those individuals who are 
blind or deaf or who cannot read or understand the English language.

[57 FR 28103, June 24, 1992]



   Subpart N_State Programs for Licensing Nursing Home Administrators



Sec.  431.700  Basis and purpose.

    This subpart implements sections 1903(a)(29) and 1908 of the Act 
which require that the State plan include a State program for licensing 
nursing home administrators.



Sec.  431.701  Definitions.

    Unless otherwise indicated, the following definitions apply for 
purposes of this subpart:
    Agency means the State agency responsible for licensing individual 
practitioners under the State's healing arts licensing act.
    Board means an appointed State board established to carry out a 
State program for licensing administrators of nursing homes, in a State 
that does not have a healing arts licensing act or an agency as defined 
in this section.
    Licensed means certified by a State agency or board as meeting all 
of the requirements for a licensed nursing home administrator specified 
in this subpart.
    Nursing home means any institution, facility, or distinct part of a 
hospital that is licensed or formally recognized as meeting nursing home 
standards established under State law, or that is determined under Sec.  
431.704 to be included under the requirements of this subpart. The term 
does not include--
    (a) A religious nonmedical institution as defined in Sec.  
440.170(b) of this chapter; or
    (b) A distinct part of a hospital, if the hospital meets the 
definition in Sec.  440.10 or Sec.  440.140 of this subchapter, and the 
distinct part is not licensed separately or formally approved as a 
nursing home by the State even though it is designated or certified as a 
skilled nursing facility.
    Nursing home administrator means any person who is in charge of the 
general administration of a nursing home whether or not the person--
    (a) Has an ownership interest in the home; or

[[Page 65]]

    (b) Shares his functions and duties with one or more other persons.

[43 FR 45188, Sept. 29, 1978, as amended at 64 FR 67052, Nov. 30, 1999]



Sec.  431.702  State plan requirement.

    A State plan must provide that the State has a program for licensing 
administrators of nursing homes that meets the requirements of 
Sec. Sec.  431.703 through 431.713 of this subpart.



Sec.  431.703  Licensing requirement.

    The State licensing program must provide that only nursing homes 
supervised by an administrator licensed in accordance with the 
requirements of this subpart may operate in the State.



Sec.  431.704  Nursing homes designated by other terms.

    If a State licensing law does not use the term ``nursing home,'' the 
CMS Administrator will determine the term or terms equivalent to 
``nursing home'' for purposes of applying the requirements of this 
subpart. To obtain this determination, the Medicaid agency must submit 
to the Regional Medicaid Director copies of current State laws that 
define institutional health care facilities for licensing purposes.



Sec.  431.705  Licensing authority.

    (a) The State licensing program must provide for licensing of 
nursing home administrators by--
    (1) The agency designated under the healing arts act of the State; 
or
    (2) A State licensing board.
    (b) The State agency or board must perform the functions and duties 
specified in Sec. Sec.  431.707 through 431.713 and the board must meet 
the membership requirements specified in Sec.  431.706 of this subpart.



Sec.  431.706  Composition of licensing board.

    (a) The board must be composed of persons representing professions 
and institutions concerned with the care and treatment of chronically 
ill or infirm elderly patients. However--
    (1) A majority of the board members may not be representative of a 
single profession or category of institution; and
    (2) Members not representative of institutions may not have a direct 
financial interest in any nursing home.
    (b) For purposes of this section, nursing home administrators are 
considered representatives of institutions.



Sec.  431.707  Standards.

    (a) The agency or board must develop, impose, and enforce standards 
that must be met by individuals in order to be licensed as a nursing 
home administrator.
    (b) The standards must be designed to insure that nursing home 
administrators are--
    (1) Of good character;
    (2) Otherwise suitable; and
    (3) Qualified to serve because of training or experience in 
institutional administration.



Sec.  431.708  Procedures for applying standards.

    The agency or board must develop and apply appropriate procedures 
and techniques, including examinations and investigations, for 
determining if a person meets the licensing standards.



Sec.  431.709  Issuance and revocation of license.

    Except as provided in Sec.  431.714 of this subpart, the agency or 
board must--
    (a) Issue licenses to persons who meet the agency's or board's 
standards; and
    (b) Revoke or suspend a license if the agency or board determines 
that the person holding the license substantially fails to meet the 
standards.



Sec.  431.710  Provisional licenses.

    To fill a position of nursing home administrator that unexpectedly 
becomes vacant, the agency or board may issue one provisional license, 
for a single period not to exceed 6 months. The license may be issued to 
a person who does not meet all of the licensing requirements established 
under Sec.  431.707 but who--
    (a) Is of good character and otherwise suitable; and
    (b) Meets any other standards established for provisional licensure 
by the agency or board.

[[Page 66]]



Sec.  431.711  Compliance with standards.

    The agency or board must establish and carry out procedures to 
insure that licensed administrators comply with the standards in this 
subpart when they serve as nursing home administrators.



Sec.  431.712  Failure to comply with standards.

    The agency or board must investigate and act on all complaints it 
receives of violations of standards.



Sec.  431.713  Continuing study and investigation.

    The agency or board must conduct a continuing study of nursing homes 
and administrators within the State to improve--
    (a) Licensing standards; and
    (b) The procedures and methods for enforcing the standards.



Sec.  431.714  Waivers.

    The agency or board may waive any standards developed under Sec.  
431.707 of this subpart for any person who has served in the capacity of 
a nursing home administrator during all of the 3 calendar years 
immediately preceding the calendar year in which the State first meets 
the requirements in this subpart.



Sec.  431.715  Federal financial participation.

    No FFP is available in expenditures by the licensing board for 
establishing and maintaining standards for the licensing of nursing home 
administrators.

Subpart O [Reserved]



                        Subpart P_Quality Control

           Medicaid Eligibility Quality Control (MEQC) Program

    Source: Sections 431.800 through 431.808 appear at 55 FR 22166, May 
31, 1990, unless otherwise noted.



Sec.  431.800  Basis and scope.

    This subpart establishes State requirements for the Medicaid 
Eligibility Quality Control (MEQC) Program designed to reduce erroneous 
expenditures by monitoring eligibility determinations and a claims 
processing assessment that monitors claims processing operations. MEQC 
will work in conjunction with the Payment Error Rate Measurement (PERM) 
Program established in subpart Q of this part. In years in which the 
State is required to participate in PERM, as stated in subpart Q of this 
part, it will only participate in the PERM program and will not be 
required to conduct a MEQC pilot. In the 2 years between PERM cycles, 
the State is required to conduct a MEQC pilot, as set forth in this 
subpart.

[82 FR 31182, July 5, 2017]



Sec.  431.804  Definitions.

    As used in this subpart--
    Active case means an individual determined to be currently 
authorized as eligible for Medicaid or CHIP by the State.
    Corrective action means action(s) to be taken by the State to reduce 
major error causes, trends in errors or other vulnerabilities for the 
purpose of reducing improper payments in Medicaid and CHIP.
    Deficiency means a finding in processing identified through active 
case review or negative case review that does not meet the definition of 
an eligibility error.
    Eligibility means meeting the State's categorical and financial 
criteria for receipt of benefits under the Medicaid or CHIP programs.
    Eligibility error is an error resulting from the States' improper 
application of Federal rules and the State's documented policies and 
procedures that causes a beneficiary to be determined eligible when he 
or she is ineligible for Medicaid or CHIP, causes a beneficiary to be 
determined eligible for the incorrect type of assistance, causes 
applications for Medicaid or CHIP to be improperly denied by the State, 
or causes existing cases to be improperly terminated from Medicaid or 
CHIP by the State. An eligibility error may also be caused when a 
redetermination did not occur timely or a required element of the 
eligibility determination process (for example income) cannot be 
verified as being performed/completed by the state.

[[Page 67]]

    Medicaid Eligibility Quality Control (MEQC) means a program designed 
to reduce erroneous expenditures by monitoring eligibility 
determinations and work in conjunction with the PERM program established 
in subpart Q of this part.
    MEQC pilot refers to the process used to implement the MEQC Program.
    MEQC review period is the 12-month timespan from which the State 
will sample and review cases.
    Negative case means an individual denied or terminated eligibility 
for Medicaid or CHIP by the State.
    Off-years are the scheduled 2-year period of time between a States' 
designated PERM years.
    Payment Error Rate Measurement (PERM) Program means the program set 
forth at subpart Q of this part utilized to calculate a national 
improper payment rate for Medicaid and CHIP.
    PERM year is the scheduled and designated year for a State to 
participate in, and be measured by, the PERM Program set forth at 
subpart Q of this part.

[82 FR 31182, July 5, 2017]



Sec.  431.806  State requirements.

    (a) General requirements. (1) In a State's PERM year, the PERM 
measurement will meet the requirements of section 1903(u) of the Act.
    (2) In the 2 years between each State's PERM year, the State is 
required to conduct one MEQC pilot, which will span parts of both off 
years.
    (i) The MEQC pilot review period will span 12 months of a calendar 
year, beginning the January 1 following the end of the State's PERM year 
through December 31.
    (ii) The MEQC pilot planning document described in Sec.  431.814 is 
due no later than the first November 1 following the end of the State's 
PERM year.
    (iii) A State must submit its MEQC pilot findings and its plan for 
corrective action(s) by the August 1 following the end of its MEQC pilot 
review period.
    (b) PERM measurement. Requirements for the State PERM review process 
are set forth in subpart Q of this part.
    (c) MEQC pilots. MEQC pilot requirements are specified in Sec. Sec.  
431.812 through 431.820.
    (d) Claims processing assessment system. Except in a State that has 
an approved Medicaid Management Information System (MMIS) under subpart 
C of part 433 of this subchapter, a State plan must provide for 
operating a Medicaid quality control claims processing assessment system 
that meets the requirements of Sec. Sec.  431.830 through 431.836.

[82 FR 31182, July 5, 2017]



Sec.  431.808  Protection of beneficiary rights.

    Any individual performing activities under the MEQC program or the 
claims processing assessment system specified in this subpart must do so 
in a manner that is consistent with the provisions of Sec. Sec.  435.902 
and 436.901 of this subchapter concerning the rights of beneficiaries.



Sec.  431.810  Basic elements of the Medicaid Eligibility Quality Control
(MEQC) Program.

    (a) General requirements. The State must operate the MEQC pilot in 
accordance with this section and Sec. Sec.  431.812 through 431.820, as 
well as other instructions established by CMS.
    (b) Review requirements. The State must conduct reviews for the MEQC 
pilot in accordance with the requirements specified in Sec.  431.812 and 
other instructions established by CMS.
    (c) Pilot planning requirements. The State must develop a MEQC pilot 
planning proposal in accordance with requirements specified in Sec.  
431.814 and other instructions established by CMS.
    (d) Reporting requirements. The State must report the finding of the 
MEQC pilots in accordance with the requirements specified in Sec.  
431.816 and other instructions established by CMS.
    (e) Corrective action requirements. The State must conduct 
corrective actions based on the findings of the MEQC pilots in 
accordance with the requirements specified in Sec.  431.820 and other 
instructions established by CMS.

[82 FR 31183, July 5, 2017]

[[Page 68]]



Sec.  431.812  Review procedures.

    (a) General requirements. Each State is required to conduct a MEQC 
pilot during the 2 years between required PERM cycles in accordance with 
the approved pilot planning document specified in Sec.  431.814, as well 
as other instructions established by CMS. The agency and personnel 
responsible for the development, direction, implementation, and 
evaluation of the MEQC reviews and associated activities, must be 
functionally and physically separate from the State agencies and 
personnel that are responsible for Medicaid and CHIP policy and 
operations, including eligibility determinations.
    (b) Active case reviews. (1) The State must review all active cases 
selected from the universe of cases, as established in the State's 
approved MEQC pilot planning document, under Sec.  431.814 to determine 
if the cases were eligible for services, as well as to identify 
deficiencies in processing subject to corrective actions.
    (2) The State must select and review, at a minimum, 400 active cases 
in total from the Medicaid and CHIP universe.
    (i) The State must review at least 200 Medicaid cases.
    (ii) The State will identify in the pilot planning document at Sec.  
431.814 the sample size per program.
    (iii) The State may sample more than 400 cases.
    (3) The State may propose to focus the active case reviews on recent 
changes to eligibility policies and processes, areas where the state 
suspects vulnerabilities, or proven error prone areas.
    (i) Unless otherwise directed by CMS, the State must propose its 
active case review approach in the pilot planning document described at 
Sec.  431.814 or perform a comprehensive review.
    (ii) When the State has a PERM eligibility improper payment rate 
that exceeds the 3 percent national standard for two consecutive PERM 
cycles, the State must follow CMS direction for its active case reviews. 
CMS guidance will be provided to any state meeting this criteria.
    (c) Negative case reviews. (1) As established in the State's 
approved MEQC pilot planning document under Sec.  431.814, the State 
must review negative cases selected from the State's universe of cases 
that are denied or terminated in the review month to determine if the 
denial, or termination, was correct, as well as to identify deficiencies 
in processing subject to corrective actions.
    (2) The State must review, at a minimum, 200 negative cases from 
Medicaid and 200 negative cases from CHIP.
    (i) The State may sample more than 200 cases from Medicaid and/or 
more than 200 cases from CHIP.
    (ii) [Reserved]
    (d) Error definition. (1) An active case error is an error resulting 
from the State's improper application of Federal rules and the State's 
documented policies and procedures that causes a beneficiary to be 
determined eligible when he or she is ineligible for Medicaid or CHIP, 
causes a beneficiary to be determined eligible for the incorrect type of 
assistance, or when a determination did not occur timely or cannot be 
verified.
    (2) Negative case errors are errors, based on the State's documented 
policies and procedures, resulting from either of the following:
    (i) Applications for Medicaid or CHIP that are improperly denied by 
the State.
    (ii) Existing cases that are improperly terminated from Medicaid or 
CHIP by the State.
    (e) Active case payment reviews. In accordance with instructions 
established by CMS, the State must also conduct payment reviews to 
identify payments for active case errors, as well as identify the 
individual's understated or overstated liability, and report payment 
findings as specified in Sec.  431.816.

[82 FR 31183, July 5, 2017]



Sec.  431.814  Pilot planning document.

    (a) Plan approval. For each MEQC pilot, the State must submit a MEQC 
pilot planning document that meets the requirements of this section to 
CMS for approval by the first November 1 following the end of the 
State's PERM year. The State must receive approval for a plan before the 
plan can be implemented.
    (b) Plan requirements. The State must have an approved pilot 
planning document in effect for each MEQC pilot

[[Page 69]]

that must be in accordance with instructions established by CMS and that 
includes, at a minimum, the following for--
    (1) Active case reviews. (i) Focus of the active case reviews in 
accordance with Sec.  431.812(b)(3) and justification for focus.
    (ii) Universe development process.
    (iii) Sample size per program.
    (iv) Sample selection procedure.
    (v) Case review process.
    (2) Negative case reviews. (i) Universe development process.
    (ii) Sample size per program.
    (iii) Sample selection procedure.
    (iv) Case review process.

[82 FR 31183, July 5, 2017]



Sec.  431.816  Case review completion deadlines and submittal of reports.

    (a) The State must complete case reviews and submit reports of 
findings to CMS as specified in paragraph (b) of this section in the 
form and at the time specified by CMS.
    (b) In addition to the reporting requirements specified in Sec.  
431.814 relating to the MEQC pilot planning document, the State must 
complete case reviews and submit reports of findings to CMS in 
accordance with paragraphs (b)(1) and (2) of this section.
    (1) For all active and negative cases reviewed, the State must 
submit a detailed case-level report in a format provided by CMS.
    (2) All case-level findings will be due by August 1 following the 
end of the MEQC review period.

[82 FR 31183, July 5, 2017]



Sec.  431.818  Access to records.

    The State, upon written request, must submit to the HHS staff, or 
other designated entity, all records, including complete local agency 
eligibility case files or legible copies and all other documents 
pertaining to its MEQC reviews to which the State has access, including 
information available under part 435, subpart I of this chapter.

[82 FR 31184, July 5, 2017]



Sec.  431.820  Corrective action under the MEQC program.

    The State must--
    (a) Take action to correct any active or negative case errors, 
including deficiencies, found in the MEQC pilot sampled cases in 
accordance with instructions established by CMS;
    (b) By the August 1 following the MEQC review period, submit to CMS 
a report that--
    (1) Identifies the root cause and any trends found in the case 
review findings.
    (2) Offers corrective actions for each unique error and deficiency 
finding based on the analysis provided in paragraph (b)(1) of this 
section.
    (c) In the corrective action report, the State must provide updates 
on corrective actions reported for the previous MEQC pilot.

[82 FR 31184, July 5, 2017]

   Medicaid Quality Control (MQC) Claims Processing Assessment System

    Source: Sections 431.830 through 431.836 appear at 55 FR 22170, May 
31, 1990, unless otherwise noted.



Sec.  431.830  Basic elements of the Medicaid quality control (MQC) 
claims processing assessment system.

    An agency must--
    (a) Operate the MQC claims processing assessment system in 
accordance with the policies, sampling methodology, review procedures, 
reporting forms, requirements, and other instructions established by 
CMS.
    (b) Identify deficiencies in the claims processing operations.
    (c) Measure cost of deficiencies;
    (d) Provide data to determine appropriate corrective action;
    (e) Provide an assessment of the State's claims processing or that 
of its fiscal agent;
    (f) Provide for a claim-by-claim review where justifiable by data; 
and
    (g) Produce an audit trail that can be reviewed by CMS or an outside 
auditor.



Sec.  431.832  Reporting requirements for claims processing assessment
systems.

    (a) The agency must submit reports and data specified in paragraph 
(b) of this section to CMS, in the form and at the time specified by 
CMS.

[[Page 70]]

    (b) Except when CMS authorizes less stringent reporting, States must 
submit:
    (1) A monthly report on claims processing reviews sampled and or 
claims processing reviews completed during the month;
    (2) A summary report on findings for all reviews in the 6-month 
sample to be submitted by the end of the 3rd month following the 
scheduled completion of reviews for that 6 month period; and
    (3) Other data and reports as required by CMS.



Sec.  431.834  Access to records: Claims processing assessment systems.

    The agency, upon written request, must provide HHS staff with access 
to all records pertaining to its MQC claims processing assessment system 
reviews to which the State has access, including information available 
under part 435, subpart J, of this chapter.



Sec.  431.836  Corrective action under the MQC claims processing assessment
system.

    The agency must--
    (a) Take action to correct those errors identified through the 
claims processing assessment system review and, if cost effective, to 
recover those funds erroneously spent;
    (b) Take administrative action to prevent and reduce the incidence 
of those errors; and
    (c) By August 31 of each year, submit to CMS a report of its error 
analysis and a corrective action plan on the reviews conducted since the 
cut-off-date of the previous corrective action plan.



Subpart Q_Requirements for Estimating Improper Payments in Medicaid and 
                                  CHIP

    Source: 71 FR 51081, Aug. 28, 2006, unless otherwise noted.



Sec.  431.950  Purpose.

    This subpart requires States and providers to submit information and 
provide support to Federal contractors as necessary to enable the 
Secretary to produce national improper payment estimates for Medicaid 
and the Children's Health Insurance Program (CHIP).

[82 FR 31184, July 5, 2017]



Sec.  431.954  Basis and scope.

    (a) Basis. The statutory bases for this subpart are as follows:
    (1) Sections 1102, 1902(a)(6), and 2107(b)(1) of the Act, which 
contain the Secretary's general rulemaking authority and obligate States 
to provide information, as the Secretary may require, to monitor program 
performance.
    (2) The Improper Payments Information Act of 2002 (Pub. L. 107-300), 
which requires Federal agencies to review and identify annually those 
programs and activities that may be susceptible to significant erroneous 
payments, estimate the amount of improper payments, report such 
estimates to the Congress, and submit a report on actions the agency is 
taking to reduce erroneous payments.
    (3) Section 1902(a)(27)(B) of the Act requires States to require 
providers to agree to furnish the State Medicaid agencies and the 
Secretary with information regarding payments claimed by Medicaid 
providers for furnishing Medicaid services.
    (4) Section 601 of the Children's Health Insurance Program 
Reauthorization Act of 2009 (CHIPRA) (Pub. L. 111-3) which requires that 
the new PERM regulations include the following: Clearly defined criteria 
for errors for both States and providers; Clearly defined processes for 
appealing error determinations; clearly defined responsibilities and 
deadlines for States in implementing any corrective action plans; 
requirements for State verification of an applicant's self-declaration 
or self-certification of eligibility for, and correct amount of, medical 
assistance under Medicaid or child health assistance under CHIP; and 
State-specific sample sizes for application of the PERM requirements.
    (b) Scope. (1) This subpart requires States under the statutory 
provisions cited in paragraph (a) of this section to submit information 
as set forth in Sec.  431.970 for, among other purposes, estimating 
improper payments in the fee-for-service (FFS) and managed care 
components of the Medicaid and CHIP

[[Page 71]]

programs and to determine whether eligibility was correctly determined. 
This subpart also requires providers to submit to the Secretary any 
medical records and other information necessary to disclose the extent 
of services provided to individuals receiving assistance, and to furnish 
information regarding any payments claimed by the provider for 
furnishing such services, as requested by the Secretary.
    (2) All information must be furnished in accordance with section 
1902(a)(7)(A) of the Act, regarding confidentiality.
    (3) This subpart does not apply with respect to Puerto Rico, Guam, 
the Virgin Islands, the Northern Mariana Islands or American Samoa.

[71 FR 51081, Aug. 28, 2006, as amended at 75 FR 48847, Aug. 11, 2010]



Sec.  431.958  Definitions and use of terms.

    Adjudication date means either the date on which money was obligated 
to pay a claim or the date the decision was made to deny a claim.
    Annual sample size means the number of fee-for-service claims, 
managed care payments, or eligibility cases that will be sampled for 
review in a given PERM cycle.
    Appeals means a process that allows the State to dispute the PERM 
Review Contractor and Eligibility Review Contractor findings with CMS 
after the difference resolution process has been exhausted.
    Beneficiary means an applicant for, or beneficiary of, Medicaid or 
CHIP program benefits.
    Children's Health Insurance Program (CHIP) means the program 
authorized and funded under Title XXI of the Act.
    Corrective action means actions to be taken by the State to reduce 
errors or other vulnerabilities for the purpose of reducing improper 
payments in Medicaid and CHIP.
    Deficiency means a finding in which a claim or payment had a 
medical, data processing, and/or eligibility error that did not result 
in federal and/or state improper payment.
    Difference resolution means a process that allows the State to 
dispute the PERM Review Contractor and Eligibility Review Contractor 
findings directly with the contractor.
    Disallowance means the percentage of Federal medical assistance 
funds the State is required to return to CMS in accordance with section 
1903(u) of the Act.
    Eligibility means meeting the State's categorical and financial 
criteria for receipt of benefits under the Medicaid or CHIP programs.
    Eligibility Review Contractor (ERC) means the CMS contractor 
responsible for conducting state eligibility reviews for the PERM 
Program.
    Federal contractor means the ERC, RC, or SC which support CMS in 
executing the requirements of the PERM program.
    Federally Facilitated Exchange (FFE) means the health insurance 
exchange established by the Federal government with responsibilities 
that include making Medicaid and CHIP determinations for states that 
delegate authority to the FFE.
    Federally Facilitated Exchange--Determination (FFE-D) means cases 
determined by the FFE in states that have delegated the authority to 
make Medicaid/CHIP eligibility determinations to the FFE.
    Federal financial participation means the Federal Government's share 
of the State's expenditures under the Medicaid program and CHIP.
    Finding means errors and/or deficiencies identified through the 
medical, data processing, and eligibility reviews.
    Improper payment means any payment that should not have been made or 
that was made in an incorrect amount (including overpayments and 
underpayments) under statutory, contractual, administrative, or other 
legally applicable requirements; and includes any payment to an 
ineligible beneficiary, any duplicate payment, any payment for services 
not received, any payment incorrectly denied, and any payment that does 
not account for credits or applicable discounts.
    Improper payment rate means an annual estimate of improper payments 
made under Medicaid and CHIP equal to the sum of the overpayments and 
underpayments in the sample, that is, the absolute value of such 
payments, expressed as a percentage of total payments made in the 
sample.

[[Page 72]]

    Lower limit means the lower bound of the 95-percent confidence 
interval for the State's eligibility improper payment rate.
    Medicaid means the joint Federal and State program, authorized and 
funded under Title XIX of the Act, that provides medical care to people 
with low incomes and limited resources.
    Payment means any payment to a provider, insurer, or managed care 
organization for a Medicaid or CHIP beneficiary for which there is 
Medicaid or CHIP Federal financial participation. It may also mean a 
direct payment to a Medicaid or CHIP beneficiary in limited 
circumstances permitted by CMS regulation or policy.
    Payment error means any claim or payment where federal and/or state 
dollars were paid improperly based on medical, data processing, and/or 
eligibility reviews.
    PERM means the Payment Error Rate Measurement process to measure 
improper payment in Medicaid and CHIP.
    PERM review period means the timeframe in which claims and 
eligibility are reviewed for national annual improper payment rate 
calculation purposes, July through June.
    Provider means any qualified provider recognized under Medicaid and 
CHIP statute and regulations.
    Provider error includes, but is not limited to, medical review 
errors as described in Sec.  431.960(c) of this subpart, as determined 
in accordance with documented State or Federal policies or both.
    Recoveries mean those monies for which the State is responsible to 
pay back to CMS based on the identification of Federal improper 
payments.
    Review Contractor (RC) means the CMS contractor responsible for 
conducting state data processing and medical record reviews for the PERM 
Program.
    Review year means the year being analyzed for improper payments 
under the PERM Program.
    State eligibility system means any system, within the State or with 
a state-delegated contractor, that is used by the state to determine 
Medicaid and/or CHIP eligibility and/or that maintains documentation 
related to Medicaid and/or CHIP eligibility determinations.
    State error includes, but is not limited to, dataprocessing errors 
and eligibility errors as described in Sec.  431.960(b) and (d), as 
determined in accordance with documented State and Federal policies. 
State errors do not include the errors described in paragraph Sec.  
431.960(e)(2).
    State payment system means any system within the State or with a 
state-delegated contractor that is used to adjudicate and pay Medicaid 
and/or CHIP FFS claims and/or managed care payments.
    State-specific sample size means the sample size determined by CMS 
that is required from each individual State to support national improper 
payment rate precision requirements.
    Statistical Contractor (SC) means the contractor responsible for 
collecting and sampling fee-for-service claims and managed care 
capitation payment data, as well as calculating Medicaid and CHIP state 
and national improper payment rates.
    States means the 50 States and the District of Columbia.

[71 FR 51081, Aug. 28, 2006, as amended at 75 FR 48847, Aug. 11, 2010; 
82 FR 31184, July 5, 2017]



Sec.  431.960  Types of payment errors.

    (a) General rule. Errors identified for the Medicaid and CHIP 
improper payments measurement under the Improper Payments Information 
Act of 2002 must affect payment under applicable Federal or State 
policy, or both.
    (b) Data processing errors. (1) A data processing error is an error 
resulting in an overpayment or underpayment that is determined from a 
review of the claim and other information available in the State's 
Medicaid Management Information System, related systems, or outside 
sources of provider verification resulting in Federal and/or State 
improper payments.
    (2) The difference in payment between what the State paid (as 
adjusted within improper payment measurement guidelines) and what the 
State should have paid, in accordance with federal and state documented 
policies, is the dollar measure of the payment error.

[[Page 73]]

    (3) Data processing errors include, but are not limited to, the 
following:
    (i) Payment for duplicate items.
    (ii) Payment for non-covered services.
    (iii) Payment for fee-for-service claims for managed care services.
    (iv) Payment for services that should have been paid by a third 
party but were inappropriately paid by Medicaid or CHIP.
    (v) Pricing errors.
    (vi) Logic edit errors.
    (vii) Data entry errors.
    (viii) Managed care rate cell errors.
    (ix) Managed care payment errors.
    (c) Medical review errors. (1) A medical review error is an error 
resulting in an overpayment or underpayment that is determined from a 
review of the provider's medical record or other documentation 
supporting the service(s) claimed, Code of Federal Regulations that are 
applicable to conditions of payment, the State's written policies, and a 
comparison between the documentation and written policies and the 
information presented on the claim resulting in Federal and/or State 
improper payments.
    (2) The difference in payment between what the State paid (as 
adjusted within improper payment measurement guidelines) and what the 
State should have paid, in accordance with the applicable conditions of 
payment per 42 CFR parts 440 through 484, this part (431), and in 
accordance with the State's documented policies, is the dollar measure 
of the payment error.
    (3) Medical review errors include, but are not limited to, the 
following:
    (i) Lack of documentation.
    (ii) Insufficient documentation.
    (iii) Procedure coding errors.
    (iv) Diagnosis coding errors.
    (v) Unbundling.
    (vi) Number of unit errors.
    (vii) Medically unnecessary services.
    (viii) Policy violations.
    (ix) Administrative errors.
    (d) Eligibility errors. (1) An eligibility error is an error 
resulting in an overpayment or underpayment that is determined from a 
review of a beneficiary's eligibility determination, in comparison to 
the documentation used to establish a beneficiary's eligibility and 
applicable federal and state regulations and policies, resulting in 
Federal and/or State improper payments.
    (2) Eligibility errors include, but are not limited to, the 
following:
    (i) Ineligible individual, but authorized as eligible when he or she 
received services.
    (ii) Eligible individual for the program, but was ineligible for 
certain services he or she received.
    (iii) Lacked or had insufficient documentation in his or her case 
record, in accordance with the State's documented policies and 
procedures, to make a definitive review decision of eligibility or 
ineligibility.
    (iv) Was ineligible for managed care but enrolled in managed care.
    (3) The dollars paid in error due to an eligibility error is the 
measure of the payment error.
    (4) A State eligibility error does not result from the State's 
verification of an applicant's self-declaration or self-certification of 
eligibility for, and the correct amount of, medical assistance or child 
health assistance, if the State process for verifying an applicant's 
self-declaration or self-certification satisfies the requirements in 
Federal law or guidance, or, if applicable, has the Secretary's 
approval.
    (e) Errors for purposes of determining the national improper payment 
rates. (1) The Medicaid and CHIP national improper payment rates 
include, but are not limited to, the errors described in paragraphs (b) 
through (d) of this section.
    (2) Eligibility errors resulting solely from determinations of 
Medicaid or CHIP eligibility delegated to, and made by, the Federally 
Facilitated Exchange will be included in the national improper payment 
rate.
    (f) Errors for purposes of determining the State improper payment 
rates. The Medicaid and CHIP State improper payment rates include, but 
are not limited to, the errors described in paragraphs (b) through (d) 
of this section, and do not include the errors described in paragraph 
(e)(2) of this section.
    (g) Error codes. CMS will define different types of errors within 
the above categories for analysis and reporting purposes. Only Federal 
and/or State

[[Page 74]]

dollars in error will factor into the State's PERM improper payment 
rate.

[82 FR 31185, July 5, 2017]



Sec.  431.970  Information submission and systems access requirements.

    (a) The State must submit information to the Secretary for, among 
other purposes, estimating improper payments in Medicaid and CHIP, that 
include, but are not limited to--
    (1) Adjudicated fee-for-service or managed care claims information, 
or both, on a quarterly basis, from the review year;
    (2) Upon request from CMS, provider contact information that has 
been verified by the State as current;
    (3) All medical, eligibility, and other related policies in effect, 
and any quarterly policy updates;
    (4) Current managed care contracts, rate information, and any 
quarterly updates applicable to the review year;
    (5) Data processing systems manuals;
    (6) Repricing information for claims that are determined during the 
review to have been improperly paid;
    (7) Information on claims that were selected as part of the sample, 
but changed in substance after selection, for example, successful 
provider appeals;
    (8) Adjustments made within 60 days of the adjudication dates for 
the original claims or line items, with sufficient information to 
indicate the nature of the adjustments and to match the adjustments to 
the original claims or line items;
    (9) Case documentation to support the eligibility review, as 
requested by CMS;
    (10) A corrective action plan for purposes of reducing erroneous 
payments in FFS, managed care, and eligibility; and
    (11) Other information that the Secretary determines is necessary 
for, among other purposes, estimating improper payments and determining 
improper payment rates in Medicaid and CHIP.
    (b) Providers must submit information to the Secretary for, among 
other purposes, estimating improper payments in Medicaid and CHIP, which 
include but are not limited to Medicaid and CHIP beneficiary medical 
records, within 75 calendar days of the date the request is made by CMS. 
If CMS determines that the documentation is insufficient, providers must 
respond to the request for additional documentation within 14 calendar 
days of the date the request is made by CMS.
    (c) The State must provide the Federal contractor(s) with access to 
all payment system(s) necessary to conduct the medical and data 
processing review, including the Medicaid Management Information System 
(MMIS), any systems that include beneficiary demographic and/or provider 
enrollment information, and any document imaging systems that store 
paper claims.
    (d) The State must provide the Federal contractor(s) with access to 
all eligibility system(s) necessary to conduct the eligibility review, 
including any eligibility systems of record, any electronic document 
management system(s) that house case file information, and systems that 
house the results of third party data matches.

[82 FR 31185, July 5, 2017]



Sec.  431.972  Claims sampling procedures.

    (a) General requirements. The State will submit quarterly FFS claims 
and managed care payments, as identified in Sec.  431.970(a), to allow 
federal contractors to conduct data processing, medical record, and 
eligibility reviews to meet the requirements of the PERM measurement.
    (b) Claims universe. (1) The PERM claims universe includes payments 
that were originally paid (paid claims) and for which payment was 
requested but denied (denied claims) during the PERM review period, and 
for which there is FFP (or would have been if the claim had not been 
denied) through Title XIX (Medicaid) or Title XXI (CHIP).
    (2) The State must establish controls to ensure FFS and managed care 
universes are accurate and complete, including comparing the FFS and 
managed care universes to the Form CMS-64 and Form CMS-21 as 
appropriate.
    (c) Sample size. CMS estimates each State's annual sample size for 
the PERM review at the beginning of the PERM cycle.

[[Page 75]]

    (1) Precision and confidence levels. The national annual sample size 
will be estimated to achieve at least a minimum National-level improper 
payment rate with a 90 percent confidence interval of plus or minus 2.5 
percent of the total amount of all payments for Medicaid and CHIP.
    (2) State-specific sample sizes. CMS will develop State-specific 
sample sizes for each State. CMS may take into consideration the 
following factors in determining each State's annual state-specific 
sample size for the current PERM cycle:
    (i) State-level precision goals for the current PERM cycle;
    (ii) The improper payment rate and precision of that improper 
payment rate from the State's previous PERM cycle;
    (iii) The State's overall Medicaid and CHIP expenditures; and
    (iv) Other relevant factors as determined by CMS.

[82 FR 31186, July 5, 2017]



Sec.  431.992  Corrective action plan.

    (a) The State must develop a separate corrective action plan for 
Medicaid and CHIP for each improper payment rate measurement, designed 
to reduce improper payments in each program based on its analysis of the 
improper payment causes in the FFS, managed care, and eligibility 
components.
    (1) The corrective action plan must address all errors that are 
included in the State improper payment rate defined at Sec.  
431.960(f)(1) and all deficiencies.
    (2) For eligibility, the corrective action plan must include an 
evaluation of whether actions the State takes to reduce eligibility 
errors will also avoid increases in improper denials.
    (b) In developing a corrective action plan, the State must take the 
following actions:
    (1) Error analysis. The State must conduct analysis such as 
reviewing causes, characteristics, and frequency of errors that are 
associated with improper payments. The State must review the findings of 
the analysis to determine specific programmatic causes to which errors 
are attributed (for example, provider lack of understanding of the 
requirement to provide documentation), if any, and to identify root 
improper payment causes.
    (2) Corrective action planning. The State must determine the 
corrective actions to be implemented that address the root improper 
payment causes and prevent that same improper payment from occurring 
again.
    (3) Implementation and monitoring. (i) The State must develop an 
implementation schedule for each corrective action and implement those 
actions in accordance with the schedule.
    (ii) The implementation schedule must identify all of the following 
for each action:
    (A) The specific corrective action.
    (B) Status.
    (C) Scheduled or actual implementation date.
    (D) Key personnel responsible for each activity.
    (E) A monitoring plan for monitoring the effectiveness of the 
action.
    (4) Evaluation. The State must submit an evaluation of the 
corrective action plan from the previous measurement. The State must 
evaluate the effectiveness of the corrective action(s) by assessing all 
of the following:
    (i) Improvements in operations.
    (ii) Efficiencies.
    (iii) Number of errors.
    (iv) Improper payments.
    (v) Ability to meet the PERM improper payment rate targets assigned 
by CMS.
    (c) The State must submit to CMS and implement the corrective action 
plan for the fiscal year it was reviewed no later than 90 calendar days 
after the date on which the State's Medicaid or CHIP improper payment 
rates are posted on the CMS contractor's Web site.
    (d) The State must provide updates on corrective action plan 
implementation progress annually and upon request by CMS.
    (e) In addition to paragraphs (a) through (d) of this section, each 
State that has an eligibility improper payment rates over the allowable 
threshold of 3 percent for consecutive PERM years, must submit updates 
on the status of corrective action implementation to CMS every other 
month. Status updates must include, but are not limited to the 
following:

[[Page 76]]

    (1) Details on any setbacks along with an alternate corrective 
action or workaround.
    (2) Actual examples of how the corrective actions have led to 
improvements in operations, and explanations for how the improvements 
will lead to a reduction in the number of errors, as well as the State's 
next PERM eligibility improper payment rate.
    (3) An overall summary on the status of corrective actions, 
planning, and implementation, which demonstrates how the corrective 
actions will provide the State with the ability to meet the 3 percent 
threshold.

[82 FR 31186, July 5, 2017]



Sec.  431.998  Difference resolution and appeal process.  Difference
resolution and appeal process.

    (a) The State may file, in writing, a request with the relevant 
Federal contractor to resolve differences in the Federal contractor's 
findings based on medical, data processing, or eligibility reviews in 
Medicaid or CHIP.
    (b) The State must file requests to resolve differences based on the 
medical, data processing, or eligibility reviews within 25 business days 
after the report of review findings is shared with the State.
    (c) To file a difference resolution request, the State must be able 
to demonstrate all of the following:
    (1) Have a factual basis for filing the request.
    (2) Provide the appropriate Federal contractor with valid evidence 
directly related to the finding(s) to support the State's position.
    (d) For a finding in which the State and the Federal contractor 
cannot resolve the difference in findings, the State may appeal to CMS 
for final resolution by filing an appeal within 15 business days from 
the date the relevant Federal contractor's finding as a result of the 
difference resolution is shared with the State. There is no minimum 
dollar threshold required to appeal a difference in findings.
    (e) To file an appeal request, the State must be able to demonstrate 
all of the following:
    (1) Have a factual basis for filing the request.
    (2) Provide CMS with valid evidence directly related to the 
finding(s) to support the State's position.
    (f) All differences, including those pending in CMS for final 
decision that are not overturned in time for improper payment rate 
calculation, will be considered as errors in the improper payment rate 
calculation in order to meet the reporting requirements of the IPIA.

[82 FR 31187, July 5, 2017]



Sec.  431.1002  Recoveries.

    (a) Medicaid. States must return to CMS the Federal share of 
overpayments based on medical and processing errors in accordance with 
section 1903(d)(2) of the Act and related regulations at part 433, 
subpart F of this chapter. Payments based on erroneous Medicaid 
eligibility determinations are addressed under section 1903(u) of the 
Act and related regulations at part 431, subpart P of this chapter.
    (b) CHIP. Quarterly Federal payments to the States under Title XXI 
of the Act must be reduced in accordance with section 2105(e) of the Act 
and related regulations at part 457, subpart B of this chapter.



Sec.  431.1010  Disallowance of Federal financial participation for
erroneous State payments (for PERM review years ending after
July 1, 2020).

    (a) Purpose. (1) This section establishes rules and procedures for 
disallowing Federal financial participation (FFP) in erroneous medical 
assistance payments due to eligibility improper payment errors, as 
detected through the PERM program required under this subpart, in effect 
on and after July 1, 2020.
    (2) After the State's eligibility improper rate has been established 
for each PERM review period, CMS will compute the amount of the 
disallowance, removing any underpayments due to eligibility errors, and 
adjust the FFP payable to each State. The disallowance or withholding is 
only applicable to the State's PERM year.
    (3) CMS will compute the amount to be withheld or disallowed as 
follows:
    (i) Subtract the 3 percent allowable threshold from the lower limit 
of the State's eligibility improper payment

[[Page 77]]

rate percentage excluding underpayments.
    (ii) If the difference is greater than zero, the Federal medical 
assistance funds for the period, are multiplied by that percentage. This 
product is the amount of the disallowance or withholding.
    (b) Notice to States and showing of good faith. (1) If CMS is 
satisfied that the State did not meet the 3 percent allowable threshold 
despite a good faith effort, CMS will reduce the funds being disallowed 
in whole.
    (2) CMS may find that a State did not meet the 3 percent allowable 
threshold despite a good faith effort if the State has taken the action 
it believed was needed to meet the threshold, but the threshold was not 
met. CMS will grant a good faith waiver only if the State both:
    (i) Participates in the MEQC pilot program in accordance with 
Sec. Sec.  431.800 through 431.820, and
    (ii) Implements PERM CAPs in accordance with Sec.  431.992.
    (3) Each State that has an eligibility improper payment rate above 
the allowable threshold will be notified by CMS of the amount of the 
disallowance.
    (c) Disallowance subject to appeal. If the State does not agree with 
a disallowance imposed under paragraph (e) of this section, it may 
appeal to the Departmental Appeals Board within 30 days from the date of 
the final disallowance notice from CMS. The regular procedures for an 
appeal of a disallowance will apply, including review by the Appeals 
Board under 45 CFR part 16.

[82 FR 31187, July 5, 2017]



PART 432_STATE PERSONNEL ADMINISTRATION--Table of Contents



                      Subpart A_General Provisions

Sec.
432.1 Basis and purpose.
432.2 Definitions.
432.10 Standards of personnel administration.

   Subpart B_Training Programs; Subprofessional and Volunteer Programs

432.30 Training programs: General requirements.
432.31 Training and use of subprofessional staff.
432.32 Training and use of volunteers.

              Subpart C_Staffing and Training Expenditures

432.45 Applicability of provisions in subpart.
432.50 FFP: Staffing and training costs.
432.55 Reporting training and administrative costs.

    Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302).

    Source: 43 FR 45199, Sept. 29, 1978, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  432.1  Basis and purpose.

    This part prescribes regulations to implement section 1902(a)(4) of 
the Act, which relates to a merit system of State personnel 
administration and training and use of subprofessional staff and 
volunteers in State Medicaid programs, and section 1903(a), rates of FFP 
for Medicaid staffing and training costs. It also prescribes 
regulations, based on the general administrative authority in section 
1902(a)(4), for State training programs for all staff.



Sec.  432.2  Definitions.

    As used in this part--
    Community service aides means subprofessional staff, employed in a 
variety of positions, whose duties are an integral part of the agency's 
responsibility for planning, administration, and for delivery of health 
services.
    Directly supporting staff means secretarial, stenographic, and 
copying personnel and file and records clerks who provide clerical 
services that directly support the responsibilities of skilled 
professional medical personnel, who are directly supervised by the 
skilled professional medical personnel, and who are in an employer-
employee relationship with the Medicaid agency.
    Fringe benefits means the employer's share of premiums for workmen's 
compensation, employees' retirement, unemployment compensation, health 
insurance, and similar expenses.

[[Page 78]]

    Full-time training means training that requires employees to be 
relieved of all responsibility for performance of current agency work to 
participate in a training program.
    Part-time training means training that allows employees to continue 
full-time in their agency jobs or requires only partial reduction of 
work activities to participate in the training activity.
    Skilled professional medical personnel means physicians, dentists, 
nurses, and other specialized personnel who have professional education 
and training in the field of medical care or appropriate medical 
practice and who are in an employer-employee relationship with the 
Medicaid agency. It does not include other nonmedical health 
professionals such as public administrators, medical analysts, 
lobbyists, senior managers or administrators of public assistance 
programs or the Medicaid program.
    Staff of other public agencies means skilled professional medical 
personnel and directly supporting staff who are employed in State or 
local agencies other than the Medicaid agency who perform duties that 
directly relate to the administration of the Medicaid program.
    Subprofessional staff means persons performing tasks that demand 
little or no formal education; a high school diploma; or less than 4 
years of college.
    Supporting staff means secretarial, stenographic, clerical, and 
other subprofessional staff whose activities are directly necessary to 
the carrying out of the functions which are the responsibility of 
skilled professional medical personnel, as defined in this section.
    Training program means a program of educational activities based on 
the agency's training needs and aimed at insuring that agency staff 
acquire the knowledge and skills necessary to perform their jobs.
    Volunteer means a person who contributes personal service to the 
community through the agency's program but is not a replacement or 
substitute for paid staff.

[43 FR 45199, Sept. 29, 1978, as amended at 50 FR 46663, Nov. 12, 1985; 
50 FR 49389, Dec. 2, 1985]



Sec.  432.10  Standards of personnel administration.

    (a) State plan requirement. A State plan must provide that the 
requirements of paragraphs (c) through (h) of this section are met.
    (b) Terms. In this section, ``standards'' refer to those specified 
in paragraph (c) of this section.
    (c) Methods of personnel administration. Methods of personnel 
administration must be established and maintained, in the Medicaid 
agency and in local agencies administering the propgram, in conformity 
with:
    (1) [Reserved]
    (2) 5 CFR part 900, subpart F, Administration of the Standards for 
Merit System of Personnel Administration.
    (d) Compliance of local jurisdictions. The Medicaid agency must have 
in effect methods to assure compliance with the standards by local 
jurisdictions included in the plan.
    (e) Review and adequacy of State laws, regulations, and policies. 
The agency must--
    (1) Assure that the U.S. Civil Service Commission has determined the 
adequacy of current State laws, regulations, and policy statements that 
effect methods of personnel administration in conformity with the 
standards, and
    (2) Submit any changes in them to the Commission for review.
    (f) Statements of acceptance by local agencies. If the Medicaid 
agency changes from a State-administered to a State-supervised, locally 
administered program, it must obtain statements of acceptance of the 
standards from the local agencies.
    (g) Affirmative action plan. The Medicaid agency must have in effect 
an affirmative action plan for equal employment opportunity, that 
includes specific action steps and timetables to assure that 
opportunity, and meets all other requirements of 45 CFR 70.4. \1\
---------------------------------------------------------------------------

    \1\ Editorial Note: The regulations formerly contained in 45 CFR 
70.4 were revised and reissued by the Office of Personnel Management at 
5 CFR part 900, (subpart F).
---------------------------------------------------------------------------

    (h) Submittal of requested materials. The Medicaid agency must 
submit to HHS, upon request, copies of the affirmative action plan and 
of the State

[[Page 79]]

---------------------------------------------------------------------------
and local materials that assure compliance with the standards.

[43 FR 45199, Sept. 29, 1978, as amended at 45 FR 24883, Apr. 11, 1980]



   Subpart B_Training Programs; Subprofessional and Volunteer Programs



Sec.  432.30  Training programs: General requirements.

    (a) A State plan must provide for a program of training for Medicaid 
agency personnel. (See also Sec. Sec.  432.31 and 432.32 for training 
programs for subprofessional staff and for volunteers.)
    (b) The program must--
    (1) Include initial inservice training for newly appointed staff, 
and continuing training opportunities to improve the operation of the 
program;
    (2) Be related to job duties performed or to be performed by the 
persons trained; and
    (3) Be consistent with the program objectives of the agency.



Sec.  432.31  Training and use of subprofessional staff.

    (a) State plan requirement. A State plan must provide for the 
training and effective use of subprofessional staff as community service 
aides, in accordance with the requirements of this section.
    (b) Recruitment and selection. The Medicaid agency must have methods 
of recruitment and selection that afford opportunity for full-time or 
part-time employment of persons of low income, including:
    (1) Young, middle-aged, and older persons;
    (2) Physically and mentally disabled; and
    (3) Beneficiaries.
    (c) Merit system. Subprofessional positions must be subject to merit 
system requirements except where special exemption is approved on the 
basis of a State alternative plan for employment of disadvantaged 
persons.
    (d) Staffing plan. The agency staffing plan must include the kinds 
of jobs that subprofessional staff can perform.
    (e) Career service. The agency must have a career service program 
that allows persons:
    (1) To enter employment at the subprofessional level; and
    (2) To progress to positions of increasing responsibility and 
reward:
    (i) In accordance with their abilities; and
    (ii) Through work experience and pre-service and in-service 
training.
    (f) Training, supervision and supportive services. The agency must 
have an organized training program, supervision, and supportive services 
for subprofessional staff.
    (g) Progressive expansion. The agency must provide for annual 
increase in the number of subprofessional staff until:
    (1) An appropriate ratio of subprofessional and professional staff 
has been achieved; and
    (2) There is maximum use of subprofessional staff as community aides 
in the operation of the program.



Sec.  432.32  Training and use of volunteers.

    (a) State plan requirement. A State plan must provide for the 
training and use of non-paid or partially paid volunteers in accordance 
with the requirements of this section.
    (b) Functions of volunteers. The Medicaid agency must make use of 
volunteers in:
    (1) Providing services to applicants and beneficiaries; and
    (2) Assisting any advisory committees established by the agency.

As used in this paragraph, ``partially paid volunteers'' means 
volunteers who are reimbursed only for actual expenses incurred in 
giving service, without regard to the value of the service or the time 
required to provide it.
    (c) Staffing. The agency must designate a position whose incumbent 
is responsible for:
    (1) The development, organization, and administration of the 
volunteer program; and
    (2) Coordination of the program with related functions.
    (d) Recruitment, selection, training, and supervision. The agency 
must have:
    (1) Methods of recruitment and selection that assure participation 
of volunteers of all income levels, in planning capacities and service 
provision; and
    (2) A program of organized training and supervision of volunteers.

[[Page 80]]

    (e) Reimbursement of expenses. The agency must--
    (1) Reimburse volunteers for actual expenses incurred in providing 
services; and
    (2) Assure that no volunteer is deprived of the opportunity to serve 
because of the expenses involved.
    (f) Progressive expansion. The agency must provide for annual 
increase in the number of volunteers used until the volunteer program is 
adequate for the achievement of the agency's service goals.



              Subpart C_Staffing and Training Expenditures



Sec.  432.45  Applicability of provisions in subpart.

    The rates of FFP specified in this subpart C do not apply to State 
personnel who conduct survey activities and certify facilities for 
participation in Medicaid, as provided for under section 1902(a)(33)(B) 
of the Act.

[50 FR 46663, Nov. 12, 1985; 50 FR 49389, Dec. 2, 1985]



Sec.  432.50  FFP: Staffing and training costs.

    (a) Availability of FFP. FFP is available in expenditures for salary 
or other compensation, fringe benefits, travel, per diem, and training, 
at rates determined on the basis of the individual's position, as 
specified in paragraph (b) of this section.
    (b) Rates of FFP. (1) For skilled professional medical personnel and 
directly supporting staff of the Medicaid agency or of other public 
agencies (as defined in Sec.  432.2), the rate is 75 percent.
    (2) For personnel engaged directly in the operation of mechanized 
claims processing and information retrieval systems, the rate is 75 
percent.
    (3) For personnel engaged in the design, development, or 
installation of mechanized claims processing and information retrieval 
systems, the rate is 50 percent for training and 90 percent for all 
other costs specified in paragraph (a) of this section.
    (4) [Reserved]
    (5) For personnel administering family planning services and 
supplies, the rate is 90 percent.
    (6) For all other staff of the Medicaid agency or other public 
agencies providing services to the Medicaid agency, and for training and 
other expenses of volunteers, the rate is 50 percent.
    (c) Application of rates. (1) FFP is prorated for staff time that is 
split among functions reimbursed at different rates.
    (2) Rates of FFP in excess of 50 percent apply only to those 
portions of the individual's working time that are spent carrying out 
duties in the specified areas for which the higher rate is authorized.
    (3) The allocation of personnel and staff costs must be based on 
either the actual percentages of time spent carrying out duties in the 
specified areas, or another methodology approved by CMS.
    (d) Other limitations for FFP rate for skilled professional medical 
personnel and directly supporting staff--(1) Medicaid agency personnel 
and staff. The rate of 75 percent FFP is available for skilled 
professional medical personnel and directly supporting staff of the 
Medicaid agency if the following criteria, as applicable, are met:
    (i) The expenditures are for activities that are directly related to 
the administration of the Medicaid program, and as such do not include 
expenditures for medical assistance;
    (ii) The skilled professional medical personnel have professional 
education and training in the field of medical care or appropriate 
medical practice. ``Professional education and training'' means the 
completion of a 2-year or longer program leading to an academic degree 
or certificate in a medically related profession. This is demonstrated 
by possession of a medical license, certificate, or other document 
issued by a recognized National or State medical licensure or certifying 
organization or a degree in a medical field issued by a college or 
university certified by a professional medical organization. Experience 
in the administration, direction, or implementation of the Medicaid 
program is not considered the equivalent of professional training in a 
field of medical care.
    (iii) The skilled professional medical personnel are in positions 
that have duties and responsibilities that require

[[Page 81]]

those professional medical knowledge and skills.
    (iv) A State-documented employer-employee relationship exists 
between the Medicaid agency and the skilled professional medical 
personnel and directly supporting staff; and
    (v) The directly supporting staff are secretarial, stenographic, and 
copying personnel and file and records clerks who provide clerical 
services that are directly necessary for the completion of the 
professional medical responsibilities and functions of the skilled 
professional medical staff. The skilled professional medical staff must 
directly supervise the supporting staff and the performance of the 
supporting staff's work.
    (2) Staff of other public agencies. The rate of 75 percent FFP is 
available for staff of other public agencies if the requirements 
specified in paragraph (d)(1) of this section are met and the public 
agency has a written agreement with the Medicaid agency to verify that 
these requirements are met.
    (e) Limitations on FFP rates for staff in mechanized claims 
processing and information retrieval systems. The special matching rates 
for persons working on mechanized claims processing and information 
retrieval systems (paragraphs (b)(2) and (3) of this section) are 
applicable only if the design, development and installation, or the 
operation, have been approved by the Administrator in accordance with 
part 433, subchapter C, of this chapter.

[43 FR 45199, Sept. 29, 1978, as amended at 46 FR 48566, Oct. 1, 1981; 
50 FR 46663, Nov. 12, 1985]



Sec.  432.55  Reporting training and administrative costs.

    (a) Scope. This section identifies activities and costs to be 
reported as training or administrative costs on quarterly estimate and 
expenditure reports to CMS.
    (b) Activities and costs to be reported on training expenditures. 
(1) For fulltime training (with no assigned agency duties): Salaries, 
fringe benefits, dependency allowances, travel, tuition, books, and 
educational supplies.
    (2) For part-time training: Travel, per diem, tuition, books and 
educational supplies.
    (3) For State and local Medicaid agency staff development personnel 
(including supporting staff) assigned fulltime training functions: 
Salaries, fringe benefits, travel, and per diem. Costs for staff 
spending less than full time on training for the Medicaid program must 
be allocated between training and administration in accordance with 
Sec.  433.34 of this subchapter.
    (4) For experts engaged to develop or conduct special programs: 
Salary, fringe benefits, travel, and per diem.
    (5) For agency training activities directly related to the program: 
Use of space, postage, teaching supplies, and purchase or development of 
teaching materials and equipment, for example, books and audiovisual 
aids.
    (6) For field instruction in Medicaid: Instructors' salaries and 
fringe benefits, rental of space, travel, clerical assistance, teaching 
materials and equipment such as books and audiovisual aids.
    (c) Activities and costs not to be reported as training 
expenditures. The following activities are to be reported as 
administrative costs:
    (1) Salaries of supervisors (day-to-day supervision of staff is not 
a training activity); and
    (2) Cost of employing students on a temporary basis, for instance, 
during summer vacation.

[43 FR 45199, Sept. 29, 1978, as amended at 44 FR 17935, Mar. 23, 1979]



PART 433_STATE FISCAL ADMINISTRATION--Table of Contents



Sec.
433.1 Purpose.

    Subpart A_Federal Matching and General Administration Provisions

433.8 [Reserved]
433.10 Rates of FFP for program services.
433.11 Enhanced FMAP rate for children.
433.15 Rates of FFP for administration.
433.32 Fiscal policies and accountability.
433.34 Cost allocation.
433.35 Equipment--Federal financial participation.
433.36 Liens and recoveries.
433.37 Reporting provider payments to Internal Revenue Service.
433.38 Interest charge on disallowed claims for FFP.

[[Page 82]]

433.40 Treatment of uncashed or cancelled (voided) Medicaid checks.

     Subpart B_General Administrative Requirements State Financial 
                              Participation

433.50 Basis, scope, and applicability.
433.51 Funds from units of government as the State share of financial 
          participation.
433.52 General definitions.
433.53 State plan requirements.
433.54 Bona fide donations.
433.55 Health care-related taxes defined.
433.56 Classes of health care services and providers defined.
433.57 General rules regarding revenues from provider-related donations 
          and health care-related taxes.
433.58-433.60 [Reserved]
433.66 Permissible provider-related donations.
433.67 Limitations on level of FFP for permissible provider-related 
          donations.
433.68 Permissible health care-related taxes.
433.70 Limitation on level of FFP for revenues from health care-related 
          taxes.
433.72 Waiver provisions applicable to health care-related taxes.
433.74 Reporting requirements.

Subpart C_Mechanized Claims Processing and Information Retrieval Systems

433.110 Basis, purpose, and applicability.
433.111 Definitions.
433.112 FFP for design, development, installation or enhancement of 
          mechanized processing and information retrieval systems.
433.114 Procedures for obtaining initial approval; notice of decision.
433.116 FFP for operation of mechanized claims processing and 
          information retrieval systems.
433.117 Initial approval of replacement systems.
433.119 Conditions for reapproval; notice of decision.
433.120 Procedures for reduction of FFP after reapproval review.
433.121 Reconsideration of the decision to reduce FFP after reapproval 
          review.
433.122 Reapproval of a disapproved system.
433.123 Notification of changes in system requirements, performance 
          standards or other conditions for approval or reapproval.
433.127 Termination of FFP for failure to provide access to claims 
          processing and information retrieval systems.
433.131 Waiver for noncompliance with conditions of approval and 
          reapproval.

                     Subpart D_Third Party Liability

433.135 Basis and purpose.
433.136 Definitions.
433.137 State plan requirements.
433.138 Identifying liable third parties.
433.139 Payment of claims.
433.140 FFP and repayment of Federal share.

                    Assignment of Rights to Benefits

433.145 Assignment of rights to benefits--State plan requirements.
433.146 Rights assigned; assignment method.
433.147 Cooperation in establishing the identity of a child's parents 
          and in obtaining medical support and payments and in 
          identifying and providing information to assist in pursuing 
          third parties who may be liable to pay.
433.148 Denial or termination of eligibility.

              Cooperative Agreements and Incentive Payments

433.151 Cooperative agreements and incentive payments--State plan 
          requirements.
433.152 Requirements for cooperative agreements for third party 
          collections.
433.153 Incentive payments to States and political subdivisions.
433.154 Distribution of collections.

   Subpart E_Methodologies for Determining Federal Share of Medicaid 
                Expenditures for Adult Eligibility Group

433.202 Scope.
433.204 Definitions.
433.206 Threshold methodology.

    Subpart F_Refunding of Federal Share of Medicaid Overpayment to 
                                Providers

433.300 Basis.
433.302 Scope of subpart.
433.304 Definitions.
433.310 Applicability of requirements.
433.312 Basic requirements for refunds.
433.316 When discovery of overpayment occurs and its significance.
433.318 Overpayments involving providers who are bankrupt or out of 
          business.
433.320 Procedures for refunds to CMS.
433.322 Maintenance of records.

Subpart G_Temporary FMAP Increase During the Public Health Emergency for 
                                COVID	19

433.400 Continued enrollment for temporary FMAP increase.

    Authority: 42 U.S.C. 1302.

    Source: 43 FR 45201, Sept. 29, 1978, unless otherwise noted.



Sec.  433.1  Purpose.

    This part specifies the rates of FFP for services and 
administration, and

[[Page 83]]

prescribes requirements, prohibitions, and FFP conditions relating to 
State fiscal activities.



    Subpart A_Federal Matching and General Administration Provisions



Sec.  433.8  [Reserved]



Sec.  433.10  Rates of FFP for program services.

    (a) Basis. Sections 1903(a)(1), 1903(g), 1905(b), 1905(y), and 
1905(z) provide for payments to States, on the basis of a Federal 
medical assistance percentage, for part of their expenditures for 
services under an approved State plan.
    (b) Federal medical assistance percentage (FMAP)--Computations. The 
FMAP is determined by the formula described in section 1905(b) of the 
Act. Under the formula, if a State's per capita income is equal to the 
national average per capita income, the Federal share is 55 percent. If 
a State's per capita income exceeds the national average, the Federal 
share is lower, with a statutory minimum of 50 percent. If a State's per 
capita income is lower than the national average, the Federal share is 
increased, with a statutory maximum of 83 percent. The formula used in 
determining the State and Federal share is as follows:

State Share = [(State per capita income) \2\/(National per capita 
          income) \2\] x 45 percent
Federal share = 100 percent minus the State share (with a minimum of 50 
          percent and a maximum of 83 percent)


The formula provides for squaring both the State and national average 
per capita incomes; this procedure magnifies any difference between the 
State's income and the national average. Consequently, Federal matching 
to lower income States is increased, and Federal matching to higher 
income States is decreased, within the statutory 50-83 percent limits. 
The FMAP for Puerto Rico, the Virgin Islands, Guam, the Northern Mariana 
Islands, and American Samoa is set by statute at 50 percent and is 
subject to dollar limitations specified in section 1108 of the Act.
    (c) Special provisions. (1) Under section 1903(a)(5) of the Act, the 
Federal share of State expenditures for family planning services is 90 
percent.
    (2) Under section 1905(b), the Federal share of State expenditures 
for services provided through Indian Health Service facilities is 100 
percent.
    (3) Under section 1903(g), the FMAP is reduced if the State does not 
have an effective program to control use of institutional services.
    (4) Under section 1905(b) of the Social Security Act, the Federal 
share of State expenditures described in Sec.  433.11(a) for services 
provided to children, is the enhanced FMAP rate determined in accordance 
with Sec.  457.622(b) of this chapter, subject to the conditions 
explained in Sec.  433.11(b).
    (5)(i) Under section 1933(d) of the Act, the Federal share of State 
expenditures for Medicare Part B premiums described in section 
1905(p)(3)(A)(ii) of the Act on behalf of Qualifying Individuals 
described in section 1902(a)(10)(E)(iv) of the Act, is 100 percent, to 
the extent that the assistance does not exceed the State's allocation 
under paragraph (c)(5)(ii) of this section. To the extent that the 
assistance exceeds that allocation, the Federal share is 0 percent.
    (ii) Under section 1933(c)(2) of the Act and subject to paragraph 
(c)(5)(iii) of this section, the allocation to each State is equal to 
the total allocation specified in section 1933(g) of the Act multiplied 
by the Secretary's estimate of the ratio of the total number of 
individuals described in section 1902(a)(10)(E)(iv) of the Act in the 
State to the total number of individuals described in section 
1902(a)(10)(E)(iv) of the Act for all eligible States. In estimating 
that ratio, the Secretary will use data from the U.S. Census Bureau.
    (iii) If, based on projected expenditures for a fiscal year, or for 
a shorter period for which funding is available under section 1933 of 
the Act, the Secretary determines that the expenditures described in 
paragraph (c)(5)(i) of this section for one or more States are projected 
to exceed the allocation made to the State, the Secretary may adjust 
each State's fiscal year allocation, as follows:
    (A) The Secretary will compare each State's projected total 
expenditures for the expenses described in paragraph (c)(5)(i) of this 
section to the State's

[[Page 84]]

initial allocation determined under paragraph (c)(5)(ii) of this 
section, to determine the extent of each State's projected surplus or 
deficit.
    (B) The surplus of each State with a projected surplus, as 
determined in accordance with paragraph (c)(5)(iii)(A) of this section 
will be added together to arrive at the Total Projected Surplus.
    (C) The deficit of each State with a projected deficit, as 
determined in accordance with paragraph (c)(5)(iii)(A) of this section 
will be added together to arrive at the Total Projected Deficit.
    (D) Each State with a projected deficit will receive an additional 
allocation equal to the amount of its projected deficit, or a prorated 
amount of such deficit, if the Total Projected Deficit is greater than 
the Total Projected Surplus. Except as described in paragraph 
(c)(5)(iii)(E) of this section, the amount to be reallocated from each 
State with a projected surplus will be equal to A x B, where A equals 
the Total Projected Deficit and B equals the amount of the State's 
projected surplus as a percentage of the Total Projected Surplus.
    (E) If the Total Projected Deficit determined under paragraph 
(c)(5)(iii)(C) of this section is greater than the Total Projected 
Surplus determined under paragraph (c)(5)(iii)(B) of this section, each 
State with a projected deficit will receive an additional allocation 
amount equal to the amount of the Total Projected Surplus multiplied by 
the amount of the projected deficit for such State as a percentage of 
the Total Projected Deficit. The amount to be reallocated from each 
State with a projected surplus will be equal to the amount of the 
projected surplus.
    (iv) CMS will notify States of any changes in allotments resulting 
from any reallocations.
    (v) The provisions in paragraph (c)(5) of this section will be in 
effect through the end of the period for which funding authority is 
available under section 1933 of the Act.
    (6)(i) Newly eligible FMAP. Beginning January 1, 2014, under section 
1905(y) of the Act, the FMAP for a State that is one of the 50 States or 
the District of Columbia, including a State that meets the definition of 
expansion State in Sec.  433.204(b), for amounts expended by such State 
for medical assistance for newly eligible individuals, as defined in 
Sec.  433.204(a)(1), will be an increased FMAP equal to:
    (A) 100 percent, for calendar quarters in calendar years (CYs) 2014 
through 2016;
    (B) 95 percent, for calendar quarters in CY 2017;
    (C) 94 percent, for calendar quarters in CY 2018;
    (D) 93 percent, for calendar quarters in CY 2019;
    (E) 90 percent, for calendar quarters in CY 2020 and all subsequent 
calendar years.
    (ii) The FMAP specified in paragraph (c)(6)(i) of this section will 
apply to amounts expended by a State for medical assistance for newly 
eligible individuals in accordance with the requirements of the 
methodology applied by the State under Sec.  433.206.
    (7)(i) Temporary FMAP increase. During the period January 1, 2014, 
through December 31, 2015, under section 1905(z)(1) of the Act for a 
State described in paragraph (c)(7)(ii) of this section, the FMAP 
determined under paragraph (b) of this section will be increased by 2.2 
percentage points.
    (ii) A State qualifies for the targeted increase in the FMAP under 
paragraph (c)(7)(i) of this section, if the State:
    (A) Is an expansion State, as described in Sec.  433.204(b) of this 
section;
    (B) Does not qualify for any payments on the basis of the increased 
FMAP under paragraph (c)(6) of this section, as determined by the 
Secretary; and
    (C) Has not been approved by the Secretary to divert a portion of 
the disproportionate share hospital allotment for the State under 
section 1923(f) of the Act to the costs of providing medical assistance 
or other health benefits coverage under a demonstration that is in 
effect on July 1, 2009.
    (iii) The increased FMAP under paragraph (c)(7)(i) of this section 
is available for amounts expended by the State for medical assistance 
for individuals that are not newly eligible as defined in Sec.  
433.204(a)(1).
    (8) Expansion State FMAP. Beginning January 1, 2014, under section 
1905(z)(2)

[[Page 85]]

of the Act, the FMAP for an expansion State defined in Sec.  433.204(b), 
for amounts expended by such State for medical assistance for 
individuals described in Sec.  435.119 of this chapter who are not newly 
eligible as defined in Sec.  433.204(a)(1), and who are nonpregnant 
childless adults with respect to whom the State may require enrollment 
in benchmark coverage under section 1937 of the Act, will be determined 
in accordance with the expansion State FMAP formula in paragraph 
(c)(8)(i).
[GRAPHIC] [TIFF OMITTED] TR02AP13.029

    (i) Expansion State FMAP.
    (ii) Transition percentage. For purposes of paragraph (c)(8)(i) of 
this section, the transition percentage is equal to:
    (A) 50 percent, for calendar quarters in CY 2014;
    (B) 60 percent, for calendar quarters in CY 2015;
    (C) 70 percent, for calendar quarters in CY 2016;
    (D) 80 percent, for calendar quarters in CY 2017;
    (E) 90 percent, for calendar quarters in CY 2018; and
    (F) 100 percent, for calendar quarters in CY 2019 and all subsequent 
calendar years.

(Sections 1902(a)(10), 1933 of the Social Security Act (42 U.S.C. 
1396a), and Pub. L. 105-33)

[43 FR 45201, Sept. 29, 1978, as amended at 46 FR 48559, Oct. 1, 1981; 
51 FR 41350, Nov. 14, 1986; 54 FR 21066, May 16, 1989; 66 FR 2666, Jan. 
11, 2001; 70 FR 50220, Aug. 26, 2005; 71 FR 25092, Apr. 28, 2006; 73 FR 
70893, Nov. 24, 2008; 78 FR 19942, Apr. 2, 2013]



Sec.  433.11  Enhanced FMAP rate for children.

    (a) Subject to the conditions in paragraph (b) of this section, the 
enhanced FMAP determined in accordance with Sec.  457.622 of this 
chapter will be used to determine the Federal share of State 
expenditures, except any expenditures pursuant to section 1923 of the 
Act for payments to disproportionate share hospitals for--
    (1) Services provided to optional targeted low-income children 
described in Sec.  435.4 or Sec.  436.3 of this chapter; and
    (2) Services provided to children born before October 1, 1983, with 
or without group health coverage or other health insurance coverage, who 
would be described in section 1902(l)(1)(D) of the Act (poverty-level-
related children's groups) if--
    (i) They had been born on or after that date; and
    (ii) They would not qualify for medical assistance under the State 
plan in effect on March 31, 1997.
    (b) Enhanced FMAP is not available if--
    (1) A State adopts income and resource standards and methodologies 
for purposes of determining a child's eligibility under the Medicaid 
State plan that are more restrictive than those applied under policies 
of the State plan (as described in the definition of optional targeted 
low-income children at Sec.  435.4 of this chapter) in effect on June 1, 
1997; or
    (2) No funds are available in the State's title XXI allotment, as 
determined under part 457, subpart F of this

[[Page 86]]

chapter for the quarter enhanced FMAP is claimed; or
    (3) The State fails to maintain a valid method of identifying 
services provided on behalf of children listed in paragraph (a) of this 
section.

[66 FR 2666, Jan. 11, 2001]



Sec.  433.15  Rates of FFP for administration.

    (a) Basis. Section 1903(a) (2) through (5) and (7) of the Act 
provide for payments to States, on the basis of specified percentages, 
for part of their expenditures for administration of an approved State 
plan.
    (b) Activities and rates. (1) [Reserved]
    (2) Administration of family planning services: 90 percent. (Section 
1903 (a)(5); 42 CFR 432.50(b)(5).)
    (3) Design, development, or installation of mechanized claims 
processing and information retrieval systems: 90 percent. (Section 
1903(a)(3)(A)(i); 42 CFR part 433, subpart C, and Sec.  432.50 (b)(3).)
    (4) Operation of mechanized claims processing and information 
retrieval systems: 75 percent. (Section 1903(a) (3)(B); 42 CFR part 433, 
subpart C and Sec.  432.50(b)(2).)
    (5) Compensation and training of skilled professional medical 
personnel and staff directly supporting those personnel if the criteria 
specified in Sec.  432.50 (c) and (d) are met: 75 percent. (Section 
1903(a)(2); 42 CFR 432.50(b)(1).)
    (6)(i) Funds expended for the performance of medical and utilization 
review by a QIO under a contract entered into under section 1902(d) of 
the Act: 75 percent (section 1903(a)(3)(C) of the Act).
    (ii) If a State contracts for medical and utilization review with 
any individual or organization not designated under Part B of Title XI 
of the Act, funds expended for such review will be reimbursed as 
provided in paragraph (b)(7) of this section.
    (7) All other activities the Secretary finds necessary for proper 
and efficient administration of the State plan: 50 percent. (Section 
1903(a)(7).) (See also Sec.  455.300 of this subchapter for FFP at 90 
percent for State Medicaid fraud control units under section 
1903(a)(6).)
    (8) Nurse aide training and competency evaluation programs and 
competency evaluation programs described in 1919(e)(1) of the Act: for 
calendar quarters beginning on or after July 1, 1988 and before July 1, 
1990: The lesser of 90% or the Federal medical assistance percentage 
plus 25 percentage points; for calendar quarters beginning on or after 
October 1, 1990: 50%. (Section 1903(a)(2)(B) of the Act.)
    (9) Preadmission screening and annual resident review (PASARR) 
activities conducted by the State: 75 percent. (Sections 1903(a)(2)(C) 
and 1919(e)(7); 42 CFR part 483, subparts C and E.)
    (10) Funds expended for the performance of external quality review 
or the related activities described in Sec.  438.358 of this chapter 
consistent with Sec.  438.370(a) of this chapter: 75 percent; consistent 
with Sec.  438.370(b): 50 percent.

[43 FR 45201, Sept. 29, 1978, as amended at 46 FR 48566, Oct. 1, 1981; 
46 FR 54744, Nov. 4, 1981; 50 FR 15327, Apr. 17, 1985; 50 FR 46664, Nov. 
12, 1985; 56 FR 48918, Sept. 26, 1991; 57 FR 56506, Nov. 30, 1992; 68 FR 
3635, Jan. 24, 2003; 81 FR 27853, May 6, 2016]



Sec.  433.32  Fiscal policies and accountability.

    A State plan must provide that the Medicaid agency and, where 
applicable, local agencies administering the plan will--
    (a) Maintain an accounting system and supporting fiscal records to 
assure that claims for Federal funds are in accord with applicable 
Federal requirements;
    (b) Retain records for 3 years from date of submission of a final 
expenditure report;
    (c) Retain records beyond the 3-year period if audit findings have 
not been resolved; and
    (d) Retain records for nonexpendable property acquired under a 
Federal grant for 3 years from the date of final disposition of that 
property.

[44 FR 17935, Mar. 23, 1979]



Sec.  433.34  Cost allocation.

    A State plan under Title XIX of the Social Security Act must provide 
that the single or appropriate Agency will have an approved cost 
allocation plan on file with the Department in accordance with the 
requirements contained in subpart E of 45 CFR part 95. Subpart E also 
sets forth the effect on FFP if

[[Page 87]]

the requirements contained in that subpart are not met.

[47 FR 17490, Apr. 23, 1982]



Sec.  433.35  Equipment--Federal financial participation.

    Claims for Federal financial participation in the cost of equipment 
under the Medicaid Program are determined in accordance with subpart G 
of 45 CFR part 95. Requirements concerning the management and 
disposition of equipment under the Medicaid Program are also prescribed 
in subpart G of 45 CFR part 95.

[47 FR 41564, Sept. 21, 1982]



Sec.  433.36  Liens and recoveries.

    (a) Basis and purpose. This section implements sections 1902(a)(18) 
and 1917(a) and (b) of the Act, which describe the conditions under 
which an agency may impose a lien against a beneficiary's property, and 
when an agency may make an adjustment or recover funds in satisfaction 
of the claim against the individual's estate or real property.
    (b) Definition of property. For purposes of this section, 
``property'' includes the homestead and all other personal and real 
property in which the beneficiary has a legal interest.
    (c) State plan requirement. If a State chooses to impose a lien 
against an individual's real property (or as provided in paragraph 
(g)(1) of this section, personal property), the State plan must provide 
that the provisions of paragraphs (d) through (i) of this section are 
met.
    (d) Procedures. The State plan must specify the process by which the 
State will determine that an institutionalized individual cannot 
reasonably be expected to be discharged from the medical institution and 
return home as provided in paragraph (g)(2)(ii) of this section. The 
description of the process must include the type of notice to be given 
the individual, the process by which the individual will be given the 
opportunity for a hearing, the hearing procedures, and by whom and on 
what basis the determination that the individual cannot reasonably be 
expected to be discharged from the institution will be made. The notice 
to the individual must explain what is meant by the term lien, and that 
imposing a lien does not mean that the individual will lose ownership of 
the home.
    (e) Definitions. The State plan must define the following terms used 
in this section:
    (1) Individual's home.
    (2) Equity interest in home.
    (3) Residing in the home for at least 1 (or 2) year(s).
    (4) On a continuing basis.
    (5) Discharge from the medical institution and return home.
    (6) Lawfully residing.
    (f) Exception. The State plan must specify the criteria by which a 
son or daughter can establish to the agency's satisfaction that he or 
she has been providing care which permitted the individual to reside at 
home rather than in an institution, as provided in paragraph 
(h)(2)(iii)(B) of this section.
    (g) Lien provisions--(1) Incorrect payments. The agency may place a 
lien against an individual's property, both personal and real, before 
his or her death because of Medicaid claims paid or to be paid on behalf 
of that individual following a court judgement which determined that 
benefits were incorrectly paid for that individual.
    (2) Correct payments. Except as provided in paragraph (g)(3) of this 
section, the agency may place a lien against the real property of an 
individual at any age before his or her death because of Medicaid claims 
paid or to be paid for that individual when--
    (i) An individual is an inpatient of a medical institution and must, 
as a condition of receiving services in the institution under the State 
plan, apply his or her income to the cost of care as provided in 
Sec. Sec.  435.725, 435.832 and 436.832; and
    (ii) The agency determines that he or she cannot reasonably be 
expected to be discharged and return home. The agency must notify the 
individual of its intention to make that determination and provide an 
opportunity for a hearing in accordance with State established 
procedures before the determination is made. The notice to an individual 
must include an explanation of liens and the effect on an individual's 
ownership of property.

[[Page 88]]

    (3) Restrictions on placing liens. The agency may not place a lien 
on an individual's home under paragraph (g)(2) of this section if any of 
the following individuals is lawfully residing in the home:
    (i) The spouse;
    (ii) The individual's child who is under age 21 or blind or disabled 
as defined in the State plan; or
    (iii) The individual's sibling (who has an equity interest in the 
home, and who was residing in the individual's home for at least one 
year immediately before the date the individual was admitted to the 
medical institution).
    (4) Termination of lien. Any lien imposed on an individual's real 
property under paragraph (g)(2) of this section will dissolve when that 
individual is discharged from the medical institution and returns home.
    (h) Adjustments and recoveries. (1) The agency may make an 
adjustment or recover funds for Medicaid claims correctly paid for an 
individual as follows:
    (i) From the estate of any individual who was 65 years of age or 
older when he or she received Medicaid; and
    (ii) From the estate or upon sale of the property subject to a lien 
when the individual is institutionalized as described in paragraph 
(g)(2) of this section.
    (2) The agency may make an adjustment or recovery under paragraph 
(h)(1) of this section only:
    (i) After the death of the individual's surviving spouse; and
    (ii) When the individual has no surviving child under age 21 or 
blind or disabled as defined in the State plan; and
    (iii) In the case of liens placed on an individual's home under 
paragraph (g)(2) of this section, when there is no--
    (A) Sibling of the individual residing in the home, who has resided 
there for at least one year immediately before the date of the 
individual's admission to the institution, and has resided there on a 
continuous basis since that time; or
    (B) Son or daughter of the individual residing in the home, who has 
resided there for at least two years immediately before the date of the 
individual's admission to the institution, has resided there on a 
continuous basis since that time, and can establish to the agency's 
satisfaction that he or she has been providing care which permitted the 
individual to reside at home rather than in an institution.
    (i) Prohibition of reduction of money payments. No money payment 
under another program may be reduced as a means of recovering Medicaid 
claims incorrectly paid.

[43 FR 45201, Sept. 29, 1978, as amended at 47 FR 43647, Oct. 1, 1982; 
47 FR 49847, Nov. 3, 1982]



Sec.  433.37  Reporting provider payments to Internal Revenue Service.

    (a) Basis and purpose. This section, based on section 1902(a)(4) of 
the Act, prescribes requirements concerning--
    (1) Identification of providers; and
    (2) Compliance with the information reporting requirements of the 
Internal Revenue Code.
    (b) Identification of providers. A State plan must provide for the 
identification of providers by--
    (1) Social security number if--
    (i) The provider is in solo practice; or
    (ii) The provider is not in solo practice but billing is by the 
individual practitioner; or
    (2) Employer identification number for all other providers.
    (c) Compliance with section 6041 of the Internal Revenue Code. The 
plan must provide that the Medicaid agency complies with the information 
reporting requirements of section 6041 of the Internal Revenue Code (26 
U.S.C. 6041). Section 6041 requires the filing of annual information 
returns showing amounts paid to providers, who are identified by name, 
address, and social security number or employer identification number.



Sec.  433.38  Interest charge on disallowed claims for FFP.

    (a) Basis and scope. This section is based on section 1903(d)(5) of 
the Act, which requires that the Secretary charge a State interest on 
the Federal share of claims that have been disallowed but have been 
retained by the State during the administrative appeals process under 
section 1116(e) of the Act and the Secretary later recovers after the 
administrative appeals

[[Page 89]]

process has been completed. This section does not apply to--
    (1) Claims that have been deferred by the Secretary and disallowed 
within the time limits of Sec.  430.40 of this chapter. Deferral of 
claims for FFP; or
    (2) Claims for expenditures that have never been paid on a grant 
award; or
    (3) Disallowances of any claims for services furnished before 
October 1, 1980, regardless of the date of the claim submitted to CMS.
    (b) General principles. (1) CMS will charge the State interest on 
FFP when--
    (i) CMS has notified the Medicaid agency under Sec.  430.42 of this 
subpart that a State's claim for FFP is not allowable;
    (ii) The agency has requested a reconsideration of the disallowance 
to the Administrator under Sec.  430.42 of this chapter and has chosen 
to retain the FFP during the administrative reconsideration process in 
accordance with paragraph (c)(2) of this section;
    (iii)(A) CMS has made a final determination upholding part or all of 
the disallowance;
    (B) The agency has withdrawn its request for administrative 
reconsideration on all or part of the disallowance; or
    (C) The agency has reversed its decision to retain the funds without 
withdrawing its request for administrative reconsideration and CMS 
upholds all or part of the disallowance.
    (iv) The agency has appealed the disallowance to the Departmental 
Appeals Board under 45 CFR part 16 and has chosen to retain the FFP 
during the administrative appeals process in accordance with paragraph 
(c)(2) of this section.
    (v)(A)The Board has made a final determination upholding part or all 
of the disallowance;
    (B) The agency has withdrawn its appeal on all or part of the 
disallowance; or
    (C) The agency has reversed its decision to retain the funds without 
withdrawing its appeal and the Board upholds all or part of the 
disallowance.
    (2) If the courts overturn, in whole or in part, a Board decision 
that has sustained a disallowance, CMS will return the principal and the 
interest collected on the funds that were disallowed, upon the 
completion of all judicial appeals.
    (3) Unless an agency decides to withdraw its request for 
administrative reconsideration or appeal on part of the disallowance and 
therefore returns only that part of the funds on which it has withdrawn 
its request for administrative reconsideration or appeal, any decision 
to retain or return disallowed funds must apply to the entire amount in 
dispute.
    (4) If the agency elects to have CMS recover the disputed amount, it 
may not reverse that election.
    (c) State procedures. (1) If the Medicaid agency has requested 
administrative reconsideration to CMS or appeal of a disallowance to the 
Board and wishes to retain the disallowed funds until CMS or the Board 
issues a final determination, the agency must notify the CMS Regional 
Office in writing of its decision to do so.
    (2) The agency must mail its notice to the CMS Regional Office 
within 60 days of the date of receipt of the notice of the disallowance, 
as established by the certified mail receipt accompanying the notice.
    (3) If the agency withdraws its decision to retain the FFP or its 
request for administrative reconsideration or appeal on all or part of 
the FFP, the agency must notify CMS in writing.
    (d) Amount of interest charged. (1) If the agency retains funds that 
later become subject to an interest charge under paragraph (b) of this 
section, CMS will offset from the next Medicaid grant award to the State 
the amount of the funds subject to the interest charge, plus interest on 
that amount.
    (2) The interest charge is at the rate CMS determines to be the 
average of the bond equivalent of the weekly 90-day Treasury bill 
auction rates during the period for which interest will be charged.
    (e) Duration of interest. (1) The interest charge on the amount of 
disallowed FFP retained by the agency will begin on the date of the 
disallowance notice and end--
    (i) On the date of the final determination by CMS of the 
administrative reconsideration if the State elects not to

[[Page 90]]

appeal to the Board, or final determination by the Board;
    (ii) On the date CMS receives written notice from the State that it 
is withdrawing its request for administrative reconsideration and elects 
not to appeal to the Board, or withdraws its appeal to the Board on all 
of the disallowed funds; or
    (iii) If the agency withdraws its request for administrative 
reconsideration on part of the funds on--
    (A) The date CMS receives written notice from the agency that it is 
withdrawing its request for administrative reconsideration on a 
specified part of the disallowed funds for the part on which the agency 
withdraws its request for administrative reconsideration; and
    (B) The date of the final determination by CMS on the part for which 
the agency pursues its administrative reconsideration; or
    (iv) If the agency withdraws its appeal on part of the funds, on--
    (A) The date CMS receives written notice from the agency that it is 
withdrawing its appeal on a specified part of the disallowed funds for 
the part on which the agency withdraws its appeal; and
    (B) The date of the final determination by the Board on the part for 
which the agency pursues its appeal; or
    (v) If the agency has given CMS written notice of its intent to 
repay by installment, in the quarter in which the final installment is 
paid. Interest during the repayment of Federal funds by installments 
will be at the Current Value of Funds Rate (CVFR); or
    (vi) The date CMS receives written notice from the agency that it no 
longer chooses to retain the funds.
    (2) CMS will not charge interest on FFP retained by an agency for 
more than 12 months for disallowances of FFP made between October 1, 
1980 and August 13, 1981.

[48 FR 29485, June 27, 1983, as amended at 77 FR 31510, May 29, 2012]



Sec.  433.40  Treatment of uncashed or cancelled (voided) Medicaid checks.

    (a) Purpose. This section provides the rules to ensure that States 
refund the Federal portion of uncashed or cancelled (voided) checks 
under title XIX.
    (b) Definitions. As used in this section--
    Cancelled (voided) check means a Medicaid check issued by a State or 
fiscal agent which prior to its being cashed is cancelled (voided) by 
the State or fiscal agent, thus preventing disbursement of funds.
    Check means a check or warrant that a State or local agency uses to 
make a payment.
    Fiscal agent means an entity that processes or pays vendor claims 
for the Medicaid State agency.
    Uncashed check means a Medicaid check issued by a State or fiscal 
agent which has not been cashed by the payee.
    Warrant means an order by which the State agency or local agency 
without the authority to issue checks recognizes a claim. Presentation 
of a warrant by the payee to a State officer with authority to issue 
checks will result in release of funds due.
    (c) Refund of Federal financial participation (FFP) for uncashed 
checks--(1) General provisions. If a check remains uncashed beyond a 
period of 180 days from the date it was issued; i.e., the date of the 
check, it will no longer be regarded as an allowable program 
expenditure. If the State has claimed and received FFP for the amount of 
the uncashed check, it must refund the amount of FFP received.
    (2) Report of refund. At the end of each calendar quarter, the State 
must identify those checks which remain uncashed beyond a period of 180 
days after issuance. The State agency must refund all FFP that it 
received for uncashed checks by adjusting the Quarterly Statement of 
Expenditures for that quarter. If an uncashed check is cashed after the 
refund is made, the State may file a claim. The claim will be considered 
to be an adjustment to the costs for the quarter in which the check was 
originally claimed. This claim will be paid if otherwise allowed by the 
Act and the regulations issued pursuant to the Act.
    (3) If the State does not refund the appropriate amount as specified 
in paragraph (c)(2) of this section, the amount will be disallowed.
    (d) Refund of FFP for cancelled (voided) checks--(1) General 
provision. If the

[[Page 91]]

State has claimed and received FFP for the amount of a cancelled 
(voided) check, it must refund the amount of FFP received.
    (2) Report of refund. At the end of each calendar quarter, the State 
agency must identify those checks which were cancelled (voided). The 
State must refund all FFP that it received for cancelled (voided) checks 
by adjusting the Quarterly Statement of Expenditures for that quarter.
    (3) If the State does not refund the appropriate amount as specified 
in paragraph (d)(2) of this section, the amount will be disallowed.

[51 FR 36227, Oct. 9, 1986]



     Subpart B_General Administrative Requirements State Financial 
                              Participation

    Source: 57 FR 55138, Nov. 24, 1992, unless otherwise noted.



Sec.  433.50  Basis, scope, and applicability.

    (a) Basis. This subpart interprets and implements--(1) Section 
1902(a)(2) of the Act which requires States to share in the cost of 
medical assistance expenditures and permit both State and local 
governments to participate in the financing of the non-Federal portion 
of medical assistance expenditures.
    (2) Section 1903(a) of the Act, which requires the Secretary to pay 
each State an amount equal to the Federal medical assistance percentage 
of the total amount expended as medical assistance under the State's 
plan.
    (3) Section 1903(w) of the Act, which specifies the treatment of 
revenues from provider-related donations and health care-related taxes 
in determining a State's medical assistance expenditures for which 
Federal financial participation (FFP) is available under the Medicaid 
program.
    (b) Scope. This subpart--
    (1) Specifies State plan requirements for State financial 
participation in expenditures for medical assistance.
    (2) Defines provider-related donations and health care-related taxes 
that may be received without a reduction in FFP.
    (3) Specifies rules for revenues received from provider-related 
donations and health care-related taxes during a transition period.
    (4) Establishes limitations on FFP when States receive funds from 
provider-related donations and revenues generated by health care-related 
taxes.
    (c) Applicability. The provisions of this subpart apply to the 50 
States and the District of Columbia, but not to any State whose entire 
Medicaid program is operated under a waiver granted under section 1115 
of the Act.

[57 FR 55138, Nov. 24, 1992; 58 FR 6095, Jan. 26, 1993; 72 FR 29832, May 
29, 2007; 72 FR 29832, May 29, 2007; 75 FR 73975, Nov. 30, 2010]



Sec.  433.51  Public Funds as the State share of financial participation.

    (a) Public Funds may be considered as the State's share in claiming 
FFP if they meet the conditions specified in paragraphs (b) and (c) of 
this section.
    (b) The public funds are appropriated directly to the State or local 
Medicaid agency, or are transferred from other public agencies 
(including Indian tribes) to the State or local agency and under its 
administrative control, or certified by the contributing public agency 
as representing expenditures eligible for FFP under this section.
    (c) The public funds are not Federal funds, or are Federal funds 
authorized by Federal law to be used to match other Federal funds.

[75 FR 73975, Nov. 30, 2010]



Sec.  433.52  General definitions.

    As used in this subpart--
    Entity related to a health care provider means--
    (1) An organization, association, corporation, or partnership formed 
by or on behalf of a health care provider;
    (2) An individual with an ownership or control interest in the 
provider, as defined in section 1124(a)(3) of the Act;
    (3) An employee, spouse, parent, child, or sibling of the provider, 
or of a person with an ownership or control interest in the provider, as 
defined in section 1124(a)(3) of the Act; or
    (4) A supplier of health care items or services or a supplier to 
providers of health care items or services.
    Health care provider means the individual or entity that receives 
any payment or payments for health care items or services provided.

[[Page 92]]

    Provider-related donation means a donation or other voluntary 
payment (in cash or in kind) made directly or indirectly to a State or 
unit of local government by or on behalf of a health care provider, an 
entity related to such a health care provider, or an entity providing 
goods or services to the State for administration of the State's 
Medicaid plan.
    (1) Donations made by a health care provider to an organization, 
which in turn donates money to the State, may be considered to be a 
donation made indirectly to the State by a health care provider.
    (2) When an organization receives less than 25 percent of its 
revenues from providers and/or provider-related entities, its donations 
will not generally be presumed to be provider-related donations. Under 
these circumstances, a provider-related donation to an organization will 
not be considered a donation made indirectly to the State. However, if 
the donations from providers to an organization are subsequently 
determined to be indirect donations to the State or unit of local 
government for administration of the State's Medicaid program, then such 
donations will be considered to be health care related.
    (3) When the organization receives more than 25 percent of its 
revenue from donations from providers or provider-related entities, the 
organization always will be considered as acting on behalf of health 
care providers if it makes a donation to the State. The amount of the 
organization's donation to the State, in a State fiscal year, that will 
be considered health care related, will be based on the percentage of 
donations the organization received from the providers during that 
period.



Sec.  433.53  State plan requirements.

    A State plan must provide that--
    (a) State (as distinguished from local) funds will be used both for 
medical assistance and administration;
    (b) State funds will be used to pay at least 40 percent of the non-
Federal share of total expenditures under the plan; and
    (c) State and Federal funds will be apportioned among the political 
subdivisions of the State on a basis that assures that--
    (1) Individuals in similar circumstances will be treated similarly 
throughout the State; and
    (2) If there is local financial participation, lack of funds from 
local sources will not result in lowering the amount, duration, scope, 
or quality of services or level of administration under the plan in any 
part of the State.

[57 FR 55138, Nov. 24, 1992; 58 FR 6095, Jan. 26, 1993]



Sec.  433.54  Bona fide donations.

    (a) A bona fide donation means a provider-related donation, as 
defined in Sec.  433.52, made to the State or unit of local government, 
that has no direct or indirect relationship, as described in paragraph 
(b) of this section, to Medicaid payments made to--
    (1) The health care provider;
    (2) Any related entity providing health care items and services; or
    (3) Other providers furnishing the same class of items or services 
as the provider or entity.
    (b) Provider-related donations will be determined to have no direct 
or indirect relationship to Medicaid payments if those donations are not 
returned to the individual provider, the provider class, or related 
entity under a hold harmless provision or practice, as described in 
paragraph (c) of this section.
    (c) A hold harmless practice exists if any of the following applies:
    (1) The State (or other unit of government) provides for a direct or 
indirect non-Medicaid payment to those providers or others making, or 
responsible for, the donation, and the payment amount is positively 
correlated to the donation. A positive correlation includes any positive 
relationship between these variables, even if not consistent over time.
    (2) All or any portion of the Medicaid payment to the donor, 
provider class, or related entity, varies based only on the amount of 
the donation, including where Medicaid payment is conditional on receipt 
of the donation.
    (3) The State (or other unit of government) receiving the donation 
provides for any direct or indirect payment, offset, or waiver such that 
the provision of that payment, offset, or

[[Page 93]]

waiver directly or indirectly guarantees to return any portion of the 
donation to the provider (or other parties responsible for the 
donation).
    (d) CMS will presume provider-related donations to be bona fide if 
the voluntary payments, including, but not limited to, gifts, 
contributions, presentations or awards, made by or on behalf of 
individual health care providers to the State, county, or any other unit 
of local government does not exceed--
    (1) $5,000 per year in the case of an individual provider donation; 
or
    (2) $50,000 per year in the case of a donation from any health care 
organizational entity.
    (e) To the extent that a donation presumed to be bona fide contains 
a hold harmless provision, as described in paragraph (c) of this 
section, it will not be considered a bona fide donation. When provider-
related donations are not bona fide, CMS will deduct this amount from 
the State's medical assistance expenditures before calculating FFP. This 
offset will apply to all years the State received such donations and any 
subsequent fiscal year in which a similar donation is received.

[57 FR 55138, Nov. 24, 1992, as amended at 73 FR 9698, Feb. 22, 2008]



Sec.  433.55  Health care-related taxes defined.

    (a) A health care-related tax is a licensing fee, assessment, or 
other mandatory payment that is related to--
    (1) Health care items or services;
    (2) The provision of, or the authority to provide, the health care 
items or services; or
    (3) The payment for the health care items or services.
    (b) A tax will be considered to be related to health care items or 
services under paragraph (a)(1) of this section if at least 85 percent 
of the burden of the tax revenue falls on health care providers.
    (c) A tax is considered to be health care related if the tax is not 
limited to health care items or services, but the treatment of 
individuals or entities providing or paying for those health care items 
or services is different than the tax treatment provided to other 
individuals or entities.
    (d) A health care-related tax does not include payment of a criminal 
or civil fine or penalty, unless the fine or penalty was imposed instead 
of a tax.
    (e) Health care insurance premiums and health maintenance 
organization premiums paid by an individual or group to ensure coverage 
or enrollment are not considered to be payments for health care items 
and services for purposes of determining whether a health care-related 
tax exists.



Sec.  433.56  Classes of health care services and providers defined.

    (a) For purposes of this subpart, each of the following will be 
considered as a separate class of health care items or services:
    (1) Inpatient hospital services;
    (2) Outpatient hospital services;
    (3) Nursing facility services (other than services of intermediate 
care facilities for individuals with intellectual disabilities);
    (4) Intermediate care facility services for individuals with 
intellectual disabilities, and similar services furnished by community-
based residences for individuals with intellectual disabilities, under a 
waiver under section 1915(c) of the Act, in a State in which, as of 
December 24, 1992, at least 85 percent of such facilities were 
classified as ICF/IIDs prior to the grant of the waiver;
    (5) Physician services;
    (6) Home health care services;
    (7) Outpatient prescription drugs;
    (8) Services of managed care organizations (including health 
maintenance organizations, preferred provider organizations);
    (9) Ambulatory surgical center services, as described for purposes 
of the Medicare program in section 1832(a)(2)(F)(i) of the Social 
Security Act. These services are defined to include facility services 
only and do not include surgical procedures;
    (10) Dental services;
    (11) Podiatric services;
    (12) Chiropractic services;
    (13) Optometric/optician services;
    (14) Psychological services;
    (15) Therapist services, defined to include physical therapy, speech 
therapy, occupational therapy, respiratory therapy, audiological 
services, and rehabilitative specialist services;

[[Page 94]]

    (16) Nursing services, defined to include all nursing services, 
including services of nurse midwives, nurse practitioners, and private 
duty nurses;
    (17) Laboratory and x-ray services, defined as services provided in 
a licensed, free-standing laboratory or x-ray facility. This definition 
does not include laboratory or x-ray services provided in a physician's 
office, hospital inpatient department, or hospital outpatient 
department;
    (18) Emergency ambulance services; and
    (19) Other health care items or services not listed above on which 
the State has enacted a licensing or certification fee, subject to the 
following:
    (i) The fee must be broad based and uniform or the State must 
receive a waiver of these requirements;
    (ii) The payer of the fee cannot be held harmless; and
    (iii) The aggregate amount of the fee cannot exceed the State's 
estimated cost of operating the licensing or certification program.
    (b) Taxes that pertain to each class must apply to all items and 
services within the class, regardless of whether the items and services 
are furnished by or through a Medicaid-certified or licensed provider.

[57 FR 55138, Nov. 24, 1992, as amended at 58 FR 43180, Aug. 13, 1993; 
73 FR 9698, Feb. 22, 2008]



Sec.  433.57  General rules regarding revenues from provider-related
donations and health care-related taxes.

    Effective January 1, 1992, CMS will deduct from a State's 
expenditures for medical assistance, before calculating FFP, funds from 
provider-related donations and revenues generated by health care-related 
taxes received by a State or unit of local government, in accordance 
with the requirements, conditions, and limitations of this subpart, if 
the donations and taxes are not--
    (a) Permissible provider-related donations, as specified in Sec.  
433.66(b); or
    (b) Health care-related taxes, as specified in Sec.  433.68(b).

[57 FR 55138, Nov. 24, 1992, as amended at 73 FR 9698, Feb. 22, 2008]



Sec. Sec.  433.58-433.60  [Reserved]



Sec.  433.66  Permissible provider-related donations.

    (a) General rule. (1) Except as specified in paragraph (a)(2) of 
this section, a State may receive revenues from provider-related 
donations without a reduction in FFP, only in accordance with the 
requirements of this section.
    (2) The provisions of this section relating to provider-related 
donations for outstationed eligibility workers are effective on October 
1, 1992.
    (b) Permissible donations. Subject to the limitations specified in 
Sec.  433.67, a State may receive, without a reduction in FFP, provider-
related donations that meet at least one of the following requirements:
    (1) The donations must be bona fide donations, as defined in Sec.  
433.54; or
    (2) The donations are made by a hospital, clinic, or similar entity 
(such as a Federally-qualified health center) for the direct costs of 
State or local agency personnel who are stationed at the facility to 
determine the eligibility (including eligibility redeterminations) of 
individuals for Medicaid or to provide outreach services to eligible (or 
potentially eligible) Medicaid individuals. Direct costs of outstationed 
eligibility workers refers to the costs of training, salaries and fringe 
benefits associated with each outstationed worker and similar allocated 
costs of State or local agency support staff, and a prorated cost of 
outreach activities applicable to the outstationed workers at these 
sites. The prorated costs of outreach activities will be calculated 
taking the percent of State outstationed eligibility workers at a 
facility to total outstationed eligibility workers in the State, and 
multiplying the percent by the total cost of outreach activities in the 
State. Costs for such items as State agency overhead and provider office 
space are not allowable for this purpose.

[57 FR 55138, Nov. 24, 1992, as amended at 58 FR 43180, Aug. 13, 1993; 
73 FR 9698, Feb. 22, 2008]

[[Page 95]]



Sec.  433.67  Limitations on level of FFP for permissible provider-
related donations.

    (a)(1) Limitations on bona fide donations. There are no limitations 
on the amount of bona fide provider-related donations that a State may 
receive without a reduction in FFP, as long as the bona fide donations 
meet the requirements of Sec.  433.66(b)(1).
    (2) Limitations on donations for outstationed eligibility workers. 
Effective October 1, 1992, the maximum amount of provider-related 
donations for outstationed eligibility workers, as described in Sec.  
433.66(b)(2), that a State may receive without a reduction in FFP may 
not exceed 10 percent of a State's medical assistance administrative 
costs (both the Federal and State share), excluding the costs of family 
planning activities. The 10 percent limit for provider-related donations 
for outstationed eligibility workers is not included in the limit in 
effect through September 30, 1995, for health care-related taxes as 
described in Sec.  433.70.
    (b) Calculation of FFP. CMS will deduct from a State's quarterly 
medical assistance expenditures, before calculating FFP, any provider-
related donations received in that quarter that do not meet the 
requirements of Sec.  433.66(b)(1) and provider donations for 
outstationed eligibility workers in excess of the limits specified under 
paragraph (a)(2) of this section.

[57 FR 55138, Nov. 24, 1992, as amended at 58 FR 43180, Aug. 13, 1993; 
73 FR 9698, Feb. 22, 2008]



Sec.  433.68  Permissible health care-related taxes.

    (a) General rule. A State may receive health care-related taxes, 
without a reduction in FFP, only in accordance with the requirements of 
this section.
    (b) Permissible health care-related taxes. Subject to the 
limitations specified in Sec.  433.70, a State may receive, without a 
reduction in FFP, health care-related taxes if all of the following are 
met:
    (1) The taxes are broad based, as specified in paragraph (c) of this 
section;
    (2) The taxes are uniformly imposed throughout a jurisdiction, as 
specified in paragraph (d) of this section; and
    (3) The tax program does not violate the hold harmless provisions 
specified in paragraph (f) of this section.
    (c) Broad based health care-related taxes. (1) A health care-related 
tax will be considered to be broad based if the tax is imposed on at 
least all health care items or services in the class or providers of 
such items or services furnished by all non-Federal, non-public 
providers in the State, and is imposed uniformly, as specified in 
paragraph (d) of this section.
    (2) If a health care-related tax is imposed by a unit of local 
government, the tax must extend to all items or services or providers 
(or to all providers in a class) in the area over which the unit of 
government has jurisdiction.
    (3) A State may request a waiver from CMS of the requirement that a 
tax program be broad based, in accordance with the procedures specified 
in Sec.  433.72. Waivers from the uniform and broad-based requirements 
will automatically be granted in cases of variations in licensing and 
certification fees for providers if the amount of such fees is not more 
than $1,000 annually per provider and the total amount raised by the 
State from the fees is used in the administration of the licensing or 
certification program.
    (d) Uniformly imposed health care-related taxes. A health care-
related tax will be considered to be imposed uniformly even if it 
excludes Medicaid or Medicare payments (in whole or in part), or both; 
or, in the case of a health care-related tax based on revenues or 
receipts with respect to a class of items or services (or providers of 
items or services), if it excludes either Medicaid or Medicare revenues 
with respect to a class of items or services, or both. The exclusion of 
Medicaid revenues must be applied uniformly to all providers being 
taxed.
    (1) A health care-related tax will be considered to be imposed 
uniformly if it meets any one of the following criteria:
    (i) If the tax is a licensing fee or similar tax imposed on a class 
of health care services (or providers of those health care items or 
services), the tax is the same amount for every

[[Page 96]]

provider furnishing those items or services within the class.
    (ii) If the tax is a licensing fee or similar tax imposed on a class 
of health care items or services (or providers of those items or 
services) on the basis of the number of beds (licensed or otherwise) of 
the provider, the amount of the tax is the same for each bed of each 
provider of those items or services in the class.
    (iii) If the tax is imposed on provider revenue or receipts with 
respect to a class of items or services (or providers of those health 
care items or services), the tax is imposed at a uniform rate for all 
services (or providers of those items or services) in the class on all 
the gross revenues or receipts, or on net operating revenues relating to 
the provision of all items or services in the State, unit, or 
jurisdiction. Net operating revenue means gross charges of facilities 
less any deducted amounts for bad debts, charity care, and payer 
discounts.
    (iv) The tax is imposed on items or services on a basis other than 
those specified in paragraphs (d)(1) (i) through (iii) of this section, 
e.g., an admission tax, and the State establishes to the satisfaction of 
the Secretary that the amount of the tax is the same for each provider 
of such items or services in the class.
    (2) A tax imposed with respect to a class of health care items or 
services will not be considered to be imposed uniformly if it meets 
either one of the following two criteria:
    (i) The tax provides for credits, exclusions, or deductions which 
have as its purpose, or results in, the return to providers of all, or a 
portion, of the tax paid, and it results, directly or indirectly, in a 
tax program in which--
    (A) The net impact of the tax and payments is not generally 
redistributive, as specified in paragraph (e) of this section; and
    (B) The amount of the tax is directly correlated to payments under 
the Medicaid program.
    (ii) The tax holds taxpayers harmless for the cost of the tax, as 
described in paragraph (f) of this section.
    (3) If a tax does not meet the criteria specified in paragraphs 
(d)(1)(i) through (iv) of this section, but the State establishes that 
the tax is imposed uniformly in accordance with the procedures for a 
waiver specified in Sec.  433.72, the tax will be treated as a uniform 
tax.
    (e) Generally redistributive. A tax will be considered to be 
generally redistributive if it meets the requirements of this paragraph. 
If the State desires waiver of only the broad-based tax requirement, it 
must demonstrate compliance with paragraph (e)(1) of this section. If 
the State desires waiver of the uniform tax requirement, whether or not 
the tax is broad-based, it must demonstrate compliance with paragraph 
(e)(2) of this section.
    (1) Waiver of broad-based requirement only. This test is applied on 
a per class basis to a tax that is imposed on all revenues but excludes 
certain providers. For example, a tax that is imposed on all revenues 
(including Medicare and Medicaid) but excludes teaching hospitals would 
have to meet this test. This test cannot be used when a State excludes 
any or all Medicaid revenue from its tax in addition to the exclusion of 
providers, since the test compares the proportion of Medicaid revenue 
being taxed under the proposed tax with the proportion of Medicaid 
revenue being taxed under a broad-based tax.
    (i) A State seeking waiver of the broad-based tax requirement only 
must demonstrate that its proposed tax plan meets the requirement that 
its plan is generally redistributive by:
    (A) Calculating the proportion of the tax revenue applicable to 
Medicaid if the tax were broad based and applied to all providers or 
activities within the class (called P1);
    (B) Calculating the proportion of the tax revenue applicable to 
Medicaid under the tax program for which the State seeks a waiver 
(called P2); and
    (C) Calculating the value of P1/P2.
    (ii) If the State demonstrates to the Secretary's satisfaction that 
the value of P1/P2 is at least 1, CMS will automatically approve the 
waiver request.
    (iii) If a tax is enacted and in effect prior to August 13, 1993, 
and the State demonstrates to the Secretary's satisfaction that the 
value of P1/P2 is at least 0.90, CMS will review the waiver request. 
Such a waiver will be approved

[[Page 97]]

only if the following two criteria are met:
    (A) The value of P1/P2 is at least 0.90; and
    (B) The tax excludes or provides credits or deductions only to one 
or more of the following providers of items and services within the 
class to be taxed:
    (1) Providers that furnish no services within the class in the 
State;
    (2) Providers that do not charge for services within the class;
    (3) Rural hospitals (defined as any hospital located outside of an 
urban area as defined in Sec.  412.62(f)(1)(ii) of this chapter);
    (4) Sole community hospitals as defined in Sec.  412.92(a) of this 
chapter;
    (5) Physicians practicing primarily in medically underserved areas 
as defined in section 1302(7) of the Public Health Service Act;
    (6) Financially distressed hospitals if:
    (i) A financially distressed hospital is defined by the State law;
    (ii) The State law specifies reasonable standards for determining 
financially distressed hospitals, and these standards are applied 
uniformly to all hospitals in the State; and
    (iii) No more than 10 percent of nonpublic hospitals in the State 
are exempt from the tax;
    (7) Psychiatric hospitals; or
    (8) Hospitals owned and operated by HMOs.
    (iv) If a tax is enacted and in effect after August 13, 1993, and 
the State demonstrates to the Secretary's satisfaction that the value of 
P1/P2 is at least 0.95, CMS will review the waiver request. Such a 
waiver request will be approved only if the following two criteria are 
met:
    (A) The value of P1/P2 is at least 0.95; and
    (B) The tax complies with the provisions of Sec.  
433.68(e)(1)(iii)(B).
    (2) Waiver of uniform tax requirement. This test is applied on a per 
class basis to all taxes that are not uniform. This includes those taxes 
that are neither broad based (as specified in Sec.  433.68(c)) nor 
uniform (as specified in Sec.  433.68(d)).
    (i) A State seeking waiver of the uniform tax requirement (whether 
or not the tax is broad based) must demonstrate that its proposed tax 
plan meets the requirement that its plan is generally redistributive by:
    (A) Calculating, using ordinary least squares, the slope (designated 
as (B) (that is. the value of the x coefficient) of two linear 
regressions, in which the dependent variable is each provider's 
percentage share of the total tax paid by all taxpayers during a 12-
month period, and the independent variable is the taxpayer's ``Medicaid 
Statistic''. The term ``Medicaid Statistic'' means the number of the 
provider's taxable units applicable to the Medicaid program during a 12-
month period. If, for example, the State imposed a tax based on provider 
charges, the amount of a provider's Medicaid charges paid during a 12-
month period would be its ``Medicaid Statistic''. If the tax were based 
on provider inpatient days, the number of the provider's Medicaid days 
during a 12-month period would be its ``Medicaid Statistic''. For the 
purpose of this test, it is not relevant that a tax program exempts 
Medicaid from the tax.
    (B) Calculating the slope (designated as B1) of the linear 
regression, as described in paragraph (e)(2)(i) of this section, for the 
State's tax program, if it were broad based and uniform.
    (C) Calculating the slope (designated as B2) of the linear 
regression, as described in paragraph (e)(2)(i) of this section, for the 
State's tax program, as proposed.
    (ii) If the State demonstrates to the Secretary's satisfaction that 
the value of B1/B2 is at least 1, CMS will automatically approve the 
waiver request.
    (iii) If the State demonstrates to the Secretary's satisfaction that 
the value of B1/B2 is at least 0.95, CMS will review the waiver request. 
Such a waiver will be approved only if the following two criteria are 
met:
    (A) The value of B1/B2 is at least 0.95; and
    (B) The tax excludes or provides credits or deductions only to one 
or more of the following providers of items and services within the 
class to be taxes:
    (1) Providers that furnish no services within the class in the 
State;
    (2) Providers that do not charge for services within the class;
    (3) Rural hospitals (defined as any hospital located outside of an 
urban

[[Page 98]]

area as defined in Sec.  412.62(f)(1)(ii) of this chapter;
    (4) Sole community hospitals as defined in Sec.  412.92(a) of this 
chapter;
    (5) Physicians practicing primarily in medically underserved areas 
as defined in section 1302(7) of the Public Health Service Act;
    (6) Financially distressed hospitals if:
    (i) A financially distressed hospital is defined by the State law;
    (ii) The State law specifies reasonable standards for determining 
financially distressed hospitals, and these standards are applied 
uniformly to all hospitals in the State; and
    (iii) No more than 10 percent of nonpublic hospitals in the State 
are exempt from the tax;
    (7) Psychiatric hospitals; or
    (8) Providers or payers with tax rates that vary based exclusively 
on regions, but only if the regional variations are coterminous with 
preexisting political (and not special purpose) boundaries. Taxes within 
each regional boundary must meet the broad-based and uniformity 
requirements as specified in paragraphs (c) and (d) of this section.
    (iv) A B1/B2 value of 0.70 will be applied to taxes that vary based 
exclusively on regional variations, and enacted and in effect prior to 
November 24, 1992, to permit such variations.
    (f) Hold harmless. A taxpayer will be considered to be held harmless 
under a tax program if any of the following conditions applies:
    (1) The State (or other unit of government) imposing the tax 
provides for a direct or indirect non-Medicaid payment to those 
providers or others paying the tax and the payment amount is positively 
correlated to either the tax amount or to the difference between the 
Medicaid payment and the tax amount. A positive correlation includes any 
positive relationship between these variables, even if not consistent 
over time.
    (2) All or any portion of the Medicaid payment to the taxpayer 
varies based only on the tax amount, including where Medicaid payment is 
conditional on receipt of the tax amount.
    (3) The State (or other unit of government) imposing the tax 
provides for any direct or indirect payment, offset, or waiver such that 
the provision of that payment, offset, or waiver directly or indirectly 
guarantees to hold taxpayers harmless for all or any portion of the tax 
amount.
    (i)(A) An indirect guarantee will be determined to exist under a two 
prong ``guarantee'' test. If the health care-related tax or taxes on 
each health care class are applied at a rate that produces revenues less 
than or equal to 6 percent of the revenues received by the taxpayer, the 
tax or taxes are permissible under this test. The phrase ``revenues 
received by the taxpayer'' refers to the net patient revenue 
attributable to the assessed permissible class of health care items or 
services. However, for the period of January 1, 2008 through September 
30, 2011, the applicable percentage of net patient service revenue is 
5.5 percent. Compliance in State fiscal year 2008 will be evaluated from 
January 1, 2008 through the last day of State fiscal year 2008. 
Beginning with State fiscal year 2009 the 5.5 percent tax collection 
will be measured on an annual State fiscal year basis.
    (B) When the tax or taxes produce revenues in excess of the 
applicable percentage of the revenue received by the taxpayer, CMS will 
consider an indirect hold harmless provision to exist if 75 percent or 
more of the taxpayers in the class receive 75 percent or more of their 
total tax costs back in enhanced Medicaid payments or other State 
payments. The second prong of the indirect hold harmless test is applied 
in the aggregate to all health care taxes applied to each class. If this 
standard is violated, the amount of tax revenue to be offset from 
medical assistance expenditures is the total amount of the taxpayers' 
revenues received by the State.
    (ii) [Reserved]

[57 FR 55138, Nov. 24, 1992, as amended at 58 FR 43181, Aug. 13, 1993; 
62 FR 53572, Oct. 15, 1997; 73 FR 9698, Feb. 22, 2008]



Sec.  433.70  Limitation on level of FFP for revenues from health 
care-related taxes.

    (a) Limitations. Beginning October 1, 1995, there is no limitation 
on the amount of health care-related taxes that a State may receive 
without a reduction in FFP, as long as the health

[[Page 99]]

care-related taxes meet the requirements specified in Sec.  433.68.
    (b) Calculation of FFP. CMS will deduct from a State's medical 
assistance expenditures, before calculating FFP, revenues from health 
care-related taxes that do not meet the requirements of Sec.  433.68 and 
any health care-related taxes in excess of the limits specified in 
paragraph (a)(1) of this section.

[57 FR 55138, Nov. 24, 1992, as amended at 73 FR 9699, Feb. 22, 2008]



Sec.  433.72  Waiver provisions applicable to health care-related taxes.

    (a) Bases for requesting waiver. (1) A State may submit to CMS a 
request for a waiver if a health care-related tax does not meet any or 
all of the following:
    (i) The tax does not meet the broad based criteria specified in 
Sec.  433.68c); and/or
    (ii) The tax is not imposed uniformly but meets the criteria 
specified in Sec.  433.68(d)(2) or (d)(3).
    (2) When a tax that meets the criteria specified in paragraph (a)(1) 
of this section is imposed on more than one class of health care items 
or services, a separate waiver must be obtained for each class of health 
care items and services subject to the tax.
    (b) Waiver conditions. In order for CMS to approve a waiver request 
that would permit a State to receive tax revenue (within specified 
limitations) without a reduction in FFP, the State must demonstrate, to 
CMS's satisfaction, that its tax program meets all of the following 
requirements:
    (1) The net impact of the tax and any payments made to the provider 
by the State under the Medicaid program is generally redistributive, as 
described in Sec.  433.68(e);
    (2) The amount of the tax is not directly correlated to Medicaid 
payments; and
    (3) The tax program does not fall within the hold harmless 
provisions specified in Sec.  433.68(f).
    (c) Effective date. A waiver will be effective:
    (1) The date of enactment of the tax for programs in existence prior 
to August 13, 1993 or;
    (2) For tax programs commencing on or after August 13, 1993, on the 
first day in the quarter in which the waiver is received by CMS.

[57 FR 55138, Nov. 24, 1992, as amended at 58 FR 43182, Aug. 13, 1993]



Sec.  433.74  Reporting requirements.

    (a) Beginning with the first quarter of Federal fiscal year 1993, 
each State must submit to CMS quarterly summary information on the 
source and use of all provider-related donations (including all bona 
fide and presumed-to-be bona fide donations) received by the State or 
unit of local government, and health care-related taxes collected. Each 
State must also provide any additional information requested by the 
Secretary related to any other donations made by, or any taxes imposed 
on, health care providers. States' reports must present a complete, 
accurate, and full disclosure of all of their donation and tax programs 
and expenditures.
    (b) Each State must provide the summary information specified in 
paragraph (a) of this section on a quarterly basis in accordance with 
procedures established by CMS.
    (c) Each State must maintain, in readily reviewable form, supporting 
documentation that provides a detailed description and legal basis for 
each donation and tax program being reported, as well as the source and 
use of all donations received and taxes collected. This information must 
be made available to Federal reviewers upon request.
    (d) If a State fails to comply with the reporting requirements 
contained in this section, future grant awards will be reduced by the 
amount of FFP CMS estimates is attributable to the sums raised by tax 
and donation programs as to which the State has not reported properly, 
until such time as the State complies with the reporting requirements. 
Deferrals and/or disallowances of equivalent amounts may also be imposed 
with respect to quarters for which the State has failed to report 
properly. Unless otherwise prohibited by law, FFP for those expenditures 
will be released when the State complies with all reporting 
requirements.

[[Page 100]]



Subpart C_Mechanized Claims Processing and Information Retrieval Systems



Sec.  433.110  Basis, purpose, and applicability.

    (a) This subpart implements the following sections of the Act:
    (1) Section 1903(a)(3) of the Act, which provides for FFP in State 
expenditures for the design, development, or installation of mechanized 
claims processing and information retrieval systems and for the 
operation of certain systems. Additional HHS regulations and CMS 
procedures for implementing these regulations are in 45 CFR part 75, 45 
CFR part 95, subpart F, and part 11, State Medicaid Manual; and
    (2) Section 1903(r) of the Act, which imposes certain standards and 
conditions on mechanized claims processing and information retrieval 
systems (including eligibility determination systems) in order for these 
systems to be eligible for Federal funding under section 1903(a) of the 
Act.
    (b) [Reserved]

[50 FR 30846, July 30, 1985, as amended at 54 FR 41973, Oct. 13, 1989; 
76 FR 21973, Apr. 19, 2011; 80 FR 75841, Dec. 4, 2015]



Sec.  433.111  Definitions.

    For purposes of this section:
    (a) The following terms are defined at 45 CFR part 95, subpart F 
Sec.  95.605:

``Advance Planning Document''; ``Design'' or ``System Design''; 
``Development''; ``Enhancement''; ``Hardware''; ``Installation''; 
``Operation''; and, ``Software''.

    (b) ``Mechanized claims processing and information retrieval 
system'' means:
    (1) ``Mechanized claims processing and information retrieval 
system'' means the system of software and/or hardware used to process 
claims for medical assistance and to retrieve and produce service 
utilization and management information required by the Medicaid single 
state agency and Federal government for program administration and audit 
purposes. It may include modules of hardware, software, and other 
technical capabilities that are used by the Medicaid Single State Agency 
to manage, monitor, and administer the Medicaid enterprise, including 
transaction processing, information management, and reporting and data 
analytics.
    (2) ``Mechanized claims processing and information retrieval 
system'' includes a ``System of Systems.'' Under this definition all 
modules or systems developed to support a Medicaid Management 
Information System (MMIS) and Eligibility and Enrollment (E&E) may be 
implemented as discrete, independent, interoperable elements. Use of a 
System of Systems requires interoperability between the systems.
    (i) The system consists of--
    (A) Required modules specified by the Secretary.
    (B) Required changes to the system or required module that are 
specified by the Secretary.
    (C) Approved enhancements to the system or module.
    (ii) A ``Mechanized claims processing and information retrieval 
system'' include--s--
    (A) An Eligibility and Enrollment (E&E) System which is used to 
process applications from Medicaid or CHIP applicants and beneficiaries 
to determine eligibility for enrollment in the Medicaid or CHIP 
programs, as well as change in circumstance updates and renewals; and
    (B) A Medicaid Management Information System (MMIS) which is used to 
process claims for Medicaid payment from providers of medical care and 
services furnished to beneficiaries under the medical assistance program 
and to perform other functions necessary for economic and efficient 
operations, management, monitoring, and administration of the Medicaid 
program. The pertinent business areas are those included in the MMIS 
Certification Toolkit, and they may be applicable to Fee-For-Service, 
Managed Care, or an Administrative Services Organization (ASO) model.
    (c) ``Medicaid Information Technology Architecture (MITA)'' is 
defined at Sec.  495.302 of this chapter.
    (d) ``Open source'' means software that can be used freely, changed, 
and shared (in modified or unmodified form) by anyone. Open source 
software is distributed under Open Source Initiative-approved licenses 
that comply

[[Page 101]]

with an open source framework that allows for free redistribution, 
provision of the source code, allowance for modifications and derived 
works, free and open distribution of licenses without restrictions and 
licenses that are technology-neutral.
    (e) ``Proprietary'' means a closed source product licensed under 
exclusive legal right of the copyright holder with the intent that the 
licensee is given the right to use the software only under certain 
conditions, and restricted from other uses, such as modification, 
sharing, studying, redistribution, or reverse engineering.
    (f) ``Service'' means a self-contained unit of functionality that is 
a discretely invokable operation. Services can be combined to provide 
the functionality of a large software application.
    (g) ``Shared Service'' means the use of a service, including SaaS, 
by one part of an organization or group, including states, where that 
service is also made available to other entities of the organization, 
group or states. Thus the funding and resourcing of the service is 
shared and the providing department effectively becomes an internal 
service provider.
    (h) ``Module'' means a packaged, functional business process or set 
of processes implemented through software, data, and interoperable 
interfaces that are enabled through design principles in which functions 
of a complex system are partitioned into discrete, scalable, reusable 
components.
    (i) ``Commercial Off the Shelf'' (COTS) software means specialized 
software (which could be a system, subsystem or module) designed for 
specific applications that is available for sale or lease to other users 
in the commercial marketplace, and that can be used with little or no 
modification.
    (j) ``Software-as-a-Service'' (SaaS) means a software delivery model 
in which software is managed and licensed by its vendor-owner on a pay-
for-use or subscription basis, centrally hosted, on-demand, and common 
to all users.

[51 FR 45330, Dec. 18, 1986, as amended at 54 FR 41973, Oct. 13, 1989; 
76 FR 21973, Apr. 19, 2011; 80 FR 75841, Dec. 4, 2015]



Sec.  433.112  FFP for design, development, installation or enhancement
of mechanized processing and information retrieval systems.

    (a) Subject to paragraph (c) of this section, FFP is available at 
the 90 percent rate in State expenditures for the design, development, 
installation, or enhancement of a mechanized claims processing and 
information retrieval system only if the APD is approved by CMS prior to 
the State's expenditure of funds for these purposes.
    (b) CMS will approve the E&E or claims system described in an APD if 
certain conditions are met. The conditions that a system must meet are:
    (1) CMS determines the system is likely to provide more efficient, 
economical, and effective administration of the State plan.
    (2) The system meets the system requirements, standards and 
conditions, and performance standards in Part 11 of the State Medicaid 
Manual, as periodically amended.
    (3) The system is compatible with the claims processing and 
information retrieval systems used in the administration of Medicare for 
prompt eligibility verification and for processing claims for persons 
eligible for both programs.
    (4) The system supports the data requirements of quality improvement 
organizations established under Part B of title XI of the Act.
    (5) The State owns any software that is designed, developed, 
installed or improved with 90 percent FFP.
    (6) The Department has a royalty free, non-exclusive, and 
irrevocable license to reproduce, publish, or otherwise use and 
authorize others to use, for Federal Government purposes, software, 
modifications to software, and documentation that is designed, 
developed, installed or enhanced with 90 percent FFP.
    (7) The costs of the system are determined in accordance with 45 CFR 
75, subpart E.
    (8) The Medicaid agency agrees in writing to use the system for the 
period of time specified in the advance planning document approved by 
CMS or for any shorter period of time that CMS determines justifies the 
Federal funds invested.

[[Page 102]]

    (9) The agency agrees in writing that the information in the system 
will be safeguarded in accordance with subpart F, part 431 of this 
subchapter.
    (10) Use a modular, flexible approach to systems development, 
including the use of open interfaces and exposed application programming 
interfaces; the separation of business rules from core programming, 
available in both human and machine readable formats.
    (11) Align to, and advance increasingly, in MITA maturity for 
business, architecture, and data.
    (12) The agency ensures alignment with, and incorporation of, 
industry standards adopted by the Office of the National Coordinator for 
Health IT in accordance with 45 CFR part 170, subpart B: The HIPAA 
privacy, security and transaction standards; accessibility standards 
established under section 508 of the Rehabilitation Act, or standards 
that provide greater accessibility for individuals with disabilities, 
and compliance with Federal civil rights laws; standards adopted by the 
Secretary under section 1104 of the Affordable Care Act; and standards 
and protocols adopted by the Secretary under section 1561 of the 
Affordable Care Act.
    (13) Promote sharing, leverage, and reuse of Medicaid technologies 
and systems within and among States.
    (14) Support accurate and timely processing and adjudications/
eligibility determinations and effective communications with providers, 
beneficiaries, and the public.
    (15) Produce transaction data, reports, and performance information 
that would contribute to program evaluation, continuous improvement in 
business operations, and transparency and accountability.
    (16) The system supports seamless coordination and integration with 
the Marketplace, the Federal Data Services Hub, and allows 
interoperability with health information exchanges, public health 
agencies, human services programs, and community organizations providing 
outreach and enrollment assistance services as applicable.
    (17) For E&E systems, the State must have delivered acceptable MAGI-
based system functionality, demonstrated by performance testing and 
results based on critical success factors, with limited mitigations and 
workarounds.
    (18) The State must submit plans that contain strategies for 
reducing the operational consequences of failure to meet applicable 
requirements for all major milestones and functionality.
    (19) The agency, in writing through the APD, must identify key state 
personnel by name, type and time commitment assigned to each project.
    (20) Systems and modules developed, installed or improved with 90 
percent match must include documentation of components and procedures 
such that the systems could be operated by a variety of contractors or 
other users.
    (21) For software systems and modules developed, installed or 
improved with 90 percent match, the State must consider strategies to 
minimize the costs and difficulty of operating the software on alternate 
hardware or operating systems.
    (22) Other conditions for compliance with existing statutory and 
regulatory requirements, issued through formal guidance procedures, 
determined by the Secretary to be necessary to update and ensure proper 
implementation of those existing requirements.
    (c)(1) FFP is available at 90 percent of a State's expenditures for 
the design, development, installation or enhancement of an E&E system 
that meets the requirements of this subpart and only for costs incurred 
for goods and services provided on or after April 19, 2011.
    (2) Design, development, installation, or enhancement costs include 
costs for initial licensing of commercial off the shelf (COTS) software, 
and the minimum necessary costs to analyze the suitability of COTS 
software, install, configure and integrate the COTS software, and modify 
non-COTS software to ensure coordination of operations. The nature and 
extent of such costs must be expressly described in the approved APD.

[43 FR 45201, Sept. 29, 1978, as amended at 44 FR 17937, Mar. 23, 1979; 
45 FR 14213, Mar. 5, 1980; 50 FR 30846, July 30, 1985; 51 FR 45330, Dec. 
18, 1986; 54 FR 41973, Oct. 13, 1989; 55 FR 1820, Jan. 19, 1990; 55 FR 
4375, Feb. 7, 1990; 76 FR 21973, Apr. 19, 2011; 80 FR 75842, Dec. 4, 
2015; 81 FR 3011, Jan. 20, 2016]

[[Page 103]]



Sec.  433.114  Procedures for obtaining initial approval; notice of
decision.

    (a) To obtain initial approval, the Medicaid agency must inform CMS 
in writing that the system meets the conditions specified in Sec.  
433.116(c) through (i).
    (b) If CMS disapproves the system, the notice will include all of 
the following information:
    (1) The findings of fact upon which the determination was made.
    (2) The procedures for appeal of the determination in the context of 
a reconsideration of the resulting disallowance to the Departmental 
Appeals Board.

[50 FR 30847, July 30, 1985, as amended at 54 FR 41973, Oct. 13, 1989; 
76 FR 21974, Apr. 19, 2011]



Sec.  433.116  FFP for operation of mechanized claims processing and 
information retrieval systems.

    (a) Subject to paragraph (j) of this section, FFP is available at 75 
percent of expenditures for operation of a mechanized claims processing 
and information retrieval system approved by CMS, from the first day of 
the calendar quarter after the date the system met the conditions of 
initial approval, as established by CMS (including a retroactive 
adjustment of FFP if necessary to provide the 75 percent rate beginning 
on the first day of that calendar quarter). Subject to 45 CFR 95.611(a), 
the State shall obtain prior written approval from CMS when it plans to 
acquire ADP equipment or services, when it anticipates the total 
acquisition costs will exceed thresholds, and meets other conditions of 
the subpart.
    (b) CMS will approve enhanced FFP for system operations if the 
conditions specified in paragraphs (c) through (i) of this section are 
met.
    (c) The conditions of Sec.  433.112(b)(1) through (22) must be met 
at the time of approval.
    (d) The system must have been operating continuously during the 
period for which FFP is claimed.
    (e) The system must provide individual notices, within 45 days of 
the payment of claims, to all or a sample group of the persons who 
received services under the plan.
    (f) The notice required by paragraph (e) of this section--
    (1) Must specify--
    (i) The service furnished;
    (ii) The name of the provider furnishing the service;
    (iii) The date on which the service was furnished; and
    (iv) The amount of the payment made under the plan for the service; 
and
    (2) Must not specify confidential services (as defined by the State) 
and must not be sent if the only service furnished was confidential.
    (g) The system must provide both patient and provider profiles for 
program management and utilization review purposes.
    (h) If the State has a Medicaid fraud control unit certified under 
section 1903(q) of the Act and Sec.  455.300 of this chapter, the 
Medicaid agency must have procedures to assure that information on 
probable fraud or abuse that is obtained from, or developed by, the 
system is made available to that unit. (See Sec.  455.21 of this chapter 
for State plan requirements.)
    (i) The standards and conditions of Sec.  433.112(b)(10) through 
(b)(16) of this subpart must be met.
    (j) Beginning, and no earlier than, April 19, 2011, FFP is available 
at 75 percent of a State's expenditures for the operation of an E&E 
system that meets the requirements of this subpart. FFP is not available 
for E&E systems that do not meet the standards and conditions.

[45 FR 14213, Mar. 5, 1980. Redesignated and amended at 50 FR 30847, 
July 30, 1985; 55 FR 4375, Feb. 7, 1990; 76 FR 21974, Apr. 19, 2011; 80 
FR 75842, Dec. 4, 2015]



Sec.  433.117  Initial approval of replacement systems.

    (a) A replacement system must meet all standards and conditions of 
initial approval of a mechanized claims processing and information 
retrieval system.
    (b) The agency must submit a APD that includes--
    (1) The date the replacement system will be in operation; and
    (2) A plan for orderly transition from the system being replaced to 
the replacement system.

[[Page 104]]

    (c) FFP is available at--
    (1) 90 percent in expenditures for design, development, and 
installation in accordance with the provisions of Sec.  433.112; and
    (2) 75 percent in expenditures for operation of an approved 
replacement system in accordance with the provisions of Sec.  433.116(b) 
through (j), from the date that the system met the conditions of initial 
approval, as established by CMS.
    (d) FFP is available at 75 percent in expenditures for the operation 
of an approved system that is being replaced (or at a reduced rate 
determined under Sec.  433.120 of this subpart for a system that has 
been disapproved) until the replacement system is in operation and 
approved.

[50 FR 30847, July 30, 1985, as amended at 76 FR 21974, Apr. 19, 2011]



Sec.  433.119  Conditions for reapproval; notice of decision.

    (a) CMS periodically reviews each system operation initially 
approved under Sec.  433.114 of this subpart and reapproves it for FFP 
at 75 percent of expenditures if the following standards and conditions 
are met:
    (1) The system meets the requirements of Sec.  433.112(b)(1), (3), 
(4), and (7) through (22).
    (2) The system meets the conditions of Sec.  433.116 (d) through 
(j).
    (3) The system meets the standards, conditions, and performance 
standards for reapproval and the system requirements in part 11 of the 
State Medicaid Manual as periodically amended.
    (4) A State system must meet all of the requirements of this subpart 
within the appropriate period CMS determines should apply as required by 
Sec.  433.123(b) of this subpart.
    (b) CMS may review an entire system operation or focus its review on 
parts of the operation. However, at a minimum, CMS will review 
standards, system requirements and other conditions of reapproval that 
have demonstrated weakness in a previous review or reviews.
    (c) After performing the review under paragraph (a) of this section, 
CMS will issue to the Medicaid agency a written notice informing the 
agency whether the system is reapproved or disapproved. If the system is 
disapproved, the notice will include the following information:
    (1) CMS's decision to reduce FFP for system operations from 75 
percent to 50 percent of expenditures, beginning with the first day of 
the first calendar quarter after CMS issues the written notice to the 
State.
    (2) The findings of fact upon which the determination was made.
    (3) A statement that State claims in excess of the reduced FFP rate 
will be disallowed and that any such disallowance will be appealable to 
the Departmental Appeals Board.

[54 FR 41973, Oct. 13, 1989; 55 FR 1820, Jan. 19, 1990; 76 FR 21974, 
Apr. 19, 2011; 80 FR 75843, Dec. 4, 2015]



Sec.  433.120  Procedures for reduction of FFP after reapproval review.

    (a) If CMS determines after the reapproval review that the system no 
longer meets the conditions for reapproval in Sec.  433.119, CMS may 
reduce FFP for certain expenditures for system operations.
    (b) CMS may reduce FFP from 75 percent to 50 percent for 
expenditures related to the operations of non-compliant functionality or 
system components.

[80 FR 75843, Dec. 4, 2015]



Sec.  433.121  Reconsideration of the decision to reduce FFP after 
reapproval review.

    (a) The State Medicaid agency may appeal (to the Departmental 
Appeals Board under 45 CFR part 16) a disallowance concerning a 
reduction in FFP claimed for system operations caused by a disapproval 
of the State's system.
    (b) The decisions concerning whether to restore any FFP 
retroactively and the actual number of quarters for which FFP will be 
restored under Sec.  433.122 of this subpart are not subject to 
administrative appeal to the Departmental Appeals Board under 45 CFR 
part 16.
    (c) An agency's request for a reconsideration before the Board under 
paragraph (a) of this section does not delay implementation of the 
reduction in FFP. However, any reduction is subject to retroactive 
adjustment if required

[[Page 105]]

by the Board's determination on reconsideration.

[50 FR 30848, July 30, 1985, as amended at 54 FR 41974, Oct. 13, 1989; 
55 FR 1820, Jan. 19, 1990; 76 FR 21974, Apr. 19, 2011]



Sec.  433.122  Reapproval of a disapproved system.

    When FFP has been reduced under Sec.  433.120(a), and CMS determines 
upon subsequent review that the system meets all current performance 
standards, system requirements and other conditions of reapproval, the 
following provisions apply:
    (a) CMS will resume FFP in expenditures for system operations at the 
75 percent level beginning with the quarter following the review 
determination that the system again meets conditions of reapproval.
    (b) CMS may retroactively waive a reduction of FFP in expenditures 
for system operations if CMS determines that the waiver could improve 
the administration of the State Medicaid plan. However, CMS cannot waive 
this reduction for any quarter before the fourth quarter immediately 
preceding the quarter in which CMS issues the determination (as part of 
the review process) stating that the system is reapproved.

[54 FR 41974, Oct. 13, 1989]



Sec.  433.123  Notification of changes in system requirements, performance
standards or other conditions for approval or reapproval.

    (a) Whenever CMS modifies system requirements or other conditions 
for approval under Sec.  433.112 or Sec.  433.116, CMS will--
    (1) Publish a notice in the Federal Register making available the 
proposed changes for public comment;
    (2) Respond in a subsequent Federal Register notice to comments 
received; and
    (3) Issue the new or modified requirements or conditions in the 
State Medicaid Manual.
    (b) For changes in system requirements or other conditions for 
approval, CMS will allow an appropriate period for Medicaid agencies to 
meet the requirement determining this period on the basis of the 
requirement's complexity and other relevant factors.
    (c) Whenever CMS modifies performance standards and other conditions 
for reapproval under Sec.  433.119, CMS will notify Medicaid agencies at 
least one calendar quarter before the review period to which the new or 
modified standards or conditions apply.

[57 FR 38782, Aug. 27, 1992]



Sec.  433.127  Termination of FFP for failure to provide access to
claims processing and information retrieval systems.

    CMS will terminate FFP at any time if the Medicaid agency fails to 
provide State and Federal representatives with full access to the 
system, including on-site inspection. CMS may request such access at any 
time to determine whether the conditions in this subpart are being met.

[43 FR 45201, Sept. 29, 1978. Redesignated and amended at 50 FR 30847 
and 30848, July 30, 1985]



Sec.  433.131  Waiver for noncompliance with conditions of approval
and reapproval.

    If a State is unable to comply with the conditions of approval or of 
reapproval and the noncompliance will cause a percentum reduction in 
FFP, CMS will waive the FFP reduction in the following circumstances:
    (a) Good cause. If CMS determines that good cause existed, CMS will 
waive the FFP reduction attributable to those items for which the good 
cause existed. A waiver of FFP consequences of the failure to meet the 
conditions of approval or reapproval based upon good cause will not 
extend beyond two consecutive quarters.
    (b) Circumstances beyond the control of a State. The State must 
satisfactorily explain the circumstances that are beyond its control. 
When CMS grants the waiver, CMS will also defer all other system 
deadlines for the same length of time that the waiver applies.
    (c) Waiver of deadline. In no case will CMS waive the December 31, 
2015 deadlines referenced in Sec.  433.112(c) and Sec.  433.116(j).

[50 FR 30848, July 30, 1985, as amended at 54 FR 41974, Oct. 13, 1989; 
76 FR 21975, Apr. 19, 2011]

[[Page 106]]



                     Subpart D_Third Party Liability

    Source: 45 FR 8984, Feb. 11, 1980, unless otherwise noted.



Sec.  433.135  Basis and purpose.

    This subpart implements sections 1902(a)(25), 1902(a)(45), 
1903(d)(2), 1903(o), 1903(p), and 1912 of the Act by setting forth State 
plan requirements concerning--
    (a) The legal liability of third parties to pay for services 
provided under the plan;
    (b) Assignment to the State of an individual's rights to third party 
payments; and
    (c) Cooperative agreements between the Medicaid agency and other 
entities for obtaining third party payments.

[50 FR 46664, Nov. 12, 1985]



Sec.  433.136  Definitions.

    For purposes of this subpart--
    Private insurer means:
    (1) Any commercial insurance company offering health or casualty 
insurance to individuals or groups (including both experience-rated 
insurance contracts and indemnity contracts);
    (2) Any profit or nonprofit prepaid plan offering either medical 
services or full or partial payment for services included in the State 
plan; and
    (3) Any organization administering health or casualty insurance 
plans for professional associations, unions, fraternal groups, employer-
employee benefit plans, and any similar organization offering these 
payments or services, including self-insured and self-funded plans.
    Third party means any individual, entity or program that is or may 
be liable to pay all or part of the expenditures for medical assistance 
furnished under a State plan.
    Title IV-D agency means the organizational unit in the State that 
has the responsibility for administering or supervising the 
administration of a State plan for child support enforcement under title 
IV-D of the Act.

[49 FR 8984, Feb. 11, 1980, as amended at 50 FR 46664, Nov. 12, 1985; 50 
FR 49389, Dec. 2, 1985]



Sec.  433.137  State plan requirements.

    (a) A State plan must provide that the requirements of Sec. Sec.  
433.138 and 433.139 are met for identifying third parties liable for 
payment of services under the plan and for payment of claims involving 
third parties.
    (b) A State plan must provide that--
    (1) The requirements of Sec. Sec.  433.145 through 433.148 are met 
for assignment of rights to benefits, cooperation with the agency in 
obtaining medical support or payments, and cooperation in identifying 
and providing information to assist the State in pursuing any liable 
third parties; and
    (2) The requirements of Sec. Sec.  433.151 through 433.154 are met 
for cooperative agreements and incentive payments for third party 
collections.
    (c) The requirements of paragraph (b)(1) of this section relating to 
assignment of rights to benefits and cooperation in obtaining medical 
support or payments and paragraph (b)(2) of this section are effective 
for medical assistance furnished on or after October 1, 1984. The 
requirements of paragraph (b)(1) of this section relating to cooperation 
in identifying and providing information to assist the State in pursuing 
liable third parties are effective for medical assistance furnished on 
or after July 1, 1986.

[50 FR 46665, Nov. 12, 1985, as amended at 55 FR 48606, Nov. 21, 1990; 
55 FR 52130, Dec. 19, 1990; 60 FR 35502, July 10, 1995]



Sec.  433.138  Identifying liable third parties.

    (a) Basic provisions. The agency must take reasonable measures to 
determine the legal liability of the third parties who are liable to pay 
for services furnished under the plan. At a minimum, such measures must 
include the requirements specified in paragraphs (b) through (k) of this 
section, unless waived under paragraph (l) of this section.
    (b) Obtaining health insurance information: Initial application and 
redetermination processes for Medicaid eligibility. (1) If the Medicaid 
agency determines eligibility for Medicaid, it must, during the initial 
application and each redetermination process, obtain from the applicant 
or beneficiary such health insurance information as would be useful

[[Page 107]]

in identifying legally liable third party resources so that the agency 
may process claims under the third party liability payment procedures 
specified in Sec.  433.139 (b) through (f). Health insurance information 
may include, but is not limited to, the name of the policy holder, his 
or her relationship to the applicant or beneficiary, the social security 
number (SSN) of the policy holder, and the name and address of insurance 
company and policy number.
    (2) If Medicaid eligibility is determined by the Federal agency 
administering the supplemental security income program under title XVI 
in accordance with a written agreement under section 1634 of the Act, 
the Medicaid agency must take the following action. It must enter into 
an agreement with CMS or must have, prior to February 1, 1985, executed 
a modified section 1634 agreement that is still in effect to provide 
for--
    (i) Collection, from the applicant or beneficiary during the initial 
application and each redetermination process, of health insurance 
information in the form and manner specified by the Secretary; and
    (ii) Transmittal of the information to the Medicaid agency.
    (3) If Medicaid eligibility is determined by any other agency in 
accordance with a written agreement, the Medicaid agency must modify the 
agreement to provide for--
    (i) Collection, from the applicant or beneficiary during the initial 
application and each redetermination process, of such health insurance 
information as would be useful in identifying legally liable third party 
resources so that the Medicaid agency may process claims under the third 
party liability payment procedures specified in Sec.  433.139 (b) 
through (f). Health insurance information may include, but is not 
limited to, those elements described in paragraph (b)(1) of this 
section; and
    (ii) Transmittal of the information to the Medicaid agency.
    (c) Obtaining other information. Except as provided in paragraph (l) 
of this section, the agency must, for the purpose of implementing the 
requirements in paragraphs (d)(1)(ii) and (d)(4)(i) of this section, 
incorporate into the eligibility case file the names and SSNs of absent 
or custodial parents of Medicaid beneficiaries to the extent such 
information is available.
    (d) Exchange of data. Except as provided in paragraph (l) of this 
section, to obtain and use information for the purpose of determining 
the legal liability of the third parties so that the agency may process 
claims under the third party liability payment procedures specified in 
Sec.  433.139(b) through (f), the agency must take the following 
actions:
    (1) Except as specified in paragraph (d)(2) of this section, as part 
of the data exchange requirements under Sec.  435.945 of this chapter, 
from the State wage information collection agency (SWICA) defined in 
Sec.  435.4 of this chapter and from the SSA wage and earnings files 
data as specified in Sec.  435.948(a)(1) of this chapter, the agency 
must--
    (i) Use the information that identifies Medicaid beneficiaries that 
are employed and their employer(s); and
    (ii) Obtain and use, if their names and SSNs are available to the 
agency under paragraph (c) of this section, information that identifies 
employed absent or custodial parents of beneficiaries and their 
employer(s).
    (2) If the agency can demonstrate to CMS that it has an alternate 
source of information that furnishes information as timely, complete and 
useful as the SWICA and SSA wage and earnings files in determining the 
legal liability of third parties, the requirements of paragraph (d)(1) 
of this section are deemed to be met.
    (3) The agency must request, as required under Sec.  435.948(a)(2) 
of this chapter, from the State title IV-A agency, information not 
previously reported that identifies those Medicaid beneficiaries who are 
employed and their employer(s).
    (4) Except as specified in paragraph (d)(5) of this section, the 
agency must attempt to secure agreements (to the extent permitted by 
State law) to provide for obtaining--
    (i) From State Workers' Compensation or Industrial Accident 
Commission files, information that identifies Medicaid beneficiaries 
and, (if their names and SSNs were available to the

[[Page 108]]

agency under paragraph (c) of this section) absent or custodial parents 
of Medicaid beneficiaries with employment-related injuries or illnesses; 
and
    (ii) From State Motor Vehicle accident report files, information 
that identifies those Medicaid beneficiaries injured in motor vehicle 
accidents, whether injured as pedestrians, drivers, passengers, or 
bicyclists.
    (5) If unable to secure agreements as specified in paragraph (d)(4) 
of this section, the agency must submit documentation to the regional 
office that demonstrates the agency made a reasonable attempt to secure 
these agreements. If CMS determines that a reasonable attempt was made, 
the requirements of paragraph (d)(4) of this section are deemed to be 
met.
    (e) Diagnosis and trauma code edits. Except as specified under 
paragraph (l) of this section, the agency must take action to identify 
those paid claims for Medicaid beneficiaries that contain diagnosis 
codes that are indicative of trauma, or injury, poisoning, and other 
consequences of external causes, for the purpose of determining the 
legal liability of third parties so that the agency may process claims 
under the third party liability payment procedures specified in Sec.  
433.139(b) through (f).
    (f) Data exchanges and trauma code edits: Frequency. Except as 
provided in paragraph (l) of this section, the agency must conduct the 
data exchanges required in paragraphs (d)(1) and (3) of this section, 
and diagnosis and trauma edits required in paragraphs (d)(4) and (e) of 
this section on a routine and timely basis. The State plan must specify 
the frequency of these activities.
    (g) Followup procedures for identifying legally liable third party 
resources. Except as provided in paragraph (l) of this section, the 
State must meet the requirements of this paragraph.
    (1) SWICA, SSA wage and earnings files, and title IV-A data 
exchanges. With respect to information obtained under paragraphs (d)(1) 
through (d)(3) of this section--
    (i) Within 45 days, the agency must follow up (if appropriate) on 
such information to identify legally liable third party resources and 
incorporate such information into the eligibility case file and into its 
third party data base and third party recovery unit so the agency may 
process claims under the third party liability payment procedures 
specified in Sec.  433.139 (b) through (f); and
    (ii) The State plan must describe the methods the agency uses for 
meeting the requirements of paragraph (g)(1)(i) of this section.
    (2) Health insurance information and workers' compensation data 
exchanges. With respect to information obtained under paragraphs (b) and 
(d)(4)(i) of this section--
    (i) Within 60 days, the agency must followup on such information (if 
appropriate) in order to identify legally liable third party resources 
and incorporate such information into the eligibility case file and into 
its third party data base and third party recovery unit so the agency 
may process claims under the third party liability payment procedures 
specified in Sec.  433.139 (b) through (f); and
    (ii) The State plan must describe the methods the agency uses for 
meeting the requirements of paragraph (g)(2)(i) of this section.
    (3) State motor vehicle accident report file data exchanges. With 
respect to information obtained under paragraph (d)(4)(ii) of this 
section--
    (i) The State plan must describe the methods the agency uses for 
following up on such information in order to identify legally liable 
third party resources so the agency may process claims under the third 
party liability payment procedures specified in Sec.  433.139 (b) 
through (f);
    (ii) After followup, the agency must incorporate all information 
that identifies legally liable third party resources into the 
eligibility case file and into its third party data base and third party 
recovery unit; and
    (iii) The State plan must specify timeframes for incorporation of 
the information.
    (4) Diagnosis and trauma code edits. With respect to the paid claims 
identified under paragraph (e) of this section--
    (i) The State plan must describe the methods the agency uses to 
follow up

[[Page 109]]

on such claims in order to identify legally liable third party resources 
so the agency may process claims under the third party liability payment 
procedures specified in Sec.  433.139 (b) through (f) (Methods must 
include a procedure for periodically identifying those trauma codes that 
yield the highest third party collections and giving priority to 
following up on those codes.);
    (ii) After followup, the agency must incorporate all information 
that identifies legally liable third party resources into the 
eligibility case file and into its third party data base and third party 
recovery unit; and
    (iii) The State plan must specify the timeframes for incorporation 
of the information.
    (h) Obtaining other information and data exchanges: Safeguarding 
information. (1) The agency must safeguard information obtained from and 
exchanged under this section with other agencies in accordance with the 
requirements set forth in part 431, subpart F of this chapter.
    (2) Before requesting information from, or releasing information to 
other agencies to identify legally liable third party resources under 
paragraph (d) of this section the agency must execute data exchange 
agreements with those agencies. The agreements, at a minimum, must 
specify--
    (i) The information to be exchanged;
    (ii) The titles of all agency officials with the authority to 
request third party information;
    (iii) The methods, including the formats to be used, and the timing 
for requesting and providing the information;
    (iv) The safeguards limiting the use and disclosure of the 
information as required by Federal or State law or regulations; and
    (v) The method the agency will use to reimburse reasonable costs of 
furnishing the information if payment is requested.
    (i) Reimbursement. The agency must, upon request, reimburse an 
agency for the reasonable costs incurred in furnishing information under 
this section to the Medicaid agency.
    (j) Reports. The agency must provide such reports with respect to 
the data exchanges and trauma code edits set forth in paragraphs (d)(1) 
through (d)(4) and paragraph (e) of this section, respectively, as the 
Secretary prescribes for the purpose of determining compliance under 
Sec.  433.138 and evaluating the effectiveness of the third party 
liability identification system. However, if the State is not meeting 
the provisions of paragraph (e) of this section because it has been 
granted a waiver of those provisions under paragraph (l) of this 
section, it is not required to provide the reports required in this 
paragraph.
    (k) Integration with the State mechanized claims processing and 
information retrieval system. Basic requirement--Development of an 
action plan. (1) If a State has a mechanized claims processing and 
information retrieval system approved by CMS under subpart C of this 
part, the agency must have an action plan for pursuing third party 
liability claims and the action plan must be integrated with the 
mechanized claims processing and information retrieval system.
    (2) The action plan must describe the actions and methodologies the 
State will follow to--
    (i) Identify third parties;
    (ii) Determine the liability of third parties;
    (iii) Avoid payment of third party claims as required in Sec.  
433.139;
    (iv) Recover reimbursement from third parties after Medicaid claims 
payment as required in Sec.  433.139; and,
    (v) Record information and actions relating to the action plan.
    (3) The action plan must be consistent with the conditions for 
reapproval set forth in Sec.  433.119. The portion of the plan which is 
integrated with MMIS is monitored in accordance with those conditions 
and if the conditions are not met; it is subject to FFP reduction in 
accordance with procedures set forth in Sec.  433.120. The State is not 
subject to any other penalty as a result of other monitoring, quality 
control, or auditing requirements for those items in the action plan.
    (4) The agency must submit its action plan to the CMS Regional 
Office within 120 days from the date CMS issues implementing 
instructions for the State Medicaid Manual. If a State does not have an 
approved MMIS on

[[Page 110]]

the date of issuance of the State Medicaid Manual but subsequently 
implements an MMIS, the State must submit its action plan within 90 days 
from the date the system is operational. The CMS Regional Office 
approves or disapproves the action plan.
    (l) Waiver of requirements. (1) The agency may request initial and 
continuing waiver of the requirements to determine third party liability 
found in paragraphs (c), (d)(4), (d)(5), (e), (f), (g)(1), (g)(2), 
(g)(3), and (g)(4) of this section if the State determines the activity 
to be not cost-effective. An activity would not be cost-effective if the 
cost of the required activity exceeds the third party liability 
recoupment and the required activity accomplishes, at the same or at a 
higher cost, the same objective as another activity that is being 
performed by the State.
    (i) The agency must submit a request for waiver of the requirement 
in writing to the CMS regional office.
    (ii) The request must contain adequate documentation to establish 
that to meet a requirement specified by the agency is not cost-
effective. Examples of documentation are claims recovery data and a 
State analysis documenting a cost-effective alternative that 
accomplished the same task.
    (iii) The agency must agree, if a waiver is granted, to notify CMS 
of any event that occurs that changes the conditions upon which the 
waiver was approved.
    (2) CMS will review a State's request to have a requirement 
specified under paragraph (l)(1) of this section waived and will request 
additional information from the State, if necessary. CMS will notify the 
State of its approval or disapproval determination within 30 days of 
receipt of a properly documented request.
    (3) CMS may rescind a waiver at any time that it determines that the 
agency no longer meets the criteria for approving the waiver. If the 
waiver is rescinded, the agency has 6 months from the date of the 
rescission notice to meet the requirement that had been waived.

[52 FR 5975, Feb. 27, 1987, as amended at 54 FR 8741, Mar. 2, 1989; 55 
FR 1432, Jan. 16, 1990; 55 FR 5118, Feb. 13, 1990; 60 FR 35502, July 10, 
1995; 81 FR 27853, May 6, 2016; 81 FR 86449, Nov. 30, 2016]



Sec.  433.139  Payment of claims.

    (a) Basic provisions. (1) For claims involving third party liability 
that are processed on or after May 12, 1986, the agency must use the 
procedures specified in paragraphs (b) through (f) of this section.
    (2) The agency must submit documentation of the methods (e.g., cost 
avoidance, pay and recover later) it uses for payment of claims 
involving third party liability to the CMS Regional Office.
    (b) Probable liability is established at the time claim is filed. 
Except as provided in paragraph (e) of this section--
    (1) If the agency has established the probable existence of third 
party liability at the time the claim is filed, the agency must reject 
the claim and return it to the provider for a determination of the 
amount of liability. The establishment of third party liability takes 
place when the agency receives confirmation from the provider or a third 
party resource indicating the extent of third party liability. When the 
amount of liability is determined, the agency must then pay the claim to 
the extent that payment allowed under the agency's payment schedule 
exceeds the amount of the third party's payment.
    (2) [Reserved]
    (3) The agency must pay the full amount allowed under the agency's 
payment schedule for the claim and seek reimbursement from any liable 
third party to the limit of legal liability (and for purposes of 
paragraph (b)(3)(ii) of this section, from a third party, if the third 
party liability is derived from an absent parent whose obligation to pay 
support is being enforced by the State title IV-D agency), consistent 
with paragraph (f) of this section if--
    (i) The claim is for preventive pediatric services, including early 
and periodic screening, diagnosis and treatment services provided for 
under part

[[Page 111]]

441, subpart B, of this chapter, that are covered under the State plan; 
or
    (ii) The claim is for a service covered under the State plan that is 
provided to an individual on whose behalf child support enforcement is 
being carried out by the State title IV-D agency. The agency prior to 
making any payment under this section must assure that the following 
requirements are met:
    (A) The State plan specifies whether or not providers are required 
to bill the third party.
    (B) For child support enforcement services beginning February 9, 
2018, the provider certifies that before billing Medicaid, if the 
provider has billed a third party, the provider has waited 100 days from 
the date of the service and has not received payment from the third 
party.
    (C) The State plan specifies the method used in determining the 
provider's compliance with the billing requirements.
    (c) Probable liability is not established or benefits are not 
available at the time claim is filed. If the probable existence of third 
party liability cannot be established or third party benefits are not 
available to pay the beneficiary's medical expenses at the time the 
claim is filed, the agency must pay the full amount allowed under the 
agency's payment schedule.
    (d) Recovery of reimbursement. (1) If the agency has an approved 
waiver under paragraph (e) of this section to pay a claim in which the 
probable existence of third party liability has been established and 
then seek reimbursement, the agency must seek recovery of reimbursement 
from the third party to the limit of legal liability within 60 days 
after the end of the month in which payment is made unless the agency 
has a waiver of the 60-day requirement under paragraph (e) of this 
section.
    (2) Except as provided in paragraph (e) of this section, if the 
agency learns of the existence of a liable third party after a claim is 
paid, or benefits become available from a third party after a claim is 
paid, the agency must seek recovery of reimbursement within 60 days 
after the end of the month it learns of the existence of the liable 
third party or benefits become available.
    (3) Reimbursement must be sought unless the agency determines that 
recovery would not be cost effective in accordance with paragraph (f) of 
this section.
    (e) Waiver of requirements. (1) The agency may request initial and 
continuing waiver of the requirements in paragraphs (b)(1), (d)(1), and 
(d)(2) of this section, if it determines that the requirement is not 
cost-effective. An activity would not be cost-effective if the cost of 
the required activity exceeds the third party liability recoupment and 
the required activity accomplishes, at the same or at a higher cost, the 
same objective as another activity that is being performed by the State.
    (i) The agency must submit a request for waiver of the requirement 
in writing to the CMS regional office.
    (ii) The request must contain adequate documentation to establish 
that to meet a requirement specified by the agency is not cost-
effective. Examples of documentation are costs associated with billing, 
claims recovery data, and a State analysis documenting a cost-effective 
alternative that accomplishes the same task.
    (iii) The agency must agree, if a waiver is granted, to notify CMS 
of any event that occurs that changes the conditions upon which the 
waiver was approved.
    (2) CMS will review a State's request to have a requirement 
specified under paragraph (e)(1) of this section waived and will request 
additional information from the State, if necessary. CMS will notify the 
State of its approval or disapproval determination within 30 days of 
receipt of a properly documented request.
    (3) CMS may rescind the waiver at any time that it determines that 
the State no longer meets the criteria for approving the waiver. If the 
waiver is rescinded, the agency has 6 months from the date of the 
rescission notice to meet the requirement that had been waived.
    (4) An agency requesting a waiver of the requirements specifically 
concerning either the 60-day limit in paragraph (d)(1) or (d)(2) of this 
section

[[Page 112]]

must submit documentation of written agreement between the agency and 
the third party, including Medicare fiscal intermediaries and carriers, 
that extension of the billing requirement is agreeable to all parties.
    (f) Suspension or termination of recovery of reimbursement. (1) An 
agency must seek reimbursement from a liable third party on all claims 
for which it determines that the amount it reasonably expects to recover 
will be greater than the cost of recovery. Recovery efforts may be 
suspended or terminated only if they are not cost effective.
    (2) The State plan must specify the threshold amount or other 
guideline that the agency uses in determining whether to seek recovery 
of reimbursement from a liable third party, or describe the process by 
which the agency determines that seeking recovery of reimbursement would 
not be cost effective.
    (3) The State plan must also specify the dollar amount or period of 
time for which it will accumulate billings with respect to a particular 
liable third party in making the decision whether to seek recovery of 
reimbursement.

[50 FR 46665, Nov. 12, 1985, as amended at 51 FR 16319, May 2, 1986; 60 
FR 35503, July 10, 1995; 62 FR 23140, Apr. 29, 1997; 85 FR 87100, Dec. 
31, 2020]



Sec.  433.140  FFP and repayment of Federal share.

    (a) FFP is not available in Medicaid payments if--
    (1) The agency failed to fulfill the requirements of Sec. Sec.  
433.138 and 433.139 with regard to establishing liability and seeking 
reimbursement from a third party;
    (2) The agency received reimbursement from a liable third party; or
    (3) A private insurer would have been obligated to pay for the 
service except that its insurance contract limits or excludes payments 
if the individual is eligible for Medicaid.
    (b) FFP is available at the 50 percent rate for the agency's 
expenditures in carrying out the requirements of this subpart.
    (c) If the State receives FFP in Medicaid payments for which it 
receives third party reimbursement, the State must pay the Federal 
government a portion of the reimbursement determined in accordance with 
the FMAP for the State. This payment may be reduced by the total amount 
needed to meet the incentive payment in Sec.  433.153.

                    Assignment of Rights to Benefits



Sec.  433.145  Assignment of rights to benefits--State plan requirements.

    (a) A State plan must provide that, as a condition of eligibility, 
each legally able applicant or beneficiary is required to:
    (1) Assign to the Medicaid agency his or her rights, or the rights 
of any other individual eligible under the plan for whom he or she can 
legally make an assignment, to medical support and to payment for 
medical care from any third party;
    (2) Cooperate with the agency in establishing the identity of a 
child's parents and in obtaining medical support and payments, unless 
the individual establishes good cause for not cooperating, and except 
for individuals described in Sec.  435.116 of this chapter (pregnant 
women), who are exempt from cooperating in establishing the identity of 
a child's parents and obtaining medical support and payments from, or 
derived from, the non-custodial parent of a child; and
    (3) Cooperate in identifying and providing information to assist the 
Medicaid agency in pursuing third parties who may be liable to pay for 
care and services under the plan, unless the individual establishes good 
cause for not cooperating.
    (b) A State plan must provide that the requirements for assignments, 
cooperation in establishing paternity and obtaining support, and 
cooperation in identifying and providing information to assist the State 
in pursuing any liable third party under Sec. Sec.  433.146 through 
433.148 are met.
    (c) A State plan must provide that the assignment of rights to 
benefits obtained from an applicant or beneficiary is effective only for 
services that are reimbursed by Medicaid.

[55 FR 48606, Nov. 21, 1990, as amended at 58 FR 4907, Jan. 19, 1993; 81 
FR 86450, Nov. 30, 2016]

[[Page 113]]



Sec.  433.146  Rights assigned; assignment method.

    (a) Except as specified in paragraph (b) of this section, the agency 
must require the individual to assign to the State--
    (1) His own rights to any medical care support available under an 
order of a court or an administrative agency, and any third party 
payments for medical care; and
    (2) The rights of any other individual eligible under the plan, for 
whom he can legally make an assignment.
    (b) Assignment of rights to benefits may not include assignment of 
rights to Medicare benefits.
    (c) If assignment of rights to benefits is automatic because of 
State law, the agency may substitute such an assignment for an 
individual executed assignment, as long as the agency informs the 
individual of the terms and consequences of the State law.



Sec.  433.147  Cooperation in establishing the identity of a child's
parents and in obtaining medical support and payments and in identifying
and providing information to assist in pursuing third parties who may be 
liable to pay.

    (a) Scope of requirement. The agency must require the individual who 
assigns his or her rights to cooperate in--
    (1) Except as exempt under Sec.  433.145(a)(2), establishing the 
identity of a child's parents and obtaining medical support and payments 
for himself or herself and any other person for whom the individual can 
legally assign rights; and
    (2) Identifying and providing information to assist the Medicaid 
agency in pursuing third parties who may be liable to pay for care and 
services under the plan.
    (b) Essentials of cooperation. As part of a cooperation, the agency 
may require an individual to--
    (1) Appear at a State or local office designated by the agency to 
provide information or evidence relevant to the case;
    (2) Appear as a witness at a court or other proceeding;
    (3) Provide information, or attest to lack of information, under 
penalty of perjury;
    (4) Pay to the agency any support or medical care funds received 
that are covered by the assignment of rights; and
    (5) Take any other reasonable steps to assist in establishing 
paternity and securing medical support and payments, and in identifying 
and providing information to assist the State in pursuing any liable 
third party.
    (c) Waiver of cooperation for good cause. The agency must waive the 
requirements in paragraphs (a) and (b) of this section if it determines 
that the individual has good cause for refusing to cooperate.
    (1) For establishing the identity of a child's parents or obtaining 
medical care support and payments, or identifying or providing 
information to assist the State in pursuing any liable third party for a 
child for whom the individual can legally assign rights, the agency must 
find that cooperation is against the best interests of the child.
    (2) With respect to obtaining medical care support and payments for 
an individual and identifying and providing information to assist in 
pursuing liable third parties in any case not covered by paragraph 
(c)(1) of this section, the agency must find that cooperation is against 
the best interests of the individual or the person to whom Medicaid is 
being furnished because it is anticipated that cooperation will result 
in reprisal against, and cause physical or emotional harm to, the 
individual or other person.

[45 FR 8984, Feb. 11, 1980, as amended at 55 FR 48606, Nov. 21, 1990; 58 
FR 4907, Jan. 19, 1993; 81 FR 86450, Nov. 30, 2016]



Sec.  433.148  Denial or termination of eligibility.

    In administering the assignment of rights provision, the agency 
must:
    (a) Deny or terminate eligibility for any applicant or beneficiary 
who--
    (1) Refuses to assign his own rights or those of any other 
individual for whom he can legally make an assignment; or
    (2) In the case of an applicant, does not attest to willingness to 
cooperate, and in the case of a beneficiary, refuses to cooperate in 
establishing the identity of a child's parents, obtaining medical child 
support and pursuing liable third parties, as required under

[[Page 114]]

Sec.  433.147(a) unless cooperation has been waived;
    (b) Provide Medicaid to any individual who--
    (1) Cannot legally assign his own rights; and
    (2) Would otherwise be eligible for Medicaid but for the refusal, by 
a person legally able to assign his rights, to assign his rights or to 
cooperate as required by this subpart; and
    (c) In denying or terminating eligibility, comply with the notice 
and hearing requirements of part 431, subpart E of this subchapter.

[45 FR 8984, Feb. 11, 1980, as amended at 81 FR 86450, Nov. 30, 2016]

              Cooperative Agreements and Incentive Payments



Sec.  433.151  Cooperative agreements and incentive payments-
-State plan requirements.

    For medical assistance furnished on or after October 1, 1984--
    (a) A State plan must provide for entering into written cooperative 
agreements for enforcement of rights to and collection of third party 
benefits with at least one of the following entities: The State title 
IV-D agency, any appropriate agency of any State, and appropriate courts 
and law enforcement officials. The agreements must be in accordance with 
the provisions of Sec.  433.152.
    (b) A State plan must provide that the requirements for making 
incentive payments and for distributing third party collections 
specified in Sec. Sec.  433.153 and 433.154 are met.

[50 FR 46665, Nov. 12, 1985; 50 FR 49389, Dec. 2, 1985]



Sec.  433.152  Requirements for cooperative agreements for third party
collections.

    (a) Except as specified in paragraph (b) of this section, the State 
agency may develop the specific terms of cooperative agreements with 
other agencies as it determines appropriate for individual 
circumstances.
    (b) Agreements with title IV-D agencies must specify that:
    (1) The Medicaid agency may not refer a case for medical support 
enforcement when the following criteria have been met:
    (i) The Medicaid referral is based solely upon health care services 
provided through an Indian Health Program (as defined at 25 U.S.C. 
1603(12)), including through the Purchased/Referred Care program, to a 
child who is eligible for health care services from the Indian Health 
Service (IHS).
    (ii) [Reserved]
    (2) The Medicaid agency will provide reimbursement to the IV-D 
agency only for those child support services performed that are not 
reimbursable by the Office of Child Support Enforcement under title IV-D 
of the Act and that are necessary for the collection of amounts for the 
Medicaid program.

[50 FR 46666, Nov. 12, 1985, as amended at 81 FR 93560, Dec. 20, 2016]



Sec.  433.153  Incentive payments to States and political subdivisions.

    (a) When payments are required. The agency must make an incentive 
payment to a political subdivision, a legal entity of the subdivision 
such as a prosecuting or district attorney or a friend of the court, or 
another State that enforces and collects medical support and payments 
for the agency.
    (b) Amount and source of payment. The incentive payment must equal 
15 percent of the amount collected, and must be made from the Federal 
share of that amount.
    (c) Payment to two or more jurisdictions. If more than one State or 
political subdivision is involved in enforcing and collecting support 
and payments:
    (1) The agency must pay all of the incentive payment to the 
political subdivision, legal entity of the subdivision, or another State 
that collected medical support and payments at the request of the 
agency.
    (2) The political subdivision, legal entity or other State that 
receives the incentive payment must then divide the incentive payment 
equally with any other political subdivisions, legal entities, or other 
States that assisted in the collection, unless an alternative allocation 
is agreed upon by all jurisdictions involved.

[[Page 115]]



Sec.  433.154  Distribution of collections.

    The agency must distribute collections as follows--
    (a) To itself, an amount equal to State Medicaid expenditures for 
the individual on whose right the collection was based.
    (b) To the Federal Government, the Federal share of the State 
Medicaid expenditures, minus any incentive payment made in accordance 
with Sec.  433.153.
    (c) To the beneficiary, any remaining amount. This amount must be 
treated as income or resources under part 435 or part 436 of this 
subchapter, as appropriate.



   Subpart E_Methodologies for Determining Federal Share of Medicaid 
                Expenditures for Adult Eligibility Group

    Source: 78 FR 19942, Apr. 2, 2013, unless otherwise noted.



Sec.  433.202  Scope.

    This subpart sets forth the requirements and procedures that are 
applicable to support State claims for the increased FMAP specified at 
Sec.  433.10(c)(6) for the medical assistance expenditures for 
individuals determined eligible as specified in Sec.  435.119 of this 
chapter who meet the definition of newly eligible individual specified 
in Sec.  433.204(a)(1). These procedures will also identify individuals 
determined eligible as specified in Sec.  435.119 of this chapter for 
whom the State may claim the regular FMAP rate specified at Sec.  
433.10(b) or the increased FMAP rate specified at Sec.  433.10(c)(7) or 
(8), as applicable.



Sec.  433.204  Definitions.

    (a)(1) Newly eligible individual means an individual determined 
eligible for Medicaid in accordance with the requirements of the adult 
group described in Sec.  435.119 of this chapter, and who, as determined 
by the State in accordance with the requirements of Sec.  433.206, would 
not have been eligible for Medicaid under the State's eligibility 
standards and methodologies for the Medicaid State plan, waiver or 
demonstration programs in effect in the State as of December 1, 2009, 
for full benefits or for benchmark coverage described in Sec.  
440.330(a), (b), or (c) of this chapter or benchmark equivalent coverage 
described in Sec.  440.335 of this chapter that has an aggregate 
actuarial value that is at least actuarially equivalent to benchmark 
coverage described in Sec.  440.330(a), (b), or (c) of this chapter, or 
would have been eligible but not enrolled (or placed on a waiting list) 
for such benefits or coverage through a waiver under the plan that had a 
capped or limited enrollment that was full.
    (2) Full benefits means, for purposes of paragraph (a)(1) of this 
section, with respect to an adult individual, medical assistance for all 
services covered under the State plan under Title XIX of the Act that is 
not less in amount, duration, or scope, or is determined by the 
Secretary to be substantially equivalent, to the medical assistance 
available for an individual described in section 1902(a)(10)(A)(i) of 
the Act.
    (3) For purposes of establishing under paragraphs (a)(1) and (2) of 
this section whether an individual would not have been eligible for full 
benefits, benchmark coverage, or benchmark equivalent coverage under a 
waiver or demonstration program in effect on December 1, 2009, the State 
must provide CMS with its analysis, in accordance with guidance issued 
by CMS, about whether the benefits available under such waiver or 
demonstration constituted full benefits, benchmark coverage, or 
benchmark equivalent coverage. CMS will review such analysis and confirm 
the applicable FMAP. Individuals for whom such benefits or coverage 
would have been available under such waiver or demonstration are not 
newly eligible individuals.
    (b)(1) Expansion State means a State that, as of March 23, 2010, 
offered health benefits coverage statewide to parents and nonpregnant, 
childless adults whose income is at least 100 percent of the Federal 
Poverty Level. A State that offers health benefits coverage to only 
parents or only nonpregnant childless adults described in the preceding 
sentence will not be considered to be an expansion State. Such health 
benefits coverage must:
    (i) Have included inpatient hospital services;

[[Page 116]]

    (ii) Not have been dependent on access to employer coverage, 
employer contribution, or employment; and
    (iii) Not have been limited to premium assistance, hospital-only 
benefits, a high deductible health plan, or benefits under a 
demonstration program authorized under section 1938 of the Act.
    (2) For purposes of paragraph (b)(1) of this section and for Sec.  
433.10(c)(8), a nonpregnant childless adult means an individual who is 
not eligible based on pregnancy and does not meet the definition of a 
caretaker relative in Sec.  435.4 of this chapter.



Sec.  433.206  Threshold methodology.

    (a) Overview. Effective January 1, 2014, States must apply the 
threshold methodology described in this paragraph for purposes of 
determining the appropriate claiming for the Federal share of 
expenditures at the applicable FMAP rates described in Sec.  433.10(b) 
and (c) for medical assistance provided with respect to individuals who 
have been determined eligible for the Medicaid program under Sec.  
435.119 of this chapter. Subject to the provisions of this paragraph, 
States must apply the CMS-approved State specific threshold methodology 
to determine and distinguish such individuals as newly or not newly 
eligible individuals in accordance with the definition in Sec.  
433.204(a)(1), and in accordance with States' Medicaid eligibility 
criteria as in effect on December 1, 2009 and to attribute their 
associated medical expenditures with the appropriate FMAP. The threshold 
methodology must not be applied by States for the purpose of determining 
the applicable FMAP for individuals under any other eligibility category 
other than Sec.  435.119 of this chapter.
    (b) General principles. The threshold methodology should:
    (1) Not impact the timing or approval of an individual's eligibility 
for Medicaid.
    (2) Not be biased in such a manner as to inappropriately establish 
the numbers of, or medical assistance expenditures for, individuals 
determined to be newly or not newly eligible.
    (3) Provide a valid and accurate accounting of individuals who would 
have been eligible in accordance with the December 1, 2009 eligibility 
standards and applicable eligibility categories for the benefits 
described in Sec.  433.204(a)(1), and subject to paragraphs (d), (e), 
and (g) of this section, by incorporating simplified assessments of 
resources, enrollment cap requirements in place at that time, and other 
special circumstances as approved by CMS, respectively.
    (4) Operate efficiently, without further review once an individual 
has been determined not to be newly eligible based on the December 1, 
2009 standards for any eligibility category.
    (c) Components of the threshold methodology. Subject to the 
submission of a threshold methodology State plan amendment as specified 
in paragraph (h) of this section, the provisions of the threshold 
methodology consist of two components, the individual income-based 
determination and population-based non-income adjustments to reflect 
resource criteria, enrollment caps in effect on December 1, 2009, and 
other factors in accordance with paragraph (g) of this section.
    (1) Scope. The threshold methodology shall apply with respect to the 
population, and the associated expenditures for such population, which 
has been determined eligible for Medicaid under section 
1902(a)(10)(A)(i)(VIII) of the Act and in accordance with Sec.  435.119 
of this chapter. This population and associated expenditures must not 
include individuals who have been determined eligible for Medicaid under 
any other mandatory or optional eligibility category.
    (2) Benefit criteria for newly eligible. An individual eligible for 
and enrolled under Sec.  435.119 of this chapter is considered newly 
eligible if, with respect to the applicable eligibility category in 
effect on December 1, 2009, the benefits did not meet the criteria 
described in the newly eligible definition at Sec.  433.204(a)(1).
    (3) Individual income-based determination. The individual income-
based determination shall be a comparison of the individual's MAGI-based 
income to the income standard in effect on December 1, 2009, as 
converted to an

[[Page 117]]

equivalent MAGI-based income standard for each applicable eligibility 
category as in effect on that date, as follows.
    (i) The amount of an individual's income under the threshold 
methodology is the MAGI-based income determined in accordance with Sec.  
435.603 of this chapter.
    (ii) For each individual, the equivalent MAGI-based income 
eligibility standard is the applicable income eligibility standard for 
the applicable category of eligibility as in effect on December 1, 2009 
that is converted to an equivalent MAGI-based income standard. For 
example, as applicable, a separate MAGI-based income standard will be 
applied for individuals determined to be disabled who would have been 
eligible under an optional eligibility category in effect on December 1, 
2009 that was based on disability. For these purposes, the applicable 
equivalent MAGI-based standard is the standard as submitted by the State 
and approved by CMS in accordance with CMS guidance.
    (iii) With respect to income eligibility criteria, if the 
individual's MAGI-based income is at or below the applicable converted 
MAGI-based income standard for the relevant eligibility category or 
group, then the individual is included in the population that is not 
newly eligible;
    (iv) With respect to income eligibility criteria, if the 
individual's MAGI-based income is greater than the applicable converted 
MAGI-based income standard for the relevant eligibility category or 
group, then the individual is included in the population that is newly 
eligible;
    (v) Treatment of spend-down programs. Treatment of medically needy 
or spend-down programs under the threshold methodology is described in 
paragraph (f) of this section.
    (vi) For purposes of comparing the individual's MAGI-based income to 
the applicable converted MAGI-based income standard in effect on 
December 1, 2009, an individual will not be considered disabled absent 
an actual disability determination for the individual that is in 
accordance with the disability definition applicable for the State under 
Title XIX of the Act.
    (4) Treatment of disability. For purposes of applying the 
appropriate FMAP under Sec.  433.10(b) or (c) for the medical assistance 
expenditures of an individual in applying the definition of newly 
eligible under Sec.  433.204(a)(1), for eligibility categories or groups 
as in effect on December 1, 2009 for which disability was an eligibility 
criteria:
    (i) During the period of a disability determination. During the 
period for which a disability determination is pending, including during 
the period of any appeal process, and absent an actual disability 
determination for the individual that is in accordance with the 
disability definition applicable for the State under Title XIX of the 
Act, the individual is not considered to be disabled.
    (ii) Following a disability determination. With respect to an 
individual for which a disability determination was pending, following 
the actual determination of disability, the individual will be 
considered disabled effective with the date of the disability 
determination, or, if later, the disability onset date, as determined.
    (5) Population-based adjustments to the populations of newly 
eligible and not newly eligible. (i) The State may elect a resource 
criteria proxy adjustment described in paragraph (d) of this section.
    (ii) States that had a waiver or demonstration program with an 
enrollment cap in effect as of December 1, 2009 must apply an adjustment 
based on enrollment caps, subject to the definition of newly eligible 
individual in Sec.  433.204(a)(1) and paragraph (e) of this section.
    (iii) States that have special circumstances may need to submit 
associated proxy methodologies to CMS for approval by CMS as described 
in paragraph (g) of this section.
    (6) Application of FMAP rates to adult group expenditures. Subject 
to population adjustments under paragraphs (d), (e), or (g) of this 
section, federal funding for a State's expenditures for medical 
assistance provided to individuals determined eligible under Sec.  
435.119 of this chapter, including individuals determined eligible under 
that eligibility group during the evaluation for another eligibility 
category, must be

[[Page 118]]

claimed using the applicable FMAP as follows:
    (i) The newly eligible FMAP under Sec.  433.10(c)(6) is applicable 
for the medical assistance expenditures for individuals determined to be 
newly eligible, as defined in Sec.  433.204(a)(1).
    (ii) The applicable FMAP under Sec.  433.10(b) or Sec.  433.10(c)(7) 
or (8) is applicable for the medical assistance expenditures for 
individuals determined not to be newly eligible.
    (7) Status as newly or not newly eligible. Under the threshold 
methodology States must provide that once individuals are determined 
under the threshold methodology to be either newly or not newly eligible 
individuals in accordance with the applicable December 1, 2009 
eligibility criteria, the State would apply that determination until a 
new determination of MAGI-based income has been made in accordance with 
Sec.  435.916 of this chapter, or the individual has been otherwise 
determined not to be covered under the adult group set forth at Sec.  
435.119 of this chapter.
    (d) Optional resource criteria proxy adjustment--(1) General. Under 
an election under this paragraph (d), the State may use a resource proxy 
methodology for purposes of adjusting the claims for the expenditures of 
the population enrolled under Sec.  435.119 of this chapter to account 
for individuals who would not have been eligible for Medicaid because of 
the application of resource criteria as in effect for such population as 
of December 1, 2009, and therefore would meet the newly eligible 
individual definition at Sec.  433.204(a)(1). Under this paragraph (d), 
a State may elect to apply a resource proxy methodology with respect to 
the resource criteria as in effect on December 1, 2009 and applied to 
the expenditures for a specific eligibility category or categories of 
individuals as in effect on December 1, 2009, or applied to the 
expenditures of the entire population enrolled under Sec.  435.119 of 
this chapter. As provided in paragraph (d)(4) of this section, the State 
must indicate any resource proxy election in the threshold methodology 
State plan amendment submitted under paragraph (h) of this section. The 
use of a resource proxy methodology must not delay or interfere with the 
eligibility determination for an individual.
    (2) A State's resource proxy methodology must:
    (i) Describe each eligibility group or groups for which an 
individual eligible under Sec.  435.119 would have been eligible on 
December 1, 2009, subject to resource criteria, and a methodology to 
apply those resource criteria as an adjustment to the total expenditures 
to adjust determinations of the newly eligible population under 
paragraph (c) of this section.
    (ii) Be auditable.
    (iii) Be based on statistically valid data, which is either:
    (A) Existing State data from and for periods before January 1, 2014 
on the resources of individuals who had applied and received a 
determination with respect to Medicaid eligibility, including resource 
eligibility under the State's applicable December 1, 2009 eligibility 
criteria. The existing State data must be specifically related to 
resource eligibility determinations, indicate the number and types of 
individuals for whom resource determinations were made, and establish 
the denial rates specifically identified as due to excess resources; or
    (B) Post-eligibility State data on the resources of individuals 
described in paragraph (d)(2)(iii)(B)(1) and (2) of this section, based 
on and obtained through a post-eligibility statistically valid sample of 
such individuals with respect to the applicable Medicaid eligibility 
categories and resource eligibility criteria under the State's 
applicable December 1, 2009 eligibility criteria:
    (1) State data from and for periods before January 1, 2014 must be 
for individuals in eligibility categories relevant to Sec.  435.119 of 
this chapter who apply and receive a determination with respect to 
Medicaid eligibility, including both approvals and denials, to establish 
denial rates specifically due to excess resources and identify numbers 
and types of individuals.
    (2) State data from and for periods on or after January 1, 2014 must 
only be for individuals determined eligible and enrolled under Sec.  
435.119 of this chapter, must compare individuals' resources to the 
applicable December 1, 2009 resource criteria to establish denial rates

[[Page 119]]

specifically due to excess resources, and identify numbers and types of 
individuals.
    (iv) Describe the State data on individuals' resources used and the 
application of such data. Whether such State data is based on data 
described in paragraph (d)(2)(iii)(A) or (B) of this section, such State 
data must represent sampling results for a period of sufficient length 
to be statistically valid.
    (v) Provide that the resource proxy methodology will account for the 
treatment of resources in a statistically valid manner when there is a 
lack of sufficient information to make a resource determination for a 
particular individual in a sampled population.
    (vi) Describe the application of the resource proxy methodology in 
establishing the amount and submission of claims for Federal funding by 
the State for the medical assistance expenditures of the applicable 
eligibility group(s). Such claims submitted under the resource proxy 
methodology must reflect the appropriate FMAP for the medical assistance 
expenditures of the affected eligibility group(s).
    (vii) As appropriate, describe and demonstrate the statistical 
validity of the resource proxy methodology and the use of data under 
such methodology.
    (3) Effective date for application of resource proxy. The resource 
proxy shall not be effective prior to the beginning of the quarter in 
which such resource proxy is submitted to CMS under the threshold 
methodology State plan in paragraph (h) of this section.
    (4) One time election for resource proxy. The election, application, 
and description of a resource proxy methodology under this paragraph for 
individuals determined eligible under Sec.  435.119 must be included in 
a one-time submission of a State plan amendment submitted under 
paragraph (h) of this section no later than one year from the first day 
of the quarter in which eligibility for individuals under Sec.  435.119 
of this chapter is initially effective for the State.
    (e) Enrollment caps adjustment--(1) Scope. Certain States may have 
applied enrollment caps, limits, or waiting lists in their Medicaid 
programs as in effect on December 1, 2009. Under the definition of newly 
eligible individual in Sec.  433.204(a)(1), such States must consider as 
newly eligible those individuals eligible under Sec.  435.119 of this 
chapter who would otherwise be eligible for full benefits, benchmark 
coverage, or benchmark equivalent coverage provided through a 
demonstration under the State plan effective December 1, 2009, but would 
not have been enrolled (or would have been on a waiting list) based on 
the application of an enrollment cap or limit determined in accordance 
with the approved demonstration as in effect on that date. Such States 
must only apply such enrollment cap, limit or waiting list provisions 
with respect to eligibility category or categories for which such 
provisions were applicable (for example, nonpregnant childless adults or 
parents/caretaker relatives) and in effect under the State's Medicaid 
program on December 1, 2009. For this purpose, individuals who would 
have been on a waiting list are considered as not enrolled under the 
demonstration.
    (2) A State for which multiple enrollment caps or limits were in 
effect under its December 1, 2009 Medicaid program may elect to combine 
such enrollment caps or limits, unless such treatment would preclude 
claiming of Federal funding at the applicable FMAP rate required under 
Sec.  433.10(b) or (c) (for example, to distinguish claims for childless 
adults and parents in an expansion State) for the medical assistance 
expenditures of individuals determined eligible and enrolled under Sec.  
435.119 of this chapter; a State with enrollment cap or limit provisions 
that would preclude combining enrollment caps or limit provisions must 
use separate caps; or, the State, at its option, may elect to use 
separate caps.
    (3) For purposes of claiming Federal funding, with respect to each 
claiming period for which the State claims Federal funding for an 
eligibility category for which an enrollment cap or limit is applicable 
and in effect on December 1, 2009, the State must account for:
    (i) The total unduplicated number of individuals eligible and 
enrolled under Sec.  435.119 of this chapter for the applicable claiming 
period.

[[Page 120]]

    (ii) The total State medical assistance expenditures for individuals 
eligible and enrolled under Sec.  435.119 of this chapter for the 
applicable claiming period.
    (iii) The enrollment cap or limit in effect on December 1, 2009 for 
the eligibility category, determined in accordance with the approved 
demonstration as in effect on December 1, 2009.
    (A) For States that elect under paragraph (e)(2) of this section to 
combine the enrollment caps, the enrollment cap is the sum of the 
enrollment caps for each eligibility group which is being combined.
    (B) For States that elect to treat the enrollment caps separately 
under paragraph (e)(2) of this section, each enrollment cap will be 
accounted for separately.
    (C) The level of the enrollment cap will be as authorized under the 
demonstration in effect on December 1, 2009; or, if the State had 
affirmatively set the cap at a lower level consistent with flexibility 
provided by the demonstration terms and conditions, the State may elect 
to apply the lower cap as in effect in the State on December 1, 2009. If 
a State elects to use such an alternate State-specified enrollment cap, 
the State will provide CMS with evidence, in its State plan amendment 
submitted to CMS under paragraph (h) of this section, that it had 
affirmatively implemented such a cap. Whether the State uses the 
authorized cap or a lower, verifiable cap as in effect in the State 
consistent with the demonstration special terms and conditions, the 
amount of expenditures up to the proportion of the 2009 enrollment cap 
to the total number of currently enrolled people in the group would not 
be claimed at the newly eligible FMAP.
    (4) States for which an enrollment cap, limit, or waiting list was 
applicable under their Medicaid programs as in effect on December 1, 
2009, must describe the treatment of such provision or provisions in the 
submission to CMS for approval by CMS in accordance with the State plan 
requirements outlined in Sec.  433.206(h).
    (f) Application of spend-down income eligibility criteria--(1) 
General. Certain States' Medicaid programs as in effect on December 1, 
2009 may have included eligibility categories for which deduction of 
incurred medical expenses from income (referred to as spend-down) under 
the provisions of sections 1902(a)(10)(C) or 1902(f) of the Act was 
applied in determining individuals' Medicaid eligibility. Paragraphs 
(f)(2) and (3) of this section apply, for purposes of determining 
whether an individual enrolled under Sec.  435.119 of this chapter meets 
the definition of newly eligible under Sec.  433.204(a)(1), and for 
purposes of applying the appropriate FMAP under Sec.  433.10(b) or (c) 
for the medical assistance expenditures of the individual for which a 
spend-down eligibility category of a State effective on December 1, 2009 
is applicable.
    (2) Not newly eligible individual. For purposes of a State's spend-
down provision, an individual enrolled under Sec.  435.119 of this 
chapter whose income before the deduction of incurred medical expenses 
is less than or equal to the applicable December 1, 2009 State spend-
down eligibility income level that would have resulted in full benefits 
is considered not newly eligible. The FMAP applicable for the medical 
assistance expenditures of such an individual is the appropriate FMAP 
under Sec.  433.10(b) and (c) as applicable for an individual who is not 
newly eligible.
    (3) Newly eligible individual. For purposes of a State's spend-down 
provision, an individual enrolled under Sec.  435.119 of this chapter 
whose income before the deduction of incurred medical expenses is 
greater than the applicable State spend-down eligibility income level is 
considered newly eligible. The FMAP applicable for the medical 
assistance expenditures of such an individual is the appropriate FMAP 
under Sec.  433.10(b) and (c) as applicable for an individual who is 
newly eligible.
    (g) Special circumstances. States may submit additional proxy 
methodologies to CMS for approval by CMS in accordance with the State 
plan requirements outlined in Sec.  433.206(h).
    (h) Threshold methodology State plan requirements. To claim 
expenditures at the increased FMAPs described in Sec.  433.210(c)(6) or 
(c)(8), the State must amend its State plan under the provisions of 
subpart B of part 430 to reflect the threshold methodology the State 
implements in accordance with the

[[Page 121]]

provisions of this section. The threshold methodology will be included 
as an attachment to the State plan and, explicitly and by reference, 
must:
    (1) Specify that the threshold methodology the State implements is 
in accordance with this section;
    (2) Specify that the threshold methodology the State implements 
accounts for the individuals determined eligible under the adult group 
in Sec.  435.119 of this chapter as a newly eligible individual or not 
newly eligible individual; and, on that basis, the State implements 
appropriate tracking for purpose of claiming Federal Medicaid funding 
for the associated medical assistance expenditures.
    (3) Reference the converted MAGI-based December 1, 2009 income 
eligibility standards and the associated eligibility groups, describe 
how the State will apply such standards and methodologies, and include 
other relevant criteria in the assignment of FMAP.
    (4) Indicate any required provisions, or options and alternatives 
the State elects, with respect to:
    (i) Treatment of resources, in accordance with paragraph (d) of this 
section;
    (ii) Treatment of enrollment caps or waiting lists, in accordance 
with paragraph (e) of this section; and
    (iii) Special circumstances as approved by CMS in accordance with 
paragraph (g) of this section.

[78 FR 19942, Apr. 2, 2013, as amended at 78 FR 32991, June 3, 2013]



    Subpart F_Refunding of Federal Share of Medicaid Overpayments to 
                                Providers

    Source: 54 FR 5460, Feb. 3, 1989, unless otherwise noted.



Sec.  433.300  Basis.

    This subpart implements--
    (a) Section 1903(d)(2)(A) of the Act, which directs that quarterly 
Federal payments to the States under title XIX (Medicaid) of the Act are 
to be reduced or increased to make adjustment for prior overpayments or 
underpayments that the Secretary determines have been made.
    (b) Section 1903(d)(2)(C) and (D) of the Act, which provides that a 
State has 1 year from discovery of an overpayment for Medicaid services 
to recover or attempt to recover the overpayment from the provider 
before adjustment in the Federal Medicaid payment to the State is made; 
and that adjustment will be made at the end of the 1-year period, 
whether or not recovery is made, unless the State is unable to recover 
from a provider because the overpayment is a debt that has been 
discharged in bankruptcy or is otherwise uncollectable.
    (c) Section 1903(d)(3) of the Act, which provides that the Secretary 
will consider the pro rata Federal share of the net amount recovered by 
a State during any quarter to be an overpayment.

[54 FR 5460, Feb. 3, 1989, as amended at 77 FR 31511, May 29, 2012]



Sec.  433.302  Scope of subpart.

    This subpart sets forth the requirements and procedures under which 
States have 1 year following discovery of overpayments made to providers 
for Medicaid services to recover or attempt to recover that amount 
before the States must refund the Federal share of these overpayments to 
CMS, with certain exceptions.

[77 FR 31511, May 29, 2012]



Sec.  433.304  Definitions.

    As used in this subpart--
    Discovery (or discovered) means identification by any State Medicaid 
agency official or other State official, the Federal Government, or the 
provider of an overpayment, and the communication of that overpayment 
finding or the initiation of a formal recoupment action without notice 
as described in Sec.  433.316.
    Final written notice means that written communication, immediately 
preceding the first level of formal administrative or judicial 
proceedings, from a Medicaid agency official or other State official 
that notifies the provider of the State's overpayment determination and 
allows the provider to contest that determination, or that notifies the 
State Medicaid agency of the filing of a civil or criminal action.
    Fraud (in accordance with Sec.  455.2) means an intentional 
deception or misrepresentation made by a person with

[[Page 122]]

the knowledge that the deception could result in some unauthorized 
benefit to himself or some other person. It includes any act that 
constitutes fraud under applicable Federal or State law.
    Overpayment means the amount paid by a Medicaid agency to a provider 
which is in excess of the amount that is allowable for services 
furnished under section 1902 of the Act and which is required to be 
refunded under section 1903 of the Act.
    Provider (in accordance with Sec.  400.203) means any individual or 
entity furnishing Medicaid services under a provider agreement with the 
Medicaid agency.
    Recoupment means any formal action by the State or its fiscal agent 
to initiate recovery of an overpayment without advance official notice 
by reducing future payments to a provider.
    Third party (in accordance with Sec.  433.136) means an individual, 
entity, or program that is or may be liable to pay for all or part of 
the expenditures for medical assistance furnished under a State plan.

[54 FR 5460, Feb. 3, 1989; 54 FR 8435, Feb. 28, 1989, as amended at 77 
FR 31511, May 29, 2012]



Sec.  433.310  Applicability of requirements.

    (a) General rule. Except as provided in paragraphs (b) and (c) of 
this section, the provisions of this subpart apply to--
    (1) Overpayments made to providers that are discovered by the State;
    (2) Overpayments made to providers that are initially discovered by 
the provider and made known to the State agency; and
    (3) Overpayments that are discovered through Federal reviews.
    (b) Third party payments and probate collections. The requirements 
of this subpart do not apply to--
    (1) Cases involving third party liability because, in these 
situations, recovery is sought for a Medicaid payment that would have 
been made had another party not been legally responsible for payment; 
and
    (2) Probate collections from the estates of deceased Medicaid 
beneficiaries, as they represent the recovery of payments properly made 
from resources later determined to be available to the State.
    (c) Unallowable costs paid under rate-setting systems. (1) 
Unallowable costs for a prior year paid to an institutional provider 
under a rate-setting system that a State recovers through an adjustment 
to the per diem rate for a subsequent period do not constitute 
overpayments that are subject to the requirements of this subpart.
    In such cases, the State is not required to refund the Federal share 
explicitly related to the original overpayment in accordance with the 
regulations in this subpart. Refund of the Federal share occurs when the 
State claims future expenditures made to the provider at a reduced rate.
    (2) Unallowable costs for a prior year paid to an institutional 
provider under a rate-setting system that a State seeks to recover in a 
lump sum, by an installment repayment plan, or through reduction of 
future payments to which the provider would otherwise be entitled 
constitute overpayments that are subject to the requirements of this 
subpart.
    (d) Recapture of depreciation upon gain on the sale of assets. 
Depreciation payments are considered overpayments for purposes of this 
subpart if a State requires their recapture in a discrete amount(s) upon 
gain on the sale of assets.



Sec.  433.312  Basic requirements for refunds.

    (a) Basic rules. (1) Except as provided in paragraph (b) of this 
section, the State Medicaid agency has 1 year from the date of discovery 
of an overpayment to a provider to recover or seek to recover the 
overpayment before the Federal share must be refunded to CMS.
    (2) The State Medicaid agency must refund the Federal share of 
overpayments at the end of the 1-year period following discovery in 
accordance with the requirements of this subpart, whether or not the 
State has recovered the overpayment from the provider.
    (b) Exception. The agency is not required to refund the Federal 
share of an overpayment made to a provider when the State is unable to 
recover the

[[Page 123]]

overpayment amount because the provider has been determined bankrupt or 
out of business in accordance with Sec.  433.318.
    (c) Applicability. (1) The requirements of this subpart apply to 
overpayments made to Medicaid providers that occur and are discovered in 
any quarter that begins on or after October 1, 1985.
    (2) The date upon which an overpayment occurs is the date upon which 
a State, using its normal method of reimbursement for a particular class 
of provider (e.g., check, interfund transfer), makes the payment 
involving unallowable costs to a provider.

[54 FR 5460, Feb. 3, 1989, as amended at 77 FR 31511, May 29, 2012]



Sec.  433.316  When discovery of overpayment occurs and its significance.

    (a) General rule. The date on which an overpayment is discovered is 
the beginning date of the 1-year period allowed for a State to recover 
or seek to recover an overpayment before a refund of the Federal share 
of an overpayment must be made to CMS.
    (b) Requirements for notification. Unless a State official or fiscal 
agent of the State chooses to initiate a formal recoupment action 
against a provider without first giving written notification of its 
intent, a State Medicaid agency official or other State official must 
notify the provider in writing of any overpayment it discovers in 
accordance with State agency policies and procedures and must take 
reasonable actions to attempt to recover the overpayment in accordance 
with State law and procedures.
    (c) Overpayments resulting from situations other than fraud. An 
overpayment resulting from a situation other than fraud is discovered on 
the earliest of---
    (1) The date on which any Medicaid agency official or other State 
official first notifies a provider in writing of an overpayment and 
specifies a dollar amount that is subject to recovery;
    (2) The date on which a provider initially acknowledges a specific 
overpaid amount in writing to the medicaid agency; or
    (3) The date on which any State official or fiscal agent of the 
State initiates a formal action to recoup a specific overpaid amount 
from a provider without having first notified the provider in writing.
    (d) Overpayments resulting from fraud. (1) An overpayment that 
results from fraud is discovered on the date of the final written notice 
(as defined in Sec.  433.304 of this subchapter) of the State's 
overpayment determination.
    (2) When the State is unable to recover a debt which represents an 
overpayment (or any portion thereof) resulting from fraud within 1 year 
of discovery because no final determination of the amount of the 
overpayment has been made under an administrative or judicial process 
(as applicable), including as a result of a judgment being under appeal, 
no adjustment shall be made in the Federal payment to such State on 
account of such overpayment (or any portion thereof) until 30 days after 
the date on which a final judgment (including, if applicable, a final 
determination on an appeal) is made.
    (3) The Medicaid agency may treat an overpayment made to a Medicaid 
provider as resulting from fraud under subsection (d) of this section 
only if it has referred a provider's case to the Medicaid fraud control 
unit, or appropriate law enforcement agency in States with no certified 
Medicaid fraud control unit, as required by Sec.  455.15, Sec.  455.21, 
or Sec.  455.23 of this chapter, and the Medicaid fraud control unit or 
appropriate law enforcement agency has provided the Medicaid agency with 
written notification of acceptance of the case; or if the Medicaid fraud 
control unit or appropriate law enforcement agency has filed a civil or 
criminal action against a provider and has notified the State Medicaid 
agency.
    (e) Overpayments identified through Federal reviews. If a Federal 
review at any time indicates that a State has failed to identify an 
overpayment or a State has identified an overpayment but has failed to 
either send written notice of the overpayment to the provider that 
specified a dollar amount subject to recovery or initiate a formal 
recoupment from the provider without having first notified the provider 
in writing, CMS will consider the overpayment as discovered on the date 
that the Federal official first notifies the State in writing of the 
overpayment

[[Page 124]]

and specifies a dollar amount subject to recovery.
    (f) Effect of changes in overpayment amount. Any adjustment in the 
amount of an overpayment during the 1-year period following discovery 
(made in accordance with the approved State plan, Federal law and 
regulations governing Medicaid, and the appeals resolution process 
specified in State administrative policies and procedures) has the 
following effect on the 1-year recovery period:
    (1) A downward adjustment in the amount of an overpayment subject to 
recovery that occurs after discovery does not change the original 1-year 
recovery period for the outstanding balance.
    (2) An upward adjustment in the amount of an overpayment subject to 
recovery that occurs during the 1-year period following discovery does 
not change the 1-year recovery period for the original overpayment 
amount. A new 1-year period begins for the incremental amount only, 
beginning with the date of the State's written notification to the 
provider regarding the upward adjustment.
    (g) Effect of partial collection by State. A partial collection of 
an overpayment amount by the State from a provider during the 1-year 
period following discovery does not change the 1-year recovery period 
for the balance of the original overpayment amount due to CMS.
    (h) Effect of administrative or judicial appeals. Any appeal rights 
extended to a provider do not extend the date of discovery.

[54 FR 5460, Feb. 3, 1989; 54 FR 8435, Feb. 28, 1989, as amended at 77 
FR 31511, May 29, 2012]



Sec.  433.318  Overpayments involving providers who are bankrupt or 
out of business.

    (a) Basic rules. (1) The agency is not required to refund the 
Federal share of an overpayment made to a provider as required by Sec.  
433.312(a) to the extent that the State is unable to recover the 
overpayment because the provider has been determined bankrupt or out of 
business in accordance with the provisions of this section.
    (2) The agency must notify the provider that an overpayment exists 
in any case involving a bankrupt or out-of-business provider and, if the 
debt has not been determined uncollectable, take reasonable actions to 
recover the overpayment during the 1-year recovery period in accordance 
with policies prescribed by applicable State law and administrative 
procedures.
    (b) Overpayment debts that the State need not refund. Overpayments 
are considered debts that the State is unable to recover within the 1-
year period following discovery if the following criteria are met:
    (1) The provider has filed for bankruptcy, as specified in paragraph 
(c) of this section; or
    (2) The provider has gone out of business and the State is unable to 
locate the provider and its assets, as specified in paragraph (d) of 
this section.
    (c) Bankruptcy. The agency is not required to refund to CMS the 
Federal share of an overpayment at the end of the 1-year period 
following discovery, if--
    (1) The provider has filed for bankruptcy in Federal court at the 
time of discovery of the overpayment or the provider files a bankruptcy 
petition in Federal court before the end of the 1-year period following 
discovery; and
    (2) The State is on record with the court as a creditor of the 
petitioner in the amount of the Medicaid overpayment.
    (d) Out of business. (1) The agency is not required to refund to CMS 
the Federal share of an overpayment at the end of the 1-year period 
following discovery if the provider is out of business on the date of 
discovery of the overpayment or if the provider goes out of business 
before the end of the 1-year period following discovery.
    (2) A provider is considered to be out of business on the effective 
date of a determination to that effect under State law. The agency 
must--
    (i) Document its efforts to locate the party and its assets. These 
efforts must be consistent with applicable State policies and 
procedures; and
    (ii) Make available an affidavit or certification from the 
appropriate State legal authority establishing that the provider is out 
of business and that the overpayment cannot be collected under State law 
and procedures and

[[Page 125]]

citing the effective date of that determination under State law.
    (3) A provider is not out of business when ownershp is transferred 
within the State unless State law and procedures deem a provider that 
has transferred ownership to be out of business and preclude collection 
of the overpayment from the provider.
    (e) Circumstances requiring refunds. If the 1-year recovery period 
has expired before an overpayment is found to be uncollectable under the 
provisions of this section, if the State recovers an overpayment amount 
under a court-approved discharge of bankruptcy, or if a bankruptcy 
petition is denied, the agency must refund the Federal share of the 
overpayment in accordance with the procedures specified in Sec.  433.320 
of this subpart.

[54 FR 5460, Feb. 3, 1989; 54 FR 8435, Feb. 28, 1989, as amended at 77 
FR 31512, May 29, 2012]



Sec.  433.320  Procedures for refunds to CMS.

    (a) Basic requirements. (1) The agency must refund the Federal share 
of overpayments that are subject to recovery to CMS through a credit on 
its Quarterly Statement of Expenditures (Form CMS-64).
    (2) The agency must credit CMS with the Federal share of 
overpayments subject to recovery on the earlier of--
    (i) The Form CMS-64 submission due to CMS for the quarter in which 
the State recovers the overpayment from the provider; or
    (ii) The Form CMS-64 due to CMS for the quarter in which the 1-year 
period following discovery, established in accordance with Sec.  
433.316, ends.
    (3) A credit on the Form CMS-64 must be made whether or not the 
overpayment has been recovered by the State from the provider.
    (4) If the State does not refund the Federal share of such 
overpayment as indicated in paragraph (a)(2) of this section, the State 
will be liable for interest on the amount equal to the Federal share of 
the non-recovered, non-refunded overpayment amount. Interest during this 
period will be at the Current Value of Funds Rate (CVFR), and will 
accrue beginning on the day after the end of the 1-year period following 
discovery until the last day of the quarter for which the State submits 
a CMS-64 report refunding the Federal share of the overpayment.
    (b) Effect of reporting collections and submitting reduced 
expenditure claims. (1) The State is not required to refund the Federal 
share of an overpayment at the end of the 1-year period if the State has 
already reported a collection or submitted an expenditure claim reduced 
by a discrete amount to recover the overpayment prior to the end of the 
1-year period following discovery.
    (2) The State is not required to report on the Form CMS-64 any 
collections made on overpayment amounts for which the Federal share has 
been refunded previously.
    (3) If a State has refunded the Federal share of an overpayment as 
required under this subpart and the State subsequently makes recovery by 
reducing future provider payments by a discrete amount, the State need 
not reflect that reduction in its claim for Federal financial 
participation.
    (c) Reclaiming overpayment amounts previously refunded to CMS. If 
the amount of an overpayment is adjusted downward after the agency has 
credited CMS with the Federal share, the agency may reclaim the amount 
of the downward adjustment on the Form CMS-64. Under this provision--
    (1) Downward adjustment to an overpayment amount previously credited 
to CMS is allowed only if it is properly based on the approved State 
plan, Federal law and regulations governing Medicaid, and the appeals 
resolution processes specified in State administrative policies and 
procedures.
    (2) The 2-year filing limit for retroactive claims for Medicaid 
expenditures does not apply. A downward adjustment is not considered a 
retroactive claim but rather a reclaiming of costs previously claimed.
    (d) Expiration of 1-year recovery period. If an overpayment has not 
been determined uncollectable in accordance with the requirements of 
Sec.  433.318 of this subpart at the end of the 1-year period following 
discovery of the overpayment, the agency must refund the Federal share 
of the overpayment to CMS in accordance with the procedures specified in 
paragraph (a) of this section.

[[Page 126]]

    (e) Court-approved discharge of bankruptcy. If the State recovers 
any portion of an overpayment under a court-approved discharge of 
bankruptcy, the agency must refund to CMS the Federal share of the 
overpayment amount collected on the next quarterly expenditure report 
that is due to CMS for the period that includes the date on which the 
collection occurs.
    (f) Bankruptcy petition denied. If a provider's petition for 
bankruptcy is denied in Federal court, the agency must credit CMS with 
the Federal share of the overpayment on the later of--
    (1) The Form CMS-64 submission due to CMS immediately following the 
date of the decision of the court; or
    (2) The Form CMS-64 submission for the quarter in which the 1-year 
period following discovery of the overpayment ends.
    (g) Reclaim of refunds. (1) If a provider is determined bankrupt or 
out of business under this section after the 1-year period following 
discovery of the overpayment ends and the State has not been able to 
make complete recovery, the agency may reclaim the amount of the Federal 
share of any unrecovered overpayment amount previously refunded to CMS. 
CMS allows the reclaim of a refund by the agency if the agency submits 
to CMS documentation that it has made reasonable efforts to obtain 
recovery.
    (2) If the agency reclaims a refund of the Federal share of an 
overpayment--
    (i) In bankruptcy cases, the agency must submit to CMS a statement 
of its efforts to recover the overpayment during the period before the 
petition for bankruptcy was filed; and
    (ii) In out-of-business cases, the agency must submit to CMS a 
statement of its efforts to locate the provider and its assets and to 
recover the overpayment during any period before the provider is found 
to be out of business in accordance with Sec.  433.318.
    (h) Supporting reports. The agency must report the following 
information to support each Quarterly Statement of Expenditures Form 
CMS-64:
    (1) Amounts of overpayments not collected during the quarter but 
refunded because of the expiration of the 1-year period following 
discovery;
    (2) Upward and downward adjustments to amounts credited in previous 
quarters;
    (3) Amounts of overpayments collected under court-approved 
discharges of bankruptcy;
    (4) Amounts of previously reported overpayments to providers 
certified as bankrupt or out of business during the quarter; and
    (5) Amounts of overpayments previously credited and reclaimed by the 
State.

[54 FR 5460, Feb. 3, 1989, as amended at 77 FR 31512, May 29, 2012]



Sec.  433.322  Maintenance of Records.

    The Medicaid agency must maintain a separate record of all 
overpayment activities for each provider in a manner that satisfies the 
retention and access requirements of 45 CFR 75.361 through 75.370.

[77 FR 31512, May 29, 2012, as amended at 81 FR 3011, Jan. 20, 2016]



Subpart G_Temporary FMAP Increase During the Public Health Emergency for 
                                COVID	19

    Source: 85 FR 71197, Nov. 6, 2020, unless otherwise noted.



Sec.  433.400  Continued enrollment for temporary FMAP increase.

    (a) Statutory basis. This subpart interprets and implements section 
6008(b)(3) of the Families First Coronavirus Response Act (FFCRA) and 
section 1902(a)(4) and (a)(19) of the Social Security Act.
    (b) Definitions. For purposes of this subpart--
    COVID-19 means Coronavirus Disease 2019.
    Medicare Savings Program means the coverage of Medicare premiums and 
cost sharing furnished to individuals described in, and determined by 
the state to be eligible under, section 1902(a)(10)(E)(i), 
1902(a)(10)(E)(iii), or 1902(a)(10)(E)(iv) of the Act.
    Minimum essential coverage (MEC) has the meaning provided under 
section 5000A(f)(1) of the Internal Revenue Code and implementing 
regulations at

[[Page 127]]

26 CFR 1.5000A-2 and includes minimum essential coverage determined by 
the Secretary under 26 CFR 1.5000A-2(f).
    Public Health Emergency for COVID-19 has the same definition 
provided in Sec.  400.200 of this chapter.
    Temporary FMAP increase means the 6.2 percentage point increase in 
the State's Federal medical assistance percentage (FMAP) that is 
authorized under section 6008(a) of the FFCRA through the end of the 
fiscal quarter in which the Public Health Emergency for COVID-19 ends.
    Validly enrolled means that the beneficiary was enrolled in Medicaid 
based on a determination of eligibility. A beneficiary is not validly 
enrolled if the agency determines the eligibility was erroneously 
granted at the most recent determination, redetermination, or renewal of 
eligibility (if such last redetermination or renewal was completed prior 
to March 18, 2020) because of agency error or fraud (as evidenced by a 
fraud conviction) or abuse (as determined following the completion of an 
investigation pursuant to Sec. Sec.  455.15 and 455.16 of this chapter) 
attributed to the beneficiary or the beneficiary's representative, which 
was material to the determination of eligibility. Individuals receiving 
medical assistance during a presumptive eligibility period in accordance 
with part 435, subpart L, of this chapter have not received a 
determination of eligibility by the state under the state plan and are 
not considered validly enrolled beneficiaries for purposes of this 
section.
    (c) General requirements. (1) In order to claim the temporary FMAP 
increase for:
    (i) The quarter in which November 2, 2020, falls, a state must meet 
the requirements described in paragraph (c)(2) of this section from 
November 2, 2020, through the end of the quarter.
    (ii) Any quarter beginning after November 2, 2020, through the 
quarter in which the public health emergency for COVID-19, including any 
extensions, ends, a state must meet the requirements described in 
paragraphs (c)(2) of this section.
    (2) Except as provided in paragraph (d) of this section, for all 
beneficiaries validly enrolled for benefits under the state plan, a 
waiver of such plan, or a demonstration project under section 1115(a) of 
the Act as of or after March 18, 2020, the state must maintain the 
beneficiary's enrollment as follows, through the end of the month in 
which the public health emergency for COVID-19 ends:
    (i)(A) For beneficiaries whose Medicaid coverage meets the 
definition of MEC in paragraph (b) of this section as of or after March 
18, 2020, the state must continue to provide Medicaid coverage that 
meets the definition of MEC, except as provided in paragraph 
(c)(2)(i)(B) of this section.
    (B) For beneficiaries described in paragraph (c)(2)(i)(A) whom the 
state subsequently determines are eligible for coverage under a Medicare 
Savings Program eligibility group, the state satisfies the requirement 
described in paragraph (c)(2) of this section if it furnishes the 
medical assistance available through the Medicare Savings Program.
    (ii) For beneficiaries whose Medicaid coverage as of or after March 
18, 2020 does not meet the definition of MEC in paragraph (b) of this 
section but does include coverage for testing services and treatments 
for COVID-19, including vaccines, specialized equipment, and therapies, 
the state must continue to provide Medicaid coverage that includes such 
testing services and treatments.
    (iii) For beneficiaries not described in paragraph (c)(2)(i) or (ii) 
of this section, the state must continue to provide at least the same 
level of medical assistance as was provided as of or after March 18, 
2020.
    (iv) If a state determines that a validly enrolled beneficiary is no 
longer eligible for Medicaid, including on a procedural basis, the state 
meets the requirements described in paragraph (c)(2)(i), (ii), or (iii) 
of this section by continuing to provide the same Medicaid coverage that 
the beneficiary would have received absent the determination of 
ineligibility.
    (3) Otherwise permissible changes to beneficiary coverage, cost 
sharing, and post-eligibility treatment of income, including both 
changes affecting an individual beneficiary and approved changes to the 
state plan, a section

[[Page 128]]

1115 demonstration and/or a waiver authorized under section 1915 of the 
Act impacting multiple beneficiaries, will not impact a state's ability 
to claim the temporary FMAP increase provided that any such changes do 
not violate the requirement to maintain beneficiary enrollment described 
at paragraph (c)(2) of this section or the requirement in section 
6008(b)(4) of the FFCRA.
    (d) Exceptions. (1) Consistent with the condition to claim the 
temporary FMAP increase described in paragraph (c)(2) of this section, a 
state may terminate a beneficiary's Medicaid enrollment prior to the 
first day of the month after the public health emergency for COVID-19 
ends in the following circumstances:
    (i) The beneficiary or the beneficiary's representative requests a 
voluntary termination of eligibility;
    (ii) The beneficiary ceases to be a resident of the state; or
    (iii) The beneficiary dies.
    (2) States which have elected the option under section 1903(v)(4) of 
the Act to provide full benefits to lawfully residing children or 
pregnant women must limit coverage for such beneficiaries if they no 
longer meet the definition of a lawfully residing child or pregnant 
woman under such section to services necessary for treatment of an 
emergency medical condition, as defined in section 1903(v)(3) of the 
Act.
    (3)(i) For purposes of paragraph (d)(1)(i) of this section, a 
beneficiary may request a voluntary termination of eligibility from the 
Medicaid coverage in which the beneficiary is enrolled to transition to 
other Medicaid coverage for which the beneficiary is eligible, even if 
the transition to the new Medicaid coverage would not be consistent with 
paragraph (c)(2) of this section.
    (ii) For purposes of paragraph (d)(1)(ii) of this section, 
beneficiaries who were identified through a data match with the Public 
Assistance Reporting Information System in accordance with Sec.  
435.945(d) of this chapter indicating simultaneous enrollment in two or 
more states, and who fail to respond to a request for information to 
verify their residency, may be treated as not being a state resident for 
purposes of paragraph (d)(1)(ii) of this section, provided that the 
state takes all reasonably available measures to attempt to verify the 
beneficiary's state residency. If a beneficiary's enrollment is 
terminated under the exception at paragraph (d)(1)(ii) of this section 
based on a PARIS data match and the state subsequently obtains 
information verifying residency, the state must reinstate the 
beneficiary's Medicaid enrollment retroactive to the date of 
termination.



PART 434_CONTRACTS--Table of Contents



                      Subpart A_General Provisions

Sec.
434.1 Basis and scope.
434.2 Definitions.
434.4 State plan requirement.
434.6 General requirements for all contracts and subcontracts.

     Subpart B_Contracts with Fiscal Agents and Private Nonmedical 
                              Institutions

434.10 Contracts with fiscal agents.
434.12 Contracts with private nonmedical institutions.
434.14 [Reserved]

Subpart C [Reserved]

         Subpart D_Contracts With Health Insuring Organizations

434.40 Contract requirements.

Subpart E [Reserved]

                Subpart F_Federal Financial Participation

434.70 Conditions for Federal Financial Participation (FFP).
434.76 Costs under fiscal agent contracts.
434.78 Right to reconsideration of disallowance.

    Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302).

    Source: 48 FR 54020, Nov. 30, 1983, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  434.1  Basis and scope.

    (a) Statutory basis. This part is based on section 1902(a)(4) of the 
Act, which requires that the State plan provide for methods of 
administration that the Secretary finds necessary for the proper and 
efficient operation of the plan.

[[Page 129]]

    (b) Scope. This part sets forth the requirements for contracts with 
certain organizations for furnishing Medicaid services or processing or 
paying Medicaid claims, or enchancing the agency's capability for 
effective administration of the program.

[48 FR 54020, Nov. 30, 1983; 48 FR 55128, Dec. 9, 1983, as amended at 67 
FR 41095, June 14, 2002]



Sec.  434.2  Definitions.

    As used in this part, unless the context indicates otherwise--
    Fiscal agent means an entity that processes or pays vendor claims 
for the agency.
    Health care projects grant center means an entity that--
    (a) Is supported in whole or in part by Federal project grant 
financial assistance; and
    (b) Provides or arranges for medical services to beneficiaries.
    Private nonmedical institution means an institution (such as a 
child-care facility or a maternity home) that--
    (a) Is not, as a matter of regular business, a health insuring 
organization or a community health care center;
    (b) Provides medical care to its residents through contracts or 
other arrangements with medical providers; and
    (c) Receives capitation payments from the Medicaid agency, under a 
nonrisk contract, for its residents who are eligible for Medicaid.
    Professional management service or consultant firm means a firm that 
performs management services such as auditing or staff training, or 
carries out studies or provides consultation aimed at improving State 
Medicaid operations, for example, with respect to reimbursement formulas 
or accounting systems.

[48 FR 54020, Nov. 30, 1983; 48 FR 55128, Dec. 9, 1983, as amended at 52 
FR 22322, June 11, 1987; 55 FR 51295, Dec. 13, 1990; 67 FR 41095, June 
14, 2002]



Sec.  434.4  State plan requirement.

    If the State plan provides for contracts of the types covered by 
this part, the plan must also provide for meeting the applicable 
requirements of this part.



Sec.  434.6  General requirements for all contracts and subcontracts.

    (a) Contracts. All contracts under this part must include all of the 
following:
    (1) Include provisions that define a sound and complete procurement 
contract, as required by 45 CFR part 75.
    (2) Identify the population covered by the contract.
    (3) Specify any procedures for enrollment or reenrollment of the 
covered population.
    (4) Specify the amount, duration, and scope of medical services to 
be provided or paid for.
    (5) Provide that the agency and HHS may evaluate through inspection 
or other means, the quality, appropriateness and timeliness of services 
performed under the contract.
    (6) Specify procedures and criteria for terminating the contract, 
including a requirement that the contractor promptly supply all 
information necessary for the reimbursement of any outstanding Medicaid 
claims.
    (7) Provide that the contractor maintains an appropriate record 
system for services to enrolled beneficiaries.
    (8) Provide that the contractor safeguards information about 
beneficiaries as required by part 431, subpart F of this chapter.
    (9) Specify any activities to be performed by the contractor that 
are related to third party liability requirements in part 433, subpart D 
of this chapter.
    (10) Specify which functions may be subcontracted.
    (11) Provide that any subcontracts meet the requirements of 
paragraph (b) of this section.
    (12) Specify the following:
    (i) No payment will be made by the contractor to a provider for 
provider-preventable conditions, as identified in the State plan.
    (ii) The contractor will require that all providers agree to comply 
with the reporting requirements in Sec.  447.26(d) of this subchapter as 
a condition of payment from the contractor.
    (iii) The contractor will comply with such reporting requirements to 
the extent the contractor directly furnishes services.

[[Page 130]]

    (b) Subcontracts. All subcontracts must be in writing and fulfill 
the requirements of this part that are appropriate to the service or 
activity delegated under the subcontract.
    (c) Continued responsibility of contractor. No subcontract 
terminates the legal responsibility of the contractor to the agency to 
assure that all activities under the contract are carried out.

[48 FR 54020, Nov. 30, 1983, as amended at 67 FR 41095, June 14, 2002; 
76 FR 32837, June 6, 2011; 81 FR 3011, Jan. 20, 2016]



     Subpart B_Contracts with Fiscal Agents and Private Nonmedical 
                              Institutions



Sec.  434.10  Contracts with fiscal agents.

    Contracts with fiscal agents must--
    (a) Meet the requirements of Sec.  434.6;
    (b) Include termination procedures that require the contractors to 
supply promptly all material necessary for continued operation of 
payment and related systems. This material includes--
    (1) Computer programs;
    (2) Data files;
    (3) User and operation manuals, and other documentation;
    (4) System and program documentation; and
    (5) Training programs for Medicaid agency staff, their agents or 
designated representatives in the operation and maintenance of the 
system;
    (c) Offer to the State one or both of the following options, if the 
fiscal agent or the fiscal agent's subcontractor has a proprietary right 
to material specified in paragraph (b) of this section:
    (1) Purchasing the material; or
    (2) Purchasing the use of the material through leasing or other 
means; and
    (d) State that payment to providers will be made in accordance with 
part 447 of this chapter.



Sec.  434.12  Contracts with private nonmedical institutions.

    Contracts with private nonmedical institutions must--
    (a) Meet the requirements of Sec.  434.6;
    (b) Specify a capitation fee based on the cost of the services 
provided, in accordance with the reimbursement requirements prescribed 
in part 447 of this chapter; and
    (c) Specify when the capitation fee must be paid.



Sec.  434.14  [Reserved]

Subpart C [Reserved]



         Subpart D_Contracts With Health Insuring Organizations



Sec.  434.40  Contract requirements.

    (a) Contracts with health insuring organizations that are not 
subject to the requirements in section 1903(m)(2)(A) must:
    (1) Meet the general requirements for all contracts and subcontracts 
specified in Sec.  434.6;
    (2) Specify that the contractor assumes at least part of the 
underwriting risk and;
    (i) If the contractor assumes the full underwriting risk, specify 
that payment of the capitation fees to the contractor during the 
contract period constitutes full payment by the agency for the cost of 
medical services provided under the contract;
    (ii) If the contractor assumes less than the full underwriting risk, 
specify how the risk is apportioned between the agency and the 
contractor;
    (3) Specify whether the contractor returns to the agency part of any 
savings remaining after the allowable costs are deducted from the 
capitations fees, and if savings are returned, the apportionment between 
agency and the contractor; and
    (4) Specify the extent, if any, to which the contractor may obtain 
reinsurance of a portion of the underwriting risk.
    (b) The contract must--
    (1) Specify that the capitation fee will not exceed the limits set 
forth under part 447 of this chapter.
    (2) Specify that, except as permitted under paragraph (b) of this 
section, the capitation fee paid on behalf of each beneficiary may not 
be renegotiated--
    (i) During the contract period if the contract period is 1 year or 
less; or
    (ii) More often than annually if the contract period is for more 
than 1 year.
    (3) Specify that the capitation fee will not include any amount for

[[Page 131]]

recoupment of any specific losses suffered by the contractor for risks 
assumed under the same contract or a prior contract with the agency; and
    (4) Specify the actuarial basis for computation of the capitation 
fee.
    (c) The capitation fee may be renegotiated more frequently than 
annually for beneficiaries who are not enrolled at the time of 
renegotiation or if the renegotiation is required by changes in Federal 
or State law.

[55 FR 51295, Dec. 13, 1990]

Subpart E [Reserved]



                Subpart F_Federal Financial Participation

    Source: 48 FR 54020, Nov. 20, 1983, unless otherwise noted. 
Redesignated at 55 FR 51295, Dec. 13, 1990.



Sec.  434.70  Conditions for Federal Financial Participation (FFP).

    (a) Basic requirements. FFP is available only for periods during 
which the contract--
    (1) Meets the requirements of this part;
    (2) Meets the applicable requirements of 45 CFR part 75; and
    (3) Is in effect.
    (b) Basis for withholding. CMS may withhold FFP for any period 
during which the State fails to meet the State plan requirements of this 
part.

[67 FR 41095, June 14, 2002, as amended at 81 FR 3011, Jan. 20, 2016]



Sec.  434.76  Costs under fiscal agent contracts.

    Under each contract with a fiscal agent--
    (a) The amount paid to the provider of medical services is a medical 
assistance cost; and
    (b) The amount paid to the contractor for performing the agreed-upon 
functions is an administrative cost.



Sec.  434.78  Right to reconsideration of disallowance.

    A Medicaid agency dissatisfied with a disallowance of FFP under this 
subpart may request and will be granted reconsideration in accordance 
with 45 CFR part 16.



PART 435_ELIGIBILITY IN THE STATES, DISTRICT OF COLUMBIA, THE NORTHERN 
MARIANA ISLANDS, AND AMERICAN SAMOA--Table of Contents



              Subpart A_General Provisions and Definitions

Sec.
435.2 Purpose and applicability.
435.3 Basis.
435.4 Definitions and use of terms.
435.10 State plan requirements.

                      Subpart B_Mandatory Coverage

435.100 Scope.

               Mandatory Coverage of Families and Children

435.110 Parents and other caretaker relatives.
435.112 Families terminated from AFDC because of increased earnings or 
          hours of employment. .
435.115 Families with Medicaid eligibility extended because of increased 
          collection of spousal support.

  Mandatory Coverage of Pregnant Women, Children Under 19, and Newborn 
                                Children

435.116 Pregnant women.
435.117 Deemed newborn children.

             Mandatory Coverage of Qualified Family Members

435.118 Infants and children under age 19.

          Mandatory Coverage for Individuals Age 19 Through 64

435.119 Coverage for individuals age 19 or older and under age 65 at or 
          below 133 percent FPL.

           Mandatory Coverage of the Aged, Blind, and Disabled

435.120 Individuals receiving SSI.
435.121 Individuals in States using more restrictive requirements for 
          Medicaid than the SSI requirements.
435.122 Individuals who are ineligible for SSI or optional State 
          supplements because of requirements that do not apply under 
          title XIX of the Act.
435.130 Individuals receiving mandatory State supplements.
435.131 Individuals eligible as essential spouses in December 1973.
435.132 Institutionalized individuals who were eligible in December 
          1973.
435.133 Blind and disabled individuals eligible in December 1973.

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435.134 Individuals who would be eligible except for the increase in 
          OASDI benefits under Pub. L. 92-336 (July 1, 1972).
435.135 Individuals who become ineligible for cash assistance as a 
          result of OASDI cost-of-living increases received after April 
          1977.
435.136 State agency implementation requirements for one-time notice and 
          annual review system.
435.137 Disabled widows and widowers who would be eligible for SSI 
          except for the increase in disability benefits resulting from 
          elimination of the reduction under Pub. L. 98-31.
435.138 Disabled widows and widowers aged 60 through 64 who would be 
          eligible for SSI benefits except for receipt of early social 
          security benefits.

                  Mandatory Coverage of Certain Aliens

435.139 Coverage for certain aliens.

   Mandatory Coverage of Adoption Assistance and Foster Care Children

435.145 Children with adoption assistance, foster care, or guardianship 
          care under title IV-E.
435.150 Former foster care children.

                  Mandatory Coverage of Special Groups

435.170 Pregnant women eligible for extended or continuous eligibility.
435.172 Continuous eligibility for hospitalized children.

                     Subpart C_Options for Coverage

435.200 Scope.
435.201 Individuals included in optional groups.

 Options for Coverage of Families and Children and the Aged, Blind, and 
                                Disabled

435.210 Optional eligibility for individuals who meet the income and 
          resource requirements of the cash assistance programs.
435.211 Optional eligibility for individuals who would be eligible for 
          cash assistance if they were not in medical institutions.
435.212 Individuals who would be ineligible if they were not enrolled in 
          an MCO or PCCM.
435.213 Optional eligibility for individuals needing treatment for 
          breast or cervical cancer.
435.214 Eligibility for Medicaid limited to family planning and related 
          services.
435.215 Individuals infected with tuberculosis.
435.217 Individuals receiving home and community-based services.
435.218 Individuals with MAGI-based income above 133 percent FPL.
435.219 Individuals receiving State plan home and community-based 
          services.

              Options for Coverage of Families and Children

435.220 Optional eligibility for parents and other caretaker relatives.
435.221 [Reserved]
435.222 Optional eligibility for reasonable classifications of 
          individuals under age 21.
435.225 Individuals under age 19 who would be eligible for Medicaid if 
          they were in a medical institution.
435.226 Optional eligibility for independent foster care adolescents.
435.227 Optional eligibility for individuals under age 21 who are under 
          State adoption assistance agreements.
435.229 Optional targeted low-income children.

          Options for Coverage of the Aged, Blind, and Disabled

435.230 Aged, blind, and disabled individuals in States that use more 
          restrictive requirements for Medicaid than SSI requirements: 
          Optional coverage.
435.232 Individuals receiving only optional State supplements.
435.234 Individuals receiving only optional State supplements in States 
          using more restrictive eligibility requirements than SSI and 
          certain States using SSI criteria.
435.236 Individuals in institutions who are eligible under a special 
          income level.

           Subpart D_Optional Coverage of the Medically Needy

435.300 Scope.
435.301 General rules.
435.308 Medically needy coverage of individuals under age 21.
435.310 Medically needy coverage of parents and other caretaker 
          relatives.
435.320 Medically needy coverage of the aged in States that cover 
          individuals receiving SSI.
435.322 Medically needy coverage of the blind in States that cover 
          individuals receiving SSI.
435.324 Medically needy coverage of the disabled in States that cover 
          individuals receiving SSI.
435.326 Individuals who would be ineligible if they were not enrolled in 
          an MCO or PCCM.
435.330 Medically needy coverage of the aged, blind, and disabled in 
          States using more restrictive eligibility requirements for 
          Medicaid than those used under SSI.
435.340 Protected medically needy coverage for blind and disabled 
          individuals eligible in December 1973.

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435.350 Coverage for certain aliens.

               Subpart E_General Eligibility Requirements

435.400 Scope.
435.401 General rules.
435.402 [Reserved]
435.403 State residence.
435.404 Applicant's choice of category.
435.406 Citizenship and non-citizen eligibility.
435.407 Types of acceptable documentary evidence of citizenship.

           Subpart F_Categorical Requirements for Eligibility

435.500 Scope.

                                   Age

435.520 Age requirements for the aged.

                                Blindness

435.530 Definition of blindness.
435.531 Determinations of blindness.

                               Disability

435.540 Definition of disability.
435.541 Determinations of disability.

    Subpart G_General Financial Eligibility Requirements and Options

435.600 Scope.
435.601 Application of financial eligibility methodologies.
435.602 Financial responsibility of relatives and other individuals.
435.603 Application of modified adjusted gross income (MAGI).
435.604 [Reserved]
435.606 [Reserved]
435.608 Applications for other benefits.
435.610 Assignment of rights to benefits.
435.622 Individuals in institutions who are eligible under a special 
          income level.
435.631 General requirements for determining income eligibility in 
          States using more restrictive requirements for Medicaid than 
          SSI.
435.640 Protected Medicaid eligibility for individuals eligible in 
          December 1973.

   Subpart H_Specific Post-Eligibility Financial Requirements for the 
                           Categorically Needy

435.700 Scope.
435.725 Post-eligibility treatment of income of institutionalized 
          individuals in SSI States: Application of patient income to 
          the cost of care.
435.726 Post-eligibility treatment of income of individuals receiving 
          home and community-based services furnished under a waiver: 
          Application of patient income to the cost of care.
435.733 Post-eligibility treatment of income of institutionalized 
          individuals in States using more restrictive requirements than 
          SSI: Application of patient income to the cost of care.
435.735 Post-eligibility treatment of income and resources of 
          individuals receiving home and community-based services 
          furnished under a waiver: Application of patient income to the 
          cost of care.

     Subpart I_Specific Eligibility and Post-Eligibility Financial 
                  Requirements for the Medically Needy

435.800 Scope.

                     Medically Needy Income Standard

435.811 Medically needy income standard: General requirements.
435.814 Medically needy income standard: State plan requirements.

                   Medically Needy Income Eligibility

435.831 Income eligibility.
435.832 Post-eligibility treatment of income of institutionalized 
          individuals: Application of patient income to the cost of 
          care.

                    Medically Needy Resource Standard

435.840 Medically needy resource standard: General requirements.
435.843 Medically needy resource standard: State plan requirements.

            Determining Eligibility on the Basis of Resources

435.845 Medically needy resource eligibility.
435.850-435.852 [Reserved]

      Subpart J_Eligibility in the States and District of Columbia

435.900 Scope.

                    General Methods of Administration

435.901 Consistency with objectives and statutes.
435.902 Simplicity of administration.
435.903 Adherence of local agencies to State plan requirements.
435.904 Establishment of outstation locations to process applications 
          for certain low-income eligibility groups.

                              Applications

435.905 Availability and accessibility of program information.
435.906 Opportunity to apply.
435.907 Written application.
435.908 Assistance with application.
435.909 Automatic entitlement to Medicaid following a determination of 
          eligibility under other programs.

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435.910 Use of social security number.

                  Determination of Medicaid Eligibility

435.911 Determination of eligibility.
435.912 Timely determination of eligibility.
435.914 Case documentation.
435.915 Effective date.

                Redeterminations of Medicaid Eligibility

435.916 Periodic renewal of Medicaid eligibility.
435.917 Notice of agency's decision concerning eligibility, benefits, or 
          services.
435.918 Use of electronic notices.
435.920 Verification of SSNs.
435.923 Authorized representatives.
435.926 Continuous eligibility for children.

                           Furnishing Medicaid

435.930 Furnishing Medicaid.

            Income and Eligibility Verification Requirements

435.940 Basis and scope.
435.945 General requirements.
435.948 Requesting information.
435.949 Verification of information through an electronic service.
435.952 Use of information.
435.956 Verification of other non-financial information.
435.960 Standardized formats for furnishing and obtaining information to 
          verifying income and eligibility.
435.965 Delay of effective date.

                Subpart K_Federal Financial Participation

435.1000 Scope.

 FFP in Expenditures for Determining Eligibility and Providing Services

435.1001 FFP for administration.
435.1002 FFP for services.
435.1003 FFP for redeterminations.
435.1004 Beneficiaries overcoming certain conditions of eligibility.

                           Limitations on FFP

435.1005 Beneficiaries in institutions eligible under a special income 
          standard.
435.1006 Beneficiaries of optional State supplements only.
435.1007 Categorically needy, medically needy, and qualified Medicare 
          beneficiaries.
435.1008 FFP in expenditures for medical assistance for individuals who 
          have declared citizenship or nationality or satisfactory 
          immigration status.
435.1009 Institutionalized individuals.
435.1010 Definitions relating to institutional status.

                   Requirements for State Supplements

435.1011 Requirement for mandatory State supplements.
435.1012 Requirement for maintenance of optional State supplement 
          expenditures.

                       FFP for Premium Assistance

435.1015 FFP for premium assistance for plans in the individual market.

   Subpart L_Options for Coverage of Special Groups under Presumptive 
                               Eligibility

435.1100 Basis for presumptive eligibility.

                  Presumptive Eligibility for Children

435.1101 Definitions related to presumptive eligibility.
435.1102 Children covered under presumptive eligibility.
435.1103 Presumptive eligibility for other individuals.
435.1110 Presumptive eligibility determined by hospitals.

 Subpart M_Coordination of Eligibility and Enrollment Between Medicaid, 
       CHIP, Exchanges and Other Insurance Affordability Programs

435.1200 Medicaid agency responsibilities for a coordinated eligibility 
          and enrollment process with other insurance affordability 
          programs.
435.1205 Alignment with exchange initial open enrollment period.

    Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302).

    Source: 43 FR 45204, Sept. 29, 1978, unless otherwise noted.



              Subpart A_General Provisions and Definitions



Sec.  435.2  Purpose and applicability.

    This part sets forth, for the 50 States, the District of Columbia, 
the Northern Mariana Islands, and American Samoa--
    (a) The eligibility provisions that a State plan must contain;
    (b) The mandatory and optional groups of individuals to whom 
Medicaid is provided under a State plan;
    (c) The eligibility requirements and procedures that the Medicaid 
agency must use in determining and redetermining eligibility, and 
requirements it may not use;
    (d) The availability of FFP for providing Medicaid and for 
administering

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the eligibility provisions of the plan; and
    (e) Other requirements concerning eligibility determinations, such 
as use of an institutionalized individual's income for the cost of care.

[43 FR 45204, Sept. 29, 1978, as amended at 44 FR 17937, Mar. 23, 1979; 
51 FR 41350, Nov. 14, 1986]



Sec.  435.3  Basis.

    (a) This part implements the following sections of the Act and 
public laws that mandate eligibility requirements and standards:

402(a)(22) Eligibility of deemed beneficiaries of AFDC who receive zero 
payments because of recoupment of overpayments.
402(a)(37) Eligibility of individuals who lose AFDC eligibility due to 
increased earnings.
414(g) Eligibility of certain individuals participating in work 
supplementation programs.
473(b) Eligibility of children in foster care and adopted children who 
are deemed AFDC beneficiaries.
1619(b) Benefits for blind individuals or those with disabling 
impairments whose income equals or exceeds a specific SSI limit.
1634(b) Preservation of benefit status for disabled widows and widowers 
who lost SSI benefits because of 1983 changes in actuarial reduction 
formula.
1634(d) Individuals who lose eligibility for SSI benefits due to 
entitlement to early widow's or widower's social security disability 
benefits under section 202(e) or (f) of the Act.
1902(a)(8) Opportunity to apply; assistance must be furnished promptly.
1902(a)(10) Required and optional groups.
1902(a)(12) Determination of blindness.
1902(a)(17) Standards for determining eligibility: flexibility in the 
application of income eligibility standards.
1902(a)(19) Safeguards for simplicity of administration and best 
interests of beneficiaries.
1902(a)(34) Three-month retroactive eligibility.
1902(a)(46)(B) Requirement to verify citizenship.
1902(a) (second paragraph after (47)) Eligibility despite increased 
monthly insurance benefits under title II.
1902(a)(55) Mandatory use of outstation locations other than welfare 
offices to receive and initially process applications of certain low-
income pregnant women, infants, and children under age 19.
1902(b) Prohibited conditions for eligibility: Age requirement of more 
that 65 years;
    State residence requirements excluding individuals who reside in the 
state; and
    Citizenship requirement excluding United States citizens.
1902(e) Four-month continued eligibility for families ineligible because 
of increased hours or income from employment.
1902(e)(2) Minimum eligibility period for beneficiary enrolled in an 
HMO.
1902(e)(3) Optional coverage of certain disabled children being cared 
for at home.
1902(e)(4) Eligibility of newborn children of Medicaid eligible women.
1902(e)(5) Eligibility of pregnant woman for extended coverage for 
specified postpartum period after pregnancy ends.
1902(f) State option to restrict Medicaid eligibility for aged, blind, 
or disabled individuals to those who would have been eligible under 
State plan in effect in January 1972.
1902(j) Medicaid program in American Samoa.
1902(ee) Option to verify citizenship through electronic data sharing 
with the Social Security Administration.
1903(f) Income limitations for medically needy and individuals covered 
by State supplement eligibility requirements.
1903(v) Payment for emergency services under Medicaid provided to non-
citizens.
1905(a) Definition of medical assistance.
1905(a) (clause following (21)) Prohibitions against providing Medicaid 
to certain institutionalized individuals.
1905(a) (second sentence) Definition of essential person.
1905(a) Definition of medical assistance.
1905(a)(i)-(viii) List of eligible individuals.
1905(d)(2) Definition of resident of an intermediate care facility for 
individuals with intellectual disabilities.
1905(j) Definition of State supplementary payment.
1905(k) Eligibility of essential spouses of eligible individuals.
1905(n) Definition of qualified pregnant woman and child.
1912(a) Conditions of eligibility.
1915(c) Home or community-based services.
1915(d) Home or community-based services for individuals age 65 or 
older.
412(e)(5) of Immigration and Nationality Act--Eligibility of certain 
refugees.
Pub. L. 93-66, section 230 Deemed eligibility of certain essential 
persons.
Pub. L. 93-66, section 231 Deemed eligibility of certain persons in 
medical institutions.
Pub. L. 93-66, section 232 Deemed eligibility of certain blind and 
disabled medically indigent persons.
Pub. L. 93-233, section 13(c) Deemed eligibility of certain individuals 
receiving mandatory State supplementary payments.
Pub. L. 94-566, section 503 Deemed eligibility of certain individuals 
who would be eligible for supplemental security income

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benefits but for cost-of-living increases in social security benefits.
Pub. L. 96-272, section 310(b)(1) Continued eligibility of certain 
beneficiaries of Veterans Administration pensions.
Pub. L. 99-509, section 9406 Payment for emergency medical services 
provided to aliens.
Pub. L. 99-603, section 201 Aliens granted legalized status under 
section 245A of the Immigration and Nationality Act (8 U.S.C. 1255a) may 
under certain circumstances be eligible for Medicaid.
Pub. L. 99-603, section 302 Aliens granted legalized status under 
section 210 of the Immigration and Nationality Act may under certain 
circumstances be eligible for Medicaid (8 U.S.C. 1160).
Pub. L. 99-603, section 303 Aliens granted legal status under section 
210A of the Immigration and Nationality Act may under certain 
circumstances be eligible for Medicaid (8 U.S.C. 1161).

    (b) This part implements the following other provisions of the Act 
or public laws that establish additional State plan requirements:

1618 Requirement for operation of certain State supplementation 
programs.
Pub. L. 93-66, section 212(a) Required mandatory minimum State 
supplementation of SSI benefits programs.

[52 FR 43071, Nov. 9, 1987; 52 FR 48438, Dec. 22, 1987, as amended at 55 
FR 36819, Sept. 7, 1990; 55 FR 48607, Nov. 21, 1990; 57 FR 29155, June 
30, 1992; 59 FR 48809, Sept. 23, 1994; 81 FR 86450, Nov. 30, 2016]



Sec.  435.4  Definitions and use of terms.

    As used in this part--
    AABD means aid to the aged, blind, and disabled under title XVI of 
the Act;
    AB means aid to the blind under title X of the Act;
    Advance payments of the premium tax credit (APTC) has the meaning 
given the term in 45 CFR 155.20.
    AFDC means aid to families with dependent children under title IV-A 
of the Act;
    Affordable Care Act means the Patient Protection and Affordable Care 
Act of 2010 (Pub. L. 111-148), as amended by the Health Care and 
Education Reconciliation Act of 2010 (Pub. L. 111-152), as amended by 
the Three Percent Withholding Repeal and Job Creation Act (Pub. L. 112-
56).
    Affordable Insurance Exchanges (Exchanges) has the meaning given the 
term ``Exchanges'' in 45 CFR 155.20.
    Agency means a single State agency designated or established by a 
State in accordance with Sec.  431.10(b) of this subchapter.
    Applicable modified adjusted gross income (MAGI) standard has the 
meaning provided in Sec.  435.911(b)(1) of this part.
    Applicant means an individual who is seeking an eligibility 
determination for himself or herself through an application submission 
or a transfer from another agency or insurance affordability program.
    Application means the single streamlined application described at 
Sec.  435.907(b) of this part or an application described in Sec.  
435.907(c)(2) of this part submitted by or on behalf of an individual.
    APTD means aid to the permanently and totally disabled under title 
XIV of the Act;
    Beneficiary means an individual who has been determined eligible and 
is currently receiving Medicaid.
    Caretaker relative means a relative of a dependent child by blood, 
adoption, or marriage with whom the child is living, who assumes primary 
responsibility for the child's care (as may, but is not required to, be 
indicated by claiming the child as a tax dependent for Federal income 
tax purposes), and who is one of the following--
    (1) The child's father, mother, grandfather, grandmother, brother, 
sister, stepfather, stepmother, stepbrother, stepsister, uncle, aunt, 
first cousin, nephew, or niece.
    (2) The spouse of such parent or relative, even after the marriage 
is terminated by death or divorce.
    (3) At State option, another relative of the child based on blood 
(including those of half-blood), adoption, or marriage; the domestic 
partner of the parent or other caretaker relative; or an adult with whom 
the child is living and who assumes primary responsibility for the 
dependent child's care.
    Categorically needy refers to families and children, aged, blind, or 
disabled individuals, and pregnant women, described under subparts B and 
C of this part who are eligible for Medicaid. Subpart B of this part 
describes the mandatory eligibility groups who, generally, are receiving 
or deemed to be receiving cash assistance under the

[[Page 137]]

Act. These mandatory groups are specified in sections 1902(a)(10)(A)(i), 
1902(e), 1902(f), and 1928 of the Act. Subpart C of this part describes 
the optional eligibility groups of individuals who, generally, meet the 
categorical requirements or income or resource requirements that are the 
same as or less restrictive than those of the cash assistance programs 
and who are not receiving cash payments. These optional groups are 
specified in sections 1902(a)(10)(A)(ii), 1902(e), and 1902(f) of the 
Act.
    Citizenship includes status as a ``national of the United States,'' 
and includes both citizens of the United States and non-citizen 
nationals of the United States described in 8 U.S.C. 1101(a)(22).
    Combined eligibility notice means an eligibility notice that informs 
an individual or multiple family members of a household of eligibility 
for each of the insurance affordability programs and enrollment in a 
qualified health plan through the Exchange, for which a determination or 
denial of eligibility was made, as well as any right to request a fair 
hearing or appeal related to the determination made for each program. A 
combined notice must meet the requirements of Sec.  435.917(a) and 
contain the content described in Sec.  435.917(b) and (c), except that 
information described in Sec.  435.917(b)(1)(iii) and (iv) may be 
included in a combined notice issued by another insurance affordability 
program or in a supplemental notice provided by the agency. A combined 
eligibility notice must be issued in accordance with the agreement(s) 
consummated by the agency in accordance with Sec.  435.1200(b)(3).
    Coordinated content means information included in an eligibility 
notice regarding, if applicable -
    (1) The transfer of an individual's or household's electronic 
account to another insurance affordability program;
    (2) Any notice sent by the agency to another insurance affordability 
program regarding an individual's eligibility for Medicaid;
    (3) The potential impact, if any, of--
    (i) The agency's determination of eligibility or ineligibility for 
Medicaid on eligibility for another insurance affordability program; or
    (ii) A determination of eligibility for, or enrollment in, another 
insurance affordability program on an individual's eligibility for 
Medicaid; and
    (4) The status of household members on the same application or 
renewal form whose eligibility is not yet determined.
    Dependent child means a child who meets both of the following 
criteria:
    (1) Is under the age of 18, or, at State option, is age 18 and a 
full-time student in secondary school (or equivalent vocational or 
technical training), if before attaining age 19 the child may reasonably 
be expected to complete such school or training.
    (2) Is deprived of parental support by reason of the death, absence 
from the home, physical or mental incapacity, or unemployment of at 
least one parent, unless the State has elected in its State plan to 
eliminate such deprivation requirement. A parent is considered to be 
unemployed if he or she is working less than 100 hours per month, or 
such higher number of hours as the State may elect in its State plan.
    Effective income level means the income standard applicable under 
the State plan for an eligibility group, after taking into consideration 
any disregard of a block of income applied in determining financial 
eligibility for such group.
    Electronic account means an electronic file that includes all 
information collected and generated by the agency regarding each 
individual's Medicaid eligibility and enrollment, including all 
documentation required under Sec.  435.914 and including any information 
collected or generated as part of a fair hearing process conducted under 
subpart E of this part, the Exchange appeals process conducted under 45 
CFR part 155, subpart F or other insurance affordability program appeals 
process.
    Eligibility determination means an approval or denial of eligibility 
in accordance with Sec.  435.911 as well as a renewal or termination of 
eligibility in accordance with Sec.  435.916 of this part.
    Family size has the meaning provided in Sec.  435.603(b) of this 
part.
    Federal poverty level (FPL) means the Federal poverty level updated 
periodically in the Federal Register by the

[[Page 138]]

Secretary of Health and Human Services under the authority of 42 U.S.C. 
9902(2), as in effect for the applicable budget period used to determine 
an individual's eligibility in accordance with Sec.  435.603(h) of this 
part.
    Household income has the meaning provided in Sec.  435.603(d) of 
this part.
    Insurance affordability program means a program that is one of the 
following:
    (1) A State Medicaid program under title XIX of the Act.
    (2) A State children's health insurance program (CHIP) under title 
XXI of the Act.
    (3) A State basic health program established under section 1331 of 
the Affordable Care Act.
    (4) A program that makes coverage in a qualified health plan through 
the Exchange with advance payments of the premium tax credit established 
under section 36B of the Internal Revenue Code available to qualified 
individuals.
    (5) A program that makes available coverage in a qualified health 
plan through the Exchange with cost-sharing reductions established under 
section 1402 of the Affordable Care Act.
    MAGI-based income has the meaning provided in Sec.  435.603(e) of 
this part.
    Mandatory State supplement means a cash payment a State is required 
to make under section 212, Pub. L. 93-66 (July 9, 1973) to an aged, 
blind, or disabled individual. Its purpose is to provide an individual 
with the same amount of cash assistance he was receiving under OAA, AB, 
APTD, or AABD if his SSI payment is less than that amount;
    Medically needy refers to families, children, aged, blind, or 
disabled individuals, and pregnant women listed under subpart D of this 
part who are not listed in subparts B and C of this part as 
categorically needy but who may be eligible for Medicaid under this part 
because their income and resources are within limits set by the State 
under its Medicaid plan (including persons whose income and resources 
fall within these limits after their incurred expenses for medical or 
remedial care are deducted) (Specific financial requirements for 
determining eligibility of the medically needy appear in subpart I of 
this part.);
    Minimum essential coverage means coverage defined in section 
5000A(f) of subtitle D of the Internal Revenue Code, as added by section 
1401 of the Affordable Care Act, and implementing regulations of such 
section issued by the Secretary of the Treasury.
    Modified adjusted gross income (MAGI) has the meaning provided at 26 
CFR 1.36B-1(e)(2).
    Non-applicant means an individual who is not seeking an eligibility 
determination for himself or herself and is included in an applicant's 
or beneficiary's household to determine eligibility for such applicant 
or beneficiary.
    Non-citizen has the same meaning as the term ``alien,'' as defined 
at 8 U.S.C. 1101(a)(3) and includes any individual who is not a citizen 
or national of the United States, defined at 8 U.S.C. 1101(a)(22).
    OAA means old age assistance under title I of the Act;
    OASDI means old age, survivors, and disability insurance under title 
II of the Act;
    Optional State supplement means a cash payment made by a State, 
under section 1616 of the Act, to an aged, blind, or disabled 
individual;
    Optional targeted low-income child means a child under age 19 who 
meets the financial and categorical standards described below.
    (1) Financial need. An optional targeted low-income child:
    (i) Has a household income at or below 200 percent of the Federal 
poverty line for a family of the size involved; and
    (ii) Resides in a State with no Medicaid applicable income level (as 
defined at Sec.  457.10 of this chapter); or
    (iii) Resides in a State that has a Medicaid applicable income level 
(as defined at Sec.  457.10 of this chapter) and has household income 
that either:
    (A) Exceeds the Medicaid applicable income level for the age of such 
child, but not by more than 50 percentage points; or
    (B) Does not exceed the income level specified for such child to be 
eligible for medical assistance under the policies of the State plan 
under title XIX on June 1, 1997.
    (2) No other coverage and State maintenance of effort. An optional 
targeted

[[Page 139]]

low-income child is not covered under a group health plan or health 
insurance coverage, or would not be eligible for Medicaid under the 
policies of the State plan in effect on March 31, 1997; except that, for 
purposes of this standard--
    (i) A child shall not be considered to be covered by health 
insurance coverage based on coverage offered by the State under a 
program in operation prior to July 1, 1997 if that program received no 
Federal financial participation;
    (ii) A child shall not be considered to be covered under a group 
health plan or health insurance coverage if the child did not have 
reasonable geographic access to care under that coverage.
    (3) For purposes of this section, policies of the State plan a under 
title XIX plan include policies under a Statewide demonstration project 
under section 1115(a) of the Act other than a demonstration project that 
covered an expanded group of eligible children but that either--
    (i) Did not provide inpatient hospital coverage; or
    (ii) Limited eligibility to children previously enrolled in 
Medicaid, imposed premiums as a condition of initial or continued 
enrollment, and did not impose a general time limit on eligibility.
    Pregnant woman means a woman during pregnancy and the post partum 
period, which begins on the date the pregnancy ends, extends 60 days, 
and then ends on the last day of the month in which the 60-day period 
ends.
    Qualified non-citizen includes the term ``qualified alien'' as 
defined at 8 U.S.C. 1641(b) and (c).
    Secure electronic interface means an interface which allows for the 
exchange of data between Medicaid and other insurance affordability 
programs and adheres to the requirements in part 433, subpart C of this 
chapter.
    Shared eligibility service means a common or shared eligibility 
system or service used by a State to determine individuals' eligibility 
for insurance affordability programs.
    SSI means supplemental security income under title XVI of the Act.
    SWICA means the State Wage Information Collection Agency under 
section 1137(a) of the Act. It is the State agency administering the 
State unemployment compensation law; a separate agency administering a 
quarterly wage reporting system; or a State agency administering an 
alternative system which has been determined by the Secretary of Labor, 
in consultation with the Secretary of Agriculture and the Secretary of 
Health and Human Services, to be as effective and timely in providing 
employment related income and eligibility data.
    Tax dependent has the same meaning as the term ``dependent'' under 
section 152 of the Internal Revenue Code, as an individual for whom 
another individual claims a deduction for a personal exemption under 
section 151 of the Internal Revenue Code for a taxable year.

[43 FR 45204, Sept. 29, 1978, as amended at 45 FR 24883, Apr. 11, 1980; 
46 FR 6909, Jan. 22, 1981; 46 FR 47984, Sept. 30, 1981; 51 FR 7211, Feb. 
28, 1986; 58 FR 4925, Jan. 19, 1993; 66 FR 2666, Jan. 11, 2001; 77 FR 
17203, Mar. 23, 2012; 81 FR 86450, Nov. 30, 2016]



Sec.  435.10  State plan requirements.

    A State plan must--
    (a) Provide that the requirements of this part are met; and
    (b) Specify the groups to whom Medicaid is provided, as specified in 
subparts B, C, and D of this part, and the conditions of eligibility for 
individuals in those groups.



                      Subpart B_Mandatory Coverage



Sec.  435.100  Scope.

    This subpart prescribes requirements for coverage of categorically 
needy individuals.

               Mandatory Coverage of Families and Children



Sec.  435.110  Parents and other caretaker relatives.

    (a) Basis. This section implements sections 1931(b) and (d) of the 
Act.
    (b) Scope. The agency must provide Medicaid to parents and other 
caretaker relatives, as defined in Sec.  435.4, and, if living with such 
parent or other caretaker relative, his or her spouse, whose household 
income is at or below the income standard established by the

[[Page 140]]

agency in the State plan, in accordance with paragraph (c) of this 
section.
    (c) Income standard. The agency must establish in its State plan the 
income standard as follows:
    (1) The minimum income standard is a State's AFDC income standard in 
effect as of May 1, 1988 for the applicable family size converted to a 
MAGI-equivalent standard in accordance with guidance issued by the 
Secretary under section 1902(e)(14)(A) and (E) of the Act.
    (2) The maximum income standard is the higher of--
    (i) The effective income level in effect for section 1931 low-income 
families under the Medicaid State plan or waiver of the State plan as of 
March 23, 2010 or December 31, 2013, if higher, converted to a MAGI-
equivalent standard in accordance with guidance issued by the Secretary 
under section 1902(e)(14)(A) and (E) of the Act; or
    (ii) A State's AFDC income standard in effect as of July 16, 1996 
for the applicable family size, increased by no more than the percentage 
increase in the Consumer Price Index for all urban consumers between 
July 16, 1996 and the effective date of such increase.

[77 FR 17204, Mar. 23, 2012, as amended at 78 FR 42302, July 15, 2013]



Sec.  435.112  Families terminated from AFDC because of increased earnings
or hours of employment.

    (a) If a family loses AFDC solely because of increased income from 
employment or increased hours of employment, the agency must continue to 
provide Medicaid for 4 months to all members of the family if--
    (1) The family received AFDC in any 3 or more months during the 6-
month period immediately before the month in which it became ineligible 
for AFDC; and
    (2) At least one member of the family is employed throughout the 4-
month period, although this need not be the same member for the whole 
period.
    (b) The 4 calendar month period begins on the date AFDC is 
terminated. If AFDC benefits are terminated retroactively, the 4 
calendar month period also begins retroactively with the first month in 
which AFDC was erroneously paid.

[43 FR 45204, Sept. 29, 1978, as amended at 45 FR 24883, Apr. 11, 1980]



Sec.  435.115  Families with Medicaid eligibility extended because of
increased collection of spousal support.

    (a) Basis. This section implements sections 408(a)(11)(B) and 
1931(c)(1) of the Act.
    (b) Eligibility. (1) The extended eligibility period is for 4 
months.
    (2) The agency must provide coverage during an extended eligibility 
period to a parent or other caretaker relative who was eligible and 
enrolled for Medicaid under Sec.  435.110, and any dependent child of 
such parent or other caretaker relative who was eligible and enrolled 
under Sec.  435.118, in at least 3 out of the 6 months immediately 
preceding the month that eligibility for the parent or other caretaker 
relative under Sec.  435.110 is lost due to increased collection of 
spousal support under title IV-D of the Act.

[81 FR 86451, Nov. 30, 2016]

  Mandatory Coverage of Pregnant Women, Children Under 19, and Newborn 
                                Children



Sec.  435.116  Pregnant women.

    (a) Basis. This section implements sections 1902(a)(10)(A)(i)(III) 
and (IV); 1902(a)(10)(A)(ii)(I), (IV), and (IX); and 1931(b) and (d) of 
the Act.
    (b) Scope. The agency must provide Medicaid to pregnant women whose 
household income is at or below the income standard established by the 
agency in its State plan, in accordance with paragraph (c) of this 
section.
    (c) Income standard. The agency must establish in its State plan the 
income standard as follows:
    (1) The minimum income standard is the higher of:
    (i) 133 percent FPL for the applicable family size; or
    (ii) Such higher income standard up to 185 percent FPL, if any, as 
the State had established as of December 19, 1989 for determining 
eligibility for pregnant women, or, as of July 1, 1989, had authorizing 
legislation to do so.

[[Page 141]]

    (2) The maximum income standard is the higher of--
    (i) The highest effective income level in effect under the Medicaid 
State plan for coverage under the sections specified at paragraph (a) of 
this section, or waiver of the State plan covering pregnant women, as of 
March 23, 2010 or December 31, 2013, if higher, converted to a MAGI-
equivalent standard in accordance with guidance issued by the Secretary 
under section 1902(e)(14)(A) and (E) of the Act; or
    (ii) 185 percent FPL.
    (d) Covered services. (1) Pregnant women are covered under this 
section for the full Medicaid coverage described in paragraph (d)(2) of 
this section, except that the agency may provide only pregnancy-related 
services described in paragraph (d)(3) of this section for pregnant 
women whose income exceeds the applicable income limit established by 
the agency in its State plan, in accordance with paragraph (d)(4) of 
this section.
    (2) Full Medicaid coverage consists of all services which the State 
is required to cover under Sec.  440.210(a)(1) of this subchapter and 
all services which it has opted to cover under Sec.  440.225 and Sec.  
440.250(p) of this subchapter.
    (3) Pregnancy-related services consists of services covered under 
the State plan consistent with Sec.  440.210(a)(2) and Sec.  440.250(p) 
of this subchapter.
    (4) Applicable income limit for full Medicaid coverage of pregnant 
women. For purposes of paragraph (d)(1) of this section--
    (i) The minimum applicable income limit is the State's AFDC income 
standard in effect as of May 1, 1988 for the applicable family size 
converted to a MAGI-equivalent standard in accordance with guidance 
issued by the Secretary under section 1902(e)(14)(A) and (E) of the Act.
    (ii) The maximum applicable income limit is the highest effective 
income level for coverage under section 1902(a)(10)(A)(i)(III) of the 
Act or under section 1931(b) and (d) of the Act in effect under the 
Medicaid State plan or waiver of the State plan as of March 23, 2010 or 
December 31, 2013, if higher, converted to a MAGI-equivalent standard.

[77 FR 17204, Mar. 23, 2012, as amended at 78 FR 42302, July 15, 2013]



Sec.  435.117  Deemed newborn children.

    (a) Basis. This section implements sections 1902(e)(4) and 2112(e) 
of the Act.
    (b) Eligibility. (1) The agency must provide Medicaid to children 
from birth until the child's first birthday without application if, for 
the date of the child's birth, the child's mother was eligible for and 
received covered services under--
    (i) The Medicaid State plan (including during a period of 
retroactive eligibility under Sec.  435.915) regardless of whether 
payment for services for the mother is limited to services necessary to 
treat an emergency medical condition, as defined in section 1903(v)(3) 
of the Act; or
    (ii) The CHIP State plan as a targeted low-income pregnant woman in 
accordance with section 2112 of the Act, with household income at or 
below the income standard established by the agency under Sec.  435.118 
for infants under age 1.
    (2) The agency may provide coverage under this section to children 
from birth until the child's first birthday without application who are 
not described in (b)(1) of this section if, for the date of the child's 
birth, the child's mother was eligible for and received covered services 
under--
    (i) The Medicaid State plan of any State (including during a period 
of retroactive eligibility under Sec.  435.915); or
    (ii) Any of the following, provided that household income of the 
child's mother at the time of the child's birth is at or below the 
income standard established by the agency under Sec.  435.118 for 
infants under age 1:
    (A) The State's separate CHIP State plan as a targeted low-income 
child;
    (B) The CHIP State plan of any State as a targeted low-income 
pregnant woman or child; or
    (C) A Medicaid or CHIP demonstration project authorized under 
section 1115 of the Act.
    (3) The child is deemed to have applied and been determined eligible 
under the Medicaid State plan effective

[[Page 142]]

as of the date of birth, and remains eligible regardless of changes in 
circumstances until the child's first birthday, unless the child dies or 
ceases to be a resident of the State or the child's representative 
requests a voluntary termination of eligibility.
    (c) Medicaid identification number. (1) The Medicaid identification 
number of the mother serves as the child's identification number, and 
all claims for covered services provided to the child may be submitted 
and paid under such number, unless and until the State issues the child 
a separate identification number.
    (2) The State must issue a separate Medicaid identification number 
for the child prior to the effective date of any termination of the 
mother's eligibility or prior to the date of the child's first birthday, 
whichever is sooner, except that the State must issue a separate 
Medicaid identification number in the case of a child born to a mother:
    (i) Whose coverage is limited to services necessary for the 
treatment of an emergency medical condition, consistent with Sec.  
435.139 or Sec.  435.350;
    (ii) Covered under the State's separate CHIP; or
    (iii) Who received Medicaid in another State on the date of birth.
    (d) Renewal of eligibility. A redetermination of eligibility must be 
completed on behalf of the children described in this provision in 
accordance with the procedures at Sec.  435.916. At that time, the State 
must collect documentary evidence of citizenship and identity as 
required under Sec.  435.406.

[72 FR 38690, July 13, 2007, as amended at 81 FR 86451, Nov. 30, 2016]

             Mandatory Coverage of Qualified Family Members



Sec.  435.118  Infants and children under age 19.

    (a) Basis. This section implements sections 1902(a)(10)(A)(i)(III), 
(IV), (VI), and (VII); 1902(a)(10)(A)(ii)(IV) and (IX); and 1931(b) and 
(d) of the Act.
    (b) Scope. The agency must provide Medicaid to children under age 19 
whose household income is at or below the income standard established by 
the agency in its State plan, in accordance with paragraph (c) of this 
section.
    (c) Income standard. (1) The minimum income standard is the higher 
of--
    (i) 133 percent FPL for the applicable family size; or
    (ii) For infants under age 1, such higher income standard up to 185 
percent FPL, if any, as the State had established as of December 19, 
1989 for determining eligibility for infants, or, as of July 1, 1989 had 
authorizing legislation to do so.
    (2) The maximum income standard for each of the age groups of 
infants under age 1, children age 1 through age 5, and children age 6 
through age 18 is the higher of--
    (i) 133 percent FPL;
    (ii) The highest effective income level for each age group in effect 
under the Medicaid State plan for coverage under the applicable sections 
of the Act listed at paragraph (a) of this section or waiver of the 
State plan covering such age group as of March 23, 2010 or December 31, 
2013, if higher, converted to a MAGI-equivalent standard in accordance 
with guidance issued by the Secretary under section 1902(e)(14)(A) and 
(E) of the Act; or
    (iii) For infants under age 1, 185 percent FPL.

[77 FR 17205, Mar. 23, 2012]

          Mandatory Coverage for Individuals Age 19 Through 64



Sec.  435.119  Coverage for individuals age 19 or older and under 
age 65 at or below 133 percent FPL.

    (a) Basis. This section implements section 1902(a)(10)(A)(i)(VIII) 
of the Act.
    (b) Eligibility. Effective January 1, 2014, the agency must provide 
Medicaid to individuals who:
    (1) Are age 19 or older and under age 65;
    (2) Are not pregnant;
    (3) Are not entitled to or enrolled for Medicare benefits under part 
A or B of title XVIII of the Act;
    (4) Are not otherwise eligible for and enrolled for mandatory 
coverage under a State's Medicaid State plan in accordance with subpart 
B of this part; and
    (5) Have household income that is at or below 133 percent FPL for 
the applicable family size.

[[Page 143]]

    (c) Coverage for dependent children. (1) A State may not provide 
Medicaid under this section to a parent or other caretaker relative 
living with a dependent child if the child is under the age specified in 
paragraph (c)(2) of this section, unless such child is receiving 
benefits under Medicaid, the Children's Health Insurance Program under 
subchapter D of this chapter, or otherwise is enrolled in minimum 
essential coverage as defined in Sec.  435.4 of this part.
    (2) For the purpose of paragraph (c)(1) of this section, the age 
specified is under age 19, unless the State had elected as of March 23, 
2010 to provide Medicaid to individuals under age 20 or 21 under Sec.  
435.222 of this part, in which case the age specified is such higher 
age.

[58 FR 48614, Sept. 17, 1993, as amended at 77 FR 17205, Mar. 23, 2012; 
78 FR 42302, July 15, 2013]

           Mandatory Coverage of the Aged, Blind, and Disabled



Sec.  435.120  Individuals receiving SSI.

    Except as allowed under Sec.  435.121, the agency must provide 
Medicaid to aged, blind, and disabled individuals or couples who are 
receiving or are deemed to be receiving SSI. This includes individuals 
who are--
    (a) Receiving SSI pending a final determination of blindness or 
disability;
    (b) Receiving SSI under an agreement with the Social Security 
Administration to dispose of resources that exceed the SSI dollar limits 
on resources; or
    (c) Receiving benefits under section 1619(a) of the Act or in 
section 1619(b) status (blind individuals or those with disabling 
impairments whose income equals or exceeds a specific Supplemental 
Security Income limit). (Regulations at 20 CFR 416.260 through 416.269 
contain requirements governing determinations of eligibility under this 
provision.) For purposes of this paragraph (c), this mandatory 
categorically needy group of individuals includes those qualified 
severely impaired individuals defined in section 1905(q) of the Act.

[55 FR 33705, Aug. 17, 1990]



Sec.  435.121  Individuals in States using more restrictive requirements
for Medicaid than the SSI requirements.

    (a) Basic eligibility group requirements. (1) If the agency does not 
provide Medicaid under Sec.  435.120 to aged, blind, and disabled 
individuals who are SSI beneficiaries, the agency must provide Medicaid 
to aged, blind, and disabled individuals who meet eligibility 
requirements that are specified in this section.
    (2) Except to the extent provided in paragraph (a)(3) of this 
section, the agency may elect to apply more restrictive eligibility 
requirements to the aged, blind, and disabled that are more restrictive 
than those of the SSI program. The more restrictive requirements may be 
no more restrictive than those requirements contained in the State's 
Medicaid plan in effect on January 1, 1972. If any of the State's 1972 
Medicaid plan requirements were more liberal than of the SSI program, 
the State must use the SSI requirement instead of the more liberal 
requirements, except to the extent the State elects to use more liberal 
criteria under Sec.  435.601.
    (3) The agency must not apply a more restrictive requirement under 
the provisions of paragraph (a)(2) of this section if:
    (i) The requirement conflicts with the requirements of section 1924 
of the Act, which governs the eligibility and post-eligibility treatment 
of income and resources of institutionalized individuals with community 
spouses;
    (ii) The requirement conflicts with a more liberal requirement which 
the agency has elected to use under Sec.  435.601; or
    (iii) The more restrictive requirement conflicts with a more liberal 
requirement the State has elected to use under Sec.  435.234(c) in 
determining eligibility for State supplementary payments.
    (b) Mandatory coverage. If the agency chooses to apply more 
restrictive requirements than SSI to aged, blind, or disabled 
individuals, it must provide Medicaid to:
    (1) Individuals who meet the requirements of section 1619(b)(3) of 
the Act even though they may not continue to

[[Page 144]]

meet the requirements of this section; and
    (2) Qualified Medicare beneficiaries described in section 1905(p) of 
the Act and qualified working disabled individuals described in section 
1905(s) of the Act without consideration of the more restrictive 
eligibility requirements specified in this section.
    (3) Individuals who:
    (i) Qualify for benefits under section 1619(a) or are in eligibility 
status under section 1619(b)(1) of the Act as determined by SSA; and
    (ii) Were eligible for Medicaid under the more restrictive criteria 
in the State's approved Medicaid plan in the reference month--the month 
immediately preceding the first month in which they became eligible 
under section 1619(a) or (b)(1) of the Act. ``Were eligible for 
Medicaid'' means that individuals were issued Medicaid cards by the 
State for the reference month. Under this provision, the reference month 
for determining Medicaid eligibility for all individuals under section 
1619 of the Act is the month immediately preceding the first month of 
the most recent period of eligibility under section 1619 of the Act.
    (c) Group composition. The agency may apply more restrictive 
requirements only to the aged, to the blind, to the disabled, or to any 
combination of these groups. For example, the agency may apply more 
restrictive requirements to the aged and disabled under this provision 
and provide Medicaid to all blind individuals who are SSI beneficiaries.
    (d) Nonfinancial conditions. The agency may apply more restrictive 
requirements that are nonfinancial conditions of eligibility. For 
example, the agency may use a more restrictive definition of disability 
or may limit eligibility of the disabled to individuals age 18 and 
older, or both. If the agency limits eligibility of disabled individuals 
to individuals age 18 or older, it must provide Medicaid to individuals 
under age 18 who receive SSI benefits and who would be eligible to 
receive AFDC under the State's approved plan if they did not receive 
SSI. If the agency imposed an age limit for disabled individuals under 
its 1972 approved State plan but does not use that limit, it must apply 
the same nonfinancial requirement to individuals under age 18 that it 
applies to disabled individuals age 18 and older.
    (e) Financial conditions. (1) The agency may apply more restrictive 
requirements that are financial conditions of eligibility.
    (2) Any income eligibility standards that the agency applies must:
    (i) Equal the income standard (or Federal Benefit Rate (FBR)) that 
would be used under SSI based on an individual's living arrangement; or
    (ii) Be a more restrictive standard which is no more restrictive 
than that under the approved State's January 1, 1972 Medicaid plan.
    (3) If the categorically needy income standard established under 
paragraph (e)(2) of this section is less than the optional categorically 
needy standard established under Sec.  435.230, the agency must provide 
Medicaid to all aged, blind, and disabled individuals who have income 
equal to or below the higher standard.
    (4) In a State that does not have a medically needy program that 
covers aged, blind, and disabled individuals, the agency must allow 
individuals to deduct from income incurred medical and remedial expenses 
(that is, spend down) to become eligible under this section. However, 
individuals with income above the categorically needy standards may only 
spend down to the standard selected by the State under paragraph (e)(2) 
of this section which applies to the individual's living arrangement.
    (5) In a State that elects to provide medically needy coverage to 
aged, blind, and disabled individuals, the agency must allow individuals 
to deduct from income incurred medical and remedial care expenses (spend 
down) to become categorically needy when they are SSI beneficiaries 
(including individuals deemed to be SSI beneficiaries under Sec. Sec.  
435.135, 435.137, and 435.138), eligible spouses of SSI beneficiaries, 
State supplement beneficiaries, and individuals who are eligible for a 
supplement but who do not receive supplementary payments. Such persons 
may only spend down to the standard selected by the State under 
paragraph (e)(2) of this section. Individuals who

[[Page 145]]

are not SSI beneficiaries, eligible spouses of SSI beneficiaries, State 
supplement beneficiaries, or individuals who are eligible for a 
supplement must spend down to the State's medically needy income 
standards for aged, blind, and disabled individuals in order to become 
Medicaid eligible.
    (f) Deductions from income. (1) In addition to any income disregards 
specified in the approved State plan in accordance with Sec.  
435.601(b), the agency must deduct from income:
    (i) SSI payments;
    (ii) State supplementary payments that meet the conditions specified 
in Sec. Sec.  435.232 and 435.234; and
    (iii) Expenses incurred by the individual or financially responsible 
relatives for necessary medical and remedial services that are 
recognized under State law and are not subject to payment by a third 
party, unless the third party is a public program of a State or 
political subdivision of a State. These expenses include Medicare and 
other health insurance premiums, deductions and coinsurance charges, and 
copayments or deductibles imposed under Sec.  447.52, Sec.  447.53, or 
Sec.  447.54 of this chapter. The agency may set reasonable limits on 
the amounts of incurred medical expenses that are deducted.
    (2) For purposes of counting income with respect to individuals who 
are receiving benefits under section 1619(a) f the Act or are in section 
1619(b)(1) of the Act status but who do not meet the requirements of 
paragraph (b)(3)(ii) of this section, the agency may disregard some or 
all of the amount of the individual's income that is in excess of the 
SSI Federal benefit rate under section 1611(b) of the Act.

[58 FR 4926, Jan. 19, 1993, as amended at 78 FR 42302, July 15, 2013]



Sec.  435.122  Individuals who are ineligible for SSI or optional State
supplements because of requirements that do not apply under title XIX of
the Act.

    If an agency provides Medicaid to aged, blind, or disabled 
individuals receiving SSI or optional State supplements, it must provide 
Medicaid to individuals who would be eligible for SSI or optional State 
supplements except for an eligibility requirement used in those programs 
that is specifically prohibited under title XIX.

[47 FR 43648, Oct. 1, 1982; 47 FR 49847, Nov. 3, 1982]



Sec.  435.130  Individuals receiving mandatory State supplements.

    The agency must provide Medicaid to individuals receiving mandatory 
State supplements.



Sec.  435.131  Individuals eligible as essential spouses in December 1973.

    (a) The agency must provide Medicaid to any person who was eligible 
for Medicaid in December 1973 as an essential spouse of an aged, blind, 
or disabled individual who was receiving cash assistance, if the 
conditions in paragraph (b) of this section are met. An ``essential 
spouse'' is defined in section 1905(a) of the Act as one who is living 
with the individual; whose needs were included in determining the amount 
of cash payment to the individual under OAA, AB, APTD, or AABD; and who 
is determined essential to the individual's well-being.
    (b) The agency must continue Medicaid if--
    (1) The aged, blind, or disabled individual continues to meet the 
December 1973 eligibility requirements of the applicable State cash 
assistance plan; and
    (2) The essential spouse continues to meet the conditions that were 
in effect in December 1973 under the applicable cash assistance plan for 
having his needs included in computing the payment to the aged, blind, 
or disabled individual.



Sec.  435.132  Institutionalized individuals who were eligible in 
December 1973.

    The agency must provide Medicaid to individuals who were eligible 
for Medicaid in December 1973, or any part of that month, as inpatients 
of medical institutions or residents of intermediate care facilities 
that were participating in the Medicaid program and who--
    (a) For each consecutive month after December 1973--
    (1) Continue to meet the requirements for Medicaid eligibility that 
were in effect under the State's plan in

[[Page 146]]

December 1973 for institutionalized individuals; and
    (2) Remain institutionalized; and
    (b) Are determined by the State or a professional standards review 
organization to continue to need institutional care.



Sec.  435.133  Blind and disabled individuals eligible in December 1973.

    The agency must provide Medicaid to individuals who--
    (a) Meet all current requirements for Medicaid eligibility except 
the criteria for blindness or disability;
    (b) Were eligible for Medicaid in December 1973 as blind or disabled 
individuals, whether or not they were receiving cash assistance in 
December 1973; and
    (c) For each consecutive month after December 1973, continue to meet 
the criteria for blindness or disability and the other conditions of 
eligibility used under the Medicaid plan in December 1973.



Sec.  435.134  Individuals who would be eligible except for the increase
in OASDI benefits under Pub. L. 92-336 (July 1, 1972).

    The agency must provide Medicaid to individuals who meet the 
following conditions:
    (a) In August 1972, the individual was entitled to OASDI and--
    (1) He was receiving OAA, AB, APTD, or AABD; or
    (2) He would have been eligible for one of those programs except 
that he had not applied, and the Medicaid plan covered this optional 
group; or
    (3) He would have been eligible for one of those programs if he were 
not in a medical institution or intermediate care facility, and the 
Medicaid plan covered this optional group.
    (b) The individual would currently be eligible for SSI or a State 
supplement except that the increase in OASDI under Pub. L. 92-336 raised 
his income over the limit allowed under SSI. This includes an individual 
who--
    (1) Meets all current SSI requirements except for the requirement to 
file an application; or
    (2) Would meet all current SSI requirements if he were not in a 
medical institution or intermediate care facility, and the State's 
Medicaid plan covers this optional group.

[43 FR 45204, Sept. 29, 1978, as amended at 45 FR 24883, Apr. 11, 1980]



Sec.  435.135  Individuals who become ineligible for cash assistance as a
result of OASDI cost-of-living increases received after April 1977.

    (a) If an agency provides Medicaid to aged, blind, or disabled 
individuals receiving SSI or State supplements, it must provide Medicaid 
to individuals who--
    (1) Are receiving OASDI;
    (2) Were eligible for and receiving SSI or State supplements but 
became ineligible for those payments after April 1977; and
    (3) Would still be eligible for SSI or State supplements if the 
amount of OASDI cost-of-living increases paid under section 215(i) of 
the Act, after the last month after April 1977 for which those 
individuals were both eligible for and received SSI or a State 
supplement and were entitled to OASDI, were deducted from current OASDI 
benefits.
    (b) Cost-of-living increases include the increases received by the 
individual or his or her financially responsible spouse or other family 
member (e.g., a parent).
    (c) If the agency adopts more restrictive eligibility requirements 
than those under SSI, it must provide Medicaid to individuals specified 
in paragraph (a) of this section on the same basis as Medicaid is 
provided to individuals continuing to receive SSI or State supplements. 
If the individual incurs enough medical expenses to reduce his or her 
income to the financial eligibility standard for the categorically 
needy, the agency must cover that individual as categorically needy. In 
determining the amount of his or her income, the agency may deduct the 
cost-of-living increases paid under section 215(i) after the last month 
after April 1977 for which that individual was both eligible for and 
received SSI or a State supplement and was entitled to OASDI, up to the 
amount that made him or her ineligible for SSI.

[51 FR 12330, Apr. 10, 1986]

[[Page 147]]



Sec.  435.136  State agency implementation requirements for one-time notice
and annual review system.

    An agency must--
    (a) Provide a one-time notice of potential Medicaid eligibility 
under Sec.  435.135 to all individuals who meet the requirements of 
Sec.  435.135 (a) or (c) who were not receiving Medicaid as of March 9, 
1984; and
    (b) Establish an annual review system to identify individuals who 
meet the requirements of Sec.  435.135 (a) or (c) and who lose 
categorically needy eligibility for Medicaid because of a loss of SSI. 
States without medically needy programs must send notices of potential 
eligibility for Medicaid to these individuals for 3 consecutive years 
following their identification through the annual review system.

[51 FR 12330, Apr. 10, 1986]



Sec.  435.137  Disabled widows and widowers who would be eligible for SSI
except for the increase in disability benefits resulting from elimination
of the reduction factor under Pub. L. 98-21.

    (a) If the agency provides Medicaid to aged, blind, or disabled 
individuals receiving SSI or State supplements, the agency much provide 
Medicaid to disabled widows and widowers who--
    (1) Became ineligible for SSI or a mandatory or optional State 
supplement as a result of the elimination of the additional reduction 
factor for disabled widows and widowers under age 60 required by section 
134 of Pub. L. 98-21, and for purposes of title XIX, are deemed to be 
title XVI payment beneficiaries under section 1634(b) of the Social 
Security Act; and
    (2) Meet the conditions of paragraphs (b) and (e) of this section.
    (b) The individuals must meet the following conditions:
    (1) They were entitled to monthly OASDI benefits under title II of 
the Act for December 1983:
    (2) They were entitled to and received widow's or widower's 
disability benefits under section 202(e) or (f) of the Act for January 
1984;
    (3) They became ineligible for SSI or a mandatory or optional State 
supplement in the first month in which the increase under Pub. L. 98-21 
was paid (and in which a retroactive payment for that increase for prior 
months was not made);
    (4) They have been continously entitled to widow's or widower's 
disability benefits under section 202(e) or (f) from the first month 
that the increase under Pub. L. 98-21 was received; and
    (5) They would be eligible for SSI benefits or a mandatory or 
optional State supplement if the amount of the increase under Pub. L. 
98-21 and subsequent cost-of-living adjustments in widow's or widower's 
benefits under section 215(i) of the Act were deducted from their 
income.
    (c) If the agency adopts more restrictive requirements than those 
under SSI, it must provide Medicaid to individuals specified in 
paragraph (a) of this section on the same basis as Medicaid is provided 
to individuals continuing to receive SSI or a mandatory or optional 
State supplement. The State must consider the individuals specified in 
paragraph (a) of this section to have no more income than the SSI 
Federal benefit rate if the individual was eligible for SSI in the month 
prior to the first month in which the increase under Public Law 98-21 
was paid (and in which retroactive payments for that increase for prior 
months was not being made), and the individual would be eligible for SSI 
except for the amount of the increase under Public Law 98-21 and 
subsequent cost-of-living adjustments in his or her widow's or widower's 
benefits under section 215(i) of the Act. The State must consider 
individuals who qualify under paragraph (a) of this section on the basis 
of loss of a mandatory or optional State supplementary payment, rather 
than the loss of SSI, to have no more income than the relevant SSP rate. 
If the State's income eligibility level is lower than the SSP or SSI 
Federal benefit rates, individuals qualifying under paragraph (a) of 
this section who are deemed to have income at either the SSP rate or the 
SSI Federal benefit rate may further reduce their countable income by 
incurring medical expenses in the amount by which their income exceeds 
the State's income eligibility standard. When the individual has reduced 
his or her income by this

[[Page 148]]

amount, he or she will be eligible for Medicaid as categorically needy.
    (d) The agency must notify each individual who may be eligible for 
Medicaid under this section of his or her potential eligibility, in 
accordance with instructions issued by the Secretary.
    (e)(1) Except as provided in paragraph (e)(2) of this section, the 
provisions of this section apply only to those individuals who filed a 
written application for Medicaid on or before June 30, 1988, to obtain 
protected Medicaid coverage.
    (2) Individuals who may be eligible under this section residing in 
States that use a more restrictive income standard than that of the SSI 
program, under section 1902(f) of the Act, have up to six months after 
the State sends notice pursuant to the District Court's order in Darling 
v. Bowen (685 F. Supp. 1125 (W.D.Mo. 1988) to file a written application 
to obtain protected Medicaid coverage.

[55 FR 48607, Nov. 21, 1990]



Sec.  435.138  Disabled widows and widowers aged 60 through 64 who would
be eligible for SSI except for early receipt of social security benefits.

    (a) If the agency provides Medicaid to aged, blind, or disabled 
individuals receiving SSI or State supplements, the agency must provide 
Medicaid to disabled widows and widowers who--
    (1) Are at least age 60;
    (2) Are not entitled to hospital insurance benefits under Medicare 
Part A; and
    (3) Become ineligible for SSI or a State supplement because of 
mandatory application (under section 1611(e)(2)) for and receipt of 
widow's or widower's social security disability benefits under section 
202(e) or (f) (or any other provision of section 202 if they are also 
eligible for benefits under subsections (e) or (f)) of the Act.
    For purposes of title XIX, individuals who meet these requirements 
are deemed to be title XVI payment beneficiaries under section 1634(d) 
of the Act.
    (b) If the agency adopts more restrictive eligibility requirements 
than those under SSI, it must provide Medicaid to individuals specified 
in paragraph (a) of this section on the same basis as Medicaid is 
provided to individuals continuing to receive SSI or a mandatory or 
optional State supplement. If the individual incurs enough medical 
expenses to reduce his or her income to the financial eligibility 
standard for the categorically needy under the State's more restrictive 
eligibility criteria, the agency must cover the individual as 
categorically needy. In determining the amount of his or her income, the 
agency may deduct all, part, or none of the amount of the social 
security disability benefits that made him or her ineligible for SSI or 
a State supplement, up to the amount that made him or her ineligible for 
SSI.
    (c) Individuals who may be eligible under this section must file a 
written application for Medicaid. Medicaid coverage may begin no earlier 
than July 1, 1988.
    (d) The agency must determine whether individuals may be eligible 
for Medicaid under this section.

[55 FR 48608, Nov. 21, 1990]

                  Mandatory Coverage of Certain Aliens



Sec.  435.139  Coverage for certain aliens.

    The agency must provide services necessary for the treatment of an 
emergency medical condition, as defined in Sec.  440.255(c) of this 
chapter, to those aliens described in Sec.  435.406(c) of this subpart.

[55 FR 36819, Sept. 7, 1990]

   Mandatory Coverage of Adoption Assistance and Foster Care Children



Sec.  435.145  Children with adoption assistance, foster care, or 
guardianship care under title IV-E.

    (a) Basis. This section implements sections 1902(a)(10)(A)(i)(I) and 
473(b)(3) of the Act.
    (b) Eligibility. The agency must provide Medicaid to individuals for 
whom--
    (1) An adoption assistance agreement is in effect with a State or 
Tribe under title IV-E of the Act, regardless of whether adoption 
assistance is being provided or an interlocutory or other

[[Page 149]]

judicial decree of adoption has been issued; or
    (2) Foster care or kinship guardianship assistance maintenance 
payments are being made by a State or Tribe under title IV-E of the Act.

[81 FR 86451, Nov. 30, 2016]



Sec.  435.150  Former foster care children.

    (a) Basis. This section implements section 1902(a)(10)(A)(i)(IX) of 
the Act.
    (b) Eligibility. The agency must provide Medicaid to individuals 
who:
    (1) Are under age 26;
    (2) Are not eligible and enrolled for mandatory coverage under 
Sec. Sec.  435.110 through 435.118 or Sec. Sec.  435.120 through 
435.145; and
    (3) Were in foster care under the responsibility of the State or a 
Tribe within the State and enrolled in Medicaid under the State's 
Medicaid State plan or under a section 1115 demonstration project upon 
attaining:
    (i) Age 18; or
    (ii) A higher age at which the State's or such Tribe's foster care 
assistance ends under title IV-E of the Act.
    (c) Options. At the State option, the agency may provide Medicaid to 
individuals who meet the requirements at paragraphs (b)(1) and (2) of 
this section, were in foster care under the responsibility of the State 
or Tribe within the State upon attaining either age described in 
paragraph (b)(3)(i) or (ii) of this section, and were:
    (1) Enrolled in Medicaid under the State's Medicaid State plan or 
under a section 1115 demonstration project at some time during the 
period in foster care during which the individual attained such age; or
    (2) Placed by the State or Tribe in another State and, while in such 
placement, were enrolled in the other State's Medicaid State plan or 
under a section 1115 demonstration project:
    (i) Upon attaining either age described in paragraph (b)(3)(i) or 
(ii) of this section; or
    (ii) At state option, at some time during the period in foster care 
during which the individual attained such age.

[81 FR 86451, Nov. 30, 2016]

                  Mandatory Coverage of Special Groups



Sec.  435.170  Pregnant women eligible for extended or continuous 
eligibility.

    (a) Basis. This section implements sections 1902(e)(5) and 
1902(e)(6) of the Act.
    (b) Extended eligibility for pregnant women. For a pregnant woman 
who was eligible and enrolled under subpart B, C, or D of this part on 
the date her pregnancy ends, the agency must provide coverage described 
in paragraph (d) of this section through the last day of the month in 
which the 60-day postpartum period ends.
    (c) Continuous eligibility for pregnant women. For a pregnant woman 
who was eligible and enrolled under subpart B, C, or D of this part and 
who, because of a change in household income, will not otherwise remain 
eligible, the agency must provide coverage described in paragraph (d) of 
this section through the last day of the month in which the 60-day post-
partum period ends.
    (d) Covered Services. The coverage described in this paragraph (d) 
consists of--
    (1) Full Medicaid coverage, as described in Sec.  435.116(d)(2); or
    (2) Pregnancy-related services described in Sec.  435.116(d)(3), if 
the agency has elected to establish an income limit under Sec.  
435.116(d)(4), above which pregnant women enrolled for coverage under 
Sec.  435.116 receive pregnancy-related services described in Sec.  
435.116(d)(3).
    (e) Presumptive Eligibility. This section does not apply to pregnant 
women covered during a presumptive eligibility period under section 1920 
of the Act.

[81 FR 86452, Nov. 30, 2016]



Sec.  435.172  Continuous eligibility for hospitalized children.

    (a) Basis. This section implements section 1902(e)(7) of the Act.
    (b) Requirement. The agency must provide Medicaid to an individual 
eligible and enrolled under Sec.  435.118 until the end of an inpatient 
stay for which inpatient services are furnished, if the individual:

[[Page 150]]

    (1) Was receiving inpatient services covered by Medicaid on the date 
the individual is no longer eligible under Sec.  435.118 based on the 
child's age; and
    (2) Would remain eligible but for attaining such age.

[81 FR 86452, Nov. 30, 2016]



                     Subpart C_Options for Coverage



Sec.  435.200  Scope.

    This subpart specifies options for coverage of individuals as 
categorically needy.



Sec.  435.201  Individuals included in optional groups.

    (a) The agency may choose to cover as optional categorically needy 
any group or groups of the following individuals who are not receiving 
cash assistance and who meet the appropriate eligibility criteria for 
groups specified in the separate sections of this subpart:
    (1) Aged individuals (65 years of age of older);
    (2) Blind individuals (as defined in Sec.  435.530);
    (3) Disabled individuals (as defined in Sec.  435.541);
    (4) Individuals under age 21 (or, at State option, under age 20, 19, 
or 18) or reasonable classifications of these individuals; and
    (5) Parents and other caretaker relatives (as defined in Sec.  
435.4).
    (b) If the agency provides Medicaid to any individual in an optional 
group specified in paragraph (a) of this section, the agency must 
provide Medicaid to all individuals who apply and are found eligible to 
be members of that group.
    (c) States that elect to use more restrictive eligibility 
requirements for Medicaid than the SSI requirements for any group or 
groups of aged, blind, and disabled individuals under Sec.  435.121 must 
apply the specific requirements of Sec.  435.230 in establishing 
eligibility of these groups of individuals as optional categorically 
needy.

[58 FR 4927, Jan. 19, 1993, as amended at 81 FR 86452, Nov. 30, 2016]

 Options for Coverage of Families and Children and the Aged, Blind, and 
                                Disabled



Sec.  435.210  Optional eligibility for individuals who meet the income
and resource requirements of the cash assistance programs.

    (a) Basis. This section implements section 1902(a)(10)(A)(ii)(I) of 
the Act.
    (b) Eligibility. The agency may provide Medicaid to any group or 
groups of individuals specified in Sec.  435.201(a)(1) through (3) who 
meet the income and resource requirements of SSI or an optional State 
supplement program in States that provide Medicaid to optional State 
supplement recipients.

[81 FR 86452, Nov. 30, 2016]



Sec.  435.211  Optional eligibility for individuals who would be eligible
for cash assistance if they were not in medical institutions.

    (a) Basis. This section implements section 1902(a)(10)(A)(ii)(IV) of 
the Act.
    (b) Eligibility. The agency may provide Medicaid to any group or 
groups of individuals specified in Sec.  435.201(a)(1) through (3) who 
are institutionalized in a title XIX reimbursable medical institution 
and who:
    (1) Are ineligible for the SSI or an optional State supplement 
program in States that provide Medicaid to optional State supplement 
recipients, because of lower income standards used under the program to 
determine eligibility for institutionalized individuals; but
    (2) Would be eligible for aid or assistance under SSI or an optional 
State supplement program (as specified in Sec.  435.232 or Sec.  
435.234) if they were not institutionalized.

[81 FR 86452, Nov. 30, 2016]



Sec.  435.212  Individuals who would be ineligible if they were not
enrolled in an MCO or PCCM.

    The State agency may provide that a beneficiary who is enrolled in 
an MCO or PCCM and who becomes ineligible for Medicaid is considered to 
continue to be eligible--
    (a) For a period specified by the agency, ending no later than 6 
months from the date of enrollment; and

[[Page 151]]

    (b) Except for family planning services (which the beneficiary may 
obtain from any qualified provider) only for services furnished to him 
or her as an MCO enrollee.

[56 FR 8849, Mar. 1, 1991, as amended at 67 FR 41095, June 14, 2002]



Sec.  435.213  Optional eligibility for individuals needing treatment
for breast or cervical cancer.

    (a) Basis. This section implements sections 
1902(a)(10)(A)(ii)(XVIII) and 1902(aa) of the Act.
    (b) Eligibility. The agency may provide Medicaid to individuals 
who--
    (1) Are under age 65;
    (2) Are not eligible and enrolled for mandatory coverage under the 
State's Medicaid State plan in accordance with subpart B of this part;
    (3) Have been screened under the Centers for Disease Control and 
Prevention (CDC) breast and cervical cancer early detection program 
(BCCEDP), established in accordance with the requirements of section 
1504 of the Public Health Service Act, and found to need treatment for 
breast or cervical cancer; and
    (4) Do not otherwise have creditable coverage, as defined in section 
2704(c) of the Public Health Service Act, for treatment of the 
individual's breast or cervical cancer. An individual is not considered 
to have creditable coverage just because the individual may:
    (i) Receive medical services provided by the Indian Health Service, 
a tribal organization, or an Urban Indian organization; or
    (ii) Obtain health insurance coverage after a waiting period of 
uninsurance.
    (c) Need for treatment. An individual is considered to need 
treatment for breast or cervical cancer if the initial screen under 
BCCEDP or, subsequent to the initial period of eligibility, the 
individual's treating health professional determines that:
    (1) Definitive treatment for breast or cervical cancer is needed, 
including treatment of a precancerous condition or early stage cancer, 
and including diagnostic services as necessary to determine the extent 
and proper course of treatment; and
    (2) More than routine diagnostic services or monitoring services for 
a precancerous breast or cervical condition are needed.

[81 FR 86452, Nov. 30, 2016]



Sec.  435.214  Eligibility for Medicaid limited to family planning and
related services.

    (a) Basis. This section implements sections 1902(a)(10)(A)(ii)(XXI) 
and 1902(ii) and clause (XVI) in the matter following section 
1902(a)(10)(G) of the Act.
    (b) Eligibility. (1) The agency may provide Medicaid limited to the 
services described in paragraph (d) of this section to individuals (of 
any gender) who--
    (i) Are not pregnant; and
    (ii) Meet the income eligibility requirements at paragraph (c) of 
this section.
    (2) [Reserved]
    (c) Income standard. (1) The income standard established in the 
State plan may not exceed the higher of the income standard for pregnant 
women in effect under--
    (i) The Medicaid State plan in accordance with Sec.  435.116.
    (ii) A Medicaid demonstration under section 1115 of the Act.
    (iii) The CHIP State plan under section 2112 of the Act.
    (iv) A CHIP demonstration under section 1115 of the Act.
    (2) The individual's household income is determined in accordance 
with Sec.  435.603. The agency must indicate in its State plan the 
options selected by it under Sec.  435.603(k).
    (d) Covered services. Individuals eligible under this section are 
covered for family planning and family planning-related benefits as 
described in clause (XVI) of the matter following section 1902(a)(10)(G) 
of the Act.

[81 FR 86453, Nov. 30, 2016]



Sec.  435.215  Individuals infected with tuberculosis.

    (a) Basis. This section implements sections 1902(a)(10)(A)(ii)(XII) 
and 1902(z)(1) of the Act.
    (b) Eligibility. The agency may provide Medicaid to individuals 
who--
    (1) Are infected with tuberculosis;
    (2) Are not eligible for full coverage under the State's Medicaid 
State plan (that is, all services which the State is

[[Page 152]]

required to cover under Sec.  440.210(a)(1) of this chapter and all 
services which it has opted to cover under Sec.  440.225 of this 
chapter, or which the State covers under an approved alternative 
benefits plan under Sec.  440.325 of this chapter), including coverage 
for tuberculosis treatment as elected by the State for this group; and
    (3) Have household income that does not exceed the income standard 
established by the State in its State plan, which standard must not 
exceed the higher of--
    (i) The maximum income standard applicable to disabled individuals 
for mandatory coverage under subpart B of this part; or
    (ii) The effective income level for coverage of individuals infected 
with tuberculosis under the State plan in effect as of March 23, 2010, 
or December 31, 2013, if higher, converted, at State option, to a MAGI-
equivalent standard in accordance with guidance issued by the Secretary 
under section 1902(e)(14)(A) and (E) of the Act.
    (c) Covered Services. Individuals eligible under this section are 
covered for the following services related to the treatment of infection 
with tuberculosis:
    (1) Prescribed drugs, described in Sec.  440.120 of this chapter;
    (2) Physician's services, described in Sec.  440.50 of this chapter;
    (3) Outpatient hospital and rural health clinic described in Sec.  
440.20 of this chapter, and Federally-qualified health center services;
    (4) Laboratory and x-ray services (including services to confirm the 
presence of the infection), described in Sec.  440.30 of this chapter;
    (5) Clinic services, described in Sec.  440.90 of this chapter;
    (6) Case management services defined in Sec.  440.169 of this 
chapter; and
    (7) Services other than room and board designated to encourage 
completion of regimens of prescribed drugs by outpatients including 
services to observe directly the intake of prescription drugs.

[81 FR 86453, Nov. 30, 2016]



Sec.  435.217  Individuals receiving home and community-based services.

    The agency may provide Medicaid to any group or groups of 
individuals in the community who meet the following requirements:
    (a) The group would be eligible for Medicaid if institutionalized.
    (b) In the absence of home and community-based services under a 
waiver granted under part 441--
    (1) Subpart G of this subchapter, the group would otherwise require 
the level of care furnished in a hospital, NF, or an ICF/IID; or
    (2) Subpart H of this subchapter, the group would otherwise require 
the level of care furnished in an NF and are age 65 or older.
    (c) The group receives the waivered services.

[57 FR 29155, June 30, 1992]



Sec.  435.218  Individuals with MAGI-based income above 133 percent FPL.

    (a) Basis. This section implements section 1902(a)(10)(A)(ii)(XX) of 
the Act.
    (b) Eligibility--(1) Criteria. The agency may provide Medicaid to 
individuals who:
    (i) Are under age 65;
    (ii) Are not eligible for and enrolled for mandatory coverage under 
a State's Medicaid State plan in accordance with subpart B of this part;
    (iii) Are not otherwise eligible for and enrolled for optional 
coverage under a State's Medicaid State plan in accordance with section 
1902(a)(10)(A)(ii)(I) through (XIX) of the Act and subpart C of this 
part, based on information available to the State from the application 
filed by or on behalf of the individual; and
    (iv) Have household income that exceeds 133 percent FPL but is at or 
below the income standard elected by the agency and approved in its 
Medicaid State plan, for the applicable family size.
    (2) Limitations. (i) A State may not, except as permitted under an 
approved phase-in plan adopted in accordance with paragraph (b)(3) of 
this section, provide Medicaid to higher income individuals described in 
paragraph (b)(1) of this section without providing Medicaid to lower 
income individuals described in such paragraph.

[[Page 153]]

    (ii) The limitation on eligibility of parents and other caretaker 
relatives specified in Sec.  435.119(c) of this section also applies to 
eligibility under this section.
    (3) Phase-in plan. A State may phase in coverage to all individuals 
described in paragraph (b)(1) of this section under a phase-in plan 
submitted in a State plan amendment to and approved by the Secretary.

[77 FR 17205, Mar. 23, 2012]



Sec.  435.219  Individuals receiving State plan home and community-based
services.

    If the agency provides State plan home and community-based services 
to individuals described in section 1915(i)(1), the agency, under its 
State plan, may, in addition, provide Medicaid to individuals in the 
community who are described in one or both of paragraphs (a) or (b) of 
this section.
    (a) Individuals who--
    (1) Are not otherwise eligible for Medicaid;
    (2) Have income that does not exceed 150 percent of the Federal 
poverty line (FPL);
    (3) Meet the needs-based criteria under Sec.  441.715 of this 
chapter; and
    (4) Will receive State plan home and community-based services as 
defined in Sec.  440.182 of this chapter.
    (b) Individuals who--
    (1) Would be determined eligible by the agency under an existing 
waiver or demonstration project under sections 1915(c), 1915(d), 1915(e) 
or 1115 of the Act, but are not required to receive services under such 
waivers or demonstration projects;
    (2) Have income that does not exceed 300 percent of the Supplemental 
Security Income Federal Benefit Rate (SSI/FBR); and
    (3) Will receive State plan home and community-based services as 
defined in Sec.  440.182 of this chapter.
    (c) For purposes of determining eligibility under paragraph (a) of 
this section, the agency may not take into account an individual's 
resources and must use income standards that are reasonable, consistent 
with the objectives of the Medicaid program, simple to administer, and 
in the best interests of the beneficiary. Income methodologies may 
include use of existing income methodologies, such as the SSI program 
rules. However, subject to the Secretary's approval, the agency may use 
other income methodologies that meet the requirements of this paragraph.

[79 FR 3028, Jan. 16, 2014]

              Options for Coverage of Families and Children



Sec.  435.220  Optional eligibility for parents and other caretaker
relatives.

    (a) Basis. This section implements section 1902(a)(10)(A)(ii)(I) of 
the Act for optional eligibility of parents and other caretaker 
relatives as defined at Sec.  435.4.
    (b) Eligibility. The agency may provide Medicaid to parents and 
other caretaker relatives defined in Sec.  435.4 and, if living with 
such parent or other caretaker relative, his or her spouse, whose 
household income is at or below the income standard established by the 
agency in its State plan, in accordance with paragraph (c) of this 
section.
    (c) Income standard. The income standard under this section--
    (1) Must exceed the income standard established by the agency under 
Sec.  435.110(c); and
    (2) May not exceed the higher of the State's AFDC payment standard 
in effect as of July 16, 1996, or the State's highest effective income 
level for eligibility of parents and other caretaker relatives in effect 
under the Medicaid State plan or demonstration program under section 
1115 of the Act as of March 23, 2010, or December 31, 2013, if higher, 
converted to a MAGI-equivalent standard in accordance with guidance 
issued by the Secretary under section 1902(e)(14)(A) and (E) of the Act.

[81 FR 86453, Nov. 30, 2016]



Sec.  435.221  [Reserved]



Sec.  435.222  Optional eligibility for reasonable classifications of
individuals under age 21.

    (a) Basis. This section implements sections 1902(a)(10)(A)(ii)(I) 
and (IV) of the Act for optional eligibility of individuals under age 
21.
    (b) Eligibility. The agency may provide Medicaid to all--or to one 
or more

[[Page 154]]

reasonable classifications, as defined in the State plan, of--
individuals under age 21 (or, at State option, under age 20, 19 or 18) 
who have household income at or below the income standard established by 
the agency in its State plan in accordance with paragraph (c) of this 
section.
    (c) Income standard. The income standard established under this 
section may not exceed the higher of the State's AFDC payment standard 
in effect as of July 16, 1996, or the State's highest effective income 
level, if any, for such individuals under the Medicaid State plan or a 
demonstration program under section 1115 of the Act as of March 23, 
2010, or December 31, 2013, if higher, converted to a MAGI-equivalent 
standard in accordance with guidance issued by the Secretary under 
section 1902(e)(14)(A) and (E) of the Act.

[81 FR 86453, Nov. 30, 2016]



Sec.  435.225  Individuals under age 19 who would be eligible for 
Medicaid if they were in a medical institution.

    (a) The agency may provide Medicaid to children 18 years of age or 
younger who qualify under section 1614(a) of the Act, who would be 
eligible for Medicaid if they were in a medical institution, and who are 
receiving, while living at home, medical care that would be provided in 
a medical institution.
    (b) If the agency elects the option provided by paragraph (a) of 
this section, it must determine, in each case, that the following 
conditions are met:
    (1) The child requires the level of care provided in a hospital, 
SNF, or ICF.
    (2) It is appropriate to provide that level of care outside such an 
institution.
    (3) The estimated Medicaid cost of care outside an institution is no 
higher than the estimated Medicaid cost of appropriate institutional 
care.
    (c) The agency must specify in its State plan the method by which it 
determines the cost-effectiveness of caring for disabled children at 
home.

[55 FR 48608, Nov. 21, 1990]



Sec.  435.226  Optional eligibility for independent foster care 
adolescents.

    (a) Basis. This section implements section 1902(a)(10)(A)(ii)(XVII) 
of the Act.
    (b) Eligibility. The agency may provide Medicaid to individuals 
under age 21 (or, at State option, under age 20 or 19) who were in 
foster care under the responsibility of a State or Tribe (or, at State 
or Tribe option, only to such individuals for whom Federal foster care 
assistance under title IV-E of the Act was being provided) on the 
individual's 18th birthday and have household income at or below the 
income standard, if any, established by the agency in its State plan in 
accordance with paragraph (c) of this section.
    (c) Income standard. (1) The income standard established under this 
section may not be lower than the State's income standard established 
under Sec.  435.110.
    (2) The State may elect to have no income standard for eligibility 
under this section.

[81 FR 86453, Nov. 30, 2016]



Sec.  435.227  Optional eligibility for individuals under age 21 who
are under State adoption assistance agreements.

    (a) Basis. This section implements section 1902(a)(10)(A)(ii)(VIII) 
of the Act.
    (b) Eligibility. The agency may provide Medicaid to individuals 
under age 21 (or, at State option, under age 20, 19, or 18):
    (1) For whom an adoption assistance agreement (other than an 
agreement under title IV-E of the Act) between a State and the adoptive 
parent(s) is in effect;
    (2) Who the State agency which entered into the adoption agreement 
determined could not be placed for adoption without Medicaid coverage 
because the child has special needs for medical or rehabilitative care; 
and
    (3) Who, prior to the adoption agreement being entered into--
    (i) Were eligible under the Medicaid State plan of the State with 
the adoption assistance agreement; or
    (ii) Had household income at or below the income standard 
established by the

[[Page 155]]

agency in its State plan in accordance with paragraph (c) of this 
section.
    (c) Income standard. The income standard established under this 
section may not exceed the effective income level (converted to a MAGI-
equivalent standard in accordance with guidance issued by the Secretary 
under section 1902(e)(14)(A) and (E) of the Act) under the State plan or 
under a demonstration program under section 1115 of the Act as of March 
23, 2010 or December 31, 2013, whichever is higher, that was applied by 
the State to the household income of a child prior to the execution of 
an adoption assistance agreement for purposes of determining eligibility 
of children described in paragraphs (b)(1) and (2) of this section.
    (d) Limit Eligibility The agency may limit eligibility under this 
section to children for whom the State, or another State identified in 
the State plan, has entered into an adoption assistance agreement.

[81 FR 86454, Nov. 30, 2016]



Sec.  435.229  Optional targeted low-income children.

    (a) Basis. This section implements section 1902(a)(10)(A)(ii)(XIV) 
of the Act.
    (b) Eligibility. The agency may provide Medicaid to individuals 
under age 19, or at State option within a range of ages under age 19 
established in the State plan, who meet the definition of an optional 
targeted low-income child in Sec.  435.4 and have household income at or 
below the income standard established by the agency in its State plan in 
accordance with paragraph (c) of this section.
    (c) Income standard. The income standard established under this 
section may not exceed the higher of--
    (1) 200 percent of the Federal poverty level (FPL);
    (2) A percentage of the FPL which exceeds the State's Medicaid 
applicable income level, defined at Sec.  457.10 of this chapter, by no 
more than 50 percentage points (converted to a MAGI-equivalent standard 
in accordance with guidance issued by the Secretary under section 
1902(e)(14)(A) and (E) of the Act); and
    (3) The highest effective income level for coverage of such 
individuals under the Medicaid State plan or demonstration program under 
section 1115 of the Act or for coverage of targeted low-income children, 
defined in Sec.  457.10 of this chapter, under the CHIP State plan or 
demonstration program under section 1115 of the Act, as of March 23, 
2010, or December 31, 2013, converted to a MAGI-equivalent standard in 
accordance with guidance issued by the Secretary under section 
1902(e)(14)(A) and (E) of the Act.

[81 FR 86454, Nov. 30, 2016]

          Options for Coverage of the Aged, Blind, and Disabled



Sec.  435.230  Aged, blind, and disabled individuals in States that use
more restrictive requirements for Medicaid than SSI requirements:
Optional coverage.

    (a) Basic optional coverage rule. If the agency elects the option 
under Sec.  435.121 to provide mandatory eligibility for aged, blind, 
and disabled SSI beneficiaries using more restrictive requirements than 
those used under SSI, the agency may provide eligibility as optional 
categorically needy to additional individuals who meet the requirements 
of this section.
    (b) Group composition. Subject to the conditions specified in 
paragraphs (d) and (e) of this section, the agency may provide Medicaid 
to individuals who:
    (1) Meet the nonfinancial criteria that the State has elected to 
apply under Sec.  435.121;
    (2) Meet the resource requirements that the State has elected to 
apply under Sec.  435.121; and
    (3) Meet the income eligibility standards specified in paragraph (c) 
of this section.
    (c) Criteria for income standards. The agency may provide Medicaid 
to the following individuals who meet the requirements of paragraphs 
(b)(1) and (b)(2) of this section:
    (1) Individuals who are financially eligible for but not receiving 
SSI benefits and who, before deduction of incurred medical and remedial 
expenses, meet the State's more restrictive eligibility requirements 
described in Sec.  435.121;

[[Page 156]]

    (2) Individuals who meet the income standards of the following 
eligibility groups:
    (i) Individuals who would be eligible for cash assistance except for 
institutional status described in Sec.  435.211;
    (ii) Individuals who are enrolled in an HMO or other entity and who 
are deemed to continue to be Medicaid eligible for a period specified by 
the agency up to 6 months from the date of enrollment and who became 
ineligible during the specified enrollment period, as described in Sec.  
435.212;
    (iii) Individuals receiving home and community-based waiver services 
described in Sec.  435.217;
    (iv) Individuals receiving only optional State supplements described 
in Sec.  435.234;
    (v) Institutionalized individuals with income below a special income 
level described in Sec.  435.236;
    (vi) Aged and disabled individuals who have income below 100 percent 
of the Federal poverty level described in section 1905(m) of the Act.
    (3) Individuals who qualify for special status under Sec. Sec.  
435.135 and 435.138, and with respect to whom the State elects to 
disregard some or the maximum amount of title II payments permitted to 
be disregarded under those sections.
    (d) Use of more liberal methods. The agency may elect to apply more 
liberal methods of counting income and resources that are approved for 
this eligibility group under the provisions of Sec.  435.601.

[58 FR 4928, Jan. 19, 1993]



Sec.  435.232  Individuals receiving only optional State supplements.

    (a) If the agency provides Medicaid to individuals receiving SSI 
under Sec.  435.120, it may provide Medicaid, in one or more of the 
following classifications, to individuals who receive only an optional 
State supplement that meets the conditions specified in paragraph (b) of 
this section and who would be eligible for SSI except for the level of 
their income.
    (1) All aged individuals.
    (2) All blind individuals.
    (3) All disabled individuals.
    (4) Only aged individuals in domiciliary facilities or other group 
living arrangements as defined under SSI.
    (5) Only blind individuals in domiciliary facilities or other group 
living arrangements as defined under SSI.
    (6) Only disabled individuals in domiciliary facilities or other 
group living arrangements as defined under SSI.
    (7) Individuals receiving a federally administered optional State 
supplement that meets the conditions specified in this section.
    (8) Individuals in additional classifications specified by the 
Secretary for federally administered supplementary payments under 20 CFR 
416.2020(d).
    (9) Reasonable groups of individuals, as specified by the State, 
receiving State-administered supplementary payments.
    (b) Payments under the optional supplement program must be--
    (1) Based on need and paid in cash on a regular basis;
    (2) Equal to the difference between the individual's countable 
income and the income standard used to determine eligibility for 
supplement. Countable income is income remaining after deductions 
required under SSI or, at State option, more liberal deductions are made 
(see Sec.  435.1006 for limitations on FFP in Medicaid expenditures for 
individuals receiving optional State supplements); and
    (3) Available to all individuals in each classification in paragraph 
(a) of this section and available on a statewide basis. However, the 
plan may provide for variations in the income standard by political 
subdivision according to cost-of-living differences.

[43 FR 45204, Sept. 29, 1978. Redesignated and amended at 58 FR 4928, 
Jan. 19, 1993]



Sec.  435.234  Individuals receiving only optional State supplements in
States using more restrictive eligibility requirements than SSI and
certain States using SSI criteria.

    (a) In States using more restrictive eligibility requirements than 
SSI or in States that use SSI criteria but do not have section 1616 or 
1634 agreements with the Social Security Administration for eligibility 
determinations, the agency may provide Medicaid to individuals specified 
in paragraph (b) of this section who receive only a State supplement if 
the State supplement

[[Page 157]]

meets the conditions specified in paragraph (c) of this section.
    (b) The agency may provide Medicaid to all individuals receiving 
only State supplements if, except for their income, the individuals meet 
the more restrictive eligibility requirements under Sec.  435.121 or SSI 
criteria, or to one or more of the following classifications of 
individuals who meet these criteria:
    (1) All aged individuals.
    (2) All blind individuals.
    (3) All disabled individuals.
    (4) Only aged individuals in domiciliary facilities or other group 
living arrangements as defined under SSI.
    (5) Only blind individuals in domiciliary facilities or other group 
living arrangements as defined under SSI.
    (6) Only disabled individuals in domiciliary facilities or other 
group living arrangements as defined under SSI.
    (7) Individuals receiving a Federally-administered optional State 
supplement that meets the conditions specified in this section.
    (8) Individuals in additional classifications specified by the 
Secretary.
    (9) Reasonable groups of individuals, as specified by the State, 
receiving State-administered supplementary payments.
    (c) Payments under the optional supplement program must be:
    (1) Based on need and paid in cash on a regular basis;
    (2) Equal to the difference between the individual's countable 
income and the income standard used to determine eligibility for 
supplements. Countable income is income remaining after deductions are 
applied. The income deductions may be more restrictive than required 
under SSI (see Sec.  435.1006 for limitations on FFP in Medicaid 
expenditures for individuals receiving optional State supplements); and
    (3) Available to all individuals in each classification in paragraph 
(b) of this section and available on a statewide basis. However, the 
plan may provide for variations in the income standard by political 
subdivision according to cost-of-living differences.

[58 FR 4928, Jan. 19, 1993]



Sec.  435.236  Individuals in institutions who are eligible under a 
special income level.

    (a) If the agency provides Medicaid under Sec.  435.211 to 
individuals in institutions who would be eligible for AFDC, SSI, or 
State supplements except for their institutional status, it may also 
cover aged, blind, and disabled individuals in institutions who--
    (1) Because of their income, would not be eligible for SSI or State 
supplements if they were not institutionalized; but
    (2) Have income below a level specified in the plan under Sec.  
435.722. (See Sec.  435.1005 for limitations on FFP in Medicaid 
expenditures for individuals specified in this section.)
    (b) The agency may cover individuals under this section whether or 
not the State pays optional supplements.

[43 FR 45204, Sept. 29, 1978, as amended at 45 FR 24884, Apr. 11, 1980. 
Redesignated at 58 FR 4928, Jan. 19, 1993]



           Subpart D_Optional Coverage of the Medically Needy



Sec.  435.300  Scope.

    This subpart specifies the option for coverage of medically needy 
individuals.



Sec.  435.301  General rules.

    (a) An agency may provide Medicaid to individuals specified in this 
subpart who:
    (1) Either:
    (i) Have income that meets the applicable standards in Sec. Sec.  
435.811 and 435.814; or
    (ii) If their income is more than allowed under the standard, have 
incurred medical expenses at least equal to the difference between their 
income and the applicable income standard; and
    (2) Have resources that meet the applicable standards in Sec. Sec.  
435.840 and 435.843.
    (b) If the agency chooses this option, the following provisions 
apply:
    (1) The agency must provide Medicaid to the following individuals 
who meet the requirements of paragraph (a) of this section:

[[Page 158]]

    (i) All pregnant women during the course of their pregnancy who, 
except for income and resources, would be eligible for Medicaid as 
mandatory or optional categorically needy under subparts B or C of this 
part;
    (ii) All individuals under 18 years of age who, except for income 
and resources, would be eligible for Medicaid as mandatory categorically 
needy under subpart B of this part;
    (iii) Women who, while pregnant, applied for, were eligible for, and 
received Medicaid services as medically needy on the day that their 
pregnancy ends. The agency must provide medically needy eligibility to 
these women for an extended period following termination of pregnancy. 
This period extends from the last day of the pregnancy through the end 
of the month in which a 60-day period, beginning on the last day of 
pregnancy, ends. Eligibility must be provided, regardless of changes in 
the woman's financial circumstances that may occur within this extended 
period. These women are eligible for the extended period for all 
services under the plan that are pregnancy-related (as defined in Sec.  
440.210(c)(1) of this subchapter).
    (2) The agency may provide Medicaid to any of the following groups 
of individuals;
    (i) Individuals under age 21 (Sec.  435.308).
    (ii) Parents and other caretaker relatives (Sec.  435.310).
    (iii) Aged (Sec. Sec.  435.320 and 435.330).
    (iv) Blind (Sec. Sec.  435.322, 435.330 and 435.340).
    (v) Disabled (Sec. Sec.  435.324, 435.330, and 435.340).
    (3) If the agency provides Medicaid to any individual in a group 
specified in paragraph (b)(2) of this section, the agency must provide 
Medicaid to all individuals eligible to be members of that group.

[46 FR 47986, Sept. 30, 1981, as amended at 52 FR 43072, Nov. 9, 1987; 
52 FR 48438, Dec. 22, 1987; 55 FR 48609, Nov. 21, 1990; 58 FR 4929, Jan. 
19, 1993; 81 FR 86454, Nov. 30, 2016]



Sec.  435.308  Medically needy coverage of individuals under age 21.

    (a) If the agency provides Medicaid to the medically needy, it may 
provide Medicaid to individuals under age 21 (or, at State option, under 
age 20, 19, or 18), as specified in paragraph (b) of this section:
    (1) Who would not be covered under the mandatory medically needy 
group of individuals under 18 under Sec.  435.301(b)(1)(ii); and
    (2) Who meet the income and resource requirements of subpart I of 
this part.
    (b) The agency may cover all individuals described in paragraph (a) 
of this section or reasonable classifications of those individuals. 
Examples of reasonable classifications are as follows:
    (1) Individuals in foster homes or private institutions for whom a 
public agency is assuming a full or partial financial responsibility. If 
the agency covers these individuals, it may also provide Medicaid to 
individuals placed in foster homes or private institutions by private 
nonprofit agencies.
    (2) Individuals in adoptions subsidized in full or in part by a 
public agency.
    (3) Individuals in nursing facilities when nursing facility services 
are provided under the plan to individuals within the age group selected 
under this provision. When the agency covers such individuals, it may 
also provide Medicaid to individuals in intermediate care facilities for 
individuals with intellectual disabilities.
    (4) Individuals receiving active treatment as inpatients in 
psychiatric facilities or programs, if inpatient psychiatric services 
for individuals under 21 are provided under the plan.

[46 FR 47986, Sept. 30, 1981, as amended at 58 FR 4929, Jan. 19, 1993]



Sec.  435.310  Medically needy coverage of parents and other caretaker
relatives.

    If the agency provides Medicaid for the medically needy, it may 
provide Medicaid to parents and other caretaker relatives who meet:
    (a) The definition of ``caretaker relative'' at Sec.  435.4, or are 
the spouse of a parent or caretaker relative; and
    (b) The medically needy income and resource requirements at subpart 
I of this part.

[81 FR 86454, Nov. 30, 2016]

[[Page 159]]



Sec.  435.320  Medically needy coverage of the aged in States that cover
individuals receiving SSI.

    If the agency provides Medicaid to individuals receiving SSI and 
elects to cover the medically needy, it may provide Medicaid to 
individuals who--
    (a) Are 65 years of age and older, as specified in Sec.  435.520; 
and
    (b) Meet the income and resource requirements of subpart I of this 
part.

[46 FR 47986, Sept. 30, 1981]



Sec.  435.322  Medically needy coverage of the blind in States that
cover individuals receiving SSI.

    If the agency provides Medicaid to individuals receiving SSI and 
elects to cover the medically needy, it may provide Medicaid to blind 
individuals who meet--
    (a) The requirements for blindness, as specified in Sec. Sec.  
435.530 and 435.531; and
    (b) The income and resource requirements of subpart I of this part.

[46 FR 47986, Sept. 30, 1981]



Sec.  435.324  Medically needy coverage of the disabled in States that
cover individuals receiving SSI.

    If the agency provides Medicaid to individuals receiving SSI and 
elects to cover the medically needy, it may provide Medicaid to disabled 
individuals who meet--
    (a) The requirements for disability, as specified in Sec. Sec.  
435.540 and 435.541; and
    (b) The income and resource requirements of subpart I of this part.

[46 FR 47986, Sept. 30, 1981; 46 FR 54743, Nov. 11, 1981]



Sec.  435.326  Individuals who would be ineligible if they were not 
enrolled in an MCO or PCCM.

    If the agency provides Medicaid to the categorically needy under 
Sec.  435.212, it may provide it under the same rules to medically needy 
beneficiaries who are enrolled in MCOs or PCCMs.

[67 FR 41095, June 14, 2002]



Sec.  435.330  Medically needy coverage of the aged, blind, and disabled
in States using more restrictive eligibility requirements for Medicaid
than those used under SSI.

    (a) If an agency provides Medicaid as categorically needy only to 
those aged, blind, or disabled individuals who meet more restrictive 
requirements than used under SSI and elects to cover the medically 
needy, it may provide Medicaid as medically needy to those aged, blind, 
or disabled individuals who:
    (1) Do not qualify for Medicaid as categorically needy under Sec.  
435.121 or Sec.  435.230; and
    (2) If applying as blind or disabled, meet the definition of 
blindness or disability established under Sec.  435.121.
    (b) Except as specified in paragraph (c) of this section, the agency 
must apply to individuals covered under the option of this section the 
same financial and nonfinancial requirements that are applied to 
individuals covered as categorically needy under Sec. Sec.  435.121 and 
435.230.
    (c) In determining the financial eligibility of individuals who are 
considered as medically needy under this section, the agency must apply 
the financial eligibility requirements of subparts G and I of this part.

[58 FR 4929, Jan. 19, 1993]



Sec.  435.340  Protected medically needy coverage for blind and disabled
individuals eligible in December 1973.

    If an agency provides Medicaid to the medically needy, it must cover 
individuals who--
    (a) Where eligible as medically needy under the Medicaid plan in 
December 1973 on the basis of the blindness or disability criteria of 
the AB, APTD, or AABD plan;
    (b) For each consecutive month after December 1973, continue to 
meet--
    (1) Those blindness or disability criteria; and
    (2) The eligibility requirements for the medically needy under the 
December 1973 Medicaid plan; and
    (c) Meet the current requirements for eligibility as medically needy 
under the Medicaid plan except for blindness or disability criteria.

[46 FR 47987, Sept. 30, 1981]

[[Page 160]]



Sec.  435.350  Coverage for certain aliens.

    If an agency provides Medicaid to the medically needy, it must 
provide the services necessary for the treatment of an emergency medical 
condition, as defined in Sec.  440.255(c) of this chapter, to those 
aliens described in Sec.  435.406(c) of this subpart.

[55 FR 36819, Sept. 7, 1990]



               Subpart E_General Eligibility Requirements



Sec.  435.400  Scope.

    This subpart prescribes general requirements for determining the 
eligibility of both categorically and medically needy individuals 
specified in subparts B, C, and D of this part.



Sec.  435.401  General rules.

    (a) A Medicaid agency may not impose any eligibility requirement 
that is prohibited under Title XIX of the Act.
    (b) The agency must base any optional group covered under subparts B 
and C of this part on reasonable classifications that do not result in 
arbitrary or inequitable treatment of individuals and groups and that 
are consistent with the objectives of Title XIX.
    (c) The agency must not use requirements for determining eligibility 
for optional coverage groups that are--
    (1) [Reserved]
    (2) For aged, blind, and disabled individuals, more restrictive than 
those used under SSI, except for individuals receiving an optional State 
supplement as specified in Sec.  435.230 or individuals in categories 
specified by the agency under Sec.  435.121.

[43 FR 45204, Sept. 29, 1978, as amended at 81 FR 86454, Nov. 30, 2016]



Sec.  435.402  [Reserved]



Sec.  435.403  State residence.

    (a) Requirement. The agency must provide Medicaid to eligible 
residents of the State, including residents who are absent from the 
State. The conditions under which payment for services is provided to 
out-of-State residents are set forth in Sec.  431.52 of this chapter.
    (b) Definition. For purposes of this section--Institution has the 
same meaning as Institution and Medical institution, as defined in Sec.  
435.1010. For purposes of State placement, the term also includes foster 
care homes, licensed as set forth in 45 CFR 1355.20, and providing food, 
shelter and supportive services to one or more persons unrelated to the 
proprietor.
    (c) Incapability of indicating intent. For purposes of this section, 
an individual is considered incapable of indicating intent if the 
individual--
    (1) Has an I.Q. of 49 or less or has a mental age of 7 or less, 
based on tests acceptable to the Intellectual Disability agency in the 
State:
    (2) Is judged legally incompetent; or
    (3) Is found incapable of indicating intent based on medical 
documentation obtained from a physician, psychologist, or other person 
licensed by the State in the field of intellectual disability.
    (d) Who is a State resident. A resident of a State is any individual 
who:
    (1) Meets the conditions in paragraphs (e) through (i) of this 
section; or
    (2) Meets the criteria specified in an interstate agreement under 
paragraph (k) of this section.
    (e) Placement by a State in an out-of-State institution--(1) General 
rule. Any agency of the State, including an entity recognized under 
State law as being under contract with the State for such purposes, that 
arranges for an individual to be placed in an institution located in 
another State, is recognized as acting on behalf of the State in making 
a placement. The State arranging or actually making the placement is 
considered as the individual's State of residence.
    (2) Any action beyond providing information to the individual and 
the individual's family would constitute arranging or making a State 
placement. However, the following actions do not constitute State 
placement:
    (i) Providing basic information to individuals about another State's 
Medicaid program, and information about the availability of health care 
services and facilities in another State.
    (ii) Assisting an individual in locating an institution in another 
State, provided the individual is capable of indicating intent and 
independently decides to move.

[[Page 161]]

    (3) When a competent individual leaves the facility in which the 
individual is placed by a State, that individual's State of residence 
for Medicaid purposes is the State where the individual is physically 
located.
    (4) Where a placement is initiated by a State because the State 
lacks a sufficient number of appropriate facilities to provide services 
to its residents, the State making the placement is the individual's 
State of residence for Medicaid purposes.
    (f) Individuals receiving a State supplementary payment (SSP). For 
individuals of any age who are receiving an SSP, the State of residence 
is the State paying the SSP.
    (g) Individuals receiving Title IV-E payments. For individuals of 
any age who are receiving Federal payments for foster care and adoption 
assistance under title IV-E of the Social Security Act, the State of 
residence is the State where the child lives.
    (h) Individuals age 21 and over. Except as provided in paragraph (f) 
of this section, with respect to individuals age 21 and over --
    (1) For an individual not residing in an institution as defined in 
paragraph (b) of this section, the State of residence is the State where 
the individual is living and--
    (i) Intends to reside, including without a fixed address; or
    (ii) Has entered the State with a job commitment or seeking 
employment (whether or not currently employed).
    (2) For an individual not residing in an institution as defined in 
paragraph (b) of this section who is not capable of stating intent, the 
State of residency is the State where the individual is living.
    (3) For any institutionalized individual who became incapable of 
indicating intent before age 21, the State of residence is--
    (i) That of the parent applying for Medicaid on the individual's 
behalf, if the parents reside in separate States (if a legal guardian 
has been appointed and parental rights are terminated, the State of 
residence of the guardian is used instead of the parent's);
    (ii) The parent's or legal guardian's State of residence at the time 
of placement (if a legal guardian has been appointed and parental rights 
are terminated, the State of residence of the guardian is used instead 
of the parent's); or
    (iii) The current State of residence of the parent or legal guardian 
who files the application if the individual is institutionalized in that 
State (if a legal guardian has been appointed and parental rights are 
terminated, the State of residence of the guardian is used instead of 
the parent's).
    (iv) The State of residence of the individual or party who files an 
application is used if the individual has been abandoned by his or her 
parent(s), does not have a legal guardian and is institutionalized in 
that State.
    (4) For any institutionalized individual who became incapable of 
indicating intent at or after age 21, the State of residence is the 
State in which the individual is physically present, except where 
another State makes a placement.
    (5) For any other institutionalized individual, the State of 
residence is the State where the individual is living and intends to 
reside.
    (i) Individuals under age 21. For an individual under age 21 who is 
not eligible for Medicaid based on receipt of assistance under title IV-
E of the Act, as addressed in paragraph (g) of this section, and is not 
receiving a State supplementary payment, as addressed in paragraph (f) 
of this section, the State of residence is as follows:
    (1) For an individual who is capable of indicating intent and who is 
emancipated from his or her parent or who is married, the State of 
residence is determined in accordance with paragraph (h)(1) of this 
section.
    (2) For an individual not described in paragraph (i)(1) of this 
section, not living in an institution as defined in paragraph (b) of 
this section and not eligible for Medicaid based on receipt of 
assistance under title IV-E of the Act, as addressed in paragraph (g) of 
this section, and is not receiving a State supplementary payment, as 
addressed in paragraph (f) of this section, the State of residence is:
    (i) The State where the individual resides, including without a 
fixed address; or

[[Page 162]]

    (ii) The State of residency of the parent or caretaker, in 
accordance with paragraph (h)(1) of this section, with whom the 
individual resides.
    (3) For any institutionalized individual who is neither married nor 
emancipated, the State of residence is--
    (i) The parent's or legal guardian's State of residence at the time 
of placement (if a legal guardian has been appointed and parental rights 
are terminated, the State of residence of the guardian is used instead 
of the parent's); or
    (ii) The current State of residence of the parent or legal guardian 
who files the application if the individual is institutionalized in that 
State (if a legal guardian has been appointed and parental rights are 
terminated, the State or residence of the guardian is used instead of 
the parent's).
    (iii) The State of residence of the individual or party who files an 
application is used if the individual has been abandoned by his or her 
parent(s), does not have a legal guardian and is institutionalized in 
that State.
    (j) Specific prohibitions. (1) The agency may not deny Medicaid 
eligibility because an individual has not resided in the State for a 
specified period.
    (2) The agency may not deny Medicaid eligibility to an individual in 
an institution, who satisfies the residency rules set forth in this 
section, on the grounds that the individual did not establish residence 
in the State before entering the institution.
    (3) The agency may not deny or terminate a resident's Medicaid 
eligibility because of that person's temporary absence from the State if 
the person intends to return when the purpose of the absence has been 
accomplished, unless another State has determined that the person is a 
resident there for purposes of Medicaid.
    (k) Interstate agreements. A State may have a written agreement with 
another State setting forth rules and procedures resolving cases of 
disputed residency. These agreements may establish criteria other than 
those specified in paragraphs (c) through (i) of this section, but must 
not include criteria that result in loss of residency in both States or 
that are prohibited by paragraph (j) of this section. The agreements 
must contain a procedure for providing Medicaid to individuals pending 
resolution of the case. States may use interstate agreements for 
purposes other than cases of disputed residency to facilitate 
administration of the program, and to facilitate the placement and 
adoption of title IV-E individuals when the child and his or her 
adoptive parent(s) move into another State.
    (l) Continued Medicaid for institutionalized beneficiaries. If an 
agency is providing Medicaid to an institutionalized beneficiary who, as 
a result of this section, would be considered a resident of a different 
State--
    (1) The agency must continue to provide Medicaid to that beneficiary 
from June 24, 1983 until July 5, 1984, unless it makes arrangements with 
another State of residence to provide Medicaid at an earlier date: and
    (2) Those arrangements must not include provisions prohibited by 
paragraph (i) of this section.
    (m) Cases of disputed residency. Where two or more States cannot 
resolve which State is the State of residence, the State where the 
individual is physically located is the State of residence.

[49 FR 13531, Apr. 5, 1984, as amended at 55 FR 48609, Nov. 21, 1990; 71 
FR 39222, July 12, 2006; 77 FR 17206, Mar. 23, 2012]



Sec.  435.404  Applicant's choice of category.

    The agency must allow an individual who would be eligible under more 
than one category to have his eligibility determined for the category he 
selects.



Sec.  435.406  Citizenship and non-citizen eligibility.

    (a) The agency must provide Medicaid to otherwise eligible 
individuals who are--
    (1) Citizens and nationals of the United States, provided that--
    (i) The individual has made a declaration of United States 
citizenship, as defined in Sec.  435.4, or an individual described in 
paragraph (a)(3) of this section has made such declaration on the 
individual's behalf, and such status is verified in accordance with 
paragraph (c) of this section; and

[[Page 163]]

    (ii) For purposes of the declaration and citizenship verification 
requirements discussed in paragraphs (a)(1)(i) of this section, an 
individual includes applicants under a section 1115 demonstration 
(including a family planning demonstration project) for which a State 
receives Federal financial participation in its expenditures.
    (iii) The following groups of individuals are exempt from the 
requirement to provide documentation to verify citizenship in paragraph 
(c) of this section:
    (A) Individuals receiving SSI benefits under title XVI of the Act.
    (B) Individuals entitled to or enrolled in any part of Medicare.
    (C) Individuals receiving disability insurance benefits under 
section 223 of the Act or monthly benefits under section 202 of the Act, 
based on the individual's disability (as defined in section 223(d) of 
the Act).
    (D) Individuals who are in foster care and who are assisted under 
Title IV-B of the Act, and individuals who are beneficiaries of foster 
care maintenance or adoption assistance payments under Title IV-E of the 
Act.
    (E)(1) Individuals who are or were deemed eligible for Medicaid in 
the State under Sec.  435.117 or Sec.  457.360 of this chapter on or 
after July 1, 2006, based on being born to a pregnant woman eligible 
under the State's Medicaid or CHIP state plan or waiver of such plan;
    (2) At State option, individuals who were deemed eligible for 
coverage under Sec.  435.117 or Sec.  457.360 of this chapter in another 
State on or after July 1, 2006, provided that the agency verifies such 
deemed eligibility.
    (2)(i) Except as specified in 8 U.S.C. 1612(b)(1) (permitting States 
an option with respect to coverage of certain qualified non-citizens), 
qualified non-citizens as described in section 431 of the Personal 
Responsibility and Work Opportunity Reconciliation Act of 1996 (8 U.S.C. 
1641) (including qualified non-citizens subject to the 5-year bar) who 
have provided satisfactory documentary evidence of Qualified Non-Citizen 
status, which status has been verified with the Department of Homeland 
Security (DHS) under a declaration required by section 1137(d) of the 
Act that the applicant or beneficiary is an non-citizen in a 
satisfactory immigration status.
    (ii) The eligibility of qualified non-citizens who are subject to 
the 5-year bar in 8 U.S.C. 1613 is limited to the benefits described in 
paragraph (b) of this section.
    (3) For purposes of paragraphs (a)(1) and (2), of this section, a 
declaration of citizenship or satisfactory immigration status may be 
provided, in writing and under penalty of perjury, by an adult member of 
the individual's household, an authorized representative, as defined in 
Sec.  435.923, or if the applicant is a minor or incapacitated, someone 
acting responsibly for the applicant provided that such individual 
attests to having knowledge of the individual's status.
    (b) The agency must provide payment for the services described in 
Sec.  440.255(c) of this chapter to residents of the State who otherwise 
meet the eligibility requirements of the State plan (except for receipt 
of AFDC, SSI, or State Supplementary payments) who are qualified non-
citizens subject to the 5-year bar or who are non-qualified non-citizens 
who meet all Medicaid eligibility criteria, except non-qualified non-
citizens need not present a social security number or document 
immigration status.
    (c) The agency must verify the declaration of citizenship or 
satisfactory immigration status under paragraph (a)(1) or (2) of this 
section in accordance with Sec.  435.956.

[55 FR 36819, Sept. 7, 1990, as amended at 56 FR 10807, Mar. 14, 1991; 
71 FR 39222, July 12, 2006; 72 FR 38691, July 13, 2007; 81 FR 86454, 
Nov. 30, 2016]



Sec.  435.407  Types of acceptable documentary evidence of citizenship.

    (a) Stand-alone evidence of citizenship. The following must be 
accepted as sufficient documentary evidence of citizenship:
    (1) A U.S. passport, including a U.S. Passport Card issued by the 
Department of State, without regard to any expiration date as long as 
such passport or Card was issued without limitation.
    (2) A Certificate of Naturalization.
    (3) A Certificate of U.S. Citizenship.

[[Page 164]]

    (4) A valid State-issued driver's license if the State issuing the 
license requires proof of U.S. citizenship, or obtains and verifies a 
SSN from the applicant who is a citizen before issuing such license.
    (5)(i) Documentary evidence issued by a Federally recognized Indian 
Tribe identified in the Federal Register by the Bureau of Indian Affairs 
within the U.S. Department of the Interior, and including Tribes located 
in a State that has an international border, which--
    (A) Identifies the Federally recognized Indian Tribe that issued the 
document;
    (B) Identifies the individual by name; and
    (C) Confirms the individual's membership, enrollment, or affiliation 
with the Tribe.
    (ii) Documents described in paragraph (a)(5)(i) of this section 
include, but are not limited to:
    (A) A Tribal enrollment card;
    (B) A Certificate of Degree of Indian Blood;
    (C) A Tribal census document;
    (D) Documents on Tribal letterhead, issued under the signature of 
the appropriate Tribal official, that meet the requirements of paragraph 
(a)(5)(i) of this section.
    (6) A data match with the Social Security Administration.
    (b) Evidence of citizenship. If an applicant does not provide 
documentary evidence from the list in paragraph (a) of this section, the 
following must be accepted as satisfactory evidence to establish 
citizenship if also accompanied by an identity document listed in 
paragraph (c) of this section--
    (1) A U.S. public birth certificate showing birth in one of the 50 
States, the District of Columbia, Guam, American Samoa, Swain's Island, 
Puerto Rico (if born on or after January 13, 1941), the Virgin Islands 
of the U.S. or the CNMI (if born after November 4, 1986, (CNMI local 
time)). The birth record document may be issued by a State, 
Commonwealth, Territory, or local jurisdiction. If the document shows 
the individual was born in Puerto Rico or the Northern Mariana Islands 
before the applicable date referenced in this paragraph, the individual 
may be a collectively naturalized citizen. The following will establish 
U.S. citizenship for collectively naturalized individuals:
    (i) Puerto Rico: Evidence of birth in Puerto Rico and the 
applicant's statement that he or she was residing in the U.S., a U.S. 
possession, or Puerto Rico on January 13, 1941.
    (ii) Northern Mariana Islands (NMI) (formerly part of the Trust 
Territory of the Pacific Islands (TTPI)):
    (A) Evidence of birth in the NMI, TTPI citizenship and residence in 
the NMI, the U.S., or a U.S. Territory or possession on November 3, 
1986, (NMI local time) and the applicant's statement that he or she did 
not owe allegiance to a foreign State on November 4, 1986 (NMI local 
time);
    (B) Evidence of TTPI citizenship, continuous residence in the NMI 
since before November 3, 1981 (NMI local time), voter registration 
before January 1, 1975, and the applicant's statement that he or she did 
not owe allegiance to a foreign State on November 4, 1986 (NMI local 
time);
    (C) Evidence of continuous domicile in the NMI since before January 
1, 1974, and the applicant's statement that he or she did not owe 
allegiance to a foreign State on November 4, 1986 (NMI local time). 
Note: If a person entered the NMI as a nonimmigrant and lived in the NMI 
since January 1, 1974, this does not constitute continuous domicile and 
the individual is not a U.S. citizen.
    (2) At State option, a cross match with a State vital statistics 
agency documenting a record of birth.
    (3) A Certification of Report of Birth, issued to U.S. citizens who 
were born outside the U.S.
    (4) A Report of Birth Abroad of a U.S. Citizen.
    (5) A Certification of birth in the United States.
    (6) A U.S. Citizen I.D. card.
    (7) A Northern Marianas Identification Card issued by the U.S. 
Department of Homeland Security (or predecessor agency).
    (8) A final adoption decree showing the child's name and U.S. place 
of birth, or if an adoption is not final, a Statement from a State-
approved

[[Page 165]]

adoption agency that shows the child's name and U.S. place of birth.
    (9) Evidence of U.S. Civil Service employment before June 1, 1976.
    (10) U.S. Military Record showing a U.S. place of birth.
    (11) A data match with the SAVE Program or any other process 
established by DHS to verify that an individual is a citizen.
    (12) Documentation that a child meets the requirements of section 
101 of the Child Citizenship Act of 2000 as amended (8 U.S.C. 1431).
    (13) Medical records, including, but not limited to, hospital, 
clinic, or doctor records or admission papers from a nursing facility, 
skilled care facility, or other institution that indicate a U.S. place 
of birth.
    (14) Life, health, or other insurance record that indicates a U.S. 
place of birth.
    (15) Official religious record recorded in the U.S. showing that the 
birth occurred in the U.S.
    (16) School records, including pre-school, Head Start and daycare, 
showing the child's name and U.S. place of birth.
    (17) Federal or State census record showing U.S. citizenship or a 
U.S. place of birth.
    (18) If the applicant does not have one of the documents listed in 
paragraphs (a) or (b)(1) through (17) of this section, he or she may 
submit an affidavit signed by another individual under penalty of 
perjury who can reasonably attest to the applicant's citizenship, and 
that contains the applicant's name, date of birth, and place of U.S. 
birth. The affidavit does not have to be notarized.
    (c) Evidence of identity. (1) The agency must accept the following 
as proof of identity, provided such document has a photograph or other 
identifying information sufficient to establish identity, including, but 
not limited to, name, age, sex, race, height, weight, eye color, or 
address:
    (i) Identity documents listed at 8 CFR 274a.2 (b)(1)(v)(B)(1), 
except a driver's license issued by a Canadian government authority.
    (ii) Driver's license issued by a State or Territory.
    (iii) School identification card.
    (iv) U.S. military card or draft record.
    (v) Identification card issued by the Federal, State, or local 
government.
    (vi) Military dependent's identification card.
    (vii) U.S. Coast Guard Merchant Mariner card.
    (viii) For children under age 19, a clinic, doctor, hospital, or 
school record, including preschool or day care records.
    (ix) A finding of identity from an Express Lane agency, as defined 
in section 1902(e)(13)(F) of the Act.
    (x) Two other documents containing consistent information that 
corroborates an applicant's identity. Such documents include, but are 
not limited to, employer identification cards; high school, high school 
equivalency and college diplomas; marriage certificates; divorce 
decrees; and property deeds or titles.
    (2) Finding of identity from a Federal or State governmental agency. 
The agency may accept as proof of identity a finding of identity from a 
Federal agency or another State agency (not described in paragraph 
(c)(1)(ix) of this section), including but not limited to a public 
assistance, law enforcement, internal revenue or tax bureau, or 
corrections agency, if the agency has verified and certified the 
identity of the individual.
    (3) If the applicant does not have any document specified in 
paragraph (c)(1) of this section and identity is not verified under 
paragraph (c)(2) of this section, the agency must accept an affidavit 
signed, under penalty of perjury, by a person other than the applicant 
who can reasonably attest to the applicant's identity. Such affidavit 
must contain the applicant's name and other identifying information 
establishing identity, as described in paragraph (c)(1) of this section. 
The affidavit does not have to be notarized.
    (d) Verification of citizenship by a Federal agency or another 
State. The agency may rely, without further documentation of citizenship 
or identity, on a verification of citizenship made by a Federal agency 
or another State agency, if such verification was done on or after July 
1, 2006.

[[Page 166]]

    (e) Assistance with obtaining documentation. States must provide 
assistance to individuals who need assistance in securing satisfactory 
documentary evidence of citizenship in a timely manner.
    (f) Documentary evidence. A photocopy, facsimile, scanned or other 
copy of a document must be accepted to the same extent as an original 
document under this section, unless information on the copy submitted is 
inconsistent with other information available to the agency or the 
agency otherwise has reason to question the validity of, or the 
information in, the document.

[81 FR 86455, Nov. 30, 2016]



           Subpart F_Categorical Requirements for Eligibility



Sec.  435.500  Scope.

    This subpart prescribes categorical requirements for determining the 
eligibility of both categorically and medically needy individuals 
specified in subparts B, C, and D of this part.

                                   Age



Sec.  435.520  Age requirements for the aged.

    The agency must not impose an age requirement of more than 65 years.

[58 FR 4929, Jan. 19, 1993]

                                Blindness



Sec.  435.530  Definition of blindness.

    (a) Definition. The agency must use the same definition of blindness 
as used under SSI, except that--
    (1) In determining the eligibility of individuals whose Medicaid 
eligibility is protected under Sec. Sec.  435.130 through 435.134, the 
agency must use the definition of blindness that was used under the 
Medicaid plan in December 1973; and
    (2) The agency may use a more restrictive definition to determine 
eligibility under Sec.  435.121, if the definition is no more 
restrictive than that used under the Medicaid plan on January 1, 1972.
    (b) State plan requirement. The State plan must contain the 
definition of blindness, expressed in ophthalmic measurements.



Sec.  435.531  Determinations of blindness.

    (a) Except as specified in paragraph (b) of this section, in 
determining blindness--
    (1) A physician skilled in the diseases of the eye or an 
optometrist, whichever the individual selects, must examine him, unless 
both of the applicant's eyes are missing;
    (2) The examiner must submit a report of examination to the Medicaid 
agency; and
    (3) A physician skilled in the diseases of the eye (for example, an 
ophthalmologist or an eye, ear, nose, and throat specialist) must review 
the report and determine on behalf of the agency--
    (i) Whether the individual meets the definition of blindness; and
    (ii) Whether and when re-examinations are necessary for periodic 
redeterminations of eligibility, as required under Sec.  435.916 of this 
part.
    (b) If an agency provides Medicaid to individuals receiving SSI on 
the basis of blindness, this section does not apply for those 
individuals.

[43 FR 45204, Sept. 29, 1978, as amended at 44 FR 17937, Mar. 23, 1979]

                               Disability



Sec.  435.540  Definition of disability.

    (a) Definition. The agency must use the same definition of 
disability as used under SSI, except that--
    (1) In determining the eligibility of individuals whose Medicaid 
eligibility is protected under Sec. Sec.  435.130 through 435.134, the 
agency must use the definition of disability that was used under the 
Medicaid plan in December 1973; and
    (2) The agency may use a more restrictive definition to determine 
eligibility under Sec.  435.121, if the definition is no more 
restrictive than that used under the Medicaid plan on January 1, 1972.
    (b) State plan requirements. The State plan must contain the 
definition of disability.

[[Page 167]]



Sec.  435.541  Determinations of disability.

    (a) Determinations made by SSA. The following rules and those under 
paragraph (b) of this section apply where an individual has applied for 
Medicaid on the basis of disability.
    (1) If the agency has an agreement with the Social Security 
Administration (SSA) under section 1634 of the Act, the agency may not 
make a determination of disability when the only application is filed 
with SSA.
    (2) The agency may not make an independent determination of 
disability if SSA has made a disability determination within the time 
limits set forth in Sec.  435.912 on the same issues presented in the 
Medicaid application. A determination of eligibility for SSI payments 
based on disability that is made by SSA automatically confers Medicaid 
eligibility, as provided for under Sec.  435.909.
    (b) Effect of SSA determinations. (1) Except in the circumstances 
specified in paragraph (c)(3) of this section--
    (i) An SSA disability determination is binding on an agency until 
the determination is changed by SSA.
    (ii) If the SSA determination is changed, the new determination is 
also binding on the agency.
    (2) The agency must refer to SSA all applicants who allege new 
information or evidence affecting previous SSA determinations of 
ineligibility based upon disability for reconsideration or reopening of 
the determination, except in cases specified in paragraph (c)(4) of this 
section.
    (c) Determinations made by the Medicaid agency. The agency must make 
a determination of disability in accordance with the requirements of 
this section if any of the following circumstances exist:
    (1) The individual applies for Medicaid as a non-cash beneficiary 
and has not applied to SSA for SSI cash benefits, whether or not a State 
has a section 1634 agreement with SSA; or an individual applies for 
Medicaid and has applied to SSA for SSI benefits and is found ineligible 
for SSI for a reason other than disability.
    (2) The individual applies both to SSA for SSI and to the State 
Medicaid agency for Medicaid, the State agency has a section 1634 
agreement with SSA, and SSA has not made an SSI disability determination 
within 90 days from the date of the individual's application for 
Medicaid.
    (3) The individual applies to SSA for SSI and to the State Medicaid 
agency for Medicaid, the State does not have a section 1634 agreement 
with SSA, and either the State uses more restrictive criteria than SSI 
for determining Medicaid eligibility under its section 1902(f) option 
or, in the case of a State that uses SSI criteria, SSA has not made an 
SSI disability determination in time for the State to comply with the 
Medicaid time limit for making a prompt determination on an individual's 
application for Medicaid.
    (4) The individual applies for Medicaid as a non-cash beneficiary, 
whether or not the State has a section 1634 agreement with SSA, and--
    (i) Alleges a disabling condition different from, or in addition to, 
that considered by SSA in making its determination; or
    (ii) Alleges more than 12 months after the most recent SSA 
determination denying disability that his or her condition has changed 
or deteriorated since that SSA determination and alleges a new period of 
disability which meets the durational requirements of the Act, and has 
not applied to SSA for a determination with respect to these 
allegations.
    (iii) Alleges less than 12 months after the most recent SSA 
determination denying disability that his or her condition has changed 
or deteriorated since that SSA determination, alleges a new period of 
disability which meets the durational requirements of the Act, and--
    (A) Has applied to SSA for reconsideration or reopening of its 
disability decision and SSA refused to consider the new allegations; 
and/or
    (B) He or she no longer meets the nondisability requirements for SSI 
but may meet the State's nondisability requirements for Medicaid 
eligibility.
    (d) Basis for determinations. The agency must make a determination 
of disability as provided in paragraph (c) of this section--
    (1) On the basis of the evidence required under paragraph (e) of 
this section; and

[[Page 168]]

    (2) In accordance with the requirements for evaluating that evidence 
under the SSI program specified in 20 CFR 416.901 through 416.998.
    (e) Medical and nonmedical evidence. The agency must obtain a 
medical report and other nonmedical evidence for individuals applying 
for Medicaid on the basis of disability. The medical report and 
nonmedical evidence must include diagnosis and other information in 
accordance with the requirements for evidence applicable to disability 
determinations under the SSI program specified in 20 CFR part 416, 
subpart I.
    (f) Disability review teams--(1) Function. A review team must review 
the medical report and other evidence required under paragraph (e) of 
this section and determine on behalf of the agency whether the 
individual's condition meets the definition of disability.
    (2) Composition. The review team must be composed of a medical or 
psychological consultant and another individual who is qualified to 
interpret and evaluate medical reports and other evidence relating to 
the individual's physical or mental impairments and, as necessary, to 
determine the capacities of the individual to perform substantial 
gainful activity, as specified in 20 CFR part 416, subpart J.
    (3) Periodic reexaminations. The review team must determine whether 
and when reexaminations will be necessary for periodic redeterminations 
of eligibility as required under Sec.  435.916 of this part, using the 
principles set forth in 20 CFR 416.989 and 416.990. If a State uses the 
same definition of disability as SSA, as provided for under Sec.  
435.540, and a beneficiary is Medicaid eligible because he or she 
receives SSI, this paragraph (f)(3) does not apply. The reexamination 
will be conducted by SSA.

[54 FR 50761, Dec. 11, 1989; 77 FR 17206, Mar. 23, 2012]



    Subpart G_General Financial Eligibility Requirements and Options



Sec.  435.600  Scope.

    This subpart prescribes:
    (a) General financial requirements and options for determining the 
eligibility of both categorically and medically needy individuals 
specified in subparts B, C, and D of this part. Subparts H and I of this 
part prescribe additional financial requirements.
    (b) [Reserved]

[58 FR 4929, Jan. 19, 1993, as amended at 59 FR 43052, Aug. 22, 1994]



Sec.  435.601  Application of financial eligibility methodologies.

    (a) Definitions. For purposes of this section, cash assistance 
financial methodologies refers to the income and resources methodologies 
of the AFDC, SSI, or State supplement programs, or, for aged, blind, and 
disabled individuals in States that use more restrictive criteria than 
SSI, the methodologies established in accordance with the requirements 
of Sec. Sec.  435.121 and 435.230.
    (b) Basic rule for use of non-MAGI financial methodologies. (1) This 
section only applies to individuals excepted from application of MAGI-
based methods in accordance with Sec.  435.603(j).
    (2) Except as specified in paragraphs (c) and (d) of this section or 
in Sec.  435.121 or as permitted under Sec.  435.831(b)(1), in 
determining financial eligibility of individuals as categorically or 
medically needy, the agency must apply the financial methodologies and 
requirements of the cash assistance program that is most closely 
categorically related to the individual's status.
    (c) Financial responsibility of relatives. The agency must use the 
requirements for financial responsibility of relatives specified in 
Sec.  435.602.
    (d) Use of less restrictive methodologies than those under cash 
assistance programs. (1) At State option, and subject to the conditions 
of paragraphs (d)(2) through (5) of this section, the agency may apply 
income and resource methodologies that are less restrictive than the 
cash assistance methodologies or methodologies permitted under Sec.  
435.831(b)(1) in determining eligibility for the following groups:
    (i) Qualified Medicare beneficiaries specified in sections 
1902(a)(10)(E) and 1905(p) of the Act;
    (ii) Optional categorically needy individuals under groups 
established under subpart C of this part and section 1902(a)(10)(A)(ii) 
of the Act;
    (iii) Medically needy individuals under groups established under 
subpart

[[Page 169]]

D of this part and section 1902(a)(10)(C)(i)(III) of the Act; and
    (iv) Aged, blind, and disabled individuals in States using more 
restrictive eligibility requirements than SSI under groups established 
under Sec. Sec.  435.121 and 435.230.
    (2) The income and resource methodologies that an agency elects to 
apply to groups of individuals described in paragraph (d)(1) of this 
section may be less restrictive, but no more restrictive (except in 
States using more restrictive requirements than SSI), than:
    (i) For groups of aged, blind, and disabled individuals, the SSI 
methodologies; or
    (ii) For all other groups, the methodologies under the State plan 
most closely categorically related to the individual's status.
    (3) A financial methodology is considered to be no more restrictive 
if, by using the methodology, additional individuals may be eligible for 
Medicaid and no individuals who are otherwise eligible are by use of 
that methodology made ineligible for Medicaid.
    (4) The less restrictive methodology applied under this section must 
be comparable for all persons within each category of assistance (aged, 
or blind, or disabled, or AFDC related) within an eligibility group. For 
example, if the agency chooses to apply less restrictive income or 
resource methodology to an eligibility group of aged individuals, it 
must apply that methodology to all aged individuals within the selected 
group.
    (5) The application of the less restrictive income and resource 
methodologies permitted under this section must be consistent with the 
limitations and conditions on FFP specified in subpart K of this part.
    (e) [Reserved]
    (f) State plan requirements. (1) The State plan must specify that, 
except to the extent precluded in Sec.  435.602, in determining 
financial eligibility of individuals, the agency will apply the cash 
assistance financial methodologies and requirements, unless the agency 
chooses to apply less restrictive income and resource methodologies in 
accordance with paragraph (d) of this section.
    (2) If the agency chooses to apply less restrictive income and 
resource methodologies, the State plan must specify:
    (i) The less restrictive methodologies that will be used; and
    (ii) The eligibility group or groups to which the less restrictive 
methodologies will be applied.

[58 FR 4929, Jan. 19, 1993, as amended at 59 FR 43052, Aug. 22, 1994; 81 
FR 86456, Nov. 30, 2016]



Sec.  435.602  Financial responsibility of relatives and other individuals.

    (a)(1) This section only applies to individuals excepted from 
application of MAGI-based methods in accordance with Sec.  435.603(j).
    (2) Basic requirements. Subject to the provisions of paragraphs (b) 
and (c) of this section, in determining financial responsibility of 
relatives and other persons for individuals under Medicaid, the agency 
must apply the following requirements and methodologies:
    (i) Except for a spouse of an individual or a parent for a child who 
is under age 21 or blind or disabled, the agency must not consider 
income and resources of any relative as available to an individual.
    (ii) In relation to individuals under age 21 (as described in 
section 1905(a)(i) of the Act), the financial responsibility 
requirements and methodologies that apply include considering the income 
and resources of parents or spouses whose income and resources will be 
considered if the individual under age 21 were dependent under the 
State's approved State plan under title IV-A of the Act in effect as of 
July 16, 1996, whether or not they are actually contributed, except as 
specified under paragraph (c) of this section. These requirements and 
methodologies must be applied in accordance with the provisions of the 
State's approved title IV-A State plan as of July 16, 1996.
    (iii) When a couple ceases to live together, the agency must count 
only the income of the individual spouse in determining his or her 
eligibility, beginning the first month following the month the couple 
ceases to live together.
    (iv) In the case of eligible institutionalized spouses who are aged, 
blind, and disabled and who have shared the

[[Page 170]]

same room in a title XIX Medicaid institution, the agency has the option 
of considering these couples as eligible couples for purposes of 
counting income and resources or as eligible individuals, whichever is 
more advantageous to the couple.
    (b) Requirements for States using more restrictive requirements. 
Subject to the provisions of paragraph (c) of this section, in 
determining financial eligibility of aged, blind, or disabled 
individuals in States that apply eligibility requirements more 
restrictive than those used under SSI, the agency must apply:
    (1) The requirements and methodologies for financial responsibility 
of relatives used under the SSI program; or
    (2) More extensive requirements for relative responsibility than 
specified in Sec.  435.602(a) but no more extensive than the 
requirements under the Medicaid plan in effect on January 1, 1972.
    (c) Use of less restrictive methodologies. The agency may apply 
income and resources methodologies that are less restrictive than those 
used under the cash assistance programs as specified in the State 
Medicaid plan in accordance with Sec.  435.601(d).
    (d) [Reserved]

[58 FR 4930, Jan. 19, 1993, as amended at 59 FR 43052, Aug. 22, 1994; 81 
FR 86456, Nov. 30, 2016]



Sec.  435.603  Application of modified adjusted gross income (MAGI).

    (a) Basis, scope, and implementation. (1) This section implements 
section 1902(e)(14) of the Act.
    (2) Effective January 1, 2014, the agency must apply the financial 
methodologies set forth in this section in determining the financial 
eligibility of all individuals for Medicaid, except for individuals 
identified in paragraph (j) of this section and as provided in paragraph 
(a)(3) of this section.
    (3) In the case of determining ongoing eligibility for beneficiaries 
determined eligible for Medicaid coverage to begin on or before December 
31, 2013, application of the financial methodologies set forth in this 
section will not be applied until March 31, 2014 or the next regularly-
scheduled renewal of eligibility for such individual under Sec.  435.916 
of this part, whichever is later.
    (b) Definitions. For purposes of this section--
    Child means a natural or biological, adopted or step child.
    Code means the Internal Revenue Code.
    Family size means the number of persons counted as members of an 
individual's household. In the case of determining the family size of a 
pregnant woman, the pregnant woman is counted as herself plus the number 
of children she is expected to deliver. In the case of determining the 
family size of other individuals who have a pregnant woman in their 
household, the pregnant woman is counted, at State option, as either 1 
or 2 person(s) or as herself plus the number of children she is expected 
to deliver.
    Parent means a natural or biological, adopted or step parent.
    Sibling means natural or biological, adopted, half, or step sibling.
    Tax dependent has the meaning provided in Sec.  435.4 of this part.
    (c) Basic rule. Except as specified in paragraph (i), (j), and (k) 
of this section, the agency must determine financial eligibility for 
Medicaid based on ``household income'' as defined in paragraph (d) of 
this section.
    (d) Household income--(1) General rule. Except as provided in 
paragraphs (d)(2) through (d)(4) of this section, household income is 
the sum of the MAGI-based income, as defined in paragraph (e) of this 
section, of every individual included in the individual's household.
    (2) Income of children and tax dependents. (i) The MAGI-based income 
of an individual who is included in the household of his or her natural, 
adopted or step parent and is not expected to be required to file a tax 
return under section 6012(a)(1) of the Code for the taxable year in 
which eligibility for Medicaid is being determined, is not included in 
household income whether or not the individual files a tax return.
    (ii) The MAGI-based income of a tax dependent described in paragraph 
(f)(2)(i) of this section who is not expected to be required to file a 
tax return under section 6012(a)(1) of the Code for the taxable year in 
which eligibility for Medicaid is being determined is not included in 
the household

[[Page 171]]

income of the taxpayer whether or not such tax dependent files a tax 
return.
    (3) In the case of individuals described in paragraph (f)(2)(i) of 
this section, household income may, at State option, also include 
actually available cash support, exceeding nominal amounts, provided by 
the person claiming such individual as a tax dependent.
    (4) Effective January 1, 2014, in determining the eligibility of an 
individual using MAGI-based income, a state must subtract an amount 
equivalent to 5 percentage points of the Federal poverty level for the 
applicable family size only to determine the eligibility of an 
individual for medical assistance under the eligibility group with the 
highest income standard using MAGI-based methodologies in the applicable 
Title of the Act, but not to determine eligibility for a particular 
eligibility group.
    (e) MAGI-based income. For the purposes of this section, MAGI-based 
income means income calculated using the same financial methodologies 
used to determine modified adjusted gross income as defined in section 
36B(d)(2)(B) of the Code, with the following exceptions--
    (1) An amount received as a lump sum is counted as income only in 
the month received.
    (2) Scholarships, awards, or fellowship grants used for education 
purposes and not for living expenses are excluded from income.
    (3) American Indian/Alaska Native exceptions. The following are 
excluded from income:
    (i) Distributions from Alaska Native Corporations and Settlement 
Trusts;
    (ii) Distributions from any property held in trust, subject to 
Federal restrictions, located within the most recent boundaries of a 
prior Federal reservation, or otherwise under the supervision of the 
Secretary of the Interior;
    (iii) Distributions and payments from rents, leases, rights of way, 
royalties, usage rights, or natural resource extraction and harvest 
from--
    (A) Rights of ownership or possession in any lands described in 
paragraph (e)(3)(ii) of this section; or
    (B) Federally protected rights regarding off-reservation hunting, 
fishing, gathering, or usage of natural resources;
    (iv) Distributions resulting from real property ownership interests 
related to natural resources and improvements--
    (A) Located on or near a reservation or within the most recent 
boundaries of a prior Federal reservation; or
    (B) Resulting from the exercise of federally-protected rights 
relating to such real property ownership interests;
    (v) Payments resulting from ownership interests in or usage rights 
to items that have unique religious, spiritual, traditional, or cultural 
significance or rights that support subsistence or a traditional 
lifestyle according to applicable Tribal Law or custom;
    (vi) Student financial assistance provided under the Bureau of 
Indian Affairs education programs.
    (f) Household--(1) Basic rule for taxpayers not claimed as a tax 
dependent. In the case of an individual who expects to file a tax return 
for the taxable year in which an initial determination or renewal of 
eligibility is being made, and who does not expect to be claimed as a 
tax dependent by another taxpayer, the household consists of the 
taxpayer and, subject to paragraph (f)(5) of this section, all persons 
whom such individual expects to claim as a tax dependent.
    (2) Basic rule for individuals claimed as a tax dependent. In the 
case of an individual who expects to be claimed as a tax dependent by 
another taxpayer for the taxable year in which an initial determination 
or renewal of eligibility is being made, the household is the household 
of the taxpayer claiming such individual as a tax dependent, except that 
the household must be determined in accordance with paragraph (f)(3) of 
this section in the case of--
    (i) Individuals other than a spouse or child who expect to be 
claimed as a tax dependent by another taxpayer; and
    (ii) Individuals under the age specified by the State under 
paragraph (f)(3)(iv) of this section who expect to be claimed by one 
parent as a tax dependent and are living with both parents but whose 
parents do not expect to file a joint tax return; and
    (iii) Individuals under the age specified by the State under 
paragraph (f)(3)(iv) of this section who expect to be claimed as a tax 
dependent by a non-custodial parent. For purposes of this section--

[[Page 172]]

    (A) A court order or binding separation, divorce, or custody 
agreement establishing physical custody controls; or
    (B) If there is no such order or agreement or in the event of a 
shared custody agreement, the custodial parent is the parent with whom 
the child spends most nights.
    (3) Rules for individuals who neither file a tax return nor are 
claimed as a tax dependent. In the case of individuals who do not expect 
to file a Federal tax return and do not expect to be claimed as a tax 
dependent for the taxable year in which an initial determination or 
renewal of eligibility is being made, or who are described in paragraph 
(f)(2)(i), (f)(2)(ii), or (f)(2)(iii) of this section, the household 
consists of the individual and, if living with the individual--
    (i) The individual's spouse;
    (ii) The individual's children under the age specified in paragraph 
(f)(3)(iv) of this section; and
    (iii) In the case of individuals under the age specified in 
paragraph (f)(3)(iv) of this section, the individual's parents and 
siblings under the age specified in paragraph (f)(3)(iv) of this 
section.
    (iv) The age specified in this paragraph is either of the following, 
as elected by the agency in the State plan--
    (A) Age 19; or
    (B) Age 19 or, in the case of full-time students, age 21.
    (4) Married couples. In the case of a married couple living 
together, each spouse will be included in the household of the other 
spouse, regardless of whether they expect to file a joint tax return 
under section 6013 of the Code or whether one spouse expects to be 
claimed as a tax dependent by the other spouse.
    (5) For purposes of paragraph (f)(1) of this section, if, consistent 
with the procedures adopted by the State in accordance with Sec.  
435.956(f) of this part, a taxpayer cannot reasonably establish that 
another individual is a tax dependent of the taxpayer for the tax year 
in which Medicaid is sought, the inclusion of such individual in the 
household of the taxpayer is determined in accordance with paragraph 
(f)(3) of this section.
    (g) No resource test or income disregards. In the case of 
individuals whose financial eligibility for Medicaid is determined in 
accordance with this section, the agency must not--
    (1) Apply any assets or resources test; or
    (2) Apply any income or expense disregards under sections 1902(r)(2) 
or 1931(b)(2)(C), or otherwise under title XIX of the Act, except as 
provided in paragraph (d)(1) of this section.
    (h) Budget period--(1) Applicants and new enrollees. Financial 
eligibility for Medicaid for applicants, and other individuals not 
receiving Medicaid benefits at the point at which eligibility for 
Medicaid is being determined, must be based on current monthly household 
income and family size.
    (2) Current beneficiaries. For individuals who have been determined 
financially-eligible for Medicaid using the MAGI-based methods set forth 
in this section, a State may elect in its State plan to base financial 
eligibility either on current monthly household income and family size 
or income based on projected annual household income and family size for 
the remainder of the current calendar year.
    (3) In determining current monthly or projected annual household 
income and family size under paragraphs (h)(1) or (h)(2) of this 
section, the agency may adopt a reasonable method to include a prorated 
portion of reasonably predictable future income, to account for a 
reasonably predictable increase or decrease in future income, or both, 
as evidenced by a signed contract for employment, a clear history of 
predictable fluctuations in income, or other clear indicia of such 
future changes in income. Such future increase or decrease in income or 
family size must be verified in the same manner as other income and 
eligibility factors, in accordance with the income and eligibility 
verification requirements at Sec.  435.940 through Sec.  435.965, 
including by self-attestation if reasonably compatible with other 
electronic data obtained by the agency in accordance with such sections.
    (i) If the household income of an individual determined in 
accordance with this section results in financial ineligibility for 
Medicaid and the household

[[Page 173]]

income of such individual determined in accordance with 26 CFR 1.36B-
1(e) is below 100 percent FPL, Medicaid financial eligibility will be 
determined in accordance with 26 CFR 1.36B-1(e).
    (j) Eligibility Groups for which MAGI-based methods do not apply. 
The financial methodologies described in this section are not applied in 
determining the Medicaid eligibility of individuals described in this 
paragraph. The agency must use the financial methods described in Sec.  
435.601 and Sec.  435.602 of this subpart.
    (1) Individuals whose eligibility for Medicaid does not require a 
determination of income by the agency, including, but not limited to, 
individuals receiving Supplemental Security Income (SSI) eligible for 
Medicaid under Sec.  435.120 of this part, individuals deemed to be 
receiving SSI and eligible for Medicaid under Sec.  435.135, Sec.  
435.137 or Sec.  435.138 of this part and individuals for whom the State 
relies on a finding of income made by an Express Lane agency, in 
accordance with section 1902(e)(13) of the Act.
    (2) Individuals who are age 65 or older when age is a condition of 
eligibility.
    (3) Individuals whose eligibility is being determined on the basis 
of being blind or disabled, or on the basis of being treated as being 
blind or disabled, including, but not limited to, individuals eligible 
under Sec.  435.121, Sec.  435.232 or Sec.  435.234 of this part or 
under section 1902(e)(3) of the Act, but only for the purpose of 
determining eligibility on such basis.
    (4) Individuals who request coverage for long-term care services and 
supports for the purpose of being evaluated for an eligibility group 
under which long-term care services and supports not covered for 
individuals determined eligible using MAGI-based financial methods are 
covered, or for individuals being evaluated for an eligibility group for 
which being institutionalized, meeting an institutional level of care or 
satisfying needs-based criteria for home and community based services is 
a condition of eligibility. For purposes of this paragraph, ``long-term 
care services and supports'' include nursing facility services, a level 
of care in any institution equivalent to nursing facility services; and 
home and community-based services furnished under a waiver or State plan 
under sections 1915 or 1115 of the Act; home health services as 
described in sections 1905(a)(7) of the Act and personal care services 
described in sections 1905(a)(24) of the Act.
    (5) Individuals who are being evaluated for eligibility for Medicare 
cost sharing assistance under section 1902(a)(10)(E) of the Act, but 
only for purposes of determining eligibility for such assistance.
    (6) Individuals who are being evaluated for coverage as medically 
needy under subparts D and I of this part, but only for the purpose of 
determining eligibility on such basis.
    (k) Eligibility. In the case of an individual whose eligibility is 
being determined under Sec.  435.214, the agency may--
    (1) Consider the household to consist of only the individual for 
purposes of paragraph (f) of this section;
    (2) Count only the MAGI-based income of the individual for purposes 
of paragraph (d) of this section.
    (3) Increase the family size of the individual, as defined in 
paragraph (b) of the section, by one.

[77 FR 17206, Mar. 23, 2012, as amended at 78 FR 42302, July 15, 2013; 
81 FR 86456, Nov. 30, 2016]



Sec.  435.604  [Reserved]



Sec.  435.606  [Reserved]



Sec.  435.608  Applications for other benefits.

    (a) As a condition of eligibility, the agency must require 
applicants and beneficiaries to take all necessary steps to obtain any 
annuities, pensions, retirement, and disability benefits to which they 
are entitled, unless they can show good cause for not doing so.
    (b) Annuities, pensions, retirement and disability benefits include, 
but are not limited to, veterans' compensation and pensions, OASDI 
benefits, railroad retirement benefits, and unemployment compensation.

[43 FR 45204, Sept. 29, 1978. Redesignated at 58 FR 4931, Jan. 19, 1993]

[[Page 174]]



Sec.  435.610  Assignment of rights to benefits.

    (a) Consistent with Sec. Sec.  433.145 through 433.148 of this 
chapter, as a condition of eligibility, the agency must require legally 
able applicants and beneficiaries to:
    (1) Assign rights to the Medicaid agency to medical support and to 
payment for medical care from any third party;
    (2) In the case of applicants, attest that they will cooperate, and, 
in the case of beneficiaries, cooperate with the agency in--
    (i) Establishing the identity of a child's parents and in obtaining 
medical support and payments, unless the individual establishes good 
cause for not cooperating or is a pregnant woman described in Sec.  
435.116; and
    (ii) Identifying and providing information to assist the Medicaid 
agency in pursuing third parties who may be liable to pay for care and 
services under the plan, unless the individual establishes good cause 
for not cooperating.
    (3) Cooperate in identifying and providing information to assist the 
Medicaid agency in pursuing third parties who may be liable to pay for 
care and services under the plan, unless the individual establishes good 
cause for not cooperating.
    (b) The requirements for assignment of rights must be applied 
uniformly for all groups covered under the plan.

[55 FR 48609, Nov. 21, 1990, as amended at 58 FR 4907, Jan. 19, 1993. 
Redesignated at 58 FR 4931, Jan. 19, 1993, as amended at 81 FR 86457, 
Nov. 30, 2016]



Sec.  435.622  Individuals in institutions who are eligible under a
special income level.

    (a) If an agency, under Sec.  435.231, provides Medicaid to 
individuals in medical institutions, nursing facilities, and 
intermediate care facilities for Individuals with Intellectual 
Disabilities who would not be eligible for SSI or State supplements if 
they were not institutionalized, the agency must use income standards 
based on the greater need for financial assistance that the individuals 
would have if they were not in the institution. The standards may vary 
by the level of institutional care needed by the individual (hospital, 
nursing facility, or intermediate level care for individuals with 
intellectual disabilities), or by other factors related to individual 
needs. (See Sec.  435.1005 for FFP limits on income standards 
established under this section.)
    (b) In determining the eligibility of individuals under the income 
standards established under this section, the agency must not take into 
account income that would be disregarded in determining eligibility for 
SSI or for an optional State supplement.
    (c) The agency must apply the income standards established under 
this section effective with the first day of a period of not less than 
30 consecutive days of institutionalization.

[43 FR 45204, Sept. 29, 1978, as amended at 45 FR 24884, Apr. 11, 1980; 
53 FR 3595, Feb. 8, 1988. Redesignated and amended at 58 FR 4932, Jan. 
19, 1993]



Sec.  435.631  General requirements for determining income eligibility
in States using more restrictive requirements for Medicaid than SSI.

    (a) Income eligibility methods. In determining income eligibility of 
aged, blind, and disabled individuals in a State using more restrictive 
eligibility requirements than SSI, the agency must use the methods for 
treating income elected under Sec. Sec.  435.121 and 435.230, under 
Sec.  435.601. The methods used must be comparable for all individuals 
within each category of individuals under Sec.  435.121 and each 
category of individuals within each optional categorically needy group 
included under Sec.  435.230 and for each category of individuals under 
the medically needy option described under Sec.  435.800.
    (b) Categorically needy versus medically needy eligibility. (1) 
Individuals who have income equal to, or below, the categorically needy 
income standards described in Sec. Sec.  435.121 and 435.230 are 
categorically needy in States that include the medically needy under 
their plans.
    (2) Categorically needy eligibility in States that do not include 
the medically needy is determined in accordance with the provisions of 
Sec.  435.121 (e)(4) and (e)(5).

[58 FR 4932, Jan. 19, 1993]

[[Page 175]]



Sec.  435.640  Protected Medicaid eligibility for individuals eligible
in December 1973.

    In determining whether individuals continue to meet the income 
requirements used in December 1973, for purposes of determining 
eligibility under Sec. Sec.  435.131, 435.132, and 435.133, the agency 
must deduct increased OASDI payments to the same extent that these 
deductions were in effect in December 1973. These deductions are 
required by section 306 of the Social Security Amendments of 1972 (Pub. 
L. 92-603) and section 1007 of Pub. L. 91-172 (enacted Dec. 30, 1969), 
modified by section 304 of Pub. L. 92-603.

[43 FR 45204, Sept. 29, 1978. Redesignated at 58 FR 4932, Jan. 19, 1993]



   Subpart H_Specific Post-Eligibility Financial Requirements for the 
                           Categorically Needy



Sec.  435.700  Scope.

    This subpart prescribes specific financial requirements for 
determining the post-eligibility treatment of income of categorically 
needy individuals, including requirements for applying patient income to 
the cost of care.

[58 FR 4931, Jan. 19, 1993]



Sec.  435.725  Post-eligibility treatment of income of institutionalized
individuals in SSI States: Application of patient income to the cost of
care.

    (a) Basic rules. (1) The agency must reduce its payment to an 
institution, for services provided to an individual specified in 
paragraph (b) of this section, by the amount that remains after 
deducting the amounts specified in paragraphs (c) and (d) of this 
section, from the individual's total income,
    (2) The individual's income must be determined in accordance with 
paragraph (e) of this section.
    (3) Medical expenses must be determined in accordance with paragraph 
(f) of this section.
    (b) Applicability. This section applies to the following individuals 
in medical institutions and intermediate care facilities.
    (1) Individuals receiving cash assistance under SSI or AFDC who are 
eligible for Medicaid under Sec.  435.110 or Sec.  435.120.
    (2) Individuals who would be eligible for AFDC, SSI, or an optional 
State supplement except for their institutional status and who are 
eligible for Medicaid under Sec.  435.211.
    (3) Aged, blind, and disabled individuals who are eligible for 
Medicaid, under Sec.  435.231, under a higher income standard than the 
standard used in determining eligibility for SSI or optional State 
supplements.
    (c) Required deductions. In reducing its payment to the institution, 
the agency must deduct the following amounts, in the following order, 
from the individual's total income, as determined under paragraph (e) of 
this section. Income that was disregarded in determining eligibility 
must be considered in this process.
    (1) Personal needs allowance. A personal needs allowance that is 
reasonable in amount for clothing and other personal needs of the 
individual while in the institution. This protected personal needs 
allowance must be at least--
    (i) $30 a month for an aged, blind, or disabled individual, 
including a child applying for Medicaid on the basis of blindness or 
disability;
    (ii) $60 a month for an institutionalized couple if both spouses are 
aged, blind, or disabled and their income is considered available to 
each other in determining eligibility; and
    (iii) For other individuals, a reasonable amount set by the agency, 
based on a reasonable difference in their personal needs from those of 
the aged, blind, and disabled.
    (2) Maintenance needs of spouse. For an individual with only a 
spouse at home, an additional amount for the maintenance needs of the 
spouse. This amount must be based on a reasonable assessment of need but 
must not exceed the highest of--
    (i) The amount of the income standard used to determine eligibility 
for SSI for an individual living in his own home, if the agency provides 
Medicaid only to individuals receiving SSI;
    (ii) The amount of the highest income standard, in the appropriate 
category of age, blindness, or disability,

[[Page 176]]

used to determine eligibility for an optional State supplement for an 
individual in his own home, if the agency provides Medicaid to optional 
State supplement beneficiaries under Sec.  435.230; or
    (iii) The amount of the medically needy income standard for one 
person established under Sec.  435.811, if the agency provides Medicaid 
under the medically needy coverage option.
    (3) Maintenance needs of family. For an individual with a family at 
home, an additional amount for the maintenance needs of the family. This 
amount must--
    (i) Be based on a reasonable assessment of their financial need;
    (ii) Be adjusted for the number of family members living in the 
home; and
    (iii) Not exceed the higher of the need standard for a family of the 
same size used to determine eligibility under the State's approved AFDC 
plan or the medically needy income standard established under Sec.  
435.811, if the agency provides Medicaid under the medically needy 
coverage option for a family of the same size.
    (4) Expenses not subject to third party payment. Amounts for 
incurred expenses for medical or remedial care that are not subject to 
payment by a third party, including--
    (i) Medicare and other health insurance premiums, deductibles, or 
coinsurance charges; and
    (ii) Necessary medical or remedial care recognized under State law 
but not covered under the State's Medicaid plan, subject to reasonable 
limits the agency may establish on amounts of these expenses.
    (5) Continued SSI and SSP benefits. The full amount of SSI and SSP 
benefits that the individual continues to receive under sections 
1611(e)(1) (E) and (G) of the Act.
    (d) Optional deduction: Allowance for home maintenance. For single 
individuals and couples, an amount (in addition to the personal needs 
allowance) for maintenance of the individual's or couple's home if--
    (1) The amount is deducted for not more than a 6-month period; and
    (2) A physician has certified that either of the individuals is 
likely to return to the home within that period.
    (3) For single individuals and couples, an amount (in addition to 
the personal needs allowance) for maintenance of the individual's or 
couple's home if--
    (i) The amount is deducted for not more than a 6-month period; and
    (ii) A physician has certified that either of the individuals is 
likely to return to the home within that period.
    (e) Determination of income--(1) Option. In determining the amount 
of an individual's income to be used to reduce the agency's payment to 
the institution, the agency may use total income received, or it may 
project monthly income for a prospective period not to exceed 6 months.
    (2) Basis for projection. The agency must base the projection on 
income received in the preceding period, not to exceed 6 months, and on 
income expected to be received.
    (3) Adjustments. At the end of the prospective period specified in 
paragraph (e)(1) of this section, or when any significant change occurs, 
the agency must reconcile estimates with income received.
    (f) Determination of medical expenses--(1) Option. In determining 
the amount of medical expenses to be deducted from an individual's 
income, the agency may deduct incurred medical expenses, or it may 
project medical expenses for a prospective period not to exceed 6 
months.
    (2) Basis for projection. The agency must base the estimate on 
medical expenses incurred in the preceding period, not to exceed 6 
months, and on medical expenses expected to be incurred.
    (3) Adjustments. At the end of the prospective period specified in 
paragraph (f)(1) of this section, or when any significant change occurs, 
the agency must reconcile estimates with incurred medical expenses.

[43 FR 45204, Sept. 29, 1978, as amended at 45 FR 24884, Apr. 11, 1980; 
48 FR 5735, Feb. 8, 1983; 53 FR 3595, Feb. 8, 1988; 55 FR 33705, Aug. 
17, 1990; 56 FR 8850, 8854, Mar. 1, 1991; 58 FR 4932, Jan. 19, 1993]

[[Page 177]]



Sec.  435.726  Post-eligibility treatment of income of individuals 
receiving home and community-based services furnished under a waiver:
Application of patient income to the cost of care.

    (a) The agency must reduce its payment for home and community-based 
services provided to an individual specified in paragraph (b) of this 
section, by the amount that remains after deducting the amounts 
specified in paragraph (c) of this section from the individual's income.
    (b) This section applies to individuals who are eligible for 
Medicaid under Sec.  435.217 and are receiving home and community-based 
services furnished under a waiver of Medicaid requirements specified in 
part 441, subpart G or H of this subchapter.
    (c) In reducing its payment for home and community-based services, 
the agency must deduct the following amounts, in the following order, 
from the individual's total income (including amounts disregarded in 
determining eligibility):
    (1) An amount for the maintenance needs of the individual that the 
State may set at any level, as long as the following conditions are met:
    (i) The deduction amount is based on a reasonable assessment of 
need.
    (ii) The State establishes a maximum deduction amount that will not 
be exceeded for any individual under the waiver.
    (2) For an individual with only a spouse at home, an additional 
amount for the maintenance needs of the spouse. This amount must be 
based on a reasonable assessment of need but must not exceed the highest 
of--
    (i) The amount of the income standard used to determine eligibility 
for SSI for an individual living in his own home, if the agency provides 
Medicaid only to individuals receiving SSI;
    (ii) The amount of the highest income standard, in the appropriate 
category of age, blindness, or disability, used to determine eligibility 
for an optional State supplement for an individual in his own home, if 
the agency provides Medicaid to optional State supplement beneficiaries 
under Sec.  435.230; or
    (iii) The amount of the medically needy income standard for one 
person established under Sec. Sec.  435.811 and 435.814, if the agency 
provides Medicaid under the medically needy coverage option.
    (3) For an individual with a family at home, an additional amount 
for the maintenance needs of the family. This amount must--
    (i) Be based on a reasonable assessment of their financial need;
    (ii) Be adjusted for the number of family members living in the 
home; and
    (iii) Not exceed the higher of the need standard for a family of the 
same size used to determine eligibility under the State's AFDC plan or 
the medically needy income standard established under Sec.  435.811 for 
a family of the same size.
    (4) Amounts for incurred expenses for medical or remedial care that 
are not subject to payment by a third party including--
    (i) Medicare and other health insurance premiums, deductibles, or 
coinsurance charges; and
    (ii) Necessary medical or remedial care recognized under State law 
but not covered under the State's Medicaid plan, subject to reasonable 
limits the agency may establish on amounts of these expenses.

[46 FR 48539, Oct. 1, 1981, as amended at 50 FR 10026, Mar. 13, 1985; 57 
FR 29155, June 30, 1992; 58 FR 4932, Jan. 19, 1993; 59 FR 37715, July 
25, 1994]



Sec.  435.733  Post-eligibility treatment of income of institutionalized
individuals in States using more restrictive requirements than SSI:
Application of patient income to the cost of care.

    (a) Basic rules. (1) The agency must reduce its payment to an 
institution, for services provided to an individual specified in 
paragraph (b) of this section, by the amount that remains after 
deducting the amounts specified in paragraphs (c) and (d) of this 
section, from the individual's total income.
    (2) The individual's income must be determined in accordance with 
paragraph (e) of this section.
    (3) Medical expenses must be determined in accordance with paragraph 
(f) of this section.

[[Page 178]]

    (b) Applicability. This section applies to the following individuals 
in medical institutions and intermediate care facilities:
    (1) Individuals receiving cash assistance under AFDC who are 
eligible for Medicaid under Sec.  435.110 and individuals eligible under 
Sec.  435.121.
    (2) Individuals who would be eligible for AFDC, SSI, or an optional 
State supplement except for their institutional status and who are 
eligible for Medicaid under Sec.  435.211.
    (3) Aged, blind, and disabled individuals who are eligible for 
Medicaid, under Sec.  435.231, under a higher income standard than the 
standard used in determining eligibility for SSI or optional State 
supplements.
    (c) Required deductions. The agency must deduct the following 
amounts, in the following order, from the individual's total income, as 
determined under paragraph (e) of this section. Income that was 
disregarded in determining eligibility must be considered in this 
process.
    (1) Personal needs allowance. A personal needs allowance that is 
reasonable in amount for clothing and other personal needs of the 
individual while in the institution. This protected personal needs 
allowance must be at least--
    (i) $30 a month for an aged, blind, or disabled individual, 
including a child applying for Medicaid on the basis of blindness or 
disability;
    (ii) $60 a month for an institutionalized couple if both spouses are 
aged, blind, or disabled and their income is considered available to 
each other in determining eligibility; and
    (iii) For other individuals, a reasonable amount set by the agency, 
based on a reasonable difference in their personal needs from those of 
the aged, blind, and disabled.
    (2) Maintenance needs of spouse. For an individual with only a 
spouse at home, an additional amount for the maintenance needs of the 
spouse. This amount must be based on a reasonable assessment of need but 
must not exceed the higher of--
    (i) The more restrictive income standard established under Sec.  
435.121; or
    (ii) The amount of the medically needy income standard for one 
person established under Sec.  435.811, if the agency provides Medicaid 
under the medically needy coverage option.
    (3) Maintenance needs of family. For an individual with a family at 
home, an additional amount for the maintenance needs of the family. This 
amount must--
    (i) Be based on a reasonable assessment of their financial need;
    (ii) Be adjusted for the number of family members living in the 
home; and
    (iii) Not exceed the higher of the need standard for a family of the 
same size used to determine eligibility under the State's approved AFDC 
plan or the medically needy income standard established under Sec.  
435.811, if the agency provides Medicaid under the medically needy 
coverage option for a family of the same size.
    (4) Expenses not subject to third party payment. Amounts for 
incurred expenses for medical or remedial care that are not subject to 
payment by a third party, including--
    (i) Medicare and other health insurance permiums, deductibles, or 
coinsurance charges; and
    (ii) Necessary medical or remedial care recognized under State law 
but not covered under the State's Medicaid plan, subject to reasonable 
limits the agency may establish on amounts of these expenses.
    (5) Continued SSI and SSP benefits. The full amount of SSI and SSP 
benefits that the individual continues to receive under sections 
1611(e)(1) (E) and (G) of the Act.
    (d) Optional deduction: Allowance for home maintenance. For single 
individuals and couples, an amount (in addition to the personal needs 
allowance) for maintenance of the individual's or couple's home if--
    (1) The amount is deducted for not more than a 6-month period; and
    (2) A physician has certified that either of the individuals is 
likely to return to the home within that period.
    (e) Determination of income--(1) Option. In determining the amount 
of an individual's income to be used to reduce the agency's payment to 
the institution, the agency may use total income received, or it may 
project total

[[Page 179]]

monthly income for a prospective period not to exceed 6 months.
    (2) Basis for projection. The agency must base the projection on 
income received in the preceding period, not to exceed 6 months, and on 
income expected to be received.
    (3) Adjustments. At the end of the prospective period specified in 
paragraph (e)(1) of this section, or when any significant change occurs, 
the agency must reconcile estimates with income received.
    (f) Determination of medical expenses--(1) Option. In determining 
the amount of medical expenses that may be deducted from an individual's 
income, the agency may deduct incurred medical expenses, or it may 
project medical expenses for a prospective period not to exceed 6 
months.
    (2) Basis for projection. The agency must base the estimate on 
medical expenses incurred in the preceding period, not to exceed 6 
months, and medical expenses expected to be incurred.
    (3) Adjustments. At the end of the prospective period specified in 
paragraph (f)(1) of this section, or when any significant change occurs, 
the agency must reconcile estimates with incurred medical expenses.

[45 FR 24884, Apr. 11, 1980, as amended at 48 FR 5735, Feb. 8, 1983; 53 
FR 3596, Feb. 8, 1988; 55 FR 33705, Aug. 17, 1990; 56 FR 8850, 8854, 
Mar. 1, 1991; 58 FR 4932, Jan. 19, 1993]



Sec.  435.735  Post-eligibility treatment of income and resources of
individuals receiving home and community-based services furnished under
a waiver: Application of patient income to the cost of care.

    (a) The agency must reduce its payment for home and community-based 
services provided to an individual specified in paragraph (b) of this 
section, by the amount that remains after deducting the amounts 
specified in paragraph (c) of this section from the individual's income.
    (b) This section applies to individuals who are eligible for 
Medicaid under Sec.  435.217, and are eligible for home and community-
based services furnished under a waiver of State plan requirements 
specified in part 441, subpart G or H of this subchapter.
    (c) In reducing its payment for home and community-based services, 
the agency must deduct the following amounts, in the following order, 
from the individual's total income (including amounts disregarded in 
determining eligibility):
    (1) An amount for the maintenance needs of the individual that the 
State may set at any level, as long as the following conditions are met:
    (i) The deduction amount is based on a reasonable assessment of 
need.
    (ii) The State establishes a maximum deduction amount that will not 
be exceeded for any individual under the waiver.
    (2) For an individual with only a spouse at home, an additional 
amount for the maintenance needs of the spouse. This amount must be 
based on a reasonable assessment of need but must not exceed the higher 
of--
    (i) The more restrictive income standard established under Sec.  
435.121; or
    (ii) The medically needy standard for an individual.
    (3) For an individual with a family at home, an additional amount 
for the maintenance needs of the family. This amount must--
    (i) Be based on a reasonable assessment of their financial need;
    (ii) Be adjusted for the number of family members living in the 
home; and
    (iii) Not exceed the higher of the need standard for a family of the 
same size used to determine eligibility under the State's approved AFDC 
plan or the medically needy income standard established under Sec.  
435.811 for a family of the same size.
    (4) Amounts for incurred expenses for medical or remedial care that 
are not subject to payment by a third party, including--
    (i) Medicare and other health insurance premiums, deductibles, or 
coinsurance charges; and
    (ii) Necessary medical or remedial care recognized under State law 
but not covered under the State's Medicaid plan, subject to reasonable 
limits the agency may establish on amounts of these expenses.

[46 FR 48540, Oct. 1, 1981, as amended at 50 FR 10026, Mar. 13, 1985; 57 
FR 29155, June 30, 1992; 58 FR 4932, Jan. 19, 1993; 59 FR 37716, July 
25, 1994]

[[Page 180]]



     Subpart I_Specific Eligibility and Post-Eligibility Financial 
                  Requirements for the Medically Needy



Sec.  435.800  Scope.

    This subpart prescribes specific financial requirements for 
determining the eligibility of medically needy individuals under subpart 
D of this part.

[58 FR 4932, Jan. 19, 1993]

                     Medically Needy Income Standard



Sec.  435.811  Medically needy income standard: General requirements.

    (a) Except as provided in paragraph (d)(2) of this section, to 
determine eligibility of medically needy individuals, a Medicaid agency 
must use a single income standard under this subpart that meets the 
requirements of this section.
    (b) The income standard must take into account the number of persons 
in the assistance unit. Subject to the limitations specified in 
paragraph (e) of this section. The standard may not diminish by an 
increase in the number of persons in the assistance unit. For example, 
if the income level in the standard for an assistance unit of two is set 
at $400, the income level in the standard for an assistance unit of 
three may not be less than $400.
    (c) In States that do not use more restrictive requirements than 
SSI, the income standard must be set at an amount that is no lower than 
the lowest income standards used under the cash assistance programs that 
are related to the State's covered medically needy eligibility group or 
groups of individuals under Sec.  435.301. The amount of the income 
standard is subject to the limitations specified in paragraph (e) of 
this section.
    (d) In States that use more restrictive requirements for aged, 
blind, and disabled individuals than SSI:
    (1) For all individuals except aged, blind, and disabled 
individuals, the income standard must be set in accordance with 
paragraph (c) of this section; and
    (2) For all aged, blind, and disabled individuals or any combination 
of these groups of individuals, the agency may establish a separate 
single medically needy income standard that is more restrictive than the 
single income standard set under paragraph (c) of this section. However, 
the amount of the more restrictive separate standard for aged, blind, or 
disabled individuals must be no lower than the higher of the lowest 
categorically needy income standard currently applied under the State's 
more restrictive criteria under Sec.  435.121 or the medically needy 
income standard in effect under the State's Medicaid plan on January 1, 
1972. The amount of the income standard is subject to the limitations 
specified in paragraph (e) of this section.
    (e) The income standards specified in paragraphs (c) and (d) of this 
section must not exceed the maximum dollar amount of income allowed for 
purposes of FFP under Sec.  435.1007.
    (f) The income standard may vary based on the variations between 
shelter costs in urban areas and rural areas.

[58 FR 4932, Jan. 19, 1993]



Sec.  435.814  Medically needy income standard: State plan requirements.

    The State plan must specify the income standard for the covered 
medically needy groups.

[58 FR 4933, Jan. 19, 1993]

                   Medically Needy Income Eligibility



Sec.  435.831  Income eligibility.

    The agency must determine income eligibility of medically needy 
individuals in accordance with this section.
    (a) Budget periods. (1) The agency must use budget periods of not 
more than 6 months to compute income. The agency may use more than one 
budget period.
    (2) The agency may include in the budget period in which income is 
computed all or part of the 3-month retroactive period specified in 
Sec.  435.915. The budget period can begin no earlier than the first 
month in the retroactive period in which the individual received covered 
services. This provision applies to all medically needy individuals 
except in groups for whom criteria more restrictive than that used in 
the SSI program apply.
    (3) If the agency elects to begin the first budget period for the 
medically

[[Page 181]]

needy in any month of the 3-month period prior to the date of the 
application in which the applicant received covered services, this 
election applies to all medically needy groups.
    (b) Determining countable income. For purposes of determining 
medically needy eligibility under this part, the agency must determine 
an individual's countable income as follows:
    (1) For individuals under age 21, pregnant women, and parents and 
other caretaker relatives, the agency may apply--
    (i) The AFDC methodologies in effect in the State as of August 16, 
1996, consistent with Sec.  435.601 (relating to financial methodologies 
for non-MAGI eligibility determinations) and Sec.  435.602 (relating to 
financial responsibility of relatives and other individuals for non-MAGI 
eligibility determinations); or
    (ii) The MAGI-based methodologies defined in Sec.  435.603(b) 
through (f). If the agency applies the MAGI-based methodologies defined 
in Sec.  435.603(b) through (f), the agency must comply with the terms 
of Sec.  435.602, except that in applying Sec.  435.602(a)(2)(ii) to 
individuals under age 21, the agency may, at State option, include all 
parents as defined in Sec.  435.603(b) (including stepparents) who are 
living with the individual in the individual's household for purposes of 
determining household income and family size, without regard to whether 
the parent's income and resources would be counted under the State's 
approved State plan under title IV-A of the Act in effect as of July 16, 
1996, if the individual were a dependent child under such State plan.
    (2) For aged, blind, or disabled individuals in States covering all 
SSI beneficiaries, the agency must deduct amounts that would be deducted 
in determining eligibility under SSI. However, the agency must also 
deduct the highest amounts from income that would be deducted in 
determining eligibility for optional State supplements if these 
supplements are paid to all individuals who are receiving SSI or would 
be eligible for SSI except for their income.
    (3) For aged, blind, or disabled individuals in States using income 
requirements more restrictive than SSI, the agency must deduct amounts 
that are no more restrictive than those used under the Medicaid plan on 
January 1, 1972 and no more liberal than those used in determining 
eligibility under SSI or an optional State supplement. However, the 
amounts must be at least the same as those that would be deducted in 
determining eligibility, under Sec.  435.121, of the categorically 
needy.
    (c) Eligibility based on countable income. If countable income 
determined under paragraph (b) of this section is equal to or less than 
that applicable income standard under Sec.  435.814, the individual is 
eligible for Medicaid.
    (d) Deduction of incurred medical expenses. If countable income 
exceeds the income standard, the agency must deduct from income medical 
expenses incurred by the individual or family or financially responsible 
relatives that are not subject to payment by a third party. An expense 
is incurred on the date liability for the expense arises. The agency 
must determine deductible incurred expenses in accordance with 
paragraphs (e), (f), and (g) of this section and deduct those expenses 
in accordance with paragraph (h) of this section.
    (e) Determination of deductible incurred expenses: Required 
deductions based on kinds of services. Subject to the provisions of 
paragraph (g), in determining incurred medical expenses to be deducted 
from income, the agency must include the following:
    (1) Expenses for Medicare and other health insurance premiums, and 
deductibles or coinsurance charges, including enrollment fees, 
copayments, or deductibles imposed under Sec.  447.51 or Sec.  447.53 of 
this subchapter;
    (2) Expenses incurred by the individual or family or financially 
responsible relatives for necessary medical and remedial services that 
are recognized under State law but not included in the plan;
    (3) Expenses incurred by the individual or family or by financially 
responsible relatives for necessary medical and remedial services that 
are included in the plan, including those that exceed agency limitations 
on amount, duration, or scope of services.
    (f) Determination of deductible incurred expenses: Required 
deductions based on

[[Page 182]]

the age of bills. Subject to the provisions of paragraph (g), in 
determining incurred medical expenses to be deducted from income, the 
agency must include the following:
    (1) For the first budget period or periods that include only months 
before the month of application for medical assistance, expenses 
incurred during such period or periods, whether paid or unpaid, to the 
extent that the expenses have not been deducted previously in 
establishing eligibility;
    (2) For the first prospective budget period that also includes any 
of the 3 months before the month of application for medical assistance, 
expenses incurred during such budget period, whether paid or unpaid, to 
the extent that the expenses have not been deducted previously in 
establishing eligibility;
    (3) For the first prospective budget period that includes none of 
the months preceding the month of application, expenses incurred during 
such budget period and any of the 3 preceding months, whether paid or 
unpaid, to the extent that the expenses have not been deducted 
previously in establishing eligibility;
    (4) For any of the 3 months preceding the month of application that 
are not includable under paragraph (f)(2) of this section, expenses 
incurred in the 3-month period that were a current liability of the 
individual in any such month for which a spenddown calculation is made 
and that had not been previously deducted from income in establishing 
eligibility for medical assistance;
    (5) Current payments (that is, payments made in the current budget 
period) on other expenses incurred before the current budget period and 
not previously deducted from income in any budget period in establishing 
eligibility for such period; and
    (6) If the individual's eligibility for medical assistance was 
established in each such preceding period, expenses incurred before the 
current budget period but not previously deducted from income in 
establishing eligibility, to the extent that such expenses are unpaid 
and are:
    (i) Described in paragraphs (e)(1) through (e)(3) of this section; 
and
    (ii) Carried over from the preceding budget period or periods 
because the individual had a spenddown liability in each such preceding 
period that was met without deducting all such incurred, unpaid 
expenses.
    (g) Determination of deductible incurred medical expenses: Optional 
deductions. In determining incurred medical expenses to be deducted from 
income, the agency--
    (1) May include medical institutional expenses (other than expenses 
in acute care facilities) projected to the end of the budget period at 
the Medicaid reimbursement rate;
    (2) May, to the extent determined by the State and specified in its 
approved plan, include expenses incurred earlier than the third month 
before the month of application (except States using more restrictive 
eligibility criteria under the option in section 1902(f) of the Act must 
deduct incurred expenses regardless of when the expenses were incurred); 
and
    (3) May set reasonable limits on the amount to be deducted for 
expenses specified in paragraphs (e)(1), (e)(2), and (g)(2) of this 
section.
    (h) Order of deduction. The agency must deduct incurred medical 
expenses that are deductible under paragraphs (e), (f), and (g) of this 
section in the order prescribed under one of the following three 
options:
    (1) Type of service. Under this option, the agency deducts expenses 
in the following order based on type of expense or service:
    (i) Cost-sharing expenses as specified in paragraph (e)(1) of this 
section.
    (ii) Services not included in the State plan as specified in 
paragraph (e)(2) of this section.
    (iii) Services included in the State plan as specified in paragraph 
(e)(3) of this section but that exceed limitations on amounts, duration, 
or scope of services.
    (iv) Services included in the State plan as specified in paragraph 
(e)(3) of this section but that are within agency limitations on amount, 
duration, or scope of services.
    (2) Chronological order by service date. Under this option, the 
agency deducts expenses in chronological order by the date each service 
is furnished, or in the

[[Page 183]]

case of insurance premiums, coinsurance or deductible charges, the date 
such amounts are due. Expenses for services furnished on the same day 
may be deducted in any reasonable order established by the State.
    (3) Chronological order by bill submission date. Under this option, 
the agency deducts expenses in chronological order by the date each bill 
is submitted to the agency by the individual. If more than one bill is 
submitted at one time, the agency must deduct the bills from income in 
the order prescribed in either paragraph (h)(1) or (h)(2) of this 
section.
    (i) Eligibility based on incurred medical expenses. (1) Whether a 
State elects partial or full month coverage, an individual who is 
expected to contribute a portion of his or her income toward the costs 
of institutional care or home and community-based services under Sec.  
435.725, Sec.  435.726, Sec.  435.733, Sec.  435.735 or Sec.  435.832 is 
eligible on the first day of the applicable budget (spenddown) period--
    (i) If his or her spenddown liability is met after the first day of 
the budget period; and
    (ii) If beginning eligibility after the first day of the budget 
period makes the individual's share of health care expenses under Sec.  
435.725, Sec.  435.726, Sec.  435.733, Sec.  435.735 or Sec.  435.832 
greater than the individual's contributable income determined under 
these sections.
    (2) At the end of the prospective period specified in paragraphs 
(f)(2) and (f)(3) of this section, and any subsequent prospective period 
or, if earlier, when any significant change occurs, the agency must 
reconcile the projected amounts with the actual amounts incurred, or 
with changes in circumstances, to determine if the adjusted deduction of 
incurred expenses reduces income to the income standard.
    (3) Except as provided in paragraph (i)(1) of this section, in 
States that elect partial month coverage, an individual is eligible for 
Medicaid on the day that the deduction of incurred health care expenses 
(and of projected institutional expenses if the agency elects the option 
under paragraph (g)(1) of this section) reduces income to the income 
standard.
    (4) Except as provided in paragraph (i)(1) of this section, in 
States that elect full month coverage, an individual is eligible on the 
first day of the month in which spenddown liability is met.
    (5) Expenses used to meet spenddown liability are not reimbursable 
under Medicaid. To the extent necessary to prevent the transfer of an 
individual's spenddown liability to the Medicaid program, States must 
reduce the amount of provider charges that would otherwise be 
reimbursable under Medicaid.

[59 FR 1672, Jan. 12, 1994, as amended at 77 FR 17208, Mar. 23, 2012; 81 
FR 86457, Nov. 30, 2016]



Sec.  435.832  Post-eligibility treatment of income of institutionalized
individuals: Application of patient income to the cost of care.

    (a) Basic rules. (1) The agency must reduce its payment to an 
institution, for services provided to an individual specified in 
paragraph (b) of this section, by the amount that remains after 
deducting the amounts specified in paragraphs (c) and (d) of this 
section, from the individual's total income.
    (2) The individual's income must be determined in accordance with 
paragraph (e) of this section.
    (3) Medical expenses must be determined in accordance with paragraph 
(f) of this section.
    (b) Applicability. This section applies to medically needy 
individuals in medical institutions and intermediate care facilities.
    (c) Required deductions. The agency must deduct the following 
amounts, in the following order, from the individual's total income, as 
determined under paragraph (e) of this section. Income that was 
disregarded in determining eligibility must be considered in this 
process.
    (1) Personal needs allowance. A personal needs allowance that is 
reasonable in amount for clothing and other personal needs of the 
individual while in the institution. This protected personal needs 
allowance must be at least--
    (i) $30 a month for an aged, blind, or disabled individual, 
including a child

[[Page 184]]

applying for Medicaid on the basis of blindness or diability.
    (ii) $60 a month for an institutionalized couple if both spouses are 
aged, blind, or disabled and their income is considered available to 
each other in determining eligibility; and
    (iii) For other individuals, a reasonable amount set by the agency, 
based on a reasonable difference in their personal needs from those of 
the aged, blind, and disabled.
    (2) Maintenance needs of spouse. For an individual with only a 
spouse at home, an additional amount for the maintenance needs of the 
spouse. This amount must be based on a reasonable assessment of need but 
must not exceed the highest of--
    (i) The amount of the income standard used to determine eligibility 
for SSI for an individual living in his own home;
    (ii) The amount of the highest income standard, in the appropriate 
category of age, blindness, or disability, used to determine eligibility 
for an optional State supplement for an individual in his own home, if 
the agency provides Medicaid to optional State supplement beneficiaries 
under Sec.  435.230; or
    (iii) The amount of the medically needy income standard for one 
person established under Sec.  435.811.
    (3) Maintenance needs of family. For an individual with a family at 
home, an additional amount for the maintenance needs of the family. This 
amount must--
    (i) Be based on a reasonable assessment of their financial need;
    (ii) Be adjusted for the number of family members living in the 
home; and
    (iii) Not exceed the highest of the following need standards for a 
family of the same size:
    (A) The standard used to determine eligibility under the State's 
approved AFDC plan.
    (B) The medically needy income standard established under Sec.  
435.811.
    (4) Expenses not subject to third party payment. Amounts for 
incurred expenses for medical or remedial care that are not subject to 
payment by a third party, including--
    (i) Medicare and other health insurance permiums, deductibles, or 
coinsurance charges; and
    (ii) Necessary medical or remedial care recognized under State law 
but not covered under the State's Medicaid plan, subject to reasonable 
limits the agency may establish on amounts of these expenses.
    (d) Optional deduction: Allowance for home maintenance. For single 
individuals and couples, an amount (in addition to the personal needs 
allowance) for maintenance of the individual's or couple's home if--
    (1) The amount is deducted for not more than a 6-month period; and
    (2) A physician has certified that either of the individuals is 
likely to return to the home within that period.
    (e) Determination of income--(1) Option. In determining the amount 
of an individual's income to be used to reduce the agency's payment to 
the institution, the agency may use total income received or it may 
project total monthly income for a prospective period not to exceed 6 
months.
    (2) Basis for projection. The agency must base the projection on 
income received in the preceding period, not to exceed 6 months, and on 
income expected to be received.
    (3) Adjustments. At the end of the prospective period specified in 
paragraph (e)(1) of this section, or when any significant change occurs, 
the agency must reconcile estimates with income received.
    (f) Determination of medical expenses--(1) Option. In determining 
the amount of medical expenses to be deducted from an individual's 
income, the agency may deduct incurred medical expenses, or it may 
project medical expenses for a prospective period not to exceed 6 
months.
    (2) Basis for projection. The agency must base the estimate on 
medical expenses incurred in the preceding period, not to exceed 6 
months, and medical expenses expected to be incurred.
    (3) Adjustments. At the end of the prospective period specified in 
paragraph (f)(1) of this section, or when any significant change occurs, 
the agency

[[Page 185]]

must reconcile estimates with incurred medical expenses.

[45 FR 24886, Apr. 11, 1980, as amended at 46 FR 47988, Sept. 30, 1981; 
48 FR 5735, Feb. 8, 1983; 53 FR 3596, Feb. 8, 1988; 53 FR 5344, Feb. 23, 
1988; 56 FR 8850, 8854, Mar. 1, 1991; 58 FR 4933, Jan. 19, 1993]

                    Medically Needy Resource Standard



Sec.  435.840  Medically needy resource standard: General requirements.

    (a) To determine eligibility of medically needy individuals, a 
Medicaid agency must use a single resource standard that meets the 
requirements of this section.
    (b) In States that do not use more restrictive criteria than SSI for 
aged, blind, and disabled individuals, the resource standard must be 
established at an amount that is no lower than the lowest resource 
standard used under the cash assistance programs that relate to the 
State's covered medically needy eligibility group or groups of 
individuals under Sec.  435.301.
    (c) In States using more restrictive requirements than SSI:
    (1) For all individuals except aged, blind, and disabled 
individuals, the resource standard must be set in accordance with 
paragraph (b) of this section; and
    (2) For all aged, blind, and disabled individuals or any combination 
of these groups of individuals, the agency may establish a separate 
single medically needy resource standard that is more restrictive than 
the single resource standard set under paragraph (b) of this section. 
However, the amount of the more restrictive separate standard for aged, 
blind, or disabled individuals must be no lower than the higher of the 
lowest categorically needy resource standard currently applied under the 
State's more restrictive criteria under Sec.  435.121 or the medically 
needy resource standard in effect under the State's Medicaid plan on 
January 1, 1972.
    (d) The resource standard established under paragraph (a) of this 
section may not diminish by an increase in the number of persons in the 
assistance unit. For example, the resource standard for an assistance 
unit of three may not be less than that set for a unit of two.

[58 FR 4933, Jan. 19, 1993]



Sec.  435.843  Medically needy resource standard: State plan requirements.

    The State plan must specify the resource standard for the covered 
medically needy groups.

[58 FR 4933, Jan. 19, 1993]

            Determining Eligibility on the Basis of Resources



Sec.  435.845  Medically needy resource eligibility.

    To determine eligibility on the basis of resources for medically 
needy individuals, the agency must:
    (a) Consider only the individual's resources and those that are 
considered available to him under the financial responsibility 
requirements for relatives in Sec.  435.602.
    (b) Deduct the amounts that would be deducted in determining 
resource eligibility for the medically needy group as provided for in 
Sec.  435.601 or under the criteria of States using more restrictive 
criteria than SSI as provided for in Sec.  435.121. In determining the 
amount of an individual's resources for Medicaid eligibility, States 
must count amounts of resources that otherwise would not be counted 
under the conditional eligibility provisions of the SSI or AFDC 
programs.
    (c) Apply the resource standard specified under Sec.  435.840.

[58 FR 4933, Jan. 19, 1993]



Sec. Sec.  435.850-435.852  [Reserved]



      Subpart J_Eligibility in the States and District of Columbia

    Source: 44 FR 17937, Mar. 23, 1979, unless otherwise noted.



Sec.  435.900  Scope.

    This subpart sets forth requirements for processing applications, 
determining eligibility, and furnishing Medicaid.

[[Page 186]]

                    General Methods of Administration



Sec.  435.901  Consistency with objectives and statutes.

    The Medicaid agency's standards and methods for providing 
information to applicants and beneficiaries and for determining 
eligibility must be consistent with the objectives of the program and 
with the rights of individuals under the United States Constitution, the 
Social Security Act, title VI of the Civil Rights Act of 1964, section 
504 of the Rehabilitation Act of 1973, the Americans with Disabilities 
Act of 1990, the Age Discrimination Act of 1975, section 1557 of the 
Affordable Care Act, and all other relevant provisions of Federal and 
State laws and their respective implementing regulations.

[81 FR 86457, Nov. 30, 2016]



Sec.  435.902  Simplicity of administration.

    The agency's policies and procedures must ensure that eligibility is 
determined in a manner consistent with simplicity of administration and 
the best interests of the applicant or beneficiary.

[44 FR 17937, Mar. 23, 1979. Redesignated at 59 FR 48809, Sept. 23, 
1994]



Sec.  435.903  Adherence of local agencies to State plan requirements.

    The agency must--
    (a) Have methods to keep itself currently informed of the adherence 
of local agencies to the State plan provisions and the agency's 
procedures for determining eligibility; and
    (b) Take corrective action to ensure their adherence.

[44 FR 17937, Mar. 23, 1979. Redesignated at 59 FR 48809, Sept. 23, 
1994]



Sec.  435.904  Establishment of outstation locations to process 
applications for certain low-income eligibility groups.

    (a) State plan requirements. The Medicaid State plan must specify 
that the requirements of this section are met.
    (b) Opportunity to apply. The agency must provide an opportunity for 
the following groups of low-income pregnant women, infants, and children 
under age 19 to apply for Medicaid at outstation locations other than 
AFDC offices:
    (1) The groups of pregnant women or infants with incomes up to 133 
percent of the Federal poverty level as specified under section 
1902(a)(10)(A)(i)(IV) of the Act;
    (2) The group of children age 1 up to age 6 with incomes at 133 
percent of the Federal poverty level as specified under section 
1902(a)(10)(A)(i)(VI) of the Act;
    (3) The group of children age 6 up to age 19 born after September 
30, 1983, with incomes up to 100 percent of the Federal poverty level as 
specified under section 1902(a)(10)(A)(i)(VII) of the Act; and
    (4) The groups of pregnant women or infants, children age 1 up to 
age 6, and children age 6 up to age 19, who are not eligible as a 
mandatory group, with incomes up to 185 percent of the Federal poverty 
level as specified under section 1902(a)(10)(A)(ii)(IX) of the Act.
    (c) Outstation locations: general requirements. (1) The agency must 
establish either--
    (i) Outstation locations at each disproportionate share hospital, as 
defined in section 1923(a)(1)(A) of the Act, and each Federally-
qualified health center, as defined in section 1905(1)(2)(B) of the Act, 
participating in the Medicaid program and providing services to 
Medicaid-eligible pregnant women and children; or
    (ii) Other outstation locations, which include at least some, 
disproportionate share hospitals and federally-qualified health centers, 
as specified under an alternative State plan that is submitted to and 
approved by CMS if the following conditions are met:
    (A) The State must demonstrate that the alternative plan for 
outstationing is equally effective as, or more effective than, a plan 
that would meet the requirements of paragraph (c)(1)(i) of this section 
in enabling the individuals described in paragraph (b) of this section 
to apply for and receive Medicaid; and
    (B) The State must provide assurances that the level of staffing and 
funding committed by the State under the alternative plan equals or 
exceeds the level of staffing and funding under

[[Page 187]]

a plan that would meet the requirements of establishing the outstation 
locations at the sites specified in paragraph (c)(1)(i) of this section.
    (2) The agency must establish outstation locations at Indian health 
clinics operated by a tribe or tribal organization as these clinics are 
specifically included in the definition of Federally-qualified health 
centers under section 1905(l)(2)(B) of the Act and are also included in 
the definition of rural health clinics under part 491, subpart A of this 
chapter.
    (3) The agency may establish additional outstation locations at any 
other site where potentially eligible pregnant women or children receive 
services--for example, at school-linked service centers and family 
support centers. These additional sites may also include sites other 
than the main outstation location of those Federally-qualified health 
centers or disproportionate share hospitals providing services to 
Medicaid-eligible pregnant women and to children and that operate more 
than one site.
    (4) The agency may, at its option, enter into reciprocal agreements 
with neighboring States to ensure that the groups described in paragraph 
(b) of this section who customarily receive services in a neighboring 
State have the opportunity to apply at outstation locations specified in 
paragraphs (c)(l) and (2) of this section.
    (d) Outstation functions. (1) The agency must provide for the 
receipt and initial processing of Medicaid applications from the 
designated eligibility groups at each outstation location.
    (2) ``Initial processing'' means taking applications, assisting 
applicants in completing the application, providing information and 
referrals, obtaining required documentation to complete processing of 
the application, assuring that the information contained on the 
application form is complete, and conducting any necessary interviews. 
It does not include evaluating the information contained on the 
application and the supporting documentation nor making a determination 
of eligibility or ineligibility.
    (3) The agency may, at its option, allow appropriate State 
eligibility workers assigned to outstation locations to evaluate the 
information contained on the application and the supporting 
documentation and make a determination of eligibility if the workers are 
authorized to determine eligibility for the agency which determines 
Medicaid eligibility under Sec.  431.10 of this subchapter.
    (e) Staffing. (1) Except for outstation locations that are 
infrequently used by the low-income eligibility groups, the State agency 
must have staff available at each outstation location during the regular 
office operating hours of the State Medicaid agency to accept 
applications and to assist applicants with the application process.
    (2) The agency may station staff at one outstation location or 
rotate staff among several locations as workload and staffing 
availability dictate.
    (3) The agency may use State employees, provider or contractor 
employees, or volunteers who have been properly trained to staff 
outstation locations under the following conditions:
    (i) State outstation intake staff may perform all eligibility 
processing functions, including the eligibility determination, if the 
staff is authorized to do so at the regular Medicaid intake office.
    (ii) Provider or contractor employees and volunteers may perform 
only initial processing functions as defined in paragraph (d)(2) of this 
section.
    (4) Provider and contractor employees and volunteers are subject to 
the confidentiality of information rules specified in part 431, subpart 
F, of this subchapter, to the prohibition against reassignment of 
provider claims specified in Sec.  447.10 of this subchapter, and to all 
other State or Federal laws concerning conflicts of interest.
    (5) At locations that are infrequently used by the designated low-
income eligibility groups, the State agency may use volunteers, provider 
or contractor employees, or its own eligibility staff, or telephone 
assistance.
    (i) The agency must display a notice in a prominent place at the 
outstation location advising potential applicants of when outstation 
intake workers will be available.
    (ii) The notice must include a telephone number that applicants may 
call for assistance.

[[Page 188]]

    (iii) The agency must comply with Federal and State laws and 
regulations governing the provision of adequate notice to persons who 
are blind or deaf or who are unable to read or understand the English 
language.

[59 FR 48809, Sept. 23, 1994]

                              Applications



Sec.  435.905  Availability and accessibility of program information.

    (a) The agency must furnish the following information in electronic 
and paper formats (including through the Internet Web site described in 
Sec.  435.1200(f) of this part), and orally as appropriate, to all 
applicants and other individuals who request it:
    (1) The eligibility requirements;
    (2) Available Medicaid services; and
    (3) The rights and responsibilities of applicants and beneficiaries.
    (b) Such information must be provided to applicants and 
beneficiaries in plain language and in a manner that is accessible and 
timely to--
    (1) Individuals who are limited English proficient through the 
provision of language services at no cost to the individual including, 
oral interpretation and written translations;
    (2) Individuals living with disabilities through the provision of 
auxiliary aids and services at no cost to the individual in accordance 
with the Americans with Disabilities Act and section 504 of the 
Rehabilitation Act; and
    (3) Individuals must be informed of the availability of the 
accessible information and language services described in this paragraph 
and how to access such information and services, at a minimum through 
providing taglines in non-English languages indicating the availability 
of language services.

[77 FR 17208, Mar. 23, 2012, as amended at 81 FR 86457, Nov. 30, 2016]



Sec.  435.906  Opportunity to apply.

    The agency must afford an individual wishing to do so the 
opportunity to apply for Medicaid without delay.



Sec.  435.907  Application.

    (a) Basis and implementation. In accordance with section 
1413(b)(1)(A) of the Affordable Care Act, the agency must accept an 
application from the applicant, an adult who is in the applicant's 
household, as defined in Sec.  435.603(f), or family, as defined in 
section 36B(d)(1) of the Code, an authorized representative, or if the 
applicant is a minor or incapacitated, someone acting responsibly for 
the applicant, and any documentation required to establish eligibility--
    (1) Via the internet Web site described in Sec.  435.1200(f) of this 
part;
    (2) By telephone;
    (3) Via mail;
    (4) In person; and
    (5) Through other commonly available electronic means.
    (b) The application must be--
    (1) The single, streamlined application for all insurance 
affordability programs developed by the Secretary; or
    (2) An alternative single, streamlined application for all insurance 
affordability programs, which may be no more burdensome on the applicant 
than the application described in paragraph (b)(1) of this section, 
approved by the Secretary.
    (c) For individuals applying, or who may be eligible, for assistance 
on a basis other than the applicable MAGI standard in accordance with 
Sec.  435.911(c)(2) of this part, the agency may use either--
    (1) An application described in paragraph (b) of this section and 
supplemental forms to collect additional information needed to determine 
eligibility on such other basis; or
    (2) An application designed specifically to determine eligibility on 
a basis other than the applicable MAGI standard. Such application must 
minimize burden on applicants.
    (3) Any MAGI-exempt applications and supplemental forms in use by 
the agency must be submitted to the Secretary.
    (d) The agency may not require an in-person interview as part of the 
application process for a determination of eligibility using MAGI-based 
income.
    (e) Limits on information. (1) The agency may only require an 
applicant to provide the information necessary to make an eligibility 
determination or for a purpose directly connected to the administration 
of the State plan.

[[Page 189]]

    (2) The agency may request information necessary to determine 
eligibility for other insurance affordability or benefit programs.
    (3) The agency may request a non-applicant's SSN provided that--
    (i) Provision of such SSN is voluntary;
    (ii) Such SSN is used only to determine an applicant's or 
beneficiary's eligibility for Medicaid or other insurance affordability 
program or for a purpose directly connected to the administration of the 
State plan; and
    (iii) At the time such SSN is requested, the agency provides clear 
notice to the individual seeking assistance, or person acting on such 
individual's behalf, that provision of the non-applicant's SSN is 
voluntary and information regarding how the SSN will be used.
    (f) The agency must require that all initial applications are signed 
under penalty of perjury. Electronic, including telephonically recorded, 
signatures and handwritten signatures transmitted via any other 
electronic transmission must be accepted.
    (g) Any application or supplemental form must be accessible to 
persons who are limited English proficient and persons who have 
disabilities, consistent with Sec.  435.905(b) of this subpart.
    (h) Reinstatement of withdrawn applications. (1) In the case of 
individuals described in paragraph (h)(2) of this section, the agency 
must reinstate the application submitted by the individual, effective as 
of the date the application was first received by the Exchange.
    (2) Individuals described in this paragraph are individuals who--
    (i) Submitted an application described in paragraph (b) of this 
section to the Exchange;
    (ii) Withdrew their application for Medicaid in accordance with 45 
CFR 155.302(b)(4)(A);
    (iii) Are assessed as potentially eligible for Medicaid by the 
Exchange appeals entity.

[77 FR 17208, Mar. 23, 2012, as amended at 78 FR 42302, July 15, 2013]



Sec.  435.908  Assistance with application and renewal.

    (a) The agency must provide assistance to any individual seeking 
help with the application or renewal process in person, over the 
telephone, and online, and in a manner that is accessible to individuals 
with disabilities and those who are limited English proficient, 
consistent with Sec.  435.905(b) of this subpart.
    (b) The agency must allow individual(s) of the applicant or 
beneficiary's choice to assist in the application process or during a 
renewal of eligibility.
    (c) Certified Application Counselors. (1) At State option, the 
agency may certify staff and volunteers of State-designated 
organizations to act as application assisters, authorized to provide 
assistance to applicants and beneficiaries with the application process 
and during renewal of eligibility. To be certified, application 
assisters must be--
    (i) Authorized and registered by the agency to provide assistance at 
application and renewal;
    (ii) Effectively trained in the eligibility and benefits rules and 
regulations governing enrollment in a QHP through the Exchange and all 
insurance affordability programs operated in the State, as implemented 
in the State; and
    (iii) Trained in and adhere to all rules regulations relating to the 
safeguarding and confidentiality of information and prohibiting conflict 
of interest, including regulations set forth at part 431, subpart F of 
this chapter, and at 45 CFR 155.260(f), regulations relating to the 
prohibition against reassignment of provider claims specified in Sec.  
447.10 of this chapter, and all other State and Federal laws concerning 
conflicts of interest and confidentiality of information.
    (2) For purposes of this section, assistance includes providing 
information on insurance affordability programs and coverage options, 
helping individuals complete an application or renewal, working with the 
individual to provide required documentation, submitting applications 
and renewals to the agency, interacting with the

[[Page 190]]

agency on the status of such applications and renewals, assisting 
individuals with responding to any requests from the agency, and 
managing their case between the eligibility determination and regularly 
scheduled renewals. Application assisters may be certified by the agency 
to act on behalf of applicants and beneficiaries for one, some or all of 
the permitted assistance activities.
    (3) If the agency elects to certify application assisters, it must 
establish procedures to ensure that--
    (i) Applicants and beneficiaries are informed of the functions and 
responsibilities of certified application assisters;
    (ii) Individuals are able to authorize application assisters to 
receive confidential information about the individual related to the 
individual's application for or renewal of Medicaid; and
    (iii) The agency does not disclose confidential applicant or 
beneficiary information to an application assister unless the applicant 
or beneficiary has authorized the application assister to receive such 
information.
    (4) Application assisters may not impose, accept or receive payment 
or compensation in any form from applicants or beneficiaries for 
application assistance.

[77 FR 17208, Mar. 23, 2012, as amended at 78 FR 42302, July 15, 2013]



Sec.  435.909  Automatic entitlement to Medicaid following a determination
of eligibility under other programs.

    The agency must not require a separate application for Medicaid from 
an individual, if--
    (a) [Reserved]
    (b) The agency has an agreement with the Social Security 
Administration (SSA) under section 1634 of the Act for determining 
Medicaid eligibility; and--
    (1) The individual receives SSI;
    (2) The individual receives a mandatory State supplement under 
either a federally-administered or State-administered program; or
    (3) The individual receives an optional State supplement and the 
agency provides Medicaid to beneficiaries of optional supplements under 
Sec.  435.230.

[44 FR 17937, Mar. 23, 1979, as amended at 81 FR 86457, Nov. 30, 2016]



Sec.  435.910  Use of social security number.

    (a) Except as provided in paragraph (h) of this section, the agency 
must require, as a condition of eligibility, that each individual 
(including children) seeking Medicaid furnish each of his or her Social 
Security numbers (SSN).
    (b) The agency must advise the applicant of--
    (1) [Reserved]
    (2) The statute or other authority under which the agency is 
requesting the applicant's SSN; and
    (3) The uses the agency will make of each SSN, including its use for 
verifying income, eligibility, and amount of medical assistance payments 
under Sec. Sec.  435.940 through 435.960.
    (c)-(d) [Reserved]
    (e) If an applicant cannot recall his SSN or SSNs or has not been 
issued a SSN the agency must--
    (1) Assist the applicant in completing an application for an SSN;
    (2) Obtain evidence required under SSA regulations to establish the 
age, the citizenship or alien status, and the true identity of the 
applicant; and
    (3) Either send the application to SSA or, if there is evidence that 
the applicant has previously been issued a SSN, request SSA to furnish 
the number.
    (f) The agency must not deny or delay services to an otherwise 
eligible individual pending issuance or verification of the individual's 
SSN by SSA or if the individual meets one of the exceptions in paragraph 
(h) of this section.
    (g) The agency must verify the SSN furnished by an applicant or 
beneficiary with SSA to ensure the SSN was issued to that individual, 
and to determine whether any other SSNs were issued to that individual.
    (h) Exception. (1) The requirement of paragraph (a) of this section 
does not apply and a State may give a Medicaid identification number to 
an individual who--
    (i) Is not eligible to receive an SSN;

[[Page 191]]

    (ii) Does not have an SSN and may only be issued an SSN for a valid 
non-work reason in accordance with 20 CFR 422.104; or
    (iii) Refuses to obtain an SSN because of well-established religious 
objections.
    (2) The identification number may be either an SSN obtained by the 
State on the applicant's behalf or another unique identifier.
    (3) The term well established religious objections means that the 
applicant--
    (i) Is a member of a recognized religious sect or division of the 
sect; and
    (ii) Adheres to the tenets or teachings of the sect or division of 
the sect and for that reason is conscientiously opposed to applying for 
or using a national identification number.
    (4) A State may use the Medicaid identification number established 
by the State to the same extent as an SSN is used for purposes described 
in paragraph (b)(3) of this section.

[44 FR 17937, Mar. 23, 1979, as amended at 51 FR 7211, Feb. 28, 1986; 66 
FR 2667, Jan. 11, 2001; 77 FR 17209, Mar. 23, 2012; 81 FR 86457, Nov. 
30, 2016]

                  Determination of Medicaid Eligibility



Sec.  435.911  Determination of eligibility.

    (a) Statutory basis. This section implements sections 1902(a)(4), 
(a)(8), (a)(10)(A), (a)(19), and (e)(14) and section 1943 of the Act.
    (b)(1) Except as provided in paragraph (b)(2) of this section, 
applicable modified adjusted gross income standard means 133 percent of 
the Federal poverty level or, if higher -
    (i) In the case of parents and other caretaker relatives described 
in Sec.  435.110(b), the income standard established in accordance with 
Sec.  435.110(c) or Sec.  435.220(c);
    (ii) In the case of pregnant women, the income standard established 
in accordance with Sec.  435.116(c) of this part;
    (iii) In the case of individuals under age 19, the income standard 
established in accordance with Sec.  435.118(c) of this part;
    (iv) The income standard established under Sec.  435.218(b)(1)(iv) 
of this part, if the State has elected to provide coverage under such 
section and, if applicable, coverage under the State's phase-in plan has 
been implemented for the individual whose eligibility is being 
determined.
    (2) In the case of individuals who have attained at least age 65 and 
individuals who have attained at least age 19 and who are entitled to or 
enrolled for Medicare benefits under part A or B or title XVIII of the 
Act, there is no applicable modified adjusted gross income standard, 
except that in the case of such individuals--
    (i) Who are also pregnant, the applicable modified adjusted gross 
income standard is the standard established under paragraph (b)(1) of 
this section; or
    (ii) Who are also a parent or caretaker relative, as described in 
Sec.  435.4, the applicable modified adjusted gross income standard is 
the higher of the income standard established in accordance with Sec.  
435.110(c) or Sec.  435.220(c).
    (c) For each individual who has submitted an application described 
in Sec.  435.907 or whose eligibility is being renewed in accordance 
with Sec.  435.916 and who meets the non-financial requirements for 
eligibility (or for whom the agency is providing a reasonable 
opportunity to verify citizenship or immigration status in accordance 
with Sec.  435.956(b)) of this chapter, the State Medicaid agency must 
comply with the following--
    (1) The agency must, promptly and without undue delay consistent 
with timeliness standards established under Sec.  435.912, furnish 
Medicaid to each such individual whose household income is at or below 
the applicable modified adjusted gross income standard.
    (2) For each individual described in paragraph (d) of this section, 
the agency must collect such additional information as may be needed 
consistent with Sec.  435.907(c), to determine whether such individual 
is eligible for Medicaid on any basis other than the applicable modified 
adjusted gross income standard, and furnish Medicaid on such basis.
    (3) For individuals not eligible on the basis of the applicable 
modified adjusted gross income standard, the agency must comply with the 
requirements set forth in Sec.  435.1200(e) of this part.

[[Page 192]]

    (d) For purposes of paragraph (c)(2) of this section, individuals 
described in this paragraph include:
    (1) Individuals whom the agency identifies, on the basis of 
information contained in an application described in Sec.  435.907(b) of 
this part, or renewal form described in Sec.  435.916(a)(3) of this 
part, or on the basis of other information available to the State, as 
potentially eligible on a basis other than the applicable MAGI standard;
    (2) Individuals who submit an alternative application described in 
Sec.  435.907(c) of this part; and
    (3) Individuals who otherwise request a determination of eligibility 
on a basis other than the applicable MAGI standard as described in Sec.  
435.603(j) of this part.

[77 FR 17209, Mar. 23, 2012, as amended at 81 FR 86457, Nov. 30, 2016]



Sec.  435.912  Timely determination of eligibility.

    (a) For purposes of this section--
    (1) ``Timeliness standards'' refer to the maximum period of time in 
which every applicant is entitled to a determination of eligibility, 
subject to the exceptions in paragraph (e) of this section.
    (2) ``Performance standards'' are overall standards for determining 
eligibility in an efficient and timely manner across a pool of 
applicants, and include standards for accuracy and consumer 
satisfaction, but do not include standards for an individual applicant's 
determination of eligibility.
    (b) Consistent with guidance issued by the Secretary, the agency 
must establish in its State plan timeliness and performance standards 
for, promptly and without undue delay--
    (1) Determining eligibility for Medicaid for individuals who submit 
applications to the single State agency or its designee.
    (2) Determining potential eligibility for, and transferring 
individuals' electronic accounts to, other insurance affordability 
programs pursuant to Sec.  435.1200(e) of this part.
    (3) Determining eligibility for Medicaid for individuals whose 
accounts are transferred from other insurance affordability programs, 
including at initial application as well as at a regularly-scheduled 
renewal or due to a change in circumstances.
    (c)(1) The timeliness and performance standards adopted by the 
agency under paragraph (b) of this section must cover the period from 
the date of application or transfer from another insurance affordability 
program to the date the agency notifies the applicant of its decision or 
the date the agency transfers the individual to another insurance 
affordability program in accordance with Sec.  435.1200(e) of this part, 
and must comply with the requirements of paragraph (c)(2) of this 
section, subject to additional guidance issued by the Secretary to 
promote accountability and consistency of high quality consumer 
experience among States and between insurance affordability programs.
    (2) Timeliness and performance standards included in the State plan 
must account for--
    (i) The capabilities and cost of generally available systems and 
technologies;
    (ii) The general availability of electronic data matching and ease 
of connections to electronic sources of authoritative information to 
determine and verify eligibility;
    (iii) The demonstrated performance and timeliness experience of 
State Medicaid, CHIP and other insurance affordability programs, as 
reflected in data reported to the Secretary or otherwise available; and
    (iv) The needs of applicants, including applicant preferences for 
mode of application (such as through an internet Web site, telephone, 
mail, in-person, or other commonly available electronic means), as well 
as the relative complexity of adjudicating the eligibility determination 
based on household, income or other relevant information.
    (3) Except as provided in paragraph (e) of this section, the 
determination of eligibility for any applicant may not exceed--
    (i) Ninety days for applicants who apply for Medicaid on the basis 
of disability; and
    (ii) Forty-five days for all other applicants.
    (d) The agency must inform applicants of the timeliness standards

[[Page 193]]

adopted in accordance with this section.
    (e) The agency must determine eligibility within the standards 
except in unusual circumstances, for example--
    (1) When the agency cannot reach a decision because the applicant or 
an examining physician delays or fails to take a required action, or
    (2) When there is an administrative or other emergency beyond the 
agency's control.
    (f) The agency must document the reasons for delay in the 
applicant's case record.
    (g) The agency must not use the time standards--
    (1) As a waiting period before determining eligibility; or
    (2) As a reason for denying eligibility (because it has not 
determined eligibility within the time standards).

[44 FR 17937, Mar. 23, 1979, as amended at 45 FR 24887, Apr. 11, 1980; 
54 FR 50762, Dec. 11, 1989. Redesignated and amended at 77 FR 17209, 
Mar. 23, 2012]



Sec.  435.914  Case documentation.

    (a) The agency must include in each applicant's case record facts to 
support the agency's decision on his application.
    (b) The agency must dispose of each application by a finding of 
eligibility or ineligibility, unless--
    (1) There is an entry in the case record that the applicant 
voluntarily withdrew the application, and that the agency sent a notice 
confirming his decision;
    (2) There is a supporting entry in the case record that the 
applicant has died; or
    (3) There is a supporting entry in the case record that the 
applicant cannot be located.

[44 FR 17937, Mar. 23, 1979. Redesignated at 77 FR 17209, Mar. 23, 2012]



Sec.  435.915  Effective date.

    (a) The agency must make eligibility for Medicaid effective no later 
than the third month before the month of application if the individual--
    (1) Received Medicaid services, at any time during that period, of a 
type covered under the plan; and
    (2) Would have been eligible for Medicaid at the time he received 
the services if he had applied (or someone had applied for him), 
regardless of whether the individual is alive when application for 
Medicaid is made.
    (b) The agency may make eligiblity for Medicaid effective on the 
first day of a month if an individual was eligible at any time during 
that month.
    (c) The State plan must specify the date on which eligibility will 
be made effective.

[44 FR 17937, Mar. 23, 1979. Redesignated at 77 FR 17209, Mar. 23, 2012]

                Redeterminations of Medicaid Eligibility



Sec.  435.916  Periodic renewal of Medicaid eligibility.

    (a) Renewal of individuals whose Medicaid eligibility is based on 
modified adjusted gross income methods (MAGI). (1) Except as provided in 
paragraph (d) of this section, the eligibility of Medicaid beneficiaries 
whose financial eligibility is determined using MAGI-based income must 
be renewed once every 12 months, and no more frequently than once every 
12 months.
    (2) Renewal on basis of information available to agency. The agency 
must make a redetermination of eligibility without requiring information 
from the individual if able to do so based on reliable information 
contained in the individual's account or other more current information 
available to the agency, including but not limited to information 
accessed through any data bases accessed by the agency under Sec. Sec.  
435.948, 435.949 and 435.956 of this part. If the agency is able to 
renew eligibility based on such information, the agency must, consistent 
with the requirements of this subpart and subpart E of part 431 of this 
chapter, notify the individual--
    (i) Of the eligibility determination, and basis; and
    (ii) That the individual must inform the agency, through any of the 
modes permitted for submission of applications under Sec.  435.907(a) of 
this subpart, if any of the information contained in such notice is 
inaccurate, but that the individual is not required to sign and return 
such notice if all information provided on such notice is accurate.

[[Page 194]]

    (3) Use of a pre-populated renewal form. If the agency cannot renew 
eligibility in accordance with paragraph (a)(2) of this section, the 
agency must--
    (i) Provide the individual with--
    (A) A renewal form containing information, as specified by the 
Secretary, available to the agency that is needed to renew eligibility.
    (B) At least 30 days from the date of the renewal form to respond 
and provide any necessary information through any of the modes of 
submission specified in Sec.  435.907(a) of this part, and to sign the 
renewal form in a manner consistent with Sec.  435.907(f) of the part;
    (C) Notice of the agency's decision concerning the renewal of 
eligibility in accordance with this subpart and subpart E of part 431 of 
this chapter;
    (ii) Verify any information provided by the beneficiary in 
accordance with Sec. Sec.  435.945 through 435.956 of this part;
    (iii) Reconsider in a timely manner the eligibility of an individual 
who is terminated for failure to submit the renewal form or necessary 
information, if the individual subsequently submits the renewal form 
within 90 days after the date of termination, or a longer period elected 
by the State, without requiring a new application;
    (iv) Not require an individual to complete an in-person interview as 
part of the renewal process.
    (b) Redetermination of individuals whose Medicaid eligibility is 
determined on a basis other than modified adjusted gross income. The 
agency must redetermine the eligibility of Medicaid beneficiaries 
excepted from modified adjusted gross income under Sec.  435.603(j) of 
this part, for circumstances that may change, at least every 12 months. 
The agency must make a redetermination of eligibility in accordance with 
the provisions of paragraph (a)(2) of this section, if sufficient 
information is available to do so. The agency may adopt the procedures 
described at Sec.  435.916(a)(3) for individuals whose eligibility 
cannot be renewed in accordance with paragraph (a)(2) of this section.
    (1) The agency may consider blindness as continuing until the 
reviewing physician under Sec.  435.531 of this part determines that a 
beneficiary's vision has improved beyond the definition of blindness 
contained in the plan; and
    (2) The agency may consider disability as continuing until the 
review team, under Sec.  435.541 of this part, determines that a 
beneficiary's disability no longer meets the definition of disability 
contained in the plan.
    (c) Procedures for reporting changes. The agency must have 
procedures designed to ensure that beneficiaries make timely and 
accurate reports of any change in circumstances that may affect their 
eligibility and that such changes may be reported through any of the 
modes for submission of applications described in Sec.  435.907(a) of 
this part.
    (d) Agency action on information about changes. (1) Consistent with 
the requirements of Sec.  435.952 of this part, the agency must promptly 
redetermine eligibility between regular renewals of eligibility 
described in paragraphs (b) and (c) of this section whenever it receives 
information about a change in a beneficiary's circumstances that may 
affect eligibility.
    (i) For renewals of Medicaid beneficiaries whose financial 
eligibility is determined using MAGI-based income, the agency must limit 
any requests for additional information from the individual to 
information relating to such change in circumstance.
    (ii) If the agency has enough information available to it to renew 
eligibility with respect to all eligibility criteria, the agency may 
begin a new 12-month renewal period under paragraphs (a) or (b) of this 
section.
    (2) If the agency has information about anticipated changes in a 
beneficiary's circumstances that may affect his or her eligibility, it 
must redetermine eligibility at the appropriate time based on such 
changes.
    (e) The agency may request from beneficiaries only the information 
needed to renew eligibility. Requests for non-applicant information must 
be conducted in accordance with Sec.  435.907(e) of this part.
    (f) Determination of ineligibility and transmission of data 
pertaining to individuals no longer eligible for Medicaid.

[[Page 195]]

    (1) Prior to making a determination of ineligibility, the agency 
must consider all bases of eligibility, consistent with Sec.  435.911 of 
this part.
    (2) For individuals determined ineligible for Medicaid, the agency 
must determine potential eligibility for other insurance affordability 
programs and comply with the procedures set forth in Sec.  435.1200(e) 
of this part.
    (g) Any renewal form or notice must be accessible to persons who are 
limited English proficient and persons with disabilities, consistent 
with Sec.  435.905(b) of this subpart.

[77 FR 17210, Mar. 23, 2012]



Sec.  435.917  Notice of agency's decision concerning eligibility,
benefits, or services.

    (a) Notice of eligibility determinations. Consistent with Sec. Sec.  
431.206 through 431.214 of this chapter, the agency must provide all 
applicants and beneficiaries with timely and adequate written notice of 
any decision affecting their eligibility, including an approval, denial, 
termination or suspension of eligibility, or a denial or change in 
benefits and services. Such notice must--
    (1) Be written in plain language;
    (2) Be accessible to persons who are limited English proficient and 
individuals with disabilities, consistent with Sec.  435.905(b), and
    (3) If provided in electronic format, comply with Sec.  435.918(b).
    (b) Content of eligibility notice--(1) Notice of approved 
eligibility. Any notice of an approval of Medicaid eligibility must 
include, but is not limited to, clear statements containing the 
following information--
    (i) The basis and effective date of eligibility;
    (ii) The circumstances under which the individual must report, and 
procedures for reporting, any changes that may affect the individual's 
eligibility;
    (iii) If applicable, the amount of medical expenses which must be 
incurred to establish eligibility in accordance with Sec.  435.121 or 
Sec.  435.831.
    (iv) Basic information on the level of benefits and services 
available based on the individual's eligibility, including, if 
applicable--
    (A) The differences in coverage available to individuals enrolled in 
benchmark or benchmark-equivalent coverage or in an Alternative Benefits 
Plan and coverage available to individuals described in Sec.  440.315 of 
this chapter (relating to exemptions from mandatory enrollment in 
benchmark or benchmark-equivalent coverage);
    (B) A description of any premiums and cost sharing required under 
Part 447 Subpart A of this chapter;
    (C) An explanation of how to receive additional detailed information 
on benefits and financial responsibilities; and
    (D) An explanation of any right to appeal the eligibility status or 
level of benefits and services approved.
    (2) Notice of adverse action including denial, termination or 
suspension of eligibility or change in benefits or services. Any notice 
of denial, termination or suspension of Medicaid eligibility or change 
in benefits or services must be consistent with Sec.  431.210 of this 
chapter.
    (c) Eligibility. Whenever an approval, denial, or termination of 
eligibility is based on an applicant's or beneficiary's having household 
income at or below the applicable modified adjusted gross income 
standard in accordance with Sec.  435.911, the eligibility notice must 
contain--
    (1) Information regarding bases of eligibility other than the 
applicable modified adjusted gross income standard and the benefits and 
services afforded to individuals eligible on such other bases, 
sufficient to enable the individual to make an informed choice as to 
whether to request a determination on such other bases; and
    (2) Information on how to request a determination on such other 
bases;
    (d) Combined Eligibility Notice. The agency's responsibility to 
provide notice under this section is satisfied by a combined eligibility 
notice, as defined in Sec.  435.4, provided by the Exchange or other 
insurance affordability program in accordance with an agreement between 
the agency and such program consummated in accordance with Sec.  
435.1200(b)(3), except that, if the information described in paragraph 
(b)(1)(iii) and (iv) of this section is not included in such combined 
eligibility notice, the agency must provide the individual with a 
supplemental notice of

[[Page 196]]

such information, consistent with this section.

[81 FR 86458, Nov. 30, 2016]



Sec.  435.918  Use of electronic notices.

    (a) Effective no earlier than October 1, 2013 and no later than 
January 1, 2015, the agency must provide individuals with a choice to 
receive notices and information required under this part or subpart E of 
part 431 of this chapter in electronic format or by regular mail and 
must be permitted to change such election.
    (b) If the individual elects to receive communications from the 
agency electronically, the agency must--
    (1) Ensure that the individual's election to receive notices 
electronically is confirmed by regular mail.
    (2) Ensure that the individual is informed of his or her right to 
change such election to receive notices through regular mail.
    (3) Post notices to the individual's electronic account within 1 
business day of notice generation.
    (4) Send an email or other electronic communication alerting the 
individual that a notice has been posted to his or her account. The 
agency may not include confidential information in the email or 
electronic alert.
    (5) Send a notice by regular mail within three business days of the 
date of a failed electronic communication if an electronic communication 
is undeliverable.
    (6) At the individual's request, provide through regular mail any 
notice posted to the individual's electronic account.

[78 FR 42303, July 15, 2013]



Sec.  435.920  Verification of SSNs.

    (a) In redetermining eligibility, the agency must review case 
records to determine whether they contain the beneficiary's SSN or, in 
the case of families, each family member's SSN.
    (b) If the case record does not contain the required SSNs, the 
agency must require the beneficiary to furnish them and meet other 
requirements of Sec.  435.910.
    (c) For any beneficiary whose SSN was established as part of the 
case record without evidence required under the SSA regulations as to 
age, citizenship, alien status, or true identity, the agency must obtain 
verification of these factors in accordance with Sec.  435.910.

[44 FR 17937, Mar. 23, 1979, as amended at 51 FR 7211, Feb. 28, 1986]



Sec.  435.923  Authorized representatives.

    (a)(1) The agency must permit applicants and beneficiaries to 
designate an individual or organization to act responsibly on their 
behalf in assisting with the individual's application and renewal of 
eligibility and other ongoing communications with the agency. Such a 
designation must be in accordance with paragraph (f) of this section, 
including the applicant's signature, and must be permitted at the time 
of application and at other times.
    (2) Authority for an individual or entity to act on behalf of an 
applicant or beneficiary accorded under state law, including but not 
limited to, a court order establishing legal guardianship or a power of 
attorney, must be treated as a written designation by the applicant or 
beneficiary of authorized representation.
    (b) Applicants and beneficiaries may authorize their representatives 
to--
    (1) Sign an application on the applicant's behalf;
    (2) Complete and submit a renewal form;
    (3) Receive copies of the applicant or beneficiary's notices and 
other communications from the agency;
    (4) Act on behalf of the applicant or beneficiary in all other 
matters with the agency.
    (c) The power to act as an authorized representative is valid until 
the applicant or beneficiary modifies the authorization or notifies the 
agency that the representative is no longer authorized to act on his or 
her behalf, or the authorized representative informs the agency that he 
or she no longer is acting in such capacity, or there is a change in the 
legal authority upon which the individual or organization's authority 
was based. Such notice must be in accordance with paragraph (f) of this 
section and should include the applicant or authorized representative's 
signature as appropriate.
    (d) The authorized representative--

[[Page 197]]

    (1) Is responsible for fulfilling all responsibilities encompassed 
within the scope of the authorized representation, as described in 
paragraph (b)(2) of this section, to the same extent as the individual 
he or she represents;
    (2) Must agree to maintain, or be legally bound to maintain, the 
confidentiality of any information regarding the applicant or 
beneficiary provided by the agency.
    (e) The agency must require that, as a condition of serving as an 
authorized representative, a provider or staff member or volunteer of an 
organization must affirm that he or she will adhere to the regulations 
in part 431, subpart F of this chapter and at 45 CFR 155.260(f) 
(relating to confidentiality of information), Sec.  447.10 of this 
chapter (relating to the prohibition against reassignment of provider 
claims as appropriate for a facility or an organization acting on the 
facility's behalf), as well as other relevant State and Federal laws 
concerning conflicts of interest and confidentiality of information.
    (f) For purposes of this section, the agency must accept electronic, 
including telephonically recorded, signatures and handwritten signatures 
transmitted by facsimile or other electronic transmission. Designations 
of authorized representatives must be accepted through all of the 
modalities described in Sec.  435.907(a).

[78 FR 42303, July 15, 2013]



Sec.  435.926  Continuous eligibility for children.

    (a) Basis. This section implements section 1902(e)(12) of the Act.
    (b) Eligibility. The agency may provide continuous eligibility for 
the period specified in paragraph (c) of this section for an individual 
who is:
    (1) Under age 19 or under a younger age specified by the agency in 
its State plan; and
    (2) Eligible and enrolled for mandatory or optional coverage under 
the State plan in accordance with subpart B or C of this part.
    (c) Continuous eligibility period. (1) The agency must specify in 
the State plan the length of the continuous eligibility period, not to 
exceed 12 months.
    (2) A continuous eligibility period begins on the effective date of 
the individual's eligibility under Sec.  435.915 or most recent 
redetermination or renewal of eligibility under Sec.  435.916 and ends 
after the period specified by the agency under paragraph (c)(1) of this 
section.
    (d) Applicability. A child's eligibility may not be terminated 
during a continuous eligibility period, regardless of any changes in 
circumstances, unless:
    (1) The child attains the maximum age specified in accordance with 
paragraph (b)(1) of this section;
    (2) The child or child's representative requests a voluntary 
termination of eligibility;
    (3) The child ceases to be a resident of the State;
    (4) The agency determines that eligibility was erroneously granted 
at the most recent determination, redetermination or renewal of 
eligibility because of agency error or fraud, abuse, or perjury 
attributed to the child or the child's representative; or
    (5) The child dies.

[81 FR 86458, Nov. 30, 2016]

                           Furnishing Medicaid



Sec.  435.930  Furnishing Medicaid.

    The agency must--
    (a) Furnish Medicaid promptly to beneficiaries without any delay 
caused by the agency's administrative procedures;
    (b) Continue to furnish Medicaid regularly to all eligible 
individuals until they are found to be ineligible; and
    (c) Make arrangements to assist applicants and beneficiaries to get 
emergency medical care whenever needed, 24 hours a day and 7 days a 
week.

            Income and Eligibility Verification Requirements

    Source: Sections 435.940 through 935.965 appear at 51 FR 7211, Feb. 
28, 1986, unless otherwise noted.



Sec.  435.940  Basis and scope.

    The income and eligibility verification requirements set forth at 
Sec. Sec.  435.940 through 435.960 are based on sections 1137, 
1902(a)(4), 1902(a)(19), 1902(a)(46)(B), 1902(ee), 1903(r)(3), 1903(x), 
and 1943(b)(3) of the Act, and section

[[Page 198]]

1413 of the Affordable Care Act. Nothing in the regulations in this 
subpart should be construed as limiting the State's program integrity 
measures or affecting the State's obligation to ensure that only 
eligible individuals receive benefits, consistent with parts 431 and 455 
of this subchapter, or its obligation to provide for methods of 
administration that are in the best interest of applicants and 
beneficiaries and are necessary for the proper and efficient operation 
of the plan, consistent with Sec.  431.15 of this subchapter and section 
1902(a)(19) of the Act.

[77 FR 17211, Mar. 23, 2012, as amended at 81 FR 86459, Nov. 30, 2016]



Sec.  435.945  General requirements.

    (a) Except where the law requires other procedures (such as for 
citizenship and immigration status information), the agency may accept 
attestation of information needed to determine the eligibility of an 
individual for Medicaid (either self-attestation by the individual or 
attestation by an adult who is in the applicant's household, as defined 
in Sec.  435.603(f) of this part, or family, as defined in section 
36B(d)(1) of the Internal Revenue Code, an authorized representative, 
or, if the individual is a minor or incapacitated, someone acting 
responsibly for the individual) without requiring further information 
(including documentation) from the individual.
    (b) The agency must request and use information relevant to 
verifying an individual's eligibility for Medicaid in accordance with 
Sec. Sec.  435.948 through 435.956 of this subpart.
    (c) The agency must furnish, in a timely manner, income and 
eligibility information, subject to regulations at part 431 subpart F of 
this chapter, needed for verifying eligibility to the following 
programs:
    (1) To other agencies in the State and other States and to the 
Federal programs both listed in Sec.  435.948(a) of this subpart and 
identified in section 1137(b) of the Act;
    (2) Other insurance affordability programs;
    (3) The child support enforcement program under part D of title IV 
of the Act; and
    (4) SSA for OASDI under title II and for SSI benefits under title 
XVI of the Act.
    (d) All State eligibility determination systems must conduct data 
matching through the Public Assistance Reporting Information System 
(PARIS).
    (e) The agency must, as required under section 1137(a)(7) of the 
Act, and upon request, reimburse another agency listed in Sec.  
435.948(a) of this subpart or paragraph (c) of this section for 
reasonable costs incurred in furnishing information, including new 
developmental costs.
    (f) Prior to requesting information for an applicant or beneficiary 
from another agency or program under this subpart, the agency must 
inform the individual that the agency will obtain and use information 
available to it under this subpart to verify income and eligibility or 
for other purposes directly connected to the administration of the State 
plan.
    (g) Consistent with Sec.  431.16 of this subchapter, the agency must 
report information as prescribed by the Secretary for purposes of 
determining compliance with Sec.  431.305 of this subchapter, subpart P 
of part 431, Sec. Sec.  435.910 and 435.940 through 435.965 and of 
evaluating the effectiveness of the income and eligibility verification 
system.
    (h) Information exchanged electronically between the State Medicaid 
agency and any other agency or program must be sent and received via 
secure electronic interfaces as defined in Sec.  435.4 of this part.
    (i) The agency must execute written agreements with other agencies 
before releasing data to, or requesting data from, those agencies. Such 
agreements must provide for appropriate safeguards limiting the use and 
disclosure of information as required by Federal or State law or 
regulations.
    (j) Verification plan. The agency must develop, and update as 
modified, and submit to the Secretary, upon request, a verification plan 
describing the verification policies and procedures adopted by the State 
agency to implement the provisions set forth in Sec. Sec.  435.940 
through 435.956 of this subpart in a format and manner prescribed by the 
Secretary.

[[Page 199]]

    (k) Flexibility in information collection and verification. Subject 
to approval by the Secretary, the agency may request and use information 
from a source or sources alternative to those listed in Sec.  435.948(a) 
of this subpart, or through a mechanism other than the electronic 
service described in Sec.  435.949(a) of this subpart, provided that 
such alternative source or mechanism will reduce the administrative 
costs and burdens on individuals and States while maximizing accuracy, 
minimizing delay, meeting applicable requirements relating to the 
confidentiality, disclosure, maintenance, or use of information, and 
promoting coordination with other insurance affordability programs.

[77 FR 17211, Mar. 23, 2012, as amended at 81 FR 86459, Nov. 30, 2016]



Sec.  435.948  Verifying financial information.

    (a) The agency must in accordance with this section request the 
following information relating to financial eligibility from other 
agencies in the State and other States and Federal programs to the 
extent the agency determines such information is useful to verifying the 
financial eligibility of an individual:
    (1) Information related to wages, net earnings from self-employment, 
unearned income and resources from the State Wage Information Collection 
Agency (SWICA), the Internal Revenue Service (IRS), the Social Security 
Administration (SSA), the agencies administering the State unemployment 
compensation laws, the State-administered supplementary payment programs 
under section 1616(a) of the Act, and any State program administered 
under a plan approved under Titles I, X, XIV, or XVI of the Act; and
    (2) Information related to eligibility or enrollment from the 
Supplemental Nutrition Assistance Program, the State program funded 
under part A of title IV of the Act, and other insurance affordability 
programs.
    (b) To the extent that the information identified in paragraph (a) 
of this section is available through the electronic service established 
in accordance with Sec.  435.949 of this subpart, the agency must obtain 
the information through such service.
    (c) The agency must request the information by SSN, or if an SSN is 
not available, using other personally identifying information in the 
individual's account, if possible.

[77 FR 17211, Mar. 23, 2012]



Sec.  435.949  Verification of information through an electronic service.

    (a) The Secretary will establish an electronic service through which 
States may verify certain information with, or obtain such information 
from, Federal agencies and other data sources, including SSA, the 
Department of Treasury, and the Department of Homeland Security.
    (b) To the extent that information related to eligibility for 
Medicaid is available through the electronic service established by the 
Secretary, States must obtain the information through such service, 
subject to the requirements in subpart C of part 433 of this chapter, 
except as provided for in Sec.  435.945(k) of this subpart.

[77 FR 17212, Mar. 23, 2012]



Sec.  435.952  Use of information and requests of additional information
from individuals.

    (a) The agency must promptly evaluate information received or 
obtained by it in accordance with regulations under Sec.  435.940 
through Sec.  435.960 of this subpart to determine whether such 
information may affect the eligibility of an individual or the benefits 
to which he or she is entitled.
    (b) If information provided by or on behalf of an individual (on the 
application or renewal form or otherwise) is reasonably compatible with 
information obtained by the agency in accordance with Sec.  435.948, 
Sec.  435.949 or Sec.  435.956 of this subpart, the agency must 
determine or renew eligibility based on such information.
    (c) An individual must not be required to provide additional 
information or documentation unless information needed by the agency in 
accordance with Sec.  435.948, Sec.  435.949 or Sec.  435.956 of this 
subpart cannot be obtained electronically or the information obtained 
electronically is not reasonably compatible, as provided in the 
verification

[[Page 200]]

plan described in Sec.  435.945(j) with information provided by or on 
behalf of the individual.
    (1) Income information obtained through an electronic data match 
shall be considered reasonably compatible with income information 
provided by or on behalf of an individual if both are either above or at 
or below the applicable income standard or other relevant income 
threshold.
    (2) If information provided by or on behalf of an individual is not 
reasonably compatible with information obtained through an electronic 
data match, the agency must seek additional information from the 
individual, including--
    (i) A statement which reasonably explains the discrepancy; or
    (ii) Other information (which may include documentation), provided 
that documentation from the individual is permitted only to the extent 
electronic data are not available and establishing a data match would 
not be effective, considering such factors as the administrative costs 
associated with establishing and using the data match compared with the 
administrative costs associated with relying on paper documentation, and 
the impact on program integrity in terms of the potential for ineligible 
individuals to be approved as well as for eligible individuals to be 
denied coverage;
    (iii) The agency must provide the individual a reasonable period to 
furnish any additional information required under paragraph (c) of this 
section.
    (3) Exception for special circumstances. The agency must establish 
an exception to permit, on a case-by-case basis, self-attestation of 
individuals for all eligibility criteria when documentation does not 
exist at the time of application or renewal, or is not reasonably 
available, such as in the case of individuals who are homeless or have 
experienced domestic violence or a natural disaster. This exception does 
not apply if documentation is specifically required under title XI or 
XIX, such as requirements for verifying citizenship and immigration 
status, as implemented at Sec.  435.956(a).
    (d) The agency may not deny or terminate eligibility or reduce 
benefits for any individual on the basis of information received in 
accordance with regulations under Sec.  435.940 through Sec.  435.960 of 
this subpart unless the agency has sought additional information from 
the individual in accordance with paragraph (c) of this section, and 
provided proper notice and hearing rights to the individual in 
accordance with this subpart and subpart E of part 431.

[77 FR 17212, Mar. 23, 2012, as amended at 81 FR 86459, Nov. 30, 2016]



Sec.  435.956  Verification of other non-financial information.

    (a) Citizenship and immigration status. (1)(i) The agency must--
    (A) Verify citizenship status through the electronic service 
established in accordance with Sec.  435.949 or alternative mechanism 
authorized in accordance with Sec.  435.945(k), if available; and
    (B) Promptly attempt to resolve any inconsistencies, including 
typographical or other clerical errors, between information provided by 
the individual and information from an electronic data source, and 
resubmit corrected information through such electronic service or 
alternative mechanism.
    (ii) If the agency is unable to verify citizenship status in 
accordance with paragraph (a)(1)(i) of this section, the agency must 
verify citizenship either--
    (A) Through a data match with the Social Security Administration; or
    (B) In accordance with Sec.  435.407.
    (2) The agency must--
    (i) Verify immigration status through the electronic service 
established in accordance with Sec.  435.949, or alternative mechanism 
authorized in accordance with Sec.  435.945(k);
    (ii) Promptly attempt to resolve any inconsistencies, including 
typographical or other clerical errors, between information provided by 
the individual and information from an electronic data source, and 
resubmit corrected information through such electronic service or 
alternative mechanism.
    (3) For purposes of the exemption from the five-year waiting period 
described in 8 U.S.C. 1613, the agency must verify that an individual is 
an honorably discharged veteran or in active military duty status, or 
the spouse or unmarried dependent child of such

[[Page 201]]

person, as described in 8 U.S.C. 1612(b)(2) through the electronic 
service described in Sec.  435.949 or alternative mechanism authorized 
in accordance with Sec.  435.945(k). If the agency is unable to verify 
such status through such service the agency may accept self-attestation 
of such status.
    (4)(i) The agency must maintain a record of having verified 
citizenship or immigration status for each individual, in a case record 
or electronic database in accordance with the State's record retention 
policies in accordance with Sec.  431.17(c) of this chapter.
    (ii) Unless the individual reports a change in citizenship or the 
agency has received information indicating a potential change in the 
individual's citizenship, the agency may not re-verify or require an 
individual to re-verify citizenship at a renewal of eligibility under 
Sec.  435.916 of this subpart, or upon a subsequent application 
following a break in coverage.
    (5) If the agency cannot promptly verify the citizenship or 
satisfactory immigration status of an individual in accordance with 
paragraph (a)(1) or (2) of this section, the agency--
    (i) Must provide a reasonable opportunity in accordance with 
paragraph (b) of this section; and
    (ii) May not delay, deny, reduce or terminate benefits for an 
individual whom the agency determines to be otherwise eligible for 
Medicaid during such reasonable opportunity period, in accordance with 
Sec.  435.911(c).
    (iii) If a reasonable opportunity period is provided, the agency may 
begin to furnish benefits to otherwise eligible individuals, effective 
the date of application, or the first day of the month of application, 
consistent with the agency's election under Sec.  435.915(b).
    (b) Reasonable opportunity period. (1) The agency must provide a 
reasonable opportunity period to individuals who have made a declaration 
of citizenship or satisfactory immigration status in accordance with 
Sec.  435.406(a), and for whom the agency is unable to verify 
citizenship or satisfactory immigration status in accordance with 
paragraph (a) of this section. During the reasonable opportunity period, 
the agency must continue efforts to complete verification of the 
individual's citizenship or satisfactory immigration status, or request 
documentation if necessary. The agency must provide notice of such 
opportunity that is accessible to persons who have limited English 
proficiency and individuals with disabilities, consistent with Sec.  
435.905(b). During such reasonable opportunity period, the agency must, 
if relevant to verification of the individual's citizenship or 
satisfactory immigration status--
    (i) In the case of individuals declaring citizenship who do not have 
an SSN at the time of such declaration, assist the individual in 
obtaining an SSN in accordance with Sec.  435.910, and attempt to verify 
the individual's citizenship in accordance with paragraph (a)(1) of this 
section once an SSN has been obtained and verified;
    (ii) Promptly provide the individual with information on how to 
contact the electronic data source described in paragraph (a) of this 
section so that he or she can attempt to resolve any inconsistencies 
defeating electronic verification directly with such source, and pursue 
verification of the individual's citizenship or satisfactory immigration 
status if the individual or source informs the agency that the 
inconsistencies have been resolved; and
    (iii) Provide the individual with an opportunity to provide other 
documentation of citizenship or satisfactory immigration status, in 
accordance with section 1137(d) of the Act and Sec.  435.406 or Sec.  
435.407.
    (2) The reasonable opportunity period--
    (i) Begins on the date on which the notice described in paragraph 
(b)(1) of this section is received by the individual. The date on which 
the notice is received is considered to be 5 days after the date on the 
notice, unless the individual shows that he or she did not receive the 
notice within the 5-day period.
    (ii)(A) Ends on the earlier of the date the agency verifies the 
individual's citizenship or satisfactory immigration status or 
determines that the individual did not verify his or her citizenship or 
satisfactory immigration status in accordance with paragraph (a)(2) of 
this section, or 90 days after the date

[[Page 202]]

described in paragraph (b)(2)(i) of this section, except that,
    (B) The agency may extend the reasonable opportunity period beyond 
90 days for individuals declaring to be in a satisfactory immigration 
status if the agency determines that the individual is making a good 
faith effort to obtain any necessary documentation or the agency needs 
more time to verify the individual's status through other available 
electronic data sources or to assist the individual in obtaining 
documents needed to verify his or her status.
    (3) If, by the end of the reasonable opportunity period, the 
individual's citizenship or satisfactory immigration status has not been 
verified in accordance with paragraph (a) of this section, the agency 
must take action within 30 days to terminate eligibility in accordance 
with part 431 subpart E (relating to notice and appeal rights) of this 
chapter, except that Sec. Sec.  431.230 and 431.231 of this chapter 
(relating to maintaining and reinstating services) may be applied at 
State option.
    (4)(i) The agency may establish in its State plan reasonable limits 
on the number of reasonable opportunity periods during which medical 
assistance is furnished which a given individual may receive once denied 
eligibility for Medicaid due to failure to verify citizenship or 
satisfactory immigration status, provided that the conditions in 
paragraph (b)(4)(ii) of this section are met.
    (ii) Prior to implementing any limits under paragraph (b)(4)(i) of 
this section, the agency must--
    (A) Demonstrate that the lack of limits jeopardizes program 
integrity; and
    (B) Receive approval of a State plan amendment prior to implementing 
limits.
    (c) State residency. (1) The agency may verify State residency in 
accordance with Sec.  435.945(a) of this subpart or through other 
reasonable verification procedures consistent with the requirements in 
Sec.  435.952 of this subpart.
    (2) Evidence of immigration status may not be used to determine that 
an individual is not a State resident.
    (d) Social Security numbers. The agency must verify Social Security 
numbers (SSNs) in accordance with Sec.  435.910 of this subpart.
    (e) Pregnancy. The agency must accept self-attestation of pregnancy 
unless the State has information that is not reasonably compatible with 
such attestation, subject to the requirements of Sec.  435.952 of this 
subpart.
    (f) Age, date of birth and household size. The agency may verify 
date of birth and the individuals that comprise an individual's 
household, as defined in Sec.  435.603(f) of this part, in accordance 
with Sec.  435.945(a) of this subpart or through other reasonable 
verification procedures consistent with the requirements in Sec.  
435.952 of this subpart.

[77 FR 17212, Mar. 23, 2012, as amended at 81 FR 86459, Nov. 30, 2016]



Sec.  435.960  Standardized formats for furnishing and obtaining 
information to verifying income and eligibility.

    (a) The agency must maintain for all applicants and beneficiaries 
within an agency file the SSN, surname and other data elements in a 
format that at a minimum allows the agency to furnish and to obtain 
eligibility and income information from the agencies or programs 
referenced in Sec.  435.945(b) and Sec.  435.948(a).
    (b) The format to be used will be prescribed by--
    (1) CMS when the agency furnishes information to, or requests 
information from, any Federal or State agency, except SSA and the 
Internal Revenue Service as specified in paragraphs (b) (2) and (3), 
respectively;
    (2) The Commissioner of Social Security when the agency requests 
information from SSA; and
    (3) The Commissioner of Internal Revenue when the agency requests 
information from the Internal Revenue Service.

[52 FR 5977, Feb. 27, 1987]



Sec.  435.965  Delay of effective date.

    (a) If the agency submits, by May 29, 1986, a plan describing a good 
faith effort to come into compliance with the requirements of section 
1137 of the Act and of Sec. Sec.  435.910 and 435.940 through 435.960 of 
this subpart, the Secretary

[[Page 203]]

may, after consultation with the Secretary of Agriculture and the 
Secretary of Labor, grant a delay in the effective date of Sec. Sec.  
435.910 and 435.940 through 435.960, but not beyond September 30, 1986.
    (b) The Secretary may not grant a delay of the effective date of 
section 1137(c) of the Act, which is implemented by Sec.  435.955 (a) 
and (c). (The provisions of these statutory and regulation sections 
require the agency to follow certain procedures before taking any 
adverse actions based on information from the Internal Revenue Service 
concerning unearned income.)



                Subpart K_Federal Financial Participation



Sec.  435.1000  Scope.

    This subpart specifies when, and the extent to which, FFP is 
available in expenditures for determining eligibility and for Medicaid 
services to individuals determined eligible under this part, and 
prescribes limitations and conditions on FFP for those expenditures.

 FFP in Expenditures for Determining Eligibility and Providing Services



Sec.  435.1001  FFP for administration.

    (a) FFP is available in the necessary administrative costs the State 
incurs in--
    (1) Determining and redetermining Medicaid eligibility and in 
providing Medicaid to eligible individuals; and
    (2) Administering presumptive eligibility.
    (b) Administrative costs include any costs incident to an eye 
examination or medical examination to determine whether an individual is 
blind or disabled.

[43 FR 45204, Sept. 29, 1978, as amended at 66 FR 2667, Jan. 11, 2001; 
81 FR 86460, Nov. 30, 2016]



Sec.  435.1002  FFP for services.

    (a) Except for the limitations and conditions specified in 
Sec. Sec.  435.1007, 35.1008, 435.1009, and 438.814 of this chapter, FFP 
is available in expenditures for Medicaid services for all beneficiaries 
whose coverage is required or allowed under this part.
    (b) FFP is available in expenditures for services provided to 
beneficiaries who were eligible for Medicaid in the month in which the 
medical care or services were provided except that, for beneficiaries 
who establish eligibility for Medicaid by deducting incurred medical 
expenses from income, FFP is not available for expenses that are the 
beneficiary's liability. (See Sec. Sec.  435.915 and 436.901 of this 
subchapter for regulations on retroactive eligibility for Medicaid.)
    (c) FFP is available in expenditures for services covered under the 
plan that are furnished--
    (1) During a presumptive eligibility period to individuals who are 
determined to be presumptively eligible for Medicaid in accordance with 
subpart L of this part;
    (2) During a period of presumptive eligibility;
    (3) By a provider that is eligible for payment under the plan; and
    (4) Regardless of whether such individuals file an application for a 
full eligibility determination or are determined eligible for Medicaid 
following the period of presumptive eligibility.

[43 FR 45204, Sept. 29, 1978, as amended at 44 FR 17939, Mar. 23, 1979; 
66 FR 2667, Jan. 11, 2001; 67 FR 41095, June 14, 2002; 71 FR 39225, July 
12, 2006; 77 FR 17212, Mar. 23, 2012; 81 FR 86460, Nov. 30, 2016]



Sec.  435.1003  FFP for redeterminations.

    (a) If the Social Security Administration (SSA) notifies an agency 
that a beneficiary has been determined ineligible for SSI, FFP is 
available in Medicaid expenditures for services to the beneficiary as 
follows:
    (1) If the agency receives the SSA notice by the 10th day of the 
month, FFP is available under this section only through the end of the 
month unless the beneficiary requests a hearing under subpart E, part 
431 of this subchapter.
    (2) If the agency receives the SSA notice after the 10th day of the 
month, FFP is available only through the end of the following month, 
unless the beneficiary requests a hearing under subpart E, part 431 of 
this subchapter.

[[Page 204]]

    (3) If a beneficiary requests a hearing, FFP is available as 
specified in subpart E, part 431 of this subchapter.
    (b) The agency must take prompt action to determine eligibility 
after receiving the SSA notice.
    (c) When a change in Federal law affects the eligibility of 
substantial numbers of Medicaid beneficiaries, the Secretary may waive 
the otherwise applicable FFP requirements and redetermination time 
limits of this section, in order to provide a reasonable time to 
complete such redeterminations. The Secretary will designate an 
additional amount of time beyond that allowed under paragraphs (a) and 
(b) of this section, within which FFP will be available, to perform 
large numbers of redeterminations arising from a change in Federal law.

[43 FR 45204, Sept. 29, 1978, as amended at 44 FR 17939, Mar. 23, 1979; 
62 FR 1685, Jan. 13, 1997]



Sec.  435.1004  Beneficiaries overcoming certain conditions of 
eligibility.

    (a) FFP is available, as specified in paragraph (b) of this section, 
in expenditures for services provided to beneficiaries who are 
overcoming certain eligibility conditions, including blindness, 
disability, continued absence or incapacity of a parent, or unemployment 
of a parent.
    (b) FFP is available for a period not to exceed--
    (1) The period during which a recipient of SSI or an optional State 
supplement continues to receive cash payments while these conditions are 
being overcome; or
    (2) For beneficiaries, eligible for Medicaid only and recipients of 
SSI or an optional State supplement who do not continue to receive cash 
payments, the second month following the month in which the 
beneficiary's Medicaid coverage will have been terminated.

[43 FR 45204, Sept. 29, 1978, as amended at 45 FR 24887, Apr. 11, 1980; 
81 FR 86460, Nov. 30, 2016]

                           Limitations on FFP



Sec.  435.1005  Beneficiaries in institutions eligible under a special
income standard.

    For beneficiaries in institutions whose Medicaid eligibility is 
based on a special income standard established under Sec.  435.236, FFP 
is available in expenditures for services provided to those individuals 
only if their income before deductions, as determined by SSI budget 
methodology, does not exceed 300 percent of the SSI benefit amount 
payable under section 1611(b)(1) of the Act to an individual in his own 
home who has no income or resources.

[58 FR 4933, Jan. 19, 1993]



Sec.  435.1006  Beneficiaries of optional State supplements only.

    FFP is available in expenditures for services provided to 
individuals receiving optional State supplements but not receiving SSI, 
if their income before deductions, as determined by SSI budget 
methodology, does not exceed 300 percent of the SSI benefit amount 
payable under section 1611(b)(1) of the Act to an individual who has no 
income and resources.

[45 FR 24887, Apr. 11, 1980]



Sec.  435.1007  Categorically needy, medically needy, and qualified
Medicare beneficiaries.

    (a) FFP is available in expenditures for covered services provided 
to categorically needy beneficiaries, medically needy beneficiaries, and 
qualified Medicare beneficiaries, subject to the restrictions contained 
in subpart K of this part and as provided in paragraphs (b) and (e) of 
this section. However, the restrictions listed in paragraphs (b) and (e) 
of this section do not apply to expenditures for medical assistance made 
on behalf of qualified Medicare beneficiaries under section 1905(p) of 
the Act; individuals receiving Medicaid as categorically needy under 
section 1902(a)(10)(A)(i) (I), (II), (III), (IV), (V), (VI), or (VII) 
and section 1902(a)(10)(A)(ii) (I), (IX), or (X) and section 1905(u) of 
the Act; individuals who are eligible to receive benefits (or would be 
eligible for those benefits if they were not in a medical institution);

[[Page 205]]

and any individuals deemed to be members of the groups identified in 
this sentence.
    (b) Except as provided in paragraphs (c) and (d) of this section, 
FFP is not available in State expenditures for individuals (including 
the medically needy) whose annual income after deductions specified in 
Sec.  435.831(a) and (c) exceeds the following amounts, rounded to the 
next higher multiple of $100.
    (c) In the case of a family consisting only of two individuals, both 
of whom are adults and at least one of whom is aged, blind, or disabled, 
the State of California may use the amount of the AFDC payment most 
frequently made to a family of one adult and two children for purposes 
of computing the 133\1/3\ percent limitation (under the authority of 
section 4106 of Public Law 100-230).
    (d) For purposes of paragraph (b)(1) of this section, a State that 
as of June 1, 1989, has in its State plan (as defined in section 
2373(c)(5) of Public Law 98-369 as amended by section 9 of Public Law 
100-93) an amount for individuals that was reasonably related to 133\1/
3\ percent of the highest amount of AFDC which would ordinarily be paid 
to a family of two without income or resources may use an amount based 
upon a reasonable relationship to such an AFDC standard for a family of 
two.
    (e) FFP is not available in expenditures for services provided to 
categorically needy and medically needy beneficiaries subject to the FFP 
limits if their annual income, after the cash assistance income 
deductions and any income disregards in the State plan authorized under 
section 1902(r)(2) of the Act are applied, exceeds the 133\1/3\ percent 
limitation described under paragraphs (b), (c), and (d) of this section.
    (f) A State may use the less restrictive income methodologies 
included under its State plan as authorized under Sec.  435.601 in 
determining whether a family's income exceeds the limitation described 
in paragraph (b) of this section.

[58 FR 4933, Jan. 19, 1993, as amended at 66 FR 2321, 2667, Jan. 11, 
2001]



Sec.  435.1008  FFP in expenditures for medical assistance for individuals
who have declared citizenship or nationality or satisfactory immigration
status.

    (a) This section implements sections 1137 and 1902(a)(46)(B) of the 
Act.
    (b) Except as provided in paragraph (c) of this section, FFP is not 
available to a State for expenditures for medical assistance furnished 
to individuals unless the State has verified citizenship or immigration 
status in accordance with Sec.  435.956.
    (c) FFP is available to States for otherwise eligible individuals 
whose declaration of U.S. citizenship or satisfactory immigration status 
in accordance with section 1137(d) of the Act and Sec.  435.406(c) has 
been verified in accordance with Sec.  435.956, who are exempt from the 
requirements to verify citizenship under Sec.  435.406(a)(1)(iii), or 
for whom benefits are provided during a reasonable opportunity period to 
verify citizenship, nationality, or satisfactory immigration status in 
accordance with section Sec.  435.956(b), including the time period 
during which an appeal is pending if the State has elected the option 
under Sec.  435.956(b)(3).

[81 FR 86460, Nov. 30, 2016]



Sec.  435.1009  Institutionalized individuals.

    (a) FFP is not available in expenditures for services provided to--
    (1) Individuals who are inmates of public institutions as defined in 
Sec.  435.1010; or
    (2) Individuals under age 65 who are patients in an institution for 
mental diseases unless they are under age 22 and are receiving inpatient 
psychiatric services under Sec.  440.160 of this subchapter.
    (b) The exclusion of FFP described in paragraph (a) of this section 
does not apply during that part of the month in which the individual is 
not an inmate of a public institution or a patient in an institution for 
tuberculosis or mental diseases.
    (c) An individual on conditional release or convalescent leave from 
an institution for mental diseases is not considered to be a patient in 
that institution. However, such an individual

[[Page 206]]

who is under age 22 and has been receiving inpatient psychiatric 
services under Sec.  440.160 of this subchapter is considered to be a 
patient in the institution until he is unconditionally released or, if 
earlier, the date he reaches age 22.

[43 FR 45204, Sept. 29, 1978, as amended at 50 FR 13199, Apr. 3, 1985; 
50 FR 38811, Sept. 25, 1985. Redesignated and amended at 71 FR 39225, 
July 12, 2006]



Sec.  435.1010  Definitions relating to institutional status.

    For purposes of FFP, the following definitions apply:
    Active treatment in intermediate care facilities for individuals 
with intellectual disabilities means treatment that meets the 
requirements specified in the standard concerning active treatment for 
intermediate care facilities for persons with Intellectual Disability 
under Sec.  483.440(a) of this subchapter.
    Child-care institution means a nonprofit private child-care 
institution, or a public child-care institution that accommodates no 
more than twenty-five children, which is licensed by the State in which 
it is situated, or has been approved by the agency of the State 
responsible for licensing or approval of institutions of this type, as 
meeting the standards established for licensing. The term does not 
include detention facilities, forestry camps, training schools or any 
other facility operated primarily for the detention of children who are 
determined to be delinquent.
    In an institution refers to an individual who is admitted to live 
there and receive treatment or services provided there that are 
appropriate to his requirements.
    Inmate of a public institution means a person who is living in a 
public institution. An individual is not considered an inmate if--
    (a) He is in a public educational or vocational training institution 
for purposes of securing education or vocational training; or
    (b) He is in a public institution for a temporary period pending 
other arrangements appropriate to his needs.
    Inpatient means a patient who has been admitted to a medical 
institution as an inpatient on recommendation of a physician or dentist 
and who--
    (1) Receives room, board and professional services in the 
institution for a 24 hour period or longer, or
    (2) Is expected by the institution to receive room, board and 
professional services in the institution for a 24 hour period or longer 
even though it later develops that the patient dies, is discharged or is 
transferred to another facility and does not actually stay in the 
institution for 24 hours.
    Institution means an establishment that furnishes (in single or 
multiple facilities) food, shelter, and some treatment or services to 
four or more persons unrelated to the proprietor.
    Institution for mental diseases means a hospital, nursing facility, 
or other institution of more than 16 beds that is primarily engaged in 
providing diagnosis, treatment or care of persons with mental diseases, 
including medical attention, nursing care and related services. Whether 
an institution is an institution for mental diseases is determined by 
its overall character as that of a facility established and maintained 
primarily for the care and treatment of individuals with mental 
diseases, whether or not it is licensed as such. An institution for 
Individuals with Intellectual Disabilities is not an institution for 
mental diseases.
    Institution for Individuals with Intellectual Disabilities or 
persons with related conditions means an institution (or distinct part 
of an institution) that--
    (a) Is primarily for the diagnosis, treatment, or rehabilitation of 
Individuals with Intellectual Disabilities or persons with related 
conditions; and
    (b) Provides, in a protected residential setting, ongoing 
evaluation, planning, 24-hour supervision, coordination, and integration 
of health or rehabilitative services to help each individual function at 
his greatest ability.
    Institution for tuberculosis means an institution that is primarily 
engaged in providing diagnosis, treatment, or care of persons with 
tuberculosis, including medical attention, nursing care, and related 
services. Whether an institution is an institution for tuberculosis is 
determined by its overall character as that of a facility established 
and maintained primarily for the care and treatment of tuberculosis, 
whether or not it is licensed as such.

[[Page 207]]

    Medical institution means an institution that--
    (a) Is organized to provide medical care, including nursing and 
convalescent care;
    (b) Has the necessary professional personnel, equipment, and 
facilities to manage the medical, nursing, and other health needs of 
patients on a continuing basis in accordance with accepted standards;
    (c) Is authorized under State law to provide medical care; and
    (d) Is staffed by professional personnel who are responsible to the 
institution for professional medical and nursing services. The services 
must include adequate and continual medical care and supervision by a 
physician; registered nurse or licensed practical nurse supervision and 
services and nurses' aid services, sufficient to meet nursing care 
needs; and a physician's guidance on the professional aspects of 
operating the institution.
    Outpatient means a patient of an organized medical facility or 
distinct part of that facility who is expected by the facility to 
receive, and who does receive, professional services for less than a 24-
hour period regardless of the hour of admission, whether or not a bed is 
used or whether or not the patient remains in the facility past 
midnight.
    Patient means an individual who is receiving needed professional 
services that are directed by a licensed practitioner of the healing 
arts toward maintenance, improvement, or protection of health, or 
lessening of illness, disability, or pain.
    Persons with related conditions means individuals who have a severe, 
chronic disability that meets all of the following conditions:
    (a) It is attributable to--
    (1) Cerebral palsy or epilepsy; or
    (2) Any other condition, other than mental illness, found to be 
closely related to Intellectual Disability because this condition 
results in impairment of general intellectual functioning or adaptive 
behavior similar to that of mentally retarded persons, and requires 
treatment or services similar to those required for these persons.
    (b) It is manifested before the person reaches age 22.
    (c) It is likely to continue indefinitely.
    (d) It results in substantial functional limitations in three or 
more of the following areas of major life activity:
    (1) Self-care.
    (2) Understanding and use of language.
    (3) Learning.
    (4) Mobility.
    (5) Self-direction.
    (6) Capacity for independent living.
    Public institution means an institution that is the responsibility 
of a governmental unit or over which a governmental unit exercises 
administrative control. The term ``public institution'' does not 
include--
    (a) A medical institution as defined in this section;
    (b) An intermediate care facility as defined in Sec. Sec.  440.140 
and 440.150 of this chapter;
    (c) A publicly operated community residence that serves no more than 
16 residents, as defined in this section; or
    (d) A child-care institution as defined in this section with respect 
to--
    (1) Children for whom foster care maintenance payments are made 
under title IV-E of the Act; and
    (2) Children receiving AFDC--foster care under title IV-A of the 
Act.
    Publicly operated community residence that serves no more than 16 
residents is defined in 20 CFR 416.231(b)(6)(i). A summary of that 
definition is repeated here for the information of readers.
    (a) In general, a publicly operated community residence means--
    (1) It is publicly operated as defined in 20 CFR 416.231(b)(2).
    (2) It is designed or has been changed to serve no more than 16 
residents and it is serving no more than 16; and
    (3) It provides some services beyond food and shelter such as social 
services, help with personal living activities, or training in 
socialization and life skills. Occasional medical or remedial care may 
also be provided as defined in 45 CFR 228.1; and
    (b) A publicly operated community residence does not include the 
following facilities, even though they accommodate 16 or fewer 
residents:

[[Page 208]]

    (1) Residential facilities located on the grounds of, or immediately 
adjacent to, any large institution or multiple purpose complex.
    (2) Educational or vocational training institutions that primarily 
provide an approved, accredited, or recognized program to individuals 
residing there.
    (3) Correctional or holding facilities for individuals who are 
prisoners, have been arrested or detained pending disposition of 
charges, or are held under court order as material witnesses or 
juveniles.
    (4) Hospitals, nursing facilities, and intermediate care facilities 
for individuals with intellectual disabilities.

[43 FR 45204, Sept. 29, 1978, as amended at 47 FR 28655, July 1, 1982; 
47 FR 31532, July 20, 1982; 51 FR 19181, May 28, 1986; 52 FR 47934, Dec. 
17, 1987; 53 FR 657, Jan. 11, 1988; 53 FR 20495, June 3, 1988; 56 FR 
8854, Mar. 1, 1991; 56 FR 23022, May 20, 1991; 59 FR 56233, Nov. 10, 
1994. Redesignated at 71 FR 39225, July 12, 2006]

                   Requirements for State Supplements



Sec.  435.1011  Requirement for mandatory State supplements.

    (a) Except as specified in paragraph (b) of this section, FFP is not 
available in Medicaid expenditures in any quarter in which the State 
does not have in effect an agreement with the Secretary under section 
212 of Pub. L. 93-66 (July 9, 1973) for minimum mandatory State 
supplements of the basic SSI benefit.
    (b) This section does not apply to any State that meets the 
conditions of section 212(f) of Pub. L. 93-66.

[43 FR 45204, Sept. 29, 1978. Redesignated at 71 FR 39225, July 12, 
2006]



Sec.  435.1012  Requirement for maintenance of optional State
supplement expenditures.

    (a) This section applies to States that make optional State 
supplement payments under section 1616(a) of the Act and mandatory 
supplement payments under section 212(a) of Pub. L. 93-66.
    (b) FFP in Medicaid expenditures is not available during any period 
in which the State does not have in effect an agreement with the 
Secretary under section 1618 of the Act to maintain its supplementary 
payments.

[43 FR 45204, Sept. 29, 1978, as amended at 55 FR 48609, Nov. 21, 1990. 
Redesignated at 71 FR 39225, July 12, 2006]

                       FFP for Premium Assistance



Sec.  435.1015  FFP for premium assistance for plans in the individual
market.

    (a) FFP is available for payment of the costs of insurance premiums 
on behalf of an eligible individual for a health plan offered in the 
individual market that provides the individual with benefits for which 
the individual is covered under the State plan, subject to the following 
conditions:
    (1) The insurer is obligated to pay primary to Medicaid for all 
health care items and services for which the insurer is legally and 
contractually responsible under the individual health plan, as required 
under part 433 subpart D of this chapter;
    (2) The agency furnishes all benefits for which the individual is 
covered under the State plan that are not available through the 
individual health plan;
    (3) The individual does not incur any cost sharing charges in excess 
of any amounts imposed by the agency under subpart A of part 447; and
    (4) The total cost of purchasing such coverage, including 
administrative expenditures, the costs of paying all cost sharing 
charges in excess of the amounts imposed by the agency under subpart A 
of part 447, and the costs of providing benefits as required by (a)(2) 
of this section, must be comparable to the cost of providing direct 
coverage under the State plan.
    (b) A State may not require an individual to receive benefits 
through premium assistance under this section, and a State must inform 
an individual that it is the individual's choice to receive either 
direct coverage under the Medicaid State plan or coverage through 
premium assistance for an individual health plan. A State must require 
that an individual who elects premium assistance obtain through the 
insurance coverage all benefits for which the insurer is responsible and 
must provide the individual with information on how to access any 
additional

[[Page 209]]

benefits and cost sharing assistance not provided by the insurer.

[78 FR 42303, July 15, 2013]



   Subpart L_Options for Coverage of Special Groups under Presumptive 
                               Eligibility

    Source: 66 FR 2667, Jan. 11, 2001, unless otherwise noted.



Sec.  435.1100  Basis for presumptive eligibility.

    This subpart implements sections 1920, 1920A, 1920B, 1920C, and 
1902(a)(47)(B) of the Act.

[81 FR 86460, Nov. 30, 2016]



Sec.  435.1101  Definitions related to presumptive eligibility.

    For the purposes of this subpart, the following definitions apply:
    Application means, consistent with the definition at Sec.  435.4, 
the single streamlined application adopted by the agency under Sec.  
435.907(a); and
    Period of presumptive eligibility means a period that begins on the 
date on which a qualified entity determines that a child is 
presumptively eligible and ends with the earlier of--
    (1) In the case of a child on whose behalf a Medicaid application 
has been filed, the day on which a decision is made on that application; 
or
    (2) In the case of a child on whose behalf a Medicaid application 
has not been filed, the last day of the month following the month in 
which the determination of presumptive eligibility was made.
    Presumptive income standard means the highest income eligibility 
standard established under the plan that is most likely to be used to 
establish the regular Medicaid eligibility of a child of the age 
involved.
    Qualified entity means an entity that is determined by the State to 
be capable of making determinations of presumptive eligibility for 
children, and that--
    (1) Furnishes health care items and services covered under the 
approved plan and is eligible to receive payments under the approved 
plan;
    (2) Is authorized to determine eligibility of a child to participate 
in a Head Start program under the Head Start Act;
    (3) Is authorized to determine eligibility of a child to receive 
child care services for which financial assistance is provided under the 
Child Care and Development Block Grant Act of 1990;
    (4) Is authorized to determine eligibility of an infant or child to 
receive assistance under the special nutrition program for women, 
infants, and children (WIC) under section 17 of the Child Nutrition Act 
of 1966;
    (5) Is authorized to determine eligibility of a child for medical 
assistance under the Medicaid State plan, or eligibility of a child for 
child health assistance under the State Children's Health Insurance 
Program;
    (6) Is an elementary or secondary school, as defined in section 
14101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 
8801);
    (7) Is an elementary or secondary school operated or supported by 
the Bureau of Indian Affairs;
    (8) Is a State or Tribal child support enforcement agency;
    (9) Is an organization that--
    (i) Provides emergency food and shelter under a grant under the 
Stewart B. McKinney Homeless Assistance Act;
    (ii) Is a State or Tribal office or entity involved in enrollment in 
the program under title XIX, Part A of title IV, or title XXI; or
    (iii) Determines eligibility for any assistance or benefits provided 
under any program of public or assisted housing that receives Federal 
funds, including the program under section 8 or any other section of the 
United States Housing Act of 1937 (42 U.S.C. 1437) or under the Native 
American Housing Assistance and Self Determination Act of 1996 (25 
U.S.C. 4101 et seq.);
    (10) Is a health facility operated by the Indian Health Service, a 
Tribe or Tribal organization under the Indian Self Determination and 
Education Assistance Act (25 U.S.C. 450 et seq.), or an Urban Indian 
Organization under title V of the Indian Health Care Improvement Act (25 
U.S.C. 1651 et seq.).
    (11) Any other entity the State so deems, as approved by the 
Secretary.

[[Page 210]]

    Services means all services covered under the plan including EPSDT 
(see part 440 of this chapter).

[66 FR 2667, Jan. 11, 2001, as amended at 66 FR 33822, June 25, 2001; 81 
FR 86460, Nov. 30, 2016]



Sec.  435.1102  Children covered under presumptive eligibility.

    (a) The agency may elect to provide Medicaid services for children 
under age 19 or a younger age specified by the State during a 
presumptive eligibility period following a determination by a qualified 
entity, on the basis of preliminary information, that the individual has 
gross income (or, at state option, a reasonable estimate of household 
income, as defined in Sec.  435.603 of this part, determined using 
simplified methods prescribed by the agency) at or below the income 
standard established by the State for the age of the child under Sec.  
435.118(c) or under Sec.  435.229 if applicable and higher.
    (b) If the agency elects to provide services to children during a 
period of presumptive eligibility, the agency must--
    (1) Provide qualified entities with application forms for Medicaid 
and information on how to assist parents, caretakers and other persons 
in completing and filing such forms;
    (2) Establish procedures to ensure that qualified entities--
    (i) Notify the parent or caretaker of the child at the time a 
determination regarding presumptive eligibility is made, in writing and 
orally if appropriate, of such determination;
    (ii) Provide the parent or caretaker of the child with a regular 
Medicaid application form;
    (iii) Within five working days after the date that the determination 
is made, notify the agency that a child is presumptively eligible;
    (iv) For children determined to be presumptively eligible, notify 
the child's parent or caretaker at the time the determination is made, 
in writing and orally if appropriate, that--
    (A) If a Medicaid application on behalf of the child is not filed by 
the last day of the following month, the child's presumptive eligibility 
will end on that last day; and
    (B) If a Medicaid application on behalf of the child is filed by the 
last day of the following month, the child's presumptive eligibility 
will end on the day that a decision is made on the Medicaid application.
    (v) For children determined not to be presumptively eligible, notify 
the child's parent or caretaker at the time the determination is made, 
in writing and orally if appropriate--
    (A) Of the reason for the determination; and
    (B) That he or she may file an application for Medicaid on the 
child's behalf with the Medicaid agency; and
    (vi) Do not delegate the authority to determine presumptive 
eligibility to another entity.
    (3) Establish oversight mechanisms to ensure that presumptive 
eligibility determinations are being made consistent with the statute 
and regulations.
    (c) The agency must adopt reasonable standards regarding the number 
of periods of presumptive eligibility that will be authorized for a 
child in a given time frame.
    (d) The agency--
    (1) May require, for purposes of making a presumptive eligibility 
determination under this section, that the individual has attested to 
being, or another person who attests to having reasonable knowledge of 
the individual's status has attested to the individual being, a--
    (i) Citizen or national of the United States or in satisfactory 
immigration status; or
    (ii) Resident of the State; and
    (2) May not--
    (i) Impose other conditions for presumptive eligibility not 
specified in this section; or
    (ii) Require verification of the conditions for presumptive 
eligibility.
    (e) Notice and fair hearing regulations in subpart E of part 431 of 
this chapter do not apply to determinations of presumptive eligibility 
under this section.

[43 FR 45204, Sept. 29, 1978, as amended at 77 FR 17212, Mar. 23, 2012; 
78 FR 42304, July 15, 2013]

[[Page 211]]



Sec.  435.1103  Presumptive eligibility for other individuals.

    (a) The terms of Sec. Sec.  435.1101 and 435.1102 apply to pregnant 
women such that the agency may provide Medicaid to pregnant women during 
a presumptive eligibility period following a determination by a 
qualified entity that the pregnant woman has income at or below the 
income standard established by the State under Sec.  435.116(c), except 
that coverage of services provided to such women is limited to 
ambulatory prenatal care and the number of presumptive eligibility 
periods that may be authorized for pregnant women is one per pregnancy.
    (b) If the agency provides Medicaid during a presumptive eligibility 
period to children under Sec.  435.1102 or to pregnant women under 
paragraph (a) of this section, the agency may also apply the terms of 
Sec. Sec.  435.1101 and 435.1102 to the individuals described in one or 
more of the following sections of this part, based on the income 
standard established by the state for such individuals and providing the 
benefits covered under that section: Sec. Sec.  435.110 (parents and 
caretaker relatives), 435.119 (individuals aged 19 or older and under 
age 65), 435.150 (former foster care children), and 435.218 (individuals 
under age 65 with income above 133 percent FPL).
    (c)(1) The terms of Sec. Sec.  435.1101 and 435.1102 apply to 
individuals who may be eligible under Sec.  435.213 of this part 
(relating to individuals with breast or cervical cancer) or Sec.  
435.214 of this part (relating to eligibility for limited family 
planning benefits) such that the agency may provide Medicaid during a 
presumptive eligibility period following a determination by a qualified 
entity described in paragraph (c)(2) of this section that--
    (i) The individual meets the eligibility requirements of Sec.  
435.213; or
    (ii) The individual meets the eligibility requirements of Sec.  
435.214, except that coverage provided during a presumptive eligibility 
period to such individuals is limited to the services described in Sec.  
435.214(d).
    (2) Qualified entities described in this paragraph include qualified 
entities which participate as providers under the State plan and which 
the agency determines are capable of making presumptive eligibility 
determinations.

[78 FR 42304, July 15, 2013]



Sec.  435.1110  Presumptive eligibility determined by hospitals.

    (a) Basic rule. The agency must provide Medicaid during a 
presumptive eligibility period to individuals who are determined by a 
qualified hospital, on the basis of preliminary information, to be 
presumptively eligible subject to the same requirements as apply to the 
State options under Sec. Sec.  435.1102 and 435.1103, but regardless of 
whether the agency provides Medicaid during a presumptive eligibility 
period under such sections.
    (b) Qualified hospitals. A qualified hospital is a hospital that--
    (1) Participates as a provider under the State plan or a 
demonstration under section 1115 of the Act, notifies the agency of its 
election to make presumptive eligibility determinations under this 
section, and agrees to make presumptive eligibility determinations 
consistent with State policies and procedures;
    (2) At State option, assists individuals in completing and 
submitting the full application and understanding any documentation 
requirements; and
    (3) Has not been disqualified by the agency in accordance with 
paragraph (d) of this section.
    (c) State options for bases of presumptive eligibility. The agency 
may--
    (1) Limit the determinations of presumptive eligibility which 
hospitals may elect to make under this section to determinations based 
on income for all of the populations described in Sec. Sec.  435.1102 
and 435.1103; or
    (2) Permit hospitals to elect to make presumptive eligibility 
determinations on additional bases approved under the State plan or an 
1115 demonstration.
    (d) Disqualification of hospitals. (1) The agency may establish 
standards for qualified hospitals related to the proportion of 
individuals determined presumptively eligible for Medicaid by the 
hospital who:
    (i) Submit a regular application, as described in Sec.  435.907, 
before the end of the presumptive eligibility period; or

[[Page 212]]

    (ii) Are determined eligible for Medicaid by the agency based on 
such application.
    (2) The agency must take action, including, but not limited to, 
disqualification of a hospital as a qualified hospital under this 
section, if the agency determines that the hospital is not--
    (i) Making, or is not capable of making, presumptive eligibility 
determinations in accordance with applicable state policies and 
procedures; or
    (ii) Meeting the standard or standards established by the agency 
under paragraph (d)(1) of this section.
    (3) The agency may disqualify a hospital as a qualified hospital 
under this paragraph only after it has provided the hospital with 
additional training or taken other reasonable corrective action measures 
to address the issue.

[78 FR 42304, July 15, 2013]



 Subpart M_Coordination of Eligibility and Enrollment Between Medicaid, 
       CHIP, Exchanges and Other Insurance Affordability Programs

    Source: 77 FR 17212, Mar. 23, 2012, unless otherwise noted.



Sec.  435.1200  Medicaid agency responsibilities for a coordinated 
eligibility and enrollment process with other insurance affordability
programs.

    (a) Statutory basis, purpose, and definitions.
    (1) Statutory basis and purpose. This section implements section 
1943(b)(3) of the Act as added by section 2201 of the Affordable Care 
Act to ensure coordinated eligibility and enrollment among insurance 
affordability programs.
    (2) Definitions. (i) Combined eligibility notice has the meaning as 
provided in Sec.  435.4.
    (ii) Coordinated content has the meaning as provided in Sec.  435.4.
    (iii) Joint fair hearing request has the meaning provided in Sec.  
431.201 of this chapter.
    (b) General requirements and definitions. The State Medicaid agency 
must--
    (1) Fulfill the responsibilities set forth in paragraphs (d) through 
(h) of this section and, if applicable, paragraph (c) of this section.
    (2) Certify for the Exchange and other insurance affordability 
programs the criteria applied in determining Medicaid eligibility.
    (3) Enter into and, upon request, provide to the Secretary one or 
more agreements with the Exchange, Exchange appeals entity and the 
agencies administering other insurance affordability programs as are 
necessary to fulfill the requirements of this section, including a clear 
delineation of the responsibilities of each program to--
    (i) Minimize burden on individuals seeking to obtain or renew 
eligibility or to appeal a determination of eligibility for enrollment 
in a QHP or for one or more insurance affordability program;
    (ii) Ensure compliance with paragraphs (d) through (h) of this 
section and, if applicable, paragraph (c) of this section;
    (iii) Ensure prompt determinations of eligibility and enrollment in 
the appropriate program without undue delay, consistent with timeliness 
standards established under Sec.  435.912, based on the date the 
application is submitted to any insurance affordability program;
    (iv) Provide for a combined eligibility notice and opportunity to 
submit a joint fair hearing request, consistent with paragraphs (g) and 
(h) of this section; and
    (v) If the agency has delegated authority to conduct fair hearings 
to the Exchange or Exchange appeals entity under Sec.  431.10(c)(1)(ii) 
of this chapter, provide for a combined appeals decision by the Exchange 
or Exchange appeals entity for individuals who requested an appeal of an 
Exchange-related determination in accordance with 45 CFR part155 subpart 
F and a fair hearing of a denial of Medicaid eligibility which is 
conducted by the Exchange or Exchange appeals entity.
    (c) Provision of Medicaid for individuals found eligible for 
Medicaid by another insurance affordability program. If the agency has 
entered into an agreement in accordance with Sec.  431.10(d) of this 
chapter under which the Exchange or other insurance affordability 
program makes final determinations of

[[Page 213]]

Medicaid eligibility, for each individual determined so eligible by the 
Exchange (including as a result of a decision made by the Exchange or 
Exchange appeals entity in accordance with paragraph (g)(6) or (7)(i)(A) 
of this section) or other program, the agency must--
    (1) Establish procedures to receive, via secure electronic 
interface, the electronic account containing the determination of 
Medicaid eligibility;
    (2) Comply with the provisions of Sec.  435.911 of this part to the 
same extent as if the application had been submitted to the Medicaid 
agency; and
    (3) Comply with the provisions of Sec.  431.10 of this subchapter to 
ensure it maintains oversight for the Medicaid program.
    (d) Transfer from other insurance affordability programs to the 
State Medicaid agency. For individuals for whom another insurance 
affordability program has not made a determination of Medicaid 
eligibility, but who have been assessed by such program (including as a 
result of a decision made by the Exchange appeals entity) as potentially 
Medicaid eligible, and for individuals not so assessed, but who 
otherwise request a full determination by the Medicaid agency, the 
agency must--
    (1) Accept, via secure electronic interface, the electronic account 
for the individual and notify such program of the receipt of the 
electronic account;
    (2) Not request information or documentation from the individual in 
the individual's electronic account, or provided to the agency by 
another insurance affordability program or appeals entity;
    (3) Promptly and without undue delay, consistent with timeliness 
standards established under Sec.  435.912, determine the Medicaid 
eligibility of the individual, in accordance with Sec.  435.911, without 
requiring submission of another application and, for individuals 
determined not eligible for Medicaid, comply with paragraph (e) of this 
section as if the individual had submitted an application to the agency;
    (4) Accept any finding relating to a criterion of eligibility made 
by such program or appeals entity, without further verification, if such 
finding was made in accordance with policies and procedures which are 
the same as those applied by the agency or approved by it in the 
agreement described in paragraph (b)(3) of this section; and
    (5) Notify such program of the final determination of the 
individual's eligibility or ineligibility for Medicaid.
    (e) Evaluation of eligibility for other insurance affordability 
programs--(1) Individuals determined not eligible for Medicaid. For each 
individual who submits an application or renewal to the agency which 
includes sufficient information to determine Medicaid eligibility, or 
whose eligibility is being renewed in accordance to a change in 
circumstance in accordance with Sec.  435.916(d), and whom the agency 
determines is not eligible for Medicaid, and for each individual 
determined ineligible for Medicaid in accordance with a fair hearing 
under subpart E of part 431 of this chapter, the agency must promptly 
and without undue delay, consistent with timeliness standards 
established under Sec.  435.912, determine potential eligibility for, 
and, as appropriate, transfer via a secure electronic interface the 
individual's electronic account to, other insurance affordability 
programs.
    (2) Individuals undergoing a Medicaid eligibility determination on a 
basis other than MAGI. In the case of an individual with household 
income greater than the applicable MAGI standard and for whom the agency 
is determining eligibility in accordance with Sec.  435.911(c)(2) of 
this part, the agency must promptly and without undue delay, consistent 
with timeliness standards established under Sec.  435.912 of this part, 
determine potential eligibility for, and as appropriate transfer via 
secure electronic interface the individual's electronic account to, 
other insurance affordability programs and provide timely notice to such 
other program--
    (i) That the individual is not Medicaid eligible on the basis of the 
applicable MAGI standard, but that a final determination of Medicaid 
eligibility is still pending; and
    (ii) Of the agency's final determination of eligibility or 
ineligibility for Medicaid.
    (3) The agency may enter into an agreement with the Exchange to make

[[Page 214]]

determinations of eligibility for enrollment in a QHP through the 
Exchange, advance payments of the premium tax credit and cost-sharing 
reductions, consistent with 45 CFR 155.110(a)(2).
    (f) Internet Web site. (1) The State Medicaid agency must make 
available to current and prospective Medicaid applicants and 
beneficiaries a Web site that--
    (i) Operates in conjunction with or is linked to the Web site 
described in Sec.  457.340(a) of this subchapter and to the Web site 
established by the Exchange under 45 CFR 155.205; and
    (ii) Supports applicant and beneficiary activities, including 
accessing information on the insurance affordability programs available 
in the State, applying for and renewing coverage, and other activities 
as appropriate.
    (2) Such Web site, any interactive kiosks and other information 
systems established by the State to support Medicaid information and 
enrollment activities must be in plain language and be accessible to 
individuals with disabilities and persons who are limited English 
proficient, consistent with Sec.  435.905(b) of this subpart.
    (g) Coordination involving appeals entities. The agency must--
    (1) Include in the agreement into which the agency has entered under 
paragraph (b)(3) of this section that, if the Exchange or other 
insurance affordability program provides an applicant or beneficiary 
with a combined eligibility notice including a determination that the 
individual is not eligible for Medicaid, the Exchange or Exchange 
appeals entity (or other insurance affordability program or other 
program's appeals entity) will--
    (i) Provide the applicant or beneficiary with an opportunity to 
submit a joint fair hearing request, including an opportunity to a 
request expedited review of his or her fair hearing request consistent 
with Sec.  431.221(a)(1)(ii) of this chapter; and
    (ii) Notify the Medicaid agency of any joint fair hearing request 
and transmit to the agency the electronic account of the individual who 
made such request, unless the fair hearing will be conducted by the 
Exchange or Exchange appeals entity in accordance to a delegation of 
authority under Sec.  431.10(c)(1)(ii) of this chapter; and
    (2) Beginning on the applicability date described in paragraph (i) 
of this section, establish a secure electronic interface the through 
which--
    (i) The Exchange or Exchange appeals entity (or other insurance 
affordability program or appeals entity) can notify the agency that an 
individual has submitted a joint fair hearing request in accordance with 
paragraph (g)(1)(ii) of this section;
    (ii) The individual's electronic account, including any information 
provided by the individual as part of an appeal to either the agency or 
Exchange appeals entity (or other insurance affordability program or 
appeals entity), can be transferred from one program or appeals entity 
to the other; and
    (iii) The agency can notify the Exchange, Exchange appeals entity 
(or other insurance affordability program or appeals entity) of the 
information described in paragraphs (g)(5)(i)(A), (B) and (C) of this 
section.
    (3) Accept and act on a joint fair hearing request submitted to the 
Exchange or Exchange appeals entity and transferred to the agency as if 
the request for fair hearing had been submitted directly to the agency 
in accordance with Sec.  431.221 of this chapter;
    (4) In conducting a fair hearing in accordance with subpart E or 
part 431 of this chapter, minimize to the maximum extent possible, 
consistent with guidance issued by the Secretary, any requests for 
information or documentation from the individual included in the 
individual's electronic account or provided to the agency by the 
Exchange or Exchange appeals entity.
    (5)(i) In the case of individuals described in paragraph (g)(5)(ii) 
of this section who submit a request a fair hearing under subpart E of 
part 431 of this chapter to the agency or who submit a joint fair 
hearing request to the Exchange or Exchange appeals entity (or other 
insurance affordability program or appeals entity), if the fair hearing 
is conducted by the Medicaid agency, transmit, through the electronic 
interface established under paragraph (g)(1) of this section, to the 
Exchange, Exchange appeals entity (or

[[Page 215]]

other insurance affordability program or appeals entity), as appropriate 
and necessary to enable such other entity to fulfill its 
responsibilities under 45 CFR part 155, 42 CFR part 457 or 42 CFR part 
600--
    (A) Notice that the individual has requested a fair hearing;
    (B) Whether Medicaid benefits will be furnished pending final 
administrative action on such fair hearing request in accordance with 
Sec.  431.230 or Sec.  431.231 of this chapter; and
    (C) The hearing decision made by the agency.
    (ii) Individuals described in this paragraph include individuals 
determined ineligible for Medicaid--
    (A) By the Exchange; or
    (B) By the agency and transferred to the Exchange or other insurance 
affordability program in accordance with paragraph (e)(1) or (2) of this 
section.
    (6)(i) In the case of individuals described in paragraph (g)(6)(ii) 
of this section, if the agency has delegated authority under Sec.  
431.10(c)(1)(i) to the Exchange to make Medicaid eligibility 
determinations, the agency must accept a determination of Medicaid 
eligibility made by the Exchange appeals entity and comply with 
paragraph (c) of this section in the same manner as if the determination 
of Medicaid eligibility had been made by the Exchange.
    (ii) Individuals described in this paragraph are individuals who 
were determined ineligible for Medicaid by the Exchange in accordance 
with 45 CFR 155.305(c), who did not request a fair hearing of such 
determination, and whom the Exchange appeals entity determines are 
eligible for Medicaid in deciding an appeal requested by the individual 
in accordance with 45 CFR part 155 subpart F.
    (7)(i) In the case of individuals described in paragraph (g)(7)(ii) 
of this section, the agency must either--
    (A) Accept a determination of Medicaid eligibility made by the 
Exchange appeals entity and comply with paragraph (c) of this section in 
the same manner as if the determination of Medicaid eligibility had been 
made by the Exchange; or
    (B) Accept a determination of Medicaid eligibility made by the 
Exchange appeals entity as an assessment of Medicaid eligibility made by 
the Exchange and make a determination of eligibility in accordance with 
paragraph (d) of this section, taking into account any additional 
information provided to or obtained by the Exchange appeals entity in 
conducting the Exchange-related appeal.
    (ii) Individuals described in this paragraph are individuals who 
were determined ineligible for Medicaid by the Medicaid agency in 
accordance with paragraph (e) of the section, who did not request a fair 
hearing of such determination of Medicaid ineligibility, and whom the 
Exchange appeals entity determines are eligible for Medicaid in deciding 
an appeal requested by the individual in accordance with 45 CFR part 155 
subpart F.
    (h) Coordination of eligibility notices. The agency must--
    (1) Include in the agreement into which the agency has entered under 
paragraph (b)(3) of this section that, to the maximum extent feasible, 
the agency, Exchange or other insurance affordability program will 
provide a combined eligibility notice, as defined in Sec.  435.4, to 
individuals, as well as to multiple members of the same household 
included on the same application or renewal form.
    (2) For individuals and other household members who will not receive 
a combined eligibility notice, include appropriate coordinated content, 
as defined in Sec.  435.4, in any notice provided by the agency in 
accordance with Sec.  435.917.
    (3) For individuals determined ineligible for Medicaid based on 
having household income above the applicable MAGI standard, but who are 
undergoing a Medicaid eligibility determination on a basis other than 
MAGI in accordance with (e)(2) of this section, the agency must--
    (i) Provide notice to the individual, consistent with Sec.  
435.917--
    (A) That the agency--
    (1) Has determined the individual ineligible for Medicaid due to 
household income over the applicable MAGI standard; and
    (2) Is continuing to evaluate Medicaid eligibility on other bases, 
including a plain language explanation of the other bases being 
considered.

[[Page 216]]

    (B) Include in such notice coordinated content that the agency has 
transferred the individual's electronic account to the other insurance 
affordability program (as required under paragraph (e)(2) of this 
section) and an explanation that eligibility for or enrollment in such 
other program will not affect the determination of Medicaid eligibility 
on a non-MAGI basis; and
    (i) Provide the individual with notice, consistent with Sec.  
435.917, of the final determination of eligibility on all bases, 
including coordinated content regarding, as applicable--
    (A) The notice being provided to the Exchange or other program in 
accordance with paragraph (e)(2)(ii) of this section;
    (B) Any impact that approval of Medicaid eligibility may have on the 
individual's eligibility for such other program; and
    (C) The transfer of the individual's electronic account to the 
Exchange in accordance with paragraph (e)(1) of this section.
    (i) Notice of applicability date. The date described in this 
paragraph is 6 months from the date of a published Federal Register 
document alerting States of the requirement to comply with paragraphs 
(g)(2) of this section and Sec. Sec.  431.221(a)(1)(i), 431.244(f)(3)(i) 
and (ii) of this chapter. The earliest we will publish such notice will 
be May 30, 2017, which would result in an earliest effective date of 
November 30, 2017.

[77 FR 17212, Mar. 23, 2012, as amended at 81 FR 86461, Nov. 30, 2016]



Sec.  435.1205  Alignment with exchange initial open enrollment period.

    (a) Definitions. For purposes of this section--
    Eligibility based on MAGI means Medicaid eligibility based on the 
eligibility requirements which will be effective under the State plan, 
or waiver of such plan, as of January 1, 2014, consistent with 
Sec. Sec.  435.110 through 435.119, 435.218 and 435.603.
    (b) Medicaid agency responsibilities to achieve coordinated open 
enrollment. For the period beginning October 1, 2013 through December 
31, 2013, the agency must
    (1) Accept all of the following:
    (i) The single streamlined application described in Sec.  435.907.
    (ii) Via secure electronic interface, an electronic account 
transferred from another insurance affordability program.
    (2) For eligibility based on MAGI, comply with the terms of Sec.  
435.1200 of this part, such that--
    (i) For each electronic account transferred to the agency under 
paragraph (c)(1)(ii) of this section, the agency consistent with either 
of the following:
    (A) Section 435.1200(c), accepts a determination of Medicaid 
eligibility based on MAGI, made by another insurance affordability 
program.
    (B) Section 435.1200(d), determines eligibility for Medicaid based 
on MAGI.
    (ii) Consistent with Sec.  435.1200(e), for each single streamlined 
application submitted directly to the agency under paragraph (b)(1)(i) 
of this section--
    (A) Determine eligibility based on MAGI; and
    (B) For each individual determined not Medicaid eligible based on 
MAGI, determine potential eligibility for other insurance affordability 
programs, based on the requirements which will be effective for each 
program, and transfer the individual's electronic account to such 
program via secure electronic interface.
    (iii) Provide notice and fair hearing rights, in accordance with 
Sec.  435.917 of this part, part 431 subpart E of this chapter, and 
Sec.  435.1200 for those determined ineligible for Medicaid.
    (3) For each individual determined eligible based on MAGI in 
accordance with paragraph (c)(2) of this section--
    (i) Provide notice, including the effective date of eligibility, to 
such individual, consistent with Sec.  435.917 of this part, and furnish 
Medicaid.
    (ii) Apply the terms of Sec.  435.916 (relating to beneficiary 
responsibility to inform the agency of any changes in circumstances that 
may affect eligibility) and Sec.  435.952 (regarding use of information 
received by the agency). The first renewal under Sec.  435.916 of this 
part may, at State option, be scheduled to occur anytime between 12 
months from the date of application and 12 months from January 1, 2014.
    (4) For eligibility effective in 2013, for all applicants--

[[Page 217]]

    (i) Consistent with the requirements of subpart J of this part, and 
applying the eligibility requirements in effect under the State plan, or 
waiver of such plan, as of the date the individual submits an 
application to any insurance affordability program--
    (A) Determine the individual's eligibility based on the information 
provided on the application or in the electronic account; or
    (B) Request additional information from the individual needed by the 
agency to determine eligibility based on the eligibility requirements in 
effect on such date, including on a basis excepted from application of 
MAGI-based methods, as described in Sec.  435.603, and determine such 
eligibility if such information is provided; and
    (C) Furnish Medicaid to individuals determined eligible under this 
clause or provide notice and fair hearing rights in accordance with part 
431 subpart E of this part if eligibility effective in 2013 is denied; 
or
    (ii) Notify the individual of the opportunity to submit a separate 
application for coverage effective in 2013 and information on how to 
obtain and submit such application.

[78 FR 42305, July 15, 2013]



PART 436_ELIGIBILITY IN GUAM, PUERTO RICO, AND THE VIRGIN ISLANDS-
-Table of Contents



              Subpart A_General Provisions and Definitions

Sec.
436.1 Purpose and applicability.
436.2 Basis.
436.3 Definitions and use of terms.
436.10 State plan requirements.

         Subpart B_Mandatory Coverage of the Categorically Needy

436.100 Scope.
436.110 Individuals receiving cash assistance.
436.111 Individuals who are not eligible for cash assistance because of 
          a requirement not applicable under Medicaid.
436.112 Individuals who would be eligible for cash assistance except for 
          increased OASDI under Pub. L. 92-336 (July 1, 1972).
436.114 Individuals deemed to be receiving AFDC.
436.116 Families terminated from AFDC because of increased earnings or 
          hours of employment.
436.118 Children for whom adoption assistance or foster care maintenance 
          payments are made.
436.120 Qualified pregnant women and children who are not qualified 
          family members.
436.121 Qualified family members.
436.122 Pregnant women eligible for extended coverage.
436.124 Newborn children.
436.128 Coverage for certain qualified aliens.

          Subpart C_Options for Coverage as Categorically Needy

436.200 Scope.
436.201 Individuals included in optional groups.

   Options for Coverage of Families and Children and Aged, Blind, and 
             Disabled Individuals, Including Pregnant Women

436.210 Individuals who meet the income and resource requirements of the 
          cash assistance programs.
436.211 Individuals who would be eligible for cash assistance if they 
          were not in medical institutions.
436.212 Individuals who would be eligible for cash assistance if the 
          State plan for OAA, AFDC, AB, APTD, or AABD were as broad as 
          allowed under the Act.
436.217 Individuals receiving home and community-based services.
436.219 Individuals receiving State plan home and community-based 
          services.
436.220 Individuals who would meet the income and resource requirements 
          under AFDC if child care costs were paid from earnings.
436.222 Individuals under age 21 who meet the income and resource 
          requirements of AFDC.
436.224 Individuals under age 21 who are under State adoption assistance 
          agreements.
436.229 Optional targeted low-income children.

          Options for Coverage of the Aged, Blind, and Disabled

436.230 Essential spouses of aged, blind, or disabled individuals 
          receiving cash assistance.

           Subpart D_Optional Coverage of the Medically Needy

436.300 Scope.
436.301 General rules.
436.308 Medically needy coverage of individuals under age 21.
436.310 Medically needy coverage of specified relatives.

[[Page 218]]

436.320 Medically needy coverage of the aged.
436.321 Medically needy coverage of the blind.
436.322 Medically needy coverage of the disabled.
436.330 Coverage for certain aliens.

               Subpart E_General Eligibility Requirements

436.400 Scope.
436.401 General rules.
436.402 [Reserved]
436.403 State residence.
436.404 Applicant's choice of category.
436.406 Citizenship and alienage.
436.407 Types of acceptable documentary evidence of citizenship.
436.408 [Reserved]

       Subpart F_Categorical Requirements for Medicaid Eligibility

436.500 Scope.

                               Dependency

436.510 Determination of dependency.

                                   Age

436.520 Age requirements for the aged.
436.522 Determination of age.

                                Blindness

436.530 Definition of blindness.
436.531 Determination of blindness.

                               Disability

436.540 Definition of disability.
436.541 Determination of disability.

    Subpart G_General Financial Eligibility Requirements and Options

436.600 Scope.
436.601 Application of financial eligibility methodologies.
436.602 Financial responsibility of relatives and other individuals.
436.604 [Reserved]
436.606 [Reserved]
436.608 Applications for other benefits.
436.610 Assignment of rights to benefits.

Subpart H [Reserved]

        Subpart I_Financial Requirements for the Medically Needy

436.800 Scope.

                     Medically Needy Income Standard

436.811 Medically needy income standard: General requirements.
436.814 Medically needy income standard: State plan requirements.

Medically Needy Income Eligibility and Liability for Payment of Medical 
                                Expenses

436.831 Income eligibility.
436.832 Post-eligibility treatment of income of institutionalized 
          individuals: Application of patient income to the cost of 
          care.

                    Medically Needy Resource Standard

436.840 Medically needy resource standard: General requirements.
436.843 Medically needy resource standard: State plan requirements.

            Determining Eligibility on the Basis of Resources

436.845 Medically needy resource eligibility.

   Subpart J_Eligibility in Guam, Puerto Rico, and the Virgin Islands

436.900 Scope.
436.901 General requirements.
436.909 Automatic entitlement to Medicaid following a determination of 
          eligibility under other programs.

             Subpart K_Federal Financial Participation (FFP)

436.1000 Scope.

 FFP for Expenditures for Determining Eligibility and Providing Services

436.1001 FFP for administration.
436.1002 FFP for services.
436.1003 Beneficiaries overcoming certain conditions of eligibility.
436.1004 FFP in expenditures for medical assistance for individuals who 
          have declared United States citizenship or nationality under 
          section 1137(d) of the Act and with respect to whom the State 
          has not documented citizenship and identity.
436.1005 Institutionalized individuals.
436.1006 Definitions relating to institutional status.

             Subpart L_Option for Coverage of Special Groups

436.1100 Basis and scope.

                  Presumptive Eligibility for Children

436.1101 Definitions related to presumptive eligibility for children.
436.1102 General rules.

    Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302).

    Source: 43 FR 45218, Sept. 29, 1978, unless otherwise noted.

[[Page 219]]



              Subpart A_General Provisions and Definitions



Sec.  436.1  Purpose and applicability.

    This part sets forth, for Guam, Puerto Rico, and the Virgin 
Islands--
    (a) The eligibility provisions that a State plan must contain;
    (b) The mandatory and optional groups of individuals to whom 
Medicaid is provided under a State plan;
    (c) The eligibility requirements and procedures that a Medicaid 
agency must use in determining and redetermining eligibility, and 
requirements it may not use; and
    (d) The availability of FFP for providing Medicaid and for 
administering the eligibility provisions of the plan.

[43 FR 45218, Sept. 29, 1978, as amended at 44 FR 17939, Mar. 23, 1979]



Sec.  436.2  Basis.

    This part implements the following sections of the Act and public 
laws that state requirements and standards for eligibility:

402(a)(22) Eligibility of deemed beneficiaries of AFDC who receive zero 
payments because of recoupment of overpayments.
402(a)(37) Eligibility of individuals who lose AFDC eligibility due to 
increased earnings.
414(g) Eligibility of certain individuals participating in work 
supplementation programs.
473(b) Eligibility of children in foster care and adopted children who 
are deemed AFDC beneficiaries.
1902(a)(8) Opportunity to apply; assistance must be furnished promptly.
1902(a)(10) Required and optional groups.
1902(a)(12) Determination of blindness.
1902(a)(16) Out-of-State care for State residents.
1902(a)(17) Standards for determining eligibility; flexibility in the 
application of income eligibility standards.
1902(a)(19) Safeguards for simplicity of administration and best 
interests of beneficiaries.
1902(a)(34) Three-month retroactive eligibility.
1902(a) (second paragraph after (47)) Eligibility despite increased 
monthly insurance benefits under title II.
1902(a)(55) Mandatory use of outstation locations other than welfare 
offices to receive and initially process applications of certain low-
income pregnant women, infants, and children under age 19.
1902(b) Prohibited conditions for eligibility:
    Age requirements of more than 65 years;
    State residence requirements excluding individuals who reside in the 
State; and
    Citizenship requirement excluding United States citizens.
1902(e) Four-month continued eligibility for families ineligible because 
of increased hours or income from employment.
1902(e)(2) Minimum eligibility period for beneficiaries enrolled in HMO.
1902(e)(3) Optional coverage of certain disabled children at home.
1902(e)(4) Eligibility of newborn children of Medicaid-eligible women.
1902(e)(5) Eligibility of pregnant women for extended coverage for a 
specified period after pregnancy ends.
1903(v) Payment for emergency services under Medicaid provided to 
aliens.
1905(a) (i)-(viii) List of eligible individuals.
1905(a) (clause following (21)) Prohibitions against providing Medicaid 
to certain institutionalized individuals.
1905(a) (second sentence) Definition f essential person.
1905(d)(2) Definition of resident of an intermediate care facility for 
individuals with intellectual disabilities.
1905(n) Definition of qualified pregnant woman and child.
1912(a) Conditions of eligibility.
1915(c) Home or community based services.
1915(d) Home and community-based services for individuals age 65 or 
older.
412(e)(5) of Immigration and Nationality Act-Eligibility of certain 
refugees.
Pub. L. 93-66, section 230 Deemed eligibility of certain essential 
persons.
Pub. L. 93-66, section 231 Deemed eligibility of certain persons in 
medical institutions.
Pub. L. 93-66, section 232 Deemed eligibility of certain blind and 
disabled medically indigent persons.
Pub. L. 96-272, section 310(b)(1) Continued eligibility of certain 
beneficiaries of Veterans Administration pensions.
Pub. L. 99-509, section 9406 Payment for emergency medical services 
provided to aliens.
Pub. L. 99-603, section 201 Aliens granted legalized status under 
section 245A of the Immigration and Nationality Act (8 U.S.C. 1255a) may 
under certain circumstances be eligible for Medicaid.
Pub. L. 99-603, section 302 Aliens granted legalized status under 
section 210 of the Immigration and Nationality Act may under certain 
circumstances be eligible for Medicaid (8 U.S.C. 1160).
Pub. L. 99-603, section 303 Aliens granted legal status under section 
210A of the Immigration and Nationality Act may under certain 
circumstances be eligible for Medicaid (8 U.S.C. 1161).

[52 FR 43072, Nov. 9, 1987; 52 FR 48438, Dec. 22, 1987, as amended at 55 
FR 36820, Sept. 7, 1990; 55 FR 48609, Nov. 21, 1990; 57 FR 29155, June 
30, 1992; 59 FR 48811, Sept. 23, 1994]

[[Page 220]]



Sec.  436.3  Definitions and use of terms.

    As used in this part--
    AABD means aid to the aged, blind, and disabled under title XVI of 
the Act;
    AB means aid to the blind under title X of the Act;
    AFDC means aid to families with dependent children under title IV-A 
of the Act;
    APTD means aid to the permanently and totally disabled under title 
XIV of the Act;
    Categorically needy refers to families and children, aged, blind or 
disabled individuals, and pregnant women listed under subparts B and C 
of this part who are eligible for Medicaid. Subpart B of this part 
describes the mandatory eligibility groups who, generally, are receiving 
or deemed to be receiving cash assistance under the Act. These mandatory 
groups are specified in sections 1902(a)(10)(A)(i) and 1902(e) of the 
Act. Subpart C of this part describes the optional eligibility groups of 
individuals who, generally, meet the categorical requirements that are 
the same as or less restrictive than those of the cash assistance 
programs but are not receiving cash payments. These optional groups are 
specified in sections 1902(a)(10)(A)(ii) and 1902(e) of the Act.
    Families and children refers to eligible members of families with 
children who are financially eligible under AFDC or medically needy 
rules and who are deprived of parental support or care as defined under 
the AFDC program (see 45 CFR 233.90; 233.100). In addition, this group 
includes individuals under age 21 who are not deprived of parental 
support or care but who are financially eligible under AFDC or medically 
needy rules (see optional coverage group, Sec.  436.222);
    Medically needy means families, children, aged, blind, or disabled 
individuals, and pregnant women listed in subpart D of this part who are 
not listed in subparts B and C of this part as categorically needy but 
who may be eligible for Medicaid under this part because their income 
and resources are within limits set by the State under its Medicaid plan 
(including persons whose income and resources fall within these limits 
after their incurred expenses for medical or remedial care are 
deducted). (Specific financial requirements for determining eligibility 
of the medically needy appear in subpart I of this part.)
    OAA means old age assistance under title I of the Act;
    OASDI means old age, survivors, and disability insurance under Title 
II of the Act.
    Optional targeted low-income child means a child under age 19 who 
meets the financial and categorical standards described below.
    (1) Financial need. An optional targeted low-income child:
    (i) Has a family income at or below 200 percent of the Federal 
poverty line for a family of the size involved;
    (ii) Resides in a State with no Medicaid applicable income level (as 
defined in Sec.  457.10 of this chapter); or,
    (iii) Resides in a State that has a Medicaid applicable income level 
(as defined in Sec.  457.10) and has family income that either:
    (A) Exceeds the Medicaid applicable income level for the age of such 
child, but not by more than 50 percentage points (expressed as a 
percentage of the Federal poverty line); or
    (B) Does not exceed the income level specified for such child to be 
eligible for medical assistance under the policies of the State plan 
under title XIX on June 1, 1997.
    (2) No other coverage and State maintenance of effort. An optional 
targeted low-income child is not covered under a group health plan or 
health insurance coverage, or would not be eligible for Medicaid under 
the policies of the State plan in effect on March 31, 1997; except that, 
for purposes of this standard--
    (i) A child shall not be considered to be covered by health 
insurance coverage based on coverage offered by the State under a 
program in operation prior to July 1, 1997 if that program received no 
Federal financial participation;
    (ii) A child shall not be considered to be covered under a group 
health plan or health insurance coverage if the child did not have 
reasonable geographic access to care under that coverage.
    (3) For purposes of this section, policies of the State plan under 
title XIX plan include policies under a Statewide demonstration project 
under section

[[Page 221]]

1115(a) of the Act other than a demonstration project that covered an 
expanded group of eligible children but that either--
    (i) Did not provide inpatient hospital coverage; or
    (ii) Limited eligibility to children previously enrolled in 
Medicaid, imposed premiums as a condition of initial or continued 
enrollment, and did not impose a general time limit on eligibility.

[43 FR 45218, Sept. 29, 1978, as amended at 45 FR 24887, Apr. 11, 1980; 
46 FR 47989, Sept. 30, 1981; 58 FR 4934, Jan. 19, 1993; 66 FR 2668, Jan. 
11, 2001]



Sec.  436.10  State plan requirements.

    A State plan must--
    (a) Provide that the requirements of this part are met; and
    (b) Specify the groups to whom Medicaid is provided, as specified in 
subparts B, C, and D of this part, and the conditions of eligibility for 
individuals in those groups.



         Subpart B_Mandatory Coverage of the Categorically Needy



Sec.  436.100  Scope.

    This subpart prescribes requirements for coverage of categorically 
needy individuals.



Sec.  436.110  Individuals receiving cash assistance.

    (a) A Medicaid agency must provide Medicaid to individuals receiving 
cash assistance under OAA, AFDC, AB, APTD, or AABD.
    (b) For purposes of this section, an individual is receiving cash 
assistance if his needs are considered in determining the amount of the 
payment. This includes an individual whose presence in the home is 
considered essential to the well-being of a beneficiary under the 
State's plan for OAA, AFDC, AB, APTD, or AABD if that plan were as broad 
as allowed under the Act for FFP.



Sec.  436.111  Individuals who are not eligible for cash assistance because
of a requirement not applicable under Medicaid.

    (a) The agency must provide Medicaid to individuals who would be 
eligible for OAA, AB, APTD, or AABD except for an eligibility 
requirement used in those programs that is specifically prohibited under 
title XIX of the Act.
    (b) The agency also must provide Medicaid to:
    (1) Individuals denied AFDC solely because of policies requiring the 
deeming of income and resources of the following individuals who are not 
included as financially responsible relatives under section 
1902(a)(17)(D) of the Act:
    (i) Stepparents who are not legally liable for support of 
stepchildren under a State law of general applicability;
    (ii) Grandparents
    (iii) Legal guardians;
    (iv) Aliens sponsors who are not organizations; and
    (v) Siblings.
    (2) [Reserved]

[58 FR 4934, Jan. 19, 1993, as amended at 59 FR 43053, Aug. 22, 1994]



Sec.  436.112  Individuals who would be eligible for cash assistance 
except for increased OASDI under Pub. L. 92-336 (July 1, 1972).

    The agency must provide Medicaid to individuals who meet the 
following conditions:
    (a) In August 1972, the individual was entitled to OASDI and--
    (1) He was receiving cash assistance; or
    (2) He would have been eligible for cash assistance if he had 
applied, and the Medicaid plan covered this optional group; or
    (3) He would have been eligible for cash assistance if he were not 
in a medical institution or intermediate care facility, and the Medicaid 
plan covered this optional group.
    (b) The individual would currently be eligible for cash assistance 
except that the increase in OASDI under Pub. L. 92-336 raised his income 
over the limit allowed under the cash assistance program. This includes 
an individual who--
    (1) Meets all current requirements for cash assistance except for 
the requirement to file an application; or
    (2) Would meet all current requirements for cash assistance if he 
were

[[Page 222]]

not in a medical institution or intermediate care facility, and the 
Medicaid plan covers this optional group.



Sec.  436.114  Individuals deemed to be receiving AFDC.

    (a) The Medicaid agency must provide Medicaid to individuals deemed 
to be receiving AFDC, as specified in this section.
    (b) The State must deem individuals to be receiving AFDC who are 
denied a cash payment from the title IV-A State agency solely because 
the amount of the AFDC payment would be less than $10.
    (c) The State may deem participants in a work supplementation 
program to be receiving AFDC under section 414(g) of the Act. This 
section permits States, for purposes of title XIX, to deem an individual 
and any child or relative of the individual (or other individual living 
in the same household) to be receiving AFDC, if the individual--
    (1) Participates in a State-operated work supplementation program 
under section 414 of the Act; and
    (2) Would be eligible for an AFDC cash payment if the individual 
were not participating in the work supplementation program.
    (d) The State must deem to be receiving AFDC those individuals who 
are denied AFDC payments from the title IV-A State agency solely because 
that agency is recovering an overpayment.
    (e) The State must deem to be receiving AFDC individuals described 
in section 473(a)(1) of the Act--
    (1) For whom an adoption assistance agreement is in effect under 
title IV-E of the Act, whether or not adoption assistance is being 
provided or an interlocutory or other judicial decree of adoption has 
been issued; or
    (2) For whom foster care maintenance payments are made under title 
IV-E of the Act.
    (f) The State must deem an individual to be receiving AFDC if a new 
collection or increased collection of child or spousal support under 
title IV-D of the Social Security Act results in the termination of AFDC 
eligibility in accordance with section 406(h) of the Social Security 
Act. States must continue to provide Medicaid for four consecutive 
calendar months, beginning with the first month of AFDC ineligibility, 
to each dependent child and each relative with whom such a child is 
living (including the eligible spouse of such relative as described in 
section 406(b) of the Social Security Act) who:
    (1) Becomes ineligible for AFDC on or after August 16, 1984; and
    (2) Has received AFDC for at least three of the six months 
immediately preceding the month in which the individual becomes 
ineligible for AFDC; and
    (3) Becomes ineligible for AFDC wholly or partly as a result of the 
initiation of or an increase in the amount of a child or spousal support 
collection under title IV-D.
    (g)(1) Except as provided in paragraph (g)(2) of this section, 
individuals who are eligible for extended Medicaid lose this coverage if 
they move to another State during the 4-month period. However, if they 
move back to and reestablish residence in the State in which they have 
extended coverage, they are eligible for any of the months remaining in 
the 4-month period in which they are residents of the State.
    (2) If a State has chosen in its State plan to provide Medicaid to 
non-residents, the State may continue to provide the 4-month extended 
benefits to individuals who have moved to another State.
    (h) For purposes of paragraph (f) of this section:
    (1) The new collection or increased collection of child or spousal 
support results in the termination of AFDC eligibility when it actively 
causes or contributes to the termination. This occurs when:
    (i) The change in support collection in and of itself is sufficient 
to cause ineligibility. This rule applies even if the support collection 
must be added to other, stable income. It also applies even if other 
independent factors, alone or in combination with each other, might 
simultaneously cause ineligibility; or
    (ii) The change in support contributes to ineligibility but does not 
by itself cause ineligibility. Ineligibility must result when the change 
in support is combined with other changes in income or changes in other 
circumstances and the other changes in

[[Page 223]]

income or circumstances cannot alone or in combination result in 
termination without the change in support.
    (2) In cases of increases in the amounts of both the support 
collections and earned income, eligibility under this section does not 
preclude eligibility under 45 CFR 233.20(a)(14) or section 1925 of the 
Social Security Act (which was added by section 303(a) of the Family 
Support Act of 1988 (42 U.S.C. 1396r-6)). Extended periods resulting 
from both an increase in the amount of the support collection and from 
an increase in earned income must run concurrently.

[46 FR 47989, Sept. 30, 1981, as amended at 52 FR 43072, Nov. 9, 1987; 
52 FR 48438, Dec. 22, 1987; 55 FR 48610, Nov. 21, 1990; 59 FR 59377, 
Nov. 17, 1994]



Sec.  436.116  Families terminated from AFDC because of increased earnings
or hours of employment.

    (a) If a family loses AFDC solely because of increased income from 
employment or increased hours of employment, the agency must continue to 
provide Medicaid for 4 months to all members of the family if--
    (1) The family received AFDC in any 3 or more months during the 6-
month period immediately before the month in which it became ineligible 
for AFDC; and
    (2) At least one member of the family is employed throughout the 4-
month period, although this need not be the same member for the whole 
period.
    (b) The 4 calendar month period begins on the date AFDC is 
terminated. If AFDC benefits are terminated retroactively, the 4 
calendar month period also begins retroactively with the first month in 
which AFDC was erroneously paid.

[43 FR 45218, Sept. 29, 1978, as amended at 45 FR 24887, Apr. 11, 1980]



Sec.  436.118  Children for whom adoption assistance or foster care 
maintenance payments are made.

    The agency must provide Medicaid to children for whom adoption 
assistance or foster care maintenance payments are made under title IV-E 
of the Act.

[47 FR 28656, July 1, 1982]



Sec.  436.120  Qualified pregnant women and children who are not
qualified family members.

    (a) The Medicaid agency must provide Medicaid to a pregnant woman 
whose pregnancy has been medically verified and who--
    (1) Would be eligible for an AFDC cash payment (or would be eligible 
for an AFDC cash payment if coverage under the State's AFDC plan 
included the AFDC-unemployed parents program) if her child had been born 
and was living with her in the month of payment;
    (2) Is a member of a family that would be eligible for an AFDC cash 
payment if the State's AFDC plan included an AFDC-unemployed parents 
program; or
    (3) Meets the income and resource requirements of the State's 
approved AFDC plan. In determining whether the woman meets the AFDC 
income and resource requirements, the unborn child or children are 
considered members of the household, and the woman's family is treated 
as though deprivation exists.
    (b) The provisions of paragraphs (a) (1) and (2) of this section are 
effective October 1, 1984. The provisions of paragraph (a)(3) of this 
section are effective July 1, 1986.
    (c) The agency must provide Medicaid to children who meet all of the 
following criteria:
    (1) They are born after September 30, 1983;
    (2) Effective October 1, 1988, they are under age 6 (or if 
designated by the State, any age that exceeds age 6 but does not exceed 
age 8), and effective October 1, 1989 they are under age 7 (or if 
designated by the State, any age that exceeds age 7 but does not exceed 
age 8); and
    (3) They meet the income and resource requirements of the State's 
approved AFDC plan.

[52 FR 43072, Nov. 9, 1987, as amended at 55 FR 48610, Nov. 21, 1990; 58 
FR 48614, Sept. 17, 1993]



Sec.  436.121  Qualified family members.

    (a) Definition. A qualified family member is any member of a family, 
including pregnant women and children eligible for Medicaid under Sec.  
436.120 of this

[[Page 224]]

subpart, who would be receiving AFDC cash benefits on the basis of the 
unemployment of the principal wage earner under section 407 of the Act 
had the State not chosen to place time limits on those benefits as 
permitted under section 407(b)(2)(B)(i) of the Act.
    (b) State plan requirement. The State plan must provide that the 
State makes Medicaid available to any individual who meets the 
definition of ``qualified family member'' as specified in paragraph (a) 
of this section.
    (c) Applicability. The provisions in this section are applicable 
from October 1, 1992, through September 30, 1998.

[58 FR 48614, Sept. 17, 1993]



Sec.  436.122  Pregnant women eligible for extended coverage.

    (a) The Medicaid agency must provide categorically needy Medicaid 
eligibility for an extended period following termination of pregnancy to 
women who, while pregnant, applied for, were eligible for, and received 
Medicaid services on the day that their pregnancy ends. This period 
extends from the last day of pregnancy through the end of the month in 
which a 60-day period, beginning on the last day of the pregnancy, ends. 
Eligibility must be provided, regardless of changes in the woman's 
financial circumstances that may occur within this extended period. 
These pregnant women are eligible for the extended period for all 
services under the plan that are pregnancy-related (as defined in Sec.  
440.210(c)(1) of this subchapter).
    (b) The provisions of paragraph (a) of this section apply to 
Medicaid furnished on or after April 7, 1986.

[55 FR 48610, Nov. 21, 1990]



Sec.  436.124  Newborn children.

    (a) The agency must provide Medicaid eligibility to a child born to 
a woman who has applied for, has been determined eligible and is 
receiving Medicaid on the date of the child's birth. The child is deemed 
to have applied and been found eligible for Medicaid on the date of 
birth and remains eligible for one year so long as the woman remains (or 
would remain if pregnant) eligible and the child is a member of the 
woman's household. This provision applies in instances where the labor 
and delivery services were furnished prior to the date of application 
and covered by Medicaid based on retroactive eligibility.
    (b) The agency must provide Medicaid eligibility in the same manner 
described in paragraph (a) of this section to a child born to an 
otherwise-eligible qualified alien woman subject to the 5-year bar so 
long as the woman has filed a complete Medicaid application, including 
but not limited to meeting residency, income and resource requirements, 
has been determined eligible, is receiving Medicaid on the date of the 
child's birth, and remains (or would remain if pregnant) Medicaid 
eligible. All standard Medicaid application procedures apply, including 
timely determination of eligibility and adequate notice of the agency's 
decision concerning eligibility. A 5-year bar qualified alien receiving 
emergency medical services only under Sec.  435.139 of this chapter is 
considered to be Medicaid-eligible and receiving Medicaid for purposes 
of this provision. With respect to whether the mother remains (or would 
remain if pregnant) eligible for Medicaid after the birth of the child, 
the State must determine whether a 5-year bar qualified alien would 
remain eligible for emergency services under Sec.  435.139 of this 
chapter. In determining whether the woman would remain eligible for 
these services, the State must consider whether the woman would remain 
eligible if pregnant. This provision applies in instances where the 
labor and delivery services were furnished prior to the date of 
application and covered by Medicaid based on retroactive eligibility.
    (c) The agency must provide Medicaid eligibility in the same manner 
described in paragraph (a) of this section to a child born to an 
otherwise-eligible non-qualified alien woman so long as the woman has 
filed a complete Medicaid application (other than providing a social 
security number or demonstrating immigration status), including but not 
limited to meeting residency, income and resource requirements, has been 
determined eligible, is receiving Medicaid on the date of the

[[Page 225]]

child's birth, and remains (or would remain if pregnant) Medicaid 
eligible. All standard Medicaid application procedures apply, including 
timely determination of eligibility and adequate notice of the agency's 
decision concerning eligibility. A non-qualified alien receiving 
emergency medical services only under Sec.  435.139 of this chapter is 
considered to be Medicaid-eligible and receiving Medicaid for purposes 
of this provision. With respect to whether the mother remains (or would 
remain if pregnant) eligible for Medicaid after the birth of the child, 
the State must determine whether a non-qualified alien would remain 
eligible for emergency services under Sec.  435.139 of this chapter. In 
determining whether the woman would remain eligible for these services, 
the State must consider whether the woman would remain eligible if 
pregnant. This provision applies in instances where the labor and 
delivery services were furnished prior to the date of application and 
covered by Medicaid based on retroactive eligibility.
    (d) A redetermination of eligibility must be completed on behalf of 
the children described in this provision in accordance with the 
procedures at Sec.  435.916. At that time, the State must collect 
documentary evidence of citizenship and identity as required under Sec.  
436.406.

[52 FR 43073, Nov. 9, 1987; 52 FR 48438, Dec. 22, 1987, as amended at 72 
FR 38694, July 13, 2007]



Sec.  436.128  Coverage for certain qualified aliens.

    The agency must provide the services necessary for the treatment of 
an emergency medical condition as defined in Sec.  440.255(c) of this 
chapter to those aliens described in Sec.  436.406(c) of this subpart.

[55 FR 36820, Sept. 7, 1990]



          Subpart C_Options for Coverage as Categorically Needy



Sec.  436.200  Scope.

    This subpart specifies options for coverage of individuals as 
categorically needy.



Sec.  436.201  Individuals included in optional groups.

    (a) The agency may choose to cover as optional categorically needy 
any group or groups of the following individuals who are not receiving 
cash assistance and who meet the appropriate eligibility criteria for 
groups specified in the separate sections of this subpart:
    (1) Aged individuals (65 years of age or older);
    (2) Blind individuals (as defined in Sec.  436.530);
    (3) Disabled individuals (as defined in Sec.  436.541);
    (4) Individuals under age 21 (or, at State option), under age 20, 
19, or 18) or reasonable classifications of these individuals;
    (5) Specified relatives under section 406(b)(1) of the Act who have 
in their care an individual who is determined to be dependent) as 
specified in Sec.  436.510;
    (6) Pregnant women; and
    (7) Essential spouses specified under Sec.  436.230.
    (b) If the agency provides Medicaid to any individual in an optional 
group specified in paragraph (a) of this section, the agency must 
provide Medicaid to all individuals who apply and are found eligible to 
be members of that group.

[58 FR 4934, Jan. 19, 1993]

   Options for Coverage of Families and Children and Aged, Blind, and 
             Disabled Individuals, Including Pregnant Women



Sec.  436.210  Individuals who meet the income and resource requirements
of the cash assistance programs.

    The agency may provide Medicaid to any group or groups of 
individuals specified under Sec.  436.201(a)(1), (a)(2), (a)(3), (a)(5), 
and (a)(6) who are not mandatory categorically needy and who meet the 
income and resource requirements of the appropriate cash assistance 
program for their status (that is, OAA, AFDC, AB, APTD, or AABD).

[58 FR 4935, Jan. 19, 1993]



Sec.  436.211  Individuals who would be eligible for cash assistance
if they were not in medical institutions.

    The agency may provide Medicaid to any group or groups of 
individuals

[[Page 226]]

specified in Sec.  436.201(a) who are in title XIX reimbursable medical 
institutions and who:
    (a) Are ineligible for the cash assistance program appropriate for 
their status (that is, OAA, AFDC, AB, APTD, or AABD) because of lower 
income standards used under the program to determine eligibility for 
institutionalized individuals; but
    (b) Would be eligible for aid or assistance under the State's 
approved plan under OAA, AFDC, AB, APTD, or AABD if they were not 
institutionalized.

[58 FR 4935, Jan. 19, 1993]



Sec.  436.212  Individuals who would be eligible for cash assistance if
the State plan for OAA, AFDC, AB, APTD, or AABD were as broad as allowed
under the Act.

    (a) The agency may provide Medicaid to any group or groups of 
individuals specified under Sec.  436.201(a) who:
    (1) Would be eligible for OAA, AFDC, AB, APTD, or AABD if the 
State's plan under those programs included individuals whose coverage 
under title I, IV-A, X, XIV, or XVI of the Act is optional (for example, 
the agency may provide Medicaid to individuals who are 18 years of age 
and who are attending secondary school full-time and are expected to 
complete their education before age 19, even though the State's AFDC 
plan does not include them); or
    (2) Would qualify for OAA, AFDC, AB, APTD, or AABD if the State's 
plan under those programs did not contain eligibility requirements more 
restrictive than, or in addition to, those required under the 
appropriate title of the Act. (For example, the agency may provide 
Medicaid to individuals who would meet the Federal definition of 
disability, 45 CFR 233.80, but who do not meet the State's more 
restrictive definitions.)
    (b) The agency may cover one or more optional groups under any of 
the titles of the Act without covering all such groups.

[43 FR 45218, Sept. 29, 1978, as amended at 45 FR 24887, Apr. 11, 1980; 
46 FR 47990, Sept. 30, 1981; 58 FR 4935, Jan. 19, 1993]



Sec.  436.217  Individuals receiving home and community-based services.

    The agency may provide Medicaid to any group or groups of 
individuals in the community who meet the following requirements:
    (a) The group would be eligible for Medicaid if institutionalized.
    (b) In the absence of home and community-based services under a 
waiver granted under part 441--
    (1) Subpart G of this subchapter, the group would otherwise require 
the level of care furnished in a hospital, NF, or an ICF/IID; or
    (2) Subpart H of this subchapter, the group would otherwise require 
the level of care furnished in a NF and are age 65 or older.
    (c) The group receives the waivered services.

[57 FR 29155, June 30, 1992]



Sec.  436.219  Individuals receiving State plan home and community-
based services.

    If the agency provides State plan home and community-based services 
to individuals described in section 1915(i)(1) of the Act, the agency, 
under its State plan, may, in addition, provide Medicaid to of 
individuals in the community who are described in one or both of 
paragraphs (a) or (b) of this section.
    (a) Individuals who--
    (1) Are not otherwise eligible for Medicaid;
    (2) Have income that does not exceed 150 percent of the Federal 
poverty line (FPL);
    (3) Meet the needs-based criteria under Sec.  441.715 of this 
chapter; and
    (4) Will receive State plan home and community-based services as 
defined in Sec.  440.182 of this chapter.
    (b) Individuals who--
    (1) Would be determined eligible by the agency under an existing 
waiver or demonstration project under sections 1915(c), 1915(d), 1915(e) 
or 1115 of the Act, but are not required to receive services under such 
waivers or demonstration projects;
    (2) Have income that does not exceed 300 percent of the Supplemental 
Security Income Federal Benefit Rate (SSI/FBR); and

[[Page 227]]

    (3) Will receive State plan home and community-based services as 
defined in Sec.  440.182 of this chapter.
    (c) For purposes of determining eligibility under paragraph (a) of 
this section, the agency may not take into account an individual's 
resources and must use income standards that are reasonable, consistent 
with the objectives of the Medicaid program, simple to administer, and 
in the best interests of the beneficiary. Income methodologies may 
include use of existing income methodologies, such as the rules of the 
OAA, AB, APTD or AABD programs. However, subject to the Secretary's 
approval, the agency may use other income methodologies that meet the 
requirements of this paragraph.

[79 FR 3029, Jan. 16, 2014]



Sec.  436.220  Individuals who would meet the income and resource 
requirements under AFDC if child care costs were paid from earnings.

    (a) The agency may provide Medicaid to any group or groups of 
individuals specified under Sec.  436.201(a)(4), (a)(5), and (a)(6) who 
would meet the income and resource requirements under the State's AFDC 
plan if their work-related child care costs were paid from their 
earnings rather than by a State agency as a service expenditure.
    (b) The agency may use this option only if the State's AFDC plan 
deducts work-related child care costs from income to determine the 
amount of AFDC.

[43 FR 45218, Sept. 29, 1978, as amended at 58 FR 4935, Jan. 19, 1993]



Sec.  436.222  Individuals under age 21 who meet the income and resource
requirements of AFDC.

    (a) The agency may provide Medicaid to individuals under age 21 (or 
at State option, under age 20, 19, or 18) or reasonable categories of 
these individuals as specified in paragraph (b) of this section, who are 
not receiving cash assistance but who meet the income and resource 
requirements of the State's approved AFDC plan.
    (b) The agency may cover all individuals described in paragraph (a) 
of this section or reasonable classifications of those individuals. 
Examples of reasonable classifications are as follows:
    (1) Individuals in foster homes or private institutions for whom a 
public agency is assuming a full or partial financial responsibility. If 
the agency covers these individuals, it may also provide Medicaid to 
individuals of the same age in foster homes or private institutions by 
private nonprofit agencies.
    (2) Individuals in adoptions subsidized in full or in part by a 
public agency.
    (3) Individuals in nursing facilities when nursing facility services 
are provided under the plan to individuals within the age group selected 
under this provision. If the agency covers these individuals, it may 
also provide Medicaid to individuals in intermediate care facilities for 
individuals with intellectual disabilities.
    (4) Individuals receiving active treatment as inpatients in 
psychiatric facilities or programs, if inpatient psychiatric services 
for individuals under 21 are provided under the plan.

[46 FR 47990, Sept. 30, 1981, as amended at 58 FR 4935, Jan. 19, 1993]



Sec.  436.224  Individuals under age 21 who are under State adoption
assistance agreements.

    (a) The agency may provide Medicaid to individuals under the age of 
21 (or, at State option, age 20, 19, or 18)--
    (1) For whom an adoption agreement (other than an agreement under 
title IV-E) between the State and adoptive parent(s) is in effect;
    (2) Who, the State agency responsible for adoption assistance has 
determined, cannot be placed with adoptive parents without Medicaid 
because the child has special needs for medical or rehabilitative care; 
and
    (3) Who meet either of the following:
    (i) Were eligible for Medicaid under the State plan before the 
adoption agreement was entered into; or
    (ii) Would have been eligible for Medicaid before the adoption 
agreement was entered into, if the eligibility standards and 
methodologies of the foster care program were used without employing the 
threshold title IV-A eligibility determination.
    (b) For adoption assistance agreements entered into before April 7, 
1986--

[[Page 228]]

    (1) The agency must deem the requirements of paragraph (a)(1) and 
(2) of this section to be met if the State adoption assistance agency 
determines that--
    (i) At the time of the adoption placement, the child had special 
needs for medical or rehabilitative care that made the child difficult 
to place; and
    (ii) There is in effect an adoption assistance agreement between the 
State and the adoptive parent(s).
    (2) The agency must deem the requirements of paragraph (a)(3) of 
this section to be met if the child was found by the State to be 
eligible for Medicaid before the adoption assistance agreement was 
entered into.

[55 FR 48610, Nov. 21, 1990]



Sec.  436.229  Optional targeted low-income children.

    The agency may provide Medicaid to--
    (a) All individuals under age 19 who are optional targeted low-
income children as defined in Sec.  436.3; or
    (b) Reasonable categories of these individuals.

[66 FR 2668, Jan. 11, 2001]

          Options for Coverage of the Aged, Blind, and Disabled



Sec.  436.230  Essential spouses of aged, blind, or disabled individuals
receiving cash assistance.

    The agency may provide Medicaid to the spouse of an individual 
receiving OAA, AB, APTD, or AABD, if--
    (a) The spouse is living with the individual receiving cash 
assistance;
    (b) The cash assistance agency has determined that the spouse is 
essential to the well-being of the individual and has considered the 
spouse's needs in determining the amount of cash assistance provided to 
the individual.



           Subpart D_Optional Coverage of the Medically Needy



Sec.  436.300  Scope.

    This subpart specifies the option for coverage of medically needy 
individuals.



Sec.  436.301  General rules.

    (a) A Medicaid agency may provide Medicaid to individuals specified 
in this subpart who:
    (1) Either:
    (i) Have income that meets the standard in Sec.  436.811; or
    (ii) If their income is more than allowed under the standard, have 
incurred medical expenses at least equal to the difference between their 
income and the applicable income standards; and
    (2) Have resources that meet the standard in Sec. Sec.  436.840 and 
436.843.
    (b) If the agency chooses this option, the following provisions 
apply:
    (1) The agency must provide Medicaid to the following individuals 
who meet the requirements of paragraph (a) of this section:
    (i) All pregnant women during the course of their pregnancy who, 
except for income and resources, would be eligible for Medicaid as 
mandatory or optional categorically needy under subparts B and C of this 
part;
    (ii) All individuals under 18 years of age who, except for income 
and resources, would be eligible for Medicaid as mandatory categorically 
needy under subpart B of this part;
    (iii) All newborn children born on or after October 1, 1984, to a 
woman who is eligible as medically needy and receiving Medicaid on the 
date of the child's birth. The child is deemed to have applied and been 
found eligible for Medicaid on the date of birth and remains eligible as 
medically needy for ne year so long as the woman remains eligible and 
the child is a member of the woman's household. If the woman's basis of 
eligibility changes to categorically needy, the child is eligible as 
categorically needy under Sec.  436.124. The woman is considered to 
remain eligible if she meets the spend-down requirements in any 
consecutive budget period following the birth of the child.
    (iv) Women who, while pregnant, applied for, were eligible for, and 
received Medicaid services as medically needed on the day that their 
pregnancy ends. The agency must provide medically needy eligibility to 
these women for an extended period following termination of pregnancy. 
This period begins on the last day of the pregnancy and extends

[[Page 229]]

through the end of the month in which a 60-day period following 
termination of pregnancy ends. Eligibility must be provided, regardless 
of changes in the women's financial circumstances that may occur within 
this extended period. These women are eligible for the extended period 
for all services under the plan that are pregnancy-related (as defined 
in Sec.  440.210(c)(1) of this subchapter).
    (2) The agency may provide Medicaid to any or all of the following 
groups of individuals:
    (i) Individuals under age 21 (Sec.  436.308).
    (ii) Specified relatives (Sec.  436.310).
    (iii) Aged (Sec.  436.320).
    (iv) Blind (Sec.  436.321).
    (v) Disabled (Sec.  436.322).
    (3) If the agency provides Medicaid to any individual in a group 
specified in paragraph (b)(2) of this section, the agency must provide 
Medicaid to all individuals eligible to be members of that group.

[46 FR 47990, Sept. 30, 1981; 46 FR 54743, Nov. 4, 1981, as amended at 
52 FR 43073, Nov. 9, 1987; 55 FR 48610, Nov. 21, 1990; 58 FR 4935, Jan. 
19, 1993]



Sec.  436.308  Medically needy coverage of individuals under age 21.

    (a) If the agency provides Medicaid to the medically needy, it may 
provide Medicaid to individuals under age 21 (or at State option, under 
age 20, 19, or 18) as specified in paragraph (b) of this section:
    (1) Who would not be covered under the mandatory medically needy 
group of individuals under 18 under Sec.  436.301(b)(1)(ii); and
    (2) Who meet the income and resource requirements of subpart I of 
this part.
    (b) The agency may cover all individuals in paragraph (a) of this 
section or individuals in reasonable classifications. Examples of 
reasonable classifications are as follows:
    (1) Individuals in foster homes or private institutions for whom a 
public agency is assuming a full or partial financial responsibility. If 
the agency covers these individuals, it may also provide Medicaid to 
individuals placed in foster homes or private institutions by private 
nonprofit agencies.
    (2) Individuals in adoptions subsidized in full or in part by a 
public agency.
    (3) Individuals in nursing facilities when nursing facility services 
are provided under the plan to individuals within the age group selected 
under this provision. When the agency covers such individuals, it may 
also provide Medicaid to individuals in intermediate care facilities for 
individuals with intellectual disabilities.
    (4) Individuals receiving active treatment as inpatients in 
psychiatric facilities or programs, if inpatient psychiatric services 
for individuals under 21 are provided under the plan.

[46 FR 47990, Sept. 30, 1981, as amended at 58 FR 4935, Jan. 19, 1993]



Sec.  436.310  Medically needy coverage of specified relatives.

    (a) If the agency provides for the medically needy, it may provide 
Medicaid to specified relatives, defined in paragraph (b) of this 
section, who meet the income and resource requirements of subpart I of 
this part.
    (b) Specified relatives means individuals who:
    (1) Are listed under section 406(b)(1) of the Act and in 45 CFR 
233.90(c)(1)(v)(A); and
    (2) Have in their care an individual who is determined to be (or 
would, if needy, be) dependent, as specified in Sec.  436.510.

[58 FR 4936, Jan. 19, 1993]



Sec.  436.320  Medically needy coverage of the aged.

    If the agency provides Medicaid to the medically needy, it may 
provide Medicaid to individuals who--
    (a) Are 65 years of age and older, as provided for in Sec.  436.520; 
and
    (b) Meet the income and resource requirements of subpart I of this 
part.

[46 FR 47991, Sept. 30, 1981]



Sec.  436.321  Medically needy coverage of the blind.

    If the agency provides Medicaid to the medically needy, it may 
provide Medicaid to blind individuals who meet--
    (a) The requirements for blindness, as specified in Sec. Sec.  
436.530 and 436.531; and

[[Page 230]]

    (b) The income and resource requirements of subpart I of this part.

[46 FR 47991, Sept. 30, 1981]



Sec.  436.322  Medically needy coverage of the disabled.

    If the agency provides Medicaid to the medically needy, it may 
provide Medicaid to disabled individuals who meet--
    (a) The requirements for disability, as specified in Sec. Sec.  
436.540 and 436.541; and
    (b) The income and resource requirements of subpart I of this part.

[46 FR 47991, Sept. 30, 1981]



Sec.  436.330  Coverage for certain aliens.

    If an agency provides Medicaid to the medically needy, it must 
provide the services necessary for the treatment of an emergency medical 
condition, as defined in Sec.  440.255(c) of this chapter to those 
aliens described in Sec.  436.406(c) of this subpart.

[55 FR 36820, Sept. 7, 1990]



               Subpart E_General Eligibility Requirements



Sec.  436.400  Scope.

    This subpart prescribes general requirements for determining the 
eligibility of both categorically needy and medically needy individuals 
specified in subparts B, C, and D of the part.



Sec.  436.401  General rules.

    (a) The agency may not impose any eligibility requirement that is 
prohibited under title XIX.
    (b) The agency must base any optional group covered under subparts B 
and C of this part on reasonable classifications that do not result in 
arbitrary or inequitable treatment of individuals and groups and are 
consistent with the objectives of title XIX.
    (c) The agency must not use requirements for determining eligibility 
for optional coverage groups that are more restrictive than those used 
under the State plans for OAA, AFDC, AB, APTD, or AABD.



Sec.  436.402  [Reserved]



Sec.  436.403  State residence.

    (a) Requirement. The agency must provide Medicaid to eligible 
residents of the State, including residents who are absent from the 
State. The conditions under which payment for service is provided to 
out-of-State residents are set forth in Sec.  431.52 of this chapter.
    (b) Definition. For purposes of this section--Institution has the 
same meaning as Institution and Medical institution, as defined in Sec.  
435.1010 of this chapter. For purposes of State placement, the term also 
includes ``foster care homes'', licensed as set forth in 45 CFR 1355.20, 
and providing food, shelter and supportive services to one or more 
persons unrelated to the proprietor.
    (c) Incapability of indicating intent. For purposes of this section, 
an individual is considered incapable of indicating intent if the 
individual--
    (1) Has an I.Q. of 49 or less or has a mental age of 7 or less, 
based on tests acceptable to the Intellectual Disability agency in the 
State;
    (2) Is judged legally incompetent; or
    (3) Is found incapable of indicating intent based on medical 
documentation obtained from a physician, psychologist, or other person 
licensed by the State in the field of intellectual disability.
    (d) Who is a State resident. A resident of a State is any individual 
who:
    (1) Meets the conditions in paragraphs (e) through (h) of this 
section; or
    (2) Meets the criteria specified in an interstate agreement under 
paragraph (j) of this section.
    (e) Placement by a State in an out-of-state institution--(1) General 
rule. Any agency of the State, including an entity recognized under 
State law as being under contract with the State for such purposes, that 
arranges for an individual to be placed in an institution located in 
another State, is recognized as acting on behalf of the State in making 
a placement. The State arranging or actually making the placement is 
considered as the individual's State of residence.

[[Page 231]]

    (2) Any action beyond providing information to the individual and 
the individual's family would constitute arranging or making a State 
placement. However, the following actions do not constitute State 
placement:
    (i) Providing basic information to individuals about another State's 
Medicaid program, and information about the availability of health care 
services and facilities in another State.
    (ii) Assisting an individual in locating an institution in another 
State provided the individual is capable of indicating intent and 
independently decides to move.
    (3) When a competent individual leaves the facility in which the 
individual is placed by a State, that individual's State of residency 
for Medicaid purposes is the State where the individual is physically 
located.
    (4) Where placement is initiated by a State because the State lacks 
a sufficient number of appropriate facilities to provide services to its 
residents, the State making the placement is the individual's State of 
residence for Medicaid purposes.
    (f) Individuals receiving title IV-E payments. For individuals of 
any age who are receiving Federal payment for foster care and adoption 
assistance under title IV-E of the Social Security Act, the State of 
residence is the State where the child lives.
    (g) Individuals under age 21. (1) For any individual who is 
emancipated from his or her parents or who is married and capable of 
indicating intent, the State of residence is the State where the 
individual is living with the intention to remain there permanently or 
for an indefinite period.
    (2) For any individual not residing in an institution as defined in 
paragraph (b) whose Medicaid eligibility is based on blindness or 
disability, the State of residence is the State in which the individual 
is living.
    (3) For any other non-institutionalized individual not subject to 
paragraph (h)(1) or (h)(2) of this section, the State of residence is 
determined in accordance with 45 CFR 233.40, the rules governing 
residence under the AFDC program.
    (4) For any institutionalized individual who is neither married nor 
emancipated, the State of residence is--
    (i) The parents' or legal guardian's current State of residence at 
the time of placement; or
    (ii) The current State of residence of the parent or legal guardian 
who files the application, if the individual is institutionalized in 
that State. If a legal guardian has been appointed and the parental 
rights are terminated, the State of residence of the guardian is used 
instead of the parent's.
    (iii) The State of residence of the individual or party who files an 
application is used if the individual has been abandoned by his or her 
parent(s), does not have a legal guardian and is institutionalized in 
that State.
    (h) Individuals age 21 and over. (1) For any individual not residing 
in an institution as defined in paragraph (b), the State of residence is 
the State where the individual is--
    (i) Living with the intention to remain there permanently or for an 
indefinite period (or if incapable of stating intent, where the 
individual is living); or
    (ii) Living and which the individual entered with a job commitment 
or seeking employment (whether or not currently employed).
    (2) For any institutionalized individual who became incapable of 
indicating intent before age 21, the State of residence is--
    (i) That of the parents applying for Medicaid on the individual's 
behalf, if the parents reside in separate States;
    (ii) The parent's or legal guardian's State of residence at the time 
of placement; or
    (iii) The current State of residence of the parent or legal guardian 
who files the application, if the individual is institutionalized in 
that State. If a legal guardian has been appointed and parental rights 
are terminated, the State of residence of the guardian is used instead 
of the legal parent's.
    (iv) The State of residence of the individual or party who files an 
application is used if the individual has been abandoned by his or her 
parent(s), does not have a legal guardian and is institutionalized in 
that State.

[[Page 232]]

    (3) For any institutionalized individual who became incapable of 
indicating intent at or after age 21, the State of residence is the 
State in which the individual is physically present, except where 
another State makes a placement.
    (4) For any other institutionalized individual, the State of 
residence is the State where the individual is living with the intention 
to remain there permanently or for an indefinite period.
    (i) Specific prohibitions. (1) The agency may not deny Medicaid 
eligibility because an individual has not resided in the State for a 
specified period.
    (2) The agency may not deny Medicaid eligibility to an individual in 
an institution, who satisfies the residency rules set forth in this 
section, on the grounds that the individual did not establish residence 
in the State before entering the institution.
    (3) The agency may not deny or terminate a resident's Medicaid 
eligibility because of that person's temporary absence from the State if 
the person intends to return when the purpose of the absence has been 
accomplished, unless another State has determined that the person is a 
resident there for purposes of Medicaid.
    (j) Interstate agreements. A State may have a written agreement with 
another State setting forth rules and procedures resolving cases of 
disputed residency. These agreements may establish criteria other than 
those specified in paragraphs (c) through (h) of this section, but must 
not include criteria that result in loss of residency in both States or 
that are prohibited by paragraph (i) of this section. The agreements 
must contain a procedure for providing Medicaid to individuals pending 
resolution of the case.

States may use interstate agreements for purposes other than cases of 
disputed residency to facilitate administration of the program, and to 
facilitate the placement and adoption of title IV-E individuals when the 
child and his or her adoptive parent(s) move into another State.
    (k) Continued Medicaid for institutionalized beneficiaries. An 
agency is providing Medicaid to an institutionalized beneficiary who, as 
a result of this section, would be considered a resident of a different 
State--
    (1) The agency must continue to provide Medicaid to that beneficiary 
from June 24, 1983 until July 5, 1984 unless it makes arrangements with 
another State of residence to provide Medicaid at an earlier date; and
    (2) Those arrangements must not include provisions prohibited by 
paragraph (g) of this section.
    (l) Cases of disputed residency. Where two or more States cannot 
resolve which State is the State of residence, the State where the 
individual is physically located is the State of residence.

[49 FR 13533, Apr. 5, 1984, as amended at 55 FR 48610, Nov. 21, 1990; 71 
FR 39225, July 12, 2006]



Sec.  436.404  Applicant's choice of category.

    The agency must allow an individual who would be eligible under more 
than one category to have his eligibility determined for the category he 
selects.



Sec.  436.406  Citizenship and alienage.

    (a) The agency must provide Medicaid to otherwise eligible residents 
of the United States who are--
    (1) Citizens: (i) Under a declaration required by section 1137(d) of 
the Act that the individual is a citizen or national of the United 
States; and
    (ii) The individual has provided satisfactory documentary evidence 
of citizenship or national status, as described in Sec.  435.407.
    (iii) An individual for purposes of the declaration and citizenship 
documentation requirements discussed in paragraphs (a)(1)(i) and 
(a)(1)(ii) of this section includes both applicants and beneficiaries 
under a section 1115 demonstration (including a family planning 
demonstration project) for which a State receives Federal financial 
participation in their expenditures, as though the expenditures were for 
medical assistance.
    (iv) Individuals must declare their citizenship and the State must 
document an individual's eligibility file on initial applications and 
initial redeterminations effective July 1, 2006.
    (v) The following groups of individuals are exempt from the 
requirements in paragraph (a)(1)(ii) of this section:

[[Page 233]]

    (A) Individuals receiving SSI benefits under title XVI of the Act;
    (B) Individuals entitled to or enrolled in any part of Medicare;
    (C) Individuals receiving disability insurance benefits under 
section 223 of the Act or monthly benefits under section 202 of the Act, 
based on the individual's disability (as defined in section 223(d) of 
the Act); and
    (D) Individuals who are in foster care and who are assisted under 
Title IV-B of the Act, and individuals who are beneficiaries of foster 
care maintenance or adoption assistance payments under Title IV-E of the 
Act.
    (2)(i) Except as specified in 8 U.S.C. 1612(b)(1) (permitting States 
an option with respect to coverage of certain qualified aliens), 
qualified aliens as described in section 431 of the Personal 
Responsibility and Work Opportunity Reconciliation Act of 1996 (8 U.S.C. 
1641) (including qualified aliens subject to the 5-year bar) who have 
provided satisfactory documentary evidence of Qualified Alien status, 
which status has been verified with the Department of Homeland Security 
(DHS) under a declaration required by section 1137(d) of the Act that 
the applicant or beneficiary is an alien in a satisfactory immigration 
status.
    (ii) The eligibility of qualified aliens who are subject to the 5-
year bar in 8 U.S.C. 1613 is limited to the benefits described in 
paragraph (b) of this section.
    (b) The agency must provide payment for the services described in 
Sec.  440.255(c) of this chapter to residents of the State who otherwise 
meet the eligibility requirements of the State plan (except for receipt 
of AFDC, SSI, or State Supplementary payments) who are qualified aliens 
subject to the 5-year bar or who are non-qualified aliens who meet all 
Medicaid eligibility criteria, except non-qualified aliens need not 
present a social security number or document immigration status.

[55 FR 36820, Sept. 7, 1990, as amended at 71 FR 39225, July 12, 2006; 
72 FR 38694, July 13, 2007]



Sec.  436.407  Types of acceptable documentary evidence of citizenship.

    For purposes of this section, the term ``citizenship'' includes 
status as a ``national of the United States'' as defined by section 
101(a)(22) of the Immigration and Nationality Act (8 U.S.C. Sec.  
1101(a)(22)) to include both citizens of the United States and non-
citizen nationals of the United States.
    (a) Primary evidence of citizenship and identity. The following 
evidence must be accepted as satisfactory documentary evidence of both 
identity and citizenship:
    (1) A U.S. passport. The Department of State issues this. A U.S. 
passport does not have to be currently valid to be accepted as evidence 
of U.S. citizenship, as long as it was originally issued without 
limitation.

    Note: Spouses and children were sometimes included on one passport 
through 1980. U.S. passports issued after 1980 show only one person. 
Consequently, the citizenship and identity of the included person can be 
established when one of these passports is presented. Exception: Do not 
accept any passport as evidence of U.S. citizenship when it was issued 
with a limitation. However, such a passport may be used as proof of 
identity.

    (2) A Certificate of Naturalization (DHS Forms N-550 or N-570.) 
Department of Homeland Security issues for naturalization.
    (3) A Certificate of U.S. Citizenship (DHS Forms N-560 or N-561.) 
Department of Homeland Security issues certificates of citizenship to 
individuals who derive citizenship through a parent.
    (4) A valid State-issued driver's license, but only if the State 
issuing the license requires proof of U.S. citizenship before issuance 
of such license or obtains a social security number from the applicant 
and verifies before certification that such number is valid and assigned 
to the applicant who is a citizen. (This provision is not effective 
until such time as a State makes providing evidence of citizenship a 
condition of issuing a driver's license and evidence that the license 
holder is a citizen is included on the license or in a system of records 
available to the Medicaid agency. States must ensure that the process 
complies with this statutory provision in section 6036 of the Deficit 
Reduction Act of 2005. CMS will monitor compliance of States 
implementing this provision.)

[[Page 234]]

    (b) Secondary evidence of citizenship. If primary evidence from the 
list in paragraph (a) of this section is unavailable, an applicant or 
beneficiary should provide satisfactory documentary evidence of 
citizenship from the list specified in this section to establish 
citizenship and satisfactory documentary evidence from paragraph (e) of 
this section to establish identity, in accordance with the rules 
specified in this section.
    (1) A U.S. public birth certificate showing birth in one of the 50 
States, the District of Columbia, Puerto Rico (if born on or after 
January 13, 1941), Guam (on or after April 10, 1899), the Virgin Islands 
of the U.S. (on or after January 17, 1917), American Samoa, Swain's 
Island, or the Northern Mariana Islands (after November 4, 1986 (NMI 
local time)). A State, at its option, may use a cross match with a State 
vital statistics agency to document a birth record. The birth record 
document may be issued by the State, Commonwealth, Territory, or local 
jurisdiction. It must have been recorded before the person was 5 years 
of age. A delayed birth record document that is recorded at or after 5 
years of age is considered fourth level evidence of citizenship. (Note: 
If the document shows the individual was born in Puerto Rico, the Virgin 
Islands of the U.S., or the Northern Mariana Islands before these areas 
became part of the U.S., the individual may be a collectively 
naturalized citizen. Collective naturalization occurred on certain dates 
listed for each of the territories.) The following will establish U.S. 
citizenship for collectively naturalized individuals:
    (i) Puerto Rico:
    (A) Evidence of birth in Puerto Rico on or after April 11, 1899 and 
the applicant's statement that he or she was residing in the U.S., a 
U.S. possession, or Puerto Rico on January 13, 1941; or
    (B) Evidence that the applicant was a Puerto Rican citizen and the 
applicant's statement that he or she was residing in Puerto Rico on 
March 1, 1917 and that he or she did not take an oath of allegiance to 
Spain.
    (ii) U.S. Virgin Islands:
    (A) Evidence of birth in the U.S. Virgin Islands, and the 
applicant's statement of residence in the U.S., a U.S. possession, or 
the U.S. Virgin Islands on February 25, 1927; or
    (B) The applicant's statement indicating residence in the U.S. 
Virgin Islands as a Danish citizen on January 17, 1917 and residence in 
the U.S., a U.S. possession, or the U.S. Virgin Islands on February 25, 
1927, and that he or she did not make a declaration to maintain Danish 
citizenship; or
    (C) Evidence of birth in the U.S. Virgin Islands and the applicant's 
statement indicating residence in the U.S., a U.S. possession, or 
Territory or the Canal Zone on June 28, 1932.
    (iii) Northern Mariana Islands (NMI) (formerly part of the Trust 
Territory of the Pacific Islands (TTPI)):
    (A) Evidence of birth in the NMI, TTPI citizenship and residence in 
the NMI, the U.S., or a U.S. Territory or possession on November 3, 1986 
(NMI local time) and the applicant's statement that he or she did not 
owe allegiance to a foreign State on November 4, 1986 (NMI local time); 
or
    (B) Evidence of TTPI citizenship, continuous residence in the NMI 
since before November 3, 1981 (NMI local time), voter registration 
before January 1, 1975 and the applicant's statement that he or she did 
not owe allegiance to a foreign State on November 4, 1986 (NMI local 
time); or
    (C) Evidence of continuous domicile in the NMI since before January 
1, 1974 and the applicant's statement that he or she did not owe 
allegiance to a foreign State on November 4, 1986 (NMI local time).
    (D) Note: If a person entered the NMI as a nonimmigrant and lived in 
the NMI since January 1, 1974, this does not constitute continuous 
domicile and the individual is not a U.S. citizen.
    (2) A Certification of Report of Birth (DS-1350). The Department of 
State issues a DS-1350 to U.S. citizens in the U.S. who were born 
outside the U.S. and acquired U.S. citizenship at birth, based on the 
information shown on the FS-240. When the birth was recorded as a 
Consular Report of Birth (FS-240), certified copies of the Certification 
of Report of Birth Abroad (DS-1350) can be issued by the Department of 
State in Washington, DC. The DS-1350 contains the same information as 
that on the current version of Consular Report

[[Page 235]]

of Birth FS-240. The DS-1350 is not issued outside the U.S.
    (3) A Report of Birth Abroad of a U.S. Citizen (Form FS-240). The 
Department of State consular office prepares and issues this. A Consular 
Report of Birth can be prepared only at an American consular office 
overseas while the child is under the age of 18. Children born outside 
the U.S. to U.S. military personnel usually have one of these.
    (4) A Certification of birth issued by the Department of State (Form 
FS-545 or DS-1350). Before November 1, 1990, Department of State 
consulates also issued Form FS-545 along with the prior version of the 
FS-240. In 1990, U.S. consulates ceased to issue Form FS-545. Treat an 
FS-545 the same as the DS-1350.
    (5) A U.S. Citizen I.D. card. (This form was issued until the 1980s 
by INS. Although no longer issued, holders of this document may still 
use it consistent with the provisions of section 1903(x) of the Act.) 
INS issued the I-179 from 1960 until 1973. It revised the form and 
renumbered it as Form I-197. INS issued the I-197 from 1973 until April 
7, 1983. INS issued Form I-179 and I-197 to naturalized U.S. citizens 
living near the Canadian or Mexican border who needed it for frequent 
border crossings. Although neither form is currently issued, either form 
that was previously issued is still valid.
    (6) A Northern Mariana Identification Card (I-873). (Issued by the 
DHS to a collectively naturalized citizen of the United States who was 
born in the Northern Mariana Islands before November 4, 1986.) The 
former Immigration and Naturalization Service (INS) issued the I-873 to 
a collectively naturalized citizen of the U.S. who was born in the NMI 
before November 4, 1986. The card is no longer issued, but those 
previously issued are still valid.
    (7) An American Indian Card (I-872) issued by the Department of 
Homeland Security with the classification code ``KIC.'' (Issued by DHS 
to identify U.S. citizen members of the Texas Band of Kickapoos living 
near the United States/Mexican border.) DHS issues this card to identify 
a member of the Texas Band of Kickapoos living near the U.S./Mexican 
border. A classification code ``KIC'' and a statement on the back denote 
U.S. citizenship
    (8) A final adoption decree showing the child's name and U.S. place 
of birth. The adoption decree must show the child's name and U.S. place 
of birth. In situations where an adoption is not finalized and the State 
in which the child was born will not release a birth certificate prior 
to final adoption, a statement from a State approved adoption agency 
that shows the child's name and U.S. place of birth is acceptable. The 
adoption agency must state in the certification that the source of the 
place of birth information is an original birth certificate.
    (9) Evidence of U.S. Civil Service employment before June 1, 1976. 
The document must show employment by the U.S. government before June 1, 
1976. Individuals employed by the U.S. Civil Service prior to June 1, 
1976 had to be U.S. citizens.
    (10) U.S. Military Record showing a U.S. place of birth. T he 
document must show a U.S. place of birth (for example a DD-214 or 
similar official document showing a U.S. place of birth.)
    (11) A data verification with the Systematic Alien Verification for 
Entitlements (SAVE) Program for naturalized citizens. A State may 
conduct a verification with SAVE to determine if an individual is a 
naturalized citizen, provided that such verification is conducted 
consistent with the terms of a Memorandum of Understanding or other 
agreement with the Department of Homeland Security (DHS) authorizing 
verification of claims to U.S. citizenship through SAVE, including but 
not limited to provision of the individual's alien registration number 
if required by DHS.
    (12) Child Citizenship Act. Adopted or biological children born 
outside the United States may establish citizenship obtained 
automatically under section 320 of the Immigration and Nationality Act 
(8 U.S.C. 1431), as amended by the Child Citizenship Act of 2000 (Pub. 
L. 106-395, enacted on October 30, 2000). The State must obtain 
documentary evidence that verifies that at any time on or after February 
27, 2001, the following conditions have been met:
    (i) At least one parent of the child is a United States citizen by 
either birth

[[Page 236]]

or naturalization (as verified under the requirements of this part);
    (ii) The child is under the age of 18;
    (iii) The child is residing in the United States in the legal and 
physical custody of the U.S. citizen parent;
    (iv) The child was admitted to the United States for lawful 
permanent residence (as verified under the requirements of 8 U.S.C. 1641 
pertaining to verification of qualified alien status); and
    (v) If adopted, the child satisfies the requirements of section 
101(b)(1) of the Immigration and Nationality Act (8 U.S.C. 1101(b)(1) 
pertaining to international adoptions (admission for lawful permanent 
residence as IR-3 (child adopted outside the United States)), or as IR-4 
(child coming to the United States to be adopted) with final adoption 
having subsequently occurred).
    (c) Third level evidence of citizenship. Third level evidence of 
U.S. citizenship is documentary evidence of satisfactory reliability 
that is used when both primary and secondary evidence is unavailable. 
Third level evidence may be used only when the applicant or beneficiary 
alleges birth in the U.S. A second document from paragraph (e) of this 
section to establish identity must also be presented:
    (1) Extract of a hospital record on hospital letterhead established 
at the time of the person's birth that was created 5 years before the 
initial application date and that indicates a U.S. place of birth. (For 
children under 16 the document must have been created near the time of 
birth or 5 years before the date of application.) Do not accept a 
souvenir ``birth certificate'' issued by the hospital.
    (2) Life, health, or other insurance record showing a U.S. place of 
birth that was created at least 5 years before the initial application 
date that indicates a U.S. place of birth. (For children under 16 the 
document must have been created near the time of birth or 5 years before 
the date of application.) Life or health insurance records may show 
biographical information for the person including place of birth; the 
record can be used to establish U.S. citizenship when it shows a U.S. 
place of birth.
    (3) Religious record recorded in the U.S. within 3 months of birth 
showing the birth occurred in the U.S. and showing either the date of 
the birth or the individual's age at the time the record was made. The 
record must be an official record recorded with the religious 
organization. Caution: In questionable cases (for example, where the 
child's religious record was recorded near a U.S. international border 
and the child may have been born outside the U.S.), the State must 
consider verifying the religious record and/or documenting that the 
mother was in the U.S. at the time of the birth.
    (4) Early school record showing a U.S. place of birth. The school 
record must show the name of the child, the date of admission to the 
school, the date of birth (or age at the time the record was made), a 
U.S. place of birth, and the name(s) and place(s) of birth of the 
applicant's parents.
    (d) Fourth level evidence of citizenship. Fourth level evidence of 
citizenship is documentary evidence of the lowest reliability. Fourth 
level evidence should only be used in the rarest of circumstances. This 
level of evidence is used only when primary, secondary and third level 
evidence is unavailable. With the exception of the affidavit process 
described in paragraph (d)(5) of this section, the applicant may only 
use fourth level evidence of citizenship if alleging a U.S. place of 
birth. In addition, a second document establishing identity must be 
presented as described in paragraph (e) of this section
    (1) Federal or State census record showing U.S. citizenship or a 
U.S. place of birth. (Generally for persons born 1900 through 1950.) The 
census record must also show the applicant's age.

    Note: Census records from 1900 through 1950 contain certain 
citizenship information. To secure this information the applicant, 
beneficiary or State should complete a Form BC-600, Application for 
Search of Census Records for Proof of Age. Add in the remarks portion 
``U.S. citizenship data requested.'' Also add that the purpose is for 
Medicaid eligibility. This form requires a fee.

    (2) One of the following documents that show a U.S. place of birth 
and was created at least 5 years before the application for Medicaid. 
(For children under 16 the document must have been

[[Page 237]]

created near the time of birth or 5 years before the date of 
application.) This document must be one of the following and show a U.S. 
place of birth:
    (i) Seneca Indian tribal census.
    (ii) Bureau of Indian Affairs tribal census records of the Navajo 
Indians.
    (iii) U.S. State Vital Statistics official notification of birth 
registration.
    (iv) A delayed U.S. public birth record that is recorded more than 5 
years after the person's birth.
    (v) Statement signed by the physician or midwife who was in 
attendance at the time of birth.
    (vi) The Roll of Alaska Natives maintained by the Bureau of Indian 
Affairs.
    (3) Institutional admission papers from a nursing facility, skilled 
care facility or other institution created at least 5 years before the 
initial application date that indicates a U.S. place of birth. Admission 
papers generally show biographical information for the person including 
place of birth; the record can be used to establish U.S. citizenship 
when it shows a U.S. place of birth.
    (4) Medical (clinic, doctor, or hospital) record created at least 5 
years before the initial application date that indicates a U.S. place of 
birth. (For children under 16 the document must have been created near 
the time of birth or 5 years before the date of application.) Medical 
records generally show biographical information for the person including 
place of birth; the record can be used to establish U.S. citizenship 
when it shows a U.S. place of birth. (Note: An immunization record is 
not considered a medical record for purposes of establishing U.S. 
citizenship.)
    (5) Written affidavit. Affidavits should ONLY be used in rare 
circumstances. If the documentation requirement needs to be met through 
affidavits, the following rules apply:
    (i) There must be at least two affidavits by two individuals who 
have personal knowledge of the event(s) establishing the applicant's or 
beneficiary's claim of citizenship (the two affidavits could be combined 
in a joint affidavit).
    (ii) At least one of the individuals making the affidavit cannot be 
related to the applicant or beneficiary. Neither of the two individuals 
can be the applicant or beneficiary.
    (iii) In order for the affidavit to be acceptable the persons making 
them must be able to provide proof of their own citizenship and 
identity.
    (iv) If the individual(s) making the affidavit has (have) 
information which explains why documentary evidence establishing the 
applicant's claim or citizenship does not exist or cannot be readily 
obtained, the affidavit should contain this information as well.
    (v) The State must obtain a separate affidavit from the applicant/
beneficiary or other knowledgeable individual (guardian or 
representative) explaining why the evidence does not exist or cannot be 
obtained.
    (vi) The affidavits must be signed under penalty of perjury and need 
not be notarized.
    (e) Evidence of identity. The following documents may be accepted as 
proof of identity and must accompany a document establishing citizenship 
from the groups of documentary evidence of citizenship in the groups in 
paragraphs (b) through (d) of this section.
    (1) Identity documents described in 8 CFR 274a.2(b)(1)(v)(B)(1).
    (i) Driver's license issued by State or Territory either with a 
photograph of the individual or other identifying information of the 
individual such as name, age, sex, race, height, weight, or eye color.
    (ii) School identification card with a photograph of the individual.
    (iii) U.S. military card or draft record.
    (iv) Identification card issued by the Federal, State, or local 
government with the same information included on driver's licenses.
    (v) Military dependent's identification card.
    (vi) Certificate of Degree of Indian Blood, or other American 
Indian/Alaska Native Tribal document with a photograph or other personal 
identifying information relating to the individual. Acceptable if the 
document carries a photograph of the applicant or beneficiary, or has 
other personal identifying information relating to the individual such 
as age, weight, height, race, sex, and eye color.

[[Page 238]]

    (vii) U.S. Coast Guard Merchant Mariner card.

    Note to paragraph (e)(1): Exception: Do not accept a voter's 
registration card or Canadian driver's license as listed in 8 CFR 
274a.2(b)(1)(v)(B)(1). CMS does not view these as reliable for identity.

    (2) At State option, a State may use a cross match with a Federal or 
State governmental, public assistance, law enforcement or corrections 
agency's data system to establish identity if the agency establishes and 
certifies true identity of individuals. Such agencies may include food 
stamps, child support, corrections, including juvenile detention, motor 
vehicle, or child protective services. The State Medicaid Agency is 
still responsible for assuring the accuracy of the identity 
determination.
    (3) At State option, a State may accept three or more documents that 
together reasonably corroborate the identity of an individual provided 
such documents have not been used to establish the individual's 
citizenship and the individual submitted second or third tier evidence 
of citizenship. The State must first ensure that no other evidence of 
identity is available to the individual prior to accepting such 
documents. Such documents must at a minimum contain the individual's 
name, plus any additional information establishing the individual's 
identity. All documents used must contain consistent identifying 
information. These documents include employer identification cards, high 
school and college diplomas from accredited institutions (including 
general education and high school equivalency diplomas), marriage 
certificates, divorce decrees, and property deeds/titles.
    (f) Special identity rules for children. For children under 16, a 
clinic, doctor, hospital or school record may be accepted for purposes 
of establishing identity. School records may include nursery or daycare 
records and report cards. If the State accepts such records, it must 
verify them with the issuing school. If none of the above documents in 
the preceding groups are available, an affidavit may be used. An 
affidavit is only acceptable if it is signed under penalty of perjury by 
a parent, guardian or caretaker relative (as defined in the regulations 
at 45 CFR 233.90(c)(v)) stating the date and place of the birth of the 
child and cannot be used if an affidavit for citizenship was provided. 
The affidavit is not required to be notarized. A State may accept an 
identity affidavit on behalf of a child under the age of 18 in instances 
when school ID cards and drivers' licenses are not available to the 
individual in that area until that age.
    (g) Special identity rules for disabled individuals in institutional 
care facilities. A State may accept an identity affidavit signed under 
penalty of perjury by a residential care facility director or 
administrator on behalf of an institutionalized individual in the 
facility. States should first pursue all other means of verifying 
identity prior to accepting an affidavit. The affidavit is not required 
to be notarized.
    (h) Special populations needing assistance. States must assist 
individuals to secure satisfactory documentary evidence of citizenship 
when because of incapacity of mind or body the individual would be 
unable to comply with the requirement to present satisfactory 
documentary evidence of citizenship in a timely manner and the 
individual lacks a representative to assist him or her.
    (i) Documentary evidence. (1) All documents must be either originals 
or copies certified by the issuing agency. Uncertified copies, including 
notarized copies, shall not be accepted.
    (2) States must maintain copies of citizenship and identification 
documents in the case record or electronic data base and make these 
copies available for compliance audits.
    (3) States may permit applicants and beneficiaries to submit such 
documentary evidence without appearing in person at a Medicaid office. 
States may accept original documents in person, by mail, or by a 
guardian or authorized representative.
    (4) If documents are determined to be inconsistent with pre-existing 
information, are counterfeit, or altered, States should investigate for 
potential fraud and abuse, including but not limited to, referral to the 
appropriate State and Federal law enforcement agencies.

[[Page 239]]

    (5) Presentation of documentary evidence of citizenship is a one 
time activity; once a person's citizenship is documented and recorded in 
a State database subsequent changes in eligibility should not require 
repeating the documentation of citizenship unless later evidence raises 
a question of the person's citizenship. The State need only check its 
databases to verify that the individual already established citizenship.
    (6) CMS requires that as a check against fraud, using currently 
available automated capabilities, States will conduct a match of the 
applicant's name against the corresponding Social Security number that 
was provided. In addition, in cooperation with other agencies of the 
Federal government, CMS encourages States to use automated capabilities 
to verify citizenship and identity of Medicaid applicants. Automated 
capabilities may fall within the computer matching provisions of the 
Privacy Act of 1974, and CMS will explore any implementation issues that 
may arise with respect to those requirements. When these capabilities 
become available, States will be required to match files for individuals 
who used third or fourth tier documents to verify citizenship and 
documents to verify identity, and CMS will make available to States 
necessary information in this regard. States must ensure that all case 
records within this category will be so identified and made available to 
conduct these automated matches. CMS may also require States to match 
files for individuals who used first or second level documents to verify 
citizenship as well. CMS may provide further guidance to States with 
respect to actions required in a case of a negative match.
    (j) Record retention. The State must retain documents in accordance 
with 45 CFR 75.361.
    (k) Reasonable opportunity to present satisfactory documentary 
evidence of citizenship. States must give an applicant or beneficiary a 
reasonable opportunity to submit satisfactory documentary evidence of 
citizenship before taking action affecting the individual's eligibility 
for Medicaid. The time States give for submitting documentation of 
citizenship should be consistent with the time allowed to submit 
documentation to establish other facets of eligibility for which 
documentation is requested. (See Sec.  435.930 and Sec.  435.911 of this 
chapter.)

[71 FR 39226, July 12, 2006, as amended at 72 FR 38695, July 13, 2007; 
81 FR 3011, Jan. 20, 2016]



Sec.  436.408  [Reserved]



       Subpart F_Categorical Requirements for Medicaid Eligibility



Sec.  436.500  Scope.

    This subpart prescribes categorical requirements for determining the 
eligibility of both categorically needy and medically needy individuals 
specified in subparts B, C, and D of this part.

                               Dependency



Sec.  436.510  Determination of dependency.

    For families with dependent children who are not receiving AFDC, the 
agency must use the definitions and procedures used under the State's 
AFDC plan to determine whether--
    (a) An individual is a dependent child because he is deprived of 
parental support or care; and
    (b) An individual is an eligible member of a family with dependent 
children.

[43 FR 45218, Sept. 29, 1978, as amended at 58 FR 4936, Jan. 19, 1993]

                                   Age



Sec.  436.520  Age requirements for the aged.

    The agency must not impose an age requirement of more than 65 years.

[58 FR 4936, Jan. 19, 1993]



Sec.  436.522  Determination of age.

    (a) In determining age, the agency must use the common law method 
(under which an age is reached the day before the anniversary of birth) 
or the popular usage method (under which a specific age is reached on 
the anniversary of birth), whichever is used under the corresponding 
State plan for OAA, AFDC, AB, APTD, or AABD.

[[Page 240]]

    (b) The agency may use an arbitrary date, such as July 1, for 
determining an individual's age if the year, but not the month, of his 
birth is known.

[58 FR 4936, Jan. 19, 1993]

                                Blindness



Sec.  436.530  Definition of blindness.

    (a) Definition. The agency must use the definition of blindness that 
is used in the State plan for AB or AABD.
    (b) State plan requirement. The State plan must contain the 
definition of blindness, expressed in ophthalmic measurements.



Sec.  436.531  Determination of blindness.

    In determining blindness--
    (a) A physician skilled in the diseases of the eye or an 
optometrist, whichever the individual selects, must examine him, unless 
both of the applicant's eyes are missing;
    (b) The examiner must submit a report of examination to the Medicaid 
agency; and
    (c) A physician skilled in the diseases of the eye (for example, an 
ophthalmologist or an eye, ear, nose, and throat specialist) must review 
the report and determine on behalf of the agency--
    (1) Whether the individual meets the definition of blindness; and
    (2) Whether and when reexaminations are necessary for periodic 
redeterminations of eligibility, as required under Sec.  435.916 of this 
subchapter. Blindness is considered to continue until the reviewing 
physician determines that the beneficiary's vision no longer meets the 
definition.

[43 FR 45218, Sept. 29, 1978, as amended at 44 FR 17939, Mar. 23, 1979]

                               Disability



Sec.  436.540  Definition of disability.

    (a) Definition. The agency must use the definition of permanent and 
total disability that is used in the State plan for APTD or AABD. (See 
45 CFR 233.80(a)(1) for the Federal recommended definition of permanent 
and total disability.)
    (b) State plan requirement. The State plan must contain the 
definition of permanent and total disability.



Sec.  436.541  Determination of disability.

    (a) Basic requirements. (1) At a minimum, the agency must use the 
review team, information, and evidence requirements specified in 
paragraph (b) through (d) of this section in making a determination of 
disability.
    (2) If the requirements or determining disability under the State's 
APTD or AABD program are more restrictive than the minimum requirements 
specified in this section, the agency must use the requirements applied 
under the APTD or AABD program.
    (b) The agency must obtain a medical report and a social history for 
individuals applying for Medicaid on the basis of disability. The 
medical report must include a diagnosis based on medical evidence. The 
social history must contain enough information to enable the agency to 
determine disability.
    (c) A physician and social worker, qualified by professional 
training and experience, must review the medical report and social 
history and determine on behalf of the agency whether the individual 
meets the definition of disability. The physician must determine whether 
and when reexaminations will be necessary for periodic redeterminations 
of eligibility as required under Sec.  435.916 of this subchapter.
    (d) In subsequently determining disability, the physician and social 
worker must review reexamination reports and the social history and 
determine whether the individual continues to meet the definition. 
Disability is considered to continue until this determination is made.

[54 FR 50762, Dec. 11, 1989]



    Subpart G_General Financial Eligibility Requirements and Options



Sec.  436.600  Scope.

    This subpart prescribes:
    (a) General financial requirements and options for determining the 
eligibility of both categorically needy and medically needy individuals 
specified in subparts B, C, and D of this part. Subparts H and I of this 
part prescribe additional financial requirements.

[[Page 241]]

    (b) [Reserved]

[58 FR 4936, Jan. 19, 1993, as amended at 59 FR 43053, Aug. 22, 1994]



Sec.  436.601  Application of financial eligibility methodologies.

    (a) Definitions. For purposes of this section, cash assistance 
financial methodologies refers to the income and resources methodologies 
of the OAA, AFDC, AB, APTD, and AABD programs.
    (b) Basic rule for use of cash assistance methodologies. Except as 
specified in paragraphs (c) and (d) of this section, in determining 
financial eligibility of individuals as categorically and medically 
needy, the agency must apply the cash assistance financial methodologies 
and requirements of the cash assistance program that is most closely 
categorically related to the individual's status.
    (c) Financial responsibility of relatives. The agency must use the 
requirements for financial responsibility of relatives specified in 
Sec.  436.602.
    (d) Use of less restrictive methodologies than under cash assistance 
program. (1) At State option, and subject to the conditions of 
paragraphs (d)(2) through (d)(5) of this section, the agency may apply 
income and resource methodologies that are less restrictive than the 
cash assistance methodologies in determining financial eligibility of 
the following groups:
    (i) Qualified pregnant women and children under the mandatory 
categorically needy group under Sec.  436.120;
    (ii) Low-income pregnant women, infants, and children specified in 
section 1902(a)(10)(i) (IV), (VI), and (VII) of the Act;
    (iii) Qualified Medicare beneficiaries specified in sections 
1902(a)(10)(E) and 1905(p) of the Act;
    (iv) Optional categorically needy individuals under groups 
established under subpart C of this part and section 1902(a)(10)(A)(ii) 
of the Act; and
    (v) Medically needy individuals under groups established under 
subpart D of this part and section 1902(a)(10)(C)(i)(III) of the Act.
    (2) The income and resource methodologies that an agency elects to 
apply to groups of individuals under paragraph (c)(1) of this section 
may be less restrictive, but no more restrictive, than:
    (i) For groups of aged, blind, and disabled individuals, the SSI 
methodologies; or
    (ii) For all other groups, the methodologies under the State plan 
most closely categorically related to the individual's status.
    (3) A financial methodology is considered to be no more restrictive 
if, by using the methodology, additional individuals may be eligible for 
Medicaid and no individuals who are otherwise eligible are by use of 
that methodology made ineligible for Medicaid.
    (4) The less restrictive methodology applied under this section must 
be comparable for all persons within each category of assistance (aged, 
or blind, or disabled, or AFDC-related) within each eligibility group. 
For example, if the agency chooses to apply a less restrictive income or 
resource methodology to aged individuals, it must apply that methodology 
to an eligibility group of all aged individuals within the selected 
group.
    (5) The application of the less restrictive income and resource 
methodologies permitted under this section must be consistent with the 
limitations and conditions on FFP specified in subpart K of this part.
    (e) [Reserved]
    (f) State plan requirements. (1) The State plan must specify that, 
except to the extent precluded by Sec.  436.602 in determining financial 
eligibility of individuals, the agency will apply the cash assistance 
financial methodologies and requirements, unless the agency chooses to 
apply less restrictive income and resource methodologies, in accordance 
with paragraph (d) of this section.
    (2) If the agency chooses to apply less restrictive income and 
resource methodologies, the State plan must specify:
    (i) The less restrictive methodologies that will used; and
    (ii) The eligibility groups or groups to which the less restrictive 
methodologies will be applied.

[58 FR 4936, Jan. 19, 1993, as amended at 59 FR 43053, Aug. 22, 1994]

[[Page 242]]



Sec.  436.602  Financial responsibility of relatives and other individuals.

    (a) Subject to the provisions of paragraphs (b) and (c) of this 
section, in determining financial responsibility of relatives and other 
persons for individuals under Medicaid, the agency must use the 
following financial eligibility requirements and methodologies.
    (1) Except for a spouse of an individual or a parent for a child who 
is under age 21 or blind or disabled, the agency must not consider 
income and resources of any relative as available to an individual.
    (2) In relation to individuals under 21 (as described in section 
1905(a)(i) of the Act), the financial responsibility requirements and 
methodologies include considering the income and resources of parents or 
spouses whose income and resources would be considered if the individual 
under age 21 were dependent under the State's approved AFDC plan, 
whether or not they are actually contributed. These requirements and 
methodologies must be applied in accordance with provisions of the 
State's approved AFDC plan.
    (3) When a couple ceases to live together, the agency must count 
only the income and resources of the individual in determining his or 
her eligibility, beginning the first month following the month the 
couple ceases to live together.
    (b) The agency may apply income and resource methodologies that are 
less restrictive than the cash assistance methodologies as specified in 
the State plan in accordance with Sec.  436.601(d).
    (c) [Reserved]

[58 FR 4936, Jan. 19, 1993, as amended at 59 FR 43053, Aug. 22, 1994]



Sec.  436.604  [Reserved]



Sec.  436.606  [Reserved]



Sec.  436.608  Applications for other benefits.

    (a) As a condition of eligibility, the agency must require 
applicants and beneficiaries to take all necessary steps to obtain any 
annuities, pensions, and retirement and disability benefits to which 
they are entitled, unless they can show good cause for not doing so.
    (b) Annuities, pensions, and retirement and disability benefits 
include, but are not limited to, veterans' compensation and pensions, 
OASDI benefits, railroad retirement benefits, and unemployment 
compensation.

[43 FR 45218, Sept. 29, 1978. Redesignated at 58 FR 4937, Jan. 19, 1993]



Sec.  436.610  Assignment of rights to benefits.

    (a) As a condition of eligibility, the agency must require legally 
able applicants and beneficiaries to:
    (1) Assign rights to the Medicaid agency to medical support and to 
payment for medical care from any third party;
    (2) Cooperate with the agency in establishing paternity and in 
obtaining medical support and payments, unless the individual 
establishes good cause for not cooperating, and except for individuals 
described in section 1902(l)(1)(A) of the Act (poverty level pregnant 
women), who are exempt from cooperating in establishing paternity and 
obtaining medical support and payments from, or derived from, the father 
of the child born out of wedlock; and
    (3) Cooperate in identifying and providing information to assist the 
Medicaid agency in pursuing third parties who may be liable to pay for 
care and services under the plan, unless the individual establishes good 
cause for not cooperating.
    (b) The requirements for assignment of rights must be applied 
uniformly for all groups covered under the plan.
    (c) The requirements of paragraph (a) of this section for assignment 
of rights to medical support and other payments and cooperation in 
obtaining medical support and payments are effective for medical 
assistance furnished on or after October 1, 1984. The requirement for 
cooperation in identifying and providing information for pursuing liable 
third parties is effective for medical assistance furnished on or after 
July 1, 1986.

[55 FR 48610, Nov. 21, 1990; 55 FR 52130, Dec. 19, 1990, as amended at 
58 FR 4908, Jan. 19, 1993. Redesignated at 58 FR 4937, Jan. 19, 1993]

Subpart H [Reserved]

[[Page 243]]



        Subpart I_Financial Requirements for the Medically Needy



Sec.  436.800  Scope.

    This subpart prescribes financial requirements for determining the 
eligibility of medically needy individuals under subpart D of this part.

                     Medically Needy Income Standard



Sec.  436.811  Medically needy income standard: General requirements.

    (a) To determine eligibility of medically needy individuals, the 
agency must use a single income standard for all covered medically needy 
groups that meets the requirements of this section.
    (b) The income standard must take into account the number of persons 
in the assistance unit. The standard may not diminish by the number of 
persons in the unit (for example, if the income level in the standard 
for an assistance unit of two is set at $400, the income level in the 
standard for an assistance unit of three may not be less than $400).
    (c) The income standard must be set at an amount that is no lower 
than the lowest income standard used on or after January 1, 1966, to 
determine eligibility under the cash assistance programs that are 
related to the State's covered medically needy group or groups of 
individuals under Sec.  436.301.
    (d) The income standard may vary based on the variations between 
shelter costs in urban areas and rural areas.

[58 FR 4938, Jan. 19, 1993]



Sec.  436.814  Medically needy income standard: State plan requirements.

    The State plan must specify the income standard for the covered 
medically needy groups.

[58 FR 4938, Jan. 19, 1993]

Medically Needy Income Eligibility and Liability for Payment of Medical 
                                Expenses



Sec.  436.831  Income eligibility.

    The agency must determine income eligibility of medically needy 
individuals in accordance with this section.
    (a) Budget periods. (1) The agency must use budget periods of not 
more than 6 months to compute income. The agency may use more than one 
budget period.
    (2) The agency must include in the budget period in which income is 
computed all or part of the 3-month retroactive period specified in 
Sec.  435.914. The budget period can begin no earlier then the first 
month in the retroactive period in which the individual received covered 
services.
    (3) If the agency elects to begin the first budget period for the 
medically needy in any month of the 3-month period prior to the date of 
application in which the applicant received covered services, this 
election applies to all medically needy groups.
    (b) Determining countable income. The agency must, to determine 
countable income, deduct amounts that would be deducted in determining 
eligibility under the State's approved plan for OAA, AFDC, AB, APTD, or 
AABD.
    (c) Eligibility based on countable income. If countable income 
determined under paragraph (b) of this section is equal to or less than 
the applicable income standard under Sec.  436.814, the individual is 
eligible for Medicaid.
    (d) Deduction of incurred medical expenses. If countable income 
exceeds the income standard, the agency must deduct from income medical 
expenses incurred by the individual or family or financially responsible 
relatives that are not subject to payment by a third party. An expense 
is incurred on the date liability for the expense arises. The agency 
must determine deductible incurred expenses in accordance with 
paragraphs (e), (f) and (g) of this section and deduct those expenses in 
accordance with paragraph (h) of this section.
    (e) Determination of deductible incurred expenses: Required 
deductions based on kinds of services. Subject to the provisions of 
paragraph (g) of this section, in determining incurred medical expenses 
to be deducted from income, the agency must include the following:
    (1) Expenses for Medicare and other health insurance premiums, and 
deductibles or coinsurance charges, including enrollment fees, 
copayments,

[[Page 244]]

or deductibles imposed under Sec.  447.52, Sec.  447.53, or Sec.  447.54 
of this chapter;
    (2) Expenses incurred by the individual or family or financially 
responsible relatives for necessary medical and remedial services that 
are recognized under State law but not included in the plan;
    (3) Expenses incurred by the individual or family or by financially 
responsible relatives for necessary medical and remedial services that 
are included in the plan, including those that exceed agency limitations 
on amount, duration or scope of services;
    (f) Determination of deductible incurred expenses: Required 
deductions based on the age of bills. Subject to the provisions of 
paragraph (g) of this section, in determining incurred medical expenses 
to be deducted from income, the agency must include the following:
    (1) For the first budget period or periods that include only months 
before the month of application for medical assistance, expenses 
incurred during such period or periods, whether paid or unpaid, to the 
extent that the expenses have not been deducted previously in 
establishing eligibility;
    (2) For the first prospective budget period that also includes any 
of the 3 months before the month of application for medical assistance, 
expenses incurred during such budget period, whether paid or unpaid, to 
the extent that the expenses have not been deducted previously in 
establishing eligibility;
    (3) For the first prospective budget period that includes none of 
the months preceding the month of application, expenses incurred during 
such budget period and any of the 3 preceding months, whether paid or 
unpaid, to the extent that the expenses have not been deducted 
previously in establishing eligibility;
    (4) For any of the 3 months preceding the month of application that 
are not includable under paragraph (f)(2) of this section, expenses 
incurred in the 3-month period that were a current liability of the 
individual in any such month for which a spenddown calculation is made 
and that had not been previously deducted from income in establishing 
eligibility for medical assistance;
    (5) Current payments (that is, payments made in the current budget 
period) on other expenses incurred before the current budget period and 
not previously deducted from income in any budget period in establishing 
eligibility for such period; and
    (6) If the individual's eligibility for medical assistance was 
established in each such preceding period, expenses incurred before the 
current budget period but not previously deducted from income, to the 
extent that such expenses are unpaid and are:
    (i) Described in paragraphs (e)(1) through (e)(3) of this section; 
and
    (ii) Are carried over from the preceding budget period or periods 
because the individual had a spenddown liability in each such preceding 
period that was met without deducting all such incurred, unpaid 
expenses.
    (g) Determination of deductible incurred medical expenses: Optional 
deductions. In determining incurred medical expenses to be deducted from 
income, the agency--
    (1) May include medical institutional expenses (other than expenses 
in acute care facilities) projected to the end of the budget period at 
the Medicaid reimbursement rate;
    (2) May, to the extent determined by the agency and specified in its 
approved plan, include expenses incurred earlier than the third month 
before the month of application; and
    (3) May set reasonable limits on the amount to be deducted for 
expenses specified in paragraphs (e)(1), (e)(2), and (g)(2) of this 
section.
    (h) Order of deduction. The agency must deduct incurred medical 
expenses that are deductible under paragraphs (e), (f), and (g) of this 
section, in the order prescribed under one of the following three 
options:
    (1) Type of service. Under this option, the agency deducts expenses 
in the following order based on type of service:
    (i) Cost-sharing expenses as specified in paragraph (e)(1) of this 
section.
    (ii) Services not included in the State plan as specified in 
paragraph (e)(2) of this section.
    (iii) Services included in the State plan as specified in paragraph 
(e)(3) of this section but that exceed agency

[[Page 245]]

limitations on amount, duration, or scope of services.
    (iv) Services included in the State plan as specified in paragraph 
(e)(3) of this section but that are within agency limitations on amount, 
duration, or scope of services.
    (2) Chronological order by service date. Under this option, the 
agency deducts expenses in chronological order by the date each service 
is furnished, or in the case of insurance premiums, coinsurance, or 
deductibles charges the date such amounts are due. Expenses for services 
furnished on the same day may be deducted in any reasonable order 
established by the State.
    (3) Chronological order by bill submission date. Under this option, 
the agency deducts expenses in chronological order by the date each bill 
is submitted to the agency by the individual. If more than one bill is 
submitted at one time, the agency must deduct the bills from income in 
the order prescribed in either paragraph (h)(1) or (h)(2) of this 
section.
    (i) Eligibility based on incurred medical expenses. (1) Whether a 
State elects partial or full month coverage, an individual who is 
expected to contribute a portion of his or her income toward the costs 
of institutional care or home and community-based services under Sec.  
436.832 is eligible on the first day of the applicable budget 
(spenddown) period--
    (i) If his or her spenddown liability is met after the first day of 
the budget period; and
    (ii) If beginning eligibility after the first day of the budget 
period makes the individual's share of health care expenses under Sec.  
436.832 greater than the individual's contributable income determined 
under this section.
    (2) At the end of the prospective period specified in paragraph 
(f)(2) or (f)(3) of this section and any subsequent prospective period 
or, if earlier, when any significant change occurs, the agency must 
reconcile the projected amounts with the actual amounts incurred, or 
with changes in circumstances, to determine if the adjusted deduction of 
incurred expenses reduces income to the income standard.
    (3) Except as provided in paragraph (i)(1) of this section, if 
agencies elect partial month coverage, an individual is eligible for 
Medicaid on the day that the deduction of incurred health care expenses 
(and of projected institutional expenses if the agency elects the option 
under paragraph (g)(1) of this section) reduces income to the income 
standard.
    (4) Except as provided in paragraph (i)(1) of this section, if 
agencies elect full month coverage, an individual is eligible on the 
first day of the month in which spenddown liability is met.
    (5) Expenses used to meet spenddown liability are not reimbursable 
under Medicaid. Therefore, to the extent necessary to prevent the 
transfer of an individual's spenddown liability to the Medicaid program, 
States must reduce the amount of provider charges that would otherwise 
be reimbursable under Medicaid.

[59 FR 1674, Jan. 12, 1994, as amended at 78 FR 42305, July 15, 2013]



Sec.  436.832  Post-eligibility treatment of income of institutionalized
individuals: Application of patient income to the cost of care.

    (a) Basic rules. (1) The agency must reduce its payment to an 
institution, for services provided to an individual specified in 
paragraph (b) of this section, by the amount that remains after 
deducting the amounts specified in paragraphs (c) and (d) of this 
section from the individual's total income.
    (2) The individual's income must be determined in accordance with 
paragraph (e) of this section.
    (3) Medical expenses must be determined in accordance with paragraph 
(f) of this section.
    (b) Applicability. This section applies to medically needy 
individuals in medical institutions and intermediate care facilities.
    (c) Required deductions. The agency must deduct the following 
amounts, in the following order, from the individual's total income as 
determined under paragraph (e) of this section. Income that was 
disregarded in determining eligibility must be considered in this 
process.

[[Page 246]]

    (1) Personal needs allowance. A personal needs allowance that is 
reasonable in amount for clothing and other personal needs of the 
individual while in the institution. This protected personal needs 
allowance must be at least--
    (i) $30 a month for an aged, blind, or disabled individual, 
including a child applying for Medicaid on the basis of blindness or 
disability;
    (ii) $60 a month for an institutionalized couple if both spouses are 
aged, blind, or disabled and their income is considered available to 
each other in determining eligibility; and
    (iii) For other individuals, a reasonable amount set by the agency, 
based on a reasonable difference in their personal needs from those of 
the aged, blind, or disabled.
    (2) Maintenance needs of spouse. For an individual with only a 
spouse at home, an additional amount for the maintenance needs of the 
spouse. This amount must be based on a reasonable assessment of need but 
must not exceed the higher of--
    (i) The amount of the highest need standard for an individual 
without income and resources under the State's approved plan for OAA, 
AFDC, AB, APTD, or AABD; or
    (ii) The amount of the highest medically needy income standard for 
one person established under Sec.  436.811.
    (3) Maintenance needs of family. For an individual with a family at 
home, an additional amount for the maintenance needs of the family. This 
amount must--
    (i) Be based on a reasonable assessment of their financial need;
    (ii) Be adjusted for the number of family members living in the 
home; and
    (iii) Not exceed the highest of the following need standards for a 
family of the same size:
    (A) The standard used to determine eligibility under the State's 
Medicaid plan, as provided for in Sec.  436.811.
    (B) The standard used to determine eligibility under the State's 
approved AFDC plan.
    (4) Expenses not subject to third party payment. Amounts for 
incurred expenses for medical or remedial care that are not subject to 
payment by a third party, including--
    (i) Medicare and other health insurance premiums, deductibles, or 
coinsurance charges; and
    (ii) Necessary medical or remedial care recognized under State law 
but not covered under the State's Medicaid plan, subject to reasonable 
limits the agency may establish on amounts of these expenses.
    (d) Optional deduction: Allowance for home maintenance. For single 
individuals and couples, an amount (in addition to the personal needs 
allowance) for maintenance of the individual's or couple's home if--
    (1) The amount is deducted for not more than a 6-month period; and
    (2) A physician has certified that either of the individuals is 
likely to return to the home within that period.
    (e) Determination of income--(1) Option. In determining the amount 
of an individual's income to be used to reduce the agency's payment to 
the institution, the agency may use total income received or it may 
project total monthly income for a prospective period not to exceed 6 
months.
    (2) Basis for projection. The agency must base the projection on 
income received in the preceding period, not to exceed 6 months, and on 
income expected to be received.
    (3) Adjustments. At the end of the prospective period specified in 
paragraph (e)(1) of this section, or when any significant change occurs, 
the agency must reconcile estimates with income received.
    (f) Determination of medical expenses--(1) Option. In determining 
the amount of medical expenses to be deducted from an individual's 
income, the agency may deduct incurred medical expenses, or it may 
project medical expenses for a prospective period not to exceed 6 
months.
    (2) Basis for projection. The agency must base the estimate on 
medical expenses incurred in the preceding period, not to exceed 6 
months, and medical expenses expected to be incurred.
    (3) Adjustments. At the end of the prospective period specified in 
paragraph (f)(1) of this section, or when any significant change occurs, 
the agency

[[Page 247]]

must reconcile estimates with incurred medical expenses.

[45 FR 24888, Apr. 11, 1980, as amended at 46 FR 47991, Sept. 30, 1981; 
48 FR 5735, Feb. 8, 1983; 53 FR 3597, Feb. 8, 1988; 56 FR 8851, 8854, 
Mar. 1, 1991; 58 FR 4938, Jan. 19, 1993]

                    Medically Needy Resource Standard



Sec.  436.840  Medically needy resource standard: General requirements.

    (a) To determine eligibility of medically needy individuals, the 
Medicaid agency must use a single resource standard that is set at an 
amount that is no lower than the lowest resource standard used on or 
after January 1, 1966, to determine eligibility under the cash 
assistance programs that are related to the State's covered medically 
needy group or groups of individuals under Sec.  436.301.
    (b) The resource standard established under paragraph (a) of this 
section may not diminish by an increase in the number of persons in the 
assistance unit. For example, the resource level in the standard for an 
assistance unit of three may not be less than that set for an assistance 
unit of two.

[58 FR 4938, Jan. 19, 1993]



Sec.  436.843  Medically needy resource standard: State plan requirements.

    The State plan must specify the resource standard for the covered 
medically needy groups.

[58 FR 4938, Jan. 19, 1993]

            Determining Eligibility on the Basis of Resources



Sec.  436.845  Medically needy resource eligibility.

    To determine eligibility on the basis of resources for medically 
needy individuals, the agency must--
    (a) Consider only the individual's resources and those that are 
considered available to him under the financial responsibility 
requirements for relatives under Sec.  436.602;
    (b) Consider only resources available during the period for which 
income is computed under Sec.  436.831(a);
    (c) Deduct the value of resources that would be deducted in 
determining eligibility under the State's plan for OAA, AFDC, AB, APTD, 
or AABD or under the State's less restrictive financial methodology 
specified in the State Medicaid plan in accordance with Sec.  436.601. 
In determining the amount of an individual's resources for Medicaid 
eligibility, States must count amounts of resources that otherwise would 
not be counted under the conditional eligibility provisions of the AFDC 
program.
    (d) Apply the resource standards established under Sec.  436.840.

[43 FR 45218, Sept. 29, 1978, as amended at 46 FR 47992, Sept. 30, 1981; 
58 FR 4938, Jan. 19, 1993]



   Subpart J_Eligibility in Guam, Puerto Rico, and the Virgin Islands

    Source: 44 FR 17939, Mar. 23, 1979, unless otherwise noted.



Sec.  436.900  Scope.

    This subpart sets forth requirements for processing applications, 
determining eligibility, and furnishing Medicaid.



Sec.  436.901  General requirements.

    The Medicaid agency must comply with all the requirements of part 
435, subpart J, of this subchapter, except those specified in Sec.  
435.909.



Sec.  436.909  Automatic entitlement to Medicaid following a determination
of eligibility under other programs.

    The agency may not require a separate application for Medicaid from 
an individual if the individual receives cash assistance under a State 
plan for OAA, AFDC, AB, APTD, or AABD.



             Subpart K_Federal Financial Participation (FFP)



Sec.  436.1000  Scope.

    This subpart specifies when, and the extent to which, FFP is 
available in expenditures for determining eligibility and for Medicaid 
services to individuals determined eligible under this part, and 
prescribes limitations and conditions on FFP for those expenditures.

[[Page 248]]

 FFP for Expenditures for Determining Eligibility and Providing Services



Sec.  436.1001  FFP for administration.

    (a) FFP is available in the necessary administrative costs the State 
incurs in--
    (1) Determining and redetermining Medicaid eligibility and in 
providing Medicaid to eligible individuals; and
    (2) Determining presumptive eligibility for children and providing 
services to presumptively eligible children.
    (b) Administrative costs include any costs incident to an eye 
examination or medical examination to determine whether an individual is 
blind or disabled.

[43 FR 45218, Sept. 29, 1978, as amended at 66 FR 2668, Jan. 11, 2001]



Sec.  436.1002  FFP for services.

    (a) FFP is available in expenditures for Medicaid services for all 
beneficiaries whose coverage is required or allowed under this part.
    (b) FFP is available in expenditures for services provided to 
beneficiaries who were eligible for Medicaid in the month in which the 
medical care or services were provided, except that, for beneficiaries 
who establish eligibility for Medicaid by deducting incurred medical 
expenses from income, FFP is not available for expenses that are the 
beneficiary's liability.
    (c) FFP is available in expenditures for services covered under the 
plan that are furnished--
    (1) To children who are determined by a qualified entity to be 
presumptively eligible;
    (2) During a period of presumptive eligibility;
    (3) By a provider that is eligible for payment under the plan; and
    (4) Regardless of whether the children are determined eligible for 
Medicaid following the period of presumptive eligibility.

[43 FR 45218, Sept. 29, 1978, as amended at 44 FR 17940, Mar. 23, 1979; 
66 FR 2669, Jan. 11, 2001]



Sec.  436.1003  beneficiaries overcoming certain conditions of eligibility.

    FFP is available for a temporary period specified in the State plan 
in expenditures for services provided to beneficiaries who are 
overcoming certain eligibility conditions, including blindness, 
disability, continued absence or incapacity of a parent, or unemployment 
of a parent.

[45 FR 24888, Apr. 11, 1980]



Sec.  436.1004  FFP in expenditures for medical assistance for individuals
who have declared United States citizenship or nationality under section
1137(d) of the Act and with respect to whom the State has not documented 
citizenship and identity.

    Except for individuals described in Sec.  436.406(a)(1)(v), FFP will 
not be available to a State with respect to expenditures for medical 
assistance furnished to individuals unless the State has obtained 
satisfactory documentary evidence of citizenship or national status, as 
described in Sec.  436.407 of this chapter that complies with the 
requirements of section 1903(x) of the Act.

[72 FR 38697, July 13, 2007]



Sec.  436.1005  Institutionalized individuals.

    (a) FFP is not available in expenditures for services provided to--
    (1) Individuals who are inmates of public institutions as defined in 
Sec.  435.1010 of this chapter; or
    (2) Individuals under age 65 who are patients in an institution for 
mental diseases unless they are under age 22 and are receiving inpatient 
psychiatric services under Sec.  440.160 of this subchapter.
    (b) The exclusion of FFP described in paragraph (a) of this section 
does not apply during that part of the month in which the individual is 
not an inmate of a public institution or a patient in an institution for 
mental diseases.
    (c) An individual on conditional release or convalescent leave from 
an institution for mental diseases is not considered to be a patient in 
that institution. However, such an individual who is under age 22 and 
has been receiving inpatient pyschiatric services

[[Page 249]]

under Sec.  440.160 of this subchapter is considered to be a patient in 
the institution until he is unconditionally released or, if earlier, the 
date he reaches age 22.

[43 FR 45204, Sept. 29, 1978, as amended at 50 FR 13200, Apr. 3, 1985; 
50 FR 38811, Sept. 25, 1985. Redesignated and amended at 71 FR 39229, 
July 12, 2006]



Sec.  436.1006  Definitions relating to institutional status.

    For purposes of FFP, the definitions in Sec.  435.1010 of this 
chapter apply to this part.

[44 FR 17939, Mar. 23, 1979. Redesignated and amended at 71 FR 39229, 
July 12, 2006]



             Subpart L_Option for Coverage of Special Groups

    Source: 66 FR 2669, Jan. 11, 2001, unless otherwise noted.



Sec.  436.1100  Basis and scope.

    (a) Statutory basis. Section 1920A of the Act allows States to 
provide Medicaid services to children under age 19 during a period of 
presumptive eligibility, prior to a formal determination of Medicaid 
eligibility.
    (b) Scope. This subpart prescribes the requirements for providing 
medical assistance to special groups who are not eligible for Medicaid 
as categorically or medically needy.

                  Presumptive Eligibility for Children



Sec.  436.1101  Definitions related to presumptive eligibility period
for children.

    Application form means at a minimum the form used to apply for 
Medicaid under the poverty-level-related eligibility groups described in 
section 1902(l) of the Act or a joint form for children to apply for the 
State Children's Health Insurance Program and Medicaid.
    Period of presumptive eligibility means a period that begins on the 
date on which a qualified entity determines that a child is 
presumptively eligible and ends with the earlier of--
    (1) In the case of a child on whose behalf a Medicaid application 
has been filed, the day on which a decision is made on that application; 
or
    (2) In the case of a child on whose behalf a Medicaid application 
has not been filed, the last day of the month following the month in 
which the determination of presumptive eligibility was made.
    Presumptive income standard means the highest income eligibility 
standard established under the plan that is most likely to be used to 
establish the regular Medicaid eligibility of a child of the age 
involved.
    Qualified entity means an entity that is determined by the State to 
be capable of making determinations of presumptive eligibility for 
children, and that--
    (1) Furnishes health care items and services covered under the 
approved plan and is eligible to receive payments under the approved 
plan;
    (2) Is authorized to determine eligibility of a child to participate 
in a Head Start program under the Head Start Act;
    (3) Is authorized to determine eligibility of a child to receive 
child care services for which financial assistance is provided under the 
Child Care and Development Block Grant Act of 1990;
    (4) Is authorized to determine eligibility of an infant or child to 
receive assistance under the special nutrition program for women, 
infants, and children (WIC) under section 17 of the Child Nutrition Act 
of 1966;
    (5) Is authorized to determine eligibility of a child for medical 
assistance under the Medicaid State plan, or eligibility of a child for 
child health assistance under the State Children's Health Insurance 
Program;
    (6) Is an elementary or secondary school, as defined in section 
14101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 
8801);
    (7) Is an elementary or secondary school operated or supported by 
the Bureau of Indian Affairs;
    (8) Is a State or Tribal child support enforcement agency;
    (9) Is an organization that--
    (i) Provides emergency food and shelter under a grant under the 
Stewart B. McKinney Homeless Assistance Act;
    (ii) Is a State or Tribal office or entity involved in enrollment in 
the program under this title, Part A of title IV, or title XXI; or

[[Page 250]]

    (iii) Determines eligibility for any assistance or benefits provided 
under any program of public or assisted housing that receives Federal 
funds, including the program under section 8 or any other section of the 
United States Housing Act of 1937 (42 U.S.C. 1437) or under the Native 
American Housing Assistance and Self Determination Act of 1996 (25 
U.S.C. 4101 et seq.); and
    (10) Any other entity the State so deems, as approved by the 
Secretary.
    Services means all services covered under the plan including EPSDT 
(see part 440 of this chapter.)

[66 FR 2669, Jan. 11, 2001, as amended at 66 FR 33822, June 25, 2001]



Sec.  436.1102  General rules.

    (a) The agency may provide services to children under age 19 during 
one or more periods of presumptive eligibility following a determination 
made by a qualified entity that the child's estimated gross family 
income or, at the State's option, the child's estimated family income 
after applying simple disregards, does not exceed the applicable income 
standard.
    (b) If the agency elects to provide services to children during a 
period of presumptive eligibility, the agency must--
    (1) Provide qualified entities with application forms for Medicaid 
and information on how to assist parents, caretakers and other persons 
in completing and filing such forms;
    (2) Establish procedures to ensure that qualified entities--
    (i) Notify the parent or caretaker of the child at the time a 
determination regarding presumptive eligibility is made, in writing and 
orally if appropriate, of such determination;
    (ii) Provide the parent or caretaker of the child with a Medicaid 
application form;
    (iii) Within 5 working days after the date that the determination is 
made, notify the agency that a child is presumptively eligible;
    (iv) For children determined to be presumptively eligible, notify 
the child's parent or caretaker at the time the determination is made, 
in writing and orally if appropriate, that--
    (A) If a Medicaid application on behalf of the child is not filed by 
the last day of the following month, the child's presumptive eligibility 
will end on that last day; and
    (B) If a Medicaid application on behalf of the child is filed by the 
last day of the following month, the child's presumptive eligibility 
will end on the day that a decision is made on the Medicaid application; 
and
    (v) For children determined not to be presumptively eligible, notify 
the child's parent or caretaker at the time the determination is made, 
in writing and orally if appropriate--
    (A) Of the reason for the determination; and
    (B) That he or she may file an application for Medicaid on the 
child's behalf with the Medicaid agency; and
    (3) Provide all services covered under the plan, including EPSDT.
    (4) Allow determinations of presumptive eligibility to be made by 
qualified entities on a Statewide basis.
    (c) The agency must adopt reasonable standards regarding the number 
of periods of presumptive eligibility that will be authorized for a 
child in a given time frame.



PART 438_MANAGED CARE--Table of Contents



                      Subpart A_General Provisions

Sec.
438.1 Basis and scope.
438.2 Definitions.
438.3 Standard contract requirements.
438.4 Actuarial soundness.
438.5 Rate development standards.
438.6 Special contract provisions related to payment.
438.7 Rate certification submission.
438.8 Medical loss ratio (MLR) standards.
438.9 Provisions that apply to non-emergency medical transportation 
          PAHPs.
438.10 Information requirements.
438.12 Provider discrimination prohibited.
438.14 Requirements that apply to MCO, PIHP, PAHP, PCCM, and PCCM entity 
          contracts involving Indians, Indian health care providers 
          (IHCPs), and Indian managed care entities (IMCEs).

                    Subpart B_State Responsibilities

438.50 State Plan requirements.
438.52 Choice of MCOs, PIHPs, PAHPs, PCCMs, and PCCM entities.
438.54 Managed care enrollment.
438.56 Disenrollment: Requirements and limitations.
438.58 Conflict of interest safeguards.

[[Page 251]]

438.60 Prohibition of additional payments for services covered under 
          MCO, PIHP or PAHP contracts.
438.62 Continued services to enrollees.
438.66 State monitoring requirements.
438.68 Network adequacy standards.
438.70 Stakeholder engagement when LTSS is delivered through a managed 
          care program.
438.71 Beneficiary support system.
438.74 State oversight of the minimum MLR requirement.

                Subpart C_Enrollee Rights and Protections

438.100 Enrollee rights.
438.102 Provider-enrollee communications.
438.104 Marketing activities.
438.106 Liability for payment.
438.108 Cost sharing.
438.110 Member advisory committee.
438.114 Emergency and poststabilization services.
438.116 Solvency standards.

                 Subpart D_MCO, PIHP and PAHP Standards

438.206 Availability of services.
438.207 Assurance of adequate capacity and services.
438.208 Coordination and continuity of care.
438.210 Coverage and authorization of services.
438.214 Provider selection.
438.224 Confidentiality.
438.228 Grievance and appeal systems.
438.230 Subcontractual relationships and delegation.
438.236 Practice guidelines.
438.242 Health information systems.

 Subpart E_Quality Measurement and Improvement; External Quality Review

438.310 Basis, scope, and applicability.
438.320 Definitions.
438.330 Quality assessment and performance improvement program.
438.332 State review of the accreditation status of MCOs, PIHPs, and 
          PAHPs.
438.334 Medicaid managed care quality rating system.
438.340 Managed care State quality strategy.
438.350 External quality review.
438.352 External quality review protocols.
438.354 Qualifications of external quality review organizations.
438.356 State contract options for external quality review.
438.358 Activities related to external quality review.
438.360 Nonduplication of mandatory activities with Medicare or 
          accreditation review.
438.362 Exemption from external quality review.
438.364 External quality review results.
438.370 Federal financial participation (FFP).

                  Subpart F_Grievance and Appeal System

438.400 Statutory basis, definitions, and applicability.
438.402 General requirements.
438.404 Timely and adequate notice of adverse benefit determination.
438.406 Handling of grievances and appeals.
438.408 Resolution and notification: Grievances and appeals.
438.410 Expedited resolution of appeals.
438.414 Information about the grievance and appeal system to providers 
          and subcontractors.
438.416 Recordkeeping requirements.
438.420 Continuation of benefits while the MCO, PIHP, or PAHP appeal and 
          the State fair hearing are pending.
438.424 Effectuation of reversed appeal resolutions.

Subpart G [Reserved]

            Subpart H_Additional Program Integrity Safeguards

438.600 Statutory basis, basic rule, and applicability.
438.602 State responsibilities.
438.604 Data, information, and documentation that must be submitted.
438.606 Source, content, and timing of certification.
438.608 Program integrity requirements under the contract.
438.610 Prohibited affiliations.

                           Subpart I_Sanctions

438.700 Basis for imposition of sanctions.
438.702 Types of intermediate sanctions.
438.704 Amounts of civil money penalties.
438.706 Special rules for temporary management.
438.708 Termination of an MCO, PCCM or PCCM entity contract.
438.710 Notice of sanction and pre-termination hearing.
438.722 Disenrollment during termination hearing process.
438.724 Notice to CMS.
438.726 State plan requirement.
438.730 Sanction by CMS: Special rules for MCOs.

     Subpart J_Conditions for Federal Financial Participation (FFP)

438.802 Basic requirements.
438.806 Prior approval.
438.808 Exclusion of entities.
438.810 Expenditures for enrollment broker services.

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438.812 Costs under risk and nonrisk contracts.
438.816 Expenditures for the beneficiary support system for enrollees 
          using LTSS.
438.818 Enrollee encounter data.

  Subpart K_Parity in Mental Health and Substance Use Disorder Benefits

438.900 Meaning of terms.
438.905 Parity requirements for aggregate lifetime and annual dollar 
          limits.
438.910 Parity requirements for financial requirements and treatment 
          limitations.
438.915 Availability of information.
438.920 Applicability.
438.930 Compliance dates.

    Authority: 42 U.S.C. 1302.

    Source: 67 FR 41095, June 14, 2002, unless otherwise noted.



                      Subpart A_General Provisions

    Source: 81 FR 27853, May 6, 2016, unless otherwise noted.



Sec.  438.1  Basis and scope.

    (a) Statutory basis. This part is based on the following statutory 
sections:
    (1) Section 1902(a)(4) of the Act requires that States provide for 
methods of administration that the Secretary finds necessary for proper 
and efficient operation of the State plan. The application of the 
requirements of this part to PIHPs and PAHPs that do not meet the 
statutory definition of an MCO or a PCCM is under the authority in 
section 1902(a)(4) of the Act.
    (2) Section 1903(i)(25) of the Act prohibits payment to a State 
unless a State provides enrollee encounter data required by CMS.
    (3) Section 1903(m) of the Act contains requirements that apply to 
comprehensive risk contracts.
    (4) Section 1903(m)(2)(H) of the Act provides that an enrollee who 
loses Medicaid eligibility for not more than 2 months may be enrolled in 
the succeeding month in the same MCO or PCCM if that MCO or PCCM still 
has a contract with the State.
    (5) Section 1905(t) of the Act contains requirements that apply to 
PCCMs.
    (6) Section 1932 of the Act--
    (i) Provides that, with specified exceptions, a State may require 
Medicaid beneficiaries to enroll in MCOs or PCCMs.
    (ii) Establishes the rules that MCOs, PCCMs, the State, and the 
contracts between the State and those entities must meet, including 
compliance with requirements in sections 1903(m) and 1905(t) of the Act 
that are implemented in this part.
    (iii) Establishes protections for enrollees of MCOs and PCCMs.
    (iv) Requires States to develop a quality assessment and performance 
improvement strategy.
    (v) Specifies certain prohibitions aimed at the prevention of fraud 
and abuse.
    (vi) Provides that a State may not enter into contracts with MCOs 
unless it has established intermediate sanctions that it may impose on 
an MCO that fails to comply with specified requirements.
    (vii) Specifies rules for Indian enrollees, Indian health care 
providers, and Indian managed care entities.
    (viii) Makes other minor changes in the Medicaid program.
    (b) Scope. This part sets forth requirements, prohibitions, and 
procedures for the provision of Medicaid services through MCOs, PIHPs, 
PAHPs, PCCMs and PCCM entities. Requirements vary depending on the type 
of entity and on the authority under which the State contracts with the 
entity. Provisions that apply only when the contract is under a 
mandatory managed care program authorized by section 1932(a)(1)(A) of 
the Act are identified as such.



Sec.  438.2  Definitions.

    As used in this part--
    Abuse means as the term is defined in Sec.  455.2 of this chapter.
    Actuary means an individual who meets the qualification standards 
established by the American Academy of Actuaries for an actuary and 
follows the practice standards established by the Actuarial Standards 
Board. In this part, Actuary refers to an individual who is acting on 
behalf of the State when used in reference to the development and 
certification of capitation rates.
    Capitation payment means a payment the State makes periodically to a 
contractor on behalf of each beneficiary enrolled under a contract and 
based on

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the actuarially sound capitation rate for the provision of services 
under the State plan. The State makes the payment regardless of whether 
the particular beneficiary receives services during the period covered 
by the payment.
    Choice counseling means the provision of information and services 
designed to assist beneficiaries in making enrollment decisions; it 
includes answering questions and identifying factors to consider when 
choosing among managed care plans and primary care providers. Choice 
counseling does not include making recommendations for or against 
enrollment into a specific MCO, PIHP, or PAHP.
    Comprehensive risk contract means a risk contract between the State 
and an MCO that covers comprehensive services, that is, inpatient 
hospital services and any of the following services, or any three or 
more of the following services:
    (1) Outpatient hospital services.
    (2) Rural health clinic services.
    (3) Federally Qualified Health Center (FQHC) services.
    (4) Other laboratory and X-ray services.
    (5) Nursing facility (NF) services.
    (6) Early and periodic screening, diagnostic, and treatment (EPSDT) 
services.
    (7) Family planning services.
    (8) Physician services.
    (9) Home health services.
    Enrollee means a Medicaid beneficiary who is currently enrolled in 
an MCO, PIHP, PAHP, PCCM, or PCCM entity in a given managed care 
program.
    Enrollee encounter data means the information relating to the 
receipt of any item(s) or service(s) by an enrollee under a contract 
between a State and a MCO, PIHP, or PAHP that is subject to the 
requirements of Sec. Sec.  438.242 and 438.818.
    Federally qualified HMO means an HMO that CMS has determined is a 
qualified HMO under section 1310(d) of the PHS Act.
    Fraud means as the term is defined in Sec.  455.2 of this chapter.
    Health insuring organization (HIO) means a county operated entity, 
that in exchange for capitation payments, covers services for 
beneficiaries--
    (1) Through payments to, or arrangements with, providers;
    (2) Under a comprehensive risk contract with the State; and
    (3) Meets the following criteria--
    (i) First became operational prior to January 1, 1986; or
    (ii) Is described in section 9517(c)(3) of the Omnibus Budget 
Reconciliation Act of 1985 (as amended by section 4734 of the Omnibus 
Budget Reconciliation Act of 1990 and section 205 of the Medicare 
Improvements for Patients and Providers Act of 2008).
    Long-term services and supports (LTSS) means services and supports 
provided to beneficiaries of all ages who have functional limitations 
and/or chronic illnesses that have the primary purpose of supporting the 
ability of the beneficiary to live or work in the setting of their 
choice, which may include the individual's home, a worksite, a provider-
owned or controlled residential setting, a nursing facility, or other 
institutional setting.
    Managed care organization (MCO) means an entity that has, or is 
seeking to qualify for, a comprehensive risk contract under this part, 
and that is--
    (1) A Federally qualified HMO that meets the advance directives 
requirements of subpart I of part 489 of this chapter; or
    (2) Any public or private entity that meets the advance directives 
requirements and is determined by the Secretary to also meet the 
following conditions:
    (i) Makes the services it provides to its Medicaid enrollees as 
accessible (in terms of timeliness, amount, duration, and scope) as 
those services are to other Medicaid beneficiaries within the area 
served by the entity.
    (ii) Meets the solvency standards of Sec.  438.116.
    Managed care program means a managed care delivery system operated 
by a State as authorized under sections 1915(a), 1915(b), 1932(a), or 
1115(a) of the Act.
    Material adjustment means an adjustment that, using reasonable 
actuarial judgment, has a significant impact on the development of the 
capitation payment such that its omission or

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misstatement could impact a determination whether the development of the 
capitation rate is consistent with generally accepted actuarial 
principles and practices.
    Network provider means any provider, group of providers, or entity 
that has a network provider agreement with a MCO, PIHP, or PAHP, or a 
subcontractor, and receives Medicaid funding directly or indirectly to 
order, refer or render covered services as a result of the state's 
contract with an MCO, PIHP, or PAHP. A network provider is not a 
subcontractor by virtue of the network provider agreement.
    Nonrisk contract means a contract between the State and a PIHP or 
PAHP under which the contractor--
    (1) Is not at financial risk for changes in utilization or for costs 
incurred under the contract that do not exceed the upper payment limits 
specified in Sec.  447.362 of this chapter; and
    (2) May be reimbursed by the State at the end of the contract period 
on the basis of the incurred costs, subject to the specified limits.
    Overpayment means any payment made to a network provider by a MCO, 
PIHP, or PAHP to which the network provider is not entitled to under 
Title XIX of the Act or any payment to a MCO, PIHP, or PAHP by a State 
to which the MCO, PIHP, or PAHP is not entitled to under Title XIX of 
the Act.
    Potential enrollee means a Medicaid beneficiary who is subject to 
mandatory enrollment or may voluntarily elect to enroll in a given MCO, 
PIHP, PAHP, PCCM or PCCM entity, but is not yet an enrollee of a 
specific MCO, PIHP, PAHP, PCCM, or PCCM entity.
    Prepaid ambulatory health plan (PAHP) means an entity that--
    (1) Provides services to enrollees under contract with the State, 
and on the basis of capitation payments, or other payment arrangements 
that do not use State plan payment rates.
    (2) Does not provide or arrange for, and is not otherwise 
responsible for the provision of any inpatient hospital or institutional 
services for its enrollees; and
    (3) Does not have a comprehensive risk contract.
    Prepaid inpatient health plan (PIHP) means an entity that--
    (1) Provides services to enrollees under contract with the State, 
and on the basis of capitation payments, or other payment arrangements 
that do not use State plan payment rates.
    (2) Provides, arranges for, or otherwise has responsibility for the 
provision of any inpatient hospital or institutional services for its 
enrollees; and
    (3) Does not have a comprehensive risk contract.
    Primary care means all health care services and laboratory services 
customarily furnished by or through a general practitioner, family 
physician, internal medicine physician, obstetrician/gynecologist, 
pediatrician, or other licensed practitioner as authorized by the State 
Medicaid program, to the extent the furnishing of those services is 
legally authorized in the State in which the practitioner furnishes 
them.
    Primary care case management means a system under which:
    (1) A primary care case manager (PCCM) contracts with the State to 
furnish case management services (which include the location, 
coordination and monitoring of primary health care services) to Medicaid 
beneficiaries; or
    (2) A PCCM entity contracts with the State to provide a defined set 
of functions.
    Primary care case management entity (PCCM entity) means an 
organization that provides any of the following functions, in addition 
to primary care case management services, for the State:
    (1) Provision of intensive telephonic or face-to-face case 
management, including operation of a nurse triage advice line.
    (2) Development of enrollee care plans.
    (3) Execution of contracts with and/or oversight responsibilities 
for the activities of FFS providers in the FFS program.
    (4) Provision of payments to FFS providers on behalf of the State.
    (5) Provision of enrollee outreach and education activities.
    (6) Operation of a customer service call center.
    (7) Review of provider claims, utilization and practice patterns to 
conduct

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provider profiling and/or practice improvement.
    (8) Implementation of quality improvement activities including 
administering enrollee satisfaction surveys or collecting data necessary 
for performance measurement of providers.
    (9) Coordination with behavioral health systems/providers.
    (10) Coordination with long-term services and supports systems/
providers.
    Primary care case manager (PCCM) means a physician, a physician 
group practice or, at State option, any of the following:
    (1) A physician assistant.
    (2) A nurse practitioner.
    (3) A certified nurse-midwife.
    Provider means any individual or entity that is engaged in the 
delivery of services, or ordering or referring for those services, and 
is legally authorized to do so by the State in which it delivers the 
services.
    Rate cell means a set of mutually exclusive categories of enrollees 
that is defined by one or more characteristics for the purpose of 
determining the capitation rate and making a capitation payment; such 
characteristics may include age, gender, eligibility category, and 
region or geographic area. Each enrollee should be categorized in one of 
the rate cells for each unique set of mutually exclusive benefits under 
the contract.
    Rating period means a period of 12 months selected by the State for 
which the actuarially sound capitation rates are developed and 
documented in the rate certification submitted to CMS as required by 
Sec.  438.7(a).
    Risk contract means a contract between the State an MCO, PIHP or 
PAHP under which the contractor--
    (1) Assumes risk for the cost of the services covered under the 
contract; and
    (2) Incurs loss if the cost of furnishing the services exceeds the 
payments under the contract.
    State means the Single State agency as specified in Sec.  431.10 of 
this chapter.
    Subcontractor means an individual or entity that has a contract with 
an MCO, PIHP, PAHP, or PCCM entity that relates directly or indirectly 
to the performance of the MCO's, PIHP's, PAHP's, or PCCM entity's 
obligations under its contract with the State. A network provider is not 
a subcontractor by virtue of the network provider agreement with the 
MCO, PIHP, or PAHP.



Sec.  438.3  Standard contract requirements.

    (a) CMS review. The CMS must review and approve all MCO, PIHP, and 
PAHP contracts, including those risk and nonrisk contracts that, on the 
basis of their value, are not subject to the prior approval requirement 
in Sec.  438.806. Proposed final contracts must be submitted in the form 
and manner established by CMS. For States seeking approval of contracts 
prior to a specific effective date, proposed final contracts must be 
submitted to CMS for review no later than 90 days prior to the effective 
date of the contract.
    (b) Entities eligible for comprehensive risk contracts. A State may 
enter into a comprehensive risk contract only with the following:
    (1) An MCO.
    (2) The entities identified in section 1903(m)(2)(B)(i), (ii), and 
(iii) of the Act.
    (3) Community, Migrant, and Appalachian Health Centers identified in 
section 1903(m)(2)(G) of the Act. Unless they qualify for a total 
exemption under section 1903(m)(2)(B) of the Act, these entities are 
subject to the regulations governing MCOs under this part.
    (4) An HIO that arranges for services and became operational before 
January 1986.
    (5) An HIO described in section 9517(c)(3) of the Omnibus Budget 
Reconciliation Act of 1985 (as amended by section 4734(2) of the Omnibus 
Budget Reconciliation Act of 1990).
    (c) Payment. The following requirements apply to the final 
capitation rate and the receipt of capitation payments under the 
contract:
    (1) The final capitation rate for each MCO, PIHP or PAHP must be:
    (i) Specifically identified in the applicable contract submitted for 
CMS review and approval.
    (ii) The final capitation rates must be based only upon services 
covered under the State plan and additional

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services deemed by the State to be necessary to comply with the 
requirements of subpart K of this part (applying parity standards from 
the Mental Health Parity and Addiction Equity Act), and represent a 
payment amount that is adequate to allow the MCO, PIHP or PAHP to 
efficiently deliver covered services to Medicaid-eligible individuals in 
a manner compliant with contractual requirements.
    (2) Capitation payments may only be made by the State and retained 
by the MCO, PIHP or PAHP for Medicaid-eligible enrollees.
    (d) Enrollment discrimination prohibited. Contracts with MCOs, 
PIHPs, PAHPs, PCCMs and PCCM entities must provide as follows:
    (1) The MCO, PIHP, PAHP, PCCM or PCCM entity accepts individuals 
eligible for enrollment in the order in which they apply without 
restriction (unless authorized by CMS), up to the limits set under the 
contract.
    (2) Enrollment is voluntary, except in the case of mandatory 
enrollment programs that meet the conditions set forth in Sec.  
438.50(a).
    (3) The MCO, PIHP, PAHP, PCCM or PCCM entity will not, on the basis 
of health status or need for health care services, discriminate against 
individuals eligible to enroll.
    (4) The MCO, PIHP, PAHP, PCCM or PCCM entity will not discriminate 
against individuals eligible to enroll on the basis of race, color, 
national origin, sex, or disability and will not use any policy or 
practice that has the effect of discriminating on the basis of race, 
color, or national origin, sex, or disability.
    (e) Services that may be covered by an MCO, PIHP, or PAHP. (1) An 
MCO, PIHP, or PAHP may cover, for enrollees, services that are in 
addition to those covered under the State plan as follows:
    (i) Any services that the MCO, PIHP or PAHP voluntarily agree to 
provide, although the cost of these services cannot be included when 
determining the payment rates under paragraph (c) of this section.
    (ii) Any services necessary for compliance by the MCO, PIHP, or PAHP 
with the requirements of subpart K of this part and only to the extent 
such services are necessary for the MCO, PIHP, or PAHP to comply with 
Sec.  438.910.
    (2) An MCO, PIHP, or PAHP may cover, for enrollees, services or 
settings that are in lieu of services or settings covered under the 
State plan as follows:
    (i) The State determines that the alternative service or setting is 
a medically appropriate and cost effective substitute for the covered 
service or setting under the State plan;
    (ii) The enrollee is not required by the MCO, PIHP, or PAHP to use 
the alternative service or setting;
    (iii) The approved in lieu of services are authorized and identified 
in the MCO, PIHP, or PAHP contract, and will be offered to enrollees at 
the option of the MCO, PIHP, or PAHP; and
    (iv) The utilization and actual cost of in lieu of services is taken 
into account in developing the component of the capitation rates that 
represents the covered State plan services, unless a statute or 
regulation explicitly requires otherwise.
    (f) Compliance with applicable laws and conflict of interest 
safeguards. All contracts with MCOs, PIHPs, PAHPs, PCCMs and PCCM 
entities must:
    (1) Comply with all applicable Federal and State laws and 
regulations including Title VI of the Civil Rights Act of 1964; Title IX 
of the Education Amendments of 1972 (regarding education programs and 
activities); the Age Discrimination Act of 1975; the Rehabilitation Act 
of 1973; the Americans with Disabilities Act of 1990 as amended; and 
section 1557 of the Patient Protection and Affordable Care Act.
    (2) Comply with the conflict of interest safeguards described in 
Sec.  438.58 and with the prohibitions described in section 
1902(a)(4)(C) of the Act applicable to contracting officers, employees, 
or independent contractors.
    (g) Provider-preventable condition requirements. All contracts with 
MCOs, PIHPs and PAHPs must comply with the requirements mandating 
provider identification of provider-preventable conditions as a 
condition of payment, as well as the prohibition against payment for 
provider-preventable conditions as set forth in Sec.  434.6(a)(12) and 
Sec.  447.26 of this chapter. MCOs, PIHPs,

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and PAHPs, must report all identified provider-preventable conditions in 
a form and frequency as specified by the State.
    (h) Inspection and audit of records and access to facilities. All 
contracts must provide that the State, CMS, the Office of the Inspector 
General, the Comptroller General, and their designees may, at any time, 
inspect and audit any records or documents of the MCO, PIHP, PAHP, PCCM 
or PCCM entity, or its subcontractors, and may, at any time, inspect the 
premises, physical facilities, and equipment where Medicaid-related 
activities or work is conducted. The right to audit under this section 
exists for 10 years from the final date of the contract period or from 
the date of completion of any audit, whichever is later.
    (i) Physician incentive plans. (1) MCO, PIHP, and PAHP contracts 
must provide for compliance with the requirements set forth in 
Sec. Sec.  422.208 and 422.210 of this chapter.
    (2) In applying the provisions of Sec. Sec.  422.208 and 422.210 of 
this chapter, references to ``MA organization,'' ``CMS,'' and ``Medicare 
beneficiaries'' must be read as references to ``MCO, PIHP, or PAHP,'' 
``State,'' and ``Medicaid beneficiaries,'' respectively.
    (j) Advance directives. (1) All MCO and PIHP contracts must provide 
for compliance with the requirements of Sec.  422.128 of this chapter 
for maintaining written policies and procedures for advance directives, 
as if such regulation applied directly to MCOs and PIHPs.
    (2) All PAHP contracts must provide for compliance with the 
requirements of Sec.  422.128 of this chapter for maintaining written 
policies and procedures for advance directives as if such regulation 
applied directly to PAHPs if the PAHP includes, in its network, any of 
those providers listed in Sec.  489.102(a) of this chapter.
    (3) The MCO, PIHP, or PAHP subject to the requirements of this 
paragraph (j) must provide adult enrollees with written information on 
advance directives policies, and include a description of applicable 
State law.
    (4) The information must reflect changes in State law as soon as 
possible, but no later than 90 days after the effective date of the 
change.
    (k) Subcontracts. All subcontracts must fulfill the requirements of 
this part for the service or activity delegated under the subcontract in 
accordance with Sec.  438.230.
    (l) Choice of network provider. The contract must allow each 
enrollee to choose his or her network provider to the extent possible 
and appropriate.
    (m) Audited financial reports. The contract must require MCOs, 
PIHPs, and PAHPs to submit audited financial reports specific to the 
Medicaid contract on an annual basis. The audit must be conducted in 
accordance with generally accepted accounting principles and generally 
accepted auditing standards.
    (n) Parity in mental health and substance use disorder benefits. (1) 
All MCO contracts, and any PIHP and PAHP contracts providing services to 
MCO enrollees, must provide for services to be delivered in compliance 
with the requirements of subpart K of this part insofar as those 
requirements are applicable.
    (2) Any State providing any services to MCO enrollees using a 
delivery system other than the MCO delivery system must provide 
documentation of how the requirements of subpart K of this part are met 
with the submission of the MCO contract for review and approval under 
paragraph (a) of this section.
    (o) LTSS contract requirements. Any contract with an MCO, PIHP or 
PAHP that includes LTSS as a covered benefit must require that any 
services covered under the contract that could be authorized through a 
waiver under section 1915(c) of the Act or a State plan amendment 
authorized through sections 1915(i) or 1915(k) of the Act be delivered 
in settings consistent with Sec.  441.301(c)(4) of this chapter.
    (p) Special rules for certain HIOs. Contracts with HIOs that began 
operating on or after January 1, 1986, and that the statute does not 
explicitly exempt from requirements in section 1903(m) of the Act, are 
subject to all the requirements of this part that apply to MCOs and 
contracts with MCOs. These HIOs may enter into comprehensive risk 
contracts only if they meet the criteria of paragraph (b) of this 
section.

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    (q) Additional rules for contracts with PCCMs. A PCCM contract must 
meet the following requirements:
    (1) Provide for reasonable and adequate hours of operation, 
including 24-hour availability of information, referral, and treatment 
for emergency medical conditions.
    (2) Restrict enrollment to beneficiaries who reside sufficiently 
near one of the PCCM's delivery sites to reach that site within a 
reasonable time using available and affordable modes of transportation.
    (3) Provide for arrangements with, or referrals to, sufficient 
numbers of physicians and other practitioners to ensure that services 
under the contract can be furnished to enrollees promptly and without 
compromise to quality of care.
    (4) Prohibit discrimination in enrollment, disenrollment, and re-
enrollment, based on the beneficiary's health status or need for health 
care services.
    (5) Provide that enrollees have the right to disenroll in accordance 
with Sec.  438.56(c).
    (r) Additional rules for contracts with PCCM entities. In addition 
to the requirements in paragraph (q) of this section, States must submit 
PCCM entity contracts to CMS for review and approval to ensure 
compliance with the provisions of this paragraph (r); Sec.  438.10; and 
Sec.  438.310(c)(2).
    (s) Requirements for MCOs, PCCMs, PIHPs, or PAHPs that provide 
covered outpatient drugs. Contracts that obligate MCOs, PCCMs, PIHPs, or 
PAHPs to provide coverage of covered outpatient drugs must include the 
following requirements:
    (1) The MCO, PIHP or PAHP provides coverage of covered outpatient 
drugs as defined in section 1927(k)(2) of the Act, that meets the 
standards for such coverage imposed by section 1927 of the Act as if 
such standards applied directly to the MCO, PIHP, or PAHP.
    (2) The MCO, PIHP, or PAHP reports drug utilization data that is 
necessary for States to bill manufacturers for rebates in accordance 
with section 1927(b)(1)(A) of the Act no later than 45 calendar days 
after the end of each quarterly rebate period. Such utilization 
information must include, at a minimum, information on the total number 
of units of each dosage form, strength, and package size by National 
Drug Code of each covered outpatient drug dispensed or covered by the 
MCO, PIHP, or PAHP.
    (3) The MCO, PIHP or PAHP establishes procedures to exclude 
utilization data for covered outpatient drugs that are subject to 
discounts under the 340B drug pricing program from the reports required 
under paragraph (s)(2) of this section when states do not require 
submission of managed care drug claims data from covered entities 
directly.
    (4) The MCO, PCCM, PIHP, or PAHP must operate a drug utilization 
review program that complies with the requirements described in section 
1927(g) of the Act and part 456, subpart K, of this chapter, as if such 
requirement applied to the MCO, PCCM, PIHP, or PAHP instead of the 
State.
    (5) The MCO, PCCM, PIHP, or PAHP must provide a detailed description 
of its drug utilization review program activities to the State on an 
annual basis.
    (6) The MCO, PIHP or PAHP must conduct a prior authorization program 
that complies with the requirements of section 1927(d)(5) of the Act, as 
if such requirements applied to the MCO, PIHP, or PAHP instead of the 
State.
    (t) Requirements for MCOs, PIHPs, or PAHPs responsible for 
coordinating benefits for dually eligible individuals. In a State that 
enters into a Coordination of Benefits Agreement (COBA) with Medicare 
for Medicaid, an MCO, PIHP, or PAHP contract that includes 
responsibility for coordination of benefits for individuals dually 
eligible for Medicaid and Medicare must specify the methodology by which 
the State ensures that the appropriate MCO, PIHP, or PAHP receives all 
applicable crossover claims for which the MCO, PIHP, or PAHP is 
responsible. If the State elects to use a methodology other than 
requiring the MCO, PIHP, or PAHP to enter into a COBA with Medicare, 
that methodology must ensure that the submitting provider is promptly 
informed on the State's remittance advice that the State has not denied 
payment and that the claim has been sent to the MCO, PIHP, or PAHP for 
payment consideration.

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    (u) Recordkeeping requirements. MCOs, PIHPs, and PAHPs must retain, 
and require subcontractors to retain, as applicable, the following 
information: enrollee grievance and appeal records in Sec.  438.416, 
base data in Sec.  438.5(c), MLR reports in Sec.  438.8(k), and the 
data, information, and documentation specified in Sec. Sec.  438.604, 
438.606, 438.608, and 438.610 for a period of no less than 10 years.
    (v) Applicability date. Sections 438.3(h) and (q) apply to the 
rating period for contracts with MCOs, PIHPs, PAHPs, PCCMs, and PCCM 
entities beginning on or after July 1, 2017. Until that applicability 
date, states are required to continue to comply with Sec.  438.6(g) and 
(k) contained in the 42 CFR, parts 430 to 481, edition revised as of 
October 1, 2015.

[81 FR 27853, May 6, 2016, as amended at 85 FR 37243, June 19, 2020; 85 
FR 72837, Nov. 13, 2020; 85 FR 87101, Dec. 31, 2020]



Sec.  438.4  Actuarial soundness.

    (a) Actuarially sound capitation rates defined. Actuarially sound 
capitation rates are projected to provide for all reasonable, 
appropriate, and attainable costs that are required under the terms of 
the contract and for the operation of the MCO, PIHP, or PAHP for the 
time period and the population covered under the terms of the contract, 
and such capitation rates are developed in accordance with the 
requirements in paragraph (b) of this section.
    (b) CMS review and approval of actuarially sound capitation rates. 
Capitation rates for MCOs, PIHPs, and PAHPs must be reviewed and 
approved by CMS as actuarially sound. To be approved by CMS, capitation 
rates must:
    (1) Have been developed in accordance with the standards specified 
in Sec.  438.5 and generally accepted actuarial principles and 
practices. Any differences in the assumptions, methodologies, or factors 
used to develop capitation rates for covered populations must be based 
on valid rate development standards that represent actual cost 
differences in providing covered services to the covered populations. 
Any differences in the assumptions, methodologies, or factors used to 
develop capitation rates must not vary with the rate of Federal 
financial participation (FFP) associated with the covered populations in 
a manner that increases Federal costs. The determination that 
differences in the assumptions, methodologies, or factors used to 
develop capitation rates for MCOs, PIHPs, and PAHPs increase Federal 
costs and vary with the rate of FFP associated with the covered 
populations must be evaluated for the entire managed care program and 
include all managed care contracts for all covered populations. CMS may 
require a State to provide written documentation and justification that 
any differences in the assumptions, methodologies, or factors used to 
develop capitation rates for covered populations or contracts represent 
actual cost differences based on the characteristics and mix of the 
covered services or the covered populations.
    (2) Be appropriate for the populations to be covered and the 
services to be furnished under the contract.
    (3) Be adequate to meet the requirements on MCOs, PIHPs, and PAHPs 
in Sec. Sec.  438.206, 438.207, and 438.208.
    (4) Be specific to payments for each rate cell under the contract.
    (5) Payments from any rate cell must not cross-subsidize or be 
cross-subsidized by payments for any other rate cell.
    (6) Be certified by an actuary as meeting the applicable 
requirements of this part, including that the rates have been developed 
in accordance with the requirements specified in Sec.  438.3(c)(1)(ii) 
and (e).
    (7) Meet any applicable special contract provisions as specified in 
Sec.  438.6.
    (8) Be provided to CMS in a format and within a timeframe that meets 
requirements in Sec.  438.7.
    (9) Be developed in such a way that the MCO, PIHP, or PAHP would 
reasonably achieve a medical loss ratio standard, as calculated under 
Sec.  438.8, of at least 85 percent for the rate year. The capitation 
rates may be developed in such a way that the MCO, PIHP, or PAHP would 
reasonably achieve a medical loss ratio standard greater than 85 
percent, as calculated under Sec.  438.8, as long as the capitation 
rates are adequate for reasonable, appropriate, and attainable non-
benefit costs.

[[Page 260]]

    (c) Option to develop and certify a rate range. (1) Notwithstanding 
the provision at paragraph (b)(4) of this section, the State may develop 
and certify a range of capitation rates per rate cell as actuarially 
sound, when all of the following conditions are met:
    (i) The rate certification identifies and justifies the assumptions, 
data, and methodologies specific to both the upper and lower bounds of 
the rate range.
    (ii) Both the upper and lower bounds of the rate range must be 
certified as actuarially sound consistent with the requirements of this 
part.
    (iii) The upper bound of the rate range does not exceed the lower 
bound of the rate range multiplied by 1.05.
    (iv) The rate certification documents the State's criteria for 
paying MCOs, PIHPs, and PAHPs at different points within the rate range.
    (v) The State does not use as a criterion for paying MCOs, PIHPs, 
and PAHPs at different points within the rate range any of the 
following:
    (A) The willingness or agreement of the MCOs, PIHPs, or PAHPs or 
their network providers to enter into, or adhere to, intergovernmental 
transfer (IGT) agreements; or
    (B) The amount of funding the MCOs, PIHPs, or PAHPs or their network 
providers provide through IGT agreements.
    (2) When a State develops and certifies a range of capitation rates 
per rate cell as actuarially sound consistent with the requirements of 
this paragraph (c), the State must:
    (i) Document the capitation rates, prior to the start of the rating 
period, for the MCOs, PIHPs, and PAHPs at points within the rate range, 
consistent with the criteria in paragraph (c)(1)(iv) of this section.
    (ii) Not modify the capitation rates under Sec.  438.7(c)(3).
    (iii) Not modify the capitation rates within the rate range, unless 
the State is increasing or decreasing the capitation rate per rate cell 
within the rate range up to 1 percent during the rating period. However, 
any changes of the capitation rate within the permissible 1 percent 
range must be consistent with a modification of the contract as required 
in Sec.  438.3(c) and are subject to the requirements at paragraph 
(b)(1) of this section. Any modification to the capitation rates within 
the rate range greater than the permissible 1 percent range will require 
the State to provide a revised rate certification for CMS approval, 
which demonstrates that--
    (A) The criteria in paragraph (c)(1)(iv) of this section, as 
described in the initial rate certification, were not applied 
accurately;
    (B) There was a material error in the data, assumptions, or 
methodologies used to develop the initial rate certification and that 
the modifications are necessary to correct the error; or
    (C) Other adjustments are appropriate and reasonable to account for 
programmatic changes.
    (iv) Post on the website required in Sec.  438.10(c)(3) the 
following information prior to executing a managed care contract or 
contract amendment that includes or modifies a rate range:
    (A) The upper and lower bounds of each rate cell;
    (B) A description of all assumptions that vary between the upper and 
lower bounds of each rate cell, including for the assumptions that vary, 
the specific assumptions used for the upper and lower bounds of each 
rate cell; and
    (C) A description of the data and methodologies that vary between 
the upper and lower bounds of each rate cell, including for the data and 
methodologies that vary, the specific data and methodologies used for 
the upper and lower bounds of each rate cell.

[81 FR 27853, May 6, 2016, as amended at 85 FR 72837, Nov. 13, 2020; 85 
FR 72837, Nov. 13, 2020]



Sec.  438.5  Rate development standards.

    (a) Definitions. As used in this section and Sec.  438.7(b), the 
following terms have the indicated meanings:
    Budget neutral means a standard for any risk sharing mechanism that 
recognizes both higher and lower expected costs among contracted MCOs, 
PIHPs, or PAHPs under a managed care program and does not create a net 
aggregate gain or loss across all payments under that managed care 
program.
    Prospective risk adjustment means a methodology to account for 
anticipated variation in risk levels among contracted MCOs, PIHPs, or 
PAHPs

[[Page 261]]

that is derived from historical experience of the contracted MCOs, 
PIHPs, or PAHPs and applied to rates for the rating period for which the 
certification is submitted.
    Retrospective risk adjustment means a methodology to account for 
variation in risk levels among contracted MCOs, PIHPs, or PAHPs that is 
derived from experience concurrent with the rating period of the 
contracted MCOs, PIHPs, or PAHPs subject to the adjustment and 
calculated at the expiration of the rating period.
    Risk adjustment is a methodology to account for the health status of 
enrollees via relative risk factors when predicting or explaining costs 
of services covered under the contract for defined populations or for 
evaluating retrospectively the experience of MCOs, PIHPs, or PAHPs 
contracted with the State.
    (b) Process and requirements for setting actuarially sound 
capitation rates. In setting actuarially sound capitation rates, the 
State must follow the steps below, in an appropriate order, in 
accordance with this section, or explain why they are not applicable:
    (1) Consistent with paragraph (c) of this section, identify and 
develop the base utilization and price data.
    (2) Consistent with paragraph (d) of this section, develop and apply 
trend factors, including cost and utilization, to base data that are 
developed from actual experience of the Medicaid population or a similar 
population in accordance with generally accepted actuarial practices and 
principles.
    (3) Consistent with paragraph (e) of this section, develop the non-
benefit component of the rate to account for reasonable expenses related 
to MCO, PIHP, or PAHP administration; taxes; licensing and regulatory 
fees; contribution to reserves; risk margin; cost of capital; and other 
operational costs associated with the MCO's, PIHP's, or PAHP's provision 
of State plan services to Medicaid enrollees.
    (4) Consistent with paragraph (f) of this section, make appropriate 
and reasonable adjustments to account for changes to the base data, 
programmatic changes, non-benefit components, and any other adjustment 
necessary to establish actuarially sound rates.
    (5) Take into account the MCO's, PIHP's, or PAHP's past medical loss 
ratio, as calculated and reported under Sec.  438.8, in the development 
of the capitation rates, and consider the projected medical loss ratio 
in accordance with Sec.  438.4(b)(9).
    (6) Consistent with paragraph (g) of this section, if risk 
adjustment is applied, select a risk adjustment methodology that uses 
generally accepted models and apply it in a budget neutral manner across 
all MCOs, PIHPs, or PAHPs in the program to calculate adjustments to the 
payments as necessary.
    (c) Base data. (1) States must provide all the validated encounter 
data, FFS data (as appropriate), and audited financial reports (as 
defined in Sec.  438.3(m)) that demonstrate experience for the 
populations to be served by the MCO, PIHP, or PAHP to the actuary 
developing the capitation rates for at least the three most recent and 
complete years prior to the rating period.
    (2) States and their actuaries must use the most appropriate data, 
with the basis of the data being no older than from the 3 most recent 
and complete years prior to the rating period, for setting capitation 
rates. Such base data must be derived from the Medicaid population, or, 
if data on the Medicaid population is not available, derived from a 
similar population and adjusted to make the utilization and price data 
comparable to data from the Medicaid population. Data must be in 
accordance with actuarial standards for data quality and an explanation 
of why that specific data is used must be provided in the rate 
certification.
    (3) Exception. (i) States that are unable to base their rates on 
data meeting the qualifications in paragraph (c)(2) of this section that 
the basis of the data be no older than from the 3 most recent and 
complete years prior to the rating period may request approval for an 
exception; the request must describe why an exception is necessary and 
describe the actions the state intends to take to come into compliance 
with those requirements.

[[Page 262]]

    (ii) States that request an exception from the base data standards 
established in this section must set forth a corrective action plan to 
come into compliance with the base data standards no later than 2 years 
after the last day of the rating period for which the deficiency was 
identified.
    (d) Trend. Each trend must be reasonable and developed in accordance 
with generally accepted actuarial principles and practices. Trend must 
be developed primarily from actual experience of the Medicaid population 
or from a similar population.
    (e) Non-benefit component of the rate. The development of the non-
benefit component of the rate must include reasonable, appropriate, and 
attainable expenses related to MCO, PIHP, or PAHP administration, taxes, 
licensing and regulatory fees, contribution to reserves, risk margin, 
cost of capital, and other operational costs associated with the 
provision of services identified in Sec.  438.3(c)(1)(ii) to the 
populations covered under the contract.
    (f) Adjustments. Each adjustment must reasonably support the 
development of an accurate base data set for purposes of rate setting, 
address appropriate programmatic changes, reflect the health status of 
the enrolled population, or reflect non-benefit costs, and be developed 
in accordance with generally accepted actuarial principles and 
practices.
    (g) Risk adjustment. Prospective or retrospective risk adjustment 
methodologies must be developed in a budget neutral manner consistent 
with generally accepted actuarial principles and practices.

[81 FR 27853, May 6, 2016, as amended at 85 FR 72837, Nov. 13, 2020]



Sec.  438.6  Special contract provisions related to payment.

    (a) Definitions. As used in this part, the following terms have the 
indicated meanings:
    Base amount is the starting amount, calculated according to 
paragraph (d)(2) of this section, available for pass-through payments to 
hospitals in a given contract year subject to the schedule in paragraph 
(d)(3) of this section.
    Incentive arrangement means any payment mechanism under which a MCO, 
PIHP, or PAHP may receive additional funds over and above the capitation 
rates it was paid for meeting targets specified in the contract.
    Pass-through payment is any amount required by the State to be added 
to the contracted payment rates, and considered in calculating the 
actuarially sound capitation rate, between the MCO, PIHP, or PAHP and 
hospitals, physicians, or nursing facilities that is not for the 
following purposes: A specific service or benefit provided to a specific 
enrollee covered under the contract; a provider payment methodology 
permitted under paragraphs (c)(1)(i) through (iii) of this section for 
services and enrollees covered under the contract; a subcapitated 
payment arrangement for a specific set of services and enrollees covered 
under the contract; GME payments; or FQHC or RHC wrap around payments.
    Risk corridor means a risk sharing mechanism in which States and 
MCOs, PIHPs, or PAHPs may share in profits and losses under the contract 
outside of a predetermined threshold amount.
    State plan approved rates means amounts calculated for specific 
services identifiable as having been provided to an individual 
beneficiary described under CMS approved rate methodologies in the 
Medicaid State plan. Supplemental payments contained in a State plan are 
not, and do not constitute, State plan approved rates.
    Supplemental payments means amounts paid by the State in its FFS 
Medicaid delivery system to providers that are described and approved in 
the State plan or under a demonstration or waiver thereof and are in 
addition to State plan approved rates. Disproportionate share hospital 
(DSH) and graduate medical education (GME) payments are not, and do not 
constitute, supplemental payments.
    Withhold arrangement means any payment mechanism under which a 
portion of a capitation rate is withheld from an MCO, PIHP, or PAHP and 
a portion of or all of the withheld amount will be paid to the MCO, 
PIHP, or PAHP for meeting targets specified in the contract. The targets 
for a withhold arrangement are distinct from

[[Page 263]]

general operational requirements under the contract. Arrangements that 
withhold a portion of a capitation rate for noncompliance with general 
operational requirements are a penalty and not a withhold arrangement.
    (b) Basic requirements. (1) If used in the payment arrangement 
between the State and the MCO, PIHP, or PAHP, all applicable risk-
sharing mechanisms, such as reinsurance, risk corridors, or stop-loss 
limits, must be documented in the contract and rate certification 
documents for the rating period prior to the start of the rating period, 
and must be developed in accordance with Sec.  438.4, the rate 
development standards in Sec.  438.5, and generally accepted actuarial 
principles and practices. Risk-sharing mechanisms may not be added or 
modified after the start of the rating period.
    (2) Contracts with incentive arrangements may not provide for 
payment in excess of 105 percent of the approved capitation payments 
attributable to the enrollees or services covered by the incentive 
arrangement, since such total payments will not be considered to be 
actuarially sound. For all incentive arrangements, the contract must 
provide that the arrangement is--
    (i) For a fixed period of time and performance is measured during 
the rating period under the contract in which the incentive arrangement 
is applied.
    (ii) Not to be renewed automatically.
    (iii) Made available to both public and private contractors under 
the same terms of performance.
    (iv) Does not condition MCO, PIHP, or PAHP participation in the 
incentive arrangement on the MCO, PIHP, or PAHP entering into or 
adhering to intergovernmental transfer agreements.
    (v) Necessary for the specified activities, targets, performance 
measures, or quality-based outcomes that support program initiatives as 
specified in the State's quality strategy at Sec.  438.340.
    (3) Contracts that provide for a withhold arrangement must ensure 
that the capitation payment minus any portion of the withhold that is 
not reasonably achievable is actuarially sound as determined by an 
actuary. The total amount of the withhold, achievable or not, must be 
reasonable and take into consideration the MCO's, PIHP's or PAHP's 
financial operating needs accounting for the size and characteristics of 
the populations covered under the contract, as well as the MCO's, PIHP's 
or PAHP's capital reserves as measured by the risk-based capital level, 
months of claims reserve, or other appropriate measure of reserves. The 
data, assumptions, and methodologies used to determine the portion of 
the withhold that is reasonably achievable must be submitted as part of 
the documentation required under Sec.  438.7(b)(6). For all withhold 
arrangements, the contract must provide that the arrangement is--
    (i) For a fixed period of time and performance is measured during 
the rating period under the contract in which the withhold arrangement 
is applied.
    (ii) Not to be renewed automatically.
    (iii) Made available to both public and private contractors under 
the same terms of performance.
    (iv) Does not condition MCO, PIHP, or PAHP participation in the 
withhold arrangement on the MCO, PIHP, or PAHP entering into or adhering 
to intergovernmental transfer agreements.
    (v) Necessary for the specified activities, targets, performance 
measures, or quality-based outcomes that support program initiatives as 
specified in the State's quality strategy under Sec.  438.340.
    (c) Delivery system and provider payment initiatives under MCO, 
PIHP, or PAHP contracts--(1) General rule. Except as specified in this 
paragraph (c), in paragraph (d) of this section, in a specific provision 
of Title XIX, or in another regulation implementing a Title XIX 
provision related to payments to providers, that is applicable to 
managed care programs, the State may not direct the MCO's, PIHP's or 
PAHP's expenditures under the contract.
    (i) The State may require the MCO, PIHP or PAHP to implement value-
based purchasing models for provider reimbursement, such as pay for 
performance arrangements, bundled payments, or other service payment 
models intended to recognize value or outcomes over volume of services.
    (ii) The State may require MCOs, PIHPs, or PAHPs to participate in a

[[Page 264]]

multi-payer or Medicaid-specific delivery system reform or performance 
improvement initiative.
    (iii) The State may require the MCO, PIHP, or PAHP to:
    (A) Adopt a minimum fee schedule for network providers that provide 
a particular service under the contract using State plan approved rates 
as defined in paragraph (a) of this section.
    (B) Adopt a minimum fee schedule for network providers that provide 
a particular service under the contract using rates other than the State 
plan approved rates defined in paragraph (a) of this section.
    (C) Provide a uniform dollar or percentage increase for network 
providers that provide a particular service under the contract.
    (D) Adopt a maximum fee schedule for network providers that provide 
a particular service under the contract, so long as the MCO, PIHP, or 
PAHP retains the ability to reasonably manage risk and has discretion in 
accomplishing the goals of the contract.
    (2) Process for approval. (i) All contract arrangements that direct 
the MCO's, PIHP's, or PAHP's expenditures under paragraphs (c)(1)(i) 
through (iii) of this section must be developed in accordance with Sec.  
438.4, the standards specified in Sec.  438.5, and generally accepted 
actuarial principles and practices.
    (ii) Contract arrangements that direct the MCO's, PIHP's, or PAHP's 
expenditures under paragraphs (c)(1)(i) and (ii) and (c)(1)(iii)(B) 
through (D) of this section must have written approval prior to 
implementation. Contract arrangements that direct the MCO's, PIHP's, or 
PAHP's expenditures under paragraph (c)(1)(iii)(A) of this section do 
not require written approval prior to implementation but are required to 
meet the criteria in paragraphs (c)(2)(ii)(A) through (F) of this 
section. To obtain written approval, a State must demonstrate, in 
writing, that the arrangement--
    (A) Is based on the utilization and delivery of services;
    (B) Directs expenditures equally, and using the same terms of 
performance, for a class of providers providing the service under the 
contract;
    (C) Expects to advance at least one of the goals and objectives in 
the quality strategy in Sec.  438.340;
    (D) Has an evaluation plan that measures the degree to which the 
arrangement advances at least one of the goals and objectives in the 
quality strategy in Sec.  438.340;
    (E) Does not condition provider participation in contract 
arrangements under paragraphs (c)(1)(i) through (iii) of this section on 
the provider entering into or adhering to intergovernmental transfer 
agreements; and
    (F) May not be renewed automatically.
    (iii) Any contract arrangements that direct the MCO's, PIHP's, or 
PAHP's expenditures under paragraph (c)(1)(i) or (ii) of this section 
must also demonstrate, in writing, that the arrangement--
    (A) Must make participation in the value-based purchasing 
initiative, delivery system reform or performance improvement initiative 
available, using the same terms of performance, to a class of providers 
providing services under the contract related to the reform or 
improvement initiative;
    (B) Must use a common set of performance measures across all of the 
payers and providers;
    (C) May not set the amount or frequency of the expenditures; and
    (D) Does not allow the State to recoup any unspent funds allocated 
for these arrangements from the MCO, PIHP, or PAHP.
    (3) Approval timeframes. (i) Approval of a payment arrangement under 
paragraphs (c)(1)(i) and (ii) of this section is for one rating period 
unless a multi-year approval is requested and meets all of the following 
criteria:
    (A) The State has explicitly identified and described the payment 
arrangement in the contract as a multi-year payment arrangement, 
including a description of the payment arrangement by year, if the 
payment arrangement varies by year.
    (B) The State has developed and described its plan for implementing 
a multi-year payment arrangement, including the State's plan for multi-
year evaluation, and the impact of a multi-year payment arrangement on 
the

[[Page 265]]

State's goals and objectives in the State's quality strategy in Sec.  
438.340.
    (C) The State has affirmed that it will not make any changes to the 
payment methodology, or magnitude of the payment, described in the 
contract for all years of the multi-year payment arrangement without CMS 
prior approval. If the State determines that changes to the payment 
methodology, or magnitude of the payment, are necessary, the State must 
obtain prior approval of such changes under paragraph (c)(2) of this 
section.
    (ii) Approval of a payment arrangement under paragraph (c)(1)(iii) 
of this section is for one rating period.
    (d) Pass-through payments under MCO, PIHP, and PAHP contracts--(1) 
General rule. States may continue to require MCOs, PIHPs, and PAHPs to 
make pass-through payments (as defined in paragraph (a) of this section) 
to network providers that are hospitals, physicians, or nursing 
facilities under the contract, provided the requirements of this 
paragraph (d) are met. States may not require MCOs, PIHPs, and PAHPs to 
make pass-through payments other than those permitted under this 
paragraph (d).
    (i) In order to use a transition period described in this paragraph 
(d), a State must demonstrate that it had pass-through payments for 
hospitals, physicians, or nursing facilities in:
    (A) Managed care contract(s) and rate certification(s) for the 
rating period that includes July 5, 2016, and were submitted for CMS 
review and approval on or before July 5, 2016; or
    (B) If the managed care contract(s) and rate certification(s) for 
the rating period that includes July 5, 2016 had not been submitted to 
CMS on or before July 5, 2016, the managed care contract(s) and rate 
certification(s) for a rating period before July 5, 2016 that had been 
most recently submitted for CMS review and approval as of July 5, 2016.
    (ii) CMS will not approve a retroactive adjustment or amendment, 
notwithstanding the adjustments to the base amount permitted in 
paragraph (d)(2) of this section, to managed care contract(s) and rate 
certification(s) to add new pass-through payments or increase existing 
pass-through payments defined in paragraph (a) of this section.
    (2) Calculation of the base amount. The base amount of pass-through 
payments is the sum of the results of paragraphs (d)(2)(i) and (ii) of 
this section.
    (i) For inpatient and outpatient hospital services that will be 
provided to eligible populations through the MCO, PIHP, or PAHP 
contracts for the rating period that includes pass-through payments and 
that were provided to the eligible populations under MCO, PIHP, or PAHP 
contracts two years prior to the rating period, the State must determine 
reasonable estimates of the aggregate difference between:
    (A) The amount Medicare FFS would have paid for those inpatient and 
outpatient hospital services utilized by the eligible populations under 
the MCO, PIHP, or PAHP contracts for the 12-month period immediately two 
years prior to the rating period that will include pass-through 
payments; and
    (B) The amount the MCOs, PIHPs, or PAHPs paid (not including pass 
through payments) for those inpatient and outpatient hospital services 
utilized by the eligible populations under MCO, PIHP, or PAHP contracts 
for the 12-month period immediately 2 years prior to the rating period 
that will include pass-through payments.
    (ii) For inpatient and outpatient hospital services that will be 
provided to eligible populations through the MCO, PIHP, or PAHP 
contracts for the rating period that includes pass-through payments and 
that were provided to the eligible populations under Medicaid FFS for 
the 12-month period immediately 2 years prior to the rating period, the 
State must determine reasonable estimates of the aggregate difference 
between:
    (A) The amount Medicare FFS would have paid for those inpatient and 
outpatient hospital services utilized by the eligible populations under 
Medicaid FFS for the 12-month period immediately 2 years prior to the 
rating period that will include pass-through payments; and
    (B) The amount the State paid under Medicaid FFS (not including pass 
through payments) for those inpatient and outpatient hospital services 
utilized by the eligible populations for the

[[Page 266]]

12-month period immediately 2 years prior to the rating period that will 
include pass-through payments.
    (iii) The base amount must be calculated on an annual basis and is 
recalculated annually.
    (iv) States may calculate reasonable estimates of the aggregate 
differences in paragraphs (d)(2)(i) and (ii) of this section in 
accordance with the upper payment limit requirements in 42 CFR part 447.
    (3) Schedule for the reduction of the base amount of pass-through 
payments for hospitals under the MCO, PIHP, or PAHP contract and maximum 
amount of permitted pass-through payments for each year of the 
transition period. For States that meet the requirement in paragraph 
(d)(1)(i) of this section, pass-through payments for hospitals may 
continue to be required under the contract but must be phased out no 
longer than on the 10-year schedule, beginning with rating periods for 
contract(s) that start on or after July 1, 2017. For rating periods for 
contract(s) beginning on or after July 1, 2027, the State cannot require 
pass-through payments for hospitals under a MCO, PIHP, or PAHP contract. 
Until July 1, 2027, the total dollar amount of pass-through payments to 
hospitals may not exceed the lesser of:
    (i) A percentage of the base amount, beginning with 100 percent for 
rating periods for contract(s) beginning on or after July 1, 2017, and 
decreasing by 10 percentage points each successive year; or
    (ii) The total dollar amount of pass-through payments to hospitals 
identified in the managed care contract(s) and rate certification(s) 
used to meet the requirement of paragraph (d)(1)(i) of this section.
    (4) Documentation of the base amount for pass-through payments to 
hospitals. All contract arrangements that direct pass-through payments 
under the MCO's, PIHP's or PAHP's contract for hospitals must document 
the calculation of the base amount in the rate certification required in 
Sec.  438.7. The documentation must include the following:
    (i) The data, methodologies, and assumptions used to calculate the 
base amount;
    (ii) The aggregate amounts calculated for paragraphs (d)(2)(i)(A), 
(d)(2)(i)(B), (d)(2)(ii)(A), (d)(2)(ii)(B) of this section; and
    (iii) The calculation of the applicable percentage of the base 
amount available for pass-through payments under the schedule in 
paragraph (d)(3) of this section.
    (5) Pass-through payments to physicians or nursing facilities. For 
States that meet the requirement in paragraph (d)(1)(i) of this section, 
rating periods for contract(s) beginning on or after July 1, 2017 
through rating periods for contract(s) beginning on or after July 1, 
2021, may continue to require pass-through payments to physicians or 
nursing facilities under the MCO, PIHP, or PAHP contract of no more than 
the total dollar amount of pass-through payments to physicians or 
nursing facilities, respectively, identified in the managed care 
contract(s) and rate certification(s) used to meet the requirement of 
paragraph (d)(1)(i) of this section. For rating periods for contract(s) 
beginning on or after July 1, 2022, the State cannot require pass-
through payments for physicians or nursing facilities under a MCO, PIHP, 
or PAHP contract.
    (6) Pass-through payments for States transitioning services and 
populations from a fee-for-service delivery system to a managed care 
delivery system. Notwithstanding the restrictions on pass-through 
payments in paragraphs (d)(1), (3), and (5) of this section, a State may 
require the MCO, PIHP, or PAHP to make pass-through payments to network 
providers that are hospitals, nursing facilities, or physicians under 
the contract, for each rating period of the transition period for up to 
3 years, when Medicaid populations or services are initially 
transitioning from a fee-for-service (FFS) delivery system to a managed 
care delivery system, provided the following requirements are met:
    (i) The services will be covered for the first time under a managed 
care contract and were previously provided in a FFS delivery system 
prior to the first rating period of the transition period.
    (ii) The State made supplemental payments, as defined in paragraph 
(a)

[[Page 267]]

of this section, to hospitals, nursing facilities, or physicians during 
the 12-month period immediately 2 years prior to the first year of the 
transition period.
    (iii) The aggregate amount of the pass-through payments that the 
State requires the MCO, PIHP, or PAHP to make is less than or equal to 
the amounts calculated in paragraph (d)(6)(iii)(A), (B), or (C) of this 
section for the relevant provider type for each rating period of the 
transition period. In determining the amount of each component for the 
calculations contained in paragraphs (d)(6)(iii)(A) through (C), the 
State must use the amounts paid for services during the 12-month period 
immediately 2 years prior to the first rating period of the transition 
period.
    (A) Hospitals. For inpatient and outpatient hospital services, 
calculate the product of the actual supplemental payments paid and the 
ratio achieved by dividing the amount paid through payment rates for 
hospital services that are being transitioned from payment in a FFS 
delivery system to the managed care contract by the total amount paid 
through state plan approved rates for hospital services made in the 
State's FFS delivery system. Both the numerator and denominator of the 
ratio should exclude any supplemental payments made to the applicable 
providers.
    (B) Nursing facilities. For nursing facility services, calculate the 
product of the actual supplemental payments paid and the ratio achieved 
by dividing the amount paid through state plan approved rates for 
nursing facility services that are being transitioned from payment in a 
FFS delivery system to the managed care contract by the total amount 
paid through payment rates for nursing facility services made in the 
State's FFS delivery system. Both the numerator and denominator of the 
ratio should exclude any supplemental payments made to the applicable 
providers.
    (C) Physicians. For physician services, calculate the product of the 
actual supplemental payments paid and the ratio achieved by dividing the 
amount paid through state plan approved rates for physician services 
that are being transitioned from payment in a FFS delivery system to the 
managed care contract by the total amount paid through payment rates for 
physician services made in the State's FFS delivery system. Both the 
numerator and denominator of the ratio should exclude any supplemental 
payments made to the applicable providers.
    (iv) The State may require the MCO, PIHP, or PAHP to make pass-
through payments for Medicaid populations or services that are initially 
transitioning from a FFS delivery system to a managed care delivery 
system for up to 3 years from the beginning of the first rating period 
in which the services were transitioned from payment in a FFS delivery 
system to a managed care contract, provided that during the 3 years, the 
services continue to be provided under a managed care contract with an 
MCO, PIHP, or PAHP.
    (e) Payments to MCOs and PIHPs for enrollees that are a patient in 
an institution for mental disease. The State may make a monthly 
capitation payment to an MCO or PIHP for an enrollee aged 21-64 
receiving inpatient treatment in an Institution for Mental Diseases, as 
defined in Sec.  435.1010 of this chapter, so long as the facility is a 
hospital providing psychiatric or substance use disorder inpatient care 
or a sub-acute facility providing psychiatric or substance use disorder 
crisis residential services, and length of stay in the IMD is for a 
short term stay of no more than 15 days during the period of the monthly 
capitation payment. The provision of inpatient psychiatric or substance 
use disorder treatment in an IMD must meet the requirements for in lieu 
of services at Sec.  438.3(e)(2)(i) through (iii). For purposes of rate 
setting, the state may use the utilization of services provided to an 
enrollee under this section when developing the inpatient psychiatric or 
substance use disorder component of the capitation rate, but must price 
utilization at the cost of the same services through providers included 
under the State plan.

[81 FR 27853, May 6, 2016, as amended at 82 FR 39, Jan. 3, 2017; 82 FR 
5428, Jan. 18, 2017; 85 FR 72837, Nov. 13, 2020; 85 FR 72839, Nov. 13, 
2020]

[[Page 268]]



Sec.  438.7  Rate certification submission.

    (a) CMS review and approval of the rate certification. States must 
submit to CMS for review and approval, all MCO, PIHP, and PAHP rate 
certifications concurrent with the review and approval process for 
contracts as specified in Sec.  438.3(a).
    (b) Documentation. The rate certification must contain the following 
information:
    (1) Base data. A description of the base data used in the rate 
setting process (including the base data requested by the actuary, the 
base data that was provided by the State, and an explanation of why any 
base data requested was not provided by the State) and of how the 
actuary determined which base data set was appropriate to use for the 
rating period.
    (2) Trend. Each trend factor, including trend factors for changes in 
the utilization and price of services, applied to develop the capitation 
rates must be adequately described with enough detail so CMS or an 
actuary applying generally accepted actuarial principles and practices 
can understand and evaluate the following:
    (i) The calculation of each trend used for the rating period and the 
reasonableness of the trend for the enrolled population.
    (ii) Any meaningful difference in how a trend differs between the 
rate cells, service categories, or eligibility categories.
    (3) Non-benefit component of the rate. The development of the non-
benefit component of the rate must be adequately described with enough 
detail so CMS or an actuary applying generally accepted actuarial 
principles and practices can identify each type of non-benefit expense 
that is included in the rate and evaluate the reasonableness of the cost 
assumptions underlying each expense. The actuary may document the non-
benefit costs according to the types of non-benefit costs under Sec.  
438.5(e).
    (4) Adjustments. All adjustments used to develop the capitation 
rates must be adequately described with enough detail so that CMS, or an 
actuary applying generally accepted actuarial principles and practices, 
can understand and evaluate all of the following:
    (i) How each material adjustment was developed and the 
reasonableness of the material adjustment for the enrolled population.
    (ii) The cost impact of each material adjustment and the aggregate 
cost impact of non-material adjustments.
    (iii) Where in the rate setting process the adjustment was applied.
    (iv) A list of all non-material adjustments used in the rate 
development process.
    (5) Risk adjustment. (i) All prospective risk adjustment 
methodologies must be adequately described with enough detail so that 
CMS or an actuary applying generally accepted actuarial principles and 
practices can understand and evaluate the following:
    (A) The data, and any adjustments to that data, to be used to 
calculate the adjustment.
    (B) The model, and any adjustments to that model, to be used to 
calculate the adjustment.
    (C) The method for calculating the relative risk factors and the 
reasonableness and appropriateness of the method in measuring the risk 
factors of the respective populations.
    (D) The magnitude of the adjustment on the capitation rate per MCO, 
PIHP, or PAHP.
    (E) An assessment of the predictive value of the methodology 
compared to prior rating periods.
    (F) Any concerns the actuary has with the risk adjustment process.
    (ii) All retrospective risk adjustment methodologies must be 
adequately described with enough detail so that CMS or an actuary 
applying generally accepted actuarial principles and practices can 
understand and evaluate the following:
    (A) The party calculating the risk adjustment.
    (B) The data, and any adjustments to that data, to be used to 
calculate the adjustment.
    (C) The model, and any adjustments to that model, to be used to 
calculate the adjustment.
    (D) The timing and frequency of the application of the risk 
adjustment.
    (E) Any concerns the actuary has with the risk adjustment process.
    (iii) Application of an approved risk adjustment methodology to 
capitation

[[Page 269]]

rates does not require a revised rate certification because payment of 
capitation rates as modified by the approved risk adjustment methodology 
must be within the scope of the original rate certification. The State 
must provide to CMS the payment terms updated by the application of the 
risk adjustment methodology consistent with Sec.  438.3(c).
    (6) Special contract provisions. A description of any of the special 
contract provisions related to payment in Sec.  438.6 that are applied 
in the contract.
    (c) Rates paid under risk contracts. The State, through its actuary, 
must certify the final capitation rate paid per rate cell under each 
risk contract and document the underlying data, assumptions and 
methodologies supporting that specific capitation rate.
    (1) The State may pay each MCO, PIHP or PAHP a capitation rate under 
the contract that is different than the capitation rate paid to another 
MCO, PIHP or PAHP, so long as each capitation rate per rate cell that is 
paid is independently developed and set in accordance with this part.
    (2) If the State determines that a retroactive adjustment to the 
capitation rate is necessary, the retroactive adjustment must be 
supported by a rationale for the adjustment and the data, assumptions 
and methodologies used to develop the magnitude of the adjustment must 
be adequately described with enough detail to allow CMS or an actuary to 
determine the reasonableness of the adjustment. These retroactive 
adjustments must be certified by an actuary in a revised rate 
certification and submitted as a contract amendment to be approved by 
CMS. All such adjustments are also subject to Federal timely claim 
filing requirements.
    (3) The State may increase or decrease the capitation rate per rate 
cell, as required in paragraph (c) of this section and Sec.  
438.4(b)(4), up to 1.5 percent during the rating period without 
submitting a revised rate certification, as required under paragraph (a) 
of this section. However, any changes of the capitation rate within the 
permissible range must be consistent with a modification of the contract 
as required in Sec.  438.3(c) and are subject to the requirements at 
Sec.  438.4(b)(1). Notwithstanding the provisions in paragraph (c) of 
this section, CMS may require a State to provide documentation that 
modifications to the capitation rate comply with the requirements in 
Sec. Sec.  438.3(c) and (e) and 438.4(b)(1).
    (d) Provision of additional information. The State must, upon CMS' 
request, provide additional information, whether part of the rate 
certification or additional supplemental materials, if CMS determines 
that information is pertinent to the approval of the certification under 
this part. The State must identify whether the information provided in 
addition to the rate certification is proffered by the State, the 
actuary, or another party.
    (e) Provision of additional guidance. CMS will issue guidance, at 
least annually, which includes all of the following:
    (1) The Federal standards for capitation rate development.
    (2) The documentation required to determine that the capitation 
rates are projected to provide for all reasonable, appropriate, and 
attainable costs that are required under the terms.
    (3) The documentation required to determine that the capitation 
rates have been developed in accordance with the requirements of this 
part.
    (4) Any updates or developments in the rate review process to reduce 
State burden and facilitate prompt actuarial reviews.
    (5) The documentation necessary to demonstrate that capitation rates 
competitively bid through a procurement process have been established 
consistent with the requirements of Sec. Sec.  438.4 through 438.8.

[81 FR 27853, May 6, 2016, as amended at 85 FR 72839, Nov. 13, 2020]



Sec.  438.8  Medical loss ratio (MLR) standards.

    (a) Basic rule. The State must ensure, through its contracts 
starting on or after July 1, 2017, that each MCO, PIHP, and PAHP 
calculate and report a MLR in accordance with this section. For multi-
year contracts that do not start in 2017, the State must require the 
MCO, PIHP, or PAHP to calculate and report a MLR for the rating period 
that begins in 2017.

[[Page 270]]

    (b) Definitions. As used in this section, the following terms have 
the indicated meanings:
    Credibility adjustment means an adjustment to the MLR for a 
partially credible MCO, PIHP, or PAHP to account for a difference 
between the actual and target MLRs that may be due to random statistical 
variation.
    Full credibility means a standard for which the experience of an 
MCO, PIHP, or PAHP is determined to be sufficient for the calculation of 
a MLR with a minimal chance that the difference between the actual and 
target medical loss ratio is not statistically significant. An MCO, 
PIHP, or PAHP that is assigned full credibility (or is fully credible) 
will not receive a credibility adjustment to its MLR.
    Member months mean the number of months an enrollee or a group of 
enrollees is covered by an MCO, PIHP, or PAHP over a specified time 
period, such as a year.
    MLR reporting year means a period of 12 months consistent with the 
rating period selected by the State.
    No credibility means a standard for which the experience of an MCO, 
PIHP, or PAHP is determined to be insufficient for the calculation of a 
MLR. An MCO, PIHP, or PAHP that is assigned no credibility (or is non-
credible) will not be measured against any MLR requirements.
    Non-claims costs means those expenses for administrative services 
that are not: Incurred claims (as defined in paragraph (e)(2) of this 
section); expenditures on activities that improve health care quality 
(as defined in paragraph (e)(3) of this section); or licensing and 
regulatory fees, or Federal and State taxes (as defined in paragraph 
(f)(2) of this section).
    Partial credibility means a standard for which the experience of an 
MCO, PIHP, or PAHP is determined to be sufficient for the calculation of 
a MLR but with a non-negligible chance that the difference between the 
actual and target medical loss ratios is statistically significant. An 
MCO, PIHP, or PAHP that is assigned partial credibility (or is partially 
credible) will receive a credibility adjustment to its MLR.
    (c) MLR requirement. If a State elects to mandate a minimum MLR for 
its MCOs, PIHPs, or PAHPs, that minimum MLR must be equal to or higher 
than 85 percent (the standard used for projecting actuarial soundness 
under Sec.  438.4(b)) and the MLR must be calculated and reported for 
each MLR reporting year by the MCO, PIHP, or PAHP, consistent with this 
section.
    (d) Calculation of the MLR. The MLR experienced for each MCO, PIHP, 
or PAHP in a MLR reporting year is the ratio of the numerator (as 
defined in paragraph (e) of this section) to the denominator (as defined 
in paragraph (f) of this section). A MLR may be increased by a 
credibility adjustment, in accordance with paragraph (h) of this 
section.
    (e) Numerator--(1) Required elements. The numerator of an MCO's, 
PIHP's, or PAHP's MLR for a MLR reporting year is the sum of the MCO's, 
PIHP's, or PAHP's incurred claims (as defined in (e)(2) of this 
section); the MCO's, PIHP's, or PAHP's expenditures for activities that 
improve health care quality (as defined in paragraph (e)(3) of this 
section); and fraud prevention activities (as defined in paragraph 
(e)(4) of this section).
    (2) Incurred claims. (i) Incurred claims must include the following:
    (A) Direct claims that the MCO, PIHP, or PAHP paid to providers 
(including under capitated contracts with network providers) for 
services or supplies covered under the contract and services meeting the 
requirements of Sec.  438.3(e) provided to enrollees.
    (B) Unpaid claims liabilities for the MLR reporting year, including 
claims reported that are in the process of being adjusted or claims 
incurred but not reported.
    (C) Withholds from payments made to network providers.
    (D) Claims that are recoverable for anticipated coordination of 
benefits.
    (E) Claims payments recoveries received as a result of subrogation.
    (F) Incurred but not reported claims based on past experience, and 
modified to reflect current conditions, such as changes in exposure or 
claim frequency or severity.
    (G) Changes in other claims-related reserves.

[[Page 271]]

    (H) Reserves for contingent benefits and the medical claim portion 
of lawsuits.
    (ii) Amounts that must be deducted from incurred claims include the 
following:
    (A) Overpayment recoveries received from network providers.
    (B) Prescription drug rebates received and accrued.
    (iii) Expenditures that must be included in incurred claims include 
the following:
    (A) The amount of incentive and bonus payments made, or expected to 
be made, to network providers.
    (B) The amount of claims payments recovered through fraud reduction 
efforts, not to exceed the amount of fraud reduction expenses. The 
amount of fraud reduction expenses must not include activities specified 
in paragraph (e)(4) of this section.
    (iv) Amounts that must either be included in or deducted from 
incurred claims include, respectively, net payments or receipts related 
to State mandated solvency funds.
    (v) Amounts that must be excluded from incurred claims:
    (A) Non-claims costs, as defined in paragraph (b) of this section, 
which include the following:
    (1) Amounts paid to third party vendors for secondary network 
savings.
    (2) Amounts paid to third party vendors for network development, 
administrative fees, claims processing, and utilization management.
    (3) Amounts paid, including amounts paid to a provider, for 
professional or administrative services that do not represent 
compensation or reimbursement for State plan services or services 
meeting the definition in Sec.  438.3(e) and provided to an enrollee.
    (4) Fines and penalties assessed by regulatory authorities.
    (B) Amounts paid to the State as remittance under paragraph (j) of 
this section.
    (C) Amounts paid to network providers under to Sec.  438.6(d).
    (vi) Incurred claims paid by one MCO, PIHP, or PAHP that is later 
assumed by another entity must be reported by the assuming MCO, PIHP, or 
PAHP for the entire MLR reporting year and no incurred claims for that 
MLR reporting year may be reported by the ceding MCO, PIHP, or PAHP.
    (3) Activities that improve health care quality. Activities that 
improve health care quality must be in one of the following categories:
    (i) An MCO, PIHP, or PAHP activity that meets the requirements of 45 
CFR 158.150(b) and is not excluded under 45 CFR 158.150(c).
    (ii) An MCO, PIHP, or PAHP activity related to any EQR-related 
activity as described in Sec.  438.358(b) and (c).
    (iii) Any MCO, PIHP, or PAHP expenditure that is related to Health 
Information Technology and meaningful use, meets the requirements placed 
on issuers found in 45 CFR 158.151, and is not considered incurred 
claims, as defined in paragraph (e)(2) of this section.
    (4) Fraud prevention activities. MCO, PIHP, or PAHP expenditures on 
activities related to fraud prevention consistent with regulations 
adopted for the private market at 45 CFR part 158. Expenditures under 
this paragraph must not include expenses for fraud reduction efforts in 
paragraph (e)(2)(iii)(B) of this section.
    (f) Denominator--(1) Required elements. The denominator of an MCO's, 
PIHP's, or PAHP's MLR for a MLR reporting year must equal the adjusted 
premium revenue. The adjusted premium revenue is the MCO's, PIHP's, or 
PAHP's premium revenue (as defined in paragraph (f)(2) of this section) 
minus the MCO's, PIHP's, or PAHP's Federal, State, and local taxes and 
licensing and regulatory fees (as defined in paragraph (f)(3) of this 
section) and is aggregated in accordance with paragraph (i) of this 
section.
    (2) Premium revenue. Premium revenue includes the following for the 
MLR reporting year:
    (i) State capitation payments, developed in accordance with Sec.  
438.4, to the MCO, PIHP, or PAHP for all enrollees under a risk contract 
approved under Sec.  438.3(a), excluding payments made under Sec.  
438.6(d).
    (ii) State-developed one time payments, for specific life events of 
enrollees.
    (iii) Other payments to the MCO, PIHP, or PAHP approved under Sec.  
438.6(b)(3).

[[Page 272]]

    (iv) Unpaid cost-sharing amounts that the MCO, PIHP, or PAHP could 
have collected from enrollees under the contract, except those amounts 
the MCO, PIHP, or PAHP can show it made a reasonable, but unsuccessful, 
effort to collect.
    (v) All changes to unearned premium reserves.
    (vi) Net payments or receipts related to risk sharing mechanisms 
developed in accordance with Sec.  438.5 or Sec.  438.6.
    (3) Federal, State, and local taxes and licensing and regulatory 
fees. Taxes, licensing and regulatory fees for the MLR reporting year 
include:
    (i) Statutory assessments to defray the operating expenses of any 
State or Federal department.
    (ii) Examination fees in lieu of premium taxes as specified by State 
law.
    (iii) Federal taxes and assessments allocated to MCOs, PIHPs, and 
PAHPs, excluding Federal income taxes on investment income and capital 
gains and Federal employment taxes.
    (iv) State and local taxes and assessments including:
    (A) Any industry-wide (or subset) assessments (other than surcharges 
on specific claims) paid to the State or locality directly.
    (B) Guaranty fund assessments.
    (C) Assessments of State or locality industrial boards or other 
boards for operating expenses or for benefits to sick employed persons 
in connection with disability benefit laws or similar taxes levied by 
States.
    (D) State or locality income, excise, and business taxes other than 
premium taxes and State employment and similar taxes and assessments.
    (E) State or locality premium taxes plus State or locality taxes 
based on reserves, if in lieu of premium taxes.
    (v) Payments made by an MCO, PIHP, or PAHP that are otherwise exempt 
from Federal income taxes, for community benefit expenditures as defined 
in 45 CFR 158.162(c), limited to the highest of either:
    (A) Three percent of earned premium; or
    (B) The highest premium tax rate in the State for which the report 
is being submitted, multiplied by the MCO's, PIHP's, or PAHP's earned 
premium in the State.
    (4) Denominator when MCO, PIHP, or PAHP is assumed. The total amount 
of the denominator for a MCO, PIHP, or PAHP which is later assumed by 
another entity must be reported by the assuming MCO, PIHP, or PAHP for 
the entire MLR reporting year and no amount under this paragraph for 
that year may be reported by the ceding MCO, PIHP, or PAHP.
    (g) Allocation of expense--(1) General requirements. (i) Each 
expense must be included under only one type of expense, unless a 
portion of the expense fits under the definition of, or criteria for, 
one type of expense and the remainder fits into a different type of 
expense, in which case the expense must be pro-rated between types of 
expenses.
    (ii) Expenditures that benefit multiple contracts or populations, or 
contracts other than those being reported, must be reported on a pro 
rata basis.
    (2) Methods used to allocate expenses. (i) Allocation to each 
category must be based on a generally accepted accounting method that is 
expected to yield the most accurate results.
    (ii) Shared expenses, including expenses under the terms of a 
management contract, must be apportioned pro rata to the contract 
incurring the expense.
    (iii) Expenses that relate solely to the operation of a reporting 
entity, such as personnel costs associated with the adjusting and paying 
of claims, must be borne solely by the reporting entity and are not to 
be apportioned to the other entities.
    (h) Credibility adjustment. (1) A MCO, PIHP, or PAHP may add a 
credibility adjustment to a calculated MLR if the MLR reporting year 
experience is partially credible. The credibility adjustment is added to 
the reported MLR calculation before calculating any remittances, if 
required by the State as described in paragraph (j) of this section.
    (2) A MCO, PIHP, or PAHP may not add a credibility adjustment to a 
calculated MLR if the MLR reporting year experience is fully credible.
    (3) If a MCO's, PIHP's, or PAHP's experience is non-credible, it is 
presumed to meet or exceed the MLR calculation standards in this 
section.
    (4) On an annual basis, CMS will publish base credibility factors 
for MCOs,

[[Page 273]]

PIHPs, and PAHPs that are developed according to the following 
methodology:
    (i) CMS will use the most recently available and complete managed 
care encounter data or FFS claims data, and enrollment data, reported by 
the states to CMS. This data may cover more than 1 year of experience.
    (ii) CMS will calculate the credibility adjustment so that a MCO, 
PIHP, or PAHP receiving a capitation payment that is estimated to have a 
medical loss ratio of 85 percent would be expected to experience a loss 
ratio less than 85 percent 1 out of every 4 years, or 25 percent of the 
time.
    (iii) The minimum number of member months necessary for a MCO's, 
PIHP's, or PAHP's medical loss ratio to be determined at least partially 
credible will be set so that the credibility adjustment would not exceed 
10 percent for any partially credible MCO, PIHP, or PAHP. Any MCO, PIHP, 
or PAHP with enrollment less than this number of member months will be 
determined non-credible.
    (iv) The minimum number of member months necessary for an MCO's, 
PIHP's, or PAHP's medical loss ratio to be determined fully credible 
will be set so that the minimum credibility adjustment for any partially 
credible MCO, PIHP, or PAHP would be greater than 1 percent. Any MCO, 
PIHP, or PAHP with enrollment greater than this number of member months 
will be determined to be fully credible.
    (v) A MCO, PIHP, or PAHP with a number of enrollee member months 
between the levels established for non-credible and fully credible plans 
will be deemed partially credible, and CMS will develop adjustments, 
using linear interpolation, based on the number of enrollee member 
months.
    (vi) CMS may adjust the number of enrollee member months necessary 
for a MCO's, PIHP's, or PAHP's experience to be non-credible, partially 
credible, or fully credible so that the standards are rounded for the 
purposes of administrative simplification. The number of member months 
will be rounded to 1,000 or a different degree of rounding as 
appropriate to ensure that the credibility thresholds are consistent 
with the objectives of this regulation.
    (i) Aggregation of data. MCOs, PIHPs, or PAHPs will aggregate data 
for all Medicaid eligibility groups covered under the contract with the 
State unless the State requires separate reporting and a separate MLR 
calculation for specific populations.
    (j) Remittance to the State if specific MLR is not met. If required 
by the State, a MCO, PIHP, or PAHP must provide a remittance for an MLR 
reporting year if the MLR for that MLR reporting year does not meet the 
minimum MLR standard of 85 percent or higher if set by the State as 
described in paragraph (c) of this section.
    (k) Reporting requirements. (1) The State, through its contracts, 
must require each MCO, PIHP, or PAHP to submit a report to the State 
that includes at least the following information for each MLR reporting 
year:
    (i) Total incurred claims.
    (ii) Expenditures on quality improving activities.
    (iii) Fraud prevention activities as defined in paragraph (e)(4) of 
this section.
    (iv) Non-claims costs.
    (v) Premium revenue.
    (vi) Taxes, licensing and regulatory fees.
    (vii) Methodology(ies) for allocation of expenditures.
    (viii) Any credibility adjustment applied.
    (ix) The calculated MLR.
    (x) Any remittance owed to the State, if applicable.
    (xi) A comparison of the information reported in this paragraph with 
the audited financial report required under Sec.  438.3(m).
    (xii) A description of the aggregation method used under paragraph 
(i) of this section.
    (xiii) The number of member months.
    (2) A MCO, PIHP, or PAHP must submit the report required in 
paragraph (k)(1) of this section in a timeframe and manner determined by 
the State, which must be within 12 months of the end of the MLR 
reporting year.
    (3) MCOs, PIHPs, or PAHPs must require any third party vendor 
providing claims adjudication activities to provide all underlying data 
associated with MLR reporting to that MCO, PIHP, or PAHP within 180 days 
of the

[[Page 274]]

end of the MLR reporting year or within 30 days of being requested by 
the MCO, PIHP, or PAHP, whichever comes sooner, regardless of current 
contractual limitations, to calculate and validate the accuracy of MLR 
reporting.
    (l) Newer experience. A State, in its discretion, may exclude a MCO, 
PIHP, or PAHP that is newly contracted with the State from the 
requirements in this section for the first year of the MCO's, PIHP's, or 
PAHP's operation. Such MCOs, PIHPs, or PAHPs must be required to comply 
with the requirements in this section during the next MLR reporting year 
in which the MCO, PIHP, or PAHP is in business with the State, even if 
the first year was not a full 12 months.
    (m) Recalculation of MLR. In any instance where a State makes a 
retroactive change to the capitation payments for a MLR reporting year 
where the report has already been submitted to the State, the MCO, PIHP, 
or PAHP must re-calculate the MLR for all MLR reporting years affected 
by the change and submit a new report meeting the requirements in 
paragraph (k) of this section.
    (n) Attestation. MCOs, PIHPs, and PAHPs must attest to the accuracy 
of the calculation of the MLR in accordance with requirements of this 
section when submitting the report required under paragraph (k) of this 
section.

[81 FR 27853, May 6, 2016, as amended at 82 FR 39, Jan. 3, 2017; 85 FR 
72840, Nov. 13, 2020]



Sec.  438.9  Provisions that apply to non-emergency medical transportation
PAHPs.

    (a) For purposes of this section, Non-Emergency Medical 
Transportation (NEMT) PAHP means an entity that provides only NEMT 
services to enrollees under contract with the State, and on the basis of 
prepaid capitation payments, or other payment arrangements that do not 
use State plan payment rates.
    (b) Unless listed in this paragraph (b), a requirement of this part 
does not apply to NEMT PAHPs, NEMT PAHP contracts, or States in 
connection with a NEMT PAHP. The following requirements and options 
apply to NEMT PAHPs, NEMT PAHP contracts, and States in connection with 
NEMT PAHPs, to the same extent that they apply to PAHPs, PAHP contracts, 
and States in connection with PAHPs.
    (1) All contract provisions in Sec.  438.3 except requirements for:
    (i) Physician incentive plans at Sec.  438.3(i).
    (ii) Advance directives at Sec.  438.3(j).
    (iii) LTSS requirements at Sec.  438.3(o).
    (iv) MHPAEA at Sec.  438.3(n).
    (2) The actuarial soundness requirements in Sec.  438.4, except 
Sec.  438.4(b)(9).
    (3) The information requirements in Sec.  438.10.
    (4) The provision against provider discrimination in Sec.  438.12.
    (5) The State responsibility provisions in Sec. Sec.  438.56, 
438.58, 438.60, 438.62(a), and 438.818.
    (6) The provisions on enrollee rights and protections in subpart C 
of this part except for Sec. Sec.  438.110 and 438.114.
    (7) The PAHP standards in Sec. Sec.  438.206(b)(1), 438.210, 
438.214, 438.224, 438.230, and 438.242.
    (8) An enrollee's right to a State fair hearing under subpart E of 
part 431 of this chapter.
    (9) Prohibitions against affiliations with individuals debarred or 
excluded by Federal agencies in Sec.  438.610.
    (10) Requirements relating to contracts involving Indians, Indian 
Health Care Providers, and Indian managed care entities in Sec.  438.14.

[81 FR 27853, May 6, 2016, as amended at 85 FR 72840, Nov. 13, 2020]



Sec.  438.10  Information requirements.

    (a) Definitions. As used in this section, the following terms have 
the indicated meanings:
    Limited English proficient (LEP) means potential enrollees and 
enrollees who do not speak English as their primary language and who 
have a limited ability to read, write, speak, or understand English may 
be LEP and may be eligible to receive language assistance for a 
particular type of service, benefit, or encounter.
    Prevalent means a non-English language determined to be spoken by a 
significant number or percentage of potential enrollees and enrollees 
that are limited English proficient.
    Readily accessible means electronic information and services which 
comply with modern accessibility standards

[[Page 275]]

such as section 508 guidelines, section 504 of the Rehabilitation Act, 
and W3C's Web Content Accessibility Guidelines (WCAG) 2.0 AA and 
successor versions.
    (b) Applicability. The provisions of this section apply to all 
managed care programs which operate under any authority in the Act.
    (c) Basic rules. (1) Each State, enrollment broker, MCO, PIHP, PAHP, 
PCCM, and PCCM entity must provide all required information in this 
section to enrollees and potential enrollees in a manner and format that 
may be easily understood and is readily accessible by such enrollees and 
potential enrollees.
    (2) The State must utilize its beneficiary support system required 
in Sec.  438.71.
    (3) The State must operate a Web site that provides the content, 
either directly or by linking to individual MCO, PIHP, PAHP, or PCCM 
entity Web sites, specified in paragraphs (g), (h), and (i) of this 
section.
    (4) For consistency in the information provided to enrollees, the 
State must develop and require each MCO, PIHP, PAHP and PCCM entity to 
use:
    (i) Definitions for managed care terminology, including appeal, co-
payment, durable medical equipment, emergency medical condition, 
emergency medical transportation, emergency room care, emergency 
services, excluded services, grievance, habilitation services and 
devices, health insurance, home health care, hospice services, 
hospitalization, hospital outpatient care, medically necessary, network, 
non-participating provider, physician services, plan, preauthorization, 
participating provider, premium, prescription drug coverage, 
prescription drugs, primary care physician, primary care provider, 
provider, rehabilitation services and devices, skilled nursing care, 
specialist, and urgent care; and
    (ii) Model enrollee handbooks and enrollee notices.
    (5) The State must ensure, through its contracts, that each MCO, 
PIHP, PAHP and PCCM entity provides the required information in this 
section to each enrollee.
    (6) Enrollee information required in this section may not be 
provided electronically by the State, MCO, PIHP, PAHP, PCCM, or PCCM 
entity unless all of the following are met:
    (i) The format is readily accessible;
    (ii) The information is placed in a location on the State, MCO's, 
PIHP's, PAHP's, or PCCM's, or PCCM entity's Web site that is prominent 
and readily accessible;
    (iii) The information is provided in an electronic form which can be 
electronically retained and printed;
    (iv) The information is consistent with the content and language 
requirements of this section; and
    (v) The enrollee is informed that the information is available in 
paper form without charge upon request and provides it upon request 
within 5 business days.
    (7) Each MCO, PIHP, PAHP, and PCCM entity must have in place 
mechanisms to help enrollees and potential enrollees understand the 
requirements and benefits of the plan.
    (d) Language and format. The State must:
    (1) Establish a methodology for identifying the prevalent non-
English languages spoken by enrollees and potential enrollees throughout 
the State, and in each MCO, PIHP, PAHP, or PCCM entity service area.
    (2) Make oral interpretation available in all languages and written 
translation available in each prevalent non-English language. Written 
materials that are critical to obtaining services for potential 
enrollees must include taglines in the prevalent non-English languages 
in the State, explaining the availability of written translations or 
oral interpretation to understand the information provided, information 
on how to request auxiliary aids and services, and the toll-free 
telephone number of the entity providing choice counseling services as 
required by Sec.  438.71(a). Taglines for written materials critical to 
obtaining services must be printed in a conspicuously-visible font size.
    (3) Require each MCO, PIHP, PAHP, and PCCM entity to make its 
written materials that are critical to obtaining services, including, at 
a minimum, provider directories, enrollee handbooks, appeal and 
grievance notices, and denial and termination notices, available in the 
prevalent non-English languages

[[Page 276]]

in its particular service area. Written materials that are critical to 
obtaining services must also be made available in alternative formats 
upon request of the potential enrollee or enrollee at no cost, include 
taglines in the prevalent non-English languages in the State and in a 
conspicuously visible font size explaining the availability of written 
translation or oral interpretation to understand the information 
provided, information on how to request auxiliary aids and services, and 
include the toll-free and TTY/TDY telephone number of the MCO's, PIHP's, 
PAHP's, or PCCM entity's member/customer service unit. Auxiliary aids 
and services must also be made available upon request of the potential 
enrollee or enrollee at no cost.
    (4) Make interpretation services available to each potential 
enrollee and require each MCO, PIHP, PAHP, and PCCM entity to make those 
services available free of charge to each enrollee. This includes oral 
interpretation and the use of auxiliary aids such as TTY/TDY and 
American Sign Language. Oral interpretation requirements apply to all 
non-English languages, not just those that the State identifies as 
prevalent.
    (5) Notify potential enrollees, and require each MCO, PIHP, PAHP, 
and PCCM entity to notify its enrollees--
    (i) That oral interpretation is available for any language and 
written translation is available in prevalent languages;
    (ii) That auxiliary aids and services are available upon request and 
at no cost for enrollees with disabilities; and
    (iii) How to access the services in paragraphs (d)(5)(i) and (ii) of 
this section.
    (6) Provide, and require MCOs, PIHPs, PAHPs, PCCMs, and PCCM 
entities to provide, all written materials for potential enrollees and 
enrollees consistent with the following:
    (i) Use easily understood language and format.
    (ii) Use a font size no smaller than 12 point.
    (iii) Be available in alternative formats and through the provision 
of auxiliary aids and services in an appropriate manner that takes into 
consideration the special needs of enrollees or potential enrollees with 
disabilities or limited English proficiency.
    (e) Information for potential enrollees. (1) The State or its 
contracted representative must provide the information specified in 
paragraph (e)(2) of this section to each potential enrollee, either in 
paper or electronic form as follows:
    (i) At the time the potential enrollee first becomes eligible to 
enroll in a voluntary managed care program, or is first required to 
enroll in a mandatory managed care program; and
    (ii) Within a timeframe that enables the potential enrollee to use 
the information in choosing among available MCOs, PIHPs, PAHPs, PCCMs, 
or PCCM entities.
    (2) The information for potential enrollees must include, at a 
minimum, all of the following:
    (i) Information about the potential enrollee's right to disenroll 
consistent with the requirements of Sec.  438.56 and which explains 
clearly the process for exercising this disenrollment right, as well as 
the alternatives available to the potential enrollee based on their 
specific circumstance;
    (ii) The basic features of managed care;
    (iii) Which populations are excluded from enrollment, subject to 
mandatory enrollment, or free to enroll voluntarily in the program. For 
mandatory and voluntary populations, the length of the enrollment period 
and all disenrollment opportunities available to the enrollee must also 
be specified;
    (iv) The service area covered by each MCO, PIHP, PAHP, PCCM, or PCCM 
entity;
    (v) Covered benefits including:
    (A) Which benefits are provided by the MCO, PIHP, or PAHP; and
    (B) Which, if any, benefits are provided directly by the State.
    (C) For a counseling or referral service that the MCO, PIHP, or PAHP 
does not cover because of moral or religious objections, the State must 
provide information about where and how to obtain the service;
    (vi) The provider directory and formulary information required in 
paragraphs (h) and (i) of this section;
    (vii) Any cost-sharing that will be imposed by the MCO, PIHP, PAHP,

[[Page 277]]

PCCM, or PCCM entity consistent with those set forth in the State plan;
    (viii) The requirements for each MCO, PIHP or PAHP to provide 
adequate access to covered services, including the network adequacy 
standards established in Sec.  438.68;
    (ix) The MCO, PIHP, PAHP, PCCM and PCCM entity's responsibilities 
for coordination of enrollee care; and
    (x) To the extent available, quality and performance indicators for 
each MCO, PIHP, PAHP and PCCM entity, including enrollee satisfaction.
    (f) Information for all enrollees of MCOs, PIHPs, PAHPs, and PCCM 
entities: General requirements. (1) The MCO, PIHP, PAHP, and, when 
appropriate, the PCCM entity, must make a good faith effort to give 
written notice of termination of a contracted provider to each enrollee 
who received his or her primary care from, or was seen on a regular 
basis by, the terminated provider. Notice to the enrollee must be 
provided by the later of 30 calendar days prior to the effective date of 
the termination, or 15 calendar days after receipt or issuance of the 
termination notice.
    (2) The State must notify all enrollees of their right to disenroll 
consistent with the requirements of Sec.  438.56 at least annually. Such 
notification must clearly explain the process for exercising this 
disenrollment right, as well as the alternatives available to the 
enrollee based on their specific circumstance. For States that choose to 
restrict disenrollment for periods of 90 days or more, States must send 
the notice no less than 60 calendar days before the start of each 
enrollment period.
    (3) The MCO, PIHP, PAHP and, when appropriate, the PCCM entity must 
make available, upon request, any physician incentive plans in place as 
set forth in Sec.  438.3(i).
    (g) Information for enrollees of MCOs, PIHPs, PAHPs and PCCM 
entities--Enrollee handbook. (1) Each MCO, PIHP, PAHP and PCCM entity 
must provide each enrollee an enrollee handbook, within a reasonable 
time after receiving notice of the beneficiary's enrollment, which 
serves a similar function as the summary of benefits and coverage 
described in 45 CFR 147.200(a).
    (2) The content of the enrollee handbook must include information 
that enables the enrollee to understand how to effectively use the 
managed care program. This information must include at a minimum:
    (i) Benefits provided by the MCO, PIHP, PAHP or PCCM entity.
    (ii) How and where to access any benefits provided by the State, 
including any cost sharing, and how transportation is provided.
    (A) In the case of a counseling or referral service that the MCO, 
PIHP, PAHP, or PCCM entity does not cover because of moral or religious 
objections, the MCO, PIHP, PAHP, or PCCM entity must inform enrollees 
that the service is not covered by the MCO, PIHP, PAHP, or PCCM entity.
    (B) The MCO, PIHP, PAHP, or PCCM entity must inform enrollees how 
they can obtain information from the State about how to access the 
services described in paragraph (g)(2)(ii)(A) of this section.
    (iii) The amount, duration, and scope of benefits available under 
the contract in sufficient detail to ensure that enrollees understand 
the benefits to which they are entitled.
    (iv) Procedures for obtaining benefits, including any requirements 
for service authorizations and/or referrals for specialty care and for 
other benefits not furnished by the enrollee's primary care provider.
    (v) The extent to which, and how, after-hours and emergency coverage 
are provided, including:
    (A) What constitutes an emergency medical condition and emergency 
services.
    (B) The fact that prior authorization is not required for emergency 
services.
    (C) The fact that, subject to the provisions of this section, the 
enrollee has a right to use any hospital or other setting for emergency 
care.
    (vi) Any restrictions on the enrollee's freedom of choice among 
network providers.
    (vii) The extent to which, and how, enrollees may obtain benefits, 
including family planning services and supplies from out-of-network 
providers. This includes an explanation that the MCO, PIHP, or PAHP 
cannot require

[[Page 278]]

an enrollee to obtain a referral before choosing a family planning 
provider.
    (viii) Cost sharing, if any is imposed under the State plan.
    (ix) Enrollee rights and responsibilities, including the elements 
specified in Sec.  438.100.
    (x) The process of selecting and changing the enrollee's primary 
care provider.
    (xi) Grievance, appeal, and fair hearing procedures and timeframes, 
consistent with subpart F of this part, in a State-developed or State-
approved description. Such information must include:
    (A) The right to file grievances and appeals.
    (B) The requirements and timeframes for filing a grievance or 
appeal.
    (C) The availability of assistance in the filing process.
    (D) The right to request a State fair hearing after the MCO, PIHP or 
PAHP has made a determination on an enrollee's appeal which is adverse 
to the enrollee.
    (E) The fact that, when requested by the enrollee, benefits that the 
MCO, PIHP, or PAHP seeks to reduce or terminate will continue if the 
enrollee files an appeal or a request for State fair hearing within the 
timeframes specified for filing, and that the enrollee may, consistent 
with state policy, be required to pay the cost of services furnished 
while the appeal or state fair hearing is pending if the final decision 
is adverse to the enrollee.
    (xii) How to exercise an advance directive, as set forth in Sec.  
438.3(j). For PAHPs, information must be provided only to the extent 
that the PAHP includes any of the providers described in Sec.  
489.102(a) of this chapter.
    (xiii) How to access auxiliary aids and services, including 
additional information in alternative formats or languages.
    (xiv) The toll-free telephone number for member services, medical 
management, and any other unit providing services directly to enrollees.
    (xv) Information on how to report suspected fraud or abuse;
    (xvi) Any other content required by the State.
    (3) Information required by this paragraph to be provided by a MCO, 
PIHP, PAHP or PCCM entity will be considered to be provided if the MCO, 
PIHP, PAHP or PCCM entity:
    (i) Mails a printed copy of the information to the enrollee's 
mailing address;
    (ii) Provides the information by email after obtaining the 
enrollee's agreement to receive the information by email;
    (iii) Posts the information on the Web site of the MCO, PIHP, PAHP 
or PCCM entity and advises the enrollee in paper or electronic form that 
the information is available on the Internet and includes the applicable 
Internet address, provided that enrollees with disabilities who cannot 
access this information online are provided auxiliary aids and services 
upon request at no cost; or
    (iv) Provides the information by any other method that can 
reasonably be expected to result in the enrollee receiving that 
information.
    (4) The MCO, PIHP, PAHP, or PCCM entity must give each enrollee 
notice of any change that the State defines as significant in the 
information specified in this paragraph (g), at least 30 days before the 
intended effective date of the change.
    (h) Information for all enrollees of MCOs, PIHPs, PAHPs, and PCCM 
entities--Provider Directory. (1) Each MCO, PIHP, PAHP, and when 
appropriate, the PCCM entity, must make available in paper form upon 
request and electronic form, the following information about its network 
providers:
    (i) The provider's name as well as any group affiliation.
    (ii) Street address(es).
    (iii) Telephone number(s).
    (iv) Web site URL, as appropriate.
    (v) Specialty, as appropriate.
    (vi) Whether the provider will accept new enrollees.
    (vii) The provider's cultural and linguistic capabilities, including 
languages (including American Sign Language) offered by the provider or 
a skilled medical interpreter at the provider's office.
    (viii) Whether the provider's office/facility has accommodations for 
people with physical disabilities, including offices, exam room(s) and 
equipment.

[[Page 279]]

    (2) The provider directory must include the information in paragraph 
(h)(1) of this section for each of the following provider types covered 
under the contract:
    (i) Physicians, including specialists;
    (ii) Hospitals;
    (iii) Pharmacies;
    (iv) Behavioral health providers; and
    (v) LTSS providers, as appropriate.
    (3) Information included in--
    (i) A paper provider directory must be updated at least--
    (A) Monthly, if the MCO, PIHP, PAHP, or PCCM entity does not have a 
mobile-enabled, electronic directory; or
    (B) Quarterly, if the MCO, PIHP, PAHP, or PCCM entity has a mobile-
enabled, electronic provider directory.
    (ii) An electronic provider directory must be updated no later than 
30 calendar days after the MCO, PIHP, PAHP, or PCCM entity receives 
updated provider information.
    (4) Provider directories must be made available on the MCO's, 
PIHP's, PAHP's, or, if applicable, PCCM entity's Web site in a machine 
readable file and format as specified by the Secretary.
    (i) Information for all enrollees of MCOs, PIHPs, PAHPs, and PCCM 
entities: Formulary. Each MCO, PIHP, PAHP, and when appropriate, PCCM 
entity, must make available in electronic or paper form, the following 
information about its formulary:
    (1) Which medications are covered (both generic and name brand).
    (2) What tier each medication is on.
    (3) Formulary drug lists must be made available on the MCO's, 
PIHP's, PAHP's, or, if applicable, PCCM entity's Web site in a machine 
readable file and format as specified by the Secretary.
    (j) Applicability date. This section applies to the rating period 
for contracts with MCOs, PIHPs, PAHPs, PCCMs, and PCCM entities 
beginning on or after July 1, 2017. Until that applicability date, 
states are required to continue to comply with Sec.  438.10 contained in 
the 42 CFR parts 430 to 481, edition revised as of October 1, 2015.

[81 FR 27853, May 6, 2016, as amended at 82 FR 39, Jan. 3, 2017; 85 FR 
72840, Nov. 13, 2020]



Sec.  438.12  Provider discrimination prohibited.

    (a) General rules. (1) An MCO, PIHP, or PAHP may not discriminate in 
the participation, reimbursement, or indemnification of any provider who 
is acting within the scope of his or her license or certification under 
applicable State law, solely on the basis of that license or 
certification. If an MCO, PIHP, or PAHP declines to include individual 
or groups of providers in its provider network, it must give the 
affected providers written notice of the reason for its decision.
    (2) In all contracts with network providers, an MCO, PIHP, or PAHP 
must comply with the requirements specified in Sec.  438.214.
    (b) Construction. Paragraph (a) of this section may not be construed 
to--
    (1) Require the MCO, PIHP, or PAHP to contract with providers beyond 
the number necessary to meet the needs of its enrollees;
    (2) Preclude the MCO, PIHP, or PAHP from using different 
reimbursement amounts for different specialties or for different 
practitioners in the same specialty; or
    (3) Preclude the MCO, PIHP, or PAHP from establishing measures that 
are designed to maintain quality of services and control costs and are 
consistent with its responsibilities to enrollees.



Sec.  438.14  Requirements that apply to MCO, PIHP, PAHP, PCCM, and
PCCM entity contracts involving Indians, Indian health care providers
(IHCPs), and Indian managed care entities (IMCEs).

    (a) Definitions. As used in this section, the following terms have 
the indicated meanings:
    Indian means any individual defined at 25 U.S.C. 1603(13), 1603(28), 
or 1679(a), or who has been determined eligible as an Indian, under 42 
CFR 136.12. This means the individual:
    (i) Is a member of a Federally recognized Indian tribe;
    (ii) Resides in an urban center and meets one or more of the four 
criteria:
    (A) Is a member of a tribe, band, or other organized group of 
Indians, including those tribes, bands, or groups

[[Page 280]]

terminated since 1940 and those recognized now or in the future by the 
State in which they reside, or who is a descendant, in the first or 
second degree, of any such member;
    (B) Is an Eskimo or Aleut or other Alaska Native;
    (C) Is considered by the Secretary of the Interior to be an Indian 
for any purpose; or
    (D) Is determined to be an Indian under regulations issued by the 
Secretary;
    (iii) Is considered by the Secretary of the Interior to be an Indian 
for any purpose; or
    (iv) Is considered by the Secretary of Health and Human Services to 
be an Indian for purposes of eligibility for Indian health care 
services, including as a California Indian, Eskimo, Aleut, or other 
Alaska Native.
    Indian health care provider (IHCP) means a health care program 
operated by the Indian Health Service (IHS) or by an Indian Tribe, 
Tribal Organization, or Urban Indian Organization (otherwise known as an 
I/T/U) as those terms are defined in section 4 of the Indian Health Care 
Improvement Act (25 U.S.C. 1603).
    Indian managed care entity (IMCE) means a MCO, PIHP, PAHP, PCCM, or 
PCCM entity that is controlled (within the meaning of the last sentence 
of section 1903(m)(1)(C) of the Act) by the Indian Health Service, a 
Tribe, Tribal Organization, or Urban Indian Organization, or a 
consortium, which may be composed of one or more Tribes, Tribal 
Organizations, or Urban Indian Organizations, and which also may include 
the Service.
    (b) Network and coverage requirements. All contracts between a State 
and a MCO, PIHP, PAHP, and PCCM entity, to the extent that the PCCM 
entity has a provider network, which enroll Indians must:
    (1) Require the MCO, PIHP, PAHP, or PCCM entity to demonstrate that 
there are sufficient IHCPs participating in the provider network of the 
MCO, PIHP, PAHP, or PCCM entity to ensure timely access to services 
available under the contract from such providers for Indian enrollees 
who are eligible to receive services.
    (2) Require that IHCPs, whether participating or not, be paid for 
covered services provided to Indian enrollees who are eligible to 
receive services from such providers as follows:
    (i) At a rate negotiated between the MCO, PIHP, PAHP, or PCCM 
entity, and the IHCP, or
    (ii) In the absence of a negotiated rate, at a rate not less than 
the level and amount of payment that the MCO, PIHP, PAHP, or PCCM entity 
would make for the services to a participating provider which is not an 
IHCP; and
    (iii) Make payment to all IHCPs in its network in a timely manner as 
required for payments to practitioners in individual or group practices 
under 42 CFR 447.45 and 447.46.
    (3) Permit any Indian who is enrolled in a MCO, PIHP, PAHP, PCCM or 
PCCM entity that is not an IMCE and eligible to receive services from a 
IHCP primary care provider participating as a network provider, to 
choose that IHCP as his or her primary care provider, as long as that 
provider has capacity to provide the services.
    (4) Permit Indian enrollees to obtain services covered under the 
contract between the State and the MCO, PIHP, PAHP, or PCCM entity from 
out-of-network IHCPs from whom the enrollee is otherwise eligible to 
receive such services.
    (5) In a State where timely access to covered services cannot be 
ensured due to few or no IHCPs, an MCO, PIHP, PAHP and PCCM entity will 
be considered to have met the requirement in paragraph (b)(1) of this 
section if--
    (i) Indian enrollees are permitted by the MCO, PIHP, PAHP, or PCCM 
entity to access out-of-State IHCPs; or
    (ii) If this circumstance is deemed to be good cause for 
disenrollment from both the MCO, PIHP, PAHP, or PCCM entity and the 
State's managed care program in accordance with Sec.  438.56(c).
    (6) MCOs, PIHPs, PAHPs, and PCCM entities, to the extent the PCCM 
entity has a provider network, must permit an out-of-network IHCP to 
refer an Indian enrollee to a network provider.
    (c) Payment requirements. (1) When an IHCP is enrolled in Medicaid 
as a FQHC but not a participating provider of the MCO, PIHP, PAHP or 
PCCM entity, it

[[Page 281]]

must be paid an amount equal to the amount the MCO, PIHP, PAHP, or PCCM 
entity would pay a FQHC that is a network provider but is not an IHCP, 
including any supplemental payment from the State to make up the 
difference between the amount the MCO, PIHP, PAHP or PCCM entity pays 
and what the IHCP FQHC would have received under FFS.
    (2) When an IHCP is not enrolled in Medicaid as a FQHC, regardless 
of whether it participates in the network of an MCO, PIHP, PAHP and PCCM 
entity or not, it has the right to receive its applicable encounter rate 
published annually in the Federal Register by the Indian Health Service, 
or in the absence of a published encounter rate, the amount it would 
receive if the services were provided under the State plan's FFS payment 
methodology.
    (3) When the amount a IHCP receives from a MCO, PIHP, PAHP, or PCCM 
entity is less than the amount required by paragraph (c)(2) of this 
section, the State must make a supplemental payment to the IHCP to make 
up the difference between the amount the MCO, PIHP, PAHP, or PCCM entity 
pays and the amount the IHCP would have received under FFS or the 
applicable encounter rate.
    (d) Enrollment in IMCEs. An IMCE may restrict its enrollment to 
Indians in the same manner as Indian Health Programs, as defined in 25 
U.S.C. 1603(12), may restrict the delivery of services to Indians, 
without being in violation of the requirements in Sec.  438.3(d).



                    Subpart B_State Responsibilities

    Source: 81 FR 27853, May 6, 2016, unless otherwise noted.



Sec.  438.50  State Plan requirements.

    (a) General rule. A State plan that requires Medicaid beneficiaries 
to enroll in MCOs, PCCMs, or PCCM entities must comply with the 
provisions of this section, except when the State imposes the 
requirement--
    (1) As part of a demonstration project under section 1115(a) of the 
Act; or
    (2) Under a waiver granted under section 1915(b) of the Act.
    (b) State plan information. The plan must specify--
    (1) The types of entities with which the State contracts.
    (2) The payment method it uses (for example, whether FFS or 
capitation).
    (3) Whether it contracts on a comprehensive risk basis.
    (4) The process the State uses to involve the public in both design 
and initial implementation of the managed care program and the methods 
it uses to ensure ongoing public involvement once the State plan has 
been implemented.
    (c) State plan assurances. The plan must provide assurances that the 
State meets applicable requirements of the following statute and 
regulations:
    (1) Section 1903(m) of the Act, for MCOs and MCO contracts.
    (2) Section 1905(t) of the Act, for PCCMs and PCCM or PCCM entity 
contracts.
    (3) Section 1932(a)(1)(A) of the Act, for the State's option to 
limit freedom of choice by requiring beneficiaries to receive their 
benefits through managed care entities.
    (4) This part, for MCOs, PCCMs, and PCCM entities.
    (5) Part 434 of this chapter, for all contracts.
    (6) Section 438.4, for payments under any risk contracts, and Sec.  
447.362 of this chapter for payments under any nonrisk contracts.
    (d) Limitations on enrollment. The State must provide assurances 
that, in implementing the State plan managed care option, it will not 
require the following groups to enroll in an MCO, PCCM or PCCM entity:
    (1) Beneficiaries who are also eligible for Medicare.
    (2) Indians as defined in Sec.  438.14(a), except as permitted under 
Sec.  438.14(d).
    (3) Children under 19 years of age who are:
    (i) Eligible for SSI under Title XVI;
    (ii) Eligible under section 1902(e)(3) of the Act;
    (iii) In foster care or other out-of-home placement;
    (iv) Receiving foster care or adoption assistance; or
    (v) Receiving services through a family-centered, community-based, 
coordinated care system that receives grant

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funds under section 501(a)(1)(D) of Title V, and is defined by the State 
in terms of either program participation or special health care needs.



Sec.  438.52  Choice of MCOs, PIHPs, PAHPs, PCCMs, and PCCM entities.

    (a) General rule. Except as specified in paragraphs (b) and (c) of 
this section, a State that requires Medicaid beneficiaries to:
    (1) Enroll in an MCO, PIHP, or PAHP, must give those beneficiaries a 
choice of at least two MCOs, PIHPs, or PAHPs.
    (2) Enroll in a primary care case management system, must give those 
beneficiaries a choice from at least two primary care case managers 
employed or contracted with the State.
    (3) Enroll in a PCCM entity, may limit a beneficiary to a single 
PCCM entity. Beneficiaries must be permitted to choose from at least two 
primary care case managers employed by or contracted with the PCCM 
entity.
    (b) Exception for rural area residents. (1) Under any managed care 
program authorized by any of the following, and subject to the 
requirements of paragraph (b)(2) of this section, a State may limit a 
rural area resident to a single MCO, PIHP, or PAHP:
    (i) A State plan amendment under section 1932(a) of the Act.
    (ii) A waiver under section 1115(a) of the Act.
    (iii) A waiver under section 1915(b) of the Act.
    (2) To comply with this paragraph (b), a State, must permit the 
beneficiary--
    (i) To choose from at least two primary care providers; and
    (ii) To obtain services from any other provider under any of the 
following circumstances:
    (A) The service or type of provider (in terms of training, 
experience, and specialization) is not available within the MCO, PIHP, 
or PAHP network.
    (B) The provider is not part of the network, but is the main source 
of a service to the beneficiary, provided that--
    (1) The provider is given the opportunity to become a participating 
provider under the same requirements for participation in the MCO, PIHP, 
or PAHP network as other network providers of that type.
    (2) If the provider chooses not to join the network, or does not 
meet the necessary qualification requirements to join, the enrollee will 
be transitioned to a participating provider within 60 calendar days 
(after being given an opportunity to select a provider who 
participates).
    (C) The only plan or provider available to the beneficiary does not, 
because of moral or religious objections, provide the service the 
enrollee seeks.
    (D) The beneficiary's primary care provider or other provider 
determines that the beneficiary needs related services that would 
subject the beneficiary to unnecessary risk if received separately (for 
example, a cesarean section and a tubal ligation) and not all of the 
related services are available within the network.
    (E) The State determines that other circumstances warrant out-of-
network treatment.
    (3) As used in this paragraph (b), ``rural area'' is any county 
designated as ``micro,'' ``rural,'' or ``County with Extreme Access 
Considerations (CEAC)'' in the Medicare Advantage Health Services 
Delivery (HSD) Reference file for the applicable calendar year.
    (c) Exception for certain health insuring organizations (HIOs). The 
State may limit beneficiaries to a single HIO if--
    (1) The HIO is one of those described in section 1932(a)(3)(C) of 
the Act; and
    (2) The beneficiary who enrolls in the HIO has a choice of at least 
two primary care providers within the entity.
    (d) Limitations on changes between primary care providers. For an 
enrollee of a single MCO, PIHP, PAHP, or HIO under paragraph (b) or (c) 
of this section, any limitation the State imposes on his or her freedom 
to change between primary care providers may be no more restrictive than 
the limitations on disenrollment under Sec.  438.56(c).



Sec.  438.54  Managed care enrollment.

    (a) Applicability. The provisions of this section apply to all 
Medicaid managed care programs which operate under any authority in the 
Act.
    (b) General rule. The State must have an enrollment system for its 
managed

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care programs, voluntary and mandatory, as appropriate.
    (1) Voluntary managed care programs are those where one or more 
groups of beneficiaries as enumerated in section of 1905(a) of the Act 
have the option to either enroll in a MCO, PIHP, PAHP, PCCM or PCCM 
entity, or remain enrolled in FFS to receive Medicaid covered benefits.
    (2) Mandatory managed care programs are those where one or more 
groups of beneficiaries as enumerated in section 1905(a) of the Act must 
enroll in a MCO, PIHP, PAHP, PCCM or PCCM entity to receive covered 
Medicaid benefits.
    (3) States must provide the demographic information listed in Sec.  
438.340(b)(6) for each Medicaid enrollee to the individual's MCO, PIHP, 
PAHP, or PCCM entity at the time of enrollment.
    (c) Voluntary managed care programs. (1) States that have a 
voluntary managed care program must have an enrollment system that:
    (i) Provides an enrollment choice period during which potential 
enrollees may make an active choice of delivery system and, if needed, 
choice of an MCO, PIHP, PAHP, PCCM or PCCM entity before enrollment is 
effectuated; or
    (ii) Employs a passive enrollment process in which the State enrolls 
the potential enrollee into a MCO, PIHP, PAHP, PCCM or PCCM entity and 
simultaneously provides a period of time for the enrollee to make an 
active choice of delivery system and, if needed, to maintain enrollment 
in the MCO, PIHP, PAHP, PCCM or PCCM entity passively assigned or to 
select a different MCO, PIHP, PAHP, PCCM or PCCM entity.
    (2) A State must provide potential enrollees the opportunity to 
actively elect to receive covered services through the managed care or 
FFS delivery system. If the potential enrollee elects to receive covered 
services through the managed care delivery system, the potential 
enrollee must then also select a MCO, PIHP, PAHP, PCCM, or PCCM entity.
    (i) If the State does not use a passive enrollment process and the 
potential enrollee does not make an active choice during the period 
allowed by the state, then the potential enrollee will continue to 
receive covered services through the FFS delivery system.
    (ii) If the State uses a passive enrollment process, the potential 
enrollee must select either to accept the MCO, PIHP, PAHP, PCCM, or PCCM 
entity selected for them by the State's passive enrollment process, 
select a different MCO, PIHP, PAHP, PCCM, or PCCM entity, or elect to 
receive covered services through the FFS delivery system. If the 
potential enrollee does not make an active choice during the time 
allowed by the state, the potential enrollee will remain enrolled with 
the MCO, PIHP, PAHP, PCCM, or PCCM entity selected by the passive 
enrollment process.
    (3) The State must provide informational notices to each potential 
enrollee at the time the potential enrollee first becomes eligible to 
enroll in a managed care program and within a timeframe that enables the 
potential enrollee to use the information in choosing among available 
delivery system and/or managed care plan options. The notices must:
    (i) Clearly explain (as relevant to the State's managed care 
program) the implications to the potential enrollee of: not making an 
active choice between managed care and FFS; selecting a different MCO, 
PIHP, PAHP, PCCM or PCCM entity; and accepting the MCO, PIHP, PAHP, 
PCCM, or PCCM entity selected by the State;
    (ii) Identify the MCOs, PIHPs, PAHPs, PCCMs or PCCM entities 
available to the potential enrollee should they elect the managed care 
delivery system;
    (iii) Provide clear instructions for how to make known to the State 
the enrollee's selection of the FFS delivery system or a MCO, PIHP, 
PAHP, PCCM or PCCM entity;
    (iv) Provide a comprehensive explanation of the length of the 
enrollment period, the 90 day without cause disenrollment period, and 
all other disenrollment options as specified in Sec.  438.56;
    (v) Include the contact information for the beneficiary support 
system in Sec.  438.71; and

[[Page 284]]

    (vi) Comply with the information requirements in Sec.  438.10.
    (4) The State's enrollment system must provide that beneficiaries 
already enrolled in an MCO, PIHP, PAHP, PCCM or PCCM entity are given 
priority to continue that enrollment if the MCO, PIHP, PAHP, PCCM or 
PCCM entity does not have the capacity to accept all those seeking 
enrollment under the program.
    (5) If a State elects to use a passive enrollment process, the 
process must assign beneficiaries to a qualified MCO, PIHP, PAHP, PCCM 
or PCCM entity. To be a qualified MCO, PIHP, PAHP, PCCM or PCCM entity, 
it must:
    (i) Not be subject to the intermediate sanction described in Sec.  
438.702(a)(4); and
    (ii) Have capacity to enroll beneficiaries.
    (6) A passive enrollment process must seek to preserve existing 
provider-beneficiary relationships and relationships with providers that 
have traditionally served Medicaid beneficiaries.
    (i) An ``existing provider-beneficiary relationship'' is one in 
which the provider was a main source of Medicaid services for the 
beneficiary during the previous year. This may be established through 
State records of previous managed care enrollment or FFS experience, 
encounter data, or through contact with the beneficiary.
    (ii) A provider is considered to have ``traditionally served'' 
Medicaid beneficiaries if it has experience in serving the Medicaid 
population.
    (7) If the approach in paragraph (c)(6) of this section is not 
possible, the State must distribute the beneficiaries equitably among 
the MCOs, PIHPs, PAHPs, PCCMs and PCCM entities.
    (i) The State may not arbitrarily exclude any MCO, PIHP, PAHP, PCCM, 
or PCCM entity from being considered.
    (ii) The State may consider additional criteria to conduct the 
passive enrollment process, including the enrollment preferences of 
family members, previous plan assignment of the beneficiary, quality 
assurance and improvement performance, procurement evaluation elements, 
accessibility of provider offices for people with disabilities (when 
appropriate), and other reasonable criteria that support the objectives 
of the managed care program.
    (8) If a passive enrollment process is used and the enrollee does 
not elect to be enrolled into the FFS delivery system, the State must 
send a notice to the enrollee:
    (i) Confirming that the enrollee's time to elect to enroll in the 
FFS delivery system has ended and that the enrollee will remain enrolled 
in the managed care delivery system for the remainder of the enrollment 
period unless one of the disenrollment reasons specified in Sec.  438.56 
applies.
    (ii) Clearly and fully explaining the enrollee's right, and process 
to follow, to disenroll from the passively assigned MCO, PIHP, PAHP, 
PCCM or PCCM entity and select a different MCO, PIHP, PAHP, PCCM or PCCM 
entity within 90 days from the effective date of the enrollment or for 
any reason specified in Sec.  438.56(d)(2).
    (iii) Within 5 calendar days of the end of the time allowed for 
making the delivery system selection.
    (d) Mandatory managed care programs. (1) States must have an 
enrollment system for a mandatory managed care program that includes the 
elements specified in paragraphs (d)(2) through (8) of this section.
    (2) The State's enrollment system must implement enrollment in a 
MCO, PIHP, PAHP, PCCM, or PCCM entity as follows:
    (i) If the State does not use a passive enrollment process and the 
potential enrollee does not make an active choice of a MCO, PIHP, PAHP, 
PCCM, or PCCM entity during the period allowed by the State, the 
potential enrollee will be enrolled into a MCO, PIHP, PAHP, PCCM, or 
PCCM entity selected by the State's default process.
    (ii) If the State uses a passive enrollment process, the potential 
enrollee must either accept the MCO, PIHP, PAHP, PCCM, or PCCM entity 
selected by the State's passive enrollment process or select a different 
MCO, PIHP, PAHP, PCCM, or PCCM entity. If the potential enrollee does 
not make an active choice during the time allowed by the State, the MCO, 
PIHP, PAHP, PCCM, or PCCM entity selected by the passive enrollment 
process will remain effective.

[[Page 285]]

    (3) A State must provide informational notices to each potential 
enrollee at the time the potential enrollee first becomes eligible to 
enroll in a managed care program and within a timeframe that enables the 
potential enrollee to use the information in choosing among available 
managed care plans. The notices must:
    (i) Include the MCOs, PIHPs, PAHPs, PCCMs, or PCCM entities 
available to the potential enrollee;
    (ii) Provide clear instructions for how to make known to the State 
the enrollee's selection of a MCO, PIHP, PAHP, PCCM, or PCCM entity;
    (iii) Clearly explain the implications to the potential enrollee of 
not making an active choice of an MCO, PIHP, PAHP, PCCM or PCCM entity 
as well as the implications of making an active choice of an MCO, PIHP, 
PAHP, PCCM or PCCM entity;
    (iv) Provide a comprehensive explanation of the length of the 
enrollment period, the 90 day without cause disenrollment period, and 
all other disenrollment options as specified in Sec.  438.56;
    (v) Include the contact information for the beneficiary support 
system in Sec.  438.71; and
    (vi) Comply with the information requirements in Sec.  438.10.
    (4) Priority for enrollment. The State's enrollment system must 
provide that beneficiaries already enrolled in an MCO, PIHP, PAHP, PCCM 
or PCCM entity are given priority to continue that enrollment if the 
MCO, PIHP, PAHP, PCCM or PCCM entity does not have the capacity to 
accept all those seeking enrollment under the program.
    (5) Enrollment by default. For potential enrollees that do not 
select an MCO, PIHP, PAHP, PCCM or PCCM entities during the period 
allowed by the state, the State must have a default enrollment process 
for assigning those beneficiaries to qualified MCOs, PIHPs, PAHPs, PCCMs 
and PCCM entities. To be a qualified MCO, PIHP, PAHP, PCCM or PCCM 
entity, it must:
    (i) Not be subject to the intermediate sanction described in Sec.  
438.702(a)(4); and
    (ii) Have capacity to enroll beneficiaries.
    (6) Passive enrollment. For States that use a passive enrollment 
process, the process must assign potential enrollees to qualified MCOs, 
PIHPs, PAHPs, PCCMs and PCCM entities. To be a qualified MCO, PIHP, 
PAHP, PCCM or PCCM entity, it must:
    (i) Not be subject to the intermediate sanction described in Sec.  
438.702(a)(4); and
    (ii) Have capacity to enroll beneficiaries.
    (7) The passive and default enrollment processes must seek to 
preserve existing provider-beneficiary relationships and relationships 
with providers that have traditionally served Medicaid beneficiaries.
    (i) An ``existing provider-beneficiary relationship'' is one in 
which the provider was a main source of Medicaid services for the 
beneficiary during the previous year. This may be established through 
State records of previous managed care enrollment or FFS experience, 
encounter data, or through contact with the beneficiary.
    (ii) A provider is considered to have ``traditionally served'' 
Medicaid beneficiaries if it has experience in serving the Medicaid 
population.
    (8) If the approach in paragraph (d)(7) of this section is not 
possible, the State must distribute the beneficiaries equitably among 
the MCOs, PIHPs, PAHPs, PCCMs and PCCM entities available to enroll 
them.
    (i) The State may not arbitrarily exclude any MCO, PIHP, PAHP, PCCM 
or PCCM entity from being considered; and
    (ii) The State may consider additional criteria to conduct the 
default enrollment process, including the enrollment preferences of 
family members, previous plan assignment of the beneficiary, quality 
assurance and improvement performance, procurement evaluation elements, 
accessibility of provider offices for people with disabilities (when 
appropriate), and other reasonable criteria related to a beneficiary's 
experience with the Medicaid program.

[81 FR 27853, May 6, 2016, as amended at 85 FR 72840, Nov. 13, 2020]



Sec.  438.56  Disenrollment: Requirements and limitations.

    (a) Applicability. The provisions of this section apply to all 
managed care

[[Page 286]]

programs whether enrollment is mandatory or voluntary and whether the 
contract is with an MCO, PIHP, PAHP, PCCM, or PCCM entity.
    (b) Disenrollment requested by the MCO, PIHP, PAHP, PCCM, or PCCM 
entity. All MCO, PIHP, PAHP, PCCM and PCCM entity contracts must:
    (1) Specify the reasons for which the MCO, PIHP, PAHP, PCCM, or PCCM 
entity may request disenrollment of an enrollee.
    (2) Provide that the MCO, PIHP, PAHP, PCCM, or PCCM entity may not 
request disenrollment because of an adverse change in the enrollee's 
health status, or because of the enrollee's utilization of medical 
services, diminished mental capacity, or uncooperative or disruptive 
behavior resulting from his or her special needs (except when his or her 
continued enrollment in the MCO, PIHP, PAHP, PCCM or PCCM entity 
seriously impairs the entity's ability to furnish services to either 
this particular enrollee or other enrollees).
    (3) Specify the methods by which the MCO, PIHP, PAHP, PCCM, or PCCM 
entity assures the agency that it does not request disenrollment for 
reasons other than those permitted under the contract.
    (c) Disenrollment requested by the enrollee. If the State chooses to 
limit disenrollment, its MCO, PIHP, PAHP, PCCM, and PCCM entity 
contracts must provide that a beneficiary may request disenrollment as 
follows:
    (1) For cause, at any time.
    (2) Without cause, at the following times:
    (i) During the 90 days following the date of the beneficiary's 
initial enrollment into the MCO, PIHP, PAHP, PCCM, or PCCM entity, or 
during the 90 days following the date the State sends the beneficiary 
notice of that enrollment, whichever is later.
    (ii) At least once every 12 months thereafter.
    (iii) Upon automatic reenrollment under paragraph (g) of this 
section, if the temporary loss of Medicaid eligibility has caused the 
beneficiary to miss the annual disenrollment opportunity.
    (iv) When the State imposes the intermediate sanction specified in 
Sec.  438.702(a)(4).
    (d) Procedures for disenrollment--(1) Request for disenrollment. The 
beneficiary (or his or her representative) must submit an oral or 
written request, as required by the State--
    (i) To the State (or its agent); or
    (ii) To the MCO, PIHP, PAHP, PCCM, or PCCM entity, if the State 
permits MCOs, PIHP, PAHPs, PCCMs, and PCCM entities to process 
disenrollment requests.
    (2) Cause for disenrollment. The following are cause for 
disenrollment:
    (i) The enrollee moves out of the MCO's, PIHP's, PAHP's, PCCM's, or 
PCCM entity's service area.
    (ii) The plan does not, because of moral or religious objections, 
cover the service the enrollee seeks.
    (iii) The enrollee needs related services (for example, a cesarean 
section and a tubal ligation) to be performed at the same time; not all 
related services are available within the provider network; and the 
enrollee's primary care provider or another provider determines that 
receiving the services separately would subject the enrollee to 
unnecessary risk.
    (iv) For enrollees that use MLTSS, the enrollee would have to change 
their residential, institutional, or employment supports provider based 
on that provider's change in status from an in-network to an out-of-
network provider with the MCO, PIHP, or PAHP and, as a result, would 
experience a disruption in their residence or employment.
    (v) Other reasons, including poor quality of care, lack of access to 
services covered under the contract, or lack of access to providers 
experienced in dealing with the enrollee's care needs.
    (3) MCO, PIHP, PAHP, PCCM, or PCCM entity action on request. (i) 
When the MCO's, PIHP's, PAHP's, PCCM's, or PCCM entity's contract with 
the State permits the MCO, PIHP, PAHP, PCCM, or PCCM entity to process 
disenrollment requests, the MCO, PIHP, PAHP, PCCM, or PCCM entity may 
either approve a request for disenrollment by or on behalf of an 
enrollee or the MCO, PIHP, PAHP, PCCM, or PCCM entity must refer the 
request to the State.

[[Page 287]]

    (ii) If the MCO, PIHP, PAHP, PCCM, PCCM entity, or State agency 
(whichever is responsible) fails to make a disenrollment determination 
so that the beneficiary can be disenrolled within the timeframes 
specified in paragraph (e)(1) of this section, the disenrollment is 
considered approved.
    (4) State agency action on request. For a request received directly 
from the beneficiary, or one referred by the MCO, PIHP, PAHP, PCCM, or 
PCCM entity, the State agency must take action to approve or disapprove 
the request based on the following:
    (i) Reasons cited in the request.
    (ii) Information provided by the MCO, PIHP, PAHP, PCCM, or PCCM 
entity at the agency's request.
    (iii) Any of the reasons specified in paragraph (d)(2) of this 
section.
    (5) Use of the MCO's, PIHP's, PAHP's grievance procedures. (i) The 
State agency may require that the enrollee seek redress through the 
MCO's, PHIP's, or PAHP's grievance system before making a determination 
on the enrollee's request.
    (ii) The grievance process, if used, must be completed in time to 
permit the disenrollment (if approved) to be effective in accordance 
with the timeframe specified in paragraph (e)(1) of this section.
    (iii) If, as a result of the grievance process, the MCO, PIHP, or 
PAHP approves the disenrollment, the State agency is not required to 
make a determination in accordance with paragraph (d)(4) of this 
section.
    (e) Timeframe for disenrollment determinations. (1) Regardless of 
the procedures followed, the effective date of an approved disenrollment 
must be no later than the first day of the second month following the 
month in which the enrollee requests disenrollment or the MCO, PIHP, 
PAHP, PCCM, or PCCM entity refers the request to the State.
    (2) If the MCO, PIHP, PAHP, PCCM, PCCM entity, or the State agency 
(whichever is responsible) fails to make the determination within the 
timeframes specified in paragraph (e)(1) of this section, the 
disenrollment is considered approved for the effective date that would 
have been established had the State or MCO, PIHP, PAHP, PCCM, PCCM 
entity complied with paragraph (e)(1) of this section.
    (f) Notice and appeals. A State that restricts disenrollment under 
this section must take the following actions:
    (1) Provide that enrollees and their representatives are given 
written notice of disenrollment rights at least 60 days before the start 
of each enrollment period. The notice must include an explanation of all 
of the enrollee's disenrollment rights as specified in this section.
    (2) Ensure timely access to State fair hearing for any enrollee 
dissatisfied with a State agency determination that there is not good 
cause for disenrollment.
    (g) Automatic reenrollment: Contract requirement. If the State plan 
so specifies, the contract must provide for automatic reenrollment of a 
beneficiary who is disenrolled solely because he or she loses Medicaid 
eligibility for a period of 2 months or less.

[81 FR 27853, May 6, 2016, as amended at 85 FR 72840, Nov. 13, 2020]



Sec.  438.58  Conflict of interest safeguards.

    As a condition for contracting with MCOs, PIHPs, or PAHPs, a State 
must have in effect safeguards against conflict of interest on the part 
of State and local officers and employees and agents of the State who 
have responsibilities relating to the MCO, PIHP, or PAHP contracts or 
the enrollment processes specified in Sec.  438.54(b). These safeguards 
must be at least as effective as the safeguards specified in section 27 
of the Office of Federal Procurement Policy Act (41 U.S.C. 423).



Sec.  438.60  Prohibition of additional payments for services covered
under MCO, PIHP or PAHP contracts.

    The State agency must ensure that no payment is made to a network 
provider other than by the MCO, PIHP, or PAHP for services covered under 
the contract between the State and the MCO, PIHP, or PAHP, except when 
these payments are specifically required to be made by the State in 
Title XIX of the Act, in 42 CFR chapter IV, or when the State agency 
makes direct payments to network providers for graduate medical 
education costs approved under the State plan.

[[Page 288]]



Sec.  438.62  Continued services to enrollees.

    (a) The State agency must arrange for Medicaid services to be 
provided without delay to any Medicaid enrollee of an MCO, PIHP, PAHP, 
PCCM, or PCCM entity the contract of which is terminated and for any 
Medicaid enrollee who is disenrolled from an MCO, PIHP, PAHP, PCCM, or 
PCCM entity for any reason other than ineligibility for Medicaid.
    (b) The State must have in effect a transition of care policy to 
ensure continued access to services during a transition from FFS to a 
MCO, PIHP, PAHP, PCCM or PCCM entity or transition from one MCO, PIHP, 
PAHP, PCCM or PCCM entity to another when an enrollee, in the absence of 
continued services, would suffer serious detriment to their health or be 
at risk of hospitalization or institutionalization.
    (1) The transition of care policy must include the following:
    (i) The enrollee has access to services consistent with the access 
they previously had, and is permitted to retain their current provider 
for a period of time if that provider is not in the MCO, PIHP or PAHP 
network.
    (ii) The enrollee is referred to appropriate providers of services 
that are in the network.
    (iii) The State, in the case of FFS, PCCM, or PCCM entity, or the 
MCO, PIHP or PAHP that was previously serving the enrollee, fully and 
timely complies with requests for historical utilization data from the 
new MCO, PIHP, PAHP, PCCM, or PCCM entity in compliance with Federal and 
State law.
    (iv) Consistent with Federal and State law, the enrollee's new 
provider(s) are able to obtain copies of the enrollee's medical records, 
as appropriate.
    (v) Any other necessary procedures as specified by the Secretary to 
ensure continued access to services to prevent serious detriment to the 
enrollee's health or reduce the risk of hospitalization or 
institutionalization.
    (vi) A process for the electronic exchange of, at a minimum, the 
data classes and elements included in the content standard adopted at 45 
CFR 170.213. Such information received by the MCO, PIHP, or PAHP must be 
incorporated into the MCO's, PIHP's, or PAHP's records about the current 
enrollee. With the approval and at the direction of a current or former 
enrollee or the enrollee's personal representative, the MCO, PIHP, or 
PAHP must:
    (A) Receive all such data for a current enrollee from any other 
payer that has provided coverage to the enrollee within the preceding 5 
years;
    (B) At any time the enrollee is currently enrolled in the MCO, PIHP, 
or PAHP and up to 5 years after disenrollment, send all such data to any 
other payer that currently covers the enrollee or a payer the enrollee 
or the enrollee's personal representative specifically requests receive 
the data; and
    (C) Send data received from another payer under this paragraph in 
the electronic form and format it was received.
    (vii) Applicability.
    (A) The MCO, PIHP, or PAHP must comply with the requirements in 
paragraph (b)(1)(vi) of this section beginning January 1, 2022 with 
regard to data:
    (1) With a date of service on or after January 1, 2016; and
    (2) That are maintained by the MCO, PIHP, or PAHP.
    (B) [Reserved]
    (2) The State must require by contract that MCOs, PIHPs, and PAHPs 
implement a transition of care policy consistent with the requirements 
in paragraph (b)(1) of this section and at least meets the State defined 
transition of care policy.
    (3) The State must make its transition of care policy publicly 
available and provide instructions to enrollees and potential enrollees 
on how to access continued services upon transition. At a minimum, the 
transition of care policy must be described in the quality strategy, 
under Sec.  438.340, and explained to individuals in the materials to 
enrollees and potential enrollees, in accordance with Sec.  438.10.
    (c) Applicability date. This section applies to the rating period 
for contracts with MCOs, PIHPs, PAHPs, PCCMs, and PCCM entities 
beginning on or after July 1, 2018. Until that applicability date, 
states are required to continue to comply with Sec.  438.62 contained

[[Page 289]]

in the 42 CFR parts 430 to 481, edition revised as of October 1, 2015.

[81 FR 27853, May 6, 2016, as amended at 85 FR 25635, May 1, 2020]



Sec.  438.66  State monitoring requirements.

    (a) General requirement. The State agency must have in effect a 
monitoring system for all managed care programs.
    (b) The State's system must address all aspects of the managed care 
program, including the performance of each MCO, PIHP, PAHP, and PCCM 
entity (if applicable) in at least the following areas:
    (1) Administration and management.
    (2) Appeal and grievance systems.
    (3) Claims management.
    (4) Enrollee materials and customer services, including the 
activities of the beneficiary support system.
    (5) Finance, including medical loss ratio reporting.
    (6) Information systems, including encounter data reporting.
    (7) Marketing.
    (8) Medical management, including utilization management and case 
management.
    (9) Program integrity.
    (10) Provider network management, including provider directory 
standards.
    (11) Availability and accessibility of services, including network 
adequacy standards.
    (12) Quality improvement.
    (13) Areas related to the delivery of LTSS not otherwise included in 
paragraphs (b)(1) through (12) of this section as applicable to the 
managed care program.
    (14) All other provisions of the contract, as appropriate.
    (c) The State must use data collected from its monitoring activities 
to improve the performance of its managed care program, including at a 
minimum:
    (1) Enrollment and disenrollment trends in each MCO, PIHP, or PAHP.
    (2) Member grievance and appeal logs.
    (3) Provider complaint and appeal logs.
    (4) Findings from the State's External Quality Review process.
    (5) Results from any enrollee or provider satisfaction survey 
conducted by the State or MCO, PIHP, or PAHP.
    (6) Performance on required quality measures.
    (7) Medical management committee reports and minutes.
    (8) The annual quality improvement plan for each MCO, PIHP, PAHP, or 
PCCM entity.
    (9) Audited financial and encounter data submitted by each MCO, 
PIHP, or PAHP.
    (10) The medical loss ratio summary reports required by Sec.  438.8.
    (11) Customer service performance data submitted by each MCO, PIHP, 
or PAHP and performance data submitted by the beneficiary support 
system.
    (12) Any other data related to the provision of LTSS not otherwise 
included in paragraphs (c)(1) through (11) of this section as applicable 
to the managed care program.
    (d)(1) The State must assess the readiness of each MCO, PIHP, PAHP 
or PCCM entity with which it contracts as follows:
    (i) Prior to the State implementing a managed care program, whether 
the program is voluntary or mandatory.
    (ii) When the specific MCO, PIHP, PAHP, or PCCM entity has not 
previously contracted with the State.
    (iii) When any MCO, PIHP, PAHP, or PCCM entity currently contracting 
with the State will provide or arrange for the provision of covered 
benefits to new eligibility groups.
    (2) The State must conduct a readiness review of each MCO, PIHP, 
PAHP, or PCCM entity with which it contracts as follows:
    (i) Started at least 3 months prior to the effective date of the 
events described in paragraph (d)(1) of this section.
    (ii) Completed in sufficient time to ensure smooth implementation of 
an event described in paragraph (d)(1) of this section.
    (iii) Submitted to CMS for CMS to make a determination that the 
contract or contract amendment associated with an event described in 
paragraph (d)(1) of this section is approved under Sec.  438.3(a).

[[Page 290]]

    (3) Readiness reviews described in paragraphs (d)(1)(i) and (ii) of 
this section must include both a desk review of documents and on-site 
reviews of each MCO, PIHP, PAHP, or PCCM entity. Readiness reviews 
described in paragraph (d)(1)(iii) of this section must include a desk 
review of documents and may, at the State's option, include an on-site 
review. On-site reviews must include interviews with MCO, PIHP, PAHP, or 
PCCM entity staff and leadership that manage key operational areas.
    (4) A State's readiness review must assess the ability and capacity 
of the MCO, PIHP, PAHP, and PCCM entity (if applicable) to perform 
satisfactorily for the following areas:
    (i) Operations/Administration, including--
    (A) Administrative staffing and resources.
    (B) Delegation and oversight of MCO, PIHP, PAHP or PCCM entity 
responsibilities.
    (C) Enrollee and provider communications.
    (D) Grievance and appeals.
    (E) Member services and outreach.
    (F) Provider Network Management.
    (G) Program Integrity/Compliance.
    (ii) Service delivery, including--
    (A) Case management/care coordination/service planning.
    (B) Quality improvement.
    (C) Utilization review.
    (iii) Financial management, including--
    (A) Financial reporting and monitoring.
    (B) Financial solvency.
    (iv) Systems management, including--
    (A) Claims management.
    (B) Encounter data and enrollment information management.
    (e)(1) The State must submit to CMS no later than 180 days after 
each contract year, a report on each managed care program administered 
by the State, regardless of the authority under which the program 
operates.
    (i) The initial report will be due after the contract year following 
the release of CMS guidance on the content and form of the report.
    (ii) For States that operate their managed care program under 
section 1115(a) of the Act authority, submission of an annual report 
that may be required by the Special Terms and Conditions of the section 
1115(a) demonstration program will be deemed to satisfy the requirement 
of this paragraph (e)(1) provided that the report includes the 
information specified in paragraph (e)(2) of this section.
    (2) The program report must provide information on and an assessment 
of the operation of the managed care program on, at a minimum, the 
following areas:
    (i) Financial performance of each MCO, PIHP, and PAHP, including MLR 
experience.
    (ii) Encounter data reporting by each MCO, PIHP, or PAHP.
    (iii) Enrollment and service area expansion (if applicable) of each 
MCO, PIHP, PAHP, and PCCM entity.
    (iv) Modifications to, and implementation of, MCO, PIHP, or PAHP 
benefits covered under the contract with the State.
    (v) Grievance, appeals, and State fair hearings for the managed care 
program.
    (vi) Availability and accessibility of covered services within the 
MCO, PIHP, or PAHP contracts, including network adequacy standards.
    (vii) Evaluation of MCO, PIHP, or PAHP performance on quality 
measures, including as applicable, consumer report card, surveys, or 
other reasonable measures of performance.
    (viii) Results of any sanctions or corrective action plans imposed 
by the State or other formal or informal intervention with a contracted 
MCO, PIHP, PAHP, or PCCM entity to improve performance.
    (ix) Activities and performance of the beneficiary support system.
    (x) Any other factors in the delivery of LTSS not otherwise 
addressed in (e)(2)(i)-(ix) of this section as applicable.
    (3) The program report required in this section must be:
    (i) Posted on the Web site required under Sec.  438.10(c)(3).
    (ii) Provided to the Medical Care Advisory Committee, required under 
Sec.  431.12 of this chapter.
    (iii) Provided to the stakeholder consultation group specified in 
Sec.  438.70, to

[[Page 291]]

the extent that the managed care program includes LTSS.
    (f) Applicability. States will not be held out of compliance with 
the requirements of paragraphs (a) through (d) of this section prior to 
the rating period for contracts starting on or after July 1, 2017, so 
long as they comply with the corresponding standard(s) codified in 42 
CFR 438.66 contained in the 42 CFR, parts 430 to 481, edition revised as 
of October 1, 2015.



Sec.  438.68  Network adequacy standards.

    (a) General rule. A State that contracts with an MCO, PIHP or PAHP 
to deliver Medicaid services must develop and enforce network adequacy 
standards consistent with this section.
    (b) Provider-specific network adequacy standards.-(1) Provider 
types. At a minimum, a State must develop a quantitative network 
adequacy standard for the following provider types, if covered under the 
contract:
    (i) Primary care, adult and pediatric.
    (ii) OB/GYN.
    (iii) Behavioral health (mental health and substance use disorder), 
adult and pediatric.
    (iv) Specialist (as designated by the State), adult, and pediatric.
    (v) Hospital.
    (vi) Pharmacy.
    (vii) Pediatric dental.
    (2) LTSS. States with MCO, PIHP, or PAHP contracts which cover LTSS 
must develop a quantitative network adequacy standard for LTSS provider 
types.
    (3) Scope of network adequacy standards. Network standards 
established in accordance with paragraphs (b)(1) and (2) of this section 
must include all geographic areas covered by the managed care program 
or, if applicable, the contract between the State and the MCO, PIHP or 
PAHP. States are permitted to have varying standards for the same 
provider type based on geographic areas.
    (c) Development of network adequacy standards. (1) States developing 
network adequacy standards consistent with paragraph (b)(1) of this 
section must consider, at a minimum, the following elements:
    (i) The anticipated Medicaid enrollment.
    (ii) The expected utilization of services.
    (iii) The characteristics and health care needs of specific Medicaid 
populations covered in the MCO, PIHP, and PAHP contract.
    (iv) The numbers and types (in terms of training, experience, and 
specialization) of network providers required to furnish the contracted 
Medicaid services.
    (v) The numbers of network providers who are not accepting new 
Medicaid patients.
    (vi) The geographic location of network providers and Medicaid 
enrollees, considering distance, travel time, the means of 
transportation ordinarily used by Medicaid enrollees.
    (vii) The ability of network providers to communicate with limited 
English proficient enrollees in their preferred language.
    (viii) The ability of network providers to ensure physical access, 
reasonable accommodations, culturally competent communications, and 
accessible equipment for Medicaid enrollees with physical or mental 
disabilities.
    (ix) The availability of triage lines or screening systems, as well 
as the use of telemedicine, e-visits, and/or other evolving and 
innovative technological solutions.
    (2) States developing standards consistent with paragraph (b)(2) of 
this section must consider the following:
    (i) All elements in paragraphs (c)(1)(i) through (ix) of this 
section.
    (ii) Elements that would support an enrollee's choice of provider.
    (iii) Strategies that would ensure the health and welfare of the 
enrollee and support community integration of the enrollee.
    (iv) Other considerations that are in the best interest of the 
enrollees that need LTSS.
    (d) Exceptions process. (1) To the extent the State permits an 
exception to any of the provider-specific network standards developed 
under this section, the standard by which the exception will be 
evaluated and approved must be:
    (i) Specified in the MCO, PIHP or PAHP contract.
    (ii) Based, at a minimum, on the number of providers in that 
specialty

[[Page 292]]

practicing in the MCO, PIHP, or PAHP service area.
    (2) States that grant an exception in accordance with paragraph 
(d)(1) of this section to a MCO, PIHP or PAHP must monitor enrollee 
access to that provider type on an ongoing basis and include the 
findings to CMS in the managed care program assessment report required 
under Sec.  438.66.
    (e) Publication of network adequacy standards. States must publish 
the standards developed in accordance with paragraphs (b)(1) and (2) of 
this section on the Web site required by Sec.  438.10. Upon request, 
network adequacy standards must also be made available at no cost to 
enrollees with disabilities in alternate formats or through the 
provision of auxiliary aids and services.

[81 FR 27853, May 6, 2016, as amended at 85 FR 72840, Nov. 13, 2020]



Sec.  438.70  Stakeholder engagement when LTSS is delivered through
a managed care program.

    The State must ensure the views of beneficiaries, individuals 
representing beneficiaries, providers, and other stakeholders are 
solicited and addressed during the design, implementation, and oversight 
of a State's managed LTSS program. The composition of the stakeholder 
group and frequency of meetings must be sufficient to ensure meaningful 
stakeholder engagement.



Sec.  438.71  Beneficiary support system.

    (a) General requirement. The State must develop and implement a 
beneficiary support system that provides support to beneficiaries both 
prior to and after enrollment in a MCO, PIHP, PAHP, PCCM or PCCM entity.
    (b) Elements of the support system. (1) A State beneficiary support 
system must include at a minimum:
    (i) Choice counseling for all beneficiaries.
    (ii) Assistance for enrollees in understanding managed care.
    (iii) Assistance as specified for enrollees who use, or express a 
desire to receive, LTSS in paragraph (d) of this section.
    (2) The beneficiary support system must perform outreach to 
beneficiaries and/or authorized representatives and be accessible in 
multiple ways including phone, Internet, in-person, and via auxiliary 
aids and services when requested.
    (c) Choice counseling. (1) Choice counseling, as defined in Sec.  
438.2, must be provided to all potential enrollees and enrollees who 
disenroll from a MCO, PIHP, PAHP, PCCM or PCCM entity for reasons 
specified in Sec.  438.56(b) and (c).
    (2) If an individual or entity provides choice counseling on the 
State's behalf under a memorandum of agreement or contract, it is 
considered an enrollment broker as defined in Sec.  438.810(a) and must 
meet the independence and freedom from conflict of interest standards in 
Sec.  438.810(b)(1) and (2).
    (3) An entity that receives non-Medicaid funding to represent 
beneficiaries at hearings may provide choice counseling on behalf of the 
State so long as the State requires firewalls to ensure that the 
requirements for the provision of choice counseling are met.
    (d) Functions specific to LTSS activities. At a minimum, the 
beneficiary support system must provide the following support to 
enrollees who use, or express a desire to receive, LTSS:
    (1) An access point for complaints and concerns about MCO, PIHP, 
PAHP, PCCM, and PCCM entity enrollment, access to covered services, and 
other related matters.
    (2) Education on enrollees' grievance and appeal rights within the 
MCO, PIHP or PAHP; the State fair hearing process; enrollee rights and 
responsibilities; and additional resources outside of the MCO, PIHP or 
PAHP.
    (3) Assistance, upon request, in navigating the grievance and appeal 
process within the MCO, PIHP or PAHP, as well as appealing adverse 
benefit determinations by the MCO, PIHP, or PAHP to a State fair 
hearing. The system may not provide representation to the enrollee at a 
State fair hearing but may refer enrollees to sources of legal 
representation.
    (4) Review and oversight of LTSS program data to provide guidance to 
the State Medicaid Agency on identification, remediation and resolution 
of systemic issues.

[[Page 293]]



Sec.  438.74  State oversight of the minimum MLR requirement.

    (a) State reporting requirement. (1) The State must annually submit 
to CMS a summary description of the report(s) received from the MCO(s), 
PIHP(s), and PAHP(s) under contract with the State, according to Sec.  
438.8(k), with the rate certification required in Sec.  438.7.
    (2) The summary description must include, at a minimum, the amount 
of the numerator, the amount of the denominator, the MLR percentage 
achieved, the number of member months, and any remittances owed by each 
MCO, PIHP, or PAHP for that MLR reporting year.
    (b) Repayment of Federal share of remittances. (1) If a State 
requires a MCO, PIHP, or PAHP to pay remittances through the contract 
for not meeting the minimum MLR required by the State, the State must 
reimburse CMS for an amount equal to the Federal share of the 
remittance, taking into account applicable differences in the Federal 
matching rate.
    (2) If a remittance is owed according to paragraph (b)(1) of this 
section, the State must submit a separate report describing the 
methodology used to determine the State and Federal share of the 
remittance with the report required in paragraph (a) of this section.



                Subpart C_Enrollee Rights and Protections

    Source: 81 FR 27853, May 6, 2016, unless otherwise noted.



Sec.  438.100  Enrollee rights.

    (a) General rule. The State must ensure that:
    (1) Each MCO, PIHP, PAHP, PCCM and PCCM entity has written policies 
regarding the enrollee rights specified in this section; and
    (2) Each MCO, PIHP, PAHP, PCCM and PCCM entity complies with any 
applicable Federal and State laws that pertain to enrollee rights, and 
ensures that its employees and contracted providers observe and protect 
those rights.
    (b) Specific rights--(1) Basic requirement. The State must ensure 
that each managed care enrollee is guaranteed the rights as specified in 
paragraphs (b)(2) and (3) of this section.
    (2) An enrollee of an MCO, PIHP, PAHP, PCCM, or PCCM entity has the 
following rights: The right to--
    (i) Receive information in accordance with Sec.  438.10.
    (ii) Be treated with respect and with due consideration for his or 
her dignity and privacy.
    (iii) Receive information on available treatment options and 
alternatives, presented in a manner appropriate to the enrollee's 
condition and ability to understand. (The information requirements for 
services that are not covered under the contract because of moral or 
religious objections are set forth in Sec.  438.10(g)(2)(ii)(A) and 
(B).)
    (iv) Participate in decisions regarding his or her health care, 
including the right to refuse treatment.
    (v) Be free from any form of restraint or seclusion used as a means 
of coercion, discipline, convenience or retaliation, as specified in 
other Federal regulations on the use of restraints and seclusion.
    (vi) If the privacy rule, as set forth in 45 CFR parts 160 and 164 
subparts A and E, applies, request and receive a copy of his or her 
medical records, and request that they be amended or corrected, as 
specified in 45 CFR 164.524 and 164.526.
    (3) An enrollee of an MCO, PIHP, or PAHP (consistent with the scope 
of the PAHP's contracted services) has the right to be furnished health 
care services in accordance with Sec. Sec.  438.206 through 438.210.
    (c) Free exercise of rights. The State must ensure that each 
enrollee is free to exercise his or her rights, and that the exercise of 
those rights does not adversely affect the way the MCO, PIHP, PAHP, PCCM 
or PCCM entity and its network providers or the State agency treat the 
enrollee.
    (d) Compliance with other Federal and State laws. The State must 
ensure that each MCO, PIHP, PAHP, PCCM and PCCM entity complies with any 
other applicable Federal and State laws (including: Title VI of the 
Civil Rights Act of 1964 as implemented by regulations at 45 CFR part 
80; the Age Discrimination Act of 1975 as implemented by regulations at 
45 CFR part 91; the

[[Page 294]]

Rehabilitation Act of 1973; Title IX of the Education Amendments of 1972 
(regarding education programs and activities); Titles II and III of the 
Americans with Disabilities Act; and section 1557 of the Patient 
Protection and Affordable Care Act.



Sec.  438.102  Provider-enrollee communications.

    (a) General rules. (1) An MCO, PIHP, or PAHP may not prohibit, or 
otherwise restrict, a provider acting within the lawful scope of 
practice, from advising or advocating on behalf of an enrollee who is 
his or her patient, for the following:
    (i) The enrollee's health status, medical care, or treatment 
options, including any alternative treatment that may be self-
administered.
    (ii) Any information the enrollee needs to decide among all relevant 
treatment options.
    (iii) The risks, benefits, and consequences of treatment or non-
treatment.
    (iv) The enrollee's right to participate in decisions regarding his 
or her health care, including the right to refuse treatment, and to 
express preferences about future treatment decisions.
    (2) Subject to the information requirements of paragraph (b) of this 
section, an MCO, PIHP, or PAHP that would otherwise be required to 
provide, reimburse for, or provide coverage of, a counseling or referral 
service because of the requirement in paragraph (a)(1) of this section 
is not required to do so if the MCO, PIHP, or PAHP objects to the 
service on moral or religious grounds.
    (b) Information requirements: MCO, PIHP, and PAHP responsibility. 
(1)(i) An MCO, PIHP, or PAHP that elects the option provided in 
paragraph (a)(2) of this section must furnish information about the 
services it does not cover as follows:
    (A) To the State--
    (1) With its application for a Medicaid contract.
    (2) Whenever it adopts the policy during the term of the contract.
    (B) Consistent with the provisions of Sec.  438.10, to enrollees, 
within 90 days after adopting the policy for any particular service.
    (ii) Although this timeframe would be sufficient to entitle the MCO, 
PIHP, or PAHP to the option provided in paragraph (a)(2) of this 
section, the overriding rule in Sec.  438.10(g)(4) requires the State, 
its contracted representative, or MCO, PIHP, or PAHP to furnish the 
information at least 30 days before the effective date of the policy.
    (2) As specified in Sec.  438.10(g)(2)(ii)(A) and (B), the MCOs, 
PIHPs, and PAHPs must inform enrollees how they can obtain information 
from the State about how to access the service excluded under paragraph 
(a)(2) of this section.
    (c) Information requirements: State responsibility. For each service 
excluded by an MCO, PIHP, or PAHP under paragraph (a)(2) of this 
section, the State must provide information on how and where to obtain 
the service, as specified in Sec.  438.10.
    (d) Sanction. An MCO that violates the prohibition of paragraph 
(a)(1) of this section is subject to intermediate sanctions under 
subpart I of this part.



Sec.  438.104  Marketing activities.

    (a) Definitions. As used in this section, the following terms have 
the indicated meanings:
    Cold-call marketing means any unsolicited personal contact by the 
MCO, PIHP, PAHP, PCCM or PCCM entity with a potential enrollee for the 
purpose of marketing as defined in this paragraph (a).
    Marketing means any communication, from an MCO, PIHP, PAHP, PCCM or 
PCCM entity to a Medicaid beneficiary who is not enrolled in that 
entity, that can reasonably be interpreted as intended to influence the 
beneficiary to enroll in that particular MCO's, PIHP's, PAHP's, PCCM's 
or PCCM entity's Medicaid product, or either to not enroll in or to 
disenroll from another MCO's, PIHP's, PAHP's, PCCM's or PCCM entity's 
Medicaid product. Marketing does not include communication to a Medicaid 
beneficiary from the issuer of a qualified health plan, as defined in 45 
CFR 155.20, about the qualified health plan.
    Marketing materials means materials that--

[[Page 295]]

    (i) Are produced in any medium, by or on behalf of an MCO, PIHP, 
PAHP, PCCM, or PCCM entity; and
    (ii) Can reasonably be interpreted as intended to market the MCO, 
PIHP, PAHP, PCCM, or PCCM entity to potential enrollees.
    MCO, PIHP, PAHP, PCCM or PCCM entity include any of the entity's 
employees, network providers, agents, or contractors.
    Private insurance does not include a qualified health plan, as 
defined in 45 CFR 155.20.
    (b) Contract requirements. Each contract with an MCO, PIHP, PAHP, 
PCCM, or PCCM entity must comply with the following requirements:
    (1) Provide that the entity--
    (i) Does not distribute any marketing materials without first 
obtaining State approval.
    (ii) Distributes the materials to its entire service area as 
indicated in the contract.
    (iii) Complies with the information requirements of Sec.  438.10 to 
ensure that, before enrolling, the beneficiary receives, from the entity 
or the State, the accurate oral and written information he or she needs 
to make an informed decision on whether to enroll.
    (iv) Does not seek to influence enrollment in conjunction with the 
sale or offering of any private insurance.
    (v) Does not, directly or indirectly, engage in door-to-door, 
telephone, email, texting, or other cold-call marketing activities.
    (2) Specify the methods by which the entity ensures the State agency 
that marketing, including plans and materials, is accurate and does not 
mislead, confuse, or defraud the beneficiaries or the State agency. 
Statements that will be considered inaccurate, false, or misleading 
include, but are not limited to, any assertion or statement (whether 
written or oral) that--
    (i) The beneficiary must enroll in the MCO, PIHP, PAHP, PCCM or PCCM 
entity to obtain benefits or to not lose benefits; or
    (ii) The MCO, PIHP, PAHP, PCCM or PCCM entity is endorsed by CMS, 
the Federal or State government, or similar entity.
    (c) State agency review. In reviewing the marketing materials 
submitted by the entity, the State must consult with the Medical Care 
Advisory Committee established under Sec.  431.12 of this chapter or an 
advisory committee with similar membership.



Sec.  438.106  Liability for payment.

    Each MCO, PIHP, and PAHP must provide that its Medicaid enrollees 
are not held liable for any of the following:
    (a) The MCO's, PIHP's, or PAHP's debts, in the event of the entity's 
insolvency.
    (b) Covered services provided to the enrollee, for which--
    (1) The State does not pay the MCO, PIHP, or PAHP; or
    (2) The State, or the MCO, PIHP, or PAHP does not pay the individual 
or health care provider that furnished the services under a contractual, 
referral, or other arrangement.
    (c) Payments for covered services furnished under a contract, 
referral, or other arrangement, to the extent that those payments are in 
excess of the amount that the enrollee would owe if the MCO, PIHP, or 
PAHP covered the services directly.



Sec.  438.108  Cost sharing.

    The contract must provide that any cost sharing imposed on Medicaid 
enrollees is in accordance with Sec. Sec.  447.50 through 447.82 of this 
chapter.



Sec.  438.110  Member advisory committee.

    (a) General rule. When LTSS are covered under a risk contract 
between a State and an MCO, PIHP, or PAHP, the contract must provide 
that each MCO, PIHP or PAHP establish and maintain a member advisory 
committee.
    (b) Committee composition. The committee required in paragraph (a) 
of this section must include at least a reasonably representative sample 
of the LTSS populations, or other individuals representing those 
enrollees, covered under the contract with the MCO, PIHP, or PAHP.



Sec.  438.114  Emergency and poststabilization services.

    (a) Definitions. As used in this section--
    Emergency medical condition means a medical condition manifesting 
itself by acute symptoms of sufficient severity

[[Page 296]]

(including severe pain) that a prudent layperson, who possesses an 
average knowledge of health and medicine, could reasonably expect the 
absence of immediate medical attention to result in the following:
    (i) Placing the health of the individual (or, for a pregnant woman, 
the health of the woman or her unborn child) in serious jeopardy.
    (ii) Serious impairment to bodily functions.
    (iii) Serious dysfunction of any bodily organ or part.
    Emergency services means covered inpatient and outpatient services 
that are as follows:
    (i) Furnished by a provider that is qualified to furnish these 
services under this Title.
    (ii) Needed to evaluate or stabilize an emergency medical condition.
    Poststabilization care services means covered services, related to 
an emergency medical condition that are provided after an enrollee is 
stabilized to maintain the stabilized condition, or, under the 
circumstances described in paragraph (e) of this section, to improve or 
resolve the enrollee's condition.
    (b) Coverage and payment: General rule. The following entities are 
responsible for coverage and payment of emergency services and 
poststabilization care services.
    (1) The MCO, PIHP, or PAHP.
    (2) The State, for managed care programs that contract with PCCMs or 
PCCM entities
    (c) Coverage and payment: Emergency services. (1) The entities 
identified in paragraph (b) of this section--
    (i) Must cover and pay for emergency services regardless of whether 
the provider that furnishes the services has a contract with the MCO, 
PIHP, PAHP, PCCM or PCCM entity; and
    (ii) May not deny payment for treatment obtained under either of the 
following circumstances:
    (A) An enrollee had an emergency medical condition, including cases 
in which the absence of immediate medical attention would not have had 
the outcomes specified in paragraphs (1), (2), and (3) of the definition 
of emergency medical condition in paragraph (a) of this section.
    (B) A representative of the MCO, PIHP, PAHP, PCCM, or PCCM entity 
instructs the enrollee to seek emergency services.
    (2) A PCCM or PCCM entity must allow enrollees to obtain emergency 
services outside the primary care case management system regardless of 
whether the case manager referred the enrollee to the provider that 
furnishes the services.
    (d) Additional rules for emergency services. (1) The entities 
specified in paragraph (b) of this section may not--
    (i) Limit what constitutes an emergency medical condition with 
reference to paragraph (a) of this section, on the basis of lists of 
diagnoses or symptoms; and
    (ii) Refuse to cover emergency services based on the emergency room 
provider, hospital, or fiscal agent not notifying the enrollee's primary 
care provider, MCO, PIHP, PAHP or applicable State entity of the 
enrollee's screening and treatment within 10 calendar days of 
presentation for emergency services.
    (2) An enrollee who has an emergency medical condition may not be 
held liable for payment of subsequent screening and treatment needed to 
diagnose the specific condition or stabilize the patient.
    (3) The attending emergency physician, or the provider actually 
treating the enrollee, is responsible for determining when the enrollee 
is sufficiently stabilized for transfer or discharge, and that 
determination is binding on the entities identified in paragraph (b) of 
this section as responsible for coverage and payment.
    (e) Coverage and payment: Poststabilization care services. 
Poststabilization care services are covered and paid for in accordance 
with provisions set forth at Sec.  422.113(c) of this chapter. In 
applying those provisions, reference to ``MA organization'' and 
``financially responsible'' must be read as reference to the entities 
responsible for Medicaid payment, as specified in paragraph (b) of this 
section, and payment rules governed by Title XIX of the Act and the 
States.
    (f) Applicability to PIHPs and PAHPs. To the extent that services 
required to treat an emergency medical condition fall within the scope 
of the services for

[[Page 297]]

which the PIHP or PAHP is responsible, the rules under this section 
apply.



Sec.  438.116  Solvency standards.

    (a) Requirement for assurances. (1) Each MCO, PIHP, and PAHP that is 
not a Federally qualified HMO (as defined in section 1310 of the Public 
Health Service Act) must provide assurances satisfactory to the State 
showing that its provision against the risk of insolvency is adequate to 
ensure that its Medicaid enrollees will not be liable for the MCO's, 
PIHP's, or PAHP's debts if the entity becomes insolvent.
    (2) Federally qualified HMOs, as defined in section 1310 of the 
Public Health Service Act, are exempt from this requirement.
    (b) Other requirements--(1) General rule. Except as provided in 
paragraph (b)(2) of this section, an MCO or PIHP, must meet the solvency 
standards established by the State for private health maintenance 
organizations, or be licensed or certified by the State as a risk-
bearing entity.
    (2) Exception. Paragraph (b)(1) of this section does not apply to an 
MCO or PIHP that meets any of the following conditions:
    (i) Does not provide both inpatient hospital services and physician 
services.
    (ii) Is a public entity.
    (iii) Is (or is controlled by) one or more Federally qualified 
health centers and meets the solvency standards established by the State 
for those centers.
    (iv) Has its solvency guaranteed by the State.



                 Subpart D_MCO, PIHP and PAHP Standards

    Source: 81 FR 27853, May 6, 2016, unless otherwise noted.



Sec.  438.206  Availability of services.

    (a) Basic rule. Each State must ensure that all services covered 
under the State plan are available and accessible to enrollees of MCOs, 
PIHPs, and PAHPs in a timely manner. The State must also ensure that 
MCO, PIHP and PAHP provider networks for services covered under the 
contract meet the standards developed by the State in accordance with 
Sec.  438.68.
    (b) Delivery network. The State must ensure, through its contracts, 
that each MCO, PIHP and PAHP, consistent with the scope of its 
contracted services, meets the following requirements:
    (1) Maintains and monitors a network of appropriate providers that 
is supported by written agreements and is sufficient to provide adequate 
access to all services covered under the contract for all enrollees, 
including those with limited English proficiency or physical or mental 
disabilities.
    (2) Provides female enrollees with direct access to a women's health 
specialist within the provider network for covered care necessary to 
provide women's routine and preventive health care services. This is in 
addition to the enrollee's designated source of primary care if that 
source is not a women's health specialist.
    (3) Provides for a second opinion from a network provider, or 
arranges for the enrollee to obtain one outside the network, at no cost 
to the enrollee.
    (4) If the provider network is unable to provide necessary services, 
covered under the contract, to a particular enrollee, the MCO, PIHP, or 
PAHP must adequately and timely cover these services out of network for 
the enrollee, for as long as the MCO, PIHP, or PAHP's provider network 
is unable to provide them.
    (5) Requires out-of-network providers to coordinate with the MCO, 
PIHP, or PAHP for payment and ensures the cost to the enrollee is no 
greater than it would be if the services were furnished within the 
network.
    (6) Demonstrates that its network providers are credentialed as 
required by Sec.  438.214.
    (7) Demonstrates that its network includes sufficient family 
planning providers to ensure timely access to covered services.
    (c) Furnishing of services. The State must ensure that each contract 
with a MCO, PIHP, and PAHP complies with the following requirements.
    (1) Timely access. Each MCO, PIHP, and PAHP must do the following:
    (i) Meet and require its network providers to meet State standards 
for

[[Page 298]]

timely access to care and services, taking into account the urgency of 
the need for services.
    (ii) Ensure that the network providers offer hours of operation that 
are no less than the hours of operation offered to commercial enrollees 
or comparable to Medicaid FFS, if the provider serves only Medicaid 
enrollees.
    (iii) Make services included in the contract available 24 hours a 
day, 7 days a week, when medically necessary.
    (iv) Establish mechanisms to ensure compliance by network providers.
    (v) Monitor network providers regularly to determine compliance.
    (vi) Take corrective action if there is a failure to comply by a 
network provider.
    (2) Access and cultural considerations. Each MCO, PIHP, and PAHP 
participates in the State's efforts to promote the delivery of services 
in a culturally competent manner to all enrollees, including those with 
limited English proficiency and diverse cultural and ethnic backgrounds, 
disabilities, and regardless of sex.
    (3) Accessibility considerations. Each MCO, PIHP, and PAHP must 
ensure that network providers provide physical access, reasonable 
accommodations, and accessible equipment for Medicaid enrollees with 
physical or mental disabilities.
    (d) Applicability date. This section applies to the rating period 
for contracts with MCOs, PIHPs, and PAHPs beginning on or after July 1, 
2018. Until that applicability date, states are required to continue to 
comply with Sec.  438.206 contained in the 42 CFR parts 430 to 481, 
edition revised as of October 1, 2015.

[81 FR 27853, May 6, 2016, as amended at 85 FR 37243, June 19, 2020]



Sec.  438.207  Assurances of adequate capacity and services.

    (a) Basic rule. The State must ensure, through its contracts, that 
each MCO, PIHP, and PAHP gives assurances to the State and provides 
supporting documentation that demonstrates that it has the capacity to 
serve the expected enrollment in its service area in accordance with the 
State's standards for access to care under this part, including the 
standards at Sec.  438.68 and Sec.  438.206(c)(1).
    (b) Nature of supporting documentation. Each MCO, PIHP, and PAHP 
must submit documentation to the State, in a format specified by the 
State, to demonstrate that it complies with the following requirements:
    (1) Offers an appropriate range of preventive, primary care, 
specialty services, and LTSS that is adequate for the anticipated number 
of enrollees for the service area.
    (2) Maintains a network of providers that is sufficient in number, 
mix, and geographic distribution to meet the needs of the anticipated 
number of enrollees in the service area.
    (c) Timing of documentation. Each MCO, PIHP, and PAHP must submit 
the documentation described in paragraph (b) of this section as 
specified by the State, but no less frequently than the following:
    (1) At the time it enters into a contract with the State.
    (2) On an annual basis.
    (3) At any time there has been a significant change (as defined by 
the State) in the MCO's, PIHP's, or PAHP's operations that would affect 
the adequacy of capacity and services, including--
    (i) Changes in MCO, PIHP, or PAHP services, benefits, geographic 
service area, composition of or payments to its provider network; or
    (ii) Enrollment of a new population in the MCO, PIHP, or PAHP.
    (d) State review and certification to CMS. After the State reviews 
the documentation submitted by the MCO, PIHP, or PAHP, the State must 
submit an assurance of compliance to CMS that the MCO, PIHP, or PAHP 
meets the State's requirements for availability of services, as set 
forth in Sec.  438.68 and Sec.  438.206. The submission to CMS must 
include documentation of an analysis that supports the assurance of the 
adequacy of the network for each contracted MCO, PIHP or PAHP related to 
its provider network.
    (e) CMS' right to inspect documentation. The State must make 
available to CMS, upon request, all documentation collected by the State 
from the MCO, PIHP, or PAHP.

[[Page 299]]

    (f) Applicability date. This section applies to the rating period 
for contracts with MCOs, PIHPs, and PAHPs beginning on or after July 1, 
2018. Until that applicability date, states are required to continue to 
comply with Sec.  438.207 contained in the 42 CFR parts 430 to 481, 
edition revised as of October 1, 2015.



Sec.  438.208  Coordination and continuity of care.

    (a) Basic requirement--(1) General rule. Except as specified in 
paragraphs (a)(2) and (3) of this section, the State must ensure through 
its contracts, that each MCO, PIHP, and PAHP complies with the 
requirements of this section.
    (2) PIHP and PAHP exception. For PIHPs and PAHPs, the State 
determines, based on the scope of the entity's services, and on the way 
the State has organized the delivery of managed care services, whether a 
particular PIHP or PAHP is required to implement mechanisms for 
identifying, assessing, and producing a treatment plan for an individual 
with special health care needs, as specified in paragraph (c) of this 
section.
    (3) Exception for MCOs that serve dually eligible enrollees. (i) For 
each MCO that serves enrollees who are also enrolled in and receive 
Medicare benefits from a Medicare Advantage Organization (as defined in 
Sec.  422.2 of this chapter), the State determines to what extent the 
MCO must meet the identification, assessment, and treatment planning 
provisions of paragraph (c) of this section for dually eligible 
individuals.
    (ii) The State bases its determination on the needs of the 
population it requires the MCO to serve.
    (b) Care and coordination of services for all MCO, PIHP, and PAHP 
enrollees. Each MCO, PIHP, and PAHP must implement procedures to deliver 
care to and coordinate services for all MCO, PIHP, and PAHP enrollees. 
These procedures must meet State requirements and must do the following:
    (1) Ensure that each enrollee has an ongoing source of care 
appropriate to his or her needs and a person or entity formally 
designated as primarily responsible for coordinating the services 
accessed by the enrollee. The enrollee must be provided information on 
how to contact their designated person or entity;
    (2) Coordinate the services the MCO, PIHP, or PAHP furnishes to the 
enrollee:
    (i) Between settings of care, including appropriate discharge 
planning for short term and long-term hospital and institutional stays;
    (ii) With the services the enrollee receives from any other MCO, 
PIHP, or PAHP;
    (iii) With the services the enrollee receives in FFS Medicaid; and
    (iv) With the services the enrollee receives from community and 
social support providers.
    (3) Provide that the MCO, PIHP or PAHP makes a best effort to 
conduct an initial screening of each enrollee's needs, within 90 days of 
the effective date of enrollment for all new enrollees, including 
subsequent attempts if the initial attempt to contact the enrollee is 
unsuccessful;
    (4) Share with the State or other MCOs, PIHPs, and PAHPs serving the 
enrollee the results of any identification and assessment of that 
enrollee's needs to prevent duplication of those activities;
    (5) Ensure that each provider furnishing services to enrollees 
maintains and shares, as appropriate, an enrollee health record in 
accordance with professional standards; and
    (6) Ensure that in the process of coordinating care, each enrollee's 
privacy is protected in accordance with the privacy requirements in 45 
CFR parts 160 and 164 subparts A and E, to the extent that they are 
applicable.
    (c) Additional services for enrollees with special health care needs 
or who need LTSS--(1) Identification. The State must implement 
mechanisms to identify persons who need LTSS or persons with special 
health care needs to MCOs, PIHPs and PAHPs, as those persons are defined 
by the State. These identification mechanisms--
    (i) Must be specified in the State's quality strategy under Sec.  
438.340.
    (ii) May use State staff, the State's enrollment broker, or the 
State's MCOs, PIHPs and PAHPs.
    (2) Assessment. Each MCO, PIHP, and PAHP must implement mechanisms 
to

[[Page 300]]

comprehensively assess each Medicaid enrollee identified by the State 
(through the mechanism specified in paragraph (c)(1) of this section) 
and identified to the MCO, PIHP, and PAHP by the State as needing LTSS 
or having special health care needs to identify any ongoing special 
conditions of the enrollee that require a course of treatment or regular 
care monitoring. The assessment mechanisms must use appropriate 
providers or individuals meeting LTSS service coordination requirements 
of the State or the MCO, PIHP, or PAHP as appropriate.
    (3) Treatment/service plans. MCOs, PIHPs, or PAHPs must produce a 
treatment or service plan meeting the criteria in paragraphs (c)(3)(i) 
through (v) of this section for enrollees who require LTSS and, if the 
State requires, must produce a treatment or service plan meeting the 
criteria in paragraphs (c)(3)(iii) through (v) of this section for 
enrollees with special health care needs that are determined through 
assessment to need a course of treatment or regular care monitoring. The 
treatment or service plan must be:
    (i) Developed by an individual meeting LTSS service coordination 
requirements with enrollee participation, and in consultation with any 
providers caring for the enrollee;
    (ii) Developed by a person trained in person-centered planning using 
a person-centered process and plan as defined in Sec.  441.301(c)(1) and 
(2) of this chapter for LTSS treatment or service plans;
    (iii) Approved by the MCO, PIHP, or PAHP in a timely manner, if this 
approval is required by the MCO, PIHP, or PAHP;
    (iv) In accordance with any applicable State quality assurance and 
utilization review standards; and
    (v) Reviewed and revised upon reassessment of functional need, at 
least every 12 months, or when the enrollee's circumstances or needs 
change significantly, or at the request of the enrollee per Sec.  
441.301(c)(3) of this chapter.
    (4) Direct access to specialists. For enrollees with special health 
care needs determined through an assessment (consistent with paragraph 
(c)(2) of this section) to need a course of treatment or regular care 
monitoring, each MCO, PIHP, and PAHP must have a mechanism in place to 
allow enrollees to directly access a specialist (for example, through a 
standing referral or an approved number of visits) as appropriate for 
the enrollee's condition and identified needs.
    (d) Applicability date. This section applies to the rating period 
for contracts with MCOs, PIHPs, and PAHPs beginning on or after July 1, 
2017. Until that applicability date, states are required to continue to 
comply with Sec.  438.208 contained in the 42 CFR parts 430 to 481, 
edition revised as of October 1, 2015.



Sec.  438.210  Coverage and authorization of services.

    (a) Coverage. Each contract between a State and an MCO, PIHP, or 
PAHP must do the following:
    (1) Identify, define, and specify the amount, duration, and scope of 
each service that the MCO, PIHP, or PAHP is required to offer.
    (2) Require that the services identified in paragraph (a)(1) of this 
section be furnished in an amount, duration, and scope that is no less 
than the amount, duration, and scope for the same services furnished to 
beneficiaries under FFS Medicaid, as set forth in Sec.  440.230 of this 
chapter, and for enrollees under the age of 21, as set forth in subpart 
B of part 441 of this chapter.
    (3) Provide that the MCO, PIHP, or PAHP--
    (i) Must ensure that the services are sufficient in amount, 
duration, or scope to reasonably achieve the purpose for which the 
services are furnished.
    (ii) May not arbitrarily deny or reduce the amount, duration, or 
scope of a required service solely because of diagnosis, type of 
illness, or condition of the beneficiary.
    (4) Permit an MCO, PIHP, or PAHP to place appropriate limits on a 
service--
    (i) On the basis of criteria applied under the State plan, such as 
medical necessity; or
    (ii) For the purpose of utilization control, provided that--

[[Page 301]]

    (A) The services furnished can reasonably achieve their purpose, as 
required in paragraph (a)(3)(i) of this section;
    (B) The services supporting individuals with ongoing or chronic 
conditions or who require long-term services and supports are authorized 
in a manner that reflects the enrollee's ongoing need for such services 
and supports; and
    (C) Family planning services are provided in a manner that protects 
and enables the enrollee's freedom to choose the method of family 
planning to be used consistent with Sec.  441.20 of this chapter.
    (5) Specify what constitutes ``medically necessary services'' in a 
manner that--
    (i) Is no more restrictive than that used in the State Medicaid 
program, including quantitative and non-quantitative treatment limits, 
as indicated in State statutes and regulations, the State Plan, and 
other State policy and procedures; and
    (ii) Addresses the extent to which the MCO, PIHP, or PAHP is 
responsible for covering services that address:
    (A) The prevention, diagnosis, and treatment of an enrollee's 
disease, condition, and/or disorder that results in health impairments 
and/or disability.
    (B) The ability for an enrollee to achieve age-appropriate growth 
and development.
    (C) The ability for an enrollee to attain, maintain, or regain 
functional capacity.
    (D) The opportunity for an enrollee receiving long-term services and 
supports to have access to the benefits of community living, to achieve 
person-centered goals, and live and work in the setting of their choice.
    (b) Authorization of services. For the processing of requests for 
initial and continuing authorizations of services, each contract must 
require--
    (1) That the MCO, PIHP, or PAHP and its subcontractors have in 
place, and follow, written policies and procedures.
    (2) That the MCO, PIHP, or PAHP--
    (i) Have in effect mechanisms to ensure consistent application of 
review criteria for authorization decisions.
    (ii) Consult with the requesting provider for medical services when 
appropriate.
    (iii) Authorize LTSS based on an enrollee's current needs assessment 
and consistent with the person-centered service plan.
    (3) That any decision to deny a service authorization request or to 
authorize a service in an amount, duration, or scope that is less than 
requested, be made by an individual who has appropriate expertise in 
addressing the enrollee's medical, behavioral health, or long-term 
services and supports needs.
    (c) Notice of adverse benefit determination. Each contract must 
provide for the MCO, PIHP, or PAHP to notify the requesting provider, 
and give the enrollee written notice of any decision by the MCO, PIHP, 
or PAHP to deny a service authorization request, or to authorize a 
service in an amount, duration, or scope that is less than requested. 
For MCOs, PIHPs, and PAHPs, the enrollee's notice must meet the 
requirements of Sec.  438.404. For Medicaid contracts with an applicable 
integrated plan, as defined in Sec.  422.561 of this chapter, in lieu of 
the provisions in this paragraph governing notices of adverse benefit 
determinations, the provisions set forth in Sec. Sec.  422.629 through 
422.634 of this chapter apply to determinations affecting dually 
eligible individuals who are also enrolled in a dual eligible special 
needs plan with exclusively aligned enrollment, as defined in Sec.  
422.2 of this chapter.
    (d) Timeframe for decisions. Each MCO, PIHP, or PAHP contract must 
provide for the following decisions and notices:
    (1) Standard authorization decisions. For standard authorization 
decisions, provide notice as expeditiously as the enrollee's condition 
requires and within State-established timeframes that may not exceed 14 
calendar days following receipt of the request for service, with a 
possible extension of up to 14 additional calendar days, if--
    (i) The enrollee, or the provider, requests extension; or
    (ii) The MCO, PIHP, or PAHP justifies (to the State agency upon 
request) a need for additional information and how the extension is in 
the enrollee's interest.

[[Page 302]]

    (2) Expedited authorization decisions. (i) For cases in which a 
provider indicates, or the MCO, PIHP, or PAHP determines, that following 
the standard timeframe could seriously jeopardize the enrollee's life or 
health or ability to attain, maintain, or regain maximum function, the 
MCO, PIHP, or PAHP must make an expedited authorization decision and 
provide notice as expeditiously as the enrollee's health condition 
requires and no later than 72 hours after receipt of the request for 
service.
    (ii) The MCO, PIHP, or PAHP may extend the 72 hour time period by up 
to 14 calendar days if the enrollee requests an extension, or if the 
MCO, PIHP, or PAHP justifies (to the State agency upon request) a need 
for additional information and how the extension is in the enrollee's 
interest.
    (3) Covered outpatient drug decisions. For all covered outpatient 
drug authorization decisions, provide notice as described in section 
1927(d)(5)(A) of the Act.
    (4) For Medicaid contracts with an applicable integrated plan, as 
defined in Sec.  422.561 of this chapter, timelines for decisions and 
notices must be compliant with the provisions set forth in Sec. Sec.  
422.629 through 422.634 of this chapter in lieu of Sec. Sec.  438.404 
through 438.424.
    (e) Compensation for utilization management activities. Each 
contract between a State and MCO, PIHP, or PAHP must provide that, 
consistent with Sec. Sec.  438.3(i), and 422.208 of this chapter, 
compensation to individuals or entities that conduct utilization 
management activities is not structured so as to provide incentives for 
the individual or entity to deny, limit, or discontinue medically 
necessary services to any enrollee.
    (f) Applicability date. (1) Subject to paragraph (f)(2) of this 
section, this section applies to the rating period for contracts with 
MCOs, PIHPs, and PAHPs beginning on or after July 1, 2017. Until that 
applicability date, States are required to continue to comply with Sec.  
438.210 contained in the 42 CFR parts 430 to 481, edition revised as of 
October 1, 2015.
    (2) Provisions in this section affecting applicable integrated 
plans, as defined in Sec.  422.561 of this chapter, are applicable no 
later than January 1, 2021.

[81 FR 27853, May 6, 2016, as amended at 82 FR 39, Jan. 3, 2017; 84 FR 
15843, Apr. 16, 2019]



Sec.  438.214  Provider selection.

    (a) General rules. The State must ensure, through its contracts, 
that each MCO, PIHP, or PAHP implements written policies and procedures 
for selection and retention of network providers and that those policies 
and procedures, at a minimum, meet the requirements of this section.
    (b) Credentialing and recredentialing requirements. (1) Each State 
must establish a uniform credentialing and recredentialing policy that 
addresses acute, primary, behavioral, substance use disorders, and LTSS 
providers, as appropriate, and requires each MCO, PIHP and PAHP to 
follow those policies.
    (2) Each MCO, PIHP, and PAHP must follow a documented process for 
credentialing and recredentialing of network providers.
    (c) Nondiscrimination. MCO, PIHP, and PAHP network provider 
selection policies and procedures, consistent with Sec.  438.12, must 
not discriminate against particular providers that serve high-risk 
populations or specialize in conditions that require costly treatment.
    (d) Excluded providers. (1) MCOs, PIHPs, and PAHPs may not employ or 
contract with providers excluded from participation in Federal health 
care programs under either section 1128 or section 1128A of the Act.
    (2) [Reserved]
    (e) State requirements. Each MCO, PIHP, and PAHP must comply with 
any additional requirements established by the State.



Sec.  438.224  Confidentiality.

    The State must ensure, through its contracts, that (consistent with 
subpart F of part 431 of this chapter), for medical records and any 
other health and enrollment information that identifies a particular 
enrollee, each MCO, PIHP, and PAHP uses and discloses such individually 
identifiable health information in accordance with the privacy 
requirements in 45 CFR parts 160

[[Page 303]]

and 164, subparts A and E, to the extent that these requirements are 
applicable.



Sec.  438.228  Grievance and appeal systems.

    (a) The State must ensure, through its contracts, that each MCO, 
PIHP, and PAHP has in effect a grievance and appeal system that meets 
the requirements of subpart F of this part.
    (b) If the State delegates to the MCO, PIHP, or PAHP responsibility 
for notice of action under subpart E of part 431 of this chapter, the 
State must conduct random reviews of each delegated MCO, PIHP, or PAHP 
and its providers and subcontractors to ensure that they are notifying 
enrollees in a timely manner.



Sec.  438.230  Subcontractual relationships and delegation.

    (a) Applicability. The requirements of this section apply to any 
contract or written arrangement that an MCO, PIHP, PAHP, or PCCM entity 
has with any subcontractor.
    (b) General rule. The State must ensure, through its contracts with 
MCOs, PIHPs, PAHPs, and PCCM entities that--
    (1) Notwithstanding any relationship(s) that the MCO, PIHP, PAHP, or 
PCCM entity may have with any subcontractor, the MCO, PIHP, PAHP, or 
PCCM entity maintains ultimate responsibility for adhering to and 
otherwise fully complying with all terms and conditions of its contract 
with the State; and
    (2) All contracts or written arrangements between the MCO, PIHP, 
PAHP, or PCCM entity and any subcontractor must meet the requirements of 
paragraph (c) of this section.
    (c) Each contract or written arrangement described in paragraph 
(b)(2) of this section must specify that:
    (1) If any of the MCO's, PIHP's, PAHP's, or PCCM entity's activities 
or obligations under its contract with the State are delegated to a 
subcontractor--
    (i) The delegated activities or obligations, and related reporting 
responsibilities, are specified in the contract or written agreement.
    (ii) The subcontractor agrees to perform the delegated activities 
and reporting responsibilities specified in compliance with the MCO's, 
PIHP's, PAHP's, or PCCM entity's contract obligations.
    (iii) The contract or written arrangement must either provide for 
revocation of the delegation of activities or obligations, or specify 
other remedies in instances where the State or the MCO, PIHP, PAHP, or 
PCCM entity determine that the subcontractor has not performed 
satisfactorily.
    (2) The subcontractor agrees to comply with all applicable Medicaid 
laws, regulations, including applicable subregulatory guidance and 
contract provisions;
    (3) The subcontractor agrees that--
    (i) The State, CMS, the HHS Inspector General, the Comptroller 
General, or their designees have the right to audit, evaluate, and 
inspect any books, records, contracts, computer or other electronic 
systems of the subcontractor, or of the subcontractor's contractor, that 
pertain to any aspect of services and activities performed, or 
determination of amounts payable under the MCO's, PIHP's, or PAHP's 
contract with the State.
    (ii) The subcontractor will make available, for purposes of an 
audit, evaluation, or inspection under paragraph (c)(3)(i) of this 
section, its premises, physical facilities, equipment, books, records, 
contracts, computer or other electronic systems relating to its Medicaid 
enrollees.
    (iii) The right to audit under paragraph (c)(3)(i) of this section 
will exist through 10 years from the final date of the contract period 
or from the date of completion of any audit, whichever is later.
    (iv) If the State, CMS, or the HHS Inspector General determines that 
there is a reasonable possibility of fraud or similar risk, the State, 
CMS, or the HHS Inspector General may inspect, evaluate, and audit the 
subcontractor at any time.
    (d) Applicability date. This section applies to the rating period 
for contracts with MCOs, PIHPs, PAHPs, and PCCM entities beginning on or 
after July 1, 2017. Until that applicability date, states are required 
to continue to comply with Sec.  438.230 contained in the 42

[[Page 304]]

CFR parts 430 to 481, edition revised as of October 1, 2015.



Sec.  438.236  Practice guidelines.

    (a) Basic rule. The State must ensure, through its contracts, that 
each MCO, PIHP, and PAHP meets the requirements of this section.
    (b) Adoption of practice guidelines. Each MCO and, when applicable, 
each PIHP and PAHP adopts practice guidelines that meet the following 
requirements:
    (1) Are based on valid and reliable clinical evidence or a consensus 
of providers in the particular field.
    (2) Consider the needs of the MCO's, PIHP's, or PAHP's enrollees.
    (3) Are adopted in consultation with network providers.
    (4) Are reviewed and updated periodically as appropriate.
    (c) Dissemination of guidelines. Each MCO, PIHP, and PAHP 
disseminates the guidelines to all affected providers and, upon request, 
to enrollees and potential enrollees.
    (d) Application of guidelines. Decisions for utilization management, 
enrollee education, coverage of services, and other areas to which the 
guidelines apply are consistent with the guidelines.

[81 FR 27853, May 6, 2016, as amended at 85 FR 72841, Nov. 13, 2020]



Sec.  438.242  Health information systems.

    (a) General rule. The State must ensure, through its contracts that 
each MCO, PIHP, and PAHP maintains a health information system that 
collects, analyzes, integrates, and reports data and can achieve the 
objectives of this part. The systems must provide information on areas 
including, but not limited to, utilization, claims, grievances and 
appeals, and disenrollments for other than loss of Medicaid eligibility.
    (b) Basic elements of a health information system. The State must 
require, at a minimum, that each MCO, PIHP, and PAHP comply with the 
following:
    (1) Section 6504(a) of the Affordable Care Act, which requires that 
State claims processing and retrieval systems are able to collect data 
elements necessary to enable the mechanized claims processing and 
information retrieval systems in operation by the State to meet the 
requirements of section 1903(r)(1)(F) of the Act.
    (2) Collect data on enrollee and provider characteristics as 
specified by the State, and on all services furnished to enrollees 
through an encounter data system or other methods as may be specified by 
the State.
    (3) Ensure that data received from providers is accurate and 
complete by--
    (i) Verifying the accuracy and timeliness of reported data, 
including data from network providers the MCO, PIHP, or PAHP is 
compensating on the basis of capitation payments.
    (ii) Screening the data for completeness, logic, and consistency.
    (iii) Collecting data from providers in standardized formats to the 
extent feasible and appropriate, including secure information exchanges 
and technologies utilized for State Medicaid quality improvement and 
care coordination efforts.
    (4) Make all collected data available to the State and upon request 
to CMS.
    (5) Implement an Application Programming Interface (API) as 
specified in Sec.  431.60 of this chapter as if such requirements 
applied directly to the MCO, PIHP, or PAHP and include--
    (i) All encounter data, including encounter data from any network 
providers the MCO, PIHP, or PAHP is compensating on the basis of 
capitation payments and adjudicated claims and encounter data from any 
subcontractors.
    (ii) [Reserved]
    (6) Implement, by January 1, 2021, and maintain a publicly 
accessible standards-based API described in Sec.  431.70, which must 
include all information specified in Sec.  438.10(h)(1) and (2) of this 
chapter.
    (c) Enrollee encounter data. Contracts between a State and a MCO, 
PIHP, or PAHP must provide for:
    (1) Collection and maintenance of sufficient enrollee encounter data 
to identify the provider who delivers any item(s) or service(s) to 
enrollees.
    (2) Submission of enrollee encounter data to the State at a 
frequency and level of detail to be specified by CMS

[[Page 305]]

and the State, based on program administration, oversight, and program 
integrity needs.
    (3) Submission of all enrollee encounter data, including allowed 
amount and paid amount, that the State is required to report to CMS 
under Sec.  438.818.
    (4) Specifications for submitting encounter data to the State in 
standardized ASC X12N 837 and NCPDP formats, and the ASC X12N 835 format 
as appropriate.
    (d) State review and validation of encounter data. The State must 
review and validate that the encounter data collected, maintained, and 
submitted to the State by the MCO, PIHP, or PAHP, meets the requirements 
of this section. The State must have procedures and quality assurance 
protocols to ensure that enrollee encounter data submitted under 
paragraph (c) of this section is a complete and accurate representation 
of the services provided to the enrollees under the contract between the 
State and the MCO, PIHP, or PAHP.
    (e) Applicability date. This section applies to the rating period 
for contracts with MCOs, PIHPs, PAHPs, and PCCM entities beginning on or 
after July 1, 2017. Until that applicability date, states are required 
to continue to comply with Sec.  438.242 contained in the 42 CFR parts 
430 to 481, edition revised as of October 1, 2015.

[81 FR 27853, May 6, 2016, as amended at 85 FR 25635, May 1, 2020; 85 FR 
72841, Nov. 13, 2020]



 Subpart E_Quality Measurement and Improvement; External Quality Review

    Source: 81 FR 27853, May 6, 2016, unless otherwise noted.



Sec.  438.310  Basis, scope, and applicability.

    (a) Statutory basis. This subpart is based on sections 1932(c), 
1903(a)(3)(C)(ii), 1902(a)(4), and 1902(a)(19) of the Act.
    (b) Scope. This subpart sets forth:
    (1) Specifications for a quality assessment and performance 
improvement program that States must require each contracting MCO, PIHP, 
and PAHP to implement and maintain.
    (2) Requirements for the State review of the accreditation status of 
all contracting MCOs, PIHPs, and PAHPs.
    (3) Specifications for a Medicaid managed care quality rating system 
for all States contracting with MCOs, PIHPs, and PAHPs.
    (4) Specifications for a Medicaid managed care quality strategy that 
States contracting with MCOs, PIHPs, PAHPs, and PCCM entities (described 
in paragraph (c)(2) of this section) must implement to ensure the 
delivery of quality health care.
    (5) Requirements for annual external quality reviews of each 
contracting MCO, PIHP, PAHP and PCCM entity (described in paragraph 
(c)(2) of this section) including--
    (i) Criteria that States must use in selecting entities to perform 
the reviews.
    (ii) Specifications for the activities related to external quality 
review.
    (iii) Circumstances under which external quality review may use the 
results of Medicare quality reviews or private accreditation reviews.
    (iv) Requirements for making the results of the reviews publicly 
available.
    (c) Applicability. (1) The provisions of this subpart apply to 
States contracting with MCOs, PIHPs, and PAHPs for the delivery of 
services covered under Medicaid.
    (2) The provisions of Sec.  438.330(b)(2), (b)(3), (c), and (e), 
Sec.  438.340, and Sec.  438.350 apply to States contracting with PCCM 
entities whose contracts with the State provide for shared savings, 
incentive payments or other financial reward for the PCCM entity for 
improved quality outcomes.
    (d) Applicability dates. States will not be held out of compliance 
with the following requirements of this subpart prior to the dates noted 
below so long as they comply with the corresponding standard(s) in 42 
CFR part 438 contained in the 42 CFR parts 430 to 481, edition revised 
as of October 1, 2015:
    (1) States must comply with Sec.  438.330 and Sec.  438.332 no later 
than the rating period for contracts beginning on or after July 1, 2017.
    (2) States must comply with Sec. Sec.  438.340, 438.350, 438.354, 
438.356, 438.358,

[[Page 306]]

438.360, 438.362, and 438.364 no later than July 1, 2018.



Sec.  438.320  Definitions.

    As used in this subpart--
    Access, as it pertains to external quality review, means the timely 
use of services to achieve optimal outcomes, as evidenced by managed 
care plans successfully demonstrating and reporting on outcome 
information for the availability and timeliness elements defined under 
Sec.  438.68 (Network adequacy standards) and Sec.  438.206 
(Availability of services).
    EQR stands for external quality review.
    EQRO stands for external quality review organization.
    External quality review means the analysis and evaluation by an 
EQRO, of aggregated information on quality, timeliness, and access to 
the health care services that an MCO, PIHP, PAHP, or PCCM entity 
(described in Sec.  438.310(c)(2)), or their contractors furnish to 
Medicaid beneficiaries.
    External quality review organization means an organization that 
meets the competence and independence requirements set forth in Sec.  
438.354, and performs external quality review, other EQR-related 
activities as set forth in Sec.  438.358, or both.
    Financial relationship means--
    (1) A direct or indirect ownership or investment interest (including 
an option or nonvested interest) in any entity. This direct or indirect 
interest may be in the form of equity, debt, or other means, and 
includes any indirect ownership or investment interest no matter how 
many levels removed from a direct interest; or
    (2) A compensation arrangement with an entity.
    Health care services means all Medicaid services provided by an MCO, 
PIHP, or PAHP under contract with the State Medicaid agency in any 
setting, including but not limited to medical care, behavioral health 
care, and long-term services and supports.
    Outcomes means changes in patient health, functional status, 
satisfaction or goal achievement that result from health care or 
supportive services.
    Quality, as it pertains to external quality review, means the degree 
to which an MCO, PIHP, PAHP, or PCCM entity (described in Sec.  
438.310(c)(2)) increases the likelihood of desired outcomes of its 
enrollees through:
    (1) Its structural and operational characteristics.
    (2) The provision of services that are consistent with current 
professional, evidenced-based-knowledge.
    (3) Interventions for performance improvement.
    Validation means the review of information, data, and procedures to 
determine the extent to which they are accurate, reliable, free from 
bias, and in accord with standards for data collection and analysis.



Sec.  438.330  Quality assessment and performance improvement program.

    (a) General rules. (1) The State must require, through its 
contracts, that each MCO, PIHP, and PAHP establish and implement an 
ongoing comprehensive quality assessment and performance improvement 
program for the services it furnishes to its enrollees that includes the 
elements identified in paragraph (b) of this section.
    (2) After consulting with States and other stakeholders and 
providing public notice and opportunity to comment, CMS may specify 
performance measures and PIPs, which must be included in the standard 
measures identified and PIPs required by the State in accordance with 
paragraphs (c) and (d) of this section. A State may request an exemption 
from including the performance measures or PIPs established under 
paragraph (a)(2) of this section, by submitting a written request to CMS 
explaining the basis for such request.
    (3) The State must require, through its contracts, that each PCCM 
entity described in Sec.  438.310(c)(2) establish and implement an 
ongoing comprehensive quality assessment and performance improvement 
program for the services it furnishes to its enrollees which 
incorporates, at a minimum, paragraphs (b)(2) and (3) of this section 
and the performance measures identified by the State per paragraph (c) 
of this section.
    (b) Basic elements of quality assessment and performance improvement 
programs. The comprehensive quality assessment

[[Page 307]]

and performance improvement program described in paragraph (a) of this 
section must include at least the following elements:
    (1) Performance improvement projects in accordance with paragraph 
(d) of this section.
    (2) Collection and submission of performance measurement data in 
accordance with paragraph (c) of this section.
    (3) Mechanisms to detect both underutilization and overutilization 
of services.
    (4) Mechanisms to assess the quality and appropriateness of care 
furnished to enrollees with special health care needs, as defined by the 
State in the quality strategy under Sec.  438.340.
    (5) For MCOs, PIHPs, or PAHPs providing long-term services and 
supports:
    (i) Mechanisms to assess the quality and appropriateness of care 
furnished to enrollees using long-term services and supports, including 
assessment of care between care settings and a comparison of services 
and supports received with those set forth in the enrollee's treatment/
service plan, if applicable; and
    (ii) Participate in efforts by the State to prevent, detect, and 
remediate critical incidents (consistent with assuring beneficiary 
health and welfare per Sec. Sec.  441.302 and 441.730(a) of this 
chapter) that are based, at a minimum, on the requirements on the State 
for home and community-based waiver programs per Sec.  441.302(h) of 
this chapter.
    (c) Performance measurement. The State must--
    (1)(i) Identify standard performance measures, including those 
performance measures that may be specified by CMS under paragraph (a)(2) 
of this section, relating to the performance of MCOs, PIHPs, and PAHPs; 
and
    (ii) In addition to the measures specified in paragraph (c)(1)(i) of 
this section, in the case of an MCO, PIHP, or PAHP providing long-term 
services and supports, identify standard performance measures relating 
to quality of life, rebalancing, and community integration activities 
for individuals receiving long-term services and supports.
    (2) Require that each MCO, PIHP, and PAHP annually--
    (i) Measure and report to the State on its performance, using the 
standard measures required by the State in paragraph (c)(1) of this 
section;
    (ii) Submit to the State data, specified by the State, which enables 
the State to calculate the MCO's, PIHP's, or PAHP's performance using 
the standard measures identified by the State under paragraph (c)(1) of 
this section; or
    (iii) Perform a combination of the activities described in 
paragraphs (c)(2)(i) and (ii) of this section.
    (d) Performance improvement projects. (1) The State must require 
that MCOs, PIHPs, and PAHPs conduct performance improvement projects, 
including any performance improvement projects required by CMS in 
accordance with paragraph (a)(2) of this section, that focus on both 
clinical and nonclinical areas.
    (2) Each performance improvement project must be designed to achieve 
significant improvement, sustained over time, in health outcomes and 
enrollee satisfaction, and must include the following elements:
    (i) Measurement of performance using objective quality indicators.
    (ii) Implementation of interventions to achieve improvement in the 
access to and quality of care.
    (iii) Evaluation of the effectiveness of the interventions based on 
the performance measures in paragraph (d)(2)(i) of this section.
    (iv) Planning and initiation of activities for increasing or 
sustaining improvement.
    (3) The State must require each MCO, PIHP, and PAHP to report the 
status and results of each project conducted per paragraph (d)(1) of 
this section to the State as requested, but not less than once per year.
    (4) The State may permit an MCO, PIHP, or PAHP exclusively serving 
dual eligibles to substitute an MA Organization quality improvement 
project conducted under Sec.  422.152(d) of this chapter for one or more 
of the performance improvement projects otherwise required under this 
section.
    (e) Program review by the State. (1) The State must review, at least 
annually, the impact and effectiveness of the quality assessment and 
performance

[[Page 308]]

improvement program of each MCO, PIHP, PAHP, and PCCM entity described 
in Sec.  438.310(c)(2). The review must include--
    (i) The MCO's, PIHP's, PAHP's, and PCCM entity's performance on the 
measures on which it is required to report.
    (ii) The outcomes and trended results of each MCO's, PIHP's, and 
PAHP's performance improvement projects.
    (iii) The results of any efforts by the MCO, PIHP, or PAHP to 
support community integration for enrollees using long-term services and 
supports.
    (2) The State may require that an MCO, PIHP, PAHP, or PCCM entity 
described in Sec.  438.310(c)(2) develop a process to evaluate the 
impact and effectiveness of its own quality assessment and performance 
improvement program.



Sec.  438.332  State review of the accreditation status of MCOs, 
PIHPs, and PAHPs.

    (a) The State must require, through its contracts, that each MCO, 
PIHP, and PAHP inform the State whether it has been accredited by a 
private independent accrediting entity.
    (b) The State must require, through its contracts, that each MCO, 
PIHP, and PAHP that has received accreditation by a private independent 
accrediting entity must authorize the private independent accrediting 
entity to provide the State a copy of its most recent accreditation 
review, including:
    (1) Accreditation status, survey type, and level (as applicable);
    (2) Accreditation results, including recommended actions or 
improvements, corrective action plans, and summaries of findings; and
    (3) Expiration date of the accreditation.
    (c) The State must--
    (1) Make the accreditation status for each contracted MCO, PIHP, and 
PAHP available on the Web site required under Sec.  438.10(c)(3), 
including whether each MCO, PIHP, and PAHP has been accredited and, if 
applicable, the name of the accrediting entity, accreditation program, 
and accreditation level; and
    (2) Update this information at least annually.



Sec.  438.334  Medicaid managed care quality rating system.

    (a) General rule. Each State contracting with an MCO, PIHP or PAHP 
to furnish services to Medicaid beneficiaries must--
    (1) Adopt the Medicaid managed care quality rating system developed 
by CMS in accordance with paragraph (b) of this section; or
    (2) Adopt an alternative Medicaid managed care quality rating system 
in accordance with paragraph (c) of this section.
    (3) Implement such Medicaid managed care quality rating system 
within 3 years of the date of a final notice published in the Federal 
Register.
    (b) Quality rating system. (1) CMS, after consulting with States and 
other stakeholders and providing public notice and opportunity to 
comment, will develop a framework for a Medicaid managed care quality 
rating system (QRS), including the identification of the performance 
measures, a subset of mandatory performance measures, and a methodology, 
that aligns where appropriate with the qualified health plan quality 
rating system developed in accordance with 45 CFR 156.1120, the Medicare 
Advantage 5-Star Rating System described in subpart D of part 422 of 
this chapter, and other related CMS quality rating approaches.
    (2) CMS, after consulting with States and other stakeholders and 
providing public notice and opportunity to comment, may periodically 
update the Medicaid managed care QRS framework developed in accordance 
with paragraph (b)(1) of this section.
    (c) Alternative quality rating system.
    (1) A state may implement an alternative Medicaid managed care 
quality rating system that utilizes different performance measures or 
applies a different methodology from that described in paragraph (b) of 
this section provided that--
    (i) The alternative quality rating system includes the mandatory 
measures identified in the framework developed under paragraph (b) of 
this section;
    (ii) The ratings generated by the alternative quality rating system 
yield information regarding MCO, PIHP, and PAHP performance which is 
substantially comparable to that yielded by

[[Page 309]]

the framework developed under paragraph (b) of this section to the 
extent feasible, taking into account such factors as differences in 
covered populations, benefits, and stage of delivery system 
transformation, to enable meaningful comparison of performance across 
States.
    (iii) The State receives CMS approval prior to implementing an 
alternative quality rating system or modifications to an approved 
alternative Medicaid managed care quality rating system.
    (2) Prior to submitting a request for, or modification of, an 
alternative Medicaid managed care quality rating system to CMS, the 
State must--
    (i) Obtain input from the State's Medical Care Advisory Committee 
established under Sec.  431.12 of this chapter; and
    (ii) Provide an opportunity for public comment of at least 30 days 
on the proposed alternative Medicaid managed care quality rating system 
or modification.
    (3) In requesting CMS approval, the State must include the 
following:
    (i) The alternative quality rating system framework, including the 
performance measures and methodology to be used in generating plan 
ratings; and,
    (ii) Documentation of the public comment process specified in 
paragraphs (c)(2)(i) and (ii) of this section, including discussion of 
the issues raised by the Medical Care Advisory Committee and the public. 
The request must document any policy revisions or modifications made in 
response to the comments and rationale for comments not accepted; and,
    (iii) Other information specified by CMS to demonstrate compliance 
with paragraph (c) of this section.
    (4) The Secretary, after consulting with States and other 
stakeholders, shall issue guidance which describes the criteria and 
process for determining if an alternative QRS system is substantially 
comparable to the Medicaid managed care quality rating system in 
paragraph (b) of this section.
    (d) Quality ratings. Each year, the State must collect data from 
each MCO, PIHP, and PAHP with which it contracts and issue an annual 
quality rating for each MCO, PIHP, and PAHP based on the data collected, 
using the Medicaid managed care quality rating system adopted under this 
section.
    (e) Availability of information. The State must prominently display 
the quality rating given by the State to each MCO, PIHP, or PAHP under 
paragraph (d) of this section on the Web site required under Sec.  
438.10(c)(3) in a manner that complies with the standards in Sec.  
438.10(d).

[81 FR 27853, May 6, 2016, as amended at 85 FR 72841, Nov. 13, 2020]



Sec.  438.340  Managed care State quality strategy.

    (a) General rule. Each State contracting with an MCO, PIHP, or PAHP 
as defined in Sec.  438.2 or with a PCCM entity as described in Sec.  
438.310(c)(2) must draft and implement a written quality strategy for 
assessing and improving the quality of health care and services 
furnished by the MCO, PIHP, PAHP or PCCM entity.
    (b) Elements of the State quality strategy. At a minimum, the 
State's quality strategy must include the following:
    (1) The State-defined network adequacy and availability of services 
standards for MCOs, PIHPs, and PAHPs required by Sec. Sec.  438.68 and 
438.206 and examples of evidence-based clinical practice guidelines the 
State requires in accordance with Sec.  438.236.
    (2) The State's goals and objectives for continuous quality 
improvement which must be measurable and take into consideration the 
health status of all populations in the State served by the MCO, PIHP, 
PAHP, and PCCM entity described in Sec.  438.310(c)(2).
    (3) A description of--
    (i) The quality metrics and performance targets to be used in 
measuring the performance and improvement of each MCO, PIHP, PAHP, and 
PCCM entity described in Sec.  438.310(c)(2) with which the State 
contracts, including but not limited to, the performance measures 
reported in accordance with Sec.  438.330(c). The State must identify 
which quality measures and performance outcomes the State will publish 
at least annually on the website required under Sec.  438.10(c)(3); and,
    (ii) The performance improvement projects to be implemented in 
accordance with Sec.  438.330(d), including a description of any 
interventions the

[[Page 310]]

State proposes to improve access, quality, or timeliness of care for 
beneficiaries enrolled in an MCO, PIHP, or PAHP.
    (4) Arrangements for annual, external independent reviews, in 
accordance with Sec.  438.350, of the quality outcomes and timeliness 
of, and access to, the services covered under each MCO, PIHP, PAHP, and 
PCCM entity (described in Sec.  438.310(c)(2)) contract.
    (5) A description of the State's transition of care policy required 
under Sec.  438.62(b)(3).
    (6) The State's plan to identify, evaluate, and reduce, to the 
extent practicable, health disparities based on age, race, ethnicity, 
sex, primary language, and disability status. For purposes of this 
paragraph (b)(6), ``disability status'' means, at a minimum, whether the 
individual qualified for Medicaid on the basis of a disability. States 
must include in this plan the State's definition of disability status 
and how the State will make the determination that a Medicaid enrollee 
meets the standard including the data source(s) that the State will use 
to identify disability status.
    (7) For MCOs, appropriate use of intermediate sanctions that, at a 
minimum, meet the requirements of subpart I of this part.
    (8) The mechanisms implemented by the State to comply with Sec.  
438.208(c)(1) (relating to the identification of persons who need long-
term services and supports or persons with special health care needs).
    (9) The information required under Sec.  438.360(c) (relating to 
nonduplication of EQR activities).
    (10) The State's definition of a ``significant change'' for the 
purposes of paragraph (c)(3)(ii) of this section.
    (c) Development, evaluation, and revision. In drafting or revising 
its quality strategy, the State must:
    (1) Make the strategy available for public comment before submitting 
the strategy to CMS for review, including:
    (i) Obtaining input from the Medical Care Advisory Committee 
(established by Sec.  431.12 of this chapter), beneficiaries, and other 
stakeholders.
    (ii) If the State enrolls Indians in the MCO, PIHP, PAHP, or PCCM 
entity described in Sec.  438.310(c)(2), consulting with Tribes in 
accordance with the State's Tribal consultation policy.
    (2) Review and update the quality strategy as needed, but no less 
than once every 3 years.
    (i) This review must include an evaluation of the effectiveness of 
the quality strategy conducted within the previous 3 years.
    (ii) The State must make the results of the review available on the 
Web site required under Sec.  438.10(c)(3).
    (iii) Updates to the quality strategy must take into consideration 
the recommendations provided pursuant to Sec.  438.364(a)(4).
    (3) Submit to CMS the following:
    (i) A copy of the initial strategy for CMS comment and feedback 
prior to adopting it in final.
    (ii) A copy of the revised strategy whenever significant changes, as 
defined in the state's quality strategy per paragraph (b)(11) of this 
section, are made to the document, or whenever significant changes occur 
within the State's Medicaid program.
    (d) Availability. The State must make the final quality strategy 
available on the Web site required under Sec.  438.10(c)(3).

[81 FR 27853, May 6, 2016, as amended at 85 FR 72841, Nov. 13, 2020]



Sec.  438.350  External quality review.

    Each State that contracts with MCOs, PIHPs, or PAHPs, or with PCCM 
entities (described in Sec.  438.310(c)(2)) must ensure that--
    (a) Except as provided in Sec.  438.362, a qualified EQRO performs 
an annual EQR for each such contracting MCO, PIHP, PAHP or PCCM entity 
(described in Sec.  438.310(c)(2)).
    (b) The EQRO has sufficient information to use in performing the 
review.
    (c) The information used to carry out the review must be obtained 
from the EQR-related activities described in Sec.  438.358 or, if 
applicable, from a Medicare or private accreditation review as described 
in Sec.  438.360.
    (d) For each EQR-related activity, the information gathered for use 
in the EQR must include the elements described in Sec.  438.364(a)(2)(i) 
through (iv).
    (e) The information provided to the EQRO in accordance with 
paragraph (b) of this section is obtained through

[[Page 311]]

methods consistent with the protocols established by the Secretary in 
accordance with Sec.  438.352.
    (f) The results of the reviews are made available as specified in 
Sec.  438.364.

[81 FR 27853, May 6, 2016, as amended at 82 FR 39, Jan. 3, 2017]



Sec.  438.352  External quality review protocols.

    The Secretary, in coordination with the National Governor's 
Association, must develop protocols for the external quality reviews 
required under this subpart. Each protocol issued by the Secretary must 
specify--
    (a) The data to be gathered;
    (b) The sources of the data;
    (c) The activities and steps to be followed in collecting the data 
to promote its accuracy, validity, and reliability;
    (d) The proposed method or methods for validly analyzing and 
interpreting the data once obtained; and
    (e) Instructions, guidelines, worksheets, and other documents or 
tools necessary for implementing the protocol.



Sec.  438.354  Qualifications of external quality review organizations.

    (a) General rule. The State must ensure that an EQRO meets the 
requirements of this section.
    (b) Competence. The EQRO must have at a minimum the following:
    (1) Staff with demonstrated experience and knowledge of--
    (i) Medicaid beneficiaries, policies, data systems, and processes;
    (ii) Managed care delivery systems, organizations, and financing;
    (iii) Quality assessment and improvement methods; and
    (iv) Research design and methodology, including statistical 
analysis.
    (2) Sufficient physical, technological, and financial resources to 
conduct EQR or EQR-related activities.
    (3) Other clinical and nonclinical skills necessary to carry out EQR 
or EQR-related activities and to oversee the work of any subcontractors.
    (c) Independence. The EQRO and its subcontractors must be 
independent from the State Medicaid agency and from the MCOs, PIHPs, 
PAHPs, or PCCM entities (described in Sec.  438.310(c)(2)) that they 
review. To qualify as ``independent''--
    (1) If a State agency, department, university, or other State 
entity:
    (i) May not have Medicaid purchasing or managed care licensing 
authority; and
    (ii) Must be governed by a Board or similar body the majority of 
whose members are not government employees.
    (2) An EQRO may not:
    (i) Review any MCO, PIHP, PAHP, or PCCM entity (described in Sec.  
438.310(c)(2)), or a competitor operating in the State, over which the 
EQRO exerts control or which exerts control over the EQRO (as used in 
this paragraph, ``control'' has the meaning given the term in 48 CFR 
19.101) through--
    (A) Stock ownership;
    (B) Stock options and convertible debentures;
    (C) Voting trusts;
    (D) Common management, including interlocking management; and
    (E) Contractual relationships.
    (ii) Deliver any health care services to Medicaid beneficiaries;
    (iii) Conduct, on the State's behalf, ongoing Medicaid managed care 
program operations related to oversight of the quality of MCO, PIHP, 
PAHP, or PCCM entity (described in Sec.  438.310(c)(2)) services, except 
for the related activities specified in Sec.  438.358;
    (iv) Review any MCO, PIHP, PAHP or PCCM entity (described in Sec.  
438.310(c)(2)) for which it is conducting or has conducted an 
accreditation review within the previous 3 years; or
    (v) Have a present, or known future, direct or indirect financial 
relationship with an MCO, PIHP, PAHP, or PCCM entity (described in Sec.  
438.310(c)(2)) that it will review as an EQRO.



Sec.  438.356  State contract options for external quality review.

    (a) The State--
    (1) Must contract with one EQRO to conduct either EQR alone or EQR 
and other EQR-related activities.
    (2) May contract with additional EQROs or other entities to conduct 
EQR-related activities as set forth in Sec.  438.358.

[[Page 312]]

    (b) Each EQRO must meet the competence requirements as specified in 
Sec.  438.354(b).
    (c) Each EQRO is permitted to use subcontractors. The EQRO is 
accountable for, and must oversee, all subcontractor functions.
    (d) Each EQRO and its subcontractors performing EQR or EQR-related 
activities must meet the requirements for independence, as specified in 
Sec.  438.354(c).
    (e) For each contract with an EQRO described in paragraph (a) of 
this section, the State must follow an open, competitive procurement 
process that is in accordance with State law and regulations. In 
addition, the State must comply with 45 CFR part 75 as it applies to 
State procurement of Medicaid services.



Sec.  438.358  Activities related to external quality review.

    (a) General rule. (1) The State, its agent that is not an MCO, PIHP, 
PAHP, or PCCM entity (described in Sec.  438.310(c)(2)), or an EQRO may 
perform the mandatory and optional EQR-related activities in this 
section.
    (2) The data obtained from the mandatory and optional EQR-related 
activities in this section must be used for the annual EQR in Sec.  
438.350 and must include, at a minimum, the elements in Sec.  
438.364(a)(2)(i) through (iv).
    (b) Mandatory activities. (1) For each MCO, PIHP, or PAHP the 
following EQR-related activities must be performed:
    (i) Validation of performance improvement projects required in 
accordance with Sec.  438.330(b)(1) that were underway during the 
preceding 12 months.
    (ii) Validation of MCO, PIHP, or PAHP performance measures required 
in accordance with Sec.  438.330(b)(2) or MCO, PIHP, or PAHP performance 
measures calculated by the State during the preceding 12 months.
    (iii) A review, conducted within the previous 3-year period, to 
determine the MCO's, PIHP's, or PAHP's compliance with the standards set 
forth in subpart D of this part, the disenrollment requirements and 
limitations described in Sec.  438.56, the enrollee rights requirements 
described in Sec.  438.100, the emergency and post-stabilization 
services requirements described in Sec.  438.114, and the quality 
assessment and performance improvement requirements described in Sec.  
438.330.
    (iv) Validation of MCO, PIHP, or PAHP network adequacy during the 
preceding 12 months to comply with requirements set forth in Sec.  
438.68 and, if the State enrolls Indians in the MCO, PIHP, or PAHP, 
Sec.  438.14(b)(1).
    (2) For each PCCM entity (described in Sec.  438.310(c)(2)), the 
EQR-related activities in paragraphs (b)(1)(ii) and (iii) of this 
section must be performed.
    (c) Optional activities. For each MCO, PIHP, PAHP, and PCCM entity 
(described in Sec.  438.310(c)(2)), the following activities may be 
performed by using information derived during the preceding 12 months:
    (1) Validation of encounter data reported by an MCO, PIHP, PAHP, or 
PCCM entity (described in Sec.  438.310(c)(2)).
    (2) Administration or validation of consumer or provider surveys of 
quality of care.
    (3) Calculation of performance measures in addition to those 
reported by an MCO, PIHP, PAHP, or PCCM entity (described in Sec.  
438.310(c)(2)) and validated by an EQRO in accordance with paragraph 
(b)(1)(ii) of this section.
    (4) Conduct of performance improvement projects in addition to those 
conducted by an MCO, PIHP, PAHP, or PCCM entity (described in Sec.  
438.310(c)(2)) and validated by an EQRO in accordance with paragraph 
(b)(1)(i) of this section.
    (5) Conduct of studies on quality that focus on a particular aspect 
of clinical or nonclinical services at a point in time.
    (6) Assist with the quality rating of MCOs, PIHPs, and PAHPs 
consistent with Sec.  438.334.
    (d) Technical assistance. The EQRO may, at the State's direction, 
provide technical guidance to groups of MCOs, PIHPs, PAHPs, or PCCM 
entities (described in Sec.  438.310(c)(2)) to assist them in conducting 
activities related to the

[[Page 313]]

mandatory and optional activities described in this section that provide 
information for the EQR and the resulting EQR technical report.

[81 FR 27853, May 6, 2016, as amended at 82 FR 39, Jan. 3, 2017; 82 FR 
12510, Mar. 6, 2017; 85 FR 72841, Nov. 13, 2020]



Sec.  438.360  Nonduplication of mandatory activities with Medicare or
accreditation review.

    (a) General rule. Consistent with guidance issued by the Secretary 
under Sec.  438.352, to avoid duplication the State may use information 
from a Medicare or private accreditation review of an MCO, PIHP, or PAHP 
to provide information for the annual EQR (described in Sec.  438.350) 
instead of conducting one or more of the EQR activities described in 
Sec.  438.358(b)(1)(i) through (iii) (relating to the validation of 
performance improvement projects, validation of performance measures, 
and compliance review) if the following conditions are met:
    (1) The MCO, PIHP, or PAHP is in compliance with the applicable 
Medicare Advantage standards established by CMS, as determined by CMS or 
its contractor for Medicare, or has obtained accreditation from a 
private accrediting organization recognized by CMS as applying standards 
at least as stringent as Medicare under the procedures in Sec.  422.158 
of this chapter;
    (2) The Medicare or private accreditation review standards are 
comparable to standards established through the EQR protocols (Sec.  
438.352) for the EQR activities described in Sec.  438.358(b)(1)(i) 
through (iii); and
    (3) The MCO, PIHP, or PAHP provides to the State all the reports, 
findings, and other results of the Medicare or private accreditation 
review activities applicable to the standards for the EQR activities.
    (b) External quality review report. If the State uses information 
from a Medicare or private accreditation review in accordance with 
paragraph (a) of this section, the State must ensure that all such 
information is furnished to the EQRO for analysis and inclusion in the 
report described in Sec.  438.364(a).
    (c) Quality strategy. The State must identify in its quality 
strategy under Sec.  438.340 the EQR activities for which it has 
exercised the option described in this section, and explain the 
rationale for the State's determination that the Medicare review or 
private accreditation activity is comparable to such EQR activities, 
consistent with paragraph (a)(2) of this section.



Sec.  438.362  Exemption from external quality review.

    (a) Basis for exemption. The State may exempt an MCO from EQR if the 
following conditions are met:
    (1) The MCO has a current Medicare contract under part C of Title 
XVIII or under section 1876 of the Act, and a current Medicaid contract 
under section 1903(m) of the Act.
    (2) The two contracts cover all or part of the same geographic area 
within the State.
    (3) The Medicaid contract has been in effect for at least 2 
consecutive years before the effective date of the exemption and during 
those 2 years the MCO has been subject to EQR under this part, and found 
to be performing acceptably for the quality, timeliness, and access to 
health care services it provides to Medicaid beneficiaries.
    (b) Information on exempted MCOs. When the State exercises this 
option, the State must obtain either of the following:
    (1) Information on Medicare review findings. Each year, the State 
must obtain from each MCO that it exempts from EQR the most recent 
Medicare review findings reported on the MCO including--
    (i) All data, correspondence, information, and findings pertaining 
to the MCO's compliance with Medicare standards for access, quality 
assessment and performance improvement, health services, or delegation 
of these activities.
    (ii) All measures of the MCO's performance.
    (iii) The findings and results of all performance improvement 
projects pertaining to Medicare enrollees.
    (2) Medicare information from a private, national accrediting 
organization that CMS approves and recognizes for Medicare Advantage 
Organization deeming. (i) If an exempted MCO has been reviewed by a 
private accrediting organization,

[[Page 314]]

the State must require the MCO to provide the State with a copy of all 
findings pertaining to its most recent accreditation review if that 
review has been used for either of the following purposes:
    (A) To fulfill certain requirements for Medicare external review 
under subpart D of part 422 of this chapter.
    (B) To deem compliance with Medicare requirements, as provided in 
Sec.  422.156 of this chapter.
    (ii) These findings must include, but need not be limited to, 
accreditation review results of evaluation of compliance with individual 
accreditation standards, noted deficiencies, corrective action plans, 
and summaries of unmet accreditation requirements.
    (c) Identification of exempted MCOs. The State must annually 
identify, on the website required under Sec.  438.10(c)(3) and in the 
same location where the EQR technical reports are posted in accordance 
with Sec.  438.364(c)(2)(i), the names of the MCOs exempt from external 
quality review by the State, including the beginning date of the current 
exemption period, or that no MCOs are exempt, as appropriate.

[81 FR 27853, May 6, 2016, as amended at 85 FR 72842, Nov. 13, 2020]



Sec.  438.364  External quality review results.

    (a) Information that must be produced. The State must ensure that 
the EQR results in an annual detailed technical report that summarizes 
findings on access and quality of care, including:
    (1) A description of the manner in which the data from all 
activities conducted in accordance with Sec.  438.358 were aggregated 
and analyzed, and conclusions were drawn as to the quality, timeliness, 
and access to the care furnished by the MCO, PIHP, PAHP, or PCCM entity 
(described in Sec.  438.310(c)(2)).
    (2) For each EQR-related activity conducted in accordance with Sec.  
438.358:
    (i) Objectives;
    (ii) Technical methods of data collection and analysis;
    (iii) Description of data obtained, including validated performance 
measurement data for each activity conducted in accordance with Sec.  
438.358(b)(1)(i) and (ii); and
    (iv) Conclusions drawn from the data.
    (3) An assessment of each MCO's, PIHP's, PAHP's, or PCCM entity's 
(described in Sec.  438.310(c)(2)) strengths and weaknesses for the 
quality, timeliness, and access to health care services furnished to 
Medicaid beneficiaries.
    (4) Recommendations for improving the quality of health care 
services furnished by each MCO, PIHP, PAHP, or PCCM entity (described in 
Sec.  438.310(c)(2)) including how the State can target goals and 
objectives in the quality strategy, under Sec.  438.340, to better 
support improvement in the quality, timeliness, and access to health 
care services furnished to Medicaid beneficiaries.
    (5) Methodologically appropriate, comparative information about all 
MCOs, PIHPs, PAHPs, and PCCM entities (described in Sec.  
438.310(c)(2)), consistent with guidance included in the EQR protocols 
issued in accordance with Sec.  438.352(e).
    (6) An assessment of the degree to which each MCO, PIHP, PAHP, or 
PCCM entity (described in Sec.  438.310(c)(2)) has addressed effectively 
the recommendations for quality improvement made by the EQRO during the 
previous year's EQR.
    (7) The names of the MCOs exempt from external quality review by the 
State, including the beginning date of the current exemption period, or 
that no MCOs are exempt, as appropriate.
    (b) Revision. States may not substantively revise the content of the 
final EQR technical report without evidence of error or omission.
    (c) Availability of information. (1) The State must contract with a 
qualified EQRO to produce and submit to the State an annual EQR 
technical report in accordance with paragraph (a) of this section. The 
State must finalize the annual technical report by April 30th of each 
year.
    (2) The State must--
    (i) Post the most recent copy of the annual EQR technical report on 
the Web site required under Sec.  438.10(c)(3) by April 30th of each 
year.
    (ii) Provide printed or electronic copies of the information 
specified in paragraph (a) of this section, upon request, to interested 
parties such as participating health care providers, enrollees

[[Page 315]]

and potential enrollees of the MCO, PIHP, PAHP, or PCCM entity 
(described in Sec.  438.310(c)(2)), beneficiary advocacy groups, and 
members of the general public.
    (3) The State must make the information specified in paragraph (a) 
of this section available in alternative formats for persons with 
disabilities, when requested.
    (d) Safeguarding patient identity. The information released under 
paragraph (c) of this section may not disclose the identity or other 
protected health information of any patient.

[81 FR 27853, May 6, 2016, as amended at 85 FR 72842, Nov. 13, 2020]



Sec.  438.370  Federal financial participation (FFP).

    (a) FFP at the 75 percent rate is available in expenditures for EQR 
(including the production of EQR results) and the EQR-related activities 
set forth in Sec.  438.358 performed on MCOs and conducted by EQROs and 
their subcontractors.
    (b) FFP at the 50 percent rate is available in expenditures for EQR-
related activities conducted by any entity that does not qualify as an 
EQRO, and for EQR (including the production of EQR results) and EQR-
related activities performed by an EQRO on entities other than MCOs.
    (c) Prior to claiming FFP at the 75 percent rate in accordance with 
paragraph (a) of this section, the State must submit each EQRO contract 
to CMS for review and approval.



                  Subpart F_Grievance and Appeal System

    Source: 81 FR 27853, May 6, 2016, unless otherwise noted.



Sec.  438.400  Statutory basis, definitions, and applicability.

    (a) Statutory basis. This subpart is based on the following 
statutory sections:
    (1) Section 1902(a)(3) of the Act requires that a State plan provide 
an opportunity for a fair hearing to any person whose claim for 
assistance is denied or not acted upon promptly.
    (2) Section 1902(a)(4) of the Act requires that the State plan 
provide for methods of administration that the Secretary finds necessary 
for the proper and efficient operation of the plan.
    (3) Section 1932(b)(4) of the Act requires Medicaid managed care 
organizations to establish internal grievance procedures under which 
Medicaid enrollees, or providers acting on their behalf, may challenge 
the denial of coverage of, or payment for, medical assistance.
    (4) Section 1859(f)(8)(B) of the Act requires that the Secretary, to 
the extent feasible, establish procedures unifying grievances and 
appeals procedures under sections 1852(f), 1852(g), 1902(a)(3), 
1902(a)(5), and 1932(b)(4) of the Act for items and services provided, 
by specialized Medicare Advantage plans for special needs individuals 
described in section 1859(b)(6)(B)(ii), under Titles XVIII and XIX of 
the Act.
    (b) Definitions. As used in this subpart, the following terms have 
the indicated meanings:
    Adverse benefit determination means, in the case of an MCO, PIHP, or 
PAHP, any of the following:
    (1) The denial or limited authorization of a requested service, 
including determinations based on the type or level of service, 
requirements for medical necessity, appropriateness, setting, or 
effectiveness of a covered benefit.
    (2) The reduction, suspension, or termination of a previously 
authorized service.
    (3) The denial, in whole or in part, of payment for a service. A 
denial, in whole or in part, of a payment for a service solely because 
the claim does not meet the definition of a ``clean claim'' at Sec.  
447.45(b) of this chapter is not an adverse benefit determination.
    (4) The failure to provide services in a timely manner, as defined 
by the State.
    (5) The failure of an MCO, PIHP, or PAHP to act within the 
timeframes provided in Sec.  438.408(b)(1) and (2) regarding the 
standard resolution of grievances and appeals.
    (6) For a resident of a rural area with only one MCO, the denial of 
an enrollee's request to exercise his or her right, under Sec.  
438.52(b)(2)(ii), to obtain services outside the network.

[[Page 316]]

    (7) The denial of an enrollee's request to dispute a financial 
liability, including cost sharing, copayments, premiums, deductibles, 
coinsurance, and other enrollee financial liabilities.
    Appeal means a review by an MCO, PIHP, or PAHP of an adverse benefit 
determination.
    Grievance means an expression of dissatisfaction about any matter 
other than an adverse benefit determination. Grievances may include, but 
are not limited to, the quality of care or services provided, and 
aspects of interpersonal relationships such as rudeness of a provider or 
employee, or failure to respect the enrollee's rights regardless of 
whether remedial action is requested. Grievance includes an enrollee's 
right to dispute an extension of time proposed by the MCO, PIHP or PAHP 
to make an authorization decision.
    Grievance and appeal system means the processes the MCO, PIHP, or 
PAHP implements to handle appeals of an adverse benefit determination 
and grievances, as well as the processes to collect and track 
information about them.
    State fair hearing means the process set forth in subpart E of part 
431 of this chapter.
    (c) Applicability. (1) Subject to paragraph (c)(2) of this section, 
this subpart applies to the rating period for contracts with MCOs, 
PIHPs, and PAHPs beginning on or after July 1, 2017. Until that 
applicability date, States, MCOs, PIHPs, and PAHPs are required to 
continue to comply with subpart F contained in the 42 CFR parts 430 to 
481, edition revised as of October 1, 2015.
    (2) Provisions in this part affecting applicable integrated plans, 
as defined in Sec.  422.561 of this chapter, are applicable no later 
than January 1, 2021.

[81 FR 27853, May 6, 2016, as amended at 84 FR 15844, Apr. 16, 2019; 85 
FR 72842, Nov. 13, 2020]



Sec.  438.402  General requirements.

    (a) The grievance and appeal system. Each MCO, PIHP, and PAHP must 
have a grievance and appeal system in place for enrollees. Non-emergency 
medical transportation PAHPs, as defined in Sec.  438.9, are not subject 
to this subpart F. For grievances and appeals at the plan level, an 
applicable integrated plan as defined in Sec.  422.561 of this chapter 
is not subject to this subpart F, and is instead subject to the 
requirements of Sec. Sec.  422.629 through 422.634 of this chapter. For 
appeals of integrated reconsiderations, applicable integrated plans are 
subject to Sec.  438.408(f).
    (b) Level of appeals. Each MCO, PIHP, and PAHP may have only one 
level of appeal for enrollees.
    (c) Filing requirements--(1) Authority to file. (i) An enrollee may 
file a grievance and request an appeal with the MCO, PIHP, or PAHP. An 
enrollee may request a State fair hearing after receiving notice under 
Sec.  438.408 that the adverse benefit determination is upheld.
    (A) Deemed exhaustion of appeals processes. In the case of an MCO, 
PIHP, or PAHP that fails to adhere to the notice and timing requirements 
in Sec.  438.408, the enrollee is deemed to have exhausted the MCO's, 
PIHP's, or PAHP's appeals process. The enrollee may initiate a State 
fair hearing.
    (B) External medical review. The State may offer and arrange for an 
external medical review if the following conditions are met.
    (1) The review must be at the enrollee's option and must not be 
required before or used as a deterrent to proceeding to the State fair 
hearing.
    (2) The review must be independent of both the State and MCO, PIHP, 
or PAHP.
    (3) The review must be offered without any cost to the enrollee.
    (4) The review must not extend any of the timeframes specified in 
Sec.  438.408 and must not disrupt the continuation of benefits in Sec.  
438.420.
    (ii) If State law permits and with the written consent of the 
enrollee, a provider or an authorized representative may request an 
appeal or file a grievance, or request a State fair hearing, on behalf 
of an enrollee. When the term ``enrollee'' is used throughout subpart F 
of this part, it includes providers and authorized representatives 
consistent with this paragraph, with the exception that providers cannot 
request continuation of benefits as specified in Sec.  438.420(b)(5).
    (2) Timing--(i) Grievance. An enrollee may file a grievance with the 
MCO, PIHP, or PAHP at any time.

[[Page 317]]

    (ii) Appeal. Following receipt of a notification of an adverse 
benefit determination by an MCO, PIHP, or PAHP, an enrollee has 60 
calendar days from the date on the adverse benefit determination notice 
in which to file a request for an appeal to the managed care plan.
    (3) Procedures--(i) Grievance. The enrollee may file a grievance 
either orally or in writing and, as determined by the State, either with 
the State or with the MCO, PIHP, or PAHP.
    (ii) Appeal. The enrollee may request an appeal either orally or in 
writing.

[81 FR 27853, May 6, 2016, as amended at 84 FR 15844, Apr. 16, 2019; 85 
FR 72842, Nov. 13, 2020]



Sec.  438.404  Timely and adequate notice of adverse benefit determination.

    (a) Notice. The MCO, PIHP, or PAHP must give enrollees timely and 
adequate notice of an adverse benefit determination in writing 
consistent with the requirements below and in Sec.  438.10.
    (b) Content of notice. The notice must explain the following:
    (1) The adverse benefit determination the MCO, PIHP, or PAHP has 
made or intends to make.
    (2) The reasons for the adverse benefit determination, including the 
right of the enrollee to be provided upon request and free of charge, 
reasonable access to and copies of all documents, records, and other 
information relevant to the enrollee's adverse benefit determination. 
Such information includes medical necessity criteria, and any processes, 
strategies, or evidentiary standards used in setting coverage limits.
    (3) The enrollee's right to request an appeal of the MCO's, PIHP's, 
or PAHP's adverse benefit determination, including information on 
exhausting the MCO's, PIHP's, or PAHP's one level of appeal described at 
Sec.  438.402(b) and the right to request a State fair hearing 
consistent with Sec.  438.402(c).
    (4) The procedures for exercising the rights specified in this 
paragraph (b).
    (5) The circumstances under which an appeal process can be expedited 
and how to request it.
    (6) The enrollee's right to have benefits continue pending 
resolution of the appeal, how to request that benefits be continued, and 
the circumstances, consistent with state policy, under which the 
enrollee may be required to pay the costs of these services.
    (c) Timing of notice. The MCO, PIHP, or PAHP must mail the notice 
within the following timeframes:
    (1) For termination, suspension, or reduction of previously 
authorized Medicaid-covered services, within the timeframes specified in 
Sec. Sec.  431.211, 431.213, and 431.214 of this chapter.
    (2) For denial of payment, at the time of any action affecting the 
claim.
    (3) For standard service authorization decisions that deny or limit 
services, within the timeframe specified in Sec.  438.210(d)(1).
    (4) If the MCO, PIHP, or PAHP meets the criteria set forth for 
extending the timeframe for standard service authorization decisions 
consistent with Sec.  438.210(d)(1)(ii), it must--
    (i) Give the enrollee written notice of the reason for the decision 
to extend the timeframe and inform the enrollee of the right to file a 
grievance if he or she disagrees with that decision; and
    (ii) Issue and carry out its determination as expeditiously as the 
enrollee's health condition requires and no later than the date the 
extension expires.
    (5) For service authorization decisions not reached within the 
timeframes specified in Sec.  438.210(d) (which constitutes a denial and 
is thus an adverse benefit determination), on the date that the 
timeframes expire.
    (6) For expedited service authorization decisions, within the 
timeframes specified in Sec.  438.210(d)(2).



Sec.  438.406  Handling of grievances and appeals.

    (a) General requirements. In handling grievances and appeals, each 
MCO, PIHP, and PAHP must give enrollees any reasonable assistance in 
completing forms and taking other procedural steps related to a 
grievance or appeal. This includes, but is not limited to, auxiliary 
aids and services upon request, such as providing interpreter services 
and toll-free numbers that have adequate TTY/TTD and interpreter 
capability.
    (b) Special requirements. An MCO's, PIHP's or PAHP's process for 
handling

[[Page 318]]

enrollee grievances and appeals of adverse benefit determinations must:
    (1) Acknowledge receipt of each grievance and appeal.
    (2) Ensure that the individuals who make decisions on grievances and 
appeals are individuals--
    (i) Who were neither involved in any previous level of review or 
decision-making nor a subordinate of any such individual.
    (ii) Who, if deciding any of the following, are individuals who have 
the appropriate clinical expertise, as determined by the State, in 
treating the enrollee's condition or disease.
    (A) An appeal of a denial that is based on lack of medical 
necessity.
    (B) A grievance regarding denial of expedited resolution of an 
appeal.
    (C) A grievance or appeal that involves clinical issues.
    (iii) Who take into account all comments, documents, records, and 
other information submitted by the enrollee or their representative 
without regard to whether such information was submitted or considered 
in the initial adverse benefit determination.
    (3) Provide that oral inquiries seeking to appeal an adverse benefit 
determination are treated as appeals.
    (4) Provide the enrollee a reasonable opportunity, in person and in 
writing, to present evidence and testimony and make legal and factual 
arguments. The MCO, PIHP, or PAHP must inform the enrollee of the 
limited time available for this sufficiently in advance of the 
resolution timeframe for appeals as specified in Sec.  438.408(b) and 
(c) in the case of expedited resolution.
    (5) Provide the enrollee and his or her representative the 
enrollee's case file, including medical records, other documents and 
records, and any new or additional evidence considered, relied upon, or 
generated by the MCO, PIHP or PAHP (or at the direction of the MCO, PIHP 
or PAHP) in connection with the appeal of the adverse benefit 
determination. This information must be provided free of charge and 
sufficiently in advance of the resolution timeframe for appeals as 
specified in Sec.  438.408(b) and (c).
    (6) Include, as parties to the appeal--
    (i) The enrollee and his or her representative; or
    (ii) The legal representative of a deceased enrollee's estate.

[81 FR 27853, May 6, 2016, as amended at 85 FR 72842, Nov. 13, 2020]



Sec.  438.408  Resolution and notification: Grievances and appeals.

    (a) Basic rule. Each MCO, PIHP, or PAHP must resolve each grievance 
and appeal, and provide notice, as expeditiously as the enrollee's 
health condition requires, within State-established timeframes that may 
not exceed the timeframes specified in this section.
    (b) Specific timeframes--(1) Standard resolution of grievances. For 
standard resolution of a grievance and notice to the affected parties, 
the timeframe is established by the State but may not exceed 90 calendar 
days from the day the MCO, PIHP, or PAHP receives the grievance.
    (2) Standard resolution of appeals. For standard resolution of an 
appeal and notice to the affected parties, the State must establish a 
timeframe that is no longer than 30 calendar days from the day the MCO, 
PIHP, or PAHP receives the appeal. This timeframe may be extended under 
paragraph (c) of this section.
    (3) Expedited resolution of appeals. For expedited resolution of an 
appeal and notice to affected parties, the State must establish a 
timeframe that is no longer than 72 hours after the MCO, PIHP, or PAHP 
receives the appeal. This timeframe may be extended under paragraph (c) 
of this section.
    (c) Extension of timeframes. (1) The MCO, PIHP, or PAHP may extend 
the timeframes from paragraph (b) of this section by up to 14 calendar 
days if--
    (i) The enrollee requests the extension; or
    (ii) The MCO, PIHP, or PAHP shows (to the satisfaction of the State 
agency, upon its request) that there is need for additional information 
and how the delay is in the enrollee's interest.
    (2) Requirements following extension. If the MCO, PIHP, or PAHP 
extends the timeframes not at the request of the enrollee, it must 
complete all of the following:
    (i) Make reasonable efforts to give the enrollee prompt oral notice 
of the delay.

[[Page 319]]

    (ii) Within 2 calendar days give the enrollee written notice of the 
reason for the decision to extend the timeframe and inform the enrollee 
of the right to file a grievance if he or she disagrees with that 
decision.
    (iii) Resolve the appeal as expeditiously as the enrollee's health 
condition requires and no later than the date the extension expires.
    (3) Deemed exhaustion of appeals processes. In the case of an MCO, 
PIHP, or PAHP that fails to adhere to the notice and timing requirements 
in this section, the enrollee is deemed to have exhausted the MCO's, 
PIHP's, or PAHP's appeals process. The enrollee may initiate a State 
fair hearing.
    (d) Format of notice--(1) Grievances. The State must establish the 
method that an MCO, PIHP, and PAHP will use to notify an enrollee of the 
resolution of a grievance and ensure that such methods meet, at a 
minimum, the standards described at Sec.  438.10.
    (2) Appeals. (i) For all appeals, the MCO, PIHP, or PAHP must 
provide written notice of resolution in a format and language that, at a 
minimum, meet the standards described at Sec.  438.10.
    (ii) For notice of an expedited resolution, the MCO, PIHP, or PAHP 
must also make reasonable efforts to provide oral notice.
    (e) Content of notice of appeal resolution. The written notice of 
the resolution must include the following:
    (1) The results of the resolution process and the date it was 
completed.
    (2) For appeals not resolved wholly in favor of the enrollees--
    (i) The right to request a State fair hearing, and how to do so.
    (ii) The right to request and receive benefits while the hearing is 
pending, and how to make the request.
    (iii) That the enrollee may, consistent with state policy, be held 
liable for the cost of those benefits if the hearing decision upholds 
the MCO's, PIHP's, or PAHP's adverse benefit determination.
    (f) Requirements for State fair hearings--(1) Availability. An 
enrollee may request a State fair hearing only after receiving notice 
that the MCO, PIHP, or PAHP is upholding the adverse benefit 
determination.
    (i) Deemed exhaustion of appeals processes. In the case of an MCO, 
PIHP, or PAHP that fails to adhere to the notice and timing requirements 
in Sec.  438.408, the enrollee is deemed to have exhausted the MCO's, 
PIHP's, or PAHP's appeals process. The enrollee may initiate a State 
fair hearing.
    (ii) External medical review. The State may offer and arrange for an 
external medical review if the following conditions are met.
    (A) The review must be at the enrollee's option and must not be 
required before or used as a deterrent to proceeding to the State fair 
hearing.
    (B) The review must be independent of both the State and MCO, PIHP, 
or PAHP.
    (C) The review must be offered without any cost to the enrollee.
    (D) The review must not extend any of the timeframes specified in 
Sec.  438.408 and must not disrupt the continuation of benefits in Sec.  
438.420.
    (2) State fair hearing. The enrollee must have no less than 90 
calendar days and no more than 120 calendar days from the date of the 
MCO's, PIHP's, or PAHP's notice of resolution to request a State fair 
hearing.
    (3) Parties. The parties to the State fair hearing include the MCO, 
PIHP, or PAHP, as well as the enrollee and his or her representative or 
the representative of a deceased enrollee's estate.

[81 FR 27853, May 6, 2016, as amended at 85 FR 72842, Nov. 13, 2020]



Sec.  438.410  Expedited resolution of appeals.

    (a) General rule. Each MCO, PIHP, and PAHP must establish and 
maintain an expedited review process for appeals, when the MCO, PIHP, or 
PAHP determines (for a request from the enrollee) or the provider 
indicates (in making the request on the enrollee's behalf or supporting 
the enrollee's request) that taking the time for a standard resolution 
could seriously jeopardize the enrollee's life, physical or mental 
health, or ability to attain, maintain, or regain maximum function.
    (b) Punitive action. The MCO, PIHP, or PAHP must ensure that 
punitive action is not taken against a provider

[[Page 320]]

who requests an expedited resolution or supports an enrollee's appeal.
    (c) Action following denial of a request for expedited resolution. 
If the MCO, PIHP, or PAHP denies a request for expedited resolution of 
an appeal, it must--
    (1) Transfer the appeal to the timeframe for standard resolution in 
accordance with Sec.  438.408(b)(2).
    (2) Follow the requirements in Sec.  438.408(c)(2).



Sec.  438.414  Information about the grievance and appeal system to
providers and subcontractors.

    The MCO, PIHP, or PAHP must provide information specified in Sec.  
438.10(g)(2)(xi) about the grievance and appeal system to all providers 
and subcontractors at the time they enter into a contract.



Sec.  438.416  Recordkeeping requirements.

    (a) The State must require MCOs, PIHPs, and PAHPs to maintain 
records of grievances and appeals and must review the information as 
part of its ongoing monitoring procedures, as well as for updates and 
revisions to the State quality strategy.
    (b) The record of each grievance or appeal must contain, at a 
minimum, all of the following information:
    (1) A general description of the reason for the appeal or grievance.
    (2) The date received.
    (3) The date of each review or, if applicable, review meeting.
    (4) Resolution at each level of the appeal or grievance, if 
applicable.
    (5) Date of resolution at each level, if applicable.
    (6) Name of the covered person for whom the appeal or grievance was 
filed.
    (c) The record must be accurately maintained in a manner accessible 
to the state and available upon request to CMS.



Sec.  438.420  Continuation of benefits while the MCO, PIHP, or PAHP
appeal and the State fair hearing are pending.

    (a) Definition. As used in this section--
    Timely files means files for continuation of benefits on or before 
the later of the following:
    (i) Within 10 calendar days of the MCO, PIHP, or PAHP sending the 
notice of adverse benefit determination.
    (ii) The intended effective date of the MCO's, PIHP's, or PAHP's 
proposed adverse benefit determination.
    (b) Continuation of benefits. The MCO, PIHP, or PAHP must continue 
the enrollee's benefits if all of the following occur:
    (1) The enrollee files the request for an appeal timely in 
accordance with Sec.  438.402(c)(1)(ii) and (c)(2)(ii);
    (2) The appeal involves the termination, suspension, or reduction of 
previously authorized services;
    (3) The services were ordered by an authorized provider;
    (4) The period covered by the original authorization has not 
expired; and
    (5) The enrollee timely files for continuation of benefits.
    (c) Duration of continued or reinstated benefits. If, at the 
enrollee's request, the MCO, PIHP, or PAHP continues or reinstates the 
enrollee's benefits while the appeal or state fair hearing is pending, 
the benefits must be continued until one of following occurs:
    (1) The enrollee withdraws the appeal or request for state fair 
hearing.
    (2) The enrollee fails to request a state fair hearing and 
continuation of benefits within 10 calendar days after the MCO, PIHP, or 
PAHP sends the notice of an adverse resolution to the enrollee's appeal 
under Sec.  438.408(d)(2).
    (3) A State fair hearing office issues a hearing decision adverse to 
the enrollee.
    (d) Enrollee responsibility for services furnished while the appeal 
or state fair hearing is pending. If the final resolution of the appeal 
or state fair hearing is adverse to the enrollee, that is, upholds the 
MCO's, PIHP's, or PAHP's adverse benefit determination, the MCO, PIHP, 
or PAHP may, consistent with the state's usual policy on recoveries 
under Sec.  431.230(b) of this chapter and as specified in the MCO's, 
PIHP's, or PAHP's contract, recover the cost of services furnished to 
the enrollee while the appeal and state fair hearing was pending, to the 
extent that they were furnished solely because of the requirements of 
this section.

[[Page 321]]



Sec.  438.424  Effectuation of reversed appeal resolutions.

    (a) Services not furnished while the appeal is pending. If the MCO, 
PIHP, or PAHP, or the State fair hearing officer reverses a decision to 
deny, limit, or delay services that were not furnished while the appeal 
was pending, the MCO, PIHP, or PAHP must authorize or provide the 
disputed services promptly and as expeditiously as the enrollee's health 
condition requires but no later than 72 hours from the date it receives 
notice reversing the determination.
    (b) Services furnished while the appeal is pending. If the MCO, 
PIHP, or PAHP, or the State fair hearing officer reverses a decision to 
deny authorization of services, and the enrollee received the disputed 
services while the appeal was pending, the MCO, PIHP, or PAHP, or the 
State must pay for those services, in accordance with State policy and 
regulations.

Subpart G [Reserved]



            Subpart H_Additional Program Integrity Safeguards

    Source: 81 FR 27853, May 6, 2016, unless otherwise noted.



Sec.  438.600  Statutory basis, basic rule, and applicability.

    (a) Statutory basis. This subpart is based on the following 
statutory sections:
    (1) Section 1128 of the Act provides for the exclusion of certain 
individuals and entities from participation in the Medicaid program.
    (2) Section 1128J(d) of the Act requires that persons who have 
received an overpayment under Medicaid report and return the overpayment 
within 60 days after the date on which the overpayment was identified.
    (3) Section 1902(a)(4) of the Act requires that the State plan 
provide for methods of administration that the Secretary finds necessary 
for the proper and efficient operation of the plan.
    (4) Section 1902(a)(19) of the Act requires that the State plan 
provide the safeguards necessary to ensure that eligibility is 
determined and services are provided in a manner consistent with 
simplicity of administration and the best interests of the 
beneficiaries.
    (5) Section 1902(a)(27) of the Act requires States to enroll persons 
or institutions that provide services under the State plan.
    (6) Section 1902(a)(68) of the Act requires that any entity that 
receives or makes annual payments under the State plan of at least 
$5,000,000 must establish certain minimum written policies relating to 
the Federal False Claims Act.
    (7) Section 1902(a)(77) of the Act requires that States comply with 
provider and supplier screening, oversight, and reporting requirements 
described in section 1902(kk)(1) of the Act.
    (8) Section 1902(a)(80) of the Act prohibits payments for items or 
services provided under the State plan or under a waiver to any 
financial institution or entity located outside of the United States.
    (9) Section 1902(kk)(7) of the Act requires States to enroll 
physicians or other professionals that order or refer services under the 
State plan.
    (10) Section 1903(i) of the Act prohibits FFP for amounts expended 
by MCOs or PCCMs for providers excluded by Medicare, Medicaid, or CHIP, 
except for emergency services.
    (11) Section 1903(m) of the Act establishes conditions for payments 
to the State for contracts with MCOs.
    (12) Section 1932(d)(1) of the Act prohibits MCOs and PCCMs from 
knowingly having certain types of relationships with individuals and 
entities debarred under Federal regulations from participating in 
specified activities, or with affiliates of those individuals.
    (b) Basic rule. As a condition for receiving payment under a 
Medicaid managed care program, an MCO, PIHP, PAHP, PCCM or PCCM entity 
must comply with the requirements in Sec. Sec.  438.604, 438.606, 
438.608 and 438.610, as applicable.
    (c) Applicability. States will not be held out compliance with the 
following requirements of this subpart prior to the dates noted below so 
long as they comply with the corresponding standard(s) in 42 CFR part 
438 contained in the CFR, parts 430 to 481, edition revised as of 
October 1, 2015:

[[Page 322]]

    (1) States must comply with Sec. Sec.  438.602(a), 438.602(c) 
through (h), 438.604, 438.606, 438.608(a), and 438.608(c) and (d), no 
later than the rating period for contracts starting on or after July 1, 
2017.
    (2) States must comply with Sec.  438.602(b) and Sec.  438.608(b) no 
later than the rating period for contracts beginning on or after July 1, 
2018.



Sec.  438.602  State responsibilities.

    (a) Monitoring contractor compliance. Consistent with Sec.  438.66, 
the State must monitor the MCO's, PIHP's, PAHP's, PCCM's or PCCM 
entity's compliance, as applicable, with Sec. Sec.  438.604, 438.606, 
438.608, 438.610, 438.230, and 438.808.
    (b) Screening and enrollment and revalidation of providers. (1) The 
State must screen and enroll, and periodically revalidate, all network 
providers of MCOs, PIHPs, and PAHPs, in accordance with the requirements 
of part 455, subparts B and E of this chapter. This requirement extends 
to PCCMs and PCCM entities to the extent the primary care case manager 
is not otherwise enrolled with the State to provide services to FFS 
beneficiaries. This provision does not require the network provider to 
render services to FFS beneficiaries.
    (2) MCOs, PIHPs, and PAHPs may execute network provider agreements 
pending the outcome of the process in paragraph (b)(1) of this section 
of up to 120 days, but must terminate a network provider immediately 
upon notification from the State that the network provider cannot be 
enrolled, or the expiration of one 120 day period without enrollment of 
the provider, and notify affected enrollees.
    (c) Ownership and control information. The State must review the 
ownership and control disclosures submitted by the MCO, PIHP, PAHP, PCCM 
or PCCM entity, and any subcontractors as required in Sec.  438.608(c).
    (d) Federal database checks. Consistent with the requirements at 
Sec.  455.436 of this chapter, the State must confirm the identity and 
determine the exclusion status of the MCO, PIHP, PAHP, PCCM or PCCM 
entity, any subcontractor, as well as any person with an ownership or 
control interest, or who is an agent or managing employee of the MCO, 
PIHP, PAHP, PCCM or PCCM entity through routine checks of Federal 
databases. This includes the Social Security Administration's Death 
Master File, the National Plan and Provider Enumeration System (NPPES), 
the List of Excluded Individuals/Entities (LEIE), the System for Award 
Management (SAM), and any other databases as the State or Secretary may 
prescribe. These databases must be consulted upon contracting and no 
less frequently than monthly thereafter. If the State finds a party that 
is excluded, it must promptly notify the MCO, PIHP, PAHP, PCCM, or PCCM 
entity and take action consistent with Sec.  438.610(c).
    (e) Periodic audits. The State must periodically, but no less 
frequently than once every 3 years, conduct, or contract for the conduct 
of, an independent audit of the accuracy, truthfulness, and completeness 
of the encounter and financial data submitted by, or on behalf of, each 
MCO, PIHP or PAHP.
    (f) Whistleblowers. The State must receive and investigate 
information from whistleblowers relating to the integrity of the MCO, 
PIHP, PAHP, PCCM, or PCCM entity, subcontractors, or network providers 
receiving Federal funds under this part.
    (g) Transparency. The State must post on its Web site, as required 
in Sec.  438.10(c)(3), the following documents and reports:
    (1) The MCO, PIHP, PAHP, or PCCM entity contract.
    (2) The data at Sec.  438.604(a)(5).
    (3) The name and title of individuals included in Sec.  
438.604(a)(6).
    (4) The results of any audits under paragraph (e) of this section.
    (h) Contracting integrity. The State must have in place conflict of 
interest safeguards described in Sec.  438.58 and must comply with the 
requirement described in section 1902(a)(4)(C) of the Act applicable to 
contracting officers, employees, or independent contractors.
    (i) Entities located outside of the U.S. The State must ensure that 
the MCO, PIHP, PAHP, PCCM, or PCCM entity with which the State contracts 
under this part is not located outside of the United States and that no 
claims paid

[[Page 323]]

by an MCO, PIHP, or PAHP to a network provider, out-of-network provider, 
subcontractor or financial institution located outside of the U.S. are 
considered in the development of actuarially sound capitation rates.



Sec.  438.604  Data, information, and documentation that must be submitted.

    (a) Specified data, information, and documentation. The State must 
require any MCO, PIHP, PAHP, PCCM or PCCM entity to submit to the State 
the following data:
    (1) Encounter data in the form and manner described in Sec.  
438.818.
    (2) Data on the basis of which the State certifies the actuarial 
soundness of capitation rates to an MCO, PIHP or PAHP under Sec.  438.4, 
including base data described in Sec.  438.5(c) that is generated by the 
MCO, PIHP or PAHP.
    (3) Data on the basis of which the State determines the compliance 
of the MCO, PIHP, or PAHP with the medical loss ratio requirement 
described in Sec.  438.8.
    (4) Data on the basis of which the State determines that the MCO, 
PIHP or PAHP has made adequate provision against the risk of insolvency 
as required under Sec.  438.116.
    (5) Documentation described in Sec.  438.207(b) on which the State 
bases its certification that the MCO, PIHP or PAHP has complied with the 
State's requirements for availability and accessibility of services, 
including the adequacy of the provider network, as set forth in Sec.  
438.206.
    (6) Information on ownership and control described in Sec.  455.104 
of this chapter from MCOs, PIHPs, PAHPs, PCCMs, PCCM entities, and 
subcontractors as governed by Sec.  438.230.
    (7) The annual report of overpayment recoveries as required in Sec.  
438.608(d)(3).
    (b) Additional data, documentation, or information. In addition to 
the data, documentation, or information specified in paragraph (a) of 
this section, an MCO, PIHP, PAHP, PCCM or PCCM entity must submit any 
other data, documentation, or information relating to the performance of 
the entity's obligations under this part required by the State or the 
Secretary.

[81 FR 27853, May 6, 2016, as amended at 82 FR 39, Jan. 3, 2017]



Sec.  438.606  Source, content, and timing of certification.

    (a) Source of certification. For the data, documentation, or 
information specified in Sec.  438.604, the State must require that the 
data, documentation or information the MCO, PIHP, PAHP, PCCM or PCCM 
entity submits to the State be certified by either the MCO's, PIHP's, 
PAHP's, PCCM's, or PCCM entity's Chief Executive Officer; Chief 
Financial Officer; or an individual who reports directly to the Chief 
Executive Officer or Chief Financial Officer with delegated authority to 
sign for the Chief Executive Officer or Chief Financial Officer so that 
the Chief Executive Officer or Chief Financial Officer is ultimately 
responsible for the certification.
    (b) Content of certification. The certification provided by the 
individual in paragraph (a) of this section must attest that, based on 
best information, knowledge, and belief, the data, documentation, and 
information specified in Sec.  438.604 is accurate, complete, and 
truthful.
    (c) Timing of certification. The State must require the MCO, PIHP, 
PAHP, PCCM, or PCCM entity to submit the certification concurrently with 
the submission of the data, documentation, or information required in 
Sec.  438.604(a) and (b).



Sec.  438.608  Program integrity requirements under the contract.

    (a) Administrative and management arrangements or procedures to 
detect and prevent fraud, waste and abuse. The State, through its 
contract with the MCO, PIHP or PAHP, must require that the MCO, PIHP, or 
PAHP, or subcontractor to the extent that the subcontractor is delegated 
responsibility by the MCO, PIHP, or PAHP for coverage of services and 
payment of claims under the contract between the State and the MCO, 
PIHP, or PAHP, implement and maintain arrangements or procedures that 
are designed to detect and prevent fraud, waste, and abuse. The 
arrangements or procedures must include the following:
    (1) A compliance program that includes, at a minimum, all of the 
following elements:

[[Page 324]]

    (i) Written policies, procedures, and standards of conduct that 
articulate the organization's commitment to comply with all applicable 
requirements and standards under the contract, and all applicable 
Federal and State requirements.
    (ii) The designation of a Compliance Officer who is responsible for 
developing and implementing policies, procedures, and practices designed 
to ensure compliance with the requirements of the contract and who 
reports directly to the Chief Executive Officer and the board of 
directors.
    (iii) The establishment of a Regulatory Compliance Committee on the 
Board of Directors and at the senior management level charged with 
overseeing the organization's compliance program and its compliance with 
the requirements under the contract.
    (iv) A system for training and education for the Compliance Officer, 
the organization's senior management, and the organization's employees 
for the Federal and State standards and requirements under the contract.
    (v) Effective lines of communication between the compliance officer 
and the organization's employees.
    (vi) Enforcement of standards through well-publicized disciplinary 
guidelines.
    (vii) Establishment and implementation of procedures and a system 
with dedicated staff for routine internal monitoring and auditing of 
compliance risks, prompt response to compliance issues as they are 
raised, investigation of potential compliance problems as identified in 
the course of self-evaluation and audits, correction of such problems 
promptly and thoroughly (or coordination of suspected criminal acts with 
law enforcement agencies) to reduce the potential for recurrence, and 
ongoing compliance with the requirements under the contract.
    (2) Provision for prompt reporting of all overpayments identified or 
recovered, specifying the overpayments due to potential fraud, to the 
State.
    (3) Provision for prompt notification to the State when it receives 
information about changes in an enrollee's circumstances that may affect 
the enrollee's eligibility including all of the following:
    (i) Changes in the enrollee's residence;
    (ii) The death of an enrollee.
    (4) Provision for notification to the State when it receives 
information about a change in a network provider's circumstances that 
may affect the network provider's eligibility to participate in the 
managed care program, including the termination of the provider 
agreement with the MCO, PIHP or PAHP.
    (5) Provision for a method to verify, by sampling or other methods, 
whether services that have been represented to have been delivered by 
network providers were received by enrollees and the application of such 
verification processes on a regular basis.
    (6) In the case of MCOs, PIHPs, or PAHPs that make or receive annual 
payments under the contract of at least $5,000,000, provision for 
written policies for all employees of the entity, and of any contractor 
or agent, that provide detailed information about the False Claims Act 
and other Federal and State laws described in section 1902(a)(68) of the 
Act, including information about rights of employees to be protected as 
whistleblowers.
    (7) Provision for the prompt referral of any potential fraud, waste, 
or abuse that the MCO, PIHP, or PAHP identifies to the State Medicaid 
program integrity unit or any potential fraud directly to the State 
Medicaid Fraud Control Unit.
    (8) Provision for the MCO's, PIHP's, or PAHP's suspension of 
payments to a network provider for which the State determines there is a 
credible allegation of fraud in accordance with Sec.  455.23 of this 
chapter.
    (b) Provider screening and enrollment requirements. The State, 
through its contracts with a MCO, PIHP, PAHP, PCCM, or PCCM entity must 
ensure that all network providers are enrolled with the State as 
Medicaid providers consistent with the provider disclosure, screening 
and enrollment requirements of part 455, subparts B and E of this 
chapter. This provision does not require the network provider to render 
services to FFS beneficiaries.
    (c) Disclosures. The State must ensure, through its contracts, that 
each

[[Page 325]]

MCO, PIHP, PAHP, PCCM, PCCM entity, and any subcontractors:
    (1) Provides written disclosure of any prohibited affiliation under 
Sec.  438.610.
    (2) Provides written disclosures of information on ownership and 
control required under Sec.  455.104 of this chapter.
    (3) Reports to the State within 60 calendar days when it has 
identified the capitation payments or other payments in excess of 
amounts specified in the contract.
    (d) Treatment of recoveries made by the MCO, PIHP or PAHP of 
overpayments to providers. (1) Contracts with a MCO, PIHP, or PAHP must 
specify:
    (i) The retention policies for the treatment of recoveries of all 
overpayments from the MCO, PIHP, or PAHP to a provider, including 
specifically the retention policies for the treatment of recoveries of 
overpayments due to fraud, waste, or abuse.
    (ii) The process, timeframes, and documentation required for 
reporting the recovery of all overpayments.
    (iii) The process, timeframes, and documentation required for 
payment of recoveries of overpayments to the State in situations where 
the MCO, PIHP, or PAHP is not permitted to retain some or all of the 
recoveries of overpayments.
    (iv) This provision does not apply to any amount of a recovery to be 
retained under False Claims Act cases or through other investigations.
    (2) Each MCO, PIHP, or PAHP requires and has a mechanism for a 
network provider to report to the MCO, PIHP or PAHP when it has received 
an overpayment, to return the overpayment to the MCO, PIHP or PAHP 
within 60 calendar days after the date on which the overpayment was 
identified, and to notify the MCO, PIHP or PAHP in writing of the reason 
for the overpayment.
    (3) Each MCO, PIHP, or PAHP must report annually to the State on 
their recoveries of overpayments.
    (4) The State must use the results of the information and 
documentation collected in paragraph (d)(1) of this section and the 
report in paragraph (d)(3) of this section for setting actuarially sound 
capitation rates for each MCO, PIHP, or PAHP consistent with the 
requirements in Sec.  438.4.



Sec.  438.610  Prohibited affiliations.

    (a) An MCO, PIHP, PAHP, PCCM, or PCCM entity may not knowingly have 
a relationship of the type described in paragraph (c) of this section 
with the following:
    (1) An individual or entity that is debarred, suspended, or 
otherwise excluded from participating in procurement activities under 
the Federal Acquisition Regulation or from participating in 
nonprocurement activities under regulations issued under Executive Order 
No. 12549 or under guidelines implementing Executive Order No. 12549.
    (2) An individual or entity who is an affiliate, as defined in the 
Federal Acquisition Regulation at 48 CFR 2.101, of a person described in 
paragraph (a)(1) of this section.
    (b) An MCO, PIHP, PAHP, PCCM, or PCCM entity may not have a 
relationship with an individual or entity that is excluded from 
participation in any Federal health care program under section 1128 or 
1128A of the Act.
    (c) The relationships described in paragraph (a) of this section, 
are as follows:
    (1) A director, officer, or partner of the MCO, PIHP, PAHP, PCCM. or 
PCCM entity.
    (2) A subcontractor of the MCO, PIHP, PAHP, PCCM, or PCCM entity, as 
governed by Sec.  438.230.
    (3) A person with beneficial ownership of 5 percent or more of the 
MCO's, PIHP's, PAHP's, PCCM's, or PCCM entity's equity.
    (4) A network provider or person with an employment, consulting or 
other arrangement with the MCO, PIHP, PAHP, PCCM, or PCCM entity for the 
provision of items and services that are significant and material to the 
MCO's, PIHP's, PAHP's, PCCM's, or PCCM entity's obligations under its 
contract with the State.
    (d) If a State finds that an MCO, PIHP, PAHP, PCCM, or PCCM entity 
is not in compliance with paragraphs (a) and (b) of this section, the 
State:
    (1) Must notify the Secretary of the noncompliance.
    (2) May continue an existing agreement with the MCO, PIHP, PAHP, 
PCCM, or PCCM entity unless the Secretary directs otherwise.

[[Page 326]]

    (3) May not renew or otherwise extend the duration of an existing 
agreement with the MCO, PIHP, PAHP, PCCM, or PCCM entity unless the 
Secretary provides to the State and to Congress a written statement 
describing compelling reasons that exist for renewing or extending the 
agreement despite the prohibited affiliations.
    (4) Nothing in this section must be construed to limit or otherwise 
affect any remedies available to the U.S. under sections 1128, 1128A or 
1128B of the Act.
    (e) Consultation with the Inspector General. Any action by the 
Secretary described in paragraphs (d)(2) or (3) of this section is taken 
in consultation with the Inspector General.



                           Subpart I_Sanctions

    Source: 81 FR 27853, May 6, 2016, unless otherwise noted.



Sec.  438.700  Basis for imposition of sanctions.

    (a) Each State that contracts with an MCO must, and each State that 
contracts with a PCCM or PCCM entity may, establish intermediate 
sanctions (which may include those specified in Sec.  438.702) that it 
may impose if it makes any of the determinations specified in paragraphs 
(b) through (d) of this section. The State may base its determinations 
on findings from onsite surveys, enrollee or other complaints, financial 
status, or any other source.
    (b) A State determines that an MCO acts or fails to act as follows:
    (1) Fails substantially to provide medically necessary services that 
the MCO is required to provide, under law or under its contract with the 
State, to an enrollee covered under the contract.
    (2) Imposes on enrollees premiums or charges that are in excess of 
the premiums or charges permitted under the Medicaid program.
    (3) Acts to discriminate among enrollees on the basis of their 
health status or need for health care services. This includes 
termination of enrollment or refusal to reenroll a beneficiary, except 
as permitted under the Medicaid program, or any practice that would 
reasonably be expected to discourage enrollment by beneficiaries whose 
medical condition or history indicates probable need for substantial 
future medical services.
    (4) Misrepresents or falsifies information that it furnishes to CMS 
or to the State.
    (5) Misrepresents or falsifies information that it furnishes to an 
enrollee, potential enrollee, or health care provider.
    (6) Fails to comply with the requirements for physician incentive 
plans, as set forth (for Medicare) in Sec. Sec.  422.208 and 422.210 of 
this chapter.
    (c) A State determines that an MCO, PCCM or PCCM entity has 
distributed directly, or indirectly through any agent or independent 
contractor, marketing materials that have not been approved by the State 
or that contain false or materially misleading information.
    (d) A State determines that--
    (1) An MCO has violated any of the other requirements of sections 
1903(m) or 1932 of the Act, or any implementing regulations.
    (2) A PCCM or PCCM entity has violated any of the other applicable 
requirements of sections 1932 or 1905(t)(3) of the Act, or any 
implementing regulations.
    (3) For any of the violations under paragraphs (d)(1) and (2) of 
this section, only the sanctions specified in Sec.  438.702(a)(3), (4), 
and (5) may be imposed.



Sec.  438.702  Types of intermediate sanctions.

    (a) The types of intermediate sanctions that a State may impose 
under this subpart include the following:
    (1) Civil money penalties in the amounts specified in Sec.  438.704.
    (2) Appointment of temporary management for an MCO as provided in 
Sec.  438.706.
    (3) Granting enrollees the right to terminate enrollment without 
cause and notifying the affected enrollees of their right to disenroll.
    (4) Suspension of all new enrollment, including default enrollment, 
after the date the Secretary or the State notifies the MCO of a 
determination of a violation of any requirement under sections 1903(m) 
or 1932 of the Act.

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    (5) Suspension of payment for beneficiaries enrolled after the 
effective date of the sanction and until CMS or the State is satisfied 
that the reason for imposition of the sanction no longer exists and is 
not likely to recur.
    (b) State agencies retain authority to impose additional sanctions 
under State statutes or State regulations that address areas of 
noncompliance specified in Sec.  438.700, as well as additional areas of 
noncompliance. Nothing in this subpart prevents State agencies from 
exercising that authority.



Sec.  438.704  Amounts of civil money penalties.

    (a) General rule. If the State imposes civil monetary penalties as 
provided under Sec.  438.702(a)(1), the maximum civil money penalty the 
State may impose varies depending on the nature of the MCO's, PCCM or 
PCCM entity's action or failure to act, as provided in this section.
    (b) Specific limits. (1) The limit is $25,000 for each determination 
under Sec.  438.700(b)(1), (5), (6), and (c).
    (2) The limit is $100,000 for each determination under Sec.  
438.700(b)(3) or (4).
    (3) The limit is $15,000 for each beneficiary the State determines 
was not enrolled because of a discriminatory practice under Sec.  
438.700(b)(3). (This is subject to the overall limit of $100,000 under 
paragraph (b)(2) of this section).
    (c) Specific amount. For premiums or charges in excess of the 
amounts permitted under the Medicaid program, the maximum amount of the 
penalty is $25,000 or double the amount of the excess charges, whichever 
is greater. The State must deduct from the penalty the amount of 
overcharge and return it to the affected enrollees.



Sec.  438.706  Special rules for temporary management.

    (a) Optional imposition of sanction. If the State imposes temporary 
management under Sec.  438.702(a)(2), the State may do so only if it 
finds (through onsite surveys, enrollee or other complaints, financial 
status, or any other source) any of the following:
    (1) There is continued egregious behavior by the MCO, including but 
not limited to behavior that is described in Sec.  438.700, or that is 
contrary to any requirements of sections 1903(m) and 1932 of the Act.
    (2) There is substantial risk to enrollees' health.
    (3) The sanction is necessary to ensure the health of the MCO's 
enrollees--
    (i) While improvements are made to remedy violations under Sec.  
438.700.
    (ii) Until there is an orderly termination or reorganization of the 
MCO.
    (b) Required imposition of sanction. The State must impose temporary 
management (regardless of any other sanction that may be imposed) if it 
finds that an MCO has repeatedly failed to meet substantive requirements 
in sections 1903(m) or 1932 of the Act, or this subpart. The State must 
also grant enrollees the right to terminate enrollment without cause, as 
described in Sec.  438.702(a)(3), and must notify the affected enrollees 
of their right to terminate enrollment.
    (c) Hearing. The State may not delay imposition of temporary 
management to provide a hearing before imposing this sanction.
    (d) Duration of sanction. The State may not terminate temporary 
management until it determines that the MCO can ensure that the 
sanctioned behavior will not recur.



Sec.  438.708  Termination of an MCO, PCCM or PCCM entity contract.

    A State has the authority to terminate an MCO, PCCM or PCCM entity 
contract and enroll that entity's enrollees in other MCOs, PCCMs or PCCM 
entities, or provide their Medicaid benefits through other options 
included in the State plan, if the State determines that the MCO, PCCM 
or PCCM entity has failed to do either of the following:
    (a) Carry out the substantive terms of its contract.
    (b) Meet applicable requirements in sections 1932, 1903(m), and 
1905(t) of the Act.



Sec.  438.710  Notice of sanction and pre-termination hearing.

    (a) Notice of sanction. Except as provided in Sec.  438.706(c), 
before imposing any of the intermediate sanctions specified in this 
subpart, the State must give the affected entity timely written notice 
that explains the following:

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    (1) The basis and nature of the sanction.
    (2) Any other appeal rights that the State elects to provide.
    (b) Pre-termination hearing--(1) General rule. Before terminating an 
MCO, PCCM or PCCM entity contract under Sec.  438.708, the State must 
provide the entity a pre-termination hearing.
    (2) Procedures. The State must do all of the following:
    (i) Give the MCO, PCCM or PCCM entity written notice of its intent 
to terminate, the reason for termination, and the time and place of the 
hearing.
    (ii) After the hearing, give the entity written notice of the 
decision affirming or reversing the proposed termination of the contract 
and, for an affirming decision, the effective date of termination.
    (iii) For an affirming decision, give enrollees of the MCO, PCCM or 
PCCM entity notice of the termination and information, consistent with 
Sec.  438.10, on their options for receiving Medicaid services following 
the effective date of termination.



Sec.  438.722  Disenrollment during termination hearing process.

    After a State notifies an MCO, PCCM or PCCM entity that it intends 
to terminate the contract, the State may do the following:
    (a) Give the entity's enrollees written notice of the State's intent 
to terminate the contract.
    (b) Allow enrollees to disenroll immediately without cause.



Sec.  438.724  Notice to CMS.

    (a) The State must give CMS written notice whenever it imposes or 
lifts a sanction for one of the violations listed in Sec.  438.700.
    (b) The notice must adhere to all of the following requirements:
    (1) Be given no later than 30 days after the State imposes or lifts 
a sanction.
    (2) Specify the affected MCO, the kind of sanction, and the reason 
for the State's decision to impose or lift a sanction.



Sec.  438.726  State plan requirement.

    (a) The State plan must include a plan to monitor for violations 
that involve the actions and failures to act specified in this part and 
to implement the provisions of this part.
    (b) A contract with an MCO must provide that payments provided for 
under the contract will be denied for new enrollees when, and for so 
long as, payment for those enrollees is denied by CMS under Sec.  
438.730(e).



Sec.  438.730  Sanction by CMS: Special rules for MCOs.

    (a) Basis for sanction. A State may recommend that CMS impose the 
denial of payment sanction specified in paragraph (e) of this section on 
an MCO with a contract under this part if the agency determines that the 
MCO acts or fails to act as specified in Sec.  438.700(b)(1) through 
(6).
    (b) Effect of an agency determination. (1) The State's determination 
becomes CMS' determination for purposes of section 1903(m)(5)(A) of the 
Act unless CMS reverses or modifies it within 15 days.
    (2) When the State decides to recommend imposing the sanction 
described in paragraph (e) of this section, this recommendation becomes 
CMS' decision, for purposes of section 1903(m)(5)(B)(ii) of the Act, 
unless CMS rejects this recommendation within 15 days.
    (c) Notice of sanction. If the State's determination becomes CMS' 
determination under paragraph (b)(2) of this section, the State takes 
all of the following actions:
    (1) Gives the MCO written notice of the nature and basis of the 
proposed sanction.
    (2) Allows the MCO 15 days from the date it receives the notice to 
provide evidence that it has not acted or failed to act in the manner 
that is the basis for the recommended sanction.
    (3) May extend the initial 15-day period for an additional 15 days 
if--
    (i) The MCO submits a written request that includes a credible 
explanation of why it needs additional time.
    (ii) The request is received by CMS before the end of the initial 
period.
    (iii) CMS has not determined that the MCO's conduct poses a threat 
to an enrollee's health or safety.

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    (d) Informal reconsideration. (1) If the MCO submits a timely 
response to the notice of sanction, the State--
    (i) Conducts an informal reconsideration that includes review of the 
evidence by a State agency official who did not participate in the 
original recommendation.
    (ii) Gives the MCO a concise written decision setting forth the 
factual and legal basis for the decision.
    (iii) Forwards the decision to CMS.
    (2) The State's decision under paragraph (d)(1)(ii) of this section 
becomes CMS' decision unless CMS reverses or modifies the decision 
within 15 days from date of receipt by CMS.
    (3) If CMS reverses or modifies the State decision, the agency sends 
the MCO a copy of CMS' decision.
    (e) Denial of payment. (1) CMS, based upon the recommendation of the 
agency, may deny payment to the State for new enrollees of the MCO under 
section 1903(m)(5)(B)(ii) of the Act in the following situations:
    (i) If a CMS determination that an MCO has acted or failed to act, 
as described in paragraphs (b)(1) through (6) of Sec.  438.700, is 
affirmed on review under paragraph (d) of this section.
    (ii) If the CMS determination is not timely contested by the MCO 
under paragraph (c) of this section.
    (2) Under Sec.  438.726(b), CMS' denial of payment for new enrollees 
automatically results in a denial of agency payments to the MCO for the 
same enrollees. (A new enrollee is an enrollee that applies for 
enrollment after the effective date in paragraph (f)(1) of this 
section.)
    (f) Effective date of sanction. (1) If the MCO does not seek 
reconsideration, a sanction is effective 15 days after the date the MCO 
is notified under paragraph (c) of this section of the decision to 
impose the sanction.
    (2) If the MCO seeks reconsideration, the following rules apply:
    (i) Except as specified in paragraph (d)(2) of this section, the 
sanction is effective on the date specified in CMS' reconsideration 
notice.
    (ii) If CMS, in consultation with the State, determines that the 
MCO's conduct poses a serious threat to an enrollee's health or safety, 
the sanction may be made effective earlier than the date of the agency's 
reconsideration decision under paragraph (d)(1)(ii) of this section.
    (g) CMS' role. (1) CMS retains the right to independently perform 
the functions assigned to the State under paragraphs (a) through (d) of 
this section.
    (2) At the same time that the State sends notice to the MCO under 
paragraph (c)(1) of this section, CMS forwards a copy of the notice to 
the OIG.
    (3) CMS conveys the determination described in paragraph (b) of this 
section to the OIG for consideration of possible imposition of civil 
money penalties under section 1903(m)(5)(A) of the Act and part 1003 of 
this title. In accordance with the provisions of part 1003, the OIG may 
impose civil money penalties on the MCO in addition to, or in place of, 
the sanctions that may be imposed under this section.



     Subpart J_Conditions for Federal Financial Participation (FFP)

    Source: 81 FR 27853, May 6, 2016, unless otherwise noted.



Sec.  438.802  Basic requirements.

    FFP is available in expenditures for payments under an MCO contract 
only for the periods during which the contract--
    (a) Meets the requirements of this part; and
    (b) Is in effect.



Sec.  438.806  Prior approval.

    (a) Comprehensive risk contracts. FFP is available under a 
comprehensive risk contract only if all of the following apply:
    (1) CMS has confirmed that the contractor meets the definition of an 
MCO or is one of the entities described in paragraphs (b)(2) through (5) 
of Sec.  438.3.
    (2) The contract meets all the requirements of section 1903(m)(2)(A) 
of the Act, the applicable requirements of section 1932 of the Act, and 
the provisions of this part.
    (b) MCO contracts. Prior approval by CMS is a condition for FFP 
under any MCO contract that extends for less than one full year or that 
has a value equal to, or greater than, the following threshold amounts:

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    (1) For 1998, the threshold is $1,000,000.
    (2) For subsequent years, the amount is increased by the percentage 
increase in the consumer price index for all urban consumers.
    (c) FFP is not available in an MCO contract that does not have prior 
approval from CMS under paragraph (b) of this section.



Sec.  438.808  Exclusion of entities.

    (a) General rule. FFP is available in payments under MCO contracts 
or PIHP, PAHP, PCCM, or PCCM entity contracts under a section 1915(b)(1) 
of the Act waiver only if the State excludes from the contracts any 
entities described in paragraph (b) of this section.
    (b) Entities that must be excluded. (1) An entity that could be 
excluded under section 1128(b)(8) of the Act as being controlled by a 
sanctioned individual.
    (2) An entity that has a substantial contractual relationship as 
defined in Sec.  431.55(h)(3) of this chapter, either directly or 
indirectly, with an individual convicted of certain crimes as described 
in section 1128(b)(8)(B) of the Act or an individual described in Sec.  
438.610(a) and (b).
    (3) An entity that employs or contracts, directly or indirectly, for 
the furnishing of health care, utilization review, medical social work, 
or administrative services, with one of the following:
    (i) Any individual or entity described in Sec.  438.610(a) and (b).
    (ii) Any individual or entity that would provide those services 
through an individual or entity described in Sec.  438.610(a) and (b).



Sec.  438.810  Expenditures for enrollment broker services.

    (a) Definitions. As used in this section--
    Enrollment activities means activities such as distributing, 
collecting, and processing enrollment materials and taking enrollments 
by phone, in person, or through electronic methods of communication.
    Enrollment broker means an individual or entity that performs choice 
counseling or enrollment activities, or both.
    Enrollment services means choice counseling, or enrollment 
activities, or both.
    (b) Conditions that enrollment brokers must meet. State expenditures 
for the use of enrollment brokers are considered necessary for the 
proper and efficient operation of the State plan and thus eligible for 
FFP only if the broker and its subcontractors meet the following 
conditions:
    (1) Independence. The broker and its subcontractors are independent 
of any MCO, PIHP, PAHP, PCCM, PCCM entity or other health care provider 
in the State in which they provide enrollment services. A broker or 
subcontractor is not considered ``independent'' if it--
    (i) Is an MCO, PIHP, PAHP, PCCM, PCCM entity or other health care 
provider in the State;
    (ii) Is owned or controlled by an MCO, PIHP, PAHP, PCCM, PCCM entity 
or other health care provider in the State; or
    (iii) Owns or controls an MCO, PIHP, PAHP, PCCM, PCCM entity, or 
other health care provider in the State.
    (2) Freedom from conflict of interest. The broker and its 
subcontractor are free from conflict of interest. A broker or 
subcontractor is not considered free from conflict of interest if any 
person who is the owner, employee, or consultant of the broker or 
subcontractor or has any contract with them--
    (i) Has any direct or indirect financial interest in any entity or 
health care provider that furnishes services in the State in which the 
broker or subcontractor provides enrollment services;
    (ii) Has been excluded from participation under Title XVIII or XIX 
of the Act;
    (iii) Has been debarred by any Federal agency; or
    (iv) Has been, or is now, subject to civil money penalties under the 
Act.
    (3) Approval. The initial contract or memorandum of agreement (MOA) 
for services performed by the broker has been reviewed and approved by 
CMS.

[[Page 331]]



Sec.  438.812  Costs under risk and nonrisk contracts.

    (a) Under a risk contract, the total amount the State agency pays 
for carrying out the contract provisions is a medical assistance cost.
    (b) Under a nonrisk contract--
    (1) The amount the State agency pays for the furnishing of medical 
services to eligible beneficiaries is a medical assistance cost; and
    (2) The amount the State agency pays for the contractor's 
performance of other functions is an administrative cost.



Sec.  438.816  Expenditures for the beneficiary support system for 
enrollees using LTSS.

    State expenditures for the person or entity providing the services 
outlined in Sec.  438.71(d) are considered necessary for the proper and 
efficient operation of the State plan and thus eligible for FFP only if 
all of the following conditions are met:
    (a) Costs must be supported by an allocation methodology that 
appears in the State's approved Public Assistance Cost Allocation Plan 
in Sec.  433.34 of this chapter.
    (b) The costs do not duplicate payment for activities that are 
already being offered or should be provided by other entities or paid by 
other programs.
    (c) The person or entity providing the services must meet the 
requirements in Sec.  438.810(b)(1) and (2).
    (d) The initial contract or MOA for services performed has been 
reviewed and approved by CMS.



Sec.  438.818  Enrollee encounter data.

    (a) FFP is available for expenditures under an MCO, PIHP, or PAHP 
contract only if the State meets the following conditions for providing 
enrollee encounter data to CMS:
    (1) Enrollee encounter data reports must comply with the Health 
Insurance Portability and Accountability Act of 1996 (HIPAA) security 
and privacy standards and be submitted in the format required by the 
Medicaid Statistical Information System or format required by any 
successor system to the Medicaid Statistical Information System.
    (2) States must ensure that enrollee encounter data is validated for 
accuracy and completeness as required under Sec.  438.242 before 
submitting data to CMS. States must also validate that the data 
submitted to CMS is a complete and accurate representation of the 
information submitted to the State by the MCOs, PIHPs, and PAHPs.
    (3) States must cooperate with CMS to fully comply with all 
encounter data reporting requirements of the Medicaid Statistical 
Information System or any successor system.
    (b) CMS will assess a State's submission to determine if it complies 
with current criteria for accuracy and completeness.
    (c) If, after being notified of compliance issues under paragraph 
(b) of this section the State is unable to make a data submission 
compliant, CMS will take appropriate steps to defer and/or disallow FFP 
on all or part of an MCO, PIHP, or PAHP contract in a manner based on 
the enrollee and specific service type of the noncompliant data. Any 
deferral and/or disallowance of FFP will be effectuated utilizing the 
processes specified in Sec. Sec.  430.40 and 430.42 of this chapter.



  Subpart K_Parity in Mental Health and Substance Use Disorder Benefits

    Source: 81 FR 18436, Mar. 30, 2016, unless otherwise noted.



Sec.  438.900  Meaning of terms.

    For purposes of this subpart, except where the context clearly 
indicates otherwise, the following terms have the meanings indicated:
    Aggregate lifetime dollar limit means a dollar limitation on the 
total amount of specified benefits that may be paid under a MCO, PIHP, 
or PAHP.
    Annual dollar limit means a dollar limitation on the total amount of 
specified benefits that may be paid in a 12-month period under a MCO, 
PIHP, or PAHP.
    Cumulative financial requirements are financial requirements that 
determine whether or to what extent benefits are provided based on 
accumulated amounts and include deductibles and out-of-pocket maximums. 
(However,

[[Page 332]]

cumulative financial requirements do not include aggregate lifetime or 
annual dollar limits because these two terms are excluded from the 
meaning of financial requirements.)
    Early and Periodic Screening, Diagnostic and Treatment (EPSDT) 
benefits are benefits defined in section 1905(r) of the Act.
    Financial requirements include deductibles, copayments, coinsurance, 
or out-of-pocket maximums. Financial requirements do not include 
aggregate lifetime or annual dollar limits.
    Medical/surgical benefits means benefits for items or services for 
medical conditions or surgical procedures, as defined by the State and 
in accordance with applicable Federal and State law, but do not include 
mental health or substance use disorder benefits. Any condition defined 
by the State as being or as not being a medical/surgical condition must 
be defined to be consistent with generally recognized independent 
standards of current medical practice (for example, the most current 
version of the International Classification of Diseases (ICD) or State 
guidelines). Medical/surgical benefits include long term care services.
    Mental health benefits means benefits for items or services for 
mental health conditions, as defined by the State and in accordance with 
applicable Federal and State law. Any condition defined by the State as 
being or as not being a mental health condition must be defined to be 
consistent with generally recognized independent standards of current 
medical practice (for example, the most current version of the 
Diagnostic and Statistical Manual of Mental Disorders (DSM), the most 
current version of the ICD, or State guidelines). Mental health benefits 
include long term care services.
    Substance use disorder benefits means benefits for items or services 
for substance use disorders, as defined by the State and in accordance 
with applicable Federal and State law. Any disorder defined by the State 
as being or as not being a substance use disorder must be defined to be 
consistent with generally recognized independent standards of current 
medical practice (for example, the most current version of the DSM, the 
most current version of the ICD, or State guidelines). Substance use 
disorder benefits include long term care services.
    Treatment limitations include limits on benefits based on the 
frequency of treatment, number of visits, days of coverage, days in a 
waiting period, or other similar limits on the scope or duration of 
treatment. Treatment limitations include both quantitative treatment 
limitations, which are expressed numerically (such as 50 outpatient 
visits per year), and nonquantitative treatment limitations, which 
otherwise limit the scope or duration of benefits for treatment under a 
plan or coverage. (See Sec.  438.910(d)(2) for an illustrative list of 
nonquantitative treatment limitations.) A permanent exclusion of all 
benefits for a particular condition or disorder, however, is not a 
treatment limitation for purposes of this definition.



Sec.  438.905  Parity requirements for aggregate lifetime and annual
dollar limits.

    (a) General parity requirement. Each MCO, PIHP, and PAHP providing 
services to MCO enrollees must comply with paragraphs (b), (c), or (e) 
of this section for all enrollees of a MCO in States that cover both 
medical/surgical benefits and mental health or substance use disorder 
benefits under the State plan. This section details the application of 
the parity requirements for aggregate lifetime and annual dollar limits.
    (b) MCOs, PIHPs, or PAHPs with no limit or limits on less than one-
third of all medical/surgical benefits. If a MCO, PIHP, or PAHP does not 
include an aggregate lifetime or annual dollar limit on any medical/
surgical benefits or includes an aggregate lifetime or annual dollar 
limit that applies to less than one-third of all medical/surgical 
benefits provided to enrollees through a contract with the State, it may 
not impose an aggregate lifetime or annual dollar limit, respectively, 
on mental health or substance use disorder benefits.
    (c) MCOs, PIHPs, or PAHPs with a limit on at least two-thirds of all 
medical/surgical benefits. If a MCO, PIHP, or PAHP includes an aggregate 
lifetime or annual dollar limit on at least two-

[[Page 333]]

thirds of all medical/surgical benefits provided to enrollees through a 
contract with the State, it must either--
    (1) Apply the aggregate lifetime or annual dollar limit both to the 
medical/surgical benefits to which the limit would otherwise apply and 
to mental health or substance use disorder benefits in a manner that 
does not distinguish between the medical/surgical benefits and mental 
health or substance use disorder benefits; or
    (2) Not include an aggregate lifetime or annual dollar limit on 
mental health or substance use disorder benefits that is more 
restrictive than the aggregate lifetime or annual dollar limit, 
respectively, on medical/surgical benefits.
    (d) Determining one-third and two-thirds of all medical/surgical 
benefits. For purposes of this section, the determination of whether the 
portion of medical/surgical benefits subject to an aggregate lifetime or 
annual dollar limit represents one-third or two-thirds of all medical/
surgical benefits is based on the total dollar amount of all 
combinations of MCO, PIHP, and PAHP payments for medical/surgical 
benefits expected to be paid under the MCO, PIHP, or PAHP for a contract 
year (or for the portion of a contract year after a change in benefits 
that affects the applicability of the aggregate lifetime or annual 
dollar limits). Any reasonable method may be used to determine whether 
the dollar amount expected to be paid under the MCOs, PIHPs, and PAHPs 
will constitute one-third or two-thirds of the dollar amount of all 
payments for medical/surgical benefits.
    (e) MCO, PIHP, or PAHP not described in this section--(1) In 
general. A MCO, PIHP, or PAHP that is not described in paragraph (b) or 
(c) of this section for aggregate lifetime or annual dollar limits on 
medical/surgical benefits, must either--
    (i) Impose no aggregate lifetime or annual dollar limit, on mental 
health or substance use disorder benefits; or
    (ii) Impose an aggregate lifetime or annual dollar limit on mental 
health or substance use disorder benefits that is no more restrictive 
than an average limit calculated for medical/surgical benefits in the 
following manner. The average limit is calculated by taking into account 
the weighted average of the aggregate lifetime or annual dollar limits, 
as appropriate, that are applicable to the categories of medical/
surgical benefits. Limits based on delivery mechanisms, such as 
inpatient/outpatient treatment or normal treatment of common, low-cost 
conditions (such as treatment of normal births), do not constitute 
categories for purposes of this paragraph (e)(1)(ii). In addition, for 
purposes of determining weighted averages, any benefits that are not 
within a category that is subject to a separately-designated dollar 
limit under the contract are taken into account as a single separate 
category by using an estimate of the upper limit on the dollar amount 
that a MCO, PIHP, or PAHP may reasonably be expected to incur for such 
benefits, taking into account any other applicable restrictions.
    (2) Weighting. For purposes of this paragraph (e), the weighting 
applicable to any category of medical/surgical benefits is determined in 
the manner set forth in paragraph (d) of this section for determining 
one-third or two-thirds of all medical/surgical benefits.



Sec.  438.910  Parity requirements for financial requirements and 
treatment limitations.

    (a) Clarification of terms--(1) Classification of benefits. When 
reference is made in this section to a classification of benefits, the 
term ``classification'' means a classification as described in paragraph 
(b)(2) of this section.
    (2) Type of financial requirement or treatment limitation. When 
reference is made in this section to a type of financial requirement or 
treatment limitation, the reference to type means its nature. Different 
types of financial requirements include deductibles, copayments, 
coinsurance, and out-of-pocket maximums. Different types of quantitative 
treatment limitations include annual, episode, and lifetime day and 
visit limits. See paragraph (d)(2) of this section for an illustrative 
list of nonquantitative treatment limitations.
    (3) Level of a type of financial requirement or treatment 
limitation. When reference is made in this section to a level of a type 
of financial requirement or treatment limitation, level refers to

[[Page 334]]

the magnitude of the type of financial requirement or treatment 
limitation.
    (b) General parity requirement--(1) General rule and scope. Each 
MCO, PIHP and PAHP providing services to MCO enrollees in a State that 
covers both medical/surgical benefits and mental health or substance use 
disorder benefits under the State plan, must not apply any financial 
requirement or treatment limitation to mental health or substance use 
disorder benefits in any classification that is more restrictive than 
the predominant financial requirement or treatment limitation of that 
type applied to substantially all medical/surgical benefits in the same 
classification furnished to enrollees (whether or not the benefits are 
furnished by the same MCO, PIHP, or PAHP). Whether a financial 
requirement or treatment limitation is a predominant financial 
requirement or treatment limitation that applies to substantially all 
medical/surgical benefits in a classification is determined separately 
for each type of financial requirement or treatment limitation. The 
application of the rules of this paragraph (b) to financial requirements 
and quantitative treatment limitations is addressed in paragraph (c) of 
this section; the application of the rules of this paragraph (b) to 
nonquantitative treatment limitations is addressed in paragraph (d) of 
this section.
    (2) Classifications of benefits used for applying rules. If an MCO 
enrollee is provided mental health or substance use disorder benefits in 
any classification of benefits described in this paragraph (b)(2), 
mental health or substance use disorder benefits must be provided to the 
enrollee in every classification in which medical/surgical benefits are 
provided. In determining the classification in which a particular 
benefit belongs, a MCO, PIHP, or PAHP must apply the same reasonable 
standards to medical/surgical benefits and to mental health or substance 
use disorder benefits. To the extent that a MCO, PIHP, or PAHP provides 
benefits in a classification and imposes any separate financial 
requirement or treatment limitation (or separate level of a financial 
requirement or treatment limitation) for benefits in the classification, 
the rules of this section apply separately for that classification for 
all financial requirements or treatment limitations. The following 
classifications of benefits are the only classifications used in 
applying the rules of this section:
    (i) Inpatient. Benefits furnished on an inpatient basis.
    (ii) Outpatient. Benefits furnished on an outpatient basis. See 
special rules for office visits in paragraph (c)(2) of this section.
    (iii) Emergency care. Benefits for emergency care.
    (iv) Prescription drugs. Benefits for prescription drugs. See 
special rules for multi-tiered prescription drug benefits in paragraph 
(c)(2) of this section.
    (c) Financial requirements and quantitative treatment limitations--
(1) Determining ``substantially all'' and ``predominant''--(i) 
Substantially all. For purposes of this section, a type of financial 
requirement or quantitative treatment limitation is considered to apply 
to substantially all medical/surgical benefits in a classification of 
benefits if it applies to at least two-thirds of all medical/surgical 
benefits in that classification. If a type of financial requirement or 
quantitative treatment limitation does not apply to at least two-thirds 
of all medical/surgical benefits in a classification, then that type 
cannot be applied to mental health or substance use disorder benefits in 
that classification.
    (ii) Predominant. (A) If a type of financial requirement or 
quantitative treatment limitation applies to at least two-thirds of all 
medical/surgical benefits in a classification as determined under 
paragraph (c)(1)(i) of this section, the level of the financial 
requirement or quantitative treatment limitation that is considered the 
predominant level of that type in a classification of benefits is the 
level that applies to more than one-half of medical/surgical benefits in 
that classification subject to the financial requirement or quantitative 
treatment limitation.
    (B) If, for a type of financial requirement or quantitative 
treatment limitation that applies to at least two-thirds of all medical/
surgical benefits in a classification, there is no single level that 
applies to more than one-half of

[[Page 335]]

medical/surgical benefits in the classification subject to the financial 
requirement or quantitative treatment limitation, the MCO, PIHP, or PAHP 
may combine levels until the combination of levels applies to more than 
one-half of medical/surgical benefits subject to the financial 
requirement or quantitative treatment limitation in the classification. 
The least restrictive level within the combination is considered the 
predominant level of that type in the classification. (For this purpose, 
a MCO, PIHP, or PAHP may combine the most restrictive levels first, with 
each less restrictive level added to the combination until the 
combination applies to more than one-half of the benefits subject to the 
financial requirement or treatment limitation.)
    (iii) Portion based on MCO, PIHP or PAHP payments. For purposes of 
this section, the determination of the portion of medical/surgical 
benefits in a classification of benefits subject to a financial 
requirement or quantitative treatment limitation (or subject to any 
level of a financial requirement or quantitative treatment limitation) 
is based on the total dollar amount of all combinations of MCO, PIHP, 
and PAHP payments for medical/surgical benefits in the classification 
expected to be paid under the MCOs, PIHPs, and PAHPs for a contract year 
(or for the portion of a contract year after a change in benefits that 
affects the applicability of the financial requirement or quantitative 
treatment limitation).
    (iv) Clarifications for certain threshold requirements. For any 
deductible, the dollar amount of MCO, PIHP, or PAHP payments includes 
all payments for claims that would be subject to the deductible if it 
had not been satisfied. For any out-of-pocket maximum, the dollar amount 
of MCO, PIHP, or PAHP payments includes all payments associated with 
out-of-pocket payments that are taken into account towards the out-of-
pocket maximum as well as all payments associated with out-of-pocket 
payments that would have been made towards the out-of-pocket maximum if 
it had not been satisfied. Similar rules apply for any other thresholds 
at which the rate of MCO, PIHP, or PAHP payment changes.
    (v) Determining the dollar amount of MCO, PIHP, or PAHP payments. 
Subject to paragraph (c)(1)(iv) of this section, any reasonable method 
may be used to determine the dollar amount expected to be paid under a 
MCO, PIHP, or PAHP for medical/surgical benefits subject to a financial 
requirement or quantitative treatment limitation (or subject to any 
level of a financial requirement or quantitative treatment limitation).
    (2) Special rules--(i) Multi-tiered prescription drug benefits. If a 
MCO, PIHP, or PAHP applies different levels of financial requirements to 
different tiers of prescription drug benefits based on reasonable 
factors determined in accordance with the rules in paragraph (d)(1) of 
this section (relating to requirements for nonquantitative treatment 
limitations) and without regard to whether a drug is generally 
prescribed for medical/surgical benefits or for mental health or 
substance use disorder benefits, the MCO, PIHP, or PAHP satisfies the 
parity requirements of this section for prescription drug benefits. 
Reasonable factors include cost, efficacy, generic versus brand name, 
and mail order versus pharmacy pick-up/delivery.
    (ii) Sub-classifications permitted for office visits, separate from 
other outpatient services. For purposes of applying the financial 
requirement and treatment limitation rules of this section, a MCO, PIHP, 
or PAHP may divide its benefits furnished on an outpatient basis into 
the two sub-classifications described in this paragraph (c)(2)(ii). 
After the sub-classifications are established, the MCO, PIHP or PAHP may 
not impose any financial requirement or quantitative treatment 
limitation on mental health or substance use disorder benefits in any 
sub-classification that is more restrictive than the predominant 
financial requirement or quantitative treatment limitation that applies 
to substantially all medical/surgical benefits in the sub-classification 
using the methodology set forth in paragraph (c)(1) of this section. 
Sub-classifications other than these special rules, such as separate 
sub-classifications for generalists and specialists,

[[Page 336]]

are not permitted. The two sub-classifications permitted under this 
paragraph (c)(2)(ii) are:
    (A) Office visits (such as physician visits); and
    (B) All other outpatient items and services (such as outpatient 
surgery, facility charges for day treatment centers, laboratory charges, 
or other medical items).
    (3) No separate cumulative financial requirements. A MCO, PIHP, or 
PAHP may not apply any cumulative financial requirement for mental 
health or substance use disorder benefits in a classification that 
accumulates separately from any established for medical/surgical 
benefits in the same classification.
    (4) Compliance with other cost-sharing rules. Each MCO, PIHP, and 
PAHP must meet the cost-sharing requirements in Sec.  438.108 when 
applying Medicaid cost-sharing.
    (d) Nonquantitative treatment limitations--(1) General rule. A MCO, 
PIHP, or PAHP may not impose a nonquantitative treatment limitation for 
mental health or substance use disorder benefits in any classification 
unless, under the policies and procedures of the MCO, PIHP, or PAHP as 
written and in operation, any processes, strategies, evidentiary 
standards, or other factors used in applying the nonquantitative 
treatment limitation to mental health or substance use disorder benefits 
in the classification are comparable to, and are applied no more 
stringently than, the processes, strategies, evidentiary standards, or 
other factors used in applying the limitation for medical/surgical 
benefits in the classification.
    (2) Illustrative list of nonquantitative treatment limitations. 
Nonquantitative treatment limitations include -
    (i) Medical management standards limiting or excluding benefits 
based on medical necessity or medical appropriateness, or based on 
whether the treatment is experimental or investigative;
    (ii) Formulary design for prescription drugs;
    (iii) For MCOs, PIHPs, or PAHPs with multiple network tiers (such as 
preferred providers and participating providers), network tier design;
    (iv) Standards for provider admission to participate in a network, 
including reimbursement rates;
    (v) MCO, PIHP, or PAHP methods for determining usual, customary, and 
reasonable charges;
    (vi) Refusal to pay for higher-cost therapies until it can be shown 
that a lower-cost therapy is not effective (also known as fail-first 
policies or step therapy protocols);
    (vii) Exclusions based on failure to complete a course of treatment;
    (viii) Restrictions based on geographic location, facility type, 
provider specialty, and other criteria that limit the scope or duration 
of benefits for services provided under the MCO, PIHP, or PAHP; and
    (ix) Standards for providing access to out-of-network providers.
    (3) Application to out-of-network providers. Any MCO, PIHP or PAHP 
providing access to out-of-network providers for medical/surgical 
benefits within a classification, must use processes, strategies, 
evidentiary standards, or other factors in determining access to out-of-
network providers for mental health or substance use disorder benefits 
that are comparable to, and applied no more stringently than, the 
processes, strategies, evidentiary standards, or other factors in 
determining access to out-of-network providers for medical/surgical 
benefits.



Sec.  438.915  Availability of information.

    (a) Criteria for medical necessity determinations. The criteria for 
medical necessity determinations, made by a MCO or by a PIHP or PAHP 
providing services to an MCO enrollee, for mental health or substance 
use disorder benefits must be made available by the MCO, PIHP, or PAHP 
administrator to any enrollee, potential enrollee, or contracting 
provider upon request. MCOs, PIHPs, and PAHPs operating in compliance 
with Sec.  438.236(c) will be deemed compliant with the requirements in 
this paragraph (a).
    (b) Reason for any denial. The reason for any denial by a MCO, PIHP, 
or PAHP of reimbursement or payment for services for mental health or 
substance use disorder benefits in the case of any enrollee must be made 
available

[[Page 337]]

by the MCO, PIHP, or PAHP administrator to the enrollee.
    (c) Provisions of other law. Compliance with the disclosure 
requirements in paragraphs (a) and (b) of this section is not 
determinative of compliance with any other provision of applicable 
Federal or State law.



Sec.  438.920  Applicability.

    (a) MCOs, PIHPs, and PAHPs. The requirements of this subpart apply 
to each MCO, PIHP, and PAHP offering services to enrollees of a MCO, in 
States covering medical/surgical and mental health or substance use 
disorder services under the State plan. These requirements regarding 
coverage for services that must be provided to enrollees of an MCO apply 
regardless of the delivery system of the medical/surgical, mental 
health, or substance use disorder services under the State plan.
    (b) State responsibilities. (1) In any instance where the full scope 
of medical/surgical and mental health and substance use disorder 
services are not provided through the MCO, the State must review the 
mental health and substance use disorder and medical/surgical benefits 
provided through the MCO, PIHP, PAHP, and fee-for service (FFS) coverage 
to ensure the full scope of services available to all enrollees of the 
MCO complies with the requirements in this subpart. The State must 
provide documentation of compliance with requirements in this subpart to 
the general public and post this information on the State Medicaid Web 
site by October 2, 2017. Such documentation must be updated prior to any 
change in MCO, PIHP, PAHP or FFS State plan benefits.
    (2) The State must ensure that all services are delivered to the 
enrollees of the MCO in compliance with this subpart.
    (c) Scope. This subpart does not--
    (1) Require a MCO, PIHP, or PAHP to provide any mental health 
benefits or substance use disorder benefits beyond what is specified in 
its contract, and the provision of benefits by a MCO, PIHP, or PAHP for 
one or more mental health conditions or substance use disorders does not 
require the MCO, PIHP or PAHP to provide benefits for any other mental 
health condition or substance use disorder;
    (2) Require a MCO, PIHP, or PAHP that provides coverage for mental 
health or substance use disorder benefits only to the extent required 
under 1905(a)(4)(D) of the Act to provide additional mental health or 
substance use disorder benefits in any classification in accordance with 
this section; or
    (3) Affect the terms and conditions relating to the amount, 
duration, or scope of mental health or substance use disorder benefits 
under the Medicaid MCO, PIHP, or PAHP contract except as specifically 
provided in Sec. Sec.  438.905 and 438.910.



Sec.  438.930  Compliance dates.

    In general, contracts with MCOs, PIHPs, and PAHPs offering Medicaid 
State plan services to enrollees, and those entities, must comply with 
the requirements of this subpart no later than October 2, 2017.



PART 440_SERVICES: GENERAL PROVISIONS--Table of Contents



                          Subpart A_Definitions

Sec.
440.1 Basis and purpose.
440.2 Specific definitions; definitions of services for FFP purposes.
440.10 Inpatient hospital services, other than services in an 
          institution for mental diseases.
440.20 Outpatient hospital services and rural health clinic services.
440.30 Other laboratory and X-ray services.
440.40 Nursing facility services for individuals age 21 or older (other 
          than services in an institution for mental disease), EPSDT, 
          and family planning services and supplies.
440.50 Physicians' services and medical and surgical services of a 
          dentist.
440.60 Medical or other remedial care provided by licensed 
          practitioners.
440.70 Home health services.
440.80 Private duty nursing services.
440.90 Clinic services.
440.100 Dental services.
440.110 Physical therapy, occupational therapy, and services for 
          individuals with speech, hearing, and language disorders.
440.120 Prescribed drugs, dentures, prosthetic devices, and eyeglasses.
440.130 Diagnostic, screening, preventive, and rehabilitative services.
440.140 Inpatient hospital services, nursing facility services, and 
          intermediate care

[[Page 338]]

          facility services for individuals age 65 or older in 
          institutions for mental diseases.
440.150 Intermediate care facility (ICF/IID) services.
440.155 Nursing facility services, other than in institutions for mental 
          diseases.
440.160 Inpatient pyschiatric services for individuals under age 21.
440.165 Nurse-midwife services.
440.166 Nurse practitioner services.
440.167 Personal care services.
440.168 Primary care case management services.
440.169 Case management services.
440.170 Any other medical or remedial care recognized under State law 
          and specified by the Secretary.
440.180 Home and community-based waiver services.
440.181 Home and community-based services for individuals age 65 or 
          older.
440.182 State plan home and community-based services.
440.185 Respiratory care for ventilator-dependent individuals.

      Subpart B_Requirements and Limits Applicable to All Services

440.200 Basis, purpose, and scope.
440.210 Required services for the categorically needy.
440.220 Required services for the medically needy.
440.225 Optional services.
440.230 Sufficiency of amount, duration, and scope.
440.240 Comparability of services for groups.
440.250 Limits on comparability of services.
440.255 Limited services available to certain aliens.
440.260 Methods and standards to assure quality of services.
440.262 Access and cultural considerations.
440.270 Religious objections.

      Subpart C_Benchmark Benefit and Benchmark-Equivalent Coverage

440.300 Basis.
440.305 Scope.
440.310 Applicability.
440.315 Exempt individuals.
440.320 State plan requirements: Optional enrollment for exempt 
          individuals.
440.325 State plan requirements: Coverage and benefits.
440.330 Benchmark health benefits coverage.
440.335 Benchmark-equivalent health benefits coverage.
440.340 Actuarial report for benchmark-equivalent coverage.
440.345 EPSDT and other required benefits.
440.347 Essential health benefits.
440.350 Employer-sponsored insurance health plans.
440.355 Payment of premiums.
440.360 State plan requirements for providing additional services.
440.365 Coverage of rural health clinic and federally qualified health 
          center (FQHC) services.
440.370 Economy and efficiency.
440.375 Comparability.
440.380 Statewideness.
440.385 Delivery of benchmark and benchmark-equivalent coverage through 
          managed care entities.
440.386 Public notice.
440.390 Assurance of transportation.
440.395 Parity in mental health and substance use disorder benefits.

    Authority: 42 U.S.C. 1302.

    Source: 43 FR 45224, Sept. 29, 1978, unless otherwise noted.



                          Subpart A_Definitions



Sec.  440.1  Basis and purpose.

    This subpart interprets and implements the following sections of the 
Act:

    1902(a)(70), State option to establish a non-emergency medical 
transportation program.
    1905(a) Services included in the term ``medical assistance.''
    1905 (c), (d), (f) through (i), (l), and (m) Definitions of 
institutions and services that are included in the term ``medical 
assistance.''
    1913 ``Swing-bed'' services. (See Sec. Sec.  447.280 and 482.58 of 
this chapter for related provisions on ``swing-bed'' services.)
    1915(c) Home and community-based services listed as ``medical 
assistance'' and furnished under waivers under that section to 
individuals who would otherwise require the level of care furnished in a 
hospital, NF, or ICF/IID.
    1915(d) Home and community-based services listed as ``medical 
assistance'' and furnished under waivers under that section to 
individuals age 65 or older who would otherwise require the level of 
care furnished in a NF.
    1915(i) Home and community-based services furnished under a State 
plan to elderly and disabled individuals.

[57 FR 29155, June 30, 1992, as amended at 61 FR 38398, July 24, 1996; 
73 FR 77530, Dec. 19, 2008; 79 FR 3029, Jan. 16, 2014; 79 FR 27153, May 
12, 2014]



Sec.  440.2  Specific definitions; definitions of services for FFP
purposes.

    (a) Specific definitions.
    Inpatient means a patient who has been admitted to a medical 
institution as an inpatient on recommendation of a physician or dentist 
and who--

[[Page 339]]

    (1) Receives room, board and professional services in the 
institution for a 24 hour period or longer, or
    (2) Is expected by the institution to receive room, board and 
professional services in the institution for a 24 hour period or longer 
even though it later develops that the patient dies, is discharged or is 
transferred to another facility and does not actually stay in the 
institution for 24 hours.
    Outpatient means a patient of an organized medical facility, or 
distinct part of that facility who is expected by the facility to 
receive and who does receive professional services for less than a 24-
hour period regardless of the hour of admission, whether or not a bed is 
used, or whether or not the patient remains in the facility past 
midnight.
    Patient means an individual who is receiving needed professional 
services that are directed by a licensed practitioner of the healing 
arts toward the maintenance, improvement, or protection of health, or 
lessening of illness, disability, or pain. (See also Sec.  435.1010 of 
this chapter for definitions relating to institutional care.)
    (b) Definitions of services for FFP purposes. Except as limited in 
part 441, FFP is available in expenditures under the State plan for 
medical or remedial care and services as defined in this subpart.

[43 FR 45224, Sept. 29, 1978, as amended at 52 FR 47934, Dec. 17, 1987; 
71 FR 39229, July 12, 2006]



Sec.  440.10  Inpatient hospital services, other than services in an
institution for mental diseases.

    (a) Inpatient hospital services means services that--
    (1) Are ordinarily furnished in a hospital for the care and 
treatment of inpatients;
    (2) Are furnished under the direction of a physician or dentist; and
    (3) Are furnished in an institution that--
    (i) Is maintained primarily for the care and treatment of patients 
with disorders other than mental diseases;
    (ii) Is licensed or formally approved as a hospital by an officially 
designated authority for State standard-setting;
    (iii) Meets the requirements for participation in Medicare as a 
hospital; and
    (iv) Has in effect a utilization review plan, applicable to all 
Medicaid patients, that meets the requirements of Sec.  482.30 of this 
chapter, unless a waiver has been granted by the Secretary.
    (b) Inpatient hospital services do not include SNF and ICF services 
furnished by a hospital with a swing-bed approval.

[47 FR 21050, May 17, 1982, as amended at 47 FR 31532, July 20, 1982; 51 
FR 22041, June 17, 1986, 52 FR 47934, Dec. 17, 1987; 60 FR 61486, Nov. 
30, 1995]



Sec.  440.20  Outpatient hospital services and rural health clinic
services.

    (a) Outpatient hospital services means preventive, diagnostic, 
therapeutic, rehabilitative, or palliative services that--
    (1) Are furnished to outpatients;
    (2) Are furnished by or under the direction of a physician or 
dentist; and
    (3) Are furnished by an institution that--
    (i) Is licensed or formally approved as a hospital by an officially 
designated authority for State standard-setting; and
    (ii) Meets the requirements for participation in Medicare as a 
hospital; and
    (4) May be limited by a Medicaid agency in the following manner: A 
Medicaid agency may exclude from the definition of ``outpatient hospital 
services'' those types of items and services that are not generally 
furnished by most hospitals in the State.
    (b) Rural health clinic services. If nurse practitioners or 
physician assistants (as defined in Sec.  491.2 of this chapter) are not 
prohibited by State law from furnishing primary health care, ``rural 
health clinic services'' means the following services when furnished by 
a rural health clinic that has been certified in accordance with part 
491 of this chapter.
    (1) Services furnished by a physician within the scope of practice 
of his profession under State law, if the physician performs the 
services in the clinic or the services are furnished away from the 
clinic and the physician has an agreement with the clinic providing

[[Page 340]]

that he will be paid by it for such services.
    (2) Services furnished by a physician assistant, nurse practitioner, 
nurse midwife or other specialized nurse practitioner (as defined in 
Sec. Sec.  405.2401 and 491.2 of this chapter) if the services are 
furnished in accordance with the requirements specified in Sec.  
405.2414(a) of this chapter.
    (3) Services and supplies that are furnished as an incident to 
professional services furnished by a physician, physician assistant, 
nurse practitioner, nurse midwife, or specialized nurse practitioner. 
(See Sec. Sec.  405.2413 and 405.2415 of this chapter for the criteria 
for determining whether services and supplies are included under this 
paragraph.)
    (4) Part-time or intermittent visiting nurse care and related 
medical supplies (other than drugs and biologicals) if:
    (i) The clinic is located in an area in which the Secretary has 
determined that there is a shortage of home health agencies (see Sec.  
405.2417 of this chapter):
    (ii) The services are furnished by a registered nurse or licensed 
practical nurse or a licensed vocational nurse employed by, or otherwise 
compensated for the services by, the clinic;
    (iii) The services are furnished under a written plan of treatment 
that is established and reviewed at least every 60 days by a supervising 
physician of the clinic or that is established by a physician, physician 
assistant, nurse practitioner, nurse midwife, or specialized nurse 
practitioner and reviewed and approved at least every 60 days by a 
supervising physician of the clinic; and
    (iv) The services are furnished to a homebound beneficiary. For 
purposes of visiting nurse care, a ``homebound'' beneficiary means one 
who is permanently or temporarily confined to his place of residence 
because of a medical or health condition. He may be considered homebound 
if he leaves the place of residence infrequently. For this purpose, 
``place of residence'' does not include a hospital or a skilled nursing 
facility.
    (c) Other ambulatory services furnished by a rural health clinic. If 
the State plan covers rural health clinic services, other ambulatory 
services means ambulatory services other than rural health clinic 
services, as defined in paragraph (b) of this section, that are 
otherwise included in the plan and meet specific State plan requirements 
for furnishing those services. Other ambulatory services furnishd by a 
rural health clinic are not subject to the physician supervision 
requirements specified in Sec.  491.8(b) of this chapter, unless 
required by State law or the State plan.

[43 FR 45224, Sept. 29, 1978, as amended at 47 FR 21050, May 17, 1982; 
52 FR 47934, Dec. 17, 1987; 60 FR 61486, Nov. 30, 1995; 73 FR 66198, 
Nov. 7, 2008; 74 FR 31195, June 30, 2009; 85 FR 72909, Nov. 16, 2020]



Sec.  440.30  Other laboratory and X-ray services.

    Other laboratory and X-ray services means professional and technical 
laboratory and radiological services--
    (a) Ordered and provided by or under the direction of a physician or 
other licensed practioner of the healing arts within the scope of his 
practice as defined by State law or ordered by a physician but provided 
by referral laboratory;
    (b) Provided in an office or similar facility other than a hospital 
outpatient department or clinic; and
    (c) Furnished by a laboratory that meets the requirements of part 
493 of this chapter.
    (d) During the Public Health Emergency defined in 42 CFR 400.200 or 
any future Public Health Emergency resulting from an outbreak of 
communicable disease, and during any subsequent period of active 
surveillance (as defined in this paragraph), Medicaid coverage is 
available for laboratory tests and X-ray services that do not meet 
conditions specified in paragraph (a) or (b) of this section, if the 
purpose of such laboratory and X-ray services is to diagnose or detect 
SARS-CoV-2, antibodies to SARS-CoV-2, COVID-19, or the communicable 
disease named in the Public Health Emergency or its causes, and if the 
deviation from the conditions specified in paragraph (a) or (b) of this 
section is intended to avoid transmission of the communicable disease. 
For purposes of this paragraph, a period of active surveillance is 
defined

[[Page 341]]

as an outbreak of communicable disease during which no approved 
treatment or vaccine is widely available, and it ends on the date the 
Secretary terminates it, or the date that is two incubation periods 
after the last known case of the communicable disease, whichever is 
sooner. Additionally, during the Public Health Emergency defined in 42 
CFR 400.200 or any future Public Health Emergency resulting from an 
outbreak of communicable disease, and during any subsequent period of 
active surveillance (as defined in this paragraph), Medicaid coverage is 
available for laboratory processing of self-collected laboratory test 
systems that are authorized by the FDA for home use, if available to 
diagnose or detect SARS-CoV-2, antibodies to SARS-CoV-2, COVID-19, or 
the communicable disease named in the Public Health Emergency or its 
causes, even if those self-collected tests would not otherwise meet the 
requirements of paragraph (a) or (b) of this section, provided that the 
self-collection of the test is intended to avoid transmission of the 
communicable disease. If, pursuant to this paragraph, a laboratory 
processes a self-collected test system that is authorized by the FDA for 
home use, and the test system does not meet the conditions in paragraph 
(a) of this section, the laboratory must notify the patient and the 
patient's physician or other licensed non-physician practitioner (if 
known by the laboratory), of the results.

[46 FR 42672, Aug. 24, 1981, as amended at 57 FR 7135, Feb. 28, 1992; 85 
FR 27626, May 8, 2020]



Sec.  440.40  Nursing facility services for individuals age 21 or older
(other than services in an institution for mental disease), EPSDT, and 
family planning services and supplies.

    (a) Nursing facility services. (1) ``Nursing facility services for 
individuals age 21 or older, other than services in an institution for 
mental diseases'', means services that are--
    (i) Needed on a daily basis and required to be provided on an 
inpatient basis under Sec. Sec.  409.31 through 409.35 of this chapter.
    (ii) Provided by--
    (A) A facility or distinct part (as defined in Sec.  483.5(b) of 
this chapter) that meets the requirements for participation under 
subpart B of part 483 of this chapter, as evidenced by a valid agreement 
between the Medicaid agency and the facility for providing nursing 
facility services and making payments for services under the plan; or
    (B) If specified in the State plan, a swing-bed hospital that has an 
approval from CMS to furnish skilled nursing facility services in the 
Medicare program; and
    (iii) Ordered by and provided under the direction of a physician.
    (2) Nursing facility services include services provided by any 
facility located on an Indian reservation and certified by the Secretary 
as meeting the requirements of subpart B of part 483 of this chapter.
    (b) EPSDT. ``Early and periodic screening and diagnosis and 
treatment'' means--
    (1) Screening and diagnostic services to determine physical or 
mental defects in beneficiaries under age 21; and
    (2) Health care, treatment, and other measures to correct or 
ameliorate any defects and chronic conditions discovered. (See subpart B 
of part 441 of this chapter.)
    (c) Family planning services and supplies for individuals of child-
bearing age. [Reserved]

[59 FR 56233, Nov. 10, 1994; 60 FR 50117, Sept. 28, 1995, as amended at 
61 FR 59198, Nov. 21, 1996; 68 FR 46071, Aug. 4, 2003]



Sec.  440.50  Physicians' services and medical and surgical services
of a dentist.

    (a) ``Physicians' services,'' whether furnished in the office, the 
beneficiary's home, a hospital, a skilled nursing facility, or 
elsewhere, means services furnished by a physician--
    (1) Within the scope of practice of medicine or osteopathy as 
defined by State law; and
    (2) By or under the personal supervision of an individual licensed 
under State law to practice medicine or osteopathy.
    (b) ``Medical and surgical services of a dentist'' means medical and 
surgical services furnished, on or after January 1, 1988, by a doctor of 
dental medicine

[[Page 342]]

or dental surgery if the services are services that--
    (1) If furnished by a physician, would be considered physician's 
services.
    (2) Under the law of the State where they are furnished, may be 
furnished either by a physician or by a doctor of dental medicine or 
dental surgery; and
    (3) Are furnished by a doctor of dental medicine or dental surgery 
who is authorized to furnish those services in the State in which he or 
she furnished the services.

[56 FR 8851, Mar. 1, 1991]



Sec.  440.60  Medical or other remedial care provided by licensed
practitioners.

    (a) ``Medical care or any other type remedial care provided by 
licensed practitioners'' means any medical or remedial care or services, 
other than physicians' services, provided by licensed practitioners 
within the scope of practice as defined under State law.
    (b) Chiropractors' services include only services that--
    (1) Are provided by a chiropractor who is licensed by the State and 
meets standards issued by the Secretary under Sec.  405.232(b) of this 
chapter; and
    (2) Consists of treatment by means of manual manipulation of the 
spine that the chiropractor is legally authorized by the State to 
perform.



Sec.  440.70  Home health services.

    (a) ``Home health services'' means the services in paragraph (b) of 
this section that are provided to a beneficiary--
    (1) At his place of residence, as specified in paragraph (c) of this 
section; and
    (2) On orders written by a physician, nurse practitioner, clinical 
nurse specialist or physician assistant, working in accordance with 
State law, as part of a written plan of care that the ordering 
practitioner reviews every 60 days for services described in (b)(1), 
(2), and (4) of this section; and
    (3) On his or her physician's orders or orders written by a licensed 
practitioner of the healing arts acting within the scope of practice 
authorized under State law, as part of a written plan of care for 
services described in paragraph (b)(3) of this section. The plan of care 
must be reviewed by the ordering practitioner as specified in paragraph 
(b)(3)(iii) of this section.
    (b) Home health services include the following services and items. 
Paragraphs (b)(1), (2) and (3) of this section are required services and 
items that must be covered according to the home health coverage 
parameters. Services in paragraph (b)(4) of this section are optional. 
Coverage of home health services cannot be contingent upon the 
beneficiary needing nursing or therapy services.
    (1) Nursing service, as defined in the State Nurse Practice Act, 
that is provided on a part-time or intermittent basis by a home health 
agency as defined in paragraph (d) of this section, or if there is no 
agency in the area, a registered nurse who--
    (i) Is currently licensed to practice in the State;
    (ii) Receives written orders from the patient's practitioner as 
defined in (a)(2) of this section;
    (iii) Documents the care and services provided; and
    (iv) Has had orientation to acceptable clinical and administrative 
recordkeeping from a health department nurse.
    (2) Home health aide service provided by a home health agency,
    (3) Medical supplies, equipment, and appliances suitable for use in 
any setting in which normal life activities take place, as defined at 
Sec.  440.70(c)(1).
    (i) Supplies are health care related items that are consumable or 
disposable, or cannot withstand repeated use by more than one 
individual, that are required to address an individual medical 
disability, illness or injury.
    (ii) Equipment and appliances are items that are primarily and 
customarily used to serve a medical purpose, generally are not useful to 
an individual in the absence of a disability, illness or injury, can 
withstand repeated use, and can be reusable or removable. State Medicaid 
coverage of equipment and appliances is not restricted to the items 
covered as durable medical equipment in the Medicare program.
    (iii) A beneficiary's need for medical supplies, equipment, and 
appliances must be reviewed by a physician or, as

[[Page 343]]

defined in Sec.  400.200 of this chapter, an other licensed practitioner 
of the healing arts acting within the scope of practice authorized under 
State law, annually.
    (iv) Frequency of further physician or, as defined in Sec.  400.200 
of this chapter, an other licensed practitioner review of a 
beneficiary's continuing need for the items is determined on a case-by-
case basis based on the nature of the item prescribed.
    (v) States can have a list of preapproved medical equipment supplies 
and appliances for administrative ease but States are prohibited from 
having absolute exclusions of coverage on medical equipment, supplies, 
or appliances. States must have processes and criteria for requesting 
medical equipment that is made available to individuals to request items 
not on the State's list. The procedure must use reasonable and specific 
criteria to assess items for coverage. When denying a request, a State 
must inform the beneficiary of the right to a fair hearing.
    (4) Physical therapy, occupational therapy, or speech pathology and 
audiology services, provided by a home health agency or by a facility 
licensed by the State to provide medical rehabilitation services. (See 
Sec.  441.15 of this subchapter.)
    (c) A beneficiary's place of residence, for home health services, 
does not include a hospital, nursing facility, or intermediate care 
facility for individuals with intellectual disabilities, except for home 
health services in an intermediate care facility for Individuals with 
Intellectual Disabilities that are not required to be provided by the 
facility under subpart I of part 483. For example, a registered nurse 
may provide short-term care for a beneficiary in an intermediate care 
facility for Individuals with Intellectual Disabilities during an acute 
illness to avoid the beneficiary's transfer to a nursing facility.
    (1) Nothing in this section should be read to prohibit a beneficiary 
from receiving home health services in any setting in which normal life 
activities take place, other than a hospital, nursing facility; 
intermediate care facility for individuals with intellectual 
disabilities; or any setting in which payment is or could be made under 
Medicaid for inpatient services that include room and board. Home health 
services cannot be limited to services furnished to beneficiaries who 
are homebound.
    (2) Additional services or service hours may, at the State's option, 
be authorized to account for medical needs that arise in the settings 
home health services are provided.
    (d) ``Home health agency'' means a public or private agency or 
organization, or part of an agency or organization, that meets 
requirements for participation in Medicare, including the capitalization 
requirements under Sec.  489.28 of this chapter.
    (e) A ``facility licensed by the State to provide medical 
rehabilitation services'' means a facility that--
    (1) Provides therapy services for the primary purpose of assisting 
in the rehabilitation of disabled individuals through an integrated 
program of--
    (i) Medical evaluation and services; and
    (ii) Psychological, social, or vocational evaluation and services; 
and
    (2) Is operated under competent medical supervision either--
    (i) In connection with a hospital; or
    (ii) As a facility in which all medical and related health services 
are prescribed by or under the direction of individuals licensed to 
practice medicine or surgery in the State.
    (f) No payment may be made for services referenced in paragraphs 
(b)(1) through (4) of this section, unless a practitioner referenced in 
paragraph (a)(2) of this section or for medical equipment, a 
practitioner described in paragraph (a)(3) of this section documents 
that there was a face-to-face encounter with the beneficiary that meets 
the following requirements.
    (1) For the initiation of home health services, the face-to-face 
encounter must be related to the primary reason the beneficiary requires 
home health services and must occur within the 90 days before or within 
the 30 days after the start of the services.
    (2) For the initiation of medical equipment, the face-to-face 
encounter must be related to the primary reason

[[Page 344]]

the beneficiary requires medical equipment and must occur no more than 6 
months prior to the start of services.
    (3) The face-to-face encounter may be conducted by one of the 
following practitioners:
    (i) A physician;
    (ii) A nurse practitioner or clinical nurse specialist, as those 
terms are defined in section 1861(aa)(5) of the Act, in accordance with 
State law;
    (iii) A certified nurse midwife, as defined in section 1861(gg) of 
the Act, as authorized by State law;
    (iv) A physician assistant, as defined in section 1861(aa)(5) of the 
Act, in accordance with State law; or
    (v) For beneficiaries admitted to home health immediately after an 
acute or post-acute stay, the attending acute or post-acute physician.
    (vi) For medical equipment, supplies, or appliances, a licensed 
practitioner of the healing arts acting within the scope of practice 
authorized under state law.
    (4) If State law does not allow the non-physician practitioner, as 
described in paragraphs (f)(3)(ii) through (vi) of this section, to 
perform the face-to-face encounter independently, the non-physician 
practitioner must communicate the clinical findings of that face-to-face 
encounter to the ordering physician. Those clinical findings must be 
incorporated into a written or electronic document included in the 
beneficiary's medical record.
    (5) To assure clinical correlation between the face-to-face 
encounter and the associated home health services, the practitioner 
responsible for ordering the services must:
    (i) Document the face-to-face encounter which is related to the 
primary reason the patient requires home health services, occurred 
within the required timeframes prior to the start of home health 
services.
    (ii) Must indicate the practitioner who conducted the encounter, and 
the date of the encounter.
    (6) The face-to-face encounter may occur through telehealth, as 
implemented by the State.
    (g)(1) No payment may be made for medical equipment, supplies, or 
appliances referenced in paragraph (b)(3) of this section to the extent 
that a face-to-face encounter requirement would apply as durable medical 
equipment (DME) under the Medicare program, unless a practitioner 
referenced in paragraph (a)(3) of this section documents a face-to-face 
encounter with the beneficiary consistent with the requirements of 
paragraph (f) of this section except as indicated in paragraph (g)(2) of 
this section.
    (2) The face-to-face encounter may be performed by any of the 
practitioners described in paragraph (f)(3) of this section, with the 
exception of certified nurse-midwives, as described in paragraph 
(f)(3)(iii) of this section.

[43 FR 45224, Sept. 29, 1978, as amended at 45 FR 24888, Apr. 11, 1980; 
62 FR 47902, Sept. 11, 1997; 63 FR 310, Jan. 5, 1998; 81 FR 5566, Feb. 
2, 2016; 85 FR 19291, Apr. 6, 2020; 85 FR 27626, May 8, 2020]



Sec.  440.80  Private duty nursing services.

    Private duty nursing services means nursing services for 
beneficiaries who require more individual and continuous care than is 
available from a visiting nurse or routinely provided by the nursing 
staff of the hospital or skilled nursing facility. These services are 
provided--
    (a) By a registered nurse or a licensed practical nurse;
    (b) Under the direction of the beneficiary's physician; and
    (c) To a beneficiary in one or more of the following locations at 
the option of the State--
    (1) His or her own home;
    (2) A hospital; or
    (3) A skilled nursing facility.

[52 FR 47934, Dec. 17, 1987]



Sec.  440.90  Clinic services.

    Clinic services means preventive, diagnostic, therapeutic, 
rehabilitative, or palliative services that are furnished by a facility 
that is not part of a hospital but is organized and operated to provide 
medical care to outpatients. The term includes the following services 
furnished to outpatients:
    (a) Services furnished at the clinic by or under the direction of a 
physician or dentist.

[[Page 345]]

    (b) Services furnished outside the clinic, by clinic personnel under 
the direction of a physician, to an eligible individual who does not 
reside in a permanent dwelling or does not have a fixed home or mailing 
address.

[56 FR 8851, Mar. 1, 1991, as amended at 60 FR 61486, Nov. 30, 1995]



Sec.  440.100  Dental services.

    (a) ``Dental services'' means diagnostic, preventive, or corrective 
procedures provided by or under the supervision of a dentist in the 
practice of his profession, including treatment of--
    (1) The teeth and associated structures of the oral cavity; and
    (2) Disease, injury, or impairment that may affect the oral or 
general health of the beneficiary.
    (b) ``Dentist'' means an individual licensed to practice dentistry 
or dental surgery.

[43 FR 45224, Sept. 29, 1978, as amended at 45 FR 24888, Apr. 11, 1980]



Sec.  440.110  Physical therapy, occupational therapy, and services for
individuals with speech, hearing, and language disorders.

    (a) Physical therapy--(1) Physical therapy means services prescribed 
by a physician or other licensed practitioner of the healing arts within 
the scope of his or her practice under State law and provided to a 
beneficiary by or under the direction of a qualified physical therapist. 
It includes any necessary supplies and equipment.
    (2) A ``qualified physical therapist'' is an individual who meets 
personnel qualifications for a physical therapist at Sec.  484.115.
    (b) Occupational therapy--(1) Occupational therapy means services 
prescribed by a physician or other licensed practitioner of the healing 
arts within the scope of his or her practice under State law and 
provided to a beneficiary by or under the direction of a qualified 
occupational therapist. It includes any necessary supplies and 
equipment.
    (2) A ``qualified occupational therapist'' is an individual who 
meets personnel qualifications for an occupational therapist at Sec.  
484.115.
    (c) Services for individuals with speech, hearing, and language 
disorders--(1) Services for individuals with speech, hearing, and 
language disorders means diagnostic, screening, preventive, or 
corrective services provided by or under the direction of a speech 
pathologist or audiologist, for which a patient is referred by a 
physician or other licensed practitioner of the healing arts within the 
scope of his or her practice under State law. It includes any necessary 
supplies and equipment.
    (2) A ``speech pathologist'' is an individual who meets one of the 
following conditions:
    (i) Has a certificate of clinical competence from the American 
Speech and Hearing Association.
    (ii) Has completed the equivalent educational requirements and work 
experience necessary for the certificate.
    (iii) Has completed the academic program and is acquiring supervised 
work experience to qualify for the certificate.
    (3) A ``qualified audiologist'' means an individual with a master's 
or doctoral degree in audiology that maintains documentation to 
demonstrate that he or she meets one of the following conditions:
    (i) The State in which the individual furnishes audiology services 
meets or exceeds State licensure requirements in paragraph (c)(3)(ii)(A) 
or (c)(3)(ii)(B) of this section, and the individual is licensed by the 
State as an audiologist to furnish audiology services.
    (ii) In the case of an individual who furnishes audiology services 
in a State that does not license audiologists, or an individual exempted 
from State licensure based on practice in a specific institution or 
setting, the individual must meet one of the following conditions:
    (A) Have a Certificate of Clinical Competence in Audiology granted 
by the American Speech-Language-Hearing Association.
    (B) Have successfully completed a minimum of 350 clock-hours of 
supervised clinical practicum (or is in the process of accumulating that 
supervised clinical experience under the supervision of a qualified 
master or doctoral-level audiologist); performed at least 9 months of 
full-time audiology services under the supervision of a qualified master 
or doctoral-level audiologist after obtaining a master's or

[[Page 346]]

doctoral degree in audiology, or a related field; and successfully 
completed a national examination in audiology approved by the Secretary.

[43 FR 45224, Sept. 29, 1978, as amended at 45 FR 24888, Apr. 11, 1980; 
56 FR 8854, Mar. 1, 1991; 60 FR 19861, Apr. 21, 1995; 69 FR 30587, May 
28, 2004; 77 FR 29031, May 16, 2012; 82 FR 4578, Jan. 13, 2017]



Sec.  440.120  Prescribed drugs, dentures, prosthetic devices, and
eyeglasses.

    (a) ``Prescribed drugs'' means simple or compound substances or 
mixtures of substances prescribed for the cure, mitigation, or 
prevention of disease, or for health maintenance that are--
    (1) Prescribed by a physician or other licensed practitioner of the 
healing arts within the scope of this professional practice as defined 
and limited by Federal and State law;
    (2) Dispensed by licensed pharmacists and licensed authorized 
practitioners in accordance with the State Medical Practice Act; and
    (3) Dispensed by the licensed pharmacist or practitioner on a 
written prescription that is recorded and maintained in the pharmacist's 
or practitioner's records.
    (b) ``Dentures'' are artificial structures made by or under the 
direction of a dentist to replace a full or partial set of teeth.
    (c) ``Prosthetic devices'' means replacement, corrective, or 
supportive devices prescribed by a physician or other licensed 
practitioner of the healing arts within the scope of his practice as 
defined by State law to--
    (1) Artificially replace a missing portion of the body;
    (2) Prevent or correct physical deformity or malfunction; or
    (3) Support a weak or deformed portion of the body.
    (d) ``Eyeglasses'' means lenses, including frames, and other aids to 
vision prescribed by a physician skilled in diseases of the eye or an 
optometrist.



Sec.  440.130  Diagnostic, screening, preventive, and rehabilitative
services.

    (a) ``Diagnostic services,'' except as otherwise provided under this 
subpart, includes any medical procedures or supplies recommended by a 
physician or other licensed practitioner of the healing arts, within the 
scope of his practice under State law, to enable him to identify the 
existence, nature, or extent of illness, injury, or other health 
deviation in a beneficiary.
    (b) ``Screening services'' means the use of standardized tests given 
under medical direction in the mass examination of a designated 
population to detect the existence of one or more particular diseases or 
health deviations or to identify for more definitive studies individuals 
suspected of having certain diseases.
    (c) ``Preventive services'' means services recommended by a 
physician or other licensed practitioner of the healing arts acting 
within the scope of authorized practice under State law to--
    (1) Prevent disease, disability, and other health conditions or 
their progression;
    (2) Prolong life; and
    (3) Promote physical and mental health and efficiency.
    (d) ``Rehabilitative services,'' except as otherwise provided under 
this subpart, includes any medical or remedial services recommended by a 
physician or other licensed practitioner of the healing arts, within the 
scope of his practice under State law, for maximum reduction of physical 
or mental disability and restoration of a beneficiary to his best 
possible functional level.

[43 FR 45224, Sept. 29, 1978, as amended at 78 FR 42306, July 15, 2013]



Sec.  440.140  Inpatient hospital services, nursing facility services,
and intermediate care facility services for individuals age 65 or older
in institutions for mental diseases.

    (a) Inpatient hospital services. ``Inpatient hospital services for 
individuals age 65 or older in institutions for mental diseases'' means 
services provided under the direction of a physician for the care and 
treatment of beneficiaries in an institution for mental diseases that 
meets the requirements specified in Sec.  482.60(b), (c), and (e) of 
this chapter and--
    (1) Meets the requirements for utilization review in Sec.  
482.30(a), (b), (d), and (e) of this chapter; or
    (2) Has been granted a waiver of those utilization review 
requirements

[[Page 347]]

under section 1903(i)(4) of the Act and subpart H of part 456 of this 
chapter.
    (b) Nursing facility services. ``Nursing facility services for 
individuals age 65 or older in institutions for mental diseases'' means 
nursing facility services as defined in Sec.  440.40 and in subpart B of 
part 483 of this chapter that are provided in institutions for mental 
diseases, as defined in Sec.  435.1010 of this chapter.

[59 FR 56234, Nov. 10, 1994, as amended at 71 FR 39229, July 12, 2006]



Sec.  440.150  Intermediate care facility (ICF/IID) services.

    (a) ``ICF/IID services'' means those items and services furnished in 
an intermediate care facility for Individuals with Intellectual 
Disabilities if the following conditions are met:
    (1) The facility fully meets the requirements for a State license to 
provide services that are above the level of room and board;
    (2) The primary purpose of the ICF/IID is to furnish health or 
rehabilitative services to persons with Intellectual Disability or 
persons with related conditions;
    (3) The ICF/IID meets the standards specified in subpart I of part 
483 of this chapter.
    (4) The beneficiary with Intellectual Disability for whom payment is 
requested is receiving active treatment, as specified in Sec.  483.440 
of this chapter.
    (5) The ICF/IID has been certified to meet the requirements of 
subpart C of part 442 of this chapter, as evidenced by a valid agreement 
between the Medicaid agency and the facility for furnishing ICF/IID 
services and making payments for these services under the plan.
    (b) ICF/IID services may be furnished in a distinct part of a 
facility other than an ICF/IID if the distinct part--
    (1) Meets all requirements for an ICF/IID, as specified in subpart I 
of part 483 of this chapter;
    (2) Is clearly an identifiable living unit, such as an entire ward, 
wing, floor or building;
    (3) Consists of all beds and related services in the unit;
    (4) Houses all beneficiaries for whom payment is being made for ICF/
IID services; and
    (5) Is approved in writing by the survey agency.

[59 FR 56234, Nov. 10, 1994]



Sec.  440.155  Nursing facility services, other than in institutions for
mental diseases.

    (a) ``Nursing facility services, other than in an institution for 
mental diseases'' means services provided in a facility that--
    (1) Fully meets the requirements for a State license to provide, on 
a regular basis, health-related services to individuals who do not 
require hospital care, but whose mental or physical condition requires 
services that--
    (i) Are above the level of room and board; and
    (ii) Can be made available only through institutional facilities;
    (2) Has been certified to meet the requirements of subpart C of part 
442 of this chapter as evidenced by a valid agreement between the 
Medicaid agency and the facility for providing nursing facility services 
and making payments for services under the plan; and
    (b) ``Nursing facility services'' include services--
    (1) Considered appropriate by the State and provided by a religious 
nonmedical institution as defined in Sec.  440.170(b); or
    (2) Provided by a facility located on an Indian reservation that--
    (i) Furnishes, on a regular basis, health-related services; and
    (ii) Is certified by the Secretary to meet the standards in subpart 
E of part 442 of this chapter.
    (c) ``Nursing facility services'' may include services provided in a 
distinct part (as defined in Sec.  483.5(b) of this chapter) of a 
facility other than a nursing facility if the distinct part (as defined 
in Sec.  483.5(b) of this chapter)--
    (1) Meets all requirements for a nursing facility;
    (2) Is an identifiable unit, such as an entire ward or contiguous 
ward, a wing, floor, or building;
    (3) Consists of all beds and related facilities in the unit;
    (4) Houses all beneficiaries for whom payment is being made for 
nursing facility services, except as provided in paragraph (d) of this 
section;
    (5) Is clearly identified; and

[[Page 348]]

    (6) Is approved in writing by the survey agency.
    (d) If a State includes as nursing facility services those services 
provided by a distinct part of a facility other than a nursing facility, 
it may not require transfer of a beneficiary within or between 
facilities if, in the opinion of the attending physician, it might be 
harmful to the physical or mental health of the beneficiary.
    (e) Nursing facility services may include services provided in a 
swing-bed hospital that has an approval to furnish nursing facility 
services.

[59 FR 56234, Nov. 10, 1994, as amended at 64 FR 67052, Nov. 30, 1999; 
68 FR 46071, Aug. 4, 2003]



Sec.  440.160  Inpatient psychiatric services for individuals under age 21.

    ``Inpatient psychiatric services for individuals under age 21'' 
means services that--
    (a) Are provided under the direction of a physician;
    (b) Are provided by--
    (1) A psychiatric hospital that undergoes a State survey to 
determine whether the hospital meets the requirements for participation 
in Medicare as a psychiatric hospital as specified in Sec.  482.60 of 
this chapter, or is accredited by a national organization whose 
psychiatric hospital accrediting program has been approved by CMS; or a 
hospital with an inpatient psychiatric program that undergoes a State 
survey to determine whether the hospital meets the requirements for 
participation in Medicare as a hospital, as specified in part 482 of 
this chapter, or is accredited by a national accrediting organization 
whose hospital accrediting program has been approved by CMS.
    (2) A psychiatric facility which is accredited by the Joint 
Commission on Accreditation of Healthcare Organizations, the Council on 
Accreditation of Services for Families and Children, the Commission on 
Accreditation of Rehabilitation Facilities, or by any other accrediting 
organization, with comparable standards, that is recognized by the 
State.
    (c) Meet the requirements in Sec.  441.151 of this subchapter.

[63 FR 64198, Nov. 19, 1998, as amended at 75 FR 50418, Aug. 16, 2010]



Sec.  440.165  Nurse-midwife service.

    (a) ``Nurse-midwife services'' means services that--
    (1) Are furnished by a nurse-midwife within the scope of practice 
authorized by State law or regulation and, in the case of inpatient or 
outpatient hospital services or clinic services, are furnished by or 
under the direction of a nurse-midwife to the extent permitted by the 
facility; and
    (2) Unless required by State law or regulations or a facility, are 
reimbursed without regard to whether the nurse-midwife is under the 
supervision of, or associated with, a physician or other health care 
provider. (See Sec.  441.21 of this chapter for provisions on 
independent provider agreements for nurse-midwives.)
    (b) ``Nurse-midwife'' means a registered professional nurse who 
meets the following requirements:
    (1) Is currently licensed to practice in the State as a registered 
professional nurse.
    (2) Is legally authorized under State law or regulations to practice 
as a nurse-midwife.
    (3) Except as provided in paragraph (b)(4) of this section, has 
completed a program of study and clinical experience for nurse-midwives, 
as specified by the State.
    (4) If the State does not specify a program of study and clinical 
experience that nurse-midwives must complete to practice in that State, 
meets one of the following conditions:
    (i) Is currently certified as a nurse-midwife by the American 
College of Nurse-Midwives (ACNM or by the ACNM Certification Council, 
Inc. (ACC).
    (ii) Has satisfactorily completed a formal education program (of at 
least one academic year) that, upon completion qualifies the nurse to 
take the certification examination offered by the American College of 
Nurse-Midwives (ACNM) or by the ACNM Certification Council, Inc. (ACC).
    (iii) Has successfully completed a formal educational program for 
preparing

[[Page 349]]

registered nurses to furnish gynecological and obstetrical care to women 
during pregnancy, delivery, and the postpartum period, and care to 
normal newborns, and was practicing as a nurse-midwife for a total of 12 
months during any 18-month period from August 8, 1976 to July 16, 1982.

[47 FR 21050, May 17, 1982; 47 FR 23448, May 28, 1982, as amended at 55 
FR 48611, Nov. 21, 1990; 61 FR 61486, Nov. 30, 1996]



Sec.  440.166  Nurse practitioner services.

    (a) Definition of nurse practitioner services. Nurse practitioner 
services means services that are furnished by a registered professional 
nurse who meets a State's advanced educational and clinical practice 
requirements, if any, beyond the 2 to 4 years of basic nursing education 
required of all registered nurses.
    (b) Requirements for certified pediatric nurse practitioner. The 
practitioner must be a registered professional nurse who meets the 
requirements specified in either paragraphs (b)(1) or (b)(2) of this 
section.
    (1) If the State specifies qualifications for pediatric nurse 
practitioners, the practitioner must--
    (i) Be currently licensed to practice in the State as a registered 
professional nurse; and
    (ii) Meet the State requirements for qualification of pediatric 
nurse practitioners in the State in which he or she furnishes the 
services.
    (2) If the State does not specify, by specialty, qualifications for 
pediatric nurse practitioners, but the State does define qualifications 
for nurses in advanced practice or general nurse practitioners, the 
practitioner must--
    (i) Meet qualifications for nurses in advanced practice or general 
nurse practitioners as defined by the State; and
    (ii) Have a pediatric nurse practice limited to providing primary 
health care to persons less than 21 years of age.
    (c) Requirements for certified family nurse practitioner. The 
practitioner must be a registered professional nurse who meets the 
requirements specified in either paragraph (c)(1) or (c)(2) of this 
section.
    (1) If the State specifies qualifications for family nurse 
practitioners, the practitioner must--
    (i) Be currently licensed to practice in the State as a registered 
professional nurse; and
    (ii) Meet the State requirements for qualification of family nurse 
practitioners in the State in which he or she furnishes the services.
    (2) If the State does not specify, by specialty, qualifications for 
family nurse practitioners, but the State does define qualifications for 
nurses in advanced practice or general nurse practitioners, the 
practitioner must--
    (i) Meet qualifications for nurses in advanced practice or general 
nurse practitioners as defined by the State; and
    (ii) Have a family nurse practice limited to providing primary 
health care to individuals and families.
    (d) Payment for nurse practitioner services. The Medicaid agency 
must reimburse nurse practitioners for their services in accordance with 
Sec.  441.22(c) of this subchapter.

[60 FR 19861, Apr. 21, 1995]



Sec.  440.167  Personal care services.

    Unless defined differently by a State agency for purposes of a 
waiver granted under part 441, subpart G of this chapter--
    (a) Personal care services means services furnished to an individual 
who is not an inpatient or resident of a hospital, nursing facility, 
intermediate care facility for individuals with intellectual 
disabilities, or institution for mental disease that are--
    (1) Authorized for the individual by a physician in accordance with 
a plan of treatment or (at the option of the State) otherwise authorized 
for the individual in accordance with a service plan approved by the 
State;
    (2) Provided by an individual who is qualified to provide such 
services and who is not a member of the individual's family; and
    (3) Furnished in a home, and at the State's option, in another 
location.
    (b) For purposes of this section, family member means a legally 
responsible relative.

[42 FR 47902, Sept. 11, 1997]

[[Page 350]]



Sec.  440.168  Primary care case management services.

    (a) Primary care case management services means case management 
related services that--
    (1) Include location, coordination, and monitoring of primary health 
care services; and
    (2) Are provided under a contract between the State and either of 
the following:
    (i) A PCCM who is a physician or may, at State option, be a 
physician assistant, nurse practitioner, or certified nurse-midwife.
    (ii) A physician group practice, or an entity that employs or 
arranges with physicians to furnish the services.
    (b) Primary care case management services may be offered by the 
State--
    (1) As a voluntary option under the State plan; or
    (2) On a mandatory basis under section 1932 (a)(1) of the Act or 
under section 1915(b) or section 1115 waiver authority.

[67 FR 41115, June 14, 2002]



Sec.  440.169  Case management services.

    (a) Case management services means services furnished to assist 
individuals, eligible under the State plan who reside in a community 
setting or are transitioning to a community setting, in gaining access 
to needed medical, social, educational, and other services, in 
accordance with Sec.  441.18 of this chapter.
    (b) Targeted case management services means case management services 
furnished without regard to the requirements of Sec.  431.50(b) of this 
chapter (related to statewide provision of services) and Sec.  440.240 
(related to comparability). Targeted case management services may be 
offered to individuals in any defined location of the State or to 
individuals within targeted groups specified in the State plan.
    (c) [Reserved]
    (d) The assistance that case managers provide in assisting eligible 
individuals obtain services includes--
    (1) Comprehensive assessment and periodic reassessment of individual 
needs, to determine the need for any medical, educational, social, or 
other services. These assessment activities include the following:
    (i) Taking client history.
    (ii) Identifying the needs of the individual, and completing related 
documentation.
    (iii) Gathering information from other sources, such as family 
members, medical providers, social workers, and educators (if necessary) 
to form a complete assessment of the eligible individual.
    (2) Development (and periodic revision) of a specific care plan 
based on the information collected through the assessment, that includes 
the following:
    (i) Specifies the goals and actions to address the medical, social, 
educational, and other services needed by the eligible individual.
    (ii) Includes activities such as ensuring the active participation 
of the eligible individual and working with the individual (or the 
individual's authorized health care decision maker) and others to 
develop those goals.
    (iii) Identifies a course of action to respond to the assessed needs 
of the eligible individual.
    (3) Referral and related activities (such as scheduling appointments 
for the individual) to help the eligible individual obtain needed 
services, including activities that help link the individual with 
medical, social, and educational providers or other programs and 
services that are capable of providing needed services to address 
identified needs and achieve goals specified in the care plan.
    (4) Monitoring and follow-up activities, including activities and 
contacts that are necessary to ensure that the care plan is effectively 
implemented and adequately addresses the needs of the eligible 
individual and which may be with the individual, family members, service 
providers, or other entities or individuals and conducted as frequently 
as necessary, and including at least one annual monitoring, to help 
determine whether the following conditions are met:
    (i) Services are being furnished in accordance with the individual's 
care plan.
    (ii) Services in the care plan are adequate.

[[Page 351]]

    (iii) There are changes in the needs or status of the eligible 
individual. Monitoring and follow-up activities include making necessary 
adjustments in the care plan and service arrangements with providers.
    (e) Case management may include contacts with non-eligible 
individuals that are directly related to the identification of the 
eligible individual's needs and care, for the purposes of helping the 
eligible individual access services, identifying needs and supports to 
assist the eligible individual in obtaining services, providing case 
managers with useful feedback, and alerting case managers to changes in 
the eligible individual's needs.

[72 FR 68091, Dec. 4, 2007, as amended at 74 FR 31196, June 30, 2009]



Sec.  440.170  Any other medical care or remedial care recognized 
under State law and specified by the Secretary.

    (a) Transportation. (1) ``Transportation'' includes expenses for 
transportation and other related travel expenses determined to be 
necessary by the agency to secure medical examinations and treatment for 
a beneficiary.
    (2) Except as provided in paragraph (a)(4), transportation, as 
defined in this section, is furnished only by a provider to whom a 
direct vendor payment can appropriately be made by the agency.
    (3) ``Travel expenses'' include--
    (i) The cost of transportation for the beneficiary by ambulance, 
taxicab, common carrier, or other appropriate means;
    (ii) The cost of meals and lodging en route to and from medical 
care, and while receiving medical care; and
    (iii) The cost of an attendant to accompany the beneficiary, if 
necessary, and the cost of the attendant's transportation, meals, 
lodging, and, if the attendant is not a member of the beneficiary's 
family, salary.
    (4) Non-emergency medical transportation brokerage program. At the 
option of the State, and notwithstanding Sec.  431.50 (statewide 
operation) and Sec.  431.51 (freedom of choice of providers) of this 
chapter and Sec.  440.240 (comparability of services for groups), a 
State plan may provide for the establishment of a non-emergency medical 
transportation brokerage program in order to more cost-effectively 
provide non-emergency medical transportation services for individuals 
eligible for medical assistance under the State plan who need access to 
medical care or services, and have no other means of transportation. 
These transportation services include wheelchair vans, taxis, stretcher 
cars, bus passes and tickets, secured transportation containing an 
occupant protection system that addresses safety needs of disabled or 
special needs individuals, and other forms of transportation otherwise 
covered under the state plan.
    (i) Non-emergency medical transportation services may be provided 
under contract with individuals or entities that meet the following 
requirements:
    (A) Is selected through a competitive bidding process that is 
consistent with 45 CFR 75.326 through 75.340 and is based on the State's 
evaluation of the broker's experience, performance, references, 
resources, qualifications, and costs.
    (B) Has oversight procedures to monitor beneficiary access and 
complaints and ensure that transportation is timely and that transport 
personnel are licensed, qualified, competent, and courteous.
    (C) Is subject to regular auditing and oversight by the State in 
order to ensure the quality and timeliness of the transportation 
services provided and the adequacy of beneficiary access to medical care 
and services.
    (D) Is subject to a written contract that imposes the requirements 
related to prohibitions on referrals and conflicts of interest described 
at Sec.  440.170(a)(4)(ii), and provides for the broker to be liable for 
the full cost of services resulting from a prohibited referral or 
subcontract.
    (ii) Federal financial participation is available at the medical 
assistance rate for the cost of a written brokerage contract that:
    (A) Except as provided in paragraph (a)(4)(ii)(B) of this section, 
prohibits the broker (including contractors, owners, investors, Boards 
of Directors, corporate officers, and employees) from providing non-
emergency medical transportation services or making a referral or 
subcontracting to a transportation service provider if:

[[Page 352]]

    (1) The broker has a financial relationship with the transportation 
provider as defined at Sec.  411.354(a) of this chapter with 
``transportation broker'' substituted for ``physician'' and ``non-
emergency transportation'' substituted for ``DHS''; or
    (2) The broker has an immediate family member, as defined at Sec.  
411.351 of this chapter, that has a direct or indirect financial 
relationship with the transportation provider, with the term 
``transportation broker'' substituted for ``physician.''
    (B) Exceptions: The prohibitions described at clause (A) of this 
paragraph do not apply if there is documentation to support the 
following:
    (1) Transportation is provided in a rural area, as defined at Sec.  
412.62(f), and there is no other available Medicaid participating 
provider or other provider determined by the State to be qualified 
except the non-governmental broker.
    (2) Transportation is so specialized that there is no other 
available Medicaid participating provider or other provider determined 
by the State to be qualified except the non-governmental broker.
    (3) Except for the non-governmental broker, the availability of 
other Medicaid participating providers or other providers determined by 
the State to be qualified is insufficient to meet the need for 
transportation.
    (4) The broker is a government entity and the individual service is 
provided by the broker, or is referred to or subcontracted with another 
government-owned or operated transportation provider generally available 
in the community, if the following conditions are met:
    (i) The contract with the broker provides for payment that does not 
exceed the actual costs calculated as though the broker were a distinct 
unit, and excludes from these payments any personnel or other costs 
shared with or allocated from parent or related entities; and the 
governmental broker maintains an accounting system such that all funds 
allocated to the Medicaid brokerage program and all costs charged to the 
brokerage program will be completely separate from any other program;
    (ii) The broker documents that, with respect to the individual's 
specific transportation needs, the government provider is the most 
appropriate and lowest cost alternative; and
    (iii) The broker documents that the Medicaid program is paying no 
more for fixed route public transportation than the rate charged to the 
general public and no more for public paratransit services than the rate 
charged to other State human services agencies for comparable services.
    (C) Transportation providers may not offer or make any payment or 
other form of remuneration, including any kickback, rebate, cash, gifts, 
or service in kind to the broker in order to influence referrals or 
subcontracting for non-emergency medical transportation provided to a 
Medicaid beneficiary.
    (D) In referring or subcontracting for non-emergency medical 
transportation with transportation providers, a broker may not withhold 
necessary non-emergency medical transportation from a Medicaid 
beneficiary or provide non-emergency medical transportation that is not 
the most appropriate and a cost-effective means of transportation for 
that beneficiary for the purpose of financial gain, or for any other 
purpose.
    (b) Services furnished in a religious nonmedical health care 
institution. Services furnished in a religious nonmedical health care 
institution are services furnished in an institution that:
    (1) Is an institution that is described in (c)(3) of section 501 of 
the Internal Revenue Code of 1986 and is exempt from taxes under section 
501(a) of that section.
    (2) Is lawfully operated under all applicable Federal, State, and 
local laws and regulations.
    (3) Furnishes only nonmedical nursing items and services to patients 
who choose to rely solely upon a religious method of healing and for 
whom the acceptance of medical health 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.

[[Page 353]]

    (5) Furnishes these nonmedical items and services to inpatients on a 
24-hour basis.
    (6) Does not furnish, on the basis of its 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 or 5 percent or more in a provider of medical treatment or 
services. Permissible affiliations are described in paragraph (c) of 
this section.
    (8) Has in effect a utilization review plan that meets the following 
criteria:
    (i) Provides for the review of admissions to the institution, 
duration of stays, cases of continuous extended duration, and items and 
services furnished by the institution.
    (ii) Requires that the reviews be made by a 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 utilization review committee.
    (iv) Meets other requirements as CMS 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 determinations.
    (10) Meets other requirements as CMS finds necessary in the interest 
of the health and safety of patients who receive services in the 
institution. These requirements are the conditions of participation 
found at part 403, subpart G of this chapter.
    (c) Affiliations. An affiliation is permissible for purposes of 
paragraph (b)(7) of this section if it is between one of the following:
    (1) 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.
    (2) An individual who is a director, trustee, officer, employee, or 
staff member of an RNHCI and an 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.
    (3) The RNHCI and an individual or entity furnishing goods or 
services as a vendor to both providers of medical treatment or services 
and RNHCIs.
    (d) Skilled nursing facility services for individuals under age 21. 
``Skilled nursing facility services for individuals under 21'' means 
those services specified in Sec.  440.40 that are provided to 
beneficiaries under 21 years of age.
    (e) Emergency hospital services. ``Emergency hospital services'' 
means services that--
    (1) Are necessary to prevent the death or serious impairment of the 
health of a beneficiary; and
    (2) Because of the threat to the life or health of the beneficiary 
necessitate the use of the most accessible hospital available that is 
equipped to furnish the services, even if the hospital does not 
currently meet--
    (i) The conditions for participation under Medicare; or
    (ii) The definitions of inpatient or outpatient hospital services 
under Sec. Sec.  440.10 and 440.20.
    (f) [Reserved]
    (g) Critical access hospital (CAH). (1) CAH services means services 
that (i) are furnished by a provider that meet the requirements for 
participation in Medicare as a CAH (see subpart F of part 485 of this 
chapter), and (ii) are of a type that would be paid for by Medicare when 
furnished to a Medicare beneficiary.

[[Page 354]]

    (2) Inpatient CAH services do not include nursing facility services 
furnished by a CAH with a swing-bed approval.

[43 FR 45224, Sept. 29, 1978, as amended at 45 FR 24889, Apr. 11, 1980; 
46 FR 48540, Oct. 1, 1981; 58 FR 30671, May 26, 1993; 62 FR 46037, Aug. 
29, 1997; 64 FR 67051, Nov. 30, 1999; 72 FR 73651, Dec. 28, 2007; 73 FR 
77530, Dec. 19, 2008; 74 FR 31196, June 30, 2009; 81 FR 3011, Jan. 20, 
2016]



Sec.  440.180  Home and community-based waiver services.

    (a) Description and requirements for services. ``Home or community-
based services'' means services, not otherwise furnished under the 
State's Medicaid plan, that are furnished under a waiver granted under 
the provisions of part 441, subpart G of this chapter.
    (1) These services may consist of any or all of the services listed 
in paragraph (b) of this section, as those services are defined by the 
agency and approved by CMS.
    (2) The services must meet the standards specified in Sec.  
441.302(a) of this chapter concerning health and welfare assurances.
    (3) The services are subject to the limits on FFP described in Sec.  
441.310 of this chapter.
    (b) Included services. Home or community-based services may include 
the following services, as they are defined by the agency and approved 
by CMS:
    (1) Case management services.
    (2) Homemaker services.
    (3) Home health aide services.
    (4) Personal care services.
    (5) Adult day health services.
    (6) Habilitation services.
    (7) Respite care services.
    (8) Day treatment or other partial hospitalization services, 
psychosocial rehabilitation services and clinic services (whether or not 
furnished in a facility) for individuals with chronic mental illness, 
subject to the conditions specified in paragraph (d) of this section.
    (9) Other services requested by the agency and approved by CMS as 
cost effective and necessary to avoid institutionalization.
    (c) Expanded habilitation services, effective October 1, 1997--(1) 
General rule. Expanded habilitation services are those services 
specified in paragraph (c)(2) of this section.
    (2) Services included. The agency may include as expanded 
habilitation services the following services:
    (i) Prevocational services, which means services that prepare an 
individual for paid or unpaid employment and that are not job-task 
oriented but are, instead, aimed at a generalized result. These services 
may include, for example, teaching an individual such concepts as 
compliance, attendance, task completion, problem solving and safety. 
Prevocational services are distinguishable from noncovered vocational 
services by the following criteria:
    (A) The services are provided to persons who are not expected to be 
able to join the general work force or participate in a transitional 
sheltered workshop within one year (excluding supported employment 
programs).
    (B) If the beneficiaries are compensated, they are compensated at 
less than 50 percent of the minimum wage;
    (C) The services include activities which are not primarily directed 
at teaching specific job skills but at underlying habilitative goals 
(for example, attention span, motor skills); and
    (D) The services are reflected in a plan of care directed to 
habilitative rather than explicit employment objectives.
    (ii) Educational services, which means special education and related 
services (as defined in sections 602(16) and (17) of the Education of 
the Handicapped Act) (20 U.S.C. 1401 (16 and 17)) to the extent they are 
not prohibited under paragraph (c)(3)(i) of this section.
    (iii) Supported employment services, which facilitate paid 
employment, that are--
    (A) Provided to persons for whom competitive employment at or above 
the minimum wage is unlikely and who, because of their disabilities, 
need intensive ongoing support to perform in a work setting;
    (B) Conducted in a variety of settings, particularly worksites in 
which persons without disabilities are employed; and
    (C) Defined as any combination of special supervisory services, 
training,

[[Page 355]]

transportation, and adaptive equipment that the State demonstrates are 
essential for persons to engage in paid employment and that are not 
normally required for nondisabled persons engaged in competitive 
employment.
    (3) Services not included. The following services may not be 
included as habilitation services:
    (i) Special education and related services (as defined in sections 
602(16) and (17) of the Education of the Handicapped Act) (20 U.S.C. 
1401 (16) and (17)) that are otherwise available to the individual 
through a local educational agency.
    (ii) Vocational rehabilitation services that are otherwise available 
to the individual through a program funded under section 110 of the 
Rehabilitation Act of 1973 (29 U.S.C. 730).
    (d) Services for the chronically mentally ill--(1) Services 
included. Services listed in paragraph (b)(8) of this section include 
those provided to individuals who have been diagnosed as being 
chronically mentally ill, for which the agency has requested approval as 
part of either a new waiver request or a renewal and which have been 
approved by CMS on or after October 21, 1986.
    (2) Services not included. Any home and community-based service, 
including those indicated in paragraph (b)(8) of this section, may not 
be included in home and community-based service waivers for the 
following individuals:
    (i) For individuals aged 22 through 64 who, absent the waiver, would 
be institutionalized in an institution for mental diseases (IMD); and, 
therefore, subject to the limitation on IMDs specified in Sec.  
435.1009(a)(2) of this chapter.
    (ii) For individuals, not meeting the age requirements described in 
paragraph (d)(2)(i) of this section, who, absent the waiver, would be 
placed in an IMD in those States that have not opted to include the 
benefits defined in Sec.  440.140 or Sec.  440.160.

[59 FR 37716, July 25, 1994, as amended at 65 FR 60107, Oct. 10, 2000; 
71 FR 39229, July 12, 2006]



Sec.  440.181  Home and community-based services for individuals 
age 65 or older.

    (a) Description of services-- Home and community-based services for 
individuals age 65 or older means services, not otherwise furnished 
under the State's Medicaid plan, or services already furnished under the 
State's Medicaid plan but in expanded amount, duration, or scope, which 
are furnished to individuals age 65 or older under a waiver granted 
under the provisions of part 441, subpart H of this subchapter. Except 
as provided in Sec.  441.310, the services may consist of any of the 
services listed in paragraph (b) of this section that are requested by 
the State, approved by CMS, and furnished to eligible beneficiaries. 
Service definitions for each service in paragraph (b) of this section 
must be approved by CMS.
    (b) Included services. (1) Case management services.
    (2) Homemaker services.
    (3) Home health aide services.
    (4) Personal care services.
    (5) Adult day health services.
    (6) Respite care services.
    (7) Other medical and social services requested by the Medicaid 
agency and approved by CMS, which will contribute to the health and 
well-being of individuals and their ability to reside in a community-
based care setting.

[57 FR 29156, June 30, 1992]



Sec.  440.182  State plan home and community-based services.

    (a) Definition. State plan home and community-based services (HCBS) 
benefit means the services listed in paragraph (c) of this section when 
provided under the State's plan (rather than through an HCBS waiver 
program) for individuals described in paragraph (b) of this section.
    (b) State plan HCBS coverage. State plan HCBS can be made available 
to individuals who--
    (1) Are eligible under the State plan and have income, calculated 
using the otherwise applicable rules, including any less restrictive 
income disregards used by the State for that group under section 
1902(r)(2) of the Act, that does not exceed 150 percent of the Federal 
Poverty Line (FPL); and
    (2) In addition to the individuals described in paragraph (b)(1) of 
this section, to individuals based on the State's election of the 
eligibility groups described in Sec.  435.219(b) or Sec.  436.219(b) of 
this chapter.

[[Page 356]]

    (c) Services. The State plan HCBS benefit consists of one or more of 
the following services:
    (1) Case management services.
    (2) Homemaker services.
    (3) Home health aide services.
    (4) Personal care services.
    (5) Adult day health services.
    (6) Habilitation services, which include expanded habilitation 
services as specified in Sec.  440.180(c).
    (7) Respite care services.
    (8) Subject to the conditions in Sec.  440.180(d)(2), for 
individuals with chronic mental illness:
    (i) Day treatment or other partial hospitalization services;
    (ii) Psychosocial rehabilitation services;
    (iii) Clinic services (whether or not furnished in a facility).
    (9) Other services requested by the agency and approved by the 
Secretary as consistent with the purpose of the benefit.
    (d) Exclusion. FFP is not available for the cost of room and board 
in State plan HCBS. The following HCBS costs are not considered room or 
board for purposes of this exclusion:
    (1) The cost of temporary food and shelter provided as an integral 
part of respite care services in a facility approved by the State.
    (2) Meals provided as an integral component of a program of adult 
day health services or another service and consistent with standard 
procedures in the State for such a program.
    (3) A portion of the rent and food costs that may be reasonably 
attributed to an unrelated caregiver providing State plan HCBS who is 
residing in the same household with the recipient, but not if the 
recipient is living in the home of the caregiver or in a residence that 
is owned or leased by the caregiver.

[79 FR 3029, Jan. 16, 2014]



Sec.  440.185  Respiratory care for ventilator-dependent individuals.

    (a) ``Respiratory care for ventilator-dependent individuals'' means 
services that are not otherwise available under the State's Medicaid 
plan, provided on a part-time basis in the beneficiary's home by a 
respiratory therapist or other health care professional trained in 
respiratory therapy (as determined by the State) to an individual who--
    (1) Is medically dependent on a ventilator for life support at least 
6 hours per day;
    (2) Has been so dependent for at least 30 consecutive days (or the 
maximum number of days authorized under the State plan, whichever is 
less) as an inpatient in one or more hospitals, NFs, or ICFs/IID;
    (3) Except for the availability of respiratory care services, would 
require respiratory care as an inpatient in a hospital, NF, or ICF/IID 
and would be eligible to have payment made for inpatient care under the 
State plan;
    (4) Has adequate social support services to be cared for at home;
    (5) Wishes to be cared for at home; and
    (6) Receives services under the direction of a physician who is 
familiar with the technical and medical components of home ventilator 
support, and who has medically determined that in-home care is safe and 
feasible for the individual.
    (b) For purposes of paragraphs (a)(4) and (5) of this section, a 
beneficiary's home does not include a hospital, NF, ICF/IID or other 
institution as defined in Sec.  435.1010 of this chapter.

[59 FR 37717, July 25, 1994, as amended at 71 FR 39229, July 12, 2006]



      Subpart B_Requirements and Limits Applicable to All Services



Sec.  440.200  Basis, purpose, and scope.

    (a) This subpart implements the following statutory requirements--
    (1) Section 1902(a)(10), regarding comparability of services for 
groups of beneficiaries, and the amount, duration, and scope of services 
described in section 1905(a) of the Act that the State plan must provide 
for beneficiaries;
    (2) Section 1902(a)(22)(D), which provides for standards and methods 
to assure quality of services;
    (3) Section 1903(v)(1), which provides that no payment may be made 
to a State under this section for medical assistance furnished to an 
alien who is not lawfully admitted for permanent

[[Page 357]]

residence or otherwise permanently residing in the United States under 
color of law;
    (4) Section 1903(v)(2) which provides that FFP will be available for 
services necessary to treat an emergency medical condition of an alien 
not described in paragraph (a)(3) of this section if that alien 
otherwise meets the eligibility requirements of the State plan;
    (5) Section 1907 on observance of religious beliefs;
    (6) Section 1915 on exceptions to section 1902(a)(10) and waivers of 
other requirements of section 1902 of the Act; and
    (7) Sections 245A(h), 210 and 210A of the Immigration and 
Nationality Act which provide that certain aliens who are legalized may 
be eligible for Medicaid.
    (b) The requirements and limits of this subpart apply for all 
services defined in subpart A of this part.

[55 FR 36822, Sept. 7, 1990]



Sec.  440.210  Required services for the categorically needy.

    (a) A State plan must specify that, at a minimum, categorically 
needy beneficiaries are furnished the following services:
    (1) The services defined in Sec. Sec.  440.10 through 440.50, 
440.70, and (to the extent nurse-midwives and nurse practitioners are 
authorized to practice under State law or regulation) the services 
defined in Sec. Sec.  440.165 and 440.166, respectively.
    (2) Pregnancy-related services and services for other conditions 
that might complicate the pregnancy.
    (i) Pregnancy-related services are those services that are necessary 
for the health of the pregnant woman and fetus, or that have become 
necessary as a result of the woman having been pregnant. These include, 
but are not limited to, prenatal care, delivery, postpartum care, and 
family planning services.
    (ii) Services for other conditions that might complicate the 
pregnancy include those for diagnoses, illnesses, or medical conditions 
which might threaten the carrying of the fetus to full term or the safe 
delivery of the fetus; and
    (3) For women who, while pregnant, applied for, were eligible for, 
and received Medicaid services under the plan, all services under the 
plan that are pregnancy-related for an extended postpartum period. The 
postpartum period begins on the last day of pregnancy and extends 
through the end of the month in which the 60-day period following 
termination of pregnancy ends.
    (b) A State plan must specify that eligible aliens as defined in 
Sec. Sec.  435.406(a) and 436.406(a) of this subchapter will receive at 
least the services provided in paragraph (a) of this section.
    (c) A State plan must specify that aliens not defined in Sec. Sec.  
435.406(a) and 436.406(a) of this subchapter will only be provided the 
limited services specified in Sec.  440.255.

[56 FR 24010, May 28, 1991, as amended at 60 FR 19862, Apr. 21, 1995]



Sec.  440.220  Required services for the medically needy.

    (a) A State plan that includes the medically needy must specify that 
the medically needy are provided, as a minimum, the following services:
    (1) Prenatal care and delivery services for pregnant women.
    (2) Ambulatory services, as defined in the State plan, for:
    (i) Individuals under age 18; and
    (ii) Groups of individuals entitled to institutional services.
    (3) Home health services (Sec.  440.70) to any individual entitled 
to skilled nursing facility services.
    (4) If the State plan includes services in an institution for mental 
diseases (Sec.  440.140 or Sec.  440.160) or in an intermediate care 
facility for Individuals with Intellectual Disabilities (Sec.  
440.150(c)) for any group of medically needy, either of the following 
sets of services to each of the medically needy groups:
    (i) The services contained in Sec. Sec.  440.10 through 440.50 and 
(to the extent nurse-midwives are authorized to practice under State law 
or regulation) Sec.  440.165; or
    (ii) The services contained in any seven of the sections in 
Sec. Sec.  440.10 through 440.165.
    (5) For women who, while pregnant, applied for, were eligible as 
medically

[[Page 358]]

needy for, and received Medicaid services under the plan, services under 
the plan that are pregnancy-related (as defined in Sec.  
440.210(a)(2)(i) of this subpart) for an extended postpartum period. The 
postpartum period begins on the last day of pregnancy and extends 
through the end of the month in which the 60-day period following 
termination of pregnancy ends.
    (b) A State plan must specify that eligible aliens as defined in 
Sec. Sec.  435.406(a) and 436.406(a) of this subchapter will receive at 
least the services provided in paragraphs (a)(4) (i) and (ii) of this 
section.
    (c) A State plan must specify that aliens defined in Sec. Sec.  
435.406(b), 435.406(c), 436.406(b) and 436.406(c) of this subchapter 
will only be provided the limited services specified in Sec.  440.255.

[56 FR 24011, May 28, 1991, as amended at 58 FR 4938, Jan. 19, 1993]



Sec.  440.225  Optional services.

    Any of the services defined in subpart A of this part that are not 
required under Sec. Sec.  440.210 and 440.220 may be furnished under the 
State plan at the State's option.

[60 FR 19862, Apr. 21, 1995]



Sec.  440.230  Sufficiency of amount, duration, and scope.

    (a) The plan must specify the amount, duration, and scope of each 
service that it provides for--
    (1) The categorically needy; and
    (2) Each covered group of medically needy.
    (b) Each service must be sufficient in amount, duration, and scope 
to reasonably achieve its purpose.
    (c) The Medicaid agency may not arbitrarily deny or reduce the 
amount, duration, or scope of a required service under Sec. Sec.  
440.210 and 440.220 to an otherwise eligible beneficiary solely because 
of the diagnosis, type of illness, or condition.
    (d) The agency may place appropriate limits on a service based on 
such criteria as medical necessity or on utilization control procedures.

[46 FR 47993, Sept. 30, 1981]



Sec.  440.240  Comparability of services for groups.

    Except as limited in Sec.  440.250--
    (a) The plan must provide that the services available to any 
categorically needy beneficiary under the plan are not less in amount, 
duration, and scope than those services available to a medically needy 
beneficiary; and
    (b) The plan must provide that the services available to any 
individual in the following groups are equal in amount, duration, and 
scope for all beneficiaries within the group:
    (1) The categorically needy.
    (2) A covered medically needy group.

[46 FR 47993, Sept. 30, 1981]



Sec.  440.250  Limits on comparability of services.

    (a) Skilled nursing facility services (Sec.  440.40(a)) may be 
limited to beneficiaries age 21 or older.
    (b) Early and periodic screening, diagnosis, and treatment (Sec.  
440.40(b)) must be limited to beneficiaries under age 21.
    (c) Family planning services and supplies must be limited to 
beneficiaries of childbearing age, including minors who can be 
considered sexually active and who desire the services and supplies.
    (d) If covered under the plan, services to beneficiaries in 
institutions for mental diseases (Sec.  440.140) must be limited to 
those age 65 or older.
    (e) If covered under the plan, inpatient psychiatric services (Sec.  
440.160) must be limited to beneficiaries under age 22 as specified in 
Sec.  441.151(c) of this subchapter.
    (f) If Medicare benefits under Part B of title XVIII are made 
available to beneficiaries through a buy-in agreement or payment of 
premiums, or part or all of the deductibles, cost sharing or similar 
charges, they may be limited to beneficiaries who are covered by the 
agreement or payment.
    (g) If services in addition to those offered under the plan are made 
available under a contract between the agency or political subdivision 
and an organization providing comprehensive health services, those 
additional services may be limited to beneficiaries who reside in the 
geographic area served by the

[[Page 359]]

contracting organization and who elect to receive services from it.
    (h) Ambulatory services for the medically needy (Sec.  
440.220(a)(2)) may be limited to:
    (1) Individuals under age 18; and
    (2) Groups of individuals entitled to institutional services.
    (i) Services provided under an exception to requirements allowed 
under Sec.  431.54 may be limited as provided under that exception.
    (j) If CMS has approved a waiver of Medicaid requirements under 
Sec.  431.55, services may be limited as provided by the waiver.
    (k) If the agency has been granted a waiver of the requirements of 
Sec.  440.240 (Comparability of services) in order to provide for home 
or community-based services under Sec.  440.180 or Sec.  440.181, the 
services provided under the waiver need not be comparable for all 
individuals within a group.
    (l) If the agency imposes cost sharing on beneficiaries in 
accordance with 447.53, the imposition of cost sharing on an individual 
who is not exempted by one of the conditions in section 447.53(b) shall 
not require the State to impose copayments on an individual who is 
eligible for such exemption.
    (m) Eligible legalized aliens who are not in the exempt groups 
described in Sec. Sec.  435.406(a) and 436.406(a), and considered 
categorically needy or medically needy must be furnished only emergency 
services (as defined in Sec.  440.255), and services for pregnant women 
as defined in section 1916(a)(2)(B) of the Social Security Act for 5 
years from the date the alien is granted lawful temporary resident 
status.
    (n) Aliens who are not lawful permanent residents, permanently 
residing in the United States under color of law, or granted lawful 
status under section 245A, 210 or 210A of the Immigration and 
Nationality Act, who, otherwise meet the eligibility requirements of the 
State plan (except for receipt of AFDC, SSI or a State Supplementary 
payment) must be furnished only those services necessary to treat an 
emergency medical condition of the alien as defined in Sec.  440.255(c).
    (o) If the agency makes respiratory care services available under 
Sec.  440.185, the services need not be made available in equal amount, 
duration, and scope to any individual not eligible for coverage under 
that section. However, the services must be made available in equal 
amount, duration, and scope to all individuals eligible for coverage 
under that section.
    (p) A State may provide a greater amount, duration, or scope of 
services to pregnant women than it provides under its plan to other 
individuals who are eligible for Medicaid, under the following 
conditions:
    (1) These services must be pregnancy-related or related to any other 
condition which may complicate pregnancy, as defined in Sec.  
440.210(a)(2) of this subpart; and
    (2) These services must be provided in equal amount, duration, and 
scope to all pregnant women covered under the State plan.
    (q) [Reserved]
    (r) If specified in the plan, targeted case management services may 
be limited to the following:
    (1) Certain geographic areas within a State, without regard to the 
statewide requirements in Sec.  431.50 of this chapter.
    (2) Targeted groups specified by the State.

[43 FR 45224, Sept. 29, 1978, as amended at 45 FR 24889, Apr. 11, 1980; 
46 FR 48541, Oct. 1, 1981; 48 FR 5735, Jan. 8, 1983; 51 FR 22041, June 
17, 1986; 55 FR 36822, Sept. 7, 1990; 56 FR 24011, May 28, 1991; 57 FR 
29156, June 30, 1992; 58 FR 4939, Jan. 19, 1993; 59 FR 37717, July 25, 
1994; 72 FR 68092, Dec. 4, 2007]



Sec.  440.255  Limited services available to certain aliens.

    (a) FFP for services. FFP is available for services provided to 
aliens described in this section which are necessary to treat an 
emergency medical condition as defined in paragraphs (b)(1) and (c) or 
services for pregnant women described in paragraph (b)(2).
    (b) Legalized aliens eligible only for emergency services and 
services for pregnant women. Aliens granted lawful temporary resident 
status, or lawful permanent resident status under sections 245A, 210 or 
210A of the Immigration and Nationality Act, who are not in one of the 
exempt groups described in Sec. Sec.  435.406(a)(3) and 436.406(a)(3) 
and who

[[Page 360]]

meet all other requirements for Medicaid will be eligible for the 
following services--
    (1) Emergency services required 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:
    (i) Placing the patient's health in serious jeopardy;
    (ii) Serious impairment to bodily functions; or
    (iii) Serious dysfunction of any bodily organ or part.
    (2) Services for pregnant women which are included in the approved 
State plan. These services include routine prenatal care, labor and 
delivery, and routine post-partum care. States, at their option, may 
provide additional plan services for the treatment of conditions which 
may complicate the pregnancy or delivery.
    (c) Effective January 1, 1987, aliens who are not lawfully admitted 
for permanent residence in the United States or permanently residing in 
the United States under the color of law must receive the services 
necessary to treat the condition defined in paragraph (1) of this 
section if--
    (1) The alien has, after sudden onset, a medical condition 
(including emergency labor and delivery) 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:
    (i) Placing the patient's health in serious jeopardy;
    (ii) Serious impairment to bodily functions; or
    (iii) Serious dysfunction of any bodily organ or part, and
    (2) The alien otherwise meets the requirements in Sec. Sec.  
435.406(c) and 436.406(c) of this subpart.

[55 FR 36823, Sept. 7, 1990; 56 FR 10807, Mar. 14, 1991]



Sec.  440.260  Methods and standards to assure quality of services.

    The plan must include a description of methods and standards used to 
assure that services are of high quality.



Sec.  440.262  Access and cultural conditions.

    The State must have methods to promote access and delivery of 
services in a culturally competent manner to all beneficiaries, 
including those with limited English proficiency, diverse cultural and 
ethnic backgrounds, disabilities, and regardless of sex. These methods 
must ensure that beneficiaries have access to covered services that are 
delivered in a manner that meets their unique needs.

[85 FR 37243, June 19, 2020]



Sec.  440.270  Religious objections.

    (a) Except as specified in paragraph (b) of this section, the agency 
may not require any individual to undergo any medical service, 
diagnosis, or treatment or to accept any other health service provided 
under the plan if the individual objects, or in the case of a child, a 
parent or guardian objects, on religious grounds.
    (b) If a physical examination is necessary to establish eligibility 
based on disability or blindness, the agency may not find an individual 
eligible for Medicaid unless he undergoes the examination.



      Subpart C_Benchmark Benefit and Benchmark-Equivalent Coverage

    Source: 75 FR 23101, Apr. 30, 2010, unless otherwise noted.



Sec.  440.300  Basis.

    This subpart implements section 1937 of the Act, which authorizes 
States to provide for medical assistance to one or more groups of 
Medicaid-eligible individuals, specified by the State under an approved 
State plan amendment, through enrollment in coverage that provides 
benchmark or benchmark-equivalent health care benefit coverage.



Sec.  440.305  Scope.

    (a) General. This subpart sets out requirements for States that 
elect to provide medical assistance to certain Medicaid eligible 
individuals within one or more groups of individuals specified by the 
State, through enrollment of the

[[Page 361]]

individuals in coverage, identified as ``benchmark'' or ``benchmark-
equivalent.'' Groups must be identified by characteristics of 
individuals rather than the amount or level of FMAP.
    (b) Limitations. A State may only apply the option in paragraph (a) 
of this section for an individual whose eligibility is based on an 
eligibility category under section 1905(a) of the Act that could have 
been covered under the State's plan on or before February 8, 2006, 
except that individuals who are eligible under section 
1902(a)(10)(A)(i)(VIII) of the Act must enroll in an Alternative Benefit 
Plan to receive medical assistance.
    (c) A State may not require but may offer enrollment in benchmark or 
benchmark-equivalent coverage to the Medicaid eligible individuals 
listed in Sec.  440.315. States allowing individuals to voluntarily 
enroll must be in compliance with the rules specified at Sec.  440.320.

[75 FR 23101, Apr. 30, 2010, as amended at 78 FR 42306, July 15, 2013]



Sec.  440.310  Applicability.

    (a) Enrollment. The State may require ``full benefit eligible'' 
individuals not excluded in Sec.  440.315 to enroll in benchmark or 
benchmark-equivalent coverage.
    (b) Full benefit eligible. An individual is a full benefit eligible 
if determined by the State to be eligible to receive the standard full 
Medicaid benefit package under the approved State plan if not for the 
application of the option available under this subpart.



Sec.  440.315  Exempt individuals.

    Individuals within one (or more) of the following categories are 
exempt from mandatory enrollment in an Alternative Benefit Plan, unless 
the individuals are eligible under section 1902(a)(10)(A)(i)(VIII) of 
the Act. Individuals in that eligibility group who meet the conditions 
for exemption must be given the option of an Alternative Benefit Plan 
that includes all benefits available under the approved State plan.
    (a) The individual is a pregnant woman who is required to be covered 
under the State plan under section 1902(a)(10)(A)(i) of the Act.
    (b) The individual qualifies for medical assistance under the State 
plan on the basis of being blind or disabled (or being treated as being 
blind or disabled) without regard to whether the individual is eligible 
for Supplemental Security Income benefits under title XVI on the basis 
of being blind or disabled and including an individual who is eligible 
for medical assistance on the basis of section 1902(e)(3) of the Act.
    (c) The individual is entitled to benefits under any part of 
Medicare.
    (d) The individual is terminally ill and is receiving benefits for 
hospice care under title XIX.
    (e) The individual is an inpatient in a hospital, nursing facility, 
intermediate care facility for individuals with intellectual 
disabilities, or other medical institution, and is required, as a 
condition of receiving services in that institution under the State 
plan, to spend for costs of medical care all but a minimal amount of the 
individual's income required for personal needs.
    (f) The individual is medically frail or otherwise an individual 
with special medical needs. For these purposes, the State's definition 
of individuals who are medically frail or otherwise have special medical 
needs must at least include those individuals described in Sec.  
438.50(d)(3) of this chapter, individuals with disabling mental 
disorders (including children with serious emotional disturbances and 
adults with serious mental illness), individuals with chronic substance 
use disorders, individuals with serious and complex medical conditions, 
individuals with a physical, intellectual or developmental disability 
that significantly impairs their ability to perform 1 or more activities 
of daily living, or individuals with a disability determination based on 
Social Security criteria or in States that apply more restrictive 
criteria than the Supplemental Security Income program, the State plan 
criteria.
    (g) The individual qualifies based on medical condition for medical 
assistance for long-term care services described in section 
1917(c)(1)(C) of the Act.
    (h) The individual is eligible and enrolled for Medicaid under Sec.  
435.145 of this chapter based on current eligibility for assistance 
under title IV-E of

[[Page 362]]

the Act or under Sec.  435.150 of this chapter based on current status 
as a former foster care child.
    (i) The individual is a parent or caretaker relative whom the State 
is required to cover under section 1931 of the Act.
    (j) The individual is a woman who is receiving medical assistance by 
virtue of the application of sections 1902(a)(10)(ii)(XVIII) and 
1902(aa) of the Act.
    (k) The individual qualifies for medical assistance on the basis of 
section 1902(a)(10)(A)(ii)(XII) of the Act.
    (l) The individual is only covered by Medicaid for care and services 
necessary for the treatment of an emergency medical condition in 
accordance with section 1903(v) of the Act.
    (m) The individual is determined eligible as medically needy or 
eligible because of a reduction of countable income based on costs 
incurred for medical or other remedial care under section 1902(f) of the 
Act or otherwise based on incurred medical costs.

[75 FR 23101, Apr. 30, 2010, as amended at 78 FR 42306, July 15, 2013]



Sec.  440.320  State plan requirements: Optional enrollment for exempt
individuals.

    (a) General rule. A State plan that offers exempt individuals as 
defined in Sec.  440.315 the option to enroll in benchmark or benchmark-
equivalent coverage must identify in its State plan the exempt groups 
for which this coverage is available, and must comply with the following 
provisions:
    (1) In any case in which the State offers an exempt individual the 
option to obtain coverage in a benchmark or benchmark-equivalent benefit 
package, the State must effectively inform the individual prior to 
enrollment that the enrollment is voluntary and that the individual may 
disenroll from the benchmark or benchmark-equivalent coverage at any 
time and regain immediate access to standard full Medicaid coverage 
under the State plan.
    (2) Prior to any enrollment in benchmark or benchmark-equivalent 
coverage, the State must inform the exempt individual of the benefits 
available under the benchmark or benchmark-equivalent benefit package 
and the costs under such a package and provide a comparison of how they 
differ from the benefits and costs available under the standard full 
Medicaid program. The State must also inform exempt individuals that 
they may disenroll at any time and provide them with information about 
the process for disenrolling.
    (3) The State must document in the exempt individual's eligibility 
file that the individual was informed in accordance with this section 
prior to enrollment, was given ample time to arrive at an informed 
choice, and voluntarily and affirmatively chose to enroll in the 
benchmark or benchmark-equivalent benefit package.
    (4) For individuals who the State determines have become exempt 
individuals while enrolled in benchmark or benchmark-equivalent 
coverage, the State must comply with the requirements in paragraphs 
(a)(1) through (a)(3) of this section above within 30 days after such 
determination.
    (b) Disenrollment Process. (1) The State must act upon requests 
promptly for exempt individuals who choose to disenroll from benchmark 
or benchmark-equivalent coverage.
    (2) The State must have a process in place to ensure that exempt 
individuals have access to all standard State plan services while 
disenrollment requests are being processed.
    (3) The State must maintain data that tracks the total number of 
beneficiaries that have voluntarily enrolled in a benchmark plan and the 
total number of individuals that have disenrolled from the benchmark 
plan.



Sec.  440.325  State plan requirements: Coverage and benefits.

    Subject to requirements in Sec. Sec.  440.345 and 440.365, States 
may elect to provide any of the following types of health benefits 
coverage:
    (a) Benchmark coverage in accordance with Sec.  440.330.
    (b) Benchmark-equivalent coverage in accordance with Sec.  440.335.

[[Page 363]]



Sec.  440.330  Benchmark health benefits coverage.

    Benchmark coverage is health benefits coverage that is equal to the 
coverage under one or more of the following benefit plans:
    (a) Federal Employees Health Benefit Plan Equivalent Coverage 
(FEHBP--Equivalent Health Insurance Coverage). A benefit plan equivalent 
to the standard Blue Cross/Blue Shield preferred provider option service 
benefit plan that is described in and offered to Federal employees under 
5 U.S.C. 8903(1).
    (b) State employee coverage. Health benefits coverage that is 
offered and generally available to State employees in the State.
    (c) Health maintenance organization (HMO) plan. A health insurance 
plan that is offered through an HMO, (as defined in section 2791(b)(3) 
of the Public Health Service Act) that has the largest insured 
commercial, non-Medicaid enrollment in the State.
    (d) Secretary-approved coverage. Any other health benefits coverage 
that the Secretary determines, upon application by a State, provides 
appropriate coverage to meet the needs of the population provided that 
coverage. Secretarial coverage may include benefits of the type that are 
available under 1 or more of the standard benchmark coverage packages 
defined in paragraphs (a) through (c) of this section, State plan 
benefits described in section 1905(a), 1915(i), 1915(j), 1915(k) or 
section 1945 of the Act, any other Medicaid State plan benefits enacted 
under title XIX, or benefits available under base benchmark plans 
described in 45 CFR 156.100.
    (1) States wishing to elect Secretary-approved coverage should 
submit a full description of the proposed coverage (including a benefit-
by-benefit comparison of the proposed plan to one or more of the three 
other benchmark plans specified above or to the State's standard full 
Medicaid coverage package), and of the population to which coverage will 
be offered. In addition, the State should submit any other information 
that will be relevant to a determination that the proposed health 
benefits coverage will be appropriate for the proposed population.
    (2) [Reserved]

[75 FR 23101, Apr. 30, 2010, as amended at 78 FR 42306, July 15, 2013]



Sec.  440.335  Benchmark-equivalent health benefits coverage.

    (a) Aggregate actuarial value. Benchmark-equivalent coverage is 
health benefits coverage that has an aggregate actuarial value, as 
determined under Sec.  440.340, that is at least actuarially equivalent 
to the coverage under one of the benchmark benefit packages described in 
Sec.  440.330 for the identified Medicaid population to which it will be 
offered.
    (b) Required coverage. Benchmark-equivalent health benefits coverage 
must include coverage for the following categories of services:
    (1) Inpatient and outpatient hospital services.
    (2) Physicians' surgical and medical services.
    (3) Laboratory and x-ray services.
    (4) Well-baby and well-child care, including age-appropriate 
immunizations.
    (5) Emergency services.
    (6) Family planning services and supplies and other appropriate 
preventive services, as designated by the Secretary.
    (7) Prescription drugs.
    (8) Mental health benefits.
    (c) Additional coverage. (1) In addition to the types of benefits of 
this section, benchmark-equivalent coverage may include coverage for any 
additional benefits of the type which are covered in 1 or more of the 
standard benchmark coverage packages described in Sec.  440.330(a) 
through (c) or State plan benefits, described in section 1905(a), 
1915(i), 1915(j), 1915(k) and 1945 of the Act, any other Medicaid State 
plan benefits enacted under title XIX, or benefits available under base-
benchmark plans described in 45 CFR 156.100.
    (2) If the benchmark coverage package used by the State for purposes 
of comparison in establishing the aggregate actuarial value of the 
benchmark-equivalent package includes any of the following four 
categories of services: Prescription drugs; mental health services; 
vision services; and hearing services; then the actuarial value of the 
coverage for each of these categories of

[[Page 364]]

service in the benchmark-equivalent coverage package must be at least 75 
percent of the actuarial value of the coverage for that category of 
service in the benchmark plan used for comparison by the State.

[75 FR 23101, Apr. 30, 2010, as amended at 78 FR 42306, July 15, 2013]



Sec.  440.340  Actuarial report for benchmark-equivalent coverage.

    (a) A State plan amendment that would provide for benchmark-
equivalent health benefits coverage described in Sec.  440.335, must 
include an actuarial report. The actuarial report must contain an 
actuarial opinion that the benchmark-equivalent health benefits coverage 
meets the actuarial requirements set forth in Sec.  440.335. The report 
must also specify the benchmark coverage used for comparison.
    (b) The actuarial report must state that it was prepared according 
to the following requirements:
    (1) By an individual who is a member of the American Academy of 
Actuaries (AAA).
    (2) Using generally accepted actuarial principles and methodologies 
of the AAA.
    (3) Using a standardized set of utilization and price factors.
    (4) Using a standardized population that is representative of the 
population involved.
    (5) Applying the same principles and factors in comparing the value 
of different coverage (or categories of services).
    (6) Without taking into account any differences in coverage based on 
the method of delivery or means of cost control or utilization used.
    (7) Taking into account the ability of the State to reduce benefits 
by considering the increase in actuarial value of health benefits 
coverage offered under the State plan that results from the limitations 
on cost sharing (with the exception of premiums) under that coverage.
    (c) The actuary preparing the opinion must select and specify the 
standardized set of factors and the standardized population to be used 
in paragraphs (b)(3) and (b)(4) of this section.
    (d) The State must provide sufficient detail to explain the basis of 
the methodologies used to estimate the actuarial value or, if requested 
by CMS, to replicate the State's result.



Sec.  440.345  EPSDT and other required benefits.

    (a) The State must assure access to early and periodic screening, 
diagnostic and treatment (EPSDT) services through benchmark or 
benchmark-equivalent plan benefits or as additional benefits provided by 
the State for any child under 21 years of age eligible under the State 
plan in a category under section 1902(a)(10)(A) of the Act.
    (1) Sufficiency. Any additional EPSDT benefits not provided by the 
benchmark or benchmark-equivalent plan must be sufficient so that, in 
combination with the benchmark or benchmark-equivalent benefits plan, 
these individuals have access to the full EPSDT benefit.
    (2) State Plan requirement. The State must include a description of 
how the additional benefits will be provided, how access to additional 
benefits will be coordinated and how beneficiaries and providers will be 
informed of these processes in order to ensure that these individuals 
have access to the full EPSDT benefit.
    (b) Family planning. Alternative Benefit Plans must include coverage 
for family planning services and supplies.
    (c) Mental health parity. Alternative Benefit Plans that provide 
both medical and surgical benefits, and mental health or substance use 
disorder benefits, must comply with the Mental Health Parity and 
Addiction Equity Act.
    (d) Essential health benefits. Alternative Benefit Plans must 
include at least the essential health benefits described in Sec.  
440.347, and include all updates or modifications made thereafter by the 
Secretary to the definition of essential health benefits.
    (e) Updating of benefits. States are not required to update 
Alternative Benefit Plans that have been determined to include essential 
health benefits as of January 1, 2014, until December 31, 2015. States 
will adhere to future guidance for updating benefits beyond that date, 
as described by the Secretary.

[[Page 365]]

    (f) Covered outpatient drugs. To the extent states pay for covered 
outpatient drugs under their Alternative Benefit Plan's prescription 
drug coverage, states must comply with the requirements under section 
1927 of the Act.

[75 FR 23101, Apr. 30, 2010, as amended at 78 FR 42306, July 15, 2013]



Sec.  440.347  Essential health benefits.

    (a) Alternative Benefit Plans must contain essential health benefits 
coverage, including benefits in each of the following ten categories, 
consistent with the applicable requirements set forth in 45 CFR part 
156:
    (1) Ambulatory patient services;
    (2) Emergency services;
    (3) Hospitalization;
    (4) Maternity and newborn care;
    (5) Mental health and substance use disorders, including behavioral 
health treatment;
    (6) Prescription drugs;
    (7) Rehabilitative and habilitative services and devices, except 
that such coverage shall be in accordance with Sec.  440.347(d);
    (8) Laboratory services;
    (9) Preventive and wellness services and chronic disease management; 
and
    (10) Pediatric services, including oral and vision care, in 
accordance with section 1905(r) of the Act.
    (b) Alternative Benefit Plans must include essential health benefits 
in one of the state options for establishing essential health benefits 
described in 45 CFR 156.100, subject to supplementation under 45 CFR 
156.110(b) and substitution as permitted under 45 CFR 156.115(b).
    (c) States may select more than one base benchmark option for 
establishing essential health benefits in keeping with the flexibility 
for States to implement more than one Alternative Benefit Plan for 
targeted populations.
    (d) To comply with paragraph (a) of this section, Alternative 
Benefit Plan coverage of habilitative services and devices will be based 
on the habilitative services and devices that are in the applicable base 
benchmark plan. If habilitative services and devices are not in the 
applicable base benchmark plan, the state will define habilitative 
services and devices required as essential health benefits using the 
methodology set forth in 45 CFR 156.115(a)(5).
    (e) Essential health benefits cannot be based on a benefit design or 
implementation of a benefit design that discriminates based on an 
individual's age, expected length of life, present or predicted 
disability, degree of medical dependency, quality of life or other 
health conditions.

[78 FR 42307, July 15, 2013]



Sec.  440.350  Employer-sponsored insurance health plans.

    (a) A State may provide benchmark or benchmark-equivalent coverage 
by obtaining employer sponsored health plans (either alone or with 
additional services covered separately under Medicaid) for individuals 
with access to private health insurance.
    (b) The State must assure that employer sponsored plans meet the 
requirements of benchmark or benchmark-equivalent coverage, including 
the economy and efficiency requirements at Sec.  440.370.
    (c) A State may provide benchmark or benchmark-equivalent coverage 
through a combination of employer sponsored health plans and additional 
benefit coverage provided by the State that wraps around the employer 
sponsored health plan which, in the aggregate, results in benchmark or 
benchmark-equivalent level of coverage for those individuals.



Sec.  440.355  Payment of premiums.

    Payment of premiums by the State, net of beneficiary contributions, 
to obtain benchmark or benchmark-equivalent benefit coverage on behalf 
of beneficiaries under this section will be treated as medical 
assistance under section 1905(a) of the Act.



Sec.  440.360  State plan requirements for providing additional
services.

    In addition to the requirements of Sec.  440.345, the State may 
elect to provide additional coverage to individuals enrolled in 
Alternative Benefit Plans, except that the coverage for individuals 
eligible only through section 1902(a)(10)(A)(i)(VIII) of the Act is 
limited to benchmark or benchmark-equivalent coverage. The State must

[[Page 366]]

describe the populations covered and the payment methodology for these 
benefits. Additional benefits must be benefits of the type, which are 
covered in 1 or more of the standard benchmark coverage packages 
described in Sec.  440.330(a) through (c) or State plan benefits 
including those described in sections 1905(a), 1915(i), 1915(j), 1915(k) 
and 1945 of the Act and any other Medicaid State plan benefits enacted 
under title XIX, or benefits available under base benchmark plans 
described in 45 CFR 156.100.

[78 FR 42307, July 15, 2013]



Sec.  440.365  Coverage of rural health clinic and federally qualified
health center (FQHC) services.

    If a State provides benchmark or benchmark-equivalent coverage to 
individuals, it must assure that the individual has access, through that 
coverage or otherwise, to rural health clinic services and FQHC services 
as defined in subparagraphs (B) and (C) of section 1905(a)(2) of the 
Act. Payment for these services must be made in accordance with the 
payment provisions of section 1902(bb) of the Act.



Sec.  440.370  Economy and efficiency.

    Benchmark and benchmark-equivalent coverage and any additional 
benefits must be provided in accordance with Federal upper payment 
limits, procurement requirements and other economy and efficiency 
principles that would otherwise be applicable to the services or 
delivery system through which the coverage and benefits are obtained.



Sec.  440.375  Comparability.

    States have the option to amend their State plan to provide 
benchmark or benchmark-equivalent coverage to individuals without regard 
to comparability.



Sec.  440.380  Statewideness.

    States have the option to amend their State plan to provide 
benchmark or benchmark-equivalent coverage to individuals without regard 
to statewideness.



Sec.  440.385  Delivery of benchmark and benchmark-equivalent coverage
through managed care entities.

    In implementing benchmark or benchmark-equivalent benefit packages, 
States must comply with the managed care provisions at section 1932 of 
the Act and part 438 of this chapter, if benchmark and benchmark-
equivalent benefits are provided through a managed care entity.



Sec.  440.386  Public notice.

    Prior to submitting to the Centers for Medicare and Medicaid 
Services for approval of a State plan amendment to establish an 
Alternative Benefit Plan or an amendment to substantially modify an 
existing Alternative Benefit Plan, a state must have provided the public 
with advance notice of the amendment and reasonable opportunity to 
comment for such amendment, and have included in the notice a 
description of the method for assuring compliance with Sec.  440.345 
related to full access to EPSDT services, and the method for complying 
with the provisions of section 5006(e) of the American Recovery and 
Reinvestment Act of 2009.

[78 FR 42307, July 15, 2013]



Sec.  440.390  Assurance of transportation.

    If a benchmark or benchmark-equivalent plan does not include 
transportation to and from medically necessary covered Medicaid 
services, the State must nevertheless assure that emergency and non-
emergency transportation is covered for beneficiaries enrolled in the 
benchmark or benchmark-equivalent plan, as required under Sec.  431.53 
of this chapter.



Sec.  440.395  Parity in mental health and substance use disorder
benefits.

    (a) Meaning of terms. For purposes of this section, except where the 
context clearly indicates otherwise, the following terms have the 
meanings indicated:
    Aggregate lifetime dollar limit means a dollar limitation on the 
total amount of specified benefits that may be paid under an ABP.
    Alternative Benefit Plans (ABPs) mean benefit packages in one or 
more of the

[[Page 367]]

benchmark coverage packages described in Sec. Sec.  440.330(a) through 
(c) and 440.335. Benefits may be delivered through managed care and non-
managed care delivery systems. Consistent with the requirements of Sec.  
440.385, States must comply with the managed care provisions at section 
1932 of the Act and part 438 of this chapter, if benchmark and 
benchmark-equivalent benefits are provided through a managed care 
entity.
    Annual dollar limit means a dollar limitation on the total amount of 
specified benefits that may be paid in a 12-month period under an ABP.
    Cumulative financial requirements are financial requirements that 
determine whether or to what extent benefits are provided based on 
accumulated amounts and include deductibles and out-of-pocket maximums. 
(However, cumulative financial requirements do not include aggregate 
lifetime or annual dollar limits because these two terms are excluded 
from the meaning of financial requirements.)
    EPSDT means benefits defined in section 1905(r) of the Act.
    Financial requirements include deductibles, copayments, coinsurance, 
or out-of-pocket maximums. Financial requirements do not include 
aggregate lifetime or annual dollar limits.
    Medical/surgical benefits means benefits for items or services for 
medical conditions or surgical procedures, as defined by the State under 
the terms of the ABP and in accordance with applicable Federal and State 
law, but does not include mental health or substance use disorder 
benefits. Any condition defined by the state as being or as not being a 
medical/surgical condition must be defined to be consistent with 
generally recognized independent standards of current medical practice 
(for example, the most current version of the International 
Classification of Diseases (ICD) or State guidelines). Medical/surgical 
benefits include long term services.
    Mental health benefits means benefits for items or services for 
mental health conditions, as defined by the State under the terms of the 
ABP and in accordance with applicable Federal and State law. Any 
condition defined by the State as being or as not being a mental health 
condition must be defined to be consistent with generally recognized 
independent standards of current medical practice (for example, the most 
current version of the Diagnostic and Statistical Manual of Mental 
Disorders (DSM), the most current version of the ICD, or State 
guidelines. Mental health benefits include long term care services.
    Substance use disorder benefits means benefits for items or services 
for substance use disorder, as defined by the State under the terms of 
the ABP and in accordance with applicable Federal and State law. Any 
disorder defined by the State as being or as not being a substance use 
disorder must be defined to be consistent with generally recognized 
independent standards of current medical practice (for example, the most 
current version of the DSM, the most current version of the ICD, or 
State guidelines). Substance use disorder benefits include long term 
care services.
    Treatment limitations include limits on benefits based on the 
frequency of treatment, number of visits, days of coverage, days in a 
waiting period, or other similar limits on the scope or duration of 
treatment. Treatment limitations include both quantitative treatment 
limitations, which are expressed numerically (such as 50 outpatient 
visits per year), and nonquantitative treatment limitations, which 
otherwise limit the scope or duration of benefits for treatment under an 
ABP. (See paragraph (b)(4)(ii) of this section for an illustrative list 
of nonquantitative treatment limitations.) A permanent exclusion of all 
benefits for a particular condition or disorder, however, is not a 
treatment limitation for purposes of this definition.
    (b) Parity requirements for financial requirements and treatment 
limitations--(1) Clarification of terms--(i) Classification of benefits. 
When reference is made in this paragraph (b) to a classification of 
benefits, the term ``classification'' means a classification as 
described in paragraph (b)(2)(ii) of this section.
    (ii) Type of financial requirement or treatment limitation. When 
reference is made in this paragraph (b) to a type of financial 
requirement or treatment limitation, the reference to type means

[[Page 368]]

its nature. Different types of financial requirements include 
deductibles, copayments, coinsurance, and out-of-pocket maximums. 
Different types of quantitative treatment limitations include annual, 
episode, and lifetime day and visit limits. See paragraph (b)(4)(ii) of 
this section for an illustrative list of nonquantitative treatment 
limitations.
    (iii) Level of a type of financial requirement or treatment 
limitation. When reference is made in this paragraph (b) to a level of a 
type of financial requirement or treatment limitation, level refers to 
the magnitude of the type of financial requirement or treatment 
limitation.
    (2) General parity requirement--(i) General rule. A State may not 
apply within an ABP any financial requirement or treatment limitation to 
mental health or substance use disorder benefits in any classification 
that is more restrictive than the predominant financial requirement or 
treatment limitation of that type applied to substantially all medical/
surgical benefits in the same classification. Whether a financial 
requirement or treatment limitation is a predominant financial 
requirement or treatment limitation that applies to substantially all 
medical/surgical benefits in a classification is determined separately 
for each type of financial requirement or treatment limitation. The 
application of the rules of this paragraph (b)(2) to financial 
requirements and quantitative treatment limitations is addressed in 
paragraph (b)(3) of this section; the application of the rules of this 
paragraph (b)(2) to nonquantitative treatment limitations is addressed 
in paragraph (b)(4) of this section.
    (ii) Classifications of benefits used for applying rules. ABPs must 
include mental health or substance use disorder benefits in every 
classification of benefits described in this paragraph (b)(2)(ii) in 
which medical/surgical benefits are provided. In determining the 
classification in which a particular benefit belongs, the State must 
apply the same reasonable standards to medical/surgical benefits and to 
mental health or substance use disorder benefits. To the extent that a 
State provides ABP benefits in a classification and imposes any separate 
financial requirement or treatment limitation (or separate level of a 
financial requirement or treatment limitation) for benefits in the 
classification, the rules of this paragraph (b) apply separately for 
that classification for all financial requirements or treatment 
limitations. The following classifications of benefits are the only 
classifications used in applying the rules of this paragraph (b):
    (A) Inpatient. Benefits furnished on an inpatient basis.
    (B) Outpatient. Benefits furnished on an outpatient basis. See 
special rules for office visits in paragraph (b)(3)(ii)(B)(1) of this 
section.
    (C) Emergency care. Benefits for emergency care.
    (D) Prescription drugs. Benefits for prescription drugs. See special 
rules for multi-tiered prescription drug benefits in paragraph 
(b)(3)(ii) of this section.
    (3) Financial requirements and quantitative treatment limitations--
(i) Determining ``substantially all'' and ``predominant''--(A) 
Substantially all. For purposes of this paragraph (b), a type of 
financial requirement or quantitative treatment limitation is considered 
to apply to substantially all medical/surgical benefits in a 
classification of benefits if it applies to at least two-thirds of all 
medical/surgical benefits in that classification. If a type of financial 
requirement or quantitative treatment limitation does not apply to at 
least two-thirds of all medical/surgical benefits in a classification, 
then that type cannot be applied to mental health or substance use 
disorder benefits in that classification.
    (B) Predominant--(1) If a type of financial requirement or 
quantitative treatment limitation applies to at least two-thirds of all 
medical/surgical benefits in a classification as determined under 
paragraph (b)(3)(i)(A) of this section, the level of the financial 
requirement or quantitative treatment limitation that is considered the 
predominant level of that type in a classification of benefits is the 
level that applies to more than one-half of medical/surgical benefits in 
that classification subject to the financial requirement or quantitative 
treatment limitation.

[[Page 369]]

    (2) If, for a type of financial requirement or quantitative 
treatment limitation that applies to at least two-thirds of all medical/
surgical benefits in a classification, there is no single level that 
applies to more than one-half of medical/surgical benefits in the 
classification subject to the financial requirement or quantitative 
treatment limitation, the State may combine levels until the combination 
of levels applies to more than one-half of medical/surgical benefits 
subject to the financial requirement or quantitative treatment 
limitation in the classification. The least restrictive level within the 
combination is considered the predominant level of that type in the 
classification. (For this purpose, a State may combine the most 
restrictive levels first, with each less restrictive level added to the 
combination until the combination applies to more than one-half of the 
benefits subject to the financial requirement or treatment limitation.)
    (C) Portion based on ABP payments. For purposes of this paragraph 
(b), the determination of the portion of medical/surgical benefits in a 
classification of benefits subject to a financial requirement or 
quantitative treatment limitation (or subject to any level of a 
financial requirement or quantitative treatment limitation) is based on 
the dollar amount of all ABP payments for medical/surgical benefits in 
the classification expected to be paid under the ABP for the plan year 
(or for the portion of the plan year after a change in ABP benefits that 
affects the applicability of the financial requirement or quantitative 
treatment limitation).
    (D) Clarifications for certain threshold requirements. For any 
deductible, the dollar amount of ABP payments includes all payments for 
claims that would be subject to the deductible if it had not been 
satisfied. For any out-of-pocket maximum, the dollar amount of ABP 
payments includes all payments associated with out-of-pocket payments 
that are taken into account towards the out-of-pocket maximum as well as 
all payments associated with out-of-pocket payments that would have been 
made towards the out-of-pocket maximum if it had not been satisfied. 
Similar rules apply for any other thresholds at which the rate of 
payment changes.
    (E) Determining the dollar amount of ABP payments. Subject to 
paragraph (b)(3)(i)(D) of this section, any reasonable method may be 
used to determine the dollar amount expected to be paid for medical/
surgical benefits subject to a financial requirement or quantitative 
treatment limitation (or subject to any level of a financial requirement 
or quantitative treatment limitation).
    (ii) Special rules--(A) Multi-tiered prescription drug benefits. If 
a State or plan administrator applies different levels of financial 
requirements to different tiers of prescription drug benefits based on 
reasonable factors determined in accordance with the rules in paragraph 
(b)(4)(i) of this section (relating to requirements for nonquantitative 
treatment limitations) and without regard to whether a drug is generally 
prescribed for medical/surgical benefits or for mental health or 
substance use disorder benefits, the ABP satisfies the parity 
requirements of this paragraph (b) for prescription drug benefits. 
Reasonable factors include cost, efficacy, generic versus brand name, 
and mail order versus pharmacy pick-up/delivery.
    (B) Sub-classifications permitted for office visits, separate from 
other outpatient services. For purposes of applying the financial 
requirement and treatment limitation rules of this paragraph (b), a 
State may divide its benefits furnished on an outpatient basis into the 
two sub-classifications described in this paragraph (b)(3)(ii)(B). After 
the sub-classifications are established, the State may not impose any 
financial requirement or quantitative treatment limitation on mental 
health or substance use disorder benefits in any sub-classification that 
is more restrictive than the predominant financial requirement or 
quantitative treatment limitation that applies to substantially all 
medical/surgical benefits in the sub-classification using the 
methodology set forth in paragraph (b)(3)(i) of this section. Sub-
classifications other than these special rules, such as separate sub-
classifications for generalists and specialists, are not permitted. The 
two sub-classifications permitted under this paragraph (b)(3)(ii)(B) 
are:

[[Page 370]]

    (1) Office visits (such as physician visits); and
    (2) All other outpatient items and services (such as outpatient 
surgery, laboratory services, or other medical items).
    (iii) No separate cumulative financial requirements. A State may not 
apply any cumulative financial requirement for mental health or 
substance use disorder benefits in a classification that accumulates 
separately from any established for medical/surgical benefits in the 
same classification.
    (iv) Compliance with other cost-sharing rules. States must meet the 
requirements of Sec. Sec.  447.50 through 447.57 of this chapter when 
applying Medicaid cost-sharing.
    (4) Nonquantitative treatment limitations--(i) General rule. A State 
may not impose a nonquantitative treatment limitation for mental health 
or substance use disorder benefits in any classification unless, under 
the terms of the ABP as written and in operation, any processes, 
strategies, evidentiary standards, or other factors used in applying the 
nonquantitative treatment limitation to mental health or substance use 
disorder benefits in the classification are comparable to, and are 
applied no more stringently than, the processes, strategies, evidentiary 
standards, or other factors used in applying the limitation for medical/
surgical benefits in the classification.
    (ii) Illustrative list of nonquantitative treatment limitations. 
Nonquantitative treatment limitations include--
    (A) Medical management standards limiting or excluding benefits 
based on medical necessity or medical appropriateness, or based on 
whether the treatment is experimental or investigative;
    (B) Formulary design for prescription drugs;
    (C) Standards for provider admission to participate in a network, 
including reimbursement rates;
    (D) Methods for determining usual, customary, and reasonable 
charges;
    (E) Refusal to pay for higher-cost therapies until it can be shown 
that a lower-cost therapy is not effective (also known as fail-first 
policies or step therapy protocols);
    (F) Exclusions based on failure to complete a course of treatment; 
and
    (G) Restrictions based on geographic location, facility type, 
provider specialty, and other criteria that limit the scope or duration 
of benefits or services provided under the ABP.
    (c) ABP providing EPSDT benefits. An ABP that provides EPSDT 
benefits is deemed to be compliant with the parity requirements for 
financial requirements and treatment limitations with respect to 
individuals entitled to such benefits. Annual or lifetime limits are not 
permissible in EPSDT benefits.
    (d) Availability of information--(1) Criteria for medical necessity 
determinations. The criteria for medical necessity determinations made 
by the State for beneficiaries served through the ABP for mental health 
or substance use disorder benefits must be made available by the State 
to any beneficiary or Medicaid provider upon request.
    (2) Reason for any denial. The reason for any denial made by the 
State in the case of a beneficiary served through an ABP of 
reimbursement or payment for services for mental health or substance use 
disorder benefits must be made available by the State to the 
beneficiary.
    (3) Provisions of other law. Compliance with the disclosure 
requirements in paragraphs (d)(1) and (2) of this section is not 
determinative of compliance with any other provision of applicable 
Federal or State law.
    (e) Applicability--(1) ABPs. The requirements of this section apply 
to States providing benefits through ABPs. For those States providing 
ABPs through an MCO, PIHP, or PAHP, the rules of 42 CFR part 438, 
subpart K also apply, and approved contracts will be viewed as evidence 
of compliance with the requirements of this section.
    (2) Scope. This section does not--
    (i) Require a State to provide any specific mental health benefits 
or substance use disorder benefits; however, in providing coverage 
through an ABP, the State must include EHBs, including the ten EHBs as 
required in Sec.  440.347, which include mental health and substance use 
disorder benefits; or
    (ii) Affect the terms and conditions relating to the amount, 
duration, or scope of mental health or substance

[[Page 371]]

use disorder benefits under the ABP except as specifically provided in 
paragraph (b) of this section.
    (3) State plan requirement. If a State plan provides for an ABP, the 
State must provide sufficient information in ABP State plan amendment 
requests to assure compliance with the requirements of this subpart.
    (4) Compliance dates--(i) In general. ABP coverage offered by States 
must comply with the requirements of this section no later than October 
2, 2017.
    (ii) [Reserved]

[81 FR 18439, Mar. 30, 2016]



PART 441_SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC
SERVICES--Table of Contents



Sec.
441.1 Purpose.

                      Subpart A_General Provisions

441.10 Basis.
441.11 Continuation of FFP for institutional services.
441.12 Inpatient hospital tests.
441.13 Prohibitions on FFP: Institutionalized individuals.
441.15 Home health services.
441.16 Home health agency requirements for surety bonds; Prohibition on 
          FFP.
441.17 Laboratory services.
441.18 Case management services.
441.20 Family planning services.
441.21 Nurse-midwife services.
441.22 Nurse practitioner services.
441.25 Prohibition on FFP for certain prescribed drugs.
441.30 Optometric services.
441.35 Organ transplants.
441.40 End-stage renal disease.

Subpart B_Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) 
                       of Individuals Under Age 21

441.50 Basis and purpose.
441.55 State plan requirements.
441.56 Required activities.
441.57 Discretionary services.
441.58 Periodicity schedule.
441.59 Treatment of requests for EPSDT screening services.
441.60 Continuing care.
441.61 Utilization of providers and coordination with related programs.
441.62 Transportation and scheduling assistance.

 Subpart C_Medicaid for Individuals Age 65 or Over in Institutions for 
                             Mental Diseases

441.100 Basis and purpose.
441.101 State plan requirements.
441.102 Plan of care for institutionalized beneficiaries.
441.103 Alternate plans of care.
441.105 Methods of administration.
441.106 Comprehensive mental health program.

Subpart D_Inpatient Psychiatric Services for Individuals Under Age 21 in 
                   Psychiatric Facilities or Programs

441.150 Basis and purpose.
441.151 General requirements.
441.152 Certification of need for services.
441.153 Team certifying need for services.
441.154 Active treatment.
441.155 Individual plan of care.
441.156 Team developing individual plan of care.
441.180 Maintenance of effort: General rule.
441.181 Maintenance of effort: Explanation of terms and requirements.
441.182 Maintenance of effort: Computation.
441.184 Emergency preparedness.

                           Subpart E_Abortions

441.200 Basis and purpose.
441.201 Definition.
441.202 General rule.
441.203 Life of the mother would be endangered.
441.204-441.205 [Reserved]
441.206 Documentation needed by the Medicaid agency.
441.207 Drugs and devices and termination of ectopic pregnancies.
441.208 Recordkeeping requirements.

                        Subpart F_Sterilizations

441.250 Applicability.
441.251 Definitions.
441.252 State plan requirements.
441.253 Sterilization of a mentally competent individual aged 21 or 
          older.
441.254 Mentally incompetent or institutionalized individuals.
441.255 Sterilization by hysterectomy.
441.256 Additional condition for Federal financial participation (FFP).
441.257 Informed consent.
441.258 Consent form requirements.
441.259 Review of regulations.

Appendix to Subpart F of Part 441--Required Consent Form

[[Page 372]]

    Subpart G_Home and Community-Based Services: Waiver Requirements

441.300 Basis and purpose.
441.301 Contents of request for a waiver.
441.302 State assurances.
441.303 Supporting documentation required.
441.304 Duration, extension, and amendment of a waiver.
441.305 Replacement of beneficiaries in approved waiver programs.
441.306 Cooperative arrangements with the Maternal and Child Health 
          program.
441.307 Notification of a waiver termination.
441.308 Hearings procedures for waiver terminations.
441.310 Limits on Federal financial participation (FFP).

Subpart H_Home and Community-Based Services Waivers for Individuals Age 
                    65 or Older: Waiver Requirements

441.350 Basis and purpose.
441.351 Contents of a request for a waiver.
441.352 State assurances.
441.353 Supporting documentation required.
441.354 Aggregate projected expenditure limit (APEL).
441.355 Duration, extension, and amendment of a waiver.
441.356 Waiver termination.
441.357 Hearing procedures for waiver denials.
441.360 Limits on Federal financial participation (FFP).
441.365 Periodic evaluation, assessment, and review.

       Subpart I_Community Supported Living Arrangements Services

441.400 Basis and purpose.
441.402 State plan requirements.
441.404 Minimum protection requirements.

  Subpart J_Optional Self-Directed Personal Assistance Services Program

441.450 Basis, scope, and definitions.
441.452 Self-direction: General.
441.454 Use of cash.
441.456 Voluntary disenrollment.
441.458 Involuntary disenrollment.
441.460 Participant living arrangements.
441.462 Statewideness, comparability, and limitations on number served.
441.464 State assurances.
441.466 Assessment of need.
441.468 Service plan elements.
441.470 Service budget elements.
441.472 Budget methodology.
441.474 Quality assurance and improvement plan.
441.476 Risk management.
441.478 Qualifications of providers of personal assistance.
441.480 Use of a representative.
441.482 Permissible purchases.
441.484 Financial management services.

Subpart K_Home and Community-Based Attendant Services and Supports State 
                  Plan Option (Community First Choice)

441.500 Basis and scope.
441.505 Definitions.
441.510 Eligibility.
441.515 Statewideness.
441.520 Included services.
441.525 Excluded services.
441.530 Home and community-based setting.
441.535 Assessment of functional need.
441.540 Person-centered service plan.
441.545 Service models.
441.550 Service plan requirements for self-directed model with service 
          budget.
441.555 Support system.
441.560 Service budget requirements.
441.565 Provider qualifications.
441.570 State assurances.
441.575 Development and Implementation Council.
441.580 Data collection.
441.585 Quality assurance system.
441.590 Increased Federal financial participation.

                 Subpart L_Vaccines for Children Program

441.600 Basis and purpose.
441.605 General requirements.
441.610 State plan requirements.
441.615 Administration fee requirements.

 Subpart M_State Plan Home and Community-Based Services for the Elderly 
                    and Individuals with Disabilities

441.700 Basis and purpose.
441.705 State plan requirements.
441.710 State plan home and community-based services under section 
          1915(i)(1) of the Act.
441.715 Needs-based criteria and evaluation.
441.720 Independent assessment.
441.725 Person-centered service plan.
441.730 Provider qualifications.
441.735 Definition of individual's representative.
441.740 Self-directed services.
441.745 State plan HCBS administration: State responsibilities and 
          quality improvement.

    Authority: 42 U.S.C. 1302.

    Source: 43 FR 45229, Sept. 29, 1978, unless otherwise noted.

[[Page 373]]



Sec.  441.1  Purpose.

    This part sets forth State plan requirements and limits on FFP for 
specific services defined in part 440 of this subchapter. Standards for 
payments for services provided in intermediate care facilities and 
skilled nursing facilities are set forth in part 442 of this subchapter.



                      Subpart A_General Provisions



Sec.  441.10  Basis.

    This subpart is based on the following sections of the Act which 
state requirements and limits on the services specified or provide 
Secretarial authority to prescribe regulations relating to services:
    (a) Section 1102 for end-stage renal disease (Sec.  441.40).
    (b) Section 1138(b) for organ procurement organization services 
(Sec.  441.13(c)).
    (c) Sections 1902(a)(10)(A) and 1905(a)(21) for nurse practitioner 
services (Sec.  441.22).
    (d) Sections 1902(a)(10)(D) and 1905(a)(7) for home health services 
(Sec.  441.15).
    (e) Section 1903(i)(1) for organ transplant procedures (Sec.  
441.35).
    (f) Section 1903(i)(5) for certain prescribed drugs (Sec.  441.25).
    (g) Section 1903(i)(6) for prohibition (except in emergency 
situations) of FFP in expenditures for inpatient hospital tests that are 
not ordered by the attending physician or other licensed practitioner 
(Sec.  441.12).
    (h) Section 1903(i)(18) for the requirement that each home health 
agency provide the Medicaid agency with a surety bond (Sec.  441.16).
    (i) Section 1905(a)(4)(C) for family planning (Sec.  441.20).
    (j) Sections 1905 (a)(12) and (e) for optometric services (Sec.  
441.30).
    (k) Section 1905(a)(17) for nurse-midwife services (Sec.  441.21).
    (l) Section 1905(a) (following (a)(24)) for prohibition of FFP in 
expenditures for certain services (Sec.  441.13).
    (m) Section 1905(a)(19) and 1915(g) of the Act for case management 
services as set forth in Sec.  441.18 and section 8435 of the Technical 
and Miscellaneous Revenue Act of 1988.

[60 FR 19862, Apr. 21, 1995, as amended at 63 FR 310, Jan. 5, 1998; 72 
FR 68092, Dec. 4, 2007]



Sec.  441.11  Continuation of FFP for institutional services.

    (a) Basic conditions for continuation of FFP. FFP may be continued 
for up to 30 days after the effective date of termination or expiration 
of a provider agreement, if the following conditions are met:
    (1) The Medicaid payments are for beneficiaries admitted to the 
facility before the effective date of termination or expiration.
    (2) The State agency is making reasonable efforts to transfer those 
beneficiaries to other facilities or to alternate care.
    (b) When the 30-day period begins. The 30-day period begins on one 
of the following:
    (1) The effective date of termination of the facility's provider 
agreement by CMS;
    (2) The effective date of termination of the facility's Medicaid 
provider agreement by the Medicaid agency on its own volition; or
    (3) In the case of an ICF/IID, the later of--
    (i) The effective date of termination or nonrenewal of the 
facility's provider agreement by the Medicaid agency on its own 
volition; or
    (ii) The date of issuance of an administrative hearing decision that 
upholds the agency's termination or nonrenewal action.
    (c) Services for which FFP may be continued. FFP may be continued 
for any of the following services, as defined in subpart A of part 440 
of this chapter:
    (1) Inpatient hospital services.
    (2) Inpatient hospital services for individuals age 65 or older in 
an institution for mental diseases.
    (3) Nursing facility services for individuals age 21 or older.
    (4) Nursing facility services for individuals age 65 or older in an 
institution for mental diseases.
    (5) Inpatient psychiatric services for individuals under age 21.
    (6) Nursing facility services for individuals under 21.

[[Page 374]]

    (7) Intermediate care facility services for individuals with 
intellectual disabilities.

[59 FR 56234, Nov. 10, 1994]



Sec.  441.12  Inpatient hospital tests.

    Except in an emergency situation (see Sec.  440.170(e)(1) of this 
chapter for definition), FFP is not available in expenditures for 
inpatient hospital tests unless the tests are specifically ordered by 
the attending physician or other licensed practitioner, acting within 
the scope of practice as defined under State law, who is responsible for 
the diagnosis or treatment of a particular patient's condition.

[46 FR 48554, Oct. 1, 1981]



Sec.  441.13  Prohibitions on FFP: Institutionalized individuals.

    (a) FFP is not available in expenditures for services for--
    (1) Any individual who is in a public institution, as defined in 
Sec.  435.1010 of this chapter; or
    (2) Any individual who is under age 65 and is in an institution for 
mental diseases, except an individual who is under age 22 and receiving 
inpatient psychiatric services under subpart D of this part.
    (b) With the exception of active treatment services (as defined in 
Sec.  483.440(a) of this chapter for residents of ICFs/IID and in Sec.  
441.154 for individuals under age 21 receiving inpatient psychiatric 
services), payments to institutions for Individuals with Intellectual 
Disabilities or persons with related conditions and to psychiatric 
facilities or programs providing inpatient psychiatric services to 
individuals under age 21 may not include reimbursement for formal 
educational services or for vocational services. Formal educational 
services relate to training in traditional academic subjects. Subject 
matter rather than setting, time of day, or class size determines 
whether a service is educational. Traditional academic subjects include, 
but are not limited to, science, history, literature, foreign languages, 
and mathematics. Vocational services relate to organized programs that 
are directly related to the preparation of individuals for paid or 
unpaid employment. An example of vocational services is time-limited 
vocational training provided as a part of a regularly scheduled class 
available to the general public.
    (c) FFP is not available in expenditures for services furnished by 
an organ procurement organization on or after April 1, 1988, that does 
not meet the requirements of part 486 subpart G of this chapter.

[43 FR 45229, Sept. 29, 1978, as amended at 51 FR 22041, June 17, 1986; 
53 FR 6549, Mar. 1, 1988; 57 FR 54709, Nov. 20, 1992; 71 FR 31046, May 
31, 2006; 71 FR 39229, July 12, 2006]



Sec.  441.15  Home health services.

    With respect to the services defined in Sec.  440.70 of this 
subchapter, a State plan must provide that--
    (a) Home health services include, as a minimum--
    (1) Nursing services;
    (2) Home health aide services; and
    (3) Medical supplies, equipment, and appliances.
    (b) The agency provides home health services to--
    (1) Categorically needy beneficiaries age 21 or over;
    (2) Categorically needy beneficiaries under age 21, if the plan 
provides skilled nursing facility services for them; individuals; and
    (3) Medically needy beneficiaries to whom skilled nursing facility 
services are provided under the plan.
    (c) The eligibility of a beneficiary to receive home health services 
does not depend on his need for or discharge from institutional care.
    (d) The agency providing home health services meets the 
capitalization requirements included in Sec.  489.28 of this chapter.

[43 FR 45229, Sept. 29, 1978, as amended at 45 FR 24889, Apr. 11, 1980; 
63 FR 310, Jan. 5, 1998]



Sec.  441.16  Home health agency requirements for surety bonds;
Prohibition on FFP.

    (a) Definitions. As used in this section, unless the context 
indicates otherwise--
    Assets includes but is not limited to any listing that identifies 
Medicaid beneficiaries to whom home health services were furnished by a 
participating or formerly participating HHA.

[[Page 375]]

    Participating home health agency means a ``home health agency'' 
(HHA) as that term is defined at Sec.  440.70(d) of this subchapter.
    Surety bond means one or more bonds issued by one or more surety 
companies under 31 U.S.C. 9304 to 9308 and 31 CFR parts 223, 224, and 
225, provided the bond otherwise meets the requirements of this section.
    Uncollected overpayment means an ``overpayment,'' as that term is 
defined under Sec.  433.304 of this subchapter, plus accrued interest, 
for which the HHA is responsible, that has not been recouped by the 
Medicaid agency within a time period determined by the Medicaid agency.
    (b) Prohibition. FFP is not available in expenditures for home 
health services under Sec.  440.70 of this subchapter unless the home 
health agency furnishing these services meets the surety bond 
requirements of paragraphs (c) through (l) of this section.
    (c) Basic requirement. Except as provided in paragraph (d) of this 
section, each HHA that is a Medicaid participating HHA or that seeks to 
become a Medicaid participating HHA must--
    (1) Obtain a surety bond that meets the requirements of this section 
and instructions issued by the Medicaid agency; and
    (2) Furnish a copy of the surety bond to the Medicaid agency.
    (d) Requirement waived for Government-operated HHAs. An HHA operated 
by a Federal, State, local, or tribal government agency is deemed to 
have provided the Medicaid agency with a comparable surety bond under 
State law, and is therefore exempt from the requirements of this section 
if, during the preceding 5 years, the HHA has not had any uncollected 
overpayments.
    (e) Parties to the bond. The surety bond must name the HHA as 
Principal, the Medicaid agency as Obligee, and the surety company (and 
its heirs, executors, administrators, successors and assignees, jointly 
and severally) as Surety.
    (f) Authorized Surety and exclusion of surety companies. An HHA may 
obtain a surety bond required under this section only from an authorized 
Surety.
    (1) An authorized Surety is a surety company that--
    (i) Has been issued a Certificate of Authority by the U.S. 
Department of the Treasury in accordance with 31 U.S.C. 9304 to 9308 and 
31 CFR parts 223, 224, and 225 as an acceptable surety on Federal bonds 
and the Certificate has neither expired nor been revoked;
    (ii) Has not been determined by the Medicaid agency to be an 
unauthorized Surety for the purpose of an HHA obtaining a surety bond 
under this section; and
    (iii) Meets other conditions, as specified by the Medicaid agency.
    (2) The Medicaid agency may determine that a surety company is an 
unauthorized Surety under this section--
    (i) If, upon request by the Medicaid agency, the surety company 
fails to furnish timely confirmation of the issuance of, and the 
validity and accuracy of information appearing on, a surety bond that an 
HHA presents to the Medicaid agency that shows the surety company as 
Surety on the bond;
    (ii) If, upon presentation by the Medicaid agency to the surety 
company of a request for payment on a surety bond and of sufficient 
evidence to establish the surety company's liability on the bond, the 
surety company fails to timely pay the Medicaid agency in full the 
amount requested up to the face amount of the bond; or
    (iii) For other good cause.
    (3) The Medicaid agency must specify the manner by which public 
notification of a determination under paragraph (f)(2) of this section 
is given and the effective date of the determination.
    (4) A determination by the Medicaid agency that a surety company is 
an unauthorized Surety under paragraph (f)(2) of this section--
    (i) Has effect only within the State; and
    (ii) Is not a debarment, suspension, or exclusion for the purposes 
of Executive Order No. 12549 (3 CFR 1986 Comp., p. 189).
    (g) Amount of the bond--(1) Basic rule. The amount of the surety 
bond must be $50,000 or 15 percent of the annual Medicaid payments made 
to the HHA by the Medicaid agency for home health services furnished 
under this subchapter for which FFP is available, whichever is greater.

[[Page 376]]

    (2) Computation of the 15 percent: Participating HHA. The 15 percent 
is computed by the Medicaid agency on the basis of Medicaid payments 
made to the HHA for the most recent annual period for which information 
is available as specified by the Medicaid agency.
    (3) Computation of 15 percent: An HHA that seeks to become a 
participating HHA by obtaining assets or ownership interest. For an HHA 
that seeks to become a participating HHA by purchasing the assets or the 
ownership interest of a participating or formerly participating HHA, the 
15 percent is computed on the basis of Medicaid payments made by the 
Medicaid agency to the participating or formerly participating HHA for 
the most recent annual period as specified by the Medicaid agency.
    (4) Computation of 15 percent: Change of ownership. For an HHA that 
undergoes a change of ownership (as ``change of ownership'' is defined 
by the State Medicaid agency) the 15 percent is computed on the basis of 
Medicaid payments made by the Medicaid agency to the HHA for the most 
recent annual period as specified by the Medicaid agency.
    (5) An HHA that seeks to become a participating HHA without 
obtaining assets or ownership interest. For an HHA that seeks to become 
a participating HHA without purchasing the assets or the ownership 
interest of a participating or formerly participating HHA, the 15 
percent computation does not apply.
    (6) Exception to the basic rule. If an HHA's overpayment in the most 
recent annual period exceeds 15 percent, the State Medicaid agency may 
require the HHA to secure a bond in an amount up to or equal to the 
amount of the overpayment, provided the amount of the bond is not less 
than $50,000.
    (7) Expiration of the 15 percent provision. For an annual surety 
bond, or for a rider on a continuous surety bond, that is required to be 
submitted on or after June 1, 2005, notwithstanding any reference in 
this section to 15 percent as a basis for determining the amount of the 
bond, the amount of the bond or rider, as applicable, must be $50,000 or 
such amount as the Medicaid agency specifies in accordance with 
paragraph (g)(6) of this section, whichever amount is greater.
    (h) Additional requirements of the surety bond. The surety bond that 
an HHA obtains under this section must meet the following additional 
requirements:
    (1) The bond must guarantee that, upon written demand by the 
Medicaid agency to the Surety for payment under the bond and the 
Medicaid agency furnishing to the Surety sufficient evidence to 
establish the Surety's liability under the bond, the Surety will timely 
pay the Medicaid agency the amount so demanded, up to the stated amount 
of the bond.
    (2) The bond must provide that the Surety is liable for uncollected 
overpayments, as defined in paragraph (a), provided such uncollected 
overpayments are determined during the term of the bond and regardless 
of when the overpayments took place. Further, the bond must provide that 
the Surety remains liable if the HHA fails to furnish a subsequent 
annual bond that meets the requirements of this subpart or fails to 
furnish a rider for a year for which a rider is required to be 
submitted, or if the HHA's provider agreement terminates and that the 
Surety's liability shall be based on the last bond or rider in effect 
for the HHA, which shall then remain in effect for an additional 2-year 
period.
    (3) The bond must provide that the Surety's liability to the 
Medicaid agency is not extinguished by any of the following:
    (i) Any action by the HHA or the Surety to terminate or limit the 
scope or term of the bond. The Surety's liability may be extinguished, 
however, when--
    (A) The Surety furnishes the Medicaid agency with notice of such 
action not later than 10 days after receiving notice from the HHA of 
action by the HHA to terminate or limit the scope of the bond, or not 
later than 60 days before the effective date of such action by the 
Surety; or
    (B) The HHA furnishes the Medicaid agency with a new bond that meets 
the requirements of both this section and the Medicaid agency.
    (ii) The Surety's failure to continue to meet the requirements of 
paragraph (f)(1) of this section or the Medicaid agency's determination 
that the surety company is an unauthorized surety under paragraph (f)(2) 
of this section.

[[Page 377]]

    (iii) Termination of the HHA's provider agreement described under 
Sec.  431.107 of this subchapter.
    (iv) Any action by the Medicaid agency to suspend, offset, or 
otherwise recover payments to the HHA.
    (v) Any action by the HHA to--
    (A) Cease operation;
    (B) Sell or transfer any assets or ownership interest;
    (C) File for bankruptcy; or
    (D) Fail to pay the Surety.
    (vi) Any fraud, misrepresentation, or negligence by the HHA in 
obtaining the surety bond or by the Surety (or by the Surety's agent, if 
any) in issuing the surety bond, except that any fraud, 
misrepresentation, or negligence by the HHA in identifying to the Surety 
(or to the Surety's agent) the amount of Medicaid payments upon which 
the amount of the surety bond is determined shall not cause the Surety's 
liability to the Medicaid agency to exceed the amount of the bond.
    (vii) The HHA's failure to exercise available appeal rights under 
Medicaid or to assign such rights to the Surety (provided the Medicaid 
agency permits such rights to be assigned).
    (4) The bond must provide that actions under the bond may be brought 
by the Medicaid agency or by an agent that the Medicaid agency 
designates.
    (i) Term and type of bond--(1) Initial term: Each participating HHA 
that is not exempted by paragraph (d) of this section must submit to the 
State Medicaid agency a surety bond for a term beginning January 1, 
1998. If an annual bond is submitted for the initial term it must be 
effective for an annual period specified by the State Medicaid agency.
    (2) Type of bond. The type of bond required to be submitted by an 
HHA, under this section, may be either--
    (i) An annual bond (that is, a bond that specifies an effective 
annual period that corresponds to an annual period specified by the 
Medicaid agency); or
    (ii) A continuous bond (that is, a bond that remains in full force 
and effect from term to term unless it is terminated or canceled as 
provided for in the bond or as otherwise provided by law) that is 
updated by the Surety for a particular period, via the issuance of a 
``rider,'' when the bond amount changes. For the purposes of this 
section, ``Rider'' means a notice issued by a Surety that a change to a 
bond has occurred or will occur. If the HHA has submitted a continuous 
bond and there is no increase or decrease in the bond amount, no action 
is necessary by the HHA to submit a rider as long as the continuous bond 
remains in full force and effect.
    (3) HHA that seeks to become a participating HHA. (i) An HHA that 
seeks to become a participating HHA must submit a surety bond before a 
provider agreement described under Sec.  431.107 of this subchapter can 
be entered into.
    (ii) An HHA that seeks to become a participating HHA through the 
purchase or transfer of assets or ownership interest of a participating 
or formerly participating HHA must also ensure that the surety bond is 
effective from the date of such purchase or transfer.
    (4) Change of ownership. An HHA that undergoes a change of ownership 
(as ``change of ownership'' is defined by the State Medicaid agency) 
must submit the surety bond to the State Medicaid agency by such time 
and for such term as is specified in the instructions of the State 
Medicaid agency.
    (5) Government-operated HHA that loses its waiver. A government-
operated HHA that, as of January 1, 1998, meets the criteria for waiver 
of the requirements of this section but thereafter is determined by the 
Medicaid agency to not meet such criteria, must submit a surety bond to 
the Medicaid agency within 60 days after it receives notice from the 
Medicaid agency that it does not meet the criteria for waiver.
    (6) Change of Surety. An HHA that obtains a replacement surety bond 
from a different Surety to cover the remaining term of a previously 
obtained bond must submit the new surety bond to the Medicaid agency 
within 60 days (or such earlier date as the Medicaid agency may specify) 
of obtaining the bond from the new Surety for a term specified by the 
Medicaid agency.
    (j) Effect of failure to obtain, maintain, and timely file a surety 
bond. (1) The Medicaid agency must terminate the HHA's provider 
agreement if the HHA fails to obtain, file timely, and maintain a surety 
bond in accordance with

[[Page 378]]

this section and the Medicaid agency's instructions.
    (2) The Medicaid agency must refuse to enter into a provider 
agreement with an HHA if an HHA seeking to become a participating HHA 
fails to obtain and file timely a surety bond in accordance with this 
section and instructions issued by the State Medicaid agency.
    (k) Evidence of compliance. (1) The Medicaid agency may at any time 
require an HHA to make a specific showing of being in compliance with 
the requirements of this section and may require the HHA to submit such 
additional evidence as the Medicaid agency considers sufficient to 
demonstrate the HHA's compliance.
    (2) The Medicaid agency may terminate the HHA's provider agreement 
or refuse to enter into a provider agreement if an HHA fails to timely 
furnish sufficient evidence at the Medicaid agency's request to 
demonstrate compliance with the requirements of this section.
    (l) Surety's standing to appeal Medicaid determinations. The 
Medicaid agency must establish procedures for granting appeal rights to 
Sureties.
    (m) Effect of conditions of payment. If a Surety has paid the 
Medicaid agency an amount on the basis of liability incurred under a 
bond obtained by an HHA under this section, and the Medicaid agency 
subsequently collects from the HHA, in whole or in part, on such 
overpayment that was the basis for the Surety's liability, the Medicaid 
agency must reimburse the Surety such amount as the Medicaid agency 
collected from the HHA, up to the amount paid by the Surety to the 
Medicaid agency, provided the Surety has no other liability under the 
bond.

[63 FR 310, Jan. 5, 1998, as amended at 63 FR 10731, Mar. 4, 1998; 63 FR 
29654, June 1, 1998; 63 FR 41170, July 31, 1998]



Sec.  441.17  Laboratory services.

    (a) The plan must provide for payment of laboratory services as 
defined in Sec.  440.30 of this subchapter if provided by--
    (1) An independent laboratory that meets the requirements for 
participation in the Medicare program found in part 491 of this chapter;
    (2) A hospital-based laboratory that meets the requirements for 
participation in the Medicare program found in Sec.  482.27 of this 
chapter;
    (3) A rural health clinic, as defined in Sec.  491.9 of this 
chapter; or
    (4) A skilled nursing facility--based clinical laboratory, as 
defined in part 491 of this chapter.
    (b) Except as provided under paragraph (c), if a laboratory or other 
entity is requesting payment under Medicaid for testing for the presence 
of the human immunodeficiency virus (HIV) antibody or for the isolation 
and identification of the HIV causative agent as described in part 491 
of this chapter, the laboratory records must contain the name and other 
identification of the person from whom the specimen was taken.
    (c) An agency may choose to approve the use of alternative 
identifiers, in place of the requirement for patient's name, in 
paragraph (b) of this section for HIV antibody or causative agent 
testing of Medicaid beneficiaries.

[54 FR 48647, Dec. 2, 1988. Redesignated at 63 FR 310, Jan. 5, 1998, as 
amended at 85 FR 72909, Nov. 16, 2020]



Sec.  441.18  Case management services.

    (a) If a State plan provides for case management services (including 
targeted case management services), as defined in Sec.  440.169 of this 
chapter, the State must meet the following requirements:
    (1) Allow individuals the free choice of any qualified Medicaid 
provider within the specified geographic area identified in the plan 
when obtaining case management services, in accordance with Sec.  431.51 
of this chapter, except as specified in paragraph (b) of this section.
    (2) Not use case management (including targeted case management) 
services to restrict an individual's access to other services under the 
plan.
    (3) Not compel an individual to receive case management services, 
condition receipt of case management (or targeted case management) 
services on the receipt of other Medicaid services, or condition receipt 
of other Medicaid services on receipt of case management (or targeted 
case management) services.

[[Page 379]]

    (4) Indicate in the plan that case management services provided in 
accordance with section 1915(g) of the Act will not duplicate payments 
made to public agencies or private entities under the State plan and 
other program authorities;
    (5) [Reserved]
    (6) Prohibit providers of case management services from exercising 
the agency's authority to authorize or deny the provision of other 
services under the plan.
    (7) Require providers to maintain case records that document for all 
individuals receiving case management as follows:
    (i) The name of the individual.
    (ii) The dates of the case management services.
    (iii) The name of the provider agency (if relevant) and the person 
providing the case management service.
    (iv) The nature, content, units of the case management services 
received and whether goals specified in the care plan have been 
achieved.
    (v) Whether the individual has declined services in the care plan.
    (vi) The need for, and occurrences of, coordination with other case 
managers.
    (vii) A timeline for obtaining needed services.
    (viii) A timeline for reevaluation of the plan.
    (8) Include a separate plan amendment for each group receiving case 
management services that includes the following:
    (i) Defines the group (and any subgroups within the group) eligible 
to receive the case management services.
    (ii) Identifies the geographic area to be served.
    (iii) Describes the case management services furnished, including 
the types of monitoring.
    (iv) Specifies the frequency of assessments and monitoring and 
provides a justification for those frequencies.
    (v) Specifies provider qualifications that are reasonably related to 
the population being served and the case management services furnished.
    (vi) [Reserved]
    (vii) Specifies if case management services are being provided to 
Medicaid-eligible individuals who are in institutions (except 
individuals between ages 22 and 64 who are served in IMDs or individuals 
who are inmates of public institutions).
    (9) Include a separate plan amendment for each subgroup within a 
group if any of the following differs among the subgroups:
    (i) The case management services to be furnished;
    (ii) The qualifications of case management providers; or
    (iii) The methodology under which case management providers will be 
paid.
    (b) If the State limits qualified providers of case management 
services for target groups of individuals with developmental disability 
or chronic mental illness, in accordance with Sec.  431.51(a)(4) of this 
chapter, the plan must identify any limitations to be imposed on the 
providers and specify how these limitations enable providers to ensure 
that individuals within the target groups receive needed services.
    (c) Case management does not include, and FFP is not available in 
expenditures for, services defined in Sec.  440.169 of this chapter when 
the case management activities constitute the direct delivery of 
underlying medical, educational, social, or other services to which an 
eligible individual has been referred, including for foster care 
programs, services such as, but not limited to, the following:
    (1) Research gathering and completion of documentation required by 
the foster care program.
    (2) Assessing adoption placements.
    (3) Recruiting or interviewing potential foster care parents.
    (4) Serving legal papers.
    (5) Home investigations.
    (6) Providing transportation.
    (7) Administering foster care subsidies.
    (8) Making placement arrangements.
    (d) After the State assesses whether the activities are within the 
scope of the case management benefit (applying the limitations described 
above), in determining the allowable costs for case management (or 
targeted case management) services that are also furnished by another 
federally-funded program, the State must use cost allocation 
methodologies, consistent with OMB Circular A-87, CMS policies, or any

[[Page 380]]

subsequent guidance and reflected in an approved cost allocation plan.

[72 FR 68092, Dec. 4, 2007, as amended at 74 FR 31196, June 30, 2009; 85 
FR 72909, Nov. 16, 2020]



Sec.  441.20  Family planning services.

    For beneficiaries eligible under the plan for family planning 
services, the plan must provide that each beneficiary is free from 
coercion or mental pressure and free to choose the method of family 
planning to be used.



Sec.  441.21  Nurse-midwife services.

    If a State plan, under Sec.  440.210 or 440.220 of this subchapter, 
provides for nurse-midwife services, as defined in Sec.  440.165, the 
plan must provide that the nurse-midwife may enter into an independent 
provider agreement, without regard to whether the nurse-midwife is under 
the supervision of, or associated with, a physician or other health care 
provider.

[47 FR 21051, May 17, 1982]



Sec.  441.22  Nurse practitioner services.

    With respect to nurse practitioner services that meet the definition 
of Sec.  440.166(a) and the requirements of either Sec.  440.166(b) or 
Sec.  440.166(c), the State plan must meet the following requirements:
    (a) Provide that nurse practitioner services are furnished to the 
categorically needy.
    (b) Specify whether those services are furnished to the medically 
needy.
    (c) Provide that services furnished by a nurse practitioner, 
regardless of whether the nurse practitioner is under the supervision 
of, or associated with, a physician or other health care provider, may--
    (1) Be reimbursed by the State Medicaid agency through an 
independent provider agreement between the State and the nurse 
practitioner; or
    (2) Be paid through the employing provider.

[60 FR 19862, Apr. 21, 1995]



Sec.  441.25  Prohibition on FFP for certain prescribed drugs.

    (a) FFP is not available in expenditures for the purchase or 
administration of 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 (see 21 CFR 310.6 for an 
explanation of this program), that there is a compelling justification 
of the drug product's medical need.
    (b) FFP is not available in expenditures for the purchase or 
administration of 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 (a) of this section.

[46 FR 48554, Oct. 1, 1981]



Sec.  441.30  Optometric services.

    The plan must provide for payment of optometric services as 
physician services, whether furnished by an optometrist or a physician, 
if--
    (a) The plan does not provide for payment for services provided by 
an optometrist, except for eligibility determinations under Sec. Sec.  
435.531 and 436.531 of this subchapter, but did provide for those 
services at an earlier period; and
    (b) The plan specifically provides that physicians' services include 
services an optometrist is legally authorized to perform.



Sec.  441.35  Organ transplants.

    (a) FFP is available in expenditures for services furnished in 
connection with organ transplant procedures only if the State plan 
includes written standards for the coverage of those procedures, and 
those standards provide that--
    (1) Similarly situated individuals are treated alike; and

[[Page 381]]

    (2) Any restriction on the practitioners or facilities that may 
provide organ transplant procedures is consistent with the accessibility 
of high quality care to individuals eligible for the procedures under 
the plan.
    (b) Nothing in paragraph (a) permits a State to provide, under its 
plan, services that are not reasonable in amount, duration, and scope to 
achieve their purpose.

[56 FR 8851, Mar. 1, 1991]



Sec.  441.40  End-stage renal disease.

    FFP in expenditures for services described in subpart A of part 440 
is available for facility treatment of end-stage renal disease only if 
the facility has been approved by the Secretary to furnish those 
services under Medicare. This requirement for approval of the facility 
does not apply under emergency conditions permitted under Medicare (see 
Sec.  482.2 of this chapter).

[43 FR 45229, Sept. 29, 1978, as amended at 51 FR 22041, June 17, 1986]



Subpart B_Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) 
                       of Individuals Under Age 21

    Source: 49 FR 43666, Oct. 31, 1984, unless otherwise noted.



Sec.  441.50  Basis and purpose.

    This subpart implements sections 1902(a)(43) and 1905(a)(4)(B) of 
the Social Security Act, by prescribing State plan requirements for 
providing early and periodic screening and diagnosis of eligible 
Medicaid beneficiaries under age 21 to ascertain physical and mental 
defects, and providing treatment to correct or ameliorate defects and 
chronic conditions found.



Sec.  441.55  State plan requirements.

    A State plan must provide that the Medicaid agency meets the 
requirements of Sec. Sec.  441.56-441.62, with respect to EPSDT 
services, as defined in Sec.  440.40(b) of this subchapter.



Sec.  441.56  Required activities.

    (a) Informing. The agency must--
    (1) Provide for a combination of written and oral methods designed 
to inform effectively all EPSDT eligible individuals (or their families) 
about the EPSDT program.
    (2) Using clear and nontechnical language, provide information about 
the following--
    (i) The benefits of preventive health care;
    (ii) The services available under the EPSDT program and where and 
how to obtain those services;
    (iii) That the services provided under the EPSDT program are without 
cost to eligible individuals under 18 years of age, and if the agency 
chooses, to those 18 or older, up to age 21, except for any enrollment 
fee, premium, or similar charge that may be imposed on medically needy 
beneficiaries; and
    (iv) That necessary transportation and scheduling assistance 
described in Sec.  441.62 of this subpart is available to the EPSDT 
eligible individual upon request.
    (3) Effectively inform those individuals who are blind or deaf, or 
who cannot read or understand the English language.
    (4) Provide assurance to CMS that processes are in place to 
effectively inform individuals as required under this paragraph, 
generally, within 60 days of the individual's initial Medicaid 
eligibility determination and in the case of families which have not 
utilized EPSDT services, annually thereafter.
    (b) Screening. (1) The agency must provide to eligible EPSDT 
beneficiaries who request it, screening (periodic comprehensive child 
health assessments); that is, regularly scheduled examinations and 
evaluations of the general physical and mental health, growth, 
development, and nutritional status of infants, children, and youth. 
(See paragraph (c)(3) of this section for requirements relating to 
provision of immunization at the time of screening.) As a minimum, these 
screenings must include, but are not limited to:
    (i) Comprehensive health and developmental history.
    (ii) Comprehensive unclothed physical examination.
    (iii) Appropriate vision testing.
    (iv) Appropriate hearing testing.
    (v) Appropriate laboratory tests.

[[Page 382]]

    (vi) Dental screening services furnished by direct referral to a 
dentist for children beginning at 3 years of age. An agency may request 
from CMS an exception from this age requirement (within an outer limit 
of age 5) for a two year period and may request additional two year 
exceptions. If an agency requests an exception, it must demonstrate to 
CMS's satisfaction that there is a shortage of dentists that prevents 
the agency from meeting the age 3 requirement.
    (2) Screening services in paragraph (b)(1) of this section must be 
provided in accordance with reasonable standards of medical and dental 
practice determined by the agency after consultation with recognized 
medical and dental organizations involved in child health care.
    (c) Diagnosis and treatment. In addition to any diagnostic and 
treatment services included in the plan, the agency must provide to 
eligible EPSDT beneficiaries, the following services, the need for which 
is indicated by screening, even if the services are not included in the 
plan--
    (1) Diagnosis of and treatment for defects in vision and hearing, 
including eyeglasses and hearing aids;
    (2) Dental care, at as early an age as necessary, needed for relief 
of pain and infections, restoration of teeth and maintenance of dental 
health; and
    (3) Appropriate immunizations. (If it is determined at the time of 
screening that immunization is needed and appropriate to provide at the 
time of screening, then immunization treatment must be provided at that 
time.)
    (d) Accountability. The agency must maintain as required by 
Sec. Sec.  431.17 and 431.18--
    (1) Records and program manuals;
    (2) A description of its screening package under paragraph (b) of 
this section; and
    (3) Copies of rules and policies describing the methods used to 
assure that the informing requirement of paragraph (a)(1) of this 
section is met.
    (e) Timeliness. With the exception of the informing requirements 
specified in paragraph (a) of this section, the agency must set 
standards for the timely provision of EPSDT services which meet 
reasonable standards of medical and dental practice, as determined by 
the agency after consultation with recognized medical and dental 
organizations involved in child health care, and must employ processes 
to ensure timely initiation of treatment, if required, generally within 
an outer limit of 6 months after the request for screening services.

[49 FR 43666, Oct. 31, 1984; 49 FR 45431, Nov. 16, 1984]



Sec.  441.57  Discretionary services.

    Under the EPSDT program, the agency may provide for any other 
medical or remedial care specified in part 440 of this subchapter, even 
if the agency does not otherwise provide for these services to other 
beneficiaries or provides for them in a lesser amount, duration, or 
scope.



Sec.  441.58  Periodicity schedule.

    The agency must implement a periodicity schedule for screening 
services that--
    (a) Meets reasonable standards of medical and dental practice 
determined by the agency after consultation with recognized medical and 
dental organizations involved in child health care;
    (b) Specifies screening services applicable at each stage of the 
beneficiary's life, beginning with a neonatal examination, up to the age 
at which an individual is no longer eligible for EPSDT services; and
    (c) At the agency's option, provides for needed screening services 
as determined by the agency, in addition to the otherwise applicable 
screening services specified under paragraph (b) of this section.



Sec.  441.59  Treatment of requests for EPSDT screening services.

    (a) The agency must provide the screening services described in 
Sec.  441.56(b) upon the request of an eligible beneficiary.
    (b) To avoid duplicate screening services, the agency need not 
provide requested screening services to an EPSDT eligible if written 
verification exists that the most recent age-appropriate screening 
services, due under the agency's periodicity schedule, have already been 
provided to the eligible.

[[Page 383]]



Sec.  441.60  Continuing care.

    (a) Continuing care provider. For purposes of this subpart, a 
continuing care provider means a provider who has an agreement with the 
Medicaid agency to provide reports as required under paragraph (b) of 
this section and to provide at least the following services to eligible 
EPSDT beneficiaries formally enrolled with the provider:
    (1) With the exception of dental services required under Sec.  
441.56, screening, diagnosis, treatment, and referral for follow-up 
services as required under this subpart.
    (2) Maintenance of the beneficiary's consolidated health history, 
including information received from other providers.
    (3) Physicians' services as needed by the beneficiary for acute, 
episodic or chronic illnesses or conditions.
    (4) At the provider's option, provision of dental services required 
under Sec.  441.56 or direct referral to a dentist to provide dental 
services required under Sec.  441.56(b)(1)(vi). The provider must 
specify in the agreement whether dental services or referral for dental 
services are provided. If the provider does not choose to provide either 
service, then the provider must refer beneficiaries to the agency to 
obtain those dental services required under Sec.  441.56.
    (5) At the provider's option, provision of all or part of the 
transportation and scheduling assistance as required under Sec.  441.62. 
The provider must specify in the agreement the transportation and 
scheduling assistance to be furnished. If the provider does not choose 
to provide some or all of the assistance, then the provider must refer 
beneficiaries to the agency to obtain the transportation and scheduling 
assistance required under Sec.  441.62.
    (b) Reports. A continuing care provider must provide to the agency 
any reports that the agency may reasonably require.
    (c) State monitoring. If the State plan provides for agreements with 
continuing care providers, the agency must employ methods described in 
the State plan to assure the providers' compliance with their 
agreements.
    (d) Effect of agreement with continuing care providers. Subject to 
the requirements of paragraphs (a), (b), and (c) of this section, CMS 
will deem the agency to meet the requirements of this subpart with 
respect to all EPSDT eligible beneficiaries formally enrolled with the 
continuing care provider. To be formally enrolled, a beneficiary or 
beneficiary's family agrees to use one continuing care provider to be a 
regular source of the described set of services for a stated period of 
time. Both the beneficiary and the provider must sign statements that 
reflect their obligations under the continuing care arrangement.
    (e) If the agreement in paragraph (a) of this section does not 
provide for all or part of the transportation and scheduling assistance 
required under Sec.  441.62, or for dental service under Sec.  441.56, 
the agency must provide for those services to the extent they are not 
provided for in the agreement.



Sec.  441.61  Utilization of providers and coordination with related
programs.

    (a) The agency must provide referral assistance for treatment not 
covered by the plan, but found to be needed as a result of conditions 
disclosed during screening and diagnosis. This referral assistance must 
include giving the family or beneficiary the names, addresses, and 
telephone numbers of providers who have expressed a willingness to 
furnish uncovered services at little or no expense to the family.
    (b) The agency must make available a variety of individual and group 
providers qualified and willing to provide EPSDT services.
    (c) The agency must make appropriate use of State health agencies, 
State vocational rehabilitation agencies, and Title V grantees (Maternal 
and Child Health/Crippled Children's Services). Further, the agency 
should make use of other public health, mental health, and education 
programs and related programs, such as Head Start, Title XX (Social 
Services) programs, and the Special Supplemental Food Program for Women, 
Infants and Children (WIC), to ensure an effective child health program.

[[Page 384]]



Sec.  441.62  Transportation and scheduling assistance.

    The agency must offer to the family or beneficiary, and provide if 
the beneficiary requests--
    (a) Necessary assistance with transportation as required under Sec.  
431.53 of this chapter; and
    (b) Necessary assistance with scheduling appointments for services.



 Subpart C_Medicaid for Individuals Age 65 or Over in Institutions for 
                             Mental Diseases

    Source: 44 FR 17940, Mar. 23, 1979, unless otherwise noted.



Sec.  441.100  Basis and purpose.

    This subpart implements section 1905(a)(14) of the Act, which 
authorizes State plans to provide for inpatient hospital services, 
skilled nursing services, and intermediate care facility services for 
individuals age 65 or older in an institution for mental diseases, and 
sections 1902(a)(20)(B) and (C) and 1902(a)(21), which prescribe the 
conditions a State must meet to offer these services. (See Sec.  431.620 
of this subchapter for regulations implementing section 1902(a)(20)(A), 
which prescribe interagency requirements related to these services.)



Sec.  441.101  State plan requirements.

    A State plan that includes Medicaid for individuals age 65 or older 
in institutions for mental diseases must provide that the requirements 
of this subpart are met.



Sec.  441.102  Plan of care for institutionalized beneficiaries.

    (a) The Medicaid agency must provide for a recorded individual plan 
of treatment and care to ensure that institutional care maintains the 
beneficiary at, or restores him to, the greatest possible degree of 
health and independent functioning.
    (b) The plan must include--
    (1) An initial review of the beneficiary's medical, psychiatric, and 
social needs--
    (i) Within 90 days after approval of the State plan provision for 
services in institutions for mental disease; and
    (ii) After that period, within 30 days after the date payments are 
initiated for services provided a beneficiary.
    (2) Periodic review of the beneficiary's medical, psychiatric, and 
social needs;
    (3) A determination, at least quarterly, of the beneficiary's need 
for continued institutional care and for alternative care arrangements;
    (4) Appropriate medical treatment in the institution; and
    (5) Appropriate social services.



Sec.  441.103  Alternate plans of care.

    (a) The agency must develop alternate plans of care for each 
beneficiary age 65 or older who would otherwise need care in an 
institution for mental diseases.
    (b) These alternate plans of care must--
    (1) Make maximum use of available resources to meet the 
beneficiary's medical, social, and financial needs; and
    (2) In Guam, Puerto Rico, and the Virgin Islands, make available 
appropriate social services authorized under sections 3(a)(4) (i) and 
(ii) or 1603(a)(4)(A) (i) and (ii) of the Act.



Sec.  441.105  Methods of administration.

    The agency must have methods of administration to ensure that its 
responsibilities under this subpart are met.



Sec.  441.106  Comprehensive mental health program.

    (a) If the plan includes services in public institutions for mental 
diseases, the agency must show that the State is making satisfactory 
progress in developing and implementing a comprehensive mental health 
program.
    (b) The program must--
    (1) Cover all ages;
    (2) Use mental health and public welfare resources; including--
    (i) Community mental health centers;
    (ii) Nursing homes; and
    (iii) Other alternatives to public institutional care; and
    (3) Include joint planning with State authorities.
    (c) The agency must submit annual progress reports within 3 months 
after the end of each fiscal year in which

[[Page 385]]

Medicaid is provided under this subpart.



Subpart D_Inpatient Psychiatric Services for Individuals Under Age 21 in 
                   Psychiatric Facilities or Programs



Sec.  441.150  Basis and purpose.

    This subpart specifies requirements applicable if a State provides 
inpatient psychiatric services to individuals under age 21, as defined 
in Sec.  440.160 of this subchapter and authorized under section 1905 
(a)(16) and (h) of the Act.



Sec.  441.151  General requirements.

    (a) Inpatient psychiatric services for individuals under age 21 must 
be:
    (1) Provided under the direction of a physician;
    (2) Provided by--
    (i) A psychiatric hospital that undergoes a State survey to 
determine whether the hospital meets the requirements for participation 
in Medicare as a psychiatric hospital as specified in Sec.  482.60 of 
this chapter, or is accredited by a national organization whose 
psychiatric hospital accrediting program has been approved by CMS; or a 
hospital with an inpatient psychiatric program that undergoes a State 
survey to determine whether the hospital meets the requirements for 
participation in Medicare as a hospital, as specified in part 482 of 
this chapter, or is accredited by a national accrediting organization 
whose hospital accrediting program has been approved by CMS.
    (ii) A psychiatric facility that is not a hospital and is accredited 
by the Joint Commission on Accreditation of Healthcare Organizations, 
the Commission on Accreditation of Rehabilitation Facilities, the 
Council on Accreditation of Services for Families and Children, or by 
any other accrediting organization with comparable standards that is 
recognized by the State.
    (3) Provided before the individual reaches age 21, or, if the 
individual was receiving the services immediately before he or she 
reached age 21, before the earlier of the following--
    (i) The date the individual no longer requires the services; or
    (ii) The date the individual reaches 22; and
    (4) Certified in writing to be necessary in the setting in which the 
services will be provided (or are being provided in emergency 
circumstances) in accordance with Sec.  441.152.
    (b) Inpatient psychiatric services furnished in a psychiatric 
residential treatment facility as defined in Sec.  483.352 of this 
chapter, must satisfy all requirements in subpart G of part 483 of this 
chapter governing the use of restraint and seclusion.
    (c) COVID-19 Vaccination of facility staff. The facility must 
develop and implement policies and procedures to ensure that all staff 
are fully vaccinated for COVID-19. For purposes of this section, staff 
are considered fully vaccinated if it has been 2 weeks or more since 
they completed a primary vaccination series for COVID-19. The completion 
of a primary vaccination series for COVID-19 is defined here as the 
administration of a single-dose vaccine, or the administration of all 
required doses of a multi-dose vaccine.
    (1) Regardless of clinical responsibility or resident contact, the 
policies and procedures must apply to the following facility staff, who 
provide any care, treatment, or other services for the facility and/or 
its residents:
    (i) Facility employees;
    (ii) Licensed practitioners;
    (iii) Students, trainees, and volunteers; and
    (iv) Individuals who provide care, treatment, or other services for 
the facility and/or its residents, under contract or by other 
arrangement.
    (2) The policies and procedures of this section do not apply to the 
following facility staff:
    (i) Staff who exclusively provide telehealth or telemedicine 
services outside of the facility setting and who do not have any direct 
contact with residents and other staff specified in paragraph (c)(1) of 
this section; and
    (ii) Staff who provide support services for the facility that are 
performed exclusively outside of the center setting and who do not have 
any direct contact with residents and other staff specified in paragraph 
(c)(1) of this section.

[[Page 386]]

    (3) The policies and procedures must include, at a minimum, the 
following components:
    (i) A process for ensuring all staff specified in paragraph (c)(1) 
of this section (except for those staff who have pending requests for, 
or who have been granted, exemptions to the vaccination requirements of 
this section, or those staff for whom COVID-19 vaccination must be 
temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination 
series for a multi-dose COVID-19 vaccine prior to staff providing any 
care, treatment, or other services for the facility and/or its 
residents;
    (ii) A process for ensuring that all staff specified in paragraph 
(c)(1) of this section are fully vaccinated for COVID-19, except for 
those staff who have been granted exemptions to the vaccination 
requirements of this section, or those staff for whom COVID-19 
vaccination must be temporarily delayed, as recommended by the CDC, due 
to clinical precautions and considerations;
    (iii) A process for ensuring that the facility follows nationally 
recognized infection prevention and control guidelines intended to 
mitigate the transmission and spread of COVID-19, and which must include 
the implementation of additional precautions for all staff who are not 
fully vaccinated for COVID-19;
    (iv) A process for tracking and securely documenting the COVID-19 
vaccination status of all staff specified in paragraph (c)(1) of this 
section;
    (v) A process for tracking and securely documenting the COVID-19 
vaccination status of any staff who have obtained any booster doses as 
recommended by the CDC;
    (vi) A process by which staff may request an exemption from the 
staff COVID-19 vaccination requirements based on an applicable Federal 
law;
    (vii) A process for tracking and securely documenting information 
provided by those staff who have requested, and for whom the facility 
has granted, an exemption from the staff COVID-19 vaccination 
requirements;
    (viii) A process for ensuring that all documentation, which confirms 
recognized clinical contraindications to COVID-19 vaccines and which 
supports staff requests for medical exemptions from vaccination, has 
been signed and dated by a licensed practitioner, who is not the 
individual requesting the exemption, and who is acting within their 
respective scope of practice as defined by, and in accordance with, all 
applicable State and local laws, and for further ensuring that such 
documentation contains:
    (A) All information specifying which of the authorized COVID-19 
vaccines are clinically contraindicated for the staff member to receive 
and the recognized clinical reasons for the contraindications; and
    (B) A statement by the authenticating practitioner recommending that 
the staff member be exempted from the facility's COVID-19 vaccination 
requirements for staff based on the recognized clinical 
contraindications;
    (ix) A process for ensuring the tracking and secure documentation of 
the vaccination status of staff for whom COVID-19 vaccination must be 
temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations, including, but not limited to, 
individuals with acute illness secondary to COVID-19, and individuals 
who received monoclonal antibodies or convalescent plasma for COVID-19 
treatment; and
    (x) Contingency plans for staff who are not fully vaccinated for 
COVID-19.

[66 FR 7160, Jan. 22, 2001, as amended at 75 FR 50418, Aug. 16, 2010; 86 
FR 61617, Nov. 5, 2021]



Sec.  441.152  Certification of need for services.

    (a) A team specified in Sec.  441.154 must certify that--
    (1) Ambulatory care resources available in the community do not meet 
the treatment needs of the beneficiary;
    (2) Proper treatment of the beneficiary's psychiatric condition 
requires services on an inpatient basis under the direction of a 
physician; and
    (3) The services can reasonably be expected to improve the 
beneficiary's condition or prevent further regression

[[Page 387]]

so that the services will no longer be needed.
    (b) The certification specified in this section and in Sec.  441.153 
satisfies the utilization control requirement for physician 
certification in Sec. Sec.  456.60, 456.160, and 456.360 of this 
subchapter.

[43 FR 45229, Sept. 29, 1978, as amended at 61 FR 38398, July 24, 1996]



Sec.  441.153  Team certifying need for services.

    Certification under Sec.  441.152 must be made by terms specified as 
follows:
    (a) For an individual who is a beneficiary when admitted to a 
facility or program, certification must be made by an independent team 
that--
    (1) Includes a physician;
    (2) Has competence in diagnosis and treatment of mental illness, 
preferably in child psychiatry; and
    (3) Has knowledge of the individual's situation.
    (b) For an individual who applies for Medicaid while in the facility 
of program, the certification must be--
    (1) Made by the team responsible for the plan of care as specified 
in Sec.  441.156; and
    (2) Cover any period before application for which claims are made.
    (c) For emergency admissions, the certification must be made by the 
team responsible for the plan of care (Sec.  441.156) within 14 days 
after admission.



Sec.  441.154  Active treatment.

    Inpatient psychiatric services must involve ``active treatment'', 
which means implementation of a professionally developed and supervised 
individual plan of care, described in Sec.  441.155 that is--
    (a) Developed and implemented no later than 14 days after admission; 
and
    (b) Designed to achieve the beneficiary's discharge from inpatient 
status at the earliest possible time.



Sec.  441.155  Individual plan of care.

    (a) ``Individual plan of care'' means a written plan developed for 
each beneficiary in accordance with Sec. Sec.  456.180 and 456.181 of 
this chapter, to improve his condition to the extent that inpatient care 
is no longer necessary.
    (b) The plan of care must--
    (1) Be based on a diagnostic evaluation that includes examination of 
the medical, psychological, social, behavioral and developmental aspects 
of the beneficiary's situation and reflects the need for inpatient 
psychiatric care;
    (2) Be developed by a team of professionals specified under Sec.  
441.156 in consultation with the beneficiary; and his parents, legal 
guardians, or others in whose care he will be released after discharge;
    (3) State treatment objectives;
    (4) Prescribe an integrated program of therapies, activities, and 
experiences designed to meet the objectives; and
    (5) Include, at an appropriate time, post-discharge plans and 
coordination of inpatient services with partial discharge plans and 
related community services to ensure continuity of care with the 
beneficiary's family, school, and community upon discharge.
    (c) The plan must be reviewed every 30 days by the team specified in 
Sec.  441.156 to--
    (1) Determine that services being provided are or were required on 
an inpatient basis, and
    (2) Recommend changes in the plan as indicated by the beneficiary's 
overall adjustment as an inpatient.
    (d) The development and review of the plan of care as specified in 
this section satisfies the utilization control requirements for--
    (1) Recertification under Sec. Sec.  456.60(b), 456.160(b), and 
456.360(b) of this subchapter; and
    (2) Establishment and periodic review of the plan of care under 
Sec. Sec.  456.80, 456.180, and 456.380 of this subchapter.

[43 FR 45229, Sept. 29, 1978, as amended at 46 FR 48560, Oct. 1, 1981; 
61 FR 38398, July 24, 1996]



Sec.  441.156  Team developing individual plan of care.

    (a) The individual plan of care under Sec.  441.155 must be 
developed by an interdisciplinary team of physicians and other personnel 
who are employed by, or provide services to patients in, the facility.
    (b) Based on education and experience, preferably including 
competence in child psychiatry, the team must be capable of--

[[Page 388]]

    (1) Assessing the beneficiary's immediate and long-range therapeutic 
needs, developmental priorities, and personal strengths and liabilities;
    (2) Assessing the potential resources of the beneficiary's family;
    (3) Setting treatment objectives; and
    (4) Prescribing therapeutic modalities to achieve the plan's 
objectives.
    (c) The team must include, as a minimum, either--
    (1) A Board-eligible or Board-certified psychiatrist;
    (2) A clinical psychologist who has a doctoral degree and a 
physician licensed to practice medicine or osteopathy; or
    (3) A physician licensed to practice medicine or osteopathy with 
specialized training and experience in the diagnosis and treatment of 
mental diseases, and a psychologist who has a master's degree in 
clinical psychology or who has been certified by the State or by the 
State psychological association.
    (d) The team must also include one of the following:
    (1) A psychiatric social worker.
    (2) A registered nurse with specialized training or one year's 
experience in treating mentally ill individuals.
    (3) An occupational therapist who is licensed, if required by the 
State, and who has specialized training or one year of experience in 
treating mentally ill individuals.
    (4) A psychologist who has a master's degree in clinical psychology 
or who has been certified by the State or by the State psychological 
association.



Sec.  441.180  Maintenance of effort: General rule.

    FFP is available only if the State maintains fiscal effort as 
prescribed under this subpart.



Sec.  441.181  Maintenance of effort: Explanation of terms and
requirements.

    (a) For purposes of Sec.  441.182:
    (1) The base year is the 4-quarter period ending December 31, 1971.
    (2) Quarterly per capita non-Federal expenditures are expenditures 
for inpatient psychiatric services determined by reimbursement 
principles under Medicare. (See part 405, subpart D.)
    (3) The number of individuals receiving inpatient psychiatric 
services in the current quarter means--
    (i) The number of individuals receiving services for the full 
quarter; plus
    (ii) The full quarter composite number of individuals receiving 
services for less than a full quarter.
    (4) In determining the per capita expenditures for the base year, 
the Medicaid agency must compute the number of individuals receiving 
services in a manner similar to that in paragraph (a)(3) of this 
section.
    (5) Non-Federal expenditures means the total amount of funds 
expended by the State and its political subdivisions, excluding Federal 
funds received directly or indirectly from any source.
    (6) Expenditures for the current calendar quarter exclude Federal 
funds received directly or indirectly from any source.
    (b) As a basis for determining the correct amount of Federal 
payments, each State must submit estimated and actual cost data and 
other information necessary for this purpose in the form and at the 
times specified in this subchapter and by CMS guidelines.
    (c) The agency must have on file adequate records to substantiate 
compliance with the requirements of Sec.  441.182 and to ensure that all 
necessary adjustments have been made.
    (d) Facilities that did not meet the requirements of Sec. Sec.  
441.151-441.156 in the base year, but are providing inpatient 
psychiatric services under those sections in the current quarter, must 
be included in the maintenance of effort computation if, during the base 
year, they were--
    (1) Providing inpatient psychiatric services for individuals under 
age 21; and
    (2) Receiving State aid.



Sec.  441.182  Maintenance of effort: Computation.

    (a) For expenditures for inpatient psychiatric services for 
individuals under age 21, in any calendar quarter, FFP is available only 
to the extent

[[Page 389]]

that the total State Medicaid expenditures in the current quarter for 
inpatient psychiatric services and outpatient psychiatric treatment for 
individuals under age 21 exceed the sum of the following:
    (1) The total number of individuals receiving inpatient psychiatric 
services in the current quarter times the average quarterly per capita 
non-Federal expenditures for the base year; and
    (2) The average non-Federal quarterly expenditures for the base year 
for outpatient psychiatric services for individuals under age 21.
    (b) FFP is available for 100 percent of the increase in expenditures 
over the base year period, but may not exceed the Federal medical 
assistance percentage times the expenditures under this subpart for 
inpatient psychiatric services for individuals under age 21.



Sec.  441.184  Emergency preparedness.

    The Psychiatric Residential Treatment Facility (PRTF) must comply 
with all applicable Federal, State, and local emergency preparedness 
requirements. The PRTF 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 PRTF must develop and maintain an emergency 
preparedness plan that must be reviewed, and updated at least every 2 
years. The plan must do 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 resident population, including, but not limited to, 
persons at-risk; the type of services the PRTF 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 PRTF 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 residents, 
whether they evacuate or shelter in place, include, but are not limited 
to the following:
    (i) Food, water, medical, and pharmaceutical supplies.
    (ii) Alternate sources of energy to maintain the following:
    (A) Temperatures to protect resident 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 
residents in the PRTF's care during and after an emergency. If on-duty 
staff and sheltered residents are relocated during the emergency, the 
PRTF must document the specific name and location of the receiving 
facility or other location.
    (3) Safe evacuation from the PRTF, which includes consideration of 
care and treatment needs of evacuees; staff responsibilities; 
transportation; identification of evacuation location(s); and primary 
and alternate means of communication with external sources of 
assistance.
    (4) A means to shelter in place for residents, staff, and volunteers 
who remain in the facility.
    (5) A system of medical documentation that preserves resident 
information, protects confidentiality of resident information, and 
secures and maintains the availability of records.
    (6) The use of volunteers in an emergency or other emergency 
staffing strategies, including the process and

[[Page 390]]

role for integration of State and Federally designated health care 
professionals to address surge needs during an emergency.
    (7) The development of arrangements with other PRTFs and other 
providers to receive residents in the event of limitations or cessation 
of operations to maintain the continuity of services to PRTF residents.
    (8) The role of the PRTF under a waiver declared by the Secretary, 
in accordance with section 1135 of Act, in the provision of care and 
treatment at an alternate care site identified by emergency management 
officials.
    (c) Communication plan. The PRTF 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) Residents' physicians.
    (iv) Other PRTFs.
    (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 PRTF's 
staff, Federal, State, tribal, regional, and local emergency management 
agencies.
    (4) A method for sharing information and medical documentation for 
residents under the PRTF's care, as necessary, with other health care 
providers to maintain the continuity of care.
    (5) A means, in the event of an evacuation, to release resident 
information as permitted under 45 CFR 164.510(b)(1)(ii).
    (6) A means of providing information about the general condition and 
location of residents under the facility's care as permitted under 45 
CFR 164.510(b)(4).
    (7) A means of providing information about the PRTF'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 PRTF must develop and maintain an 
emergency preparedness training 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 PRTF must do all of the following:
    (i) Provide 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) After initial training, provide emergency preparedness training 
every 2 years.
    (iii) Demonstrate staff knowledge of emergency procedures.
    (iv) Maintain documentation of all emergency preparedness training.
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the PRTF must conduct training on the updated 
policies and procedures.
    (2) Testing. The PRTF must conduct exercises to test the emergency 
plan twice per year. The PRTF must do the following:
    (i) Participate in an annual full-scale exercise that is community-
based; or
    (A) When a community-based exercise is not accessible, conduct an 
annual individual, facility-based functional exercise; or
    (B) If the PRTF experiences an actual natural or man-made emergency 
that requires activation of the emergency plan, the PRTF is exempt from 
engaging in its next required full-scale community-based or individual, 
facility-based functional exercise following the onset of the emergency 
event.
    (ii) Conduct an additional annual exercise that may include, but is 
not limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, a facility-based functional exercise; or

[[Page 391]]

    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that is led by a facilitator and 
includes a group discussion, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the PRTF's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events and revise the 
PRTF's emergency plan, as needed.
    (e) Integrated healthcare systems. If a PRTF is part of a healthcare 
system consisting of multiple separately certified healthcare facilities 
that elects to have a unified and integrated emergency preparedness 
program, the PRTF may choose to participate in the healthcare system's 
coordinated emergency preparedness program. If elected, the unified and 
integrated emergency preparedness program must do the following:
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance with the program.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and include 
the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for each 
separately certified facility within the health system, utilizing an 
all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.

[81 FR 64025, Sept. 16, 2016, as amended at 84 FR 51816, Sept. 30, 2019]



                           Subpart E_Abortions



Sec.  441.200  Basis and purpose.

    This subpart implements section 402 of Pub. L. 97-12, and subsequent 
laws that appropriate funds for the Medicaid program, including section 
204 of Pub. L. 98-619. All of these laws prohibit the use of Federal 
funds to pay for abortions except when continuation of the pregnancy 
would endanger the mother's life.

[52 FR 47935, Dec. 17, 1987]



Sec.  441.201  Definition.

    As used in this subpart, ``physician'' means a doctor of medicine or 
osteopathy who is licensed to practice in the State.

[52 FR 47935, Dec. 17, 1987]



Sec.  441.202  General rule.

    FFP is not available in expenditures for an abortion unless the 
conditions specified in Sec. Sec.  441.203 and 441.206 are met.

[52 FR 47935, Dec. 17, 1987]



Sec.  441.203  Life of the mother would be endangered.

    FFP is available in expenditures for an abortion when a physician 
has found, and certified in writing to the Medicaid agency, that on the 
basis of his professional judgment, the life of the mother would be 
endangered if the fetus were carried to term. The certification must 
contain the name and address of the patient.



Sec. Sec.  441.204-441.205  [Reserved]



Sec.  441.206  Documentation needed by the Medicaid agency.

    FFP is not available in any expenditures for abortions or other 
medical procedures otherwise provided for under Sec.  441.203 if the 
Medicaid agency has paid without first having received

[[Page 392]]

the certifications and documentation specified in that section.

[52 FR 47935, Dec. 17, 1987]



Sec.  441.207  Drugs and devices and termination of ectopic pregnancies.

    FFP is available in expenditures for drugs or devices to prevent 
implantation of the fertilized ovum and for medical procedures necessary 
for the termination of an ectopic pregnancy.



Sec.  441.208  Recordkeeping requirements.

    Medicaid agencies must maintain copies of the certifications and 
documentation specified in Sec.  441.203 for 3 years under the 
recordkeeping requirements at 45 CFR 75.361.

[52 FR 47935, Dec. 17, 1987, as amended at 81 FR 3011, Jan. 20, 2016]



                        Subpart F_Sterilizations

    Source: 43 FR 52171, Nov. 8, 1978, unless otherwise noted.



Sec.  441.250  Applicability.

    This subpart applies to sterilizations and hysterectomies reimbursed 
under Medicaid.



Sec.  441.251  Definitions.

    As used in this subpart:
    Hysterectomy means a medical procedure or operation for the purpose 
of removing the uterus.
    Institutionalized individual means an individual who is (a) 
involuntarily confined or detained, under a civil or criminal statute, 
in a correctional or rehabilitative facility, including a mental 
hospital or other facility for the care and treatment of mental illness; 
or (b) confined, under a voluntary commitment, in a mental hospital or 
other facility for the care and treatment of mental illness.
    Mentally incompetent individual means an individual who has been 
declared mentally incompetent by a Federal, State, or local court of 
competent jurisdiction for any purpose, unless the individual has been 
declared competent for purposes which include the ability to consent to 
sterilization.
    Sterilization means any medical procedure, treatment, or operation 
for the purpose of rendering an individual permanently incapable of 
reproducing.



Sec.  441.252  State plan requirements.

    A State plan must provide that the Medicaid agency will make payment 
under the plan for sterilization procedures and hysterectomies only if 
all the requirements of this subpart were met.



Sec.  441.253  Sterilization of a mentally competent individual
aged 21 or older.

    FFP is available in expenditures for the sterilization of an 
individual only if--
    (a) The individual is at least 21 years old at the time consent is 
obtained;
    (b) The individual is not a mentally incompetent individual;
    (c) The individual has voluntarily given informed consent in 
accordance with all the requirements precribed in Sec. Sec.  441.257 and 
441.258; and
    (d) At least 30 days, but not more than 180 days, have passed 
between the date of informed consent and the date of the sterilization, 
except in the case of premature delivery or emergency abdominal surgery. 
An individual may consent to be sterilized at the time of a premature 
delivery or emergency abdominal surgery, if at least 72 hours have 
passed since he or she gave informed consent for the sterilization. In 
the case of premature delivery, the informed consent must have been 
given at least 30 days before the expected date of delivery.



Sec.  441.254  Mentally incompetent or institutionalized individuals.

    FFP is not available for the sterilization of a mentally incompetent 
or institutionalized individual.



Sec.  441.255  Sterilization by hysterectomy.

    (a) FFP is not available in expenditures for a hysterectomy if--
    (1) It was performed solely for the purpose of rendering an 
individual permanently incapable of reproducing; or
    (2) If there was more than one purpose to the procedure, it would 
not have been performed but for the purpose of rendering the individual 
permanently incapable of reproducing.

[[Page 393]]

    (b) FFP is available in expenditures for a hysterectomy not covered 
by paragraph (a) of this section only under the conditions specified in 
paragraph (c), (d), or (e) of this section.
    (c) FFP is available if--
    (1) The person who secured authorization to perform the hysterectomy 
has informed the individual and her representative, if any, orally and 
in writing, that the hysterectomy will make the individual permanently 
incapable of reproducing; and
    (2) The individual or her representative, if any, has signed a 
written acknowledgment of receipt of that information.
    (d) Effective on March 8, 1979 or any date thereafter through the 
date of publication of these regulations at the option of the State, FFP 
is available if--
    (1) The individual--
    (i) Was already sterile before the hysterectomy; or
    (ii) Requires a hysterectomy because of a life-threatening emergency 
situation in which the physician determines that prior acknowledgment is 
not possible; and
    (2) The physician who performs the hysterectomy--
    (i) Certifies in writing that the individual was already sterile at 
the time of the hysterectomy, and states the cause of the sterility; or
    (ii) Certifies in writing that the hysterectomy was performed under 
a life-threatening emergency situation in which he or she determined 
prior acknowledgment was not possible. He or she must also include a 
description of the nature of the emergency.
    (e) Effective March 8, 1979, or any date thereafter through the date 
of publication of these regulations at the option of the State, FFP is 
available for hysterectomies performed during a period of an 
individual's retroactive Medicaid eligibility if the physician who 
performed the hysterectomy certifies in writing that--
    (1) The individual was informed before the operation that the 
hysterectomy would make her permanently incapable of reproducing; or
    (2) One of the conditions in paragraph (d)(1) of this section was 
met. The physician must supply the information specified in paragraph 
(d)(2) of this section.

[47 FR 33702, Aug. 4, 1982]



Sec.  441.256  Additional condition for Federal financial participation
(FFP).

    (a) FFP is not available in expenditures for any sterilization or 
hysterectomy unless the Medicaid agency, before making payment, obtained 
documentation showing that the requirements of this subpart were met. 
This documentation must include a consent from, an acknowledgement of 
receipt of hysterectomy information or a physician's certification under 
Sec.  441.255(d)(2), as applicable.
    (b) With regard to the requirements of Sec.  441.255(d) for 
hysterectomies performed from March 8, 1979 through November 2, 1982, 
FFP is available in expenditures for those services if the documentation 
showing that the requirements of that paragraph were met is obtained by 
the Medicaid agency before submitting a claim for FFP for that 
procedure.

[47 FR 33702, Aug. 4, 1982]



Sec.  441.257  Informed consent.

    (a) Informing the individual. For purposes of this subpart, an 
individual has given informed consent only if--
    (1) The person who obtained consent for the sterilization procedure 
offered to answer any questions the individual to be sterilized may have 
concerning the procedure, provided a copy of the consent form and 
provided orally all of the following information or advice to the 
individual to be sterilized:
    (i) Advice that the individual is free to withhold or withdraw 
consent to the procedure at any time before the sterilization without 
affecting the right to future care or treatment and without loss or 
withdrawal of any federally funded program benefits to which the 
individual might be otherwise entitled.
    (ii) A description of available alternative methods of family 
planning and birth control.
    (iii) Advice that the sterilization procedure is considered to be 
irreversible.
    (iv) A thorough explanation of the specific sterilization procedure 
to be performed.

[[Page 394]]

    (v) A full description of the discomforts and risks that may 
accompany or follow the performing of the procedure, including an 
explanation of the type and possible effects of any anesthetic to be 
used.
    (vi) A full description of the benefits or advantages that may be 
expected as a result of the sterilization.
    (vii) Advice that the sterilization will not be performed for at 
least 30 days, except under the circumstances specified in Sec.  
441.253(c).
    (2) Suitable arrangements were made to insure that the information 
specified in paragraph (a)(1) of this section was effectively 
communicated to any individual who is blind, deaf, or otherwise 
handicapped;
    (3) An interpreter was provided if the individual to be sterilized 
did not understand the language used on the consent form or the language 
used by the person obtaining consent;
    (4) The individual to be sterilized was permitted to have a witness 
of his or her choice present when consent was obtained;
    (5) The consent form requirements of Sec.  441.258 were met; and
    (6) Any additional requirement of State or local law for obtaining 
consent, except a requirement for spousal consent, was followed.
    (b) When informed consent may not be obtained. Informed consent may 
not be obtained while the individual to be sterilized is--
    (1) In labor or childbirth;
    (2) Seeking to obtain or obtaining an abortion; or
    (3) Under the influence of alcohol or other substances that affect 
the individual's state of awareness.



Sec.  441.258  Consent form requirements.

    (a) Content of consent form. The consent form must be a copy of the 
form appended to this subpart or another form approved by the Secretary.
    (b) Required signatures. The consent form must be signed and dated 
by--
    (1) The individual to be sterilized;
    (2) The interpreter, if one was provided;
    (3) The person who obtained the consent; and
    (4) The physician who performed the sterilization procedure.
    (c) Required certifications. (1) The person securing the consent 
must certify, by signing the consent form, that
    (i) Before the individual to be sterilized signed the consent form, 
he or she advised the individual to be sterilized that no Federal 
benefits may be withdrawn because of the decision not to be sterilized;
    (ii) He or she explained orally the requirements for informed 
consent as set forth on the consent form; and
    (iii) To the best of his or her knowledge and belief, the individual 
to be sterilized appeared mentally competent and knowingly and 
voluntarily consented to be sterilized.
    (2) The physician performing the sterilization must certify, by 
signing the consent form, that:
    (i) Shortly before the performance of sterilization, he or she 
advised the individual to be sterilized that no Federal benefits may be 
withdrawn because of the decision not to be sterilized;
    (ii) He or she explained orally the requirements for informed 
consent as set forth on the consent form; and
    (iii) To the best of his or her knowledge and belief, the individual 
appeared mentally competent and knowingly and voluntarily consented to 
be sterilized.

Except in the case of premature delivery or emergency abdominal surgery, 
the physician must further certify that at least 30 days have passed 
between the date of the individual's signature on the consent form and 
the date upon which the sterilization was performed.
    (3) In the case of premature delivery or emergency abdominal surgery 
performed within 30 days of consent, the physician must certify that the 
sterilization was performed less than 30 days, but not less than 72 
hours after informed consent was obtained because of premature delivery 
or emergency abdominal surgery and--
    (i) In the case of premature delivery, must state the expected date 
of delivery; or
    (ii) In the case of abdominal surgery, must describe the emergency.
    (4) If an interpreter is provided, the interpreter must certify that 
he or she translated the information and advice presented orally and 
read the consent

[[Page 395]]

form and explained its contents to the individual to be sterilized and 
that, to the best of the interpreter's knowledge and belief, the 
individual understood what the interpreter told him or her.



Sec.  441.259  Review of regulations.

    The Secretary will request public comment on the operation of this 
subpart not later than 3 years after its effective date.



      Sec. Appendix to Subpart F of Part 441--Required Consent Form

    Notice: Your decision at any time not to be sterilized will not 
result in the withdrawal or withholding of any benefits provided by 
programs or projects receiving Federal funds.

                        consent to sterilization

    I have asked for and received information about sterilization from 
(doctor or clinic). When I first asked for the information, I was told 
that the decision to be sterilized is completely up to me. I was told 
that I could decide not to be sterilized. If I decide not to be 
sterilized, my decision will not affect my right to future care or 
treatment. I will not lose any help or benefits from programs receiving 
Federal funds, such as A.F.D.C. or Medicaid that I am now getting or for 
which I may become eligible.
    I understand that the sterilization must be considered permanent and 
not reversible. I have decided that I do not want to become pregnant, 
bear children or father children.
    I was told about those temporary methods of birth control that are 
available and could be provided to me which will allow me to bear or 
father a child in the future. I have rejected these alternatives and 
chosen to be sterilized.
    I understand that I will be sterilized by an operation known as a 
______. The discomforts, risks and benefits associated with the 
operation have been explained to me. All my questions have been answered 
to my satisfaction.
    I understand that the operation will not be done until at least 30 
days after I sign this form. I understand that I can change my mind at 
any time and that my decision at any time not to be sterilized will not 
result in the withholding of any benefits or medical services provided 
by Federally funded programs.
    I am at least 21 years of age and was born on (Day) (Month) (Year).
    I, ______, hereby consent of my own free will to be sterilized by 
______ by a method called ______. My consent expires 180 days from the 
date of my signature below.
    I also consent to the release of this form and other medical records 
about the operation to:
    Representatives of the Department of Health and Human Services or
    Employees of programs or projects funded by that Department but only 
for determining if Federal laws were observed.
    I have received a copy of this form. (Signature) (Date) (Month) 
(Day) (Year).
    You are requested to supply the following information, but it is not 
required: (Race and ethnicity designation (please check)) Black (not of 
Hispanic origin); Hispanic; Asian or Pacific Islander; American Indian 
or Alaskan native; or White (not of Hispanic origin).

                         interpreter's statement

    If an interpreter is provided to assist the individual to be 
sterilized:
    I have translated the information and advice presented orally to the 
individual to be sterilized by the person obtaining this consent. I have 
also read him/her the consent form in ______ ______ language and 
explained its contents to him/her. To the best of my knowledge and 
belief he/she understood this explanation. (Interpreter) (Date).

                  statement of person obtaining consent

    Before (name of individual) signed the consent form, I explained to 
him/her the nature of the sterilization operation ______, the fact that 
it is intended to be a final and irreversible procedure and the 
discomforts, risks and benefits associated with it.
    I counseled the individual to be sterilized that alternative methods 
of birth control are available which are temporary. I explained that 
sterilization is different because it is permanent.
    I informed the individual to be sterilized that his/her consent can 
be withdrawn at any time and that he/she will not lose any health 
services or any benefits provided by Federal funds.
    To the best of my knowledge and belief the individual to be 
sterilized is at least 21 years old and appears mentally competent. He/
She knowingly and voluntarily requested to be sterilized and appears to 
understand the nature and consequence of the procedure. (Signature of 
person obtaining consent) (Date) (Facility) (Address).

                          physician's statement

    Shortly before I performed a sterilization operation upon (Name of 
individual to be sterilized) on (Date of sterilization) (operation), I 
explained to him/her the nature of the sterilization operation (specify 
type of operation), the fact that it is intended to be a final and 
irreversible procedure and the discomforts, risks and benefits 
associated with it.

[[Page 396]]

    I counseled the individual to be sterilized that alternative methods 
of birth control are available which are temporary. I explained that 
sterilization is different because it is permanent.
    I informed the individual to be sterilized that his/her consent can 
be withdrawn at any time and that he/she will not lose any health 
services or benefits provided by Federal funds.
    To the best of my knowledge and belief the individual to be 
sterilized is at least 21 years old and appears mentally competent. He/
She knowingly and voluntarily requested to be sterilized and appeared to 
understand the nature and consequences of the procedure.
    (Instructions for use of alternative final paragraphs: Use the first 
paragraph below except in the case of premature delivery or emergency 
abdominal surgery where the sterilization is performed less than 30 days 
after the date of the individual's signature on the consent form. In 
those cases, the second paragraph below must be used. Cross out the 
paragraph which is not used.)
    (1) At least 30 days have passed between the date of the 
individual's signature on this consent form and the date the 
sterilization was performed.
    (2) This sterilization was performed less than 30 days but more than 
72 hours after the date of the individual's signature on this consent 
form because of the following circumstances (check applicable box and 
fill in information requested): Premature delivery.
    Individual's expected date of delivery: ______
    [ballot] Emergency abdominal surgery: (describe 
circumstances):______ (Physician) (Date).



    Subpart G_Home and Community-Based Services: Waiver Requirements

    Source: 46 FR 48541, Oct. 1, 1981, unless otherwise noted.



Sec.  441.300  Basis and purpose.

    Section 1915(c) of the Act permits States to offer, under a waiver 
of statutory requirements, an array of home and community-based services 
that an individual needs to avoid institutionalization. Those services 
are defined in Sec.  440.180 of this subchapter. This subpart describes 
what the Medicaid agency must do to obtain a waiver.



Sec.  441.301  Contents of request for a waiver.

    (a) A request for a waiver under this section must consist of the 
following:
    (1) The assurances required by Sec.  441.302 and the supporting 
documentation required by Sec.  441.303.
    (2) When applicable, requests for waivers of the requirements of 
section 1902(a)(1), section 1902(a)(10)(B), or section 
1902(a)(10)(C)(i)(III) of the Act, which concern respectively, statewide 
application of Medicaid, comparability of services, and income and 
resource rules applicable to medically needy individuals living in the 
community.
    (3) A statement explaining whether the agency will refuse to offer 
home or community-based services to any beneficiary if the agency can 
reasonably expect that the cost of the services would exceed the cost of 
an equivalent level of care provided in--
    (i) A hospital (as defined in Sec.  440.10 of this chapter);
    (ii) A NF (as defined in section 1919(a) of the Act); or
    (iii) An ICF/IID (as defined in Sec.  440.150 of this chapter), if 
applicable.
    (b) If the agency furnishes home and community-based services, as 
defined in Sec.  440.180 of this subchapter, under a waiver granted 
under this subpart, the waiver request must--
    (1) Provide that the services are furnished--
    (i) Under a written person-centered service plan (also called plan 
of care) that is based on a person-centered approach and is subject to 
approval by the Medicaid agency.
    (ii) Only to beneficiaries who are not inpatients of a hospital, NF, 
or ICF/IID; and
    (iii) Only to beneficiaries who the agency determines would, in the 
absence of these services, require the Medicaid covered level of care 
provided in--
    (A) A hospital (as defined in Sec.  440.10 of this chapter);
    (B) A NF (as defined in section 1919(a) of the Act); or
    (C) An ICF/IID (as defined in Sec.  440.150 of this chapter);
    (2) Describe the qualifications of the individual or individuals who 
will be responsible for developing the individual plan of care;
    (3) Describe the group or groups of individuals to whom the services 
will be offered;

[[Page 397]]

    (4) Describe the services to be furnished so that each service is 
separately defined. Multiple services that are generally considered to 
be separate services may not be consolidated under a single definition. 
Commonly accepted terms must be used to describe the service and 
definitions may not be open ended in scope. CMS will, however, allow 
combined service definitions (bundling) when this will permit more 
efficient delivery of services and not compromise either a beneficiary's 
access to or free choice of providers.
    (5) Provide that the documentation requirements regarding individual 
evaluation, specified in Sec.  441.303(c), will be met; and
    (6) Be limited to one or more of the following target groups or any 
subgroup thereof that the State may define:
    (i) Aged or disabled, or both.
    (ii) Individuals with Intellectual or Developmental Disabilities, or 
both.
    (iii) Mentally ill.
    (c) A waiver request under this subpart must include the following--
    (1) Person-centered planning process. The individual will lead the 
person-centered planning process where possible. The individual's 
representative should have a participatory role, as needed and as 
defined by the individual, unless State law confers decision-making 
authority to the legal representative. All references to individuals 
include the role of the individual's representative. In addition to 
being led by the individual receiving services and supports, the person-
centered planning process:
    (i) Includes people chosen by the individual.
    (ii) Provides necessary information and support to ensure that the 
individual directs the process to the maximum extent possible, and is 
enabled to make informed choices and decisions.
    (iii) Is timely and occurs at times and locations of convenience to 
the individual.
    (iv) Reflects cultural considerations of the individual and is 
conducted by providing information in plain language and in a manner 
that is accessible to individuals with disabilities and persons who are 
limited English proficient, consistent with Sec.  435.905(b) of this 
chapter.
    (v) Includes strategies for solving conflict or disagreement within 
the process, including clear conflict-of-interest guidelines for all 
planning participants.
    (vi) Providers of HCBS for the individual, or those who have an 
interest in or are employed by a provider of HCBS for the individual 
must not provide case management or develop the person-centered service 
plan, except when the State demonstrates that the only willing and 
qualified entity to provide case management and/or develop person-
centered service plans in a geographic area also provides HCBS. In these 
cases, the State must devise conflict of interest protections including 
separation of entity and provider functions within provider entities, 
which must be approved by CMS. Individuals must be provided with a clear 
and accessible alternative dispute resolution process.
    (vii) Offers informed choices to the individual regarding the 
services and supports they receive and from whom.
    (viii) Includes a method for the individual to request updates to 
the plan as needed.
    (ix) Records the alternative home and community-based settings that 
were considered by the individual.
    (2) The Person-Centered Service Plan. The person-centered service 
plan must reflect the services and supports that are important for the 
individual to meet the needs identified through an assessment of 
functional need, as well as what is important to the individual with 
regard to preferences for the delivery of such services and supports. 
Commensurate with the level of need of the individual, and the scope of 
services and supports available under the State's 1915(c) HCBS waiver, 
the written plan must:
    (i) Reflect that the setting in which the individual resides is 
chosen by the individual. The State must ensure that the setting chosen 
by the individual is integrated in, and supports full access of 
individuals receiving Medicaid HCBS to the greater community, including 
opportunities to seek employment and

[[Page 398]]

work in competitive integrated settings, engage in community life, 
control personal resources, and receive services in the community to the 
same degree of access as individuals not receiving Medicaid HCBS.
    (ii) Reflect the individual's strengths and preferences.
    (iii) Reflect clinical and support needs as identified through an 
assessment of functional need.
    (iv) Include individually identified goals and desired outcomes.
    (v) Reflect the services and supports (paid and unpaid) that will 
assist the individual to achieve identified goals, and the providers of 
those services and supports, including natural supports. Natural 
supports are unpaid supports that are provided voluntarily to the 
individual in lieu of 1915(c) HCBS waiver services and supports.
    (vi) Reflect risk factors and measures in place to minimize them, 
including individualized back-up plans and strategies when needed.
    (vii) Be understandable to the individual receiving services and 
supports, and the individuals important in supporting him or her. At a 
minimum, for the written plan to be understandable, it must be written 
in plain language and in a manner that is accessible to individuals with 
disabilities and persons who are limited English proficient, consistent 
with Sec.  435.905(b) of this chapter.
    (viii) Identify the individual and/or entity responsible for 
monitoring the plan.
    (ix) Be finalized and agreed to, with the informed consent of the 
individual in writing, and signed by all individuals and providers 
responsible for its implementation.
    (x) Be distributed to the individual and other people involved in 
the plan.
    (xi) Include those services, the purpose or control of which the 
individual elects to self-direct.
    (xii) Prevent the provision of unnecessary or inappropriate services 
and supports.
    (xiii) Document that any modification of the additional conditions, 
under paragraph (c)(4)(vi)(A) through (D) of this section, must be 
supported by a specific assessed need and justified in the person-
centered service plan. The following requirements must be documented in 
the person-centered service plan:
    (A) Identify a specific and individualized assessed need.
    (B) Document the positive interventions and supports used prior to 
any modifications to the person-centered service plan.
    (C) Document less intrusive methods of meeting the need that have 
been tried but did not work.
    (D) Include a clear description of the condition that is directly 
proportionate to the specific assessed need.
    (E) Include a regular collection and review of data to measure the 
ongoing effectiveness of the modification.
    (F) Include established time limits for periodic reviews to 
determine if the modification is still necessary or can be terminated.
    (G) Include informed consent of the individual.
    (H) Include an assurance that interventions and supports will cause 
no harm to the individual.
    (3) Review of the Person-Centered Service Plan. The person-centered 
service plan must be reviewed, and revised upon reassessment of 
functional need as required by Sec.  441.365(e), at least every 12 
months, when the individual's circumstances or needs change 
significantly, or at the request of the individual.
    (4) Home and Community-Based Settings. Home and community-based 
settings must have all of the following qualities, and such other 
qualities as the Secretary determines to be appropriate, based on the 
needs of the individual as indicated in their person-centered service 
plan:
    (i) The setting is integrated in and supports full access of 
individuals receiving Medicaid HCBS to the greater community, including 
opportunities to seek employment and work in competitive integrated 
settings, engage in community life, control personal resources, and 
receive services in the community, to the same degree of access as 
individuals not receiving Medicaid HCBS.
    (ii) The setting is selected by the individual from among setting 
options including non-disability specific settings and an option for a 
private unit

[[Page 399]]

in a residential setting. The setting options are identified and 
documented in the person-centered service plan and are based on the 
individual's needs, preferences, and, for residential settings, 
resources available for room and board.
    (iii) Ensures an individual's rights of privacy, dignity and 
respect, and freedom from coercion and restraint.
    (iv) Optimizes, but does not regiment, individual initiative, 
autonomy, and independence in making life choices, including but not 
limited to, daily activities, physical environment, and with whom to 
interact.
    (v) Facilitates individual choice regarding services and supports, 
and who provides them.
    (vi) In a provider-owned or controlled residential setting, in 
addition to the qualities at Sec.  441.301(c)(4)(i) through (v), the 
following additional conditions must be met:
    (A) The unit or dwelling is a specific physical place that can be 
owned, rented, or occupied under a legally enforceable agreement by the 
individual receiving services, and the individual has, at a minimum, the 
same responsibilities and protections from eviction that tenants have 
under the landlord/tenant law of the State, county, city, or other 
designated entity. For settings in which landlord tenant laws do not 
apply, the State must ensure that a lease, residency agreement or other 
form of written agreement will be in place for each HCBS participant, 
and that the document provides protections that address eviction 
processes and appeals comparable to those provided under the 
jurisdiction's landlord tenant law.
    (B) Each individual has privacy in their sleeping or living unit:
    (1) Units have entrance doors lockable by the individual, with only 
appropriate staff having keys to doors.
    (2) Individuals sharing units have a choice of roommates in that 
setting.
    (3) Individuals have the freedom to furnish and decorate their 
sleeping or living units within the lease or other agreement.
    (C) Individuals have the freedom and support to control their own 
schedules and activities, and have access to food at any time.
    (D) Individuals are able to have visitors of their choosing at any 
time.
    (E) The setting is physically accessible to the individual.
    (F) Any modification of the additional conditions, under Sec.  
441.301(c)(4)(vi)(A) through (D), must be supported by a specific 
assessed need and justified in the person-centered service plan. The 
following requirements must be documented in the person-centered service 
plan:
    (1) Identify a specific and individualized assessed need.
    (2) Document the positive interventions and supports used prior to 
any modifications to the person-centered service plan.
    (3) Document less intrusive methods of meeting the need that have 
been tried but did not work.
    (4) Include a clear description of the condition that is directly 
proportionate to the specific assessed need.
    (5) Include regular collection and review of data to measure the 
ongoing effectiveness of the modification.
    (6) Include established time limits for periodic reviews to 
determine if the modification is still necessary or can be terminated.
    (7) Include the informed consent of the individual.
    (8) Include an assurance that interventions and supports will cause 
no harm to the individual.
    (5) Settings that are not Home and Community-Based. Home and 
community-based settings do not include the following:
    (i) A nursing facility;
    (ii) An institution for mental diseases;
    (iii) An intermediate care facility for individuals with 
intellectual disabilities;
    (iv) A hospital; or
    (v) Any other locations that have qualities of an institutional 
setting, as determined by the Secretary. Any setting that is located in 
a building that is also a publicly or privately operated facility that 
provides inpatient institutional treatment, or in a building on the 
grounds of, or immediately adjacent to, a public institution, or any 
other setting that has the effect of isolating individuals receiving 
Medicaid HCBS from the broader community of

[[Page 400]]

individuals not receiving Medicaid HCBS will be presumed to be a setting 
that has the qualities of an institution unless the Secretary determines 
through heightened scrutiny, based on information presented by the State 
or other parties, that the setting does not have the qualities of an 
institution and that the setting does have the qualities of home and 
community-based settings.
    (6) Home and Community-Based Settings: Compliance and Transition:
    (i) States submitting new and initial waiver requests must provide 
assurances of compliance with the requirements of this section for home 
and community-based settings as of the effective date of the waiver.
    (ii) CMS will require transition plans for existing section 1915(c) 
waivers and approved state plans providing home and community-based 
services under section 1915(i) to achieve compliance with this section, 
as follows:
    (A) For each approved section 1915(c) HCBS waiver subject to renewal 
or submitted for amendment within one year after the effective date of 
this regulation, the State must submit a transition plan at the time of 
the waiver renewal or amendment request that sets forth the actions the 
State will take to bring the specific waiver into compliance with this 
section. The waiver approval will be contingent on the inclusion of the 
transition plan approved by CMS. The transition plan must include all 
elements required by the Secretary; and within one hundred and twenty 
days of the submission of the first waiver renewal or amendment request 
the State must submit a transition plan detailing how the State will 
operate all section 1915(c) HCBS waivers and any section 1915(i) State 
plan benefit in accordance with this section. The transition plan must 
include all elements including timelines and deliverables as approved by 
the Secretary.
    (B) For States that do not have a section 1915(c) HCBS waiver or a 
section 1915(i) State plan benefit due for renewal or proposed for 
amendments within one year of the effective date of this regulation, the 
State must submit a transition plan detailing how the State will operate 
all section 1915(c) HCBS waivers and any section 1915(i) State plan 
benefit in accordance with this section. This plan must be submitted no 
later than one year after the effective date of this regulation. The 
transition plan must include all elements including timelines and 
deliverables as approved by the Secretary.
    (iii) A State must provide at least a 30-day public notice and 
comment period regarding the transition plan(s) that the State intends 
to submit to CMS for review and consideration, as follows:
    (A) The State must at a minimum provide two (2) statements of public 
notice and public input procedures.
    (B) The State must ensure the full transition plan(s) is available 
to the public for public comment.
    (C) The State must consider and modify the transition plan, as the 
State deems appropriate, to account for public comment.
    (iv) A State must submit to CMS, with the proposed transition plan:
    (A) Evidence of the public notice required.
    (B) A summary of the comments received during the public notice 
period, reasons why comments were not adopted, and any modifications to 
the transition plan based upon those comments.
    (v) Upon approval by CMS, the State will begin implementation of the 
transition plans. The State's failure to submit an approvable transition 
plan as required by this section and/or to comply with the terms of the 
approved transition plan may result in compliance actions, including but 
not limited to deferral/disallowance of Federal Financial Participation.

[46 FR 48541, Oct. 1, 1981, as amended at 50 FR 10026, Mar. 13, 1985; 59 
FR 37717, July 25, 1994; 65 FR 60107, Oct. 10, 2000; 79 FR 3029, Jan. 
16, 2014]



Sec.  441.302  State assurances.

    Unless the Medicaid agency provides the following satisfactory 
assurances to CMS, CMS will not grant a waiver under this subpart and 
may terminate a waiver already granted:
    (a) Health and Welfare--Assurance that necessary safeguards have 
been taken to protect the health and welfare

[[Page 401]]

of the beneficiaries of the services. Those safeguards must include--
    (1) Adequate standards for all types of providers that provide 
services under the waiver;
    (2) Assurance that the standards of any State licensure or 
certification requirements are met for services or for individuals 
furnishing services that are provided under the waiver; and
    (3) Assurance that all facilities covered by section 1616(e) of the 
Act, in which home and community-based services will be provided, are in 
compliance with applicable State standards that meet the requirements of 
45 CFR part 1397 for board and care facilities.
    (4) Assurance that the State is able to meet the unique service 
needs of the individuals when the State elects to serve more than one 
target group under a single waiver, as specified in Sec.  441.301(b)(6).
    (i) On an annual basis the State will include in the quality section 
of the CMS-372 form (or any successor form designated by CMS) data that 
indicates the State continues to serve multiple target groups in the 
single waiver and that a single target group is not being prioritized to 
the detriment of other groups.
    (ii) [Reserved]
    (5) Assurance that services are provided in home and community based 
settings, as specified in Sec.  441.301(c)(4).
    (b) Financial accountability-- The agency will assure financial 
accountability for funds expended for home and community-based services, 
provide for an independent audit of its waiver program (except as CMS 
may otherwise specify for particular waivers), and it will maintain and 
make available to HHS, the Comptroller General, or other designees, 
appropriate financial records documenting the cost of services provided 
under the waiver, including reports of any independent audits conducted.
    (c) Evaluation of need. Assurance that the agency will provide for 
the following:
    (1) Initial evaluation. An evaluation of the need for the level of 
care provided in a hospital, a NF, or an ICF/IID when there is a 
reasonable indication that a beneficiary might need the services in the 
near future (that is, a month or less) unless he or she receives home or 
community-based services. For purposes of this section, ``evaluation'' 
means a review of an individual beneficiary's condition to determine--
    (i) If the beneficiary requires the level of care provided in a 
hospital as defined in Sec.  440.10 of this subchapter, a NF as defined 
in section 1919(a) of the Act, or an ICF/IID as defined by Sec.  440.150 
of this subchapter; and
    (ii) That the beneficiary, but for the provision of waiver services, 
would otherwise be institutionalized in such a facility.
    (2) Periodic reevaluations. Reevaluations, at least annually, of 
each beneficiary receiving home or community-based services to determine 
if the beneficiary continues to need the level of care provided and 
would, but for the provision of waiver services, otherwise be 
institutionalized in one of the following institutions:
    (i) A hospital;
    (ii) A NF; or
    (iii) An ICF/IID.
    (d) Alternatives--Assurance that when a beneficiary is determined to 
be likely to require the level of care provided in a hospital, NF, or 
ICF/IID, the beneficiary or his or her legal representative will be--
    (1) Informed of any feasible alternatives available under the 
waiver; and
    (2) Given the choice of either institutional or home and community-
based services.
    (e) Average per capita expenditures. Assurance that the average per 
capita fiscal year expenditures under the waiver will not exceed 100 
percent of the average per capita expenditures that would have been made 
in the fiscal year for the level of care provided in a hospital, NF, or 
ICF/IID under the State plan had the waiver not been granted.
    (1) These expenditures must be reasonably estimated and documented 
by the agency.
    (2) The estimate must be on an annual basis and must cover each year 
of the waiver period.
    (f) Actual total expenditures. Assurance that the agency's actual 
total expenditures for home and community-based and other Medicaid 
services under the waiver and its claim for FFP

[[Page 402]]

in expenditures for the services provided to beneficiaries under the 
waiver will not, in any year of the waiver period, exceed 100 percent of 
the amount that would be incurred by the State's Medicaid program for 
these individuals, absent the waiver, in--
    (1) A hospital;
    (2) A NF; or
    (3) An ICF/IID.
    (g) Institutionalization absent waiver. Assurance that, absent the 
waiver, beneficiaries in the waiver would receive the appropriate type 
of Medicaid-funded institutional care (hospital, NF, or ICF/IID) that 
they require.
    (h) Reporting. Assurance that annually, the agency will provide CMS 
with information on the waiver's impact. The information must be 
consistent with a data collection plan designed by CMS and must address 
the waiver's impact on--
    (1) The type, amount, and cost of services provided under the State 
plan; and
    (2) The health and welfare of beneficiaries.
    (i) Habilitation services. Assurance that prevocational, 
educational, or supported employment services, or a combination of these 
services, if provided as habilitation services under the waiver, are--
    (1) Not otherwise available to the individual through a local 
educational agency under section 602 (16) and (17) of the Education of 
the Handicapped Act (20 U.S.C. 1401 (16 and 17)) or as services under 
section 110 of the Rehabilitation Act of 1973 (29 U.S.C. 730); and
    (2) Furnished as part of expanded habilitation services, if the 
State has requested and received CMS's approval under a waiver or an 
amendment to a waiver.
    (j) Day treatment or partial hospitalization, psychosocial 
rehabilitation services, and clinic services for individuals with 
chronic mental illness. Assurance that FFP will not be claimed in 
expenditures for waiver services including, but not limited to, day 
treatment or partial hospitalization, psychosocial rehabilitation 
services, and clinic services provided as home and community-based 
services to individuals with chronic mental illnesses if these 
individuals, in the absence of a waiver, would be placed in an IMD and 
are--
    (1) Age 22 to 64;
    (2) Age 65 and older and the State has not included the optional 
Medicaid benefit cited in Sec.  440.140; or
    (3) Age 21 and under and the State has not included the optional 
Medicaid benefit cited in Sec.  440.160.

[50 FR 10026, Mar. 13, 1985, as amended at 59 FR 37717, July 25, 1994; 
65 FR 60107, Oct. 10, 2000; 79 FR 3031, Jan. 16, 2014]



Sec.  441.303  Supporting documentation required.

    The agency must furnish CMS with sufficient information to support 
the assurances required by Sec.  441.302. Except as CMS may otherwise 
specify for particular waivers, the information must consist of the 
following:
    (a) A description of the safeguards necessary to protect the health 
and welfare of beneficiaries. This information must include a copy of 
the standards established by the State for facilities that are covered 
by section 1616(e) of the Act.
    (b) A description of the records and information that will be 
maintained to support financial accountability.
    (c) A description of the agency's plan for the evaluation and 
reevaluation of beneficiaries, including--
    (1) A description of who will make these evaluations and how they 
will be made;
    (2) A copy of the evaluation form to be used; and if it differs from 
the form used in placing beneficiaries in hospitals, NFs, or ICFs/IID, a 
description of how and why it differs and an assurance that the outcome 
of the new evaluation form is reliable, valid, and fully comparable to 
the form used for hospital, NF, or ICF/IID placement;
    (3) The agency's procedure to ensure the maintenance of written 
documentation on all evaluations and reevaluations; and
    (4) The agency's procedure to ensure reevaluations of need at 
regular intervals.
    (d) A description of the agency's plan for informing eligible 
beneficiaries of the feasible alternatives available under the waiver 
and allowing beneficiaries to choose either institutional

[[Page 403]]

services or home and community-based services.
    (e) An explanation of how the agency will apply the applicable 
provisions regarding the post-eligibility treatment of income and 
resources of those individuals receiving home and community-based 
services who are eligible under a special income level (included in 
Sec.  435.217 of this chapter).
    (f) An explanation with supporting documentation satisfactory to CMS 
of how the agency estimated the average per capita expenditures for 
services.
    (1) The annual average per capita expenditure estimate of the cost 
of home and community-based and other Medicaid services under the waiver 
must not exceed the estimated annual average per capita expenditures of 
the cost of services in the absence of a waiver. The estimates are to be 
based on the following equation:

D + D' <=G + G'.

The symbol ``<='' means that the result of the left side of the equation 
          must be less than or equal to the result of the right side of 
          the equation.
D = the estimated annual average per capita Medicaid cost for home and 
          community-based services for individuals in the waiver 
          program.
D' = the estimated annual average per capita Medicaid cost for all other 
          services provided to individuals in the waiver program.
G = the estimated annual average per capita Medicaid cost for hospital, 
          NF, or ICF/IID care that would be incurred for individuals 
          served in the waiver, were the waiver not granted.
G' = the estimated annual average per capita Medicaid costs for all 
          services other than those included in factor G for individuals 
          served in the waiver, were the waiver not granted.

    (2) For purposes of the equation, the prime factors include the 
average per capita cost for all State plan services and expanded EPSDT 
services provided that are not accounted for in other formula values.
    (3) In making estimates of average per capita expenditures for a 
waiver that applies only to individuals with a particular illness (for 
example, acquired immune deficiency syndrome) or condition (for example, 
chronic mental illness) who are inpatients in or who would require the 
level of care provided in hospitals as defined by Sec.  440.10, NFs as 
defined in section 1919(a) of the Act, or ICFs/IID, the agency may 
determine the average per capita expenditures for these individuals 
absent the waiver without including expenditures for other individuals 
in the affected hospitals, NFs, or ICFs/IID.
    (4) In making estimates of average per capita expenditures for a 
separate waiver program that applies only to individuals identified 
through the preadmission screening annual resident review (PASARR) 
process who are developmentally disabled, inpatients of a NF, and 
require the level of care provided in an ICF/IID as determined by the 
State on the basis of an evaluation under Sec.  441.303(c), the agency 
may determine the average per capita expenditures that would have been 
made in a fiscal year for those individuals based on the average per 
capita expenditures for inpatients in an ICF/IID. When submitting 
estimates of institutional costs without the waiver, the agency may use 
the average per capita costs of ICF/IID care even though the 
deinstitutionalized developmentally disabled were inpatients of NFs.
    (5) For persons diverted rather than deinstitutionalized, the 
State's evaluation process required by Sec.  441.303(c) must provide for 
a more detailed description of their evaluation and screening procedures 
for beneficiaries to ensure that waiver services will be limited to 
persons who would otherwise receive the level of care provided in a 
hospital, NF, or ICF/IID, as applicable.
    (6) The State must indicate the number of unduplicated beneficiaries 
to which it intends to provide waiver services in each year of its 
program. This number will constitute a limit on the size of the waiver 
program unless the State requests and the Secretary approves a greater 
number of waiver participants in a waiver amendment.
    (7) In determining the average per capita expenditures that would 
have been made in a waiver year, for waiver estimates that apply to 
persons with Intellectual Disability or related conditions, the agency 
may include costs of Medicaid residents in ICFs/IID that have been 
terminated on or after November 5, 1990.

[[Page 404]]

    (8) In submitting estimates for waivers that include personal 
caregivers as a waiver service, the agency may include a portion of the 
rent and food attributed to the unrelated personal caregiver who resides 
in the home or residence of the beneficiary covered under the waiver. 
The agency must submit to CMS for review and approval the method it uses 
to apportion the costs of rent and food. The method must be explained 
fully to CMS. A personal caregiver provides a waiver service to meet the 
beneficiary's physical, social, or emotional needs (as opposed to 
services not directly related to the care of the beneficiary; that is, 
housekeeping or chore services). FFP for live-in caregivers is not 
available if the beneficiary lives in the caregiver's home or in a 
residence that is owned or leased by the caregiver.
    (9) In submitting estimates for waivers that apply to individuals 
with Intellectual Disability or a related condition, the agency may 
adjust its estimate of average per capita expenditures to include 
increases in expenditures for ICF/IID care resulting from implementation 
of a PASARR program for making determinations for individuals with 
Intellectual Disability or related conditions on or after January 1, 
1989.
    (10) For a State that has CMS approval to bundle waiver services, 
the State must continue to compute separately the costs and utilization 
of the component services that make up the bundled service to support 
the final cost and utilization of the bundled service that will be used 
in the cost-neutrality formula.
    (g) The State, at its option, may provide for an independent 
assessment of its waiver that evaluates the quality of care provided, 
access to care, and cost-neutrality. The results of the assessment 
should be submitted to CMS at least 90 days prior to the expiration date 
of the approved waiver-period and cover the first 24 or 48 months of the 
waiver. If a State chooses to provide for an independent assessment, FFP 
is available for the costs attributable to the independent assessment.
    (h) For States offering habilitation services that include 
prevocational, educational, or supported employment services, or a 
combination of these services, consistent with the provisions of Sec.  
440.180(c) of this chapter, an explanation of why these services are not 
available as special education and related services under sections 602 
(16) and (17) of the Education of the Handicapped Act (20 U.S.C. 1401 
(16 and 17)) or as services under section 110 of the Rehabilitation Act 
of 1973 (29 U.S.C. section 730);
    (i) For States offering home and community-based services for 
individuals diagnosed as chronically mentally ill, an explanation of why 
these individuals would not be placed in an institution for mental 
diseases (IMD) absent the waiver, and the age group of these 
individuals.

[46 FR 48532, Oct. 1, 1981, as amended at 50 FR 10027, Mar. 13, 1985; 50 
FR 25080, June 17, 1985; 59 FR 37718, July 25, 1994]



Sec.  441.304  Duration, extension, and amendment of a waiver.

    (a) The effective date for a new waiver of Medicaid requirements to 
provide home and community-based services approved under this subpart is 
established by CMS prospectively on or after the date of approval and 
after consultation with the State agency. The initial approved waiver 
continues for a 3-year period from the effective date. If the agency 
requests it, the waiver may be extended for additional periods unless--
    (1) CMS's review of the prior waiver period shows that the 
assurances required by Sec.  441.302 were not met; and
    (2) CMS is not satisfied with the assurances and documentation 
provided by the State in regard to the extension period.
    (b) CMS will determine whether a request for extension of an 
existing waiver is actually an extension request or a request for a new 
waiver. If a State submits an extension request that would add a new 
group to the existing group of beneficiaries covered under the waiver 
(as defined under Sec.  441.301(b)(6)), CMS will consider it to be two 
requests: One as an extension request for the existing group, and the 
other as a new waiver request for the new group. Waivers may be extended 
for additional 5-year periods.

[[Page 405]]

    (c) CMS may grant a State an extension of its existing waiver for up 
to 90 days to permit the State to document more fully the satisfaction 
of statutory and regulatory requirements needed to approve a new waiver 
request. CMS will consider this option when it requests additional 
information on a new waiver request submitted by a State to extend its 
existing waiver or when CMS disapproves a State's request for extension.
    (d) The agency may request that waiver modifications be made 
effective retroactive to the first day of a waiver year, or another date 
after the first day of a waiver year, in which the amendment is 
submitted, unless the amendment involves substantive changes as 
determined by CMS.
    (1) Substantive changes include, but are not limited to, revisions 
to services available under the waiver including elimination or 
reduction of services, or reduction in the scope, amount, and duration 
of any service, a change in the qualifications of service providers, 
changes in rate methodology or a constriction in the eligible 
population.
    (2) A request for an amendment that involves a substantive change as 
determined by CMS, may only take effect on or after the date when the 
amendment is approved by CMS, and must be accompanied by information on 
how the State has assured smooth transitions and minimal effect on 
individuals adversely impacted by the change.
    (e) The agency must provide public notice of any significant 
proposed change in its methods and standards for setting payment rates 
for services in accordance with Sec.  447.205 of this chapter.
    (f) The agency must establish and use a public input process, for 
any changes in the services or operations of the waiver.
    (1) This process must be described fully in the State's waiver 
application and be sufficient in light of the scope of the changes 
proposed, to ensure meaningful opportunities for input for individuals 
served, or eligible to be served, in the waiver.
    (2) This process must be completed at a minimum of 30 days prior to 
implementation of the proposed change or submission of the proposed 
change to CMS, whichever comes first.
    (3) This process must be used for both existing waivers that have 
substantive changes proposed, either through the renewal or the 
amendment process, and new waivers.
    (4) This process must include consultation with Federally-recognized 
Tribes, and in accordance with section 5006(e) of the American Recovery 
and Reinvestment Act of 2009 (Pub. L. 111-5), Indian health programs and 
Urban Indian Organizations.
    (g)(1) If CMS finds that the Medicaid agency is not meeting one or 
more of the requirements for a waiver contained in this subpart, the 
agency is given a notice of CMS' findings and an opportunity for a 
hearing to rebut the findings.
    (2) If CMS determines that the agency is substantively out of 
compliance with this subpart after the notice and any hearing, CMS may 
employ strategies to ensure compliance as described in paragraph (g)(3) 
of this section or terminate the waiver.
    (3)(i) Strategies to ensure compliance may include the imposition of 
a moratorium on waiver enrollments, other corrective strategies as 
appropriate to ensure the health and welfare of waiver participants, or 
the withholding of a portion of Federal payment for waiver services 
until such time that compliance is achieved, or other actions as 
determined by the Secretary as necessary to address non-compliance with 
1915(c) of the Act, or termination. When a waiver is terminated, the 
State must comport with Sec.  441.307.
    (ii) CMS will provide states with a written notice of the impending 
strategies to ensure compliance for a waiver program. The notice of CMS' 
intent to utilize strategies to ensure compliance would include the 
nature of the noncompliance, the strategy to be employed, the effective 
date of the compliance strategy, the criteria for removing the 
compliance strategy and the opportunity for a hearing.

[50 FR 10028, Mar. 13, 1985; 50 FR 25080, June 17, 1985, as amended at 
59 FR 37719, July 25, 1994; 79 FR 3032, Jan. 16, 2014]

[[Page 406]]



Sec.  441.305  Replacement of beneficiaries in approved waiver programs.

    (a) Regular waivers. A State's estimate of the number of individuals 
who may receive home and community-based services must include those who 
will replace beneficiaries who leave the program for any reason. A State 
may replace beneficiaries who leave the program due to death or loss of 
eligibility under the State plan without regard to any federally-imposed 
limit on utilization, but must maintain a record of beneficiaries 
replaced on this basis.
    (b) Model waivers. (1) The number of individuals who may receive 
home and community-based services under a model waiver may not exceed 
200 beneficiaries at any one time.
    (2) The agency may replace any individuals who die or become 
ineligible for State plan services to maintain a count up to the number 
specified by the State and approved by CMS within the 200-maximum limit.

[59 FR 37719, July 25, 1994]



Sec.  441.306  Cooperative arrangements with the Maternal and Child
Health program.

    Whenever appropriate, the State agency administering the plan under 
Medicaid may enter into cooperative arrangements with the State agency 
responsible for administering a program for children with special health 
care needs under the Maternal and Child Health program (Title V of the 
Act) in order to ensure improved access to coordinated services to meet 
the children's needs.

[59 FR 37720, July 25, 1994]



Sec.  441.307  Notification of a waiver termination.

    (a) If a State chooses to terminate its waiver before the initial 3-
year period or 5-year renewal period expires, it must notify CMS in 
writing 30 days before terminating services to beneficiaries.
    (b) If CMS or the State terminates the waiver, the State must notify 
beneficiaries of services under the waiver in accordance with Sec.  
431.210 of this subchapter and notify them 30 days before terminating 
services.

[46 FR 48541, Oct. 1, 1981. Redesignated at 59 FR 37719, July 25, 1994, 
as amended at 65 FR 60107, Oct. 10, 2000]



Sec.  441.308  Hearings procedures for waiver terminations.

    The procedures specified in subpart D of part 430 of this chapter 
are applicable to State requests for hearings on terminations.

[50 FR 10028, Mar. 13, 1985. Redesignated at 59 FR 37720, July 25, 1994]



Sec.  441.310  Limits on Federal financial participation (FFP).

    (a) FFP for home and community-based services listed in Sec.  
440.180 of this chapter is not available in expenditures for the 
following:
    (1) Services provided in a facility subject to the health and 
welfare requirements described in Sec.  441.302(a) during any period in 
which the facility is found not to be in compliance with the applicable 
State standards described in that section.
    (2) The cost of room and board except when provided as--
    (i) Part of respite care services in a facility approved by the 
State that is not a private residence; or
    (ii) For waivers that allow personal caregivers as providers of 
approved waiver services, a portion of the rent and food that may be 
reasonably attributed to the unrelated caregiver who resides in the same 
household with the waiver beneficiary. FFP for a live-in caregiver is 
not available if the beneficiary lives in the caregiver's home or in a 
residence that is owned or leased by the provider of Medicaid services 
(the caregiver). For purposes of this provision, ``board'' means 3 meals 
a day or any other full nutritional regimen and does not include meals 
provided as part of a program of adult day health services as long as 
the meals provided do not constitute a ``full'' nutritional regimen.
    (3) Prevocational, educational, or supported employment services, or 
any combination of these services, as part of habilitation services that 
are--
    (i) Provided in approved waivers that include a definition of 
``habilitation services'' but which have not included

[[Page 407]]

prevocational, educational, and supported employment services in that 
definition; or
    (ii) Otherwise available to the beneficiary under either special 
education and related services as defined in section 602(16) and (17) of 
the Education of the Handicapped Act (20 U.S.C. 1401(16) and (17)) or 
vocational rehabilitation services available to the individual through a 
program funded under section 110 of the Rehabilitation Act of 1973 (29 
U.S.C. 730).
    (4) For waiver applications and renewals approved on or after 
October 21, 1986, home and community-based services provided to 
individuals aged 22 through 64 diagnosed as chronically mentally ill who 
would be placed in an institution for mental diseases. FFP is also not 
available for such services provided to individuals aged 65 and over and 
21 and under as an alternative to institutionalization in an IMD if the 
State does not include the appropriate optional Medicaid benefits 
specified at Sec. Sec.  440.140 and 440.160 of this chapter in its State 
plan.
    (b) FFP is available for expenditures for expanded habilitation 
services, as described in Sec.  440.180 of this chapter, if the services 
are included under a waiver or waiver amendment approved by CMS.

[59 FR 37720, July 25, 1994, as amended at 65 FR 60107, Oct. 10, 2000]



Subpart H_Home and Community-Based Services Waivers for Individuals Age 
                    65 or Older: Waiver Requirements

    Source: 57 FR 29156, June 30, 1992, unless otherwise noted.



Sec.  441.350  Basis and purpose.

    Section 1915(d) of the Act permits States to offer, under a waiver 
of statutory requirements, home and community-based services not 
otherwise available under Medicaid to individuals age 65 or older, in 
exchange for accepting an aggregate limit on the amount of expenditures 
for which they claim FFP for certain services furnished to these 
individuals. The home and community-based services that may be furnished 
are listed in Sec.  440.181 of this subchapter. This subpart describes 
the procedures the Medicaid agency must follow to request a waiver.



Sec.  441.351  Contents of a request for a waiver.

    A request for a waiver under this section must meet the following 
requirements:
    (a) Required signatures. The request must be signed by the Governor, 
the Director of the Medicaid agency or the Director of the larger State 
agency of which the Medicaid agency is a component or any official of 
the Medicaid agency to whom this authority has been delegated. A request 
from any other agency of State government will not be accepted.
    (b) Assurances and supporting documentation. The request must 
provide the assurances required by Sec.  441.352 of this part and the 
supporting documentation required by Sec.  441.353.
    (c) Statement for sections of the Act. The request must provide a 
statement as to whether waiver of section 1902(a)(1), 1902(a)(10)(B), or 
1902(a)(10)(C)(i)(III) of the Act is requested. If the State requests a 
waiver of section 1902(a)(1) of the Act, the waiver must clearly specify 
the geographic areas or political subdivisions in which the services 
will be offered. The State must indicate whether it is requesting a 
waiver of one or all of these sections. The State may request a waiver 
of any one of the sections cited above.
    (d) Identification of services. The request must identify all 
services available under the approved State plan, which are also 
included in the APEL and which are identified under Sec.  440.181, and 
any limitations that the State has imposed on the provision of any 
service. The request must also identify and describe each service 
specified in Sec.  440.181 of this subchapter to be furnished under the 
waiver, and any additional services to be furnished under the authority 
of Sec.  440.181(b)(7). Descriptions of additional services must explain 
how each additional service included under Sec.  440.181(b)(7) will 
contribute to the health and well-being of the beneficiaries and to 
their ability to reside in a community-based setting.

[[Page 408]]

    (e) Beneficiaries served. The request must provide that the home and 
community-based services described in Sec.  440.181 of this subchapter, 
are furnished only to individuals who--
    (1) Are age 65 or older;
    (2) Are not inpatients of a hospital, NF, or ICF/IID; and
    (3) The agency determines would be likely to require the care 
furnished in a NF under Medicaid.
    (f) Plan of care. The request must provide that the home and 
community-based services described in Sec.  440.181 of this subchapter, 
are furnished under a written plan of care based on an assessment of the 
individual's health and welfare needs and developed by qualified 
individuals for each beneficiary under the waiver. The qualifications of 
the individual or individuals who will be responsible for developing the 
individual plan of care must be described. Each plan of care must 
contain, at a minimum, the medical and other services to be provided, 
their frequency, and the type of provider to furnish them. Plans of care 
must be subject to the approval of the Medicaid agency.
    (g) Medicaid agency review. The request must assure that the State 
agency maintain and exercise its authority to review (at a minimum) a 
valid statistical sample of each month's plans of care. When the 
services in a plan do not comport with the stated disabilities and needs 
of the beneficiary, the agency must implement immediate corrective 
action procedures to ensure that the needs of the beneficiary are 
adequately addressed.
    (h) Groups served. The request must describe the group or groups of 
individuals to whom the services will be offered.
    (i) Assurances regarding amount expended. The request must assure 
that the total amount expended by the State under the plan for 
individuals age 65 or older during a waiver year for medical assistance 
with respect to NF, home health, private duty nursing, personal care, 
and home and community-based services described in Sec. Sec.  440.180 
and 440.181 of this subchapter and furnished as an alternative to NF 
care will not exceed the aggregate projected expenditure limit (APEL) 
defined in Sec.  441.354.

    Effective Date Note: At 57 FR 29156, June 30, 1992, Sec.  441.351 
was added. This section contains information collection and 
recordkeeping requirements and will not become effective until approval 
has been given by the Office of Management and Budget.



Sec.  441.352  State assurances.

    Unless the Medicaid agency provides the following satisfactory 
assurances to CMS, CMS will not grant a waiver under this subpart and 
may terminate a waiver already granted.
    (a) Health and welfare. The agency must assure that necessary 
safeguards have been taken to protect the health and welfare of the 
beneficiaries of services by assuring that the following conditions are 
met:
    (1) Adequate standards for all types of providers that furnish 
services under the waiver are met. (These standards must be reasonably 
related to the requirements of the waiver service to be furnished.)
    (2) The standards of any State licensure or certification 
requirements are met for services or for individuals furnishing services 
under the waiver.
    (3) All facilities covered by section 1616(e) of the Act, in which 
home and community-based services are furnished, are in compliance with 
applicable State standards that meet the requirements of 45 CFR part 
1397 for board and care facilities.
    (4) Physician reviews of prescribed psychotropic drugs (when 
prescribed for purposes of behavior control of waiver beneficiaries) 
occur at least every 30 days.
    (b) Financial accountability. The agency must assure financial 
accountability for funds expended for home and community-based services. 
The State must provide for an independent audit f its waiver program. 
The performance of a single financial audit, in accordance with the 
Single Audit Act of 1984 (Pub. L. 98-502, enacted on October 19, 1984), 
is deemed to satisfy the requirement for an independent audit. The 
agency must maintain and make available to HHS, the Comptroller General, 
or other designees, appropriate financial records documenting the cost 
of services furnished to individuals age 65 or older under the waiver 
and the State plan, including reports of any independent audits 
conducted.

[[Page 409]]

    (c) Evaluation of need. The agency must provide for an initial 
evaluation (and periodic reevaluations) of the need for the level of 
care furnished in a NF when there is a reasonable indication that 
individuals age 65 or older might need those services in the near 
future, but for the availability of home and community-based services. 
The procedures used to assess level of care for a potential waiver 
beneficiary must be at least as stringent as any existing State 
procedures applicable to individuals entering a NF. The qualifications 
of individuals performing the waiver assessment must be as high as those 
of individuals assessing the need for NF care, and the assessment 
instrument itself must be the same as any assessment instrument used to 
establish level of care of prospective inpatients in NFs. A periodic 
reevaluation of the level of care must be performed. The period of 
reevaluation of level of care cannot extend beyond 1 year.
    (d) Expenditures. The agency must assure that the total amount 
expended by the State for medical assistance with respect to NF, home 
health, private duty nursing, personal care services, home and 
community-based services furnished under a section 1915(c) waiver 
granted under Subpart G of this part to individuals age 65 or older, and 
the home and community-based services approved and furnished under a 
section 1915(d) waiver for individuals age 65 or older during a waiver 
year will not exceed the APEL, calculated in accordance with Sec.  
441.354.
    (e) Reporting. The agency must assure that it will provide CMS 
annually with information on the waiver's impact. The information must 
be consistent with a reasonable data collection plan designed by CMS and 
must address the waiver's impact on--
    (1) The type, amount, and cost of services furnished under the State 
plan; and
    (2) The health and welfare of beneficiaries of the services 
described in Sec.  440.181 of this chapter.

    Effective Date Note: At 57 FR 29156, June 30, 1992, Sec.  441.352 
was added. This section contains information collection and 
recordkeeping requirements and will not become effective until approval 
has been given by the Office of Management and Budget.



Sec.  441.353  Supporting documentation required.

    The agency must furnish CMS with sufficient information to support 
the assurances required under Sec.  441.352, in order to meet the 
requirement that the assurances are satisfactory. At a minimum, this 
information must consist of the following:
    (a) Safeguards. A description of the safeguards necessary to protect 
the health and welfare of beneficiaries.
    This information must include:
    (1) A copy of the standards established by the State for facilities 
(in which services will be furnished) that are covered by section 
1616(e) of the Act.
    (2) The minimum educational or professional qualifications of the 
providers of the services.
    (3) A description of the administrative oversight mechanisms 
established by the State to ensure quality of care.
    (b) Records. A description of the records and information that are 
maintained by the agency and by providers of services to support 
financial accountability, information regarding how the State meets the 
requirement for financial accountability, and an explanation of how the 
State assures that there is an audit trail for State and Federal funds 
expended for section 1915(d) home and community-based waiver services. 
If the State has an approved Medicaid Management Information System 
(MMIS), this system must be used to process individual claims data and 
account for funds expended for services furnished under the waiver.
    (c) Evaluation and reevaluation of beneficiaries. A description of 
the agency's plan for the evaluation and reevaluation of beneficiaries' 
level of care, including the following:
    (1) A description of who makes these evaluations and how they are 
made.
    (2) A copy of the evaluation instrument.
    (3) The agency's procedure to assure the maintenance of written 
documentation on all evaluations and reevaluations and copies of the 
forms. In accordance with regulations at 45 CFR part 75, written 
documentation of all evaluations and reevaluations must be maintained 
for a minimum period of 3 years.

[[Page 410]]

    (4) The agency's procedure to assure reevaluations of need at 
regular intervals.
    (5) The intervals at which reevaluations occur, which may be no less 
frequent than for institutionalized individuals at comparable levels of 
care.
    (6) The procedures and criteria used for evaluation and reevaluation 
of waiver beneficiaries must be the same or more stringent than those 
used for individuals served in NFs.
    (d) Alternatives available. A description of the agency's plan for 
informing eligible beneficiaries of the feasible alternatives available 
under the waiver and allowing beneficiaries to choose either 
institutional or home and community-based services must be submitted to 
CMS. A copy of the forms or documentation used by the agency to verify 
that this choice has been offered and that beneficiaries of waiver 
services, or their legal representatives, have been given the free 
choice of the providers of both waiver and State plan services must also 
be available for CMS review. The Medicaid agency must provide an 
opportunity for a fair hearing, under 42 CFR part 431, subpart E, to 
beneficiaries who are not given the choice of home or community-based 
services as an alternative to institutional care in a NF or who are 
denied the service(s) or the providers of their choice.
    (e) Post-eligibility of income. An explanation of how the agency 
applies the applicable provisions regarding the post-eligibility 
treatment of income and resources of those individuals receiving home 
and community-based services who are eligible under a special income 
level (included in Sec.  435.217 of this subchapter).

[57 FR 29156, June 30, 1992, as amended at 81 FR 3012, Jan. 20, 2016]

    Effective Date Note: At 57 FR 29156, June 30, 1992, Sec.  441.353 
was added. This section contains information collection and 
recordkeeping requirements and will not become effective until approval 
has been given by the Office of Management and Budget.



Sec.  441.354  Aggregate projected expenditure limit (APEL).

    (a) Definitions. For purposes of this section, the term base year 
means--
    (1) Federal fiscal year (FFY) 1987 (that is, October 1, 1986 through 
September 30, 1987); or
    (2) In the case of a State which did not report expenditures on the 
basis of age categories during FFY 1987, the base year means FFY 1989 
(that is, October 1, 1988 through September 30, 1989).
    (b) General. (1) The total amount expended by the State for medical 
assistance with respect to NF, home and community-based services under 
the waiver, home health services, personal care services, private duty 
nursing services, and services furnished under a waiver under subpart G 
of this part to individuals age 65 or older furnished as an alternative 
to care in an SNF or ICF (NF effective October 1, 1990), may not exceed 
the APEL calculated in accordance with paragraph (c) of this section.
    (2) In applying for a waiver under this subpart, the agency must 
clearly identify the base year it intends to use.
    (3) The State may make a preliminary calculation of the expenditure 
limit at the time of the waiver approval; however, CMS makes final 
calculations of the aggregate limit after base data have been verified 
and accepted.
    (4) All base year and waiver year data are subject to final cost 
settlement within 2 years from the end of the base or waiver year 
involved.
    (c) Formula for calculating APEL. Except as provided in paragraph 
(d) of this section, the formula for calculating the APEL follows:

APEL = P x (1 + Y) + V x (1 + Z), where

P = The aggregate amount of the State's medical assistance under title 
          XIX for SNF and ICF (NF effective October 1, 1990) services 
          furnished to individuals who have reached age 65, defined as 
          the total medical assistance payments (Federal and State) 
          reported on line 6 of form CMS 64 (as adjusted) for SNF 
          services, ICF-other services, and mental health facility 
          services for the base year, multiplied by the ratio of 
          expenditures for SNF and ICF-other services for the aged to 
          total expenditures for these services as reported on form CMS 
          2082 for the base year.
Q = The market basket index for SNF and ICF (NF effective October 1, 
          1990) services for the waiver year involved, defined as the 
          total SNF Input Price Index used

[[Page 411]]

          in the Medicare program, identified as the third quarter data 
          available from CMS's Office of National Cost Estimates in 
          August preceding the start of the fiscal year.
R = The SNF Input Price Index for the base year.
S = The number of residents in the State in the waiver year involved who 
          have reached age 65, defined as the number of aged Medicare 
          beneficiaries in the State, equal to the Mid-Period Enrollment 
          in HI or SMI in that State on July 1 preceding the start of 
          the fiscal year.
T = The number of aged Medicare beneficiaries in the State who are 
          enrolled in either the HI or SMI programs in the base year, as 
          defined in S, above.
U = The number of years beginning after the base year and ending on the 
          last day of the waiver year involved.
V = The aggregate amount of the State's medical assistance under title 
          XIX in the base year for home and community-based services for 
          individuals who have reached age 65, defined as the total 
          medical assistance payments (Federal and State) reported on 
          line 6 of form CMS 64 (as adjusted) for home health, personal 
          care, and home and community-based services waivers, which 
          provide services as an alternative to care in a SNF or ICF (NF 
          effective October 1, 1990), increased by an estimate 
          (acceptable to CMS) of expenditures for private duty nursing 
          services, multiplied by the ratio of expenditures for home 
          health services for the aged to total expenditures for home 
          health services, as reported on form CMS 2082, for the base 
          year.
W = The market basket index for home and community-based services for 
          the waiver year involved, defined as the Home Agency Input 
          Price Index, used in the Medicare program identified as the 
          third quarter data available from CMS's Office of National 
          Cost Estimates in August preceding the start of the fiscal 
          year.
X = The Home Health Agency Input Price Index for the base year.
Y = The greater of--
    (U x .07), or (Q/R)-1 + (S/T)-1 + (U x .02).
Z = The greater of--
    (U x .07), or (W/X)-1 + (S/T)-1 + + (U x .02).

    (d) Amendment of the APEL. The State may request amendment of its 
APEL to reflect an increase in the aggregate amount of medical 
assistance for NF services and for services included in the calculation 
of the APEL as required by paragraph (c) of this section when the 
increase is directly attributable to legislation enacted on or after 
December 22, 1987, which amends title XIX of the Act. Costs attributable 
to laws enacted before December 22, 1987 will not be considered. Because 
the APEL for each year of the waiver is computed separately from the 
APEL for any other waiver year, a separate amendment must be submitted 
for each year in which the State chooses to raise its APEL. 
Documentation specific to the waiver year involved must be submitted to 
CMS.



Sec.  441.355  Duration, extension, and amendment of a waiver.

    (a) Effective dates and extension periods. (1) The effective date 
for a waiver of Medicaid requirements to furnish home and community-
based services to individuals age 65 or older under this subpart is 
established by CMS prospectively on the first day of the FFY following 
the date on which the waiver is approved.
    (2) The initial waiver is approved for a 3-year period from the 
effective date. Subsequent renewals are approved for 5-year periods.
    (3) If the agency requests it, the waiver may be extended for an 
additional 5-year period if CMS's review of the prior period shows that 
the assurances required by Sec.  441.352 were met.
    (4) The agency may request that waiver modifications be made 
effective retroactive to the first day of the waiver year in which the 
amendment is submitted, unless the amendment involves substantive 
change. Substantive changes may include, but are not limited to, 
addition of services under the waiver, a change in the qualifications of 
service providers, or a change in the eligible population.
    (5) A request for an amendment that involves a substantive change is 
given a prospective effective date, but this date need not coincide with 
the start of the next FFY.
    (b) Extension or new waiver request. CMS determines whether a 
request for extension of an existing waiver is actually an extension 
request, or a request for a new waiver. Generally, if a State's 
extension request proposes a substantive change in services furnished, 
eligible population, service area, statutory sections waived, or 
qualifications of service providers, CMS considers it a new waiver 
request.

[[Page 412]]

    (c) Reconsideration of denial. A determination of CMS to deny a 
request for a waiver (or for extension of a waiver) under this subpart 
may be reconsidered in accordance with Sec.  441.357.
    (d) Existing waiver effectiveness after denial. If CMS denies a 
request for an extension of an existing waiver under this subpart:
    (1) The existing waiver remains in effect for a period of not less 
than 90 days after the date on which CMS denies the request, or, if the 
State seeks reconsideration in accordance with Sec.  441.357, the date 
on which a final determination is made with respect to that review.
    (2) CMS calculates an APEL for the period for which the waiver 
remains in effect, and this calculation is used to pro-rate the limit 
according to the number of days to which it applies.



Sec.  441.356  Waiver termination.

    (a) Termination by the State. If a State chooses to terminate its 
waiver before an approved program is due to expire, the following 
conditions apply:
    (1) The State must notify CMS in writing at least 30 days before 
terminating services to beneficiaries.
    (2) The State must notify beneficiaries of services under the waiver 
at least 30 days before terminating services in accordance with Sec.  
431.210 of this chapter.
    (3) CMS continues to apply the APEL described in Sec.  441.354 
through the end of the waiver year, but this limit is not applied in 
subsequent years.
    (4) The State may not decrease the services available under the 
approved State plan to individuals age 65 or older by an amount that 
violates the comparability of service requirements set forth in Sec.  
440.240 of this chapter.
    (b) Termination by CMS. (1) If CMS finds, during an approved waiver 
period, that an agency is not meeting one or more of the requirements 
for a waiver contained in this subpart, CMS notifies the agency in 
writing of its findings and grants an opportunity for a hearing in 
accordance with Sec.  441.357. If CMS determines that the agency is not 
in compliance with this subpart after the notice and any hearing, CMS 
may terminate the waiver.
    (2) If CMS terminates the waiver, the following conditions apply:
    (i) The State must notify beneficiaries of services under the waiver 
at least 30 days before terminating services in accordance with Sec.  
431.210 of this chapter.
    (ii) CMS continues to apply the APEL in Sec.  441.354 of this 
subpart, but the limit is prorated according to the number of days in 
the fiscal year during which waiver services were offered. The limit 
expires concurrently with the termination of home and community-based 
services under the waiver.

    Effective Date Note: At 57 FR 29156, June 30, 1992, Sec.  441.356 
was added. This section contains information collection and 
recordkeeping requirements and will not become effective until approval 
has been given by the Office of Management and Budget.



Sec.  441.357  Hearing procedures for waiver denials.

    The procedures specified in Sec.  430.18 of this subchapter apply to 
State requests for hearings on denials, renewals, or amendments of 
waivers for home and community-based services for individuals age 65 or 
older.



Sec.  441.360  Limits on Federal financial participation (FFP).

    FFP for home and community-based services listed in Sec.  440.181 of 
this subchapter is not available in expenditures for the following:
    (a) Services furnished in a facility subject to the health and 
welfare requirements described in Sec.  441.352(a) during any period in 
which the facility is found not to be in compliance with the applicable 
State requirements described in that section.
    (b) The cost of room and board except when furnished as part of 
respite care services in a facility, approved by the State, that is not 
a private residence. For purposes of this subpart, ``board'' means three 
meals a day or any other full nutritional regimen. ``Board'' does not 
include meals, which do not comprise a full nutritional regimen, 
furnished as part of adult day health services.
    (c) The portion of the cost of room and board attributed to 
unrelated, live-in personal caregivers when the waiver beneficiary lives 
in the caregiver's

[[Page 413]]

home or a residence owned or leased by the provider of the Medicaid 
services (the caregiver).
    (d) Services that are not included in the approved State plan and 
not approved as waiver services by CMS.
    (e) Services furnished to beneficiaries who are ineligible under the 
terms of the approved waiver.
    (f) Services furnished by a provider when either the services or the 
provider do not meet the standards that are set by the State and 
included in the approved waiver.
    (g) Services furnished to a beneficiary by his or her spouse.



Sec.  441.365  Periodic evaluation, assessment, and review.

    (a) Purpose. This section prescribes requirements for periodic 
evaluation, assessment, and review of the care and services furnished to 
individuals receiving home and community-based waiver services under 
this subpart.
    (b) Evaluation and assessment review team. (1) A review team, as 
described in paragraphs (b)(2) and (c) of this section, must 
periodically evaluate and assess the care and services furnished to 
beneficiaries under this subpart. The review team must be created by the 
State agency directly, or (through interagency agreement) by other 
departments of State government (such as the Department of Health or the 
Agency on Aging).
    (2) Each review team must consist of at least one physician or 
registered nurse, and at least one other individual with health and 
social service credentials who the State believes is qualified to 
properly evaluate and assess the care and services provided under the 
waiver. If there is no physician on the review team, the Medicaid agency 
must ensure that a physician is available to provide consultation to the 
review team.
    (3) For waiver services furnished to individuals who have been found 
to be likely to require the level of care furnished in a NF that is also 
an IMD, each review team must have a psychiatrist or physician and other 
appropriate mental health or social service personnel who are 
knowledgeable about geriatric mental illness.
    (c) Financial interests and employment of review team members. (1) 
No member of a review team may have a financial interest in or be 
employed by any entity that furnishes care and services under the waiver 
to a beneficiary whose care is under review.
    (2) No physician member of a review team may evaluate or assess the 
care of a beneficiary for whom he or she is the attending physician.
    (3) No individual who serves as case manager, caseworker, benefit 
authorizer, or any similar position, may serve as member of a review 
team that evaluates and assesses care furnished to a beneficiary with 
whom he or she has had a professional relationship.
    (d) Number and location of review teams. A sufficient number of 
teams must be located within the State so that onsite inspections can be 
made at appropriate intervals at sites where waiver beneficiaries 
receive care and services.
    (e) Frequency of periodic evaluations and assessments. Periodic 
evaluations and assessments must be conducted at least annually for each 
beneficiary under the waiver. The review team and the agency have the 
option to determine the frequency of further periodic evaluations and 
assessments, based on the quality of services and access to care being 
furnished under the waiver and the condition of patients receiving care 
and services.
    (f) Notification before inspection. No provider of care and services 
under the waiver may be notified in advance of a periodic evaluation, 
assessment, and review. However, when a beneficiary receives services in 
his own home or the home of a relative, notification must be provided to 
the residents of the household at least 48 hours in advance. The 
beneficiary must have an opportunity to decline access to the home. If 
the beneficiary declines access to his or her own home, or the home of a 
relative, the review is limited solely to the review of the provider's 
records. If the beneficiary is incompetent, the head of the household 
has the authority to decline access to the home.
    (g) Personal contact with and observation of beneficiaries and 
review of records. (1) For beneficiaries of care and services under a 
waiver, the review team's

[[Page 414]]

evaluation and assessment must include--
    (i) A review of each beneficiary's medical record, the evaluation 
and reevaluation required by Sec.  441.353(c), and the plan of care 
under which the waiver and other services are furnished; and
    (ii) If the records described in paragraph (g)(1)(i) of this section 
are inadequate or incomplete, personal contact and observation of each 
beneficiary.
    (2) The review team may personally contact and observe any 
beneficiary whose care the team evaluates and assesses.
    (3) The review team may consult with both formal and informal 
caregivers when the beneficiary's records are inadequate or incomplete 
and when any apparent discrepancy exists between services required by 
the beneficiary and services furnished under the waiver.
    (h) Determinations by the review team. The review team must 
determine in its evaluation and assessment whether--
    (1) The services included in the plan of care are adequate to meet 
the health and welfare needs of each beneficiary;
    (2) The services included in the plan of care have been furnished to 
the beneficiary as planned;
    (3) It is necessary and in the interest of the beneficiary to 
continue receiving services through the waiver program; and
    (4) It is feasible to meet the beneficiary's health and welfare 
needs through the waiver program.
    (i) Other information considered by review team. When making 
determinations, under paragraph (h) of this section, for each 
beneficiary, the review team must consider the following information and 
may consider other information as it deems necessary:
    (1) Whether the medical record, the determination of level of care, 
and the plan of care are consistent, and whether all ordered services 
have been furnished and properly recorded.
    (2) Whether physician review of prescribed psychotropic medications 
(when required for behavior control) has occurred at least every 30 
days.
    (3) Whether tests or observations of each beneficiary indicated by 
his or her medical record are made at appropriate times and properly 
recorded.
    (4) Whether progress notes entered in the record by formal and 
informal caregivers are made as required and appear to be consistent 
with the observed condition of the beneficiary.
    (5) Whether reevaluations of the beneficiary's level of care have 
occurred at least as frequently as would be required if that individual 
were served in a NF.
    (6) Whether the beneficiary receives adequate care and services, 
based, at a minimum, on the following when observations are necessary 
(the requirements for the necessity of observations are set forth in new 
Sec.  441.365(g)(3)):
    (i) Cleanliness.
    (ii) Absence of bedsores.
    (iii) Absence of signs of malnutrition or dehydration.
    (7) Whether the beneficiary needs any service that is not included 
in the plan of care, or if included, is not being furnished by formal or 
informal caregivers under the waiver or through arrangements with 
another public or private source of assistance.
    (8) Determination as to whether continued home and community-based 
services are required by the beneficiary to avoid the likelihood of 
placement in a NF.
    (j) Submission of review team's results. The review team must submit 
to the Medicaid agency the results of its periodic evaluation, 
assessment and review of the care of the beneficiary:
    (1) Within 1 month of the completion of the review.
    (2) Immediately upon its determination that conditions exist that 
may constitute a threat to the life or health of a beneficiary.
    (k) Agency's action. The Medicaid agency must establish and adhere 
to procedures for taking appropriate action in response to the findings 
reported by the review team. These procedures must provide for immediate 
response to any finding that the life or health of a beneficiary may be 
jeopardized.

    Effective Date Note: At 57 FR 29156, June 30, 1992, Sec.  441.365 
was added. This section contains information collection and 
recordkeeping requirements and will not become effective until approval 
has been given by the Office of Management and Budget.

[[Page 415]]



       Subpart I_Community Supported Living Arrangements Services

    Source: 56 FR 48114, Sept. 24, 1991, unless otherwise noted.



Sec.  441.400  Basis and purpose.

    This subpart implements section 1905(a)(24) of the Act, which adds 
community supported living arrangements services to the list of services 
that States may provide as medical assistance under title XIX (to the 
extent and as defined in section 1930 of the Act), and section 
1930(h)(1)(B) of the Act, which specifies minimum protection 
requirements that a State which provides community supported living 
arrangements services as an optional Medicaid service to developmentally 
disabled individuals must meet to ensure the health, safety and welfare 
of those individuals.



Sec.  441.402  State plan requirements.

    If a State that is eligible to provide community supported living 
arrangements services as an optional Medicaid service to developmentally 
disabled individuals provides such services, the State plan must specify 
that it complies with the minimum protection requirements in Sec.  
441.404.



Sec.  441.404  Minimum protection requirements.

    To be eligible to provide community supported living arrangements 
services to developmentally disabled individuals, a State must assure, 
through methods other than reliance on State licensure processes or the 
State quality assurance programs described under section 1930(d) of the 
Act, that:
    (a) Individuals receiving community supported living arrangements 
services are protected from neglect, physical and sexual abuse, and 
financial exploitation;
    (b) Providers of community supported living arrangements services--
    (1) Do not use individuals who have been convicted of child or 
client abuse, neglect, or mistreatment, or of a felony involving 
physical harm to an individual; and
    (2) Take all reasonable steps to determine whether applicants for 
employment by the provider have histories indicating involvement in 
child or client abuse, neglect, or mistreatment, or a criminal record 
involving physical harm to an individual;
    (c) Providers of community supported living arrangements services 
are not unjustly enriched as a result of abusive financial arrangements 
(such as owner lease-backs) with developmentally disabled clients; and
    (d) Providers of community supported living arrangements services, 
or the relatives of such providers, are not named beneficiaries of life 
insurance policies purchased by or on behalf of developmentally disabled 
clients.



  Subpart J_Optional Self-Directed Personal Assistance Services Program

    Source: 73 FR 57881, Oct. 3, 2008, unless otherwise noted.



Sec.  441.450  Basis, scope, and definitions.

    (a) Basis. This subpart implements section 1915(j) of the Act 
concerning the self-directed personal assistance services (PAS) option 
through a State Plan.
    (b) Scope. A self-directed PAS option is designed to allow 
individuals, or their representatives, if applicable, to exercise 
decision-making authority in identifying, accessing, managing and 
purchasing their PAS. This authority includes, at a minimum, all of the 
following:
    (1) The purchase of PAS and supports for PAS.
    (2) Recruiting workers.
    (3) Hiring and discharging workers.
    (4) Training workers and accessing training provided by or through 
the State if additional worker training is required or desired by the 
participant, or participant's representative, if applicable.
    (5) Specifying worker qualifications.
    (6) Determining worker duties.
    (7) Scheduling workers.
    (8) Supervising workers.
    (9) Evaluating worker performance.
    (10) Determining the amount paid for a service, support or item.
    (11) Scheduling when services are provided.
    (12) Identifying service workers.

[[Page 416]]

    (13) Reviewing and approving invoices.
    (c) Definitions. As used in this part--
    Assessment of need means an evaluation of the needs, strengths, and 
preferences of participants for services. This includes one or more 
processes to obtain information about an individual, including health 
condition, personal goals and preferences, functional limitation, age, 
school, employment, household, and other factors that are relevant to 
the authorization and provision of services. Assessment information 
supports the development of the service plan and the subsequent service 
budget.
    Individualized backup plan means a written plan that meets all of 
the following:
    (1) Is sufficiently individualized to address each participant's 
critical contingencies or incidents that would pose a risk of harm to 
the participant's health or welfare;
    (2) Must demonstrate an interface with the risk management provision 
at Sec.  441.476 which requires States to assess and identify the 
potential risks to the participant (such as any critical health needs), 
and ensure that the risks and how they will be managed are the result of 
discussion and negotiation among the persons involved in the service 
plan development;
    (3) Must not include the 911 emergency system or other emergency 
system as the sole backup feature of the plan; and
    (4) Must be incorporated into the participant's service plan.
    Legally liable relatives means persons who have a duty under the 
provisions of State law to care for another person. Legally liable 
relatives may include any of the following:
    (1) The parent (biological or adoptive) of a minor child or the 
guardian of a minor child who must provide care to the child.
    (2) Legally-assigned caretaker relatives.
    (3) A spouse.
    Self-directed personal assistance services (PAS) means personal care 
and related services, or home and community-based services otherwise 
available under the State plan or a 1915(c) waiver program that are 
provided to an individual who has been determined eligible for the PAS 
option. Self-directed PAS also includes, at the State's option, items 
that increase the individual's independence or substitutes (such as a 
microwave oven or an accessibility ramp) for human assistance, to the 
extent the expenditures would otherwise be made for the human 
assistance.
    Self-direction means the opportunity for participants or their 
representatives to exercise choice and control over the budget, 
planning, and purchase of self-directed PAS, including the amount, 
duration, scope, provider, and location of service provision.
    Service budget means an amount of funds that is under the control 
and direction of a participant, or the participant's representative, if 
any, when the State has selected the State plan option for provision of 
self-directed PAS. It is developed using a person-centered and directed 
process and is individually tailored in accordance with the 
participant's needs and personal preferences as established in the 
service plan.
    Service plan means the written document that specifies the services 
and supports (regardless of funding source) that are to be furnished to 
meet the needs of a participant in the self-directed PAS option and to 
assist the participant to direct the PAS and to remain in the community. 
The service plan is developed based on the assessment of need using a 
person-centered and directed process. The service plan builds upon the 
participant's capacity to engage in activities that promote community 
life and respects the participant's preferences, choices, and abilities. 
The participant's representative, if any, families, friends and 
professionals, as desired or required by the participant, will be 
involved in the service-planning process.
    Support system means information, counseling, training, and 
assistance that support the participant (or the participant's family or 
representative, as appropriate) in identifying, accessing, managing, and 
directing their PAS and supports and in purchasing their PAS identified 
in the service plan and budget.

[[Page 417]]

    Supports broker or consultant means an individual who supports 
participants in directing their PAS and service budgets. The supports 
broker or consultant is an agent of the participants and takes direction 
from the participants, or their representatives, if applicable, about 
what information, counseling, training or assistance is needed or 
desired. The supports broker or consultant is primarily responsible for 
facilitating participants' development of a service budget and effective 
management of the participants' PAS and budgets in a manner that 
comports with the participants' preferences. States must develop a 
protocol to ensure that supports brokers or consultants: are accessible 
to participants; have regularly scheduled phone and in-person contacts 
with participants; monitor whether participants' health status has 
changed and whether expenditure of funds are being made in accordance 
with service budgets. States must also develop the training requirements 
and qualifications for supports brokers or consultants that include, at 
a minimum, the following:
    (1) An understanding of the philosophy of self-direction and person-
centered and directed planning;
    (2) The ability to facilitate participants' independence and 
participants' preferences in managing PAS and budgets, including any 
risks assumed by participants;
    (3) The ability to develop service budgets and ensure appropriate 
documentation; and
    (4) Knowledge of the PAS and resources available in the 
participant's community and how to access them.
    The availability of a supports broker or consultant to each 
participant is a requirement of the support system.



Sec.  441.452  Self-direction: General.

    (a) States must have in place, before electing the self-directed PAS 
option, personal care services through the State plan, or home and 
community-based services under a section 1915(c) waiver.
    (b) The State must have both traditional service delivery and the 
self-directed PAS service delivery option available in the event that an 
individual voluntarily disenrolls or is involuntarily disenrolled, from 
the self-directed PAS service delivery option.
    (c) The State's assessment of an individual's needs must form the 
basis of the level of services for which the individual is eligible.
    (d) Nothing in this subpart will be construed as affecting an 
individual's Medicaid eligibility, including that of an individual whose 
Medicaid eligibility is attained through receipt of section 1915(c) 
waiver services.



Sec.  441.454  Use of cash.

    (a) States have the option of disbursing cash prospectively to 
participants, or their representatives, as applicable, self-directing 
their PAS.
    (b) States that choose to offer the cash option must ensure 
compliance with all applicable requirements of the Internal Revenue 
Service, including, but not limited to, retaining required forms and 
payment of FICA, FUTA and State unemployment taxes.
    (c) States must permit participants, or their representatives, as 
applicable, using the cash option to choose to use the financial 
management entity for some or all of the functions described in Sec.  
441.484(c).
    (d) States must make available a financial management entity to a 
participant, or the participant's representative, if applicable, who has 
demonstrated, after additional counseling, information, training, or 
assistance, that the participant cannot effectively manage the cash 
option described in paragraph (a) of this section.



Sec.  441.456  Voluntary disenrollment.

    (a) States must permit a participant to voluntarily disenroll from 
the self-directed PAS option at any time and return to a traditional 
service delivery system.
    (b) The State must specify in a section 1915(j) State plan amendment 
the safeguards that are in place to ensure continuity of services during 
the transition from self-directed PAS.



Sec.  441.458  Involuntary disenrollment.

    (a) States must specify the conditions under which a participant may 
be involuntarily disenrolled from the self-directed PAS option.

[[Page 418]]

    (b) CMS must approve the State's conditions under which a 
participant may be involuntarily disenrolled.
    (c) The State must specify in the section 1915(j) State plan 
amendment the safeguards that are in place to ensure continuity of 
services during the transition from self-directed PAS.



Sec.  441.460  Participant living arrangements.

    (a) Self-directed PAS are not available to an individual who resides 
in a home or property that is owned, operated, or controlled by a PAS 
provider who is not related to the individual by blood or marriage.
    (b) States may specify additional restrictions on a participant's 
living arrangements if they have been approved by CMS.



Sec.  441.462  Statewideness, comparability and limitations on number
served.

    A State may do the following:
    (a) Provide self-directed PAS without regard to the requirements of 
statewideness.
    (b) Limit the population eligible to receive these services without 
regard to comparability of amount, duration, and scope of services.
    (c) Limit the number of persons served without regard to 
comparability of amount, duration, and scope of services.



Sec.  441.464  State assurances.

    A State must assure that the following requirements are met:
    (a) Necessary safeguards. Necessary safeguards have been taken to 
protect the health and welfare of individuals furnished services under 
the program and to assure the financial accountability for funds 
expended for self-directed services.
    (1) Safeguards must prevent the premature depletion of the 
participant directed budget as well as identify potential service 
delivery problems that might be associated with budget underutilization.
    (2) These safeguards may include the following:
    (i) Requiring a case manager, support broker or other person to 
monitor the participant's expenditures.
    (ii) Requiring the financial management entity to flag significant 
budget variances (over and under expenditures) and bring them to the 
attention of the participant, the participant's representative, if 
applicable, case manager, or support broker.
    (iii) Allocating the budget on a monthly or quarterly basis.
    (iv) Other appropriate safeguards as determined by the State.
    (3) Safeguards must be designed so that budget problems are 
identified on a timely basis so that corrective action may be taken, if 
necessary.
    (b) Evaluation of need. The State must perform an evaluation of the 
need for personal care under the State Plan or services under a section 
1915(c) waiver program for individuals who meet the following 
requirements:
    (1) Are entitled to medical assistance for personal care services 
under the State plan or receiving home and community based services 
under a section 1915(c) waiver program.
    (2) May require self-directed PAS.
    (3) May be eligible for self-directed PAS.
    (c) Notification of feasible alternatives. Individuals who are 
likely to require personal care under the State plan, or home and 
community-based services under a section 1915(c) waiver program are 
informed of the feasible alternatives, if available, under the State's 
self-directed PAS State plan option, at the choice of these individuals, 
to the provision of personal care services under the State plan, or PAS 
under a section 1915(c) home and community-based services waiver 
program. Information on feasible alternatives must be communicated to 
the individual in a manner and language understandable by the 
individual. Such information includes, but is not limited to, the 
following:
    (1) Information about self-direction opportunities that is 
sufficient to inform decision-making about the election of self-
direction and provided on a timely basis to an individual or the 
representative which minimally includes the following:
    (i) Elements of self-direction compared to non-self-directed PAS.

[[Page 419]]

    (ii) Individual responsibilities and potential liabilities under the 
self-direction service delivery model.
    (iii) The choice to receive PAS through a waiver program 
administered under section 1915(c) of the Act, regardless of delivery 
system, if applicable.
    (iv) The option, if available, to receive and manage the cash amount 
of their individual budget allocation.
    (2) When and how this information is provided.
    (d) Support system. States must provide, or arrange for the 
provision of, a support system that meets the following conditions:
    (1) Appropriately assesses and counsels an individual, or the 
individual's representative, if applicable, before enrollment, including 
information about disenrollment.
    (2) Provides appropriate information, counseling, training, and 
assistance to ensure that a participant is able to manage the services 
and budgets. Such information must be communicated to the participant in 
a manner and language understandable by the participant. The support 
activities must include at least the following:
    (i) Person-centered planning and how it is applied.
    (ii) Information about the services available for self-direction.
    (iii) Range and scope of individual choices and options.
    (iv) Process for changing the service plan and service budget.
    (v) Grievance process.
    (vi) Risks and responsibilities of self-direction.
    (vii) The ability to freely choose from available PAS providers.
    (viii) Individual rights.
    (ix) Reassessment and review schedules.
    (x) Defining goals, needs, and preferences.
    (xi) Identifying and accessing services, supports, and resources.
    (xii) Development of risk management agreements.
    (xiii) Development of an individualized backup plan.
    (xiv) Recognizing and reporting critical events.
    (xv) Information about an advocate or advocacy systems available in 
the State and how a participant, or a participant's representative, if 
applicable, can access the advocate or advocacy systems.
    (3) Offers additional information, counseling, training, or 
assistance, including financial management services under either of the 
following conditions:
    (i) At the request of the participant, or participant's 
representative, if applicable, for any reason.
    (ii) When the State has determined the participant, or participant's 
representative, if applicable, is not effectively managing the services 
identified in the service plan or budget.
    (4) The State may mandate the use of additional assistance, 
including the use of a financial management entity, or may initiate an 
involuntary disenrollment in accordance with Sec.  441.458, if, after 
additional information, counseling, training or assistance is provided 
to a participant (or participant's representative, if applicable), the 
participant (or participant's representative, if applicable) has 
continued to demonstrate an inability to effectively manage the services 
and budget.
    (e) Annual report. The State must provide to CMS an annual report on 
the number of individuals served and the total expenditures on their 
behalf in the aggregate.
    (f) Three-year evaluation. The State must provide to CMS an 
evaluation of the overall impact of the self-directed PAS option on the 
health and welfare of participating individuals compared to non-
participants every 3 years.



Sec.  441.466  Assessment of need.

    States must conduct an assessment of the participant's needs, 
strengths, and preferences in accordance with the following:
    (a) States may use one or more processes and techniques to obtain 
information about an individual, including health condition, personal 
goals and preferences for the provision of services, functional 
limitations, age, school, employment, household, and other factors that 
are relevant to the need for and authorization and provision of 
services.

[[Page 420]]

    (b) Assessment information supports the determination that an 
individual requires PAS and also supports the development of the service 
plan and budget.



Sec.  441.468  Service plan elements.

    (a) The service plan must include at least the following:
    (1) The scope, amount, frequency, and duration of each service.
    (2) The type of provider to furnish each service.
    (3) Location of the service provision.
    (4) The identification of risks that may pose harm to the 
participant along with a written individualized backup plan for 
mitigating those risks.
    (b) A State must develop a service plan for each program participant 
using a person-centered and directed planning process to ensure the 
following:
    (1) The identification of each program participant's preferences, 
choices, and abilities, and strategies to address those preferences, 
choices, and abilities.
    (2) The option for the program participant, or participant's 
representative, if applicable, to exercise choice and control over 
services and supports discussed in the plan.
    (3) Assessment of, and planning for avoiding, risks that may pose 
harm to a participant.
    (c) All of the State's applicable policies and procedures associated 
with service plan development must be carried out and include, but are 
not limited to, the following:
    (1) Allow the participant, or participant's representative, if 
applicable, the opportunity to engage in, and direct, the process to the 
extent desired.
    (2) Allow the participant, or participant's representative, if 
applicable, the opportunity to involve family, friends, and 
professionals (as desired or required) in the development and 
implementation of the service plan.
    (3) Ensure the planning process is timely.
    (4) Ensure the participant's needs are assessed and that the 
services meet the participant's needs.
    (5) Ensure the responsibilities for service plan development are 
identified.
    (6) Ensure the qualifications of the individuals who are responsible 
for service plan development reflect the nature of the program's target 
population(s).
    (7) Ensure the State reviews the service plan annually, or whenever 
necessary due to a change in the participant's needs or health status.
    (8) Ensure that a participant may request revisions to a service 
plan, based on a change in needs or health status.
    (d) When an entity that is permitted to provide other State plan 
services is responsible for service plan development, the State must 
describe the safeguards that are in place to ensure that the service 
provider's role in the planning process is fully disclosed to the 
participant, or participant's representative, if applicable, and 
controls are in place to avoid any possible conflict of interest.
    (e) An approved self-directed service plan conveys authority to the 
participant, or participant's representative, if applicable, to perform, 
at a minimum, the following tasks:
    (1) Recruit and hire workers to provide self-directed services, 
including specifying worker qualifications.
    (2) Fire workers.
    (3) Supervise workers in the provision of self-directed services.
    (4) Manage workers in the provision of self-directed services, which 
includes the following functions:
    (i) Determining worker duties.
    (ii) Scheduling workers.
    (iii) Training workers in assigned tasks.
    (iv) Evaluating workers performance.
    (5) Determine the amount paid for a service, support, or item.
    (6) Review and approve provider invoices.



Sec.  441.470  Service budget elements.

    A service budget must be developed and approved by the State based 
on the assessment of need and service plan and must include the 
following:
    (a) The specific dollar amount a participant may utilize for 
services and supports.
    (b) How the participant is informed of the amount of the service 
budget before the service plan is finalized.

[[Page 421]]

    (c) The procedures for how the participant, or participant's 
representative, if applicable, may adjust the budget, including the 
following:
    (1) How the participant, or participant's representative, if 
applicable, may freely make changes to the budget.
    (2) The circumstances, if any, that may require prior approval 
before a budget adjustment is made.
    (3) The circumstances, if any, that may require a change in the 
service plan.
    (d) The procedure(s) that governs how a person, at the election of 
the State, may reserve funds to purchase items that increase 
independence or substitute for human assistance, to the extent that 
expenditures would otherwise be made for the human assistance, including 
additional goods, supports, services or supplies.
    (e) The procedure(s) that governs how a person may use a 
discretionary amount, if applicable, to purchase items not otherwise 
delineated in the budget or reserved for permissible purchases.
    (f) How participants, or their representative, if applicable, are 
afforded the opportunity to request a fair hearing under Sec.  441.300 
if a participant's, or participant's representative, if applicable, 
request for a budget adjustment is denied or the amount of the budget is 
reduced.



Sec.  441.472  Budget methodology.

    (a) The State shall set forth a budget methodology that ensures 
service authorization resides with the State and meets the following 
criteria:
    (1) The State's method of determining the budget allocation is 
objective and evidence based utilizing valid, reliable cost data.
    (2) The State's method is applied consistently to participants.
    (3) The State's method is open for public inspection.
    (4) The State's method includes a calculation of the expected cost 
of the self-directed PAS and supports, if those services and supports 
were not self-directed.
    (5) The State has a process in place that describes the following:
    (i) Any limits it places on self-directed services and supports, and 
the basis for the limits.
    (ii) Any adjustments that will be allowed and the basis for the 
adjustments.
    (b) The State must have procedures to safeguard participants when 
the budgeted service amount is insufficient to meet a participant's 
needs.
    (c) The State must have a method of notifying participants, or their 
representative, if applicable, of the amount of any limit that applies 
to a participant's self-directed PAS and supports.
    (d) The budget may not restrict access to other medically necessary 
care and services furnished under the plan and approved by the State but 
not included in the budget.
    (e) The State must have a procedure to adjust a budget when a 
reassessment indicates a change in a participant's medical condition, 
functional status or living situation.



Sec.  441.474  Quality assurance and improvement plan.

    (a) The State must provide a quality assurance and improvement plan 
that describes the State's system of how it will perform activities of 
discovery, remediation and quality improvement in order to learn of 
critical incidents or events that affect participants, correct 
shortcomings, and pursue opportunities for system improvement.
    (b) The quality assurance and improvement plan shall also describe 
the system performance measures, outcome measures, and satisfaction 
measures that the State must use to monitor and evaluate the self-
directed State plan option. Quality of care measures must be made 
available to CMS upon request and include indicators approved or 
prescribed by the Secretary.



Sec.  441.476  Risk management.

    (a) The State must specify the risk assessment methods it uses to 
identify potential risks to the participant.
    (b) The State must specify any tools or instruments it uses to 
mitigate identified risks.
    (c) The State must ensure that each service plan includes the risks 
that an

[[Page 422]]

individual is willing and able to assume, and the plan for how 
identified risks will be mitigated.
    (d) The State must ensure that the risk management plan is the 
result of discussion and negotiation among the persons designated by the 
State to develop the service plan, the participant, the participant's 
representative, if any, and others from whom the participant may seek 
guidance.



Sec.  441.478  Qualifications of providers of personal assistance.

    (a) States have the option to permit participants, or their 
representatives, if applicable, to hire any individual capable of 
providing the assigned tasks, including legally liable relatives, as 
paid providers of the PAS identified in the service plan and budget.
    (b) Participants, or their representatives, if applicable, retain 
the right to train their workers in the specific areas of personal 
assistance needed by the participant and to perform the needed 
assistance in a manner that comports with the participant's personal, 
cultural, and/or religious preferences. Participants, or their 
representatives, if applicable, also have the right to access other 
training provided by or through the State so that their PAS providers 
can meet any additional qualifications required or desired by 
participants, or participants' representatives, if applicable.
    (c) Participants, or their representatives, if applicable, retain 
the right to establish additional staff qualifications based on 
participants' needs and preferences.



Sec.  441.480  Use of a representative.

    (a) States may permit participants to appoint a representative to 
direct the provision of self-directed PAS on their behalf. The following 
types of representatives are permissible:
    (1) A minor child's parent or guardian.
    (2) An individual recognized under State law to act on behalf of an 
incapacitated adult.
    (3) A State-mandated representative, after approval by CMS of the 
State criteria, if the participant has demonstrated, after additional 
counseling, information, training or assistance, the inability to self-
direct PAS.
    (b) A person acting as a representative for a participant receiving 
self-directed PAS is prohibited from acting as a provider of self-
directed PAS to the participant.



Sec.  441.482  Permissible purchases.

    (a) Participants, or their representatives, if applicable, may, at 
the State's option, use their service budgets to pay for items that 
increase a participant's independence or substitute (such as a microwave 
oven or an accessibility ramp) for human assistance, to the extent that 
expenditures would otherwise be made for the human assistance.
    (b) The services, supports and items that are purchased with a 
service budget must be linked to an assessed participant need or goal 
established in the service plan.



Sec.  441.484  Financial management services.

    (a) States may choose to provide financial management services to 
participants, or their representatives, as applicable, self-directing 
PAS, with the exception of those participants utilizing the cash option 
who directly perform those functions, utilizing a financial management 
entity, through the following arrangements:
    (1) States may use a reporting or subagent through its fiscal 
intermediary in accordance with section 3504 of the IRS Code and Revenue 
Procedure 80-4 and Notice 2003-70; or
    (2) States may use a vendor organization that has the capabilities 
to perform the required tasks in accordance with Section 3504 of the IRS 
Code and Revenue Procedure 70-6. When private entities furnish financial 
management services, the procurement method must meet the requirements 
set forth in 45 CFR 75.326 through 75.340.
    (b) States must provide oversight of financial management services 
by performing the following functions:
    (1) Monitoring and assessing the performance of financial management 
entity, including assuring the integrity of financial transactions they 
perform.
    (2) Designating a State entity or entities responsible for this 
monitoring.

[[Page 423]]

    (3) Determining how frequently financial management entity 
performance will be assessed.
    (c) A financial management entity must provide functions including, 
but not limited to, the following:
    (1) Collect and process timesheets of the participant's workers.
    (2) Process payroll, withholding, filing and payment of applicable 
Federal, State and local employment-related taxes and insurance.
    (3) Maintain a separate account for each participant's budget.
    (4) Track and report disbursements and balances of participant 
funds.
    (5) Process and pay invoices for goods and services approved in the 
service plan.
    (6) Provide to participants periodic reports of expenditures and the 
status of the approved service budget.
    (d) States not utilizing a financial management entity must perform 
the functions listed in paragraph (c) of this section on behalf of 
participants self-directing PAS, with the exception of those 
participants utilizing the cash option who directly perform those 
functions.
    (e) States will be reimbursed for the cost of financial management 
services, either provided directly or through a financial management 
entity, at the administrative rate of 50 percent.

[73 FR 57881, Oct. 3, 2008, as amended at 81 FR 3012, Jan. 20, 2016]



Subpart K_Home and Community-Based Attendant Services and Supports State 
                  Plan Option (Community First Choice)

    Source: 77 FR 26898, May 7, 2012, unless otherwise noted.



Sec.  441.500  Basis and scope.

    (a) Basis. This subpart implements section 1915(k) of the Act, 
referred to as the Community First Choice option (hereafter Community 
First Choice), to provide home and community-based attendant services 
and supports through a State plan.
    (b) Scope. Community First Choice is designed to make available home 
and community-based attendant services and supports to eligible 
individuals, as needed, to assist in accomplishing activities of daily 
living (ADLs), instrumental activities of daily living (IADLs), and 
health-related tasks through hands-on assistance, supervision, or 
cueing.



Sec.  441.505  Definitions.

    As used in this subpart:
    Activities of daily living (ADLs) means basic personal everyday 
activities including, but not limited to, tasks such as eating, 
toileting, grooming, dressing, bathing, and transferring.
    Agency-provider model means a method of providing Community First 
Choice services and supports under which entities contract for or 
provide through their own employees, the provision of such services and 
supports, or act as the employer of record for attendant care providers 
selected by the individual enrolled in Community First Choice.
    Backup systems and supports means electronic devices used to ensure 
continuity of services and supports. These items may include an array of 
available technology, personal emergency response systems, and other 
mobile communication devices. Persons identified by an individual can 
also be included as backup supports.
    Health-related tasks means specific tasks related to the needs of an 
individual, which can be delegated or assigned by licensed health-care 
professionals under State law to be performed by an attendant.
    Individual means the eligible individual and, if applicable, the 
individual's representative.
    Individual's representative means a parent, family member, guardian, 
advocate, or other person authorized by the individual to serve as a 
representative in connection with the provision of CFC services and 
supports. This authorization should be in writing, when feasible, or by 
another method that clearly indicates the individual's free choice. An 
individual's representative may not also be a paid caregiver of an 
individual receiving services and supports under this subpart.
    Instrumental activities of daily living (IADLs) means activities 
related to living independently in the community,

[[Page 424]]

including but not limited to, meal planning and preparation, managing 
finances, shopping for food, clothing, and other essential items, 
performing essential household chores, communicating by phone or other 
media, and traveling around and participating in the community.
    Other models means methods, other than an agency-provider model or 
the self-directed model with service budget, for the provision of self-
directed services and supports, as approved by CMS.
    Self-directed means a consumer controlled method of selecting and 
providing services and supports that allows the individual maximum 
control of the home and community-based attendant services and supports, 
with the individual acting as the employer of record with necessary 
supports to perform that function, or the individual having a 
significant and meaningful role in the management of a provider of 
service when the agency-provider model is utilized. Individuals exercise 
as much control as desired to select, train, supervise, schedule, 
determine duties, and dismiss the attendant care provider.
    Self-directed model with service budget means methods of providing 
self-directed services and supports using an individualized service 
budget. These methods may include the provision of vouchers, direct cash 
payments, and/or use of a fiscal agent to assist in obtaining services.



Sec.  441.510  Eligibility.

    To receive Community First Choice services and supports under this 
section, an individual must meet the following requirements:
    (a) Be eligible for medical assistance under the State plan;
    (b) As determined annually--
    (1) Be in an eligibility group under the State plan that includes 
nursing facility services; or
    (2) If in an eligibility group under the State plan that does not 
include such nursing facility services, have an income that is at or 
below 150 percent of the Federal poverty level (FPL). In determining 
whether the 150 percent of the FPL requirement is met, States must apply 
the same methodologies as would apply under their Medicaid State plan, 
including the same income disregards in accordance with section 
1902(r)(2) of the Act; and,
    (c) Receive a determination, at least annually, that in the absence 
of the home and community-based attendant services and supports provided 
under this subpart, the individual would otherwise require the level of 
care furnished in a hospital, a nursing facility, an intermediate care 
facility for individuals with intellectual disabilities, an institution 
providing psychiatric services for individuals under age 21, or an 
institution for mental diseases for individuals age 65 or over, if the 
cost could be reimbursed under the State plan. The State administering 
agency may permanently waive the annual recertification requirement for 
an individual if:
    (1) It is determined that there is no reasonable expectation of 
improvement or significant change in the individual's condition because 
of the severity of a chronic condition or the degree of impairment of 
functional capacity; and
    (2) The State administering agency, or designee, retains 
documentation of the reason for waiving the annual recertification 
requirement.
    (d) For purposes of meeting the criterion under paragraph (b) of 
this section, individuals who qualify for medical assistance under the 
special home and community-based waiver eligibility group defined at 
section 1902(a)(10)(A)(ii)(VI) of the Act must meet all section 1915(c) 
requirements and receive at least one home and community-based waiver 
service per month.
    (e) Individuals receiving services through Community First Choice 
will not be precluded from receiving other home and community-based 
long-term care services and supports through other Medicaid State plan, 
waiver, grant or demonstration authorities.



Sec.  441.515  Statewideness.

    States must provide Community First Choice to individuals:
    (a) On a statewide basis.
    (b) In a manner that provides such services and supports in the most 
integrated setting appropriate to the individual's needs, and without 
regard to

[[Page 425]]

the individual's age, type or nature of disability, severity of 
disability, or the form of home and community-based attendant services 
and supports that the individual requires to lead an independent life.



Sec.  441.520  Included services.

    (a) If a State elects to provide Community First Choice, the State 
must provide all of the following services:
    (1) Assistance with ADLs, IADLs, and health-related tasks through 
hands-on assistance, supervision, and/or cueing.
    (2) Acquisition, maintenance, and enhancement of skills necessary 
for the individual to accomplish ADLs, IADLs, and health-related tasks.
    (3) Backup systems or mechanisms to ensure continuity of services 
and supports, as defined in Sec.  441.505 of this subpart.
    (4) Voluntary training on how to select, manage and dismiss 
attendants.
    (b) At the State's option, the State may provide permissible 
services and supports that are linked to an assessed need or goal in the 
individual's person-centered service plan. Permissible services and 
supports may include, but are not limited to, the following:
    (1) Expenditures for transition costs such as rent and utility 
deposits, first month's rent and utilities, bedding, basic kitchen 
supplies, and other necessities linked to an assessed need for an 
individual to transition from a nursing facility, institution for mental 
diseases, or intermediate care facility for Individuals with 
Intellectual Disabilities to a home and community-based setting where 
the individual resides;
    (2) Expenditures relating to a need identified in an individual's 
person-centered service plan that increases an individual's independence 
or substitutes for human assistance, to the extent that expenditures 
would otherwise be made for the human assistance.



Sec.  441.525  Excluded services.

    Community First Choice may not include the following:
    (a) Room and board costs for the individual, except for allowable 
transition services described in Sec.  441.520(b)(1) of this subpart.
    (b) Special education and related services provided under the 
Individuals with Disabilities Education Act that are related to 
education only, and vocational rehabilitation services provided under 
the Rehabilitation Act of 1973.
    (c) Assistive devices and assistive technology services, other than 
those defined in Sec.  441.520(a)(3) of this subpart, or those that meet 
the requirements at Sec.  441.520(b)(2) of this subpart.
    (d) Medical supplies and medical equipment, other than those that 
meet the requirements at Sec.  441.520(b)(2) of this subpart.
    (e) Home modifications, other than those that meet the requirements 
at Sec.  441.520(b) of this subpart.



Sec.  441.530  Home and Community-Based Setting.

    (a) States must make available attendant services and supports in a 
home and community-based setting consistent with both paragraphs (a)(1) 
and (a)(2) of this section.
    (1) Home and community-based settings must have all of the following 
qualities, and such other qualities as the Secretary determines to be 
appropriate, based on the needs of the individual as indicated in their 
person-centered service plan:
    (i) The setting is integrated in and supports full access of 
individuals receiving Medicaid HCBS to the greater community, including 
opportunities to seek employment and work in competitive integrated 
settings, engage in community life, control personal resources, and 
receive services in the community, to the same degree of access as 
individuals not receiving Medicaid HCBS.
    (ii) The setting is selected by the individual from among setting 
options, including non-disability specific settings and an option for a 
private unit in a residential setting. The setting options are 
identified and documented in the person-centered service plan and are 
based on the individual's needs, preferences, and, for residential 
settings, resources available for room and board.
    (iii) Ensures an individual's rights of privacy, dignity and 
respect, and freedom from coercion and restraint.
    (iv) Optimizes but does not regiment individual initiative, 
autonomy, and

[[Page 426]]

independence in making life choices, including but not limited to, daily 
activities, physical environment, and with whom to interact.
    (v) Facilitates individual choice regarding services and supports, 
and who provides them.
    (vi) In a provider-owned or controlled residential setting, in 
addition to the above qualities at paragraphs (a)(1)(i) through (v) of 
this section, the following additional conditions must be met:
    (A) The unit or dwelling is a specific physical place that can be 
owned, rented or occupied under a legally enforceable agreement by the 
individual receiving services, and the individual has, at a minimum, the 
same responsibilities and protections from eviction that tenants have 
under the landlord tenant law of the State, county, city or other 
designated entity. For settings in which landlord tenant laws do not 
apply, the State must ensure that a lease, residency agreement or other 
form of written agreement will be in place for each participant and that 
the document provides protections that address eviction processes and 
appeals comparable to those provided under the jurisdiction's landlord 
tenant law.
    (B) Each individual has privacy in their sleeping or living unit:
    (1) Units have entrance doors lockable by the individual, with only 
appropriate staff having keys to doors as needed.
    (2) Individuals sharing units have a choice of roommates in that 
setting.
    (3) Individuals have the freedom to furnish and decorate their 
sleeping or living units within the lease or other agreement.
    (C) Individuals have the freedom and support to control their own 
schedules and activities, and have access to food at any time.
    (D) Individuals are able to have visitors of their choosing at any 
time.
    (E) The setting is physically accessible to the individual.
    (F) Any modification of the additional conditions, under paragraphs 
(a)(1)(vi)(A) through (D) of this section, must be supported by a 
specific assessed need and justified in the person-centered service 
plan. The following requirements must be documented in the person-
centered service plan:
    (1) Identify a specific and individualized assessed need.
    (2) Document the positive interventions and supports used prior to 
any modifications to the person-centered service plan.
    (3) Document less intrusive methods of meeting the need that have 
been tried but did not work.
    (4) Include a clear description of the condition that is directly 
proportionate to the specific assessed need.
    (5) Include regulation collection and review of data to measure the 
ongoing effectiveness of the modification.
    (6) Include established time limits for periodic reviews to 
determine if the modification is still necessary or can be terminated.
    (7) Include the informed consent of the individual.
    (8) Include an assurance that interventions and supports will cause 
no harm to the individual.
    (2) Home and community-based settings do not include the following:
    (i) A nursing facility;
    (ii) An institution for mental diseases;
    (iii) An intermediate care facility for individuals with 
intellectual disabilities;
    (iv) A hospital providing long-term care services; or
    (v) Any other locations that have qualities of an institutional 
setting, as determined by the Secretary. Any setting that is located in 
a building that is also a publicly or privately operated facility that 
provides inpatient institutional treatment, or in a building on the 
grounds of, or immediately adjacent to, a public institution, or any 
other setting that has the effect of isolating individuals receiving 
Medicaid HCBS from the broader community of individuals not receiving 
Medicaid HCBS will be presumed to be a setting that has the qualities of 
an institution unless the Secretary determines through heightened 
scrutiny, based on information presented by the State or other parties, 
that the setting does not have the qualities of an institution and that 
the setting does have the qualities of home and community-based 
settings.

[[Page 427]]

    (b) [Reserved]

[79 FR 3032, Jan. 16, 2014]



Sec.  441.535  Assessment of functional need.

    States must conduct a face-to-face assessment of the individual's 
needs, strengths, preferences, and goals for the services and supports 
provided under Community First Choice in accordance with the following:
    (a) States may use one or more processes and techniques to obtain 
information, including telemedicine, or other information technology 
medium, in lieu of a face-to-face assessment if the following conditions 
apply:
    (1) The health care professional(s) performing the assessment meet 
the provider qualifications defined by the State, including any 
additional qualifications or training requirements for the operation of 
required information technology;
    (2) The individual receives appropriate support during the 
assessment, including the use of any necessary on-site support-staff; 
and
    (3) The individual is provided the opportunity for an in-person 
assessment in lieu of one performed via telemedicine.
    (b) Assessment information supports the determination that an 
individual requires Community First Choice and also supports the 
development of the person-centered service plan and, if applicable, 
service budget.
    (c) The assessment of functional need must be conducted at least 
every 12 months, as needed when the individual's support needs or 
circumstances change significantly necessitating revisions to the 
person-centered service plan, and at the request of the individual.
    (d) Other requirements as determined by the Secretary.



Sec.  441.540  Person-centered service plan.

    (a) Person-centered planning process. The person-centered planning 
process is driven by the individual. The process--
    (1) Includes people chosen by the individual.
    (2) Provides necessary information and support to ensure that the 
individual directs the process to the maximum extent possible, and is 
enabled to make informed choices and decisions.
    (3) Is timely and occurs at times and locations of convenience to 
the individual.
    (4) Reflects cultural considerations of the individual.
    (5) Includes strategies for solving conflict or disagreement within 
the process, including clear conflict-of-interest guidelines for all 
planning participants.
    (6) Offers choices to the individual regarding the services and 
supports they receive and from whom.
    (7) Includes a method for the individual to request updates to the 
plan.
    (8) Records the alternative home and community-based settings that 
were considered by the individual.
    (b) The person-centered service plan. The person-centered service 
plan must reflect the services and supports that are important for the 
individual to meet the needs identified through an assessment of 
functional need, as well as what is important to the individual with 
regard to preferences for the delivery of such services and supports. 
Commensurate with the level of need of the individual, and the scope of 
services and supports available under Community First Choice, the plan 
must:
    (1) Reflect that the setting in which the individual resides is 
chosen by the individual.
    (2) Reflect the individual's strengths and preferences.
    (3) Reflect clinical and support needs as identified through an 
assessment of functional need.
    (4) Include individually identified goals and desired outcomes.
    (5) Reflect the services and supports (paid and unpaid) that will 
assist the individual to achieve identified goals, and the providers of 
those services and supports, including natural supports. Natural 
supports cannot supplant needed paid services unless the natural 
supports are unpaid supports that are provided voluntarily to the 
individual in lieu of an attendant.
    (6) Reflect risk factors and measures in place to minimize them, 
including individualized backup plans.
    (7) Be understandable to the individual receiving services and 
supports,

[[Page 428]]

and the individuals important in supporting him or her.
    (8) Identify the individual and/or entity responsible for monitoring 
the plan.
    (9) Be finalized and agreed to in writing by the individual and 
signed by all individuals and providers responsible for its 
implementation.
    (10) Be distributed to the individual and other people involved in 
the plan.
    (11) Incorporate the service plan requirements for the self-directed 
model with service budget at Sec.  441.550, when applicable.
    (12) Prevent the provision of unnecessary or inappropriate care.
    (13) Other requirements as determined by the Secretary.
    (c) Reviewing the person-centered service plan. The person-centered 
service plan must be reviewed, and revised upon reassessment of 
functional need, at least every 12 months, when the individual's 
circumstances or needs change significantly, and at the request of the 
individual.



Sec.  441.545  Service models.

    A State may choose one or more of the following as the service 
delivery model to provide self-directed home and community-based 
attendant services and supports:
    (a) Agency-provider model. (1) The agency-provider model is a 
delivery method in which the services and supports are provided by 
entities, under a contract or provider agreement with the State Medicaid 
agency or delegated entity to provide services. Under this model, the 
entity either provides the services directly through their employees or 
arranges for the provision of services under the direction of the 
individual receiving services.
    (2) Under the agency-provider model for Community First Choice, 
individuals maintain the ability to have a significant role in the 
selection and dismissal of the providers of their choice, for the 
delivery of their specific care, and for the services and supports 
identified in their person-centered service plan.
    (b) Self-directed model with service budget. A self-directed model 
with a service budget is one in which the individual has both a person-
centered service plan and a service budget based on the assessment of 
functional need.
    (1) Financial management entity. States must make available 
financial management activities to all individuals with a service 
budget. The financial management entity performs functions including, 
but not limited to, the following activities:
    (i) Collect and process timesheets of the individual's attendant 
care providers.
    (ii) Process payroll, withholding, filing, and payment of applicable 
Federal, State, and local employment related taxes and insurance.
    (iii) Separately track budget funds and expenditures for each 
individual.
    (iv) Track and report disbursements and balances of each 
individual's funds.
    (v) Process and pay invoices for services in the person-centered 
service plan.
    (vi) Provide individual periodic reports of expenditures and the 
status of the approved service budget to the individual and to the 
State.
    (vii) States may perform the functions of a financial management 
entity internally or use a vendor organization that has the capabilities 
to perform the required tasks in accordance with all applicable 
requirements of the Internal Revenue Service.
    (2) Direct cash. States may disburse cash prospectively to 
individuals self-directing their Community First Choice services and 
supports, and must meet the following requirements:
    (i) Ensure compliance with all applicable requirements of the 
Internal Revenue Service, and State employment and taxation authorities, 
including but not limited to, retaining required forms and payment of 
FICA, FUTA and State unemployment taxes.
    (ii) Permit individuals using the cash option to choose to use the 
financial management entity for some or all of the functions described 
in paragraph (b)(1)(ii) of this section.
    (iii) Make available a financial management entity to an individual 
who has demonstrated, after additional counseling, information, 
training, or assistance that the individual cannot effectively manage 
the cash option described in this section.

[[Page 429]]

    (iv) The State may require an individual to use a financial 
management entity, but must provide the individual with the conditions 
under which this option would be enforced.
    (3) Vouchers. States have the option to issue vouchers to 
individuals who self-direct their Community First Choice services and 
supports as long as the requirements in paragraphs (b)(2)(i) through 
(iv) of this paragraph are met.
    (c) Other service delivery models. States have the option of 
proposing other service delivery models. Such models are defined by the 
State and approved by CMS.



Sec.  441.550  Service plan requirements for self-directed model with 
service budget.

    The person-centered service plan under the self-directed model with 
service budget conveys authority to the individual to perform, at a 
minimum, the following tasks:
    (a) Recruit and hire or select attendant care providers to provide 
self-directed Community First Choice services and supports, including 
specifying attendant care provider qualifications.
    (b) Dismiss specific attendant care providers of Community First 
Choice services and supports.
    (c) Supervise attendant care providers in the provision of Community 
First Choice services and supports.
    (d) Manage attendant care providers in the provision of Community 
First Choice services and supports, which includes the following 
functions:
    (1) Determining attendant care provider duties.
    (2) Scheduling attendant care providers.
    (3) Training attendant care providers in assigned tasks.
    (4) Evaluating attendant care providers' performance.
    (e) Determining the amount paid for a service, support, or item, in 
accordance with State and Federal compensation requirements.
    (f) Reviewing and approving provider payment requests.



Sec.  441.555  Support system.

    For each service delivery model available, States must provide, or 
arrange for the provision of, a support system that meets all of the 
following conditions:
    (a) Appropriately assesses and counsels an individual before 
enrollment.
    (b) Provides appropriate information, counseling, training, and 
assistance to ensure that an individual is able to manage the services 
and budgets if applicable.
    (1) This information must be communicated to the individual in a 
manner and language understandable by the individual. To ensure that the 
information is communicated in an accessible manner, information should 
be communicated in plain language and needed auxiliary aids and services 
should be provided.
    (2) The support activities must include at least the following:
    (i) Person-centered planning and how it is applied.
    (ii) Range and scope of individual choices and options.
    (iii) Process for changing the person-centered service plan and, if 
applicable, service budget.
    (iv) Grievance process.
    (v) Information on the risks and responsibilities of self-direction.
    (vi) The ability to freely choose from available home and community-
based attendant providers, available service delivery models and if 
applicable, financial management entities.
    (vii) Individual rights, including appeal rights.
    (viii) Reassessment and review schedules.
    (ix) Defining goals, needs, and preferences of Community First 
Choice services and supports.
    (x) Identifying and accessing services, supports, and resources.
    (xi) Development of risk management agreements.
    (A) The State must specify in the State Plan amendment any tools or 
instruments used to mitigate identified risks.
    (B) States utilizing criminal or background checks as part of their 
risk management agreement will bear the costs of such activities.
    (xii) Development of a personalized backup plan.
    (xiii) Recognizing and reporting critical events.

[[Page 430]]

    (xiv) Information about an advocate or advocacy systems available in 
the State and how an individual can access the advocate or advocacy 
systems.
    (c) Establishes conflict of interest standards for the assessments 
of functional need and the person-centered service plan development 
process that apply to all individuals and entities, public or private. 
At a minimum, these standards must ensure that the individuals or 
entities conducting the assessment of functional need and person-
centered service plan development process are not:
    (1) Related by blood or marriage to the individual, or to any paid 
caregiver of the individual.
    (2) Financially responsible for the individual.
    (3) Empowered to make financial or health-related decisions on 
behalf of the individual.
    (4) Individuals who would benefit financially from the provision of 
assessed needs and services.
    (5) Providers of State plan HCBS for the individual, or those who 
have an interest in or are employed by a provider of State plan HCBS for 
the individual, except when the State demonstrates that the only willing 
and qualified entity/entities to perform assessments of functional need 
and develop person-centered service plans in a geographic area also 
provides HCBS, and the State devises conflict of interest protections 
including separation of assessment/planning and HCBS provider functions 
within provider entities, which are described in the State plan, and 
individuals are provided with a clear and accessible alternative dispute 
resolution process.
    (d) Ensures the responsibilities for assessment of functional need 
and person-centered service plan development are identified.



Sec.  441.560  Service budget requirements.

    (a) For the self-directed model with a service budget, a service 
budget must be developed and approved by the State based on the 
assessment of functional need and person-centered service plan and must 
include all of the following requirements:
    (1) The specific dollar amount an individual may use for Community 
First Choice services and supports.
    (2) The procedures for informing an individual of the amount of the 
service budget before the person-centered service plan is finalized.
    (3) The procedures for how an individual may adjust the budget 
including the following:
    (i) The procedures for an individual to freely adjust amounts 
allocated to specific services and supports within the approved service 
budget.
    (ii) The circumstances, if any, that may require prior approval by 
the State before a budget adjustment is made.
    (4) The circumstances, if any, that may require a change in the 
person-centered service plan.
    (5) The procedures that govern the determination of transition costs 
and other permissible services and supports as defined at Sec.  
441.520(b).
    (6) The procedures for an individual to request a fair hearing under 
Subpart E of this title if an individual's request for a budget 
adjustment is denied or the amount of the budget is reduced.
    (b) The budget methodology set forth by the State to determine an 
individual's service budget amount must:
    (1) Be objective and evidence-based utilizing valid, reliable cost 
data.
    (2) Be applied consistently to individuals.
    (3) Be included in the State plan.
    (4) Include a calculation of the expected cost of Community First 
Choice services and supports, if those services and supports are not 
self-directed.
    (5) Have a process in place that describes the following:
    (i) Any limits the State places on Community First Choice services 
and supports, and the basis for the limits.
    (ii) Any adjustments that are allowed and the basis for the 
adjustments.
    (c) The State must have procedures in place that will provide 
safeguards to individuals when the budgeted service amount is 
insufficient to meet the individual's needs.
    (d) The State must have a method of notifying individuals of the 
amount of any limit that applies to an individual's Community First 
Choice services

[[Page 431]]

and supports. Notice must be communicated in an accessible format, 
communicated in plain language, and needed auxiliary aids and services 
should be provided.
    (e) The budget may not restrict access to other medically necessary 
care and services furnished under the State plan and approved by the 
State but which are not included in the budget.
    (f) The State must have a procedure to adjust a budget when a 
reassessment indicates a change in an individual's medical condition, 
functional status, or living situation.



Sec.  441.565  Provider qualifications.

    (a) For all service delivery models:
    (1) An individual retains the right to train attendant care 
providers in the specific areas of attendant care needed by the 
individual, and to have the attendant care provider perform the needed 
assistance in a manner that comports with the individual's personal, 
cultural, and/or religious preferences.
    (2) An individual retains the right to establish additional staff 
qualifications based on the individual's needs and preferences.
    (3) Individuals also have the right to access other training 
provided by or through the State so that their attendant care 
provider(s) can meet any additional qualifications required or desired 
by individuals.
    (b) For the agency-provider model, the State must define in writing 
adequate qualifications for providers in the agency model of Community 
First Choice services and supports.
    (c) For the self-directed model with service budget, an individual 
has the option to permit family members, or any other individuals, to 
provide Community First Choice services and supports identified in the 
person-centered service plan, provided they meet the qualifications to 
provide the services and supports established by the individual, 
including additional training.
    (d) For other models, the applicability of requirements at 
paragraphs (b) or (c) of this section will be determined based on the 
description and approval of the model.



Sec.  441.570  State assurances.

    A State must assure the following requirements are met:
    (a) Necessary safeguards have been taken to protect the health and 
welfare of enrollees in Community First Choice, including adherence to 
section 1903(i) of the Act that Medicaid payment shall not be made for 
items or services furnished by individuals or entities excluded from 
participating in the Medicaid Program.
    (b) For the first full 12 month period in which the State plan 
amendment is implemented, the State must maintain or exceed the level of 
State expenditures for home and community-based attendant services and 
supports provided under sections 1115, 1905(a), 1915, or otherwise under 
the Act, to individuals with disabilities or elderly individuals 
attributable to the preceding 12 month period.
    (c) All applicable provisions of the Fair Labor Standards Act of 
1938.
    (d) All applicable provisions of Federal and State laws regarding 
the following:
    (1) Withholding and payment of Federal and State income and payroll 
taxes.
    (2) The provision of unemployment and workers compensation 
insurance.
    (3) Maintenance of general liability insurance.
    (4) Occupational health and safety.
    (5) Any other employment or tax related requirements.



Sec.  441.575  Development and Implementation Council.

    (a) States must establish a Development and Implementation Council, 
the majority of which is comprised of individuals with disabilities, 
elderly individuals, and their representatives.
    (b) States must consult and collaborate with the Council when 
developing and implementing a State plan amendment to provide Community 
First Choice services and supports.



Sec.  441.580  Data collection.

    A State must provide the following information regarding the 
provision of home and community-based attendant

[[Page 432]]

services and supports under Community First Choice for each Federal 
fiscal year for which the services and supports are provided:
    (a) The number of individuals who are estimated to receive Community 
First Choice services and supports under this State plan option during 
the Federal fiscal year.
    (b) The number of individuals who received the services and supports 
during the preceding Federal fiscal year.
    (c) The number of individuals served broken down by type of 
disability, age, gender, education level, and employment status.
    (d) The specific number of individuals who have been previously 
served under sections 1115, 1915(c) and (i) of the Act, or the personal 
care State plan option.
    (e) Data regarding how the State provides Community First Choice and 
other home and community-based services.
    (f) The cost of providing Community First Choice and other home and 
community-based services and supports.
    (g) Data regarding how the State provides individuals with 
disabilities who otherwise qualify for institutional care under the 
State plan or under a waiver the choice to receive home and community-
based services in lieu of institutional care.
    (h) Data regarding the impact of Community First Choice services and 
supports on the physical and emotional health of individuals.
    (i) Other data as determined by the Secretary.



Sec.  441.585  Quality assurance system.

    (a) States must establish and maintain a comprehensive, continuous 
quality assurance system, described in the State plan amendment, which 
includes the following:
    (1) A quality improvement strategy.
    (2) Methods to continuously monitor the health and welfare of each 
individual who receives home and community-based attendant services and 
supports, including a process for the mandatory reporting, 
investigation, and resolution of allegations of neglect, abuse, or 
exploitation in connection with the provision of such services and 
supports.
    (3) Measures individual outcomes associated with the receipt of home 
and community-based attendant services and supports as set forth in the 
person centered service plan, particularly for the health and welfare of 
individuals receiving such services and supports. These measures must be 
reported to CMS upon request.
    (4) Standards for all service delivery models for training, appeals 
for denials and reconsideration procedures for an individual's person-
centered service plan.
    (5) Other requirements as determined by the Secretary.
    (b) The State must ensure the quality assurance system will employ 
methods that maximizes individual independence and control, and provides 
information about the provisions of quality improvement and assurance to 
each individual receiving such services and supports.
    (c) The State must elicit and incorporate feedback from individuals 
and their representatives, disability organizations, providers, families 
of disabled or elderly individuals, members of the community and others 
to improve the quality of the community-based attendant services and 
supports benefit.



Sec.  441.590  Increased Federal financial participation.

    Beginning October 1, 2011, the FMAP applicable to the State will be 
increased by 6 percentage points, for the provision of Community First 
Choice services and supports, under an approved State plan amendment.



                 Subpart L_Vaccines for Children Program

    Source: 77 FR 66700, Nov. 6, 2012, unless otherwise noted.



Sec.  441.600  Basis and purpose.

    This subpart implements sections 1902(a)(62) and 1928 of the Act by 
requiring states to provide for a program for the purchase and 
distribution of pediatric vaccines to program-registered providers for 
the immunization of vaccine-eligible children.

[[Page 433]]



Sec.  441.605  General requirements.

    (a) Federally-purchased vaccines under the VFC Program are made 
available to children who are 18 years of age or younger and who are any 
of the following:
    (1) Eligible for Medicaid.
    (2) Not insured.
    (3) Not insured with respect to the vaccine and who are administered 
pediatric vaccines by a federally qualified health center (FQHC) or 
rural health clinic.
    (4) An Indian, as defined in section 4 of the Indian Health Care 
Improvement Act.
    (b) Under the VFC program, vaccines must be administered by program-
registered providers. Section 1928(c) of the Act defines a program-
registered provider as any health care provider that meets the following 
requirements:
    (1) Is licensed or authorized to administer pediatric vaccines under 
the law of the state in which the administration occurs without regard 
to whether or not the provider is a Medicaid-participating provider.
    (2) Submits to the state an executed provider agreement in the form 
and manner specified by the Secretary.
    (3) Has not been found, by the Secretary or the state to have 
violated the provider agreement or other applicable requirements 
established by the Secretary or the state.



Sec.  441.610  State plan requirements.

    A state plan must provide that the Medicaid agency meets the 
requirements of this part.



Sec.  441.615  Administration fee requirements.

    (a) Under the VFC Program, a provider who administers a qualified 
pediatric vaccine to a federally vaccine-eligible child, may not impose 
a charge for the cost of the vaccine.
    (1) A provider can impose a fee for the administration of a 
qualified pediatric vaccine as long as the fee does not exceed the costs 
of the administration (as determined by the Secretary based on actual 
regional costs for the administration).
    (2) A provider may not deny administration of a qualified pediatric 
vaccine to a vaccine-eligible child due to the inability of the child's 
parents or legal guardian to pay the administration fee.
    (b) The Secretary must publish each State's regional maximum charge 
for the VFC program, which represents the maximum amount that a provider 
in a state could charge for the administration of qualified pediatric 
vaccines to federally vaccine-eligible children under the VFC program.
    (c) An interim formula has been established for the calculation of a 
state's regional maximum administration fee. That formula is as follows: 
National charge data x updated geographic adjustment factors (GAFs) = 
maximum VFC fee.
    (d) The State Medicaid Agency must submit a state plan amendment 
that identifies the amount that the state will pay providers for the 
administration of a qualified pediatric vaccine to a Medicaid-eligible 
child under the VFC program. The amount identified by the state cannot 
exceed the state's regional maximum administration fee.
    (e) Physicians participating in the VFC program can charge federally 
vaccine-eligible children who are not enrolled in Medicaid the maximum 
administration fee (if that fee reflects the provider's cost of 
administration) regardless of whether the state has established a lower 
administration fee under the Medicaid program. However, there would be 
no federal Medicaid matching funds available for the administration 
since these children are not eligible for Medicaid.



 Subpart M_State Plan Home and Community-Based Services for the Elderly 
                    and Individuals with Disabilities

    Source: 79 FR 3033, Jan. 16, 2014, unless otherwise noted.



Sec.  441.700  Basis and purpose.

    Section 1915(i) of the Act permits States to offer one or more home 
and community-based services (HCBS) under their State Medicaid plans to 
qualified individuals with disabilities or individuals who are elderly. 
Those services are listed in Sec.  440.182 of this chapter, and are 
described by the State, including any limitations of the

[[Page 434]]

services. This optional benefit is known as the State plan HCBS benefit. 
This subpart describes what a State Medicaid plan must provide when the 
State elects to include the optional benefit, and defines State 
responsibilities.



Sec.  441.705  State plan requirements.

    A State plan that provides section 1915(i) of the Act State plan 
home and community-based services must meet the requirements of this 
subpart.



Sec.  441.710  State plan home and community-based services under 
section 1915(i)(1) of the Act.

    (a) Home and Community-Based Setting. States must make State plan 
HCBS available in a home and community-based setting consistent with 
both paragraphs (a)(1) and (a)(2) of this section.
    (1) Home and community-based settings must have all of the following 
qualities, and such other qualities as the Secretary determines to be 
appropriate, based on the needs of the individual as indicated in their 
person-centered service plan:
    (i) The setting is integrated in and supports full access of 
individuals receiving Medicaid HCBS to the greater community, including 
opportunities to seek employment and work in competitive integrated 
settings, engage in community life, control personal resources, and 
receive services in the community, to the same degree of access as 
individuals not receiving Medicaid HCBS.
    (ii) The setting is selected by the individual from among setting 
options, including non-disability specific settings and an option for a 
private unit in a residential setting. The setting options are 
identified and documented in the person-centered service plan and are 
based on the individual's needs, preferences, and, for residential 
settings, resources available for room and board.
    (iii) Ensures an individual's rights of privacy, dignity and 
respect, and freedom from coercion and restraint.
    (iv) Optimizes, but does not regiment, individual initiative, 
autonomy, and independence in making life choices, including but not 
limited to, daily activities, physical environment, and with whom to 
interact.
    (v) Facilitates individual choice regarding services and supports, 
and who provides them.
    (vi) In a provider-owned or controlled residential setting, in 
addition to the above qualities at paragraphs (a)(1)(i) through (v) of 
this section, the following additional conditions must be met:
    (A) The unit or dwelling is a specific physical place that can be 
owned, rented, or occupied under a legally enforceable agreement by the 
individual receiving services, and the individual has, at a minimum, the 
same responsibilities and protections from eviction that tenants have 
under the landlord/tenant law of the state, county, city, or other 
designated entity. For settings in which landlord tenant laws do not 
apply, the State must ensure that a lease, residency agreement or other 
form of written agreement will be in place for each HCBS participant and 
that the document provides protections that address eviction processes 
and appeals comparable to those provided under the jurisdiction's 
landlord tenant law;
    (B) Each individual has privacy in their sleeping or living unit:
    (1) Units have entrance doors lockable by the individual, with only 
appropriate staff having keys to doors;
    (2) Individuals sharing units have a choice of roommates in that 
setting; and
    (3) Individuals have the freedom to furnish and decorate their 
sleeping or living units within the lease or other agreement.
    (C) Individuals have the freedom and support to control their own 
schedules and activities, and have access to food at any time;
    (D) Individuals are able to have visitors of their choosing at any 
time;
    (E) The setting is physically accessible to the individual; and
    (F) Any modification of the additional conditions, under paragraphs 
(a)(1)(vi)(A) through (D) of this section, must be supported by a 
specific assessed need and justified in the person-centered service 
plan. The following requirements must be documented in the person-
centered service plan:

[[Page 435]]

    (1) Identify a specific and individualized assessed need.
    (2) Document the positive interventions and supports used prior to 
any modifications to the person-centered service plan.
    (3) Document less intrusive methods of meeting the need that have 
been tried but did not work.
    (4) Include a clear description of the condition that is directly 
proportionate to the specific assessed need.
    (5) Include regular collection and review of data to measure the 
ongoing effectiveness of the modification.
    (6) Include established time limits for periodic reviews to 
determine if the modification is still necessary or can be terminated.
    (7) Include the informed consent of the individual.
    (8) Include an assurance that interventions and supports will cause 
no harm to the individual.
    (2) Home and community-based settings do not include the following:
    (i) A nursing facility.
    (ii) An institution for mental diseases.
    (iii) An intermediate care facility for individuals with 
intellectual disabilities.
    (iv) A hospital.
    (v) Any other locations that have qualities of an institutional 
setting, as determined by the Secretary. Any setting that is located in 
a building that is also a publicly or privately operated facility that 
provides inpatient institutional treatment, or in a building on the 
grounds of, or immediately adjacent to, a public institution, or any 
other setting that has the effect of isolating individuals receiving 
Medicaid HCBS from the broader community of individuals not receiving 
Medicaid HCBS will be presumed to be a setting that has the qualities of 
an institution unless the Secretary determines through heightened 
scrutiny, based on information presented by the State or other parties, 
that the setting does not have the qualities of an institution and that 
the setting does have the qualities of home and community-based 
settings.
    (3) Compliance and transition:
    (i) States submitting state plan amendments for new section 1915(i) 
of the Act benefits must provide assurances of compliance with the 
requirements of this section for home and community-based settings as of 
the effective date of the state plan amendment;
    (ii) CMS will require transition plans for existing section 1915(c) 
waivers and approved state plans providing home and community-based 
services under section 1915(i) to achieve compliance with this section, 
as follows:
    (A) For each approved section 1915(i) of the Act benefit subject to 
renewal or submitted for amendment within one year after the effective 
date of this regulation, the State must submit a transition plan at the 
time of the renewal or amendment request that sets forth the actions the 
State will take to bring the specific 1915(i) State plan benefit into 
compliance with this section. The approval will be contingent on the 
inclusion of the transition plan approved by CMS. The transition plan 
must include all elements required by the Secretary; and within one 
hundred and twenty days of the submission of the first renewal or 
amendment request the State must submit a transition plan detailing how 
the State will operate all section 1915(c) HCBS waivers and any section 
1915(i) State plan benefit in accordance with this section. The 
transition plan must include all elements including timelines and 
deliverables as approved by the Secretary.
    (B) For States that do not have a section 1915(c) waiver or a 
section 1915(i) State plan benefit due for renewal or proposed for 
amendments within one year of the effective date of this regulation, the 
State must submit a transition plan detailing how the State will operate 
all section 1915(c) waivers and any section 1915(i) State plan benefit 
in accordance with this section. This plan must be submitted no later 
than one year after the effective date of this regulation. The 
transition plan must include all elements including timelines and 
deliverables as approved by the Secretary.
    (iii) A State must provide at least a 30-day public notice and 
comment period regarding the transition plan(s) that the State intends 
to submit to

[[Page 436]]

CMS for review and consideration, as follows:
    (A) The State must at a minimum provide two (2) statements of public 
notice and public input procedures.
    (B) The State must ensure the full transition plan(s) is available 
to the public for public comment.
    (C) The State must consider and modify the transition plan, as the 
State deems appropriate, to account for public comment.
    (iv) A State must submit to CMS, with the proposed transition plan:
    (A) Evidence of the public notice required.
    (B) A summary of the comments received during the public notice 
period, reasons why comments were not adopted, and any modifications to 
the transition plan based upon those comments.
    (v) Upon approval by CMS, the State will begin implementation of the 
transition plans. The State's failure to submit an approvable transition 
plan as required by this section and/or to comply with the terms of the 
approved transition plan may result in compliance actions, including but 
not limited to deferral/disallowance of Federal Financial Participation.
    (b) Needs-Based Eligibility Requirement. Meet needs-based criteria 
for eligibility for the State plan HCBS benefit, as required in Sec.  
441.715(a).
    (c) Minimum State plan HCBS Requirement. Be assessed to require at 
least one section 1915(i) home and community-based service at a 
frequency determined by the State, as required in Sec.  441.720(a)(5).
    (d) Target Population. Meet any applicable targeting criteria 
defined by the State under the authority of paragraph (e)(2) of this 
section.
    (e) Nonapplication. The State may elect in the State plan amendment 
approved under this subpart not to apply the following requirements when 
determining eligibility:
    (1) Section 1902(a)(10)(C)(i)(III) of the Act, pertaining to income 
and resource eligibility rules for the medically needy living in the 
community, but only for the purposes of providing State plan HCBS.
    (2) Section 1902(a)(10)(B) of the Act, pertaining to comparability 
of Medicaid services, but only for the purposes of providing section 
1915(i) State plan HCBS. In the event that a State elects not to apply 
comparability requirements:
    (i) The State must describe the group(s) receiving State plan HCBS, 
subject to the Secretary's approval. Targeting criteria cannot have the 
impact of limiting the pool of qualified providers from which an 
individual would receive services, or have the impact of requiring an 
individual to receive services from the same entity from which they 
purchase their housing. These groups must be defined on the basis of any 
combination of the following:
    (A) Age.
    (B) Diagnosis.
    (C) Disability.
    (D) Medicaid Eligibility Group.
    (ii) The State may elect in the State plan amendment to limit the 
availability of specific services defined under the authority of Sec.  
440.182(c) of this chapter or to vary the amount, duration, or scope of 
those services, to one or more of the group(s) described in this 
paragraph.



Sec.  441.715  Needs-based criteria and evaluation.

    (a) Needs-based criteria. The State must establish needs-based 
criteria for determining an individual's eligibility under the State 
plan for the HCBS benefit, and may establish needs-based criteria for 
each specific service. Needs-based criteria are factors used to 
determine an individual's requirements for support, and may include risk 
factors. The criteria are not characteristics that describe the 
individual or the individual's condition. A diagnosis is not a 
sufficient factor on which to base a determination of need. A criterion 
can be considered needs-based if it is a factor that can only be 
ascertained for a given person through an individualized evaluation of 
need.
    (b) More stringent institutional and waiver needs-based criteria. 
The State plan HCBS benefit is available only if the State has in effect 
needs-based criteria (as defined in paragraph (a) of this section), for 
receipt of services in nursing facilities as defined in section

[[Page 437]]

1919(a) of the Act, intermediate care facilities for individuals with 
intellectual disabilities as defined in Sec.  440.150 of this chapter, 
and hospitals as defined in Sec.  440.10 of this chapter for which the 
State has established long-term level of care (LOC) criteria, or waivers 
offering HCBS, and these needs-based criteria are more stringent than 
the needs-based criteria for the State plan HCBS benefit. If the State 
defines needs-based criteria for individual State plan home and 
community-based services, it may not have the effect of limiting who can 
benefit from the State plan HCBS in an unreasonable way, as determined 
by the Secretary.
    (1) These more stringent criteria must meet the following 
requirements:
    (i) Be included in the LOC determination process for each 
institutional service and waiver.
    (ii) Be submitted for inspection by CMS with the State plan 
amendment that establishes the State Plan HCBS benefit.
    (iii) Be in effect on or before the effective date of the State plan 
HCBS benefit.
    (2) In the event that the State modifies institutional LOC criteria 
to meet the requirements under paragraph (b) or (c)(6) of this section 
that such criteria be more stringent than the State plan HCBS needs-
based eligibility criteria, States may continue to receive FFP for 
individuals receiving institutional services or waiver HCBS under the 
LOC criteria previously in effect.
    (c) Adjustment authority. The State may modify the needs-based 
criteria established under paragraph (a) of this section, without prior 
approval from the Secretary, if the number of individuals enrolled in 
the State plan HCBS benefit exceeds the projected number submitted 
annually to CMS. The Secretary may approve a retroactive effective date 
for the State plan amendment modifying the criteria, as early as the day 
following the notification period required under paragraph (c)(1) of 
this section, if all of the following conditions are met:
    (1) The State provides at least 60 days notice of the proposed 
modification to the Secretary, the public, and each individual enrolled 
in the State plan HCBS benefit.
    (2) The State notice to the Secretary is submitted as an amendment 
to the State plan.
    (3) The adjusted needs-based eligibility criteria for the State plan 
HCBS benefit are less stringent than needs-based institutional and 
waiver LOC criteria in effect after the adjustment.
    (4) Individuals who were found eligible for the State plan HCBS 
benefit before modification of the needs-based criteria under this 
adjustment authority must remain eligible for the HCBS benefit until 
such time as:
    (i) The individual no longer meets the needs-based criteria used for 
the initial determination of eligibility; or
    (ii) The individual is no longer eligible for or enrolled in 
Medicaid or the HCBS benefit.
    (5) Any changes in service due to the modification of needs-based 
criteria under this adjustment authority are treated as actions as 
defined in Sec.  431.201 of this chapter and are subject to the 
requirements of part 431, subpart E of this chapter.
    (6) In the event that the State also needs to modify institutional 
level of care criteria to meet the requirements under paragraph (b) of 
this section that such criteria be more stringent than the State plan 
HCBS needs-based eligibility criteria, the State may adjust the modified 
institutional LOC criteria under this adjustment authority. The adjusted 
institutional LOC criteria must be at least as stringent as those in 
effect before they were modified to meet the requirements in paragraph 
(b) of this section.
    (d) Independent evaluation and determination of eligibility. 
Eligibility for the State plan HCBS benefit must be determined through 
an independent evaluation of each individual according to the 
requirements of this subpart. The independent evaluation complies with 
the following requirements:
    (1) Is performed by an agent that is independent and qualified as 
defined in Sec.  441.730.
    (2) Applies the needs-based eligibility criteria that the State has 
established under paragraph (a) of this section, and the general 
eligibility requirements under Sec. Sec.  435.219 and 436.219 of this 
chapter.

[[Page 438]]

    (3) Includes consultation with the individual, and if applicable, 
the individual's representative as defined under Sec.  441.735.
    (4) Assesses the individual's support needs.
    (5) Uses only current and accurate information from existing 
records, and obtains any additional information necessary to draw valid 
conclusions about the individual's support needs.
    (6) Evaluations finding that an individual is not eligible for the 
State plan HCBS benefit are treated as actions defined in Sec.  431.201 
of this chapter and are subject to the requirements of part 431 subpart 
E of this chapter.
    (e) Periodic redetermination. Independent reevaluations of each 
individual receiving the State plan HCBS benefit must be performed at 
least every 12 months, to determine whether the individual continues to 
meet eligibility requirements. Redeterminations must meet the 
requirements of paragraph (d) of this section.



Sec.  441.720  Independent assessment.

    (a) Requirements. For each individual determined to be eligible for 
the State plan HCBS benefit, the State must provide for an independent 
assessment of needs, which may include the results of a standardized 
functional needs assessment, in order to establish a service plan. In 
applying the requirements of section 1915(i)(1)(F) of the Act, the State 
must:
    (1) Perform a face-to-face assessment of the individual by an agent 
who is independent and qualified as defined in Sec.  441.730, and with a 
person-centered process that meets the requirements of Sec.  441.725(a) 
and is guided by best practice and research on effective strategies that 
result in improved health and quality of life outcomes.
    (i) For the purposes of this section, a face-to-face assessment may 
include assessments performed by telemedicine, or other information 
technology medium, if the following conditions are met:
    (A) The agent performing the assessment is independent and qualified 
as defined in Sec.  441.730 and meets the provider qualifications 
defined by the State, including any additional qualifications or 
training requirements for the operation of required information 
technology.
    (B) The individual receives appropriate support during the 
assessment, including the use of any necessary on-site support-staff.
    (C) The individual provides informed consent for this type of 
assessment.
    (ii) [Reserved]
    (2) Conduct the assessment in consultation with the individual, and 
if applicable, the individual's authorized representative, and include 
the opportunity for the individual to identify other persons to be 
consulted, such as, but not limited to, the individual's spouse, family, 
guardian, and treating and consulting health and support professionals 
responsible for the individual's care.
    (3) Examine the individual's relevant history including the findings 
from the independent evaluation of eligibility, medical records, an 
objective evaluation of functional ability, and any other records or 
information needed to develop the person-centered service plan as 
required in Sec.  441.725.
    (4) Include in the assessment the individual's physical, cognitive, 
and behavioral health care and support needs, strengths and preferences, 
available service and housing options, and if unpaid caregivers will be 
relied upon to implement any elements of the person-centered service 
plan, a caregiver assessment.
    (5) For each service, apply the State's additional needs-based 
criteria (if any) that the individual may require. Individuals are 
considered enrolled in the State plan HCBS benefit only if they meet the 
eligibility and needs-based criteria for the benefit, and are also 
assessed to require and receive at least one home and community-based 
service offered under the State plan for medical assistance.
    (6) Include in the assessment, if the State offers individuals the 
option to self-direct a State plan home and community-based service or 
services, any information needed for the self-directed portion of the 
service plan, as required in Sec.  441.740(b), including the ability of 
the individual (with and without supports) to exercise budget or 
employer authority.

[[Page 439]]

    (7) Include in the assessment, for individuals receiving 
habilitation services, documentation that no Medicaid services are 
provided which would otherwise be available to the individual, 
specifically including but not limited to services available to the 
individual through a program funded under section 110 of the 
Rehabilitation Act of 1973, or the Individuals with Disabilities 
Education Improvement Act of 2004.
    (8) Include in the assessment and subsequent service plan, for 
individuals receiving Secretary approved services under the authority of 
Sec.  440.182 of this chapter, documentation that no State plan HCBS are 
provided which would otherwise be available to the individual through 
other Medicaid services or other Federally funded programs.
    (9) Include in the assessment and subsequent service plan, for 
individuals receiving HCBS through a waiver approved under Sec.  
441.300, documentation that HCBS provided through the State plan and 
waiver are not duplicative.
    (10) Coordinate the assessment and subsequent service plan with any 
other assessment or service plan required for services through a waiver 
authorized under section 1115 or section 1915 of the Social Security 
Act.
    (b) Reassessments. The independent assessment of need must be 
conducted at least every 12 months and as needed when the individual's 
support needs or circumstances change significantly, in order to revise 
the service plan.



Sec.  441.725  Person-centered service plan.

    (a) Person-centered planning process. Based on the independent 
assessment required in Sec.  441.720, the State must develop (or 
approve, if the plan is developed by others) a written service plan 
jointly with the individual (including, for purposes of this paragraph, 
the individual and the individual's authorized representative if 
applicable). The person-centered planning process is driven by the 
individual. The process:
    (1) Includes people chosen by the individual.
    (2) Provides necessary information and support to ensure that the 
individual directs the process to the maximum extent possible, and is 
enabled to make informed choices and decisions.
    (3) Is timely and occurs at times and locations of convenience to 
the individual.
    (4) Reflects cultural considerations of the individual and is 
conducted by providing information in plain language and in a manner 
that is accessible to individuals with disabilities and persons who are 
limited English proficient, consistent with Sec.  435.905(b) of this 
chapter.
    (5) Includes strategies for solving conflict or disagreement within 
the process, including clear conflict of interest guidelines for all 
planning participants.
    (6) Offers choices to the individual regarding the services and 
supports the individual receives and from whom.
    (7) Includes a method for the individual to request updates to the 
plan, as needed.
    (8) Records the alternative home and community-based settings that 
were considered by the individual.
    (b) The person-centered service plan. The person-centered service 
plan must reflect the services and supports that are important for the 
individual to meet the needs identified through an assessment of 
functional need, as well as what is important to the individual with 
regard to preferences for the delivery of such services and supports. 
Commensurate with the level of need of the individual, and the scope of 
services and supports available under the State plan HCBS benefit, the 
written plan must:
    (1) Reflect that the setting in which the individual resides is 
chosen by the individual. The State must ensure that the setting chosen 
by the individual is integrated in, and supports full access of 
individuals receiving Medicaid HCBS to the greater community, including 
opportunities to seek employment and work in competitive integrated 
settings, engage in community life, control personal resources, and 
receive services in the community to the same degree of access as 
individuals not receiving Medicaid HCBS.
    (2) Reflect the individual's strengths and preferences.
    (3) Reflect clinical and support needs as identified through an 
assessment of functional need.

[[Page 440]]

    (4) Include individually identified goals and desired outcomes.
    (5) Reflect the services and supports (paid and unpaid) that will 
assist the individual to achieve identified goals, and the providers of 
those services and supports, including natural supports. Natural 
supports are unpaid supports that are provided voluntarily to the 
individual in lieu of State plan HCBS.
    (6) Reflect risk factors and measures in place to minimize them, 
including individualized backup plans and strategies when needed.
    (7) Be understandable to the individual receiving services and 
supports, and the individuals important in supporting him or her. At a 
minimum, for the written plan to be understandable, it must be written 
in plain language and in a manner that is accessible to individuals with 
disabilities and persons who are limited English proficient, consistent 
with Sec.  435.905(b) of this chapter.
    (8) Identify the individual and/or entity responsible for monitoring 
the plan.
    (9) Be finalized and agreed to, with the informed consent of the 
individual in writing, and signed by all individuals and providers 
responsible for its implementation.
    (10) Be distributed to the individual and other people involved in 
the plan.
    (11) Include those services, the purchase or control of which the 
individual elects to self-direct, meeting the requirements of Sec.  
441.740.
    (12) Prevent the provision of unnecessary or inappropriate services 
and supports.
    (13) Document that any modification of the additional conditions, 
under Sec.  441.710(a)(1)(vi)(A) through (D) of this chapter, must be 
supported by a specific assessed need and justified in the person-
centered service plan. The following requirements must be documented in 
the person-centered service plan:
    (i) Identify a specific and individualized assessed need.
    (ii) Document the positive interventions and supports used prior to 
any modifications to the person-centered service plan.
    (iii) Document less intrusive methods of meeting the need that have 
been tried but did not work.
    (iv) Include a clear description of the condition that is directly 
proportionate to the specific assessed need.
    (v) Include a regular collection and review of data to measure the 
ongoing effectiveness of the modification.
    (vi) Include established time limits for periodic reviews to 
determine if the modification is still necessary or can be terminated.
    (vii) Include informed consent of the individual; and
    (viii) Include an assurance that the interventions and supports will 
cause no harm to the individual.
    (c) Reviewing the person-centered service plan. The person-centered 
service plan must be reviewed, and revised upon reassessment of 
functional need as required in Sec.  441.720, at least every 12 months, 
when the individual's circumstances or needs change significantly, and 
at the request of the individual.



Sec.  441.730  Provider qualifications.

    (a) Requirements. The State must provide assurances that necessary 
safeguards have been taken to protect the health and welfare of 
enrollees in State plan HCBS, and must define in writing standards for 
providers (both agencies and individuals) of HCBS and for agents 
conducting individualized independent evaluation, independent 
assessment, and service plan development.
    (b) Conflict of interest standards. The State must define conflict 
of interest standards that ensure the independence of individual and 
agency agents who conduct (whether as a service or an administrative 
activity) the independent evaluation of eligibility for State plan HCBS, 
who are responsible for the independent assessment of need for HCBS, or 
who are responsible for the development of the service plan. The 
conflict of interest standards apply to all individuals and entities, 
public or private. At a minimum, these agents must not be any of the 
following:
    (1) Related by blood or marriage to the individual, or to any paid 
caregiver of the individual.

[[Page 441]]

    (2) Financially responsible for the individual.
    (3) Empowered to make financial or health-related decisions on 
behalf of the individual.
    (4) Holding financial interest, as defined in Sec.  411.354 of this 
chapter, in any entity that is paid to provide care for the individual.
    (5) Providers of State plan HCBS for the individual, or those who 
have an interest in or are employed by a provider of State plan HCBS for 
the individual, except when the State demonstrates that the only willing 
and qualified agent to perform independent assessments and develop 
person-centered service plans in a geographic area also provides HCBS, 
and the State devises conflict of interest protections including 
separation of agent and provider functions within provider entities, 
which are described in the State plan for medical assistance and 
approved by the Secretary, and individuals are provided with a clear and 
accessible alternative dispute resolution process.
    (c) Training. Qualifications for agents performing independent 
assessments and plans of care must include training in assessment of 
individuals whose physical, cognitive, or mental conditions trigger a 
potential need for home and community-based services and supports, and 
current knowledge of available resources, service options, providers, 
and best practices to improve health and quality of life outcomes.



Sec.  441.735  Definition of individual's representative.

    In this subpart, the term individual's representative means, with 
respect to an individual being evaluated for, assessed regarding, or 
receiving State plan HCBS, the following:
    (a) The individual's legal guardian or other person who is 
authorized under State law to represent the individual for the purpose 
of making decisions related to the person's care or well-being. In 
instances where state law confers decision-making authority to the 
individual representative, the individual will lead the service planning 
process to the extent possible.
    (b) Any other person who is authorized under Sec.  435.923 of this 
chapter, or under the policy of the State Medicaid Agency to represent 
the individual, including but not limited to, a parent, a family member, 
or an advocate for the individual.
    (c) When the State authorizes representatives in accordance with 
paragraph (b) of this section, the State must have policies describing 
the process for authorization; the extent of decision-making authorized; 
and safeguards to ensure that the representative uses substituted 
judgment on behalf of the individual. State policies must address 
exceptions to using substituted judgment when the individual's wishes 
cannot be ascertained or when the individual's wishes would result in 
substantial harm to the individual. States may not refuse the authorized 
representative that the individual chooses, unless in the process of 
applying the requirements for authorization, the State discovers and can 
document evidence that the representative is not acting in accordance 
with these policies or cannot perform the required functions. States 
must continue to meet the requirements regarding the person-centered 
planning process at Sec.  441.725 of this chapter.



Sec.  441.740  Self-directed services.

    (a) State option. The State may choose to offer an election for 
self-directing HCBS. The term ``self-directed'' means, with respect to 
State plan HCBS listed in Sec.  440.182 of this chapter, services that 
are planned and purchased under the direction and control of the 
individual, including the amount, duration, scope, provider, and 
location of the HCBS. For purposes of this paragraph, individual means 
the individual and, if applicable, the individual's representative as 
defined in Sec.  441.735.
    (b) Service plan requirement. Based on the independent assessment 
required in Sec.  441.720, the State develops a service plan jointly 
with the individual as required in Sec.  441.725. If the individual 
chooses to direct some or all HCBS, the service plan must meet the 
following additional requirements:
    (1) Specify the State plan HCBS that the individual will be 
responsible for directing.

[[Page 442]]

    (2) Identify the methods by which the individual will plan, direct 
or control services, including whether the individual will exercise 
authority over the employment of service providers and/or authority over 
expenditures from the individualized budget.
    (3) Include appropriate risk management techniques that explicitly 
recognize the roles and sharing of responsibilities in obtaining 
services in a self-directed manner and assure the appropriateness of 
this plan based upon the resources and support needs of the individual.
    (4) Describe the process for facilitating voluntary and involuntary 
transition from self-direction including any circumstances under which 
transition out of self-direction is involuntary. There must be state 
procedures to ensure the continuity of services during the transition 
from self-direction to other service delivery methods.
    (5) Specify the financial management supports, as required in 
paragraph (e) of this section, to be provided.
    (c) Employer authority. If the person-centered service plan includes 
authority to select, manage, or dismiss providers of the State plan 
HCBS, the person-centered service plan must specify the authority to be 
exercised by the individual, any limits to the authority, and specify 
parties responsible for functions outside the authority the individual 
exercises.
    (d) Budget authority. If the person-centered service plan includes 
an individualized budget (which identifies the dollar value of the 
services and supports under the control and direction of the 
individual), the person-centered service plan must meet the following 
requirements:
    (1) Describe the method for calculating the dollar values in the 
budget, based on reliable costs and service utilization.
    (2) Define a process for making adjustments in dollar values to 
reflect changes in an individual's assessment and service plan.
    (3) Provide a procedure to evaluate expenditures under the budget.
    (4) Not result in payment for medical assistance to the individual.
    (e) Functions in support of self-direction. When the State elects to 
offer self-directed State plan HCBS, it must offer the following 
individualized supports to individuals receiving the services and their 
representatives:
    (1) Information and assistance consistent with sound principles and 
practice of self-direction.
    (2) Financial management supports to meet the following 
requirements:
    (i) Manage Federal, State, and local employment tax, labor, worker's 
compensation, insurance, and other requirements that apply when the 
individual functions as the employer of service providers.
    (ii) Make financial transactions on behalf of the individual when 
the individual has personal budget authority.
    (iii) Maintain separate accounts for each individual's budget and 
provide periodic reports of expenditures against budget in a manner 
understandable to the individual.
    (3) Voluntary training on how to select, manage, and dismiss 
providers of State plan HCBS.



Sec.  441.745  State plan HCBS administration: State responsibilities 
and quality improvement.

    (a) State plan HCBS administration--(1) State responsibilities. The 
State must carry out the following responsibilities in administration of 
its State plan HCBS:
    (i) Number served. The State will annually provide CMS with the 
projected number of individuals to be enrolled in the benefit and the 
actual number of unduplicated individuals enrolled in State plan HCBS in 
the previous year.
    (ii) Access to services. The State must grant access to all State 
plan HCBS assessed to be needed in accordance with a service plan 
consistent with Sec.  441.725, to individuals who have been determined 
to be eligible for the State plan HCBS benefit, subject to the following 
requirements:
    (A) A State must determine that provided services meet medical 
necessity criteria.
    (B) A State may limit access to services through targeting criteria 
established by Sec.  441.710(e)(2).
    (C) A State may not limit access to services based upon the income 
of eligible individuals, the cost of services, or the individual's 
location in the State.

[[Page 443]]

    (iii) Appeals. A State must provide individuals with advance notice 
of and the right to appeal terminations, suspensions, or reductions of 
Medicaid eligibility or covered services as described in part 431, 
subpart E.
    (2) Administration--(i) Option for presumptive payment. (A) The 
State may provide for a period of presumptive payment, not to exceed 60 
days, for Medicaid eligible individuals the State has reason to believe 
may be eligible for the State plan HCBS benefit. FFP is available for 
both services that meet the definition of medical assistance and 
necessary administrative expenditures for evaluation of eligibility for 
the State plan HCBS benefit under Sec.  441.715(d) and assessment of 
need for specific HCBS under Sec.  441.720(a), prior to an individual's 
receipt of State plan HCBS or determination of ineligibility for the 
benefit.
    (B) If an individual the State has reason to believe may be eligible 
for the State plan HCBS benefit is evaluated and assessed under the 
presumptive payment option and found not to be eligible for the benefit, 
FFP is available for services that meet the definition of medical 
assistance and necessary administrative expenditures. The individual so 
determined will not be considered to have enrolled in the State plan 
HCBS benefit for purposes of determining the annual number of 
participants in the benefit.
    (ii) Option for phase-in of services and eligibility. (A) In the 
event that a State elects to establish targeting criteria through Sec.  
441.710(e)(2), the State may limit the enrollment of individuals or the 
provision services to enrolled individuals based upon criteria described 
in a phase-in plan, subject to CMS approval. A State which elects to 
target the State plan HCBS benefit and to phase-in enrollment and/or 
services must submit a phase-in plan for approval by CMS that describes, 
at a minimum:
    (1) The criteria used to limit enrollment or service delivery.
    (2) The rationale for phasing-in services and/or eligibility.
    (3) Timelines and benchmarks to ensure that the benefit is available 
statewide to all eligible individuals within the initial 5-year 
approval.
    (B) If a State elects to phase-in the enrollment of individuals 
based on highest need, the phase-in plan must use the needs-based 
criteria described in Sec.  441.715(a) to establish priority for 
enrollment. Such criteria must be based upon the assessed need of 
individuals, with higher-need individuals receiving services prior to 
individuals with lower assessed need.
    (C) If a State elects to phase-in the provision of any services, the 
phase-in plan must include a description of the services that will not 
be available to all eligible individuals, the rationale for limiting the 
provision of services, and assurance that all individuals with access to 
a willing and qualified provider may receive services.
    (D) The plan may not include a cap on the number of enrollees.
    (E) The plan must include a timeline to assure that all eligible 
individuals receive all included services prior to the end of the first 
5-year approval period, described in paragraph (a)(2)(vi) of this 
section.
    (iii) Reimbursement methodology. The State plan amendment to provide 
State plan HCBS must contain a description of the reimbursement 
methodology for each covered service, in accordance with CMS sub-
regulatory guidance. To the extent that the reimbursement methodologies 
for any self-directed services differ from those descriptions, the 
method for setting reimbursement methodology for the self-directed 
services must also be described.
    (iv) Operation. The State plan amendment to provide State plan HCBS 
must contain a description of the State Medicaid agency line of 
authority for operating the State plan HCBS benefit, including 
distribution of functions to other entities.
    (v) Modifications. The agency may request that modifications to the 
benefit be made effective retroactive to the first day of a fiscal year 
quarter, or another date after the first day of a fiscal year quarter, 
in which the amendment is submitted, unless the amendment involves 
substantive change. Substantive changes may include, but are not limited 
to, the following:
    (A) Revisions to services available under the benefit including 
elimination or reduction in services, and changes in

[[Page 444]]

the scope, amount and duration of the services.
    (B) Changes in the qualifications of service providers, rate 
methodology, or the eligible population.
    (1) Request for Amendments. A request for an amendment that involves 
a substantive change as determined by CMS--
    (i) May only take effect on or after the date when the amendment is 
approved by CMS; and
    (ii) Must be accompanied by information on how the State will ensure 
for transitions with minimal adverse impact on individuals impacted by 
the change.
    (2) [Reserved]
    (vi) Periods of approval. (A) If a State elects to establish 
targeting criteria through Sec.  441.710(e)(2)(i), the approval of the 
State Plan Amendment will be in effect for a period of 5 years from the 
effective date of the amendment. To renew State plan HCBS for an 
additional 5-year period, the State must provide a written request for 
renewal to CMS at least 180 days prior to the end of the approval 
period. CMS approval of a renewal request is contingent upon State 
adherence to Federal requirements and the state meeting its objectives 
with respect to quality improvement and beneficiary outcomes.
    (B) If a State does not elect to establish targeting criteria 
through Sec.  441.710(e)(2)(i), the limitations on length of approval 
does not apply.
    (b) Quality improvement strategy: Program performance and quality of 
care. States must develop and implement an HCBS quality improvement 
strategy that includes a continuous improvement process and measures of 
program performance and experience of care. The strategy must be 
proportionate to the scope of services in the State plan HCBS benefit 
and the number of individuals to be served. The State will make this 
information available to CMS at a frequency determined by the Secretary 
or upon request.
    (1) Quality Improvement Strategy. The quality improvement strategy 
must include all of the following:
    (i) Incorporate a continuous quality improvement process that 
includes monitoring, remediation, and quality improvement.
    (ii) Be evidence-based, and include outcome measures for program 
performance, quality of care, and individual experience as determined by 
the Secretary.
    (iii) Provide evidence of the establishment of sufficient 
infrastructure to implement the program effectively.
    (iv) Measure individual outcomes associated with the receipt of 
HCBS, related to the implementation of goals included in the individual 
service plan.
    (2) [Reserved]



PART 442_STANDARDS FOR PAYMENT TO NURSING FACILITIES AND INTERMEDIATE 
CARE FACILITIES FOR INDIVIDUALS WITH INTELLECTUAL DISABILITIES-
-Table of Contents



                      Subpart A_General Provisions

Sec.
442.1 Basis and purpose.
442.2 Terms.

                      Subpart B_Provider Agreements

442.10 State plan requirement.
442.12 Provider agreement: General requirements.
442.13 Effective date of provider agreement.
442.14 Effect of change of ownership.
442.15 Duration of agreement for ICF/IIDs.
442.16 [Reseved]
442.30 Agreement as evidence of certification.
442.40 Availability of FFP during appeals for ICFs/IID.
442.42 FFP under a retroactive provider agreement following appeal.

                   Subpart C_Certification of ICFs/IID

442.100 State plan requirements.
442.101 Obtaining certification.
442.105 [Reserved]
442.109 Certification period for ICF/IIDs: General provisions.
442.110 Certification period for ICF/IID with standard-level 
          deficiencies.
442.117 Termination of certification for ICFs/IID whose deficiencies 
          pose immediate jeopardy.
442.118 Denial of payments for new admissions to an ICF/IID.
442.119 Duration of denial of payments and subsequent termination of an 
          ICF/IID.

Subparts D-F [Reserved]

    Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302), 
unless otherwise noted.

[[Page 445]]


    Source: 43 FR 45233, Sept. 29, 1978, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  442.1  Basis and purpose.

    (a) This part states requirements for provider agreements for 
facility certification relating to the provision of services furnished 
by nursing facilities and intermediate care facilities for individuals 
with intellectual disabilities. This part is based on the following 
sections of the Act:

Section 1902(a)(4), administrative methods for proper and efficient 
operation of the State plan;
Section 1902(a)(27), provider agreements;
Section 1902(a)(28), nursing facility standards;
Section 1902(a)(33)(B), State survey agency functions; Section 1902(i), 
circumstances and procedures for denial of payment and termination of 
provider agreements in certain cases;
Section 1905(c), definition of nursing facility;
Section 1905(d), definition of intermediate care facility for 
individuals with intellectual disabilities;
Section 1905 (f), definition of nursing facility services;
Section 1910, certification and approval of ICFs/IID and of RHCs;
Section 1913, hospital providers of nursing facility services;
Section 1919 (g) and (h), survey, certification and enforcement of 
nursing facilities; and
Section 1922, correction and reduction plans for intermediate care 
facilities for individuals with intellectual disabilities.

    (b) Section 431.610 of this subchapter contains requirements for 
designating the State licensing agency to survey these facilities and 
for certain survey agency responsibilities.

[43 FR 45233, Sept. 29, 1978, as amended at 47 FR 31533, July 20, 1982; 
59 FR 56235, Nov. 10, 1994]



Sec.  442.2  Terms.

    In this part--
    Facility refers to a nursing facility, and an intermediate care 
facility for Individuals with Intellectual Disabilities or persons with 
related conditions (ICF/IID).
    Facility, and any specific type of facility referred to, may include 
a distinct part of a facility as specified in Sec.  440.40 or Sec.  
440.150 of this subchapter.
    Immediate jeopardy means a situation in which immediate corrective 
action is necessary because the provider's noncompliance with one or 
more requirements of participation or conditions of participation has 
caused, or is likely to cause, serious injury, harm, impairment, or 
death to an individual receiving care in a facility.
    New admission means the admission of a Medicaid beneficiary who has 
never been in the facility or, if previously admitted, had been 
discharged or had voluntarily left the facility. The term does not 
include the following:
    (a) Individuals who were in the facility before the effective date 
of denial of payment for new admissions, even if they become eligible 
for Medicaid after that date.
    (b) If the approved State plan includes payments for reserved beds, 
individuals who, after a temporary absence from the facility, are 
readmitted to beds reserved for them in accordance with Sec.  447.40(a) 
of this chapter.

[43 FR 45233, Sept. 29, 1978, as amended at 51 FR 24491, July 3, 1986; 
53 FR 1993, Jan. 25, 1988; 54 FR 5358, Feb. 2, 1989; 56 FR 48865, Sept. 
26, 1991; 59 FR 56235, Nov. 10, 1994]



                      Subpart B_Provider Agreements



Sec.  442.10  State plan requirement.

    A State plan must provide that requirements of this subpart are met.



Sec.  442.12  Provider agreement: General requirements.

    (a) Certification and recertification. Except as provided in 
paragraph (b) of this section, a Medicaid agency may not execute a 
provider agreement with a facility for nursing facility services nor 
make Medicaid payments to a facility for those services unless the 
Secretary or the State survey agency has certified the facility under 
this part to provide those services. (See Sec.  442.101 for 
certification by the Secretary or by the State survey agency).
    (b) Exception. The certification requirement of paragraph (a) of 
this section does not apply with respect to religious nonmedical 
institutions as defined in Sec.  440.170(b) of this chapter.

[[Page 446]]

    (c) Conformance with certification condition. An agreement must be 
in accordance with the certification provisions set by the Secretary or 
the survey agency under subpart C of this part for ICFs/IID or subpart E 
of part 488 of this chapter for NFs.
    (d) Denial for good cause. (1) If the Medicaid agency has adequate 
documentation showing good cause, it may refuse to execute an agreement, 
or may cancel an agreement, with a certified facility.
    (2) A provider agreement is not a valid agreement for purposes of 
this part even though certified by the State survey agency, if the 
facility fails to meet the civil rights requirements set forth in 45 CFR 
parts 80, 84, and 90.

[45 FR 22936, Apr. 4, 1980, as amended at 56 FR 48865, Sept. 26, 1991; 
59 FR 56235, Nov. 10, 1994; 64 FR 67052, Nov. 30, 1999]



Sec.  442.13  Effective date of provider agreement.

    The effective date of a provider agreement with an NF or ICF/IID is 
determined in accordance with the rules set forth in Sec.  431.108.

[62 FR 43936, Aug. 18, 1997]



Sec.  442.14  Effect of change of ownership.

    (a) Assignment of agreement. When there is a change of ownership, 
the Medicaid agency must automatically assign the agreement to the new 
owner.
    (b) 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) Any existing plan of correction.
    (2) Any expiration date for ICFs/IID.
    (3) Compliance with applicable health and safety requirements.
    (4) Compliance with the ownership and financial interest disclosure 
requirements of Sec. Sec.  455.104 and 455.105 of this chapter.
    (5) Compliance with civil rights requirements set forth in 45 CFR 
parts 80, 84, and 90.
    (6) Compliance with any additional requirements imposed by the 
Medicaid agency.

[45 FR 22936, Apr. 4, 1980, as amended at 53 FR 20495, June 3, 1988; 59 
FR 56235, Nov. 10, 1994]



Sec.  442.15  Duration of agreement for ICF/IIDs.

    (a) The agreement for an ICF/IID remains in effect until the 
Secretary determines that the facility no longer meets the applicable 
requirements. The State Survey Agency must conduct a survey of the 
facility to determine compliance with the requirements at a survey 
interval of no greater than 15 months.
    (b) FFP is available for services furnished by a facility for up to 
30 days after its agreement expires or terminates under the conditions 
specified in Sec.  441.11 of this subchapter.

[77 FR 29031, May 16, 2012]



Sec.  442.16  [Reserved]



Sec.  442.30  Agreement as evidence of certification.

    (a) Under Sec. Sec.  440.40(a) and 440.150 of this chapter, FFP is 
available in expenditures for NF and ICF/IID services only if the 
facility has been certified as meeting the requirements for Medicaid 
participation, as evidenced by a provider agreement executed under this 
part. An agreement is not valid evidence that a facility has met those 
requirements if CMS determines that--
    (1) The survey agency failed to apply the applicable requirements 
under subpart B of part 483 of this chapter for NFs or subpart I of part 
483 of this chapter, which set forth the conditions of participation for 
ICFs/IID.
    (2) The survey agency failed to follow the rules and procedures for 
certification set forth in subpart C of this part, subpart E of part 
488, and Sec.  431.610 of this subchapter;
    (3) The survey agency failed to perform any of the functions 
specified in Sec.  431.610(g) of this subchapter relating to evaluating 
and acting on information about the facility and inspecting the 
facility;
    (4) The agency failed to use the Federal standards, and the forms, 
methods and procedures prescribed by CMS as

[[Page 447]]

required under Sec.  431.610(f)(1) or Sec.  488.318(b) of this chapter, 
for determining the qualifications of providers; or
    (5) The survey agency failed to adhere to the following principles 
in determining compliance:
    (i) The survey process is the means to assess compliance with 
Federal health, safety and quality standards;
    (ii) The survey process uses resident outcomes as the primary means 
to establish the compliance status of facilities. Specifically, 
surveyors will directly observe the actual provision of care and 
services to residents, and the effects of that care, to assess whether 
the care provided meets the needs of individual residents;
    (iii) Surveyors are professionals who use their judgment, in concert 
with Federal forms and procedures, to determine compliance;
    (iv) Federal procedures are used by all surveyors to ensure uniform 
and consistent application and interpretation of Federal requirements;
    (v) Federal forms are used by all surveyors to ensure proper 
recording of findings and to document the basis for the findings.
    (6) The survey agency failed to assess in a systematic manner a 
facility's actual provision of care and services to residents and 
effects of that care on residents.
    (7) Required elements of the NF survey process fails to include all 
of the following:
    (i) An entrance conference;
    (ii) A resident-centered tour of facility;
    (iii) An in-depth review of a sample of residents including 
observation, interview and record review;
    (iv) Observation of the preparation and administration of drugs for 
a sample of residents;
    (v) Evaluation of a facility's meals, dining areas and eating 
assistance procedures;
    (vi) Formulation of a deficiency statement based on the 
incorporation of all appropriate findings onto the survey report form;
    (vii) An exit conference; and
    (viii) Follow-up surveys as appropriate.
    (8) The agreement's terms and conditions do not meet the 
requirements of this subpart.
    (b) The Administrator will make the determination under paragraph 
(a) of this section through onsite surveys, other Federal reviews, State 
certification records, or reports he may require from the Medicaid or 
survey agency.
    (c) If the Administrator disallows a State's claim for FFP because 
of a determination under paragraph (a) of this section, the State is 
entitled upon request to reconsideration of the disallowance under 45 
CFR part 16.

[43 FR 45233, Sept. 29, 1978, as amended at 51 FR 21558, June 13, 1986; 
53 FR 20495, June 3, 1988; 53 FR 23101, June 17, 1988; 56 FR 48865, 
Sept. 26, 1991; 59 FR 56235, Nov. 10, 1994]



Sec.  442.40  Availability of FFP during appeals for ICFs/IID.

    (a) Definitions. As used in this section--
    Effective date of expiration means the date of expiration originally 
specified in the provider agreement, or the later date specified if the 
agreement is extended under Sec.  442.16; and
    Effective date of termination means a date earlier than the 
expiration date, set by the Medicaid agency when continuing 
participation until the expiration date is not justified, because the 
facility no longer meets the requirements for participation.
    (b) Scope, applicability, and effective date--(1) Scope. This 
section sets forth the extent of FFP in State Medicaid payments to an 
ICF/IID after its provider agreement has been terminated or has expired 
and not been renewed.
    (2) Applicability. (i) This section and Sec.  442.42 apply only when 
the Medicaid agency, of its own volition, terminates or does not a renew 
a provider agreement, and only when the survey agency certifies that 
there is no jeopardy to beneficiary health and safety. When the survey 
agency certifies that there is jeopardy to beneficiary health and 
safety, or when it fails to certify that there is no jeopardy, FFP ends 
on the effective date of termination or expiration.
    (ii) When the State acts under instructions from CMS, FFP ends on 
the date specified by CMS (CMS instructs

[[Page 448]]

the State to terminate the Medicaid provider agreement when CMS in 
validating a State survey agency certification, determines that an ICF/
IID does not meet the requirements for participation.)
    (3) Effective date. This section and Sec.  442.42 apply to 
terminations or expirations that are effective on or after September 28, 
1987. For terminations or nonrenewals that were effective before that 
date, FFP may continue for up to 120 days from September 28, 1987, or 12 
months from the effective date of termination or nonrenewal, whichever 
is earlier.
    (c) Basic rules. (1) Except as provided in paragraphs (d) and (e) of 
this section, FFP in payments to an ICF/IID ends on the effective date 
of termination of the facility's provider agreement, or if the agreement 
is not terminated, on the effective date of expiration.
    (2) If State law, or a Federal or State court order or injunction, 
requires the agency to extend the provider agreement or continue 
payments to a facility after the dates specified in paragraph (d) of 
this section, FFP is not available in those payments.
    (d) Exception: Continuation of FFP after termination or expiration 
of provider agreement--(1) Conditions for continuation. FFP is available 
after the effective date of termination or expiration only if--
    (i) The evidentiary hearing required under Sec.  431.153 of this 
chapter is provided by the State agency after the effective date of 
termination or expiration (or, if begun before termination or 
expiration, is not completed until after that date); and
    (ii) Termination or nonrenewal action is based on a survey agency 
certification that there is no jeopardy to beneficiaries' health and 
safety.
    (2) Extent of continuation. FFP is available only through the 
earlier of the following:
    (i) The date of issuance of an administrative hearing decision that 
upholds the agency's termination or nonrenewal action.
    (ii) The 120th day after the effective date of termination of the 
facility's provider agreement or, if the agreement is not terminated, 
the 120th day after the effective date of expiration. (If a hearing 
decision that upholds the facility is issued after the end of the 120-
day period, when FFP has already been discontinued, the rules of Sec.  
442.42 on retroactive agreements apply).
    (e) Applicability of Sec.  441.11. If FFP is continued during appeal 
under paragraph (d) of this section, the 30-day period provided by Sec.  
441.11 of this chapter would not begin to run until issuance of a 
hearing decision that upholds the agency's termination or nonrenewal 
action.

[52 FR 32551, Aug. 28, 1987, as amended at 56 FR 48865, Sept. 26, 1991; 
59 FR 56236, Nov. 10, 1994]



Sec.  442.42  FFP under a retroactive provider agreement following appeal.

    (a) Basic rule. Except as specified in paragraph (b) of this 
section, if an NF or ICF/IID prevails on appeal from termination or, in 
the case of an ICF/IID, nonrenewal of a provider agreement, and the 
State issues a retroactive agreement, FFP is available beginning with 
the retroactive effective date, which must be determined in accordance 
with Sec.  442.13.
    (b) Exception. This rule does not apply if CMS determines, under 
Sec.  442.30, that the agreement is not valid evidence that the facility 
meets the requirements for participation. This exclusion applies even if 
the State issues the new agreement as the result of an administrative 
hearing decision favorable to the facility or under a Federal or State 
court order.

[52 FR 32551, Aug. 28, 1987, as amended at 59 FR 56236, Nov. 10, 1994]



                   Subpart C_Certification of ICFs/IID



Sec.  442.100  State plan requirements.

    A State plan must provide that the requirements of this subpart and 
part 483 are met.

[53 FR 20495, June 3, 1988]



Sec.  442.101  Obtaining certification.

    (a) This section states the requirements for obtaining notice of an 
ICF/IID's certification before a Medicaid agency executes a provider 
agreement under Sec.  442.12.

[[Page 449]]

    (b) The agency must obtain notice of certification from the 
Secretary for an ICF/IID located on an Indian reservation.
    (c) The agency must obtain notice of certification from the survey 
agency for all other ICFs/IID.
    (d) The notice must indicate that one of the following provisions 
pertains to the ICF/IID:
    (1) An ICF/IID meets the conditions of participation set forth in 
subpart I of part 483 of this chapter.
    (2) The ICF/IID has been granted a waiver or variance by CMS or the 
survey agency under subpart I of part 483 of this chapter.
    (3) An ICF/IID has been certified with standard-level deficiencies 
and
    (i) All conditions of participation are found met; and
    (ii) The facility submits an acceptable plan of correction covering 
the remaining deficiencies.
    (e) The failure to meet one or more of the applicable conditions of 
participation is cause for termination or non-renewal of the ICF/IID 
provider agreement.

[56 FR 48866, Sept. 26, 1991, as amended at 57 FR 43924, Sept. 23, 1992; 
59 FR 56236, Nov. 10, 1994; 79 FR 27153, May 12, 2014]



Sec.  442.105  [Reserved]



Sec.  442.109  Certification period for ICF/IIDs: General provisions.

    (a) A survey agency may certify a facility that fully meets 
applicable requirements. The State Survey Agency must conduct a survey 
of each ICF/IID not later than 15 months after the last day of the 
previous survey.
    (b) The statewide average interval between surveys must be 12 months 
or less, computed in accordance with paragraph (c) of this section.
    (c) The statewide average interval is computed at the end of each 
Federal fiscal year by comparing the last day of the most recent survey 
for each participating facility to the last day of each facility's 
previous survey.

[77 FR 29031, May 16, 2012]



Sec.  442.110  Certification period for ICF/IID with standard-level
deficiencies.

    Facilities with standard-level deficiencies may be certified under 
Sec.  442.101 with a condition that the certification will continue if 
either of the following applies:
    (a) The survey agency finds that all deficiencies have been 
satisfactorily corrected.
    (b) The survey agency finds that the facility has made substantial 
progress in correcting the deficiencies and has a new plan of correction 
that is acceptable.

[79 FR 27153, May 12, 2014]



Sec.  442.117  Termination of certification for ICFs/IID whose 
deficiencies pose immediate jeopardy.

    (a) A survey agency must terminate a facility's certification if it 
determines that--
    (1) The facility no longer meets conditions of participation for 
ICFs/IID as specified in subpart I of part 483 of this chapter.
    (2) The facility's deficiencies pose immediate jeopardy to 
residents' health and safety.
    (b) Subsequent to a certification of a facility's noncompliance, the 
Medicaid agency must, in terminating the provider agreement, follow the 
appeals process specified in part 431, subpart D of this chapter.

[51 FR 24491, July 3, 1986, as amended at 59 FR 56236, Nov. 10, 1994]



Sec.  442.118  Denial of payments for new admissions to an ICF/IID.

    (a) Basis for denial of payments. The Medicaid agency may deny 
payment for new admissions to an ICF/IID that no longer meets the 
applicable conditions of participation specified under subpart I of part 
483 of this chapter.
    (b) Agency procedures. Before denying payments for new admissions, 
the Medicaid agency must comply with the following requirements:
    (1) Provide the facility up to 60 days to correct the cited 
deficiencies and comply with conditions of participation for ICFs/IID.

[[Page 450]]

    (2) If at the end of the specified period the facility has not 
achieved compliance, give the facility notice of intent to deny payment 
for new admissions, and opportunity for an informal hearing.
    (3) If the facility requests a hearing, provide an informal hearing 
that includes--
    (i) The opportunity for the facility to present, before a State 
Medicaid official who was not involved in making the initial 
determination, evidence or documentation, in writing or in person, to 
refute the decision that the facility is out of compliance with the 
conditions of participation for ICFs/IID.
    (ii) A written decision setting forth the factual and legal bases 
pertinent to a resolution of the dispute.
    (4) If the decision of the informal hearing is to deny payments for 
new admissions, provide the facility and the public, at least 15 days 
before the effective date of the sanction, with a notice that includes 
the effective date and the reasons for the denial of payments.

[51 FR 24491, July 3, 1986, as amended at 59 FR 56236, Nov. 10, 1994]



Sec.  442.119  Duration of denial of payments and subsequent termination
of an ICF/IID.

    (a) Period of denial. The denial of payments for new admissions will 
continue for 11 months after the month it was imposed unless, before the 
end of that period, the Medicaid agency finds that--
    (1) The facility has corrected the deficiencies or is making a good 
faith effort to achieve compliance with the conditions of participation 
for ICFs/IID; or
    (2) The deficiencies are such that it is necessary to terminate the 
facility's provider agreement.
    (b) Subsequent termination. The Medicaid agency must terminate a 
facility's provider agreement--
    (1) Upon the agency's finding that the facility has been unable to 
achieve compliance with the conditions of participation for ICFs/IID 
during the period that payments for new admissions have been denied;
    (2) Effective the day following the last day of the denial of 
payments period; and
    (3) In accordance with the procedures for appeal of terminations set 
forth in subpart D of part 431 of this chapter.

[51 FR 24491, July 3, 1986, as amended at 59 FR 56236, Nov. 10, 1994]

Subparts D-F [Reserved]



PART 447_PAYMENTS FOR SERVICES--Table of Contents



                 Subpart A_Payments: General Provisions

Sec.
447.1 Purpose.
447.10 Prohibition against reassignment of provider claims.
447.15 Acceptance of State payment as payment in full.
447.20 Provider restrictions: State plan requirements.
447.21 Reduction of payments to providers.
447.25 Direct payments to certain beneficiaries for physicians' or 
          dentists' services.
447.26 Prohibition on payment for provider-preventable conditions.
447.30 Withholding the Federal share of payments to Medicaid providers 
          to recover Medicare overpayments.
447.31 Withholding Medicare payments to recover Medicaid overpayments.
447.40 Payments for reserving beds in institutions.
447.45 Timely claims payment.
447.46 Timely claims payment by MCOs.

                   Medicaid Premiums and Cost Sharing

447.50 Premiums and cost sharing: Basis and purpose.
447.51 Definitions.
447.52 Cost sharing.
447.53 Cost sharing for drugs.
447.54 Cost sharing for services furnished in a hospital emergency 
          department.
447.55 Premiums.
447.56 Limitations on premiums and cost sharing.
447.57 Beneficiary and public notice requirements.
447.88 Options for claiming FFP payment for section 1920A presumptive 
          eligibility medical assistance payments.
447.90 FFP: Conditions related to pending investigations of credible 
          allegations of fraud against the Medicaid program.

              Subpart B_Payment Methods: General Provisions

447.200 Basis and purpose.
447.201 State plan requirements.
447.202 Audits.
447.203 Documentation of access to care and service payment rates.

[[Page 451]]

447.204 Medicaid provider participation and public process to inform 
          access to care.
447.205 Public notice of changes in Statewide methods and standards for 
          setting payment rates.

  Subpart C_Payment For Inpatient Hospital and Long-Term Care Facility 
                                Services

447.250 Basis and purpose.

                              Payment Rates

447.251 Definitions.
447.252 State plan requirements.
447.253 Other requirements.
447.255 Related information.
447.256 Procedures for CMS action on assurances and State plan 
          amendments.

                     Federal Financial Participation

447.257 FFP: Conditions relating to institutional reimbursement.

                              Upper Limits

447.271 Upper limits based on customary charges.
447.272 Inpatient services: Application of upper payment limits.

                           Swing-Bed Hospitals

447.280 Hospital providers of NF services (swing-bed hospitals).

Subpart D [Reserved]

        Subpart E_Payment Adjustments for Hospitals That Serve a 
             Disproportionate Number of Low-Income Patients

447.294 Medicaid disproportionate share hospital (DSH) allotment 
          reductions.
447.295 Hospital-specific disproportionate share hospital payment limit: 
          Determination of individuals without health insurance or other 
          third party coverage.
447.296 Limitations on aggregate payments for disproportionate share 
          hospitals for the period January 1, 1992 through September 30, 
          1992.
447.297 Limitations on aggregate payments for disproportionate share 
          hospitals beginning October 1, 1992.
447.298 State disproportionate share hospital allotments.
447.299 Reporting requirements.

 Subpart F_Payment Methods for Other Institutional and Noninstitutional 
                                Services

447.300 Basis and purpose.
447.302 State plan requirements.
447.304 Adherence to upper limits; FFP.

                 Outpatient Hospital and Clinic Services

447.321 Outpatient hospital and clinic services: Application of upper 
          payment limits.

                Other Inpatient and Outpatient Facilities

447.325 Other inpatient and outpatient facility services: Upper limits 
          of payment.
447.342 [Reserved]

                        Prepaid Capitation Plans

447.362 Upper limits of payment: Nonrisk contract.

                      Rural Health Clinic Services

447.371 Services furnished by rural health clinics.

  Subpart G_Payments for Primary Care Services Furnished by Physicians

447.400 Primary care services furnished by physicians with a specified 
          specialty or subspecialty.
447.405 Amount of required minimum payments.
447.410 State plan requirements.
447.415 Availability of Federal financial participation (FFP).

Subpart H [Reserved]

                       Subpart I_Payment for Drugs

447.500 Basis and purpose.
447.502 Definitions.
447.504 Determination of average manufacturer price.
447.505 Determination of best price.
447.506 Authorized generic drugs.
447.507 Identification of inhalation, infusion, instilled, implanted, or 
          injectable drugs (5i drugs).
447.508 Exclusion from best price of certain sales at a nominal price.
447.509 Medicaid drug rebates (MDR).
447.510 Requirements for manufacturers.
447.511 Requirements for States.
447.512 Drugs: Aggregate upper limits of payment.
447.514 Upper limits for multiple source drugs.
447.516 Upper limits for drugs furnished as part of services.
447.518 State plan requirements, findings, and assurances.
447.520 Federal Financial Participation (FFP): Conditions relating to 
          physician-administered drugs.
447.522 Optional coverage of investigational drugs and other drugs not 
          subject to rebate.

    Authority: 42 U.S.C. 1302 and 1396r-8.

    Source: 43 FR 45253, Sept. 29, 1978, unless otherwise noted.

[[Page 452]]



                 Subpart A_Payments: General Provisions



Sec.  447.1  Purpose.

    This subpart prescribes State plan requirements, FFP limitations and 
procedures concerning payments made by State Medicaid agencies for 
Medicaid services.



Sec.  447.10  Prohibition against reassignment of provider claims.

    (a) Basis and purpose. This section implements section 1902(a)(32) 
of the Act which prohibits State payments for Medicaid services to 
anyone other than a provider or beneficiary, under an assignment, power 
of attorney, or similar arrangement, except in specified circumstances.
    (b) Definitions. For purposes of this section:
    Facility means an institution that furnishes health care services to 
inpatients.
    Factor means an individual or an organization, such as a collection 
agency or service bureau, that advances money to a provider for accounts 
receivable that the provider has assigned, sold or transferred to the 
individual organization for an added fee or a deduction of a portion of 
the accounts receivable. Factor does not include a business 
representative as described in paragraph (f) of this section.
    Organized health care delivery system means a public or private 
organization for delivering health services. It includes, but is not 
limited to, a clinic, a group practice prepaid capitation plan, and a 
health maintenance organization.
    (c) State plan requirements. A State plan must provide that the 
requirements of paragraphs (d) through (h) of this section are met.
    (d) Who may receive payment. Payment may be made only--
    (1) To the provider; or
    (2) To the beneficiary if he is a noncash beneficiary eligible to 
receive the payment under Sec.  447.25; or
    (3) In accordance with paragraphs (e), (f), and (g) of this section.
    (e) Reassignments. Payment may be made in accordance with a 
reassignment from the provider to a government agency or reassignment by 
a court order.
    (f) Business agents. Payment may be made to a business agent, such 
as a billing service or an accounting firm, that furnishes statements 
and receives payments in the name of the provider, if the agent's 
compensation for this service is--
    (1) Related to the cost of processing the billing;
    (2) Not related on a percentage or other basis to the amount that is 
billed or collected; and
    (3) Not dependent upon the collection of the payment.
    (g) Individual practitioners. Payment may be made to--
    (1) The employer of the practitioner, if the practitioner is 
required as a condition of employment to turn over his fees to the 
employer;
    (2) The facility in which the service is provided, if the 
practitioner has a contract under which the facility submits the claim; 
or
    (3) A foundation, plan, or similar organization operating an 
organized health care delivery system, if the practitioner has a 
contract under which the organization submits the claim.
    (h) Prohibition of payment to factors. Payment for any service 
furnished to a beneficiary by a provider may not be made to or through a 
factor, either directly or by power of attorney.
    (i) The payment prohibition in section 1902(a)(32) of the Act and 
paragraph (d) of this section does not apply to payments to a third 
party on behalf of an individual practitioner for benefits such as 
health insurance, skills training, and other benefits customary for 
employees, in the case of a class of practitioners for which the 
Medicaid program is the primary source of revenue, if the practitioner 
voluntarily consents to such payments to third parties on the 
practitioner's behalf.

[43 FR 45253, Sept. 29, 1978, as amended at 46 FR 42672, Aug. 24, 1981; 
61 FR 38398, July 24, 1996; 79 FR 3039, Jan. 16, 2014; 84 FR 19728, May 
6, 2019; 87 FR 29690, May 16, 2022]

[[Page 453]]



Sec.  447.15  Acceptance of State payment as payment in full.

    A State plan must provide that the Medicaid agency must limit 
participation in the Medicaid program to providers who accept, as 
payment in full, the amounts paid by the agency plus any deductible, 
coinsurance or copayment required by the plan to be paid by the 
individual. The provider may only deny services to any eligible 
individual on account of the individual's inability to pay the cost 
sharing amount imposed by the plan in accordance with Sec.  447.52(e). 
The previous sentence does not apply to an individual who is able to 
pay. An individual's inability to pay does not eliminate his or her 
liability for the cost sharing charge.

[78 FR 42307, July 15, 2013]



Sec.  447.20  Provider restrictions: State plan requirements.

    A State plan must provide for the following:
    (a) In the case of an individual who is eligible for medical 
assistance under the plan for service(s) for which a third party or 
parties is liable for payment, if the total amount of the established 
liability of the third party or parties for the service is--
    (1) Equal to or greater than the amount payable under the State plan 
(which includes, when applicable, cost-sharing payments provided for in 
Sec. Sec.  447.52 through 447.54), the provider furnishing the service 
to the individual may not seek to collect from the individual (or any 
financially responsible relative or representative of that individual) 
any payment amount for that service; or
    (2) Less than the amount payable under the State plan (including 
cost sharing payments set forth in Sec. Sec.  447.52 through 447.54), 
the provider furnishing the service to that individual may collect from 
the individual (or any financially responsible relative or 
representative of the individual) an amount which is the lesser of--
    (i) Any cost-sharing payment amount imposed upon the individual 
under Sec. Sec.  447.52 through 447.54; or
    (ii) An amount which represents the difference between the amount 
payable under the State plan (which includes, where applicable, cost-
sharing payments provided for in Sec. Sec.  447.52 through 447.54) and 
the total of the established third party liability for the services.
    (b) A provider may not refuse to furnish services covered under the 
plan to an individual who is eligible for medical assistance under the 
plan on account of a third party's potential liability for the 
service(s).

[55 FR 1433, Jan. 16, 1990, as amended at 78 FR 42307, July 15, 2013]



Sec.  447.21  Reduction of payments to providers.

    If a provider seeks to collect from an individual (or any 
financially responsible relative or representative of that individual) 
an amount that exceeds an amount specified under Sec.  447.20(a)--
    (a) The Medicaid agency may provide for a reduction of any payment 
amount otherwise due to the provider in addition to any other sanction 
available to the agency; and
    (b) The reduction may be equal to up to three times the amount that 
the provider sought to collect in violation of Sec.  447.20(a).

[55 FR 1433, Jan. 16, 1990]



Sec.  447.25  Direct payments to certain beneficiaries for physicians
' or dentists' services.

    (a) Basis and purpose. This section implements section 1905(a) of 
the Act by prescribing requirements applicable to States making direct 
payments to certain beneficiaries for physicians' or dentists' services.
    (b) State plan requirements. Except for groups specified in 
paragraph (c) of this section, a State may make direct payments to 
beneficiaries for physicians' or dentists' services. If it does so, the 
State plan must--
    (1) Provide for direct payments; and
    (2) Specify the conditions under which payments are made.
    (c) Federal financial participation. No FFP is available in 
expenditures for direct payment for physicians' or dentists' services to 
any beneficiary--
    (1) Who is receiving assistance under the State's approved plan 
under title I, IV-A, X, XIV or XVI (AABD) of the Act; or

[[Page 454]]

    (2) To whom supplemental security benefits are being paid under 
title XVI of the Act; or
    (3) Who is receiving or eligible for a State supplementary payment 
or would be eligible if he were not in a medical institution, and who is 
eligible for Medicaid as a categorically needy beneficiary.
    (d) Federal requirements. (1) Direct payments to beneficiaries under 
this section are an alternative to payments directly to providers and 
are subject to the same conditions; for example, the State's reasonable 
charge schedules are applicable.
    (2) Direct payments must be supported by providers' bills for 
services.



Sec.  447.26  Prohibition on payment for provider-preventable conditions.

    (a) Basis and purpose. The purpose of this section is to protect 
Medicaid beneficiaries and the Medicaid program by prohibiting payments 
by States for services related to provider-preventable conditions.
    (1) Section 2702 of the Affordable Care Act requires that the 
Secretary exercise authority to prohibit Federal payment for certain 
provider preventable conditions (PPCs) and health care-acquired 
conditions (HCACs).
    (2) Section 1902(a)(19) of the Act requires that States provide care 
and services consistent with the best interests of the beneficiaries.
    (3) Section 1902(a)(30) of the Act requires that State payment 
methods must be consistent with efficiency, economy, and quality of 
care.
    (b) Definitions. As used in this section--
    Health care-acquired condition means a condition occurring in any 
inpatient hospital setting, identified as a HAC by the Secretary under 
section 1886(d)(4)(D)(iv) of the Act for purposes of the Medicare 
program identified in the State plan as described in section 
1886(d)(4)(D)(ii) and (iv) of the Act; other than Deep Vein Thrombosis 
(DVT)/Pulmonary Embolism (PE) as related to total knee replacement or 
hip replacement surgery in pediatric and obstetric patients.
    Other provider-preventable condition means a condition occurring in 
any health care setting that meets the following criteria:
    (i) Is identified in the State plan.
    (ii) Has been found by the State, based upon a review of medical 
literature by qualified professionals, to be reasonably preventable 
through the application of procedures supported by evidence-based 
guidelines.
    (iii) Has a negative consequence for the beneficiary.
    (iv) Is auditable.
    (v) Includes, at a minimum, wrong surgical or other invasive 
procedure performed on a patient; surgical or other invasive procedure 
performed on the wrong body part; surgical or other invasive procedure 
performed on the wrong patient.
    Provider-preventable condition means a condition that meets the 
definition of a ``health care-acquired condition'' or an ``other 
provider-preventable condition'' as defined in this section.
    (c) General rules. (1) A State plan must provide that no medical 
assistance will be paid for ``provider-preventable conditions'' as 
defined in this section; and as applicable for individuals dually 
eligible for both the Medicare and Medicaid programs.
    (2) No reduction in payment for a provider preventable condition 
will be imposed on a provider when the condition defined as a PPC for a 
particular patient existed prior to the initiation of treatment for that 
patient by that provider.
    (3) Reductions in provider payment may be limited to the extent that 
the following apply:
    (i) The identified provider-preventable conditions would otherwise 
result in an increase in payment.
    (ii) The State can reasonably isolate for nonpayment the portion of 
the payment directly related to treatment for, and related to, the 
provider-preventable conditions.
    (4) FFP will not be available for any State expenditure for 
provider-preventable conditions.
    (5) A State plan must ensure that non-payment for provider-
preventable conditions does not prevent access to services for Medicaid 
beneficiaries.
    (d) Reporting. State plans must require that providers identify 
provider-

[[Page 455]]

preventable conditions that are associated with claims for Medicaid 
payment or with courses of treatment furnished to Medicaid patients for 
which Medicaid payment would otherwise be available.

[76 FR 32837, June 6, 2011]



Sec.  447.30  Withholding the Federal share of payments to Medicaid
providers to recover Medicare overpayments.

    (a) Basis and purpose. This section implements section 1914 of the 
Act, which provides for withholding the Federal share of Medicaid 
payments to a provider if the provider has not arranged to repay 
Medicare overpayments or has failed to provide information to determine 
the amount of the overpayments. The intent of the statute and 
regulations is to facilitate the recovery of Medicare overpayments. The 
provision enables recovery of overpayments when institutions have 
reduced participation in Medicare or when physicians and suppliers have 
submitted few or no claims under Medicare, thus not receiving enough in 
Medicare reimbursement to permit offset of the overpayment.
    (b) When withholding occurs. The Federal share of Medicaid payments 
may be withheld from any provider specified in paragraph (c) of this 
section to recover Medicare overpayments that CMS has been unable to 
collect if the provider participates in Medicaid and--
    (1) The provider has not made arrangements satisfactory to CMS to 
repay the Medicare overpayment; or
    (2) CMS has been unable to collect information from the provider to 
determine the existence or amount of Medicare overpayment.
    (c) The Federal share of Medicaid payments may be withheld with 
respect to the following providers:
    (1) An institutional provider that has or previously had in effect a 
Medicare provider agreement under section 1866 of the Act; and
    (2) A Medicaid provider who has previously accepted Medicare payment 
on the basis of an assignment under section 1842(b)(3)(B)(ii) of the 
Act; and during the 12 month period preceding the quarter in which the 
Federal share is to be withheld for a Medicare overpayment, submitted no 
claims under Medicare or submitted claims which total less than the 
amount of overpayment.
    (d) Order to reduce State payment. (1) CMS may, at its discretion, 
issue an order to the Medicaid agency of any State that is using the 
provider's services, to reduce its payment to the provider by the amount 
specified in paragraph (f) of this section.
    (2) The order to reduce payment to the provider will remain in 
effect until--
    (i) The Medicaid agency determines that the overpayment has been 
completely recovered; or
    (ii) CMS terminates the order.
    (3) CMS may withhold FFP from any State that does not comply with 
the order specified in paragraph (d)(1) of this section to reduce 
payment to the provider and claims FFP for the expenditure on its 
quarterly expenditure report.
    (e) Notice of withholding. (1) Before the Federal share of payments 
may be withheld under this section, CMS will notify the provider and the 
Medicaid agency of each State that CMS believes may use the overpaid 
provider's services under Medicaid.
    (2) The notice will include the instruction to reduce State 
payments, as provided under paragraph (d) of this section.
    (3) CMS will send the notice referred to in paragraph (e)(1) by 
certified mail, return receipt requested.
    (4) Each Medicaid agency must identify the amount of payment due the 
provider under Medicaid and give that information to CMS in the next 
quarterly expenditure report.
    (5) The Medicaid agency may appeal any disallowance of FFP resulting 
from the withholding decision to the Grant Appeals Board, in accordance 
with 45 CFR part 16.
    (f) Amount to be withheld. CMS may require the Medicaid agency to 
reduce the Federal share of its payment to the provider by the lesser of 
the following amounts.
    (1) The Federal matching share of payments to the provider, or
    (2) The total Medicare overpayment to the provider.

[[Page 456]]

    (g) Effective date of withholding. Withholding of payment will 
become effective no less than 60 days after the day on which the agency 
receives notice of withholding.
    (h) Duration of withholding. No Federal funds are available in 
expenditures for services that are furnished by a provider specified in 
paragraph (c) of this section from the date on which the withholding 
becomes effective until the termination of withholding under paragraph 
(i) of this section.
    (i) Termination of withholding. (1) CMS will terminate the order to 
reduce State payment if it determines that any of the following has 
occurred:
    (i) The Medicare overpayment is completely recovered:
    (ii) The institution or person makes an agreement satisfactory to 
CMS to repay the overpayment; or
    (iii) CMS determines that there is no overpayment based on newly 
acquired evidence or a subsequent audit.
    (2) CMS will notify each State that previously received a notice 
ordering the withholding that the withholding has been terminated.
    (j) Procedures for restoring excess withholding. If an amount 
ultimately determined to be in excess of the Medicare overpayment is 
withheld, CMS will restore any excess funds withheld.
    (k) Recovery of funds from Medicaid agency. A provider is not 
entitled to recover from the Medicaid agency the amount of payment 
withheld by the agency in accordance with a CMS order issued under 
paragraph (d) of this section.

[50 FR 19688, May 10, 1985; 50 FR 23307, June 3, 1985]



Sec.  447.31  Withholding Medicare payments to recover Medicaid 
overpayments.

    (a) Basis and purpose. Section 1885 of the Act provides authority 
for CMS to withhold Medicare payments to a Medicaid provider in order to 
recover Medicaid overpayments to the provider. Section 405.377 of this 
chapter sets forth the Medicare rules implementing section 1885, and 
specifies under what circumstances withholding will occur and the 
providers that are subject to withholding. This section establishes the 
procedures that the Medicaid agency must follow when requesting that CMS 
withhold Medicare payments.
    (b) Agency notice to providers. (1) Before the agency requests 
recovery of a Medicaid overpayment through Medicare, the agency must 
send either or both of the following notices, in addition to that 
required under paragraph (b)(2) of this section, to the provider.
    (i) Notice that--
    (A) There has been an overpayment;
    (B) Repayment is required; and
    (C) The overpayment determination is subject to agency appeal 
procedures, but we may withhold Medicare payments while an appeal is in 
progress.
    (ii) Notice that--
    (A) Information is needed to determine the amount of overpayment if 
any; and
    (B) The provider has at least 30 days in which to supply the 
information to the agency.
    (2) Notice that, 30 days or later from the date of the notice, the 
agency intends to refer the case to CMS for withholding of Medicare 
payments.
    (3) The agency must send all notices to providers by certified mail, 
return receipt requested.
    (c) Documentation to be submitted to CMS. The agency must submit the 
following information or documentation to CMS (unless otherwise 
specified) with the request for withholding of Medicare payments.
    (1) A statement of the reason that withholding is requested.
    (2) The amount of overpayment, type of overpayment, date the 
overpayment was determined, and the closing date of the pertinent cost 
reporting period (if applicable).
    (3) The quarter in which the overpayment was reported on the 
quarterly expenditure report (Form CMS 64).
    (4) As needed, and upon request from CMS, the names and addresses of 
the provider's officers and owners for each period that there is an 
outstanding overpayment.
    (5) A statement of assurance that the State agency has met the 
notice requirements under paragraph (b) of this section.
    (6) As needed, and upon request for CMS, copies of notices (under 
paragraph (b) of this section), and reports of contact or attempted 
contact with

[[Page 457]]

the provider concerning the overpayment, including any reduction or 
suspension of Medicaid payments made with respect to that overpayment.
    (7) A copy of the provider's agreement with the agency under Sec.  
431.107 of this chapter.
    (d) Notification to terminate withholding. (1) If an agency has 
requested withholding under this section, it must notify CMS if any of 
the following occurs:
    (i) The Medicaid provider makes an agreement satisfactory to the 
agency to repay the overpayment;
    (ii) The Medicaid overpayment is completely recovered; or
    (iii) The agency determines that there is no overpayment, based on 
newly acquired evidence or subsequent audit.
    (2) Upon receipt of notification from the State agency, CMS will 
terminate withholding.
    (e) Accounting for returned overpayment. The agency must treat as a 
recovered overpayment the amounts received from CMS to offset Medicaid 
overpayments.
    (f) Procedures for restoring excess withholding. The agency must 
establish procedures satisfactory to CMS to assure the return to the 
provider of amounts withheld under this section that are ultimately 
determined to be in excess of overpayments. Those procedures are subject 
to CMS review.

[50 FR 19689, May 10, 1985, as amended at 61 FR 63749, Dec. 2, 1996]



Sec.  447.40  Payments for reserving beds in institutions.

    (a) The Medicaid agency may make payments to reserve a bed during a 
beneficiary's temporary absence from an inpatient facility, if--
    (1) The State plan provides for such payments and specifies any 
limitations on the policy; and
    (2) Absences for purposes other than required hospitalization (which 
cannot be anticipated and planned) are included in the patient's plan of 
care.
    (b) An agency that pays for reserved beds in an inpatient facility 
may pay less for a reserved bed than an occupied bed if there is a cost 
differential between the two beds. (Section 1102 of the Act.)

[43 FR 45253, Sept. 29, 1978, as amended at 51 FR 24491, July 3, 1986]



Sec.  447.45  Timely claims payment.

    (a) Basis and purpose. This section implements section 1902(a)(37) 
of the Act by specifying--
    (1) State plan requirements for--
    (i) Timely processing of claims for payment;
    (ii) Prepayment and postpayment claims reviews; and
    (2) Conditions under which the Administrator may grant waivers of 
the time requirements.
    (b) Definitions. Claim means (1) a bill for services, (2) a line 
item of service, or (3) all services for one beneficiary within a bill.
    Clean claim means one that can be processed without obtaining 
additional information from the provider of the service or from a third 
party. It includes a claim with errors originating in a State's claims 
system. It does not include a claim from a provider who is under 
investigation for fraud or abuse, or a claim under review for medical 
necessity.
    A shared health facility means any arrangement in which--
    (1) Two or more health care practitioners practice their professions 
at a common physical location;
    (2) The practitioners share common waiting areas, examining rooms, 
treatment rooms, or other space, the services of supporting staff, or 
equipment;
    (3) The practitioners have a person (who may himself be a 
practitioner)--
    (i) Who is in charge of, controls, manages, or supervises 
substantial aspects of the arrangement or operation for the delivery of 
health or medical services at the common physical location other than 
the direct furnishing of professional health care services by the 
practitioners to their patients; or
    (ii) Who makes available to the practitioners the services of 
supporting staff who are not employees of the practitioners; and
    (iii) Who is compensated in whole or in part, for the use of the 
common physical location or related support services, on a basis related 
to amounts charged or collected for the services

[[Page 458]]

rendered or ordered at the location or on any basis clearly unrelated to 
the value of the services provided by the person; and
    (4) At least one of the practitioners received payments on a fee-
for-service basis under titles V, XVIII, and XIX in an amount exceeding 
$5,000 for any one month during the preceding 12 months or in an 
aggregate amount exceeding $40,000 during the preceding 12 months.

The term does not include a provider of services (as specified in Sec.  
489.2(b) of this chapter), a health maintenance organization (as defined 
in section 1301(a) of the Public Health Service Act), a hospital 
cooperative shared services organization meeting the requirements of 
section 501(e) of the Internal Revenue Code of 1954, or any public 
entity.
    Third party is defined in Sec.  433.135 of this chapter.
    (c) State plan requirements. A State plan must (1) provide that the 
requirements of paragraphs (d), (e)(2), (f) and (g) of this section are 
met; and
    (2) Specify the definition of a claim, as provided in paragraph (b) 
of this section, to be used in meeting the requirements for timely 
claims payment. The definition may vary by type of service (e.g., 
physician service, hospital service).
    (d) Timely processing of claims. (1) The Medicaid agency must 
require providers to submit all claims no later than 12 months from the 
date of service.
    (2) The agency must pay 90 percent of all clean claims from 
practitioners, who are in individual or group practice or who practice 
in shared health facilities, within 30 days of the date of receipt.
    (3) The agency must pay 99 percent of all clean claims from 
practitioners, who are in individual or group practice or who practice 
in shared health facilities, within 90 days of the date of receipt.
    (4) The agency must pay all other claims within 12 months of the 
date of receipt, except in the following circumstances:
    (i) This time limitation does not apply to retroactive adjustments 
paid to providers who are reimbursed under a retrospective payment 
system, as defined in Sec.  447.272 of this part.
    (ii) If a claim for payment under Medicare has been filed in a 
timely manner, the agency may pay a Medicaid claim relating to the same 
services within 6 months after the agency or the provider receives 
notice of the disposition of the Medicare claim.
    (iii) The time limitation does not apply to claims from providers 
under investigation for fraud or abuse.
    (iv) The agency may make payments at any time in accordance with a 
court order, to carry out hearing decisions or agency corrective actions 
taken to resolve a dispute, or to extend the benefits of a hearing 
decision, corrective action, or court order to others in the same 
situation as those directly affected by it.
    (5) The date of receipt is the date the agency receives the claim, 
as indicated by its date stamp on the claim.
    (6) The date of payment is the date of the check or other form of 
payment.
    (e) Waivers. (1) The Administrator may waive the requirements of 
paragraphs (d) (2) and (3) of this section upon request by an agency if 
he finds that the agency has shown good faith in trying to meet them. In 
deciding whether the agency has shown good faith, the Administrator will 
consider whether the agency has received an unusually high volume of 
claims which are not clean claims, and whether the agency is making 
diligent efforts to implement an automated claims processing and 
information retrieval system.
    (2) The agency's request for a waiver must contain a written plan of 
correction specifying all steps it will take to meet the requirements of 
this section.
    (3) The Administrator will review each case and if he approves a 
waiver, will specify its expiration date, based on the State's 
capability and efforts to meet the requirements of this section.
    (f) Prepayment and postpayment claims review. (1) For all claims, 
the agency must conduct prepayment claims review consisting of--
    (i) Verification that the beneficiary was included in the 
eligibility file and that the provider was authorized to furnish the 
service at the time the service was furnished;
    (ii) Checks that the number of visits and services delivered are 
logically

[[Page 459]]

consistent with the beneficiary's characteristics and circumstances, 
such as type of illness, age, sex, service location;
    (iii) Verification that the claim does not duplicate or conflict 
with one reviewed previously or currently being reviewed;
    (iv) Verification that a payment does not exceed any reimbursement 
rates or limits in the State plan; and
    (v) Checks for third party liability within the requirements of 
Sec.  433.137 of this chapter.
    (2) The agency must conduct post-payment claims review that meets 
the requirements of parts 455 and 456 of this chapter, dealing with 
fraud and utilization control.
    (g) Reports. The agency must provide any reports and documentation 
on compliance with this section that the Administrator may require.

(Secs. 1102 and 1902(a)(37) of the Social Security Act (42 U.S.C. 1302, 
1396a(a)(37)))

[44 FR 30344, May 25, 1979, as amended at 55 FR 1434, Jan. 16, 1990]



Sec.  447.46  Timely claims payment by MCOs.

    (a) Basis and scope. This section implements section 1932(f) of the 
Act by specifying the rules and exceptions for prompt payment of claims 
by MCOs.
    (b) Definitions. ``Claim'' and ``clean claim'' have the meaning 
given those terms in Sec.  447.45.
    (c) Contract requirements--(1) Basic rule. A contract with an MCO 
must provide that the organization will meet the requirements of Sec.  
447.45(d)(2) and (d)(3), and abide by the specifications of Sec.  
447.45(d)(5) and (d)(6).
    (2) Exception. The MCO and its providers may, by mutual agreement, 
establish an alternative payment schedule.
    (3) Alternative schedule. Any alternative schedule must be 
stipulated in the contract.

[67 FR 41115, June 14, 2002]

                   Medicaid Premiums and Cost Sharing

    Source: 78 FR 42307, July 15, 2013, unless otherwise noted.



Sec.  447.50  Premiums and cost sharing: Basis and purpose.

    Sections 1902(a)(14), 1916 and 1916A of the Act permit states to 
require certain beneficiaries to share in the costs of providing medical 
assistance through premiums and cost sharing. Sections 447.52 through 
447.56 specify the standards and conditions under which states may 
impose such premiums and or cost sharing.



Sec.  447.51  Definitions.

    As used in this part--
    Alternative non-emergency services provider means a Medicaid 
provider, such as a physician's office, health care clinic, community 
health center, hospital outpatient department, or similar provider that 
can provide clinically appropriate services in a timely manner.
    Contract health service means any health service that is:
    (1) Delivered based on a referral by, or at the expense of, an 
Indian health program; and
    (2) Provided by a public or private medical provider or hospital 
that is not a provider or hospital of the IHS or any other Indian health 
program
    Cost sharing means any copayment, coinsurance, deductible, or other 
similar charge.
    Emergency services has the same meaning as in Sec.  438.114 of this 
chapter.
    Federal poverty level (FPL) means the Federal poverty level updated 
periodically in the Federal Register by the Secretary of Health and 
Human Services under the authority of 42 U.S.C. 9902(2).
    Indian means any individual defined at 25 U.S.C. 1603(13), 1603(28), 
or 1679(a), or who has been determined eligible as an Indian, under 42 
CFR 136.12. This means the individual:
    (1) Is a member of a Federally-recognized Indian tribe;
    (2) Resides in an urban center and meets one or more of the 
following four criteria:
    (i) Is a member of a tribe, band, or other organized group of 
Indians, including those tribes, bands, or groups terminated since 1940 
and those recognized now or in the future by the State in which they 
reside, or who is a descendant, in the first or second degree, of any 
such member;

[[Page 460]]

    (ii) Is an Eskimo or Aleut or other Alaska Native;
    (iii) Is considered by the Secretary of the Interior to be an Indian 
for any purpose; or
    (iv) Is determined to be an Indian under regulations promulgated by 
the Secretary;
    (3) Is considered by the Secretary of the Interior to be an Indian 
for any purpose; or
    (4) Is considered by the Secretary of Health and Human Services to 
be an Indian for purposes of eligibility for Indian health care 
services, including as a California Indian, Eskimo, Aleut, or other 
Alaska Native.
    Indian health care provider means a health care program operated by 
the Indian Health Service (IHS) or by an Indian Tribe, Tribal 
Organization, or Urban Indian Organization (otherwise known as an I/T/U) 
as those terms are defined in section 4 of the Indian Health Care 
Improvement Act (25 U.S.C. 1603).
    Inpatient stay means the services received during a continuous 
period of inpatient days in either a single medical institution or 
multiple medical institutions, and also includes a return to an 
inpatient medical institution after a brief period when the return is 
for treatment of a condition that was present in the initial period. 
Inpatient has the same meaning as in Sec.  440.2 of this chapter.
    Non-emergency services means any care or services that are not 
considered emergency services as defined in this section. This does not 
include any services furnished in a hospital emergency department that 
are required to be provided as an appropriate medical screening 
examination or stabilizing examination and treatment under section 1867 
of the Act.
    Outpatient services for purposes of imposing cost sharing means any 
service or supply not meeting the definition of an inpatient stay.
    Preferred drugs means drugs that the state has identified on a 
publicly available schedule as being determined by a pharmacy and 
therapeutics committee for clinical efficacy as the most cost effective 
drugs within each therapeutically equivalent or therapeutically similar 
class of drugs, or all drugs within such a class if the agency does not 
differentiate between preferred and non-preferred drugs.
    Premium means any enrollment fee, premium, or other similar charge.



Sec.  447.52  Cost sharing.

    (a) Applicability. Except as provided in Sec.  447.56(a) 
(exemptions), the agency may impose cost sharing for any service under 
the state plan.
    (b) Maximum Allowable Cost Sharing. (1) At State option, cost 
sharing imposed for any service (other than for drugs and non-emergency 
services furnished in an emergency department, as described in 
Sec. Sec.  447.53 and 447.54 respectively) may be established at or 
below the amounts shown in the following table (except that the maximum 
allowable cost sharing for individuals with family income at or below 
100 percent of the FPL shall be increased each year, beginning October 
1, 2015, by the percentage increase in the medical care component of the 
CPI-U for the period of September to September of the preceding calendar 
year, rounded to the next higher 5-cent increment):

----------------------------------------------------------------------------------------------------------------
                                                              Maximum allowable cost sharing
                                        ------------------------------------------------------------------------
                Services                  Individuals with   Individuals with family    Individuals with family
                                           family income      income 101-150% of the   income 150% of
                                         <=100% of the FPL             FPL                      the FPL
----------------------------------------------------------------------------------------------------------------
Outpatient Services (physician visit,                   $4  10% of cost the agency     20% of cost the agency
 physical therapy, etc.).                                    pays.                      pays.
Inpatient Stay.........................                 75  10% of total cost the      20% of total cost the
                                                             agency pays for the        agency pays for the
                                                             entire stay.               entire stay.
----------------------------------------------------------------------------------------------------------------

    (2) States with cost sharing for an inpatient stay that exceeds $75, 
as of July 15, 2013, must submit a plan to CMS that provides for 
reducing inpatient cost sharing to $75 on or before July 1, 2017.

[[Page 461]]

    (3) In states that do not have fee-for-service payment rates, any 
cost sharing imposed on individuals at any income level may not exceed 
the maximum amount established, for individuals with income at or below 
100 percent of the FPL described in paragraph (b)(1) of this section.
    (c) Maximum cost sharing. In no case shall the maximum cost sharing 
established by the agency be equal to or exceed the amount the agency 
pays for the service.
    (d) Targeted cost sharing. (1) Except as provided in paragraph 
(d)(2) of this section, the agency may target cost sharing to specified 
groups of individuals with family income above 100 percent of the FPL.
    (2) For cost sharing imposed for non-preferred drugs under Sec.  
447.53 and for non-emergency services provided in a hospital emergency 
department under Sec.  447.54, the agency may target cost sharing to 
specified groups of individuals regardless of income.
    (e) Denial of service for nonpayment. (1) The agency may permit a 
provider, including a pharmacy or hospital, to require an individual to 
pay cost sharing as a condition for receiving the item or service if--
    (i) The individual has family income above 100 percent of the FPL,
    (ii) The individual is not part of an exempted group under Sec.  
447.56(a), and
    (iii) For cost sharing imposed for non-emergency services furnished 
in an emergency department, the conditions under Sec.  447.54(d) of this 
part have been satisfied.
    (2) Except as provided under paragraph (e)(1) of this section, the 
state plan must specify that no provider may deny services to an 
eligible individual on account of the individual's inability to pay the 
cost sharing.
    (3) Nothing in this section shall be construed as prohibiting a 
provider from choosing to reduce or waive such cost sharing on a case-
by-case basis.
    (f) Prohibition against multiple charges. For any service, the 
agency may not impose more than one type of cost sharing.
    (g) Income-related charges. Subject to the maximum allowable charges 
specified in Sec. Sec.  447.52(b), 447.53(b) and 447.54(b), the plan may 
establish different cost sharing charges for individuals at different 
income levels. If the agency imposes such income-related charges, it 
must ensure that lower income individuals are charged less than 
individuals with higher income.
    (h) Services furnished by a managed care organization (MCO). 
Contracts with MCOs must provide that any cost-sharing charges the MCO 
imposes on Medicaid enrollees are in accordance with the cost sharing 
specified in the state plan and the requirements set forth in Sec. Sec.  
447.50 through 447.57.
    (i) State Plan Specifications. For each cost sharing charge imposed 
under this part, the state plan must specify--
    (1) The service for which the charge is made;
    (2) The group or groups of individuals that may be subject to the 
charge;
    (3) The amount of the charge;
    (4) The process used by the state to--
    (i) Ensure individuals exempt from cost sharing are not charged,
    (ii) Identify for providers whether cost sharing for a specific item 
or service may be imposed on an individual and whether the provider may 
require the individual, as a condition for receiving the item or 
service, to pay the cost sharing charge; and
    (5) If the agency imposes cost sharing under Sec.  447.54, the 
process by which hospital emergency room services are identified as non-
emergency service.



Sec.  447.53  Cost sharing for drugs.

    (a) The agency may establish differential cost sharing for preferred 
and non-preferred drugs. The provisions in Sec.  447.56(a) shall apply 
except as the agency exercises the option under paragraph (d) of this 
section. All drugs will be considered preferred drugs if so identified 
or if the agency does not differentiate between preferred and non-
preferred drugs.
    (b) At state option, cost sharing for drugs may be established at or 
below the amounts shown in the following table (except that the maximum 
allowable cost sharing shall be increased each year, beginning October 
1, 2015, by the percentage increase in the medical care component of the 
CPI-U for the period of September to September of the preceding calendar 
year, rounded to the next higher 5-cent increment.

[[Page 462]]

Such increase shall not be applied to any cost sharing that is based on 
the amount the agency pays for the service):

----------------------------------------------------------------------------------------------------------------
                                                            Maximum allowable cost sharing
                                    ----------------------------------------------------------------------------
              Services                Individuals with
                                       family income      Individuals with family income 150% of the
                                     <=150% of the FPL                             FPL
----------------------------------------------------------------------------------------------------------------
Preferred Drugs....................                 $4  $4.
Non-Preferred Drugs................                  8  20% of the cost the agency pays.
----------------------------------------------------------------------------------------------------------------

    (c) In states that do not have fee-for-service payment rates, cost 
sharing for prescription drugs imposed on individuals at any income 
level may not exceed the maximum amount established for individuals with 
income at or below 150 percent of the FPL in paragraph (b) of this 
section.
    (d) For individuals otherwise exempt from cost sharing under Sec.  
447.56(a), the agency may impose cost sharing for non-preferred drugs, 
not to exceed the maximum amount established in paragraph (b) of this 
section.
    (e) In the case of a drug that is identified by the agency as a non-
preferred drug within a therapeutically equivalent or therapeutically 
similar class of drugs, the agency must have a timely process in place 
so that cost sharing is limited to the amount imposed for a preferred 
drug if the individual's prescribing provider determines that a 
preferred drug for treatment of the same condition either will be less 
effective for the individual, will have adverse effects for the 
individual, or both. In such cases the agency must ensure that 
reimbursement to the pharmacy is based on the appropriate cost sharing 
amount.



Sec.  447.54  Cost sharing for services furnished in a hospital
emergency department.

    (a) The agency may impose cost sharing for non-emergency services 
provided in a hospital emergency department. The provisions in Sec.  
447.56(a) shall apply except as the agency exercises the option under 
paragraph (c) of this section.
    (b) At state option, cost sharing for non-emergency services 
provided in an emergency department may be established at or below the 
amounts shown in the following table (except that the maximum allowable 
cost sharing identified for individuals with family income at or below 
150 percent of the FPL shall be increased each year, beginning October 
1, 2015, by the percentage increase in the medical care component of the 
CPI-U for the period of September to September of the preceding calendar 
year, rounded to the next higher 5-cent increment):

------------------------------------------------------------------------
                                    Maximum allowable cost sharing
                             -------------------------------------------
                                                      Individuals with
          Services              Individuals with     family income 150% of the
                                   of the FPL                FPL
------------------------------------------------------------------------
Non-emergency Use of the      $8..................  No Limit.
 Emergency Department.
------------------------------------------------------------------------

    (c) For individuals otherwise exempt from cost sharing under Sec.  
447.56(a), the agency may impose cost sharing for non-emergency use of 
the emergency department, not to exceed the maximum amount established 
in paragraph (b) of this section for individuals with income at or below 
150 percent of the FPL.
    (d) For the agency to impose cost sharing under paragraph (a) or (c) 
of this section for non-emergency use of the emergency department, the 
hospital providing the care must--
    (1) Conduct an appropriate medical screening under Sec.  489.24 
subpart G to determine that the individual does not need emergency 
services.
    (2) Before providing non-emergency services and imposing cost 
sharing for such services:

[[Page 463]]

    (i) Inform the individual of the amount of his or her cost sharing 
obligation for non-emergency services provided in the emergency 
department;
    (ii) Provide the individual with the name and location of an 
available and accessible alternative non-emergency services provider;
    (iii) Determine that the alternative provider can provide services 
to the individual in a timely manner with the imposition of a lesser 
cost sharing amount or no cost sharing if the individual is otherwise 
exempt from cost sharing; and
    (iv) Provide a referral to coordinate scheduling for treatment by 
the alternative provider.
    (e) Nothing in this section shall be construed to:
    (1) Limit a hospital's obligations for screening and stabilizing 
treatment of an emergency medical condition under section 1867 of the 
Act; or
    (2) Modify any obligations under either state or federal standards 
relating to the application of a prudent-layperson standard for payment 
or coverage of emergency medical services by any managed care 
organization.



Sec.  447.55  Premiums.

    (a) The agency may impose premiums upon individuals whose income 
exceeds 150 percent of the FPL, subject to the exemptions set forth in 
Sec.  447.56(a) and the aggregate limitations set forth in Sec.  
447.56(f) of this part, except that:
    (1) Pregnant women described in described in paragraph (a)(1)(ii) of 
this section may be charged premiums that do not exceed 10 percent of 
the amount by which their family income exceeds 150 percent of the FPL 
after deducting expenses for care of a dependent child.
    (i) The agency may use state or local funds available under other 
programs for payment of a premium for such pregnant women. Such funds 
shall not be counted as income to the individual for whom such payment 
is made.
    (ii) Pregnant women described in this clause include pregnant women 
eligible for Medicaid under Sec.  435.116 of this chapter whose income 
exceeds the higher of -
    (A) 150 percent FPL; and
    (B) If applicable, the percent FPL described in section 
1902(l)(2)(A)(iv) of the Act up to 185 percent FPL.
    (2) Individuals provided medical assistance only under sections 
1902(a)(10)(A)(ii)(XV) or 1902(a)(10)(A)(ii)(XVI) of the Act and the 
Ticket to Work and Work Incentives Improvement Act of 1999 (TWWIIA), may 
be charged premiums on a sliding scale based on income.
    (3) Disabled children provided medical assistance under section 
1902(a)(10)(A)(ii)(XIX) of the Act in accordance with the Family 
Opportunity Act, may be charged premiums on a sliding scale based on 
income. The aggregate amount of the child's premium imposed under this 
paragraph and any premium that the parent is required to pay for family 
coverage under section 1902(cc)(2)(A)(i) of the Act, and other cost 
sharing charges may not exceed:
    (i) 5 percent of the family's income if the family's income is no 
more than 200 percent of the FPL.
    (ii) 7.5 percent of the family's income if the family's income 
exceeds 200 percent of the FPL but does not exceed 300 percent of the 
FPL.
    (4) Qualified disabled and working individuals described in section 
1905(s) of the Act, whose income exceeds 150 percent of the FPL, may be 
charged premiums on a sliding scale based on income, expressed as a 
percentage of Medicare cost sharing described at section 
1905(p)(3)(A)(i) of the Act.
    (5) Medically needy individuals, as defined in Sec. Sec.  435.4 and 
436.3 of this chapter, may be charged on a sliding scale. The agency 
must impose an appropriately higher charge for each higher level of 
family income, not to exceed $20 per month for the highest level of 
family income.
    (b) Consequences for non-payment. (1) For premiums imposed under 
paragraphs (a)(1), (a)(2), (a)(3) and (a)(4) of this section, the agency 
may not require a group or groups of individuals to prepay.
    (2) Except for premiums imposed under paragraph (a)(5) of this 
section, the agency may terminate an individual from medical assistance 
on the basis of failure to pay for 60 days or more.

[[Page 464]]

    (3) For premiums imposed under paragraph (a)(2) of this section--
    (i) For individuals with annual income exceeding 250 percent of the 
FPL, the agency may require payment of 100 percent of the premiums 
imposed under this paragraph for a year, such that payment is only 
required up to 7.5 percent of annual income for individuals whose annual 
income does not exceed 450 percent of the FPL.
    (ii) For individuals whose annual adjusted gross income (as defined 
in section 62 of the Internal Revenue Code of 1986) exceeds $75,000, 
increased by inflation each calendar year after 2000, the agency must 
require payment of 100 percent of the premiums for a year, except that 
the agency may choose to subsidize the premiums using state funds which 
may not be federally matched by Medicaid.
    (4) For any premiums imposed under this section, the agency may 
waive payment of a premium in any case where the agency determines that 
requiring the payment will create an undue hardship for the individual 
or family.
    (5) The agency may not apply further consequences or penalties for 
non-payment other than those listed in this section.
    (c) State plan specifications. For each premium, enrollment fee, or 
similar charge imposed under paragraph (a) of this section, subject to 
the requirements of paragraph (b) of this section, the plan must 
specify--
    (1) The group or groups of individuals that may be subject to the 
charge;
    (2) The amount and frequency of the charge;
    (3) The process used by the state to identify which beneficiaries 
are subject to premiums and to ensure individuals exempt from premiums 
are not charged; and
    (4) The consequences for an individual or family who does not pay.



Sec.  447.56  Limitations on premiums and cost sharing.

    (a) Exemptions. (1) The agency may not impose premiums or cost 
sharing upon the following groups of individuals:
    (i) Individuals ages 1 and older and under age 18 eligible under 
Sec.  435.118 of this chapter.
    (ii) Infants under age 1 eligible under Sec.  435.118 of this 
chapter whose income does not exceed the higher of--
    (A) 150 percent FPL (for premiums) or 133 percent FPL (for cost 
sharing); and
    (B) If applicable, the percent FPL described in section 
1902(l)(2)(A)(iv) of the Act up to 185 percent FPL.
    (iii) Individuals under age 18 eligible under Sec. Sec.  435.120-
435.122 or Sec.  435.130 of this chapter.
    (iv) Children for whom child welfare services are made available 
under Part B of title IV of the Act on the basis of being a child in 
foster care and individuals receiving benefits under Part E of that 
title, without regard to age.
    (v) At state option, individuals under age 19, 20 or age 21, 
eligible under Sec.  435.222 of this chapter.
    (vi) Disabled children, except as provided at Sec.  447.55(a)(4) 
(premiums), who are receiving medical assistance by virtue of the 
application of the Family Opportunity Act in accordance with sections 
1902(a)(10)(A)(ii)(XIX) and 1902(cc) of the Act.
    (vii) Pregnant women, except for premiums allowed under Sec.  
447.55(a)(1) and cost sharing for services specified in the state plan 
as not pregnancy-related, during the pregnancy and through the 
postpartum period which begins on the last day of pregnancy and extends 
through the end of the month in which the 60-day period following 
termination of pregnancy ends.
    (viii) Any individual whose medical assistance for services 
furnished in an institution, or at state option in a home and community-
based setting, is reduced by amounts reflecting available income other 
than required for personal needs.
    (ix) An individual receiving hospice care, as defined in section 
1905(o) of the Act.
    (x) An Indian who is eligible to receive or has received an item or 
service furnished by an Indian health care provider or through referral 
under contract health services is exempt from premiums. Indians who are 
currently receiving or have ever received an item or service furnished 
by an Indian

[[Page 465]]

health care provider or through referral under contract health services 
are exempt from all cost sharing.
    (xi) Individuals who are receiving Medicaid because of the state's 
election to extend coverage as authorized by Sec.  435.213 of this 
chapter (Breast and Cervical Cancer).
    (2) The agency may not impose cost sharing for the following 
services:
    (i) Emergency services as defined at section 1932(b)(2) of the Act 
and Sec.  438.114(a) of this chapter;
    (ii) Family planning services and supplies described in section 
1905(a)(4)(C) of the Act, including contraceptives and pharmaceuticals 
for which the State claims or could claim Federal match at the enhanced 
rate under section 1903(a)(5) of the Act for family planning services 
and supplies;
    (iii) Preventive services, at a minimum the services specified at 
Sec.  457.520 of chapter D, provided to children under 18 years of age 
regardless of family income, which reflect the well-baby and well child 
care and immunizations in the Bright Futures guidelines issued by the 
American Academy of Pediatrics; and
    (iv) Pregnancy-related services, including those defined at 
Sec. Sec.  440.210(a)(2) and 440.250(p) of this chapter, and counseling 
and drugs for cessation of tobacco use All services provided to pregnant 
women will be considered as pregnancy-related, except those services 
specifically identified in the state plan as not being related to the 
pregnancy.
    (v) Provider-preventable services as defined in Sec.  447.26(b).
    (b) Applicability. Except as permitted under Sec.  447.52(d) 
(targeted cost sharing), the agency may not exempt additional 
individuals from cost sharing obligations that apply generally to the 
population at issue.
    (c) Payments to providers. (1) Except as provided under paragraphs 
(c)(2) and (c)(3) of this section, the agency must reduce the payment it 
makes to a provider by the amount of a beneficiary's cost sharing 
obligation, regardless of whether the provider has collected the payment 
or waived the cost sharing.
    (2) For items and services provided to Indians who are exempt from 
cost sharing under paragraph (a)(1)(x) of this section, the agency may 
not reduce the payment it makes to a provider, including an Indian 
health care provider, by the amount of cost sharing that will otherwise 
be due from the Indian.
    (3) For those providers that the agency reimburses under Medicare 
reasonable cost reimbursement principles, in accordance with subpart B 
of this part, an agency may increase its payment to offset uncollected 
cost sharing charges that are bad debts of providers.
    (d) Payments to managed care organizations. If the agency contracts 
with a managed care organization, the agency must calculate its payments 
to the organization to include cost sharing established under the state 
plan, for beneficiaries not exempt from cost sharing under paragraph (a) 
of this section, regardless of whether the organization imposes the cost 
sharing on its recipient members or the cost sharing is collected.
    (e) Payments to states. No FFP in the state's expenditures for 
services is available for--
    (1) Any premiums or cost sharing amounts that recipients should have 
paid under Sec. Sec.  447.52 through 447.55 (except for amounts that the 
agency pays as bad debts of providers under paragraph (c)(3) of this 
section; and
    (2) Any amounts paid by the agency on behalf of ineligible 
individuals, whether or not the individual had paid any required 
premium, except for amounts for premium assistance to obtain coverage 
for eligible individuals through family coverage that may include 
ineligible individuals when authorized in the approved state plan.
    (f) Aggregate limits. (1) Medicaid premiums and cost sharing 
incurred by all individuals in the Medicaid household may not exceed an 
aggregate limit of 5 percent of the family's income applied on either a 
quarterly or monthly basis, as specified by the agency.
    (2) If the state adopts premiums or cost sharing rules that could 
place beneficiaries at risk of reaching the aggregate family limit, the 
state plan must indicate a process to track each family's incurred 
premiums and cost sharing through an effective mechanism that does not 
rely on beneficiary documentation.

[[Page 466]]

    (3) The agency must inform beneficiaries and providers of the 
beneficiaries aggregate limit and notify beneficiaries and providers 
when a beneficiary has incurred out-of-pocket expenses up to the 
aggregate family limit and individual family members are no longer 
subject to cost sharing for the remainder of the family's current 
monthly or quarterly cap period.
    (4) The agency must have a process in place for beneficiaries to 
request a reassessment of their family aggregate limit if they have a 
change in circumstances or if they are being terminated for failure to 
pay a premium.
    (5) Nothing in paragraph (f) shall preclude the agency from 
establishing additional aggregate limits, including but not limited to a 
monthly limit on cost sharing charges for a particular service.



Sec.  447.57  Beneficiary and public notice requirements.

    (a) The agency must make available a public schedule describing 
current premiums and cost sharing requirements containing the following 
information:
    (1) The group or groups of individuals who are subject to premiums 
and/or cost sharing and the current amounts;
    (2) Mechanisms for making payments for required premiums and cost 
sharing charges;
    (3) The consequences for an applicant or recipient who does not pay 
a premium or cost sharing charge;
    (4) A list of hospitals charging cost sharing for non-emergency use 
of the emergency department; and
    (5) A list of preferred drugs or a mechanism to access such a list, 
including the agency Web site.
    (b) The agency must make the public schedule available to the 
following in a manner that ensures that affected applicants, 
beneficiaries, and providers are likely to have access to the notice:
    (1) Beneficiaries, at the time of their enrollment and reenrollment 
after a redetermination of eligibility, and when premiums, cost sharing 
charges, or aggregate limits are revised, notice to beneficiaries must 
be in accordance with Sec.  435.905(b) of this chapter;
    (2) Applicants, at the time of application;
    (3) All participating providers; and
    (4) The general public.
    (c) Prior to submitting to the Centers for Medicare & Medicaid 
Services for approval a state plan amendment (SPA) to establish or 
substantially modify existing premiums or cost sharing, or change the 
consequences for non-payment, the agency must provide the public with 
advance notice of the SPA, specifying the amount of premiums or cost 
sharing and who is subject to the charges. The agency must provide a 
reasonable opportunity to comment on such SPAs. The agency must submit 
documentation with the SPA to demonstrate that these requirements were 
met. If premiums or cost sharing is substantially modified during the 
SPA approval process, the agency must provide additional public notice.



Sec.  447.88  Options for claiming FFP payment for section 1920A 
presumptive eligibility medical assistance payments.

    (a) The FMAP rate for medical assistance payments made available to 
a child during a presumptive eligibility period under section 1920A of 
the Act is the regular FMAP under title XIX, based on the category of 
medical assistance; that is, the enhanced FMAP is not available for 
section 1920A presumptive eligibility expenditures.
    (b) States have the following 3 options for identifying Medicaid 
section 1920A presumptive eligibility expenditures and the application 
of payments for those expenditures:
    (1) A State may identify Medicaid section 1920A presumptive 
eligibility expenditures in the quarter expended with no further 
adjustment based on the results of a subsequent actual eligibility 
determination (if any).
    (2) A State may identify Medicaid section 1920A presumptive 
eligibility expenditures in the quarter expended but may adjust reported 
expenditures based on results of the actual eligibility determination 
(if any) to reflect the actual eligibility status of the individual, if 
other than presumptively eligible.

[[Page 467]]

    (3) A State may elect to delay submission of claims for payments of 
section 1920A presumptive eligibility expenditures until after the 
actual eligibility determination (if any) is made and, at that time 
identify such expenditures based on the actual eligibility status of 
individuals if other than presumptively eligible. At that time, the 
State would, as appropriate, recategorize the medical assistance 
expenditures made during the section 1920A presumptive eligibility 
period based on the results of the actual eligibility determination, and 
claim them appropriately.

[65 FR 33622, May 24, 2000]



Sec.  447.90  FFP: Conditions related to pending investigations of 
credible allegations of fraud against the Medicaid program.

    (a) Basis and purpose. This section implements section 1903(i)(2)(C) 
of the Act which prohibits payment of FFP with respect to items or 
services furnished by an individual or entity with respect to which 
there is pending an investigation of a credible allegation of fraud 
except under specified circumstances.
    (b) Denial of FFP. No FFP is available with respect to any amount 
expended for an item or service furnished by any individual or entity to 
whom a State has failed to suspend payments in whole or part as required 
by Sec.  455.23 of this chapter unless--
    (1) The item or service is furnished as an emergency item or 
service, but not including items or services furnished in an emergency 
room of a hospital; or
    (2) The State determines and documents that good cause as specified 
at Sec.  455.23(e) or (f) of this chapter exists not to suspend such 
payments, to suspend payments only in part, or to discontinue a 
previously imposed payment suspension.

[76 FR 5965, Feb. 2, 2011]



              Subpart B_Payment Methods: General Provisions



Sec.  447.200  Basis and purpose.

    This subpart prescribes State plan requirements for setting payment 
rates to implement, in part, section 1902(a)(30) of the Act, which 
requires that payments for services be consistent with efficiency, 
economy, and quality of care.

[46 FR 48560, Oct. 1, 1981]



Sec.  447.201  State plan requirements.

    (a) A State plan must provide that the requirements in this subpart 
are met.
    (b) The plan must describe the policy and the methods to be used in 
setting payment rates for each type of service included in the State's 
Medicaid program.



Sec.  447.202  Audits.

    The Medicaid agency must assure appropriate audit of records if 
payment is based on costs of services or on a fee plus cost of 
materials.



Sec.  447.203  Documentation of access to care and service payment rates.

    (a) The agency must maintain documentation of payment rates and make 
it available to HHS upon request.
    (b) In consultation with the medical care advisory committee under 
Sec.  431.12 of this chapter, the agency must develop a medical 
assistance access monitoring review plan and update it, in accordance 
with the timeline established in paragraph (b)(5) of this section. The 
plan must be published and made available to the public for review and 
comment for a period of no less than 30 days, prior to being finalized 
and submitted to CMS for review.
    (1) Access monitoring review plan data requirements. The access 
monitoring review plan must include an access monitoring analysis that 
includes: Data sources, methodologies, baselines, assumptions, trends 
and factors, and thresholds that analyze and inform determinations of 
the sufficiency of access to care which may vary by geographic location 
within the state and will be used to inform state policies affecting 
access to Medicaid services such as provider payment rates, as well as 
the items specified in this section. The access monitoring review plan 
must specify data elements that will support the state's analysis of 
whether beneficiaries have sufficient access to care. The plan and 
monitoring analysis will consider:

[[Page 468]]

    (i) The extent to which beneficiary needs are fully met;
    (ii) The availability of care through enrolled providers to 
beneficiaries in each geographic area, by provider type and site of 
service;
    (iii) Changes in beneficiary utilization of covered services in each 
geographic area.
    (iv) The characteristics of the beneficiary population (including 
considerations for care, service and payment variations for pediatric 
and adult populations and for individuals with disabilities); and
    (v) Actual or estimated levels of provider payment available from 
other payers, including other public and private payers, by provider 
type and site of service.
    (2) Access monitoring review plan beneficiary and provider input. 
The access monitoring review plan must include an analysis of data and 
the state's conclusion of the sufficiency of access to care that will 
consider relevant provider and beneficiary information, including 
information obtained through public rate-setting processes, the medical 
care advisory committees established under Sec.  431.12 of this chapter, 
the processes described in paragraph (b)(7) of this section, and other 
mechanisms (such as letters from providers and beneficiaries to State or 
Federal officials), which describe access to care concerns or 
suggestions for improvement in access to care.
    (3) Access monitoring review plan comparative payment rate review. 
For each of the services reviewed, by the provider types and sites of 
service (e.g., primary care physicians in office settings) described 
within the access monitoring analysis, the access monitoring review plan 
must include an analysis of the percentage comparison of Medicaid 
payment rates to other public (including, as practical, Medicaid managed 
care rates) and private health insurer payment rates within geographic 
areas of the state.
    (4) Access monitoring review plan standards and methodologies. The 
access monitoring review plan and analysis must, at a minimum, include: 
The specific measures that the state uses to analyze access to care 
(such as, but not limited to: Time and distance standards, providers 
participating in the Medicaid program, providers with open panels, 
providers accepting new Medicaid beneficiaries, service utilization 
patterns, identified beneficiary needs, data on beneficiary and provider 
feedback and suggestions for improvement, the availability of 
telemedicine and telehealth, and other similar measures), how the 
measures relate to the access monitoring review plan described in 
paragraph (b)(1) of this section, baseline and updated data associated 
with the measures, any issues with access that are discovered as a 
result of the review, and the state agency's recommendations on the 
sufficiency of access to care based on the review. In addition, the 
access monitoring review plan must include procedures to periodically 
monitor access for at least 3 years after the implementation of a 
provider rate reduction or restructuring, as discussed in paragraph 
(b)(6)(ii) of this section.
    (5) Access monitoring review plan timeframe. Beginning October 1, 
2016 the State agency must:
    (i) Develop its access monitoring review plan by October 1 of the 
first review year, and update this plan by October 1 of each subsequent 
review period;
    (ii) For all of the following, complete an analysis of the data 
collected using the methodology specified in the access monitoring 
review plan in paragraphs (b)(1) through (4) of this section, with a 
separate analysis for each provider type and site of service furnishing 
the type of service at least once every 3 years:
    (A) Primary care services (including those provided by a physician, 
FQHC, clinic, or dental care).
    (B) Physician specialist services (for example, cardiology, urology, 
radiology).
    (C) Behavioral health services (including mental health and 
substance use disorder).
    (D) Pre- and post-natal obstetric services including labor and 
delivery.
    (E) Home health services.
    (F) Any additional types of services for which a review is required 
under paragraph (b)(6) of this section;
    (G) Additional types of services for which the state or CMS has 
received a

[[Page 469]]

significantly higher than usual volume of beneficiary, provider or other 
stakeholder access complaints for a geographic area, including 
complaints received through the mechanisms for beneficiary input 
consistent with paragraph (b)(7) of this section; and
    (H) Additional types of services selected by the state.
    (6) Special provisions for proposed provider rate reductions or 
restructuring--(i) Compliance with access requirements. The State shall 
submit with any State plan amendment that proposes to reduce provider 
payment rates or restructure provider payments in circumstances when the 
changes could result in diminished access, an access review, in 
accordance with the access monitoring review plan, for each service 
affected by the State plan amendments as described under paragraph 
(b)(1) of this section completed within the prior 12 months. That access 
review must demonstrate sufficient access for any service for which the 
state agency proposes to reduce payment rates or restructure provider 
payments to demonstrate compliance with the access requirements at 
section 1902(a)(30)(A) of the Act.
    (ii) Monitoring procedures. In addition to the analysis conducted 
through paragraphs (b)(1) through (4) of this section that demonstrates 
access to care is sufficient as of the effective date of the State plan 
amendment, a state must establish procedures in its access monitoring 
review plan to monitor continued access to care after implementation of 
state plan service rate reduction or payment restructuring. The 
frequency of monitoring should be informed by the public review 
described in paragraph (b) of this section and should be conducted no 
less frequently than annually.
    (A) The procedures must provide for a periodic review of state 
determined and clearly defined measures, baseline data, and thresholds 
that will serve to demonstrate continued sustained service access, 
consistent with efficiency, economy, and quality of care.
    (B) The monitoring procedures must be in place for a period of at 
least 3 years after the effective date of the state plan amendment that 
authorizes the payment reductions or restructuring.
    (7) Mechanisms for ongoing beneficiary and provider input. (i) 
States must have ongoing mechanisms for beneficiary and provider input 
on access to care (through hotlines, surveys, ombudsman, review of 
grievance and appeals data, or another equivalent mechanisms), 
consistent with the access requirements and public process described in 
Sec.  447.204.
    (ii) States should promptly respond to public input through these 
mechanisms citing specific access problems, with an appropriate 
investigation, analysis, and response.
    (iii) States must maintain a record of data on public input and how 
the state responded to this input. This record will be made available to 
CMS upon request.
    (8) Addressing access questions and remediation of inadequate access 
to care. When access deficiencies are identified, the state must, within 
90 days after discovery, submit a corrective action plan with specific 
steps and timelines to address those issues. While the corrective action 
plan may include longer-term objectives, remediation of the access 
deficiency should take place within 12 months.
    (i) The state's corrective actions may address the access 
deficiencies through a variety of approaches, including, but not limited 
to: Increasing payment rates, improving outreach to providers, reducing 
barriers to provider enrollment, proving additional transportation to 
services, providing for telemedicine delivery and telehealth, or 
improving care coordination.
    (ii) The resulting improvements in access must be measured and 
sustainable.

[43 FR 45253, Sept. 29, 1978, as amended at 80 FR 67611, Nov. 2, 2015; 
81 FR 21480, Apr. 12, 2016]



Sec.  447.204  Medicaid provider participation and public process to
inform access to care.

    (a) The agency's payments must be consistent with efficiency, 
economy, and quality of care and sufficient to enlist enough providers 
so that services under the plan are available to beneficiaries at least 
to the extent that

[[Page 470]]

those services are available to the general population. In reviewing 
payment sufficiency, states are required to consider, prior to the 
submission of any state plan amendment that proposes to reduce or 
restructure Medicaid service payment rates:
    (1) The data collected, and the analysis performed, under Sec.  
447.203.
    (2) Input from beneficiaries, providers and other affected 
stakeholders on beneficiary access to the affected services and the 
impact that the proposed rate change will have, if any, on continued 
service access. The state should maintain a record of the public input 
and how it responded to such input.
    (b) The state must submit to CMS with any such proposed state plan 
amendment affecting payment rates:
    (1) Its most recent access monitoring review plan performed under 
Sec.  447.203(b)(6) for the services at issue;
    (2) An analysis of the effect of the change in payment rates on 
access; and
    (3) A specific analysis of the information and concerns expressed in 
input from affected stakeholders.
    (c) CMS may disapprove a proposed state plan amendment affecting 
payment rates if the state does not include in its submission the 
supporting documentation described in paragraph (b) of this section, for 
failure to document compliance with statutory access requirements. Any 
such disapproval would follow the procedures described at part 430 
Subpart B of this title.
    (d) To remedy an access deficiency, CMS may take a compliance action 
using the procedures described at Sec.  430.35 of this chapter.

[80 FR 67612, Nov. 2, 2015]



Sec.  447.205  Public notice of changes in Statewide methods and standards
for setting payment rates.

    (a) When notice is required. Except as specified in paragraph (b) of 
this section, the agency must provide public notice of any significant 
proposed change in its methods and standards for setting payment rates 
for services.
    (b) When notice is not required. Notice is not required if--
    (1) The change is being made to conform to Medicare methods or 
levels of reimbursement;
    (2) The change is required by court order; or
    (3) The change is based on changes in wholesalers' or manufacturers' 
prices of drugs or materials, if the agency's reimbursement system is 
based on material cost plus a professional fee.
    (c) Content of notice. The notice must--
    (1) Describe the proposed change in methods and standards;
    (2) Give an estimate of any expected increase or decrease in annual 
aggregate expenditures;
    (3) Explain why the agency is changing its methods and standards;
    (4) Identify a local agency in each county (such as the social 
services agency or health department) where copies of the proposed 
changes are available for public review;
    (5) Give an address where written comments may be sent and reviewed 
by the public; and
    (6) If there are public hearings, give the location, date and time 
for hearings or tell how this information may be obtained.
    (d) Publication of notice. The notice must--
    (1) Be published before the proposed effective date of the change; 
and
    (2) Appear as a public announcement in one of the following 
publications:
    (i) A State register similar to the Federal Register.
    (ii) The newspaper of widest circulation in each city with a 
population of 50,000 or more.
    (iii) The newspaper of widest circulation in the State, if there is 
no city with a population of 50,000 or more.
    (iv) A Web site developed and maintained by the single State agency 
or other responsible State agency that is accessible to the general 
public, provided that the Web site:
    (A) Is clearly titled and can be easily reached from a hyperlink 
included on Web sites that provide general information to beneficiaries 
and providers, and included on the State-specific page on the Federal 
Medicaid Web site.
    (B) Is updated for bulletins on a regular and known basis (for 
example, the first day of each month), and the public notice is issued 
as part of the regular update;

[[Page 471]]

    (C) Includes the actual date it was released to the public on the 
Web site; or
    (D) Complies with national standards to ensure access to individuals 
with disabilities; and
    (E) Includes protections to ensure that the content of the issued 
notice is not modified after the initial publication and is maintained 
on the Web site for no less than a 3-year period.

[46 FR 58680, Dec. 3, 1981; 47 FR 8567, Mar. 1, 1982, as amended at 48 
FR 56057, Dec. 19, 1983; 80 FR 67612, Nov. 2, 2015]



  Subpart C_Payment for Inpatient Hospital and Long-Term Care Facility 
                                Services

    Source: 46 FR 47971, Sept. 30, 1981, unless otherwise noted.



Sec.  447.250  Basis and purpose.

    (a) This subpart implements section 1902(a)(13)(A) of the Act, which 
requires that the State plan provide for payment for hospital and long-
term care facility services through the use of rates that the State 
finds, and makes assurances satisfactory to the Secretary, are 
reasonable and adequate to meet the costs that must be incurred by 
efficiently and economically operated facilities to provide services in 
conformity with State and Federal laws, regulations, and quality and 
safety standards.
    (b) Section 447.253(a)(2) implements section 1902(a)(30) of the Act, 
which requires that payments be consistent with efficiency, economy, and 
quality of care;
    (c) Sections 447.253 (c) and (d) implement sections 1902(a)(13)(B) 
and 1902(a)(13)(C) of the Act, which require a State Medicaid agency to 
make certain assurances to the Secretary regarding increases in payments 
resulting solely from changes in ownerships of hospitals, NFs, and ICFs/
IID.
    (d) Section 447.271 implements section 1903(i)(3) of the Act, which 
requires that payments for inpatient hospital services not exceed the 
hospital's customary charges.
    (e) Section 447.280 implements section 1913(b) of the Act, which 
concerns reimbursement for long-term care services furnished by swing-
bed hospitals.

[48 FR 56057, Dec. 19, 1983, as amended at 57 FR 43921, Sept. 23, 1992]

                              Payment Rates



Sec.  447.251  Definitions.

    For the purposes of this subpart--
    Long-term care facility services means intermediate care facility 
services for Individuals with Intellectual Disabilities (ICF/IID) and 
nursing facility (NF) services.
    Provider means an institution that furnishes inpatient hospital 
services or an institution that furnishes long-term care facility 
services.

[46 FR 47971, Sept. 30, 1981, as amended at 54 FR 5359, Feb. 2, 1989; 56 
FR 48867, Sept. 26, 1991]



Sec.  447.252  State plan requirements.

    (a) The plan must provide that the requirements of this subpart are 
met.
    (b) The plan must specify comprehensively the methods and standards 
used by the agency to set payment rates in a manner consistent with 
Sec.  430.10 of this chapter.
    (c) If the agency chooses to apply the cost limits established under 
Medicare (see Sec.  413.30 of this chapter) on an individual provider 
basis, the plan must specify this requirement.

(Approved by the Office of Management and Budget under control number 
0938-0193)

[48 FR 56058, Dec. 19, 1983, as amended at 51 FR 34833, Sept. 30, 1986]



Sec.  447.253  Other requirements.

    (a) State assurances. In order to receive CMS approval of a State 
plan change in payment methods and standards, the Medicaid agency must 
make assurances satisfactory to CMS that the requirements set forth in 
paragraphs (b) through (i) of this section are being met, must submit 
the related information required by Sec.  447.255 of this subpart, and 
must comply with all other requirements of this subpart.
    (b) Findings. Whenever the Medicaid agency makes a change in its 
methods and standards, but not less often than annually, the agency must 
make the following findings:

[[Page 472]]

    (1) Payment rates. (i) The Medicaid agency pays for inpatient 
hospital services and long-term care facility services through the use 
of rates that are reasonable and adequate to meet the costs that must be 
incurred by efficiently and economically operated providers to provide 
services in conformity with applicable State and Federal laws, 
regulations, and quality and safety standards.
    (ii) With respect to inpatient hospital services--
    (A) The methods and standards used to determine payment rates take 
into account the situation of hospitals which serve a disproportionate 
number of low income patients with special needs;
    (B) If a State elects in its State plan to cover inappropriate level 
of care services (that is, services furnished to hospital inpatients who 
require a lower covered level of care such as skilled nursing or 
intermediate care services) under conditions similar to those described 
in section 1861(v)(1)(G) of the Act, the methods and standards used to 
determine payment rates must specify that the payments for this type of 
care must be made at rates lower than those for inpatient hospital level 
of care services, reflecting the level of care actually received, in a 
manner consistent with section 1861(v)(1)(G) of the Act; and
    (C) The payment rates are adequate to assure that beneficiaries have 
reasonable access, taking into account geographic location and 
reasonable travel time, to inpatient hospital services of adequate 
quality.
    (iii) With respect to nursing facility services--
    (A) Except for preadmission screening for individuals with mental 
illness and Intellectual Disability under Sec.  483.20(f) of this 
Chapter, the methods and standards used to determine payment rates take 
into account the costs of complying with the requirements of part 483 
subpart B of this chapter;
    (B) The methods and standards used to determine payment rates 
provide for an appropriate reduction to take into account the lower 
costs (if any) of the facility for nursing care under a waiver of the 
requirement in Sec.  483.35(e) of this Chapter to provide licensed 
nurses on a 24-hour basis;
    (C) The State establishes procedures under which the data and 
methodology used in establishing payment rates are made available to the 
public.
    (2) Upper payment limits. The agency's proposed payment rate will 
not exceed the upper payment limits as specified in Sec.  447.272.
    (c) Changes in ownership of hospitals. In determining payment when 
there has been a sale or transfer of the assets of a hospital, the 
State's methods and standards must provide that payment rates can 
reasonably be expected not to increase in the aggregate solely as a 
result of changes of ownership, more than the payments would increase 
under Medicare under Sec. Sec.  413.130, 413.134, 413.153, and 413.157 
of this chapter, insofar as these sections affect payments for 
depreciation, interest on capital indebtedness, return on equity capital 
(if applicable), acquisition costs for which payments were previously 
made to prior owners, and the recapture of depreciation.
    (d) Changes in ownership of NFs and ICFs/IID. In determining payment 
when there has been a sale or transfer of assets of an NF or ICF/IID, 
the State's methods and standards must provide the following depending 
upon the date of the transfer.
    (1) For transfers on or after July 18, 1984 but before October 1, 
1985, the State's methods and standards must provide that payment rates 
can reasonably be expected not to increase in the aggregate, solely as 
the result of a change in ownership, more than payments would increase 
under Medicare under Sec. Sec.  413.130, 413.134, 413.153 and 413.157 of 
this chapter, insofar as these sections affect payment for depreciation, 
interest on capital indebtedness, return on equity capital (if 
applicable), acquisition costs for which payments were previously made 
to prior owners, and the recapture of depreciation.
    (2) For transfers on or after October 1, 1985, the State's methods 
and standards must provide that the valuation of capital assets for 
purposes of determining payment rates for NFs and ICFs/IID is not to 
increase (as measured from the date of acquisition by the seller to the 
date of the change of

[[Page 473]]

ownership) solely as a result of a change of ownership, by more than the 
lesser of--
    (i) One-half of the percentage increase (as measured from the date 
of acquisition by the seller to the date of the change of ownership, or, 
if necessary, as extrapolated retrospectively by the Secretary) in the 
Dodge construction index applied in the aggregate with respect to those 
facilities that have undergone a change of ownership during the fiscal 
year; or
    (ii) One-half of the percentage increase (as measured from the date 
of acquisition by the seller to the date of the change of ownership) in 
the Consumer Price Index for All Urban Consumers (CPI-U) (United States 
city average) applied in the aggregate with respect to those facilities 
that have undergone a change of ownership during the fiscal year.
    (e) Provider appeals. The Medicaid agency must provide an appeals or 
exception procedure that allows individual providers an opportunity to 
submit additional evidence and receive prompt administrative review, 
with respect to such issues as the agency determines appropriate, of 
payment rates.
    (f) Uniform cost reporting. The Medicaid agency must provide for the 
filing of uniform cost reports by each participating provider.
    (g) Audit requirements. The Medicaid agency must provide for 
periodic audits of the financial and statistical records of 
participating providers.
    (h) Public notice. The Medicaid agency must provide that it has 
complied with the public notice requirements in Sec.  447.205 of this 
part when it is proposing significant changes to its methods or 
standards for setting payment rates for inpatient hospital or LTC 
facility services.
    (i) Rates paid. The Medicaid agency must pay for inpatient hospital 
and long term care services using rates determined in accordance with 
methods and standards specified in an approved State plan.

[48 FR 56057, Dec. 19, 1983, as amended at 52 FR 28147, July 28, 1987; 
54 FR 5359, Feb. 2, 1989; 57 FR 43921, Sept. 23, 1992; 81 FR 68847, Oct. 
4, 2016]



Sec.  447.255  Related information.

    The Medicaid agency must submit, with the assurances described in 
Sec.  447.253(a), the following information:
    (a) The amount of the estimated average proposed payment rate for 
each type of provider (hospital, ICF/IID, or nursing facility), and the 
amount by which that estimated average rate increased or decreased 
relative to the average payment rate in effect for each type or provider 
for the immediately preceding rate period;
    (b) An estimate of the short-term and, to the extent feasible, long-
term effect the change in the estimated average rate will have on--
    (1) The availability of services on a Statewide and geographic area 
basis;
    (2) The type of care furnished;
    (3) The extent of provider participation; and
    (4) The degree to which costs are covered in hospitals that serve a 
disproportionate number of low income patients with special needs.

[48 FR 56058, Dec. 19, 1983, as amended at 54 FR 5359, Feb. 2, 1989; 56 
FR 48867, Sept. 26, 1991; 57 FR 43924, Sept. 23, 1992; 57 FR 46431, Oct. 
8, 1992]



Sec.  447.256  Procedures for CMS action on assurances and State plan amendments.

    (a) Criteria for approval. (1) CMS approval action on State plans 
and State plan amendments, is taken in accordance with subpart B of part 
430 of this chapter and sections 1116, 1902(b) and 1915(f) of the Act.
    (2) In the case of State plan and plan amendment changes in payment 
methods and standards, CMS bases its approval on the acceptability of 
the Medicaid agency's assurances that the requirements of Sec.  447.253 
have been met, and the State's compliance with the other requirements of 
this subpart.
    (b) Time limit. CMS will send a notice to the agency of its 
determination as to whether the assurances regarding a State plan 
amendment are acceptable within 90 days of the date CMS receives the 
assurances described in Sec.  447.253, and the related information 
described in Sec.  447.255 of this subpart. If CMS does not send a 
notice to the agency of its determination within this time limit and the 
provisions in paragraph (a) of

[[Page 474]]

this section are met, the assurances and/or the State plan amendment 
will be deemed accepted and approved.
    (c) Effective date. A State plan amendment that is approved will 
become effective not earlier than the first day of the calendar quarter 
in which an approvable amendment is submitted in accordance with 
Sec. Sec.  430.20 of this chapter and 447.253.

[48 FR 56058, Dec. 19, 1983, as amended at 52 FR 28147, July 28, 1987]

                     Federal Financial Participation



Sec.  447.257  FFP: Conditions relating to institutional reimbursement.

    FFP is not available for a State's expenditures for hospital 
inpatient or long-term care facility services that are in excess of the 
amounts allowable under this subpart.

[52 FR 28147, July 28, 1987]

                              Upper Limits



Sec.  447.271  Upper limits based on customary charges.

    (a) Except as provided in paragraph (b) of this section, the agency 
may not pay a provider more for inpatient hospital services under 
Medicaid than the provider's customary charges to the general public for 
the services.
    (b) The agency may pay a public provider that provides services free 
or at a nominal charge at the same rate that would be used if the 
provider charges were equal to or greater than its costs.

[75 FR 73975, Nov. 30, 2010]



Sec.  447.272  Inpatient services: Application of upper payment limits.

    (a) Scope. This section applies to rates set by the agency to pay 
for inpatient services furnished by hospitals, NFs, and ICFs/IID within 
one of the following categories:
    (1) State government-owned or operated facilities (that is, all 
facilities that are either owned or operated by the State).
    (2) Non-State government-owned or operated facilities (that is, all 
government facilities that are neither owned nor operated by the State).
    (3) Privately-owned and operated facilities.
    (b) General rules. (1) Upper payment limit refers to a reasonable 
estimate of the amount that would be paid for the services furnished by 
the group of facilities under Medicare payment principles in subchapter 
B of this chapter.
    (2) Except as provided for in paragraph (c) of this section, 
aggregate Medicaid payments to a group of facilities within one of the 
categories described in paragraph (a) of this section may not exceed the 
upper payment limit described in paragraph (b)(1) of this section.
    (c) Exceptions--(1) Indian Health Services and tribal facilities. 
The limitation in paragraph (b) of this section does not apply to Indian 
Health Services facilities and tribal facilities that are funded through 
the Indian Self-Determination and Education Assistance Act (Pub. L. 93-
638).
    (2) Disproportionate share hospitals. The limitation in paragraph 
(b) of this section does not apply to payment adjustments made under 
section 1923 of the Act that are made under a State plan to hospitals 
found to serve a disproportionate number of low-income patients with 
special needs as provided in section 1902(a)(13)(A)(iv) of the Act. 
Disproportionate share hospital (DSH) payments are subject to the 
following limits:
    (i) The aggregate DSH limit using the Federal share of the DSH limit 
under section 1923(f) of the Act.
    (ii) The hospital-specific DSH limit in section 1923(g) of the Act.
    (iii) The aggregate DSH limit for institutions for mental disease 
(IMDs) under section 1923(h) of the Act.
    (d) Compliance dates. Except as permitted under paragraph (e) of 
this section, a State must comply with the upper payment limit described 
in paragraph (b) of this section by one of the following dates:
    (1) For non-State government owned or operated hospitals,--March 19, 
2002.
    (2) For all other facilities--March 13, 2001.

[66 FR 3175, Jan. 12, 2001, as amended at 66 FR 46399, Sept. 5, 2001; 67 
FR 2610, Jan. 18, 2002; 72 FR 29834, May 29, 2007; 75 FR 73975, Nov. 30, 
2010; 77 FR 31512, May 29, 2012]

[[Page 475]]

                           Swing-Bed Hospitals



Sec.  447.280  Hospital providers of NF services (swing-bed hospitals).

    (a) General rule. If the State plan provides for NF services 
furnished by a swing-bed hospital, as specified in Sec. Sec.  440.40(a) 
and 440.150(f) of this chapter, the methods and standards used to 
determine payment rates for routine NF services must--
    (1) Provide for payment at the average rate per patient day paid to 
NFs, as applicable, for routine services furnished during the previous 
calendar year; or
    (2) Meet the State plan and payment requirements described in this 
subpart, as applicable.
    (b) Application of the rule. The payment methodology used by a State 
to set payment rates for routine NF services must apply to all swing-bed 
hospitals in the State.

[59 FR 56237, Nov. 10, 1994]

Subpart D [Reserved]



        Subpart E_Payment Adjustments for Hospitals That Serve a 
             Disproportionate Number of Low-Income Patients

    Source: 57 FR 55143, Nov. 24, 1992, unless otherwise noted.



Sec.  447.294  Medicaid disproportionate share hospital (DSH) allotment
reductions.

    (a) Basis and purpose. This section sets forth the DSH health reform 
methodology (DHRM) for calculating State-specific annual DSH allotment 
reductions as required under section 1923(f) of the Act.
    (b) Definitions. For purposes of this section--
    Aggregate DSH allotment reductions mean the amounts identified in 
section 1923(f)(7)(A)(ii) of the Act.
    Budget neutrality factor (BNF) is a factor incorporated in the DHRM 
that takes into account the extent to which the DSH allotment for a 
State was included in the budget neutrality calculation for a coverage 
expansion approved under section 1115 as of July 31, 2009.
    DSH payment means the amount reported in accordance with Sec.  
447.299(c)(17).
    Effective DSH allotment means the amount of DSH allotment determined 
by subtracting the State-specific DSH allotment reduction from a State's 
unreduced DSH allotment.
    High level of uncompensated care factor (HUF) is a factor 
incorporated in the DHRM that results in larger percentage DSH allotment 
reduction for States that do not target DSH payments on hospitals with 
high levels of uncompensated care.
    High Medicaid volume hospital means a disproportionate share 
hospital that has an MIUR at least one standard deviation above the mean 
MIUR for hospitals receiving Medicaid payments in the State.
    High uncompensated care hospital means a hospital that exceeds the 
mean ratio of uncompensated care costs to total Medicaid and uninsured 
inpatient and outpatient hospital service costs for all disproportionate 
share hospitals within a state.
    High volume of Medicaid inpatients factor (HMF) is a factor 
incorporated in the DHRM that results in larger percentage DSH allotment 
reduction for States that do not target DSH payments on hospitals with 
high volumes of Medicaid inpatients.
    Hospital with high volumes of Medicaid inpatients means a 
disproportionate share hospital that meets the requirements of section 
1923(b)(1)(A) of the Act.
    Low DSH adjustment factor (LDF) is a factor incorporated in the DHRM 
that results in a smaller percentage DSH allotment reduction on low DSH 
States.
    Low DSH State means a State that meets the criterion described in 
section 1923(f)(5)(B) of the Act.
    Mean HUF reduction percentage is determined by calculating the 
quotient of each state's HUF reduction amount divided by its unreduced 
DSH allotment, then calculating the mean for each state group, then 
converting the result to a percentage.
    Medicaid inpatient utilization rate (MIUR) means the rate defined in 
section 1923(b)(2) of the Act.

[[Page 476]]

    Non-high Medicaid volume hospital means a disproportionate share 
hospitals that does not meet the requirements of section 1923(b)(1)(A) 
of the Act.
    State group means similarly situated States that are collectively 
identified by DHRM as defined in Sec.  447.294(e)(1).
    State-specific DSH allotment reduction means the amount of annual 
DSH allotment reduction for a particular State as determined by the 
DHRM.
    Total hospital cost has the meaning given the term in Sec.  
447.299(c)(20).
    Total Medicaid cost means the amount for each hospital reported in 
accordance with Sec.  447.299(c)(10).
    Total population means the 1-year estimates data of the total non-
institutionalized population identified by United States Census Bureau's 
American Community Survey.
    Total uninsured cost means the amount reported for each DSH in 
accordance with Sec.  447.299(c)(14).
    Uncompensated care cost means the amount reported for each hospital 
in accordance with Sec.  447.299(c)(16).
    Uncompensated care level means a hospital's uncompensated care cost 
divided by the sum of its total Medicaid cost and its total uninsured 
cost.
    Unreduced DSH allotment means the DSH allotment calculated under 
section 1923(f) of the Act prior to annual reductions under this 
section.
    Uninsured percentage factor (UPF) is a factor incorporated in the 
DHRM that results in larger percentage DSH allotment reductions for 
States that have the lowest percentages of uninsured individuals.
    Uninsured population means 1-year estimates data of the number of 
uninsured identified by United States Census Bureau's American Community 
Survey.
    (c) Aggregate DSH allotment reduction amounts. The aggregate DSH 
allotment reduction amounts are as provided in section 1923(f)(7)(A)(ii) 
of the Act.
    (d) State data submission requirements. States are required to 
submit the mean MIUR, determined in accordance with section 
1923(b)(1)(A) of the Act, for all hospitals receiving Medicaid payments 
in the State and the value of one standard deviation above such mean. 
The State must provide this data to CMS by June 30 of each year. To 
determine which state plan rate year's data the state must submit, 
subtract 3 years from the calendar year in which the data is due.
    (e) DHRM methodology. Section 1923(f)(7) of the Act requires 
aggregate annual reduction amounts as specified in paragraph (f) of this 
section to be reduced through the DHRM. The DHRM is calculated on an 
annual basis based on the most recent data available to CMS at the time 
of the calculation. The DHRM is determined as follows:
    (1) Establishing State groups. For each FY, CMS will separate low-
DSH States and non-low DSH states into distinct State groups.
    (2) Aggregate DSH allotment reduction allocation. CMS will allocate 
a portion of the aggregate DSH allotment reductions to each State group 
by the following:
    (i) Dividing the sum of each State group's preliminary unreduced DSH 
allotments by the sum of both State groups' preliminary unreduced DSH 
allotment amounts to determine a percentage.
    (ii) Multiplying the value of paragraph (e)(2)(i) of this section by 
the aggregate DSH allotment reduction amount under paragraph (c) of this 
section for the applicable fiscal year.
    (iii) Applying the low DSH adjustment factor under paragraph (e)(3) 
of this section.
    (3) Low DSH adjustment factor (LDF) calculation. CMS will calculate 
the LDF by the following:
    (i) Dividing each State's preliminary unreduced DSH allotment by 
their respective total estimated Medicaid service expenditures for the 
applicable fiscal year.
    (ii) Calculating for each State group the mean of all values 
determined in paragraph (e)(3)(i) of this section.
    (iii) Dividing the value of paragraph (e)(3)(ii) of this section for 
the low-DSH State group by the value of paragraph (e)(3)(ii) for the 
non-low DSH state group.
    (4) LDF application. CMS will determine the final aggregate DSH 
allotment reduction allocation for each State group through application 
of the LDF by the following:

[[Page 477]]

    (i) Multiplying the LDF by the aggregate DSH allotment reduction for 
the low DSH State group.
    (ii) Utilizing the value of paragraph (e)(4)(i) of this section as 
the aggregate DSH allotment reduction allocated to the low DSH State 
group.
    (iii) Subtracting the value of paragraph (e)(4)(ii) of this section 
from the value of paragraph (e)(2)(ii) of this section for the low DSH 
State group; and
    (iv) Adding the value of paragraph (e)(4)(iii) of this section to 
the value of paragraph (e)(2)(ii) of this section for the non-low DSH 
State group.
    (5) Reduction factor allocation. CMS will allocate the aggregate DSH 
allotment reduction amount to three core factors by multiply the 
aggregate DSH allotment reduction amount for each State group by the 
following:
    (i) UPF--50 percent.
    (ii) HMF--25 percent.
    (iii) HUF--25 percent.
    (6) Uninsured percentage factor (UPF) calculation. CMS will 
calculate the UPF by the following:
    (i) Dividing the total State population by the uninsured in State 
for each State.
    (ii) Determining the uninsured reduction allocation component for 
each State as a percentage by dividing each State's value of paragraph 
(e)(6)(i) of this section by the sum of the values of paragraph 
(e)(6)(i) of this section for the respective State group (the sum of the 
values of all States in the State group should total 100 percent).
    (iii) Determine a weighting factor by dividing each State's 
unreduced DSH allotment by the sum of all preliminary unreduced DSH 
allotments for the respective State group.
    (iv) Multiply the weighting factor calculated in (e)(6)(iii) of this 
section by the value of each State's uninsured reduction allocation 
component from paragraph (e)(6)(ii) of this section.
    (v) Determine the UPF as a percentage by dividing the product of 
paragraph (e)(6)(iv) of this section for each State by the sum of the 
values of paragraph (e)(6)(iv) of this section for the respective State 
group (the sum of the values of all States in the State group should 
total 100 percent).
    (7) UPF application and reduction amount. CMS will determine the UPF 
portion of the final aggregate DSH allotment reduction allocation for 
each State by multiplying the State's UPF by the aggregate DSH allotment 
reduction allocated to the UPF factor under paragraph (e)(5) of this 
section for the respective State group.
    (8) High volume of Medicaid inpatients factor (HMF) calculation. CMS 
will calculate the HMF by determining a percentage for each State by 
dividing the State's total DSH payments made to non-high Medicaid volume 
hospitals by the total of such payments for the entire State group.
    (9) HMF application and reduction amount. CMS will determine the HMF 
portion of the final aggregate DSH allotment reduction allocation for 
each State by multiplying the State's HMF by the aggregate DSH allotment 
reduction allocated to the HMF factor under paragraph (e)(5) of this 
section for the respective State group.
    (10) High level of uncompensated care factor (HUF) calculation. CMS 
will calculate the HUF by determining a percentage for each State by 
dividing the State's total DSH payments made to non-High Uncompensated 
Care Level hospitals by the total of such payments for the entire State 
group.
    (11) HUF application and reduction amount. CMS will determine the 
HUF portion of the final aggregate DSH allotment reduction allocation by 
multiplying each State's HUF by the aggregate DSH allotment reduction 
allocated to the HUF factor under paragraph (e)(5) of this section for 
the respective State group.
    (12) Section 1115 budget neutrality factor (BNF) calculation. This 
factor is only calculated for States for which all or a portion of the 
DSH allotment was included in the calculation of budget neutrality under 
a section 1115 demonstration for the specific fiscal year subject to 
reduction pursuant to an approval on or before July 31, 2009. CMS will 
calculate the BNF for qualifying states by the following:
    (i) For States whose DSH allotment was included in the budget 
neutrality calculation for a coverage expansion that was approved under 
section 1115 as of July 31, 2009, (without regard to approved amendments 
since that date) determining the amount of the State's

[[Page 478]]

DSH allotment included in the budget neutrality calculation for coverage 
expansion for the specific fiscal year subject to reduction. This amount 
is not subject to reductions under the HMF and HUF calculations.
    (ii) Determining the amount of the State's DSH allotment included in 
the budget neutrality calculation for non-coverage expansion purposes 
for the specific fiscal year subject to reduction.
    (iii) Multiplying each qualifying State's value of paragraph 
(e)(12)(ii) of this section by the mean HMF reduction percentage for the 
respective State group.
    (iv) Multiplying each qualifying State's value of paragraph 
(e)(12)(ii) of this section by the mean HUF reduction percentage for the 
respective State group.
    (v) For each State, calculating the sum of the value of paragraphs 
(e)(12)(iii) and of (e)(12)(iv) of this section.
    (13) Section 1115 budget neutrality factor (BNF) application. This 
factor will be applied in the State-specific DSH allotment reduction 
calculation.
    (14) State-specific DSH allotment reduction calculation. CMS will 
calculate the state-specific DSH reduction by the following:
    (i) Taking the sum of the value of paragraphs (e)(7), (e)(9), and 
(e)(11) of this section for each State.
    (ii) For States qualifying under paragraph (e)(12) of this section, 
adding the value of paragraph (e)(12)(v) of this section.
    (iii) Reducing the amount of paragraph (e)(14)(i) of this section 
for each State that does not qualify under paragraph (e)(12)(v) of this 
section based on the proportion of each State's preliminary unreduced 
DSH allotment compared to the national total of preliminary unreduced 
DSH allotments so that the sum of paragraph (e)(14)(iii) of this section 
equals the sum of paragraph (e)(12)(v) of this section.
    (iv) No state will receive a reduction as calculated in paragraph 
(e)(14) of this section in excess of 90 percent of its preliminary 
unreduced DSH allotment for the respective fiscal year. For any state 
assigned a reduction amount determined under paragraph (e)(14) of this 
section in excess of 90 percent of its unreduced DSH allotment, the 
reduction amount that exceeds 90 percent of that state's unreduced DSH 
allotment will be distributed among the remaining states in the state 
group that do not exceed the 90 percent reduction cap, based on the 
proportion of each of these remaining states' allotment reduction amount 
before any distribution is performed pursuant to this paragraph 
(e)(14)(iv) to the aggregate allotment reduction amount for the state 
group. This operation will be performed until all reduction amounts in 
excess of the 90 percent reduction cap for all states are allocated 
within each respective state group.
    (f) Annual DSH allotment reduction application. For each fiscal year 
identified in section 1923(f)(7)(A)(ii) of the Act, CMS will subtract 
the State-specific DSH allotment amount determined in paragraph (e)(14) 
of this section from that State's final unreduced DSH allotment. This 
amount is the State's final DSH allotment for the fiscal year.

[78 FR 57311, Sept. 18, 2013, as amended at 84 FR 50332, Sept. 25, 2019]



Sec.  447.295  Hospital-specific disproportionate share hospital payment
limit: Determination of individuals without health insurance or other 
third party coverage.

    (a) Basis and purpose. This section sets forth the methodology for 
determining the costs for individuals who have no health insurance or 
other source of third party coverage for services furnished during the 
year for purposes of calculating the hospital-specific disproportionate 
share hospital payment limit under section 1923(g) of the Act.
    (b) Definitions.
    Health insurance coverage limit means a limit imposed by a third 
party payer that establishes a maximum dollar value or maximum number of 
specific services, for benefits received by an individual.
    Individuals who have no health insurance (or other source of third 
party coverage) for the services furnished during the year means 
individuals who have no source of third party coverage for the

[[Page 479]]

specific inpatient hospital or outpatient hospital service furnished by 
the hospital.
    No source of third party coverage for a specific inpatient hospital 
or outpatient hospital service means that the service is not included in 
an individual's health benefits coverage through a group health plan or 
health insurer, and for which there is no other legally liable third 
party. When a health insurance coverage limit is imposed by a third 
party payer, specific services beyond the limit would not be within the 
individual's health benefit package from that third party payer. For 
American Indians/Alaska Natives, IHS and tribal coverage is only 
considered third party coverage when services are received directly from 
IHS or tribal health programs (direct health care services) or when IHS 
or a tribal health program has authorized coverage through the contract 
health service program (through a purchase order or equivalent 
document). Administrative denials of payment, or requirements for 
satisfaction of deductible, copayment or coinsurance liability, do not 
affect the determination that a specific service is included in the 
health benefits coverage.
    (c) Determination of an individual's third party coverage status. 
Individuals who have no source of third party coverage for a specific 
inpatient hospital or outpatient hospital service must be considered, 
for purposes of that service, to be uninsured. This determination is not 
dependent on the receipt of payment by the hospital from the third 
party.
    (1) The determination of an individual's status as having a source 
of third party coverage must be a service-specific coverage 
determination. The service-specific coverage determination can occur 
only once per individual per service provided and applies to the entire 
service, including all elements as that service, or similar services, 
would be defined in Medicaid.
    (2) Individuals who are inmates in a public institution or are 
otherwise involuntarily in secure custody as a result of criminal 
charges are considered to have a source of third party coverage.
    (d) Hospital-specific DSH limit calculation. Only costs incurred in 
providing inpatient hospital and outpatient hospital services to 
Medicaid individuals, and revenues received with respect to those 
services, and costs incurred in providing inpatient hospital and 
outpatient hospital services, and revenues received with respect to 
those services, for which a determination has been made in accordance 
with paragraph (c) of this section that the services were furnished to 
individuals who have no source of third party coverage for the specific 
inpatient hospital or outpatient hospital service are included when 
calculating the costs and revenues for Medicaid individuals and 
individuals who have no health insurance or other source of third party 
coverage for purposes of section 1923(g)(1) of the Act.

[79 FR 71694, Dec. 3, 2014]



Sec.  447.296  Limitations on aggregate payments for disproportionate share
hospitals for the period January 1, 1992 through September 30, 1992.

    (a) The provisions of this section apply to the 50 States and the 
District of Columbia, but not to any State whose entire Medicaid program 
is operated under a waiver granted under section 1115 of the Act.
    (b) For the period January 1, 1992 through September 30, 1992, FFP 
is available for aggregate payments to hospitals that serve a 
disproprotionate number of low-income patients with special needs only 
if the payments are made in accordance with sections 1902(a)(13)(A) and 
1923 of the Act, and with one of the following:
    (1) An approved State plan in effect as of September 30, 1991.
    (2) A State plan amendment submitted to CMS by September 30, 1991.
    (3) A State plan amendment, or modification thereof, submitted to 
CMS between October 1, 1991 and November 26, 1991, if the amendment, or 
modification thereof, was intended to limit the State's definition of 
disproportionate share hospitals to those hospitals with Medicaid 
inpatient utilization rates or low-income utilization rates (as defined 
in section 1923 (b) of the Act) at

[[Page 480]]

or above the statewide arithmetic mean.
    (4) A methodology for disproportionate share hospital payments that 
was established and in effect as of September 30, 1991, or in accordance 
with a State law enacted or State regulation adopted as of September 30, 
1991.
    (5) A State plan amendment submitted to CMS by September 30, 1992 
that increases aggregate disproportionate share hospitals payments in 
order to meet the minimum payment adjustments required by section 
1923(c)(1) of the Act. The minimum payment adjustment is the amount 
required by the Medicare methodology described in section 1923(c)(1) of 
the Act for those hospitals that satisfy the minimum Federal definition 
of a disproportionate share hospital in section 1923(b) of the Act.
    (6) A State plan amendment submitted to CMS by September 30, 1992 
that provides for a redistribution of disproportionate share hospital 
payments within the State without raising total payments compared to the 
previously approved State plan. CMS will approve the amendment only if 
the State submits written documentation that demonstrates to CMS that 
the aggregate payments that will be made after the redistribution are no 
greater than those payments made before the redistribution.
    (7) A State plan amendment submitted to CMS by September 30, 1992 
that provides for a reduction in disproportionate share hospital 
payments.



Sec.  447.297  Limitations on aggregate payments for disproportionate
share hospitals beginning October 1, 1992.

    (a) Applicability. The provisions of this section apply to the 50 
States and the District of Columbia, but not to any State whose entire 
Medicaid program is operated under a waiver granted under section 1115 
of the Act.
    (b) National payment target. The national payment target for 
disproportionate share hospital (DSH) payments for any Federal fiscal 
year is equal to 12 percent of the total medical assistance expenditures 
that will be made during the Federal fiscal year under State plans, 
excluding administrative costs. A preliminary national expenditure 
target will be published by CMS prior to October 1 of each year. This 
preliminary national expenditure target will be superseded by a final 
national expenditure target published by April 1 of each Federal fiscal 
year, as specified in paragraph (d) of this section.
    (c) State disproportionate share hospital allotments. Prior to 
October 1 of each Federal fiscal year, CMS will publish in the Federal 
Register preliminary State DSH allotments for each State. These 
preliminary State DSH allotments will be determined using the most 
current applicable actual and estimated State expenditure information as 
reported to CMS and adjusted by CMS as may be necessary using the 
methodology described in Sec.  447.298. CMS will publish final State DSH 
allotments by April 1 of each Federal fiscal year, as described in 
paragraph (d) of this section.
    (d) Final national disproportionate share hospitals expenditure 
target and State disproportionate share hospitals allotments. (1) CMS 
will revise the preliminary national expenditure target and the 
preliminary State DSH allotments by April 1 of each Federal fiscal year. 
The final national DSH expenditure target and State DSH allotments will 
be based on the most current applicable actual and estimated expenditure 
information reported to CMS and adjusted by CMS as may be necessary 
immediately prior to the April 1 publication date. The final national 
expenditure target and State DSH allotments will not be recalculated for 
that Federal fiscal year based upon any subsequent actual or estimated 
expenditure information reported to CMS.
    (2) If CMS determines that at any time a State has exceeded its 
final DSH allotment for a Federal fiscal year, FFP attributable to the 
excess DSH expenditures will be disallowed.
    (3) If a State's actual DSH expenditures applicable to a Federal 
fiscal year are less than its final State DSH allotment for that Federal 
fiscal year, the State is permitted, to the extent allowed by its 
approved State plan, to make additional DSH expenditures applicable to 
that Federal fiscal year up

[[Page 481]]

to the amount of its final DSH allotment for that Federal fiscal year.
    (e) Publication of limits. (1) Before the beginning of each Federal 
fiscal year, CMS will publish in the Federal Register--
    (i) A preliminary national DSH expenditure target for the Federal 
fiscal year; and
    (ii) A preliminary DSH allotment for each State for the Federal 
fiscal year.
    (2) The final national DSH expenditure target and State DSH 
allotments will be published in the Federal Register by April 1 of each 
Federal fiscal year.

[57 FR 55143, Nov. 24, 1992, as amended at 58 FR 43182, Aug. 13, 1993]



Sec.  447.298  State disproportionate share hospital allotments.

    (a) Calculation of State's base allotment for Federal fiscal year 
1993. (1) For Federal fiscal year 1993, CMS will calculate for each 
State a DSH allotment, using the State's ``base allotment.'' The State's 
base allotment is the greater of:
    (i) The total amount of the State's projected DSH payments for 
Federal fiscal year 1992 under the State plan applicable to Federal 
fiscal year 1992, calculated in accordance with paragraph (a)(2) of this 
section; or
    (ii) $1,000,000.
    (2) In calculating the State's DSH payments applicable to Federal 
fiscal year 1992, CMS will derive amounts from payments applicable to 
the period of October 1, 1991, through September 30, 1992, under State 
plans or plan amendments that meet the requirements specified in Sec.  
447.296(b). The calculation will not include--
    (i) DSH payment adjustments made by the State applicable to the 
period October 1, 1991 through December 31, 1991 under State plans or 
plan amendments that do not meet the criteria described in Sec.  
447.296; and
    (ii) Retroactive DSH payments made in 1992 that are not applicable 
to Federal fiscal year 1992.
    (3) CMS will calculate a percentage for each State by dividing the 
DSH base allotment by the total unadjusted medical assistance 
expenditures, excluding administrative costs, made during Federal fiscal 
year 1992. On the basis of this percentage, CMS will classify each State 
as a ``high-DSH'' or ``low-DSH'' State.
    (i) If the State's base allotment exceeded 12 percent of its total 
unadjusted medical assistance expenditures made under the State plan in 
Federal fiscal year 1992, CMS will classify the State as a ``high-DSH'' 
State.
    (ii) If the State's base allotment was 12 percent or less of its 
total unadjusted medical assistance expenditures made under the State 
plan in Federal fiscal year 1992, CMS will classify the State as a 
``low-DSH'' State.
    (b) State disproportionate share hospital allotments for Federal 
fiscal year 1993. (1) For Federal fiscal year 1993, CMS will calculate a 
DSH allotment for each low-DSH State that equals the State's base 
allotment described under paragraph (a) of this section, increased by 
State growth, as specified in paragraph (d) of this section.
    (2) For high-DSH States, the dollar amount of DSH payments in 
Federal fiscal year 1993 may not exceed the dollar amount of DSH 
payments applicable to Federal fiscal year 1992 (that is, the State base 
allotment).
    (c) State disproportionate share hospital allotment for Federal 
fiscal years 1994 and after. For Federal fiscal years 1994 and after--
    (1) For low-DSH States, CMS will calculate the DSH allotment for 
each Federal fiscal year by increasing the prior year's State DSHs 
allotment by--
    (i) State growth, as specified in paragraph (d) of this section; and
    (ii) A supplemental amount, if applicable, as described in paragraph 
(e) of this section.
    (2) For high-DSH States, the dollar amount of DSH payments 
applicable to any Federal fiscal year may not exceed the dollar amount 
of payments applicable to Federal fiscal year 1992 (that is, the State 
base allotment). This payment limitation will apply until the Federal 
fiscal year in which the State's DSH payments applicable to that Federal 
fiscal year, expressed as a percentage of the State's total unadjusted 
medical assistance expenditures in that Federal fiscal year, equal 12 
percent or less. When a high-DSH State's percentage equals 12 percent or 
less, the State will be reclassified as a low-DSH State.

[[Page 482]]

    (d) State growth. (1) The State growth for a State in a Federal 
fiscal year is equal to the product of--
    (i) The growth factor that is CMS's projected percentage increase in 
the State's total unadjusted medical assistance expenditures (including 
administrative costs) relative to the corresponding amount in the 
previous year; and
    (ii) The State's prior year DSH allotment.
    (2) If the growth factor is zero or is negative, the State growth is 
zero.
    (3) If a low-DSH State experiences a level of negative growth to the 
extent that its previous Federal fiscal year's DSH allotment would be 
more than 12 percent of its current Federal fiscal year's total 
unadjusted medical assistance expenditures (excluding administrative 
costs), the low-DSH State's previous year's DSH allotment will be 
reduced to the extent necessary to maintain the individual low-DSH 
State's 12-percent limit and that amount will become the low-DSH State's 
DSH allotment for the current Federal fiscal year. In no Federal fiscal 
year will a low-DSH State's DSH allotment be allowed to exceed its 
individual State 12-percent limit.
    (e) Supplemental amount available for low-DSH States. (1) A 
supplemental amount is the State's share of a pool of money (referred to 
as a redistribution pool).
    (2) CMS will calculate the redistribution pool for the appropriate 
Federal fiscal year by subtracting from the projected national DSH 
expenditure target the following:
    (i) The total of the State DSH base allotments for all high-DSH 
States;
    (ii) The total of the previous year's State DSH allotments for all 
low-DSH States;
    (iii) The State growth amount for all low-DSH States; and
    (iv) The total amount of additional DSH payment adjustments made in 
order to meet the minimum payment adjustments required under section 
1923(c)(l) of the Act, which are made in accordance with Sec.  
447.296(b)(5).
    (3) CMS will determine the percent of the redistribution pool for 
each low-DSH State on the basis of each State's relative share of the 
total unadjusted medical assistance expenditures for the Federal fiscal 
year compared to the total unadjusted medical assistance expenditures 
for the Federal fiscal year projected to be made by all low-DSH States. 
The percent of the redistribution pool that each State will receive is 
equal to the State's total unadjusted medical assistance expenditures 
divided by the total unadjusted medical assistance expenditures for all 
low-DSH States.
    (4) CMS will not provide any low-DSH State a supplemental amount 
that would result in the State's total DSH allotment exceeding 12 
percent of its projected total unadjusted medical assistance 
expenditures. CMS will reallocate any supplemental amounts not allocated 
to States because of this 12-percent limitation to other low-DSH States 
in accordance with the percentage determined in paragraph (e)(3) of this 
section.
    (5) CMS will not reallocate to low-DSH States the difference between 
any State's actual DSH expenditures applicable to a Federal fiscal year 
and its State DSH allotment applicable to that Federal fiscal year. 
Thus, any unspent DSH allotment may not be reallocated.
    (f) Special provision. Any increases in a State's aggregate 
disproportionate payments, that are made to meet the minimum payment 
requirements specified in Sec.  447.296(b)(5), may exceed the State base 
allotment to the extent such increases are made to satisfy the minimum 
payment requirement. In such cases, CMS will adjust the State's base 
allotment in the subsequent Federal fiscal year to include the increased 
minimum payments.

[57 FR 55143, Nov. 24, 1992, as amended at 58 FR 43182, Aug. 13, 1993]



Sec.  447.299  Reporting requirements.

    (a) Beginning with the first quarter of Federal fiscal year 1993, 
each State must submit to CMS the quarterly aggregate amount of its 
disproportionate share hospital payments made to each individual public 
and private provider or facility. States' reports must present a 
complete, accurate, and full disclosure of all of their DSH programs and 
expenditures.

[[Page 483]]

    (b) Each State must report the aggregate information specified under 
paragraph (a) of this section on a quarterly basis in accordance with 
procedures established by CMS.
    (c) Beginning with each State's Medicaid State plan rate year 2005, 
for each Medicaid State plan rate year, the State must submit to CMS, at 
the same time as it submits the completed audit required under Sec.  
455.304 of this chapter, the following information for each DSH hospital 
to which the State made a DSH payment in order to permit verification of 
the appropriateness of such payments:
    (1) Hospital name. The name of the hospital that received a DSH 
payment from the State, identifying facilities that are institutes for 
mental disease (IMDs) and facilities that are located out-of-state.
    (2) Estimate of hospital-specific DSH limit. The State's estimate of 
eligible uncompensated care for the hospital receiving a DSH payment for 
the year under audit based on the State's methodology for determining 
such limit.
    (3) Medicaid inpatient utilization rate. The hospital's Medicaid 
inpatient utilization rate, as defined in Section 1923(b)(2) of the Act, 
if the State does not use alternative qualification criteria described 
in paragraph (c)(5) of this section.
    (4) Low income utilization rate. The hospital's low income 
utilization rate, as defined in Section 1923(b)(3) of the Act if the 
State does not use alternative qualification criteria described in 
paragraph (c)(5) of this section.
    (5) State defined DSH qualification criteria. If the State uses an 
alternate broader DSH qualification methodology as authorized in Section 
1923(b)(4) of the Act, the value of the statistic and the methodology 
used to determine that statistic.
    (6) IP/OP Medicaid fee-for-service (FFS) basic rate payments. The 
total annual amount paid to the hospital under the State plan, including 
Medicaid FFS rate adjustments, but not including DSH payments or 
supplemental/enhanced Medicaid payments, for inpatient and outpatient 
services furnished to Medicaid eligible individuals.
    (7) IP/OP Medicaid managed care organization payments. The total 
annual amount paid to the hospital by Medicaid managed care 
organizations for inpatient hospital and outpatient hospital services 
furnished to Medicaid eligible individuals.
    (8) Supplemental/enhanced Medicaid IP/OP payments. Indicate the 
total annual amount of supplemental/enhanced Medicaid payments made to 
the hospital under the State plan. These amounts do not include DSH 
payments, regular Medicaid FFS rate payments, and Medicaid managed care 
organization payments.
    (9) Total Medicaid IP/OP Payments. Provide the total sum of items 
identified in Sec.  447.299(c)(6), (7) and (8).
    (10) Total Cost of Care for Medicaid IP/OP Services. The total 
annual costs incurred by each hospital for furnishing inpatient hospital 
and outpatient hospital services to Medicaid eligible individuals. The 
total annual costs are determined on a hospital-specific basis, not a 
service-specific basis. For purposes of this section, costs--
    (i) Are defined as costs net of third-party payments, including, but 
not limited to, payments by Medicare and private insurance.
    (ii) Must capture the total burden on the hospital of treating 
Medicaid eligible patients prior to payment by Medicaid. Thus, costs 
must be determined in the aggregate and not by estimating the cost of 
individual patients. For example, if a hospital treats two Medicaid 
eligible patients at a cost of $2,000 and receives a $500 payment from a 
third party for each individual, the total cost to the hospital for 
purposes of this section is $1,000, regardless of whether the third 
party payment received for one patient exceeds the cost of providing the 
service to that individual.
    (11) Total Medicaid Uncompensated Care. The total amount of 
uncompensated care attributable to Medicaid inpatient and outpatient 
services. The amount should be the result of subtracting the amount 
identified in Sec.  447.299(c)(9) from the amount identified in Sec.  
447.299(c)(10). The uncompensated care costs of providing Medicaid 
physician services cannot be included in this amount.

[[Page 484]]

    (12) Uninsured IP/OP revenue. Total annual payments received by the 
hospital by or on behalf of individuals with no source of third party 
coverage for inpatient and outpatient hospital services they receive. 
This amount does not include payments made by a State or units of local 
government, for services furnished to indigent patients.
    (13) Total Applicable Section 1011 Payments. Federal Section 1011 
payments for uncompensated inpatient and outpatient hospital services 
provided to Section 1011 eligible aliens with no source of third party 
coverage for the inpatient and outpatient hospital services they 
receive.
    (14) Total cost of IP/OP care for the uninsured. Indicate the total 
costs incurred for furnishing inpatient hospital and outpatient hospital 
services to individuals with no source of third party coverage for the 
hospital services they receive.
    (15) Total uninsured IP/OP uncompensated care costs. Total annual 
amount of uncompensated IP/OP care for furnishing inpatient hospital and 
outpatient hospital services to individuals with no source of third 
party coverage for the hospital services they receive.
    (i) The amount should be the result of subtracting paragraphs 
(c)(12) and (c)(13), from paragraph (c)(14) of this section.
    (ii) The uncompensated care costs of providing physician services to 
the uninsured cannot be included in this amount.
    (iii) The uninsured uncompensated amount also cannot include amounts 
associated with unpaid co-pays or deductibles for individuals with third 
party coverage for the inpatient and/or outpatient hospital services 
they receive or any other unreimbursed costs associated with inpatient 
and/or outpatient hospital services provided to individuals with those 
services in their third party coverage benefit package.
    (iv) The uncompensated care costs do not include bad debt or payer 
discounts related to services furnished to individuals who have health 
insurance or other third party payer.
    (16) Total annual uncompensated care costs. The total annual 
uncompensated care cost equals the total cost of care for furnishing 
inpatient hospital and outpatient hospital services to Medicaid eligible 
individuals and to individuals with no source of third party coverage 
for the hospital services they receive less the sum of regular Medicaid 
FFS rate payments, Medicaid managed care organization payments, 
supplemental/enhanced Medicaid payments, uninsured revenues, and Section 
1011 payments for inpatient and outpatient hospital services. This 
should equal the sum of paragraphs (c)(9),(c)(12), and (c)(13) 
subtracted from the sum of paragraphs (c)(10) and (c)(14) of this 
section.
    (17) Disproportionate share hospital payments. Indicate total annual 
payment adjustments made to the hospital under Section 1923 of the Act.
    (18) Medicaid provider number. The provider identification number 
assigned by the Medicaid program.
    (19) Medicare provider number. The provider identification number 
assigned by the Medicare program.
    (20) Total hospital cost. The total annual costs incurred by each 
hospital for furnishing inpatient hospital and outpatient hospital 
services.
    (21) Reporting. States must report DSH payments made to all 
hospitals under the authority of the approved Medicaid State plan. This 
includes both in-State and out-of-State hospitals. For out-of-State 
hospitals, States must report, at a minimum, the information identified 
in Sec.  447.299(c)(1) through (c)(6), (c)(8), (c)(9), (c)(17), (c)(18), 
and (c)(19).
    (d) Each State must maintain, in readily reviewable form, supporting 
documentation that provides a detailed description of each DSH program, 
the legal basis of each DSH program, and the amount of DSH payments made 
to each individual public and private provider or facility each quarter. 
This information must be made available to Federal reviewers upon 
request.
    (e) If a State fails to comply with the reporting requirements 
contained in this section, future grant awards will be reduced by the 
amount of FFP CMS estimates is attributable to the expenditures made to 
the disproportionate share hospitals as to which the State has not 
reported properly, until such time as the State complies with the 
reporting requirements. Deferrals

[[Page 485]]

and/or disallowances of equivalent amounts may also be imposed with 
respect to quarters for which the State has failed to report properly. 
Unless otherwise prohibited by law, FFP for those expenditures will be 
released when the State complies with all reporting requirements.

[46 FR 47971, Sept. 30, 1981, as amended at 73 FR 77950, Dec. 19, 2008; 
74 FR 18657, Apr. 24, 2009; 77 FR 31512, May 29, 2012; 78 FR 57313, 
Sept. 18, 2013; 82 FR 16122, Apr. 3, 2017; 85 FR 72909, Nov. 16, 2020]



 Subpart F_Payment Methods for Other Institutional and Noninstitutional 
                                Services

    Source: 43 FR 45253, Sept. 29, 1978, unless otherwise noted. 
Redesignated at 46 FR 47973, Sept. 30, 1981, and further redesignated at 
58 FR 6095, Jan. 26, 1993.



Sec.  447.300  Basis and purpose.

    In this subpart, Sec. Sec.  447.302 through 447.325 and 447.361 
implement section 1902(a)(30) of the Act, which requires that payments 
be consistent with efficiency, economy and quality of care. Section 
447.371 implements section 1902(a)(15) of the Act, which requires that 
the State plan provide for payment for rural health clinic services in 
accordance with regulations prescribed by the Secretary.

[72 FR 39239, July 17, 2007]



Sec.  447.302  State plan requirements.

    A State plan must provide that the requirements of this subpart are 
met.

[46 FR 48560, Oct. 1, 1981]



Sec.  447.304  Adherence to upper limits; FFP.

    (a) The Medicaid agency must not pay more than the upper limits 
described in this subpart.
    (b) In the case of payments made under the plan for deductibles and 
coinsurance payable on an assigned Medicare claim for noninstitutional 
services, those payments may be made only up to the reasonable charge 
under Medicare.
    (c) FFP is not available for a State's expenditures for services 
that are in excess of the amounts allowable under this subpart.
    Note: The Secretary may waive any limitation on reimbursement 
imposed by subpart F of this part for experiments conducted under 
section 402 of Pub. L. 90-428, Incentives for Economy Experimentation, 
as amended by section 222(b) of Pub. L. 92-603, and under section 222(a) 
of Pub. L. 92-603.

[46 FR 48560, Oct. 1, 1981; 46 FR 54744, Nov. 4, 1981, as amended at 66 
FR 3176, Jan. 12, 2001]

                 Outpatient Hospital and Clinic Services



Sec.  447.321  Outpatient hospital and clinic services: Application of
upper payment limits.

    (a) Scope. This section applies to rates set by the agency to pay 
for outpatient services furnished by hospitals and clinics within one of 
the following categories:
    (1) State government-owned or operated facilities (that is, all 
facilities that are owned or operated by the State.)
    (2) Non-State government owned or operated facilities (that is, all 
government operated facilities that are neither owned nor operated by 
the State).
    (3) Privately-owned and operated facilities.
    (b) General rules. (1) Upper payment limit refers to a reasonable 
estimate of the amount that would be paid for the services furnished by 
the group of facilities under Medicare payment principles in subchapter 
B of this chapter.
    (2) Except as provided in paragraph (c) of this section, aggregate 
Medicaid payments to a group of facilities within one of the categories 
described in paragraph (a) of this section may not exceed the upper 
payment limit described in paragraph (b)(1) of this section.
    (c) Exceptions. Indian Health Services and tribal facilities. The 
limitation in paragraph (b) of this section does not apply to Indian 
Health Services facilities and tribal facilities that are funded through 
the Indian Self-Determination and Education Assistance Act (Pub. L. 93-
638).
    (d) Compliance dates. Except as permitted under paragraph (e) of 
this section, a State must comply with the upper payment limit described 
in paragraph (b)(1) of this section by one of the following dates:

[[Page 486]]

    (1) For non-State government-owned or operated hospitals--March 19, 
2002.
    (2) For all other facilities--March 13, 2001.

[66 FR 3176, Jan. 12, 2001, as amended at 66 FR 46399, Sept. 5, 2001; 67 
FR 2611, Jan. 18, 2002; 72 FR 29835, May 29, 2007; 75 FR 73975, Nov. 30, 
2010; 77 FR 31513, May 29, 2012]

                Other Inpatient and Outpatient Facilities



Sec.  447.325  Other inpatient and outpatient facility services: 
Upper limits of payment.

    The agency may pay the customary charges of the provider but must 
not pay more than the prevailing charges in the locality for comparable 
services under comparable circumstances.



Sec.  447.342  [Reserved]

                        Prepaid Capitation Plans



Sec.  447.362  Upper limits of payment: Nonrisk contract.

    Under a nonrisk contract, Medicaid payments to the contractor may 
not exceed--
    (a) What Medicaid would have paid, on a fee-for-service basis, for 
the services actually furnished to beneficiaries: plus
    (b) The net savings of administrative costs the Medicaid agency 
achieves by contracting with the plan instead of purchasing the services 
on a fee-for-service basis.

[48 FR 54025, Nov. 30, 1983]

                      Rural Health Clinic Services



Sec.  447.371  Services furnished by rural health clinics.

    The agency must pay for rural health clinic services, as defined in 
Sec.  440.20(b) of this subchapter, and for other ambulatory services 
furnished by a rural health clinic, as defined in Sec.  440.20(c) of 
this subchapter, as follows:
    (a) For provider clinics, the agency must pay the reasonable cost of 
rural health clinic services and other ambulatory services on the basis 
of the cost reimbursement principles in part 413 of this chapter. For 
purposes of this section, a provider clinic is an integral part of a 
hospital, skilled nursing facility, or home health agency that is 
participating in Medicare and is licensed, governed, and supervised with 
other departments of the facility.
    (b) For clinics other than provider clinics that do not offer any 
ambulatory services other than rural health clinic services, the agency 
must pay for rural health clinic services at the reasonable cost rate 
per visit determined by a Medicare carrier under Sec. Sec.  405.2426 
through 405.2429 of this chapter.
    (c) For clinics other than provider clinics that do offer ambulatory 
services other than rural health clinic services, the agency must pay 
for the other ambulatory services by one of the following methods:
    (1) The agency may pay for other ambulatory services and rural 
health clinic services at a single rate per visit that is based on the 
cost of all services furnished by the clinic. The rate must be 
determined by a Medicare carrier under Sec. Sec.  405.2426 through 
405.2429 of this chapter.
    (2) The agency may pay for other ambulatory services at a rate set 
for each service by the agency. The rate must not exceed the upper 
limits in this subpart. The agency must pay for rural health clinic 
services at the Medicare reimbursement rate per visit, as specified in 
Sec.  405.2426 of this chapter.
    (3) The agency may pay for dental services at a rate per visit that 
is based on the cost of dental services furnished by the clinic. The 
rate must be determined by a Medicare carrier under Sec. Sec.  405.2426 
through 405.2429 of this chapter. The agency must pay for ambulatory 
services other than dental services under paragraph (c) (1) or (2) of 
this section.
    (d) For purposes of paragraph (c) (1) and (3) of this section, 
``visit'' means a face-to-face encounter between a clinic patient and 
any health professional whose services are reimbursed under the State 
plan. 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, after the first encounter, suffers illness or injury 
requiring additional diagnosis or treatment.

[43 FR 45253, Sept. 29, 1978, as amended at 51 FR 34833, Sept. 30, 1986]

[[Page 487]]



  Subpart G_Payments for Primary Care Services Furnished by Physicians

    Source: 77 FR 66700, Nov. 6, 2012, unless otherwise noted.



Sec.  447.400  Primary care services furnished by physicians with a
specified specialty or subspecialty.

    (a) States pay for services furnished by a physician as defined in 
Sec.  440.50 of this chapter, or under the personal supervision of a 
physician who self-attests to a specialty designation of family 
medicine, general internal medicine or pediatric medicine or a 
subspecialty recognized by the American Board of Medical Specialties 
(ABMS), the American Board of Physician Specialties (ABPS) or the 
American Osteopathic Association (AOA). Such physician then attests that 
he/she:
    (1) Is Board certified with such a specialty or subspecialty and/or
    (2) Has furnished evaluation and management services and vaccine 
administration services under codes described in paragraph (b) of this 
section that equal at least 60 percent of the Medicaid codes he or she 
has billed during the most recently completed CY or, for newly eligible 
physicians, the prior month.
    (b) At the end of CY 2013 and 2014 the Medicaid agency must review a 
statistically valid sample of physicians who received higher payments to 
verify that they meet the requirements of paragraph (a)(1) or (2) of 
this section.
    (c) Primary care services designated in the Healthcare Common 
Procedure Coding System (HCPCS) are as follows:
    (1) Evaluation and Management (E&M) codes 99201 through 99499.
    (2) Current Procedural Terminology (CPT) vaccine administration 
codes 90460, 90461, 90471, 90472, 90473 and 90474, or their successor 
codes.
    (d)(1) The state must submit to CMS, in such form and at such time 
as CMS specifies, information relating to participation by physicians 
described in paragraph (a) of this section and the utilization of E&M 
codes described in paragraph (c) of this section (whether furnished by 
or under the supervision of a physician described in paragraph (a)) of 
this section for the following peri--s--
    (i) As of July 1, 2009, and
    (ii) CY 2013
    (2) As soon as practicable after receipt, CMS will post this 
information on www.Medicaid.gov.

[77 FR 66700, Nov. 6, 2012, as amended at 77 FR 74382, Dec. 14, 2012]



Sec.  447.405  Amount of required minimum payments.

    (a) For CYs 2013 and 2014, a state must pay for physician services 
described in Sec.  447.400 based on the lower of:
    (1) The Medicare Part B fee schedule rate that is applicable to the 
specific site of service or, at the state's option, the office setting 
and is also adjusted for either the specific geographic location of the 
service or reflects the mean over all counties of the rate for each E&M 
code. If there is no applicable rate, the rate specified in a fee 
schedule established and announced by CMS (that is, the product of 
multiplying the Medicare CF in effect at the beginning of CYs 2013 or 
2014 (or the CY 2009 CF, if higher) and the CY 2013 and 2014 relative 
value units (RVUs).
    (2) The provider's actual billed charge for the service.
    (b) For vaccines provided under the Vaccines for Children Program in 
CYs 2013 and 2014, a State must pay the lesser of:
    (1) The Regional Maximum Administration Fee; or,
    (2) The Medicare fee schedule rate in CY 2013 or 2014 (or, if 
higher, the rate using the 2009 conversion factor and the 2013 and 2014 
RVUs) for code 90460.

[77 FR 66700, Nov. 6, 2012, as amended at 77 FR 74382, Dec. 14, 2012]



Sec.  447.410  State plan requirements.

    The state must amend its state plan to reflect the increase in fee 
schedule payments in CYs 2013 and 2014 unless, for each of the billing 
codes eligible for payment, the state currently reimburses at least as 
much as the higher of the CY 2013 and CY 2014 Medicare rate or the rate 
that would be derived using the CY 2009 conversion factor and the CY 
2013 and 2014 Medicare relative value units (RVUs). The amendment must:

[[Page 488]]

    (a) Identify all eligible codes that the state will reimburse at the 
Medicare rate in CYs 2013 and 2014.
    (b) Identify all codes that were not reimbursed under the Medicaid 
program as of July 1, 2009.
    (c) Specify either that the state will make all adjustments 
applicable to the specific site of service or, at the state's option, 
the office setting and will also either adjust for the specific 
geographic location of the service or pay rates that reflect the mean 
over all counties of the rate for each E&M code. The state must specify 
the formula that the state will use to determine the mean rate for each 
E&M code.



Sec.  447.415  Availability of Federal financial participation (FFP).

    (a) For primary care services furnished by physicians specified in 
Sec.  447.400, FFP will be available at the rate of 100 percent for the 
amount by which the payment required to comply with Sec.  447.405 
exceeds the Medicaid payment that would have been made under the 
approved state plan in effect on July 1, 2009.
    (b) For purposes of calculating the payment that would have been 
made under the approved State plan in effect on July 1, 2009, the state 
must exclude incentive, bonus, and performance-based payments but must 
include supplemental payments for which the approved methodology is 
linked to volume and payment for specific codes.
    (c) For vaccine administration, the state must impute the payment 
that would have been made for code 90460 under the approved Medicaid 
state plan. The imputed rate for July 1, 2009, for code 90460 equals the 
payment rates for codes 90465 and 90471 weighted by service volume.
    (d) For any payment made under a bundled rate methodology, including 
bundled rates for vaccines and vaccine administration, the amount 
directly attributable to the applicable primary care service must be 
isolated for purposes of determining the availability of the 100 percent 
FFP rate. Bundled rates, for purposes of this provision, do not include 
encounter and per diem rates.

Subpart H [Reserved]



                       Subpart I_Payment for Drugs

    Source: 81 FR 5347, Feb. 1, 2016, unless otherwise noted.



Sec.  447.500  Basis and purpose.

    (a) Basis. This subpart:
    (1) Interprets those provisions of section 1927 of the Act that set 
forth requirements for drug manufacturers' calculating and reporting 
average manufacturer prices (AMPs) and best prices and that set upper 
payment limits for covered outpatient drugs.
    (2) Implements section 1903(i)(10) of the Act with regard to the 
denial of Federal financial participation (FFP) in expenditures for 
certain physician-administered drugs.
    (3) Implements section 1902(a)(54) of the Act with regard to a State 
plan that provides covered outpatient drugs.
    (4) Implements section 1903(m)(2)(A)(xiii) of the Act, in part, and 
section 1927(b) of the Act with regard to rebates for covered outpatient 
drugs dispensed to individuals eligible for medical assistance who are 
enrolled in Medicaid managed care organizations (MCOs).
    (5) Implements section 1902(a)(30)(A) of the Act with regard to the 
efficiency, economy, and quality of care in the context of payments for 
covered outpatient drugs.
    (b) Purpose. This subpart specifies certain requirements in the 
Social Security Act, including changes from the Affordable Care Act and 
other requirements pertaining to Medicaid payment for drugs.



Sec.  447.502  Definitions.

    For the purpose of this subpart, the following definitions apply:
    Actual acquisition cost (AAC) means the agency's determination of 
the pharmacy providers' actual prices paid to acquire drug products 
marketed or sold by specific manufacturers.
    Authorized generic drug means any drug sold, licensed, or marketed 
under a new drug application (NDA) approved by the Food and Drug 
Administration (FDA) under section 505(c) of the Federal Food, Drug and 
Cosmetic Act (FFDCA) that is marketed, sold or distributed under a 
different labeler code, product code, trade name, trademark,

[[Page 489]]

or packaging (other than repackaging the listed drug for use in 
institutions) than the brand name drug.
    Bona fide service fee means a fee paid by a manufacturer to an 
entity that represents fair market value for a bona fide, itemized 
service actually performed on behalf of the manufacturer that the 
manufacturer would otherwise perform (or contract for) in the absence of 
the service arrangement, and that is not passed on in whole or in part 
to a client or customer of an entity, whether or not the entity takes 
title to the drug. The fee includes, but is not limited to, distribution 
service fees, inventory management fees, product stocking allowances, 
and fees associated with administrative service agreements and patient 
care programs (such as medication compliance programs and patient 
education programs).
    Brand name drug means a single source or innovator multiple source 
drug.
    Bundled sale means any arrangement regardless of physical packaging 
under which the rebate, discount, or other price concession is 
conditioned upon the purchase of the same drug, drugs of different types 
(that is, at the nine-digit national drug code (NDC) level) or another 
product or some other performance requirement (for example, the 
achievement of market share, inclusion or tier placement on a 
formulary), or where the resulting discounts or other price concessions 
are greater than those which would have been available had the bundled 
drugs been purchased separately or outside the bundled arrangement.
    (1) The discounts in a bundled sale, including those discounts 
resulting from a contingent arrangement, are allocated proportionally to 
the total dollar value of the units of all drugs or products sold under 
the bundled arrangement.
    (2) For bundled sales where multiple drugs are discounted, the 
aggregate value of all the discounts in the bundled arrangement must be 
proportionally allocated across all the drugs or products in the bundle.
    (3) Value-based purchasing (VBP) arrangements may qualify as a 
bundled sale.
    Clotting factor means a hemophilia clotting factor for which a 
separate furnishing payment is made under section 1842(o)(5) of the Act 
and which is included on a list of such factors specified and updated 
regularly by CMS and posted on the CMS Web site.
    CMS-authorized supplemental rebate agreement means an agreement that 
is approved through a state plan amendment (SPA) by CMS, which allows a 
state to enter into single and/or multi-state supplemental drug rebate 
arrangements that generate rebates that are at least as large as the 
rebates set forth in the Secretary's national rebate agreement with drug 
manufacturers. Revenue from these rebates must be paid directly to the 
state and be used by the state to offset a state's drug expenditures 
resulting in shared savings with the Federal Government.
    Consumer Price Index--Urban (CPI-U) means the index of consumer 
prices developed and updated by the U.S. Department of Labor. It is the 
CPI for all urban consumers (U.S. average) for the month before the 
beginning of the calendar quarter for which the rebate is paid.
    Covered outpatient drug means, of those drugs which are treated as a 
prescribed drug for the purposes of section 1905(a)(12) of the Act, a 
drug which may be dispensed only upon a prescription (except as provided 
in paragraphs (2) and (3) of this definition).
    (1) A drug can only be considered a covered outpatient drug if it:
    (i) Is approved for safety and effectiveness as a prescription drug 
by the FDA under section 505 or 507 of the FFDCA or under section 505(j) 
of the FFDCA;
    (ii) Was commercially used or sold in the United States before the 
enactment of the Drug Amendments of 1962 or which is identical, similar, 
or related (within the meaning described in FDA regulations at 21 CFR 
310.6(b)(1)) to such a drug, and which has not been the subject of a 
final determination by the Secretary that it is a ``new drug'' (within 
the meaning of section 201(p) of the FFDCA) or an action brought by the 
Secretary under sections 301, 302(a), or 304(a) of FFDCA to enforce 
section 502(f) or 505(a) of the FFDCA;

[[Page 490]]

    (iii) Is described in section 107(c)(3) of the Drug Amendments of 
1962 and for which the Secretary has determined there is a compelling 
justification for its medical need or is identical, similar, or related 
(within the meaning described in FDA regulations at 21 CFR 310.6(b)(1)) 
to such a drug or for which the Secretary has not issued a notice for an 
opportunity for a hearing under section 505(e) of the FFDCA on a 
proposed order of the Secretary to withdraw approval of an application 
for such drug under section 505(e) of the FFDCA because the Secretary 
has determined that the drug is less than effective for some or all 
conditions of use prescribed, recommended, or suggested in its labeling;
    (iv) Is a biological product other than a vaccine that may only be 
dispensed upon a prescription and is licensed under section 351 of the 
Public Health Service Act (PHSA) and is produced at an establishment 
licensed under section 351 of the PHSA to produce such product; or
    (v) Is insulin certified under section 506 of the FFDCA.
    (2) A covered outpatient drug does not include any drug, biological 
product, or insulin provided as part of or incident to and in the same 
setting as any of the following services (and for which payment may be 
made as part of that service instead of as a direct reimbursement for 
the drug):
    (i) Inpatient Services;
    (ii) Hospice Services;
    (iii) Dental Services, except that drugs for which the State plan 
authorizes direct reimbursement to the dispensing dentist are covered 
outpatient drugs;
    (iv) Physician services;
    (v) Outpatient hospital services;
    (vi) Nursing facility and services provided by an intermediate care 
facility for individuals with intellectual disabilities;
    (vii) Other laboratory and x-ray services; or
    (viii) Renal dialysis.
    (3) A covered outpatient drug does not include:
    (i) Any drug product, prescription or over-the-counter (OTC), for 
which an NDC number is not required by the FDA;
    (ii) Any drug product for which a manufacturer has not submitted to 
CMS evidence to demonstrate that the drug product satisfies the criteria 
in paragraph (1) of this definition;
    (iii) Any drug product or biological used for a medical indication 
which is not a medically accepted indication; or
    (iv) Over-the-counter products that are not drugs.
    Customary prompt pay discount means any discount off of the purchase 
price of a drug routinely offered by the manufacturer to a wholesaler 
for prompt payment of purchased drugs within a specified timeframe and 
consistent with customary business practices for payment.
    Innovator multiple source drug means a multiple source drug, 
including an authorized generic drug, that is marketed under a new drug 
application (NDA) approved by FDA, unless the Secretary determines that 
a narrow exception applies (as described in this section). It also 
includes a drug product marketed by any cross-licensed producers, 
labelers, or distributors operating under the NDA and a covered 
outpatient drug approved under a biologics license application (BLA), 
product license application (PLA), establishment license application 
(ELA) or antibiotic drug application (ADA).
    Lagged price concession means any discount or rebate that is 
realized after the sale of the drug, but does not include customary 
prompt pay discounts.
    Line extension means, for a drug, a new formulation of the drug, but 
does not include an abuse-deterrent formulation of the drug (as 
determined by the Secretary).
    Manufacturer means any entity that holds the NDC for a covered 
outpatient drug or biological product and meets the following criteria:
    (1) Is engaged in the production, preparation, propagation, 
compounding, conversion, or processing of covered outpatient drug 
products, either directly or indirectly by extraction from substances of 
natural origin, or independently by means of chemical synthesis, or by a 
combination of extraction and chemical synthesis; or

[[Page 491]]

    (2) Is engaged in the packaging, repackaging, labeling, relabeling, 
or distribution of covered outpatient drug products and is not a 
wholesale distributor of drugs or a retail pharmacy licensed under State 
law.
    (3) For authorized generic products, the term ``manufacturer'' will 
also include the original holder of the NDA.
    (4) For drugs subject to private labeling arrangements, the term 
``manufacturer'' will also include the entity under whose own label or 
trade name the product will be distributed.
    Multiple source drug means, for a rebate period, a covered 
outpatient drug, including a drug product approved for marketing as a 
non-prescription drug that is regarded as a covered outpatient drug 
under section 1927(k)(4) of the Act, for which there is at least 1 other 
drug product which meets all of the following criteria:
    (1) Is rated as therapeutically equivalent (under the FDA's most 
recent publication of ``Approved Drug Products with Therapeutic 
Equivalence Evaluations'' which is available at http://
www.accessdata.fda.gov/scripts/cder/ob/).
    (2) Except as provided at section 1927(k)(7)(B) of the Act, is 
pharmaceutically equivalent and bioequivalent, as defined at section 
1927(k)(7)(C) of the Act and as determined by FDA.
    (3) Is sold or marketed in the United States during the period.
    National drug code (NDC) means the numerical code maintained by the 
FDA that includes the labeler code, product code, and package code. For 
purposes of this subpart, the NDC is considered to be an 11-digit code, 
unless otherwise specified in this subpart as being without regard to 
package size (that is, the 9-digit numerical code).
    National rebate agreement means the rebate agreement developed by 
CMS and entered into by CMS on behalf of the Secretary or his or her 
designee and a manufacturer to implement section 1927 of the Act.
    New formulation means, for a drug, a change to the drug, including, 
but not limited to: an extended release formulation or other change in 
release mechanism, a change in dosage form, strength, route of 
administration, or ingredients.
    Nominal price means a price that is less than 10 percent of the 
average manufacturer price (AMP) in the same quarter for which the AMP 
is computed.
    Noninnovator multiple source drug means:
    (1) A multiple source drug that is not an innovator multiple source 
drug or a single source drug;
    (2) A multiple source drug that is marketed under an ANDA or an 
abbreviated antibiotic drug application;
    (3) A covered outpatient drug that entered the market before 1962 
that was not originally marketed under an NDA;
    (4) Any drug that has not gone through an FDA approval process, but 
otherwise meets the definition of covered outpatient drug; or
    (5) If any of the drug products listed in this definition of a 
noninnovator multiple source drug subsequently receives an NDA or ANDA 
approval from FDA, the product's drug category changes to correlate with 
the new product application type.
    Oral solid dosage form means, an orally administered dosage form 
that is not a liquid or gas at the time the drug enters the oral cavity.
    Over-the-counter (OTC) drug means a drug that is appropriate for use 
without the supervision of a health care professional such as a 
physician, and which can be purchased by a consumer without a 
prescription.
    Pediatric indication means a specifically stated indication for use 
by the pediatric age group meaning from birth through 16 years of age, 
or a subset of this group as specified in the ``Indication and Usage'' 
section of the FDA approved labeling, or in an explanation elsewhere in 
the labeling that makes it clear that the drug is for use only in a 
pediatric age group, or a subset of this group.
    Professional dispensing fee means the professional fee which:
    (1) Is incurred at the point of sale or service and pays for costs 
in excess of the ingredient cost of a covered outpatient drug each time 
a covered outpatient drug is dispensed;
    (2) Includes only pharmacy costs associated with ensuring that 
possession of the appropriate covered outpatient

[[Page 492]]

drug is transferred to a Medicaid beneficiary. Pharmacy costs include, 
but are not limited to, reasonable costs associated with a pharmacist's 
time in checking the computer for information about an individual's 
coverage, performing drug utilization review and preferred drug list 
review activities, measurement or mixing of the covered outpatient drug, 
filling the container, beneficiary counseling, physically providing the 
completed prescription to the Medicaid beneficiary, delivery, special 
packaging, and overhead associated with maintaining the facility and 
equipment necessary to operate the pharmacy; and
    (3) Does not include administrative costs incurred by the State in 
the operation of the covered outpatient drug benefit including systems 
costs for interfacing with pharmacies.
    Rebate period means a calendar quarter.
    Single source drug means a covered outpatient drug, including a drug 
product approved for marketing as a non-prescription drug that is 
regarded as a covered outpatient drug under section 1927(k)(4) of the 
Act, which is produced or distributed under a new drug application 
approved by the FDA, including a drug product marketed by any cross-
licensed producers or distributors operating under the new drug 
application unless the Secretary determines that a narrow exception 
applies (as described in this section), and includes a covered 
outpatient drug that is a biological product licensed, produced, or 
distributed under a biologics license application approved by the FDA.
    States means the 50 States and the District of Columbia and, 
beginning January 1, 2023, also includes the Commonwealth of Puerto 
Rico, the Virgin Islands of the United States, Guam, the Commonwealth of 
the Northern Mariana Islands, and American Samoa.
    United States means the 50 States and the District of Columbia and, 
beginning January 1, 2023, also includes the Commonwealth of Puerto 
Rico, the Virgin Islands of the United States, Guam, the Commonwealth of 
the Northern Mariana Islands, and American Samoa.
    Value-based purchasing (VBP) arrangement means an arrangement or 
agreement intended to align pricing and/or payments to an observed or 
expected therapeutic or clinical value in a select population and 
includes, but is not limited to:
    (1) Evidence-based measures, which substantially link the cost of a 
covered outpatient drug to existing evidence of effectiveness and 
potential value for specific uses of that product; and/or
    (2) Outcomes-based measures, which substantially link payment for 
the covered outpatient drug to that of the drug's actual performance in 
patient or a population, or a reduction in other medical expenses.
    Wholesaler means a drug wholesaler that is engaged in wholesale 
distribution of prescription drugs to retail community pharmacies, 
including but not limited to repackers, distributors, own-label 
distributors, private-label distributors, jobbers, brokers, warehouses 
(including distributor's warehouses, chain drug warehouses, and 
wholesale drug warehouses), independent wholesale drug traders, and 
retail community pharmacies that conduct wholesale distributions.

[81 FR 5347, Feb. 1, 2016, as amended at 81 FR 80005, Nov. 15, 2016; 84 
FR 64786, Nov. 25, 2019; 85 FR 87101, Dec. 31, 2020; 86 FR 64825, Nov. 
19, 2021]



Sec.  447.504  Determination of average manufacturer price.

    (a) Definitions. For the purpose of this section, the following 
definitions apply:
    Average manufacturer price (AMP) means, for a covered outpatient 
drug of a manufacturer (including those sold under an NDA approved under 
section 505(c) of the Federal Food, Drug, and Cosmetic Act), the average 
price paid to the manufacturer for the drug in the United States by 
wholesalers for drugs distributed to retail community pharmacies and 
retail community pharmacies that purchase drugs directly from the 
manufacturer.
    Average unit price means a manufacturer's sales included in AMP less 
all required adjustments divided by the total units sold and included in 
AMP by the manufacturer in a quarter.
    Charitable and not-for profit pharmacies means organizations exempt 
from taxation as defined by section

[[Page 493]]

501(c)(3) of the Internal Revenue Code of 1986.
    Insurers means entities that are responsible for payment to 
pharmacies for drugs dispensed to their members, and do not take actual 
possession of these drugs or pass on manufacturer discounts or rebates 
to pharmacies.
    Net sales means quarterly gross sales revenue less cash discounts 
allowed, except customary prompt pay discounts extended to wholesalers, 
and all other price reductions (other than rebates under section 1927 of 
the Act or price reductions specifically excluded by statute or 
regulation) which reduce the amount received by the manufacturer.
    Retail community pharmacy means an independent pharmacy, a chain 
pharmacy, a supermarket pharmacy, or a mass merchandiser pharmacy that 
is licensed as a pharmacy by the State and that dispenses medications to 
the general public at retail prices. Such term does not include a 
pharmacy that dispenses prescription medications to patients primarily 
through the mail, nursing home pharmacies, long-term care facility 
pharmacies, hospital pharmacies, clinics, charitable or not-for-profit 
pharmacies, government pharmacies, or pharmacy benefit managers.
    (b) Sales, nominal price sales, and associated discounts, rebates, 
payments, or other financial transactions included in AMP. Except for 
those sales, nominal price sales, and associated discounts, rebates, 
payments or other financial transactions identified in paragraph (c) of 
this section, AMP for covered outpatient drugs includes the following 
sales, nominal price sales, and associated discounts, rebates, payments, 
or other financial transactions:
    (1) Sales to wholesalers for drugs distributed to retail community 
pharmacies.
    (2) Sales to retail community pharmacies (including those sales, 
nominal price sales, and associated discounts, rebates (other than 
rebates under section 1927 of the Act or as specified in regulations), 
payments, or other financial transactions that are received by, paid by, 
or passed through to retail community pharmacies).
    (c) Sales, nominal price sales, and associated discounts, rebates, 
payments, or other financial transactions excluded from AMP. AMP 
excludes the following sales, nominal price sales, and associated 
discounts, rebates, payments, or other financial transactions:
    (1) Any prices on or after October 1, 1992, to the Indian Health 
Service (IHS), the Department of Veterans Affairs (DVA), a State home 
receiving funds under 38 U.S.C. 1741, the Department of Defense (DoD), 
the Public Health Service (PHS), or a covered entity described in 
section 1927(a)(5)(B) of the Act (including inpatient prices charged to 
hospitals described in section 340B(a)(4)(L) of the PHSA).
    (2) Any prices charged under the Federal Supply Schedule (FSS) of 
the General Services Administration (GSA).
    (3) Any depot prices (including TRICARE) and single award contract 
prices, as defined by the Secretary, of any agency of the Federal 
government.
    (4) Sales outside the United States.
    (5) Sales to hospitals.
    (6) Sales to health maintenance organizations (HMOs) (including 
managed care organizations (MCOs)), including HMO or MCO operated 
pharmacies.
    (7) Sales to long-term care providers, including nursing facility 
pharmacies, nursing home pharmacies, long-term care facilities, contract 
pharmacies for the nursing facility where these sales can be identified 
with adequate documentation, and other entities where the drugs are 
dispensed through a nursing facility pharmacy, such as assisted living 
facilities.
    (8) Sales to mail order pharmacies.
    (9) Sales to clinics and outpatient facilities (for example, 
surgical centers, ambulatory care centers, dialysis centers, and mental 
health centers).
    (10) Sales to government pharmacies (for example, a Federal, State, 
county, or municipal-owned pharmacy).
    (11) Sales to charitable pharmacies.
    (12) Sales to not-for-profit pharmacies.
    (13) Sales, associated rebates, discounts, or other price 
concessions paid directly to insurers.
    (14) Bona fide service fees, as defined in Sec.  447.502, paid by 
manufacturers to wholesalers or retail community pharmacies.
    (15) Customary prompt pay discounts extended to wholesalers.

[[Page 494]]

    (16) Reimbursement by the manufacturer for recalled, damaged, 
expired, or otherwise unsalable returned goods, including (but not 
limited to) reimbursement for the cost of the goods and any 
reimbursement of costs associated with return goods handling and 
processing, reverse logistics, and drug destruction, but only to the 
extent that such payment covers only those costs.
    (17) Associated discounts, rebates, or other price concessions 
provided under the Medicare Coverage Gap Discount Program under section 
1860D-14A of the Act.
    (18) Payments received from and rebates and discounts provided to 
pharmacy benefit manufacturers (PBMs).
    (19) Rebates under the national rebate agreement or a CMS-authorized 
State supplemental rebate agreement paid to State Medicaid Agencies 
under section 1927 of the Act.
    (20) Sales to hospices (inpatient and outpatient).
    (21) Sales to prisons.
    (22) Sales to physicians.
    (23) Direct sales to patients.
    (24) Free goods, not contingent upon any purchase requirement.
    (25) Manufacturer coupons to a consumer redeemed by the 
manufacturer, agent, pharmacy or another entity acting on behalf of the 
manufacturer, but only to the extent that the full value of the coupon 
is passed on to the consumer and the pharmacy, agent, or other AMP-
eligible entity does not receive any price concession.
    (26) Manufacturer-sponsored programs that provide free goods, 
including but not limited to vouchers and patient assistance programs, 
but only to the extent that: The voucher or benefit of such a program is 
not contingent on any other purchase requirement; the full value of the 
voucher or benefit of such a program is passed on to the consumer; and 
the pharmacy, agent, or other AMP eligible entity does not receive any 
price concession.
    (27) Manufacturer-sponsored drug discount card programs, but only to 
the extent that the full value of the discount is passed on to the 
consumer and the pharmacy, agent, or other AMP eligible entity does not 
receive any price concession.
    (28) Manufacturer-sponsored patient refund/rebate programs, to the 
extent that the manufacturer provides a full or partial refund or rebate 
to the patient for out-of-pocket costs and the pharmacy, agent, or other 
AMP eligible entity does not receive any price concessions.
    (29) Manufacturer copayment assistance programs, to the extent that 
the program benefits are provided entirely to the patient and the 
pharmacy, agent, or other AMP eligible entity does not receive any price 
concession.
    (30) Any rebates, discounts, or price concessions provided to a 
designated State Pharmacy Assistance Program (SPAP).
    (d) Sales, nominal price sales, and associated discounts, rebates, 
payments, or other financial transactions included in AMP for 5i drugs 
that are not generally dispensed through retail community pharmacies. 
Except for those sales, nominal price sales, and associated discounts, 
rebates, payments, and other financial transactions identified in 
paragraph (e) of this section, AMP for inhalation, infusion, instilled, 
implanted, or injectable drugs (5i) covered outpatient drugs identified 
in accordance with Sec.  447.507 shall include sales, nominal price 
sales, and associated discounts, rebates, payments, or other financial 
transactions to all entities specified in paragraph (b) of this section, 
as well as the following sales, nominal price sales, and associated 
discounts, rebates, payments, or other financial transactions:
    (1) Sales to physicians.
    (2) Sales to pharmacy benefit managers.
    (3) Sales to health maintenance organizations (HMOs), including 
managed care organizations (MCOs).
    (4) Sales to insurers (except for rebates under section 1927 of the 
Act and this subpart).
    (5) Sales to hospitals.
    (6) Sales to clinics and outpatient facilities (for example, 
surgical centers, ambulatory care centers, dialysis centers, mental 
health centers).
    (7) Sales to mail order pharmacies.
    (8) Sales to long-term care providers, including nursing facility 
pharmacies, nursing home pharmacies, long-term care facilities, contract 
pharmacies for

[[Page 495]]

the nursing facility where these sales can be identified with adequate 
documentation, and other entities where the drugs are dispensed through 
a nursing facility pharmacy, such as assisted living facilities.
    (9) Sales to hospices (inpatient and outpatient).
    (10) Sales to manufacturers, or any other entity that does not 
conduct business as a wholesaler or retail community pharmacy.
    (e) Sales, nominal price sales, and associated discounts, rebates, 
payments, or other transactions excluded from AMP for 5i drugs that are 
not generally dispensed through retail community pharmacies. AMP for 5i 
covered outpatient drugs identified in accordance with Sec.  447.507 
excludes the following sales, nominal price sales, and associated 
discounts, rebates, or other financial transactions:
    (1) Any prices on or after October 1, 1992, to the Indian Health 
Service (IHS), the Department of Veterans Affairs (DVA), a State home 
receiving funds under 38 U.S.C. 1741, the Department of Defense (DoD), 
the Public Health Service (PHS), or a covered entity described in 
section 1927(a)(5)(B) of the Act (including inpatient prices charged to 
hospitals described in section 340B(a)(4)(L) of the PHSA).
    (2) Any prices charged under the Federal Supply Schedule (FSS) of 
the General Services Administration (GSA).
    (3) Any depot prices (including TRICARE) and single award contract 
prices, as defined by the Secretary, of any agency of the Federal 
government.
    (4) Sales outside the United States.
    (5) Bona fide service fees as defined in Sec.  447.502 paid by 
manufacturers to wholesalers or retail community pharmacies.
    (6) Customary prompt pay discounts extended to wholesalers.
    (7) Reimbursement by the manufacturer for recalled, damaged, 
expired, or otherwise unsalable returned goods, including (but not 
limited to) reimbursement for the cost of the goods and any 
reimbursement of costs associated with return goods handling and 
processing, reverse logistics, and drug destruction, but only to the 
extent that such payment covers only these costs.
    (8) Any prices charged which are negotiated by a prescription drug 
plan under Part D of title XVIII, by any MA-PD plan under Part C of such 
title for covered Part D drugs, or by a Qualified Retiree Prescription 
Drug Plan (as defined in section 1860D-22(a)(2) of the Act) for such 
drugs on behalf of individuals entitled to benefits under Part A or 
enrolled under Part B of Medicare, or any discounts provided by 
manufacturers under the Medicare coverage gap discount program under 
section 1860D-14A of the Act.
    (9) Rebates under the national rebate agreement or a CMS-authorized 
State supplemental rebate agreement paid to State Medicaid Agencies 
under section 1927 of the Act.
    (10) Any rebates, discounts, or price concessions provided to a 
designated State Pharmacy Assistance Program (SPAP).
    (11) Sales to patients.
    (12) Free goods, not contingent upon any purchase requirement.
    (13) Manufacturer coupons to a consumer redeemed by the 
manufacturer, agent, pharmacy or another entity acting on behalf of the 
manufacturer, but only to the extent that the full value of the coupon 
is passed on to the consumer and the pharmacy, agent, or other AMP 
eligible entity does not receive any price concession.
    (14) Manufacturer-sponsored programs that provide free goods, 
including, but not limited to vouchers and patient assistance programs, 
but only to the extent that the voucher or benefit of such a program is 
not contingent on any other purchase requirement; the full value of the 
voucher or benefit of such a program is passed on to the consumer; and 
the pharmacy, agent, or other AMP eligible entity does not receive any 
price concession.
    (15) Manufacturer-sponsored drug discount card programs, but only to 
the extent that the full value of the discount is passed on to the 
consumer and the pharmacy, agent, or other AMP eligible entity does not 
receive any price concession.
    (16) Manufacturer-sponsored patient refund/rebate programs, to the 
extent that the manufacturer provides a full or partial refund or rebate 
to the patient for out-of-pocket costs and the

[[Page 496]]

pharmacy, agent, or other AMP eligible entity does not receive any price 
concessions.
    (17) Manufacturer copayment assistance programs, to the extent that 
the program benefits are provided entirely to the patient and the 
pharmacy, agent, or other AMP eligible entity does not receive any price 
concession.
    (18) Sales to government pharmacies (for example, a Federal, State, 
county, or municipal-owned pharmacy).
    (19) Sales to charitable pharmacies.
    (20) Sales to not-for-profit pharmacies.
    (f) Further clarification of AMP calculation. (1) AMP includes cash 
discounts except customary prompt pay discounts extended to wholesalers, 
free goods that are contingent on any purchase requirement, volume 
discounts, chargebacks that can be identified with adequate 
documentation, incentives, administrative fees, service fees, 
distribution fees (other than bona fide service fees), and any other 
rebates, discounts or other financial transactions, other than rebates 
under section 1927 of the Act, which reduce the price received by the 
manufacturer for drugs distributed to retail community pharmacies.
    (2) Quarterly AMP is calculated as a weighted average of monthly 
AMPs in that quarter.
    (3) The manufacturer must adjust the AMP for a rebate period if 
cumulative discounts, rebates, or other arrangements subsequently adjust 
the prices actually realized, to the extent that such cumulative 
discounts, rebates, or other arrangements are not excluded from the 
determination of AMP by statute or regulation.

[81 FR 5347, Feb. 1, 2016, as amended at 85 FR 87102, Dec. 31, 2020]

    Effective Date Note: At 85 FR 87102, Dec. 31, 2020, Sec.  557.504 
was amended, effective January 1, 2023, by revising paragraphs (c)(25) 
through (29) and paragraphs (e)(13) through (17) to read as follows:



Sec.  447.504  Determination of average manufacturer price.

                                * * * * *

    (c) * * *
    (25) Manufacturer coupons to a consumer redeemed by the 
manufacturer, agent, pharmacy or another entity acting on behalf of the 
manufacturer, but only to the extent that the manufacturer ensures the 
full value of the coupon is passed on to the consumer and the pharmacy, 
agent, or other AMP-eligible entity does not receive any price 
concession.
    (26) Manufacturer-sponsored programs that provide free goods, 
including but not limited to vouchers and patient assistance programs, 
but only to the extent that the manufacturer ensures: the voucher or 
benefit of such a program is not contingent on any other purchase 
requirement; the full value of the voucher or benefit of such a program 
is passed on to the consumer; and the pharmacy, agent, or other AMP-
eligible entity does not receive any price concession.
    (27) Manufacturer-sponsored drug discount card programs, but only to 
the extent that the manufacturer ensures the full value of the discount 
is passed on to the consumer and the pharmacy, agent, or the other AMP-
eligible entity does not receive any price concession.
    (28) Manufacturer-sponsored patient refund/rebate programs, to the 
extent that the manufacturer ensures that the manufacturer provides a 
full or partial refund or rebate to the patient for out-of-pocket costs 
and the pharmacy, agent, or other AMP-eligible entity does not receive 
any price concession.
    (29) Manufacturer copayment assistance programs, to the extent that 
the manufacturer ensures the program benefits are provided entirely to 
the patient and the pharmacy, agent, or other AMP-eligible entity does 
not receive any price concession

                                * * * * *

    (e) * * *
    (13) Manufacturer coupons to a consumer redeemed by the 
manufacturer, agent, pharmacy or another entity acting on behalf of the 
manufacturer, but only to the extent that the manufacturer ensures the 
full value of the coupon is passed on to the consumer and the pharmacy, 
agent, or other AMP-eligible entity does not receive any price 
concession
    (14) Manufacturer-sponsored programs that provide free goods, 
including, but not limited to vouchers and patient assistance programs, 
but only to the extent that the manufacturer ensures: the voucher or 
benefit of such a program is not contingent on any other purchase 
requirement; the full value of the voucher or benefit of such a program 
is passed on to the consumer; and the pharmacy, agent, or other AMP-
eligible entity does not receive any price concession.
    (15) Manufacturer-sponsored drug discount card programs, but only to 
the extent that the manufacturer ensures the full value of the discount 
is passed on to the consumer and the pharmacy, agent, or the other AMP-

[[Page 497]]

eligible entity does not receive any price concession.
    (16) Manufacturer-sponsored patient refund/rebate programs, to the 
extent that the manufacturer ensures the manufacturer provided a full or 
partial refund or rebate to the patient for out-of-pocket costs and the 
pharmacy agent, or other AMP-eligible entity does not receive any price 
concession.
    (17) Manufacturer copayment assistance programs, to the extent that 
the manufacturer ensures the program benefits are provided entirely to 
the patient and the pharmacy agent, or other AMP-eligible entity does 
not receive any price concession.

                                * * * * *



Sec.  447.505  Determination of best price.

    (a) Definitions. For the purpose of this section, the following 
definitions apply:
    Best price means, for a single source drug or innovator multiple 
source drug of a manufacturer (including the lowest price available to 
any entity for an authorized generic drug), the lowest price available 
from the manufacturer during the rebate period to any wholesaler, 
retailer, provider, health maintenance organization, nonprofit entity, 
or governmental entity in the United States in any pricing structure 
(including capitated payments) in the same quarter for which the AMP is 
computed. If a manufacturer offers a value-based purchasing arrangement 
(as defined at Sec.  447.502) to all states, the lowest price available 
from a manufacturer may include varying best price points for a single 
dosage form and strength as a result of that value based purchasing 
arrangement.
    Provider means a hospital, HMO, including an MCO, or entity that 
treats or provides coverage or services to individuals for illnesses or 
injuries or provides services or items in the provision of health care.
    (b) Prices included in best price. Except for those prices 
identified in paragraph (c) of this section, best price for covered 
outpatient drugs includes all prices, including applicable discounts, 
rebates, or other transactions that adjust prices either directly or 
indirectly to the best price-eligible entities listed in paragraph (a) 
of this section.
    (c) Prices excluded from best price. Best price excludes the 
following:
    (1) Any prices on or after October 1, 1992, charged to the IHS, the 
DVA, a State home receiving funds under 38 U.S.C. 1741, the DoD, or the 
PHS.
    (2) Any prices charged to a covered entity described in section 
1927(a)(5)(B) of the Act (including inpatient prices charged to 
hospitals described in section 340B(a)(4)(L) of the PHSA).
    (3) Any prices charged under the FSS of the GSA.
    (4) Any prices, rebates, or discounts provided to a designated State 
Pharmacy Assistance Program (SPAP).
    (5) Any depot prices (including TRICARE) and single award contract 
prices, as defined by the Secretary, of any agency of the Federal 
government.
    (6) Any prices charged which are negotiated by a prescription drug 
plan under Part D of title XVIII, by any MA-PD plan under Part C of such 
title for covered Part D drugs, or by a Qualified Retiree Prescription 
Drug Plan (as defined in section 1860D-22(a)(2) of the Act) for such 
drugs on behalf of individuals entitled to benefits under Part A or 
enrolled under Part B of Medicare, or any discounts provided by 
manufacturers under the Medicare coverage gap discount program under 
section 1860D-14A of the Act.
    (7) Rebates under the national rebate agreement or a CMS-authorized 
supplemental rebate agreement paid to State Medicaid Agencies under 
section 1927 of the Act.
    (8) Manufacturer-sponsored drug discount card programs, but only to 
the extent that the full value of the discount is passed on to the 
consumer and the pharmacy, agent, or other entity does not receive any 
price concession.
    (9) Manufacturer coupons to a consumer redeemed by a consumer, 
agent, pharmacy, or another entity acting on behalf of the manufacturer; 
but only to the extent that the full value of the coupon is passed on to 
the consumer, and the pharmacy, agent, or other entity does not receive 
any price concession.
    (10) Manufacturer copayment assistance programs, to the extent that 
the program benefits are provided entirely to the patient and the 
pharmacy, agent, or other entity does not receive any price concession.

[[Page 498]]

    (11) Manufacturer-sponsored patient refund or rebate programs, to 
the extent that the manufacturer provides a full or partial refund or 
rebate to the patient for out-of-pocket costs and the pharmacy, agent, 
or other entity does not receive any price concession.
    (12) Manufacturer-sponsored programs that provide free goods, 
including but not limited to vouchers and patient assistance programs, 
but only to the extent that the voucher or benefit of such a program is 
not contingent on any other purchase requirement; the full value of the 
voucher or benefit of such a program is passed on to the consumer; and 
the pharmacy, agent, or other entity does not receive any price 
concession.
    (13) Free goods, not contingent upon any purchase requirement.
    (14) Reimbursement by the manufacturer for recalled, damaged, 
expired, or otherwise unsalable returned goods, including, but not 
limited to, reimbursement for the cost of the goods and any 
reimbursement of costs associated with return goods handling and 
processing, reverse logistics, and drug destruction but only to the 
extent that such payment covers only these costs.
    (15) Nominal prices to certain entities as set forth in Sec.  
447.508.
    (16) Bona fide service fees as defined in Sec.  447.502.
    (17) PBM rebates, discounts, or other financial transactions except 
their mail order pharmacy's purchases or where such rebates, discounts, 
or other financial transactions are designed to adjust prices at the 
retail or provider level.
    (18) Sales outside the United States.
    (19) Direct sales to patients.
    (d) Further clarification of best price. (1) Best price is net of 
cash discounts, free goods that are contingent on any purchase 
requirement, volume discounts, customary prompt pay discounts, 
chargebacks, incentives, promotional fees, administrative fees, service 
fees (except bona fide service fees), distribution fees, and any other 
discounts or price reductions and rebates, other than rebates under 
section 1927 of the Act, which reduce the price available from the 
manufacturer.
    (2) Best price must be determined on a unit basis without regard to 
package size, special packaging, labeling, or identifiers on the dosage 
form or product or package.
    (3) The manufacturer must adjust the best price for a rebate period 
if cumulative discounts, rebates, or other arrangements subsequently 
adjust the prices available, to the extent that such cumulative 
discounts, rebates, or other arrangements are not excluded from the 
determination of best price by statute or regulation.

[81 FR 5347, Feb. 1, 2016, as amended at 85 FR 87102, Dec. 31, 2020]

    Effective Date Note: At 85 FR 87102, Dec. 31, 2020, Sec.  447.505 
was amended by revising paragraphs (c)(8) through (12), effective Jan. 
1, 2023. For the convenience of the user, the revised text is set forth 
as follows:



Sec.  447.505  Determination of best price.

                                * * * * *

    (c) * * *
    (8) Manufacturer-sponsored drug discount card programs, but only to 
the extent the manufacturer ensures that the full value of the discount 
is passed on to the consumer and the pharmacy, agent, or other entity 
does not receive any price concession.
    (9) Manufacturer coupons to a consumer redeemed by a consumer, 
agent, pharmacy, or another entity acting on behalf of the manufacturer; 
but only to the extent the manufacturer ensures that the full value of 
the coupon is passed on to the consumer, and the pharmacy, agent, or 
other entity does not receive any price concession.
    (10) Manufacturer copayment assistance programs, to the extent that 
the manufacturer ensures the program benefits are provided entirely to 
the patient and the pharmacy, agent, or other entity does not receive 
any price concession.
    (11) Manufacturer-sponsored patient refund or rebate programs, to 
the extent that the manufacturer ensures the manufacturer provides a 
full or partial refund or rebate to the patient for out-of-pocket costs 
and the pharmacy, agent, or other entity does not receive any price 
concession.
    (12) Manufacturer-sponsored programs that provide free goods, 
including but not limited to vouchers and patient assistance programs, 
but only to the extent that the manufacturer ensures the voucher or 
benefit of such a program is not contingent on any other purchase 
requirement; the full value of the voucher or benefit of such a program 
is

[[Page 499]]

passed on to the consumer; and the pharmacy, agent, or other entity does 
not receive any price concession.

                                * * * * *



Sec.  447.506  Authorized generic drugs.

    (a) Definitions. For the purpose of this section, the following 
definitions apply:
    Primary manufacturer means a manufacturer that holds the NDA of the 
authorized generic drug.
    Secondary manufacturer of an authorized generic drug means a 
manufacturer that is authorized by the primary manufacturer to sell the 
drug.
    (b) Exclusion of authorized generic drugs from AMP by a primary 
manufacturer. The primary manufacturer must exclude from its calculation 
of AMP any sales of authorized generic drugs to wholesalers for drugs 
distributed to retail community pharmacies when reporting the AMP of the 
brand name drug of that authorized generic drug.
    (c) Inclusion of authorized generic drugs in best price by a primary 
manufacturer. A primary manufacturer holding the NDA must include the 
best price of an authorized generic drug in its computation of best 
price for a single source or an innovator multiple source drug during a 
rebate period to any manufacturer, wholesaler, retailer, provider, HMO, 
non-profit entity, or governmental entity in the United States, only 
when such drugs are being sold by the manufacturer holding the NDA.
    (d) Inclusion of authorized generic in AMP and best price by a 
secondary manufacturer. The secondary manufacturer of an authorized 
generic drug must provide a rebate based on its sales of authorized 
generics, and must calculate AMP and best price, consistent with the 
requirements specified in Sec. Sec.  447.504 and 447.505.

[81 FR 5347, Feb. 1, 2016, as amended at 85 FR 87102, Dec. 31, 2020]



Sec.  447.507  Identification of inhalation, infusion, instilled, implanted, or injectable drugs (5i drugs).

    (a) Identification of a 5i drug. A manufacturer must identify to CMS 
each covered outpatient drug that qualifies as a 5i drug.
    (b) Not generally dispensed through a retail community pharmacy. A 
manufacturer must determine if the 5i drug is not generally dispensed 
through a retail community pharmacy based on the percentage of sales to 
entities other than retail community pharmacies.
    (1) A 5i drug is not generally dispensed through a retail community 
pharmacy if 70 percent or more of the sales (based on units at the NDC-9 
level) of the 5i drug, were to entities other than retail community 
pharmacies or wholesalers for drugs distributed to retail community 
pharmacies.
    (2) A manufacturer is responsible for determining and reporting to 
CMS whether a 5i drug is not generally dispensed through a retail 
community pharmacy on a monthly basis.



Sec.  447.508  Exclusion from best price of certain sales at a nominal
price.

    (a) Exclusion from best price. Sales of covered outpatient drugs by 
a manufacturer at nominal prices are excluded from best price when 
purchased by the following entities:
    (1) A covered entity as described in section 340B(a)(4) of the PHSA.
    (2) An ICF/IID providing services as set forth in Sec.  440.150 of 
this chapter.
    (3) A State-owned or operated nursing facility providing services as 
set forth in Sec.  440.155 of this chapter.
    (4) A public or non-profit entity, or an entity based at an 
institution of higher learning whose primary purpose is to provide 
health care services to students of that institution, that provides 
family planning services described under section of 1001(a) of PHSA, 42 
U.S.C. 300.
    (5) An entity that:
    (i) Is described in section 501(c)(3) of the Internal Revenue Code 
of 1986 and exempt from tax under section 501(a) of that Act or is 
State-owned or operated; and
    (ii) Is providing the same services to the same type of population 
as a covered entity described in section 340B(a)(4) of the PHSA but does 
not receive funding under a provision of law referred to in such 
section.
    (b) Nonapplication. This restriction does not apply to sales by a 
manufacturer of covered outpatient drugs that

[[Page 500]]

are sold under a master agreement under 38 U.S.C. 8126.
    (c) Rule of construction. Nothing in this section is construed to 
alter any existing statutory or regulatory prohibition on services for 
an entity described paragraph (a)(5) of this section, including the 
prohibition set forth in section 1008 of the PHSA.



Sec.  447.509  Medicaid drug rebates (MDR).

    (a) Determination of rebate amount--(1) Basic rebate for single 
source drugs and innovator multiple source drugs. The amount of basic 
rebate for each dosage form and strength of a single source drug or an 
innovator multiple source drug is equal to the product of:
    (i) The total number of units of each dosage form and strength paid 
for under the State plan in the rebate period (as reported by the 
State); and
    (ii) The greater of:
    (A) The difference between the AMP and the best price for the dosage 
form and strength of the drug; or
    (B) The AMP for the dosage form and strength of the drug multiplied 
by one of the following percentages:
    (1) For a clotting factor, 17.1 percent;
    (2) For a drug approved by FDA exclusively for pediatric 
indications, 17.1 percent; or
    (3) For all other single source drugs and innovator multiple source 
drugs, 23.1 percent.
    (2) Additional rebate for single source and innovator multiple 
source drugs. In addition to the basic rebate described in paragraph 
(a)(1) of this section, for each dosage form and strength of a single 
source drug or an innovator multiple source drug, the rebate amount will 
be increased by an amount equal to the product of the following:
    (i) The total number of units of such dosage form and strength paid 
for under the State plan in the rebate period.
    (ii) The amount, if any, by which:
    (A) The AMP for the dosage form and strength of the drug for the 
period exceeds:
    (B) The base date AMP for such dosage form and strength, increased 
by the percentage by which the consumer price index for all urban 
consumers (United States city average) for the month before the month in 
which the rebate period begins exceeds such index associated with the 
base date AMP of the drug.
    (3) Total rebate. The total rebate amount for single source drugs 
and innovator multiple source drugs is equal to the basic rebate amount 
plus the additional rebate amount, if any.
    (4) Treatment of new formulations. (i) In the case of a drug that is 
a line extension of a single source drug or an innovator multiple source 
drug that is an oral solid dosage form, the rebate obligation for the 
rebate periods beginning January 1, 2010 through September 30, 2018 is 
the amount computed under paragraphs (a)(1) through (3) of this section 
for such new drug or, if greater, the product of all of the following:
    (A) The AMP of the line extension of a single source drug or an 
innovator multiple source drug that is an oral solid dosage form.
    (B) The highest additional rebate (calculated as a percentage of 
AMP) under this section for any strength of the original single source 
drug or innovator multiple source drug.
    (C) The total number of units of each dosage form and strength of 
the line extension product paid for under the State plan in the rebate 
period (as reported by the State).
    (ii) In the case of a drug that is a line extension of a single 
source drug or an innovator multiple source drug that is an oral solid 
dosage form, the rebate obligation for the rebate periods beginning on 
October 1, 2018 through December 31, 2021 is the amount computed under 
paragraphs (a)(1) through (3) of this section for such new drug or, if 
greater, the amount computed under paragraph (a)(1) of this section plus 
the product of all of the following:
    (A) The AMP of the line extension of a single source drug or an 
innovator multiple source drug that is an oral solid dosage form.
    (B) The highest additional rebate (calculated as a percentage of 
AMP) under this section for any strength of the original single source 
drug or innovator multiple source drug.
    (C) The total number of units of each dosage form and strength of 
the line extension product paid for under the

[[Page 501]]

State plan in the rebate period (as reported by the State).
    (iii) In the case of a drug that is a line extension of a single 
source drug or an innovator multiple source drug, provided that the 
initial single source drug or innovator multiple source drug is an oral 
solid dosage form, the rebate obligation for the rebate periods 
beginning on and after January 1, 2022 is the amount computed under 
paragraphs (a)(1) through (3) of this section for such new drug or, if 
greater, the amount computed under paragraph (a)(1) of this section plus 
the product of all of the following:
    (A) The AMP of the line extension of a single source drug or an 
innovator multiple source drug.
    (B) The highest additional rebate (calculated as a percentage of 
AMP) under this section for any strength of the original single source 
drug or innovator multiple source drug.
    (C) The total number of units of each dosage form and strength of 
the line extension product paid for under the State plan in the rebate 
period (as reported by the State).
    (iv) The alternative rebate is required to be calculated if the 
manufacturer of the line extension drug also manufactures the initial 
brand name listed drug or has a corporate relationship with the 
manufacturer of the initial brand name listed drug.
    (5) Limit on rebate. In no case will the total rebate amount exceed 
100 percent of the AMP of the single source or multiple source innovator 
drug.
    (6) Rebate for noninnovator multiple source drugs. The amount of the 
basic rebate for each dosage form and strength of a noninnovator 
multiple source drug will be equal to the product of:
    (i) The total number of units of such dosage form and strength for 
which payment was made under the State plan for the rebate period; and
    (ii) The AMP for the dosage form and strength for the rebate period 
multiplied by 13 percent.
    (7) Additional rebate for noninnovator multiple source drugs. In 
addition to the basic rebate described in paragraph (a)(6) of this 
section, for each dosage form and strength of a noninnovator multiple 
source drug, the rebate amount will be increased by an amount equal to 
the product of the following:
    (i) The total number of units of such dosage form and strength paid 
for under the State plan in the rebate period.
    (ii) The amount, if any, by which:
    (A) The AMP for the dosage form and strength of the drug for the 
period exceeds the base date AMP for such dosage form and strength, 
increased by the percentage by which the consumer price index for all 
urban consumers (United States city average) for the month before the 
month in which the rebate period begins exceeds such index associated 
with the base date AMP of the drug.
    (B) The base date AMP has the meaning of AMP set forth in sections 
1927(c)(2)(A)(ii)(II), 1927(c)(2)(B) and 1927(c)(3)(C) of the Act.
    (8) Total rebate. The total rebate amount for noninnovator multiple 
source drugs is equal to the basic rebate amount plus the additional 
rebate amount, if any.
    (9) Limit on rebate. In no case will the total rebate amount exceed 
100 percent of the AMP for the noninnovator multiple source drug.
    (b) Rebates for drugs dispensed through Medicaid managed care 
organizations (MCOs). (1) Manufacturers participating in the Medicaid 
drug rebate program will provide a rebate for covered outpatient drugs 
dispensed to individuals enrolled in Medicaid MCOs if the MCO is 
contractually required to provide such drugs.
    (2) Manufacturers are exempt from the requirement in paragraph 
(b)(1) of this section if such drugs are the following:
    (i) Dispensed by health maintenance organizations including MCOs 
that contract under section 1903(m) of the Act; and
    (ii) Discounted under section 340B of the PHSA.
    (c) Federal offset of rebates. States must remit to the Federal 
government the amount of the savings resulting from the following 
increases in the rebate percentages.
    (1) For single source or innovator multiple source drugs other than 
blood clotting factors and drugs approved by

[[Page 502]]

FDA exclusively for pediatric indications:
    (i) If AMP minus best price is less than or equal to AMP times 15.1 
percent, then the offset amount is the full 8.0 percent of AMP (the 
difference between 23.1 percent of AMP and 15.1 percent of AMP).
    (ii) If AMP minus best price is greater than AMP times 15.1 percent 
but less than AMP times 23.1 percent, then the offset amount is the 
difference between AMP times 23.1 percent and AMP minus best price.
    (iii) If AMP minus best price is equal to or greater than AMP times 
23.1 percent, then there is no offset amount.
    (2) For single source or innovator multiple source drugs that are 
clotting factors and drugs approved by FDA exclusively for pediatric 
indications that are subject to a rebate percentage of 17.1 percent of 
AMP:
    (i) If AMP minus best price is less than or equal to AMP times 15.1 
percent, then the offset amount is the full 2.0 percent of AMP (the 
difference between 17.1 percent of AMP and 15.1 percent of AMP).
    (ii) If AMP minus best price is greater than AMP times 15.1 percent 
but less than AMP times 17.1 percent, then the offset amount is the 
difference between AMP times 17.1 percent and AMP minus best price.
    (iii) If AMP minus best price is equal to or greater than AMP times 
17.1 percent, then there is no offset amount.
    (3) For a drug that is a line extension of a single source or 
innovator multiple source drug that is an oral solid dosage form, the 
offset amount is the difference between the unit rebate amount (URA) 
calculation for the drug calculated based on the applicable rebate 
percentage in section 1927 of the Act prior to the Affordable Care Act 
and the calculation of the URA for the line extension drug, if greater, 
in accordance with the Affordable Care Act.
    (4) For noninnovator multiple source drugs, the offset amount is 
equal to 2.0 percent of the AMP (the difference between 13.0 percent of 
AMP and 11.0 percent of AMP).

[81 FR 5347, Feb. 1, 2016, as amended at 84 FR 12136, Apr. 1, 2019; 85 
FR 87103, Dec. 31, 2020]



Sec.  447.510  Requirements for manufacturers.

    (a) Quarterly reports. A manufacturer must report product and 
pricing information for covered outpatient drugs to CMS not later than 
30 days after the end of the rebate period. The quarterly pricing report 
must include the following:
    (1) AMP, calculated in accordance with Sec.  447.504.
    (2) Best price, calculated in accordance with Sec.  447.505.
    (3) Customary prompt pay discounts, which are reported as an 
aggregate dollar amount for each covered outpatient drug at the nine-
digit NDC level, provided to all wholesalers in the rebate period.
    (4) Prices that fall within the nominal price exclusion, which are 
reported as an aggregate dollar amount and include all sales of single 
source and innovator multiple source drugs to the entities listed in 
Sec.  447.508(a) for the rebate period.
    (b) Reporting revised quarterly AMP, best price, customary prompt 
pay discounts, or nominal prices. (1) A manufacturer must report to CMS 
any revision to AMP, best price, customary prompt pay discounts, or 
nominal prices for a period not to exceed 12 quarters from the quarter 
in which the data were due. Any revision request that exceeds 12 
quarters will not be considered, except for the following reasons:
    (i) The change is a result of the drug category change or a market 
date change.
    (ii) The change is an initial submission for a product.
    (iii) The change is due to termination of a manufacturer from the 
MDR program for failure to submit pricing data and must submit pricing 
data to reenter the program.
    (iv) The change is due to a technical correction; that is, not based 
on any changes in sales transactions or pricing adjustments from such 
transactions.
    (v) The change is to address specific rebate adjustments to States 
by manufacturers, as required by CMS or court order, or under an 
internal investigation, or an OIG or Department of Justice (DOJ) 
investigation.

[[Page 503]]

    (vi) The change is a result of a VBP arrangement, as defined in 
Sec.  447.502, requiring the manufacturer to make changes outside of the 
12-quarter rule in this paragraph (b), when the outcome must be 
evaluated outside of the 12-quarter period.
    (2) A manufacturer must report revised AMP within the 12-quarter 
time period, except when the revision would be solely as a result of 
data pertaining to lagged price concessions.
    (c) Base date AMP report--(1) Reporting period. A manufacturer may 
report a revised Deficit Reduction Act (DRA) base date AMP to CMS within 
the first 4 full calendar quarters following July 17, 2007.
    (2) Recalculation of the DRA base date AMP. (i) A manufacturer's 
recalculation of the DRA base date AMP must only reflect the revisions 
to AMP as provided for in Sec.  447.504 in effect from October 1, 2007 
to December 14, 2010.
    (ii) A manufacturer may choose to recalculate the DRA base date AMP 
on a product-by-product basis.
    (iii) A manufacturer must use actual and verifiable pricing records 
in recalculating the DRA base date AMP.
    (3) Reporting a revised Affordable Care Act base date AMP. A 
manufacturer may report a revised Affordable Care Act base date AMP to 
CMS within the first 4 full calendar quarters following April 1, 2016.
    (4) Recalculation of the Affordable Care Act base date AMP. (i) A 
manufacturer's recalculation of the Affordable Care Act base date AMP 
must only reflect the revisions to AMP as provided for in Sec.  447.504.
    (ii) A manufacturer may choose to recalculate the Affordable Care 
Act base date AMP on a product-by-product basis.
    (iii) A manufacturer must use actual and verifiable pricing records 
in recalculating the Affordable Care Act base date AMP.
    (d) Monthly AMP--(1) Definition. Monthly AMP means the AMP that is 
calculated on a monthly basis. A manufacturer must submit a monthly AMP 
to CMS not later than 30 days after the last day of each prior month.
    (2) Calculation of monthly AMP. Monthly AMP is calculated based on 
Sec.  447.504, except the period covered is based on monthly, as opposed 
to quarterly, sales.
    (i) The monthly AMP is calculated based on the weighted average of 
prices for all the manufacturer's package sizes of each covered 
outpatient drug sold by the manufacturer during a month.
    (ii) It is calculated as net sales divided by number of units sold, 
excluding goods or any other items specifically excluded in the statute 
or regulations. Monthly AMP is calculated based on the best data 
available to the manufacturer at the time of submission.
    (iii) In calculating monthly AMP, a manufacturer must estimate the 
impact of its lagged AMP-eligible price concessions using a 12-month 
rolling percentage in accordance with the methodology described in this 
paragraph (d)(2).
    (A) For each NDC-9 with at least 12 months of AMP-eligible sales, 
after adjusting for sales excluded from AMP, the manufacturer calculates 
a percentage equal to the sum of the price concessions for the most 
recent 12-month period (inclusive of the current reporting period) 
available associated with sales subject to the AMP reporting requirement 
divided by the total in dollars for the sales subject to the AMP 
reporting requirement for the same 12-month period.
    (B) For each NDC-9 with less than 12 months of AMP-eligible sales, 
the calculation described in paragraph (d)(2)(iii)(A) of this section is 
performed for the time period equaling the total number of months of 
AMP-eligible sales.
    (iv) The manufacturer multiplies the applicable percentage described 
in paragraph (d)(2)(iii)(A) or (B) of this section by the total in 
dollars for the sales subject to the AMP reporting requirement (after 
adjusting for sales excluded from AMP) for the month being submitted. 
The result of this multiplication is then subtracted from the total in 
dollars for the sales subject to the AMP reporting requirement (after 
adjusting for sales excluded from AMP) for the month being submitted.
    (v) The manufacturer uses the result of the calculation described in 
paragraph (d)(2)(iv) of this section as the

[[Page 504]]

numerator and the number of units sold in the month (after adjusting for 
sales excluded from AMP) as the denominator to calculate the 
manufacturer's AMP for the NDC for the month being submitted.
    (vi) Example. After adjusting for sales excluded from AMP, the total 
lagged price concessions over the most recent 12-month period available 
associated with sales for NDC 12345-6789 subject to the AMP reporting 
requirement equal $200,000, and the total in dollars for the sales 
subject to the AMP reporting requirement for the same period equals 
$600,000. The lagged price concessions percentage for this period equals 
200,000/600,000 = 0.33333. The total in dollars for the sales subject to 
the AMP reporting requirement for the month being reported equals 
$50,000 for 10,000 units sold. The manufacturer's AMP calculation for 
this NDC for this month is: $50,000-(0.33333 x $50,000) = $33,334 (net 
total sales amount); $33,334/10,000 = $3.33340 (AMP).
    (3) Timeframe for reporting revised monthly AMP. A manufacturer must 
report to CMS revisions to monthly AMP for a period not to exceed 36 
months from the month in which the data were due, except as allowed in 
paragraph (b)(1) of this section.
    (4) Exception. A manufacturer must report revisions to monthly AMP 
within the 36-month time period, except when the revision would be 
solely as a result of data pertaining to lagged price concessions.
    (5) Terminated products. A manufacturer must not report a monthly 
AMP for a terminated product beginning with the first month after the 
expiration date of the last lot sold.
    (6) Monthly AMP units. A manufacturer must report the total number 
of units that are used to calculate the monthly AMP in the same unit 
type as used to compute the AMP to CMS not later than 30 days after the 
last day of each month.
    (e) Certification of pricing reports. Each report submitted under 
paragraphs (a) through (d) of this section must be certified by one of 
the following:
    (1) The manufacturer's chief executive officer (CEO).
    (2) The manufacturer's chief financial officer (CFO).
    (3) An individual other than a CEO or CFO, who has authority 
equivalent to a CEO or a CFO; or
    (4) An individual with the directly delegated authority to perform 
the certification on behalf of an individual described in paragraphs 
(e)(1) through (3) of this section.
    (f) Recordkeeping requirements. (1) A manufacturer must retain 
records (written or electronic) for 10 years from the date the 
manufacturer reports data to CMS for that rebate period.
    (i) The records must include these data and any other materials from 
which the calculations of the AMP, the best price, customary prompt pay 
discounts, and nominal prices are derived, including a record of any 
assumptions made in the calculations.
    (ii) The 10-year timeframe applies to a manufacturer's quarterly and 
monthly submissions of pricing data, as well as any revised pricing data 
subsequently submitted to CMS.
    (2) A manufacturer must retain records beyond the 10-year period if 
all of the following circumstances exist:
    (i) The records are the subject of an audit, or of a government 
investigation related to pricing data that are used in AMP, best price, 
customary prompt pay discounts, or nominal prices of which the 
manufacturer is aware.
    (ii) The audit findings or investigation related to the AMP, best 
price, customary prompt pay discounts, or nominal price have not been 
resolved.
    (g) Data reporting format. All product and pricing data, whether 
submitted on a quarterly or monthly basis, must be submitted to CMS in 
an electronic format designated by CMS.

[81 FR 5347, Feb. 1, 2016, as amended at 85 FR 87103, Dec. 31, 2020]



Sec.  447.511  Requirements for States.

    (a) Invoices submitted to participating drug manufacturers. Within 
60 days of the end of each quarter, the State must bill participating 
drug manufacturers an invoice which includes, at a minimum, all of the 
following data and any subsequent changes to the data fields on the CMS-
R-144 Medicaid Drug Rebate Invoice form:
    (1) The State code.

[[Page 505]]

    (2) National Drug Code.
    (3) Period covered.
    (4) Product FDA list name.
    (5) Unit rebate amount.
    (6) Units reimbursed.
    (7) Rebate amount claimed.
    (8) Number of prescriptions.
    (9) Medicaid amount reimbursed.
    (10) Non-Medicaid amount reimbursed.
    (11) Total amount reimbursed.
    (b) Data submitted to CMS. On a quarterly basis, the State must 
submit drug utilization data to CMS, which will be the same information 
as submitted to the manufacturers on the CMS-R-144, as specified in 
paragraph (a) of this section. The state data submission will be due no 
later than 60 days after the end of each rebate period. In the event 
that a due date falls on a weekend or Federal holiday, the submission 
will be due on the first business day following that weekend or Federal 
holiday. Any adjustments to previously submitted data will be 
transmitted to the manufacturer and CMS in the same reporting period.
    (c) State that has participating Medicaid Managed care organizations 
(MCO). A State that has participating Medicaid managed care 
organizations (MCO) which includes covered outpatient drugs in its 
contracts with the MCOs, must report data described in paragraph (a) of 
this section for covered outpatient drugs dispensed to individuals 
eligible for medical assistance who are enrolled with the MCO and for 
which the MCO is required under contract for coverage of such drugs 
under section 1903 of the Act. These data must be identified separately 
from the data pertaining to drugs that the State reimburses on a fee-
for-service basis.
    (d) State data certification. Each data submission in this section 
must be certified by one of the following:
    (1) The State Medicaid Director (SMD);
    (2) The Deputy State Medicaid Director (DSMD);
    (3) An individual other than the SMD or DSMD, who has authority 
equivalent to an SMD or DSMD; or
    (4) An individual with the directly delegated authority to perform 
the certification on behalf of an individual described in paragraphs 
(d)(1) through (3) of this section.
    (e) State data certification language. Each data submission by a 
state must include the following certification language: ``I hereby 
certify, to the best of my knowledge, that the state's data submission 
is complete and accurate at the time of this submission, and was 
prepared in accordance with the state's good faith, reasonable efforts 
based on existing guidance from CMS, section 1927 of the Act and 
applicable Federal regulations. I further certify that the state has 
transmitted data to CMS, including any adjustments to previous rebate 
periods, in the same reporting period as provided to the manufacturer. 
Further, the state certifies that it has applied any necessary edits to 
the data for both CMS and the manufacturer to avoid inaccuracies at both 
the NDC/line item and file/aggregate level. Such edits are to be applied 
in the same manner and in the same reporting period to both CMS and the 
manufacturer.''

[43 FR 45253, Sept. 29, 1978, as amended at 85 FR 87103, Dec. 31, 2020]



Sec.  447.512  Drugs: Aggregate upper limits of payment.

    (a) Multiple source drugs. Except for brand name drugs that are 
certified in accordance with paragraph (c) of this section, the agency 
payment for multiple source drugs must not exceed, in the aggregate, the 
amount that would result from the application of the specific limits 
established in accordance with Sec.  447.514. If a specific limit has 
not been established under Sec.  447.514, then the rule for ``other 
drugs'' set forth in paragraph (b) of this section applies.
    (b) Other drugs. The agency payments for brand name drugs certified 
in accordance with paragraph (c) of this section and drugs other than 
multiple source drugs for which a specific limit has been established 
under Sec.  447.514 must not exceed, in the aggregate, payment levels 
that the agency has determined by applying the lower of the following:
    (1) AAC plus a professional dispensing fee established by the 
agency; or
    (2) Providers' usual and customary charges to the general public.

[[Page 506]]

    (c) Certification of brand name drugs. (1) The upper limit for 
payment for multiple source drugs for which a specific limit has been 
established under Sec.  447.514 does not apply if a physician certifies 
in his or her own handwriting (or by an electronic alternative means 
approved by the Secretary) that a specific brand is medically necessary 
for a particular beneficiary.
    (2) The agency must decide what certification form and procedure are 
used.
    (3) A check off box on a form is not acceptable but a notation like 
``brand necessary'' is allowable.
    (4) The agency may allow providers to keep the certification forms 
if the forms will be available for inspection by the agency or HHS.



Sec.  447.514  Upper limits for multiple source drugs.

    (a) Establishment and issuance of a listing. (1) CMS will establish 
and issue listings that identify and set upper limits for multiple 
source drugs available for purchase by retail community pharmacies on a 
nationwide basis that FDA has rated at least three drug products as 
pharmaceutically and therapeutically equivalent in the ``Approved Drug 
Products with Therapeutic Equivalence Evaluations'' which is available 
at http://www.accessdata.fda.gov/scripts/cder/ob/. Only pharmaceutically 
and therapeutically equivalent formulations will be used to determine 
such limit, and such limit will only be applied to those equivalent drug 
products.
    (2) CMS publishes the list of multiple source drugs for which upper 
limits have been established and any revisions to the list in Medicaid 
Program issuances.
    (b) Specific upper limits. (1) The agency's payments for multiple 
source drugs identified and listed periodically by CMS in Medicaid 
Program issuances must not exceed, in the aggregate, prior to the 
application of any federal or state drug rebate considerations, payment 
levels determined by applying for each pharmaceutically and 
therapeutically equivalent multiple source drug product, a professional 
dispensing fee established by the state agency plus an amount 
established by CMS that is equal to 175 percent of the weighted average 
of the most recently reported monthly AMPs for such multiple source 
drugs, using manufacturer submitted utilization data for each multiple 
source drug for which a Federal upper limit (FUL) is established.
    (2) Exception. If the amount established by CMS in paragraph (b)(1) 
of this section for a pharmaceutically and therapeutically equivalent 
multiple source drug product is lower than the average retail community 
pharmacies' acquisition cost for such drug product, as determined by the 
most current national survey of such costs, CMS will use a percent of 
the weighted average of the most recently reported monthly AMPs that 
equals the most current average acquisition costs paid by retail 
community pharmacies as determined by such survey.
    (c) Ensuring a drug is for sale nationally. To assure that a 
multiple source drug is for sale nationally, CMS will consider the 
following additional criteria:
    (1) The AMP of a terminated NDC will not be used to set the Federal 
upper limit (FUL) beginning with the first day of the month after the 
termination date reported by the manufacturer to CMS.
    (2) The monthly AMP units data will be used to calculate the 
weighted average of monthly AMPs for all multiple source drugs to 
establish the FUL.
    (d) The FUL will be applied as an aggregate upper limit.



Sec.  447.516  Upper limits for drugs furnished as part of services.

    The upper limits for payment for prescribed drugs in this subpart 
also apply to payment for drugs provided as part of skilled nursing 
facility services and intermediate care facility services and under 
prepaid capitation arrangements.



Sec.  447.518  State plan requirements, findings, and assurances.

    (a) State plan. (1) The State plan must describe comprehensively the 
agency's payment methodology for prescription drugs, including the 
agency's payment methodology for drugs dispensed by all of the 
following:
    (i) A covered entity described in section 1927(a)(5)(B) of the Act.

[[Page 507]]

    (ii) A contract pharmacy under contract with a covered entity 
described in section 1927(a)(5)(B) of the Act.
    (iii) An Indian Health Service, tribal and urban Indian pharmacy.
    (2) The agency's payment methodology in paragraph (a)(1) of this 
section must be in accordance with the definition of AAC in Sec.  
447.502.
    (b) Findings and assurances. Upon proposing significant State plan 
changes in payments for prescription drugs, and at least annually for 
multiple source drugs and triennially for all other drugs, the agency 
must make the following findings and assurances:
    (1) Findings. The agency must make the following separate and 
distinct findings:
    (i) In the aggregate, its Medicaid expenditures for multiple source 
drugs, identified and listed in accordance with Sec.  447.514(a), are in 
accordance with the upper limits specified in Sec.  447.514(b).
    (ii) In the aggregate, its Medicaid expenditures for all other drugs 
are in accordance with Sec.  447.512.
    (2) Assurances. The agency must make assurances satisfactory to CMS 
that the requirements set forth in Sec. Sec.  447.512 and 447.514 
concerning upper limits and in paragraph (b)(1) of this section 
concerning agency findings are met.
    (c) Recordkeeping. The agency must maintain and make available to 
CMS, upon request, data, mathematical or statistical computations, 
comparisons, and any other pertinent records to support its findings and 
assurances.
    (d)(1) Data requirements. When proposing changes to either the 
ingredient cost reimbursement or professional dispensing fee 
reimbursement, States are required to evaluate their proposed changes in 
accordance with the requirements of this subpart, and States must 
consider both the ingredient cost reimbursement and the professional 
dispensing fee reimbursement when proposing such changes to ensure that 
total reimbursement to the pharmacy provider is in accordance with 
requirements of section 1902(a)(30)(A) of the Act. States must provide 
adequate data such as a State or national survey of retail pharmacy 
providers or other reliable data other than a survey to support any 
proposed changes to either or both of the components of the 
reimbursement methodology. States must submit to CMS the proposed change 
in reimbursement and the supporting data through a State plan amendment 
through the formal review process.
    (2) A State participating in VBP arrangements approved under a CMS-
authorized supplemental rebate agreement (SRA) must report data 
described in paragraph (d)(3) of this section on an annual basis.
    (3) Within 60 days of the end of each year, the State must submit 
all of the following data, including cumulative data to date:
    (i) State.
    (ii) National drug code(s) (for drugs covered under the CMS-
authorized VBP SRA).
    (iii) Product's FDA list name.
    (iv) Number of prescriptions.
    (v) Cost to the State to administer the CMS-authorized VBP SRA (for 
example, systems changes, tracking outcomes, etc.).
    (vi) Total savings generated by the supplemental rebate due to the 
CMS-authorized VBP SRA.

[81 FR 5347, Feb. 16, 2016, as amended at 86 FR 87104, Dec. 31, 2020]



Sec.  447.520  Federal Financial Participation (FFP): Conditions relating
to physician-administered drugs.

    (a) No FFP is available for physician-administered drugs for which a 
State has not required the submission of claims using codes that 
identify the drugs sufficiently for the State to bill a manufacturer for 
rebates.
    (1) As of January 1, 2006, a State must require providers to submit 
claims for single source, physician-administered drugs using Healthcare 
Common Procedure Coding System codes or NDC numbers to secure rebates.
    (2) As of January 1, 2007, a State must require providers to submit 
claims for physician-administered single source drugs and the 20 
multiple source drugs identified by the Secretary using NDC numbers.
    (b) As of January 1, 2008, a State must require providers to submit 
claims for the 20 multiple source physician-administered drugs 
identified by the Secretary as having the highest

[[Page 508]]

dollar value under the Medicaid Program using NDC numbers to secure 
rebates.
    (c) A State that requires additional time to comply with the 
requirements of this section may apply to the Secretary for an 
extension.



Sec.  447.522  Optional coverage of investigational drugs and other
drugs not subject to rebate.

    (a) Medicaid coverage of investigational drugs may be provided at 
State option under section 1905(a)(12) of the Act when such drug is the 
subject of an investigational new drug application (IND) that has been 
allowed by FDA to proceed.
    (b) A State agency electing to provide coverage of an 
investigational drug must include in its State plan a description of the 
coverage and payment for such drug.
    (c) The State plan must indicate that any reimbursement for 
investigational drugs by the State are consistent with FDA regulations 
at 21 CFR part 312 if they are to be eligible to receive FFP for these 
drugs.
    (d) Medicaid coverage of other drugs may be provided at State option 
under section 1905(a)(12) of the Act provided that they are not eligible 
to be covered as covered outpatient drugs in the Medicaid Drug Rebate 
program.
    (e) Investigational drugs and other drugs are not subject to the 
rebate requirements of section 1927 of the Act provided they do not meet 
the definition of a covered outpatient drug as set forth in section 
1927(k) of the Act.



PART 455_PROGRAM INTEGRITY: MEDICAID--Table of Contents



Sec.
455.1 Basis and scope.
455.2 Definitions.
455.3 Other applicable regulations.

   Subpart A_Medicaid Agency Fraud Detection and Investigation Program

455.12 State plan requirement.
455.13 Methods for identification, investigation, and referral.
455.14 Preliminary investigation.
455.15 Full investigation.
455.16 Resolution of full investigation.
455.17 Reporting requirements.
455.18 Provider's statements on claims forms.
455.19 Provider's statement on check.
455.20 Beneficiary verification procedure.
455.21 Cooperation with State Medicaid fraud control units.
455.23 Suspension of payments in cases of fraud.

   Subpart B_Disclosure of Information by Providers and Fiscal Agents

455.100 Purpose.
455.101 Definitions.
455.102 Determination of ownership or control percentages.
455.103 State plan requirement.
455.104 Disclosure by Medicaid providers and fiscal agents: Information 
          on ownership and control.
455.105 Disclosure by providers: Information related to business 
          transactions.
455.106 Disclosure by providers: Information on persons convicted of 
          crimes.
455.107 xxx

                  Subpart C_Medicaid Integrity Program

455.200 Basis and scope.
455.202 Limitation on contractor liability.
455.230 Eligibility requirements.
455.232 Medicaid integrity audit program contractor functions.
455.234 Awarding of a contract.
455.236 Renewal of a contract.
455.238 Conflict of interest.
455.240 Conflict of interest resolution.

 Subpart D_Independent Certified Audit of State Disproportionate Share 
                      Hospital Payment Adjustments

455.300 Purpose.
455.301 Definitions.
455.304 Condition for Federal financial participation (FFP).

               Subpart E_Provider Screening and Enrollment

455.400 Purpose.
455.405 State plan requirements.
455.410 Enrollment and screening of providers.
455.412 Verification of provider licenses.
455.414 Revalidation of enrollment.
455.416 Termination or denial of enrollment.
455.420 Reactivation of provider enrollment.
455.422 Appeal rights.
455.432 Site visits.
455.434 Criminal background checks.
455.436 Federal database checks.
455.440 National Provider Identifier.
455.450 Screening levels for Medicaid providers.
455.452 Other State screening methods.
455.460 Application fee.

[[Page 509]]

455.470 Temporary moratoria.

          Subpart F_Medicaid Recovery Audit Contractors Program

455.500 Purpose.
455.502 Establishment of program.
455.504 Definitions.
455.506 Activities to be conducted by Medicaid RACs and States.
455.508 Eligibility requirements for Medicaid RACs.
455.510 Payments to RACs.
455.512 Medicaid RAC provider appeals.
455.514 Federal share of State expense for the Medicaid RAC program.
455.516 Exceptions from Medicaid RAC programs.
455.518 Applicability to the territories.

    Authority: 42 U.S.C. 1302.

    Source: 43 FR 45262, Sept. 29, 1978, unless otherwise noted.



Sec.  455.1  Basis and scope.

    This part sets forth requirements for a State fraud detection and 
investigation program, and for disclosure of information on ownership 
and control.
    (a) Under the authority of sections 1902(a)(4), 1903(i)(2), and 1909 
of the Social Security Act, Subpart A provides State plan requirements 
for the identification, investigation, and referral of suspected fraud 
and abuse cases. In addition, the subpart requires that the State--
    (1) Report fraud and abuse information to the Department; and
    (2) Have a method to verify whether services reimbursed by Medicaid 
were actually furnished to beneficiaries.
    (b) Subpart B implements sections 1124, 1126, 1902(a)(36), 
1903(i)(2), and 1903(n) of the Act. It requires that providers and 
fiscal agents must agree to disclose ownership and control information 
to the Medicaid State agency.
    (c) Subpart C implements section 1936 of the Act. It establishes the 
Medicaid Integrity Program under which the Secretary will promote the 
integrity of the program by entering into contracts with eligible 
entities to carry out the activities of subpart C.

[51 FR 34787, Sept. 30, 1986, as amended at 72 FR 67655, Nov. 30, 2007]



Sec.  455.2  Definitions.

    As used in this part unless the context indicates otherwise--
    Abuse means provider practices that are inconsistent with sound 
fiscal, business, or medical practices, and result in an unnecessary 
cost to the Medicaid program, or in reimbursement for services that are 
not medically necessary or that fail to meet professionally recognized 
standards for health care. It also includes beneficiary practices that 
result in unnecessary cost to the Medicaid program.
    Conviction or Convicted means that a judgment of conviction has been 
entered by a Federal, State, or local court, regardless of whether an 
appeal from that judgment is pending.
    Credible allegation of fraud. A credible allegation of fraud may be 
an allegation, which has been verified by the State, from any source, 
including but not limited to the following:
    (1) Fraud hotline tips verified by further evidence.
    (2) Claims data mining.
    (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 and the State Medicaid 
agency has reviewed all allegations, facts, and evidence carefully and 
acts judiciously on a case-by-case basis.
    Exclusion means that items or services furnished by a specific 
provider who has defrauded or abused the Medicaid program will not be 
reimbursed under Medicaid.
    Fraud means an intentional deception or misrepresentation made by a 
person with the knowledge that the deception could result in some 
unauthorized benefit to himself or some other person. It includes any 
act that constitutes fraud under applicable Federal or State law.
    Fraud hotline tip. A fraud hotline tip is 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.
    Furnished refers to items and services provided directly by, or 
under the direct supervision of, or ordered by, a practitioner or other 
individual (either

[[Page 510]]

as an employee or in his or her own capacity), a provider, or other 
supplier of services. (For purposes of denial of reimbursement within 
this part, it does not refer to services ordered by one party but billed 
for and provided by or under the supervision of another.)
    Practitioner means a physician or other individual licensed under 
State law to practice his or her profession.
    Suspension means that items or services furnished by a specified 
provider who has been convicted of a program-related offense in a 
Federal, State, or local court will not be reimbursed under Medicaid.

[48 FR 3755, Jan. 27, 1983, as amended at 50 FR 37375, Sept. 13, 1985; 
51 FR 34788, Sept. 30, 1986; 76 FR 5965, Feb. 2, 2011; 86 FR 6131, Jan. 
19, 2021]



Sec.  455.3  Other applicable regulations.

    Part 1002 of this title sets forth the following:
    (a) State plan requirements for excluding providers for fraud and 
abuse, and suspending practitioners convicted of program-related crimes.
    (b) The limitations on FFP for services furnished by excluded 
providers or suspended practitioners.
    (c) The requirements and procedures for reinstatement after 
exclusion or suspension.
    (d) Requirements for the establishment and operation of State 
Medicaid fraud control units and the rates of FFP for their fraud 
control activities.

[51 FR 34788, Sept. 30, 1986]



   Subpart A_Medicaid Agency Fraud Detection and Investigation Program



Sec.  455.12  State plan requirement.

    A State plan must meet the requirements of Sec. Sec.  455.13 through 
455.23.

[52 FR 48817, Dec. 28, 1987]



Sec.  455.13  Methods for identification, investigation, and referral.

    The Medicaid agency must have--
    (a) Methods and criteria for identifying suspected fraud cases;
    (b) Methods for investigating these cases that--
    (1) Do not infringe on the legal rights of persons involved; and
    (2) Afford due process of law; and
    (c) Procedures, developed in cooperation with State legal 
authorities, for referring suspected fraud cases to law enforcement 
officials.

[43 FR 45262, Sept. 29, 1978, as amended at 48 FR 3755, Jan. 27, 1983]



Sec.  455.14  Preliminary investigation.

    If the agency receives a complaint of Medicaid fraud or abuse from 
any source or identifies any questionable practices, it must conduct a 
preliminary investigation to determine whether there is sufficient basis 
to warrant a full investigation.

[48 FR 3756, Jan. 27, 1983]



Sec.  455.15  Full investigation.

    If the findings of a preliminary investigation give the agency 
reason to believe that an incident of fraud or abuse has occurred in the 
Medicaid program, the agency must take the following action, as 
appropriate:
    (a) If a provider is suspected of fraud or abuse, the agency must--
    (1) In States with a State Medicaid fraud control unit certified 
under subpart C of part 1002 of this title, refer the case to the unit 
under the terms of its agreement with the unit entered into under Sec.  
1002.309 of this title; or
    (2) In States with no certified Medicaid fraud control unit, or in 
cases where no referral to the State Medicaid fraud control unit is 
required under paragraph (a)(1) of this section, conduct a full 
investigation or refer the case to the appropriate law enforcement 
agency.
    (b) If there is reason to believe that a beneficiary has defrauded 
the Medicaid program, the agency must refer the case to an appropriate 
law enforcement agency.
    (c) If there is reason to believe that a beneficiary has abused the 
Medicaid program, the agency must conduct a full investigation of the 
abuse.

[48 FR 3756, Jan. 27, 1983, as amended at 51 FR 34788, Sept. 30, 1986]



Sec.  455.16  Resolution of full investigation.

    A full investigation must continue until--

[[Page 511]]

    (a) Appropriate legal action is initiated;
    (b) The case is closed or dropped because of insufficient evidence 
to support the allegations of fraud or abuse; or
    (c) The matter is resolved between the agency and the provider or 
beneficiary. This resolution may include but is not limited to--
    (1) Sending a warning letter to the provider or beneficiary, giving 
notice that continuation of the activity in question will result in 
further action;
    (2) Suspending or terminating the provider from participation in the 
Medicaid program;
    (3) Seeking recovery of payments made to the provider; or
    (4) Imposing other sanctions provided under the State plan.

[43 FR 45262, Sept. 29, 1978, as amended at 48 FR 3756, Jan. 27, 1983]



Sec.  455.17  Reporting requirements.

    The agency must report the following fraud or abuse information to 
the appropriate Department officials at intervals prescribed in 
instructions.
    (a) The number of complaints of fraud and abuse made to the agency 
that warrant preliminary investigation.
    (b) For each case of suspected provider fraud and abuse that 
warrants a full investigation--
    (1) The provider's name and number;
    (2) The source of the complaint;
    (3) The type of provider;
    (4) The nature of the complaint;
    (5) The approximate range of dollars involved; and
    (6) The legal and administrative disposition of the case, including 
actions taken by law enforcement officials to whom the case has been 
referred.

(Approved by the Office of Management and Budget under control number 
0938-0076)

[43 FR 45262, Sept. 29, 1978, as amended at 48 FR 3756, Jan. 27, 1983]



Sec.  455.18  Provider's statements on claims forms.

    (a) Except as provided in Sec.  455.19, the agency must provide that 
all provider claims forms be imprinted in boldface type with the 
following statements, or with alternate wording that is approved by the 
Regional CMS Administrator:
    (1) ``This is to certify that the foregoing information is true, 
accurate, and complete.''
    (2) ``I understand that payment of this claim will be from Federal 
and State funds, and that any falsification, or concealment of a 
material fact, may be prosecuted under Federal and State laws.''
    (b) The statements may be printed above the claimant's signature or, 
if they are printed on the reverse of the form, a reference to the 
statements must appear immediately preceding the claimant's signature.



Sec.  455.19  Provider's statement on check.

    As an alternative to the statements required in Sec.  455.18, the 
agency may print the following wording above the claimant's endorsement 
on the reverse of checks or warrants payable to each provider: ``I 
understand in endorsing or depositing this check that payment will be 
from Federal and State funds and that any falsification, or concealment 
of a material fact, may be prosecuted under Federal and State laws.''



Sec.  455.20  Beneficiary verification procedure.

    (a) The agency must have a method for verifying with beneficiaries 
whether services billed by providers were received.
    (b) In States receiving Federal matching funds for a mechanized 
claims processing and information retrieval system under part 433, 
subpart C, of this subchapter, the agency must provide prompt written 
notice as required by Sec.  433.116 (e) and (f).

[48 FR 3756, Jan. 27, 1983, as amended at 56 FR 8854, Mar. 1, 1991]



Sec.  455.21  Cooperation with State Medicaid fraud control units.

    In a State with a Medicaid fraud control unit established and 
certified under subpart C of this part,
    (a) The agency must--
    (1) Refer all cases of suspected provider fraud to the unit;
    (2) If the unit determines that it may be useful in carrying out the 
unit's responsibilities, promptly comply with a request from the unit 
for--

[[Page 512]]

    (i) Access to, and free copies of, any records or information kept 
by the agency or its contractors;
    (ii) Computerized data stored by the agency or its contractors. 
These data must be supplied without charge and in the form requested by 
the unit; and
    (iii) Access to any information kept by providers to which the 
agency is authorized access by section 1902(a)(27) of the Act and Sec.  
431.107 of this subchapter. In using this information, the unit must 
protect the privacy rights of beneficiaries; and
    (3) On referral from the unit, initiate any available administrative 
or judicial action to recover improper payments to a provider.
    (b) The agency need not comply with specific requirements under this 
subpart that are the same as the responsibilities placed on the unit 
under subpart D of this part.
    (c) The agency must enter into a written agreement with the unit 
under which:
    (1) The agency will agree to comply with all requirements of Sec.  
455.21(a);
    (2) The unit will agree to comply with the requirements of Sec.  
1007.11(c) of this title; and
    (3) The agency and the unit will agree to--
    (i) Establish a practice of regular meetings or communication 
between the two entities;
    (ii) Establish procedures for how they will coordinate their 
efforts;
    (iii) Establish procedures for Sec. Sec.  1007.9(e) through 
1007.9(h) of this title;
    (iv) Establish procedures by which the unit will receive referrals 
of potential fraud from managed care organizations, if applicable, 
either directly or through the agency, as required at Sec.  
438.608(a)(7) of this title; and
    (v) Review and, as necessary, update the agreement no less 
frequently than every five (5) years to ensure that the agreement 
reflects current law and practice.

[43 FR 45262, Sept. 29, 1978, as amended at 84 FR 10713, Mar. 22, 2019]



Sec.  455.23  Suspension of payments in cases of fraud.

    (a) Basis for suspension. (1) The State Medicaid agency must suspend 
all Medicaid payments to a provider after the agency determines there is 
a credible allegation of fraud for which an investigation is pending 
under the Medicaid program against an individual or entity unless the 
agency has good cause to not suspend payments or to suspend payment only 
in part.
    (2) The State Medicaid agency may suspend payments without first 
notifying the provider of its intention to suspend such payments.
    (3) A provider may request, and must be granted, administrative 
review where State law so requires.
    (b) Notice of suspension. (1) The State agency must send notice of 
its suspension of program payments within the following timeframes:
    (i) Five days of taking such action unless requested in writing by a 
law enforcement agency to temporarily withhold such notice.
    (ii) Thirty days if requested by law enforcement in writing to delay 
sending such notice, which request for delay may be renewed in writing 
up to twice and in no event may exceed 90 days.
    (2) The notice must include or address all of the following:
    (i) State that payments are being suspended in accordance with this 
provision.
    (ii) Set forth the general allegations as to the nature of the 
suspension action, but need not disclose any specific information 
concerning an ongoing investigation.
    (iii) State that the suspension is for a temporary period, as stated 
in paragraph (c) of this section, and cite the circumstances under which 
the suspension will be terminated.
    (iv) Specify, when applicable, to which type or types of Medicaid 
claims or business units of a provider suspension is effective.
    (v) Inform the provider of the right to submit written evidence for 
consideration by State Medicaid Agency.
    (vi) Set forth the applicable State administrative appeals process 
and corresponding citations to State law.
    (c) Duration of suspension. (1) All suspension of payment actions 
under this section will be temporary and will not continue after either 
of the following:

[[Page 513]]

    (i) The agency or the prosecuting authorities determine that there 
is insufficient evidence of fraud by the provider.
    (ii) Legal proceedings related to the provider's alleged fraud are 
completed.
    (2) A State must document in writing the termination of a suspension 
including, where applicable and appropriate, any appeal rights available 
to a provider.
    (d) Referrals to the Medicaid fraud control unit. (1) Whenever a 
State Medicaid agency investigation leads to the initiation of a payment 
suspension in whole or part, the State Medicaid Agency must make a fraud 
referral to either of the following:
    (i) To a Medicaid fraud control unit established and certified under 
part 1007 of this title; or
    (ii) In States with no certified Medicaid fraud control unit, to an 
appropriate law enforcement agency.
    (2) The fraud referral made under paragraph (d)(1) of this section 
must meet all of the following requirements:
    (i) Be made in writing and provided to the Medicaid fraud control 
unit not later than the next business day after the suspension is 
enacted.
    (ii) Conform to fraud referral performance standards issued by the 
Secretary.
    (3)(i) If the Medicaid fraud control unit or other law enforcement 
agency accepts the fraud referral for investigation, the payment 
suspension may be continued until such time as the investigation and any 
associated enforcement proceedings are completed.
    (ii) On a quarterly basis, the State must request a certification 
from the Medicaid fraud control unit or other law enforcement agency 
that any matter accepted on the basis of a referral continues to be 
under investigation thus warranting continuation of the suspension.
    (4) If the Medicaid fraud control unit or other law enforcement 
agency declines to accept the fraud referral for investigation the 
payment suspension must be discontinued unless the State Medicaid agency 
has alternative Federal or State authority by which it may impose a 
suspension or makes a fraud referral to another law enforcement agency. 
In that situation, the provisions of paragraph (d)(3) of this section 
apply equally to that referral as well.
    (5) A State's decision to exercise the good cause exceptions in 
paragraphs (e) or (f) of this section not to suspend payments or to 
suspend payments only in part does not relieve the State of the 
obligation to refer any credible allegation of fraud as provided in 
paragraph (d)(1) of this section.
    (e) Good cause not to suspend payments. A State may find that good 
cause exists not to suspend payments, or not to continue a payment 
suspension previously imposed, to an individual or entity against which 
there is an investigation of a credible allegation of fraud if any of 
the following are applicable:
    (1) Law enforcement officials have specifically requested that a 
payment suspension not be imposed because such a payment suspension may 
compromise or jeopardize an investigation.
    (2) Other available remedies implemented by the State more 
effectively or quickly protect Medicaid funds.
    (3) The State determines, based upon the submission of written 
evidence by the individual or entity that is the subject of the payment 
suspension, that the suspension should be removed.
    (4) beneficiary access to items or services would be jeopardized by 
a payment suspension because of either of the following:
    (i) An individual or entity is the sole community physician or the 
sole source of essential specialized services in a community.
    (ii) The individual or entity serves a large number of beneficiaries 
within a HRSA-designated medically underserved area.
    (5) Law enforcement declines to certify that a matter continues to 
be under investigation per the requirements of paragraph (d)(3) of this 
section.
    (6) The State determines that payment suspension is not in the best 
interests of the Medicaid program.
    (f) Good cause to suspend payment only in part. A State may find 
that good cause exists to suspend payments in part, or to convert a 
payment suspension previously imposed in whole to

[[Page 514]]

one only in part, to an individual or entity against which there is an 
investigation of a credible allegation of fraud if any of the following 
are applicable:
    (1) beneficiary access to items or services would be jeopardized by 
a payment suspension in whole or part because of either of the 
following:
    (i) An individual or entity is the sole community physician or the 
sole source of essential specialized services in a community.
    (ii) The individual or entity serves a large number of beneficiaries 
within a HRSA-designated medically underserved area.
    (2) The State determines, based upon the submission of written 
evidence by the individual or entity that is the subject of a whole 
payment suspension, that such suspension should be imposed only in part.
    (3)(i) The credible allegation focuses solely and definitively on 
only a specific type of claim or arises from only a specific business 
unit of a provider; and
    (ii) The State determines and documents in writing that a payment 
suspension in part would effectively ensure that potentially fraudulent 
claims were not continuing to be paid.
    (4) Law enforcement declines to certify that a matter continues to 
be under investigation per the requirements of paragraph (d)(3) of this 
section.
    (5) The State determines that payment suspension only in part is in 
the best interests of the Medicaid program.
    (g) Documentation and record retention. State Medicaid agencies must 
meet the following requirements:
    (1) Maintain for a minimum of 5 years from the date of issuance all 
materials documenting the life cycle of a payment suspension that was 
imposed in whole or part, including the following:
    (i) All notices of suspension of payment in whole or part.
    (ii) All fraud referrals to the Medicaid fraud control unit or other 
law enforcement agency.
    (iii) All quarterly certifications of continuing investigation 
status by law enforcement.
    (iv) All notices documenting the termination of a suspension.
    (2)(i) Maintain for a minimum of 5 years from the date of issuance 
all materials documenting each instance where a payment suspension was 
not imposed, imposed only in part, or discontinued for good cause.
    (ii) This type of documentation must include, at a minimum, detailed 
information on the basis for the existence of the good cause not to 
suspend payments, to suspend payments only in part, or to discontinue a 
payment suspension and, where applicable, must specify how long the 
State anticipates such good cause will exist.
    (3) Annually report to the Secretary summary information on each of 
following:
    (i) Suspension of payment, including the nature of the suspected 
fraud, the basis for suspension, and the outcome of the suspension.
    (ii) Situation in which the State determined good cause existed to 
not suspend payments, to suspend payments only in part, or to 
discontinue a payment suspension as described in this section, including 
describing the nature of the suspected fraud and the nature of the good 
cause.

[76 FR 5966, Feb. 2, 2011]



   Subpart B_Disclosure of Information by Providers and Fiscal Agents

    Source: 44 FR 41644, July 17, 1979, unless otherwise noted.



Sec.  455.100  Purpose.

    This subpart implements sections 1124, 1126, 1902(a)(38), 
1903(i)(2), and 1903(n) of the Social Security Act. It sets forth State 
plan requirements regarding--
    (a) Disclosure by providers and fiscal agents of ownership and 
control information; and
    (b) Disclosure of information on a provider's owners and other 
persons convicted of criminal offenses against Medicare, Medicaid, or 
the title XX services program.

The subpart also specifies conditions under which the Administrator will 
deny Federal financial participation

[[Page 515]]

for services furnished by providers or fiscal agents who fail to comply 
with the disclosure requirements.



Sec.  455.101  Definitions.

    Affiliation means, for purposes of applying Sec.  455.107, any of 
the following:
    (1) A 5 percent or greater direct or indirect ownership interest 
that an individual or entity has in another organization.
    (2) A general or limited partnership interest (regardless of the 
percentage) that an individual or entity has in another organization.
    (3) An interest in which an individual or entity exercises 
operational or managerial control over, or directly or indirectly 
conducts, the day-to-day operations of another organization (including, 
for purposes of this paragraph (3), sole proprietorships), either under 
contract or through some other arrangement, regardless of whether or not 
the managing individual or entity is a W-2 employee of the organization.
    (4) An interest in which an individual is acting as an officer or 
director of a corporation.
    (5) Any payment assignment relationship under Sec.  447.10(g) of 
this chapter.
    Agent means any person who has been delegated the authority to 
obligate or act on behalf of a provider.
    Disclosable event means, for purposes of Sec.  455.107, any of the 
following:
    (1) Currently has an uncollected debt to Medicare, Medicaid, or 
CHIP, regardless of--
    (i) The amount of the debt;
    (ii) Whether the debt is currently being repaid (for example, as 
part of a repayment plan); or
    (iii) Whether the debt is currently being appealed;
    (2) Has been or is subject to a payment suspension under a federal 
health care program (as that latter term is defined in section 1128B(f) 
of the Act), regardless of when the payment suspension occurred or was 
imposed;
    (3) Has been or is excluded by the OIG from participation in 
Medicare, Medicaid, or CHIP, regardless of whether the exclusion is 
currently being appealed or when the exclusion occurred or was imposed; 
or
    (4) Has had its Medicare, Medicaid, or CHIP enrollment denied, 
revoked or terminated, regardless of--
    (i) The reason for the denial, revocation, or termination;
    (ii) Whether the denial, revocation, or termination is currently 
being appealed; or
    (iii) When the denial, revocation, or termination occurred or was 
imposed.
    Disclosing entity means a Medicaid provider (other than an 
individual practitioner or group of practitioners), or a fiscal agent.
    Other disclosing entity means any other Medicaid disclosing entity 
and any entity that does not participate in Medicaid, but is required to 
disclose certain ownership and control information because of 
participation in any of the programs established under title V, XVIII, 
or XX of the Act. This includes:
    (a) Any hospital, skilled nursing facility, home health agency, 
independent clinical laboratory, renal disease facility, rural health 
clinic, or health maintenance organization that participates in Medicare 
(title XVIII);
    (b) Any Medicare intermediary or carrier; and
    (c) Any entity (other than an individual practitioner or group of 
practitioners) that furnishes, or arranges for the furnishing of, 
health-related services for which it claims payment under any plan or 
program established under title V or title XX of the Act.
    Fiscal agent means a contractor that processes or pays vendor claims 
on behalf of the Medicaid agency.
    Group of practitioners means two or more health care practitioners 
who practice their profession at a common location (whether or not they 
share common facilities, common supporting staff, or common equipment).
    Health insuring organization (HIO) has the meaning specified in 
Sec.  438.2.
    Indirect ownership interest means an ownership interest in an entity 
that has an ownership interest in the disclosing entity. This term 
includes an ownership interest in any entity that has an indirect 
ownership interest in the disclosing entity.
    Managed care entity (MCE) means managed care organizations (MCOs), 
PIHPs, PAHPs, PCCMs, and HIOs.

[[Page 516]]

    Managing employee means a general manager, business manager, 
administrator, director, or other individual who exercises operational 
or managerial control over, or who directly or indirectly conducts the 
day-to-day operation of an institution, organization, or agency.
    Ownership interest means the possession of equity in the capital, 
the stock, or the profits of the disclosing entity.
    Person with an ownership or control interest means a person or 
corporation that--
    (a) Has an ownership interest totaling 5 percent or more in a 
disclosing entity;
    (b) Has an indirect ownership interest equal to 5 percent or more in 
a disclosing entity;
    (c) Has a combination of direct and indirect ownership interests 
equal to 5 percent or more in a disclosing entity;
    (d) Owns an interest of 5 percent or more in any mortgage, deed of 
trust, note, or other obligation secured by the disclosing entity if 
that interest equals at least 5 percent of the value of the property or 
assets of the disclosing entity;
    (e) Is an officer or director of a disclosing entity that is 
organized as a corporation; or
    (f) Is a partner in a disclosing entity that is organized as a 
partnership.
    Prepaid ambulatory health plan (PAHP) has the meaning specified in 
Sec.  438.2.
    Prepaid inpatient health plan (PIHP) has the meaning specified in 
Sec.  438.2.
    Primary care case manager (PCCM) has the meaning specified in Sec.  
438.2.
    Significant business transaction means any business transaction or 
series of transactions that, during any one fiscal year, exceed the 
lesser of $25,000 and 5 percent of a provider's total operating 
expenses.
    Subcontractor means--
    (a) An individual, agency, or organization to which a disclosing 
entity has contracted or delegated some of its management functions or 
responsibilities of providing medical care to its patients; or
    (b) An individual, agency, or organization with which a fiscal agent 
has entered into a contract, agreement, purchase order, or lease (or 
leases of real property) to obtain space, supplies, equipment, or 
services provided under the Medicaid agreement.
    Supplier means an individual, agency, or organization from which a 
provider purchases goods and services used in carrying out its 
responsibilities under Medicaid (e.g., a commercial laundry, a 
manufacturer of hospital beds, or a pharmaceutical firm).
    Termination means--
    (1) For a--
    (i) Medicaid or CHIP provider, a State Medicaid program or CHIP has 
taken an action to revoke the provider's billing privileges, and the 
provider has exhausted all applicable appeal rights or the timeline for 
appeal has expired; and
    (ii) Medicare provider, supplier or eligible professional, the 
Medicare program has revoked the provider or supplier's billing 
privileges, and the provider has exhausted all applicable appeal rights 
or the timeline for appeal has expired.
    (2)(i) In all three programs, there is no expectation on the part of 
the provider or supplier or the State or Medicare program that the 
revocation is temporary.
    (ii) The provider, supplier, or eligible professional will be 
required to reenroll with the applicable program if they wish billing 
privileges to be reinstated.
    (3) The requirement for termination applies in cases where 
providers, suppliers, or eligible professionals were terminated or had 
their billing privileges revoked for cause which may include, but is not 
limited to--
    (i) Fraud;
    (ii) Integrity; or
    (iii) Quality.
    Wholly owned supplier means a supplier whose total ownership 
interest is held by a provider or by a person, persons, or other entity 
with an ownership or control interest in a provider.

[44 FR 41644, July 17, 1979, as amended at 51 FR 34788, Sept. 30, 1986; 
76 FR 5967, Feb. 2, 2011; 84 FR 47856, Sept. 10, 2019]



Sec.  455.102  Determination of ownership or control percentages.

    (a) Indirect ownership interest. The amount of indirect ownership 
interest is determined by multiplying the percentages of ownership in 
each entity.

[[Page 517]]

For example, if A owns 10 percent of the stock in a corporation which 
owns 80 percent of the stock of the disclosing entity, A's interest 
equates to an 8 percent indirect ownership interest in the disclosing 
entity and must be reported. Conversely, if B owns 80 percent of the 
stock of a corporation which owns 5 percent of the stock of the 
disclosing entity, B's interest equates to a 4 percent indirect 
ownership interest in the disclosing entity and need not be reported.
    (b) Person with an ownership or control interest. In order to 
determine percentage of ownership, mortgage, deed of trust, note, or 
other obligation, the percentage of interest owned in the obligation is 
multiplied by the percentage of the disclosing entity's assets used to 
secure the obligation. For example, if A owns 10 percent of a note 
secured by 60 percent of the provider's assets, A's interest in the 
provider's assets equates to 6 percent and must be reported. Conversely, 
if B owns 40 percent of a note secured by 10 percent of the provider's 
assets, B's interest in the provider's assets equates to 4 percent and 
need not be reported.



Sec.  455.103  State plan requirement.

    A State plan must provide that the requirements of Sec. Sec.  
455.104 through 455.107 are met.

[84 FR 47856, Sept. 10, 2019]



Sec.  455.104  Disclosure by Medicaid providers and fiscal agents: 
Information on ownership and control.

    (a) Who must provide disclosures. The Medicaid agency must obtain 
disclosures from disclosing entities, fiscal agents, and managed care 
entities.
    (b) What disclosures must be provided. The Medicaid agency must 
require that disclosing entities, fiscal agents, and managed care 
entities provide the following disclosures:
    (1)(i) The name and address of any person (individual or 
corporation) with an ownership or control interest in the disclosing 
entity, fiscal agent, or managed care entity. The address for corporate 
entities must include as applicable primary business address, every 
business location, and P.O. Box address.
    (ii) Date of birth and Social Security Number (in the case of an 
individual).
    (iii) Other tax identification number (in the case of a corporation) 
with an ownership or control interest in the disclosing entity (or 
fiscal agent or managed care entity) or in any subcontractor in which 
the disclosing entity (or fiscal agent or managed care entity) has a 5 
percent or more interest.
    (2) Whether the person (individual or corporation) with an ownership 
or control interest in the disclosing entity (or fiscal agent or managed 
care entity) is related to another person with ownership or control 
interest in the disclosing entity as a spouse, parent, child, or 
sibling; or whether the person (individual or corporation) with an 
ownership or control interest in any subcontractor in which the 
disclosing entity (or fiscal agent or managed care entity) has a 5 
percent or more interest is related to another person with ownership or 
control interest in the disclosing entity as a spouse, parent, child, or 
sibling.
    (3) The name of any other disclosing entity (or fiscal agent or 
managed care entity) in which an owner of the disclosing entity (or 
fiscal agent or managed care entity) has an ownership or control 
interest.
    (4) The name, address, date of birth, and Social Security Number of 
any managing employee of the disclosing entity (or fiscal agent or 
managed care entity).
    (c) When the disclosures must be provided--(1) Disclosures from 
providers or disclosing entities. Disclosure from any provider or 
disclosing entity is due at any of the following times:
    (i) Upon the provider or disclosing entity submitting the provider 
application.
    (ii) Upon the provider or disclosing entity executing the provider 
agreement.
    (iii) Upon request of the Medicaid agency during the re-validation 
of enrollment process under Sec.  455.414.
    (iv) Within 35 days after any change in ownership of the disclosing 
entity.
    (2) Disclosures from fiscal agents. Disclosures from fiscal agents 
are due at any of the following times:

[[Page 518]]

    (i) Upon the fiscal agent submitting the proposal in accordance with 
the State's procurement process.
    (ii) Upon the fiscal agent executing the contract with the State.
    (iii) Upon renewal or extension of the contract.
    (iv) Within 35 days after any change in ownership of the fiscal 
agent.
    (3) Disclosures from managed care entities. Disclosures from managed 
care entities (MCOs, PIHPs, PAHPs, and HIOs), except PCCMs are due at 
any of the following times:
    (i) Upon the managed care entity submitting the proposal in 
accordance with the State's procurement process.
    (ii) Upon the managed care entity executing the contract with the 
State.
    (iii) Upon renewal or extension of the contract.
    (iv) Within 35 days after any change in ownership of the managed 
care entity.
    (4) Disclosures from PCCMs. PCCMs will comply with disclosure 
requirements under paragraph (c)(1) of this section.
    (d) To whom must the disclosures be provided. All disclosures must 
be provided to the Medicaid agency.
    (e) Consequences for failure to provide required disclosures. 
Federal financial participation (FFP) is not available in payments made 
to a disclosing entity that fails to disclose ownership or control 
information as required by this section.

[76 FR 5967, Feb. 2, 2011]



Sec.  455.105  Disclosure by providers: Information related to business 
transactions.

    (a) Provider agreements. A Medicaid agency must enter into an 
agreement with each provider under which the provider agrees to furnish 
to it or to the Secretary on request, information related to business 
transactions in accordance with paragraph (b) of this section.
    (b) Information that must be submitted. A provider must submit, 
within 35 days of the date on a request by the Secretary or the Medicaid 
agency, full and complete information about--
    (1) The ownership of any subcontractor with whom the provider has 
had business transactions totaling more than $25,000 during the 12-month 
period ending on the date of the request; and
    (2) Any significant business transactions between the provider and 
any wholly owned supplier, or between the provider and any 
subcontractor, during the 5-year period ending on the date of the 
request.
    (c) Denial of Federal financial participation (FFP). (1) FFP is not 
available in expenditures for services furnished by providers who fail 
to comply with a request made by the Secretary or the Medicaid agency 
under paragraph (b) of this section or under Sec.  420.205 of this 
chapter (Medicare requirements for disclosure).
    (2) FFP will be denied in expenditures for services furnished during 
the period beginning on the day following the date the information was 
due to the Secretary or the Medicaid agency and ending on the day before 
the date on which the information was supplied.



Sec.  455.106  Disclosure by providers: Information on persons convicted
of crimes.

    (a) Information that must be disclosed. Before the Medicaid agency 
enters into or renews a provider agreement, or at any time upon written 
request by the Medicaid agency, the provider must disclose to the 
Medicaid agency the identity of any person who:
    (1) Has ownership or control interest in the provider, or is an 
agent or managing employee of the provider; and
    (2) Has been convicted of a criminal offense related to that 
person's involvement in any program under Medicare, Medicaid, or the 
title XX services program since the inception of those programs.
    (b) Notification to Inspector General. (1) The Medicaid agency must 
notify the Inspector General of the Department of any disclosures made 
under paragraph (a) of this section within 20 working days from the date 
it receives the information.
    (2) The agency must also promptly notify the Inspector General of 
the Department of any action it takes on the provider's application for 
participation in the program.
    (c) Denial or termination of provider participation. (1) The 
Medicaid agency

[[Page 519]]

may refuse to enter into or renew an agreement with a provider if any 
person who has an ownership or control interest in the provider, or who 
is an agent or managing employee of the provider, has been convicted of 
a criminal offense related to that person's involvement in any program 
established under Medicare, Medicaid or the title XX Services Program.
    (2) The Medicaid agency may refuse to enter into or may terminate a 
provider agreement if it determines that the provider did not fully and 
accurately make any disclosure required under paragraph (a) of this 
section.



Sec.  455.107  Disclosure of affiliations.

    (a) Definitions. For purposes of this section only, the following 
terms apply to the definition of disclosable event in Sec.  455.101:
    (1) ``Uncollected debt'' only applies to the following:
    (i) Medicare, Medicaid, or CHIP overpayments for which CMS or the 
State has sent notice of the debt to the affiliated provider or 
supplier.
    (ii) Civil money penalties imposed under this title.
    (iii) Assessments imposed under this title.
    (2) ``Revoked,'' ``Revocation,'' ``Terminated,'' and ``Termination'' 
include situations where the affiliated provider or supplier voluntarily 
terminated its Medicare, Medicaid, or CHIP enrollment to avoid a 
potential revocation or termination.
    (b) General. (1)(i) Selection of option. A State, in consultation 
with CMS, must select one of the two options identified in paragraph 
(b)(2) of this section for requiring the disclosure of affiliation 
information.
    (ii) Change of selection. A State may not change its selection under 
paragraph (b) of this section after it has been made.
    (2)(i) First option. In a State that has selected the option in this 
paragraph (b)(2)(i), a provider that is not enrolled in Medicare but is 
initially enrolling in Medicaid or CHIP (or is revalidating its Medicaid 
or CHIP enrollment information) must disclose any and all affiliations 
that it or any of its owning or managing employees or organizations 
(consistent with the terms ``person with an ownership or control 
interest'' and ``managing employee'' as defined in Sec.  455.101) has 
or, within the previous 5 years, had with a currently or formerly 
enrolled Medicare, Medicaid, or CHIP provider or supplier that has a 
disclosable event (as defined in Sec.  455.101).
    (ii) Second option. In a State that has selected the option in this 
paragraph (b)(2)(ii), and upon request by the State, a provider that is 
not enrolled in Medicare but is initially enrolling in Medicaid or CHIP 
(or is revalidating its Medicaid or CHIP enrollment information) must 
disclose any and all affiliations that it or any of its owning or 
managing employees or organizations (consistent with the terms ``person 
with an ownership or control interest'' and ``managing employee'' as 
defined in Sec.  455.101) has or, within the previous 5 years, had with 
a currently or formerly enrolled Medicare, Medicaid, or CHIP provider or 
supplier that has a disclosable event (as defined in Sec.  455.101). The 
State will request such disclosures when it, in consultation with CMS, 
has determined that the initially enrolling or revalidating provider may 
have at least one such affiliation.
    (c) Information. The initially enrolling or revalidating provider 
must disclose the following information about each affiliation:
    (1) General identifying information about the affiliated provider or 
supplier, which includes the following:
    (i) Legal name as reported to the Internal Revenue Service or the 
Social Security Administration (if the affiliated provider or supplier 
is an individual).
    (ii) ``Doing business as'' name (if applicable).
    (iii) Tax identification number.
    (iv) National Provider Identifier (NPI).
    (2) Reason for disclosing the affiliated provider or supplier.
    (3) Specific data regarding the affiliation relationship, including 
the following:
    (i) Length of the relationship.
    (ii) Type of relationship.
    (iii) Degree of affiliation.
    (4) If the affiliation has ended, the reason for the termination.

[[Page 520]]

    (d) Mechanism. The information described in paragraphs (b) and (c) 
of this section must be furnished to the State in a manner prescribed by 
the State in consultation with the Secretary.
    (e) Denial or termination. The failure of the provider to fully and 
completely report the information required in this section when the 
provider knew or should reasonably have known of this information may 
result in, as applicable, the denial of the provider's initial 
enrollment application or the termination of the provider's enrollment 
in Medicaid or CHIP.
    (f) Undue risk. Upon receipt of the information described in 
paragraphs (b) and (c) of this section, the State, in consultation with 
CMS, determines whether any of the disclosed affiliations poses an undue 
risk of fraud, waste, or abuse by considering the following factors:
    (1) The duration of the affiliation.
    (2) Whether the affiliation still exists and, if not, how long ago 
the affiliation ended.
    (3) The degree and extent of the affiliation.
    (4) If applicable, the reason for the termination of the 
affiliation.
    (5) Regarding the affiliated provider's or supplier's disclosable 
event under paragraph (b) of this section, all of the following:
    (i) The type of disclosable event.
    (ii) When the disclosable event occurred or was imposed.
    (iii) Whether the affiliation existed when the disclosable event 
occurred or was imposed.
    (iv) If the disclosable event is an uncollected debt--
    (A) The amount of the debt;
    (B) Whether the affiliated provider or supplier is repaying the 
debt; and
    (C) To whom the debt is owed.
    (v) If a denial, revocation, termination, exclusion, or payment 
suspension is involved, the reason for the disclosable event.
    (6) Any other evidence that the State, in consultation with CMS, 
deems relevant to its determination.
    (g) Determination of undue risk. A determination by the State, in 
consultation with CMS, that a particular affiliation poses an undue risk 
of fraud, waste, or abuse will result in, as applicable, the denial of 
the provider's initial enrollment in Medicaid or CHIP or the termination 
of the provider's enrollment in Medicaid or CHIP.
    (h) Undisclosed affiliations. The State, in consultation with CMS, 
may apply paragraph (g) of this section to situations where a reportable 
affiliation (as described in paragraphs (b) and (c) of this section) 
poses an undue risk of fraud, waste, or abuse, but the provider has not 
yet disclosed or is not required at that time to disclose the 
affiliation to the State.

[84 FR 47856, Sept. 10, 2019]



                  Subpart C_Medicaid Integrity Program

    Source: 72 FR 67655, Nov. 30, 2007, unless otherwise noted.



Sec.  455.200  Basis and scope.

    (a) Statutory basis. This subpart implements section 1936 of the 
Social Security Act that establishes the Medicaid Integrity Program, 
under which the Secretary will promote the integrity of the program by 
entering into contracts with eligible entities to carry out the 
activities under this subpart C.
    (b) Scope. This subpart provides for the limitation on a 
contractor's liability to carry out a contract under the Medicaid 
Integrity Program and to carry out the Medicaid integrity audit program 
functions.

[73 FR 55771, Sept. 26, 2008]



Sec.  455.202  Limitation on contractor liability.

    (a) A program contractor, a person, or an entity employed by, or 
having a fiduciary relationship with, or who furnishes professional 
services to a program contractor will not be held to have violated any 
criminal law and will not be held liable in any civil action, under any 
law of the United States or of any State (or political subdivision 
thereof), by reason of the performance of any duty, function, or 
activity required or authorized under this subpart or under a valid 
contract entered into under this subpart, provided

[[Page 521]]

due care was exercised in that performance and the contractor has a 
contract with CMS under this subpart.
    (b) CMS pays a contractor, a person, or an entity described in 
paragraph (a) of this section, or anyone who furnishes legal counsel or 
services to a contractor or person, a sum equal to the reasonable amount 
of the expenses, as determined by CMS, incurred in connection with the 
defense of a suit, action, or proceeding, if the following conditions 
are met:
    (1) The suit, action, or proceeding was brought against the 
contractor, person or entity by a third party and relates to the 
contractor's, person's or entity's performance of any duty, function, or 
activity under a contract entered into with CMS under this subpart.
    (2) The funds are available.
    (3) The expenses are otherwise allowable under the terms of the 
contract.



Sec.  455.230  Eligibility requirements.

    CMS may enter into a contract with an entity to perform the 
activities described at Sec.  455.232, if it meets the following 
conditions:
    (a) The entity has demonstrated capability to carry out the 
activities described below.
    (b) In carrying out such activities, the entity agrees to cooperate 
with the Inspector General of the Department of Health and Human 
Services, the Attorney General, and other law enforcement agencies, as 
appropriate, in the investigation and deterrence of fraud and abuse in 
relation to Title XIX of the Social Security Act and in other cases 
arising out of such activities.
    (c) Maintains an appropriate written code of conduct and compliance 
policies that include, without limitation, an enforced policy on 
employee conflicts of interest.
    (d) The entity complies with such conflict of interest standards as 
are generally applicable to Federal acquisition and procurement.
    (e) The entity meets such other requirements the Secretary may 
impose.

[73 FR 55771, Sept. 26, 2008]



Sec.  455.232  Medicaid integrity audit program contractor functions.

    The contract between CMS and a Medicaid integrity audit program 
contractor specifies the functions the contractor will perform. The 
contract may include any or all of the following functions:
    (a) Review of the actions of individuals or entities furnishing 
items or services (whether on a fee-for-service, risk, or other basis) 
for which payment may be made under a State Plan approved under title 
XIX of the Act (or under any waiver of such plan approved under section 
1115 of the Act) to determine whether fraud, waste, or abuse has 
occurred, is likely to occur, or whether such actions have the potential 
for resulting in an expenditure of funds under title XIX in a manner 
which is not intended under the provisions of title XIX.
    (b) Auditing of claims for payment for items or services furnished, 
or administrative services rendered, under a State Plan under title XIX 
to ensure proper payments were made. This includes: cost reports, 
consulting contracts, and risk contracts under section 1903(m) of the 
Act.
    (c) Identifying if overpayments have been made to individuals or 
entities receiving Federal funds under title XIX.
    (d) Educating providers of service, managed care entities, 
beneficiaries, and other individuals with respect to payment integrity 
and quality of care.

[73 FR 55771, Sept. 26, 2008]



Sec.  455.234  Awarding of a contract.

    (a) CMS awards and administers Medicaid integrity audit program 
contracts in accordance with acquisition regulations set forth at 48 CFR 
chapters 1 and 3, this subpart, and all other applicable laws and 
regulations. These competitive procedures and requirements for awarding 
Medicaid integrity audit program contracts are to be used as follows:
    (1) When entering into new contracts under this section.
    (2) At any other time considered appropriate by the Secretary.
    (b) An entity is eligible to be awarded a Medicaid integrity audit 
program contract only if meets the eligibility

[[Page 522]]

requirements established in Sec.  455.202, 48 CFR chapter 3, and all 
other applicable laws and requirements.

[73 FR 55771, Sept. 26, 2008]



Sec.  455.236  Renewal of a contract.

    (a) CMS specifies the initial contract term in the Medicaid 
integrity audit program contract. CMS may, but is not required to, renew 
a Medicaid integrity audit program contract without regard to any 
provision of law requiring competition if the contractor has met or 
exceeded the performance requirements established in the current 
contract.
    (b) CMS may renew a Medicaid integrity audit program contract 
without competition if all of the following conditions are met:
    (1) The Medicaid integrity audit program contractor continues to 
meet the requirements established in this subpart.
    (2) The Medicaid integrity audit program contractor meets or exceeds 
the performance requirements established in its current contract.
    (3) It is in the best interest of the government.
    (c) If CMS does not renew a contract, the contract will end in 
accordance with its terms. The contractor will not have a right to a 
hearing or judicial review regarding CMS's renewal or non-renewal 
decision.

[73 FR 55771, Sept. 26, 2008]



Sec.  455.238  Conflict of interest.

    (a) Offerors for Medicaid integrity audit program contracts, and 
Medicaid integrity audit program contractors, are subject to the 
following requirements:
    (1) The conflict of interest standards and requirements of the 
Federal Acquisition Regulation organizational conflict of interest 
guidance, found under 48 CFR subpart 9.5.
    (2) The standards and requirements that are contained in each 
individual contract awarded to perform activities described under 
section 1936 of the Act.
    (b) Post-award conflicts of interest: CMS considers that a post-
award conflict of interest has developed if, during the term of the 
contract, one of the following occurs:
    (1) The contractor or any of its employees, agents, or 
subcontractors received, solicited, or arranged to receive any fee, 
compensation, gift (defined at 5 CFR 2635.203(b)), payment of expenses, 
offer of employment, or any other thing of value from any entity that is 
reviewed, audited, investigated, or contacted during the normal course 
of performing activities under the Medicaid integrity audit program 
contract.
    (2) CMS determines that the contractor's activities are creating a 
conflict of interest.
    (c) If CMS determines that a conflict of interest exists during the 
term of the contract, among other actions, CMS may:
    (1) Not renew the contract for an additional term.
    (2) Modify the contract.
    (3) Terminate the contract.

[73 FR 55771, Sept. 26, 2008]



Sec.  455.240  Conflict of interest resolution.

    (a) Review Board: CMS may establish a Conflicts of Interest Review 
Board to assist in resolving organizational conflicts of interest.
    (b) Resolution: Resolution of an organizational conflict of interest 
is a determination by the contracting officer that:
    (1) The conflict is mitigated.
    (2) The conflict precludes award of a contract to the offeror.
    (3) The conflict requires that CMS modify an existing contract.
    (4) The conflict requires that CMS terminate an existing contract.
    (5) It is in the best interest of the government to contract with 
the offeror or contractor even though the conflict of interest exists 
and a request for waiver is approved in accordance with 48 CFR 9.503.

[73 FR 55771, Sept. 26, 2008]



 Subpart D_Independent Certified Audit of State Disproportionate Share 
                      Hospital Payment Adjustments

    Source: 73 FR 77951, Dec. 19, 2008, unless otherwise noted.

[[Page 523]]



Sec.  455.300  Purpose.

    This subpart implements Section 1923(j)(2) of the Act.



Sec.  455.301  Definitions.

    For the purposes of this subpart--
    Independent certified audit means an audit that is conducted by an 
auditor that operates independently from the Medicaid agency or subject 
hospitals and is eligible to perform the DSH audit. Certification means 
that the independent auditor engaged by the State reviews the criteria 
of the Federal audit regulation and completes the verification, 
calculations and report under the professional rules and generally 
accepted standards of audit practice. This certification would include a 
review of the State's audit protocol to ensure that the Federal 
regulation is satisfied, an opinion for each verification detailed in 
the regulation, and a determination of whether or not the State made DSH 
payments that exceeded any hospital's specific DSH limit in the Medicaid 
State plan rate year under audit. The certification should also identify 
any data issues or other caveats that the auditor identified as 
impacting the results of the audit.
    Medicaid State Plan Rate Year means the 12-month period defined by a 
State's approved Medicaid State plan in which the State estimates 
eligible uncompensated care costs and determines corresponding 
disproportionate share hospital payments as well as all other Medicaid 
payment rates. The period usually corresponds with the State's fiscal 
year or the Federal fiscal year but can correspond to any 12-month 
period defined by the State as the Medicaid State plan rate year.



Sec.  455.304  Condition for Federal financial participation (FFP).

    (a) General rule. (1) The State must submit an independent certified 
audit to CMS for each completed Medicaid State plan rate year, 
consistent with the requirements in this subpart, to receive Federal 
payments under Section 1903(a)(1) of the Act based on State expenditures 
for disproportionate share hospital (DSH) payments for Medicaid State 
plan rate years subsequent to the date the audit is due, except as 
provided in paragraph (e) of this section.
    (2) FFP is not available in expenditures for DSH payments that are 
found in the independent certified audit to exceed the hospital-specific 
eligible uncompensated care cost limit, except as provided in paragraph 
(e) of this section.
    (b) Timing. For Medicaid State plan rate years 2005 and 2006, a 
State must submit to CMS an independent certified audit report no later 
than the last day of calendar year 2009. Each subsequent audit beginning 
with Medicaid State plan rate year 2007 must be completed by the last 
day of the Federal fiscal year ending three years from the end of the 
Medicaid State plan rate year under audit. Completed audit reports must 
be submitted to CMS no later than 90 days after completion. Post-audit 
adjustments based on claims for the Medicaid State plan rate year paid 
subsequent to the audit date, if any, must be submitted in the quarter 
the claim was paid.
    (c) Documentation. In order to complete the independent certified 
audit, States must use the following data sources:
    (1) Approved Medicaid State plan for the Medicaid State plan rate 
year under audit.
    (2) Payment and utilization information from the State's Medicaid 
Management Information System.
    (3) The Medicare 2552-96 hospital cost report(s) applicable to the 
Medicaid State plan rate year under audit. If the Medicare 2552-96 is 
superseded by an alternate Medicare developed cost reporting tool during 
an audit year, that tool must be used for the Medicaid State plan rate 
year under audit.
    (4) Audited hospital financial statements and hospital accounting 
records.
    (d) Specific requirements. The independent certified audit report 
must verify the following:
    (1) Verification 1: Each hospital that qualifies for a DSH payment 
in the State is allowed to retain that payment so that the payment is 
available to offset its uncompensated care costs for furnishing 
inpatient hospital and outpatient hospital services during the

[[Page 524]]

Medicaid State plan rate year to Medicaid eligible individuals and 
individuals with no source of third party coverage for the services in 
order to reflect the total amount of claimed DSH expenditures.
    (2) Verification 2: DSH payments made to each qualifying hospital 
comply with the hospital-specific DSH payment limit. For each audited 
Medicaid State plan rate year, the DSH payments made in that audited 
Medicaid State plan rate year must be measured against the actual 
uncompensated care cost in that same audited Medicaid State plan rate 
year.
    (3) Verification 3: Only uncompensated care costs of furnishing 
inpatient and outpatient hospital services to Medicaid eligible 
individuals and individuals with no third party coverage for the 
inpatient and outpatient hospital services they received as described in 
Section 1923(g)(1)(A) of the Act are eligible for inclusion in the 
calculation of the hospital-specific disproportionate share limit 
payment limit, as described in Section 1923(g)(1)(A) of the Act.
    (4) Verification 4: For purposes of this hospital-specific limit 
calculation, any Medicaid payments (including regular Medicaid fee-for-
service rate payments, supplemental/enhanced Medicaid payments, and 
Medicaid managed care organization payments) made to a disproportionate 
share hospital for furnishing inpatient hospital and outpatient hospital 
services to Medicaid eligible individuals, which are in excess of the 
Medicaid incurred costs of such services, are applied against the 
uncompensated care costs of furnishing inpatient hospital and outpatient 
hospital services to individuals with no source of third party coverage 
for such services.
    (5) Verification 5: Any information and records of all of its 
inpatient and outpatient hospital service costs under the Medicaid 
program; claimed expenditures under the Medicaid program; uninsured 
inpatient and outpatient hospital service costs in determining payment 
adjustments under this Section; and any payments made on behalf of the 
uninsured from payment adjustments under this Section has been 
separately documented and retained by the State.
    (6) Verification 6: The information specified in paragraph (d)(5) of 
this Section includes a description of the methodology for calculating 
each hospital's payment limit under Section 1923(g)(1) of the Act. 
Included in the description of the methodology, the audit report must 
specify how the State defines incurred inpatient hospital and outpatient 
hospital costs for furnishing inpatient hospital and outpatient hospital 
services to Medicaid eligible individuals and individuals with no source 
of third party coverage for the inpatient hospital and outpatient 
hospital services they received.
    (e) Transition Provisions: To ensure a period for developing and 
refining reporting and auditing techniques, findings of State reports 
and audits for Medicaid State Plan years 2005-2010 will not be given 
weight except to the extent that the findings draw into question the 
reasonableness of State uncompensated care cost estimates used for 
calculations of prospective DSH payments for Medicaid State plan year 
2011 and thereafter.



               Subpart E_Provider Screening and Enrollment

    Source: 76 FR 5968, Feb. 2, 2011, unless otherwise noted.



Sec.  455.400  Purpose.

    This subpart implements sections 1866(j), 1902(a)(39), 1902(a)(77), 
and 1902(a)(78) of the Act. It sets forth State plan requirements 
regarding the following:
    (a) Provider screening and enrollment requirements.
    (b) Fees associated with provider screening.
    (c) Temporary moratoria on enrollment of providers.



Sec.  455.405  State plan requirements.

    A State plan must provide that the requirements of Sec.  455.410 
through Sec.  455.450 and Sec.  455.470 are met.



Sec.  455.410  Enrollment and screening of providers.

    (a) The State Medicaid agency must require all enrolled providers to 
be screened under to this subpart.

[[Page 525]]

    (b) The State Medicaid agency must require all ordering or referring 
physicians or other professionals providing services under the State 
plan or under a waiver of the plan to be enrolled as participating 
providers.
    (c) The State Medicaid agency may rely on the results of the 
provider screening performed by any of the following:
    (1) Medicare contractors.
    (2) Medicaid agencies or Children's Health Insurance Programs of 
other States.
    (d) The State Medicaid agency must allow enrollment of all Medicare-
enrolled providers and suppliers for purposes of processing claims to 
determine Medicare cost-sharing (as defined in section 1905(p)(3) of the 
Act) if the providers or suppliers meet all Federal Medicaid enrollment 
requirements, including, but not limited to, all applicable provisions 
of 42 CFR part 455, subparts B and E. This paragraph (d) applies even if 
the Medicare-enrolled provider or supplier is of a type not recognized 
by the State Medicaid Agency.

[76 FR 5968, Feb. 2, 2011, as amended at 86 FR 45521, Aug. 13, 2021]



Sec.  455.412  Verification of provider licenses.

    The State Medicaid agency must--
    (a) Have a method for verifying that any provider purporting to be 
licensed in accordance with the laws of any State is licensed by such 
State.
    (b) Confirm that the provider's license has not expired and that 
there are no current limitations on the provider's license.



Sec.  455.414  Revalidation of enrollment.

    The State Medicaid agency must revalidate the enrollment of all 
providers regardless of provider type at least every 5 years.



Sec.  455.416  Termination or denial of enrollment.

    The State Medicaid agency--
    (a) Must terminate the enrollment of any provider where any person 
with a 5 percent or greater direct or indirect ownership interest in the 
provider did not submit timely and accurate information and cooperate 
with any screening methods required under this subpart.
    (b) Must deny enrollment or terminate the enrollment of any provider 
where any person with a 5 percent or greater direct or indirect 
ownership interest in the provider has been convicted of a criminal 
offense related to that person's involvement with the Medicare, 
Medicaid, or title XXI program in the last 10 years, unless the State 
Medicaid agency determines that denial or termination of enrollment is 
not in the best interests of the Medicaid program and the State Medicaid 
agency documents that determination in writing.
    (c) Must deny enrollment or terminate the enrollment of any provider 
that is terminated on or after January 1, 2011, under title XVIII of the 
Act or under the Medicaid program or CHIP of any other State.
    (d) Must terminate the provider's enrollment or deny enrollment of 
the provider if the provider or a person with an ownership or control 
interest or who is an agent or managing employee of the provider fails 
to submit timely or accurate information, unless the State Medicaid 
agency determines that termination or denial of enrollment is not in the 
best interests of the Medicaid program and the State Medicaid agency 
documents that determination in writing.
    (e) Must terminate or deny enrollment if the provider, or any person 
with a 5 percent or greater direct or indirect ownership interest in the 
provider, fails to submit sets of fingerprints in a form and manner to 
be determined by the Medicaid agency within 30 days of a CMS or a State 
Medicaid agency request, unless the State Medicaid agency determines 
that termination or denial of enrollment is not in the best interests of 
the Medicaid program and the State Medicaid agency documents that 
determination in writing.
    (f) Must terminate or deny enrollment if the provider fails to 
permit access to provider locations for any site visits under Sec.  
455.432, unless the State Medicaid agency determines that termination or 
denial of enrollment is not in the best interests of the Medicaid

[[Page 526]]

program and the State Medicaid agency documents that determination in 
writing.
    (g) May terminate or deny the provider's enrollment if CMS or the 
State Medicaid agency--
    (1) Determines that the provider has falsified any information 
provided on the application; or
    (2) Cannot verify the identity of any provider applicant.



Sec.  455.420  Reactivation of provider enrollment.

    After deactivation of a provider enrollment number for any reason, 
before the provider's enrollment may be reactivated, the State Medicaid 
agency must re-screen the provider and require payment of associated 
provider application fees under Sec.  455.460.



Sec.  455.422  Appeal rights.

    The State Medicaid agency must give providers terminated or denied 
under Sec.  455.416 any appeal rights available under procedures 
established by State law or regulations.



Sec.  455.432  Site visits.

    The State Medicaid agency--
    (a) Must conduct pre-enrollment and post-enrollment site visits of 
providers who are designated as ``moderate'' or ``high'' categorical 
risks to the Medicaid program. The purpose of the site visit will be to 
verify that the information submitted to the State Medicaid agency is 
accurate and to determine compliance with Federal and State enrollment 
requirements.
    (b) Must require any enrolled provider to permit CMS, its agents, 
its designated contractors, or the State Medicaid agency to conduct 
unannounced on-site inspections of any and all provider locations.



Sec.  455.434  Criminal background checks.

    The State Medicaid agency--
    (a) As a condition of enrollment, must require providers to consent 
to criminal background checks including fingerprinting when required to 
do so under State law or by the level of screening based on risk of 
fraud, waste or abuse as determined for that category of provider.
    (b) Must establish categorical risk levels for providers and 
provider categories who pose an increased financial risk of fraud, waste 
or abuse to the Medicaid program.
    (1) Upon the State Medicaid agency determining that a provider, or a 
person with a 5 percent or more direct or indirect ownership interest in 
the provider, meets the State Medicaid agency's criteria hereunder for 
criminal background checks as a ``high'' risk to the Medicaid program, 
the State Medicaid agency will require that each such provider or person 
submit fingerprints.
    (2) The State Medicaid agency must require a provider, or any person 
with a 5 percent or more direct or indirect ownership interest in the 
provider, to submit a set of fingerprints, in a form and manner to be 
determined by the State Medicaid agency, within 30 days upon request 
from CMS or the State Medicaid agency.



Sec.  455.436  Federal database checks.

    The State Medicaid agency must do all of the following:
    (a) Confirm the identity and determine the exclusion status of 
providers and any person with an ownership or control interest or who is 
an agent or managing employee of the provider through routine checks of 
Federal databases.
    (b) Check the Social Security Administration's Death Master File, 
the National Plan and Provider Enumeration System (NPPES), the List of 
Excluded Individuals/Entities (LEIE), the Excluded Parties List System 
(EPLS), and any such other databases as the Secretary may prescribe.
    (c)(1) Consult appropriate databases to confirm identity upon 
enrollment and reenrollment; and
    (2) Check the LEIE and EPLS no less frequently than monthly.



Sec.  455.440  National Provider Identifier.

    The State Medicaid agency must require all claims for payment for 
items and services that were ordered or referred to contain the National 
Provider Identifier (NPI) of the physician or other professional who 
ordered or referred such items or services.

[[Page 527]]



Sec.  455.450  Screening levels for Medicaid providers.

    A State Medicaid agency must screen all initial applications, 
including applications for a new practice location, and any applications 
received in response to a re-enrollment or revalidation of enrollment 
request based on a categorical risk level of ``limited,'' ``moderate,'' 
or ``high.'' If a provider could fit within more than one risk level 
described in this section, the highest level of screening is applicable.
    (a) Screening for providers designated as limited categorical risk. 
When the State Medicaid agency designates a provider as a limited 
categorical risk, the State Medicaid agency must do all of the 
following:
    (1) Verify that a provider meets any applicable Federal regulations, 
or State requirements for the provider type prior to making an 
enrollment determination.
    (2) Conduct license verifications, including State licensure 
verifications in States other than where the provider is enrolling, in 
accordance with Sec.  455.412.
    (3) Conduct database checks on a pre- and post-enrollment basis to 
ensure that providers continue to meet the enrollment criteria for their 
provider type, in accordance with Sec.  455.436.
    (b) Screening for providers designated as moderate categorical risk. 
When the State Medicaid agency designates a provider as a ``moderate'' 
categorical risk, a State Medicaid agency must do both of the following:
    (1) Perform the ``limited'' screening requirements described in 
paragraph (a) of this section.
    (2) Conduct on-site visits in accordance with Sec.  455.432.
    (c) Screening for providers designated as high categorical risk. 
When the State Medicaid agency designates a provider as a ``high'' 
categorical risk, a State Medicaid agency must do both of the following:
    (1) Perform the ``limited'' and ``moderate'' screening requirements 
described in paragraphs (a) and (b) of this section.
    (2)(i) Conduct a criminal background check; and
    (ii) Require the submission of a set of fingerprints in accordance 
with Sec.  455.434.
    (d) Denial or termination of enrollment. A provider, or any person 
with 5 percent or greater direct or indirect ownership in the provider, 
who is required by the State Medicaid agency or CMS to submit a set of 
fingerprints and fails to do so may have its--
    (1) Application denied under Sec.  455.434; or
    (2) Enrollment terminated under Sec.  455.416.
    (e) Adjustment of risk level. The State agency must adjust the 
categorical risk level from ``limited'' or ``moderate'' to ``high'' when 
any of the following occurs:
    (1) The State Medicaid agency imposes a payment suspension on a 
provider based on credible allegation of fraud, waste or abuse, the 
provider has an existing Medicaid overpayment, or the provider has been 
excluded by the OIG or another State's Medicaid program within the 
previous 10 years.
    (2) The State Medicaid agency or CMS in the previous 6 months lifted 
a temporary moratorium for the particular provider type and a provider 
that was prevented from enrolling based on the moratorium applies for 
enrollment as a provider at any time within 6 months from the date the 
moratorium was lifted.



Sec.  455.452  Other State screening methods.

    Nothing in this subpart must restrict the State Medicaid agency from 
establishing provider screening methods in addition to or more stringent 
than those required by this subpart.



Sec.  455.460  Application fee.

    (a) Beginning on or after March 25, 2011, States must collect the 
applicable application fee prior to executing a provider agreement from 
a prospective or re-enrolling provider other than either of the 
following:
    (1) Individual physicians or nonphysician practitioners.
    (2)(i) Providers who are enrolled in either of the following:
    (A) Title XVIII of the Act.
    (B) Another State's title XIX or XXI plan.
    (ii) Providers that have paid the applicable application fee to--
    (A) A Medicare contractor; or

[[Page 528]]

    (B) Another State.
    (b) If the fees collected by a State agency in accordance with 
paragraph (a) of this section exceed the cost of the screening program, 
the State agency must return that portion of the fees to the Federal 
government.



Sec.  455.470  Temporary moratoria.

    (a)(1) The Secretary consults with any affected State Medicaid 
agency regarding imposition of temporary moratoria on enrollment of new 
providers or provider types prior to imposition of the moratoria, in 
accordance with Sec.  424.570 of this chapter.
    (2) The State Medicaid agency will impose temporary moratoria on 
enrollment of new providers or provider types identified by the 
Secretary as posing an increased risk to the Medicaid program.
    (3)(i) The State Medicaid agency is not required to impose such a 
moratorium if the State Medicaid agency determines that imposition of a 
temporary moratorium would adversely affect beneficiaries' access to 
medical assistance.
    (ii) If a State Medicaid agency makes such a determination, the 
State Medicaid agency must notify the Secretary in writing.
    (b)(1) A State Medicaid agency may impose temporary moratoria on 
enrollment of new providers, or impose numerical caps or other limits 
that the State Medicaid agency identifies as having a significant 
potential for fraud, waste, or abuse and that the Secretary has 
identified as being at high risk for fraud, waste, or abuse.
    (2) Before implementing the moratoria, caps, or other limits, the 
State Medicaid agency must determine that its action would not adversely 
impact beneficiaries' access to medical assistance.
    (3) The State Medicaid agency must notify the Secretary in writing 
in the event the State Medicaid agency seeks to impose such moratoria, 
including all details of the moratoria; and obtain the Secretary's 
concurrence with imposition of the moratoria.
    (c)(1) The State Medicaid agency must impose the moratorium for an 
initial period of 6 months.
    (2) If the State Medicaid agency determines that it is necessary, 
the State Medicaid agency may extend the moratorium in 6-month 
increments.
    (3) Each time, the State Medicaid agency must document in writing 
the necessity for extending the moratorium.



          Subpart F_Medicaid Recovery Audit Contractors Program

    Source: 76 FR 57843, Sept. 16, 2011, unless otherwise noted.



Sec.  455.500  Purpose.

    This subpart implements section 1902(a)(42)(B) of the Act that 
establishes the Medicaid Recovery Audit Contractor (RAC) program.



Sec.  455.502  Establishment of program.

    (a) The Medicaid Recovery Audit Contractor program (Medicaid RAC 
program) is established as a measure for States to promote the integrity 
of the Medicaid program.
    (b) States must enter into contracts, consistent with State law and 
in accordance with this section, with one or more eligible Medicaid RACs 
to carry out the activities described in Sec.  455.506 of this subpart.
    (c) States must comply with reporting requirements describing the 
effectiveness of their Medicaid RAC programs as specified by CMS.



Sec.  455.504  Definitions.

    As used in this subpart--
    Medicaid RAC program means a recovery audit contractor program 
administered by a State to identify overpayments and underpayments and 
recoup overpayments.
    Medicare RAC program means a recovery audit contractor program 
administered by CMS to identify underpayments and overpayments and 
recoup overpayments, established under the authority of section 1893(h) 
of the Act.



Sec.  455.506  Activities to be conducted by Medicaid RACs and States.

    (a) Medicaid RACs will review claims submitted by providers of items 
and services or other individuals furnishing items and services for 
which payment

[[Page 529]]

has been made under section 1902(a) of the Act or under any waiver of 
the State Plan to identify underpayments and overpayments and recoup 
overpayments for the States.
    (1) States may exclude Medicaid managed care claims from review by 
Medicaid RACs.
    (b) States may coordinate with Medicaid RACs regarding the 
recoupment of overpayments.
    (c) States must coordinate the recovery audit efforts of their RACs 
with other auditing entities.
    (d) States must make referrals of suspected fraud and/or abuse, as 
defined in 42 CFR 455.2, to the MFCU or other appropriate law 
enforcement agency.
    (e) States must set limits on the number and frequency of medical 
records to be reviewed by the RACs, subject to requests for exception 
from RACs to States.



Sec.  455.508  Eligibility requirements for Medicaid RACs.

    An entity that wishes to perform the functions of a Medicaid RAC 
must enter into a contract with a State to carry out any of the 
activities described in Sec.  455.506 under the following conditions:
    (a) The entity must demonstrate to a State that it has the technical 
capability to carry out the activities described in Sec.  455.506 of 
this subpart. Evaluation of technical capability must include the 
employment of trained medical professionals, as defined by the State, 
who are in good standing with the relevant State licensing authorities, 
where applicable, to review Medicaid claims.
    (b) The entity must hire a minimum of 1.0 FTE Contractor Medical 
Director who is a Doctor of Medicine or Doctor of Osteopathy in good 
standing with the relevant State licensing authorities and has relevant 
work and educational experience. A State may seek to be excepted, in 
accordance with Sec.  455.516, from requiring its RAC to hire a minimum 
of 1.0 FTE Contractor Medical Director by submitting to CMS a written 
request for CMS review and approval.
    (c) The entity must hire certified coders unless the State 
determines that certified coders are not required for the effective 
review of Medicaid claims.
    (d) The entity must work with the State to develop an education and 
outreach program, which includes notification to providers of audit 
policies and protocols.
    (e) The entity must provide minimum customer service measures 
including:
    (1) Providing a toll-free customer service telephone number in all 
correspondence sent to providers and staffing the toll-free number 
during normal business hours from 8:00 a.m. to 4:30 p.m. in the 
applicable time zone.
    (2) Compiling and maintaining provider approved addresses and points 
of contact.
    (3) Mandatory acceptance of provider submissions of electronic 
medical records on CD/DVD or via facsimile at the providers' request.
    (4) Notifying providers of overpayment findings within 60 calendar 
days.
    (f) The entity must not review claims that are older than 3 years 
from the date of the claim, unless it receives approval from the State.
    (g) The entity should not audit claims that have already been 
audited or that are currently being audited by another entity.
    (h) The entity must refer suspected cases of fraud and/or abuse to 
the State in a timely manner, as defined by the State.
    (i) The entity meets other requirements as the State may require.



Sec.  455.510  Payments to RACs.

    (a) General. Fees paid to RACs must be made only from amounts 
recovered.
    (b) Overpayments. States must determine the contingency fee rate to 
be paid to Medicaid RACs for the identification and recovery of Medicaid 
provider overpayments.
    (1) The contingency fees paid to Medicaid RACs must be based on a 
percentage of the overpayment recovered.
    (2) States must determine at what stage in the Medicaid RAC audit 
process, after an overpayment has been recovered, Medicaid RACs will 
receive contingency fee payments.
    (3) If a provider appeals a Medicaid RAC overpayment determination 
and the determination is reversed, at any

[[Page 530]]

level, then the Medicaid RAC must return the contingency fees associated 
with that payment within a reasonable timeframe, as prescribed by the 
State.
    (4) Except as provided in paragraph (5) of this section, the 
contingency fee may not exceed that of the highest Medicare RAC, as 
specified by CMS in the Federal Register, unless the State submits, and 
CMS approves, a waiver of the specified maximum rate. If a State does 
not obtain a waiver of the specified maximum rate, any amount exceeding 
the specified maximum rate is not eligible for FFP, either from the 
collected overpayment amounts, or in the form of any other 
administrative or medical assistance claimed expenditure.
    (5) CMS will review and consider, on a case-by-case basis, a State's 
well-justified request that CMS provide FFP in paying a Medicaid RAC(s) 
a contingency fee in excess of the then-highest contingency fee paid to 
a Medicare RAC.
    (c) Underpayments. (1) States must determine the fee paid to a 
Medicaid RAC to identify underpayments.
    (2) States must adequately incentivize the detection of 
underpayments.
    (3) States must notify providers of underpayments that are 
identified by the RACs.



Sec.  455.512  Medicaid RAC provider appeals.

    States must provide appeal rights under State law or administrative 
procedures to Medicaid providers that seek review of an adverse Medicaid 
RAC determination.



Sec.  455.514  Federal share of State expense of the Medicaid RAC program.

    (a) Funds expended by States for the operation and maintenance of a 
Medicaid RAC program, not including fees paid to RACs, are considered 
necessary for the proper and efficient administration of the States' 
plan or waivers of the plan.
    (b) FFP is available to States for administrative costs of operation 
and maintenance of Medicaid RACs subject to CMS' reporting requirements.



Sec.  455.516  Exceptions from Medicaid RAC programs.

    A State may seek to be excepted from some or all Medicaid RAC 
contracting requirements by submitting to CMS a written justification 
for the request for CMS review and approval through the State Plan 
amendment process.



Sec.  455.518  Applicability to the territories.

    The aforementioned provisions in Sec.  455.500 through Sec.  455.516 
of this subpart are applicable to Guam, Puerto Rico, U.S. Virgin 
Islands, American Samoa, and the Commonwealth of the Northern Mariana 
Islands.

(Authority: Catalog of Federal Domestic Assistance Program No. 93.778, 
Medical Assistance Program)




PART 456_UTILIZATION CONTROL--Table of Contents



                      Subpart A_General Provisions

Sec.
456.1 Basis and purpose of part.
456.2 State plan requirements.
456.3 Statewide surveillance and utilization control program.
456.4 Responsibility for monitoring the utilization control program.
456.5 Evaluation criteria.
456.6 Review by State medical agency of appropriateness and quality of 
          services.

          Subpart B_Utilization Control: All Medicaid Services

456.21 Scope.
456.22 Sample basis evaluation of services.
456.23 Post-payment review process.

                Subpart C_Utilization Control: Hospitals

456.50 Scope.
456.51 Definitions.

                     Certification of Need for Care

456.60 Certification and recertification of need for inpatient care.

                              Plan of Care

456.80 Individual written plan of care.

            Utilization Review (UR) Plan: General Requirement

456.100 Scope.
456.101 UR plan required for inpatient hospital services.

[[Page 531]]

                  UR Plan: Administrative Requirements

456.105 UR committee required.
456.106 Organization and composition of UR committee; disqualification 
          from UR committee membership.

                   UR Plan: Informational Requirements

456.111 Beneficiary information required for UR.
456.112 Records and reports.
456.113 Confidentiality.

                  UR Plan: Review of Need for Admission

456.121 Admission review required.
456.122 Evaluation criteria for admission review.
456.123 Admission review process.
456.124 Notification of adverse decision.
456.125 Time limits for admission review.
456.126 Time limits for final decision and notification of adverse 
          decision.
456.127 Pre-admission review.
456.128 Initial continued stay review date.
456.129 Description of methods and criteria: Initial continued stay 
          review date; close professional scrutiny; length of stay 
          modification.

               UR Plan: Review of Need for Continued Stay

456.131 Continued stay review required.
456.132 Evaluation criteria for continued stay.
456.133 Subsequent continued stay review dates.
456.134 Description of methods and criteria: Subsequent continued stay 
          review dates; length of stay modification.
456.135 Continued stay review process.
456.136 Notification of adverse decision.
456.137 Time limits for final decision and notification of adverse 
          decision.

                UR Plan: Medical Care Evaluation Studies

456.141 Purpose and general description.
456.142 UR plan requirements for medical care evaluation studies.
456.143 Content of medical care evaluation studies.
456.144 Data sources for studies.
456.145 Number of studies required to be performed.

             Subpart D_Utilization Control: Mental Hospitals

456.150 Scope.
456.151 Definitions.

                     Certification of Need for Care

456.160 Certification and recertification of need for inpatient care.

    Medical, Psychiatric, and Social Evaluations and Admission Review

456.170 Medical, psychiatric, and social evaluations.
456.171 [Reserved]

                              Plan of Care

456.180 Individual written plan of care.
456.181 Reports of evaluations and plans of care.

            Utilization Review (UR) Plan: General Requirement

456.200 Scope.
456.201 UR plan required for inpatient mental hospital services.

                  UR Plan: Administrative Requirements

456.205 UR committee required.
456.206 Organization and composition of UR committee; disqualification 
          from UR committee membership.

                   UR Plan: Informational Requirements

456.211 Beneficiary information required for UR.
456.212 Records and reports.
456.213 Confidentiality.

               UR Plan: Review of Need for Continued Stay

456.231 Continued stay review required.
456.232 Evaluation criteria for continued stay.
456.233 Initial continued stay review date.
456.234 Subsequent continued stay review dates.
456.235 Description of methods and criteria: Continued stay review 
          dates; length of stay modification.
456.236 Continued stay review process.
456.237 Notification of adverse decision.
456.238 Time limits for final decision and notification of adverse 
          decision.

                UR Plan: Medical Care Evaluation Studies

456.241 Purpose and general description.
456.242 UR plan requirements for medical care evaluation studies.
456.243 Content of medical care evaluation studies.
456.244 Data sources for studies.
456.245 Number of studies required to be performed.

Subpart E [Reserved]

       Subpart F_Utilization Control: Intermediate Care Facilities

456.350 Scope.
456.351 Definition.

[[Page 532]]

                     Certification of Need for Care

456.360 Certification and recertification of need for inpatient care.

   Medical, Psychological, and Social Evaluations and Admission Review

456.370 Medical, psychological, and social evaluations.
456.371 Exploration of alternative services.
456.372 Medicaid agency review of need for admission.

                              Plan of Care

456.380 Individual written plan of care.
456.381 Reports of evaluations and plans of care.

            Utilization Review (UR) Plan: General Requirement

456.400 Scope.
456.401 State plan UR requirements and options; UR plan required for 
          intermediate care facility services.

                  UR Plan: Administrative Requirements

456.405 Description of UR review function: How and when.
456.406 Description of UR review function: Who performs UR; 
          disqualification from performing UR.
456.407 UR responsibilities of administrative staff.

                   UR Plan: Informational Requirements

456.411 Beneficiary informtion required for UR.
456.412 Records and reports.
456.413 Confidentiality.

               UR Plan: Review of Need for Continued Stay

456.431 Continued stay review required.
456.432 Evaluation criteria for continued stay.
456.433 Initial continued stay review date.
456.434 Subsequent continued stay review dates.
456.435 Description of methods and criteria: Continued stay review 
          dates.
456.436 Continued stay review process.
456.437 Notification of adverse decision.
456.438 Time limits for notification of adverse decision.

 Subpart G_Inpatient Psychiatric Services for Individuals Under Age 21: 
                 Admission and Plan of Care Requirements

456.480 Scope.
456.481 Admission certification and plan of care.
456.482 Medical, psychiatric, and social evaluations.

  Subpart H_Utilization Review Plans: FFP, Waivers, and Variances for 
                     Hospitals and Mental Hospitals

456.500 Purpose.
456.501 UR plans as a condition for FFP.

                     UR Plan: Waiver of Requirements

456.505 Applicability of waiver.
456.506 Waiver options for Medicaid agency.
456.507 Review and granting of waiver requests.
456.508 Withdrawal of waiver.

        UR Plan: Remote Facility Variances from Time Requirements

456.520 Definitions.
456.521 Conditions for granting variance requests.
456.522 Content of request for variance.
456.523 Revised UR plan.
456.524 Notification of Administrator's action and duration of variance.
456.525 Request for renewal of variance.

   Subpart I_Inspections of Care in Intermediate Care Facilities and 
                    Institutions for Mental Diseases

456.600 Purpose.
456.601 Definitions.
456.602 Inspection team.
456.603 Financial interests and employment of team members.
456.604 Physician team member inspecting care of beneficiaries.
456.605 Number and location of teams.
456.606 Frequency of inspections.
456.607 Notification before inspection.
456.608 Personal contact with and observation of beneficiaries and 
          review of records.
456.609 Determinations by team.
456.610 Basis for determinations.
456.611 Reports on inspections.
456.612 Copies of reports.
456.613 Action on reports.
456.614 Inspections by utilization review committee.

   Subpart J_Penalty for Failure To Make a Satisfactory Showing of An 
           Effective Institutional Utilization Control Program

456.650 Basis, purpose, and scope.
456.651 Definitions.
456.652 Requirements for an effective utilization control program.
456.653 Acceptable reasons for not meeting requirements for annual on-
          site review.
456.654 Requirements for content of showings and procedures for 
          submittal.
456.655 Validation of showings.

[[Page 533]]

456.656 Reductions in FFP.
456.657 Computation of reductions in FFP.

Subpart K_Drug Use Review (DUR) Program and Electronic Claims Management 
                    System for Outpatient Drug Claims

456.700 Scope.
456.702 Definitions.
456.703 Drug use review program.
456.705 Prospective drug review.
456.709 Retrospective drug use review.
456.711 Educational program.
456.712 Annual report.
456.714 DUR/surveillance and utilization review relationship.
456.716 DUR Board.
456.719 Funding for DUR program.
456.722 Electronic claims management system.
456.725 Funding of ECM system.

    Authority: 42 U.S.C. 1302.

    Source: 43 FR 45266, Sept. 29, 1978, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  456.1  Basis and purpose of part.

    (a) This part prescribes requirements concerning control of the 
utilization of Medicaid services including--
    (1) A statewide program of control of the utilization of all 
Medicaid services; and
    (2) Specific requirements for the control of the utilization of 
Medicaid services in institutions.
    (3) Specific requirements for an outpatient drug use review program.
    (b) The requirements in this part are based on the following 
sections of the Act. Table 1 shows the relationship between these 
sections of the Act and the requirements in this part.
    (1) Methods and procedures to safeguard against unnecessary 
utilization of care and services. Section 1902(a)(30) requires that the 
State plan provide methods and procedures to safeguard against 
unnecessary utilization of care and services.
    (2) Penalty for failure to have an effective program to control 
utilization of institutional services. Section 1903(g)(1) provides for a 
reduction in the amount of Federal Medicaid funds paid to a State for 
long-stay inpatient services if the State does not make a showing 
satisfactory to the Secretary that it has an effective program of 
control over utilization of those services. This penalty provision 
applies to inpatient services in hospitals, mental hospitals, and 
intermediate care facilities (ICF's). Specific requirements are:
    (i) Under section 1903(g)(1)(A), a physician must certify at 
admission, and a physician (or physician assistant or nurse practitioner 
under the supervision of a physician) must periodically recertify, the 
individual's need for inpatient care.
    (ii) Under section 1903(g)(1)(B), services must be furnished under a 
plan established and periodically evaluated by a physician.
    (iii) Under section 1903(g)(1)(C), the State must have in effect a 
continuous program of review of utilization of care and services under 
section 1902(a)(30) whereby each admission is reviewed or screened in 
accordance with criteria established by medical and other professional 
personnel.
    (iv) Under section 1903(g)(1)(D), the State must have an effective 
program under sections 1902(a) (26) and (31) of review of care in 
intermediate care facilities and mental hospitals. This must include 
evaluation at least annually of the professional management of each 
case.
    (3) Medical review in mental hospitals. Section 1902(a)(26)(A) 
requires that the plan provide for a program of medical review that 
includes a medical evaluation of each individual's need for care in a 
mental hospital, a plan of care, and, where applicable, a plan of 
rehabilitation.
    (4) Independent professional review in intermediate care facilities. 
Section 1902(a)(31)(A) requires that the plan provide for a program of 
independent professional review that includes a medical evaluation of 
each individual's need for intermediate care and a written plan of 
service.
    (5) Inspection of care and services in institutions. Sections 
1902(a)(26) (B) and (C) and 1902(a)(31) (B) and (C) require that the 
plan provide for periodic inspections and reports, by a team of 
professional persons, of the care being provided to each beneficiary in 
institutions for mental diseases (IMD's), and ICF's participating in 
Medicaid.
    (6) Denial of FFP for failure to have specified utilization review 
procedures. Section 1903(i)(4) provides that FFP is

[[Page 534]]

not available in a State's expenditures for hospital or mental hospital 
services unless the institution has in effect a utilization review plan 
that meets Medicare requirements. However, the Secretary may waive this 
requirement if the Medicaid agency demonstrates to his satisfaction that 
it has utilization review procedures superior in effectiveness to the 
Medicare procedures.
    (7) State health agency guidance on quality and appropriateness of 
care and services. Section 1902(a)(33)(A) requires that the plan provide 
that the State health or other appropriate medical agency establish a 
plan for review, by professional health personnel, of the 
appropriateness and quality of Medicaid services to provide guidance to 
the Medicaid agency and the State licensing agency in administering the 
Medicaid program.
    (8) Drug use review program. Section 1927(g) of the Act provides 
that, for payment to be made under section 1903 of the Act for covered 
outpatient drugs, the State must have in operation, by not later than 
January 1, 1993, a drug use review (DUR) program. It also requires that 
each State provide, either directly or through a contract with a private 
organization, for the establishment of a DUR Board.

                                 Table 1
 [This table relates the regulations in this part to the sections of the
                      Act on which they are based.]
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Subpart A--General........................  1902(a)(30)
                                            1902(a)(33)(A)
Subpart B--Utilization Control: All         1902(a)(30)
 Medicaid Services.
Subpart C--Utilization Control: Hospitals
  Certification of need for care..........  1903(g)(1)(A)
  Plan of care............................  1903(g)(1)(B)
  Utilization review plan (including        1902(a)(30)
   admission review).                       1903(g)(1)(C)
                                            1903(i)(4)
Subpart D--Utilization Control: Mental
 Hospitals
  Certification of need for care..........  1903(g)(1)(A)
  Medical evaluation and admission review.  1902(a)(26)(A)
                                            1903(g)(1)(C)
  Plan of care............................  1902(a)(26)(A)
                                            1903(g)(1)(B)
  Admission and plan of care requirements   1902(a)(26)(A)
   for individuals under 21.                1903(g)(1) (B), (C)
  Utilization review plan.................  1902(a)(30)
                                            1903(g)(1)(C)
                                            1903(i)(4)
Subpart F--Utilization Control:
 Intermediate Care Facilities
  Certification of need for care..........  1903(g)(1)(A)
  Medical evaluation and admission review.  1902(a)(31)(A)
                                            1903(g)(1)(C)
  Plan of care............................  1902(a)(31)(A)
                                            1903(g)(1)(B)
  Utilization review plan.................  1902(a)(30)
                                            1903(g)(1)(C)
                                            1903(i)(4)
Subpart G--Inpatient Psychiatric Services   1905 (a)(16) and (h)
 for Individuals Under Age 21: Admission
 and Plan of Care Requirements.
Subpart H--Utilization Review Plans: FFP,   ............................
 Waivers, and Variances for Hospitals and
 Mental Hospitals.
Subpart I--Inspections of Care in           ............................
 Intermediate Care Facilities and
 Institutions for Mental Diseases.
Subpart J--Penalty for Failure To Make a    1903(g)
 Satisfactory Showing of An Effective
 Institutional Utilization Control Program.
Subpart K--Drug Use Review (DUR) Program    1927(g) and (h)
 and Electronic Claims Management System
 for Outpatient Drug Claims.
------------------------------------------------------------------------


[43 FR 45266, Sept. 29, 1978, as amended at 46 FR 48561, Oct. 1, 1981; 
57 FR 49408, Nov. 2, 1992; 61 FR 38398, July 24, 1996]



Sec.  456.2  State plan requirements.

    (a) A State plan must provide that the requirements of this part are 
met.
    (b) These requirements may be met by the agency by:
    (1) Assuming direct responsibility for assuring that the 
requirements of this part are met; or
    (2) Deeming of medical and utilization review requirements if the 
agency contracts with a QIO to perform that review, which in the case of 
inpatient acute care review will also serve as the initial determination 
for QIO medical necessity and appropriateness review for patients who 
are dually entitled to benefits under Medicare and Medicaid.
    (c) In accordance with Sec.  431.15 of this subchapter, FFP will be 
available for expenses incurred in meeting the requirements of this 
part.

[46 FR 48566, Oct. 1, 1981, as amended at 50 FR 15327, Apr. 17, 1985; 51 
FR 43198, Dec. 1, 1986]



Sec.  456.3  Statewide surveillance and utilization control program.

    The Medicaid agency must implement a statewide surveillance and 
utilization control program that--

[[Page 535]]

    (a) Safeguards against unnecessary or inappropriate use of Medicaid 
services and against excess payments;
    (b) Assesses the quality of those services;
    (c) Provides for the control of the utilization of all services 
provided under the plan in accordance with subpart B of this part; and
    (d) Provides for the control of the utilization of inpatient 
services in accordance with subparts C through I of this part.



Sec.  456.4  Responsibility for monitoring the utilization control
program.

    (a) The agency must--
    (1) Monitor the statewide utilization control program;
    (2) Take all necessary corrective action to ensure the effectiveness 
of the program;
    (3) Establish methods and procedures to implement this section;
    (4) Keep copies of these methods and procedures on file; and
    (5) Give copies of these methods and procedures to all staff 
involved in carrying out the utilization control program.



Sec.  456.5  Evaluation criteria.

    The agency must establish and use written criteria for evaluating 
the appropriateness and quality of Medicaid services. This section does 
not apply to services in hospitals and mental hospitals. For these 
facilities, see the following sections: Sec. Sec.  456.122 and 456.132 
of subpart C; and Sec.  456.232 of subpart D.

[43 FR 45266, Sept. 29, 1978, as amended at 61 FR 38399, July 24, 1996]



Sec.  456.6  Review by State medical agency of appropriateness and quality
of services.

    (a) The Medicaid agency must have an agreement with the State health 
agency or other appropriate State medical agency, under which the health 
or medical agency is responsible for establishing a plan for the review 
by professional health personnel of the appropriateness and quality of 
Medicaid services.
    (b) The purpose of this review plan is to provide guidance to the 
Medicaid agency in the administration of the State plan and, where 
applicable, to the State licensing agency described in Sec.  431.610.



          Subpart B_Utilization Control: All Medicaid Services



Sec.  456.21  Scope.

    This subpart prescribes utilization control requirements applicable 
to all services provided under a State plan.



Sec.  456.22  Sample basis evaluation of services.

    To promote the most effective and appropriate use of available 
services and facilities the Medicaid agency must have procedures for the 
on-going evaluation, on a sample basis, of the need for and the quality 
and timeliness of Medicaid services.



Sec.  456.23  Post-payment review process.

    The agency must have a post-payment review process that--
    (a) Allows State personnel to develop and review--
    (1) Beneficiary utilization profiles;
    (2) Provider service profiles; and
    (3) Exceptions criteria; and
    (b) Identifies exceptions so that the agency can correct 
misutilization practices of beneficiaries and providers.



                Subpart C_Utilization Control: Hospitals



Sec.  456.50  Scope.

    This subpart prescribes requirements for control of utilization of 
inpatient hospital services, including requirements concerning--
    (a) Certification of need for care;
    (b) Plan of care; and
    (c) Utilization review plans.



Sec.  456.51  Definitions.

    As used in this subpart:
    Inpatient hospital services--
    (a) Include--
    (1) Services provided in an institution other than an institution 
for mental disease, as defined in Sec.  440.10;
    (2) [Reserved]
    (3) Services provided in specialty hospitals and

[[Page 536]]

    (b) Exclude services provided in mental hospitals. Utilization 
control requirements for mental hospitals appear in subpart D.
    Medical care appraisal norms or norms means numerical or statistical 
measures of usually observed performance.
    Medical care criteria or criteria means predetermined elements 
against which aspects of the quality of a medical service may be 
compared. These criteria are developed by health professionals relying 
on their expertise and the professional health care literature.

[43 FR 45266, Sept. 29, 1978, as amended at 51 FR 22041, June 17, 1986]

                     Certification of Need for Care



Sec.  456.60  Certification and recertification of need for inpatient care.

    (a) Certification. (1) A physician must certify for each applicant 
or beneficiary that inpatient services in a hospital are or were needed.
    (2) The certification must be made at the time of admission or, if 
an individual applies for assistance while in a hospital, before the 
Medicaid agency authorizes payment.
    (b) Recertification. (1) A physician, or physician assistant or 
nurse practitioner (as defined in Sec.  491.2 of this chapter) acting 
within the scope of practice as defined by State law and under the 
supervision of a physician, must recertify for each applicant or 
beneficiary that inpatient services in a hospital are needed.
    (2) Recertifications must be made at least every 60 days after 
certification.

[46 FR 48561, Oct. 1, 1981]

                              Plan of Care



Sec.  456.80  Individual written plan of care.

    (a) Before admission to a hospital or before authorization for 
payment, a physician and other personnel involved in the care of the 
individual must establish a written plan of care for each applicant or 
beneficiary.
    (b) The plan of care must include--
    (1) Diagnoses, symptoms, complaints, and complications indicating 
the need for admission;
    (2) A description of the functional level of the individual;
    (3) Any orders for--
    (i) Medications;
    (ii) Treatments;
    (iii) Restorative and rehabilitative services;
    (iv) Activities;
    (v) Social services;
    (vi) Diet;
    (4) Plans for continuing care, as appropriate; and
    (5) Plans for discharge, as appropriate.
    (c) Orders and activities must be developed in accordance with 
physician's instructions.
    (d) Orders and activities must be reviewed and revised as 
appropriate by all personnel involved in the care of an individual.
    (e) A physician and other personnel involved in the beneficiary's 
case must review each plan of care at least every 60 days.

            Utilization Review (UR) Plan: General Requirement



Sec.  456.100  Scope.

    Sections 456.101 through 456.145 of this subpart prescribe 
requirements for a written utilization review (UR) plan for each 
hospital providing Medicaid services. Sections 456.105 and 456.106 
prescribe administrative requirements: Sec. Sec.  456.111 through 
456.113 prescribe informational requirements; Sec. Sec.  456.121 through 
456.129 prescribe requirements for admission review; Sec. Sec.  456.131 
through 456.137 prescribe requirements for continued stay review; and 
Sec. Sec.  456.141 through 456.145 prescribe requirements for medical 
care evaluation studies.



Sec.  456.101  UR plan required for inpatient hospital services.

    (a) A State plan must provide that each hospital furnishing 
inpatient services under the plan has in effect a written UR plan that 
provides for review of each beneficiary's need for the services that the 
hospital furnishes him.
    (b) Each written hospital UR plan must meet the requirements under 
Sec. Sec.  456.101 through 456.145.

                  UR Plan: Administrative Requirements



Sec.  456.105  UR committee required.

    The UR plan must--

[[Page 537]]

    (a) Provide for a committee to perform UR required under this 
subpart;
    (b) Describe the organization, composition, and functions of this 
committee; and
    (c) Specify the frequency of meetings of the committee.



Sec.  456.106  Organization and composition of UR committee;
disqualification from UR committee membership.

    (a) For the purpose of this subpart, ``UR committee'' includes any 
group organized under paragraphs (b) and (c) of this section.
    (b) The UR committee must be composed of two or more physicians, and 
assisted by other professional personnel.
    (c) The UR committee must be constituted as--
    (1) A committee of the hospital staff;
    (2) A group outside the hospital staff, established by the local 
medical or osteopathic society and at least some of the hospitals and 
SNFs in the locality;
    (3) A group capable of performing utilization review, established 
and organized in a manner approved by the Secretary.
    (d) The UR committee may not include any individual who--
    (1) Is directly responsible for the care of the patient whose care 
is being reviewed; or
    (2) Has a financial interest in any hospital.

                   UR Plan: Informational Requirements



Sec.  456.111  Beneficiary information required for UR.

    The UR plan must provide that each beneficiary's record includes 
information needed for the UR committee to perform UR required under 
this subpart. This information must include, at least, the following:
    (a) Identification of the beneficiary.
    (b) The name of the beneficiary's physician.
    (c) Date of admission, and dates of application for and 
authorization of Medicaid benefits if application is made after 
admission.
    (d) The plan of care required under Sec.  456.70.
    (e) Initial and subsequent continued stay review dates described 
under Sec. Sec.  456.128 and 456.133.
    (f) Date of operating room reservation, if applicable.
    (g) Justification of emergency admission, if applicable.
    (h) Reasons and plan for continued stay, if the attending physician 
believes continued stay is necessary.
    (i) Other supporting material that the committee believes 
appropriate to be included in the record.



Sec.  456.112  Records and reports.

    The UR plan must describe--
    (a) The types of records that are kept by the committee; and
    (b) The type and frequency of committee reports and arrangements for 
their distribution to appropriate individuals.



Sec.  456.113  Confidentiality.

    The UR plan must provide that the identities of individual 
beneficiaries in all UR records and reports are kept confidential.

                UR Plan: Review of Need for Admission \1\
---------------------------------------------------------------------------

    \1\ The Department was enjoined in 1975 in the case of American 
Medical Assn. et al. v. Weinberger, 395 F. Supp. 515 (N.D. Ill., 1975), 
aff'd., 522 F2d 921 (7th cir., 1975) from implementing the admission 
review requirements contained in Sec. Sec.  456.121-456.127. This case 
was dismissed on the condition that these requirements be revised. They 
are presently being revised, and will not be in force until that 
revision is completed.
---------------------------------------------------------------------------



Sec.  456.121  Admission review required.

    The UR plan must provide for a review of each beneficiary's 
admission to the hospital to decide whether it is needed, in accordance 
with the requirements of Sec. Sec.  456.122 through 456.129.



Sec.  456.122  Evaluation criteria for admission review.

    The UR plan must provide that--
    (a) The committee develops written medical care criteria to assess 
the need for admission; and
    (b) The committee develops more extensive written criteria for cases 
that its experience shows are--
    (1) Associated with high costs;

[[Page 538]]

    (2) Associated with the frequent furnishing of excessive services; 
or
    (3) Attended by physicians whose patterns of care are frequently 
found to be questionable.



Sec.  456.123  Admission review process.

    The UR plan must provide that--
    (a) Admission review is conducted by--
    (1) The UR committee;
    (2) A subgroup of the UR committee; or
    (3) A designee of the UR committee;
    (b) The committee, subgroup, or designee evaluates the admission 
against the criteria developed under Sec.  456.122 and applies close 
professional scrutiny to cases selected under Sec.  456.129(b);
    (c) If the committee, subgroup, or designee finds that the admission 
is needed, the committee assigns an initial continued stay review date 
in accordance with Sec.  456.128;
    (d) If the committee, subgroup, or designee finds that the admission 
does not meet the criteria, the committee or a subgroup that includes at 
least one physician reviews the case to decide the need for admission;
    (e) If the committee or subgroup making the review under paragraph 
(d) of this section finds that the admission is not needed, it notifies 
the beneficiary's attending physician and gives him an opportunity to 
present his views before it makes a final decision on the need for the 
continued stay;
    (f) If the attending physician does not present additional 
information or clarification of the need for the admission, the decision 
of the committee or subgroup is final; and
    (g) If the attending physician presents additional information or 
clarification, at least two physician members of the committee review 
the need for the admission. If they find that the admission is not 
needed, their decision if final.



Sec.  456.124  Notification of adverse decision.

    The UR plan must provide that written notice of any adverse final 
decision on the need for admission under Sec.  456.123 (e) through (g) 
is sent to--
    (a) The hospital administrator;
    (b) The attending physician;
    (c) The Medicaid agency;
    (d) The beneficiary; and
    (e) If possible, the next of kin or sponsor.



Sec.  456.125  Time limits for admission review.

    Except as required under Sec.  456.127, the UR plan must provide 
that review of each beneficiary's admission to the hospital is 
conducted--
    (a) Within one working day after admission, for an individual who is 
receiving Medicaid at that time; or
    (b) Within one working day after the hospital is notified of the 
application for Medicaid, for an individual who applies while in the 
hospital.



Sec.  456.126  Time limits for final decision and notification of adverse
decision.

    Except as required under Sec.  456.127, the UR plan must provide 
that the committee makes a final decision on a beneficiary's need for 
admission and gives notice of an adverse final decision--
    (a) Within two working days after admission, for an individual who 
is receiving Medicaid at that time; or
    (b) Within two working days after the hospital is notified of the 
application for Medicaid, for an individual who applies while in the 
hospital.



Sec.  456.127  Pre-admission review.

    The UR plan must provide for review and final decision prior to 
admission for certain providers or categories of admissions that the UR 
committee designates under Sec.  456.142(b) (4)(iii) to receive pre-
admission review.



Sec.  456.128  Initial continued stay review date.

    The UR plan must provide that--
    (a) When a beneficiary is admitted to the hospital under the 
admission review requirements of this subpart, the committee assigns a 
specified date by which the need for his continued stay will be 
reviewed;
    (b) The committee bases its assignment of the initial continued stay 
review date on--
    (1) The methods and criteria required to be described under Sec.  
456.129;
    (2) The individual's condition; and

[[Page 539]]

    (3) The individual's projected discharge date;
    (c)(1) The committee uses any available appropriate regional medical 
care appraisal norms, such as those developed by abstracting services or 
third party payors, to assign the initial continued stay review date;
    (2) These regional norms are based on current and statistically 
valid data on duration of stay in hospitals for patients whose 
characteristics, such as age and diagnosis, are similar to those of the 
individual whose case is being reviewed;
    (3) If the committee uses norms to assign the initial continued stay 
review date, the number of days between the individual's admission and 
the initial continued stay review date is no greater than the number of 
days reflected in the 50th percentile of the norms. However, the 
committee may assign a later review date if it documents that the later 
date is more appropriate; and
    (d) The committee ensures that the initial continued stay review 
date is recorded in the individual's record.



Sec.  456.129  Description of methods and criteria: Initial continued
stay review date; close professional scrutiny; length of stay modification.

    The UR plan must describe--
    (a) The methods and criteria, including norms if used, that the 
committee uses to assign the initial continued stay review date under 
Sec.  456.128.
    (b) The methods that the committee uses to select categories of 
admission to receive close professional scrutiny under Sec.  456.123(b); 
and
    (c) The methods that the committee uses to modify an approved length 
of stay when the beneficiary's condition or treatment schedule changes.

               UR Plan: Review of Need for Continued Stay



Sec.  456.131  Continued stay review required.

    The UR plan must provide for a review of each beneficiary's 
continued stay in the hospital to decide whether it is needed, in 
accordance with the requirements of Sec. Sec.  456.132 through 456.137.



Sec.  456.132  Evaluation criteria for continued stay.

    The UR plan must provide that--
    (a) The committee develops written medical care criteria to assess 
the need for continued stay.
    (b) The committee develops more extensive written criteria for cases 
that its experience shows are--
    (1) Associated with high costs;
    (2) Associated with the frequent furnishing of excessive services; 
or
    (3) Attended by physicians whose patterns of care are frequently 
found to be questionable.



Sec.  456.133  Subsequent continued stay review dates.

    The UR plan must provide that--
    (a) The committee assigns subsequent continued stay review dates in 
accordance with Sec. Sec.  456.128 and 456.134(a);
    (b) The committee assigns a subsequent review date each time it 
decides under Sec.  456.135 that the continued stay is needed; and
    (c) The committee ensures that each continued stay review date it 
assigns is recorded in the beneficiary's record.



Sec.  456.134  Description of methods and criteria: Subsequent continued
stay review dates; length of stay modification.

    The UR plan must describe--
    (a) The methods and criteria, including norms if used, that the 
committee uses to assign subsequent continued stay review dates under 
Sec.  456.133; and
    (b) The methods that the committee uses to modify an approved length 
of stay when the beneficiary's condition or treatment schedule changes.



Sec.  456.135  Continued stay review process.

    The UR plan must provide that--
    (a) Review of continued stay cases is conducted by--
    (1) The UR committee;
    (2) A subgroup of the UR committee; or
    (3) A designee of the UR committee;
    (b) The committee, subgroup or designee reviews a beneficiary's 
continued stay on or before the expiration of each assigned continued 
stay review date;
    (c) For each continued stay of a beneficiary in the hospital, the 
committee,

[[Page 540]]

subgroup or designee reviews and evaluates the documentation described 
under Sec.  456.111 against the criteria developed under Sec.  456.132 
and applies close professional scrutiny to cases selected under Sec.  
456.129(b);
    (d) If the committee, subgroup, or designee finds that a 
beneficiary's continued stay in the hospital is needed, the committee 
assigns a new continued stay review date in accordance with Sec.  
456.133;
    (e) If the committee, subgroup, or designee finds that a continued 
stay case does not meet the criteria, the committee or a subgroup that 
includes at least one physician reviews the case to decide the need for 
continued stay;
    (f) If the committee or subgroup making the review under paragraph 
(e) of this section finds that a continued stay is not needed, it 
notifies the beneficiary's attending physician and gives him an 
opportunity to present his reviews before it makes a final decision on 
the need for the continued stay;
    (g) If the attending physician does not present additional 
information or clarification of the need for the continued stay, the 
decision of the committee or subgroup is final; and
    (h) If the attending physician presents additional information or 
clarification, at least two physician members of the committee review 
the need for the continued stay. If they find that the beneficiary no 
longer needs inpatient hospital services, their decision is final.



Sec.  456.136  Notification of adverse decision.

    The UR plan must provide that written notice of any adverse final 
decision on the need for continued stay under Sec.  456.135 (f) through 
(h) is sent to--
    (a) The hospital administrator;
    (b) The attending physician;
    (c) The Medicaid agency;
    (d) The beneficiary; and
    (e) If possible, the next of kin or sponsor.



Sec.  456.137  Time limits for final decision and notification of adverse
decision.

    The UR plan must provide that--
    (a) The committee makes a final decision on a beneficiary's need for 
continued stay and gives notice under Sec.  456.136 of an adverse final 
decision within 2 working days after the assigned continued stay review 
dates, except as required under paragraph (b) of this section.
    (b) If the committee makes an adverse final decision on a 
beneficiary's need for continued stay before the assigned review date, 
the committee gives notice under Sec.  456.136 within 2 working days 
after the date of the final decision.

                UR Plan: Medical Care Evaluation Studies



Sec.  456.141  Purpose and general description.

    (a) The purpose of medical care evaluation studies is to promote the 
most effective and efficient use of available health facilities and 
services consistent with patient needs and professionally recognized 
standards of health care.
    (b) Medical care evaluation studies--
    (1) Emphasize identification and analysis of patterns of patient 
care; and
    (2) Suggest appropriate changes needed to maintain consistently high 
quality patient care and effective and efficient use of services.



Sec.  456.142  UR plan requirements for medical care evaluation studies.

    (a) The UR plan must describe the methods that the committee uses to 
select and conduct medical care evaluation studies under paragraph 
(b)(1) of this section.
    (b) The UR plan must provide that the UR committee--
    (1) Determines the methods to be used in selecting and conducting 
medical care evaluation studies in the hospital;
    (2) Documents for each study--
    (i) Its results; and
    (ii) How the results have been used to make changes to improve the 
quality of care and promote more effective and efficient use of 
facilities and services;
    (3) Analyzes its findings for each study; and
    (4) Takes action as needed to--
    (i) Correct or investigate further any deficiencies or problems in 
the review

[[Page 541]]

process for admissions or continued stay cases;
    (ii) Recommend more effective and efficient hospital care 
procedures; or
    (iii) Designate certain providers or categories of admissions for 
review prior to admission.



Sec.  456.143  Content of medical care evaluation studies.

    Each medical care evaluation study must--
    (a) Identify and analyze medical or administrative factors related 
to the hospital's patient care;
    (b) Include analysis of at least the following:
    (1) Admissions;
    (2) Durations of stay;
    (3) Ancillary services furnished, including drugs and biologicals;
    (4) Professional services performed in the hospital; and
    (c) If indicated, contain recommendations for changes beneficial to 
patients, staff, the hospital, and the community.



Sec.  456.144  Data sources for studies.

    Data that the committee uses to perform studies must be obtained 
from one or more of the following sources:
    (a) Medical records or other appropriate hospital data;
    (b) External organizations that compile statistics, design profiles, 
and produce other comparative data;
    (c) Cooperative endeavors with--
    (1) QIOs;
    (2) Fiscal agents;
    (3) Other service providers; or
    (4) Other appropriate agencies.

[43 FR 45266, Sept. 29, 1978, as amended at 51 FR 43198, Dec. 1, 1986]



Sec.  456.145  Number of studies required to be performed.

    The hospital must, at least, have one study in progress at any time 
and complete one study each calendar year.



             Subpart D_Utilization Control: Mental Hospitals



Sec.  456.150  Scope.

    This subpart prescribes requirements for control of utilization of 
inpatient services in mental hospitals, including requirements 
concerning--
    (a) Certification of need for care;
    (b) Medical evaluation and admission review;
    (c) Plan of care; and
    (d) Utilization review plans.



Sec.  456.151  Definitions.

    As used in this subpart:
    Medical care appraisal norms or norms means numerical or statistical 
measures of usually observed performance.
    Medical care criteria or criteria means predetermined elements 
against which aspects of the quality of a medical service may be 
compared. These criteria are developed by health professionals relying 
on their expertise and the professional health care literature.

                     Certification of Need for Care



Sec.  456.160  Certification and recertification of need for inpatient care.

    (a) Certification. (1) A physician must certify for each applicant 
or beneficiary that inpatient services in a mental hospital are or were 
needed.
    (2) The certification must be made at the time of admission or, if 
an individual applies for assistance while in a mental hospital, before 
the Medicaid agency authorizes payment.
    (b) Recertification. (1) A physician, or physician assistant or 
nurse practitioner (as defined in Sec.  491.2 of this chapter) acting 
within the scope of practice as defined by State law and under the 
supervision of a physician, must recertify for each applicant or 
beneficiary that inpatient services in a mental hospital are needed.
    (2) Recertification must be made at least every 60 days after 
certification.

[46 FR 48561, Oct. 1, 1981]

    Medical, Psychiatric, and Social Evaluations and Admission Review



Sec.  456.170  Medical, psychiatric, and social evaluations.

    (a) Before admission to a mental hospital or before authorization 
for payment, the attending physician or staff physician must make a 
medical evaluation of each applicant's or beneficiary's need for care in 
the hospital; and appropriate professional personnel must make a 
psychiatric and social evaluation.

[[Page 542]]

    (b) Each medical evaluation must include--
    (1) Diagnoses;
    (2) Summary of present medical findings;
    (3) Medical history;
    (4) Mental and physical functional capacity;
    (5) Prognoses; and
    (6) A recommendation by a physician concerning--
    (i) Admission to the mental hospital; or
    (ii) Continued care in the mental hospital for individuals who apply 
for Medicaid while in the mental hospital.



Sec.  456.171  [Reserved]

                              Plan of Care



Sec.  456.180  Individual written plan of care.

    (a) Before admission to a mental hospital or before authorization 
for payment, the attending physician or staff physician must establish a 
written plan of care for each applicant or beneficiary.
    (b) The plan of care must include--
    (1) Diagnoses, symptoms, complaints, and complications indicating 
the need for admission;
    (2) A description of the functional level of the individual;
    (3) Objectives;
    (4) Any orders for--
    (i) Medications;
    (ii) Treatments;
    (iii) Restorative and rehabilitative services;
    (iv) Activities;
    (v) Therapies;
    (vi) Social services;
    (vii) Diet; and
    (viii) Special procedures recommended for the health and safety of 
the patient;
    (5) Plans for continuing care, including review and modification to 
the plan of care; and
    (6) Plans for discharge.
    (c) The attending or staff physician and other personnel involved in 
the beneficiary's care must review each plan of care at least every 90 
days.



Sec.  456.181  Reports of evaluations and plans of care.

    A written report of each evaluation and plan of care must be entered 
in the applicant's or beneficiary's record--
    (a) At the time of admission; or
    (b) If the individual is already in the facility, immediately upon 
completion of the evaluation or plan.

           Utilization Review (UR) Plan: General Requirements



Sec.  456.200  Scope.

    Sections 456.201 through 456.245 of this subpart prescribe 
requirements for a written utilization review (UR) plan for each mental 
hospital providing Medicaid services. Sections 456.205 and 456.206 
prescribe administrative requirements; Sec. Sec.  456.211 through 
456.213 prescribe informational requirements; Sec. Sec.  456.231 through 
456.238 prescribe requirements for continued stay review; and Sec. Sec.  
456.241 through 456.245 prescribe requirements for medical care 
evaluation studies.



Sec.  456.201  UR plan required for inpatient mental hospital services.

    (a) The State plan must provide that each mental hospital furnishing 
inpatient services under the plan has in effect a written UR plan that 
provides for review of each beneficiary's need for the services that the 
mental hospital furnishes him.
    (b) Each written mental hospital UR plan must meet the requirements 
under Sec. Sec.  456.201 through 456.245.

                  UR Plan: Administrative Requirements



Sec.  456.205  UR committee required.

    The UR plan must--
    (a) Provide for a committee to perform UR required under this 
subpart;
    (b) Describe the organization, composition, and functions of this 
committee; and
    (c) Specify the frequency of meetings of the committee.

[[Page 543]]



Sec.  456.206  Organization and composition of UR committee;
disqualification from UR committee membership.

    (a) For the purpose of this subpart, ``UR committee'' includes any 
group organized under paragraphs (b) and (c) of this section.
    (b) The UR committee must be composed of two or more physicians, one 
of whom is knowledgeable in the diagnosis and treatment of mental 
diseases, and assisted by other professional personnel.
    (c) The UR committee must be constituted as--
    (1) A committee of the mental hospital staff;
    (2) A group outside the mental hospital staff, established by the 
local medical or osteopathic society and at least some of the hospitals 
and SNFs in the locality; or
    (3) A group capable of performing utilization review, established 
and organized in a manner approved by the Secretary.
    (d) The UR committee may not include any individual who--
    (1) Is directly responsible for the care of patients whose care is 
being reviewed; or
    (2) Has a financial interest in any mental hospital.

                   UR Plan: Informational Requirements



Sec.  456.211  Beneficiary information required for UR.

    The UR plan must provide that each beneficiary's record includes 
information needed to perform UR required under this subpart. This 
information must include, at least, the following:
    (a) Identification of the beneficiary.
    (b) The name of the beneficiary's physician.
    (c) Date of admission, and dates of application for and 
authorization of Medicaid benefits if application is made after 
admission.
    (d) The plan of care required under Sec.  456.172.
    (e) Initial and subsequent continued stay review dates described 
under Sec. Sec.  456.233 and 456.234.
    (f) Reasons and plan for continued stay, if the attending physician 
believes continued stay is necessary.
    (g) Other supporting material that the committee believes 
appropriate to be included in the record.



Sec.  456.212  Records and reports.

    The UR plan must describe--
    (a) The types of records that are kept by the committee; and
    (b) The type and frequency of committee reports and arrangements for 
their distribution to appropriate individuals.



Sec.  456.213  Confidentiality.

    The UR plan must provide that the identities of individual 
beneficiaries in all UR records and reports are kept confidential.

               UR Plan: Review of Need for Continued Stay



Sec.  456.231  Continued stay review required.

    The UR plan must provide for a review of each beneficiary's 
continued stay in the mental hospital to decide whether it is needed, in 
accordance with the requirements of Sec. Sec.  456.232 through 456.238.



Sec.  456.232  Evaluation criteria for continued stay.

    The UR plan must provide that--
    (a) The committee develops written medical care criteria to assess 
the need for continued stay.
    (b) The committee develops more extensive written criteria for cases 
that its experience shows are--
    (1) Associated with high costs;
    (2) Associated with the frequent furnishing of excessive services; 
or
    (3) Attended by physicians whose patterns of care are frequently 
found to be questionable.



Sec.  456.233  Initial continued stay review date.

    The UR plan must provide that--
    (a) When a beneficiary is admitted to the mental hospital under 
admission review requirements of this subpart, the committee assigns a 
specified date by which the need for his continued stay will be 
reviewed;

[[Page 544]]

    (b) If an individual applies for Medicaid while in the mental 
hospital, the committee assigns the initial continued stay review date 
within 1 working day after the mental hospital is notified of the 
application for Medicaid;
    (c) The committee bases its assignment of the initial continued stay 
review date on--
    (1) The methods and criteria required to be described under Sec.  
456.235(a);
    (2) The individual's condition; and
    (3) The individual's projected discharge date;
    (d)(1) The committee uses any available appropriate regional medical 
care appraisal norms, such as those developed by abstracting services or 
third party payors, to assign the initial continued stay review date;
    (2) These norms are based on current and statistically valid data on 
duration of stay in mental hospitals for patients whose characteristics, 
such as age and diagnosis, are similar to those of the individual whose 
need for continued stay is being reviewed;
    (3) If the committee uses norms to assign the initial continued stay 
review date, the number of days between the individual's admission and 
the initial continued stay review date is no greater than the number of 
days reflected in the 50th percentile of the norms. However, the 
committee may assign a later review date if it documents that the later 
date is more appropriate;
    (e) The initial continued stay review date is not in any case later 
than 30 days after admission of the individual or notice to the mental 
hospital of his application for Medicaid; and
    (f) The committee insures that the initial continued stay review 
date is recorded in the individual's record.



Sec.  456.234  Subsequent continued stay review dates.

    The UR plan must provide that--
    (a) The committee assigns subsequent continued stay review dates in 
accordance with Sec. Sec.  456.235(a) and 456.233;
    (b) The committee assigns a subsequent continued stay review date at 
least every 90 days each time it decides under Sec.  456.236 that the 
continued stay is needed; and
    (c) The committee insures that each continued stay review date it 
assigns is recorded in the beneficiary's record.



Sec.  456.235  Description of methods and criteria: Continued stay review
dates; length of stay modification.

    The UR plan must describe--
    (a) The methods and criteria, including norms if used, that the 
committee uses to assign initial and subsequent continued stay review 
dates under Sec. Sec.  456.233 and 456.234 of this subpart; and
    (b) The methods that the committee uses to modify an approved length 
of stay when the beneficiary's condition or treatment schedule changes.



Sec.  456.236  Continued stay review process.

    The UR plan must provide that--
    (a) Review of continued stay cases is conducted by--
    (1) The UR committee;
    (2) A subgroup of the UR committee; or
    (3) A designee of the UR committee;
    (b) The committee, subgroup or designee reviews a beneficiary's 
continued stay on or before the expiration of each assigned continued 
stay review date;
    (c) For each continued stay of a beneficiary in the mental hospital, 
the committee, subgroup or designee reviews and evaluates the 
documentation described under Sec.  456.211 against the criteria 
developed under Sec.  456.232 and applies close professional scrutiny to 
cases described under Sec.  456.232(b).
    (d) If the committee, subgroup or designee finds that a 
beneficiary's continued stay in the mental hospital is needed, the 
committee assigns a new continued stay review date in accordance with 
Sec.  456.234;
    (e) If the committee, subgroup or designee finds that a continued 
stay case does not meet the criteria, the committee or a subgroup that 
includes at least one physician reviews the case to decide the need for 
continued stay;
    (f) If the committee or subgroup making the review under paragraph 
(e) of this section finds that a continued stay is not needed, it 
notifies the beneficiary's attending or staff physician and gives him an 
opportunity to present his views before it makes a

[[Page 545]]

final decision on the need for the continued stay;
    (g) If the attending or staff physician does not present additional 
information or clarification of the need for the continued stay, the 
decision of the committee or subgroup is final; and
    (h) If the attending or staff physician presents additional 
information or clarification, at least two physician members of the 
committee, one of whom is knowledgeable in the treatment of mental 
diseases, review the need for the continued stay. If they find that the 
beneficiary no longer needs inpatient mental hospital services, their 
decision is final.



Sec.  456.237  Notification of adverse decision.

    The UR plan must provide that written notice of any adverse final 
decision on the need for continued stay under Sec.  456.236 (f) through 
(h) is sent to--
    (a) The hospital administrator;
    (b) The attending or staff physician;
    (c) The Medicaid agency;
    (d) The beneficiary; and
    (e) If possible, the next of kin or sponsor.



Sec.  456.238  Time limits for final decision and notification of adverse
decision.

    The UR plan must provide that--
    (a) The committee makes a final decision on a beneficiary's need for 
continued stay and gives notice under Sec.  456.237 of an adverse 
decision within 2 working days after the assigned continued stay review 
date, except as required under paragraph (b) of this section.
    (b) If the committee makes an adverse final decision on a 
beneficiary's need for continued stay before the assigned review date, 
the committee gives notice under Sec.  456.237 within 2 working days 
after the date of the final decision.

                UR Plan: Medical Care Evaluation Studies



Sec.  456.241  Purpose and general description.

    (a) The purpose of medical care evaluation studies is to promote the 
most effective and efficient use of available health facilities and 
services consistent with patient needs and professionally recognized 
standards of health care.
    (b) Medical care evaluation studies--
    (1) Emphasize identification and analysis of patterns of patient 
care; and
    (2) Suggest appropriate changes needed to maintain consistently high 
quality patient care and effective and efficient use of services.



Sec.  456.242  UR plan requirements for medical care evaluation studies.

    (a) The UR plan must describe the methods that the committee uses to 
select and conduct medical care evaluation studies under paragraph 
(b)(1) of this section.
    (b) The UR plan must provide that the UR committee--
    (1) Determines the methods to be used in selecting and conducting 
medical care evaluation studies in the mental hospital;
    (2) Documents for each study--
    (i) Its results; and
    (ii) How the results have been used to make changes to improve the 
quality of care and promote more effective and efficient use of 
facilities and services;
    (3) Analyzes its findings for each study; and
    (4) Takes action as needed to--
    (i) Correct or investigate further any deficiencies or problems in 
the review process; or
    (ii) Recommend more effective and efficient hospital care 
procedures.



Sec.  456.243  Content of medical care evaluation studies.

    Each medical care evaluation study must--
    (a) Identify and analyze medical or administrative factors related 
to the mental hospital's patient care;
    (b) Include analysis of at least the following:
    (1) Admissions.
    (2) Durations of stay.
    (3) Ancillary services furnished, including drugs and biologicals.
    (4) Professional services performed in the hospital; and
    (c) If indicated, contain recommendations for change beneficial to 
patients, staff, the hospital, and the community.

[[Page 546]]



Sec.  456.244  Data sources for studies.

    Data that the committee uses to perform studies must be obtained 
from one or more of the following sources:
    (a) Medical records or other appropriate hospital data.
    (b) External organizations that compile statistics, design profiles, 
and produce other comparative data.
    (c) Cooperative endeavors with--
    (1) QIOs;
    (2) Fiscal agents;
    (3) Other service providers; or
    (4) Other appropriate agencies.

[43 FR 45266, Sept. 29, 1978, as amended at 51 FR 43198, Dec. 1, 1986]



Sec.  456.245  Number of studies required to be performed.

    The mental hospital must, at least, have one study in progress at 
any time and complete one study each calendar year.

Subpart E [Reserved]



       Subpart F_Utilization Control: Intermediate Care Facilities



Sec.  456.350  Scope.

    This subpart prescribes requirements for control of utilization of 
intermediate care facility (ICF) services including requirements 
concerning--
    (a) Certification of need for care;
    (b) Medical evaluation and admission review;
    (c) Plan of care; and
    (d) Utilization review plans.



Sec.  456.351  Definition.

    As used in this subpart:
    Intermediate care facility services means those items and services 
furnished in an intermediate care facility as defined in Sec. Sec.  
440.140 and 440.150 of this subchapter, but excludes those services if 
they are provided in religious nonmedical institutions as defined in 
Sec.  440.170(b) of this chapter.

[43 FR 45266, Sept. 29, 1978, as amended at 64 FR 67052, Nov. 30, 1999]

                     Certification of Need for Care



Sec.  456.360  Certification and recertification of need for inpatient
care.

    (a) Certification. (1) A physician must certify for each applicant 
or beneficiary that ICF services are or were needed.
    (2) The certification must be made at the time of admission or, if 
an individual applies for assistance while in an ICF, before the 
Medicaid agency authorizes payment.
    (b) Recertification. (1) A physician, or physician assistant or 
nurse practitioner (as defined in Sec.  491.2 of this chapter) acting 
within the scope of practice as defined by State law and under the 
supervision of a physician, must recertify for each applicant or 
beneficiary that ICF services are needed.
    (2) Recertification must be made at least--
    (i) Every 12 months after certification in an institution for 
Individuals with Intellectual Disabilities or persons with related 
conditions; and
    (ii) Every 60 days after certification in an ICF other than an 
institution for Individuals with Intellectual Disabilities or persons 
with related conditions.

[46 FR 48561, Oct. 1, 1981, as amended at 50 FR 33034, Aug. 16, 1985]

   Medical, Psychological, and Social Evaluations and Admission Review



Sec.  456.370  Medical, psychological, and social evaluations.

    (a) Before admission to an ICF or before authorization for payment, 
an interdisciplinary team of health professionals must make a 
comprehensive medical and social evaluation and, where appropriate, a 
psychological evaluation of each applicant's or beneficiary's need for 
care in the ICF.
    (b) In an institution for Individuals with Intellectual Disabilities 
or persons with related conditions, the team must also make a 
psychological evaluation of need for care. The psychological evaluation 
must be made before admission or authorization of payment, but not more 
than three months before admission.
    (c) Each evaluation must include--
    (1) Diagnoses;

[[Page 547]]

    (2) Summary of present medical, social, and where appropriate, 
developmental findings;
    (3) Medical and social family history;
    (4) Mental and physical functional capacity;
    (5) Prognoses;
    (6) Kinds of services needed;
    (7) Evaluation by an agency worker of the resources available in the 
home, family and community; and
    (8) A recommendation concerning--
    (i) Admission to the ICF; or
    (ii) Continued care in the ICF for individuals who apply for 
Medicaid while in the ICF.



Sec.  456.371  Exploration of alternative services.

    If the comprehensive evaluation recommends ICF services for an 
applicant or beneficiary whose needs could be met by alternative 
services that are currently unavailable, the facility must enter this 
fact in the beneficiary's record and begin to look for alternative 
services.



Sec.  456.372  Medicaid agency review of need for admission.

    Medical and other professional personnel of the Medicaid agency or 
its designees must evaluate each applicant's or beneficiary's need for 
admission by reviewing and assessing the evaluations required by Sec.  
456.370.

                              Plan of Care



Sec.  456.380  Individual written plan of care.

    (a) Before admission to an ICF or before authorization for payment, 
a physician must establish a written plan of care for each applicant or 
beneficiary.
    (b) The plan of care must include--
    (1) Diagnoses, symptoms, complaints, and complications indicating 
the need for admission;
    (2) A description of the functional level of the individual;
    (3) Objectives;
    (4) Any orders for--
    (i) Medications;
    (ii) Treatments;
    (iii) Restorative and rehabilitative services;
    (iv) Activities;
    (v) Therapies;
    (vi) Social services;
    (vii) Diet; and
    (viii) Special procedures designed to meet the objectives of the 
plan of care;
    (5) Plans for continuing care, including review and modification of 
the plan of care; and
    (6) Plans for discharge.
    (c) The team must review each plan of care at least every 90 days.



Sec.  456.381  Reports of evaluations and plans of care.

    A written report of each evaluation and plan of care must be entered 
in the applicant's or beneficiary's record--
    (a) At the time of admission; or
    (b) If the individual is already in the ICF, immediately upon 
completion of the evaluation or plan.

            Utilization Review (UR) Plan: General Requirement



Sec.  456.400  Scope.

    Sections 456.401 through 456.438 of this subpart prescribe 
requirements for a written utilization review (UR) plan for each ICF 
providing Medicaid services. Sections 456.405 through 456.407 prescribe 
administrative requirements; Sec. Sec.  456.411 through 456.413 
prescribe informational requirements; and Sec. Sec.  456.431 through 
456.438 prescribe requirements for continued stay review.



Sec.  456.401  State plan UR requirements and options; UR plan required 
for intermediate care facility services.

    (a) The State plan must provide that--
    (1) UR is performed for each ICF that furnishes inpatient services 
under the plan;
    (2) Each ICF has on file a written UR plan that provides for review 
of each beneficiary's need for the services that the ICF furnishes him; 
and
    (3) Each written ICF UR plan meets requirements under Sec. Sec.  
456.401 through 456.438.
    (b) The State plan must specify the method used to perform UR, which 
may be--
    (1) Review conducted by the facility;
    (2) Direct review in the facility by individuals--
    (i) Employed by the medical assistance unit of the Medicaid agency; 
or
    (ii) Under contract to the Medicaid agency; or

[[Page 548]]

    (3) Any other method.

                  UR Plan: Administrative Requirements



Sec.  456.405  Description of UR review function: How and when.

    The UR plan must include a written description of--
    (a) How UR is performed in the ICF; and
    (b) When UR is performed.



Sec.  456.406  Description of UR review function: Who performs UR; 
disqualification from performing UR.

    (a) The UR plan must include a written description of who performs 
UR in the ICF.
    (b) UR must be performed using a method specified under Sec.  
456.401(b) by a group of professional personnel that includes--
    (1) At least one physician;
    (2) In an ICF that cares primarily for mental patients, at least one 
individual knowledgeable in the treatment of mental diseases; and
    (3) In an institution for individuals with intellectual 
disabilities, a least one individual knowledgeable in the treatment of 
intellectual disability.
    (c) The group performing UR may not include any individual who--
    (1) Is directly responsible for the care of the beneficiary whose 
care is being reviewed;
    (2) Is employed by the ICF; or
    (3) Has a financial interest in any ICF.



Sec.  456.407  UR responsibilities of administrative staff.

    The UR plan must describe--
    (a) The UR support responsibilities of the ICF's administrative 
staff; and
    (b) Procedures used by the staff for taking needed corrective 
action.

                   UR Plan: Informational Requirements



Sec.  456.411  Beneficiary information required for UR.

    The UR plan must provide that each beneficiary's record include 
information needed to perform UR required under this subpart. This 
information must include, at least, the following:
    (a) Identification of the beneficiary.
    (b) The name of the beneficiary's physician.
    (c) The name of the qualified Intellectual Disability professional 
(as defined under Sec.  442.401 of this subchapter), if applicable.
    (d) Date of admission, and dates of application for and 
authorization of Medicaid benefits if application is made after 
admission.
    (e) The plan of care required under Sec.  456.372;
    (f) Initial and subsequent continued stay review dates described 
under Sec. Sec.  456.433 and 456.434.
    (g) Reasons and plan for continued stay, if the attending physician 
or qualified Intellectual Disability professional believes continued 
stay is necessary.
    (h) Other supporting material that the UR group believes appropriate 
to be included in the record.



Sec.  456.412  Records and reports.

    The UR plan must describe--
    (a) The types of records that are kept by the group performing UR; 
and
    (b) The type and frequency of reports made by the UR group, and 
arrangements for distribution of the reports to appropriate individuals.



Sec.  456.413  Confidentiality.

    The UR plan must provide that the identities of individual 
beneficiaries in all UR records and reports are kept confidential.

               UR Plan: Review of Need for Continued Stay



Sec.  456.431  Continued stay review required.

    (a) The UR plan must provide for a review of each beneficiaries 
continued stay in the ICF at least every 6 months to decide whether it 
is needed.
    (b) The UR plan requirement for continued stay review may be met 
by--
    (1) Reviews that are performed in accordance with the requirements 
of Sec. Sec.  456.432 through 456.437; or
    (2) Reviews that meet on-site inspection requirements under subpart 
I if--
    (i) The composition of the independent professional review team 
under subpart I meets the requirements of Sec.  456.406; and

[[Page 549]]

    (ii) Reviews are conducted as frequently as required under 
Sec. Sec.  456.433 and 456.434.



Sec.  456.432  Evaluation criteria for continued stay.

    The UR plan must provide that--
    (a) The group performing UR develops written criteria to assess the 
need for continued stay.
    (b) The group develops more extensive written criteria for cases 
that its experience shows are--
    (1) Associated with high costs;
    (2) Associated with the frequent furnishing of excessive services; 
or
    (3) Attended by physicians whose patterns of care are frequently 
found to be questionable.



Sec.  456.433  Initial continued stay review date.

    The UR plan must provide that--
    (a) When a beneficiary is admitted to the ICF under admission review 
requirements of this subpart, the group performing UR assigns a 
specified date by which the need for his continued stay will be 
reviewed;
    (b) The group performing UR bases its assignment of the initial 
continued stay review date on the methods and criteria required to be 
described under Sec.  456.435(a);
    (c) The initial continued stay review date is--
    (1) Not later than 6 months after admission; or
    (2) Earlier than 6 months after admission, if indicated at the time 
of admission; and
    (d) The group performing UR insures that the initial continued stay 
review date is recorded in the beneficiary's record.



Sec.  456.434  Subsequent continued stay review dates.

    The UR plan must provide that--
    (a) The group performing UR assigns subsequent continued stay review 
dates in accordance with Sec.  456.435.
    (b) The group assigns a subsequent continued stay review date each 
time it decides under Sec.  456.436 that the continued stay is needed--
    (1) At least every 6 months; or
    (2) More frequently than every six months if indicated at the time 
of continued stay review; and
    (c) The group insures that each continued stay review date it 
assigns is recorded in the beneficiary's record.



Sec.  456.435  Description of methods and criteria: Continued stay 
review dates.

    The UR plan must describe the methods and criteria that the group 
performing UR uses to assign initial and subsequent continued stay 
review dates under Sec. Sec.  456.433 and 456.434.



Sec.  456.436  Continued stay review process.

    The UR plan must provide that--
    (a) Review of continued stay cases is conducted by--
    (1) The group performing UR; or
    (2) A designee of the UR group;
    (b) The group or its designee reviews a beneficiary's continued stay 
on or before the expiration of each assigned continued stay review date.
    (c) For each continued stay of a beneficiary in the ICF, the group 
or its designee reviews and evaluates the documentation described under 
Sec.  456.411 against the criteria developed under Sec.  456.432 and 
applies close professional scrutiny to cases described under Sec.  
456.432(b);
    (d) If the group or its designee finds that a beneficiary's 
continued stay in the ICF is needed, the group assigns a new continued 
stay review date in accordance with Sec.  456.434;
    (e) If the group or its designee finds that a continued stay case 
does not meet the criteria, the group or a subgroup that includes at 
least one physician reviews the case to decide the need for continued 
stay;
    (f) If the group or subgroup making the review under paragraph (e) 
of this section finds that a continued stay is not needed, it notifies 
the beneficiary's attending physician or, in institutions for 
individuals with intellectual disabilities, the beneficiary's qualified 
Intellectual Disability professional, within 1 working day of its 
decision, and gives him 2 working days from the notification date to 
present his views before it makes a final decision on the need for the 
continued stay;

[[Page 550]]

    (g) If the attending physician or qualified Intellectual Disability 
professional does not present additional information or clarification of 
the need for the continued stay, the decision of the UR group is final;
    (h) If the attending physician or qualified Intellectual Disability 
professional presents additional information or clarification, the need 
for continued stay is reviewed by--
    (1) The physician member(s) of the UR group, in cases involving a 
medical determination; or
    (2) The UR group, in cases not involving a medical determination; 
and
    (i) If the individuals performing the review under paragraph (h) of 
this section find that the beneficiary no longer needs ICF services, 
their decision is final.



Sec.  456.437  Notification of adverse decision.

    The UR plan must provide that written notice of any adverse final 
decision on the need for continued stay under Sec.  456.436 (g) through 
(i) is sent to--
    (a) The ICF administrator;
    (b) The attending physician;
    (c) The qualified Intellectual Disability professional, if 
applicable;
    (d) The Medicaid agency;
    (e) The beneficiary; and
    (f) If possible, the next of kin or sponsor.



Sec.  456.438  Time limits for notification of adverse decision.

    The UR plan must provide that the group gives notice under Sec.  
456.437 of an adverse decision not later than 2 days after the date of 
the final decision.



 Subpart G_Inpatient Psychiatric Services for Individuals Under Age 21: 
                 Admission and Plan of Care Requirements



Sec.  456.480  Scope.

    This subpart concerns admission and plan of care requirements that 
apply to inpatient psychiatric services for individuals under age 21 in 
hospitals, mental hospitals, and intermediate care facilities.

[43 FR 45266, Sept. 29, 1978, as amended at 61 FR 38399, July 24, 1996]



Sec.  456.481  Admission certification and plan of care.

    If a facility provides inpatient psychiatric services to a 
beneficiary under age 21--
    (a) The admission certification by the review team required in Sec.  
441.152 satisfies the requirement for physician certification of need 
for care in Sec. Sec.  456.60, 456.160, and 456.360; and
    (b) The development and review of the plan of care required in Sec.  
441.154 satisfies the requirement for physician recertification of need 
for care in the sections cited in paragraph (a) and the requirement for 
establishment and periodic review of the plan of care in Sec. Sec.  
456.80, 456.180, and 456.380.
    (c) The plan of care must be established by the team described in 
Sec.  441.156.

[43 FR 45266, Sept. 29, 1978, as amended at 61 FR 38399, July 24, 1996]



Sec.  456.482  Medical, psychiatric, and social evaluations.

    If a facility provides inpatient psychiatric services to a 
beneficiary under age 21, the medical, psychiatric, and social 
evaluations required by Sec. Sec.  456.170, and 456.370 must be made by 
the team described in Sec.  441.153.

[43 FR 45266, Sept. 29, 1978, as amended at 61 FR 38399, July 24, 1996]



  Subpart H_Utilization Review Plans: FFP, Waivers, and Variances for 
                     Hospitals and Mental Hospitals



Sec.  456.500  Purpose.

    For hospitals and mental hospitals, this subpart--
    (a) Prescribes conditions for the availability of FFP relating to UR 
plans;
    (b) Prescribes conditions for granting a waiver of UR plan 
requirements; and
    (c) Prescribes conditions for granting a variance in UR plan 
requirements for remote facilities.

[43 FR 45266, Sept. 29, 1978, as amended at 61 FR 38399, July 24, 1996]

[[Page 551]]



Sec.  456.501  UR plans as a condition for FFP.

    (a) Except when waived under Sec. Sec.  456.505 through 456.508, FFP 
is not available in expenditures for Medicaid services furnished by a 
hospital or mental hospital unless the facility has in effect a UR plan 
that meets the utilization review requirements for Medicare under 
section 1861(k) of the Act.
    (b) A facility that participates in Medicare and Medicaid must use 
the same UR standards and procedures and review committee for Medicaid 
as it uses for Medicare.
    (c) A facility that does not participate in Medicare must meet the 
UR plan requirements in subpart C or D of this part, which are 
equivalent to the Medicare UR plan requirements in Sec. Sec.  405.1137, 
482.30, and 482.60 of this chapter.

[43 FR 45266, Sept. 29, 1978, as amended at 51 FR 22042, June 17, 1986; 
61 FR 38399, July 24, 1996]

                     UR Plan: Waiver of Requirements



Sec.  456.505  Applicability of waiver.

    The Administrator may waive the UR plan requirements of subparts C 
or D of this part, except for provisions relating to disqualification of 
UR committee members under Sec.  456.106 of subpart C, and Sec.  456.206 
of subpart D, if the Medicaid agency--
    (a) Applies for a waiver; and
    (b) Demonstrates to the Administrator's satisfaction that it has in 
operation specific UR procedures that are superior in their 
effectiveness to the UR plan requirements under subpart C or D of this 
part.

[43 FR 45266, Sept. 29, 1978, as amended at 61 FR 38399, July 24, 1996]



Sec.  456.506  Waiver options for Medicaid agency.

    (a) The agency may apply for a waiver at any time it has the 
procedures referred to under Sec.  456.505(b) in operation at least--
    (1) On a demonstration basis; or
    (2) In any part of the State.
    (b) Any hospital or mental hospital participating under the plan 
that is not covered by a waiver must continue to meet all the UR plan 
requirements under subpart C or D of this part.

[43 FR 45266, Sept. 29, 1978, as amended at 61 FR 38399, July 24, 1996]



Sec.  456.507  Review and granting of waiver requests.

    (a) When the agency applies for a waiver, the Administrator will 
assess the agency's UR procedures and grant the waiver if he determines 
that the procedures meet criteria he establishes.
    (b) The Administrator will review and evaluate each waiver between 1 
and 2 years after he has granted it and between 1 and 2 years 
periodically thereafter.



Sec.  456.508  Withdrawal of waiver.

    (a) The Administrator will withdraw a waiver if he determines that 
State procedures are no longer superior in their effectiveness to the 
procedures required for UR plans under subpart C or D of this part.
    (b) If a waiver is withdrawn by the Administrator, each hospital or 
mental hospital covered by the waiver must meet all the UR plan 
requirements under subpart C or D of this part.

[43 FR 45266, Sept. 29, 1978, as amended at 61 FR 38399, July 24, 1996]

        UR Plan: Remote Facility Variances from Time Requirements



Sec.  456.520  Definitions.

    As used in Sec. Sec.  456.521 through 456.525 of this subpart:
    Available physician or other professional personnel means an 
individual who--
    (a) Is professionally qualified;
    (b) Is not precluded from participating in UR under Sec.  456.107 of 
subpart C; or Sec.  456.207 of subpart D; and
    (c) Is not precluded from effective participation in UR because he 
requires more than approximately 1 hour to travel between the remote 
facility and his place of work.
    Remote facility means a facility located in an area that does not 
have enough available physicians or other professional personnel to 
perform UR as required under subparts C or D of this part, and for which 
the State requests a variance.

[[Page 552]]

    Variance means permission granted by the Administrator to the 
Medicaid agency for a specific remote facility to use time periods 
different from those specified for the start and completion of reviews 
of all cases under the following sections: Sec. Sec.  456.125, 456.126, 
456.136, and 456.137 of subpart C; and Sec.  456.238 of subpart D.

[43 FR 45266, Sept. 29, 1978, as amended at 61 FR 38399, July 24, 1996]



Sec.  456.521  Conditions for granting variance requests.

    (a) Except as described under paragraph (b) of this section, the 
administrator may grant a variance for a specific remote facility if the 
agency submits concurrently--
    (1) A request for the variance that documents to his satisfaction 
that the facility is unable to meet the time requirements for which the 
variance is requested; and
    (2) A revised UR plan for the facility.
    (b) The Administrator will not grant a variance if the remote 
facility is operating under a UR plan waiver that the Secretary has 
granted or is considering under Sec. Sec.  456.505 through 456.508.



Sec.  456.522  Content of request for variance.

    The agency's request for a variance must include--
    (a) The name, location, and type of the remote facility;
    (b) The number of total patient admissions and the average daily 
patient census at the facility in the 6 months preceding the request;
    (c) The number of Medicare and Medicaid patient admissions and the 
average daily Medicare and Medicaid patient census at the facility in 
the 6 months preceding the request;
    (d) The name and location of each hospital, mental hospital, and ICF 
located within a 50-mile radius of the facility;
    (e) The distance and average travel time between the remote facility 
and each facility listed in paragraph (e) of this section;
    (f) Documentation by the facility of its attempts to obtain the 
services of available physicians or other professional personnel, or 
both;
    (g) The names of all physicians on the active staff, and the names 
of all other professional personnel on the staff whose availability is 
relevant to the request;
    (h) The practice locations of available physicians and the estimated 
number of available professional personnel whose availability is 
relevant to the request;
    (i) Documentation by the facility of its inability to perform UR 
within the time requirements for which the variance is requested and its 
good faith efforts to comply with the UR plan requirements of subpart C 
or D of this part;
    (j) An assurance by the facility that it will continue its good 
faith efforts to meet the UR plan requirements of subpart C or D of this 
part; and
    (k) A statement of whether a planning or conditional PSRO exists in 
the area where the facility is located.

[43 FR 45266, Sept. 29, 1978, as amended at 61 FR 38399, July 24, 1996]



Sec.  456.523  Revised UR plan.

    (a) The revised UR plan for the remote facility must specify the 
methods and procedures that the facility will use if a variance is 
granted to insure that it--
    (1) Maintains effective and timely control over the utilization of 
services; and
    (2) Conducts reviews in a way that improves the quality of care 
provided to patients.
    (b) The revised UR plan for the remote facility is the basis for 
validation of UR under sec. 1903(g)(2) of the Act for the period when a 
variance is in effect.



Sec.  456.524  Notification of Administrator's action and duration of variance.

    (a) The Administrator--
    (1) Will notify the agency of the action he takes on its request for 
a variance; and
    (2) Will specify the period of time, not to exceed 1 year, for which 
the variance may be granted.
    (b) When it receives the Administrator's notification, the agency 
must promptly notify the remote facility of his action.

[[Page 553]]



Sec.  456.525  Request for renewal of variance.

    (a) The agency must submit a request for renewal of a variance to 
the Administrator at least 30 days before the variance expires.
    (b) The renewal request must contain the information required under 
Sec.  456.522.
    (c) The renewal request must show, to the Administrator's 
satisfaction, that the remote facility continues to meet the 
requirements of Sec. Sec.  456.521 through 456.523.



   Subpart I_Inspections of Care in Intermediate Care Facilities and 
                    Institutions for Mental Diseases



Sec.  456.600  Purpose.

    This subpart prescribes requirements for periodic inspections of 
care and services intermediate care facilities (ICF's), and institutions 
for mental diseases (IMD's).

[43 FR 45266, Sept. 29, 1978, as amended at 61 FR 38399, July 24, 1996]



Sec.  456.601  Definitions.

    For purposes of this subpart--
    Facility means an institution for mental diseases, or an 
intermediate care facility.
    Intermediate care facility includes institutions for Individuals 
with Intellectual Disabilities or persons with related conditions but 
excludes religious nonmedical institutions as defined in Sec.  
440.170(b) of this chapter.
    Institution for mental diseases includes a mental hospital, a 
psychiatric facility, and an intermediate care facility that primarily 
cares for mental patients.
    Psychiatric facility includes a facility or program that provides 
inpatient psychiatric services for individuals under 21, as specified in 
Sec.  441.151 of this chapter, but does not include psychiatric wards in 
acute care hospitals.

[44 FR 56337, Oct. 1, 1979, as amended at 61 FR 38399, July 24, 1996; 64 
FR 67052, Nov. 30, 1999]



Sec.  456.602  Inspection team.

    (a) A team, as described in this section and Sec.  456.603 must 
periodically inspect the care and services provided to beneficiaries in 
each facility.
    (b) Each team conducting periodic inspections must have a least one 
member who is at physician or registered nurse and other appropriate 
health and social service personnel.
    (c) For an IMD other than an ICF, each team must have a psychiatrist 
or physician knowledgeable about mental institutions and other 
appropriate mental health and social service personnel.
    (d) For an ICF that primarily cares for mental patients, each team 
must have at least one member who knows the problems and needs of 
mentally retarded individuals.
    (e) For an institution for Individuals with Intellectual 
Disabilities or persons with related conditions, each team must have at 
least one member who knows the problems and needs of mentally retarded 
individuals.
    (f) For ICFs primarily serving individuals 65 years of age or older, 
each team must have at least one member who knows the problems and needs 
of those individuals.
    (g) If there is no physician on the team, the Medicaid agency must 
insure that a physician is available to provide consultation to the 
team.
    (h) If a team has one or more physicians, it must be supervised by a 
physician.



Sec.  456.603  Financial interests and employment of team members.

    (a) Except as provided in paragraph (b) of this section--
    (1) [Reserved]
    (2) No member of a team that reviews care in an ICF may have a 
financial interest in or be employed by any ICF.
    (b) A member of a team that reviews care in an IMD or an institution 
for Individuals with Intellectual Disabilities or persons with related 
conditions--
    (1) May not have a financial interest in any institution of that 
same type but may have a financial interest in other facilities or 
institutions; and
    (2) May not review care in an institution where he is employed but 
may review care in any other facility or institution.

[43 FR 45266, Sept. 29, 1978, as amended at 61 FR 38399, July 24, 1996]

[[Page 554]]



Sec.  456.604  Physician team member inspecting care of beneficiaries.

    No physician member of a team may inspect the care of a beneficiary 
for whom he is the attending physician.



Sec.  456.605  Number and location of teams.

    There must be a sufficient number of teams so located within the 
State that onsite inspections can be made at appropriate intervals in 
each facility caring for beneficiaries.



Sec.  456.606  Frequency of inspections.

    The team and the agency must determine, based on the quality of care 
and services being provided in a facility and the condition of 
beneficiaries in the facility, at what intervals inspections will be 
made. However, the team must inspect the care and services provided to 
each beneficiary in the facility at least annually.



Sec.  456.607  Notification before inspection.

    No facility may be notified of the time of inspection more than 48 
hours before the scheduled arrival of the team.



Sec.  456.608  Personal contact with and observation of beneficiaries
and review of records.

    (a) For beneficiaries under age 21 in psychiatric facilities and 
beneficiaries in ICFs, other than those described in paragraph (b) of 
this section, the team's inspection must include--
    (1) Personal contact with and observation of each beneficiary; and
    (2) Review of each beneficiary's medical record.
    (b) For beneficiaries age 65 or older in IMDs, the team's inspection 
must include--
    (1) Review of each beneficiary's medical record; and
    (2) If the record does not contain complete reports of periodic 
assessments required by Sec.  441.102 of this subchapter or, if such 
reports are inadequate, personal contact with and observation of each 
beneficiary

[43 FR 45266, Sept. 29, 1978, as amended at 44 FR 17940, Mar. 23, 1979; 
61 FR 38399, July 24, 1996]



Sec.  456.609  Determinations by team.

    The team must determine in its inspection whether--
    (a) The services available in the facility are adequate to--
    (1) Meet the health needs of each beneficiary, and the 
rehabilitative and social needs of each beneficiary in an ICF; and
    (2) Promote his maximum physical, mental, and psychosocial 
functioning.
    (b) It is necessary and desirable for the beneficiary to remain in 
the facility;
    (c) It is feasible to meet the beneficiary's health needs and, in an 
ICF, the beneficiary's rehabilitative needs, through alternative 
institutional or noninstitutional services; and
    (d) Each beneficiary under age 21 in a psychiatric facility and each 
beneficiary in an institution for Individuals with Intellectual 
Disabilities or persons with related conditions is receiving active 
treatment as defined in Sec.  441.154 of this subchapter.



Sec.  456.610  Basis for determinations.

    In making the determinations on adequacy of services and related 
matters under Sec.  456.609 for each beneficiary, the team may consider 
such items as whether--
    (a) The medical evaluation, any required social and psychological 
evaluations, and the plan of care are complete and current; the plan of 
care and, where required, the plan of rehabilitation are followed; and 
all ordered services, including dietary orders, are provided and 
properly recorded;
    (b) The attending physician reviews prescribed medications--
    (1) At least every 30 days in psychiatric facilities, and mental 
hospitals; and
    (2) At least quarterly in ICFs;
    (c) Tests or observations of each beneficiary indicated by his 
medication regimen are made at appropriate times and properly recorded;
    (d) Physician, nurse, and other professional progress notes are made 
as required and appear to be consistent with the observed condition of 
the beneficiary;
    (e) The beneficiary receives adequate services, based on such 
observations as--

[[Page 555]]

    (1) Cleanliness;
    (2) Absence of bedsores;
    (3) Absence of signs of malnutrition or dehydration; and
    (4) Apparent maintenance of maximum physical, mental, and 
psychosocial funtion;
    (f) In an ICF, the beneficiary receives adequate rehabilitative 
services, as evidenced by--
    (1) A planned program of activities to prevent regression; and
    (2) Progress toward meeting objectives of the plan of care;
    (g) The beneficiary needs any service that is not furnished by the 
facility or through arrangements with others; and
    (h) The beneficiary needs continued placement in the facility or 
there is an appropriate plan to transfer the beneficiary to an alternate 
method of care.

[43 FR 45266, Sept. 29, 1978, as amended at 61 FR 38399, July 24, 1996]



Sec.  456.611  Reports on inspections.

    (a) The team must submit a report promptly to the agency on each 
inspection.
    (b) The report must contain the observations, conclusions, and 
recommendations of the team concerning--
    (1) The adequacy, appropriateness, and quality of all services 
provided in the facility or through other arrangements, including 
physician services to beneficiaries; and
    (2) Specific findings about individual beneficiaries in the 
facility.
    (c) The report must include the dates of the inspection and the 
names and qualifications of the members of the team.

[43 FR 45266, Sept. 29, 1978, as amended at 44 FR 56337, Oct. 1, 1979]



Sec.  456.612  Copies of reports.

    The agency must send a copy of each inspection report to--
    (a) The facility inspected;
    (b) The facility's utilization review committee;
    (c) The agency responsible for licensing, certification, or approval 
of the facility for purposes of Medicare and Medicaid; and
    (d) Other State agencies that use the information in the reports to 
perform their official function, including, if inspection reports 
concern IMD's, the appropriate State mental health authorities.



Sec.  456.613  Action on reports.

    The agency must take corrective action as needed based on the report 
and recommendations of the team submitted under this subpart.



Sec.  456.614  Inspections by utilization review committee.

    A utilization review committee under subparts C through F of this 
part may conduct the periodic inspections required by this subpart if--
    (a) The committee is not based in the facility being reviewed; and
    (b) The composition of the committee meets the requirements of this 
subpart.



   Subpart J_Penalty for Failure To Make a Satisfactory Showing of an 
           Effective Institutional Utilization Control Program

    Authority: Secs. 1102 and 1903(g) of the Social Security Act (42 
U.S.C. 1302 and 1396 b(g)).

    Source: 44 FR 56338, Oct. 1, 1979, unless otherwise noted.



Sec.  456.650  Basis, purpose and scope.

    (a) Basis. Section 1903(g) of the Act requires that FFP for long-
stay inpatient services at a level of care be reduced, by a specified 
formula, for any quarter in which a State fails to make a satisfactory 
showing that it has an effective program of utilization control for that 
level of care.
    (b) Purpose. This subpart specifies--
    (1) What States must do to make a satisfactory showing;
    (2) How the Administrator will determine whether reductions will be 
imposed; and
    (3) How the required reductions will be implemented.
    (c) Scope. The reductions required by this subpart do not apply to--
    (1) Services provided under a contract with a health maintenance 
organization; or

[[Page 556]]

    (2) Facilities in which a QIO is performing medical and utilization 
reviews under contract with the Medicaid agency in accordance with Sec.  
431.630 of this chapter.

[44 FR 56338, Oct. 1, 1979, as amended at 50 FR 15327, Apr. 17, 1985; 51 
FR 43198, Dec. 1, 1986]



Sec.  456.651  Definitions.

    For purposes of this subpart--
    Facility, with respect to inpatient psychiatric services for 
individuals under 21, includes a psychiatric program as specified in 
Sec.  441.151 of this chapter.
    Level of care means one of the following types of inpatient 
services: hospital, mental hospital, intermediate care facility, or 
psychiatric services for individuals under 21.
    Long-stay services means services provided to a beneficiary after a 
total of 60 days of inpatient stay (90 in the case of mental hospital 
services) during a 12-month period beginning July 1, not counting days 
of stay paid for wholly or in part by Medicare.

[43 FR 45266, Sept. 29, 1978, as amended at 61 FR 38399, July 24, 1996]



Sec.  456.652  Requirements for an effective utilization control program.

    (a) General requirements. In order to avoid a reduction in FFP, the 
Medicaid agency must make a satisfactory showing to the Administrator, 
in each quarter, that it has met the following requirements for each 
beneficiary:
    (1) Certification and recertification of the need for inpatient 
care, as specified in Sec. Sec.  456.60, 456.160, 456.360 and 456.481.
    (2) A plan of care established and periodically reviewed and 
evaluated by a physician, as specified in Sec. Sec.  456.80, 456.180, 
and 456.481.
    (3) A continuous program of utilization review under which the 
admission of each beneficiary is reviewed or screened in accordance with 
section 1903(g)(1)(C) of the Act; and
    (4) A regular program of reviews, including medical evaluations, and 
annual on-site reviews of the care of each beneficiary, as specified in 
Sec. Sec.  456.170, and 456.482 and subpart I of this part.
    (b) Annual on-site review requirements. (1) An agency meets the 
quarterly on-site review requirements of paragraph (a)(4) of this 
section for a quarter if it completes on-site reviews of each 
beneficiary in every facility in the State, and in every State-owned 
facility regardless of location, by the end of the quarter in which a 
review is required under paragraph (b)(2) of this section.
    (2) An on-site review is required in a facility by the end of a 
quarter if the facility entered the Medicaid program during the same 
calendar quarter 1 year earlier or has not been reviewed since the same 
calendar quarter 1 year earlier. If there is no Medicaid beneficiary in 
the facility on the day a review is scheduled, the review is not 
required until the next quarter in which there is a Medicaid beneficiary 
in the facility.
    (3) If a facility is not reviewed in the quarter in which it is 
required to be reviewed under paragraph (b)(2) of this section, it will 
continue to require a review in each subsequent quarter until the review 
is performed.
    (4) The requirement for an on-site review in a given quarter is not 
affected by the addition or deletion of a level of care in a facility's 
provider agreement.
    (c) Facilities without valid provider agreements. The requirements 
of paragraphs (a) and (b) of this section apply with respect to 
beneficiaries for whose care the agency intends to claim FFP even if the 
beneficiaries receive care in a facility whose provider agreement has 
expired or been terminated.

[44 FR 56338, Oct. 1, 1979, as amended at 46 FR 48561, Oct. 1, 1981; 61 
FR 38399, July 24, 1996]



Sec.  456.653  Acceptable reasons for not meeting requirements for 
annual on-site review.

    The Administrator will find an agency's showing satisfactory, even 
if it failed to meet the annual review requirements of Sec.  
456.652(a)(4), if--
    (a) The agency demonstrates that--
    (1) It completed reviews by the end of the quarter in at least 98 
percent of all facilities requiring review by the end of the quarter;
    (2) It completed reviews by the end of the quarter in all facilities 
with 200 or more certified Medicaid beds requiring review by the end of 
the quarter; and
    (3) With respect to all unreviewed facilities, the agency exercised 
good faith and due diligence by attempting

[[Page 557]]

to review those facilities and would have succeeded but for events 
beyond its control which it could not have reasonably anticipated; or
    (b) The agency demonstrates that it failed to meet the standard in 
paragraph (a) (1) and (2) of this section by the close of the quarter 
for technical reasons, but met the standard within 30 days after the 
close of the quarter. Technical reasons are circumstances within the 
agency's control.
    (c) Facilities that are reviewed under paragraph (b) of this 
section, after the quarter in which they were due for review, retain 
their original anniversary quarter due date for purposes of subsequent 
reviews.



Sec.  456.654  Requirements for content of showings and procedures
for submittal.

    (a) An agency's showing for a quarter must--
    (1) Include a certification by the agency that the requirements of 
Sec.  456.652(a) (1) through (4) were met during the quarter for each 
level of care or, if applicable, a certification of the reasons the 
annual on-site review requirements of Sec.  456.652(a)(4) were not met 
in any facilities;
    (2) For all mental hospitals, intermediate care facilities, and 
facilities providing inpatient psychiatric services for individuals 
under 21, participating in Medicaid any time during the 12-month period 
ending on the last day of the quarter, list each facility by level of 
care, name, address and provider number;
    (3) For each facility entering or leaving the program during the 12-
month period ending on the last day of the quarter, list the beginning 
or ending dates of the provider agreement and supply a copy of the 
provider agreement;
    (4) If review has been contracted to a QIO under Sec.  431.630 of 
this chapter, list the date the QIO contracted for review.
    (5) List all dates of on-site reviews completed by review teams 
anytime during the 12-month period ending on the last day of the 
quarter;
    (6) For all facilities in which an on-site review was required but 
not conducted, list the facility by name, address and provider number;
    (7) For each on-site review in a mental hospital, intermediate care 
facility that primarily cares for mental patients, or inpatient 
psychiatric facility, list the name and qualifications of one team 
member who is a physician; and
    (8) For each on-site review in an intermediate care facility that 
does not primarily care for mental patients, list the name and 
qualifications of one team member who is either a physician or 
registered nurse.
    (b) The quarterly showing must be in the form prescribed by the 
Administrator.
    (c) The quarterly showing must be postmarked or received within 30 
days after the close of the quarter for which it is made, unless the 
agency demonstrates good cause for later submittal and the showing is 
postmarked or received within 45 days after the close of the quarter. 
Good cause means unanticipated circumstances beyond the agency's 
control.

[44 FR 56338, Oct. 1, 1979, as amended at 50 FR 15327, Apr. 17, 1985; 51 
FR 43198, Dec. 1, 1986; 61 FR 38399, July 24, 1996]



Sec.  456.655  Validation of showings.

    (a) The Administrator will periodically validate showings submitted 
under Sec.  456.654. Validation procedures will include on-site sample 
surveys of institutions and surveys at the Medicaid agencies.
    (b) The Administrator will not find an agency's showing satisfactory 
if the information obtained through his validation procedures 
demonstrates, that any of the requirements of Sec.  456.652(a) (1) 
through (4) were not met during the quarter for which the showing was 
made.



Sec.  456.656  Reductions in FFP.

    (a) If the Administrator determines an agency's showing does not 
meet each of the requirements of this sub-part, he will give the agency 
30 days notice before making the required reduction.
    (b) If the Administrator determines that a showing for any quarter 
is unsatisfactory on its face, he will make the required reduction in 
the grant award based on the Quarterly Medicaid Statement of 
Expenditures for the

[[Page 558]]

Medical Assistance Program for that quarter. (This form CMS-64 is 
described in Sec.  430.30(c) of this chapter.)
    (c) If the Administrator finds a showing satisfactory on its face, 
but after validation determines the showing to be unsatisfactory, he 
will notify the agency of any required reduction in FFP no later than 
the first day of the fourth calendar quarter following the calendar 
quarter for which the showing was made. Any required reduction will be 
made by amending or adjusting the agency's grant award.
    (d) The agency may request reconsideration of a reduction in 
accordance with the procedures specified in 45 CFR part 16.



Sec.  456.657  Computation of reductions in FFP.

    (a) For each level of care specified in a provider agreement, and 
for each quarter for which a satisfactory showing is not made, the 
amount of the reduction in FFP is computed as follows:
    (1) For each level of care, the number of beneficiaries who received 
services in facilities that did not meet the requirements of this 
subpart is divided by the total number of beneficiaries who received 
services in facilities for which a showing was required under this 
subpart. If any of the requirements specified in Sec.  456.652(a)(1) 
through (4) were not met for any beneficiary in a facility, the 
reduction will be computed on the total number of beneficiaries in that 
facility at the level of care in question.
    (2) The fraction obtained in paragraph (a)(1) of this section is 
multiplied by one-third.
    (3) The product obtained in paragraph (a)(2) of this section is 
multiplied by the Federal Medical Assistance Percentage (FMAP).
    (4) The product obtained in paragraph (a)(3) of this section is 
multiplied by the agency payments for longstay services furnished during 
the quarter at that level of care.
    (b) If any of the data required to compute the amount of the 
reduction in FFP are unavailable, the Administrator will substitute an 
estimate. If the agency determines the exact data to the satisfaction of 
the Administrator, the estimate may later be adjusted. If the number of 
beneficiaries in individual facilities is not available, the fraction 
specified in paragraph (a)(1) of this section will be estimated, for 
each level of care, by dividing the number of facilities in which the 
requirements were not met by the total number of facilities for which a 
showing is required under this subpart.



Subpart K_Drug Use Review (DUR) Program and Electronic Claims Management 
                    System for Outpatient Drug Claims

    Source: 57 FR 49408, Nov. 2, 1992, unless otherwise noted.



Sec.  456.700  Scope.

    This subpart prescribes requirements for--
    (a) An outpatient DUR program that includes prospective drug review, 
retrospective drug use review, and an educational program;
    (b) The establishment, composition, and functions of a State DUR 
Board; and
    (c) An optional point-of-sale electronic claims management system 
for processing claims for covered outpatient drugs.



Sec.  456.702  Definitions.

    For purposes of this subpart--
    Abuse is defined as in Sec.  455.2 of this chapter.
    Adverse medical result means a clinically significant undesirable 
effect, experienced by a patient, due to a course of drug therapy.
    Appropriate and medically necessary means drug prescribing and 
dispensing that is in conformity with the predetermined standards 
established in accordance with Sec.  456.703.
    Criteria is defined as in Sec.  466.1 of this chapter.
    Fraud is defined as in Sec.  455.2 of this chapter.
    Gross overuse means repetitive overutilization without therapeutic 
benefit.
    Inappropriate and medically unnecessary means drug prescribing and 
dispensing not in conformity with the definition of appropriate and 
medically necessary.

[[Page 559]]

    Overutilization means use of a drug in a quantity, strength, or 
duration that is greater than necessary to achieve a desired therapeutic 
goal or that puts the beneficiary at risk of a clinically significant 
undesirable effect, or both.
    Predetermined standards means criteria and standards that have been 
established in accordance with the requirements of Sec.  456.703.
    Standards is defined as in Sec.  466.1 of this chapter.
    Underutilization means use of a drug by a beneficiary in 
insufficient quantity, strength, or duration to achieve a desired 
therapeutic goal or that puts the beneficiary at risk of a clinically 
significant undesired effect, or both.

[57 FR 49408, Nov. 2, 1992, as amended at 59 FR 48824, Sept. 23, 1994]



Sec.  456.703  Drug use review program.

    (a) General. Except as provided in paragraphs (b) and (c) of this 
section, in order for FFP to be paid or made available under section 
1903 of the Act for covered outpatient drugs, the State must have in 
operation, by not later than January 1, 1993, a DUR program consisting 
of prospective drug review, retrospective drug use review, and an 
educational program that meets the requirements of this subpart. The 
goal of the State's DUR program must be to ensure appropriate drug 
therapy, while permitting sufficient professional prerogatives to allow 
for individualized drug therapy.
    (b) Exception for drugs dispensed to certain nursing facility 
residents. Prospective drug review and retrospective drug use review 
(including interventions and education) under the DUR program are not 
required for drugs dispensed to residents of nursing facilities that are 
in compliance with the drug regimen review procedures set forth in part 
483 of this chapter. This does not preclude the State agency from making 
such drugs subject to prospective DUR or retrospective DUR or both, 
provided the State agency makes the drugs subject to all the 
requirements of this subpart applicable to the respective review.
    (c) Exemption for certain covered outpatient drugs dispensed by 
hospitals and health maintenance organizations. (1) The State plan must 
provide that covered outpatient drugs dispensed by a hospital using drug 
formulary systems and billed to the plan at no more than the hospital's 
purchasing costs are not subject to the requirements of this subpart. 
Individual hospitals requesting this exemption must provide assurances 
to the State agency that they meet the requirements specified in section 
1927(j)(2) of the Act.
    (2) The State plan must provide that covered outpatient drugs 
dispensed by health maintenance organizations are not subject to the 
requirements of this subpart.
    (d) Use of predetermined standards. A DUR program must assess drug 
use information against predetermined standards.
    (e) Source of predetermined standards. The predetermined standards 
must be--
    (1) Developed directly by the State or its contractor;
    (2) Obtained by the State through contracts with commercial vendors 
of DUR services;
    (3) Obtained by the State from independent organizations, such as 
the United States Pharmacopeial Convention, or entities receiving 
funding from the Public Health Service, CMS, or State agencies; or
    (4) Any combination of paragraphs (e)(1) through (e)(3) of this 
section.
    (f) Requirements for predetermined standards. The predetermined 
standards used in the DUR program must meet the following requirements:
    (1) The source materials for their development are consistent with 
peer-reviewed medical literature (that is, scientific, medical, and 
pharmaceutical publications in which original manuscripts are published 
only after having been critically reviewed by unbiased independent 
experts) and the following compendia:
    (i) American Hospital Formulary Service Drug Information;
    (ii) United States Pharmacopeia-Drug Information;
    (iii) American Medical Association Drug Evaluations.
    (2) Differences between source materials were resolved by physicians 
and pharmacists developing consensus solutions. The consensus process 
means the reliance, by the criteria developers, on

[[Page 560]]

the expertise of physicians and pharmacists to evaluate differences in 
criteria source materials and to come to agreement on how differences 
should be resolved.
    (3) They are non-proprietary and readily available to providers of 
services. Systems and algorithms using the predetermined standards may 
remain proprietary.
    (4) They are clinically-based and scientifically valid.
    (5) The review based on clinical criteria uses predetermined 
standards to determine the population at risk of a clinically 
significant adverse medical result and applies standards, appropriate to 
this population, across providers and patients to determine the provider 
outliers whose prescribing, dispensing, or consumption practices may not 
conform to accepted standards of care. Various statistical measures 
(including mean, range, or other measures at the discretion of the 
State) may be applied to these data. Standards may be considered in 
deciding if an in-depth review is needed to determine whether to 
intervene once the potential therapeutic problems have been identified 
through the use of clinical criteria.
    (6) They have been tested against claims data prior to adoption in 
order to validate the level of possibly significant therapeutic problems 
without undue levels of false positives.
    (7) The predetermined standards for prospective and retrospective 
DUR are compatible.
    (8) They are subjected to ongoing evaluation and modification either 
as a result of actions by their developer or as a result of 
recommendations by the DUR Board.
    (g) Access to predetermined standards. Upon their adoption, 
predetermined standards must be available to the public. Pharmacists and 
physicians must be informed of the existence of predetermined standards 
and of how they can obtain copies of them.
    (h) Minimum standards for DUR programs--(1) Minimum standards. In 
operating their DUR programs, States must include the following minimum 
standards:
    (i) Prospective safety edit limitations for opioid prescriptions, as 
specified by the State, on:
    (A) Days' supply for patients not currently receiving opioid therapy 
for initial prescription fills;
    (B) Quantity of prescription dispensed for initial and subsequent 
prescription fills;
    (C) Therapeutically-duplicative initial and subsequent opioid 
prescription fills; and
    (D) Early refills, for subsequent prescription fills.
    (ii) Prospective safety edit limitations for opioid prescriptions, 
as specified by the State, on the maximum daily morphine milligram 
equivalent for treatment of pain, for initial and subsequent 
prescription fills.
    (iii) A retrospective claims review automated process that indicates 
prescription fills of opioids in excess of the prospective safety edit 
limitations specified by the state under paragraph (h)(1)(i) or (ii) of 
this section to provide for the ongoing review of opioid claims data to 
identify patterns of fraud, abuse, excessive utilization, inappropriate 
or medically unnecessary care, or prescribing or billing practices that 
indicate abuse or provision of inappropriate or medically unnecessary 
care among prescribers, pharmacists and individuals receiving Medicaid 
benefits.
    (iv) A retrospective claims review automated process and, at the 
option of the State, prospective safety edits that monitor when an 
individual is concurrently prescribed opioids and:
    (A) Benzodiazepines; or
    (B) Antipsychotics.
    (v) A program to monitor and manage the appropriate use of 
antipsychotic medications by children enrolled under the State plan, 
including any Medicaid expansion groups for the Children's Health 
Insurance Program (CHIP).
    (vi) A process to identify potential fraud or abuse of controlled 
substances by individuals enrolled under the State plan, health care 
providers prescribing drugs to individuals so enrolled, and pharmacies 
dispensing drugs to individuals so enrolled.

[[Page 561]]

    (vii) Prospective safety edits, retrospective claims review 
automated processes, or a combination of these approaches as determined 
by the State, to identify when:
    (A) A beneficiary is prescribed an opioid after the beneficiary has 
been prescribed one or more drugs used for Medication Assisted Treatment 
(MAT) of an opioid use disorder or has been diagnosed with an opioid use 
disorder, within a timeframe specified by the State, in the absence of a 
new indication to support utilization of opioids (such as new cancer 
diagnosis or entry into hospice care); and
    (B) A beneficiary could be at high risk of opioid overdose and 
should be considered for co-prescription or co-dispensing of any FDA-
approved opioid antagonist/reversal agent.
    (2) Exclusion. The requirements in paragraphs (h)(1)(i) through 
(vii) of this section do not apply with respect to individuals receiving 
hospice or palliative care or treatment for cancer; individuals who are 
residents of long-term care facilities, intermediate care facilities for 
the intellectually disabled, or facilities that dispense frequently 
abused drugs through a contract with a single pharmacy; or other 
individuals the State elects to exempt. While States are not required to 
apply the requirements in paragraphs (h)(1)(i) through (vii) with 
respect to these individuals, States may elect to do so.
    (i) Confidentiality of patient related data. In implementing the DUR 
program, the agency must establish, in regulations or through other 
means, policies concerning confidentiality of patient related data that 
are consistent with applicable Federal confidentiality requirements at 
part 431, subpart F of this chapter; the State Pharmacy Practice Act; 
and the guidelines adopted by the State Board of Pharmacy or other 
relevant licensing bodies.

[57 FR 49408, Nov. 2, 1992, as amended at 59 FR 48824, Sept. 23, 1994; 
85 FR 87104, Dec. 31, 2020]



Sec.  456.705  Prospective drug review.

    (a) General. Except as provided in Sec.  456.703 (b) and (c), the 
State plan must provide for a review of drug therapy before each 
prescription is filled or delivered to a beneficiary, and applicable 
State law (including State Board policy incorporated in the State law by 
reference) must establish standards for counseling of the beneficiary or 
the beneficiary's caregiver. The State must provide pharmacies with 
detailed information as to what they must do to comply with prospective 
DUR requirements, including guidelines on counseling, profiling, and 
documentation of prospective DUR activities by the pharmacists. The 
pharmacies, in turn, must provide this information to their pharmacists. 
This information is to be based on guidelines provided by this subpart 
and by other sources that the State may specify.
    (b) Point-of-sale or point-of-distribution review. Except as 
provided in Sec.  456.703 (b) and (c), the State plan must provide for 
point-of-sale or point-of-distribution review of drug therapy using 
predetermined standards before each prescription is filled or delivered 
to the beneficiary or the beneficiary's caregiver. The review must 
include screening to identify potential drug therapy problems of the 
following types:
    (1) Therapeutic duplication, that is, the prescribing and dispensing 
of two or more drugs from the same therapeutic class such that the 
combined daily dose puts the beneficiary at risk of an adverse medical 
result or incurs additional program costs without additional therapeutic 
benefit.
    (2) Drug-disease contraindication, that is, the potential for, or 
the occurrence of--
    (i) An undesirable alteration of the therapeutic effect of a given 
drug because of the presence, in the patient for whom it is prescribed, 
of a disease condition; or
    (ii) An adverse effect of the drug on the patient's disease 
condition.
    (3) Adverse drug-drug interaction, that is, the potential for, or 
occurrence of, a clinically significant adverse medical effect as a 
result of the beneficiary using two or more drugs together.
    (4) Incorrect drug dosage, that is, the dosage lies outside the 
daily dosage specified in predetermined standards as necessary to 
achieve therapeutic benefit. Dosage is the strength multiplied by the 
quantity dispensed divided by day's supply.

[[Page 562]]

    (5) Incorrect duration of drug treatment, that is, the number of 
days of prescribed therapy exceeds or falls short of the recommendations 
contained in the predetermined standards.
    (6) Drug-allergy interactions, that is, the significant potential 
for, or the occurrence of, an allergic reaction as a result of drug 
therapy.
    (7) Clinical abuse/misuse, that is, the occurrence of situations 
referred to in the definitions of abuse, gross overuse, overutilization, 
and underutilization, as defined in Sec.  456.702, and incorrect dosage 
and incorrect duration, as defined in paragraphs (b)(4) and (b)(5) of 
this section, respectively.
    (c) Drug counseling. (1) As part of the prospective drug review 
program, standards for counseling by pharmacists of beneficiaries or the 
beneficiaries' caregivers must be established by State law or other 
method that is satisfactory to the State agency. A State agency's 
counseling standards must address special situations where the patient 
or the patient's representative, is not readily available to receive the 
offer to counsel or the actual counseling, for example, prescriptions 
delivered offsite or through the mail. The State agency, at a minimum, 
must also address the following issues in their counseling standards:
    (i) Whether the offer to counsel is required for new prescriptions 
only, or for both new and refill prescriptions;
    (ii) Whether pharmacists must make the offer to counsel or auxiliary 
personnel are authorized to make the offer;
    (iii) Whether only a patient's refusal of the offer to counsel must 
be documented, or whether documentation of all offers is required;
    (iv) Whether documentation of counseling is required; and
    (v) Whether counseling is required in situations where the patient's 
representative is not readily available to receive a counseling offer or 
the counseling itself.
    (2) The standards must meet the following requirements:
    (i) They must require pharmacists to offer to counsel (in person, 
whenever practicable, or through access to a telephone service that is 
toll-free for long-distance calls) each beneficiary or beneficiary's 
caregiver who presents a prescription. A pharmacist whose primary 
patient population is accessible through a local measured or toll-free 
exchange need not be required to offer toll-free service. Mail order 
pharmacies are required to provide toll-free telephone service for long 
distance calls.
    (ii) They need not require a pharmacist to provide consultation when 
a Medicaid beneficiary or the beneficiary's caregiver refuses that 
consultation.
    (iii) They must specify what documentation by the pharmacy of 
refusal of the offer of counseling is required.
    (3) The standards must specify that the counseling include those 
matters listed in paragraphs (c)(3)(i) through (c)(3)(viii) of this 
section that, in the exercise of his or her professional judgement 
(consistent with State law regarding the provision of such information), 
the pharmacist considers significant as well as other matters the 
pharmacist considers significant.
    (i) The name and description of the medication;
    (ii) The dosage form, dosage, route of administration, and duration 
of drug therapy;
    (iii) Special directions and precautions for preparation, 
administration, and use by the patient;
    (iv) Common severe side or adverse effects or interactions and 
therapeutic contraindications that may be encountered, including their 
avoidance, and the action required if they occur;
    (v) Techniques for self-monitoring drug therapy;
    (vi) Proper storage;
    (vii) Prescription refill information; and
    (viii) Action to be taken in the event of a missed dose.
    (d) Profiling. The State agency must require that, in the case of 
Medicaid beneficiaries, the pharmacist make a reasonable effort to 
obtain, record, and maintain patient profiles containing, at a minimum, 
the information listed in paragraphs (d)(1) through (d)(3) of this 
section.
    (1) Name, address, telephone number, date of birth (or age), and 
gender of the patient;
    (2) Individual history, if significant, including disease state or 
states,

[[Page 563]]

known allergies and drug reactions, and a comprehensive list of 
medications and relevant devices; and
    (3) Pharmacist's comments relevant to the individual's drug therapy.

[57 FR 49408, Nov. 2, 1992, as amended at 59 FR 48824, Sept. 23, 1994]



Sec.  456.709  Retrospective drug use review.

    (a) General. The State plan must provide for a retrospective DUR 
program for ongoing periodic examination (no less frequently than 
quarterly) of claims data and other records in order to identify 
patterns of fraud, abuse, gross overuse, or inappropriate or medically 
unnecessary care among physicians, pharmacists, and Medicaid 
beneficiaries, or associated with specific drugs or groups of drugs. 
This examination must involve pattern analysis, using predetermined 
standards, of physician prescribing practices, drug use by individual 
patients and, where appropriate, dispensing practices of pharmacies. 
This program must be provided through the State's mechanized drug claims 
processing and information retrieval systems approved by CMS (that is, 
the Medicaid Management Information System (MMIS)) or an electronic drug 
claims processing system that is integrated with MMIS. States that do 
not have MMIS systems may use existing systems provided that the results 
of the examination of drug claims as described in this section are 
integrated within their existing system.
    (b) Use of predetermined standards. Retrospective DUR includes, but 
is not limited to, using predetermined standards to monitor for the 
following:
    (1) Therapeutic appropriateness, that is, drug prescribing and 
dispensing that is in conformity with the predetermined standards.
    (2) Overutilization and underutilization, as defined in Sec.  
456.702.
    (3) Appropriate use of generic products, that is, use of such 
products in conformity with State product selection laws.
    (4) Therapeutic duplication as described in Sec.  456.705(b)(1).
    (5) Drug-disease contraindication as described in Sec.  
456.705(b)(2).
    (6) Drug-drug interaction as described in Sec.  456.705(b)(3).
    (7) Incorrect drug dosage as described in Sec.  456.705(b)(4).
    (8) Incorrect duration of drug treatment as described in Sec.  
456.705(b)(5).
    (9) Clinical abuse or misuse as described in Sec.  456.705(b)(7).



Sec.  456.711  Educational program.

    The State plan must provide for ongoing educational outreach 
programs that, using DUR Board data on common drug therapy problems, 
educate practitioners on common drug therapy problems with the aim of 
improving prescribing and dispensing practices. The program may be 
established directly by the DUR Board or through contracts with 
accredited health care educational institutions, State medical societies 
or State pharmacists associations/societies, or other organizations. The 
program must include the interventions listed in paragraphs (a) through 
(d) of this section. The DUR Board determines the content of education 
regarding common therapy problems and the circumstances in which each of 
the interventions is to be used.
    (a) Dissemination of information to physicians and pharmacists in 
the State concerning the duties and powers of the DUR Board and the 
basis for the standards required by Sec.  456.705(c) for use in 
assessing drug use.
    (b) Written, oral, or electronic reminders containing patient-
specific or drug-specific information (or both) and suggested changes in 
prescribing or dispensing practices. These reminders must be conveyed in 
a manner designed to ensure the privacy of patient-related information.
    (c) Face-to-face discussions, with follow up discussions when 
necessary, between health care professionals expert in appropriate drug 
therapy and selected prescribers and pharmacists who have been targeted 
for educational intervention on optimal prescribing, dispensing, or 
pharmacy care practices.
    (d) Intensified review or monitoring of selected prescribers or 
dispensers.



Sec.  456.712  Annual report.

    (a) DUR Board report. The State must require the DUR Board to 
prepare and

[[Page 564]]

submit an annual DUR report to the Medicaid agency that contains 
information specified by the State.
    (b) Medicaid agency report. The Medicaid agency must prepare and 
submit, on an annual basis, a report to the Secretary that incorporates 
the DUR Board's report and includes the following information:
    (1) A description of the nature and scope of the prospective drug 
review program.
    (2) A description of how pharmacies performing prospective DUR 
without computers are expected to comply with the statutory requirement 
for written criteria.
    (3) Detailed information on the specific criteria and standards in 
use. After the first annual report, information regarding only new or 
changed criteria must be provided and deleted criteria must be 
identified.
    (4) A description of the steps taken by the State to include in the 
prospective and retrospective DUR program drugs dispensed to residents 
of a nursing facility that is not in compliance with the drug regimen 
review procedures set forth in part 483 of this chapter. After the first 
annual report, only changes must be reported.
    (5) A description of the actions taken by the State Medicaid agency 
and the DUR Board to ensure compliance with the requirements for 
predetermined standards at Sec.  456.703(f) and with the access to the 
predetermined standards requirement at Sec.  456.703(g). After the first 
annual report, only changes must be reported.
    (6) A description of the nature and scope of the retrospective DUR 
program.
    (7) A summary of the educational interventions used and an 
assessment of the effect of these educational interventions on the 
quality of care.
    (8) A description of the steps taken by the State Agency to monitor 
compliance by pharmacies with the prospective DUR counseling 
requirements contained in Federal and State laws and regulations. After 
the first annual report, only changes must be reported.
    (9) Clear statements of purpose that delineate the respective goals, 
objectives, and scopes of responsibility of the DUR and surveillance and 
utilization (SUR) functions. These statements must clarify the working 
relationships between DUR and SUR functions and other entities such as 
the Medicaid Fraud Control Unit and State Board of Pharmacy. The annual 
report also must include a statement delineating how functional 
separation will be maintained between the fraud and abuse activities and 
the educational activities. After the first annual report, only changes 
must be reported.
    (10) An estimate of the cost savings generated as a result of the 
DUR program. This report must identify costs of DUR and savings to the 
Medicaid drug program attributable to prospective and retrospective DUR.
    (c) Public availability. All fee-for-service (FFS) and managed care 
DUR reports received by CMS under paragraph (b) of this section and, as 
applicable, pursuant to Sec.  438.3(s) of this chapter, will be publicly 
posted on a website maintained by CMS for the sharing of reports and 
other information concerning Medicaid DUR programs.

[57 FR 49408, Nov. 2, 1992, as amended at 85 FR 87104, Dec. 31, 2020]



Sec.  456.714  DUR/surveillance and utilization review relationship.

    (a) The retrospective DUR requirements in this subpart parallel a 
portion of the surveillance and utilization review (SUR) requirements in 
subpart A of this part and in part 455 of this chapter.
    (b) A State agency may direct DUR staffs to limit review activities 
to those that focus on what constitutes appropriate and medically 
necessary care to avoid duplication of activities relating to fraud and 
abuse under the SUR program.

[59 FR 48825, Sept. 23, 1994]



Sec.  456.716  DUR Board.

    (a) State DUR Board requirement and member qualifications. Each 
State must establish, either directly or through a contract with a 
private organization, a DUR Board. The DUR Board must include health 
care professionals who have recognized knowledge and expertise in at 
least one of the following:
    (1) Clinically appropriate prescribing of covered outpatient drugs.

[[Page 565]]

    (2) Clinically appropriate dispensing and monitoring of covered 
outpatient drugs.
    (3) Drug use review, evaluation, and intervention.
    (4) Medical quality assurance.
    (b) Board composition. At least one-third but not more than 51 
percent of the DUR Board members must be physicians, and at least one-
third of the Board members must be pharmacists. These physicians and 
pharmacists must be actively practicing and licensed.
    (c) Medicaid agency/DUR Board relationship. The Medicaid agency is 
ultimately responsible for ensuring that the DUR program is operational 
and conforms with the requirements of this subpart. The agency has the 
authority to accept or reject the recommendations or decisions of the 
DUR Board.
    (d) DUR Board activities. The State agency must ensure that the 
operational tasks involved in carrying out the DUR Board activities set 
forth at section 1927(g)(3)(C) of the Act are assigned, limited only by 
the requirements of section 1927(g)(3)(C) of the Act, based on 
consideration of operational requirements and on where the necessary 
expertise resides. Except as limited by the requirements of section 
1927(g)(3)(C) of the Act, the State agency may alter the suggested 
working relationships set forth in this paragraph.
    (1) Application of predetermined standards: Board's activities. The 
DUR Board should perform the following activities:
    (i) Review and make recommendations on predetermined standards 
submitted to it by the Medicaid agency or the agency's contractor.
    (ii) Evaluate the use of the predetermined standards, including 
assessing the operational effect of the predetermined standards in use, 
and make recommendations to the Medicaid agency or the agency's 
contractor concerning modification or elimination of existing 
predetermined standards or the addition of new ones.
    (iii) Recommend guidelines governing written predetermined standards 
that pharmacies not using approved software must use in conducting 
prospective DUR.
    (2) Application of predetermined standards: Medicaid agency role. 
The Medicaid agency or its contractor should perform the following 
activities:
    (i) Submit predetermined standards to the DUR Board for its review 
and recommendations before the Medicaid agency applies them to drug 
claims data.
    (ii) If prospective DUR is conducted using an electronic claims 
management (ECM) system, apply software approved by the Board.
    (iii) If prospective DUR is not conducted through an ECM system, as 
part of general compliance monitoring, ensure that Medicaid 
participating pharmacies conduct prospective drug review that screens 
for the potential drug therapy problems listed in section 1927(g)(2)(A) 
of the Act.
    (3) Retrospective DUR: Board's activities. The DUR Board should 
perform the following activities:
    (i) Review and make recommendations on predetermined standards 
submitted to it by the Medicaid agency or the agency's contractor.
    (ii) Make recommendations to the Medicaid agency or the agency's 
contractor concerning modification or elimination of existing 
predetermined standards or the addition of new ones.
    (4) Retrospective DUR: Medicaid agency role. The Medicaid agency or 
its contractor should apply the predetermined standards to drug claims 
data in order to generate reports that identify patterns of fraud, 
abuse, gross overuse, or inappropriate or medically unnecessary care.
    (5) Education program (including interventions): Board's activities. 
The DUR Board must perform the following activities:
    (i) Identify and develop educational topics if education of 
practitioners on common drug therapy problems is needed to improve 
prescribing or dispensing practices.
    (ii) Make recommendations as to which mix of the interventions set 
forth in Sec.  456.711 (a) through (d) would most effectively lead to 
improvement in the quality of drug therapy. The DUR board 
recommendations must be based upon an in-depth review of the results of 
the application of predetermined standards against claims data

[[Page 566]]

reports, must be appropriate based upon program experience, and must 
match the educational program with the drug therapy problems identified.
    (iii) Periodically re-evaluate and, if necessary, modify the 
interventions.
    (6) Education program (including interventions): Medicaid agency's 
role. The Medicaid agency or its contractor should perform the following 
activities.
    (i) Apply predetermined standards to drug claims data to generate 
reports that provide the basis for retrospective education and 
interventions and furnish those reports to the Board.
    (ii) Carry out the educational programs and interventions specified 
by the Board.
    (e) Funding for the Board. FFP is available for expenses associated 
with the operation of the DUR Board in carrying out its 
responsibilities, and payment is made under procedures established in 
part 433 of this chapter as follows:
    (1) If the requirements for skilled professional medical personnel 
at Sec.  432.50 of this chapter are met, at the rate of 75 percent.
    (2) If the requirements for skilled professional medical personnel 
at Sec.  432.50 of this chapter are not met, at the rate specified in 
Sec.  456.719.

[57 FR 49408, Nov. 2, 1992, as amended at 59 FR 48825, Sept. 23, 1994]



Sec.  456.719  Funding for DUR program.

    FFP is available for sums that the Secretary determines are 
attributable to the Statewide adoption of a DUR program as described in 
this subpart, and payment is made under procedures established in part 
433 of this chapter as follows:
    (a) For funds expended by the State during calendar years 1991 
through 1993, at the rate of 75 percent.
    (b) For funds expended by the State after December 31, 1993, at the 
rate of 50 percent.



Sec.  456.722  Electronic claims management system.

    (a) Point-of-sale system. Each Medicaid agency, at its option, may 
establish, as its principal (but not necessarily exclusive) means of 
processing claims for covered outpatient drugs, a point-of-sale 
electronic claims management (ECM) system to perform on-line, real-time 
(that is, immediate) eligibility verifications, claims data capture, 
adjudication of claims, and to assist pharmacists and other authorized 
persons (including dispensing physicians) in applying for and receiving 
payment. The State determines who must participate in an ECM system and 
who may decline to do so. If the State exercises this option and wishes 
to receive FFP for its ECM system, the system must meet the functional 
and additional procurement and system requirements in paragraphs (b) and 
(c) of this section.
    (b) Functional requirements. The ECM system developed by the State 
must include at least the on-line, real-time capabilities specified in 
paragraphs (b)(1) through (3) of this section. The real-time requirement 
for prescriptions filled for nursing facilities and prescriptions filled 
by mail order dispensers may be waived by the State to permit claims to 
be processed in the batch mode at the end of the day or other time 
mutually agreed to by the nursing facility or mail order dispenser and 
Medicaid agency.
    (1) Eligibility verification, including identification of the 
following:
    (i) Third-party payers.
    (ii) beneficiaries in managed care programs.
    (iii) beneficiaries and providers in restricted service programs 
(for example, lock-in and lock-out).
    (iv) Properly enrolled providers.
    (2) Claims data capture, including the following:
    (i) Transfer of claims information from the pharmacy to the Medicaid 
agency or the Medicaid agency's contractor.
    (ii) Identification of prescriber.
    (iii) Minimum data set (as defined in Part 11 of the State Medicaid 
Manual).
    (3) Claims adjudication, including the following:
    (i) Performing all edits and audits contained in the State's 
Medicaid Management Information System (MMIS) applicable to prescription 
drugs.
    (ii) Notifying the pharmacist (or other authorized person, such as 
the dispensing physician) about the claim status.

[[Page 567]]

    (iii) Taking steps up to, but not including, payment of the claim.
    (c) Additional requirements. In order to receive FFP for its ECM 
system, the State must meet the following requirements:
    (1) The ECM system must be acquired through applicable competitive 
procurement process in the State and must be the most cost-effective 
telecommunications network and automatic data processing services and 
equipment. The procurement must meet the procurement requirements set 
forth in 45 CFR part 75.326 through 75.340. The request for proposal 
(RFP) may be substituted for the advance planning and implementation 
documents otherwise required by part 433 of this chapter, 45 CFR 95.205, 
and 45 CFR part 307. A cost-benefit analysis must accompany the RFP. If 
in its advance planning document, a State establishes that a separate 
procurement is not cost-effective, modification of an existing fiscal 
agent contract will be acceptable. In this case, procurement of network 
services and equipment (but not software modifications) must be 
competitively procured.
    (2) States wishing to do prospective DUR as part of their ECM must 
do the following:
    (i) Submit a cost benefit analysis showing the cost-effectiveness of 
such a system. A State's decisions as to who must participate in the ECM 
system and who may decline to do so must be included in the cost-benefit 
analysis.
    (ii) Establish a central State-wide electronic repository for 
capturing, storing, and updating data for all prescriptions dispensed 
and for providing access to such data by all authorized participants.
    (iii) Design the system to assess data for a review of drug therapy 
before each prescription is filled or delivered to a Medicaid 
beneficiary. The type of review conducted must meet the requirements for 
prospective drug review set forth in Sec.  456.705.
    (3) ECM is considered a subsystem and must be fully integrated with 
the remainder of the State's MMIS. In addition, information about ECM 
claims must be part of the single comprehensive utilization and 
management reporting system used by the DUR program.

[57 FR 49408, Nov. 2, 1992, as amended at 81 FR 3012, Jan. 20, 2016]



Sec.  456.725  Funding of ECM system.

    (a) For funds expended during calendar quarters in fiscal years 1991 
and 1992 and attributable to the design, development, and implementation 
of an on-line, real-time claims management system (that is, the most 
cost-effective telecommunications network and automatic data processing 
services and equipment) that meets the requirements of Sec.  456.722, 
FFP is available at a matching rate of 90 percent. After fiscal year 
1992, ECM subsystems are funded at the standard applicable MMIS enhanced 
rates, subject to the requirements of part 433, subpart A of this 
chapter.
    (b) FFP is available at a matching rate of 75 percent for funds 
expended for the following:
    (1) Telecommunications equipment and other equipment to directly 
access MMIS files.
    (2) Telecommunications equipment (such as modems and point of sale 
terminals) furnished to providers.
    (3) Operational costs including telecommunications network costs, 
provided that the ECM system includes eligibility verification systems, 
electronic claims capture, claims adjudication (except for payment), and 
a claims data process that is integrated into a single comprehensive 
utilization and information reporting system.

[[Page 568]]



    SUBCHAPTER D_STATE CHILDREN'S HEALTH INSURANCE PROGRAMS (SCHIPs)





PART 457_ALLOTMENTS AND GRANTS TO STATES--Table of Contents



Subpart A_Introduction; State Plans for Child Health Insurance Programs 
                         and Outreach Strategies

Sec.
457.1 Program description.
457.2 Basis and scope of subchapter D.
457.10 Definitions and use of terms.
457.30 Basis, scope, and applicability of subpart A.
457.40 State program administration.
457.50 State plan.
457.60 Amendments.
457.65 Effective date and duration of State plans and plan amendments.
457.70 Program options.
457.80 Current State child health insurance coverage and coordination.
457.90 Outreach.
457.110 Enrollment assistance and information requirements.
457.120 Public involvement in program development.
457.125 Provision of child health assistance to American Indian and 
          Alaska Native children.
457.130 Civil rights assurance.
457.135 Assurance of compliance with other provisions.
457.140 Budget.
457.150 CMS review of State plan material.
457.160 Notice and timing of CMS action on State plan material.
457.170 Withdrawal process.

  Subpart B_General Administration_Reviews and Audits; Withholding for 
  Failure to Comply; Deferral and Disallowance of Claims; Reduction of 
                        Federal Medical Payments

457.200 Program reviews.
457.202 Audits.
457.203 Administrative and judicial review of action on State plan 
          material.
457.204 Withholding of payment for failure to comply with Federal 
          requirements.
457.206 Administrative appeals under CHIP.
457.208 Judicial review.
457.216 Treatment of uncashed or canceled (voided) CHIP checks.
457.220 Funds from units of government as the State share of financial 
          participation.
457.222 FFP for equipment.
457.224 FFP: Conditions relating to cost sharing.
457.226 Fiscal policies and accountability.
457.228 Cost allocation.
457.230 FFP for State ADP expenditures.
457.232 Refunding of Federal share of CHIP overpayments to providers and 
          referral of allegations of waste, fraud or abuse of the Office 
          of Inspector General.
457.236 Audit of records.
457.238 Documentation of payment rates.

Subpart C_State Plan Requirements: Eligibility, Screening, Applications, 
                             and Enrollment

457.300 Basis, scope, and applicability.
457.301 Definitions and use of terms.
457.305 State plan provisions.
457.310 Targeted low-income child.
457.315 Application of modified adjusted gross income and household
457.320 Other eligibility standards.
457.330 Application.
457.340 Application for and enrollment in CHIP.
457.342 Continuous eligibility for children.
457.343 Periodic renewal of CHIP eligibility.
457.348 Determinations of Children's Health Insurance Program 
          eligibility by other insurance affordability programs.
457.350 Eligibility screening and enrollment in other insurance 
          affordability programs.
457.351 Coordination involving appeals entities for different insurance 
          affordability programs.
457.353 Monitoring and evaluation of screening process.
457.355 Presumptive eligibility for children.
457.360 Deemed newborn children.
457.370 Alignment with Exchange initial open enrollment period.
457.380 Eligibility verification.

        Subpart D_State Plan Requirements: Coverage and Benefits

457.401 Basis, scope, and applicability.
457.402 Definition of child health assistance.
457.410 Health benefits coverage options.
457.420 Benchmark health benefits coverage.
457.430 Benchmark-equivalent health benefits coverage.
457.431 Actuarial report for benchmark-equivalent coverage.
457.440 Existing comprehensive State-based coverage.
457.450 Secretary-approved coverage.
457.470 Prohibited coverage.
457.475 Limitations on coverage: Abortions.
457.480 Preexisting condition exclusions and relation to other laws.

[[Page 569]]

457.490 Delivery and utilization control systems.
457.495 State assurance of access to care and procedures to assure 
          quality and appropriateness of care.
457.496 Parity in mental health and substance use disorder benefits.

 Subpart E_State Plan Requirements: Enrollee Financial Responsibilities

457.500 Basis, scope, and applicability.
457.505 General State plan requirements.
457.510 Premiums, enrollment fees, or similar fees: State plan 
          requirements.
457.515 Co-payments, coinsurance, deductibles, or similar cost-sharing 
          charges: State plan requirements.
457.520 Cost sharing for well-baby and well-child care services.
457.525 Public schedule.
457.530 General cost-sharing protection for lower income children.
457.535 Cost-sharing protection to ensure enrollment of American Indians 
          and Alaska Natives.
457.540 Cost-sharing charges for children in families with incomes at or 
          below 150 percent of the FPL.
457.555 Maximum allowable cost-sharing charges on targeted low-income 
          children in families with income from 101 to 150 percent of 
          the FPL.
457.560 Cumulative cost-sharing maximum.
457.570 Disenrollment protections.

                       Subpart F_Payment to States

457.600 Purpose and basis of this subpart.
457.602 Applicability.
457.606 Conditions for State allotments and Federal payments for a 
          fiscal year.
457.608 Process and calculation of State allotments prior to FY 2009.
457.609 Process and calculation of State allotments for a fiscal year 
          after FY 2008.
457.610 Period of availability for State allotments prior to FY 2009.
457.611 Period of availability for State allotments for a fiscal year 
          after FY 2008.
457.614 General payment process.
457.616 Application and tracking of payments against the fiscal year 
          allotments.
457.618 Ten percent limit on certain Children's Health Insurance Program 
          expenditures.
457.622 Rate of FFP for State expenditures.
457.626 Prevention of duplicate payments.
457.628 Other applicable Federal regulations.
457.630 Grants procedures.

         Subpart G_Strategic Planning, Reporting, and Evaluation

457.700 Basis, scope, and applicability.
457.710 State plan requirements: Strategic objectives and performance 
          goals.
457.720 State plan requirement: State assurance regarding data 
          collection, records, and reports.
457.730 Beneficiary access to and exchange of data.
457.740 State expenditures and statistical reports.
457.750 Annual report.
457.760 Access to published provider directory information.

                   Subpart H_Substitution of Coverage

457.800 Basis, scope, and applicability.
457.805 State plan requirements: Procedures to address substitution 
          under group health plans.
457.810 Premium assistance programs: Required protections against 
          substitution.

                       Subpart I_Program Integrity

457.900 Basis, scope, and applicability.
457.910 State program administration.
457.915 Fraud detection and investigation.
457.925 Preliminary investigation.
457.930 Full investigation, resolution, and reporting requirements.
457.935 Sanctions and related penalties.
457.940 Procurement standards.
457.945 Certification for contracts and proposals.
457.950 Contract and payment requirements including certification of 
          payment-related information.
457.960 Reporting changes in eligibility and redetermining eligibility.
457.965 Documentation.
457.980 Verification of enrollment and provider services received.
457.985 Integrity of professional advice to enrollees.

             Subpart J_Allowable Waivers: General Provisions

457.990 Provider and supplier screening, oversight, and reporting 
          requirements.
457.1000 Basis, scope, and applicability.
457.1003 CMS review of waiver requests.
457.1005 Cost-effective coverage through a community-based health 
          delivery system.
457.1010 Purchase of family coverage.
457.1015 Cost-effectiveness.

  Subpart K_State Plan Requirements: Applicant and Enrollee Protections

457.1100 Basis, scope and applicability.
457.1110 Privacy protections.
457.1120 State plan requirement: Description of review process.
457.1130 Program specific review process: Matters subject to review.
457.1140 Program specific review process: Core elements of review.

[[Page 570]]

457.1150 Program specific review process: Impartial review.
457.1160 Program specific review process: Time frames.
457.1170 Program specific review process: Continuation of enrollment.
457.1180 Program specific review process: Notice.
457.1190 Application of review procedures when States offer premium 
          assistance for group health plans.

                         Subpart L_Managed Care

                           General Provisions

457.1200 Basis, scope, and applicability.
457.1201 Standard contract requirements.
457.1203 Rate development standards and medical loss ratio.
457.1206 Non-emergency medical transportation PAHPs.
457.1207 Information requirements.
457.1208 Provider discrimination prohibited.
457.1209 Requirements that apply to MCO, PIHP, PAHP, PCCM, and PCCM 
          entity contracts involving Indians, Indian health care 
          provider (IHCP), and Indian managed care entities (IMCE).

                         State Responsibilities

457.1210 Enrollment process.
457.1212 Disenrollment.
457.1214 Conflict of interest safeguards.
457.1216 Continued services to enrollees.
457.1218 Network adequacy standards.

                     Enrollee Rights and Protections

457.1220 Enrollee rights.
457.1222 Provider-enrollee communication.
457.1224 Marketing activities.
457.1226 Liability for payment.
457.1228 Emergency and poststabilization services.

                      MCO, PIHP, and PAHP Standards

457.1230 Access standards.
457.1233 Structure and operation standards.

      Quality Measurement and Improvement; External Quality Review

457.1240 Quality measurement and improvement.
457.1250 External quality review.

                            Grievance System

457.1260 Grievance system.

                                Sanctions

457.1270 Sanctions.
457.1280 Conditions necessary to contract as an MCO, PAHP, or PIHP.
457.1285 Program integrity safeguards.

    Authority: 42 U.S.C. 1302.

    Source: 65 FR 33622, May 24, 2000, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 457 appear at 75 FR 
48852, Aug. 11, 2010 and 77 FR 17213, 2013.



Subpart A_Introduction; State Plans for Child Health Insurance Programs 
                         and Outreach Strategies

    Source: 66 FR 2670, Jan. 11, 2001, unless otherwise noted.



Sec.  457.1  Program description.

    Title XXI of the Social Security Act, enacted in 1997 by the 
Balanced Budget Act, authorizes Federal grants to States for provision 
of child health assistance to uninsured, low-income children. The 
program is jointly financed by the Federal and State governments and 
administered by the States. Within broad Federal rules, each State 
decides eligible groups, types and ranges of services, payment levels 
for benefit coverage, and administrative and operating procedures.



Sec.  457.2  Basis and scope of subchapter D.

    (a) Basis. This subchapter implements title XXI of the Act, which 
authorizes Federal grants to States for the provision of child health 
assistance to uninsured, low-income children.
    (b) Scope. The regulations in subchapter D set forth State plan 
requirements, standards, procedures, and conditions for obtaining 
Federal financial participation (FFP) to enable States to provide health 
benefits coverage to targeted low-income children, as defined at Sec.  
457.310.



Sec.  457.10  Definitions and use of terms.

    For purposes of this part the following definitions apply:
    Actuarially sound principles means generally accepted actuarial 
principles and practices that are applied to determine aggregate 
utilization patterns, are appropriate for the population and services to 
be covered, and have been certified by actuaries who meet the 
qualification standards established by the Actuarial Standards Board.

[[Page 571]]

    Advanced payments of the premium tax credit (APTC) has the meaning 
given the term in 45 CFR 155.20.
    Affordable Insurance Exchange (Exchange) has the meaning given the 
term ``Exchange'' in 45 CFR 155.20.
    American Indian/Alaska Native (AI/AN) means--
    (1) A member of a Federally recognized Indian tribe, band, or group;
    (2) An Eskimo or Aleut or other Alaska Native enrolled by the 
Secretary of the Interior pursuant to the Alaska Native Claims 
Settlement Act, 43 U.S.C. 1601 et. seq.; or
    (3) A person who is considered by the Secretary of the Interior to 
be an Indian for any purpose.
    Applicant means a child who has filed an application (or who has an 
application filed on their behalf) for health benefits coverage through 
the Children's Health Insurance Program. A child is an applicant until 
the child receives coverage through CHIP.
    Application means the single, streamlined application form that is 
used by the State in accordance with Sec.  435.907(b) of this chapter 
and 45 CFR 155.405 for individuals to apply for coverage for all 
insurance affordability programs.
    Child means an individual under the age of 19 including the period 
from conception to birth.
    Child health assistance means payment for part or all of the cost of 
health benefits coverage provided to targeted low-income children for 
the services listed at Sec.  457.402.
    Children's Health Insurance Program (CHIP) means a program 
established and administered by a State, jointly funded with the Federal 
government, to provide child health assistance to uninsured, low-income 
children through a separate child health program, a Medicaid expansion 
program, or a combination program.
    Combination program means a program under which a State implements 
both a Medicaid expansion program and a separate child health program.
    Combined eligibility notice means an eligibility notice that informs 
an individual, or multiple family members of a household of eligibility 
for each of the insurance affordability programs and enrollment in a 
qualified health plan through the Exchange, for which a determination or 
denial of eligibility was made, as well as any right to request a 
review, fair hearing or appeal related to the determination made for 
each program. A combined notice must meet the requirements of Sec.  
457.340(e) and contain the content described in Sec.  457.340(e)(1), 
except that information described in Sec.  457.340(e)(1)(i)(C) may be 
provided in a combined notice issued by another insurance affordability 
program or in a supplemental notice provided by the State. A combined 
eligibility notice must be issued in accordance with the agreement(s) 
consummated by the State in accordance with Sec.  457.348(a).
    Comprehensive risk contract means a risk contract between the State 
and an MCO that covers comprehensive services, that is, inpatient 
hospital services and any of the following services, or any three or 
more of the following services:
    (1) Outpatient hospital services.
    (2) Rural health clinic services.
    (3) Federally Qualified Health Center (FQHC) services.
    (4) Other laboratory and X-ray services.
    (5) Nursing facility (NF) services.
    (6) Early and periodic screening, diagnostic, and treatment (EPSDT) 
services.
    (7) Family planning services.
    (8) Physician services.
    (9) Home health services.
    Coordinated content means information included in an eligibility 
notice regarding, if applicable--
    (1) The transfer of an individual's or household's electronic 
account to another insurance affordability program;
    (2) Any notice sent by the State to another insurance affordability 
program regarding an individual's eligibility for CHIP;
    (3) The potential impact, if any, of--
    (i) The State's determination of eligibility or ineligibility for 
CHIP on eligibility for another insurance affordability program; or
    (ii) A determination of eligibility for, or enrollment in, another 
insurance affordability program on an individual's eligibility for CHIP; 
and
    (iii) [Reserved]
    (4) The status of household members on the same application or 
renewal

[[Page 572]]

form whose eligibility is not yet determined.
    Cost sharing means premium charges, enrollment fees, deductibles, 
coinsurance, copayments, or other similar fees that the enrollee has 
responsibility for paying.
    Creditable health coverage has the meaning given the term 
``creditable coverage'' at 45 CFR 146.113 and includes coverage that 
meets the requirements of Sec.  457.410 and is provided to a targeted 
low-income child.
    Electronic account means an electronic file that includes all 
information collected and generated by the State regarding each 
individual's CHIP eligibility and enrollment, including all 
documentation required under Sec.  457.380 and including any information 
collected or generated as part of a review process conducted in 
accordance with subpart K of this part, the Exchange appeals process 
conducted under 45 CFR part 155, subpart F or other insurance 
affordability program appeals process.
    Emergency medical condition means a medical condition manifesting 
itself by acute symptoms of sufficient severity (including severe pain) 
such that a prudent layperson, with an average knowledge of health and 
medicine, could reasonably expect the absence of immediate medical 
attention to result in--
    (1) Serious jeopardy to the health of the individual or, in the case 
of a pregnant woman, the health of a woman or her unborn child;
    (2) Serious impairment of bodily function; or
    (3) Serious dysfunction of any bodily organ or part.
    Emergency services means health care services that are--
    (1) Furnished by any provider qualified to furnish such services; 
and (2) Needed to evaluate, treat, or stabilize an emergency medical 
condition.
    Enrollee means a child who receives health benefits coverage through 
CHIP.
    Enrollment cap means a limit, established by the State in its State 
plan, on the total number of children permitted to enroll in a State's 
separate child health program.
    Exchange appeals entity has the meaning given to the term ``appeals 
entity,'' as defined in 45 CFR 155.500.
    External quality review (EQR) means the analysis and evaluation by 
an EQRO, of aggregated information on quality, timeliness, and access to 
the health care services that an MCO, PIHP, or PAHP, or their 
contractors furnish to CHIP beneficiaries.
    External quality review organization (EQRO) means an organization 
that meets the competence and independence requirements set forth in 
Sec.  438.354 of this chapter, and holds a contract with a State to 
perform external quality review, other EQR-related activities as set 
forth in Sec.  438.358 of this chapter, or both.
    Federal fiscal year starts on the first day of October each year and 
ends on the last day of the following September.
    Federally qualified HMO means an HMO that CMS has determined is a 
qualified HMO under section 2791(b)(3) of the Public Health Service Act.
    Fee-for-service entity means any individual or entity that furnishes 
services under the program on a fee-for-service basis, including health 
insurance services.
    Group health insurance coverage has the meaning assigned at 45 CFR 
144.103.
    Group health plan has the meaning assigned at 45 CFR 144.103.
    Health benefits coverage means an arrangement under which enrolled 
individuals are protected from some or all liability for the cost of 
specified health care services.
    Health care services means any of the services, devices, supplies, 
therapies, or other items listed in Sec.  457.402.
    Health insurance coverage has the meaning assigned at 45 CFR 
144.103.
    Health insurance issuer has the meaning assigned at 45 CFR 144.103.
    Health maintenance organization (HMO) plan has the meaning assigned 
at Sec.  457.420.
    Health services initiatives means activities that protect the public 
health, protect the health of individuals, improve or promote a State's 
capacity to deliver public health services, or strengthen the human and 
material resources necessary to accomplish public health goals relating 
to improving the health of children (including targeted low-income 
children and other low-income children).

[[Page 573]]

    Household income is defined as provided in Sec.  435.603(d) of this 
chapter.
    Insurance affordability program is defined as provided in Sec.  
435.4 of this chapter.
    Joint application has the meaning assigned at Sec.  457.301.
    Joint review request means a request for a review under subpart K of 
this part which is included in an appeal request submitted to an 
Exchange or Exchange appeals entity or other insurance affordability 
program or appeals entity, in accordance with the signed agreement 
between the State and an Exchange or Exchange appeals entity or other 
program or appeals entity in accordance with Sec.  457.348(b).
    Low-income child means a child whose household income is at or below 
200 percent of the poverty line for the size of the family involved.
    Managed care entity (MCE) means an entity that enters into a 
contract to provide services in a managed care delivery system, 
including but not limited to managed care organizations, prepaid health 
plans, and primary care case managers.
    Managed care organization (MCO) means an entity that has, or is 
seeking to qualify for, a comprehensive risk contract under this part, 
and that is--
    (1) A Federally qualified HMO that meets the requirements of subpart 
I of part 489 of this chapter; or
    (2) Makes the services it provides to its CHIP enrollees as 
accessible (in terms of timeliness, amount, duration, and scope) as 
those services are to other CHIP beneficiaries within the area served by 
the entity and
    (3) Meets the solvency standards of Sec.  438.116 of this chapter.
    Medicaid expansion program means a program under which a State 
receives Federal funding to expand Medicaid eligibility to optional 
targeted low-income children.
    Optional targeted low-income child has the meaning assigned at Sec.  
435.4 (for States) and Sec.  436.3 (for Territories) of this chapter.
    Period of presumptive eligibility has the meaning assigned at Sec.  
457.301.
    Poverty line/Federal poverty level means the poverty guidelines 
updated annually in the Federal Register by the U.S. Department of 
Health and Human Services under authority of 42 U.S.C. 9902(2).
    Preexisting condition exclusion has the meaning assigned at 45 CFR 
144.103.
    Premium assistance program means a component of a separate child 
health program, approved under the State plan, under which a State pays 
part or all of the premiums for a CHIP enrollee or enrollees' group 
health insurance coverage or coverage under a group health plan.
    Premium Lock-Out is defined as a State-specified period of time not 
to exceed 90 days that a CHIP eligible child who has an unpaid premium 
or enrollment fee (as applicable) will not be permitted to reenroll for 
coverage in CHIP. Premium lock-out periods are not applicable to 
children who have paid outstanding premiums or enrollment fees.
    Prepaid ambulatory health plan (PAHP) means an entity that--
    (1) Provides services to enrollees under contract with the State, 
and on the basis of prepaid capitation payments, or other payment 
arrangements that do not use State plan payment rates.
    (2) Does not provide or arrange for, and is not otherwise 
responsible for the provision of any inpatient hospital or institutional 
services for its enrollees.
    (3) Does not have a comprehensive risk contract.
    Prepaid inpatient health plan (PIHP) means an entity that--
    (1) Provides services to enrollees under contract with the State, 
and on the basis of prepaid capitation payments, or other payment 
arrangements that do not use State plan payment rates.
    (2) Provides, arranges for, or otherwise has responsibility for the 
provision of any inpatient hospital or institutional services for its 
enrollees.
    (3) Does not have a comprehensive risk contract.
    Presumptive income standard has the meaning assigned at Sec.  
457.301.
    Primary care case management means a system under which:
    (1) A PCCM contracts with the State to furnish case management 
services (which include the location, coordination and monitoring of 
primary health care services) to CHIP beneficiaries; or

[[Page 574]]

    (2) A PCCM entity contracts with the State to provide a defined set 
of functions to CHIP beneficiaries.
    Primary care case management entity (PCCM entity) means an 
organization that provides any of the following functions, in addition 
to primary care case management services, for the State:
    (1) Provision of intensive telephonic or face-to-face case 
management, including operation of a nurse triage advice line.
    (2) Development of enrollee care plans.
    (3) Execution of contracts with and/or oversight responsibilities 
for the activities of fee-for-service providers in the fee-for-service 
program.
    (4) Provision of payments to fee-for-service providers on behalf of 
the State.
    (5) Provision of enrollee outreach and education activities.
    (6) Operation of a customer service call center.
    (7) Review of provider claims, utilization and practice patterns to 
conduct provider profiling and/or practice improvement.
    (8) Implementation of quality improvement activities including 
administering enrollee satisfaction surveys or collecting data necessary 
for performance measurement of providers.
    (9) Coordination with behavioral health systems/providers.
    (10) Coordination with long-term services and supports systems/
providers.
    Primary care case manager (PCCM) means a physician, a physician 
group practice or, at State option, any of the following in addition to 
primary care case management services:
    (1) A physician assistant.
    (2) A nurse practitioner.
    (3) A certified nurse-midwife.
    Provider means any individual or entity that is engaged in the 
delivery of services, or ordering or referring for those services, and 
is legally authorized to do so by the State in which it delivers the 
services.
    Public agency has the meaning assigned in Sec.  457.301.
    Qualified entity has the meaning assigned at Sec.  457.301.
    Risk contract means a contract under which the contractor--
    (1) Assumes risk for the cost of the services covered under the 
contract.
    (2) Incurs loss if the cost of furnishing the services exceeds the 
payments under the contract.
    Secure electronic interface is defined as provided in Sec.  435.4 of 
this chapter.
    Separate child health program means a program under which a State 
receives Federal funding from its title XXI allotment to provide child 
health assistance through obtaining coverage that meets the requirements 
of section 2103 of the Act and Sec.  457.402.
    Shared eligibility service is defined as provided in Sec.  435.4 of 
this chapter.
    State means all States, the District of Columbia, Puerto Rico, the 
U.S. Virgin Islands, Guam, American Samoa and the Northern Mariana 
Islands. The Territories are excluded from this definition for purposes 
of Sec.  457.740.
    State health benefits plan has the meaning assigned in Sec.  
457.301.
    State plan means the title XXI State child health plan.
    Targeted low-income child has the meaning assigned in Sec.  457.310.
    Uncovered or uninsured child means a child who does not have 
creditable health coverage.
    Well-baby and well-child care services means regular or preventive 
diagnostic and treatment services necessary to ensure the health of 
babies, children and adolescents as defined by the State. For purposes 
of cost sharing, the term has the meaning assigned at Sec.  457.520.

[66 FR 2670, Jan. 11, 2001, as amended at 67 FR 61974, Oct. 2, 2002; 75 
FR 48852, Aug. 11, 2010; 77 FR 17213, Mar. 23, 2012; 78 FR 42312, July 
15, 2013; 81 FR 27896, May 6, 2016; 81 FR 47046, July 20, 2016; 81 FR 
86463, Nov. 30, 2016]



Sec.  457.30  Basis, scope, and applicability of subpart A.

    (a) Statutory basis. This subpart implements the following sections 
of the Act:
    (1) Section 2101(b), which requires that the State submit a State 
plan.
    (2) Section 2102(a), which sets forth requirements regarding the 
contents of the State plan.
    (3) Section 2102(b), which relates to eligibility standards and 
methodologies.

[[Page 575]]

    (4) Section 2102(c), which requires that the State plan include a 
description of the procedures to be used by the State to accomplish 
outreach and coordination with other health insurance programs.
    (5) Section 2106, which specifies the process for submission, 
approval, and amendment of State plans.
    (6) Section 2107(c), which requires that the State plan include a 
description of the process used to involve the public in the design and 
implementation of the plan.
    (7) Section 2107(d), which requires that the State plan include a 
description of the budget for the plan.
    (8) Section 2107(e), which provides that certain provisions of title 
XIX and title XI of the Act apply under title XXI in the same manner 
that they apply under title XIX.
    (b) Scope. This subpart sets forth provisions governing the 
administration of CHIP, the general requirements for a State plan, and a 
description of the process for review of a State plan or plan amendment.
    (c) Applicability. This subpart applies to all States that request 
Federal financial participation to provide child health assistance under 
title XXI.



Sec.  457.40  State program administration.

    (a) Program operation. The State must implement its program in 
accordance with the approved State plan, any approved State plan 
amendments, the requirements of title XXI and title XIX (as 
appropriate), and the requirements in this chapter. CMS monitors the 
operation of the approved State plan and plan amendments to ensure 
compliance with the requirements of title XXI, title XIX (as 
appropriate) and this chapter.
    (b) State authority to submit State plan. A State plan or plan 
amendment must be signed by the State Governor, or signed by an 
individual who has been delegated authority by the Governor to submit 
it.
    (c) State program officials. The State must identify in the State 
plan or State plan amendment, by position or title, the State officials 
who are responsible for program administration and financial oversight.
    (d) State legislative authority. The State plan must include an 
assurance that the State will not claim expenditures for child health 
assistance prior to the time that the State has legislative authority to 
operate the State plan or plan amendment as approved by CMS.



Sec.  457.50  State plan.

    The State plan is a comprehensive written statement, submitted by 
the State to CMS for approval, that describes the purpose, nature, and 
scope of the State's CHIP and gives an assurance that the program is 
administered in conformity with the specific requirements of title XXI, 
title XIX (as appropriate), and the regulations in this chapter. The 
State plan contains all information necessary for CMS to determine 
whether the plan can be approved to serve as a basis for Federal 
financial participation (FFP) in the State program. The Secretary will 
periodically specify updated requirements on the format of State plan 
through a process consistent with the requirements of the Paperwork 
Reduction Act.

[81 FR 86463, Nov. 30, 2016]



Sec.  457.60  Amendments.

    A State may seek to amend its approved State plan in whole or in 
part at any time through the submission of an amendment to CMS. The 
Secretary will periodically specify updated requirements on the format 
of State plan amendments through a process consistent with the 
requirements of the Paperwork Reduction Act. When the State plan 
amendment has a significant impact on the approved budget, the amendment 
must include an amended budget that describes the State's planned 
expenditures for a 1-year period. A State must amend its State plan 
whenever necessary to reflect--
    (a) Changes in Federal law, regulations, policy interpretations, or 
court decisions that affect provisions in the approved State plan;
    (b) Changes in State law, organization, policy, or operation of the 
program that affect the following program elements described in the 
State plan:

[[Page 576]]

    (1) Eligibility standards, enrollment caps, and disenrollment 
policies as described in Sec.  457.305.
    (2) Procedures to prevent substitution of private coverage as 
described in Sec.  457.805, and in Sec.  457.810 for premium assistance 
programs.
    (3) The type of health benefits coverage offered, consistent with 
the options described in Sec.  457.410.
    (4) Addition or deletion of specific categories of benefits covered 
under the State plan.
    (5) Basic delivery system approach as described in Sec.  457.490.
    (6) Cost-sharing as described in Sec.  457.505.
    (7) Screen and enroll procedures, and other Medicaid coordination 
procedures as described in Sec.  457.350.
    (8) Review procedures as described in Sec.  457.1120.
    (9) Other comparable required program elements.
    (c) Changes in the source of the State share of funding, except for 
changes in the type of non-health care related revenues used to generate 
general revenue.

[66 FR 2670, Jan. 11, 2001, as amended at 66 FR 33822, June 25, 2001; 81 
FR 86463, Nov. 30, 2016]



Sec.  457.65  Effective date and duration of State plans and plan amendments.

    (a) Effective date in general. Except as otherwise limited by this 
section--
    (1) A State plan or plan amendment takes effect on the day specified 
in the plan or plan amendment, but no earlier than October 1, 1997.
    (2) The effective date may be no earlier than the date on which the 
State begins to incur costs to implement its State plan or plan 
amendment.
    (3) A State plan amendment that takes effect prior to submission of 
the amendment to CMS may remain in effect only until the end of the 
State fiscal year in which the State makes it effective, or, if later, 
the end of the 90-day period following the date on which the State makes 
it effective, unless the State submits the amendment to CMS for approval 
before the end of that State fiscal year or that 90-day period.
    (b) Amendments relating to eligibility or benefits. A State plan 
amendment that eliminates or restricts eligibility or benefits may not 
be in effect for longer than a 60-day period, unless the amendment is 
submitted to CMS before the end of that 60-day period. The amendment may 
not take effect unless--
    (1) The State certifies that it has provided prior public notice of 
the proposed change in a form and manner provided under applicable State 
law; and
    (2) The public notice was published before the requested effective 
date of the change.
    (c) Amendments relating to cost sharing. A State plan amendment that 
implements cost-sharing charges, increases existing cost-sharing 
charges, or increases the cumulative cost-sharing maximum as set forth 
at Sec.  457.560 is considered an amendment that restricts benefits and 
must meet the requirements in paragraph (b) of this section.
    (d) Amendments relating to enrollment procedures. A State plan 
amendment that implements a required period of uninsurance, increases 
the length of existing required periods of uninsurance, or institutes or 
extends the use of waiting lists, enrollments caps or closed enrollment 
periods is considered an amendment that restricts eligibility and must 
meet the requirements in paragraph (b) of this section.
    (e) Amendments relating to the source of State funding. A State plan 
amendment that changes the source of the State share of funding can take 
effect no earlier than the date of submission of the amendment.
    (f) Continued approval. An approved State plan continues in effect 
unless--
    (1) The State adopts a new plan by obtaining approval under Sec.  
457.60 of an amendment to the State plan;
    (2) Withdraws its plan in accordance with Sec.  457.170(b); or
    (3) The Secretary finds substantial noncompliance of the plan with 
the requirements of the statute or regulations.



Sec.  457.70  Program options.

    (a) Health benefits coverage options. A State may elect to obtain 
health benefits coverage under its plan through--
    (1) A separate child health program;
    (2) A Medicaid expansion program; or

[[Page 577]]

    (3) A combination program.
    (b) State plan requirement. A State must include in the State plan 
or plan amendment a description of the State's chosen program option.
    (c) Medicaid expansion program requirements. A State plan under 
title XXI for a State that elects to obtain health benefits coverage 
through its Medicaid plan must--
    (1) Meet the requirements of--
    (i) Subpart A;
    (ii) Subpart B (to the extent that the State claims administrative 
costs under title XXI);
    (iii) Subpart F (with respect to determination of the allotment for 
purposes of the enhanced matching rate, determination of the enhanced 
matching rate, and payment of any claims for administrative costs under 
title XXI only);
    (iv) Subpart G; and
    (v) Subpart J (if the State claims administrative costs under title 
XXI and seeks a waiver of limitations on such claims based on a 
community based health delivery system).
    (2) Be consistent with the State's Medicaid State plan, or an 
approvable amendment to that plan, as required under title XIX.
    (d) Separate child health program requirements. A State that elects 
to obtain health benefits coverage under its plan through a separate 
child health program must meet all the requirements of part 457.
    (e) Combination program requirements. A State that elects to obtain 
health benefits coverage through both a separate child health program 
and a Medicaid expansion program must meet the requirements of 
paragraphs (c) and (d) of this section.



Sec.  457.80  Current State child health insurance coverage and
coordination.

    A State plan must include a description of--
    (a) The extent to which, and manner in which, children in the State, 
including targeted low-income children and other classes of children, by 
income level and other relevant factors, currently have creditable 
health coverage (as defined in Sec.  457.10) and, if sufficient 
information is available, whether the creditable health coverage they 
have is under public health insurance programs or health insurance 
programs that involve public-private partnerships;
    (b) Current State efforts to provide or obtain creditable health 
coverage for uncovered children, including the steps the State is taking 
to identify and enroll all uncovered children who are eligible to 
participate in public health insurance programs and health insurance 
programs that involve public-private partnerships; and
    (c) Procedures the State uses to accomplish coordination of CHIP 
with other public and private health insurance programs, sources of 
health benefits coverage for children, and relevant child health 
programs, such as title V, that provide health care services for low-
income children. Such procedures include those designed to--
    (1) Increase the number of children with creditable health coverage;
    (2) Assist in the enrollment in CHIP of children determined 
ineligible for Medicaid; and
    (3) Ensure coordination with other insurance affordability programs 
in the determination of eligibility and enrollment in coverage to ensure 
that all eligible individuals are enrolled in the appropriate program, 
including through use of the procedures described in Sec. Sec.  457.305, 
457.348 and 457.350 of this part.

[65 FR 33622, May 24, 2000, as amended at 77 FR 17214, Mar. 23, 2012]



Sec.  457.90  Outreach.

    (a) Procedures required. A State plan must include a description of 
procedures used to inform families of children likely to be eligible for 
child health assistance under the plan or under other public or private 
health coverage programs of the availability of the programs, and to 
assist them in enrolling their children in one of the programs.
    (b) Examples. Outreach strategies may include but are not limited to 
the following:
    (1) Education and awareness campaigns, including targeted mailings 
and information distribution through various organizations.
    (2) Enrollment simplification, such as simplified or joint 
application forms.

[[Page 578]]

    (3) Application assistance, including opportunities to apply for 
child health assistance under the plan through community-based 
organizations and in combination with other benefits and services 
available to children.



Sec.  457.110  Enrollment assistance and information requirements.

    (a) Information disclosure. The State must make accurate, easily 
understood, information available to families of potential applicants, 
applicants and enrollees, and provide assistance to these families in 
making informed decisions about their health plans, professionals, and 
facilities. This information must be provided in plain language and is 
accessible to individuals with disabilities and persons who are limited 
English proficient, consistent with Sec.  435.905(b) of this chapter.
    (1) The State must provide individuals with a choice to receive 
notices and information required under this subpart and subpart K of 
this part, in electronic format or by regular mail, provided that the 
State establish safeguards in accordance with Sec.  435.918 of this 
chapter.
    (2) [Reserved]
    (b) Required information. The State must make available to potential 
applicants and provide applicants and enrollees the following 
information in a timely manner:
    (1) Types of benefits, and amount, duration and scope of benefits 
available under the program.
    (2) Cost-sharing requirements as described in Sec.  457.525.
    (3) Names and locations of current participating providers.
    (4) If an enrollment cap is in effect or the State is using a 
waiting list, a description of the procedures relating to the cap or 
waiting list, including the process for deciding which children will be 
given priority for enrollment, how children will be informed of their 
status on a waiting list and the circumstances under which enrollment 
will reopen.
    (5) Information on physician incentive plans as required by Sec.  
457.985.
    (6) Review processes available to applicants and enrollees as 
described in the State plan pursuant to Sec.  457.1120.

[65 FR 33622, May 24, 2000, as amended at 78 FR 42312, July 15, 2013; 81 
FR 86463, Nov. 30, 2016]



Sec.  457.120  Public involvement in program development.

    A State plan must include a description of the method the State uses 
to--
    (a) Involve the public in both the design and initial implementation 
of the program;
    (b) Ensure ongoing public involvement once the State plan has been 
implemented; and
    (c) Ensure interaction with Indian Tribes and organizations in the 
State on the development and implementation of the procedures required 
at Sec.  457.125.



Sec.  457.125  Provision of child health assistance to American Indian 
and Alaska Native children.

    (a) Enrollment. A State must include in its State plan a description 
of procedures used to ensure the provision of child health assistance to 
American Indian and Alaska Native children.
    (b) Exemption from cost sharing. The procedures required by 
paragraph (a) of this section must include an exemption from cost 
sharing for American Indian and Alaska Native children in accordance 
with Sec.  457.535.



Sec.  457.130  Civil rights assurance.

    The State plan must include an assurance that the State will comply 
with all applicable civil rights requirements, including title VI of the 
Civil Rights Act of 1964, title II of the Americans with Disabilities 
Act of 1990, section 504 of the Rehabilitation Act of 1973, the Age 
Discrimination Act of 1975, 45 CFR part 80, part 84, and part 91, and 28 
CFR part 35.



Sec.  457.135  Assurance of compliance with other provisions.

    The State plan must include an assurance that the State will comply, 
under title XXI, with the following provisions of titles XIX and XI of 
the Social Security Act:
    (a) Section 1902(a)(4)(C) (relating to conflict of interest 
standards).

[[Page 579]]

    (b) Paragraphs (2), (16) and (17) of section 1903(i) (relating to 
limitations on payment).
    (c) Section 1903(w) (relating to limitations on provider donations 
and taxes).
    (d) Section 1132 (relating to periods within which claims must be 
filed).



Sec.  457.140  Budget.

    The State plan, or plan amendment that has a significant impact on 
the approved budget, must include a budget that describes the State's 
planned expenditures for a 1-year period. The budget must describe--
    (a) Planned use of funds, including--
    (1) Projected amount to be spent on health services;
    (2) Projected amount to be spent on administrative costs, such as 
outreach, child health initiatives, and evaluation; and
    (3) Assumptions on which the budget is based, including cost per 
child and expected enrollment; and
    (b) Projected sources of non-Federal plan expenditures, including 
any requirements for cost sharing by enrollees.



Sec.  457.150  CMS review of State plan material.

    (a) Basis for action. CMS reviews each State plan and plan amendment 
to determine whether it meets or continues to meet the requirements for 
approval under relevant Federal statutes, regulations, and guidelines 
furnished by CMS to assist in the interpretation of these regulations.
    (b) Action on complete plan. CMS approves or disapproves the State 
plan or plan amendment only in its entirety.
    (c) Authority. The CMS Administrator exercises delegated authority 
to review and then to approve or disapprove the State plan or plan 
amendment, or to determine that previously approved material no longer 
meets the requirements for approval. The Administrator does not make a 
final determination of disapproval without first consulting the 
Secretary.
    (d) Initial submission. The Administrator designates an official to 
receive the initial submission of State plans.
    (e) Review process. (1) The Administrator designates an individual 
to coordinate CMS's review for each State that submits a State plan.
    (2) CMS notifies the State of the identity of the designated 
individual in the first correspondence relating to that plan, and at any 
time there is a change in the designated individual.
    (3) In the temporary absence of the designated individual during 
regular business hours, an alternate individual will act in place of the 
designated individual.



Sec.  457.160  Notice and timing of CMS action on State plan material.

    (a) Notice of final determination. The Administrator provides 
written notification to the State of the approval or disapproval of a 
State plan or plan amendment.
    (b) Timing. (1) A State plan or plan amendment will be considered 
approved unless CMS, within 90 calendar days after receipt of the State 
plan or plan amendment in the CMS central office, sends the State--
    (i) Written notice of disapproval; or
    (ii) Written notice of additional information it needs in order to 
make a final determination.
    (2) A State plan or plan amendment is considered received when the 
designated official or individual, as determined in Sec.  457.150(d) and 
(e), receives an electronic, fax or paper copy of the complete material.
    (3) If CMS requests additional information, the 90-day review period 
for CMS action on the State plan or plan amendment--
    (i) Stops on the day CMS sends a written request for additional 
information or the next business day if the request is sent on a Federal 
holiday or weekend; and
    (ii) Resumes on the next calendar day after the CMS designated 
individual receives an electronic, fax, or hard copy from the State of 
all the requested additional information, unless the information is 
received after 5 p.m. eastern standard time on a day prior to a non-
business day or any time on a non-business day, in which case the review 
period resumes on the following business day.
    (4) The 90-day review period cannot stop or end on a non-business 
day. If the 90th calendar day falls on a non-

[[Page 580]]

business day, CMS will consider the 90th day to be the next business 
day.
    (5) CMS may send written notice of its need for additional 
information as many times as necessary to obtain the complete 
information necessary to review the State plan or plan amendment.



Sec.  457.170  Withdrawal process.

    (a) Withdrawal of proposed State plans or plan amendments. A State 
may withdraw a proposed State plan or plan amendment, or any portion of 
a proposed State plan or plan amendment, at any time during the review 
process by providing written notice to CMS of the withdrawal.
    (b) Withdrawal of approved State plans. A State may request 
withdrawal of an approved State plan by submitting a State plan 
amendment to CMS in accordance with Sec.  457.60.



  Subpart B_General Administration_Reviews and Audits; Withholding for 
  Failure to Comply; Deferral and Disallowance of Claims; Reduction of 
                        Federal Medical Payments



Sec.  457.200  Program reviews.

    (a) Review of State and local administration of the CHIP plan. In 
order to determine whether the State is complying with the Federal 
requirements and the provisions of its plan, CMS reviews State and local 
administration of the CHIP plan through analysis of the State's policies 
and procedures, on-site reviews of selected aspects of agency operation, 
and examination of samples of individual case records.
    (b) Action on review findings. If Federal or State reviews reveal 
serious problems with respect to compliance with any Federal or State 
plan requirement, the State must correct its practice accordingly.



Sec.  457.202  Audits.

    (a) Purpose. The Department's Office of Inspector General (OIG) 
periodically audits State operations in order to determine whether--
    (1) The program is being operated in a cost-efficient manner; and
    (2) Funds are being properly expended for the purposes for which 
they were appropriated under Federal and State law and regulations.
    (b) Reports. (1) The OIG releases audit reports simultaneously to 
State officials and the Department's program officials.
    (2) The reports set forth OIG opinion and recommendations regarding 
the practices it reviewed, and the allowability of the costs it audited.
    (3) Cognizant officials of the Department make final determinations 
on all audit findings.
    (c) Action on audit exceptions--(1) Concurrence or clearance. The 
State agency has the opportunity of concurring in the exceptions or 
submitting additional facts that support clearance of the exceptions.
    (2) Appeal. Any exceptions that are not disposed of under paragraph 
(c)(1) of this section are included in a disallowance letter that 
constitutes the Department's final decision unless the State requests 
reconsideration by the Appeals Board. (Specific rules are set forth in 
Sec.  457.212.)
    (3) Adjustment. If the decision by the Board requires an adjustment 
of FFP, either upward or downward, a subsequent grant award promptly 
reflects the amount of increase or decrease.



Sec.  457.203  Administrative and judicial review of action on State
plan material.

    (a) Request for reconsideration. Any State dissatisfied with the 
Administrator's action on State plan material under Sec.  457.150 may, 
within 60 days after receipt of the notice of final determination 
provided under Sec.  457.160(a), request that the Administrator 
reconsider whether the State plan or plan amendment conforms with the 
requirements for approval.
    (b) Notice of hearing. Within 30 days after receipt of the request, 
the Administrator notifies the State of the time and place of a hearing 
to be held for the purpose of reconsideration.
    (c) Hearing procedures. The hearing procedures set forth in part 
430, subpart D of this chapter govern a hearing requested under this 
section.
    (d) Effect of hearing decision. CMS does not delay the denial of 
Federal

[[Page 581]]

funds, if required by the Administrator's original determination, 
pending a hearing decision. If the Administrator determines that his or 
her original decision was incorrect, CMS will pay the State a lump sum 
equal to any funds incorrectly denied.

[66 FR 2674, Jan. 11, 2001]



Sec.  457.204  Withholding of payment for failure to comply with
Federal requirements.

    (a) Basis for withholding. CMS withholds payments to the State, in 
whole or in part, only if, after giving the State notice, a reasonable 
opportunity for correction, and an opportunity for a hearing, the 
Administrator finds--
    (1) That the State plan is in substantial noncompliance with the 
requirements of Title XXI of the Act or the regulations in this part; or
    (2) That the State is conducting its program in substantial 
noncompliance with either the State plan or the requirements of Title 
XXI of the Act or the regulations in this part. (Hearings are generally 
not called until a reasonable effort has been made to resolve the issues 
through conferences and discussions. These efforts may be continued even 
if a date and place have been set for the hearing.)
    (3) For purposes of this paragraph (a), substantial non-compliance 
includes, but is not limited to, failure to comply with requirements 
that significantly affect federal or state oversight or state reporting.
    (b) Noncompliance of the plan. A question of noncompliance of a 
State plan may arise from an unapprovable change in the approved State 
plan or the failure of the State to change its approved plan to conform 
to a new Federal requirement for approval of State plans.
    (c) Noncompliance in practice. A question of noncompliance in 
practice may arise from the State's failure to actually comply with a 
Federal requirement, regardless of whether the plan itself complies with 
that requirement.
    (d) Notice, reasonable opportunity for correction, and 
implementation of withholding. If the Administrator makes a finding of 
noncompliance under paragraph (a) of this section, the following steps 
apply:
    (1) Preliminary notice. The Administrator provides a preliminary 
notice to the State--
    (i) Of the findings of noncompliance;
    (ii) The proposed enforcement actions to withhold payments; and
    (iii) If enforcement action is proposed, that the State has a 
reasonable opportunity for correction, described in paragraph (d)(2) of 
this section, before the Administrator takes final action.
    (2) Opportunity for corrective action. If enforcement actions are 
proposed, the State must submit evidence of corrective action related to 
the findings of noncompliance to the Administrator within 30 days from 
the date of the preliminary notification. Corrective action is action to 
ensure that the plan is, and will be, administered consistent with 
applicable law and regulations, to ameliorate past deficiencies in plan 
administration, or to ensure that enrollees will be treated equitably.
    (3) Final notice. Taking into account any evidence submitted by the 
State under paragraph (d)(2) of this section, the Administrator makes a 
final determination related to the findings of noncompliance, and 
provides a final notice to the State--
    (i) Of the final determination on the findings of noncompliance;
    (ii) If enforcement action is appropriate--
    (A) No further payments will be made to the State (or that payments 
will be made only for those portions or aspects of the programs that are 
not affected by the noncompliance); and
    (B) The total or partial withholding will continue until the 
Administrator is satisfied that the State's plan and practice are, and 
will continue to be, in compliance with Federal requirements.
    (4) Hearing. An opportunity for a hearing will be provided to the 
State prior to withholding under paragraph (d)(5) of this section.
    (5) Withholding. CMS withholds payments, in whole or in part, until 
the Administrator is satisfied regarding the State's compliance.

[65 FR 33622, May 24, 2000, as amended at 66 FR 2674, Jan. 11, 2001; 81 
FR 27897, May 6, 2016]

[[Page 582]]



Sec.  457.206  Administrative appeals under CHIP.

    Three distinct types of determinations are subject to Departmental 
reconsideration upon request by a State.
    (a) Compliance with Federal requirements. A determination that a 
State's plan or proposed plan amendments, or its practice under the plan 
do not meet (or continue to meet) Federal requirements are subject to 
the hearing provisions of 42 CFR part 430, subpart D of this chapter.
    (b) FFP in State CHIP expenditures. Disallowances of FFP in State 
CHIP expenditures (mandatory grants) are subject to Departmental 
reconsideration by the Departmental Appeals Board (the Board) in 
accordance with procedures set forth in 45 CFR part 16.
    (c) Discretionary grants disputes. Determinations listed in 45 CFR 
part 16, appendix A, pertaining to discretionary grants, such as grants 
for special demonstration projects under Section 1115 of the Act, that 
may be awarded to an CHIP agency, are subject to reconsideration by the 
Departmental Grant Appeals Board.



Sec.  457.208  Judicial review.

    (a) Right to judicial review. Any State dissatisfied with the 
Administrator's final determination on approvability of plan material 
(Sec.  457.203) or compliance with Federal requirements (Sec.  457.204) 
has a right to judicial review.
    (b) Petition for review. (1) The State must file a petition for 
review with the U.S. Court of Appeals for the circuit in which the State 
is located, within 60 days after it is notified of the determination.
    (2) After the clerk of the court files a copy of the petition with 
the Administrator, the Administrator files in the court the record of 
the proceedings on which the determination was based.
    (c) Court action. (1) The court is bound by the Administrator's 
findings of fact, if they are supported by substantial evidence.
    (2) The court has jurisdiction to affirm the Administrator's 
decision, to set it aside in whole or in part, or, for good cause, to 
remand the case for additional evidence.
    (d) Response to remand. (1) If the court remands the case, the 
Administrator may make new or modified findings of fact and may modify 
his or her previous determination.
    (2) The Administrator certifies to the court the transcript and 
record of the further proceedings.
    (e) Review by the Supreme Court. The judgment of the appeals court 
is subject to review by the U.S. Supreme Court upon certiorari or 
certification, as provided in 28 U.S.C. 1254.

[65 FR 33622, May 24, 2000, as amended at 66 FR 2674, Jan. 11, 2001]



Sec.  457.216  Treatment of uncashed or canceled (voided) CHIP checks.

    (a) Purpose. This section provides rules to ensure that States 
refund the Federal portion of uncashed or canceled (voided) checks under 
title XXI.
    (b) Definitions. As used in this section--
    Canceled (voided) check means an CHIP check issued by a State or 
fiscal agent that prior to its being cashed is canceled (voided) by the 
State or fiscal agent, thus preventing disbursement of funds.
    Fiscal agent means an entity that processes or pays vendor claims 
for the CHIP agency.
    Uncashed check means an CHIP check issued by a State or fiscal agent 
that has not been cashed by the payee.
    Warrant means an order by which the CHIP agency or local agency 
without the authority to issue checks recognizes a claim. Presentation 
of a warrant by the payee to a State officer with authority to issue 
checks will result in release of funds due.
    (c) Refund of Federal financial participation (FFP) for uncashed 
checks--(1) General provisions. If a check remains uncashed beyond a 
period of 180 days from the date it was issued; that is, the date of the 
check, it is no longer regarded as an allowable program expenditure. If 
the State has claimed and received FFP for the amount of the uncashed 
check, it must refund the amount of FFP received.
    (2) Report of refund. At the end of each calendar quarter, the State 
agency must identify those checks that remain uncashed beyond a period 
of 180 days after issuance. The CHIP agency must refund all FFP that it 
received for uncashed checks by adjusting the

[[Page 583]]

Quarterly Statement of Expenditures for that quarter. If an uncashed 
check is cashed after the refund is made, the State may file a claim. 
The claim will be considered to be an adjustment to the costs for the 
quarter in which the check was originally claimed. This claim will be 
paid if otherwise allowed by the Act and the regulations issued in 
accordance with the Act.
    (3) If the State does not refund the appropriate amount as specified 
in paragraph (c)(2) of this section, the amount will be disallowed.
    (d) Refund of FFP for canceled (voided) checks--(1) General 
provisions. If the State has claimed and received FFP for the amount of 
a canceled (voided) check, it must refund the amount of FFP received.
    (2) Report of refund. At the end of each calendar quarter, the CHIP 
agency must identify those checks that were canceled (voided). The State 
must refund all FFP that it received for canceled (voided) checks by 
adjusting the Quarterly Statement of Expenditures for that quarter.
    (3) If the State does not refund the appropriate amount as specified 
in paragraph (d)(2) of this section, the amount will be disallowed.



Sec.  457.220  Funds from units of government as the State share of
financial participation.

    (a) Public funds may be considered as the State's share in claiming 
FFP if they meet the conditions specified in paragraphs (b) and (c) of 
this section.
    (b) The public funds are appropriated directly to the State or local 
CHIP agency, or are transferred from other public agencies (including 
Indian tribes) to the State or local agency and are under its 
administrative control, or are certified by the contributing public 
agency as representing expenditures eligible for FFP under this section.
    (c) The public funds are not Federal funds, or are Federal funds 
authorized by Federal law to be used to match other Federal funds.

[75 FR 73976, Nov. 30, 2010]



Sec.  457.222  FFP for equipment.

    Claims for Federal financial participation in the cost of equipment 
under CHIP are determined in accordance with subpart G of 45 CFR part 
95. Requirements concerning the management and disposition of equipment 
under CHIP are also prescribed in subpart G of 45 CFR part 95.



Sec.  457.224  FFP: Conditions relating to cost sharing.

    (a) No FFP is available for the following amounts, even when related 
to services or benefit coverage which is or could be provided under a 
State CHIP program--
    (1) Any cost sharing amounts that beneficiaries should have paid as 
enrollment fees, premiums, deductibles, coinsurance, copayments, or 
similar charges.
    (2) Any amounts paid by the agency for health benefits coverage or 
services furnished to individuals who would not be eligible for that 
coverage or those services under the approved State child health plan, 
whether or not the individual paid any required premium or enrollment 
fee.
    (b) The amount of expenditures under the State child health plan 
must be reduced by the amount of any premiums and other cost-sharing 
received by the State.



Sec.  457.226  Fiscal policies and accountability.

    A State plan must provide that the CHIP agency and, where 
applicable, local agencies administering the plan will--
    (a) Maintain an accounting system and supporting fiscal records to 
assure that claims for Federal funds are in accord with applicable 
Federal requirements;
    (b) Retain records for 3 years from date of submission of a final 
expenditure report;
    (c) Retain records beyond the 3-year period if audit findings have 
not been resolved; and
    (d) Retain records for nonexpendable property acquired under a 
Federal grant for 3 years from the date of final disposition of that 
property.



Sec.  457.228  Cost allocation.

    A State plan must provide that the single or appropriate CHIP Agency 
will have an approved cost allocation plan

[[Page 584]]

on file with the Department in accordance with the requirements 
contained in subpart E of 45 CFR part 95. Subpart E also sets forth the 
effect on FFP if the requirements contained in that subpart are not met.



Sec.  457.230  FFP for State ADP expenditures.

    FFP is available for State ADP expenditures for the design, 
development, or installation of mechanized claims processing and 
information retrieval systems and for the operation of certain systems. 
Additional HHS regulations and CMS procedures regarding the availability 
of FFP for ADP expenditures are in 45 CFR part 75, 45 CFR part 95, 
subpart F, and part 11, State Medicaid Manual.

[65 FR 33622, May 24, 2000, as amended at 81 FR 3012, Jan. 20, 2016]



Sec.  457.232  Refunding of Federal Share of CHIP overpayments to providers
and referral of allegations of waste, fraud or abuse to the Office of
Inspector General.

    (a) Quarterly Federal payments to the States under title XXI (CHIP) 
of the Act are to be reduced or increased to make adjustment for prior 
overpayments or underpayments that the Secretary determines have been 
made.
    (b) The Secretary will consider the pro rata Federal share of the 
net amount recovered by a State during any quarter to be an overpayment.
    (c) Allegations or indications of waste fraud and abuse with respect 
to the CHIP program shall be referred promptly to the Office of 
Inspector General.



Sec.  457.236  Audits.

    The CHIP agency must assure appropriate audit of records on costs of 
provider services.



Sec.  457.238  Documentation of payment rates.

    The CHIP agency must maintain documentation of payment rates and 
make it available to HHS upon request.



Subpart C_State Plan Requirements: Eligibility, Screening, Applications, 
                             and Enrollment

    Source: 66 FR 2675, Jan. 11, 2001, unless otherwise noted.



Sec.  457.300  Basis, scope, and applicability.

    (a) Statutory basis. This subpart interprets and implements--
    (1) Section 2102 of the Act, which relates to eligibility standards 
and methodologies, coordination with other health insurance programs, 
and outreach and enrollment efforts to identify and enroll children who 
are eligible to participate in other public health insurance programs;
    (2) Section 2105(c)(6)(B) of the Act, which relates to the 
prohibition against expenditures for child health assistance provided to 
children eligible for coverage under other Federal health care programs 
other than programs operated or financed by the Indian Health Service; 
and
    (3) Section 2110(b) of the Act, which provides a definition of 
targeted low-income child.
    (4) Section 2107(e)(1)(O) of the Affordable Care Act, which relates 
to coordination of CHIP with the Exchanges and the State Medicaid 
agency.
    (5) Section 2107(e)(1)(F) of the Affordable Care Act, which relates 
to income determined based on modified adjusted gross income.
    (b) Scope. This subpart sets forth the requirements relating to 
eligibility standards and to screening, application and enrollment 
procedures.
    (c) Applicability. The requirements of this subpart apply to child 
health assistance provided under a separate child health program. 
Regulations relating to eligibility, screening, applications and 
enrollment that are applicable to a Medicaid expansion program are found 
at Sec. Sec.  435.4, 435.229, 435.905 through 435.908, 435.1102, 435.940 
through 435.958, 435.1200, 436.3, 436.229, and 436.1102 of this chapter.

[65 FR 33622, May 24, 2000, as amended at 77 FR 17214, Mar. 23, 2012]



Sec.  457.301  Definitions and use of terms.

    As used in this subpart--

[[Page 585]]

    Eligibility determination means an approval or denial of eligibility 
in accordance with Sec.  457.340 as well as a renewal or termination of 
eligibility under Sec.  457.343 of this subpart.
    Family size is defined as provided in Sec.  435.603(b) of this 
chapter.
    Medicaid applicable income level means, for a child, the effective 
income level (expressed as a percentage of the Federal poverty level and 
converted to a modified adjusted gross income equivalent level in 
accordance with guidance issued by the Secretary under section 
1902(e)(14)(A) and (E) of the Act) specified under the policies of the 
State plan under title XIX of the Act as of March 31, 1997 for the child 
to be eligible for Medicaid under either section 1902(l)(2) or 
1905(n)(2) of the Act, or under a section 1115 waiver authorized by the 
Secretary (taking into consideration any applicable income methodologies 
adopted under the authority of section 1902(r)(2) of the Act).
    Non-applicant means an individual who is not seeking an eligibility 
determination for him or herself and is included in an applicant's or 
enrollee's household to determine eligibility for such applicant or 
enrollee.
    Period of presumptive eligibility means a period that begins on the 
date on which a qualified entity determines that a child is 
presumptively eligible and ends with the earlier of--
    (1) In the case of a child on whose behalf a separate child health 
program application has been filed, the day on which a decision is made 
on that application; or
    (2) In the case of a child on whose behalf an application for the 
separate child health program has not been filed, the last day of the 
month following the month in which the determination of presumptive 
eligibility was made.
    Presumptive income standard means the highest income eligibility 
standard established under the plan that is most likely to be used to 
establish eligibility of a child of the age involved.
    Public agency means a State, county, city or other type of municipal 
agency, including a public school district, transportation district, 
irrigation district, or any other type of public entity.
    Qualified entity means an entity that is determined by the State to 
be capable of making determinations of presumptive eligibility for 
children, and that--
    (1) Furnishes health care items and services covered under the 
approved plan and is eligible to receive payments under the approved 
plan;
    (2) Is authorized to determine eligibility of a child to participate 
in a Head Start program under the Head Start Act;
    (3) Is authorized to determine eligibility of a child to receive 
child care services for which financial assistance is provided under the 
Child Care and Development Block Grant Act of 1990;
    (4) Is authorized to determine eligibility of an infant or child to 
receive assistance under the special nutrition program for women, 
infants, and children (WIC) under section 17 of the Child Nutrition Act 
of 1966;
    (5) Is authorized to determine eligibility of a child for medical 
assistance under the Medicaid State plan, or eligibility of a child for 
child health assistance under the Children's Health Insurance Program;
    (6) Is an elementary or secondary school, as defined in section 
14101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 
8801);
    (7) Is an elementary or secondary school operated or supported by 
the Bureau of Indian Affairs;
    (8) Is a State or Tribal child support enforcement agency;
    (9) Is an organization that--
    (i) Provides emergency food and shelter under a grant under the 
Stewart B. McKinney Homeless Assistance Act;
    (ii) Is a State or Tribal office or entity involved in enrollment in 
the program under this title, Part A of title IV, or title XXI; or
    (iii) Determines eligibility for any assistance or benefits provided 
under any program of public or assisted housing that receives Federal 
funds, including the program under section 8 or any other section of the 
United States Housing Act of 1937 (42 U.S.C. 1437) or under the Native 
American Housing Assistance and Self Determination Act of 1996 (25 
U.S.C. 4101 et seq.); and
    (10) Any other entity the State so deems, as approved by the 
Secretary.

[[Page 586]]

    State health benefits plan means a health insurance coverage plan 
that is offered or organized by the State government on behalf of State 
employees or other public agency employees within the State. The term 
does not include a plan in which the State provides no contribution 
toward the cost of coverage and in which no State employees participate, 
or a plan that provides coverage only for a specific type of care, such 
as dental or vision care.

[66 FR 2675, Jan. 11, 2001, as amended at 66 FR 33823, June 25, 2001; 75 
FR 48852, Aug. 11, 2010; 77 FR 17214, Mar. 23, 2012]



Sec.  457.305  State plan provisions.

    The State plan must include a description of--
    (a) The standards, consistent with Sec.  457.310 and Sec.  457.320 
of this subpart, and financial methodologies consistent with Sec.  
457.315 of this subpart used to determine the eligibility of children 
for coverage under the State plan.
    (b) The State's policies governing enrollment and disenrollment; 
processes for screening applicants for and, if eligible, facilitating 
their enrollment in other insurance affordability programs; and 
processes for implementing waiting lists and enrollment caps (if any).

[77 FR 17214, Mar. 23, 2012]



Sec.  457.310  Targeted low-income child.

    (a) Definition. A targeted low-income child is a child who meets the 
standards set forth below and the eligibility standards established by 
the State under Sec.  457.320.
    (b) Standards. A targeted low-income child must meet the following 
standards:
    (1) Financial need standard. A targeted low-income child:
    (i) Has a household income, as determined in accordance with Sec.  
457.315 of this subpart, at or below 200 percent of the Federal poverty 
level for a family of the size involved;
    (ii) Resides in a State with no Medicaid applicable income level;
    (iii) Resides in a State that has a Medicaid applicable income level 
and has a household income that either--
    (A) Exceeds the Medicaid applicable income level for the age of such 
child, but not by more than 50 percentage points; or
    (B) Does not exceed the income level specified for such child to be 
eligible for medical assistance under policies of the State plan under 
title XIX on June 1, 1997.
    (2) No other coverage standard. A targeted low-income child must not 
be--
    (i) Found eligible or potentially eligible for Medicaid under 
policies of the State plan (determined through either the Medicaid 
application process or the screening process described at Sec.  
457.350), except for eligibility under Sec.  435.214 of this chapter 
(related to coverage for family planning services);
    (ii) Covered under a group health plan or under health insurance 
coverage, as defined in section 2791 of the Public Health Service Act, 
unless the plan or health insurance coverage program has been in 
operation since before July 1, 1997 and is administered by a State that 
receives no Federal funds for the program's operation. A child is not 
considered covered under a group health plan or health insurance 
coverage if the child does not have reasonable geographic access to care 
under that plan.
    (3) For purposes of this section, policies of the State plan under 
title XIX plan include policies under a Statewide demonstration project 
under section 1115(a) of the Act other than a demonstration project that 
covered an expanded group of eligible children but that either--
    (i) Did not provide inpatient hospital coverage; or
    (ii) Limited eligibility to children previously enrolled in 
Medicaid, imposed premiums as a condition of initial or continued 
enrollment, and did not impose a general time limit on eligibility.
    (c) Exclusions. Notwithstanding paragraph (a) of this section, the 
following groups are excluded from the definition of targeted low-income 
children:
    (1) Children eligible for certain State health benefits coverage. 
(i) A targeted low-income child may not be eligible for health benefits 
coverage under a State health benefits plan in the State on the basis of 
a family member's employment with a public agency, even if

[[Page 587]]

the family declines to accept the coverage.
    (ii) A child is considered eligible for health benefits coverage 
under a State health benefits plan if a more than nominal contribution 
to the cost of health benefits coverage under a State health benefits 
plan is available from the State or public agency with respect to the 
child or would have been available from those sources on November 8, 
1999. A contribution is considered more than nominal if the State or 
public agency makes a contribution toward the cost of an employee's 
dependent(s) that is $10 per family, per month, more than the State or 
public agency's contribution toward the cost of covering the employee 
only.
    (2) Residents of an institution. A child must not be--
    (i) An inmate of a public institution as defined at Sec.  435.1010 
of this chapter; or
    (ii) A patient in an institution for mental diseases, as defined at 
Sec.  435.1010 of this chapter, at the time of initial application or 
any redetermination of eligibility.
    (d) A targeted low-income child must also include any child enrolled 
in Medicaid on December 31, 2013 who is determined to be ineligible for 
Medicaid as a result of the elimination of income disregards as 
specified under Sec.  435.603(g) of this chapter, regardless of any 
other standards set forth in this section except those in paragraph (c) 
of this section. Such a child shall continue to be a targeted low-income 
child under this paragraph until the date of the child's next renewal 
under Sec.  457.343 of this subpart.

[66 FR 2675, Jan. 11, 2001, as amended at 71 FR 39229, July 12, 2006; 77 
FR 17214, Mar. 23, 2012; 81 FR 86463, Nov. 30, 2016]



Sec.  457.315  Application of modified adjusted gross income and 
household definition.

    (a) Effective January 1, 2014, the State must apply the financial 
methodologies set forth in paragraphs (b) through (i) of Sec.  435.603 
of this chapter in determining the financial eligibility of all 
individuals for CHIP. The exception to application of such methods for 
individuals for whom the State relies on a finding of income made by an 
Express Lane agency at Sec.  435.603(j)(1) of this subpart also applies.
    (b) In the case of determining ongoing eligibility for enrollees 
determined eligible for CHIP on or before December 31, 2013, application 
of the financial methodologies set forth in this section will not be 
applied until March 31, 2014 or the next regularly-scheduled renewal of 
eligibility for such individual under Sec.  457.343, whichever is later.

[77 FR 17214, Mar. 23, 2012]



Sec.  457.320  Other eligibility standards.

    (a) Eligibility standards. To the extent consistent with title XXI 
of the Act and except as provided in paragraph (b) of this section, the 
State plan may adopt eligibility standards for one or more groups of 
children related to--
    (1) Geographic area(s) served by the plan;
    (2) Age (up to, but not including, age 19);
    (3) Income;
    (4) Spenddowns;
    (5) Residency, in accordance with paragraph (d) of this section;
    (6) Disability status, provided that such standards do not restrict 
eligibility;
    (7) Access to, or coverage under, other health coverage; and
    (8) Duration of eligibility, in accordance with paragraph (e) of 
this section.
    (b) Prohibited eligibility standards. In establishing eligibility 
standards and methodologies, a State may not--
    (1) Cover children with a higher household income without covering 
children with a lower household income within any defined group of 
covered targeted low-income children;
    (2) Deny eligibility based on a preexisting medical condition;
    (3) Discriminate on the basis of diagnosis;
    (4) Require any family member who is not requesting services to 
provide a social security number (including those family members whose 
income or resources might be used in making the child's eligibility 
determination);
    (5) Exclude American Indian or Alaska Native children based on 
eligibility for, or access to, medical care funded by the Indian Health 
Service;
    (6) Exclude individuals based on citizenship or nationality, to the 
extent

[[Page 588]]

that the children are U.S. citizens, U.S. nationals or qualified aliens, 
(as defined at section 431 of the Personal Responsibility and Work 
Opportunity Reconciliation Act (PRWORA) of 1996, as amended by the BBA 
of 1997, except to the extent that section 403 of PRWORA precludes them 
from receiving Federal means-tested public benefits); or
    (7) Violate any other Federal laws or regulations pertaining to 
eligibility for a separate child health program under title XXI.
    (c) [Reserved]
    (d) Citizenship and immigration status. All individuals seeking 
coverage under a separate child health plan must make a declaration of 
United States citizenship or satisfactory immigration status. Such 
declaration may be made by an adult member of the individual's 
household, an authorized representative, as defined in Sec.  435.923 of 
this chapter (referenced at Sec.  457.340), or if the individual is a 
minor or incapacitated, someone acting responsibly for the individual 
provided that such individual attests to having knowledge of the 
individual's status.
    (e) Residency. (1) Residency for a non-institutionalized child who 
is not a ward of the State must be determined in accordance with Sec.  
435.403(i) of this chapter.
    (2) Residency for a targeted low-income pregnant woman defined at 
2112 of the Act must be determined in accordance with Sec.  435.403(h) 
of this chapter.
    (3) A State may not--
    (i) Impose a durational residency requirement;
    (ii) Preclude the following individuals from declaring residence in 
a State--
    (A) An institutionalized child who is not a ward of a State, if the 
State is the State of residence of the child's custodial parent or 
caretaker at the time of placement; or
    (B) A child who is a ward of a State, regardless of where the child 
lives
    (4) In cases of disputed residency, the State must follow the 
process described in Sec.  435.403(m) of this chapter.
    (f) Duration of eligibility. (1) The State may not impose a lifetime 
cap or other time limit on the eligibility of an individual applicant or 
enrollee, based on the length of time such applicant or enrollee has 
received benefits under the State's separate child health program.
    (2) [Reserved]

[66 FR 2675, Jan. 11, 2001, as amended at 66 FR 33823, June 25, 2001, 77 
FR 17214, Mar. 23, 2012; 81 FR 86463, Nov. 30, 2016]



Sec.  457.330  Application.

    The State shall use the single, streamlined application used by the 
State in accordance with paragraph (b) of Sec.  435.907 of this chapter, 
and otherwise comply with such section, except that the terms of Sec.  
435.907(c) of this chapter (relating to applicants seeking coverage on a 
basis other than modified adjusted gross income) do not apply.

[77 FR 17215, Mar. 23, 2012]



Sec.  457.340  Application for and enrollment in CHIP.

    (a) Application and renewal assistance, availability of program 
information, and Web site. The terms of Sec. Sec.  435.905, 435.906, 
435.908, and 435.1200(f) of this chapter apply equally to the State in 
administering a separate CHIP.
    (b) Use of Social Security number. The terms of Sec. Sec.  435.910 
and 435.907(e) of this chapter regarding the provision and use of Social 
Security Numbers and non-applicant information apply equally to the 
State in administering a separate CHIP.
    (c) Notice of rights and responsibilities. A State must inform 
applicants at the time of application, in writing and orally if 
appropriate, about the application and eligibility requirements, the 
time frame for determining eligibility, and the right to review of 
eligibility determinations as described in Sec.  457.1130.
    (d) Timely determination of eligibility. (1) The terms in Sec.  
435.912 of this chapter apply equally to CHIP, except that standards for 
transferring electronic accounts to other insurance affordability 
programs are pursuant to Sec.  457.350 and the standards for receiving 
applications from other insurance affordability programs are pursuant to 
Sec.  457.348 of this part.

[[Page 589]]

    (2) In applying timeliness standards, the State must define ``date 
of application'' and must count each calendar day from the date of 
application to the day the agency provides notice of its eligibility 
decision.
    (3) In the case of individuals subject to a period of uninsurance 
under this part, the state must identify and implement processes to 
facilitate enrollment of CHIP-eligible children who have satisfied a 
period of uninsurance (as described under Sec.  457.805). To minimize 
burden on individuals, a state may not require a new application or 
information already provided by a family immediately preceding the 
beginning of a waiting period. States must also ensure that the proper 
safeguards are in place to prevent a disruption in coverage for children 
transitioning from coverage under another insurance affordability 
program after the completion of a period of uninsurance.
    (e) Notice of eligibility determinations. The State must provide 
each applicant or enrollee with timely and adequate written notice of 
any decision affecting his or her eligibility, including an approval, 
denial or termination, or suspension of eligibility, consistent with 
Sec. Sec.  457.315, 457.348, and 457.350. The notice must be written in 
plain language; and accessible to persons who are limited English 
proficient and individuals with disabilities, consistent with Sec.  
435.905(b) of this chapter and Sec.  457.110.
    (1) Content of eligibility notice. (i) Any notice of an approval of 
CHIP eligibility must include, but is not limited to, the following--
    (A) The basis and effective date of eligibility;
    (B) The circumstances under which the individual must report and 
procedures for reporting, any changes that may affect the individual's 
eligibility;
    (C) Basic information on benefits and services and if applicable, 
any premiums, enrollment fees, and cost sharing required, and an 
explanation of how to receive additional detailed information on 
benefits and financial responsibilities; and
    (D) Information on the enrollees' right and responsibilities, 
including the opportunity to request a review of matters described in 
Sec.  457.1130.
    (ii) Any notice of denial, termination, or suspension of CHIP 
eligibility must include, but is not limited to the following--
    (A) The basis supporting the action and the effective date,
    (B) Information on the individual's right to a review process, in 
accordance with Sec.  457.1180;
    (iii) In the case of a suspension or termination of eligibility, the 
State must provide sufficient notice to enable the child's parent or 
other caretaker to take any appropriate actions that may be required to 
allow coverage to continue without interruption.
    (2) The State's responsibility to provide notice under this 
paragraph is satisfied by a combined eligibility notice, as defined in 
Sec.  457.10, provided by an Exchange or other insurance affordability 
program in accordance with paragraph (f) of this section, except that, 
if the information described in paragraph (e)(1)(i)(C) of this section 
is not included in such combined eligibility notice, the State must 
provide the individual with a supplemental notice of such information, 
consistent with this section.
    (f) Coordination of notices with other programs. The State must--
    (1) Include in the agreement into which the State has entered under 
Sec.  457.348(a) that for individuals who are transferred between the 
State and another insurance affordability program in accordance with 
Sec.  457.348 or Sec.  457.350, the State, Exchange or other insurance 
affordability program will provide, to the maximum extent feasible, a 
combined eligibility notice to individuals, as well as to multiple 
members of the same household included on the same application or 
renewal form.
    (2) For individuals and other household members who will not receive 
a combined eligibility notice, include appropriate coordinated content, 
as defined in Sec.  457.10, in any notice provided by the State in 
accordance with paragraph (e)(1) of this section.
    (g) Effective date of eligibility. A State must specify a method for 
determining the effective date of eligibility for CHIP, which can be 
determined based on the date of application or through

[[Page 590]]

any other reasonable method that ensures coordinated transition of 
children between CHIP and other insurance affordability programs as 
family circumstances change and avoids gaps or overlaps in coverage.

[66 FR 2675, Jan. 11, 2001, as amended at 66 FR 33823, June 25, 2001; 77 
FR 17215, Mar. 23, 2012; 78 FR 42312, July 15, 2013; 81 FR 86464, Nov. 
30, 2016]



Sec.  457.342  Continuous eligibility for children.

    (a) A State may provide continuous eligibility for children under a 
separate CHIP in accordance with the terms of Sec.  435.926 of this 
chapter, and subject to a child remaining ineligible for Medicaid, as 
required by section 2110(b)(1) of the Act and Sec.  457.310 (related to 
the definition and standards for being a targeted low-income child) and 
the requirements of section 2102(b)(3) of the Act and Sec.  457.350 
(related to eligibility screening and enrollment).
    (b) In addition to the reasons provided at Sec.  435.926(d) of this 
chapter, a child may be terminated during the continuous eligibility 
period for failure to pay required premiums or enrollment fees required 
under the State plan, subject to the disenrollment protections afforded 
under section 2103(e)(3)(C) of the Act (related to premium grace 
periods) and Sec.  457.570 (related to disenrollment protections).

[81 FR 86464, Nov. 30, 2016]



Sec.  457.343  Periodic renewal of CHIP eligibility.

    The renewal procedures described in Sec.  435.916 of this chapter 
apply equally to the State in administering a separate CHIP, except that 
the State shall verify information needed to renew CHIP eligibility in 
accordance with Sec.  457.380 of this subpart, shall provide notice 
regarding the State's determination of renewed eligibility or 
termination in accordance with Sec.  457.340(e) of this subpart and 
shall comply with the requirements set forth in Sec.  457.350 of this 
subpart for screening individuals for other insurance affordability 
programs and transmitting such individuals' electronic account and other 
relevant information to the appropriate program.

[77 FR 17215, Mar. 23, 2012]



Sec.  457.348  Determinations of Children's Health Insurance Program
eligibility by other insurance affordability programs.

    (a) Agreements with other insurance affordability programs. The 
State must enter into and, upon request, provide to the Secretary one or 
more agreements with an Exchange and the agencies administering other 
insurance affordability programs as are necessary to fulfill the 
requirements of this section, including a clear delineation of the 
responsibilities of each program to--
    (1) Minimize burden on individuals seeking to obtain or renew 
eligibility or to appeal a determination of eligibility for one or more 
insurance affordability program;
    (2) Ensure compliance with paragraphs (b) and (c) of this section 
and Sec.  457.350;
    (3) Ensure prompt determination of eligibility and enrollment in the 
appropriate program without undue delay, consistent with the timeliness 
standards established under Sec.  457.340(d), based on the date the 
application is submitted to any insurance affordability program, and
    (4) Provide for coordination of notices with other insurance 
affordability programs, consistent with Sec.  457.340(f), and an 
opportunity for individuals to submit a joint review request, as defined 
in Sec.  457.10, consistent with Sec.  457.351.
    (5) Provide for a combined appeals decision by an Exchange or 
Exchange appeals entity (or other insurance affordability program or 
appeals entity) for individuals who requested an appeal of an Exchange-
related determination in accordance with 45 CFR part 155 subpart F (or 
of a determination related to another program) and an appeal of a denial 
of CHIP eligibility which is conducted by an Exchange or Exchange 
appeals entity (or other program or appeals entity) in accordance with 
the State plan.

[[Page 591]]

    (b) Provision of CHIP for individuals found eligible for CHIP by 
another insurance affordability program. If a State accepts final 
determinations of CHIP eligibility made by another insurance 
affordability program, for each individual determined so eligible by the 
other insurance affordability program (including as a result of a 
decision made by an Exchange appeals entity authorized by the State to 
adjudicate reviews of CHIP eligibility determinations), the State must--
    (1) Establish procedures to receive, via secure electronic 
interface, the electronic account containing the determination of CHIP 
eligibility and notify such program of the receipt of the electronic 
account;
    (2) Comply with the provisions of Sec.  457.340 to the same extent 
as if the application had been submitted to the State; and
    (3) Maintain proper oversight of the eligibility determinations made 
by the other program.
    (c) Transfer from other insurance affordability programs to CHIP. 
For individuals for whom another insurance affordability program has not 
made a determination of CHIP eligibility, but who have been screened as 
potentially CHIP eligible by such program (including as a result of a 
decision made by an Exchange or other program appeals entity), the State 
must--
    (1) Accept, via secure electronic interface, the electronic account 
for the individual and notify such program of the receipt of the 
electronic account;
    (2) Not request information or documentation from the individual in 
the individual's electronic account, or provided to the State by another 
insurance affordability program or appeals entity;
    (3) Promptly and without undue delay, consistent with the timeliness 
standards established under Sec.  457.340(d), determine the CHIP 
eligibility of the individual, in accordance with Sec.  457.340, without 
requiring submission of another application and, for individuals 
determined not eligible for CHIP, comply with Sec.  457.350(i) of this 
section;
    (4) Accept any finding relating to a criterion of eligibility made 
by such program or appeals entity, without further verification, if such 
finding was made in accordance with policies and procedures which are 
the same as those applied by the State in accordance with Sec.  457.380 
or approved by it in the agreement described in paragraph (a) of this 
section; and
    (5) Notify such program of the final determination of the 
individual's eligibility or ineligibility for CHIP.
    (d) Certification of eligibility criteria. The State must certify 
for the Exchange and other insurance affordability programs the criteria 
applied in determining CHIP eligibility.

[77 FR 17215, Mar. 23, 2012, as amended at 78 FR 42312, July 15, 2013; 
81 FR 86464, Nov. 30, 2016]



Sec.  457.350  Eligibility screening and enrollment in other insurance 
affordability programs.

    (a) State plan requirement. The State plan shall include a 
description of the coordinated eligibility and enrollment procedures 
used, at an initial and any follow-up eligibility determination, 
including any periodic redetermination, to ensure that:
    (1) Only targeted low-income children are furnished CHIP coverage 
under the plan; and
    (2) Enrollment is facilitated for applicants and enrollees found to 
be potentially eligible for other insurance affordability programs in 
accordance with this section.
    (b) Screening objectives. A State must, promptly and without undue 
delay, consistent with the timeliness standards established under Sec.  
457.340(d), identify potential eligibility for other insurance 
affordability programs of any applicant, enrollee, or other individual 
who submits an application or renewal form to the State which includes 
sufficient information to determine CHIP eligibility, or whose 
eligibility is being renewed due to a change in circumstance in 
accordance with Sec.  457.343 or who is determined not eligible for CHIP 
in accordance to a review conducted in accordance with subpart K of this 
part, as follows:
    (1) Medicaid on the basis of having household income at or below the 
applicable modified adjusted gross income standard, as defined in Sec.  
435.911(b) of this chapter;

[[Page 592]]

    (2) Medicaid on another basis, as indicated by information provided 
on the application or renewal form provided;
    (3) Eligibility for other insurance affordability programs.
    (c) Income eligibility test. To identify the individuals described 
in paragraphs (b)(1) and (b)(3) of this section, a State must apply the 
methodologies used to determine household income described in Sec.  
457.315 of this subpart or such methodologies as are applied by such 
other programs.
    (d) [Reserved]
    (e) Children found potentially ineligible for Medicaid. If a State 
uses a screening procedure other than a full determination of Medicaid 
eligibility under all possible eligibility groups, and the screening 
process reveals that the child does not appear to be eligible for 
Medicaid, the State must provide the child's family with the following 
in writing:
    (1) A statement that based on a limited review, the child does not 
appear eligible for Medicaid, but Medicaid eligibility can only be 
determined based on a full review of a Medicaid application under all 
Medicaid eligibility groups;
    (2) Information about Medicaid eligibility and benefits; and
    (3) Information about how and where to apply for Medicaid under all 
eligibility groups.
    (4) The State will determine the written format and timing of the 
information regarding Medicaid eligibility, benefits, and the 
application process required under this paragraph (e).
    (f) Applicants found potentially eligible for Medicaid based on 
modified adjusted gross income. For individuals identified in paragraph 
(b)(1) of this section, the State must--
    (1) Promptly and without undue delay, consistent with the timeliness 
standards established under Sec.  457.340(d) of this subpart, transfer 
the individual's electronic account to the Medicaid agency via a secure 
electronic interface; and
    (2) Except as provided in Sec.  457.355 of this subpart, find the 
applicant ineligible, provisionally ineligible, or suspend the 
applicant's application for CHIP unless and until the Medicaid 
application for the applicant is denied; and
    (3) Determine or redetermine eligibility for CHIP, consistent with 
the timeliness standards established under Sec.  457.340(d) of this 
subpart, if--
    (i) The State is notified, in accordance with Sec.  435.1200(d)(5) 
of this chapter that the applicant has been found ineligible for 
Medicaid; or
    (ii) The State is notified prior to the final Medicaid eligibility 
determination that the applicant's circumstances have changed and 
another screening shows that the applicant is no longer potentially 
eligible for Medicaid.
    (g) Informed application decisions. To enable a family to make an 
informed decision about applying for Medicaid or completing the Medicaid 
application process, a State must provide the child's family with 
information, in writing, about--
    (1) The State's Medicaid program, including the benefits covered, 
and restrictions on cost sharing; and
    (2) Eligibility rules that prohibit children who have been screened 
eligible for Medicaid from being enrolled in a separate child health 
program, other than provisional temporary enrollment while a final 
Medicaid eligibility determination is being made.
    (3) The State will determine the written format and timing of the 
information regarding Medicaid eligibility, benefits, and the 
application process required under this paragraph (g).
    (h) Waiting lists, enrollment caps and closed enrollment. The State 
must establish procedures to ensure that--
    (1) The procedures developed in accordance with this section have 
been followed for each child applying for a separate child health 
program before placing the child on a waiting list or otherwise 
deferring action on the child's application for the separate child 
health program;
    (2) Children placed on a waiting list or for whom action on their 
application is otherwise deferred are transferred to other insurance 
affordability programs in accordance with paragraph (i) of this section; 
and
    (3) Families are informed that a child may be eligible for other 
insurance affordability programs, while the child is on a waiting list 
for a separate child

[[Page 593]]

health program or if circumstances change, for Medicaid.
    (i) Individuals found potentially eligible for other insurance 
affordability programs. For individuals identified in paragraph (b)(3) 
of this section, including during a period of uninsurance imposed by the 
State under Sec.  457.805, the State must--
    (1) Promptly and without undue delay, consistent with the timeliness 
standards established under Sec.  457.340(d), transfer the electronic 
account to the applicable program via a secure electronic interfaces.
    (2) In the case of individuals subject to a period of uninsurance 
under Sec.  457.805 and transferred to another insurance affordability 
program in accordance with paragraph (i)(1) of this section, the State 
must--
    (i) Notify such program of the date on which such period ends and 
the individual is eligible to enroll in CHIP; and
    (ii) Consistent with Sec.  457.340(e), provide the individual with--
    (A) An initial notice that the individual is not currently eligible 
to enroll in the State's separate child health plan and the reasons 
therefor; the date on which the individual will be eligible to enroll in 
the State's separate child health plan; and that the individual's 
account has been transferred to another insurance affordability program 
for a determination of eligibility to enroll in such program during the 
period of underinsurance. Such notice also must contain coordinated 
content informing the individual of the notice being provided to the 
other insurance affordability program per paragraph (i)(3)(i) of this 
section and the impact that the individual's eligibility to enroll in 
the State's separate child health plan will have on the individual's 
eligibility for such other program.
    (B) Prior to the end of the individual's period of uninsurance 
(sufficient to enable the individual to disenroll from the insurance 
affordability program to which the individual's account was transferred 
per paragraph (i)(1) of this section), notice reminding the individual 
of the information described in paragraph (i)(2)(A) of this section, as 
appropriate.
    (3) In the case of individuals subject to a period of uninsurance 
under this part, the state must notify such program of the date on which 
such period ends and the individual is eligible to enroll in CHIP.
    (j) Applicants potentially eligible for Medicaid on a basis other 
than modified adjusted gross income. For individuals identified in 
paragraph (b)(2) of this section, the State must--
    (1) Promptly and without undue delay, consistent with the timeliness 
standards established under Sec.  457.340(d) of this subpart, transfer 
the electronic account to the Medicaid agency via a secure electronic 
interface;
    (2) Complete the determination of eligibility for CHIP in accordance 
with Sec.  457.340 or evaluation for potential eligibility for other 
insurance affordability programs in accordance with paragraph (b) of 
this section.
    (3) Include in the notice of CHIP eligibility or ineligibility 
provided under Sec.  457.340(e), as appropriate, coordinated content 
relating to--
    (i) The transfer of the individual's electronic account to the 
Medicaid agency per paragraph (j)(1) of this section;
    (ii) The transfer of the individual's account to another insurance 
affordability program in accordance with paragraph (i)(1) of this 
section, if applicable; and
    (iii) The impact that an approval of Medicaid eligibility will have 
on the individual's eligibility for CHIP or another insurance 
affordability program, as appropriate.
    (4) Dis-enroll the enrollee from CHIP if the State is notified in 
accordance with Sec.  435.1200(d)(5) of this chapter that the applicant 
has been determined eligible for Medicaid.
    (k) A State may enter into an arrangement with the Exchange for the 
entity that determines eligibility for CHIP to make determinations of 
eligibility for advanced premium tax credits and cost sharing 
reductions, consistent with 45 CFR 155.110(a)(2).

[66 FR 2675, Jan. 11, 2001, as amended at 66 FR 33823, June 25, 2001; 67 
FR 61974, Oct. 2, 2002; 77 FR 17216, Mar. 23, 2012; 78 FR 42312, July 
15, 2013; 81 FR 86465, Nov. 30, 2016]

[[Page 594]]



Sec.  457.351  Coordination involving appeals entities for different 
insurance affordability programs.

    (a) The terms of Sec.  435.1200(g) of this chapter apply equally to 
the State in administering a separate CHIP. References to a ``fair 
hearing'' and ``joint fair hearing request'' in Sec.  435.1200(g) of 
this chapter are treated as references to a ``review'' under subpart K 
of this part and to a ``joint appeal request'' as defined in Sec.  
457.10. Reference to ``expedited review of a fair hearing request 
consistent with Sec.  431.221(a)(1)(ii) of this chapter'' is considered 
a reference to ``expedited review of an eligibility or enrollment matter 
under Sec.  457.1160(a)''. Reference to Sec.  435.1200(b)(3), (c), (d) 
and (e) are treated as a reference to Sec.  457.348(b), (c) and (d) and 
Sec.  457.350(c), respectively.
    (b) [Reserved]

[81 FR 86466, Nov. 30, 2016]



Sec.  457.353  Monitoring and evaluation of screening process.

    States must establish a mechanism and monitor to evaluate the screen 
and enroll process described at Sec.  457.350 of this subpart to ensure 
that children who are:
    (a) Screened as potentially eligible for other insurance 
affordability programs are enrolled in such programs, if eligible; or
    (b) Determined ineligible for other insurance affordability programs 
are enrolled in CHIP, if eligible.

[77 FR 17216, Mar. 23, 2012]



Sec.  457.355  Presumptive eligibility for children.

    The State may provide coverage under a separate child health program 
for children determined by a qualified entity to be presumptively 
eligible for the State's separate CHIP in the same manner and to the 
same extent as permitted under Medicaid under Sec.  435.1101 and Sec.  
435.1102 of this chapter.

[81 FR 86466, Nov. 30, 2016]



Sec.  457.360  Deemed newborn children.

    (a) Basis. This section implements section 2112(e) of the Act.
    (b) Eligibility. (1) The State must provide CHIP to children from 
birth until the child's first birthday without application if--
    (i) The child's mother was eligible for and received covered 
services for the date of the child's birth under the State plan as a 
targeted low-income pregnant woman in accordance with section 2112 of 
the Act; and
    (ii) The child is not eligible for Medicaid under Sec.  435.117 of 
this chapter.
    (2)(i) The State may provide coverage under this section to children 
who are not eligible for Medicaid under Sec.  435.117 from birth until 
the child's first birthday without application if the requirement in 
paragraph (b)(2)(ii) of this section is met and if, for the date of the 
child's birth, the child's mother was eligible for and received covered 
services under--
    (A) The State plan as a targeted low-income child;
    (B) CHIP coverage in another State; or
    (C) Coverage under the State's demonstration under section 1115 of 
the Act as a Medicaid or CHIP population.
    (ii) For purposes of paragraph (b)(2)(i) of this section, the State 
may only elect the optional populations described if it elects to cover 
the corresponding optional populations in Medicaid under Sec.  
435.117(b)(2)(ii) of this chapter.
    (3) The child is deemed to have applied and been determined eligible 
under the State's separate CHIP State plan effective as of the date of 
birth, and remains eligible regardless of changes in circumstances 
(except if the child dies or ceases to be a resident of the State or the 
child's representative requests a voluntary termination of the child's 
eligibility) until the child's first birthday.
    (c) CHIP identification number. (1) The CHIP identification number 
of the mother serves as the child's identification number, and all 
claims for covered services provided to the child may be submitted and 
paid under such number, unless and until the State issues a separate 
identification number for the child.
    (2) The State must issue a separate CHIP identification number for 
the child prior to the effective date of any termination of the mother's 
eligibility or prior to the date of the child's first

[[Page 595]]

birthday, whichever is sooner, except that the State must issue a 
separate CHIP identification number for the child if the mother was 
covered in another State at the time of birth.

[81 FR 86466, Nov. 30, 2016]



Sec.  457.370  Alignment with Exchange initial open enrollment period.

    The terms of Sec.  435.1205 apply equally to the State in 
administering a separate CHIP, except that the State shall make 
available and accept the application described in Sec.  457.330, shall 
accept electronic accounts as described in Sec.  457.348, and furnish 
coverage in accordance with Sec.  457.340.

[78 FR 42312, July 15, 2013]



Sec.  457.380  Eligibility verification.

    (a) General requirements. Except where law requires other procedures 
(such as for citizenship and immigration status information), the State 
may accept attestation of information needed to determine the 
eligibility of an individual for CHIP (either self-attestation by the 
individual or attestation by an adult who is in the applicant's 
household, as defined in Sec.  435.603(f) of this subchapter, or family, 
as defined in section 36B(d)(1) of the Internal Revenue Code, an 
authorized representative, or if the individual is a minor or 
incapacitated, someone acting responsibly for the individual) without 
requiring further information (including documentation) from the 
individual.
    (b) Status as a citizen, national or a non-citizen. (1) Except for 
newborns identified in Sec.  435.406(a)(1)(iii)(E) of this chapter, who 
are exempt from any requirement to verify citizenship, the agency must--
    (i) Verify citizenship or immigration status in accordance with 
Sec.  435.956(a) of this chapter, except that the reference to Sec.  
435.945(k) is read as a reference to paragraph (i) of this section; and
    (ii) Provide a reasonable opportunity period to verify such status 
in accordance with Sec.  435.956(a)(5) and (b) of this chapter and 
provide benefits during such reasonable opportunity period to 
individuals determined to be otherwise eligible for CHIP.
    (2) [Reserved]
    (c) State residents. If the State does not accept self-attestation 
of residency, the State must verify residency in accordance with Sec.  
435.956(c) of this chapter.
    (d) Income. If the State does not accept self-attestation of income, 
the State must verify the income of an individual by using the data 
sources and following standards and procedures for verification of 
financial eligibility consistent with Sec.  435.945(a), Sec.  435.948 
and Sec.  435.952 of this chapter.
    (e) Verification of other factors of eligibility. For eligibility 
requirements not described in paragraphs (c) or (d) of this section, a 
State may adopt reasonable verification procedures, consistent with the 
requirements in Sec.  435.952 of this chapter, except that the State 
must accept self-attestation of pregnancy unless the State has 
information that is not reasonably compatible with such attestation.
    (f) Requesting information. The terms of Sec.  435.952 of this 
chapter apply equally to the State in administering a separate CHIP.
    (g) Electronic service. Except to the extent permitted under 
paragraph (i) of this section, to the extent that information sought 
under this section is available through the electronic service described 
in Sec.  435.949 of this chapter, the State must obtain the information 
through that service.
    (h) Interaction with program integrity requirements. Nothing in this 
section should be construed as limiting the State's program integrity 
measures or affecting the State's obligation to ensure that only 
eligible individuals receive benefits or its obligation to provide for 
methods of administration that are in the best interest of applicants 
and enrollees and are necessary for the proper and efficient operation 
of the plan.
    (i) Flexibility in information collection and verification. Subject 
to approval by the Secretary, the State may modify the methods to be 
used for collection of information and verification of information as 
set forth in this section, provided that such alternative source will 
reduce the administrative costs and burdens on individuals and States

[[Page 596]]

while maximizing accuracy, minimizing delay, meeting applicable 
requirements relating to the confidentiality, disclosure, maintenance, 
or use of information, and promoting coordination with other insurance 
affordability programs.
    (j) Verification plan. The State must develop, and update as 
modified, and submit to the Secretary, upon request, a verification plan 
describing the verification policies and procedures adopted by the State 
to implement the provisions set forth in this section in a format and 
manner prescribed by the Secretary.

[77 FR 17216, Mar. 23, 2012, as amended at 81 FR 86466, Nov. 30, 2016]



        Subpart D_State Plan Requirements: Coverage and Benefits

    Source: 66 FR 2678, Jan. 11, 2001, unless otherwise noted.



Sec.  457.401  Basis, scope, and applicability.

    (a) Statutory basis. This subpart interprets and implements--
    (1) Section 2102(a)(7) of the Act, which requires that States make 
assurances relating to, the quality and appropriateness of care, and 
access to covered services;
    (2) Section 2103 of the Act, which outlines coverage requirements 
for children's health insurance;
    (3) Section 2109 of the Act, which describes the relation of the 
CHIP program to other laws;
    (4) Section 2110(a) of the Act, which describes child health 
assistance; and
    (5) Section 2110(c) of the Act, which contains definitions 
applicable to this subpart.
    (b) Scope. This subpart sets forth requirements for health benefits 
coverage and child health assistance under a separate child health plan.
    (c) Applicability. The requirements of this subpart apply to child 
health assistance provided under a separate child health program and do 
not apply to a Medicaid expansion program.



Sec.  457.402  Definition of child health assistance.

    For the purpose of this subpart, the term ``child health 
assistance'' means payment for part or all of the cost of health 
benefits coverage provided to targeted low-income children for the 
following services:
    (a) Inpatient hospital services.
    (b) Outpatient hospital services.
    (c) Physician services.
    (d) Surgical services.
    (e) Clinic services (including health center services) and other 
ambulatory health care services.
    (f) Prescription drugs and biologicals and the administration of 
these drugs and biologicals, only if these drugs and biologicals are not 
furnished for the purpose of causing, or assisting in causing, the 
death, suicide, euthanasia, or mercy killing of a person.
    (g) Over-the-counter medications.
    (h) Laboratory and radiological services.
    (i) Prenatal care and pre-pregnancy family planning services and 
supplies.
    (j) Inpatient mental health services, other than services described 
in paragraph (r) of this section but including services furnished in a 
State-operated mental hospital and including residential or other 24-
hour therapeutically planned structured services.
    (k) Outpatient mental health services, other than services described 
in paragraph (s) of this section but including services furnished in a 
State-operated mental hospital and including community-based services.
    (l) Durable medical equipment and other medically-related or 
remedial devices (such as prosthetic devices, implants, eyeglasses, 
hearing aids, dental devices and adaptive devices).
    (m) Disposable medical supplies.
    (n) Home and community-based health care services and related 
supportive services (such as home health nursing services, personal 
care, assistance with activities of daily living, chore services, day 
care services, respite care services, training for family members and 
minor modification to the home.)
    (o) Nursing care services (such as nurse practitioner services, 
nurse midwife services, advanced practice nurse

[[Page 597]]

services, private duty nursing, pediatric nurse services and respiratory 
care services) in a home, school, or other setting.
    (p) Abortion only if necessary to save the life of the mother or if 
the pregnancy is the result of rape or incest.
    (q) Dental services.
    (r) Inpatient substance abuse treatment services and residential 
substance abuse treatment services.
    (s) Outpatient substance abuse treatment services.
    (t) Case management services.
    (u) Care coordination services.
    (v) Physical therapy, occupational therapy, and services for 
individuals with speech, hearing and language disorders.
    (w) Hospice care.
    (x) Any other medical, diagnostic, screening, preventive, 
restorative, remedial, therapeutic, or rehabilitative services (whether 
in a facility, home, school, or other setting) if recognized by State 
law and only if the service is--
    (1) Prescribed by or furnished by a physician or other licensed or 
registered practitioner within the scope of practice as defined by State 
law;
    (2) Performed under the general supervision or at the direction of a 
physician; or
    (3) Furnished by a health care facility that is operated by a State 
or local government or is licensed under State law and operating within 
the scope of the license.
    (y) Premiums for private health care insurance coverage.
    (z) Medical transportation.
    (aa) Enabling services (such as transportation, translation, and 
outreach services) only if designed to increase the accessibility of 
primary and preventive health care services for eligible low-income 
individuals.
    (bb) Any other health care services or items specified by the 
Secretary and not excluded under this subchapter.



Sec.  457.410  Health benefits coverage options.

    (a) Types of health benefits coverage. States may choose to obtain 
any of the following four types of health benefits coverage:
    (1) Benchmark coverage in accordance with Sec.  457.420.
    (2) Benchmark-equivalent coverage in accordance with Sec.  457.430.
    (3) Existing comprehensive State-based coverage in accordance with 
Sec.  457.440.
    (4) Secretary-approved coverage in accordance with Sec.  457.450.
    (b) Required coverage. Regardless of the type of health benefits 
coverage, described at paragraph (a) of this section, that the State 
chooses to obtain, the State must obtain coverage for--
    (1) Well-baby and well-child care services as defined by the State;
    (2) Age-appropriate immunizations in accordance with the 
recommendations of the Advisory Committee on Immunization Practices 
(ACIP); and
    (3) Emergency services as defined in Sec.  457.10.



Sec.  457.420  Benchmark health benefits coverage.

    Benchmark coverage is health benefits coverage that is substantially 
equal to the health benefits coverage in one of the following benefit 
plans:
    (a) Federal Employees Health Benefit Plan (FEHBP). The standard Blue 
Cross/Blue Shield preferred provider option service benefit plan that is 
described in, and offered to Federal employees under, 5 U.S.C. 8903(1).
    (b) State employee plan. A health benefits plan that is offered and 
generally available to State employees in the State.
    (c) Health maintenance organization (HMO) plan. A health insurance 
coverage plan that is offered through an HMO (as defined in section 
2791(b)(3) of the Public Health Service Act) and has the largest insured 
commercial, non-Medicaid enrollment in the State.



Sec.  457.430  Benchmark-equivalent health benefits coverage.

    (a) Aggregate actuarial value. Benchmark-equivalent coverage is 
health benefits coverage that has an aggregate actuarial value 
determined in accordance with Sec.  457.431 that is at least actuarially 
equivalent to the coverage under one of the benchmark packages specified 
in Sec.  457.420.
    (b) Required coverage. In addition to the coverage required under 
Sec.  457.410(b),

[[Page 598]]

benchmark-equivalent health benefits coverage must include coverage for 
the following categories of services:
    (1) Inpatient and outpatient hospital services.
    (2) Physicians' surgical and medical services.
    (3) Laboratory and x-ray services.
    (c) Additional coverage. (1) In addition to the categories of 
services in paragraph (b) of this section, benchmark-equivalent coverage 
may include coverage for any additional services specified in Sec.  
457.402.
    (2) If the benchmark coverage package used by the State for purposes 
of comparison in establishing the aggregate actuarial value of the 
benchmark-equivalent coverage package includes coverage for prescription 
drugs, mental health services, vision services or hearing services, then 
the actuarial value of the coverage for each of these categories of 
service in the benchmark-equivalent coverage package must be at least 75 
percent of the value of the coverage for such a category or service in 
the benchmark plan used for comparison by the State.
    (3) If the benchmark coverage package does not cover one of the 
categories of services in paragraph (c)(2) of this section, then the 
benchmark-equivalent coverage package may, but is not required to, 
include coverage for that category of service.



Sec.  457.431  Actuarial report for benchmark-equivalent coverage.

    (a) To obtain approval for benchmark-equivalent health benefits 
coverage described under Sec.  457.430, the State must submit to CMS an 
actuarial report that contains an actuarial opinion that the health 
benefits coverage meets the actuarial requirements under Sec.  457.430. 
The report must also specify the benchmark coverage used for comparison.
    (b) The actuarial report must state that it was prepared--
    (1) By an individual who is a member of the American Academy of 
Actuaries;
    (2) Using generally accepted actuarial principles and methodologies 
of the American Academy of Actuaries;
    (3) Using a standardized set of utilization and price factors;
    (4) Using a standardized population that is representative of 
privately insured children of the age of those expected to be covered 
under the State plan;
    (5) Applying the same principles and factors in comparing the value 
of different coverage (or categories of services);
    (6) Without taking into account any differences in coverage based on 
the method of delivery or means of cost control or utilization used; and
    (7) Taking into account the ability of a State to reduce benefits by 
considering the increase in actuarial value of health benefits coverage 
offered under the State plan that results from the limitations on cost 
sharing (with the exception of premiums) under that coverage.
    (c) The actuary who prepares the opinion must select and specify the 
standardized set and population to be used under paragraphs (b)(3) and 
(b)(4) of this section.
    (d) The State must provide sufficient detail to explain the basis of 
the methodologies used to estimate the actuarial value or, if requested 
by CMS, to replicate the State's result.



Sec.  457.440  Existing comprehensive State-based coverage.

    (a) General requirements. Existing comprehensive State-based health 
benefits is coverage that--
    (1) Includes coverage of a range of benefits;
    (2) Is administered or overseen by the State and receives funds from 
the State;
    (3) Is offered in the State of New York, Florida or Pennsylvania; 
and
    (4) Was offered as of August 5, 1997.
    (b) Modifications. A State may modify an existing comprehensive 
State-based coverage program described in paragraph (a) of this section 
if--
    (1) The program continues to include a range of benefits;
    (2) The State submits an actuarial report demonstrating that the 
modification does not reduce the actuarial value of the coverage under 
the program below the lower of either--
    (i) The actuarial value of the coverage under the program as of 
August 5, 1997; or

[[Page 599]]

    (ii) The actuarial value of a benchmark benefit package as described 
in Sec.  457.430 evaluated at the time the modification is requested.



Sec.  457.450  Secretary-approved coverage.

    Secretary-approved coverage is health benefits coverage that, in the 
determination of the Secretary, provides appropriate coverage for the 
population of targeted low-income children covered under the program. 
Secretary-approved coverage, for which no actuarial analysis is 
required, may include, but is not limited to the following:
    (a) Coverage that is the same as the coverage provided to children 
under the Medicaid State plan.
    (b) Comprehensive coverage for children offered by the State under a 
Medicaid demonstration project approved by the Secretary under section 
1115 of the Act.
    (c) Coverage that either includes the full Early and Periodic 
Screening, Diagnosis, and Treatment (EPSDT) benefit or that the State 
has extended to the entire Medicaid population in the State.
    (d) Coverage that includes benchmark health benefits coverage, as 
specified in Sec.  457.420, plus any additional coverage.
    (e) Coverage that is the same as the coverage provided under Sec.  
457.440.
    (f) Coverage, including coverage under a group health plan purchased 
by the State, that the State demonstrates to be substantially equivalent 
to or greater than coverage under a benchmark health benefits plan, as 
specified in Sec.  457.420, through use of a benefit-by-benefit 
comparison which demonstrates that coverage for each benefit meets or 
exceeds the corresponding coverage under the benchmark health benefits 
plan.

[66 FR 33823, June 25, 2001]



Sec.  457.470  Prohibited coverage.

    A State is not required to provide health benefits coverage under 
the plan for an item or service for which payment is prohibited under 
title XXI even if any benchmark health benefits plan includes coverage 
for that item or service.



Sec.  457.475  Limitations on coverage: Abortions.

    (a) General rule. FFP under title XXI is not available in 
expenditures for an abortion, or in expenditures for the purchase of 
health benefits coverage that includes coverage of abortion services 
unless the abortion services meet the conditions specified in paragraph 
(b) of this section.
    (b) Exceptions--(1) Life of mother. FFP is available in expenditures 
for abortion services when a physician has found that the abortion is 
necessary to save the life of the mother.
    (2) Rape or incest. FFP is available in expenditures for abortion 
services performed to terminate a pregnancy resulting from an act of 
rape or incest.
    (c) Partial Federal funding prohibited. (1) FFP is not available to 
a State for any amount expended under the title XXI plan to assist in 
the purchase, in whole or in part, of health benefits coverage that 
includes coverage of abortions other than those specified in paragraph 
(b) of this section.
    (2) If a State wishes to have managed care entities provide 
abortions in addition to those specified in paragraph (b) of this 
section, those abortions must be provided under a separate contract 
using non-Federal funds. A State may not set aside a portion of the 
capitated rate paid to a managed care entity to be paid with State-only 
funds, or append riders, attachments or addenda to existing contracts 
with managed care entities to separate the additional abortion services 
from the other services covered by the contract.
    (3) Nothing in this section affects the expenditure by a State, 
locality, or private person or entity of State, local, or private funds 
(other than those expended under the State plan) for any abortion 
services or for health benefits coverage that includes coverage of 
abortion services.



Sec.  457.480  Preexisting condition exclusions and relation to other laws.

    (a) Preexisting condition exclusions. (1) Except as permitted under 
paragraph (a)(2) of this section, the State may not permit the 
imposition of any pre-existing condition exclusion for covered services 
under the State plan.

[[Page 600]]

    (2) If the State obtains health benefits coverage through payment or 
a contract for health benefits coverage under a group health plan or 
group health insurance coverage, the State may permit the imposition of 
a pre-existing condition exclusion but only to the extent that the 
exclusion is permitted under the applicable provisions of part 7 of 
subtitle B of title I of the Employee Retirement Income Security Act of 
1974 (ERISA) and title XXVII of the Public Health Service Act.
    (b) Relation of title XXI to other laws. (1) ERISA. Nothing in this 
title affects or modifies section 514 of ERISA with respect to a group 
health plan as defined by section 2791(a)(1) of the Public Health 
Service Act.
    (2) Health Insurance Portability and Accountability Act (HIPAA). 
Health benefits coverage provided under a State plan and coverage 
provided as a cost-effective alternative, as described in subpart J of 
this part, is creditable coverage for purposes of part 7 of subtitle B 
of title II of ERISA, title XXVII of the Public Health Service Act, and 
subtitle K of the Internal Revenue Code of 1986.
    (3) Mental Health Parity Act (MHPA). Health benefits coverage under 
a group health plan provided under a State plan must comply with the 
requirements of the MHPA of 1996 regarding parity in the application of 
annual and lifetime dollar limits to mental health benefits in 
accordance with 45 CFR 146.136.
    (4) Newborns and Mothers Health Protection Act (NMHPA). Health 
benefits coverage under a group health plan provided under a State plan 
must comply with the requirements of the NMHPA of 1996 regarding 
requirements for minimum hospital stays for mothers and newborns in 
accordance with 45 CFR 146.130 and 148.170.



Sec.  457.490  Delivery and utilization control systems.

    A State that elects to obtain health benefits coverage through a 
separate child health program must include in its State plan a 
description of the child health assistance provided under the plan for 
targeted low-income children, including a description of the proposed 
methods of delivery and utilization control systems. A State must--
    (a) Describe the methods of delivery of child health assistance 
including the choice of financing and the methods for assuring delivery 
of the insurance products and delivery of health care services covered 
by such products to the enrollees, including any variations; and
    (b) Describe utilization control systems designed to ensure that 
enrollees receiving health care services under the State plan receive 
only appropriate and medically necessary health care consistent with the 
benefit package described in the approved State plan.



Sec.  457.495  State assurance of access to care and procedures to assure
quality and appropriateness of care.

    A State plan must include a description of the methods that a State 
uses for assuring the quality and appropriateness of care provided under 
the plan, including how the State will assure:
    (a) Access to well-baby care, well-child care, well-adolescent care 
and childhood and adolescent immunizations.
    (b) Access to covered services, including emergency services as 
defined at Sec.  457.10.
    (c) Appropriate and timely procedures to monitor and treat enrollees 
with chronic, complex, or serious medical conditions, including access 
to an adequate number of visits to specialists experienced in treating 
the specific medical condition and access to out-of-network providers 
when the network is not adequate for the enrollee's medical condition.
    (d) That decisions related to the prior authorization of health 
services are completed as follows:
    (1) In accordance with the medical needs of the patient, within 14 
days after receipt of a request for services. A possible extension of up 
to 14 days may be permitted if the enrollee requests the extension or if 
the physician or health plan determines that additional information is 
needed; or

[[Page 601]]

    (2) In accordance with existing State law regarding prior 
authorization of health services.

[66 FR 2678, Jan. 11, 2001, as amended at 66 FR 33824, June 25, 2001]



Sec.  457.496  Parity in mental health and substance use disorder benefits.

    (a) Meaning of terms. For purposes of this section, except where the 
context clearly indicates otherwise, the following terms have the 
meanings indicated:
    Aggregate lifetime dollar limit means a dollar limitation on the 
total amount of specified benefits that may be paid under a State plan 
or a Managed Care Entity (MCE) (as defined at Sec.  457.10) that 
contracts with the State plan. State plans must meet the requirements of 
Sec.  457.480.
    Annual dollar limit means a dollar limitation on the total amount of 
specified benefits that may be paid in a 12-month period under a State 
plan or a MCE that contracts with a State plan. State plans must meet 
the requirements at Sec.  457.480.
    Cumulative financial requirements are financial requirements that 
determine whether or to what extent benefits are provided based on 
accumulated amounts and include deductibles and out-of-pocket maximums. 
(However, cumulative financial requirements do not include aggregate 
lifetime or annual dollar limits because these two terms are excluded 
from the meaning of financial requirements.)
    Early and Periodic Screening, Diagnostic and Treatment (EPSDT) 
benefits has the meaning defined in section 1905(r) of the Act and must 
be provided in accordance with section 1902(a)(43) of the Act.
    Financial requirements include deductibles, copayments, coinsurance, 
or out-of-pocket maximums. Financial requirements do not include 
aggregate lifetime or annual dollar limits.
    Medical/surgical benefits means benefits for items or services for 
medical conditions or surgical procedures, as defined under the terms of 
the State plan in accordance with applicable Federal and State law, but 
does not include mental health or substance use disorder benefits. Any 
condition defined by the State plan as being or not being a medical/
surgical condition must be defined to be consistent with generally 
recognized independent standards of current medical practice (for 
example, the most current version of the International Classification of 
Diseases (ICD) or generally applicable State guidelines). Medical/
surgical benefits include long term care services.
    Mental health benefits means benefits for items or services that 
treat or otherwise address mental health conditions, as defined under 
the terms of the State plan in accordance with applicable Federal and 
State law, and consistent with generally recognized independent 
standards of current medical practice. Standards of current medical 
practice can be based on the most current version of the DSM, the most 
current version of the ICD, or generally applicable State guidelines. 
The term includes long term care services.
    State Plan has the meaning assigned at Sec. Sec.  457.10 and 457.50.
    Substance use disorder benefits means benefits for items or services 
for substance use disorder, as defined under the terms of the State plan 
in accordance with applicable Federal and State law, and consistent with 
generally recognized independent standards of current medical practice. 
Standards of current medical practice can be based on the most current 
version of the DSM, the most current version of the ICD, or generally 
applicable State guidelines. The term includes long term care services.
    Treatment limitations include limits on benefits based on the 
frequency of treatment, number of visits, days of coverage, days in a 
waiting period, or other similar limits on the scope or duration of 
treatment. Treatment limitations include both quantitative treatment 
limitations, which are expressed numerically (such as 50 outpatient 
visits per year), and nonquantitative treatment limitations, which 
otherwise limit the scope or duration of benefits for treatment under 
the State plan. (See paragraph (d)(4)(ii) of this section for an 
illustrative list of nonquantitative treatment limitations.) A permanent 
exclusion of all benefits for a particular condition or disorder, 
however, is not a treatment limitation for purposes of this definition.

[[Page 602]]

    (b) State plan providing EPSDT benefits. (1) A State child health 
plan is deemed to be in compliance with this section if--
    (i) The State elects in the State child health plan to cover 
Secretary-approved coverage defined in Sec.  457.450(a) that includes 
all EPSDT benefits, as defined in section 1905(r) of the Act, in 
accordance with the requirement applied under section 1905(r)(5) of the 
Act to provide necessary health care, diagnostic services, treatment, 
and other measures described in section 1905(a) of the Act to correct or 
ameliorate defects and physical and mental illnesses and conditions 
discovered by the screening services, as well as the informing and 
administrative requirements under 1902(a)(43) of the Act and the 
approved State Medicaid plan; and
    (ii) The State child health plan does not exclude EPSDT benefits for 
any particular condition, disorder, or diagnosis.
    (2) The child health plan must include a description of how the 
State will comply with paragraph (b)(1)(i) of this section.
    (3) If a State has elected in its state plan to cover EPSDT benefits 
only for certain populations enrolled in the state child health plan, 
the State is deemed compliant with this section only with respect to 
such children.
    (c) Parity requirements for aggregate lifetime and annual dollar 
limits. This paragraph (c) details the application of the parity 
requirements for aggregate lifetime and annual dollar limits. A State 
plan that provides both medical/surgical benefits and mental health or 
substance use disorder benefits must comply with paragraph (c)(1), (2), 
or (4) of this section.
    (1) Plan with no limit or limits on less than one-third of all 
medical/surgical benefits. If a State plan does not include an aggregate 
lifetime or annual dollar limit on any medical/surgical benefits or 
includes an aggregate lifetime or annual dollar limit that applies to 
less than one-third of all medical/surgical benefits, it may not impose 
an aggregate lifetime or annual dollar limit, respectively, on mental 
health or substance use disorder benefits.
    (2) State plans with a limit on at least two-thirds of all medical/
surgical benefits. If a State plan includes an aggregate lifetime or 
annual dollar limit on at least two-thirds of all medical/surgical 
benefits, it must either--
    (i) Apply the aggregate lifetime or annual dollar limit both to the 
medical/surgical benefits to which the limit would otherwise apply and 
to mental health or substance use disorder benefits in a manner that 
does not distinguish between the medical/surgical benefits and mental 
health or substance use disorder benefits; or
    (ii) Not include an aggregate lifetime or annual dollar limit on 
mental health or substance use disorder benefits that is more 
restrictive than the aggregate lifetime or annual dollar limit, 
respectively, on medical/surgical benefits. (For cumulative limits other 
than aggregate lifetime or annual dollar limits, see paragraph 
(d)(3)(iii) of this section prohibiting separately accumulating 
cumulative financial requirements.)
    (3) Determining one-third and two-thirds of all medical/surgical 
benefits. For purposes of this paragraph (c), the determination of 
whether the portion of medical/surgical benefits subject to an aggregate 
lifetime or annual dollar limit represents one-third or two-thirds of 
all medical/surgical benefits is based on the dollar amount of all plan 
payments for medical/surgical benefits expected to be paid under the 
State plan for the State plan year (or for the portion of the plan year 
after a change in plan benefits that affects the applicability of the 
aggregate lifetime or annual dollar limits). Any reasonable method may 
be used to determine whether the dollar amount expected to be paid under 
the State plan will constitute one-third or two-thirds of the dollar 
amount of all plan payments for medical/surgical benefits.
    (4) Plan not described in this section--(i) In general. A State plan 
that is not described in paragraph (c)(1) or (2) of this section for 
aggregate lifetime or annual dollar limits on medical/surgical benefits, 
must either--
    (A) Impose no aggregate lifetime or annual dollar limit, as 
appropriate, on mental health or substance use disorder benefits; or
    (B) Impose an aggregate lifetime or annual dollar limit on mental 
health or

[[Page 603]]

substance use disorder benefits that is no more restrictive than an 
average limit calculated for medical/surgical benefits in the following 
manner. The average limit is calculated by taking into account the 
weighted average of the aggregate lifetime or annual dollar limits, as 
appropriate, that are applicable to the categories of medical/surgical 
benefits. Limits based on delivery systems, such as inpatient/outpatient 
treatment or normal treatment of common, low-cost conditions (such as 
treatment of normal births), do not constitute categories for purposes 
of this paragraph (c)(4)(i)(B). In addition, for purposes of determining 
weighted averages, any benefits that are not within a category that is 
subject to a separately-designated dollar limit under the plan are taken 
into account as a single separate category by using an estimate of the 
upper limit on the dollar amount that a plan may reasonably be expected 
to incur for such benefits, taking into account any other applicable 
restrictions under the plan.
    (ii) Weighting. For purposes of this paragraph (c)(4), the weighting 
applicable to any category of medical/surgical benefits is determined in 
the manner set forth in paragraph (c)(3) of this section for determining 
one-third or two-thirds of all medical/surgical benefits.
    (d) Parity requirements for financial requirements and treatment 
limitations--(1) Clarification of terms--(i) Classification of benefits. 
When reference is made in this paragraph (d) to a classification of 
benefits, the term ``classification'' means a classification as 
described in paragraph (d)(2)(ii) of this section.
    (ii) Type of financial requirement or treatment limitation. When 
reference is made in this paragraph (d) to a type of financial 
requirement or treatment limitation, the reference to type means its 
nature. Different types of financial requirements include deductibles, 
copayments, coinsurance, and out-of-pocket maximums. Different types of 
quantitative treatment limitations include annual, episode, and lifetime 
day and visit limits. See paragraph (d)(4)(ii) of this section for an 
illustrative list of nonquantitative treatment limitations.
    (iii) Level of a type of financial requirement or treatment 
limitation. When reference is made in this paragraph (d) to a level of a 
type of financial requirement or treatment limitation, level refers to 
the magnitude of the type of financial requirement or treatment 
limitation.
    (2) General parity requirement--(i) General rule. A State plan or a 
MCE that contracts with CHIP through its State plan that provides both 
medical/surgical benefits and mental health or substance use disorder 
benefits, including when such benefits are delivered through an MCE, may 
not apply any financial requirement or treatment limitation to mental 
health or substance use disorder benefits in any classification that is 
more restrictive than the predominant financial requirement or treatment 
limitation of that type applied to substantially all medical/surgical 
benefits in the same classification. Whether a financial requirement or 
treatment limitation is a predominant financial requirement or treatment 
limitation that applies to substantially all medical/surgical benefits 
in a classification is determined separately for each type of financial 
requirement or treatment limitation. The application of the rules of 
this paragraph (d)(2) to financial requirements and quantitative 
treatment limitations is addressed in paragraph (d)(3) of this section; 
the application of the rules of this paragraph (d)(2) to nonquantitative 
treatment limitations is addressed in paragraph (d)(4) of this section.
    (ii) Classifications of benefits used for applying rules. If a State 
plan provides mental health or substance use disorder benefits in any 
classification of benefits described in this paragraph (d)(2)(ii), 
mental health or substance use disorder benefits must be provided in 
every classification in which medical/surgical benefits are provided. In 
determining the classification in which a particular benefit belongs, 
the same reasonable standards must apply to medical/surgical benefits 
and to mental health or substance use disorder benefits. To the extent 
that a State plan provides benefits in a classification and imposes any 
separate financial requirement or treatment limitation (or separate 
level of a financial requirement or treatment limitation) for benefits 
in the classification, the rules of this

[[Page 604]]

paragraph (d) apply separately for that classification for all financial 
requirements or treatment limitations. The following classifications of 
benefits are the only classifications used in applying the rules of this 
paragraph (d):
    (A) Inpatient. Benefits furnished on an inpatient basis.
    (B) Outpatient. Benefits furnished on an outpatient basis. See 
special rules for office visits in paragraph (d)(3)(iii) of this 
section.
    (C) Emergency care. Benefits for emergency care.
    (D) Prescription drugs. Benefits for prescription drugs. See special 
rules for multi-tiered prescription drug benefits in paragraph 
(d)(3)(iii) of this section.
    (3) Financial requirements and quantitative treatment limitations--
(i) Determining ``substantially all'' and ``predominant''--(A) 
Substantially all. For purposes of this paragraph (d), a type of 
financial requirement or quantitative treatment limitation is considered 
to apply to substantially all medical/surgical benefits in a 
classification of benefits if it applies to at least two-thirds of all 
medical/surgical benefits in that classification. If a type of financial 
requirement or quantitative treatment limitation does not apply to at 
least two-thirds of all medical/surgical benefits in a classification, 
then that type cannot be applied to mental health or substance use 
disorder benefits in that classification.
    (B) Predominant. (1) If a type of financial requirement or 
quantitative treatment limitation applies to at least two-thirds of all 
medical/surgical benefits in a classification as determined under 
paragraph (d)(3)(i)(A) of this section, the level of the financial 
requirement or quantitative treatment limitation that is considered the 
predominant level of that type in a classification of benefits is the 
level that applies to more than one-half of medical/surgical benefits in 
that classification subject to the financial requirement or quantitative 
treatment limitation.
    (2) If, for a type of financial requirement or quantitative 
treatment limitation that applies to at least two-thirds of all medical/
surgical benefits in a classification, there is no single level that 
applies to more than one-half of medical/surgical benefits in the 
classification subject to the financial requirement or quantitative 
treatment limitation, the State plan (or health insurance issuer) may 
combine levels until the combination of levels applies to more than one-
half of medical/surgical benefits subject to the financial requirement 
or quantitative treatment limitation in the classification. The least 
restrictive level within the combination is considered the predominant 
level of that type in the classification. (For this purpose, a State 
plan may combine the most restrictive levels first, with each less 
restrictive level added to the combination until the combination applies 
to more than one-half of the benefits subject to the financial 
requirement or treatment limitation.)
    (C) Portion based on plan payments. For purposes of this paragraph 
(d), the determination of the portion of medical/surgical benefits in a 
classification of benefits subject to a financial requirement or 
quantitative treatment limitation (or subject to any level of a 
financial requirement or quantitative treatment limitation) is based on 
the dollar amount of all State plan payments and combinations of MCE 
payments for medical/surgical benefits in the classification expected to 
be paid under the plan or MCE or combination that contracts with the 
State plan for the plan year (or for the portion of the plan year after 
a change in plan benefits that affects the applicability of the 
financial requirement or quantitative treatment limitation).
    (D) Clarifications for certain threshold requirements. For any 
deductible, the dollar amount of a State plan payments includes all plan 
payments for claims that would be subject to the deductible if it had 
not been satisfied. In accordance with the cumulative cost-sharing 
maximum in Sec.  457.560, or any other out-of-pocket maximum in the 
State plan, the dollar amount of plan payments includes all State plan 
payments associated with out-of-pocket payments that are taken into 
account towards the out-of-pocket maximum as well as all plan payments 
associated with out-of-pocket payments that would have been made towards 
the out-of-pocket maximum if it had not been satisfied. Similar rules 
apply for any

[[Page 605]]

other thresholds at which the rate of health plan payment changes.
    (E) Determining the dollar amount of State plan payments. Subject to 
paragraph (d)(3)(i)(D) of this section, any reasonable method may be 
used to determine the dollar amount expected to be paid under a State 
plan for medical/surgical benefits subject to a financial requirement or 
quantitative treatment limitation (or subject to any level of a 
financial requirement or quantitative treatment limitation).
    (ii) Special rules--(A) Multi-tiered prescription drug benefits. If 
a State plan applies different levels of financial requirements to 
different tiers of prescription drug benefits based on reasonable 
factors determined in accordance with the rules in paragraph (d)(4)(i) 
of this section (relating to requirements for nonquantitative treatment 
limitations) and without regard to whether a drug is generally 
prescribed for medical/surgical benefits or for mental health or 
substance use disorder benefits, the health plan satisfies the parity 
requirements of this paragraph (d) for prescription drug benefits. 
Reasonable factors include cost, efficacy, generic versus brand name, 
and mail order versus pharmacy pick-up/delivery.
    (B) Sub-classifications permitted for office visits, separate from 
other outpatient services. For purposes of applying the financial 
requirement and treatment limitation rules of this paragraph (d), a 
State plan may divide its benefits furnished on an outpatient basis into 
the two sub-classifications described in this paragraph (d)(3)(ii)(B). 
After the sub-classifications are established, the State plan may not 
impose any financial requirement or quantitative treatment limitation on 
mental health or substance use disorder benefits in any sub-
classification that is more restrictive than the predominant financial 
requirement or quantitative treatment limitation that applies to 
substantially all medical/surgical benefits in the sub-classification 
using the methodology set forth in paragraph (d)(3)(i) of this section. 
Sub-classifications other than these special rules, such as separate 
sub-classifications for generalists and specialists, are not permitted. 
The two sub-classifications permitted under this paragraph (d)(3)(ii)(B) 
are:
    (1) Office visits (such as physician visits); and
    (2) All other outpatient items and services (such as outpatient 
surgery, facility charges for day treatment centers, laboratory charges, 
or other medical items).
    (iii) No separate cumulative financial requirements. A State plan 
may not apply any cumulative financial requirement for mental health or 
substance use disorder benefits in a classification that accumulates 
separately from any established for medical/surgical benefits in the 
same classification.
    (4) Nonquantitative treatment limitations--(i) General rule. A State 
plan may not impose a nonquantitative treatment limitation for mental 
health or substance use disorder benefits in any classification unless, 
under the terms of the CHIP State plan as written and in operation, any 
processes, strategies, evidentiary standards, or other factors used in 
applying the nonquantitative treatment limitation to mental health or 
substance use disorder benefits in the classification are comparable to, 
and are applied no more stringently than, the processes, strategies, 
evidentiary standards, or other factors used in applying the limitation 
for medical/surgical benefits in the classification.
    (ii) Illustrative list of nonquantitative treatment limitations. 
Nonquantitative treatment limitations include--
    (A) Medical management standards limiting or excluding benefits 
based on medical necessity or medical appropriateness, or based on 
whether the treatment is experimental or investigative;
    (B) Formulary design for prescription drugs;
    (C) For plans with multiple network tiers (such as preferred 
providers and participating providers), network tier design;
    (D) Standards for provider admission to participate in a network, 
including reimbursement rates;
    (E) Plan methods for determining usual, customary, and reasonable 
charges;

[[Page 606]]

    (F) Refusal to pay for higher-cost therapies until it can be shown 
that a lower-cost therapy is not effective (also known as fail-first 
policies or step therapy protocols);
    (G) Exclusions based on failure to complete a course of treatment;
    (H) Restrictions based on geographic location, facility type, 
provider specialty, and other criteria that limit the scope or duration 
of benefits for services provided under the plan or coverage; and
    (I) Standards for providing access to out-of-network providers.
    (5) Application to out-of-network providers. Any State plan 
providing access to out-of-network providers for medical/surgical 
benefits within a classification must use processes, strategies, 
evidentiary standards, or other factors in determining access to out-of-
network providers for mental health or substance use disorder benefits 
that are comparable to, and applied no more stringently than, the 
processes, strategies, evidentiary standards, or other factors in 
determining access to out-of-network providers for medical/surgical 
benefits.
    (e) Availability of plan information--(1) Criteria for medical 
necessity determinations. The criteria for medical necessity 
determinations made under a State plan including when benefits are 
furnished through a MCE contractor for mental health or substance use 
disorder benefits must be made available by the plan administrator (or 
the State offering the coverage) to any current enrollee or potential 
enrollee or contracting provider upon request. Health plans operating in 
compliance with Sec.  438.236(c) of this chapter will be deemed 
compliant with the requirements in this paragraph (e).
    (2) Reason for any denial. The reason for any denial under a health 
plan of reimbursement or payment for services for mental health or 
substance use disorder benefits in the case of any enrollee must be made 
available by the plan administrator or the State to the enrollee.
    (3) Provisions of other law. Compliance with the disclosure 
requirements in paragraphs (e)(1) and (2) of this section is not 
determinative of compliance with any other provision of applicable 
Federal or State law.
    (f) Applicability--(1) State plans. The requirements of this section 
apply to State plans offering medical/surgical benefits and mental 
health or substance use disorder benefits to their enrollees including 
when benefits are furnished under a contract with MCEs. If, under an 
arrangement or arrangements to provide State plan benefits any enrollee 
can simultaneously receive coverage for medical/surgical benefits and 
coverage for mental health or substance use disorder benefits, then the 
requirements of this section apply separately for each combination of 
medical/surgical benefits and of mental health or substance use disorder 
benefits that any enrollee can simultaneously receive from the State.
    (i) Standard for defining benefits. States must indicate the 
standard used for defining the following benefits in the State plan:
    (A) Medical/surgical benefits.
    (B) Mental health benefits.
    (C) Substance use disorder benefits.
    (ii) [Reserved]
    (2) Scope. This section does not--
    (i) Require a State plan or a MCE that contracts with a State plan 
to provide any mental health benefits or substance use disorder 
benefits, and the provision of benefits by a State plan or a MCE that 
contracts with a State plan for one or more mental health conditions or 
substance use disorders does not require the plan or health insurance 
coverage under this section to provide benefits for any other mental 
health condition or substance use disorder;
    (ii) Affect the terms and conditions relating to the amount, 
duration, or scope of mental health or substance use disorder benefits 
under the State plan or a MCE that contracts with a CHIP State plan 
except as specifically provided in paragraphs (c) and (d) of this 
section.
    (g) Compliance dates--(1) In general. State plans (including those 
that contract with a MCE) must comply with the requirements of this 
section no later than October 2, 2017.
    (2) [Reserved]

[81 FR 18842, Mar. 30, 2016]

[[Page 607]]



 Subpart E_State Plan Requirements: Enrollee Financial Responsibilities

    Source: 66 FR 2681, Jan. 11, 2001, unless otherwise noted.



Sec.  457.500  Basis, scope, and applicability.

    (a) Statutory basis. This subpart implements--
    (1) Section 2101(a) of the Act, which provides that the purpose of 
title XXI is to provide funds to States to enable them to initiate and 
expand the provision of child health assistance to uninsured, low-income 
children in an effective and efficient manner; and
    (2) Section 2103(e) of the Act, which sets forth provisions 
regarding State plan requirements and options for cost sharing.
    (b) Scope. This subpart consists of provisions relating to the 
imposition under a separate child health program of cost-sharing charges 
including enrollment fees, premiums, deductibles, coinsurance, 
copayments, and similar cost-sharing charges.
    (c) Applicability. The requirements of this subpart apply to 
separate child health programs.



Sec.  457.505  General State plan requirements.

    The State plan must include a description of--
    (a) The amount of premiums, deductibles, coinsurance, copayments, 
and other cost sharing imposed;
    (b) The methods, including the public schedule, the State uses to 
inform enrollees, applicants, providers and the general public of the 
cost-sharing charges, the cumulative cost-sharing maximum, and any 
changes to these amounts;
    (c) The disenrollment protections as required under Sec.  457.570;
    (d) In the case of coverage obtained through premium assistance for 
group health plans--
    (1) The procedures the State uses to ensure that eligible children 
are not charged copayments, coinsurance, deductibles or similar fees on 
well-baby and well-child care services described at Sec.  457.520, and 
that any cost sharing complies with the requirements of this subpart;
    (2) The procedures to ensure that American Indian and Alaska Native 
children are not charged premiums, copayments, coinsurance, deductibles, 
or similar fees in accordance with Sec.  457.535;
    (3) The procedures to ensure that eligible children are not charged 
cost sharing in excess of the cumulative cost-sharing maximum specified 
in Sec.  457.560.
    (e) Procedures that do not primarily rely on a refund given by the 
State for overpayment on behalf of an eligible child to ensure 
compliance with this subpart.

[66 FR 2681, Jan. 11, 2001, as amended at 66 FR 33824, June 25, 2001]



Sec.  457.510  Premiums, enrollment fees, or similar fees: State plan
requirements.

    When a State imposes premiums, enrollment fees, or similar fees on 
enrollees, the State plan must describe--
    (a) The amount of the premium, enrollment fee or similar fee imposed 
on enrollees;
    (b) The time period for which the charge is imposed;
    (c) The group or groups that are subject to the premiums, enrollment 
fees, or similar charges;
    (d) The consequences for an enrollee or applicant who does not pay a 
charge, and the disenrollment protections adopted by the State in 
accordance with Sec.  457.570; and
    (e) The methodology used to ensure that total cost-sharing liability 
for a family does not exceed the cumulative cost-sharing maximum 
specified in Sec.  457.560.



Sec.  457.515  Co-payments, coinsurance, deductibles, or similar
cost-sharing charges: State plan requirements.

    To impose copayments, coinsurance, deductibles or similar charges on 
enrollees, the State plan must describe--
    (a) The service for which the charge is imposed;
    (b) The amount of the charge;
    (c) The group or groups of enrollees that may be subject to the 
cost-sharing charge;

[[Page 608]]

    (d) The consequences for an enrollee who does not pay a charge, and 
the disenrollment protections adopted by the State in accordance with 
Sec.  457.570;
    (e) The methodology used to ensure that total cost-sharing liability 
for a family does not exceed the cumulative cost-sharing maximum 
specified in Sec.  457.560; and
    (f) An assurance that enrollees will not be held liable for cost-
sharing amounts for emergency services that are provided at a facility 
that does not participate in the enrollee's managed care network beyond 
the copayment amounts specified in the State plan for emergency services 
as defined in Sec.  457.10.



Sec.  457.520  Cost sharing for well-baby and well-child care services.

    (a) A State may not impose copayments, deductibles, coinsurance or 
other cost sharing with respect to the well-baby and well-child care 
services covered under the State plan in either the managed care 
delivery setting or the fee-for-service delivery setting.
    (b) For the purposes of this subpart, at a minimum, any of the 
following services covered under the State plan will be considered well-
baby and well-child care services:
    (1) All healthy newborn physician visits, including routine 
screening, whether provided on an inpatient or outpatient basis.
    (2) Routine physical examinations as recommended and updated by the 
American Academy of Pediatrics (AAP) ``Guidelines for Health Supervision 
III'' and described in ``Bright Futures: Guidelines for Health 
Supervision of Infants, Children and Adolescents.''
    (3) Laboratory tests associated with the well-baby and well-child 
routine physical examinations as described in paragraph (b)(2) of this 
section.
    (4) Immunizations and related office visits as recommended and 
updated by the Advisory Committee on Immunization Practices (ACIP).
    (5) Routine preventive and diagnostic dental services (such as oral 
examinations, prophylaxis and topical fluoride applications, sealants, 
and x-rays) as described in the most recent guidelines issued by the 
American Academy of Pediatric Dentistry (AAPD).



Sec.  457.525  Public schedule.

    (a) The State must make available to the groups in paragraph (b) of 
this section a public schedule that contains the following information:
    (1) Current cost-sharing charges.
    (2) Enrollee groups subject to the charges.
    (3) Cumulative cost-sharing maximums.
    (4) Mechanisms for making payments for required charges.
    (5) The consequences for an applicant or an enrollee who does not 
pay a charge, including the disenrollment protections required by Sec.  
457.570.
    (b) The State must make the public schedule available to the 
following groups:
    (1) Enrollees, at the time of enrollment and reenrollment after a 
redetermination of eligibility, and when cost-sharing charges and 
cumulative cost-sharing maximums are revised.
    (2) Applicants, at the time of application.
    (3) All participating providers.
    (4) The general public.



Sec.  457.530  General cost-sharing protection for lower income children.

    The State may vary premiums, deductibles, coinsurance, copayments or 
any other cost sharing based on household income only in a manner that 
does not favor children from families with higher income over children 
from families with lower income.



Sec.  457.535  Cost-sharing protection to ensure enrollment of American
Indians and Alaska Natives.

    States may not impose premiums, deductibles, coinsurance, copayments 
or any other cost-sharing charges on children who are American Indians 
or Alaska Natives, as defined in Sec.  457.10.



Sec.  457.540  Cost-sharing charges for children in families with incomes
at or below 150 percent of the FPL.

    The State may impose premiums, enrollment fees, deductibles, 
copayments, coinsurance, cost sharing and other similar charges for 
children whose

[[Page 609]]

household income is at or below 150 percent of the FPL as long as--
    (a) Aggregate monthly enrollment fees, premiums, or similar charges 
imposed on a family are less than or equal to the maximum amounts 
permitted under Sec.  447.52, Sec.  447.53, or Sec.  447.54 of this 
chapter for a Medicaid eligible family of the same size and income;
    (b) Any copayments, coinsurance, deductibles or similar charges for 
children whose household income is at or below 100 percent of the FPL 
are equal to or less than the amounts permitted under Sec.  447.54 of 
this chapter;
    (c) For children whose household income is from 101 percent to 150 
percent of the FPL, any copayments, coinsurance, deductibles or similar 
charges are equal to or less than the maximum amounts permitted under 
Sec.  457.555;
    (d) The State does not impose more than one type of cost-sharing 
charge (deductible, copayment, or coinsurance) on a service;
    (e) The State only imposes one copayment based on the total cost of 
services furnished during one office visit; and
    (f) Aggregate annual cost sharing of all types, with respect to all 
targeted low-income children in a family, does not exceed the maximum 
permitted under Sec.  457.560(a).

[66 FR 2681, Jan. 11, 2001, as amended at 66 FR 33824, June 25, 2001; 78 
FR 42312, July 15, 2013]



Sec.  457.555  Maximum allowable cost-sharing charges on targeted
low-income children in families with income from 101 to 150 percent
of the FPL.

    (a) Non-institutional services. For targeted low-income children 
whose household income is from 101 to 150 percent of the FPL, the State 
plan must provide that for non-institutional services, including 
emergency services, the following requirements must be met:
    (1)(i) For Federal FY 2009, any co-payment or similar charge the 
State imposes under a fee-for-service delivery system may not exceed the 
amounts shown in the following table:

------------------------------------------------------------------------
                                                                Maximum
                State payment for the service                  Copayment
------------------------------------------------------------------------
$15 or less.................................................       $1.15
$15.01 to $40...............................................       $2.30
$40.01 to $80...............................................       $3.40
$80.01 or more..............................................       $5.70
------------------------------------------------------------------------

    (ii) Thereafter, any copayments may not exceed these amounts as 
updated each October 1 by the percentage increase in the medical care 
component of the CPI-U for the period of September to September ending 
in the preceding calendar year and then rounded to the next higher 5-
cent increment.
    (2) For Federal FY 2009, any co-payment that the State imposes for 
services provided by a managed care organization may not exceed $5.70 
per visit. In succeeding years, any copayment may not exceed this amount 
as updated each October 1 by the percentage increase in the medical care 
component of the CPI-U for the period of September to September ending 
in the preceding calendar year and then rounded to the next higher 5-
cent increment.
    (3) Any coinsurance rate the State imposes may not exceed 5 percent 
of the payment the State directly or through contract makes for the 
service; and
    (4) For Federal FY 2009, any deductible the State imposes may not 
exceed $3.40 per month, per family for each period of eligibility. 
Thereafter, any deductible may not exceed this amount as updated each 
October 1 by the percentage increase in the medical care component of 
the CPI-U for the period of September to September ending in the 
preceding calendar year and then rounded to the next higher 5-cent 
increment.
    (b) Institutional services. For targeted low-income children whose 
household income is from 101 to 150 percent of the FPL, the maximum 
deductible, coinsurance or copayment charge for each institutional 
admission may not exceed 50 percent of the payment the State would make 
under the Medicaid fee-for-service system for the first day of care in 
the institution.
    (c) Institutional emergency services. For Federal FY 2009, any 
copayment that the State imposes on emergency services provided by an 
institution may not exceed $5.70. Thereafter, any

[[Page 610]]

copayment may not exceed this amount as updated each October 1 by the 
percentage increase in the medical care component of the CPI-U for the 
period of September to September ending in the preceding calendar year 
and then rounded to the next higher 5-cent increment.
    (d) Non-emergency use of the emergency room. For Federal FY 2009, 
for targeted low-income children whose household income is from 101 to 
150 percent of the FPL, the State may charge up to twice the charge for 
non-institutional services, up to a maximum amount of $11.35 for 
services furnished in a hospital emergency room if those services are 
not emergency services as defined in Sec.  457.10. Thereafter, any 
charge may not exceed this amount as updated each October 1 by the 
percentage increase in the medical care component of the CPI-U for the 
period of September to September ending in the preceding calendar year 
and then rounded to the next higher 5-cent increment.
    (e) Standard copayment amount. For targeted low-income children 
whose household income is from 101 to 150 percent of the FPL, a standard 
copayment amount for any service may be determined by applying the 
maximum copayment amounts specified in paragraphs (a), (b), and (c) of 
this section to the State's average or typical payment for that service.

[66 FR 2681, Jan. 11, 2001, as amended at 73 FR 71854, Nov. 25, 2008; 75 
FR 30265, May 28, 2010]



Sec.  457.560  Cumulative cost-sharing maximum.

    (a) A State may not impose premiums, enrollment fees, copayments, 
coinsurance, deductibles, or similar cost-sharing charges that, in the 
aggregate, exceed 5 percent of a family's total income for the length of 
a child's eligibility period in the State.
    (b) The State must inform the enrollee's family in writing and 
orally if appropriate of their individual cumulative cost-sharing 
maximum amount at the time of enrollment and reenrollment.

[66 FR 2681, Jan. 11, 2001, as amended at 66 FR 33824, June 25, 2001]



Sec.  457.570  Disenrollment protections.

    (a) The State must give enrollees reasonable notice of and an 
opportunity to pay past due premiums, copayments, coinsurance, 
deductibles or similar fees prior to disenrollment.
    (b) The disenrollment process must afford the enrollee an 
opportunity to show that the enrollee's household income has declined 
prior to disenrollment for non payment of cost-sharing charges, and in 
the event that such a showing indicates that the enrollee may have 
become eligible for Medicaid or for a lower level of cost sharing, the 
State must facilitate enrolling the child in Medicaid or adjust the 
child's cost-sharing category as appropriate.
    (c) The State must ensure that disenrollment policies, such as 
policies related to non-payment of premiums, do not present barriers to 
the timely determination of eligibility and enrollment in coverage of an 
eligible child in the appropriate insurance affordability program. A 
State may not--
    (1) Establish a premium lock-out period that exceeds 90-days in 
accordance with Sec.  457.10 of this part.
    (2) Continue to impose a premium lock-out period after a child's 
past due premiums have been paid.
    (3) Require the collection of past due premiums or enrollment fees 
as a condition of eligibility for reenrollment once the State-defined 
lock out period has expired, regardless of the length of the lock-out 
period.
    (d) The State must provide the enrollee with an opportunity for an 
impartial review to address disenrollment from the program in accordance 
with Sec.  457.1130(a)(3).

[66 FR 2681, Jan. 11, 2001, as amended at 78 FR 42312, July 15, 2013]



                      Subpart F_Payments to States



Sec.  457.600  Purpose and basis of this subpart.

    This subpart interprets and implements--
    (a) Section 2104 of the Act which specifies the total allotment 
amount available for allotment to each State for child health assistance 
for fiscal years 1998 through 2015, the formula for

[[Page 611]]

determining each State allotment for a fiscal year, including the 
Commonwealth and Territories, and the amounts of payments for 
expenditures that are applied to reduce the State allotments.
    (b) Section 2105 of the Act which specifies the provisions for 
making payment to States, the limitations and conditions on such 
payments, and the calculation of the enhanced Federal medical assistance 
percentage.

[66 FR 2670, Jan. 11, 2001, as amended at 76 FR 9246, Feb. 17, 2011]



Sec.  457.602  Applicability.

    The provisions of this subpart apply to the 50 States and the 
District of Columbia, and the Commonwealths and Territories.



Sec.  457.606  Conditions for State allotments and Federal payments 
for a fiscal year.

    (a) Basic conditions. In order to receive a State allotment for a 
fiscal year, a State must have a State child health plan submitted in 
accordance with section 2106 of the Act, and
    (1) For fiscal years 1998 and 1999, the State child health plan must 
be approved before October 1, 1999;
    (2) For fiscal years after 1999, the State child health plan must be 
approved by the end of the fiscal year;
    (3) An allotment for a fiscal year is not available to a State prior 
to the beginning of the fiscal year; and
    (4) Federal payments out of an allotment are based on State 
expenditures which are allowable under the approved State child health 
plan.
    (b) Federal payments for Children's Health Insurance Program (CHIP) 
expenditures under an approved State child health plan are--
    (1) Limited to the amount of available funds remaining in State 
allotments calculated in accordance with the allotment process and 
formula specified in Sec. Sec.  457.608 and 457.610, and payment process 
in Sec. Sec.  457.614 and 457.616.
    (2) Available based on a percentage of State CHIP expenditures, at a 
rate equal to the enhanced Federal medical assistance percentage (FMAP) 
for each fiscal year, calculated in accordance with Sec.  457.622.
    (3) Available through the grants process specified in Sec.  457.630.

[65 FR 33622, May 24, 2000, as amended at 75 FR 48852, Aug. 11, 2010]



Sec.  457.608  Process and calculation of State allotments prior to 
FY 2009.

    (a) General--(1) State allotments for a fiscal year are determined 
by CMS for each State and the District of Columbia with an approved 
State child health plan, as described in paragraph (e) of this section, 
and for each Commonwealth and Territory, as described in paragraph (f) 
of this section.
    (2) In order to determine each State allotment, CMS determines the 
national total allotment amount for each fiscal year available to the 50 
States and the District of Columbia, as described in paragraph (c) of 
this section, and the total allotment amount available for each fiscal 
year for allotment to the Commonwealths and Territories, as described in 
paragraph (d) of this section.
    (3) The amount of allotments redistributed under section 2104(f) of 
the Act will not be applied or taken into account in determining the 
amounts of a fiscal year allotment for a State and the District of 
Columbia under this section.
    (b) Definition of Proportion. As used in this section, proportion 
means the amount of the allotment for a State or the District of 
Columbia for a fiscal year, divided by the national total allotment 
amount available for allotment to all States and the District of 
Columbia, as specified in paragraph (c) of this section, for that fiscal 
year.
    (c) National total allotment amount for the 50 States and the 
District of Columbia. (1) The national total allotment amount available 
for allotment to the 50 States and the District of Columbia is 
determined by subtracting the following amounts in the following order 
from the total appropriation specified in section 2104(a) of the Act for 
the fiscal year--
    (i) The total allotment amount available for allotment for each 
fiscal year to the Commonwealths and Territories, as determined in 
paragraph (d)(1) of this section;
    (ii) The total amount of the grant for the fiscal year for children 
with Type I

[[Page 612]]

Diabetes under Section 4921 of Public Law 105-33. This is $30,000,000 
for each of the fiscal years 1998 through 2002; and
    (iii) The total amount of the grant for the fiscal year for diabetes 
programs for Indians under Section 4922 of Public Law 105-33. This is 
$30,000,000 for each of the fiscal years 1998 through 2002.
    (2) The following formula illustrates the calculation of the 
national total allotment amount available for allotment to the 50 States 
and the District of Columbia for a fiscal year:

ATA = S2104(a)-T2104(c)-
D4921-D4922

ATA = National total allotment amount available for allotment 
          to the 50 States and the District of Columbia for the fiscal 
          year.
S2104(a) = Total appropriation for the fiscal year indicated 
          in Section 2104(a) of the Act.
T2104(c) = Total allotment amount for a fiscal year available 
          for allotment to the Commonwealths and Territories; as 
          determined under paragraph (d)(1) of this section.
D4921 = Amount of total grant for children with Type I 
          Diabetes under Section 4921 of Public Law 105-33. This is 
          $30,000,000 for each of the fiscal years 1998 through 2002.

    (d) Total allotment amount available to the Commonwealths and 
Territories--(1) General. The total allotment amount available to all 
the Commonwealths and Territories for a fiscal year is equal to .25 
percent of the total appropriation for the fiscal year indicated in 
section 2104(a) of the Act, plus the additional amount for the fiscal 
year specified in paragraph (d)(2) of this section.
    (2) Additional amounts for allotment to the Commonwealths and 
Territories. The following amounts are available for allotment to the 
Commonwealths and Territories for the indicated fiscal years in addition 
to the amount specified in paragraph (d)(1) of this section: For FY 
1999, $32 million; for each of FY 2000 and FY 2001, $34.2 million; for 
each fiscal year FY 2002 through 2004, $25.2 million; for each fiscal 
year FY 2005 and FY 2006, $32.4 million; and for FY 2007, $40 million. 
The additional amount for allotment for FY 1999 for the Commonwealths 
and Territories was provided under Public Law 105-277. The additional 
amounts for allotment for FY 2000 through FY 2007 were provided for the 
Commonwealths and Territories under section 702 of Public Law 106-113.
    (e) Determination of State allotments for a fiscal year--(1) 
General. The allotment for a State and the District of Columbia for a 
fiscal year is the product of:
    (i) The proportion for the State or the District of Columbia for the 
fiscal year, as defined in paragraph (b) of this section, and determined 
after application of the provisions of paragraphs (e)(2) and (3), 
related to the preadjusted proportion, and the floors, ceilings, and 
reconciliation process, respectively; and
    (ii)(A) The national total allotment amount available for allotment 
for the fiscal year, as specified in paragraph (c) of this section. The 
State and the District of Columbia's allotment for a fiscal year is 
determined in accordance with the following general formula:

SAi = Pi x ATA

SAi = Allotment for a State or District of Columbia for a 
          fiscal year.
Pi = Proportion for a State or District of Columbia for a 
          fiscal year.
ATA = Total amount available for allotment to the 50 States 
          and the District of Columbia for the fiscal year.

    (B) There are two steps for determining the proportion for a State 
and the District of Columbia. The first step determines the preadjusted 
proportions, and is described under paragraph (e)(2) of this section. 
The first step applies in determining the proportion for all fiscal 
years. The second step applies floors and ceilings and, if necessary, 
applies a reconciliation to the preadjusted proportion. The second step 
is described in paragraph (e)(3) of this section. The second step 
applies in determining the proportion only for FY 2000 and subsequent 
fiscal years. For FY 1998 and FY 1999, the preadjusted proportion is the 
State or District of Columbia's proportion for the fiscal year.
    (2) Determination of the Preadjusted Proportions for a Fiscal Year. 
(i)The methodology for determining the State preadjusted proportion, 
referring to the determination of the proportion before the application 
of floors and ceilings

[[Page 613]]

and reconciliation for a fiscal year is in accordance with the following 
formula:

PPi = (Ci x SCFi)/ 
[Sigma](Ci x x SCFi)

PPi = Preadjusted proportion for a State or District of 
          Columbia for a fiscal year.
Ci = Number of children in a State (section 2104(b)(1)(A)(I) 
          of the Act) for a fiscal year. This number is based on the 
          number of low-income children for a State for a fiscal year 
          and the number of low-income children for a State for a fiscal 
          year with no health insurance coverage for the fiscal year 
          determined on the basis of the arithmetic average of the 
          number of such children as reported and defined in the 3 most 
          recent March supplements to the Current Population Survey 
          (CPS) of the Bureau of the Census, and for FY 2000 and 
          subsequent fiscal years, officially available before the 
          beginning of the calendar year in which the fiscal year 
          begins. For FY 1998 and FY 1999, the availability of the CPS 
          data obtained from the Bureau of the Census is as specified in 
          paragraphs (e)(4) and (5) of this section, respectively. 
          (section 2104(b)(2)(B) of the Act).

    (ii) For each of the fiscal years 1998 and 1999, the number of 
children is equal to the number of low-income children in the State for 
the fiscal year with no health insurance coverage. For fiscal year 2000, 
the number of children is equal to the sum of 75 percent of the number 
of low-income children in the State for the fiscal year with no health 
insurance coverage and 25 percent of the number of low-income children 
in the State for the fiscal year. For fiscal years 2001 and thereafter, 
the number of children is equal to the sum of 50 percent of the number 
of low-income children in the State for the fiscal year with no health 
insurance coverage and 50 percent of the number of low-income children 
in the State for the fiscal year. (section 2104(b)(2)(A) of the Act).

SCFi = State cost factor for a State (section 
2104(b)(1)(A)(ii) of the Act). For a fiscal year, this is equal to: .15 
+ .85 x (Wi/WN) (section 2104(b)(3)(A) of the 
Act).

Wi = The annual average wages per employee for a State for 
          such year (section 2104(b)(3)(A)(ii)(I) of the Act).
WN = The annual average wages per employee for the 50 States 
          and the District of Columbia (section 2104(b)(3)(A)(ii)(II) of 
          the Act). The annual average wages per employee for a State or 
          for all States and the District of Columbia for a fiscal year 
          is equal to the average of such wages for employees in the 
          health services industry (SIC 80), as reported by the Bureau 
          of Labor Statistics of the Department of Labor for each of the 
          most recent 3 years, and for FY 2000 and subsequent fiscal 
          years, finally available before the beginning of the calendar 
          year in which the fiscal year begins. For FY 1998 and FY 1999, 
          the availability of the wage data obtained from the Bureau of 
          Labor Statistics is as specified in paragraphs (e)(4) and (5), 
          respectively. (section 2104(b)(3)(B) of the Act).
[Sigma](Ci x SCFi) = The sum of the products of 
          (Ci x SCFi) for each State (section 
          2104(b)(1)(B) of the Act).
ATA = Total amount available for allotment to the 50 States 
          and the District of Columbia for the fiscal year as determined 
          under paragraph (c) of this section.

    (3) Application of floors and ceilings and reconciliation in 
determining proportion--(i) Floors and ceilings in proportions. The 
preadjusted State proportions for a fiscal year are subject to the 
application of floors and ceilings in paragraphs (e)(3)(i)(A) and (B) of 
this section.
    (A) The proportion floors, or minimum proportions, that apply in 
determining a State's proportion for the fiscal year are:
    (1) $2,000,000 divided by the total of the amount available 
nationally;
    (2) 90 percent of the State's proportion for the previous fiscal 
year; and
    (3) 70 percent of the State's proportion for FY 1999.
    (B) The proportion ceiling, or maximum proportion, for a fiscal year 
that applies in determining the State's fiscal year proportion is 145 
percent of the State's proportion for FY 1999.
    (ii) Reconciliation of State proportions. If, after the application 
of the floors and ceilings in paragraph (e)(3)(i), the sum of the 
States' proportions is not equal to one, the Secretary will reconcile 
the States' proportions by applying either paragraph (e)(3)(i)(A) or (B) 
of this paragraph, as appropriate, such that the sum of the proportions 
after reconciliation equals one. If, after the application of the floors 
and ceilings in paragraph (e)(3)(i), the sum of the States' proportions 
is equal to one, no reconciliation is necessary, and the States' 
proportions will be the same as

[[Page 614]]

the preadjusted proportions determined under paragraph (e)(2) of this 
section.
    (A) If, after the application of the floors and ceilings under 
paragraphs (e)(3)(i)(A) and (B) of this section, the sum of the States' 
proportions is greater than one, the Secretary will establish a maximum 
percentage increase in States' proportions, such that when applied to 
the States' proportions, the sum of the proportions is exactly equal to 
one.
    (B) If, after the application of the floors and ceilings under 
paragraphs (e)(3)(i)(A) and (B), the sum of the proportions is less than 
one, the Secretary will increase States' proportions (as computed before 
the application of the floors under paragraph (e)(3)(i)(A)) in a pro 
rata manner (but not to exceed the 145 percent ceiling computed under 
paragraph (e)(3)(i)(B)), such that when applied to the States' 
proportions, the sum of the proportions is exactly equal to one.
    (4) Data used for calculating the FY 1998 CHIP allotments. The FY 
1998 CHIP allotments were calculated in accordance with the methodology 
described in paragraphs (e)(1) and (2) of this section, using the most 
recent official and final data that were available from the Bureau of 
the Census and the Bureau of Labor Statistics, respectively, prior to 
the September 1 before the beginning of FY 1998 (that is, through August 
31, 1997). In particular, through August 31, 1997, the only official 
data available on the numbers of children were data from the 3 March 
CPSs conducted in March 1994, 1995, and 1996 that reflected data for the 
3 calendar years 1993, 1994, and 1995.
    (5) Data used for calculating the FY 1999 CHIP allotments. In 
accordance with section 101(f) of Public Law 105-277, the FY 1999 
allotments were calculated in accordance with the methodology described 
in paragraph (e)(2) of this section, using the same data as were used in 
calculating the FY 1998 CHIP allotments.
    (f) Methodology for determining the Commonwealth and Territory 
allotments for a fiscal year. The total amount available for the 
Commonwealths and Territories for each fiscal year, as determined under 
paragraph (d) of this section, is allotted to each Territory and 
Commonwealth below which has an approved State child health plan. These 
allotments are in the proportion that the following percentages for each 
Commonwealth Territory bear to the sum of such percentages, as specified 
in section 2104(c)(2) of the Act:

Puerto Rico--91.6%
Guam--3.5%
Virgin Islands--2.6%
American Samoa--1.2%
Northern Mariana Islands--1.1%

    (g) Reserved State allotments for a fiscal year. (1) For FY 2000 and 
subsequent fiscal years, CMS determines and publishes the State reserved 
allotments for a fiscal year for each State, the District of Columbia, 
and Commonwealths and Territories in the Federal Register based on the 
most recent official and final data available before the beginning of 
the calendar year in which the fiscal year begins for the number of 
children and the State cost factor.
    (2) For FY 1998 and FY 1999, CMS determined and published the State 
reserved allotments using the available data described in paragraphs 
(e)(4) and (e)(5) of this section, respectively, on the basis of the 
statutory allotment formula as it existed prior to the enactment of 
Public Law 106-113.
    (3) If all States, the District of Columbia, and the Commonwealths 
and Territories have approved State child health plans in place prior to 
the beginning of the fiscal year, as appropriate, CMS may publish the 
allotments as final in the Federal Register, without the need for 
publication as reserved allotments.
    (h) Final allotments. (1) Final State allotments for FY 1998 and FY 
1999 for each State, the District of Columbia, and the Commonwealths and 
Territories are determined by CMS based only on those States, the 
District of Columbia, and the Commonwealths and Territories that have 
approved State child health plans by the end of fiscal year 1999, in 
accordance with the formula and methodology specified in paragraphs (a) 
through (g) of this section.
    (2) Final State allotments for a fiscal year after FY 1999 for each 
State, the District of Columbia, and the Commonwealths and Territories 
are determined by CMS based only on those States, the

[[Page 615]]

District of Columbia, and the Commonwealths and Territories that have 
approved State child health plans by the end of the fiscal year, in 
accordance with the formula and methodology specified in paragraphs (a) 
through (g) of this section.
    (3) CMS determines and publishes the States' final fiscal year 
allotments in the Federal Register based on the same data, with respect 
to the number of children and State cost factor, as were used in 
determining the reserved allotments for the fiscal year.

[66 FR 2670, Jan. 11, 2001, as amended at 76 FR 9246, Feb. 17, 2011]



Sec.  457.609  Process and calculation of State allotments for a fiscal
year after FY 2008.

    (a) General. For each of the 50 States and the District of Columbia 
and for each Commonwealth and Territory with an approved State child 
health plan, the State allotments for FY 2009 through FY 2015 are 
determined by CMS as described in paragraphs (b) through (g) of this 
section. Unless otherwise indicated in this section, the reference to 
``State'' refers to the 50 States and the District of Columbia and the 
Commonwealths and Territories (American Samoa, Guam, the Northern 
Mariana Islands, Puerto Rico, and the Virgin Islands).
    (b) Amounts available for allotment. The total amounts available for 
allotment for each fiscal year are as follows:
    (1) FY 2009: $10,562,000,000.
    (2) FY 2010: $12,520,000,000.
    (3) FY 2011: $13,459,000,000.
    (4) FY 2012: $14,982,000,000.
    (5) FY 2013: $17,406,000,000.
    (6) FY 2014: $19,147,000,000.
    (7) FY 2015, for the period beginning October 1, 2014 and ending 
March 31, 2015, the following amounts are available for allotment:
    (i) $2,850,000,000.
    (ii) 15,361,000,000.
    (8) FY 2015, for the period beginning April 1, 2013 and ending on 
September 30, 2013, $2,850,000,000.
    (c) Determination of a State allotment for FY 2009--(1) For the 50 
States and the District of Columbia. From the amount in paragraph (b)(1) 
of this section as appropriated for the fiscal year under section 
2104(a) of the Act, subject to paragraph (e) related to proration, and 
paragraph (c)(3) of this section relating to coordination of funding, 
the allotment for FY 2009 is equal to 110 percent of the highest of the 
following amounts for each State and the District of Columbia:
    (i) The total Federal payments to the State under title XXI of the 
Act for FY 2008 as reported by the State and certified to the Secretary 
through the November 2008 submission of the quarterly expenditure 
reports, Forms CMS-21 (OMB  0938-0731) and CMS-64 (OMB  0938-0067), 
multiplied by the allotment increase factor determined under paragraph 
(f) of this section.
    (ii) The amount allotted to the State for FY 2008, multiplied by the 
allotment increase factor determined under paragraph (f) of this 
section;
    (iii) The projected total Federal payments to the State under title 
XXI of the Act for FY 2009, subject to paragraph (c)(1)(iv) of this 
section, as determined based on the February 2009 projections certified 
by the State to CMS by no later than March 31, 2009.
    (iv) In the case of a State described in section 2105(g) of the Act 
and electing the option under paragraph (4) of such section, for 
purposes of the projections described in paragraph (c)(1)(iii) of this 
section, such projections would include an amount equal to the 
difference between the following amounts:
    (A) the amount of Federal payments for the expenditures described in 
section 2105(g)(4)(B) of the Act made after February 4, 2009 that would 
have been paid to the State if claimed at the enhanced Federal medical 
assistance percentage determined under section 2105(b) of the Act.
    (B) the amount of Federal payments for the expenditures described in 
section 2105(g)(4)(B) of the Act made after February 4, 2009 that would 
have been paid to the State if claimed at the Federal medical assistance 
percentage defined in section 1905(b) of the Act; during the recession 
adjustment period described in section 5001(h) of the American Recovery 
and Reinvestment Act of 2009 (ARRA), as amended the Federal medical 
assistance percentage is as determined for the State under section 5001 
of ARRA.

[[Page 616]]

    (2) For the Commonwealths or Territories. (i) From the amount in 
paragraph (b)(1) of this section, as appropriated for the FY 2009 under 
section 2104(a) of the Act, subject to paragraph (e) of this section 
related to proration, and paragraph (c)(3) of this section relating to 
coordination of funding, an amount equal to the highest amount of 
Federal payments made to the Commonwealth or Territory under title XXI 
of the Social Security Act for any fiscal year occurring during the 
period for FY 1999 through FY 2008, multiplied by the allotment increase 
factor determined under paragraph (f) of this section, plus the 
additional amount for the fiscal year specified in paragraph (c)(2)(ii) 
of this section.
    (ii) Additional Amounts for FY 2009. From the amount appropriated 
for the fiscal year under section 2104(c)(4)(B) of the Act, the 
additional amount for each Commonwealth or Territory is equal to 
$40,000,000 multiplied by the following percentage as specified in 
section 2104(c)(2) of the Act:
    (A) For Puerto Rico, 91.6 percent.
    (B) For Guam, 3.5 percent.
    (C) For the Virgin Islands, 2.6 percent.
    (D) For American Samoa, 1.2 percent.
    (E) For the Northern Mariana Islands, 1.1 percent.
    (3) Coordination of CHIP Funding for FY 2009. The amount of the CHIP 
allotment for FY 2009 available for payment for a States' expenditures 
may be reduced by the amounts appropriated and obligated before April 1, 
2009 for States' FY 2009 allotments, FY 2006 allotments redistributed to 
the State in FY 2009 determined under section 2104(k) of the Act, and 
the amounts of additional FY 2009 shortfall allotments determined under 
section 2104(l) of the Act.
    (d) Determination of a State allotment for FY 2010 through FY 2015--
(1) General. Subject to the provisions of paragraph (e) of this section 
relating to proration and paragraph (g) of the section relating to 
increases in a fiscal year allotment for approved program expansions, 
the State allotments for FY 2010 through FY 2015 are determined as 
follows.
    (2) Determination of a State Allotment for FY 2010. (i) For the 50 
States and the District of Columbia, and for the Commonwealths and 
Territories subject to paragraph (d)(2)(ii) of this section, the State 
allotment for FY 2010 is equal to the product of the following:
    (A) The sum of:
    (1) The State Allotment for FY 2009, as determined under paragraph 
(c) of the section.
    (2) The amount of any Federal payments made as redistributions of 
unexpended FY 2006 allotments under section 2104(k) of the Act.
    (3) The amount of any Federal payments made as additional FY 2009 
allotments under section 2104(l) of the Act.
    (4) The amount of any Federal payments made as contingency fund 
payments for FY 2009 under section 2104(n) of the Act.
    (B) The State allotment increase factor for FY 2010 as determined 
under paragraph (f) of the section.
    (ii) In determining the amount of the FY 2010 allotment for each 
Commonwealth and Territory, for purposes of determining the amount of 
the FY 2009 allotment under paragraph (d)(2)(i)(A)(1) of this section, 
the amount of such FY 2009 allotment will not include the additional 
amount determined under paragraph (c)(2)(ii).
    (3) Determination of a State Allotment for FY 2011. For the 50 
States and the District of Columbia, and the Commonwealths and 
Territories, the State allotment for FY 2011 is equal to the product of:
    (i) The amount of Federal payments attributable and countable toward 
the available State allotments in FY 2010, including:
    (A) Any amount redistributed to the State in FY 2010, and
    (B) Any Federal payments made as contingency fund payments for FY 
2010 under section 2104(n) of the Act.
    (ii) The State allotment increase factor for FY 2011 as determined 
under paragraph (f) of the section.
    (4) Determination of a State Allotment for FY 2012. For the 50 
States and the District of Columbia, and the Commonwealths and 
Territories, the State allotment for FY 2012 is equal to the product of:
    (i) The sum of:

[[Page 617]]

    (A) The State Allotment for FY 2011, as determined under paragraph 
(d)(3) of this section.
    (B) The amount of any Federal payments made as contingency fund 
payments for FY 2011 under section 2104(n) of the Act.
    (ii) The State allotment increase factor for FY 2012 as determined 
under paragraph (f) of this section.
    (5) Determination of a State Allotment for FY 2013. For the 50 
States and the District of Columbia, and the Commonwealths and 
Territories, the State allotment for FY 2013 is equal to the product of:
    (i) The amount of Federal payments attributable and countable toward 
the available State allotments in FY 2012, including:
    (A) Any amount redistributed to the State in FY 2012, and
    (B) Any Federal payments made as contingency fund payments for FY 
2012 under section 2104(n) of the Act.
    (ii) The State allotment increase factor for FY 2013 as determined 
under paragraph (f) of the section.
    (6) Determination of a State Allotment for FY 2014. For the 50 
States and the District of Columbia, and the Commonwealths and 
Territories, the State allotment for FY 2014 is equal to the product of:
    (i) The sum of:
    (A) The State Allotment for FY 2013, as determined under paragraph 
(d)(5) of this section.
    (B) The amount of any Federal payments made as contingency fund 
payments for FY 2013 under section 2104(n) of the Act.
    (ii) The State allotment increase factor for FY 2014 as determined 
under paragraph (f) of this section.
    (7) Determination of a State Allotment for FY 2015--(i) General. 
There are two State allotments for FY 2015; one for the period beginning 
October 1, 2014 and ending March 31, 2015 and the second beginning April 
1, 2015 and ending September 30, 2015. These State allotments are 
determined for each of the 50 States and the District of Columbia, and 
the Commonwealths and Territories.
    (ii) The State allotment for FY 2015 for the period October 1, 2014 
and ending March 31, 2015 is determined as the product of the following:
    (A) The first half ratio determined as the amount in paragraph 
(d)(7)(ii)(A)(1) of this section divided by the amount in paragraph 
(d)(7)(ii)(A)(2) of this section as follows:
    (1) $18,211,000,000 (calculated as the sum of the amount in 
paragraph (b)(7)(i) of this section, $2,850,000,000 (appropriated in 
section 2104(a)(18)(A) of the Act) and the amount in paragraph 
(b)(7)(ii) of this section, $15,361,000,000 (appropriated in section 108 
of Pub. L. 111-3, as amended by section 10203 of Pub. L. 111-148)).
    (2) $21,061,000,000, determined as the sum of the amount determined 
in paragraph (1) of this section, $18,211,000,000, and $2,850,000,000, 
the amount in paragraph (b)(8) of this section, as appropriated in 
section 2104(a)(18)(B) of the Act, as amended by section 10203 Of Public 
Law 111-148.
    (B) The product of:
    (1) The amount of Federal payments attributable and countable toward 
the total amount of available State allotments in FY 2014, to include:
    (i) Any amount redistributed to the State in FY 2014; and
    (ii) Any Federal payments made as contingency fund payments for FY 
2014 under section 2104(n) of the Act.
    (2) The State allotment increase factor for FY 2015 as determined 
under paragraph (f) of this section.
    (iii) The State allotment for FY 2015 for the period April 1, 2015 
and ending September 30, 2015 is determined as the product of the 
following:
    (A) $2,850,000,000 the amount in paragraph (b)(8) of this section, 
as appropriated in section 2104(a)(18)(B) of the Act; and
    (B) The ratio determined as the amount in paragraph 
(d)(7)(iii)(B)(1) of this section divided by the amount in paragraph 
(d)(7)(iii)(B)(2) of this section:
    (1) The amount of the State allotment determined in paragraph 
(d)(7)(ii) of this section.
    (2) The total of all the State allotments determined in paragraph 
(d)(7)(ii) of this section.
    (e) Proration. (1) If for a fiscal year the sum of the State 
allotments for the 50 States and the District of Columbia,

[[Page 618]]

and the State allotments for the Commonwealths and Territories (not 
including the additional amount for FY 2009 determined under paragraph 
(c)(2)(ii) of this section), exceeds the total amount available for 
allotment for the fiscal year in paragraph (b) of this section, the 
amount of the allotment for each of the 50 States and the District of 
Columbia, and for each of the Commonwealths and Territories (not 
including the additional amount for FY 2009 determined under paragraph 
(c)(2)(ii) of this section) will be reduced on a proportional basis as 
indicated in paragraph (e)(2) of this section.
    (2) The amount of the allotment for each of the 50 States and the 
District of Columbia, and for each of the Commonwealths and Territories 
(not including the additional amount for FY 2009 determined in paragraph 
(c)(2)(ii) of this section) is equal to the product of:
    (i) The percentage determined by dividing the amount in paragraph 
(e)(2)(i)(A) by the amount in paragraph (e)(2)(i)(B) of this section.
    (A) The amount of the State allotment for each of the 50 States and 
the District of Columbia, and for each of the Commonwealths and 
Territories (not including the additional amount for FY 2009 determined 
under paragraph (c)(2)(ii) of this section).
    (B) The sum of the amounts for each of the 50 States and the 
District of Columbia, and the Commonwealths and Territories in paragraph 
(e)(2)(i) of this section.
    (ii) The total amount available for allotment for the fiscal year 
under paragraph (b) of this section.
    (f) Allotment increase factor. The allotment increase factor for a 
fiscal year is equal to the product of the following:
    (1) Per capita health care growth factor. The per capita health care 
growth factor for a fiscal year is equal to 1 plus the percentage 
increase in the projected per capita amount of the National Health 
Expenditures from the calendar year in which the previous fiscal year 
ends to the calendar year in which the fiscal year involved ends, as 
most recently published by CMS before the beginning of the fiscal year 
involved.
    (2) Child Population Growth Factor (CPGF). The CPGF for a fiscal 
year is equal to 1 plus the percentage increase (if any) in the 
population of children in the State from July 1 in the previous fiscal 
year to July 1 in the fiscal year involved, as determined by CMS based 
on the most recent published estimates of the Census Bureau available 
before the beginning of the fiscal year involved plus 1 percentage 
point. For purposes of determining the CPGF for FY 2009 for the 
Commonwealths and Territories only, in applying the previous sentence, 
``United States'' is substituted for ``the State''.
    (g) Increase in State allotment for the 50 States and the District 
of Columbia for FY 2010 through FY 2015 to account for approved program 
expansions. In the case of the 50 States and the District of Columbia, 
the State allotment for FY 2010 through FY 2015, as determined in 
accordance with the provisions of this section, may be increased under 
the following conditions and amounts:
    (1) The State has submitted to the Secretary, and has approved by 
the Secretary a State plan amendment or waiver request relating to an 
expansion of eligibility for children or benefits under title XXI of the 
Act that becomes effective for a fiscal year (beginning with FY 2010 and 
ending with FY 2015).
    (2) The State has submitted to the Secretary, before the August 31 
preceding the beginning of the fiscal year, a request for an expansion 
allotment adjustment under this paragraph for such fiscal year that 
specifies.
    (i) The additional expenditures that are attributable to the 
eligibility or benefit expansion provided under the amendment or waiver 
described in paragraph (g)(1) of this section, as certified by the State 
and submitted to the Secretary by not later than August 31 preceding the 
beginning of the fiscal year.
    (ii) The extent to which such additional expenditures are projected 
to exceed the allotment of the State or District for the year.
    (3) Subject to paragraph (e) of this section relating to proration, 
the amount of the allotment of the State or District under this section 
for such

[[Page 619]]

fiscal year shall be increased by the excess amount described in 
paragraph (g)(2)(i)of this section. A State or District may only obtain 
an increase under paragraph (g)(2)(ii) of this section for an allotment 
for FY 2010, FY 2012, or FY 2014.
    (h) CHIP Fiscal Year Allotment Process. As determined by the 
Secretary, the CHIP allotments for a fiscal year may be published as 
Preliminary Allotments or Final Allotments in the Federal Register.

[76 FR 9246, Feb. 17, 2011]



Sec.  457.610  Period of availability for State allotments prior
to FY 2009.

    The amount of a final allotment prior to FY 2009, as determined 
under Sec.  457.608(h) and reduced to reflect certain Medicaid 
expenditures in accordance with Sec.  457.616, remains available until 
expended for Federal payments based on expenditures claimed during a 3-
year period of availability, beginning with the fiscal year of the final 
allotment and ending with the end of the second fiscal year following 
the fiscal year.

[66 FR 2670, Jan. 11, 2001, as amended at 76 FR 9249, Feb. 17, 2011]



Sec.  457.611  Period of availability for State allotments for a 
fiscal year after FY 2008.

    The amount of a final allotment for a fiscal year after FY 2008, as 
determined under Sec.  457.609 and reduced to reflect certain Medicaid 
expenditures in accordance with Sec.  457.616, remains available until 
expended for Federal payments based on expenditures claimed during a 2-
year period of availability, beginning with the fiscal year of the final 
allotment and ending with the end of the succeeding fiscal year 
following the fiscal year.

(Authority: Section 1102 of the Social Security Act (42 U.S.C. 1302).

[76 FR 9249, Feb. 17, 2011]



Sec.  457.614  General payment process.

    (a) A State may make claims for Federal payment based on 
expenditures incurred by the State prior to or during the period of 
availability related to that fiscal year.
    (b) In order to receive Federal financial participation (FFP) for a 
State's claims for payment for the State's expenditures, a State must--
    (1) Submit budget estimates of quarterly funding requirements for 
Medicaid and the Children's Health Insurance Programs; and
    (2) Submit an expenditure report.
    (c) Based on the State's quarterly budget estimates, CMS--
    (1) Issues an advance grant to a State as described in Sec.  
457.630;
    (2) Tracks and applies Federal payments claimed quarterly by each 
State, the District of Columbia, and each Commonwealth and Territory to 
ensure that payments do not exceed the applicable allotments for the 
fiscal year; and
    (3) Track and apply relevant State, District of Columbia, 
Commonwealth and Territory expenditures reported each quarter against 
the 10 percent limit on expenditures other than child health assistance 
for standard benefit package, on a fiscal year basis as specified in 
Sec.  457.618.

[65 FR 33622, May 24, 2000, as amended at 75 FR 48852, Aug. 11, 2010]



Sec.  457.616  Application and tracking of payments against the fiscal
year allotments.

    (a) Categories of payments applied to reduce the State allotments. 
In accordance with the principles described in paragraph (c) of this 
section, the following categories of payments are applied to reduce the 
State allotments for a fiscal year:
    (1) Payments made to the State for expenditures claimed during the 
fiscal year under its title XIX Medicaid program, to the extent the 
payments were made on the basis of the enhanced FMAP described in 
sections 1905(b) and 2105(b) of the Act for expenditures attributable to 
children described in section 1905(u)(2) of the Act.
    (2) Payments made to the State for expenditures claimed during the 
fiscal year under its title XIX Medicaid program, to the extent the 
payments were made on the basis of the enhanced FMAP described in 
sections 1905(b) and 2105(b) of the Act for expenditures attributable to 
children described in section 1905(u)(3) of the Act.

[[Page 620]]

    (3) [Reserved]
    (4) Payments made to a State under its title XXI State Children's 
Health Insurance Program with respect to section 2105(a) of the Act for 
expenditures claimed by the State during a fiscal year.
    (b) Application of principles. CMS applies the principles in 
paragraph (c) of this section to--
    (1) Coordinate the application of the payments made to a State for 
the State's expenditures claimed under the Medicaid and State Children's 
Health Insurance programs against the State allotment for a fiscal year;
    (2) Determine the order of these payments in that application; and
    (3) Determine the application of payments against multiple State 
Child Health Insurance Program fiscal year allotments.
    (c) Principles for applying Federal payments against the allotment. 
CMS--
    (1) Applies the payments attributable to Medicaid expenditures 
specified in paragraphs (a)(1) through (a)(3) of this section, against 
the State child health plan allotment for a fiscal year before State 
child health plan expenditures specified in paragraph (a)(4) of this 
section are applied.
    (2) Applies the payments attributable to Medicaid and State child 
health plan expenditures specified in paragraph (a) of this section 
against the applicable allotments for a fiscal year based on the quarter 
in which the expenditures are claimed by the State.
    (3) Applies payments against the State allotments for a fiscal year 
in a manner that is consistent for all States.
    (4) Applies payments attributable to Medicaid expenditures specified 
in paragraphs (a)(1) through (a)(3) of this section, in an order that 
maximizes Federal reimbursement for States. Expenditures for which the 
enhanced FMAP is available are applied before expenditures for which the 
regular FMAP is available.
    (5) Applies payments for expenditures against State Child Health 
Insurance Program fiscal year allotments in the least administratively 
burdensome, and most effective and efficient manner; payments are 
applied on a quarterly basis as they are claimed by the State, and are 
applied to reduce the earliest fiscal year State allotments before the 
payments are applied to reduce later fiscal year allotments.
    (6) Subject to paragraphs (c)(6)(i) and (ii) of this section, 
applies payments for expenditures for a fiscal year's allotment against 
a subsequent fiscal year's allotment; however, the subsequent fiscal 
year's allotment must be available at the time of application. For 
example, if the allotment for fiscal year 1998 has been fully expended, 
payments for expenditures claimed in fiscal year 1998 are carried over 
for application against the fiscal year 1999 allotment when it becomes 
available.
    (i) In accordance with Sec.  457.618, the amount of non-primary 
expenditures that are within the 10 percent limit for the fiscal year 
for which they are claimed may be applied against a fiscal year 
allotment or allotments available in a subsequent fiscal year.
    (ii) In accordance with Sec.  457.618, the amounts of non-primary 
expenditures that exceed the 10 percent limit for the fiscal year for 
which they are claimed may not be applied against a fiscal year 
allotment or allotments available in a subsequent fiscal year.
    (7) Carries over unexpended amounts of a State's allotment for a 
fiscal year for use in subsequent fiscal years through the end of the 3-
year period of availability. For example, if the amounts of the fiscal 
year 1998 allotment are not fully expended by the end of fiscal year 
1998, these amounts are carried over to fiscal year 1999 and are 
available to provide FFP for expenditures claimed by the State for that 
fiscal year.
    (d) Amount of Federal payment for expenditures claimed. The amount 
of the Federal payment for expenditures claimed by a State, District of 
Columbia, or the Commonwealths and Territories is determined by the 
enhanced FMAP applicable to the fiscal year in which the State paid the 
expenditure. For example, Federal payment for an expenditure paid by a 
State in fiscal year 1998 that was carried over to fiscal year 1999 (in 
accordance with paragraph (c)(6) of this section), because the State 
exceeded its fiscal year 1998

[[Page 621]]

allotment, is available at the fiscal year 1998 enhanced FMAP rate.

[65 FR 33622, May 24, 2000, as amended at 81 FR 86466, Nov. 30, 2016]



Sec.  457.618  Ten percent limit on certain Children's Health Insurance
Program expenditures.

    (a) Expenditures--(1) Primary expenditures are expenditures under a 
State plan for child health assistance to targeted low-income children 
in the form of a standard benefit package, and Medicaid expenditures 
claimed during the fiscal year to the extent Federal payments made for 
these expenditures on the basis of the enhanced FMAP described in 
sections 1905(b) and 2105(b) of the Act that are used to calculate the 
10 percent limit.
    (2) Non-primary expenditures are other expenditures under a State 
plan. Subject to the 10 percent limit described in paragraph (c) of this 
section, a State may receive Federal funds at the enhanced FMAP for 4 
categories of non-primary expenditures:
    (i) Administrative expenditures;
    (ii) Outreach;
    (iii) Health initiatives; and
    (iv) Certain other child health assistance.
    (b) Federal payment. Federal payment will not be available based on 
a State's non-primary expenditures for a fiscal year which exceed the 10 
percent limit of the total of expenditures under the plan, as specified 
in paragraph (c) of this section.
    (c) 10 Percent Limit. The 10 percent limit is--
    (1) Applied on an annual fiscal year basis;
    (2) Calculated based on the total computable expenditures claimed by 
the State on quarterly expenditure reports submitted for a fiscal year. 
Expenditures claimed on a quarterly report for a different fiscal year 
may not be used in the calculation; and
    (3) Calculated using the following formula:

L10% = (a1 + u2 + u3)/9;

L10% = 10 Percent Limit for a fiscal year
a1 = Total computable amount of expenditures for the fiscal year under 
          section 2105(a)(1) of the Act for which Federal payments are 
          available at the enhanced FMAP described in Section 2105(b) of 
          the Act;
u2 = Total computable expenditures for medical assistance for which 
          Federal payments are made during the fiscal year based on the 
          enhanced FMAP described in sections 1905(b) and 2105(b) of the 
          Act for individuals described in section 1905(u)(2) of the 
          Act; and
u3 = Total computable expenditures for medical assistance for which 
          Federal payments are made during the fiscal year based on the 
          enhanced FMAP described in sections 1905(b) and 2105(b) of the 
          Act for individuals described in section 1905(u)(3) of the 
          Act.

    (d) The expenditures under section 2105(a)(2) of the Act that are 
subject to the 10 percent limit are applied--
    (1) On an annual fiscal year basis; and
    (2) Against the 10 percent limit in the fiscal year for which the 
State submitted a quarterly expenditure report including the 
expenditures. Expenditures claimed on a quarterly report for one fiscal 
year may not be applied against the 10 percent limit for any other 
fiscal year.
    (e)(1) The 10 percent limit for a fiscal year, as calculated under 
paragraph (c)(3) of this section, may be no greater than 10 percent of 
the total computable amount (determined under paragraph (e)(2) of this 
section) of the State allotment or allotments available in that fiscal 
year. Therefore, the 10 percent limit is the lower of the amount 
calculated under paragraph (c)(3) of this section, and 10 percent of the 
total computable amount of the State allotment available in that fiscal 
year.
    (2) As used in paragraph (e)(1) of this section, the total 
computable amount of a State's allotment for a fiscal year is determined 
by dividing the State's allotment for the fiscal year by the State's 
enhanced FMAP for the year. For example, if a State allotment for a 
fiscal year is $65 million and the enhanced FMAP rate for the fiscal 
year is 65 percent, the total computable amount of the allotment for the 
fiscal year is $100 million ($65 million/.65). In this example, the 10 
percent limit may be no greater than a total computable amount of $10 
million (10 percent of $100 million).

[65 FR 33622, May 24, 2000, as amended at 75 FR 48852, Aug. 11, 2010]

[[Page 622]]



Sec.  457.622  Rate of FFP for State expenditures.

    (a) Basis. Sections 1905(b), 2105(a) and 2105(b) of the Act provides 
for payments to States from the States' allotments for a fiscal year, as 
determined under Sec.  457.608, for part of the cost of expenditures for 
services and administration made under an approved State child health 
assistance plan. The rate of payment is generally the enhanced Federal 
medical assistance percentage described below.
    (b) Enhanced Federal medical assistance percentage (Enhanced FMAP)--
Computations. The enhanced FMAP is the lower of the following:
    (1) 70 percent of the regular FMAP determined under section 1905(b) 
of the Act, plus 30 percentage points; or
    (2) 85 percent.
    (c) Conditions for availability of enhanced FMAP based on a State's 
expenditures--The enhanced FMAP is available for payments based on a 
State's expenditures claimed under the State's title XXI program from 
the State's fiscal year allotment only under the following conditions:
    (1) The State has an approved title XXI State child health plan;
    (2) The expenditures are allowable under the State's approved title 
XXI State child health plan;
    (3) State allotment amounts are available in the fiscal year, that 
is, the State's allotment or allotments (as reduced in accordance with 
Sec.  457.616) remain available for a fiscal year and have not been 
fully expended.
    (4) Expenditures claimed against the 10 percent limit are within the 
State's 10 percent limit for the fiscal year.
    (5) For States that elect to extend eligibility to unborn children 
under the approved Child Health Plan, the State does not adopt 
eligibility standards and methodologies for purposes of determining a 
child's eligibility under the Medicaid State plan that were more 
restrictive than those applied under policies of the State plan in 
effect on June 1, 1997. This limitation applies also to more restrictive 
standards and methodologies for determining eligibility for services for 
a child based on the eligibility of a pregnant woman.
    (d) Categories of expenditures for which enhanced FMAP are 
available. Except as otherwise provided below, the enhanced FMAP is 
available with respect to the following States' expenditures:
    (1) Child health assistance under the plan for targeted low-income 
children in the form of providing health benefits coverage that meets 
the requirements of section 2103 of the Act; and
    (2) Subject to the 10 percent limit provisions under Sec.  
457.618(a)(2), the following expenditures:
    (i) Payment for other child health assistance for targeted low-
income children;
    (ii) Expenditures for health services initiatives under the State 
child health assistance plan for improving the health of children 
(including targeted low-income children);
    (iii) Expenditures for outreach activities; and
    (iv) Other reasonable costs incurred by the State to administer the 
State child health assistance plan.
    (e) CHIP administrative expenditures and CHIP related title XIX 
administrative expenditures--(1) General rule. Allowable title XXI 
administrative expenditures should support the operation of the State 
child health assistance plan. In general, FFP for administration under 
title XXI is not available for costs of activities related to the 
operation of other programs.
    (2) Exception. FFP is available under title XXI, at the enhanced FFP 
rate, for Medicaid administrative expenditures attributable to the 
provision of medical assistance to children described in sections 
1905(u)(2) and 1905(u)(3), and during the presumptive eligibility period 
described in section 1920A of the Act, to the extent that the State does 
not claim those costs under the Medicaid program.
    (3) FFP is not available in expenditures for administrative 
activities for items or services included within the scope of another 
claimed expenditure.
    (4) FFP is available in expenditures for activities defined in 
sections 2102(c)(1) and 2105(a)(2)(C) of the Act as outreach to families 
of children likely to be eligible for child health assistance under the 
plan or under other public or private health coverage programs to inform 
these families of the availability of, and to assist them in

[[Page 623]]

enrolling their children in such a program.
    (5) FFP is available in administrative expenditures for activities 
specified in sections 2102(c)(2) of the Act as coordination of the 
administration of the Children's Health Insurance Program with other 
public and private health insurance programs. FFP would not be available 
for the costs of administering the other public and private health 
insurance programs. Coordination activities must be distinguished from 
other administrative activities common among different programs.

[65 FR 33622, May 24, 2000, as amended at 67 FR 61974, Oct. 2, 2002; 75 
FR 48852, Aug. 11, 2010]



Sec.  457.626  Prevention of duplicate payments.

    (a) General rule. No payment shall be made to a State for 
expenditures for child health assistance under its State child health 
plan to the extent that:
    (1) A non-governmental health insurer would have been obligated to 
pay for those services but for a provision of its insurance contract 
that has the effect of limiting or excluding those obligations based on 
the actual or potential eligibility of the individual for child health 
assistance under the State child health insurance plan.
    (2) Payment has been made or can reasonably be expected to be made 
promptly under any other Federally operated or financed health insurance 
or benefits program, other than a program operated or financed by the 
Indian Health Service.
    (3) Services are for an unborn child and are payable under Medicaid 
as a service to an eligible pregnant woman under that program.
    (b) Definitions. As used in paragraph (a) of this section--
    Non-governmental health insurer includes any health insurance 
issuer, group health plan, or health maintenance organization, as those 
terms are defined in 45 CFR 144.103, which is not part of, or wholly 
owned by, a governmental entity.
    Prompt payment can reasonably be expected when payment is required 
by applicable statute, or under an approved State plan.
    Programs operated or financed by the Indian Health Service means 
health programs operated by the Indian Health Service, or Indian tribe 
or tribal organization pursuant to a contract, grant, cooperative 
agreement or compact with the Indian Health Service under the authority 
of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 
450, et seq.), or by an urban Indian organization in accordance with a 
grant or contract with the Indian Health Service under the authority of 
title V of the Indian Health Care Improvement Act (25 U.S.C. 1601, et 
seq.).

[65 FR 33622, May 24, 2000, as amended at 67 FR 61974, Oct. 2, 2002]



Sec.  457.628  Other applicable Federal regulations.

    Other regulations applicable to CHIP programs include the following:
    (a) HHS regulations in Sec. Sec.  431.800 through 431.1010 of this 
chapter (related to the PERM and MEQC programs); Sec. Sec.  433.312 
through 433.322 of this chapter (related to Overpayments); Sec.  433.38 
of this chapter (Interest charge on disallowed claims of FFP); 
Sec. Sec.  430.40 through 430.42 of this chapter (Deferral of claims for 
FFP and Disallowance of claims for FFP); Sec.  430.48 of this chapter 
(Repayment of Federal funds by installments); Sec. Sec.  433.50 through 
433.74 of this chapter (sources of non-Federal share and Health Care-
Related Taxes and Provider Related Donations); and Sec.  447.207 of this 
chapter (Retention of Payments) apply to State's CHIP programs in the 
same manner as they apply to State's Medicaid programs.
    (b) HHS Regulations in 45 CFR subtitle A:

Part 16--Procedures of the Departmental Appeals Board.
45 CFR part 75--Uniform Administrative Requirements, Cost Principles, 
          and Audit Requirements for HHS Awards (except as specifically 
          excepted).
Part 80--Nondiscrimination Under Programs Receiving Federal Assistance 
          Through the Department of Health and Human Services: 
          Effectuation of title VI of the Civil Rights Act of 1964.
Part 81--Practice and Procedure for Hearings Under 45 CFR part 80.

[[Page 624]]

Part 84--Nondiscrimination on the Basis of Handicap in Programs and 
          activities Receiving or Benefiting From Federal Financial 
          Assistance.
Part 95--General Administration--grant programs (public assistance and 
          medical assistance).

[66 FR 2670, Jan. 11, 2001, as amended at 72 FR 29836, May 29, 2007; 75 
FR 73976, Nov. 30, 2010; 77 FR 31513, May 29, 2012; 81 FR 3012, Jan. 20, 
2016; 82 FR 31187, July 5, 2017]



Sec.  457.630  Grants procedures.

    (a) General provisions. Once CMS has approved a State child health 
plan, CMS makes quarterly grant awards to the State to cover the Federal 
share of expenditures for child health assistance, other child health 
assistance, special health initiatives, outreach and administration.
    (1) For fiscal year 1998, a State must submit a budget request in an 
appropriate format for the 4 quarters of the fiscal year. CMS bases the 
grant awards for the 4 quarters of fiscal year 1998 based on the State's 
budget requests for those quarters.
    (2) For fiscal years after 1998, a State must submit a budget 
request in an appropriate format for the first 3 quarters of the fiscal 
year. CMS bases the grant awards for the first 3 quarters of the fiscal 
year on the State's budget requests for those quarters.
    (3) For fiscal years after 1998, a State must also submit a budget 
request for the fourth quarter of the fiscal year. The amount of this 
quarter's grant award is based on the difference between a State's final 
allotment for the fiscal year, and the total of the grants for the first 
3 quarters that were already issued in order to ensure that the total of 
all grant awards for the fiscal year are equal to the State's final 
allotment for that fiscal year.
    (4) The amount of the quarterly grant is determined on the basis of 
information submitted by the State (in quarterly estimate and quarterly 
expenditure reports) and other pertinent information. This information 
must be submitted by the State through the Medicaid Budget and 
Expenditure System (MBES) for the Medicaid program, and through the 
Child Health Budget and Expenditure System (CBES) for the title XXI 
program.
    (b) Quarterly estimates. The Children's Health Insurance Program 
agency must submit Form CMS-21B (State Children's Health Insurance 
Program Budget Report for State Children's Health Insurance Program 
State expenditures) to the CMS central office (with a copy to the CMS 
regional office) 45 days before the beginning of each quarter.
    (c) Expenditure reports. (1) The State must submit Form CMS-64 
(Quarterly Medicaid Statement of Expenditures for the Medical Assistance 
Program) and Form CMS-21 (Quarterlye Children's Health Insurance Program 
Statement of Expenditures for title XXI), to central office (with a copy 
to the regional office) not later than 30 days after the end of the 
quarter.
    (2) This report is the State's accounting of actual recorded 
expenditures. This disposition of Federal funds may not be reported on 
the basis of estimates.
    (d) Additional required information. A State must provide CMS with 
the following information regarding the administration of the title XXI 
program:
    (1) Name and address of the State Agency/organization administering 
the program;
    (2) The employer identification number (EIN); and
    (3) A State official contact name and telephone number.
    (e) Grant award--(1) Computation by CMS. Regional office staff 
analyzes the State's estimates and sends a recommendation to the central 
office. Central office staff considers the State's estimates, the 
regional office recommendations and any other relevant information, 
including any adjustments to be made under paragraph (e)(2) of this 
section, and computes the grant.
    (2) Content of award. The grant award computation form shows the 
estimate of expenditures for the ensuing quarter, and the amounts by 
which that estimate is increased or decreased because of an increase or 
overestimate for prior quarters, or for any of the following reasons:
    (i) Penalty reductions imposed by law.
    (ii) Deferrals or disallowances.
    (iii) Interest assessments.

[[Page 625]]

    (iv) Mandated adjustments such as those required by Section 1914 of 
the Act.
    (3) Effect of award. The grant award authorizes the State to draw 
Federal funds as needed to pay the Federal share of disbursements.
    (4) Draw procedure. The draw is through a commercial bank and the 
Federal Reserve system against a continuing letter of credit certified 
to the Secretary of the Treasury in favor of the State payee. (The 
letter of credit payment system was established in accordance with 
Treasury Department regulations--Circular No.1075.)
    (f) General administrative requirements. With the following 
exceptions, the provisions of 45 CFR part 75, that establish uniform 
administrative requirements and cost principles, apply to all grants 
made to States under this subpart:
    (1) Cost sharing or matching, 45 CFR 75.306; and
    (2) Financial reporting, 45 CFR 75.341.

[65 FR 33622, May 24, 2000, as amended at 75 FR 48852, Aug. 11, 2010; 81 
FR 3012, Jan. 20, 2016]



         Subpart G_Strategic Planning, Reporting, and Evaluation

    Source: 66 FR 2683, Jan. 11, 2001, unless otherwise noted.



Sec.  457.700  Basis, scope, and applicability.

    (a) Statutory basis. This subpart implements--
    (1) Section 2101(a) of the Act, which sets forth that the purpose of 
title XXI is to provide funds to States to provide child health 
assistance to uninsured, low-income children in an effective and 
efficient manner that is coordinated with other sources of health 
benefits coverage;
    (2) Sections 2107(a), (b) and (d) of the Act, which set forth 
requirements for strategic planning, reports, and program budgets; and
    (3) Section 2108 of the Act, which sets forth provisions regarding 
annual reports and evaluation.
    (b) Scope. This subpart sets forth requirements for strategic 
planning, monitoring, reporting and evaluation under title XXI.
    (c) Applicability. The requirements of this subpart apply to 
separate child health programs and Medicaid expansion programs, except 
that Sec.  457.730 does not apply to Medicaid expansion programs. 
Separate child health programs that provide benefits exclusively through 
managed care organizations may meet the requirements of Sec.  457.730 by 
requiring the managed care organizations to meet the requirements of 
Sec.  457.1233(d)(2).

[66 FR 2683, Jan. 11, 2001, as amended at 85 FR 25635, May 1, 2020]



Sec.  457.710  State plan requirements: Strategic objectives and
performance goals.

    (a) Plan description. A State plan must include a description of--
    (1) The strategic objectives as described in paragraph (b) of this 
section;
    (2) The performance goals as described in paragraph (c) of this 
section; and
    (3) The performance measurements, as described in paragraph (d) of 
this section, that the State has established for providing child health 
assistance to targeted low-income children under the plan and otherwise 
for maximizing health benefits coverage for other low-income children 
and children generally in the State.
    (b) Strategic objectives. The State plan must identify specific 
strategic objectives relating to increasing the extent of creditable 
health coverage among targeted low-income children and other low-income 
children.
    (c) Performance goals. The State plan must specify one or more 
performance goals for each strategic objective identified.
    (d) Performance measurements. The State plan must describe how 
performance under the plan is--
    (1) Measured through objective, independently verifiable means; and
    (2) Compared against performance goals.
    (e) Core elements. The State's strategic objectives, performance 
goals and performance measures must include a common core of national 
performance goals and measures consistent with the data collection, 
standard methodology, and verification requirements, as developed by the 
Secretary.

[[Page 626]]



Sec.  457.720  State plan requirement: State assurance regarding data 
collection, records, and reports.

    A State plan must include an assurance that the State collects data, 
maintains records, and furnishes reports to the Secretary, at the times 
and in the standardized format the Secretary may require to enable the 
Secretary to monitor State program administration and compliance and to 
evaluate and compare the effectiveness of State plans under Title XXI of 
the Act. This includes collection of data and reporting as required 
under Sec.  431.970 of this chapter.

[71 FR 51084, Aug. 28, 2006]



Sec.  457.730  Beneficiary access to and exchange of data.

    (a) Application Programming Interface to support CHIP beneficiaries. 
A State must implement and maintain a standards-based Application 
Programming Interface (API) that permits third-party applications to 
retrieve, with the approval and at the direction of the current 
individual beneficiary or the beneficiary's personal representative, 
data specified in paragraph (b) of this section through the use of 
common technologies and without special effort from the beneficiary.
    (b) Accessible content. A State must make the following information 
accessible to its current beneficiaries or the beneficiary's personal 
representative through the API described in paragraph (a) of this 
section:
    (1) Data concerning adjudicated claims, including claims data for 
payment decisions that may be appealed, were appealed, or are in the 
process of appeal, and provider remittances and beneficiary cost-sharing 
pertaining to such claims, no later than one (1) business day after a 
claim is processed;
    (2) Encounter data no later than 1 business day after receiving the 
data from providers, other than MCOs, PIHPs, or PAHPs, compensated on 
the basis of capitation payments;
    (3) Clinical data, including laboratory results, if a State 
maintains any such data, no later than one (1) business day after the 
data is received by the State; and
    (4) Information, about covered outpatient drugs and updates to such 
information, including, where applicable, preferred drug list 
information, no later than one (1) business day after the effective date 
of the information or updates to such information.
    (c) Technical requirements. A State implementing an API under 
paragraph (a) of this section:
    (1) Must implement, maintain, and use API technology conformant with 
45 CFR 170.215;
    (2) Must conduct routine testing and monitoring, and update as 
appropriate, to ensure the API functions properly, including assessments 
to verify that the API technology is fully and successfully implementing 
privacy and security features such as, but not limited to, those 
required to comply with HIPAA privacy and security requirements in 45 
CFR parts 160 and 164, 42 CFR parts 2 and 3, and other applicable law 
protecting the privacy and security of individually identifiable data;
    (3) Must comply with the content and vocabulary standard 
requirements in paragraphs (c)(3)(i) and (ii) of this section, as 
applicable to the data type or data element, unless alternate standards 
are required by other applicable law:
    (i) Content and vocabulary standards at 45 CFR 170.213 where such 
standards are applicable to the data type or element, as appropriate; 
and
    (ii) Content and vocabulary standards at 45 CFR part 162 and Sec.  
423.160 of this chapter where required by law, or where such standards 
are applicable to the data type or element, as appropriate.
    (4) May use an updated version of any standard or all standards 
required under paragraphs (c)(1) or (3) of this section, where:
    (i) Use of the updated version of the standard is required by other 
applicable law, or
    (ii) Use of the updated version of the standard is not prohibited 
under other applicable law, provided that:
    (A) For content and vocabulary standards other than those at 45 CFR 
170.213, the Secretary has not prohibited use of the updated version of 
a standard for purposes of this section or 45 CFR part 170;
    (B) For standards at 45 CFR 170.213 and 170.215, the National 
Coordinator

[[Page 627]]

has approved the updated version for use in the ONC Health IT 
Certification Program; and
    (C) Use of the updated version of a standard does not disrupt an end 
user's ability to access the data described in paragraph (b) of this 
section through the API described in paragraph (a) of this section.
    (d) Documentation requirements for APIs. For each API implemented in 
accordance with paragraph (a) of this section, a State must make 
publicly accessible, by posting directly on its website or via publicly 
accessible hyperlink(s), complete accompanying documentation that 
contains, at a minimum the information listed in this paragraph. For the 
purposes of this section, ``publicly accessible'' means that any person 
using commonly available technology to browse the internet could access 
the information without any preconditions or additional steps, such as a 
fee for access to the documentation; a requirement to receive a copy of 
the material via email; a requirement to register or create an account 
to receive the documentation; or a requirement to read promotional 
material or agree to receive future communications from the organization 
making the documentation available;
    (1) API syntax, function names, required and optional parameters 
supported and their data types, return variables and their types/
structures, exceptions and exception handling methods and their returns;
    (2) The software components and configurations that an application 
must use in order to successfully interact with the API and process its 
response(s); and
    (3) All applicable technical requirements and attributes necessary 
for an application to be registered with any authorization server(s) 
deployed in conjunction with the API.
    (e) Denial or discontinuation of access to the API. A State may deny 
or discontinue any third-party application's connection to the API 
required under paragraph (a) of this section if the State:
    (1) Reasonably determines, consistent with its security risk 
analysis under 45 CFR part 164 subpart C, that allowing an application 
to connect or remain connected to the API would present an unacceptable 
level of risk to the security of protected health information on the 
State's systems; and
    (2) Makes this determination using objective, verifiable criteria 
that are applied fairly and consistently across all applications and 
developers through which beneficiaries seek to access their electronic 
health information as defined at 45 CFR 171.102, including but not 
limited to criteria that may rely on automated monitoring and risk 
mitigation tools.
    (f) Beneficiary resources regarding privacy and security. A State 
must provide in an easily accessible location on its public website and 
through other appropriate mechanisms through which it ordinarily 
communicates with current and former beneficiaries seeking to access 
their health information held by the State CHIP agency, educational 
resources in non-technical, simple and easy-to-understand language 
explaining at a minimum:
    (1) General information on steps the individual may consider taking 
to help protect the privacy and security of their health information, 
including factors to consider in selecting an application including 
secondary uses of data, and the importance of understanding the security 
and privacy practices of any application to which they will entrust 
their health information; and
    (2) An overview of which types of organizations or individuals are 
and are not likely to be HIPAA covered entities, the oversight 
responsibilities of OCR and FTC, and how to submit a complaint to:
    (i) The HHS Office for Civil Rights (OCR); and
    (ii) The Federal Trade Commission (FTC).
    (g) Data availability. (1) The State must comply with the 
requirements in paragraphs (a) through (f) of this section beginning 
January 1, 2021 with regard to data:
    (i) With a date of service on or after January 1, 2016; and
    (ii) That are maintained by the State.
    (2) [Reserved]

[85 FR 25636, May 1, 2020]

[[Page 628]]



Sec.  457.740  State expenditures and statistical reports.

    (a) Required quarterly reports. A State must submit reports to CMS 
that contain quarterly program expenditures and statistical data no 
later than 30 days after the end of each quarter of the Federal fiscal 
year. A State must collect required data beginning on the date of 
implementation of the approved State plan. Territories are exempt from 
the definition of ``State'' for purposes of the required quarterly 
reporting under this section. The quarterly reports must include data 
on--
    (1) Program expenditures;
    (2) The number of children enrolled in the title XIX Medicaid 
program, the separate child health program, and the Medicaid expansion 
program, as applicable, as of the last day of each quarter of the 
Federal fiscal year; and
    (3) The number of children under 19 years of age who are enrolled in 
the title XIX Medicaid program, the separate child health program, and 
in the Medicaid expansion program, as appropriate, by the following 
categories:
    (i) Age (under 1 year of age, 1 through 5 years of age, 6 through 12 
years of age, and 13 through 18 years of age).
    (ii) Gender, race, and ethnicity.
    (iii) Service delivery system (managed care, fee-for-service, and 
primary care case management).
    (iv) Household income as a percentage of the Federal poverty level 
as described in paragraph (b) of this section.
    (b) Reportable household income categories. (1) A State that does 
not impose cost sharing or a State that imposes cost sharing based on a 
fixed percentage of income must report by two household income 
categories:
    (i) At or below 150 percent of FPL.
    (ii) Over 150 percent of FPL.
    (2) A State that imposes a different level or percentage of cost 
sharing at different poverty levels must report by poverty level 
categories that match the poverty level categories used for purposes of 
cost sharing.
    (c) Required unduplicated counts. Thirty days after the end of the 
Federal fiscal year, the State must submit an unduplicated count for the 
Federal fiscal year of children who were enrolled in the Medicaid 
program, the separate child health program, and the Medicaid expansion 
program, as appropriate, by age, gender, race, ethnicity, service 
delivery system, and poverty level categories described in paragraphs 
(a) and (b) of this section.



Sec.  457.750  Annual report.

    (a) Report required for each Federal fiscal year. A State must 
report to CMS by January 1 following the end of each Federal fiscal 
year, on the results of the State's assessment of the operation of the 
State plan.
    (b) Contents of annual report. In the annual report required under 
paragraph (a) of this section, a State must--
    (1) Describe the State's progress in reducing the number of 
uncovered, low-income children and; in meeting other strategic 
objectives and performance goals identified in the State plan; and 
provide information related to a core set of national performance goals 
and measures as developed by the Secretary;
    (2) Report on the effectiveness of the State's policies for 
discouraging the substitution of public coverage for private coverage;
    (3) Identify successes and barriers in State plan design and 
implementation, and the approaches the State is considering to overcome 
these barriers;
    (4) Describe the State's progress in addressing any specific issues 
(such as outreach) that the State plan proposed to periodically monitor 
and assess;
    (5) Provide an updated budget for a 3-year period that describes 
those elements required in Sec.  457.140, including any changes in the 
sources of the non-Federal share of State plan expenditures;
    (6) Identify the total State expenditures for family coverage and 
total number of children and adults, respectively, covered by family 
coverage during the preceding Federal fiscal year;
    (7) Describe the State's current income standards and methodologies 
for its Medicaid expansion program, separate child health program, and 
title XIX Medicaid program, as appropriate.
    (c) Methodology for estimate of number of uninsured, low-income 
children. (1) To report on the progress made in reducing the number of 
uninsured, low-income children as required in paragraph

[[Page 629]]

(b) of this section, a State must choose a methodology to establish an 
initial baseline estimate of the number of low-income children who are 
uninsured in the State.
    (i) A State may base the estimate on data from--
    (A) The March supplement to the Current Population Survey (CPS);
    (B) A State-specific survey;
    (C) A statistically adjusted CPS; or
    (D) Another appropriate source.
    (ii) If the State does not base the estimate on data from the March 
supplement to the CPS, the State must submit a description of the 
methodology used to develop the initial baseline estimate and the 
rationale for its use.
    (2) The State must provide an annual estimate of changes in the 
number of uninsured in the State using--
    (i) The same methodology used in establishing the initial baseline; 
or
    (ii) Another methodology based on new information that enables the 
State to establish a new baseline.
    (3) If a new methodology is used, the State must also provide annual 
estimates based on either the March supplement to the CPS or the 
methodology used to develop the initial baseline.

[66 FR 2683, Jan. 11, 2001, as amended at 66 FR 33824, June 25, 2001]



Sec.  457.760  Access to published provider directory information.

    (a) The State must implement and maintain a publicly accessible, 
standards-based Application Programming Interface (API) that is 
conformant with the technical requirements at Sec.  457.730(c), 
excluding the security protocols related to user authentication and 
authorization and any other protocols that restrict the availability of 
this information to particular persons or organizations, the 
documentation requirements at Sec.  457.730(d), and is accessible via a 
public-facing digital endpoint on the State's website.
    (b) The API must provide a complete and accurate directory of--
    (1) The State's provider directory information including provider 
names, addresses, phone numbers, and specialties, updated no later than 
30 calendar days after the State receives provider directory information 
or updates to provider directory information.
    (2) [Reserved]
    (c) This section is applicable beginning January 1, 2021.

[85 FR 25637, May 1, 2020]



                   Subpart H_Substitution of Coverage

    Source: 66 FR 2684, Jan. 11, 2001, unless otherwise noted.



Sec.  457.800  Basis, scope, and applicability.

    (a) Statutory basis. This subpart interprets and implements section 
2102(b)(3)(C) of the Act, which provides that the State plan must 
include a description of procedures the State uses to ensure that health 
benefits coverage provided under the State plan does not substitute for 
coverage under group health plans.
    (b) Scope. This subpart sets forth State plan requirements relating 
to substitution of coverage in general and specific requirements 
relating to substitution of coverage under premium assistance programs.
    (c) Applicability. The requirements of this subpart apply to 
separate child health programs.



Sec.  457.805  State plan requirement: Procedures to address substitution
under group health plans.

    (a) State plan requirements. The state plan must include a 
description of reasonable procedures to ensure that health benefits 
coverage provided under the State plan does not substitute for coverage 
provided under group health plans as defined at Sec.  457.10.
    (b) Limitations. (1) A state may not, under this section, impose a 
period of uninsurance which exceeds 90 days from the date a child 
otherwise eligible for CHIP is disenrolled from coverage under a group 
health plan.
    (2) A waiting period may not be applied to a child following the 
loss of eligibility for and enrollment in Medicaid or another insurance 
affordability program.
    (3) If a state elects to impose a period of uninsurance following 
the loss of

[[Page 630]]

coverage under a group health plan under this section, such period may 
not be imposed in the case of any child if:
    (i) The premium paid by the family for coverage of the child under 
the group health plan exceeded 5 percent of household income;
    (ii) The child's parent is determined eligible for advance payment 
of the premium tax credit for enrollment in a QHP through the Exchange 
because the ESI in which the family was enrolled is determined 
unaffordable in accordance with 26 CFR 1.36B-2(c)(3)(v).
    (iii) The cost of family coverage that includes the child exceeds 
9.5 percent of the household income.
    (iv) The employer stopped offering coverage of dependents (or any 
coverage) under an employer-sponsored health insurance plan;
    (v) A change in employment, including involuntary separation, 
resulted in the child's loss of employer-sponsored insurance (other than 
through full payment of the premium by the parent under COBRA);
    (vi) The child has special health care needs; or
    (vii) The child lost coverage due to the death or divorce of a 
parent.

[78 FR 42313, July 15, 2013, as amended at 81 FR 86466, Nov. 30, 2016]



Sec.  457.810  Premium assistance programs: Required protections against
substitution.

    A State that operates a premium assistance program, as defined at 
Sec.  457.10, must provide the protections against substitution of CHIP 
coverage for coverage under group health plans specified in this 
section. The State must describe these protections in the State plan; 
and report on results of monitoring of substitution in its annual 
reports.
    (a) Period without coverage under a group health plan. For health 
benefits coverage provided through premium assistance for group health 
plans, the following rules apply:
    (1) Any waiting period imposed under the state child health plan 
prior to the provision of child health assistance to a targeted low-
income child under the state plan shall apply to the same extent to the 
provision of a premium assistance subsidy for the child and shall not 
exceed 90 days.
    (2) States must permit the same exemptions to the required waiting 
period for premium assistance as specified under the state plan at Sec.  
457.805(a)(2), and Sec.  457.805(a)(3) for the provision of child health 
assistance to a targeted low-income child.
    (b) Employer contribution. For health benefits coverage obtained 
through premium assistance for group health plans, the employee who is 
eligible for the coverage must apply for the full premium contribution 
available from the employer.
    (c) Cost effectiveness. In establishing cost effectiveness--
    (1) The State's cost for coverage for children under premium 
assistance programs must not be greater than the cost of other CHIP 
coverage for these children; and
    (2) The State may base its demonstration of cost effectiveness on an 
assessment of the cost of coverage for children under premium assistance 
programs to the cost of other CHIP coverage for these children, done on 
a case-by-case basis, or on the cost of premium assisted coverage in the 
aggregate.
    (d) State evaluation. The State must evaluate and report in the 
annual report (in accordance with Sec.  457.750(b)(2)) the amount of 
substitution that occurs as a result of premium assistance programs and 
the effect of those programs on access to coverage.

[66 FR 2684, Jan. 11, 2001, as amended at 78 FR 42313, July 15, 2013]



                       Subpart I_Program Integrity

    Source: 66 FR 2685, Jan. 11, 2001, unless otherwise noted.



Sec.  457.900  Basis, scope and applicability.

    (a) Statutory basis. This subpart implements--
    (1) Section 2101(a) of the Act, which provides that the purpose of 
title XXI is to provide funds to States to enable them to initiate and 
expand the provision of child health assistance to uninsured, low-income 
children in an effective and efficient manner; and

[[Page 631]]

    (2) Section 2107(e) of the Act, which provides that certain title 
XIX and title XI provisions, including the following, apply to States 
under title XXI in the same manner as they apply to a State under title 
XIX:
    (i) Section 1902(a)(4)(C) of the Act, relating to conflict of 
interest standards.
    (ii) Paragraphs (2), (16), and (17), of section 1903(i) of the Act, 
relating to limitations on payment.
    (iii) Section 1903(w) of the Act, relating to limitations on 
provider taxes and donations.
    (iv) Section 1124 of the Act, relating to disclosure of ownership 
and related information.
    (v) Section 1126 of the Act, relating to disclosure of information 
about certain convicted individuals.
    (vi) Section 1128 of the Act, relating to exclusions.
    (vii) Section 1128A of the Act, relating to civil monetary 
penalties.
    (viii) Section 1128B(d) of the Act, relating to criminal penalties 
for certain additional charges.
    (ix) Section 1132 of the Act, relating to periods within which 
claims must be filed.
    (x) Sections 1902(a)(77) and 1902(kk) of the Act relating to 
provider and supplier screening, oversight, and reporting requirements.
    (b) Scope. This subpart sets forth requirements, options, and 
standards for program integrity assurances that must be included in the 
approved State plan.
    (c) Applicability. This subpart applies to separate child health 
programs. Medicaid expansion programs are subject to the program 
integrity rules and requirements specified under title XIX.

[66 FR 2685, Jan. 11, 2001, as amended at 76 FR 5970, Feb. 2, 2011]



Sec.  457.910  State program administration.

    The State's child health program must include--
    (a) Methods of administration that the Secretary finds necessary for 
the proper and efficient operation of the separate child health program; 
and
    (b) Safeguards necessary to ensure that--
    (1) Eligibility will be determined appropriately in accordance with 
subpart C of this part; and
    (2) Services will be provided in a manner consistent with 
administrative simplification and with the provisions of subpart D of 
this part.



Sec.  457.915  Fraud detection and investigation.

    (a) State program requirements. The State must establish procedures 
for ensuring program integrity and detecting fraudulent or abusive 
activity. These procedures must include the following:
    (1) Methods and criteria for identifying suspected fraud and abuse 
cases.
    (2) Methods for investigating fraud and abuse cases that--
    (i) Do not infringe on legal rights of persons involved; and
    (ii) Afford due process of law.
    (b) State program integrity unit. The State may establish an 
administrative agency responsible for monitoring and maintaining the 
integrity of the separate child health program.
    (c) Program coordination. The State must develop and implement 
procedures for referring suspected fraud and abuse cases to the State 
program integrity unit (if such a unit is established) and to 
appropriate law enforcement officials. Law enforcement officials include 
the--
    (1) U.S. Department of Health and Human Services Office of Inspector 
General (OIG);
    (2) U.S. Attorney's Office, Department of Justice (DOJ);
    (3) Federal Bureau of Investigation (FBI); and
    (4) State Attorney General's office.



Sec.  457.925  Preliminary investigation.

    If the State agency receives a complaint of fraud or abuse from any 
source or identifies questionable practices, the State agency must 
conduct a preliminary investigation or take otherwise appropriate action 
within a reasonable period of time to determine whether there is 
sufficient basis to warrant a full investigation.

[[Page 632]]



Sec.  457.930  Full investigation, resolution, and reporting requirements.

    The State must establish and implement effective procedures for 
investigating and resolving suspected and apparent instances of fraud 
and abuse. Once the State determines that a full investigation is 
warranted, the State must implement procedures including, but not 
limited to the following:
    (a) Cooperate with and refer potential fraud and abuse cases to the 
State program integrity unit, if such a unit exists.
    (b) Conduct a full investigation.
    (c) Refer the fraud and abuse case to appropriate law enforcement 
officials.



Sec.  457.935  Sanctions and related penalties.

    (a) A State may not make payments for any item or service furnished, 
ordered, or prescribed under a separate child health program to any 
provider who has been excluded from participating in the Medicare and 
Medicaid programs.
    (b) The following provisions and their corresponding regulations 
apply to a State under title XXI, in the same manner as these provisions 
and regulations apply to a State under title XIX:
    (1) Part 455, subpart B of this chapter.
    (2) Section 1124 of the Act pertaining to disclosure of ownership 
and related information.
    (3) Section 1126 of the Act pertaining to disclosure by 
institutions, organizations, and agencies of owners and certain other 
individuals who have been convicted of certain offenses.
    (4) Section 1128 of the Act pertaining to exclusions.
    (5) Section 1128A of the Act pertaining to civil monetary penalties.
    (6) Section 1128B of the Act pertaining to criminal penalties for 
acts involving Federal health care programs.
    (7) Section 1128E of the Act pertaining to the reporting of final 
adverse actions on liability findings made against health care 
providers, suppliers, and practitioners under the health care fraud and 
abuse data collection program.



Sec.  457.940  Procurement standards.

    (a) A State must submit to CMS a written assurance that Title XXI 
services will be provided in an effective and efficient manner. The 
State must submit the assurance--
    (1) With the initial State plan; or
    (2) For States with approved plans, with the first request to amend 
the approved plan.
    (b) A State must provide for free and open competition, to the 
maximum extent practical, in the bidding of all procurement contracts 
for coverage or other services in accordance with the procurement 
requirements of 45 CFR part 75, as applicable.
    (c) All contracts under this part must include provisions that 
define a sound and complete procurement contract, as required by 45 CFR 
part 75, as applicable.

[81 FR 27897, May 6, 2016]



Sec.  457.945  Certification for contracts and proposals.

    Entities that contract with the State under a separate child health 
program must certify the accuracy, completeness, and truthfulness of 
information in contracts and proposals, including information on 
subcontractors, and other related documents, as specified by the State.



Sec.  457.950  Contract and payment requirements including certification
of payment-related information.

    (a) MCOs, PAHPs, PIHPs, PCCMs, and PCCM entities. The contract 
requirements for MCOs, PAHPs, PIHPs, PCCMs, and PCCM entities are 
provided in Sec.  457.1201.
    (b) Fee-for-service entities. A State that makes payments to fee-
for-service entities under a separate child health program must--
    (1) Establish procedures to ensure that the entity certifies and 
attests that information on claim forms is truthful, accurate, and 
complete;
    (2) Ensure that fee-for-service entities understand that payment and 
satisfaction of the claims will be from Federal and State funds, and 
that any false claims may be prosecuted under applicable Federal or 
State laws; and
    (3) Require, as a condition of participation, that fee-for-service 
entities

[[Page 633]]

provide the State, CMS and/or the HHS Office of the Inspector General 
with access to enrollee health claims data, claims payment data and 
related records.

[66 FR 2685, Jan. 11, 2001, as amended at 81 FR 27897, May 6, 2016]



Sec.  457.960  Reporting changes in eligibility and redetermining
eligibility.

    If the State requires reporting of changes in circumstances that may 
affect the enrollee's eligibility for child health assistance, the State 
must:
    (a) Establish procedures to ensure that enrollees make timely and 
accurate reports of any such change; and
    (b) Promptly redetermine eligibility when the State has information 
about these changes.



Sec.  457.965  Documentation.

    The State must include in each applicant's record facts to support 
the State's determination of the applicant's eligibility for CHIP.



Sec.  457.980  Verification of enrollment and provider services received.

    The State must establish and maintain systems to identify, report, 
and verify the accuracy of claims for those enrolled children who meet 
requirements of section 2105(a) of the Act, where enhanced Federal 
medical assistance percentage computations apply.

[66 FR 2685, Jan. 11, 2001, as amended at 66 FR 33824, June 25, 2001]



Sec.  457.985  Integrity of professional advice to enrollees.

    The State must ensure through its contracts for coverage and 
services that its contractors comply with--
    (a) Section 422.206(a) of this chapter, which prohibits interference 
with health care professionals' advice to enrollees and requires that 
professionals provide information about treatment in an appropriate 
manner; and
    (b) Sections 422.208 and 422.210 of this chapter, which place 
limitations on physician incentive plans, and information disclosure 
requirements related to those physician incentive plans, respectively.



Sec.  457.990  Provider and supplier screening, oversight, and
reporting requirements.

    The following provisions and their corresponding regulations apply 
to a State under title XXI of the Act, in the same manner as these 
provisions and regulations apply to a State under title XIX of the Act:
    (a) Section 455.107.
    (b) Part 455, subpart E, of this chapter.
    (c) Sections 1902(a)(77) and 1902(kk) of the Act pertaining to 
provider and supplier screening, oversight, and reporting requirements.

[76 FR 5970, Feb. 2, 2011, as amended at 84 FR 47857, Sept. 10, 2019]



             Subpart J_Allowable Waivers: General Provisions

    Source: 66 FR 2686, Jan. 11, 2001, unless otherwise noted.



Sec.  457.1000  Basis, scope, and applicability.

    (a) Statutory basis. This subpart interprets and implements--
    (1) Section 2105(c)(2)(B) of the Act, which sets forth the 
requirements to permit a State to exceed the 10 percent cost limit on 
expenditures other than benefit expenditures; and
    (2) Section 2105(c)(3) of the Act, which permits the purchase of 
family coverage.
    (b) Scope. This subpart sets forth requirements for obtaining a 
waiver under title XXI.
    (c) Applicability. This subpart applies to separate child health 
programs; and applies to Medicaid expansion programs when the State 
claims administrative costs under title XXI and seeks a waiver of 
limitations on such claims for use of a community-based health delivery 
system. This subpart does not apply to demonstrations requested under 
section 1115 of the Act.

[66 FR 2686, Jan. 11, 2001, as amended at 66 FR 33824, June 25, 2001]



Sec.  457.1003  CMS review of waiver requests.

    CMS will review the waiver requests under this subpart using the 
same time

[[Page 634]]

frames used for State plan amendments, as specified in Sec.  457.160.



Sec.  457.1005  Cost-effective coverage through a community-based
health delivery system.

    (a) Availability of waiver. The Secretary may waive the requirements 
of Sec.  457.618 (the 10 percent limit on expenditures not used for 
health benefits coverage for targeted low-income children, that meets 
the requirements of Sec.  457.410) in order to provide child health 
assistance to targeted low-income children under the State plan through 
a cost-effective, community-based health care delivery system, such as 
through contracts with health centers receiving funds under section 330 
of the Public Health Service Act or with hospitals such as those that 
receive disproportionate share payment adjustments under section 
1886(c)(5)(F) or section 1923 of the Act.
    (b) Requirements for obtaining a waiver. To obtain a waiver for 
cost-effective coverage through a community-based health delivery 
system, a State must demonstrate that--
    (1) The coverage meets all of the requirements of this part, 
including subpart D and subpart E.
    (2) The cost of such coverage, on an average per child basis, does 
not exceed the cost of coverage under the State plan.
    (c) Three-year approval period. An approved waiver remains in effect 
for no more than 3 years.
    (d) Application of cost savings. If the cost of coverage of a child 
under a community-based health delivery system is equal to or less than 
the cost of coverage of a child under the State plan, the State may use 
the difference in the cost of coverage for each child enrolled in a 
community-based health delivery system for--
    (1) Other child health assistance, health services initiatives, or 
outreach; or
    (2) Any reasonable costs necessary to administer the State's 
program.



Sec.  457.1010  Purchase of family coverage.

    A State may purchase family coverage that includes coverage for 
targeted low-income children if the State establishes that--
    (a) Purchase of family coverage is cost-effective under the 
standards described in Sec.  457.1015;
    (b) The State does not purchase the coverage if it would otherwise 
substitute for health insurance coverage that would be provided to 
targeted, low-income children but for the purchase of family coverage; 
and
    (c) The coverage for the family otherwise meets the requirements of 
this part.



Sec.  457.1015  Cost-effectiveness.

    (a) Definition. For purposes of this subpart, ``cost-effective'' 
means that the State's cost of purchasing family coverage that includes 
coverage for targeted low-income children is equal to or less than the 
State's cost of obtaining coverage under the State plan only for the 
eligible targeted low-income children involved.
    (b) Cost comparisons. A State may demonstrate cost-effectiveness by 
comparing the cost of coverage for the family to the cost of coverage 
only for the targeted low-income children under the health benefits 
package offered by the State under the State plan for which the child is 
eligible.
    (c) Individual or aggregate basis. (1) The State may base its 
demonstration of the cost-effectiveness of family coverage on an 
assessment of the cost of family coverage for individual families, done 
on a case-by-case basis, or on the cost of family coverage in the 
aggregate.
    (2) The State must assess cost-effectiveness in its initial request 
for a waiver and then annually.
    (3) For any State that chooses the aggregate cost method, if an 
annual assessment of the cost-effectiveness of family coverage in the 
aggregate reveals that it is not cost-effective, the State must assess 
cost-effectiveness on a case-by-case basis.
    (d) Reports on family coverage. A State with a waiver under this 
section must include in its annual report pursuant to Sec.  457.750, the 
cost of family coverage purchased under the waiver, and the number of 
children and adults, respectively, covered under family coverage 
pursuant to the waiver.

[[Page 635]]



  Subpart K_State Plan Requirements: Applicant and Enrollee Protections

    Source: 66 FR 2687, Jan. 11, 2001, unless otherwise noted.



Sec.  457.1100  Basis, scope and applicability.

    (a) Statutory basis. This subpart interprets and implements--
    (1) Section 2101(a) of the Act, which states that the purpose of 
title XXI of the Act is to provide funds to States to enable them to 
initiate and expand the provision of child health assistance to 
uninsured, low-income children in an effective and efficient manner;
    (2) Section 2102(a)(7)(B) of the Act, which requires that the State 
plan include a description of the methods used to assure access to 
covered services, including emergency services;
    (3) Section 2102(b)(2) of the Act, which requires that the State 
plan include a description of methods of establishing and continuing 
eligibility and enrollment; and
    (4) Section 2103 of the Act, which outlines coverage requirements 
for a State that provides child health assistance through a separate 
child health program.
    (b) Scope. This subpart sets forth minimum standards for privacy 
protection and for procedures for review of matters relating to 
eligibility, enrollment, and health services.
    (c) Applicability. This subpart only applies to a separate child 
health program.



Sec.  457.1110  Privacy protections.

    The State must ensure that, for individual medical records and any 
other health and enrollment information maintained with respect to 
enrollees, that identifies particular enrollees (in any form), the State 
establishes and implements procedures to--
    (a) Abide by all applicable Federal and State laws regarding 
confidentiality and disclosure, including those laws addressing the 
confidentiality of information about minors and the privacy of minors, 
and privacy of individually identifiable health information;
    (b) Comply with subpart F of part 431 of this chapter;
    (c) Maintain the records and information in a timely and accurate 
manner;
    (d) Specify and make available to any enrollee requesting it--
    (1) The purposes for which information is maintained or used; and
    (2) To whom and for what purposes the information will be disclosed 
outside the State;
    (e) Except as provided by Federal and State law, ensure that each 
enrollee may request and receive a copy of records and information 
pertaining to the enrollee in a timely manner and that an enrollee may 
request that such records or information be supplemented or corrected.



Sec.  457.1120  State plan requirement: Description of review process.

    (a) The State must have one of the following review processes:
    (1) Program specific review. A process that meets the requirements 
of Sec. Sec.  457.1130, 457.1140, 457.1150, 457.1160, 457.1170, and 
457.1180; or
    (2) Statewide Standard Review. A process that complies with State 
review requirements currently in effect for all health insurance issuers 
(as defined in section 2791 of the Public Health Service Act) in the 
State.
    (b) The State plan must include a description of the State's review 
process.

[66 FR 33824, June 25, 2001]



Sec.  457.1130  Program specific review process: Matters subject to review.

    (a) Eligibility or enrollment matter. A State must ensure that an 
applicant or enrollee has an opportunity for review, consistent with 
Sec. Sec.  457.1140 and 457.1150, of a--
    (1) Denial of eligibility;
    (2) Failure to make a timely determination of eligibility; and
    (3) Suspension or termination of enrollment, including disenrollment 
for failure to pay cost sharing.
    (b) Health services matter. A State must ensure that an enrollee has 
an opportunity for external review of a--
    (1) Delay, denial, reduction, suspension, or termination of health 
services, in whole or in part, including a determination about the type 
or level of services; and

[[Page 636]]

    (2) Failure to approve, furnish, or provide payment for health 
services in a timely manner.
    (c) Exception. A State is not required to provide an opportunity for 
review of a matter described in paragraph (a) or (b) of this section if 
the sole basis for the decision is a provision in the State plan or in 
Federal or State law requiring an automatic change in eligibility, 
enrollment, or a change in coverage under the health benefits package 
that affects all applicants or enrollees or a group of applicants or 
enrollees without regard to their individual circumstances.



Sec.  457.1140  Program specific review process: Core elements of review.

    In adopting the procedures for review of matters described in Sec.  
457.1130, a State must ensure that--
    (a) Reviews are conducted by an impartial person or entity in 
accordance with Sec.  457.1150;
    (b) Review decisions are timely in accordance with Sec.  457.1160;
    (c) Review decisions are written; and
    (d) Applicants and enrollees have an opportunity to--
    (1) Represent themselves or have representatives of their choosing 
in the review process;
    (2) Timely review their files and other applicable information 
relevant to the review of the decision;
    (3) Fully participate in the review process, whether the review is 
conducted in person or in writing, including by presenting supplemental 
information during the review process; and
    (4) Receive continued enrollment in accordance with Sec.  457.1170.



Sec.  457.1150  Program specific review process: Impartial review.

    (a) Eligibility or enrollment matter. The review of a matter 
described in Sec.  457.1130(a) must be conducted by a person or entity 
who has not been directly involved in the matter under review.
    (b) Health services matter. The State must ensure that an enrollee 
has an opportunity for an independent external review of a matter 
described in Sec.  457.1130(b). External review must be conducted by the 
State or a contractor other than the contractor responsible for the 
matter subject to external review.



Sec.  457.1160  Program specific review process: Time frames.

    (a) Eligibility or enrollment matter. A State must complete the 
review of a matter described in Sec.  457.1130(a) within a reasonable 
amount of time. In setting time frames, the State must consider the need 
for expedited review when there is an immediate need for health 
services.
    (b) Health services matter. The State must ensure that reviews are 
completed in accordance with the medical needs of the patient. If the 
medical needs of the patient do not dictate a shorter time frame, the 
review must be completed within the following time frames:
    (1) Standard timeframe. A State must ensure that external review, as 
described in Sec.  457.1150(b), is completed within 90 calendar days of 
the date an enrollee requests internal (if available) or external 
review. If both internal and external review are available to the 
enrollee, both types of review must be completed within the 90 calendar 
day period.
    (2) Expedited timeframe. A State must ensure that external review, 
as described in Sec.  457.1150(b), is completed within 72 hours of the 
time an enrollee requests external review, if the enrollee's physician 
or health plan determines that operating under the standard time frame 
could seriously jeopardize the enrollee's life or health or ability to 
attain, maintain or regain maximum function. If the enrollee has access 
to internal and external review, then each level of review may take no 
more than 72 hours. The State may extend the 72-hour time frame by up to 
14 calendar days, if the enrollee requests an extension.



Sec.  457.1170  Program specific review process: Continuation of enrollment.

    A State must ensure the opportunity for continuation of enrollment 
pending the completion of review of a suspension or termination of 
enrollment, including a decision to disenroll for failure to pay cost 
sharing.

[[Page 637]]



Sec.  457.1180  Program specific review process: Notice.

    A State must provide enrollees and applicants timely written notice 
of any determinations required to be subject to review under Sec.  
457.1130 that includes the reasons for the determination, an explanation 
of applicable rights to review of that determination, the standard and 
expedited time frames for review, the manner in which a review can be 
requested, and the circumstances under which enrollment may continue 
pending review.



Sec.  457.1190  Application of review procedures when States offer
premium assistance for group health plans.

    A State that has a premium assistance program through which it 
provides coverage under a group health plan that does not meet the 
requirements of a program specific review or a Statewide standard 
review, as described in Sec.  457.1120, must give applicants and 
enrollees the option to obtain health benefits coverage other than 
through that group health plan. The State must provide this option at 
initial enrollment and at each redetermination of eligibility.

[66 FR 2686, Jan. 11, 2001, as amended at 66 FR 33824, June 25, 2001]



                         Subpart L_Managed Care

    Source: 81 FR 27897, May 6, 2016, unless otherwise noted.

                           General Provisions



Sec.  457.1200  Basis, scope, and applicability.

    (a) Statutory basis. This subpart implements the following sections 
of the Act:
    (1) Section 2101(a) of the Act, which provides that the purpose of 
Title XXI is to provide funds to States to enable them to initiate and 
expand the provision of child health assistance to uninsured, low-income 
children in an effective and efficient manner.
    (2) Section 2103(f)(3) and 2107(e)(1)(M) of the Act, which apply 
certain provisions of Title XIX related to Medicaid managed care to 
CHIP.
    (3) Sections 2107(b) and 2107(e)(2) of the Act, which relate to 
program integrity.
    (b) Scope. This subpart sets forth requirements for the provision of 
services through MCOs, PIHPs, PAHPs, and PCCM entities, as defined in 
Sec.  457.10.
    (c) Applicability. The requirements of this subpart apply to child 
health assistance provided under a separate child health program 
operating a managed care delivery system. Regulations relating to 
managed care that are applicable to a Medicaid expansion program are 
found at part 438 of this chapter.



Sec.  457.1201  Standard contract requirements.

    (a) CMS review. The State must submit all MCO, PAHP, PIHP, PCCM, and 
PCCM entity contracts for review in the form and manner established by 
CMS.
    (b) Entities eligible for comprehensive risk contracts. The State 
may enter into a comprehensive risk contract only with the entities 
specified in Sec.  438.3(b)(1) through (3) of this chapter.
    (c) Payment. The final capitation rates for all MCO, PIHP or PAHP 
contracts must be identified and developed, and payment must be made in 
accordance with Sec.  438.3(c) of this chapter, except that the 
requirement for preapproval of contracts does not apply, and contract 
rates must be submitted to CMS upon request of the Secretary.
    (d) Enrollment discrimination prohibited. Contracts with MCOs, 
PAHPs, PIHPs, PCCMs and PCCM entities must comply with prohibitions on 
enrollment discrimination in accordance with Sec.  438.3(d) of this 
chapter, except that Sec.  438.3(d)(2) of this chapter (related to 
voluntary enrollment) does not apply.
    (e) Services that may be covered by an MCO, PIHP, or PAHP. An MCO, 
PIHP, or PAHP may cover, for enrollees, services that are not covered 
under the State plan in accordance with Sec.  438.3(e) of this chapter.
    (f) Compliance with applicable laws and conflict of interest 
safeguards. Contracts with MCOs, PAHPs, PIHPs, PCCMs or

[[Page 638]]

PCCM entities must comply with Federal laws and regulations in 
accordance with Sec.  438.3(f) of this chapter.
    (g) Inspection and audit of records and access to facilities. 
Contracts with MCOs, PIHPs, PAHPs, PCCMs or PCCM entities must allow for 
the inspection and audit of records and access to facilities in 
accordance with Sec.  438.3(h) of this chapter.
    (h) Physician incentive plans. If a contract with an MCO, PAHP, or 
PIHP provides for a physician incentive plan, it must comply with Sec.  
438.3(i) of this chapter (which cross references Sec. Sec.  422.208 and 
422.210 of this chapter).
    (i) Subcontractual relationships and delegations. The state must 
ensure, through its contracts with MCOs, PIHPs, and PAHPs, that any 
contract or written agreement that the MCO, PIHP, or PAHP has with any 
individual or entity that relates directly or indirectly to the 
performance of the MCOs, PIHPs, or PAHPs obligations under its contract 
comply with Sec.  457.1233(b) (which cross references Sec.  438.230 of 
this chapter).
    (j) Choice of network provider. The contract must allow each 
enrollee to choose his or her network provider in accordance with Sec.  
438.3(l) of this chapter.
    (k) Audited financial reports. Contracts with MCOs, PAHPs, and PIHPs 
must comply with the requirements for submission of audited financial 
reports in Sec.  438.3(m) of this chapter.
    (l) Parity in mental health and substance use disorder benefits. 
Contracts with MCOs, PAHPs, and PIHPs must comply with the requirements 
of Sec.  457.496.
    (m) Additional rules for contracts with PCCMs. Contracts with PCCMs 
must comply with the requirements of Sec.  438.3(q) of this chapter, 
except that the right to disenroll is in accordance with Sec.  457.1212.
    (n) Additional rules for contracts with PCCM entities. (1) States 
must submit PCCM entity contracts to CMS for review.
    (2) Contracts with PCCMs must comply with the requirements of 
paragraph (o) of this section; Sec.  457.1207; Sec.  457.1240(b) (cross-
referencing Sec.  438.330(b)(2), (b)(3), (c), and (e) of this chapter); 
Sec.  457.1240(e) (cross-referencing Sec.  438.340 of this chapter); and 
Sec.  457.1250(a) (cross-referencing Sec.  438.350 of this chapter).
    (o) Attestations. Contracts with MCO, PAHP, PIHP, PCCM or PCCM 
entities must include an attestation to the accuracy, completeness, and 
truthfulness of claims and payment data, under penalty of perjury.
    (p) Guarantee not to avoid costs. Contracts with an MCO, PAHP, PIHP, 
PCCM or PCCM entities must include a guarantee that the MCO, PAHP, PIHP, 
PCCM or PCCM entity will not avoid costs for services covered in its 
contract by referring enrollees to publicly supported health care 
resources.
    (q) Recordkeeping requirements. Contracts with MCOs, PIHPs, and 
PAHPs, must comply with the recordkeeping requirements of Sec.  438.3(u) 
of this chapter.

[81 FR 27897, May 6, 2016, as amended at 82 FR 40, Jan. 3, 2017]



Sec.  457.1203  Rate development standards and medical loss ratio.

    (a) A state must use payment rates based on public or private 
payment rates for comparable services for comparable populations, 
consistent with actuarially sound principles as defined at Sec.  457.10. 
This requirement for using actuarially sound principles to develop 
payment rates does not prohibit a state from implementing value-based 
purchasing models for provider reimbursement, such as pay for 
performance arrangements, bundled payments, or other service payment 
models intended to recognize value or outcomes over volume of services; 
such alternate payment models should be developed using actuarially 
sound principles to the extent applicable.
    (b) A State may establish higher rates than permitted under 
paragraph (a) of this section if such rates are necessary to ensure 
sufficient provider participation or provider access or to enroll 
providers who demonstrate exceptional efficiency or quality in the 
provision of services.
    (c) The rates must be designed to reasonably achieve a medical loss 
ratio standard, calculated in accordance with the provisions of Sec.  
438.8 of this chapter, that--
    (1) Is equal to at least 85 percent for the rate year; and

[[Page 639]]

    (2) Provides for reasonable administrative costs.
    (d) The State must provide to CMS, if requested, a description of 
the manner in which rates were developed in accordance with the 
requirements of paragraphs (a), (b), or (c) of this section.
    (e) The state must comply with the requirements related to medical 
loss ratios in accordance with the terms of Sec.  438.74 of this 
chapter, except that the description of the reports received from the 
MCOs, PIHPs and PAHPs under Sec.  438.8(k) of this chapter will be 
submitted independently, and not with the actuarial certification 
described in Sec.  438.7 of this chapter.
    (f) The state must ensure, through its contracts, that each MCO, 
PIHP, and PAHP complies with the requirements Sec.  438.8 of this 
chapter.

[81 FR 27897, May 6, 2016, as amended at 82 FR 40, Jan. 3, 2017]



Sec.  457.1206  Non-emergency medical transportation PAHPs.

    (a) For purposes of this section Non-Emergency Medical 
Transportation (NEMT) Prepaid Ambulatory Health Plan (PAHP) means an 
entity that provides only NEMT services to enrollees under contract with 
the State, and on the basis of prepaid capitation payments, or other 
payment arrangements that do not use State plan payment rates.
    (b) The following requirements and options apply to NEMT PAHPs, NEMT 
PAHP contracts, and States in connection with NEMT PAHPs, to the same 
extent that they apply to PAHPs, PAHP contracts, and States in 
connection with PAHPs.
    (1) All contract provisions in Sec.  457.1201 except those set forth 
in Sec.  457.1201(h) (related to physician incentive plans) Sec.  
457.1201(l) (related to mental health parity).
    (2) The information requirements in Sec.  457.1207.
    (3) The provision against provider discrimination in Sec.  457.1208.
    (4) The State responsibility provisions in Sec. Sec.  457.1212 and 
457.1214, and Sec.  438.62(a) of this chapter, as cross-referenced in 
Sec.  457.1216.
    (5) The provisions on enrollee rights and protections in Sec. Sec.  
457.1220, 457.1222, 457.1224, and 457.1226.
    (6) The PAHP standards in Sec.  438.206(b)(1) of this chapter, as 
cross-referenced by Sec. Sec.  457.1230(a), 457.1230(d), and 
457.1233(a), (b) and (d).
    (7) An enrollee's right to a State review under subpart K of this 
part.
    (8) Prohibitions against affiliations with individuals debarred or 
excluded by Federal agencies in Sec.  438.610 of this chapter, as cross 
referenced by Sec.  457.1285.
    (9) Requirements relating to contracts involving Indians, Indian 
Health Care Providers, and Indian managed care entities in Sec.  
457.1209.



Sec.  457.1207  Information requirements.

    The State must provide, or ensure its contracted MCO, PAHP, PIHP, 
PCCM, and PCCM entities provide, all enrollment notices, informational 
materials, and instructional materials related to enrollees and 
potential enrollees in accordance with the terms of Sec.  438.10 of this 
chapter, except that the terms of Sec.  438.10(c)(2), (g)(2)(xi)(E), and 
(g)(2)(xii) of this chapter do not apply.

[85 FR 72842, Nov. 13, 2020]



Sec.  457.1208  Provider discrimination prohibited.

    The state must ensure through its contracts that each MCO, PIHP, and 
PAHP follow the requirements related to the prohibition on provider 
discrimination in Sec.  438.12 of this chapter.



Sec.  457.1209  Requirements that apply to MCO, PIHP, PAHP, PCCM, and
PCCM entity contracts involving Indians, Indian health care provider
(IHCP), and Indian managed care entities (IMCE).

    The State must follow, and ensure through its contracts, that each 
MCO, PIHP, PAHP, PCCM, and PCCM entity follows, the requirements related 
to Indians, IHCPs, and IMCEs in accordance with the terms of Sec.  
438.14 of this chapter.

                         State Responsibilities



Sec.  457.1210  Enrollment process.

    (a) Default enrollment process. (1) If a state uses a default 
enrollment process

[[Page 640]]

to assign beneficiaries to a MCO, PIHP, PAHP, PCCM, or PCCM entity, the 
process must:
    (i) Assign beneficiaries to a qualified MCO, PIHP, PAHP, PCCM or 
PCCM entity. To be qualified, the MCO, PIHP, PAHP, PCCM or PCCM entity 
must:
    (A) Not be subject to the intermediate sanction described in Sec.  
438.702(a)(4) of this chapter.
    (B) Have capacity to enroll beneficiaries.
    (ii) Maximize continuation of existing provider-beneficiary 
relationships. An ``existing provider-beneficiary relationship'' is one 
in which the provider was the main source of CHIP services for the 
beneficiary during the previous year. This may be established through 
State records of previous managed care enrollment or fee-for-service 
experience, encounter data, or through contact with the beneficiary.
    (iii) If the approach in paragraph (a)(1)(ii) of this section is not 
possible, the State must distribute the beneficiaries equitably among 
the MCOs, PIHPs, PAHPs, PCCMs and PCCM entities. The State may not 
arbitrarily exclude any MCO, PIHP, PAHP, PCCM or PCCM entity from being 
considered.
    (2) The State may consider additional reasonable criteria to conduct 
the default enrollment process, including the previous plan assignment 
of the beneficiary, quality assurance and improvement performance, 
procurement evaluation elements, accessibility of provider offices for 
people with disabilities (when appropriate), and other reasonable 
criteria that support the objectives of the managed care program.
    (3) The State must send a confirmation of the enrollee's managed 
care enrollment to the enrollee within 5 calendar days of the date such 
enrollment is processed by the State. The confirmation must clearly 
explain the enrollee's right to disenroll within 90 days from the 
effective date of the enrollment.
    (b) Priority for enrollment. The state must have an enrollment 
system under which beneficiaries already enrolled in an MCO, PIHP, PAHP, 
PCCM, or PCCM entity are given priority to continue that enrollment if 
the MCO, PIHP, PAHP, PCCM, or PCCM entity does not have the capacity to 
accept all those seeking enrollment under the program.
    (c) Informational notices. A State must provide an informational 
notice to each potential enrollee who may enroll in an MCO, PIHP, PAHP, 
PCCM, or PCCM entity. Such notice must:
    (1) Include the MCOs, PIHPs, PAHPs, PCCMs, or PCCM entities 
available to the potential enrollee;
    (2) Explain how to select an MCO, PIHP, PAHP, PCCM, or PCCM entity;
    (3) Explain the implications of making or not making an active 
choice of an MCO, PIHP, PAHP, PCCM or PCCM entity;
    (4) Explain the length of the enrollment period as well as the 
disenrollment policies in Sec.  457.1212; and
    (5) Comply with the information requirements in Sec.  457.1207 and 
accessibility standards established under Sec.  457.340.

[81 FR 27897, May 6, 2016, as amended at 82 FR 40, Jan. 3, 2017]



Sec.  457.1212  Disenrollment.

    The State must comply with and ensure, through its contracts, that 
each MCO, PAHP, PIHP, PCCM and PCCM entity complies with the 
disenrollment requirements in accordance with the terms of Sec.  438.56 
of this chapter, except that references to fair hearings should be read 
to refer to reviews as described in subpart K of this part.



Sec.  457.1214  Conflict of interest safeguards.

    The State must have in effect safeguards against conflict of 
interest in accordance with the terms of Sec.  438.58 of this chapter, 
except that references to Sec.  438.54(b) should be read to refer to the 
enrollment processes described in Sec.  457.1210(a).

[82 FR 40, Jan. 3, 2017]



Sec.  457.1216  Continued services to enrollees.

    The State must follow the requirements related to continued services 
to enrollees in accordance with the terms of Sec.  438.62 of this 
chapter.

[[Page 641]]



Sec.  457.1218  Network adequacy standards.

    The State must develop network adequacy standards in accordance with 
the terms of Sec.  438.68 of this chapter, and, ensure through its 
contracts, that each MCO, PAHP, and PIHP meets such standards.

                     Enrollee Rights and Protections



Sec.  457.1220  Enrollee rights.

    The State must ensure, through its contracts, that each MCO, PIHP, 
PAHP, PCCM, and PCCM entity follow the enrollee rights requirements in 
accordance with the terms of Sec.  438.100 of this chapter.



Sec.  457.1222  Provider-enrollee communication.

    The State must ensure, through its contracts, that each MCO, PIHP, 
and PAHP protects communications between providers and enrollees in 
accordance with the terms of Sec.  438.102 of this chapter.



Sec.  457.1224  Marketing activities.

    The State must ensure, through its contracts, that each MCO, PIHP, 
PAHP, PCCM, and PCCM entity follows the requirements related to 
marketing activities in accordance with the terms of Sec.  438.104 of 
this chapter, except Sec.  438.104(c) of this chapter related to state 
agency review does not apply.



Sec.  457.1226  Liability for payment.

    The State must ensure, through its contracts, that enrollees of 
MCOs, PIHPs, and PAHPs are not held liable for services or debts of the 
MCO, PIHP, or PAHPs in accordance with the terms of Sec.  438.106 of 
this chapter.



Sec.  457.1228  Emergency and poststabilization services.

    The State must ensure that emergency and poststabilization care 
services are available and accessible to enrollees in accordance with 
the terms of Sec.  438.114 of this chapter.

[82 FR 40, Jan. 3, 2017]

                      MCO, PIHP, and PAHP Standards



Sec.  457.1230  Access standards.

    (a) Availability of services. The State must ensure that the 
services are available and accessible to enrollees in accordance with 
the terms of Sec.  438.206 of this chapter.
    (b) Assurances of adequate capacity and services. The State must 
ensure, through its contracts, that each MCO, PIHP and PAHP has adequate 
capacity to serve the expected enrollment in accordance with the terms 
of Sec.  438.207 of this chapter.
    (c) Coordination and continuity of care. The State must ensure, 
through its contracts, that each MCO, PIHP and PAHP complies with the 
coordination and continuity of care requirements in accordance with the 
terms of Sec.  438.208 of this chapter, except that the applicability 
date in Sec.  438.208(d) does not apply.
    (d) Coverage and authorization of services. The State must ensure, 
through its contracts, that each MCO, PIHP or PAHP complies with the 
coverage and authorization of services requirements in accordance with 
the terms of Sec.  438.210 of this chapter, except that the following do 
not apply: Sec.  438.210(a)(5) of this chapter (related to medical 
necessity standard); Sec.  438.210(b)(2)(iii) of this chapter (related 
to authorizing LTSS), and Sec.  438.210(f) (relating to the 
applicability date).

[81 FR 27897, May 6, 2016, as amended at 82 FR 40, Jan. 3, 2017]



Sec.  457.1233  Structure and operation standards.

    (a) Provider selection. The State must ensure, through its 
contracts, that each MCO, PIHP or PAHP complies with the provider 
selection requirements as provided in Sec.  438.214 of this chapter.
    (b) Subcontractual relationships and delegation. The State must 
ensure, through its contracts, that each MCO, PIHP, PAHP, and PCCM 
entity complies with the subcontractual relationships and delegation 
requirements as provided in Sec.  438.230 of this chapter.
    (c) Practice guidelines. The state must ensure, through its 
contracts, that each MCO and, when applicable, each PIHP and PAHP, 
complies with the

[[Page 642]]

practice guidelines requirements as provided in Sec.  438.236 of this 
chapter.
    (d) Health information systems. The State must ensure, through its 
contracts, that each MCO, PIHP, and PAHP complies with the health 
information systems requirements as provided in Sec.  438.242 of this 
chapter, except that the applicability date in Sec.  438.242(e) of this 
chapter does not apply. The State is required to submit enrollee 
encounter data to CMS in accordance with Sec.  438.818 of this chapter.
    (e) Privacy protections. The state must ensure, through its 
contracts, that each MCO, PIHP, and PAHP complies with the privacy 
protections as provided in Sec.  457.1110.

[81 FR 27897, May 6, 2016, as amended at 82 FR 40, Jan. 3, 2017; 85 FR 
25637, May 1, 2020; 85 FR 72842, Nov. 13, 2020]

      Quality Measurement and Improvement; External Quality Review



Sec.  457.1240  Quality measurement and improvement.

    (a) Scope. This section sets forth requirements related to quality 
assessment and performance improvement that the State must meet in 
contracting with an MCO, PIHP, PAHP, or certain PCCM entities.
    (b) Quality assessment and performance improvement program. (1) The 
State must require, through its contracts, that each MCO, PIHP, and PAHP 
establish and implement an ongoing comprehensive quality assessment and 
performance improvement program for the services it furnishes to its 
enrollees, in accordance with the requirements and standards in Sec.  
438.330 of this chapter, except that the terms of Sec.  438.330(d)(4) of 
this chapter (related to dually eligible beneficiaries) do not apply.
    (2) In the case of a contract with a PCCM entity described in 
paragraph (f) of this section, Sec.  438.330(b)(2) and (3), (c), and (e) 
of this chapter apply.
    (c) State review of the accreditation status of MCOs, PIHPs, and 
PAHPs. The State must review the accreditation status of each MCO, PIHP, 
and PAHP in accordance with the requirements as set forth in Sec.  
438.332 of this chapter.
    (d) Managed care quality rating system. The State must determine a 
quality rating or ratings for each MCO, PIHP, and PAHP in accordance 
with the requirements set forth in Sec.  438.334 of this chapter, except 
that the terms of Sec.  438.334(c)(2)(i) and (c)(3) of this chapter 
(related to consultation with the Medical Care Advisory Committee) do 
not apply.
    (e) Managed care quality strategy. The State must draft and 
implement a written quality strategy for assessing and improving the 
quality of health care and services furnished CHIP enrollees as 
described in Sec.  438.340 of this chapter, except that the reference to 
consultation with the Medical Care Advisory Committee described in Sec.  
438.340(c)(1)(i) of this chapter does not apply.
    (f) Applicability to PCCM entities. For purposes of paragraphs (b) 
and (e) of this section and Sec.  457.1250(a), a PCCM entity described 
in this paragraph is a PCCM entity whose contract with the State 
provides for shared savings, incentive payments or other financial 
reward for improved quality outcomes.

[81 FR 27897, May 6, 2016, as amended at 82 FR 40, Jan. 3, 2017; 85 FR 
72842, Nov. 13, 2020]



Sec.  457.1250  External quality review.

    (a) Each State that contracts with MCOs, PIHPs, or PAHPs must follow 
all applicable external quality review requirements as set forth in 
Sec. Sec.  438.350 (except for references to Sec.  438.362), 438.352, 
438.354, 438.356, 438.358, 438.360 (only with respect to nonduplication 
of EQR activities with private accreditation) and Sec.  438.364 of this 
chapter. In the case of a contract with a PCCM entity described in Sec.  
457.1240(f), Sec.  438.350 (except for references to Sec.  438.362) of 
this chapter applies.
    (b) A State may amend an existing EQRO contract to include the 
performance of EQR-related activities and/or EQR in accordance with 
paragraph (a) of this section.

[81 FR 27897, May 6, 2016, as amended at 82 FR 40, Jan. 3, 2017]

                            Grievance System



Sec.  457.1260  Grievance system.

    (a) Statutory basis and definitions--(1) Statutory basis. This 
section implements section 2103(f)(3) of the Act, which provides that 
the State CHIP

[[Page 643]]

must provide for the application of section 1932(a)(4), (a)(5), (b), 
(c), (d), and (e) of the Act (relating to requirements for managed care) 
to coverage, State agencies, enrollment brokers, managed care entities, 
and managed care organizations. Section 1932(b)(4) of the Act requires 
managed care plans to establish an internal grievance procedure under 
which an enrollee, or a provider on behalf of such an enrollee, may 
challenge the denial of coverage of or payment for covered benefits.
    (2) Definitions. The following definitions from Sec.  438.400(b) of 
this chapter apply to this section--
    (i) Paragraphs (1) through (5) and (7) of the definition of 
``adverse benefit determination''; and
    (ii) The definitions of ``appeal'', ``grievance'', and ``grievance 
and appeal system''.
    (b) General requirements. (1) The State must ensure that its 
contracted MCOs, PIHPs, and PAHPs comply with the provisions of Sec.  
438.402(a), (b), and (c)(2) and (3) of this chapter with regard to the 
establishment and operation of a grievances and appeals system.
    (2) An enrollee may file a grievance and request an appeal with the 
MCO, PIHP, or PAHP. An enrollee may request a State external review in 
accordance with the terms of subpart K of this part after receiving 
notice under paragraph (e) of this section that the adverse benefit 
decision is upheld by the MCO, PIHP, or PAHP.
    (3) If State law permits and with the written consent of the 
enrollee, a provider or an authorized representative may request an 
appeal or file a grievance, or request a State external review in 
accordance with the terms of subpart K of this part, on behalf of an 
enrollee. When the term ``enrollee'' is used throughout this section, it 
includes providers and authorized representatives consistent with this 
paragraph (b).
    (c) Timely and adequate notice of adverse benefit determination. (1) 
The State must ensure that its contracted MCOs, PIHPs, and PAHPs comply 
with the provisions at Sec.  438.404(a) and (b)(1), (2), and (5) of this 
chapter (regarding the content of the notice of an adverse benefit 
determination).
    (2) In addition to the requirements referenced in paragraph (c)(1) 
of this section, the notice must explain:
    (i) The enrollee's right to request an appeal of the MCO's, PIHP's, 
or PAHP's adverse benefit determination, including information on 
exhausting the MCO's, PIHP's, or PAHP's one level of appeal described at 
Sec.  438.402(b) of this chapter referenced in paragraph (b)(1) of this 
section, and the right to request a State external review in accordance 
with the terms of subpart K of this part; and
    (ii) The procedures for the enrollee to exercise his or her rights 
provided under this paragraph (c).
    (3) The MCO, PIHP, or PAHP must provide timely written notice to the 
enrollee of the adverse benefit determination. The terms of Sec. Sec.  
438.404(c)(6) and 438.210(d)(2) of this chapter apply in the 
circumstances of expedited service authorization decisions.
    (d) Handling of grievances and appeals. The State must ensure that 
its contracted MCOs, PIHPs, and PAHPs comply with the provisions at 
Sec.  438.406 of this chapter.
    (e) Resolution and notification: Grievances and appeals. (1) The 
State must ensure that its contracted MCOs, PIHPs, and PAHPs comply with 
the provisions at Sec.  438.408(b) (relating to the timeframe for 
resolution of grievances and appeals), (c)(1) and (2) (the extension of 
timeframes for resolution of grievances and appeals), (d) (relating to 
the format of the notice of resolution for grievances and appeals), and 
(e)(1) (relating to the content of the notice of resolution for 
grievances and appeals) of this chapter.
    (2) Each MCO, PIHP, or PAHP must resolve each grievance and appeal, 
and provide notice, as expeditiously as the enrollee's health condition 
requires, within State-established timeframes that may not exceed the 
timeframes specified in this paragraph (e).
    (3) In the case of an MCO, PIHP, or PAHP that fails to adhere to the 
notice and timing requirements in this section, the enrollee is deemed 
to have exhausted the MCO's, PIHP's, or PAHP's appeals process. The 
enrollee may initiate a State external review in accordance with the 
terms of subpart K of this part.

[[Page 644]]

    (4) For appeals not resolved wholly in favor of an enrollee, in 
addition to the information required under paragraph (e)(1) of this 
section and Sec.  438.408(e)(1) of this chapter, the content of the 
notice of appeal resolution must include the enrollee's right to request 
a State external review in accordance with the terms of subpart K of 
this part, and how to do so.
    (5) Except as provided in paragraph (e)(3) of this section, an 
enrollee may request a State external review only after receiving notice 
that the MCO, PIHP, or PAHP is upholding the adverse benefit 
determination. The State must provide enrollees no less than 90 calendar 
days and no more than 120 calendar days from the date of the MCO's, 
PIHP's, or PAHP's notice of resolution to request a State external 
review. The parties to the State external review include the MCO, PIHP, 
or PAHP, as well as the enrollee and his or her representative or the 
representative of a deceased enrollee's estate.
    (f) Expedited resolution of appeals. The State must ensure that its 
contracted MCOs, PIHPs, and PAHPs comply with the provisions at Sec.  
438.410 of this chapter.
    (g) Information about the grievance and appeal system to providers 
and subcontractors. The State must ensure that its contracted MCOs, 
PIHPs, and PAHPs comply with the provisions at Sec.  438.414 of this 
chapter.
    (h) Recordkeeping requirements. The State must ensure that its 
contracted MCOs, PIHPs, and PAHPs comply with the provisions at Sec.  
438.416 of this chapter.
    (i) Effectuation of reversed appeal resolutions. If the MCO, PIHP, 
or PAHP, or the result of a State external review, in accordance with 
the terms of subpart K of this part, reverses a decision to deny, limit, 
or delay services, the MCO, PIHP, or PAHP must authorize or provide the 
disputed services promptly and as expeditiously as the enrollee's health 
condition requires but no later than 72 hours from the date it receives 
notice reversing the determination.

[85 FR 72842, Nov. 13, 2020]

                                Sanctions



Sec.  457.1270  Sanctions.

    (a) General. The State must comply with Sec. Sec.  438.700 through 
438.704, 438.706(c) and (d), and 438.708 through 438.730 of this 
chapter.
    (b) Optional imposition of temporary management. Except as provided 
in paragraph (c) of this section, the State may impose temporary 
management under Sec.  438.702(a)(2) of this chapter as referenced in 
paragraph (a) of this section, only if it finds (through onsite surveys, 
enrollee or other complaints, financial status, or any other source) any 
of the following:
    (1) There is continued egregious behavior by the MCO, including but 
not limited to behavior that is described in Sec.  438.700 of this 
chapter (as referenced in paragraph (a) of this section), or that is 
contrary to any of the requirements of this subpart.
    (2) There is substantial risk to enrollees' health.
    (3) The sanction is necessary to ensure the health of the MCO's 
enrollees--
    (i) While improvements are made to remedy violations under Sec.  
438.700 of this chapter as referenced in paragraph (a) of this section.
    (ii) Until there is an orderly termination or reorganization of the 
MCO.
    (c) Required imposition of temporary management. The State must 
impose temporary management (regardless of any other sanction that may 
be imposed) if it finds that an MCO has repeatedly failed to meet 
substantive requirements in this subpart. The State must also grant 
enrollees the right to terminate enrollment without cause, as described 
in Sec.  438.702(a)(3) of this chapter as referenced in paragraph (a) of 
this section, and must notify the affected enrollees of their right to 
terminate enrollment.

[85 FR 72843, Nov. 13, 2020]



Sec.  457.1280  Conditions necessary to contract as an MCO, PAHP, or PIHP.

    (a) The State must assure that any entity seeking to contract as an 
MCO, PAHP, or PIHP under a separate child health program has 
administrative and

[[Page 645]]

management arrangements or procedures designed to safeguard against 
fraud and abuse.
    (b) The State must ensure that the arrangements or procedures 
required in paragraph (a) of this section--
    (1) Enforce MCO, PAHP, and PIHP compliance with all applicable 
Federal and State statutes, regulations, and standards.
    (2) Prohibit MCOs, PAHPs, and PIHPs from conducting any unsolicited 
personal contact with a potential enrollee by an employee or agent of 
the MCO, PAHP, or PIHP for the purpose of influencing the individual to 
enroll with the entity.
    (3) Include a mechanism for MCOs, PAHPs, and PIHPs to report to the 
State, to CMS, or to the Office of Inspector General (OIG) as 
appropriate, information on violations of law by subcontractors, 
providers, or enrollees of an MCO, PAHP, or PIHP and other individuals.
    (c) With respect to enrollees, the reporting requirement in 
paragraph (b)(3) of this section applies only to information on 
violations of law that pertain to enrollment in the plan, or the 
provision of, or payment for, health services.
    (d) The State may inspect, evaluate, and audit MCOs, PIHPs, and 
PAHPs at any time, as necessary, in instances where the State determines 
that there is a reasonable possibility of fraudulent or abusive 
activity.

[66 FR 2685, Jan. 11, 2011. Redesignated and amended at 81 FR 27900, May 
6, 2016]



Sec.  457.1285  Program integrity safeguards.

    The State must comply with the program integrity safeguards in 
accordance with the terms of subpart H of part 438 of this chapter, 
except that the terms of Sec. Sec.  438.604(a)(2) and 438.608(d)(4) of 
this chapter do not apply.

[85 FR 72844, Nov. 13, 2020]

[[Page 646]]



   SUBCHAPTER E_PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)





PART 460_PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)--Table of Contents



                 Subpart A_Basis, Scope, and Definitions

Sec.
460.2 Basis.
460.3 Part D program requirements.
460.4 Scope and purpose.
460.6 Definitions.

       Subpart B_PACE Organization Application and Waiver Process

460.10 Purpose.
460.12 Application requirements.
460.14 [Reserved]
460.16 [Reserved]
460.18 CMS evaluation of applications.
460.20 Notice of CMS determination.
460.24 Limit on number of PACE program agreements.
460.26 Submission and evaluation of waiver requests.
460.28 Notice of CMS determination on waiver requests.

                    Subpart C_PACE Program Agreement

460.30 Program agreement requirement.
460.32 Content and terms of PACE program agreement.
460.34 Duration of PACE program agreement.

        Subpart D_Sanctions, Enforcement Actions, and Termination

460.40 Violations for which CMS may impose sanctions.
460.42 Suspension of enrollment or payment by CMS.
460.46 Civil money penalties.
460.48 Additional actions by CMS or the State.
460.50 Termination of PACE program agreement.
460.52 Transitional care during termination.
460.54 Termination procedures.
460.56 Procedures for imposing sanctions and civil money penalties.

               Subpart E_PACE Administrative Requirements

460.60 PACE organizational structure.
460.62 Governing body.
460.63 Compliance oversight requirements.
460.64 Personnel qualifications.
460.66 Training.
460.68 Program integrity.
460.70 Contracted services.
460.71 Oversight of direct participant care.
460.72 Physical environment.
460.74 Infection control.
460.76 Transportation services.
460.78 Dietary services.
460.80 Fiscal soundness.
460.82 Marketing.
460.84 Emergency preparedness.
460.86 Payment to individuals and entities excluded by the OIG or 
          included on the preclusion list.

                         Subpart F_PACE Services

460.90 PACE benefits under Medicare and Medicaid.
460.92 Required services.
460.94 Required services for Medicare participants.
460.96 Excluded services.
460.98 Service delivery.
460.100 Emergency care.
460.102 Interdisciplinary team.
460.104 Participant assessment.
460.106 Plan of care.

                      Subpart G_Participant Rights

460.110 Bill of rights.
460.112 Specific rights to which a participant is entitled.
460.114 Restraints.
460.116 Explanation of rights.
460.118 Violation of rights.
460.120 Grievance process.
460.122 PACE organization's appeals process.
460.124 Additional appeal rights under Medicare or Medicaid.

                      Subpart H_Quality Improvement

460.130 General rule.
460.132 Quality improvement plan.
460.134 Minimum requirements for quality improvement program.
460.136 Internal quality improvement activities.
460.138 Committees with community input.

           Subpart I_Participant Enrollment and Disenrollment

460.150 Eligibility to enroll in a PACE program.
460.152 Enrollment process.
460.154 Enrollment agreement.
460.156 Other enrollment procedures.
460.158 Effective date of enrollment.
460.160 Continuation of enrollment.

[[Page 647]]

460.162 Voluntary disenrollment.
460.164 Involuntary disenrollment.
460.166 Disenrollment responsibilities.
460.168 Reinstatement in other Medicare and Medicaid programs.
460.170 Reinstatement in PACE.
460.172 Documentation of disenrollment.

                            Subpart J_Payment

460.180 Medicare payment to PACE organizations.
460.182 Medicaid payment.
460.184 Post-eligibility treatment of income.
460.186 PACE premiums.

                   Subpart K_Federal/State Monitoring

460.190 Monitoring during trial period.
460.192 Ongoing monitoring after trial period.
460.194 Corrective action.
460.196 Disclosure of review results.

      Subpart L_Data Collection, Record Maintenance, and Reporting

460.200 Maintenance of records and reporting of data.
460.202 Participant health outcomes data.
460.204 Financial recordkeeping and reporting requirements.
460.208 Financial statements.
460.210 Medical records.

    Authority: 42 U.S.C. 1302, 1395, 1395eee(f), and 1396u-4(f).

    Source: 64 FR 66279, Nov. 24, 1999, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 460 appear at 67 FR 
61504, Oct. 1, 2002.



                 Subpart A_Basis, Scope, and Definitions



Sec.  460.2  Basis.

    This part implements sections 1894, 1905(a), and 1934 of the Act, 
which authorize the following:
    (a) Medicare payments to, and coverage of benefits under, PACE.
    (b) The establishment of PACE as a State option under Medicaid to 
provide for Medicaid payments to, and coverage of benefits under, PACE.



Sec.  460.3  Part D program requirements.

    PACE organizations offering qualified prescription drug coverage and 
meeting the definition of a Part D plan sponsor, as defined in Sec.  
423.4 of this chapter, must abide by all applicable Part D program 
requirements in part 423 of this chapter.

[84 FR 25671, June 3, 2019]



Sec.  460.4  Scope and purpose.

    (a) General. This part sets forth the following:
    (1) The requirements that an entity must meet to be approved as a 
PACE organization that operates a PACE program under Medicare and 
Medicaid.
    (2) How individuals may qualify to enroll in a PACE program.
    (3) How Medicare and Medicaid payments will be made for PACE 
services.
    (4) Provisions for Federal and State monitoring of PACE programs.
    (5) Procedures for sanctions and terminations.
    (b) Program purpose. PACE provides pre-paid, capitated, 
comprehensive health care services designed to meet the following 
objectives:
    (1) Enhance the quality of life and autonomy for frail, older 
adults.
    (2) Maximize dignity of, and respect for, older adults.
    (3) Enable frail, older adults to live in the community as long as 
medically and socially feasible.
    (4) Preserve and support the older adult's family unit.



Sec.  460.6  Definitions.

    As used in this part, unless the context indicates otherwise, the 
following definitions apply:
    Contract year means the term of a PACE program agreement, which is a 
calendar year, except that a PACE organization's initial contract year 
may be from 12 to 23 months, as determined by CMS.
    Medicare beneficiary means an individual who is entitled to Medicare 
Part A benefits or enrolled under Medicare Part B, or both.
    Medicaid participant means an individual determined eligible for 
Medicaid who is enrolled in a PACE program.
    Medicare participant means a Medicare beneficiary who is enrolled in 
a PACE program.
    PACE stands for programs of all-inclusive care for the elderly.
    PACE center is a facility which includes a primary care clinic, and 
areas for therapeutic recreation, restorative therapies, socialization, 
personal care,

[[Page 648]]

and dining, and which serves as the focal point for coordination and 
provision of most PACE services.
    PACE organization means an entity that has in effect a PACE program 
agreement to operate a PACE program under this part.
    PACE program means a program of all-inclusive care for the elderly 
that is operated by an approved PACE organization and that provides 
comprehensive healthcare services to PACE enrollees in accordance with a 
PACE program agreement.
    PACE program agreement means an agreement between a PACE 
organization, CMS, and the State administering agency for the operation 
of a PACE program.
    Participant means an individual who is enrolled in a PACE program.
    Service, as used in this part, means all services that could be 
required under Sec.  460.92, including items and drugs.
    State administering agency means the State agency responsible for 
administering the PACE program agreement.
    Trial period means the first 3 contract years in which a PACE 
organization operates under a PACE program agreement, including any 
contract year during which the entity operated under a PACE 
demonstration waiver program.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71334, Dec. 8, 2006; 86 
FR 6131, Jan. 19, 2021]



       Subpart B_PACE Organization Application and Waiver Process



Sec.  460.10  Purpose.

    (a) Applications. This subpart sets forth the application procedures 
for the following:
    (1) An entity that seeks approval from CMS as a PACE organization.
    (2) A PACE organization that seeks to expand its service area or to 
add a new PACE center.
    (3) A PACE organization that seeks to expand its service area and to 
add a new PACE center.
    (b) Waiver. This subpart sets forth the process by which a PACE 
organization may request waiver of certain regulatory requirements. The 
purpose of the waivers is to provide for reasonable flexibility in 
adapting the PACE model to the needs of particular organizations (such 
as those in rural areas).

[84 FR 25671, June 3, 2019]



Sec.  460.12  Application requirements.

    (a) Submission of application. An individual authorized to act for 
an entity that seeks to become a PACE organization or a PACE 
organization that seeks to expand its service area and/or add a PACE 
center site must submit to CMS a complete application in the form and 
manner specified by CMS that describes how the entity or PACE 
organization meets all requirements in this part.
    (b) State assurance. (1) An entity's application to become a PACE 
organization must include an assurance from the State administering 
agency of the State in which the program is located indicating that the 
State considers the entity to be qualified to be a PACE organization and 
is willing to enter into a PACE program agreement with the entity.
    (2) A PACE organization's application to expand its service area 
and/or add a PACE center site must include an assurance from the State 
administering agency of the State in which the program is located 
indicating that the State is willing to amend the PACE program agreement 
to include the new site and/or expand the PACE organization's service 
area.
    (c) Service area designation. (1) An entity submitting an 
application to become a PACE organization or a PACE organization 
submitting an application seeking to expand its service area must 
describe the proposed service area in its application.
    (2) CMS, in consultation with the State administering agency, may 
exclude from designation an area that is already covered under another 
PACE program agreement to avoid unnecessary duplication of services and 
avoid impairing the financial and service viability of an existing 
program.
    (d) Service area and/or PACE center site expansion. CMS and the 
State administering agency will only approve a service area expansion or 
PACE center site expansion after the PACE organization has successfully 
completed its

[[Page 649]]

first trial period audit and, if applicable, has implemented an 
acceptable corrective action plan.

[84 FR 25671, June 3, 2019]



Sec.  460.14  [Reserved]



Sec.  460.16  [Reserved]



Sec.  460.18  CMS evaluation of applications.

    CMS evaluates an application on the basis of the following 
information:
    (a) Information contained in the application.
    (b) Information obtained by CMS or the State administering agency 
through on-site visits or any other means.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25671, June 3, 2019]



Sec.  460.20  Notice of CMS determination.

    (a) Time limit for notification of determination. Within 90 days, or 
45 days for applications set forth in Sec.  460.10(a)(2), after an 
entity submits a complete application to CMS, CMS takes one of the 
following actions in the form and manner specified by CMS:
    (1) Approves the application.
    (2) Denies the application and notifies the entity in writing of the 
basis for the denial and the process for requesting reconsideration of 
the denial.
    (b) Complete application. An application is only considered complete 
when CMS receives all information necessary to make a determination 
regarding approval or denial.
    (c) Additional information requested. If CMS determines that an 
application is not complete because it does not include sufficient 
information to make a determination, CMS will request additional 
information within 90 days, or 45 days for applications set forth in 
Sec.  460.10(a)(2), after the date of submission of the application.
    (1) The time limits in paragraph (a) of this section do not begin 
until CMS receives all requested information and the application is 
complete.
    (2) If more than 12 months elapse between the date of initial 
submission of the application and the entity's response to the CMS 
request for additional information, the entity must update the 
application to provide the most current information and materials 
related to the application.
    (d) Deemed approval. An entity's application to become a PACE 
organization is deemed approved if CMS fails to act on the complete 
application within 90 days, after the later of the following dates:
    (1) The date the application is submitted by the organization.
    (2) The date CMS receives all requested additional information.
    (e) Date of submission. For purposes of the time limits described in 
this section, the date that an application is submitted to CMS is the 
date on which the application is delivered to the address designated by 
CMS.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25672, June 3, 2019]



Sec.  460.24  Limit on number of PACE program agreements.

    (a) Numerical limit. Except as specified in paragraph (b) of this 
section, CMS does not permit the number of PACE organizations with which 
agreements are in effect under this part or under section 9412(b) of the 
Omnibus Budget Reconciliation Act of 1986, to exceed the following:
    (1) As of August 5, 1997--40.
    (2) As of each succeeding August 5, the numerical limit for the 
preceding year plus 20, without regard to the actual number of 
agreements in effect on a previous anniversary date. (For example, the 
limit is 60 on August 5, 1998 and 80 on August 5, 1999.)
    (b) Exception. The numerical limit does not apply to a private, for-
profit PACE organization that meets the following conditions:
    (1) Is operating under a demonstration project waiver under section 
1894(h) and 1934(h) of the Act.
    (2) Was operating under a waiver and subsequently qualifies for PACE 
organization status in accordance with sections 1894(a)(3)(B)(ii) and 
1934(a)(3)(B)(ii) of the Act.



Sec.  460.26  Submission and evaluation of waiver requests.

    (a) A PACE organization, or an entity submitting an application to 
become a PACE organization, must submit its waiver request through the 
State administering agency for initial review.

[[Page 650]]

    (1) The State administering agency forwards a PACE organization's 
waiver requests to CMS along with any concurrence, concerns or 
conditions regarding the waiver.
    (2) Entities submitting an application to become a PACE organization 
may:
    (i) Submit a waiver request as a document separate from the 
application by submitting it first to the State administering agency 
which, in turn, will forward the waiver request to CMS indicating the 
State's concurrence, concerns or conditions regarding the waiver 
request; or
    (ii) Submit a waiver request directly to CMS in conjunction with the 
application. This request must include a letter from the State 
administering agency indicating the State's concurrence, concerns or 
conditions regarding the waiver request.
    (b) CMS evaluates a waiver request from a PACE organization or PACE 
applicant on the basis of the following information:
    (1) The adequacy of the description and rationale for the waiver 
provided by the PACE organization or PACE applicant, including any 
additional information requested by CMS.
    (2) Information obtained by CMS and the State administering agency 
in on-site reviews and monitoring of the PACE organization.
    (c) Requirements related to the following principles may not be 
waived:
    (1) A focus on frail elderly qualifying individuals who require the 
level of care provided in a nursing facility.
    (2) The delivery of comprehensive, integrated acute and long-term 
care services.
    (3) An interdisciplinary team approach to care management and 
service delivery.
    (4) Capitated, integrated financing that allows the provider to pool 
payments received from public and private programs and individuals.
    (5) The assumption by the provider of full financial risk.

[67 FR 61505, Oct. 1, 2002; 67 FR 63966, Oct. 16, 2002, as amended at 71 
FR 71334, Dec. 8, 2006; 84 FR 25672, June 3, 2019]



Sec.  460.28  Notice of CMS determination on waiver requests.

    (a) General. Within 90 days after receipt of a complete waiver 
request, CMS takes one of the following actions, in the form and manner 
specified by CMS:
    (1) Approves the waiver request.
    (2) Conditionally approves the waiver request and notifies the PACE 
applicant.
    (3) Denies the waiver request and notifies the PACE organization or 
PACE applicant of the basis for the denial.
    (b) Additional information requested. A waiver request is only 
considered complete when CMS receives all information necessary to make 
a determination regarding approval or denial. If CMS determines that the 
waiver request is not complete because it does not include sufficient 
information to make a determination, CMS will request additional 
information from the PACE organization or PACE applicant. The 90-day 
time limit in paragraph (a) of this section will start when CMS receives 
the complete waiver request.
    (c) Waiver approval. A waiver request is deemed approved if CMS 
fails to act on the request within 90 days after CMS receives a complete 
waiver request.
    (d) Withdrawal of CMS approval for good cause. (1) CMS in 
consultation with the State administering agency may withdraw approval 
of a waiver for good cause.
    (2) If the waiver approval is withdrawn, CMS must notify the PACE 
organization or PACE applicant and the State administering agency that 
approval of a waiver has been withdrawn and the reason for doing so and 
must specify the effective date of the withdrawal in the notice.

[84 FR 25672, June 3, 2019]



                    Subpart C_PACE Program Agreement



Sec.  460.30  Program agreement requirement.

    (a) A PACE organization must have an agreement with CMS and the 
State administering agency for the operation of a PACE program by the 
PACE organization under Medicare and Medicaid.

[[Page 651]]

    (b) The agreement must be signed by an authorized official of CMS, 
the PACE organization and the State administering agency.
    (c) CMS may only sign program agreements with PACE organizations 
that are located in States with approved State plan amendments electing 
PACE as an optional benefit under their Medicaid State plan.

[64 FR 66279, Nov. 24, 1999, as amended at 67 FR 61505, Oct. 1, 2002]



Sec.  460.32  Content and terms of PACE program agreement.

    (a) Required content. A PACE program agreement must include the 
following information:
    (1) A designation of the service area of the organization's program. 
The area may be identified by county, zip code, street boundaries, 
census tract, block, or tribal jurisdictional area, as applicable. CMS 
and the State administering agency must approve any change in the 
designated service area.
    (2) The organization's commitment to meet all applicable 
requirements under Federal, State, and local laws and regulations, 
including provisions of the Civil Rights Act, the Age Discrimination 
Act, and the Americans With Disabilities Act.
    (3) The effective date and term of the agreement.
    (4) A description of the organizational structure of the PACE 
organization and information on administrative contacts, including the 
following:
    (i) Name and phone number of the program director.
    (ii) Name of all governing body members.
    (iii) Name and phone number of a contact person for the governing 
body.
    (5) A participant bill of rights approved by CMS and an assurance 
that the rights and protections will be provided.
    (6) A description of the process for handling participant grievances 
and appeals.
    (7) A statement of the organization's policies on eligibility, 
enrollment, voluntary disenrollment, and involuntary disenrollment.
    (8) A description of services available to participants.
    (9) A description of the organization's quality improvement program.
    (10) A statement of the levels of performance required by CMS on 
standard quality measures.
    (11) A statement of the data and information required by CMS and the 
State administering agency to be collected on participant care.
    (12) The state's Medicaid capitation rate or Medicaid payment rate 
methodology, and the methodology used to calculate the Medicare 
capitation rate.
    (13) A description of procedures that the organization will follow 
if the PACE program agreement is terminated.
    (b) Optional content. (1) An agreement may provide additional 
requirements for individuals to qualify as PACE program eligible 
individuals, in accordance with Sec.  460.150(b)(4).
    (2) An agreement may contain any additional terms and conditions 
agreed to by the parties if the terms and conditions are consistent with 
sections 1894 and 1934 of the Act and regulations in this part.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71334, Dec. 8, 2006; 84 
FR 25672, June 3, 2019]



Sec.  460.34  Duration of PACE program agreement.

    An agreement is effective for a contract year, but may be extended 
for additional contract years in the absence of a notice by a party to 
terminate.



        Subpart D_Sanctions, Enforcement Actions, and Termination



Sec.  460.40  Violations for which CMS may impose sanctions.

    (a) In addition to other remedies authorized by law, CMS may impose 
any of the sanctions specified in Sec. Sec.  460.42 and 460.46 if CMS 
determines that a PACE organization commits any of the following 
violations:
    (1) Fails substantially to provide to a participant medically 
necessary items and services that are covered PACE services, if the 
failure has adversely affected (or has substantial likelihood of 
adversely affecting) the participant.
    (2) Involuntarily disenrolls a participant in violation of Sec.  
460.164.

[[Page 652]]

    (3) Discriminates in enrollment or disenrollment among Medicare 
beneficiaries or Medicaid beneficiaries, or both, who are eligible to 
enroll in a PACE program, on the basis of an individual's health status 
or need for health care services.
    (4) Engages in any practice that would reasonably be expected to 
have the effect of denying or discouraging enrollment, except as 
permitted by Sec.  460.150, by Medicare beneficiaries or Medicaid 
beneficiaries whose medical condition or history indicates a need for 
substantial future medical services.
    (5) Imposes charges on participants enrolled under Medicare or 
Medicaid for premiums in excess of the premiums permitted.
    (6) Misrepresents or falsifies information that is furnished--
    (i) To CMS or the State under this part; or
    (ii) To an individual or any other entity under this part.
    (7) Prohibits or otherwise restricts a covered health care 
professional from advising a participant who is a patient of the 
professional about the participant's health status, medical care, or 
treatment for the participant's condition or disease, regardless of 
whether the PACE program provides benefits for that care or treatment, 
if the professional is acting within his or her lawful scope of 
practice.
    (8) Operates a physician incentive plan that does not meet the 
requirements of section 1876(i)(8) of the Act.
    (9) Employs or contracts with any individual who is excluded from 
participation in Medicare or Medicaid under section 1128 or section 
1128A of the Act (or with any entity that employs or contracts with that 
individual) for the provision of health care, utilization review, 
medical social work, or administrative services.
    (10) Makes payment to any individual or entity that is included on 
the preclusion list, defined in Sec.  422.2 of this chapter.
    (b) If CMS or the State administering agency makes a determination 
that could lead to termination of a PACE program agreement under Sec.  
460.50, CMS may impose any of the sanctions specified at Sec. Sec.  
460.42 and 460.46.

[64 FR 66279, Nov. 24, 1999, as amended at 81 FR 80561, Nov. 15, 2016; 
83 FR 16756, Apr. 16, 2018; 84 FR 25672, June 3, 2019]



Sec.  460.42  Suspension of enrollment or payment by CMS.

    (a) Enrollment. If a PACE organization commits one or more 
violations specified in Sec.  460.40, CMS may suspend enrollment of 
Medicare beneficiaries after the date CMS notifies the organization of 
the violation.
    (b) Payment. If a PACE organization commits one or more violations 
specified in Sec.  460.40, for individuals enrolled after the date CMS 
notifies the PACE organization of the violation, CMS may take the 
following actions:
    (1) Suspend Medicare payment to the PACE organization.
    (2) Deny payment to the State for medical assistance for services 
furnished under the PACE program agreement.
    (c) Term of suspension. A suspension or denial of payment remains in 
effect until CMS is satisfied that the following conditions are met:
    (1) The PACE organization has corrected the cause of the violation.
    (2) The violation is not likely to recur.



Sec.  460.46  Civil money penalties.

    (a) CMS may impose civil money penalties up to the maximum amounts 
specified in paragraphs (a)(1) through (4) of this section. These 
amounts will be adjusted in accordance with the Federal Civil Penalties 
Inflation Adjustment Act Improvements Act of 2015 (Sec. 701 of Pub. L. 
114-74) and updated amounts specified in 45 CFR part 102.
    (1) For each violation regarding enrollment or disenrollment 
specified in Sec.  460.40(a)(3) or (4), $100,000 plus $15,000 for each 
individual not enrolled as a result of the PACE organization's 
discrimination in enrollment or disenrollment or practice that would 
deny or discourage enrollment.
    (2) For each violation regarding excessive premiums specified in 
Sec.  460.40(a)(5), $25,000 plus double the excess amount above the 
permitted premium charged a participant by the PACE organization. (The 
excess

[[Page 653]]

amount charged is deducted from the penalty and returned to the 
participant).
    (3) For each misrepresentation or falsification of information, 
specified in Sec.  460.40(a)(6)(i), $100,000.
    (4) For any other violation specified in Sec.  460.40, $25,000.
    (b) The provisions of section 1128A of the Act (other than 
subsections (a) and (b)) apply to a civil money penalty under this 
section in the same manner as they apply to a civil money penalty or 
proceeding under section 1128A(a).

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25672, June 3, 2019]



Sec.  460.48  Additional actions by CMS or the State.

    After consultation with the State administering agency, if CMS 
determines that the PACE organization is not in substantial compliance 
with requirements in this part, CMS or the State administering agency 
may take one or more of the following actions:
    (a) Condition the continuation of the PACE program agreement upon 
timely execution of a corrective action plan.
    (b) Withhold some or all payments under the PACE program agreement 
until the organization corrects the deficiency.
    (c) Terminate the PACE program agreement.



Sec.  460.50  Termination of PACE program agreement.

    (a) Termination of agreement by CMS or State. CMS or a State 
administering agency may terminate at any time a PACE program agreement 
for cause, including, but not limited to the circumstances in paragraphs 
(b) or (c) of this section.
    (b) Termination due to uncorrected deficiencies. CMS or the State 
administering agency may terminate a PACE program agreement if CMS or 
the State administering agency determines that both of the following 
circumstances exist:
    (1) Either--
    (i) There are significant deficiencies in the quality of care 
furnished to participants; or
    (ii) The PACE organization failed to comply substantially with 
conditions for a PACE program or PACE organization under this part, or 
with terms of its PACE program agreement, including making payment to an 
individual or entity that is included on the preclusion list, defined in 
Sec.  422.2 of this chapter.
    (2) Within 30 days of the date of the receipt of written notice of a 
determination made under paragraph (b)(1) of this section, the PACE 
organization failed to develop and successfully initiate a plan to 
correct the deficiencies, or failed to continue implementation of the 
plan of correction.
    (c) Termination due to health and safety risk. CMS or a State 
administering agency may terminate a PACE program agreement if CMS or 
the State administering agency determines that the PACE organization 
cannot ensure the health and safety of its participants. This 
determination may result from the identification of deficiencies that 
CMS or the State administering agency determines cannot be corrected.
    (d) Termination of agreement by PACE organization. A PACE 
organization may terminate an agreement after timely notice to CMS, the 
State administering agency, and participants, as follows:
    (1) To CMS and the State administering agency, 90 days before 
termination.
    (2) To participants, 60 days before termination.

[64 FR 66279, Nov. 24, 1999, as amended at 81 FR 80561, Nov. 15, 2016; 
83 FR 16756, Apr. 16, 2018]



Sec.  460.52  Transitional care during termination.

    (a) The PACE organization must develop a detailed written plan for 
phase-down in the event of termination, which describes how the 
organization plans to take the following actions:
    (1) Inform participants, the community, CMS and the State 
administering agency in writing about termination and transition 
procedures.
    (2) Assist participants to obtain reinstatement of conventional 
Medicare and Medicaid benefits.
    (3) Transition participants' care to other providers.
    (4) Terminate marketing and enrollment activities.

[[Page 654]]

    (b) An entity whose PACE program agreement is in the process of 
being terminated must provide assistance to each participant in 
obtaining necessary transitional care through appropriate referrals and 
making the participant's medical records available to new providers.



Sec.  460.54  Termination procedures.

    (a) Except as provided in paragraph (b) of this section, if CMS 
terminates an agreement with a PACE organization, it furnishes the PACE 
organization with the following:
    (1) A reasonable opportunity to develop and implement a corrective 
action plan to correct the deficiencies that were the basis of CMS's 
determination that cause exists for termination.
    (2) Reasonable notice and opportunity for hearing (including the 
right to appeal an initial determination) before terminating the 
agreement.
    (b) CMS may terminate an agreement without invoking the procedures 
described in paragraph (a) of this section if CMS determines that a 
delay in termination, resulting from compliance with these procedures 
before termination, would pose an imminent and serious risk to the 
health of participants enrolled with the organization.



Sec.  460.56  Procedures for imposing sanctions and civil money penalties.

    CMS provides notice and a right to request a hearing according to 
the procedures set forth in either of the following:
    (a) Section 422.756(a) and (b) of this chapter if CMS imposes a 
suspension of enrollment or payment under Sec.  460.42 or Sec.  
460.48(b).
    (b) Section 422.756(e)(2)(v) of this chapter if CMS imposes civil 
money penalties under Sec.  460.46.

[86 FR 6132, Jan. 19, 2021]



               Subpart E_PACE Administrative Requirements



Sec.  460.60  PACE organizational structure.

    (a) Program director. The organization must employ, or contract with 
in accordance with Sec.  460.70, a program director who is responsible 
for oversight and administration of the entity.
    (b) Medical director. The organization must employ, or contract with 
in accordance with Sec.  460.70, a medical director who is responsible 
for the delivery of participant care, for clinical outcomes, and for the 
implementation, as well as oversight, of the quality improvement 
program.
    (c) Organizational chart. (1) The PACE organization must have a 
current organizational chart showing officials in the PACE organization 
and relationships to any other organizational entities.
    (2) The chart for a corporate entity must indicate the PACE 
organization's relationship to the corporate board and to any parent, 
affiliate, or subsidiary corporate entities.
    (3) Except as provided in paragraph (d) of this section, a PACE 
organization planning a change in organizational structure must notify 
CMS and the State administering agency, in writing, at least 14 days 
before the change takes effect.
    (d) Change of ownership. A PACE organization planning a change of 
ownership must comply with all requirements in 42 CFR part 422, subpart 
L, and must notify CMS and the State administering agency, in writing, 
at least 60 days before the anticipated effective date of the change.

[64 FR 66279, Nov. 24, 1999, as amended at 67 FR 61505, Oct. 1, 2002; 71 
FR 71334, Dec. 8, 2006; 84 FR 25673, June 3, 2019]



Sec.  460.62  Governing body.

    (a) Governing body. A PACE organization must be operating under the 
control of an identifiable governing body (for example, a board of 
directors) or a designated person functioning as a governing body with 
full legal authority and responsibility for the following:
    (1) Governance and operation of the organization.
    (2) Development of policies consistent with the mission.
    (3) Management and provision of all services, including the 
management of contractors.
    (4) Establishment of personnel policies that address adequate notice 
of

[[Page 655]]

termination by employees or contractors with direct patient care 
responsibilities.
    (5) Fiscal operations.
    (6) Development of policies on participant health and safety, 
including a comprehensive, systemic operational plan to ensure the 
health and safety of participants.
    (7) A quality improvement program as described in Sec.  460.130.
    (b) Participant advisory committee. (1) A PACE organization must 
establish a participant advisory committee to provide advice to the 
governing body on matters of concern to participants. Participants and 
representatives of participants must constitute a majority of the 
membership of this committee.
    (2) The participant advisory committee must provide the liaison to 
the governing body with meeting minutes that include participant issues.
    (c) Participant representation on the governing body. (1) A PACE 
organization must ensure participant representation on issues related to 
participant care. This shall be achieved by having a participant 
representative on the governing body.
    (2) The participant representative is a liaison of the participant 
advisory committee to the PACE organization governing body.
    (3) Duty of the participant representative. The participant 
representative must present issues from the participant advisory 
committee to the governing body.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71334, Dec. 8, 2006; 84 
FR 25673, June 3, 2019]



Sec.  460.63  Compliance oversight requirements.

    A PACE organization must adopt and implement effective compliance 
oversight requirements, which must include measures that prevent, 
detect, and correct non-compliance with CMS' program requirements, as 
well as measures that prevent, detect, and correct fraud, waste, and 
abuse. The compliance oversight program must, at a minimum, include 
establishment and implementation of procedures and a system for promptly 
responding to compliance issues as they are raised, investigating 
potential compliance problems as identified in the course of self-
evaluations and audits, correcting such problems promptly and thoroughly 
to reduce the potential for recurrence, and ensure ongoing compliance 
with CMS requirements.
    (a) If the PACE organization discovers evidence of misconduct 
related to payment or delivery of items or services, it must conduct a 
timely, reasonable inquiry into that conduct.
    (b) The PACE organization must conduct appropriate corrective 
actions (for example, repayment of overpayments, disciplinary actions 
against responsible employees) in response to the potential violation.
    (c) The PACE organization should have procedures to voluntarily 
self-report potential fraud or misconduct related to the PACE program to 
CMS and the State administering agency.

[84 FR 25673, June 3, 2019]



Sec.  460.64  Personnel qualifications for staff with direct participant 
contact.

    (a) General qualification requirements. Each member of the PACE 
organization's staff (employee or contractor) that has direct contact 
with participants must meet the following conditions:
    (1) Be legally authorized (for example, currently licensed, 
registered or certified if applicable) to practice in the State in which 
he or she performs the function or action;
    (2) Only act within the scope of his or her authority to practice;
    (3) Have 1 year of experience working with a frail or elderly 
population or, if the individual has less than 1 year of experience but 
meets all other requirements under paragraph (a) of this section, must 
receive appropriate training from the PACE organization on working with 
a frail or elderly population upon hiring.
    (4) Meet a standardized set of competencies for the specific 
position description established by the PACE organization before working 
independently.
    (5) Be medically cleared for communicable diseases and have all 
immunizations up-to-date before engaging in direct participant contact.

[[Page 656]]

    (b) Federally-defined qualifications for physician. In addition to 
the qualification specified in paragraph (a) of this section, a 
physician must meet the qualifications and conditions in Sec.  410.20 of 
this chapter.

[71 FR 71334, Dec. 8, 2006, as amended at 84 FR 25673, June 3, 2019]



Sec.  460.66  Training.

    The PACE organization must provide training to maintain and improve 
the skills and knowledge of each staff member with respect to the 
individual's specific duties that results in his or her continued 
ability to demonstrate the skills necessary for the performance of the 
position.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71335, Dec. 8, 2006; 84 
FR 25673, June 3, 2019]



Sec.  460.68  Program integrity.

    (a) Persons with criminal convictions. A PACE organization must not 
employ individuals or contract with organizations or individuals--
    (1) Who have been excluded from participation in the Medicare or 
Medicaid programs;
    (2) Who have been convicted of criminal offenses related to their 
involvement in Medicaid, Medicare, other health insurance or health care 
programs, or social service programs under title XX of the Act;
    (3) If the PACE organization determines that an individual's contact 
with participants would pose a potential risk because the individual has 
been convicted of one or more criminal offenses related to physical, 
sexual, drug, or alcohol abuse or use;
    (4) Who have been found guilty of abusing, neglecting, or 
mistreating individuals by a court of law or who have had a finding 
entered into the State nurse aide registry concerning abuse, neglect, 
mistreatment of residents, or misappropriation of their property; or
    (5) Who have been convicted of specific crimes for any offense 
described in section 1128(a) of the Social Security Act.
    (b) Direct or indirect interest in contracts. The PACE organization 
shall identify members of its governing body or any immediate family 
member having a direct or indirect interest in any contract that 
supplies any administrative or care-related service or materials to the 
PACE organization.
    (1) PACE organizations must develop policies and procedures for 
handling any direct or indirect conflict of interest by a member of the 
governing body or by the member's immediate family.
    (2) In the event of a direct or indirect conflict of interest by a 
member of the PACE organization's governing body or his or her immediate 
family member, the board member must--
    (i) Fully disclose the exact nature of the conflict to the board of 
directors and have the disclosure documented; and
    (ii) Recuse himself or herself from discussing, negotiating, or 
voting on any issue or contract that could result in an inappropriate 
conflict.
    (c) Disclosure and recusal requirements. A PACE organization must 
have a formal process in place to gather information related to 
paragraphs (a) and (b) of this section and must be able to respond in 
writing to a request for information from CMS within a reasonable amount 
of time.

[64 FR 66279, Nov. 24, 1999, as amended at 67 FR 61505, Oct. 1, 2002; 71 
FR 71335, Dec. 8, 2006; 81 FR 80561, Nov. 15, 2016; 83 FR 16756, Apr. 
16, 2018; 84 FR 25673, June 3, 2019]



Sec.  460.70  Contracted services.

    (a) General rule. The PACE organization must have a written contract 
with each outside organization, agency, or individual that furnishes 
administrative or care-related services not furnished directly by the 
PACE organization except for emergency services as described in Sec.  
460.100.
    (b) Contract requirements. A contract between a PACE organization 
and a contractor must meet the following requirements:
    (1) The PACE organization must contract only with an entity that 
meets all applicable Federal and State requirements, including, but not 
limited to, the following:
    (i) An institutional contractor, such as a hospital or skilled 
nursing facility, must meet Medicare or Medicaid participation 
requirements.

[[Page 657]]

    (ii) A practitioner or supplier must meet Medicare or Medicaid 
requirements applicable to the services it furnishes.
    (iii) A contractor must comply with the requirements of this part 
with respect to service delivery, participant rights, and quality 
improvement activities.
    (2) A contractor must be accessible to participants, located either 
within or near the PACE organization's service area.
    (3) A PACE organization must designate an official liaison to 
coordinate activities between contractors and the organization.
    (c) List of contractors. A current list of contractors must be on 
file at the PACE center and a copy must be provided to anyone upon 
request.
    (d) Content of contract. Each contract must be in writing and 
include the following information:
    (1) Name of contractor.
    (2) Services furnished (including work schedule if appropriate).
    (3) Payment rate and method.
    (4) Terms of the contract, including beginning and ending dates, 
methods of extension, renegotiation, and termination.
    (5) Contractor agreement to do the following:
    (i) Furnish only those services authorized by the PACE 
interdisciplinary team.
    (ii) Accept payment from the PACE organization as payment in full, 
and not bill participants, CMS, the State administering agency, or 
private insurers.
    (iii) Hold harmless CMS, the State, and PACE participants if the 
PACE organization does not pay for services performed by the contractor 
in accordance with the contract.
    (iv) Not assign the contract or delegate duties under the contract 
unless it obtains prior written approval from the PACE organization.
    (v) Submit reports required by the PACE organization.
    (6) With respect to an individual who is contracting as a program 
director or medical director or to be part of the interdisciplinary team 
as set forth at Sec.  460.60(a) and (b) and Sec.  460.102(b), the 
contract must specify that the individual agrees to:
    (i) Perform all the duties related to its position as specified in 
this part.
    (ii) Participate in interdisciplinary team meetings as required.
    (iii) Be accountable to the PACE organization.
    (iv) Cooperate with the competency evaluation program and direct 
participant care requirements specified in Sec.  460.71.
    (e) Contracting with another entity to furnish PACE center services. 
(1) A PACE organization may only contract for PACE center services if it 
is fiscally sound as defined in Sec.  460.80(a) of this part and has 
demonstrated competence with the PACE model as evidenced by successful 
monitoring by CMS and the State administering agency.
    (2) The PACE organization retains responsibility for all 
participants and may only contract for the PACE Center services 
identified in Sec.  460.98(c).

[64 FR 66279, Nov. 24, 1999, as amended at 67 FR 61505, Oct. 1, 2002; 71 
FR 71335, Dec. 8, 2006; 81 FR 80561, Nov. 15, 2016; 83 FR 16756, Apr. 
16, 2018; 84 FR 25673, June 3, 2019]



Sec.  460.71  Oversight of direct participant care.

    (a) The PACE organization must ensure that all employees and 
contracted staff furnishing care directly to participants demonstrate 
the skills necessary for performance of their position.
    (1) The PACE organization must provide each employee and all 
contracted staff with an orientation that includes, at a minimum, the 
organization's mission, philosophy, policies on participant rights, 
emergency plan, ethics, the PACE benefit, and any policies related to 
the job duties of specific staff.
    (2) The PACE organization must develop a competency evaluation 
program that identifies those skills, knowledge, and abilities that must 
be demonstrated by direct participant care staff (employees and 
contractors).
    (3) The competency program must be evidenced as completed before 
performing participant care and on an ongoing basis by qualified 
professionals.
    (4) The PACE organization must designate a staff member to oversee 
these activities for employees and work with

[[Page 658]]

the PACE contractor liaison to ensure compliance by contracted staff.
    (b) The PACE organization must develop a program to ensure that all 
staff furnishing direct participant care services meet the following 
requirements:
    (1) Comply with any State or Federal requirements for direct patient 
care staff in their respective settings.
    (2) Comply with the requirements of Sec.  460.68(a) regarding 
persons with criminal convictions.
    (3) Have verified current certifications or licenses for their 
respective positions.
    (4) Be medically cleared for communicable diseases and have all 
immunizations up-to-date before engaging in direct participant contact 
as required under Sec.  460.64(a)(5).
    (5) Have been oriented to the PACE program.
    (6) Agree to abide by the philosophy, practices, and protocols of 
the PACE organization.
    (c) The PACE organization must develop a training program for each 
personal care attendant to establish the individual's competency in 
furnishing personal care services and specialized skills associated with 
specific care needs of individual participants.
    (d) Personal care attendants must exhibit competency before 
performing personal care services independently.

[67 FR 61505, Oct. 1, 2002, as amended at 71 FR 71335, Dec. 8, 2006; 81 
FR 80562, Nov. 15, 2016; 83 FR 16756, Apr. 16, 2018; 84 FR 25674, June 
3, 2019]



Sec.  460.72  Physical environment.

    (a) Space and equipment--(1) Safe design. A PACE center must meet 
the following requirements:
    (i) Be designed, constructed, equipped, and maintained to provide 
for the physical safety of participants, personnel, and visitors.
    (ii) Ensure a safe, sanitary, functional, accessible, and 
comfortable environment for the delivery of services that protects the 
dignity and privacy of the participant.
    (2) Primary care clinic. The PACE center must include sufficient 
suitable space and equipment to provide primary medical care and 
suitable space for team meetings, treatment, therapeutic recreation, 
restorative therapies, socialization, personal care, and dining.
    (3) Equipment maintenance. (i) A PACE organization must establish, 
implement, and maintain a written plan to ensure that all equipment is 
maintained in accordance with the manufacturer's recommendations.
    (ii) A PACE organization must perform the manufacturer's recommended 
maintenance on all equipment as indicated in the organization's written 
plan.
    (b) Fire safety--(1) General rule. Except as otherwise provided in 
this section--
    (i) A PACE center 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 (b)(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) Exceptions. (i) The Life Safety Code provisions do not apply in 
a State in which CMS determines that a fire and safety code imposed by 
State law adequately protects participants and staff.
    (ii) 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 PACE 
facility, but only if the waiver will not adversely affect the health 
and safety of the patients.
    (3) A PACE center may install alcohol-based hand rub dispensers in 
its facility if the dispensers are installed in a manner that adequately 
protects against inappropriate access.
    (4) When a sprinkler system is shut down for more than 10 hours in a 
24-hour period, the PACE must:
    (i) Evacuate the building or portion of the building affected by the 
system outage until the system is back in service, or

[[Page 659]]

    (ii) Establish a fire watch until the system is back in service.
    (c) [Reserved]
    (d) Standard: Building Safety. Except as otherwise provided in this 
section, a PACE center 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).
    (1) Chapters 7, 8, 12, and 13 of the adopted Health Care Facilities 
Code do not apply to a PACE center.
    (2) If application of the Health Care Facilities Code required under 
paragraph (d) of this section would result in unreasonable hardship for 
the PACE center, 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 patients.
    (e) 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.
    (vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 
2011;
    (viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
    (ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
    (x) TIA 12-3 to NFPA 101, issued October 22, 2013.
    (xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
    (2) [Reserved]

[64 FR 66279, Nov. 24, 1999, as amended at 68 FR 1386, Jan. 10, 2003; 69 
FR 49266, Aug. 11, 2004; 70 FR 15238, Mar. 25, 2005; 71 FR 55340, Sept. 
22, 2006; 71 FR 71335, Dec. 8, 2006; 81 FR 26898, May 4, 2016; 81 FR 
64026, Sept. 16, 2016]



Sec.  460.74  Infection control.

    (a) Standard procedures. The PACE organization must follow accepted 
policies and standard procedures with respect to infection control, 
including at least the standard precautions developed by the Centers for 
Disease Control and Prevention.
    (b) Infection control plan. The PACE organization must establish, 
implement, and maintain a documented infection control plan that meets 
the following requirements:
    (1) Ensures a safe and sanitary environment.
    (2) Prevents and controls the transmission of disease and infection.
    (c) Contents of infection control plan. The infection control plan 
must include, but is not limited to, the following:
    (1) Procedures to identify, investigate, control, and prevent 
infections in every Pace center and in each participant's place of 
residence.
    (2) Procedures to record any incidents of infection.
    (3) Procedures to analyze the incidents of infection to identify 
trends and develop corrective actions related to the reduction of future 
incidents.
    (d) COVID-19 Vaccination of PACE organization staff. The PACE 
organization must develop and implement policies and procedures to 
ensure that all staff are fully vaccinated for COVID-19. For purposes of 
this section, staff are considered fully vaccinated if it has been 2 
weeks or more since they completed a primary vaccination series for 
COVID-

[[Page 660]]

19. The completion of a primary vaccination series for COVID-19 is 
defined here as the administration of a single-dose vaccine, or the 
administration of all required doses of a multi-dose vaccine.
    (1) Regardless of clinical responsibility or participant contact, 
the policies and procedures must apply to the following PACE 
organization staff, who provide any care, treatment, or other services 
for the PACE organization and/or its participants:
    (i) PACE organization employees;
    (ii) Licensed practitioners providing services on behalf of the PACE 
organization;
    (iii) Students, trainees, and volunteers providing services on 
behalf of the PACE organization; and
    (iv) Individuals who provide care, treatment, or other services on 
behalf of the PACE organization, under contract or by other arrangement.
    (2) The policies and procedures of this section do not apply to the 
following PACE organization staff:
    (i) Staff who exclusively provide telehealth or telemedicine 
services for the PACE organization and/or its participants and who do 
not have any direct contact with participants and other PACE 
organization staff specified in paragraph (d)(1) of this section; and
    (ii) Staff who provide support services for the PACE organization 
and/or its participants and who do not have any direct contact with 
participants and other PACE organization staff specified in paragraph 
(d)(1) of this section.
    (3) The policies and procedures must include, at a minimum, the 
following components:
    (i) A process for ensuring all staff specified in paragraph (d)(1) 
of this section (except for those staff who have pending requests for, 
or who have been granted, exemptions to the vaccination requirements of 
this section, or those staff for whom COVID-19 vaccination must be 
temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination 
series for a multi-dose COVID-19 vaccine prior to staff providing any 
care, treatment, or other services for the PACE organization and/or its 
participants;
    (ii) A process for ensuring that all staff specified in paragraph 
(d)(1) of this section are fully vaccinated for COVID-19, except for 
those staff who have been granted exemptions to the vaccination 
requirements of this section, or those staff for whom COVID-19 
vaccination must be temporarily delayed, as recommended by the CDC, due 
to clinical precautions and considerations;
    (iii) A process for ensuring the implementation of additional 
precautions, intended to mitigate the transmission and spread of COVID-
19, for all staff who are not fully vaccinated for COVID-19;
    (iv) A process for tracking and securely documenting the COVID-19 
vaccination status of all staff specified in paragraph (d)(1) of this 
section;
    (v) A process for tracking and securely documenting the COVID-19 
vaccination status of any staff who have obtained any booster doses as 
recommended by the CDC;
    (vi) A process by which staff may request an exemption from the 
staff COVID-19 vaccination requirements based on an applicable Federal 
law;
    (vii) A process for tracking and securely documenting information 
provided by those staff who have requested, and for whom the PACE 
organization has granted, an exemption from the staff COVID-19 
vaccination requirements based on recognized clinical contraindications 
or applicable Federal laws;
    (viii) A process for ensuring that all documentation, which confirms 
recognized clinical contraindications to COVID-19 vaccines and which 
supports staff requests for medical exemptions from vaccination, has 
been signed and dated by a licensed practitioner, who is not the 
individual requesting the exemption, and who is acting within their 
respective scope of practice as defined by, and in accordance with, all 
applicable State and local laws, and for further ensuring that such 
documentation contains:
    (A) All information specifying which of the authorized COVID-19 
vaccines are clinically contraindicated for the

[[Page 661]]

staff member to receive and the recognized clinical reasons for the 
contraindications; and
    (B) A statement by the authenticating practitioner recommending that 
the staff member be exempted from the PACE organization's COVID-19 
vaccination requirements for staff based on the recognized clinical 
contraindications;
    (ix) A process for ensuring the tracking and secure documentation of 
the vaccination status of staff for whom COVID-19 vaccination must be 
temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations, including, but not limited to, 
individuals with acute illness secondary to COVID-19, and individuals 
who received monoclonal antibodies or convalescent plasma for COVID-19 
treatment; and
    (x) Contingency plans for staff who are not fully vaccinated for 
COVID-19.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71334, Dec. 8, 2006; 86 
FR 61618, Nov. 5, 2021]



Sec.  460.76  Transportation services.

    (a) Safety, accessibility, and equipment. A PACE organization's 
transportation services must be safe, accessible, and equipped to meet 
the needs of the participant population.
    (b) Maintenance of vehicles. (1) If the PACE organization owns, 
rents, or leases transportation vehicles, it must maintain these 
vehicles in accordance with the manufacturer's recommendations.
    (2) If a contractor provides transportation services, the PACE 
organization must ensure that the vehicles are maintained in accordance 
with the manufacturer's recommendations.
    (c) Communication with PACE center. The PACE organization must 
ensure that transportation vehicles are equipped to communicate with the 
PACE center.
    (d) Training. The PACE organization must train all transportation 
personnel (employees and contractors) in the following:
    (1) Managing the special needs of participants.
    (2) Handling emergency situations.
    (e) Changes in care plan. As part of the interdisciplinary team 
process, PACE organization staff (employees and contractors) must 
communicate relevant changes in a participant's care plan to 
transportation personnel.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71334, Dec. 8, 2006]



Sec.  460.78  Dietary services.

    (a) Meal requirements. (1) Except as specified in paragraphs (a)(2) 
or (a)(3) of this section, the PACE organization must ensure, through 
the assessment and care planning process, that each participant receives 
nourishing, palatable, well-balanced meals that meet the participant's 
daily nutritional and special dietary needs. Each meal must meet the 
following requirements:
    (i) Be prepared by methods that conserve nutritive value, flavor, 
and appearance.
    (ii) Be prepared in a form designed to meet individual needs.
    (iii) Be prepared and served at the proper temperature.
    (2) The PACE organization must provide substitute foods or 
nutritional supplements that meet the daily nutritional and special 
dietary needs of any participant who has any of the following problems:
    (i) Refuses the food served.
    (ii) Cannot tolerate the food served.
    (iii) Does not eat adequately.
    (3) The PACE organization must provide nutrition support to meet the 
daily nutritional needs of a participant, if indicated by his or her 
medical condition or diagnosis. Nutrition support consists of tube 
feedings, total parenteral nutrition, or peripheral parenteral 
nutrition.
    (b) Sanitary conditions. The PACE organization must do the 
following:
    (1) Procure foods (including nutritional supplements and nutrition 
support items) from sources approved, or considered satisfactory, by 
Federal, State, Tribal, or local authorities with jurisdiction over the 
service area of the organization.
    (2) Store, prepare, distribute, and serve foods (including 
nutritional supplements and nutrition support items) under sanitary 
conditions.
    (3) Dispose of garbage and refuse properly.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71335, Dec. 8, 2006]

[[Page 662]]



Sec.  460.80  Fiscal soundness.

    (a) Fiscally sound operation. A PACE organization must have a 
fiscally sound operation, as demonstrated by the following:
    (1) Total assets greater than total unsubordinated liabilities.
    (2) Sufficient cash flow and adequate liquidity to meet obligations 
as they become due.
    (3) A net operating surplus or a financial plan for maintaining 
solvency that is satisfactory to CMS and the State administering agency.
    (b) Insolvency plan. The organization must have a documented plan in 
the event of insolvency, approved by CMS and the State administering 
agency, which provides for the following:
    (1) Continuation of benefits for the duration of the period for 
which capitation payment has been made.
    (2) Continuation of benefits to participants who are confined in a 
hospital on the date of insolvency until their discharge.
    (3) Protection of participants from liability for payment of fees 
that are the legal obligation of the PACE organization.
    (c) Arrangements to cover expenses. (1) A PACE organization must 
demonstrate that it has arrangements to cover expenses in the amount of 
at least the sum of the following in the event it becomes insolvent:
    (i) One month's total capitation revenue to cover expenses the month 
before insolvency.
    (ii) One month's average payment to all contractors, based on the 
prior quarter's average payment, to cover expenses the month after the 
date it declares insolvency or ceases operations.
    (2) Arrangements to cover expenses may include, but are not limited 
to, the following:
    (i) Insolvency insurance or reinsurance.
    (ii) Hold harmless arrangement.
    (iii) Letters of credit, guarantees, net worth, restricted State 
reserves, or State law provisions.



Sec.  460.82  Marketing.

    (a) Information that a PACE organization must include in its 
marketing materials. (1) A PACE organization must inform the public 
about its program and give prospective participants the following 
written information:
    (i) An adequate description of the PACE organization's enrollment 
and disenrollment policies and requirements.
    (ii) PACE enrollment procedures.
    (iii) Description of benefits and services.
    (iv) Premiums.
    (v) Other information necessary for prospective participants to make 
an informed decision about enrollment.
    (2) Marketing information must be free of material inaccuracies, 
misleading information, or misrepresentations.
    (b) Approval of marketing information. (1) CMS must approve all 
marketing information before distribution by the PACE organization, 
including any revised or updated material.
    (2) CMS reviews initial marketing information as part of an entity's 
application for approval as a PACE organization, and approval of the 
application includes approval of marketing information.
    (3) Once a PACE organization is under a PACE program agreement, any 
revisions to existing marketing information and new information are 
subject to the following:
    (i) Time period for approval. CMS approves or disapproves marketing 
information within 45 days after CMS receives the information from the 
organization.
    (ii) Deemed approval. Marketing information is deemed approved, and 
the organization can distribute it, if CMS and the State administering 
agency do not disapprove the marketing material within the 45-day review 
period.
    (c) Special language requirements. A PACE organization must furnish 
printed marketing materials to prospective and current participants as 
specified below:
    (1) In English and in any other principal languages of the 
community, as determined by the State in which the PACE organization is 
located. In the absence of a State standard, a principal language of the 
community is any language that is spoken in the home by at least 5 
percent of the individuals in the PACE organization's service area.

[[Page 663]]

    (2) In Braille, if necessary.
    (d) Information on restriction of services. (1) Marketing materials 
must inform a potential participant that he or she must receive all 
needed health care, including primary care and specialist physician 
services (other than emergency services), from the PACE organization or 
from an entity authorized by the PACE organization.
    (2) All marketing materials must state clearly that PACE 
participants may be fully and personally liable for the costs of 
unauthorized or out-of-PACE program agreement services.
    (e) Prohibited marketing practices. A PACE organization must not use 
the following marketing practices, which are prohibited:
    (1) Discrimination of any kind, except that marketing may be 
directed to individuals eligible for PACE by reason of their age.
    (2) Activities that could mislead or confuse potential participants, 
or misrepresent the PACE organization, CMS, or the State administering 
agency.
    (3) Gifts or payments to induce enrollment, unless the gifts are of 
nominal value as defined in CMS guidance, are offered to all potential 
enrollees without regard to whether they enroll in the PACE program, and 
are not in the form of cash or other monetary rebates.
    (4) Marketing by any individual or entity that is directly or 
indirectly compensated by the PACE organization based on activities or 
outcomes unless the individual or entity has been appropriately trained 
on PACE program requirements, including but not limited to, subparts G 
and I of this part.
    (i) PACE organizations are responsible for the activities of 
contracted individuals or entities who market on their behalf.
    (ii) PACE organizations that choose to use contracted individuals or 
entities for marketing purposes must develop a method to document 
training has been provided.
    (5) Unsolicited door-to-door marketing or other unsolicited means of 
direct contact, including calling or emailing a potential or current 
participant without the individual initiating the contact.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25674, June 3, 2019]



Sec.  460.84  Emergency preparedness.

    The Program for the All-Inclusive Care for the Elderly (PACE) 
organization must comply with all applicable Federal, State, and local 
emergency preparedness requirements. The PACE organization 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 PACE organization must develop and maintain 
an emergency preparedness plan that must be reviewed, and updated at 
least every 2 years. The plan must do 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 participant population, including, but not limited to, 
the type of services the PACE organization 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 PACE organization 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 
address management of medical and nonmedical emergencies, including, but 
not limited to: Fire; equipment, power, or water failure; care-related 
emergencies; and natural disasters likely to threaten the health or 
safety of the participants, staff, or

[[Page 664]]

the public. 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 participants, 
whether they evacuate or shelter in place, include, but are not limited 
to the following:
    (i) Food, water, and medical supplies.
    (ii) Alternate sources of energy to maintain the following:
    (A) Temperatures to protect participant 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 
participants under the PACE center(s) care during and after an 
emergency. If on-duty staff and sheltered participants are relocated 
during the emergency, the PACE must document the specific name and 
location of the receiving facility or other location.
    (3) Safe evacuation from the PACE center, which includes 
consideration of care and treatment needs of evacuees; staff 
responsibilities; transportation; identification of evacuation 
location(s); and primary and alternate means of communication with 
external sources of assistance.
    (4) The procedures to inform State and local emergency preparedness 
officials about PACE participants in need of evacuation from their 
residences at any time due to an emergency situation based on the 
participant's medical and psychiatric conditions and home environment.
    (5) A means to shelter in place for participants, staff, and 
volunteers who remain in the facility.
    (6) A system of medical documentation that preserves participant 
information, protects confidentiality of participant information, and 
secures and maintains the availability of records.
    (7) The use of volunteers in an emergency or other emergency 
staffing strategies, including the process and role for integration of 
State or Federally designated health care professionals to address surge 
needs during an emergency.
    (8) The development of arrangements with other PACE organizations, 
PACE centers, or other providers to receive participants in the event of 
limitations or cessation of operations to maintain the continuity of 
services to PACE participants.
    (9) The role of the PACE organization under a waiver declared by the 
Secretary, in accordance with section 1135 of the Act, in the provision 
of care and treatment at an alternate care site identified by emergency 
management officials.
    (10)(i) Emergency equipment, including easily portable oxygen, 
airways, suction, and emergency drugs.
    (ii) Staff who know how to use the equipment must be on the premises 
of every center at all times and be immediately available.
    (iii) A documented plan to obtain emergency medical assistance from 
outside sources when needed.
    (c) Communication plan. The PACE organization 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 staff; entities providing 
services under arrangement; participants' physicians; other PACE 
organizations; and 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) PACE organization's staff.
    (ii) Federal, State, tribal, regional, and local emergency 
management agencies.
    (4) A method for sharing information and medical documentation for 
participants under the organization's care, as necessary, with other 
health care providers to maintain the continuity of care.
    (5) A means, in the event of an evacuation, to release participant 
information as permitted under 45 CFR 164.510(b)(1)(ii).

[[Page 665]]

    (6) A means of providing information about the general condition and 
location of participants under the facility's care as permitted under 45 
CFR 164.510(b)(4).
    (7) A means of providing information about the PACE organization's 
needs, and its ability to provide assistance, to the authority having 
jurisdiction, the Incident Command Center, or designee.
    (d) Training and testing. The PACE organization 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 PACE organization must do all of the 
following:
    (i) Initial training in emergency preparedness policies and 
procedures to all new and existing staff, individuals providing on-site 
services under arrangement, contractors, participants, and volunteers, 
consistent with their expected roles.
    (ii) Provide emergency preparedness training at least every 2 years.
    (iii) Demonstrate staff knowledge of emergency procedures, including 
informing participants of what to do, where to go, and whom to contact 
in case of an emergency.
    (iv) Maintain documentation of all training.
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the PACE must conduct training on the updated 
policies and procedures.
    (2) Testing. The PACE organization must conduct exercises to test 
the emergency plan at least annually. The PACE organization must do the 
following:
    (i) Participate in a full-scale exercise that is community-based or;
    (A) When a community-based exercise is not accessible, conduct an 
annual individual, facility-based functional exercise every 2 years; or
    (B) If the PACE experiences an actual natural or man-made emergency 
that requires activation of the emergency plan, the PACE is exempt from 
engaging in its next required full-scale community-based or individual, 
facility-based functional exercise following the onset of the emergency 
event.
    (ii) Conduct an additional exercise every 2 years opposite the year 
the full-scale or functional exercise under paragraph (d)(2)(i) of this 
section is conducted that may include, but is not limited to the 
following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that is led by a facilitator and 
includes a group discussion, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the PACE's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events and revise the 
PACE's emergency plan, as needed.
    (e) Integrated healthcare systems. If a PACE is part of a healthcare 
system consisting of multiple separately certified healthcare facilities 
that elects to have a unified and integrated emergency preparedness 
program, the PACE may choose to participate in the healthcare system's 
coordinated emergency preparedness program. If elected, the unified and 
integrated emergency preparedness program must--
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, participant 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance with the program.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4)

[[Page 666]]

of this section. The unified and integrated emergency plan must also be 
based on and include the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for each 
separately certified facility within the health system, utilizing an 
all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.

[81 FR 64026, Sept. 16, 2016, as amended at 84 FR 51816, Sept. 30, 2019]



Sec.  460.86  Payment to individuals and entities excluded by the OIG 
or included on the preclusion list.

    (a) A PACE organization may not pay, directly or indirectly, on any 
basis, for items or services (other than emergency or urgently needed 
services as defined in Sec.  460.100) furnished to a Medicare enrollee 
by any individual or entity that is excluded by the OIG or is included 
on the preclusion list, defined in Sec.  422.2 of this chapter.
    (b) If a PACE organization receives a request for payment by, or on 
behalf of, an individual or entity that is excluded by the OIG or is 
included on the preclusion list, defined in Sec.  422.2 of this chapter, 
the PACE organization must notify the enrollee and the excluded 
individual or entity or the individual or entity that is included on the 
preclusion list in writing, as directed by contract or other direction 
provided by CMS, that payments will not be made. Payment may not be made 
to, or on behalf of, an individual or entity that is excluded by the OIG 
or is included on the preclusion list.

[83 FR 16756, Apr. 16, 2018]



                         Subpart F_PACE Services



Sec.  460.90  PACE benefits under Medicare and Medicaid.

    If a Medicare beneficiary or Medicaid beneficiary chooses to enroll 
in a PACE program, the following conditions apply:
    (a) Medicare and Medicaid benefit limitations and conditions 
relating to amount, duration, scope of services, deductibles, 
copayments, coinsurance, or other cost-sharing do not apply.
    (b) The participant, while enrolled in a PACE program, must receive 
Medicare and Medicaid benefits solely through the PACE organization.



Sec.  460.92  Required services.

    (a) The PACE benefit package for all participants, regardless of the 
source of payment, must include the following:
    (1) All Medicare-covered services.
    (2) All Medicaid-covered services, as specified in the State's 
approved Medicaid plan.
    (3) Other services determined necessary by the interdisciplinary 
team to improve and maintain the participant's overall health status.
    (b) Decisions by the interdisciplinary team to provide or deny 
services under paragraph (a) of this section must be based on an 
evaluation of the participant that takes into account:
    (1) The participant's current medical, physical, emotional, and 
social needs; and
    (2) Current clinical practice guidelines and professional standards 
of care applicable to the particular service.

[86 FR 6132, Jan. 19, 2021]



Sec.  460.94  Required services for Medicare participants.

    (a) Except for Medicare requirements that are waived for the PACE 
program, as specified in paragraph (b) of this section, the PACE benefit 
package for Medicare participants must include the following services:
    (1) The scope of hospital insurance benefits described in part 409 
of this chapter.
    (2) The scope of supplemental medical insurance benefits described 
in part 410 of this chapter.
    (b) Waivers of Medicare coverage requirements. The following 
Medicare requirements are waived for purposes of the PACE program and do 
not apply:
    (1) The provisions of subpart F of part 409 of this chapter that 
limit coverage of institutional services.

[[Page 667]]

    (2) The provisions of subparts G and H of part 409 of this chapter, 
and parts 412 through 414 of this chapter that relate to payment for 
benefits.
    (3) The provisions of subparts D and E of part 409 of this chapter 
that limit coverage of extended care services or home health services.
    (4) The provisions of subpart D of part 409 of this chapter that 
impose a 3-day prior hospitalization requirement for coverage of 
extended care services.
    (5) Section 411.15(g) and Sec.  411.15(k) of this chapter that may 
prevent payment for PACE program services that are provided to PACE 
participants.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71335, Dec. 8, 2006]



Sec.  460.96  Excluded services.

    The following services are excluded from coverage under PACE:
    (a) Cosmetic surgery, which does not include surgery that is 
required for improved functioning of a malformed part of the body 
resulting from an accidental injury or for reconstruction following 
mastectomy.
    (b) Experimental medical, surgical, or other health procedures.
    (c) Services furnished outside of the United States, except as 
follows:
    (1) In accordance with Sec.  424.122 and Sec.  424.124 of this 
chapter.
    (2) As permitted under the State's approved Medicaid plan.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71335, Dec. 8, 2006; 86 
FR 6132, Jan. 19, 2021]



Sec.  460.98  Service delivery.

    (a) Access to services. A PACE organization is responsible for 
providing care that meets the needs of each participant across all care 
settings, 24 hours a day, every day of the year, and must establish and 
implement a written plan to ensure that care is appropriately furnished.
    (b) Provision of services. (1) The PACE organization must furnish 
comprehensive medical, health, and social services that integrate acute 
and long-term care. These services must be furnished in accordance with 
Sec.  460.70(a).
    (2) These services must be furnished in at least the PACE center, 
the home, and inpatient facilities.
    (3) The PACE organization may not discriminate against any 
participant in the delivery of required PACE services based on race, 
ethnicity, national origin, religion, sex, age, mental or physical 
disability, or source of payment.
    (4) Services must be provided as expeditiously as the participant's 
health condition requires, taking into account the participant's 
medical, physical, emotional, and social needs.
    (5) The PACE organization must document, track and monitor the 
provision of services across all care settings in order to ensure the 
interdisciplinary team remains alert to the participant's medical, 
physical, emotional, and social needs regardless of whether services are 
formally incorporated into the participant's plan of care.
    (c) Minimum services furnished at each PACE center. At a minimum, 
the following services must be furnished at each PACE center:
    (1) Primary care, including services furnished by a primary care 
provider as defined in Sec.  460.102(c) and nursing services.
    (2) Social services.
    (3) Restorative therapies, including physical therapy and 
occupational therapy.
    (4) Personal care and supportive services.
    (5) Nutritional counseling.
    (6) Recreational therapy.
    (7) Meals.
    (d) PACE center operation. (1) A PACE organization must operate at 
least one PACE center either in, or contiguous to, its defined service 
area with sufficient capacity to allow routine attendance by 
participants.
    (2) A PACE organization must ensure accessible and adequate services 
to meet the needs of its participants. If necessary, a PACE organization 
must increase the number of PACE centers, staff, or other PACE services.
    (3) If a PACE organization operates more than one center, each PACE 
center must offer the full range of services and have sufficient staff 
to meet the needs of participants.

[[Page 668]]

    (e) Center attendance. The frequency of a participant's attendance 
at a center is determined by the interdisciplinary team, based on the 
needs and preferences of each participant.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71334, 71335, Dec. 8, 
2006; 84 FR 25674, June 3, 2019; 85 FR 37243, June 19, 2020; 86 FR 6132, 
Jan. 19, 2021]



Sec.  460.100  Emergency care.

    (a) Written plan. A PACE organization must establish and maintain a 
written plan to handle emergency care. The plan must ensure that CMS, 
the State, and PACE participants are held harmless if the PACE 
organization does not pay for emergency services.
    (b) Emergency care. Emergency care is appropriate when services are 
needed immediately because of an injury or sudden illness and the time 
required to reach the PACE organization or one of its contract 
providers, would cause risk of permanent damage to the participant's 
health. Emergency services include inpatient and outpatient services 
that meet the following requirements:
    (1) Are furnished by a qualified emergency services provider, other 
than the PACE organization or one of its contract providers, either in 
or out of the PACE organization's service area.
    (2) Are needed to evaluate or stabilize an emergency medical 
condition.
    (c) An emergency medical condition means a condition manifesting 
itself by acute symptoms of sufficient severity (including severe pain) 
such that a prudent layperson, with an average knowledge of health and 
medicine, could reasonably expect the absence of immediate medical 
attention to result in the following:
    (1) Serious jeopardy to the health of the participant.
    (2) Serious impairment to bodily functions.
    (3) Serious dysfunction of any bodily organ or part.
    (d) Explanation to participant. The organization must ensure that 
the participant or caregiver, or both, understand when and how to get 
access to emergency services and that no prior authorization is needed.
    (e) On-call providers. The plan must provide for the following:
    (1) An on-call provider, available 24-hours per day to address 
participant questions about emergency services and respond to requests 
for authorization of urgently needed out-of-network services and post 
stabilization care services following emergency services.
    (2) Coverage of urgently needed out-of-network and post-
stabilization care services when either of the following conditions are 
met:
    (i) The services are preapproved by the PACE organization.
    (ii) The services are not preapproved by the PACE organization 
because the PACE organization did not respond to a request for approval 
within 1 hour after being contacted or cannot be contacted for approval.
    (3) Definitions. As used in this section, the following definitions 
apply:
    (i) Post stabilization care means services provided subsequent to an 
emergency that a treating physician views as medically necessary after 
an emergency medical condition has been stabilized. They are not 
emergency services, which PACE organizations are obligated to cover. 
Rather, they are non-emergency services that the PACE organization 
should approve before they are provided outside the service area.
    (ii) Urgent care means the care provided to a PACE participant who 
is out of the PACE service area, and who believes their illness or 
injury is too severe to postpone treatment until they return to the 
service area, but their life or function is not in severe jeopardy.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71335, Dec. 8, 2006; 84 
FR 25674, June 3, 2019]



Sec.  460.102  Interdisciplinary team.

    (a) Basic requirement. A PACE organization must meet the following 
requirements:
    (1) Establish an interdisciplinary team, composed of members that 
fill the roles described in paragraph (b) of this section, at each PACE 
center to comprehensively assess and meet the individual needs of each 
participant.
    (2) Assign each participant to an interdisciplinary team functioning 
at the PACE center that the participant attends.

[[Page 669]]

    (b) Composition of interdisciplinary team. The interdisciplinary 
team must be composed of members qualified to fill, at minimum, the 
following roles, in accordance with CMS guidelines. One individual may 
fill two separate roles on the interdisciplinary team where the 
individual meets applicable state licensure requirements and is 
qualified to fill the two roles and able to provide appropriate care to 
meet the needs of participants.
    (1) Primary care provider.
    (2) Registered nurse.
    (3) Master's-level social worker.
    (4) Physical therapist.
    (5) Occupational therapist.
    (6) Recreational therapist or activity coordinator.
    (7) Dietitian.
    (8) PACE center manager.
    (9) Home care coordinator.
    (10) Personal care attendant or his or her representative.
    (11) Driver or his or her representative.
    (c) Primary care provider. (1) Primary medical care must be 
furnished to a participant by any of the following:
    (i) A primary care physician.
    (ii) A community-based physician.
    (iii) A physician assistant who is licensed in the State and 
practices within his or her scope of practice as defined by State laws 
with regard to oversight, practice authority and prescriptive authority.
    (iv) A nurse practitioner who is licensed in the State and practices 
within his or her scope of practice as defined by State laws with regard 
to oversight, practice authority and prescriptive authority.
    (2) Each primary care provider is responsible for the following:
    (i) Managing a participant's medical situations.
    (ii) Overseeing a participant's use of medical specialists and 
inpatient care.
    (d) Responsibilities of interdisciplinary team. (1) The 
interdisciplinary team is responsible for the following:
    (i) The initial assessment, periodic reassessments, plan of care, 
and coordination of 24-hour care delivery.
    (ii) Documenting all recommendations for care or services and the 
reason(s) for not approving or providing recommended care or services, 
if applicable, in accordance with Sec.  460.210(b).
    (2) Each team member is responsible for the following:
    (i) Regularly informing the interdisciplinary team of the medical, 
functional, and psychosocial condition of each participant.
    (ii) Remaining alert to pertinent input from any individual with 
direct knowledge of or contact with the participant, including the 
following:
    (A) Other team members.
    (B) Participants.
    (C) Caregivers.
    (D) Employees.
    (E) Contractors.
    (F) Specialists.
    (G) Designated representatives.
    (iii) Documenting changes of a participant's condition in the 
participant's medical record consistent with documentation polices 
established by the medical director.
    (e) Team member qualifications. The PACE organization must ensure 
that all members of the interdisciplinary team have appropriate licenses 
or certifications under State law, act within the scope of practice as 
defined by State laws, and meet the requirements set forth in Sec.  
460.71.
    (f) Exchange of information between team members. The PACE 
organization must establish, implement, and maintain documented internal 
procedures governing the exchange of information between team members, 
contractors, and participants and their caregivers consistent with the 
requirements for confidentiality in Sec.  460.200(e).

[64 FR 66279, Nov. 24, 1999, as amended at 67 FR 61506, Oct. 1, 2002; 71 
FR 71334, 71336, Dec. 8, 2006; 84 FR 25674, June 3, 2019; 86 FR 6132, 
Jan. 21, 2021]



Sec.  460.104  Participant assessment.

    (a) Initial comprehensive assessment--(1) Basic requirement. The 
interdisciplinary team must conduct an initial in-person comprehensive 
assessment on each participant. The assessment must be completed in a 
timely manner in order to meet the requirements in paragraph (b) of this 
section.
    (2) Members present. As part of the initial comprehensive 
assessment, each of the following members of the interdisciplinary team 
must evaluate the

[[Page 670]]

participant in person and develop a discipline-specific assessment of 
the participant's health and social status:
    (i) Primary care provider
    (ii) Registered nurse.
    (iii) Master's-level social worker.
    (iv) Physical therapist.
    (v) Occupational therapist.
    (vi) Recreational therapist or activity coordinator.
    (vii) Dietitian.
    (viii) Home care coordinator.
    (3) Additional professional disciplines. At the recommendation of 
the interdisciplinary team, other professional disciplines (for example, 
speech-language pathology, dentistry, or audiology) may be included in 
the initial comprehensive assessment process.
    (4) Initial comprehensive assessment criteria. The initial in-person 
comprehensive assessment must at a minimum include the evaluation of:
    (i) Physical and cognitive function and ability.
    (ii) Medication use.
    (iii) Participant and caregiver preferences for care.
    (iv) Socialization and availability of family support.
    (v) Current health status and treatment needs.
    (vi) Nutritional status.
    (vii) Home environment, including home access and egress.
    (viii) Participant behavior.
    (ix) Psychosocial status.
    (x) Medical and dental status.
    (xi) Participant language.
    (b) Development of plan of care. Within 30 days of the date of 
enrollment, the interdisciplinary team must consolidate discipline-
specific assessments into a single plan of care for each participant 
through team discussions and consensus of the entire interdisciplinary 
team. In developing the plan of care:
    (1) If the interdisciplinary team determines that certain services 
are not necessary to the care of a participant, the reasoning behind 
this determination must be documented in the plan of care.
    (2) Female participants must be informed that they are entitled to 
choose a qualified specialist for women's health services from the PACE 
organization's network to furnish routine or preventive women's health 
services.
    (c) Semi-annual reassessment. On at least a semi-annual basis, or 
more often if a participant's condition dictates, the following members 
of the interdisciplinary team must conduct an in-person reassessment:
    (1) Primary care provider.
    (2) Registered nurse.
    (3) Master's-level social worker.
    (4) Other team members that the primary care provider, registered 
nurse and Master's-level social worker determine are actively involved 
in the development or implementation of the participant's plan of care.
    (d) Unscheduled reassessments. In addition to semi-annual 
reassessments, unscheduled reassessments may be required based on the 
following:
    (1) A change in participant status. If the health or psychosocial 
status of a participant changes, the members of the interdisciplinary 
team listed in paragraph (c) of this section must conduct an in-person 
reassessment.
    (2) In response to a service determination request. In accordance 
with Sec.  460.121(h), the PACE organization must conduct an in-person 
reassessment if it expects to deny or partially deny a service 
determination request, and may conduct reassessments as determined 
necessary for approved services.
    (e) Changes to plan of care. Team members who conduct a reassessment 
must meet the following requirements:
    (1) Reevaluate the participant's plan of care.
    (2) Discuss any changes in the plan with the interdisciplinary team.
    (3) Obtain approval of the revised plan from the interdisciplinary 
team and the participant (or designated representative).
    (4) Furnish any services included in the revised plan of care as a 
result of a reassessment to the participant as expeditiously as the 
participant's health condition requires.

[[Page 671]]

    (f) Documentation. Interdisciplinary team members must document all 
assessment and reassessment information in the participant's medical 
record.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71336, Dec. 8, 2006; 84 
FR 25674, June 3, 2019; 86 FR 6132, Jan. 19, 2021]



Sec.  460.106  Plan of care.

    (a) Basic requirement. Within 30 days of the date of enrollment, the 
interdisciplinary team members specified in Sec.  460.104(a)(2) must 
develop a comprehensive plan of care for each participant based on the 
initial comprehensive assessment findings.
    (b) Content of plan of care. The plan of care must meet the 
following requirements:
    (1) Specify the care needed to meet the participant's medical, 
physical, emotional, and social needs, as identified in the initial 
comprehensive assessment.
    (2) Identify measurable outcomes to be achieved.
    (3) Utilize the most appropriate interventions for each care need 
that advances the participant toward a measurable goal and outcome.
    (4) Identify each intervention and how it will be implemented.
    (5) Identify how each intervention will be evaluated to determine 
progress in reaching specified goals and desired outcomes.
    (c) Implementation of the plan of care. (1) The team must implement, 
coordinate, and monitor the plan of care whether the services are 
furnished by PACE employees or contractors.
    (2) The team must continuously monitor the participant's health and 
psychosocial status, as well as the effectiveness of the plan of care, 
through the provision of services, informal observation, input from 
participants or caregivers, and communications among members of the 
interdisciplinary team and other providers.
    (d) Evaluation of plan of care. On at least a semi-annual basis, the 
interdisciplinary team must reevaluate the plan of care, including 
defined outcomes, and make changes as necessary.
    (e) Participant and caregiver involvement in plan of care. The team 
must develop, review, and reevaluate the plan of care in collaboration 
with the participant or caregiver, or both, to ensure that there is 
agreement with the plan of care and that the participant's concerns are 
addressed.
    (f) Documentation. The team must document the plan of care, and any 
changes made to it, in the participant's medical record.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25675, June 3, 2019]



                      Subpart G_Participant Rights



Sec.  460.110  Bill of rights.

    (a) Written bill of rights. A PACE organization must have a written 
participant bill of rights designed to protect and promote the rights of 
each participant. Those rights include, at a minimum, the ones specified 
in Sec.  460.112.
    (b) Explanation of rights. The organization must inform a 
participant upon enrollment, in writing, of his or her rights and 
responsibilities, and all rules and regulations governing participation.
    (c) Protection of rights. The organization must protect and provide 
for the exercise of the participant's rights.



Sec.  460.112  Specific rights to which a participant is entitled.

    (a) Respect and nondiscrimination. Each participant has the right to 
considerate, respectful care from all PACE employees and contractors at 
all times and under all circumstances. Each participant has the right 
not to be discriminated against in the delivery of required PACE 
services based on race, ethnicity, national origin, religion, sex, age, 
sexual orientation, mental or physical disability, or source of payment. 
Specifically, each participant has the right to the following:
    (1) To receive comprehensive health care in a safe and clean 
environment and in an accessible manner.
    (2) To be treated with dignity and respect, be afforded privacy and 
confidentiality in all aspects of care, and be provided humane care.
    (3) Not to be required to perform services for the PACE 
organization.
    (4) To have reasonable access to a telephone.

[[Page 672]]

    (5) To be free from harm, including physical or mental abuse, 
neglect, corporal punishment, involuntary seclusion, excessive 
medication, and any physical or chemical restraint imposed for purposes 
of discipline or convenience and not required to treat the participant's 
medical symptoms.
    (6) To be encouraged and assisted to exercise rights as a 
participant, including the Medicare and Medicaid appeals processes as 
well as civil and other legal rights.
    (7) To be encouraged and assisted to recommend changes in policies 
and services to PACE staff.
    (b) Information disclosure. Each PACE participant has the right to 
receive accurate, easily understood information and to receive 
assistance in making informed health care decisions. Specifically, each 
participant has the following rights:
    (1) To be fully informed in writing of the services available from 
the PACE organization, including identification of all services that are 
delivered through contracts, rather than furnished directly by the PACE 
organization at the following times:
    (i) Prior to and upon enrollment in the PACE organization.
    (ii) At the time a participant's needs necessitate the disclosure 
and delivery of such information in order to allow the participant to 
make an informed choice.
    (2) To have the enrollment agreement, described in Sec.  460.154, 
fully explained in a manner understood by the participant.
    (3) To examine, or upon reasonable request, to be helped to examine 
the results of the most recent review of the PACE organization conducted 
by CMS or the State administering agency and any plan of correction in 
effect.
    (4) To contact 1-800-MEDICARE for information and assistance, 
including to make a complaint related to the quality of care or the 
delivery of a service.
    (c) Choice of providers. Each participant has the right to a choice 
of health care providers, within the PACE organization's network, that 
is sufficient to ensure access to appropriate high-quality health care. 
Specifically, each participant has the right to the following:
    (1) To choose his or her primary care physician and specialists from 
within the PACE network.
    (2) To request that a qualified specialist for women's health 
services furnish routine or preventive women's health services.
    (3) To have reasonable and timely access to specialists as indicated 
by the participant's health condition and consistent with current 
clinical practice guidelines.
    (4) To receive necessary care in all care settings, up to and 
including placement in a long-term care facility when the PACE 
organization can no longer provide the services necessary to maintain 
the participant safely in the community.
    (5) To disenroll from the program at any time and have such 
disenrollment be effective the first day of the month following the date 
the PACE organization receives the participant's notice of voluntary 
disenrollment as set forth in Sec.  460.162(a).
    (d) Access to emergency services. Each participant has the right to 
access emergency health care services when and where the need arises 
without prior authorization by the PACE interdisciplinary team.
    (e) Participation in treatment decisions. Each participant has the 
right to participate fully in all decisions related to his or her 
treatment. A participant who is unable to participate fully in treatment 
decisions has the right to designate a representative. Specifically, 
each participant has the following rights:
    (1) To have all treatment options explained in a culturally 
competent manner and to make health care decisions, including the right 
to refuse treatment, and be informed of the consequences of the 
decisions.
    (2) To have the PACE organization explain advance directives and to 
establish them, if the participant so desires, in accordance with 
Sec. Sec.  489.100 and 489.102 of this chapter.
    (3) To be fully informed of his or her health and functional status 
by the interdisciplinary team.
    (4) To participate in the development and implementation of the plan 
of care.

[[Page 673]]

    (5) To request a reassessment by the interdisciplinary team.
    (6) To be given reasonable advance notice, in writing, of any 
transfer to another treatment setting and the justification for the 
transfer (that is, due to medical reasons or for the participant's 
welfare, or that of other participants). The PACE organization must 
document the justification in the participant's medical record.
    (f) Confidentiality of health information. Each participant has the 
right to communicate with health care providers in confidence and to 
have the confidentiality of his or her individually identifiable health 
care information protected. Each participant also has the right to 
review and copy his or her own medical records and request amendments to 
those records. Specifically, each participant has the following rights:
    (1) To be assured of confidential treatment of all information 
contained in the health record, including information contained in an 
automated data bank.
    (2) To be assured that his or her written consent will be obtained 
for the release of information to persons not otherwise authorized under 
law to receive it.
    (3) To provide written consent that limits the degree of information 
and the persons to whom information may be given.
    (g) Complaints and appeals. Each participant has the right to a fair 
and efficient process for resolving differences with the PACE 
organization, including a rigorous system for internal review by the 
organization and an independent system of external review. Specifically, 
each participant has the following rights:
    (1) To be encouraged and assisted to voice complaints to PACE staff 
and outside representatives of his or her choice, free of any restraint, 
interference, coercion, discrimination, or reprisal by the PACE staff.
    (2) To appeal any treatment decision of the PACE organization, its 
employees, or contractors through the process described in Sec.  
460.122.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71336, Dec. 8, 2006; 84 
FR 25675, June 3, 2019; 86 FR 6132, Jan. 19, 2021]



Sec.  460.114  Restraints.

    (a) The PACE organization must limit use of restraints to the least 
restrictive and most effective method available. The term restraint 
includes either a physical restraint or a chemical restraint.
    (1) A physical restraint is any manual method or physical or 
mechanical device, materials, or equipment attached or adjacent to the 
participant's body that he or she cannot easily remove that restricts 
freedom of movement or normal access to one's body.
    (2) A chemical restraint is a medication used to control behavior or 
to restrict the participant's freedom of movement and is not a standard 
treatment for the participant's medical or psychiatric condition.
    (b) If the interdisciplinary team determines that a restraint is 
needed to ensure the participant's physical safety or the safety of 
others, the use must meet the following conditions:
    (1) Be imposed for a defined, limited period of time, based upon the 
assessed needs of the participant.
    (2) Be imposed in accordance with safe and appropriate restraining 
techniques.
    (3) Be imposed only when other less restrictive measures have been 
found to be ineffective to protect the participant or others from harm.
    (4) Be removed or ended at the earliest possible time.
    (c) The condition of the restrained participant must be continually 
assessed, monitored, and reevaluated.



Sec.  460.116  Explanation of rights.

    (a) Written policies. A PACE organization must have written policies 
and implement procedures to ensure that the participant, his or her 
representative, if any, and staff understand these rights.
    (b) Explanation of rights. The PACE organization must fully explain 
the rights to the participant and his or her representative, if any, at 
the time of enrollment in a manner understood by the participant.
    (c) Display. The PACE organization must meet the following 
requirements:

[[Page 674]]

    (1) Write the participant rights in English, and in any other 
principal languages of the community, as determined by the State in 
which the PACE organization is located. In the absence of a State 
standard, a principal language of the community is any language that is 
spoken by at least 5 percent of the individuals in the PACE 
organization's service area.
    (2) Display the PACE participant rights in a prominent place in the 
PACE center.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25675, June 3, 2019]



Sec.  460.118  Violation of rights.

    The PACE organization must have established documented procedures to 
respond to and rectify a violation of a participant's rights.



Sec.  460.120  Grievance process.

    For purposes of this part, a grievance is a complaint, either 
written or oral, expressing dissatisfaction with service delivery or the 
quality of care furnished.
    (a) Process to resolve grievances. A PACE organization must have a 
formal written process to evaluate and resolve medical and nonmedical 
grievances by participants, their family members, or representatives.
    (b) Notification to participants. Upon enrollment, and at least 
annually thereafter, the PACE organization must give a participant 
written information on the grievance process.
    (c) Minimum requirements. At a minimum, the PACE organization's 
grievance process must include written procedures for the following:
    (1) How a participant files a grievance.
    (2) Documentation of a participant's grievance.
    (3) Response to, and resolution of, grievances in a timely manner.
    (4) Maintenance of confidentiality of a participant's grievance.
    (d) Continuing care during grievance process. The PACE organization 
must continue to furnish all required services to the participant during 
the grievance process.
    (e) Explaining the grievance process. The PACE organization must 
discuss with and provide to the participant in writing the specific 
steps, including timeframes for response, that will be taken to resolve 
the participant's grievance.
    (f) Analyzing grievance information. The PACE organization must 
maintain, aggregate, and analyze information on grievance proceedings. 
This information must be used in the PACE organization's internal 
quality improvement program.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25675, June 3, 2019]



Sec.  460.121  Service determination process.

    (a) Written procedures. Each PACE organization must have formal 
written procedures for identifying and processing service determination 
requests in accordance with the requirements of this Part.
    (b) What is a service determination request--(1) Requests that 
constitute a service determination request. Except as provided in 
paragraph (b)(2) of this section, the following requests constitute 
service determination requests:
    (i) A request to initiate a service.
    (ii) A request to modify an existing service, including to increase, 
reduce, eliminate, or otherwise change a service.
    (iii) A request to continue coverage of a service that the PACE 
organization is recommending be discontinued or reduced.
    (2) Requests that do not constitute a service determination request. 
Requests to initiate, modify, or continue a service do not constitute a 
service determination request if the request is made prior to completing 
the development of the initial plan of care.
    (c) Who can make a service determination request. Any of the 
following individuals can make a service determination request:
    (1) The participant.
    (2) The participant's designated representative.
    (3) The participant's caregiver.
    (d) Method for making a service determination request. An individual 
may make a service determination request as follows:
    (1) Either orally or in writing.
    (2) To any employee or contractor of the PACE organization that 
provides

[[Page 675]]

direct care to a participant in the participant's residence, the PACE 
center, or while transporting participants.
    (e) Processing a service determination request. (1) Except as 
provided in paragraph (e)(2) of this section, the PACE organization must 
bring a service determination request to the interdisciplinary team as 
expeditiously as the participant's condition requires, but no later than 
3 calendar days from the time the request is made.
    (2) If a member of the interdisciplinary team is able to approve the 
service determination request in full at the time the request is made, 
the PACE organization--
    (i) Must fulfill all of the following:
    (A) Notice of the decision to approve a service determination 
request requirements specified in paragraph (j)(1) of this section.
    (B) Effectuation requirements specified in paragraph (k) of this 
section.
    (C) Recordkeeping requirements specified in paragraph (m) of this 
section.
    (ii) Is not required to process the service determination request in 
accordance with paragraphs (f) through (i), (j)(2), and (l) of this 
section.
    (f) Who must review a service determination request. The full 
interdisciplinary team must review and discuss each service 
determination request and decide to approve, deny, or partially deny the 
request based on that review.
    (g) Interdisciplinary team decision making. The interdisciplinary 
team must consider all relevant information when evaluating a service 
determination request, including, but not limited to, the findings and 
results of any reassessments required in paragraph (h) of this section, 
as well as the criteria specified in Sec.  460.92(b).
    (h) Reassessments in response to a service determination request. 
(1) If the interdisciplinary team expects to deny or partially deny a 
service determination request, the appropriate members of the 
interdisciplinary team, as identified by the interdisciplinary team, 
must conduct an in-person reassessment before the interdisciplinary team 
makes a final decision. The team members performing the reassessment 
must evaluate whether the requested service is necessary to meet the 
participant's medical, physical, emotional, and social needs.
    (2) The interdisciplinary team may conduct a reassessment prior to 
approving a service determination request, either in-person or through 
the use of remote technology, if the team determines that a reassessment 
is necessary.
    (i) Notification timeframe. Except as provided in paragraph (i)(1) 
of this section, when the interdisciplinary team receives a service 
determination request, it must make its decision and notify the 
participant or their designated representative of its decision as 
expeditiously as the participant's condition requires, but no later than 
3 calendar days after the date the interdisciplinary team receives the 
request.
    (1) Extensions. The interdisciplinary team may extend the timeframe 
for review and notification by up to 5 calendar days if either of the 
following occur:
    (i) The participant or other requestor listed in paragraph (c)(2) or 
(3) of this section requests the extension.
    (ii) The extension is in the participant's interest because the 
interdisciplinary team needs additional information from an individual 
not directly employed by the PACE organization that may change the 
interdisciplinary team's decision to deny a service. The 
interdisciplinary team must document the circumstances that led to the 
extension and demonstrate how the extension is in the participant's best 
interest.
    (2) Notice of extension. When the interdisciplinary team extends the 
timeframe, it must notify the participant or their designated 
representative in writing. The notice must explain the reason(s) for the 
delay and must be issued as expeditiously as the participant's condition 
requires, but no later than 24 hours after the IDT decides to extend the 
timeframe.
    (j) Notification requirements--(1) Notice of decisions to approve a 
service determination request. If the interdisciplinary team makes a 
determination to approve a service determination request, it must 
provide the participant or the designated representative either

[[Page 676]]

oral or written notice of the determination. Notice of any decision to 
approve a service determination request must explain the conditions of 
the approval in understandable language, including when the participant 
may expect to receive the approved service.
    (2) Notice of decisions to deny a service determination request. If 
the interdisciplinary team decides to deny or partially deny a service, 
it must provide the participant or the designated representative both 
oral and written notice of the determination. Notice of any denial 
must--
    (i) State the specific reason(s) for the denial, including why the 
service is not necessary to maintain or improve the participant's 
overall health status, taking into account the participant's medical, 
physical, emotional, and social needs, and the results of the 
reassessment(s) in understandable language.
    (ii) Inform the participant or designated representative of his or 
her right to appeal the decision under Sec.  460.122.
    (iii) Describe the standard and expedited appeals processes, 
including the right to, and conditions for, obtaining expedited 
consideration of an appeal of a denial of services as specified in Sec.  
460.122.
    (iv) For a Medicaid participant, inform the participant of both of 
the following, as specified in Sec.  460.122(e)(1):
    (A) His or her right to continue receiving disputed services during 
the appeals process until issuance of the final determination.
    (B) The conditions for continuing to receive disputed services.
    (k) Effectuation requirements. If the interdisciplinary team 
approves a service determination request, in whole or in part, the PACE 
organization must provide the approved service as expeditiously as the 
participant's condition requires, taking into account the participant's 
medical, physical, emotional, and social needs. The interdisciplinary 
team must explain when the participant may expect to receive the service 
in accordance with paragraph (j)(1) of this section.
    (l) Effect of failure to meet the processing timeframes. If the 
interdisciplinary team fails to provide the participant with timely 
notice of the resolution of the request or does not furnish the services 
required by the revised plan of care, this failure constitutes an 
adverse decision, and the participant's request must be automatically 
processed by the PACE organization as an appeal in accordance with Sec.  
460.122.
    (m) Recordkeeping. The PACE organization must establish and 
implement a process to document, track, and maintain records related to 
all processing requirements for service determination requests received 
both orally and in writing. These records must be available to the 
interdisciplinary team to ensure that all members remain alert to 
pertinent participant information.

[86 FR 6132, Jan. 19, 2021]



Sec.  460.122  PACE organization's appeals process.

    For purposes of this section, an appeal is a participant's action 
taken with respect to the PACE organization's noncoverage of, or 
nonpayment for, a service including denials, reductions, or termination 
of services. A request to initiate, modify or continue a service must 
first be processed as a service determination request under Sec.  
460.121 before the PACE organization can process an appeal under this 
section.
    (a) PACE organization's written appeals process. The PACE 
organization must have a formal written appeals process, with specified 
timeframes for response, to address noncoverage or nonpayment of a 
service.
    (b) Notification of participants. Upon enrollment, at least annually 
thereafter, and whenever the interdisciplinary team denies a service 
determination request or request for payment, the PACE organization must 
give a participant written information on the appeals process.
    (c) Minimum requirements. At a minimum, the PACE organization's 
appeals process must include written procedures for the following:
    (1) Timely preparation and processing of a written denial of 
coverage or payment as provided in Sec. Sec.  460.121(i) and (m).
    (2) How a participant or their designated representative files an 
appeal,

[[Page 677]]

including procedures for accepting oral and written appeal requests.
    (3) Documentation of a participant's appeal.
    (4) Review of an appeal by an appropriate third party reviewer or 
committee. An appropriate third party reviewer or member of a review 
committee must be an individual who meets all of the following:
    (i) Appropriately credentialed in the field(s) or discipline(s) 
related to the appeal.
    (ii) An impartial third party who meets both of the following:
    (A) Was not involved in the original action.
    (B) Does not have a stake in the outcome of the appeal.
    (5) The distribution of written or electronic materials to the third 
party reviewer or committee that, at a minimum, explain all of the 
following:
    (i) Services must be provided in a manner consistent with the 
requirements in Sec. Sec.  460.92 and 460.98.
    (ii) The need to make decisions in a manner consistent with how 
determinations under section 1862(a)(1)(A) of the Act are made.
    (iii) The rules in Sec.  460.90(a) that specify that certain 
limitations and conditions applicable to Medicare or Medicaid or both 
benefits do not apply.
    (6) Responses to, and resolution of, appeals as expeditiously as the 
participant's health condition requires, but no later than 30 calendar 
days after the organization receives an appeal.
    (7) Maintenance of confidentiality of appeals.
    (d) Opportunity to submit evidence. A PACE organization must give 
all parties involved in the appeal a reasonable opportunity to present 
evidence related to the dispute, in person, as well as in writing.
    (e) Services furnished during appeals process. During the appeals 
process, the PACE organization must meet the following requirements:
    (1) For a Medicaid participant, continue to furnish the disputed 
services until issuance of the final determination if the following 
conditions are met:
    (i) The PACE organization is proposing to terminate or reduce 
services currently being furnished to the participant.
    (ii) The participant requests continuation with the understanding 
that he or she may be liable for the costs of the contested services if 
the determination is not made in his or her favor.
    (2) Continue to furnish to the participant all other required 
services, as specified in subpart F of this part.
    (f) Expedited appeals process. (1) A PACE organization must have an 
expedited appeals process for situations in which the participant 
believes that his or her life, health, or ability to regain or maintain 
maximum function could be seriously jeopardized, absent provision of the 
service in dispute.
    (2) Except as provided in paragraph (f)(3) of this section, the PACE 
organization must respond to the appeal as expeditiously as the 
participant's health condition requires, but no later than 72 hours 
after it receives the appeal.
    (3) The PACE organization may extend the 72-hour timeframe by up to 
14 calendar days for either of the following reasons:
    (i) The participant requests the extension.
    (ii) The organization justifies to the State administering agency 
the need for additional information and how the delay is in the interest 
of the participant.
    (g) Notification. A PACE organization must give all parties involved 
in the appeal appropriate written notification of the decision to 
approve or deny the appeal.
    (1) Notice of a favorable decision. Notice of any favorable decision 
must explain the conditions of the approval in understandable language.
    (2) Notice of partially or fully adverse decisions. (i) Notice of 
any denial must--
    (A) State the specific reason(s) for the denial;
    (B) Explain the reason(s) why the service would not improve or 
maintain the participant's overall health status;
    (C) Inform the participant of his or her right to appeal the 
decision; and
    (D) Describe the external appeal rights under Sec.  460.124.

[[Page 678]]

    (ii) At the same time the decision is made, the PACE organization 
must also notify the following:
    (A) CMS.
    (B) The State administering agency.
    (h) Actions following a favorable decision. A PACE organization must 
furnish the disputed service as expeditiously as the participant's 
health condition requires if a determination is made in favor of the 
participant on appeal.
    (i) Analyzing appeals information. A PACE organization must 
maintain, aggregate, and analyze information on appeal proceedings and 
use this information in the organization's internal quality improvement 
program.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71336, Dec. 8, 2006; 84 
FR 25675, June 3, 2019; 86 FR 6134, Jan. 19, 2021]



Sec.  460.124  Additional appeal rights under Medicare or Medicaid.

    A PACE organization must inform a participant in writing of his or 
her appeal rights under Medicare or Medicaid managed care, or both, 
assist the participant in choosing which to pursue if both are 
applicable, and forward the appeal to the appropriate external entity.
    (a) Appeal rights under Medicare. Medicare participants have the 
right to a reconsideration by an independent review entity.
    (1) A written request for reconsideration must be filed with the 
independent review entity within 60 calendar days from the date of the 
decision by the third party reviewer under Sec.  460.122.
    (2) The independent outside entity must conduct the review as 
expeditiously as the participant's health condition requires but must 
not exceed the deadlines specified in the contract.
    (3) If the independent review entity conducts a reconsideration, the 
parties to the reconsideration are the same parties described in Sec.  
460.122(c)(2), with the addition of the PACE organization.
    (b) Appeal rights under Medicaid. Medicaid participants have the 
right to a State Fair Hearing as described in part 431, subpart E, of 
this chapter.
    (c) Appeal rights for dual eligible participants. Participants who 
are eligible for both Medicare and Medicaid have the right to external 
review by means of either the Independent Review Entity described in 
paragraph (a) of this section or the State Fair Hearing process 
described in paragraph (b) of this section.

[86 FR 6134, Jan. 19, 2021]



                      Subpart H_Quality Improvement



Sec.  460.130  General rule.

    (a) A PACE organization must develop, implement, maintain, and 
evaluate an effective, data-driven quality improvement program.
    (b) The program must reflect the full range of services furnished by 
the PACE organization.
    (c) A PACE organization must take actions that result in 
improvements in its performance in all types of care.
    (d) A PACE organization must meet external quality assessment and 
reporting requirements, as specified by CMS or the State administering 
agency, in accordance with Sec.  460.202.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25676, June 3, 2019]



Sec.  460.132  Quality improvement plan.

    (a) Basic rule. A PACE organization must have a written quality 
improvement plan that is collaborative and interdisciplinary in nature.
    (b) Annual review. The PACE governing body must review the plan 
annually and revise it, if necessary.
    (c) Minimum plan requirements. At a minimum, the plan must specify 
how the PACE organization proposes to meet the following requirements:
    (1) Identify areas to improve or maintain the delivery of services 
and patient care.
    (2) Develop and implement plans of action to improve or maintain 
quality of care.
    (3) Document and disseminate to PACE staff and contractors the 
results from the quality improvement activities.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25676, June 3, 2019]

[[Page 679]]



Sec.  460.134  Minimum requirements for quality improvement program.

    (a) Minimum program requirements. A PACE organization's quality 
improvement program must include, but is not limited to, the use of 
objective measures to demonstrate improved performance with regard to 
the following:
    (1) Utilization of PACE services, such as decreased inpatient 
hospitalizations and emergency room visits.
    (2) Caregiver and participant satisfaction.
    (3) Outcome measures that are derived from data collected during 
assessments, including data on the following:
    (i) Physiological well being.
    (ii) Functional status.
    (iii) Cognitive ability.
    (iv) Social/behavioral functioning.
    (v) Quality of life of participants.
    (4) Effectiveness and safety of staff-provided and contracted 
services, including the following:
    (i) Competency of clinical staff.
    (ii) Promptness of service delivery.
    (iii) Achievement of treatment goals and measurable outcomes.
    (5) Nonclinical areas, such as grievances and appeals, 
transportation services, meals, life safety, and environmental issues.
    (b) Basis for outcome measures. Outcome measures must be based on 
current clinical practice guidelines and professional practice standards 
applicable to the care of PACE participants.
    (c) Minimum levels of performance. The PACE organization must meet 
or exceed minimum levels of performance, established by CMS and the 
State administering agency, on standardized quality measures, such as 
influenza immunization rates, which are specified in the PACE program 
agreement.
    (d) Accuracy of data. The PACE organization must ensure that all 
data used for outcome monitoring are accurate and complete.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25676, June 3, 2019]



Sec.  460.136  Internal quality improvement activities.

    (a) Quality improvement requirements. A PACE organization must do 
the following:
    (1) Use a set of outcome measures to identify areas of good or 
problematic performance.
    (2) Take actions targeted at maintaining or improving care based on 
outcome measures.
    (3) Incorporate actions resulting in performance improvement into 
standards of practice for the delivery of care and periodically track 
performance to ensure that any performance improvements are sustained 
over time.
    (4) Set priorities for performance improvement, considering 
prevalence and severity of identified problems, and give priority to 
improvement activities that affect clinical outcomes.
    (5) Immediately correct any identified problem that directly or 
potentially threatens the health and safety of a PACE participant.
    (b) Quality improvement coordinator. A PACE organization must 
designate an individual to coordinate and oversee implementation of 
quality assessment and performance improvement activities.
    (c) Involvement in quality improvement activities. (1) A PACE 
organization must ensure that all interdisciplinary team members, PACE 
staff, and contract providers are involved in the development and 
implementation of quality improvement activities and are aware of the 
results of these activities.
    (2) The quality improvement coordinator must encourage a PACE 
participant and his or her caregivers to be involved in quality 
improvement activities, including providing information about their 
satisfaction with services.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25676, June 3, 2019]



Sec.  460.138  Committees with community input.

    A PACE organization must establish one or more committees, with 
community input, to do the following:
    (a) Evaluate data collected pertaining to quality outcome measures.
    (b) Address the implementation of, and results from, the quality 
improvement plan.
    (c) Provide input related to ethical decisionmaking, including end-
of-life

[[Page 680]]

issues and implementation of the Patient Self-Determination Act.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25676, June 3, 2019]



           Subpart I_Participant Enrollment and Disenrollment



Sec.  460.150  Eligibility to enroll in a PACE program.

    (a) General rule. To enroll in a PACE program, an individual must 
meet eligibility requirements specified in this section. To continue to 
be eligible for PACE, an individual must meet the annual recertification 
requirements specified in Sec.  460.160.
    (b) Basic eligibility requirements. To be eligible to enroll in 
PACE, an individual must meet the following requirements:
    (1) Be 55 years of age or older.
    (2) Be determined by the State administering agency to need the 
level of care required under the State Medicaid plan for coverage of 
nursing facility services, which indicates that the individual's health 
status is comparable to the health status of individuals who have 
participated in the PACE demonstration waiver programs.
    (3) Reside in the service area of the PACE organization.
    (4) Meet any additional program specific eligibility conditions 
imposed under the PACE program agreement. These additional conditions 
may not modify the requirements of paragraph (b)(1) through (b)(3) of 
this section.
    (c) Other eligibility requirements. (1) At the time of enrollment, 
an individual must be able to live in a community setting without 
jeopardizing his or her health or safety.
    (2) The State administering agency criteria used to determine if an 
individual's health or safety would be jeopardized by living in a 
community setting must be specified in the program agreement.
    (d) Eligibility under Medicare and Medicaid. Eligibility to enroll 
in a PACE program is not restricted to an individual who is either a 
Medicare beneficiary or Medicaid beneficiary. A potential PACE enrollee 
may be, but is not required to be, any or all of the following:
    (1) Entitled to Medicare Part A.
    (2) Enrolled under Medicare Part B.
    (3) Eligible for Medicaid.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25676, June 3, 2019]



Sec.  460.152  Enrollment process.

    (a) Intake process. Intake is an intensive process during which PACE 
staff members make one or more visits to a potential participant's place 
of residence and the potential participant makes one or more visits to 
the PACE center. At a minimum, the intake process must include the 
following activities:
    (1) The PACE staff must explain to the potential participant and his 
or her representative or caregiver the following information:
    (i) The PACE program, using a copy of the enrollment agreement 
described in Sec.  460.154, specifically references the elements of the 
agreement including but not limited to Sec.  460.154(e), (i) through 
(m), and (r).
    (ii) The requirement that the PACE organization would be the 
participant's sole service provider and clarification that the PACE 
organization guarantees access to services, but not to a specific 
provider.
    (iii) A list of the employees of the PACE organization who furnish 
care and the most current list of contracted health care providers under 
Sec.  460.70(c).
    (iv) Monthly premiums, if any.
    (v) Any Medicaid spenddown obligations.
    (vi) Post-eligibility treatment of income.
    (2) The potential participant must sign a release to allow the PACE 
organization to obtain his or her medical and financial information and 
eligibility status for Medicare and Medicaid.
    (3) The State administering agency must assess the potential 
participant, including any individual who is not eligible for Medicaid, 
to ensure that he or she needs the level of care required under the 
State Medicaid plan for coverage of nursing facility services, which 
indicates that the individual's health status is comparable to the 
health status of individuals who have participated in the PACE 
demonstration waiver programs.

[[Page 681]]

    (4) PACE staff must assess the potential participant to ensure that 
he or she can be cared for appropriately in a community setting and that 
he or she meets all requirements for PACE eligibility specified in this 
part.
    (b) Denial of Enrollment. If a prospective participant is denied 
enrollment because his or her health or safety would be jeopardized by 
living in a community setting, the PACE organization must meet the 
following requirements:
    (1) Notify the individual in writing of the reason for the denial.
    (2) Refer the individual to alternative services, as appropriate.
    (3) Maintain supporting documentation of the reason for the denial.
    (4) Notify CMS and the State administering agency in the form and 
manner specified by CMS and make the documentation available for review.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71337, Dec. 8, 2006; 84 
FR 25676, June 3, 2019]



Sec.  460.154  Enrollment agreement.

    If the potential participant meets the eligibility requirements and 
wants to enroll, he or she must sign an enrollment agreement which 
contains, at a minimum, the following information:
    (a) Applicant's name, sex, and date of birth.
    (b) Medicare beneficiary status (Part A, Part B, or both) and 
number, if applicable.
    (c) Medicaid beneficiary status and number, if applicable.
    (d) Other health insurance information, if applicable.
    (e) Conditions for enrollment and disenrollment in PACE.
    (f) Description of participant premiums, if any, and procedures for 
payment of premiums.
    (g) Notification that a Medicaid participant and a participant who 
is eligible for both Medicare and Medicaid are not liable for any 
premiums, but may be liable for any applicable spenddown liability under 
Sec. Sec.  435.121 and 435.831 of this chapter and any amounts due under 
the post-eligibility treatment of income process under Sec.  460.184.
    (h) Notification that a Medicare participant may not enroll or 
disenroll at a Social Security office.
    (i) Notification that enrollment in PACE results in disenrollment 
from any other Medicare or Medicaid prepayment plan or optional benefit. 
Electing enrollment in any other Medicare or Medicaid prepayment plan or 
optional benefit, including the hospice benefit, after enrolling as a 
PACE participant is considered a voluntary disenrollment from PACE. If a 
Medicaid-only or private pay participant becomes eligible for Medicare 
after enrollment in PACE, the participant will be disenrolled from PACE 
if he or she elects to obtain Medicare coverage other than from the 
participant's PACE organization.
    (j) Information on the consequences of subsequent enrollment in 
other optional Medicare or Medicaid programs following disenrollment 
from PACE.
    (k) Description of PACE services available, including all Medicare 
and Medicaid covered services, and how services are obtained from the 
PACE organization.
    (l) Description of the procedures for obtaining emergency and 
urgently needed out-of-network services.
    (m) The participant bill of rights.
    (n) Information on the process for grievances and appeals and 
Medicare/Medicaid phone numbers for use in appeals.
    (o) Notification of a participant's obligation to inform the PACE 
organization of a move or lengthy absence from the organization's 
service area.
    (p) An acknowledgment by the applicant or representative that he or 
she understands the requirement that the PACE organization must be the 
applicant's sole service provider.
    (q) A statement that the PACE organization has an agreement with CMS 
and the State administering agency that is subject to renewal on a 
periodic basis and, if the agreement is not renewed, the program will be 
terminated.
    (r) The applicant's authorization for disclosure and exchange of 
personal information between CMS, its agents, the State administering 
agency, and the PACE organization.
    (s) The effective date of enrollment.

[[Page 682]]

    (t) The signature of the applicant or his or her designated 
representative and the date.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71337, Dec. 8, 2006; 84 
FR 25676, June 3, 2019]



Sec.  460.156  Other enrollment procedures.

    (a) Items a PACE organization must give a participant upon 
enrollment. After the participant signs the enrollment agreement, the 
PACE organization must give the participant the following:
    (1) A copy of the enrollment agreement.
    (2) A PACE membership card that indicates that he or she is a PACE 
participant and that includes the phone number of the PACE organization.
    (3) Emergency information to be posted in his or her home 
identifying the individual as a PACE participant and explaining how to 
access emergency services.
    (b) Submittal of participant information to CMS and the State. The 
PACE organization must submit participant information to CMS and the 
State administering agency, in accordance with established procedures.
    (c) Changes in enrollment agreement information. If there are 
changes in the enrollment agreement information at any time during the 
participant's enrollment, the PACE organization must meet the following 
requirements:
    (1) Give an updated copy of the information to the participant.
    (2) Explain the changes to the participant and his or her 
representative or caregiver in a manner they understand.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25676, June 3, 2019]



Sec.  460.158  Effective date of enrollment.

    A participant's enrollment in the program is effective on the first 
day of the calendar month following the date the PACE organization 
receives the signed enrollment agreement.



Sec.  460.160  Continuation of enrollment.

    (a) Duration of enrollment. Enrollment continues until the 
participant's death, regardless of changes in health status, unless 
either of the following actions occur:
    (1) The participant voluntarily disenrolls.
    (2) The participant is involuntarily disenrolled, as described in 
Sec.  460.164.
    (b) Annual recertification requirement. At least annually, the State 
administering agency must reevaluate whether a participant needs the 
level of care required under the State Medicaid plan for coverage of 
nursing facility services.
    (1) Waiver of annual requirement. (i) The State administering agency 
may permanently waive the annual recertification requirement for a 
participant if it determines that there is no reasonable expectation of 
improvement or significant change in the participant's condition because 
of the severity of a chronic condition or the degree of impairment of 
functional capacity.
    (ii) The PACE organization must retain in the participant's medical 
record the documentation of the reason for waiving the annual 
recertification requirement.
    (2) Deemed continued eligibility. If the State administering agency 
determines that a PACE participant no longer meets the State Medicaid 
nursing facility level of care requirements, the participant may be 
deemed to continue to be eligible for the PACE program until the next 
annual reevaluation, if, in the absence of continued coverage under this 
program, the participant reasonably would be expected to meet the 
nursing facility level of care requirement within the next 6 months.
    (3) Continued eligibility criteria. (i) The State administering 
agency, must establish criteria to use in making the determination of 
``deemed continued eligibility.'' The State administering agency, in 
consultation with the PACE organization, makes a determination of deemed 
continued eligibility based on a review of the participant's medical 
record and plan of care. These criteria must be applied in reviewing the 
participant's medical record and plan of care.
    (ii) The criteria used to make the determination of continued 
eligibility must be specified in the program agreement.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71337, Dec. 8, 2006]

[[Page 683]]



Sec.  460.162  Voluntary disenrollment.

    (a) Effective date. A participant's voluntary disenrollment is 
effective on the first day of the month following the date the PACE 
organization receives the participant's notice of voluntary 
disenrollment.
    (b) Reasons for voluntary disenrollment. A PACE participant may 
voluntarily disenroll from the program without cause at any time.
    (c) Responsibilities of PACE organization. A PACE organization must 
ensure that its employees or contractors do not engage in any practice 
that would reasonably be expected to have the effect of steering or 
encouraging disenrollment of participants due to a change in health 
status.

[84 FR 25676, June 3, 2019]



Sec.  460.164  Involuntary disenrollment.

    (a) Effective date. A participant's involuntary disenrollment occurs 
after the PACE organization meets the requirements set forth in this 
section and is effective on the first day of the next month that begins 
30 days after the day the PACE organization sends notice of the 
disenrollment to the participant.
    (b) Reasons for involuntary disenrollment. A participant may be 
involuntarily disenrolled for any of the following reasons:
    (1) The participant, after a 30-day grace period, fails to pay or 
make satisfactory arrangements to pay any premium due the PACE 
organization.
    (2) The participant, after a 30-day grace period, fails to pay or 
make satisfactory arrangements to pay any applicable Medicaid spend down 
liability or any amount due under the post-eligibility treatment of 
income process, as permitted under Sec. Sec.  460.182 and 460.184.
    (3) The participant or the participant's caregiver engages in 
disruptive or threatening behavior, as described in paragraph (c) of 
this section.
    (4) The participant engages in disruptive or threatening behavior, 
as described in paragraph (c) of this section.
    (5) The participant moves out of the PACE program service area or is 
out of the service area for more than 30 consecutive days, unless the 
PACE organization agrees to a longer absence due to extenuating 
circumstances.
    (6) The participant is determined to no longer meet the State 
Medicaid nursing facility level of care requirements and is not deemed 
eligible.
    (7) The PACE program agreement with CMS and the State administering 
agency is not renewed or is terminated.
    (8) The PACE organization is unable to offer health care services 
due to the loss of State licenses or contracts with outside providers.
    (c) Disruptive or threatening behavior. (1) For purposes of this 
section, a participant who engages in disruptive or threatening behavior 
refers to a participant who exhibits either of the following:
    (i) A participant whose behavior jeopardizes his or her health or 
safety, or the safety of others; or
    (ii) A participant with decision-making capacity who consistently 
refuses to comply with his or her individual plan of care or the terms 
of the PACE enrollment agreement.
    (2) For purposes of this section, a participant's caregiver who 
engages in disruptive or threatening behavior exhibits behavior that 
jeopardizes the participant's health or safety, or the safety of the 
caregiver or others.
    (d) Documentation of disruptive or threatening behavior. If a PACE 
organization proposes to disenroll a participant based on the disruptive 
or threatening behavior of the participant or the participant's 
caregiver, the organization must document the following information in 
the participant's medical record:
    (1) The reasons for proposing to disenroll the participant.
    (2) All efforts to remedy the situation.
    (e) Noncompliant behavior. (1) A PACE organization may not disenroll 
a PACE participant on the grounds that the participant has engaged in 
noncompliant behavior if the behavior is related to a mental or physical 
condition of the participant, unless the participant's behavior 
jeopardizes his or her health or safety, or the safety of others.
    (2) For purposes of this section, noncompliant behavior includes 
repeated noncompliance with medical advice

[[Page 684]]

and repeated failure to keep appointments.
    (f) State administering agency review and final determination. 
Before an involuntary disenrollment is effective, the State 
administering agency must review it and determine in a timely manner 
that the PACE organization has adequately documented acceptable grounds 
for disenrollment.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25677, June 3, 2019]



Sec.  460.166  Disenrollment responsibilities.

    (a) In disenrolling a participant, the PACE organization must take 
the following actions:
    (1) Use the most expedient process allowed under Medicare and 
Medicaid procedures, as set forth in the PACE program agreement.
    (2) Coordinate the disenrollment date between Medicare and Medicaid 
(for a participant who is eligible for both Medicare and Medicaid).
    (3) Give reasonable advance notice to the participant.
    (b) Until the date enrollment is terminated, the following 
requirements must be met:
    (1) PACE participants must continue to use PACE organization 
services and remain liable for any premiums.
    (2) The PACE organization must continue to furnish all needed 
services.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25676, June 3, 2019]



Sec.  460.168  Reinstatement in other Medicare and Medicaid programs.

    To facilitate a participant's reinstatement in other Medicare and 
Medicaid programs after disenrollment, the PACE organization must do the 
following:
    (a) Make appropriate referrals and ensure medical records are made 
available to new providers within 30 days.
    (b) Work with CMS and the State administering agency to reinstate 
the participant in other Medicare and Medicaid programs for which the 
participant is eligible.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25677, June 3, 2019]



Sec.  460.170  Reinstatement in PACE.

    (a) A previously disenrolled participant may be reinstated in a PACE 
program.
    (b) If the reason for disenrollment is failure to pay the premium 
and the participant pays the premium before the effective date of 
disenrollment, the participant is reinstated in the PACE program with no 
break in coverage.



Sec.  460.172  Documentation of disenrollment.

    A PACE organization must meet the following requirements:
    (a) Have a procedure in place to document the reasons for all 
voluntary and involuntary disenrollments.
    (b) Make documentation available for review by CMS and the State 
administering agency.
    (c) Use the information on voluntary disenrollments in the PACE 
organization's internal quality improvement program.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25677, June 3, 2019]



                            Subpart J_Payment



Sec.  460.180  Medicare payment to PACE organizations.

    (a) Principle of payment. Under a PACE program agreement, CMS makes 
a prospective monthly payment to the PACE organization of a capitation 
amount for each Medicare participant in a payment area based on the rate 
it pays to a Medicare Advantage organization.
    (b) Determination of rate. (1) The PACE program agreement specifies 
the methodology used to calculate the monthly capitation amount 
applicable to a PACE organization.
    (2) Except as specified in paragraph (b)(4) of this section, the 
monthly capitation amount is based on the Part A and Part B payment 
rates established for purposes of payment to Medicare Advantage 
organizations. As used in this section, ``Medicare Advantage rates'' 
means the Part A and Part B rates calculated by CMS for making payment 
to Medicare Advantage organizations under section 1853(c) of the Act.

[[Page 685]]

    (3) CMS will adjust the monthly capitation payment amount derived 
under paragraph (b)(2) of this section based on a risk adjustment that 
reflects the individual's health status. CMS will ensure that payments 
take into account the comparative frailty of PACE enrollees relative to 
the general Medicare population.
    (4) For Medicare participants who require ESRD services, the monthly 
capitation amount is based on the Medicare Advantage ESRD risk 
adjustment model.
    (5) CMS may adjust the monthly capitation amount to take into 
account other factors CMS determines to be appropriate.
    (6) The monthly capitation payment is a fixed amount, regardless of 
changes in the participant's health status.
    (7) The monthly capitation payment amount is an all-inclusive 
payment for Medicare benefits provided to participants. A PACE 
organization must not seek any additional payment from Medicare. The 
only additional payment that a PACE organization may collect from, or on 
behalf of, a Medicare participant for PACE services is the following:
    (i) Any applicable premium amount specified in Sec.  460.186.
    (ii) Any charge permitted under paragraph (d) of this section when 
Medicare is not the primary payer.
    (iii) Any payment from the State, as specified in Sec.  460.182, for 
a participant who is eligible for both Medicare and Medicaid.
    (iv) Payment with respect to any applicable spenddown liability 
under Sec. Sec.  435.121 and 435.831 of this chapter and any amount due 
under the post-eligibility treatment of income process under Sec.  
460.184 for a participant who is eligible for both Medicare and 
Medicaid.
    (8) CMS computes the Medicare monthly capitation payment amount 
under a PACE program agreement so that the total payment level for all 
participants is less than the projected payment under Medicare for a 
comparable population not enrolled under a PACE program.
    (c) Adjustments to payments. If the actual number of Medicare 
participants differs from the estimated number of participants on which 
the amount of the prospective monthly payment was based, CMS adjusts 
subsequent monthly payments to account for the difference.
    (d) Application of Medicare secondary payer provisions--(1) Basic 
rule. CMS does not pay for services to the extent that Medicare is not 
the primary payer under part 411 of this chapter.
    (2) Responsibilities of the PACE organization. The PACE organization 
must do the following:
    (i) Identify payers that are primary to Medicare under part 411 of 
this chapter.
    (ii) Determine the amounts payable by those payers.
    (iii) Coordinate benefits to Medicare participants with the benefits 
of the primary payers.
    (3) Charges to other entities. The PACE organization may charge 
other individuals or entities for PACE services covered under Medicare 
for which Medicare is not the primary payer, as specified in paragraphs 
(d)(4) and (5) of this section.
    (4) Charge to other insurers or the participant. If a Medicare 
participant receives from a PACE organization covered services that are 
also covered under State or Federal workers' compensation, any no-fault 
insurance, or any liability insurance policy or plan, including a self-
insured plan, the PACE organization may charge any of the following:
    (i) The insurance carrier, the employer, or any other entity that is 
liable for payment for the services under part 411 of this chapter.
    (ii) The Medicare participant, to the extent that he or she has been 
paid by the carrier, employer, or other entity.
    (5) Charge to group health plan (GHP) or large group health plan 
(LGHP). If Medicare is not the primary payer for services that a PACE 
organization furnished to a Medicare participant who is covered under a 
GHP or LGHP, the organization may charge the following:
    (i) GHP or LGHP for those services.
    (ii) Medicare participant to the extent that he or she has been paid 
by the GHP or LGHP for those services.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71337, Dec. 8, 2006]

[[Page 686]]



Sec.  460.182  Medicaid payment.

    (a) Under a PACE program agreement, the State administering agency 
makes a prospective monthly payment to the PACE organization of a 
capitation amount for each Medicaid participant.
    (b) The monthly capitation amount is negotiated between the PACE 
organization and the State administering agency, and the amount, or the 
methodology used to calculate the amount, is specified in the PACE 
program agreement. The amount represents the following:
    (1) Is less than the amount that would otherwise have been paid 
under the State plan if the participants were not enrolled under the 
PACE program.
    (2) Takes into account the comparative frailty of PACE participants.
    (3) Is a fixed amount regardless of changes in the participant's 
health status.
    (4) Can be renegotiated on an annual basis.
    (c) The PACE organization must accept the capitation payment amount 
as payment in full for Medicaid participants and may not bill, charge, 
collect, or receive any other form of payment from the State 
administering agency or from, or on behalf of, the participant, except 
as follows:
    (1) Payment with respect to any applicable spenddown liability under 
Sec. Sec.  435.121 and 435.831 of this chapter and any amounts due under 
the post-eligibility treatment of income process under Sec.  460.184.
    (2) Medicare payment received from CMS or from other payers, in 
accordance with Sec.  460.180(d).
    (d) State procedures for the enrollment and disenrollment of 
participants in the State's system, including procedures for any 
adjustment to account for the difference between the estimated number of 
participants on which the prospective monthly payment was based and the 
actual number of participants in that month, are included in the PACE 
program agreement.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25677, June 3, 2019]



Sec.  460.184  Post-eligibility treatment of income.

    (a) A State may provide for post-eligibility treatment of income for 
Medicaid participants in the same manner as a State treats post-
eligibility income for individuals receiving services under a waiver 
under section 1915(c) of the Act.
    (b) Post-eligibility treatment of income is applied as it is under a 
waiver of section 1915(c) of the Act, as specified in Sec. Sec.  435.726 
and 435.735 of this chapter, and section 1924 of the Act.



Sec.  460.186  PACE premiums.

    The amount that a PACE organization can charge a participant as a 
monthly premium depends on the participant's eligibility under Medicare 
and Medicaid, as follows:
    (a) Medicare Parts A and B. For a participant who is entitled to 
Medicare Part A, enrolled under Medicare Part B, but not eligible for 
Medicaid, the premium equals the Medicaid capitation amount.
    (b) Medicare Part A only. For a participant who is entitled to 
Medicare Part A, not enrolled under Medicare Part B, and not eligible 
for Medicaid, the premium equals the Medicaid capitation amount plus the 
Medicare Part B capitation rate.
    (c) Medicare Part B only. For a participant who is enrolled only 
under Medicare Part B and not eligible for Medicaid, the premium equals 
the Medicaid capitation amount plus the Medicare Part A capitation rate.
    (d) Medicaid, with or without Medicare. A PACE organization may not 
charge a premium to a participant who is eligible for both Medicare and 
Medicaid, or who is only eligible for Medicaid.



                   Subpart K_Federal/State Monitoring



Sec.  460.190  Monitoring during trial period.

    (a) Trial period review. During the trial period, CMS, in 
cooperation with the State administering agency, conducts comprehensive 
annual reviews of the operations of a PACE organization to ensure 
compliance with the requirements of this part.

[[Page 687]]

    (b) Scope of review. The review includes the following:
    (1) An onsite visit to the PACE organization, which may include, but 
is not limited to, observation of program operations;
    (2) Detailed analysis of the entity's substantial compliance with 
all significant requirements of sections 1894 and 1934 of the Act and 
this part, which may include review of marketing, participant services, 
enrollment and disenrollment, and grievances and appeals.
    (3) A comprehensive assessment of an organization's fiscal 
soundness.
    (4) A comprehensive assessment of the organization's capacity to 
furnish all PACE services to all participants.
    (5) Any other elements that CMS or the State administering agency 
find necessary.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25677, June 3, 2019]



Sec.  460.192  Ongoing monitoring after trial period.

    (a) At the conclusion of the trial period, CMS, in cooperation with 
the State administering agency, continues to conduct reviews of a PACE 
organization, as appropriate, taking into account the quality of care 
furnished and the organization's compliance with all of the requirements 
of this part.
    (b) CMS in cooperation with the State administering agency will 
conduct reviews of the operations of PACE organizations as appropriate, 
as determined by a risk assessment of each PACE organization which takes 
into account the PACE organization's performance level and compliance 
with the significant requirements of sections 1834 and 1934 of the 
Social Security Act and this part.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25677, June 3, 2019]



Sec.  460.194  Corrective action.

    (a) A PACE organization must take action to correct deficiencies 
identified by CMS or the State administering agency through the 
following:
    (1) Ongoing monitoring of the PACE organization.
    (2) Reviews and audits of the PACE organization.
    (3) Complaints from PACE participants or caregivers.
    (4) Any other instance CMS or the State administering agency 
identifies programmatic deficiencies requiring correction.
    (b) CMS or the State administering agency monitors the effectiveness 
of corrective actions.
    (c) Failure to correct deficiencies may result in sanctions or 
termination, as specified in subpart D of this part.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25677, June 3, 2019]



Sec.  460.196  Disclosure of review results.

    (a) CMS and the State administering agency promptly report the 
results of reviews under Sec. Sec.  460.190 and 460.192 to the PACE 
organization, along with any recommendations for changes to the 
organization's program.
    (b) CMS and the State administering agency make the results of 
reviews available to the public upon request.
    (c) The PACE organization must post a notice of the availability of 
the results of the most recent review and any plans of correction or 
responses related to the most recent review.
    (d) The PACE organization must make the review results available for 
examination in a place readily accessible to participants, their 
families, their caregivers, and their authorized representatives.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25677, June 3, 2019]



      Subpart L_Data Collection, Record Maintenance, and Reporting



Sec.  460.200  Maintenance of records and reporting of data.

    (a) General rule. A PACE organization must collect data, maintain 
records, and submit reports as required by CMS and the State 
administering agency.
    (b) Access to data and records. A PACE organization must allow CMS 
and the State administering agency access to data and records including, 
but not limited to, the following:
    (1)(i) Participant health outcomes data.
    (ii) Financial books and records.

[[Page 688]]

    (iii) Medical records.
    (iv) Personnel records.
    (2) CMS and the State administering agency must be able to obtain, 
examine or retrieve the information specified at paragraph (b)(1) of 
this section, which may include reviewing information at the PACE site 
or remotely. PACE organizations may also be required to upload or 
electronically transmit information, or send hard copies of required 
information by mail.
    (c) Reporting. A PACE organization must submit to CMS and the State 
administering agency all reports that CMS and the State administering 
agency require to monitor the operation, cost, quality, and 
effectiveness of the program and establish payment rates.
    (d) Safeguarding data and records. A PACE organization must do all 
of the following:
    (1) Establish written policies and implement procedures to safeguard 
all data, books, and records against loss, destruction, unauthorized 
use, or inappropriate alteration.
    (2) Maintain all written communications received from participants 
or other parties in their original form when the communications relate 
to a participant's care, health, or safety in accordance with Sec.  
460.210(b)(6).
    (e) Confidentiality of health information. A PACE organization must 
establish written policies and implement procedures to do the following:
    (1) Safeguard the privacy of any information that identifies a 
particular participant. Information from, or copies of, records may be 
released only to authorized individuals. Original medical records are 
released only in accordance with Federal or State laws, court orders, or 
subpoenas.
    (2) Maintain complete records and relevant information in an 
accurate and timely manner.
    (3) Grant each participant timely access, upon request, to review 
and copy his or her own medical records and to request amendments to 
those records.
    (4) Abide by all Federal and State laws regarding confidentiality 
and disclosure for mental health records, medical records, and other 
participant health information.
    (f) Retention of records. (1) A PACE organization must retain 
records for the longest of the following periods:
    (i) The period of time specified in State law.
    (ii) Ten years from the last entry date.
    (iii) For medical records of disenrolled participants, 10 years 
after the date of disenrollment.
    (2) If litigation, a claim, a financial management review, or an 
audit arising from the operation of the PACE program is started before 
the expiration of the retention period, specified in paragraph (f)(1) of 
this section, the PACE organization must retain the records until the 
completion of the litigation, or resolution of the claims or audit 
findings.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25677, June 3, 2019; 86 
FR 6134, Jan. 19, 2021]



Sec.  460.202  Participant health outcomes data.

    (a) A PACE organization must establish and maintain a health 
information system that collects, analyzes, integrates, and reports data 
necessary to measure the organization's performance, including outcomes 
of care furnished to participants.
    (b) A PACE organization must furnish data and information pertaining 
to its provision of participant care in the manner, and at the time 
intervals, specified by CMS and the State administering agency. The 
items collected are specified in the PACE program agreement.



Sec.  460.204  Financial recordkeeping and reporting requirements.

    (a) Accurate reports. A PACE organization must provide CMS and the 
State administering agency with accurate financial reports that are--
    (1) Prepared using an accrual basis of accounting; and
    (2) Verifiable by qualified auditors.
    (b) Accrual accounting. A PACE organization must maintain an accrual 
accounting recordkeeping system that does the following:
    (1) Accurately documents all financial transactions.
    (2) Provides an audit trail to source documents.

[[Page 689]]

    (3) Generates financial statements.
    (c) Accepted reporting practices. Except as specified under Medicare 
principles of reimbursement, as defined in part 413 of this chapter, a 
PACE organization must follow standardized definitions, accounting, 
statistical, and reporting practices that are widely accepted in the 
health care industry.
    (d) Audit or inspection. A PACE organization must permit CMS and the 
State administering agency to audit or inspect any books and records of 
original entry that pertain to the following:
    (1) Any aspect of services furnished.
    (2) Reconciliation of participants' benefit liabilities.
    (3) Determination of Medicare and Medicaid amounts payable.



Sec.  460.208  Financial statements.

    (a) General rule. (1) Not later than 180 days after the 
organization's fiscal year ends, a PACE organization must submit a 
certified financial statement that includes appropriate footnotes.
    (2) The financial statement must be certified by an independent 
certified public accountant.
    (b) Contents. At a minimum, the certified financial statement must 
consist of the following:
    (1) A certification statement.
    (2) A balance sheet.
    (3) A statement of revenues and expenses.
    (4) A source and use of funds statement.
    (c) Quarterly financial statement--(1) During trial period. A PACE 
organization must submit a quarterly financial statement throughout the 
trial period within 45 days after the last day of each quarter of the 
PACE organization's fiscal year.
    (2) After trial period. If CMS or the State administering agency 
determines that an organization's performance requires more frequent 
monitoring and oversight due to concerns about fiscal soundness, CMS or 
the State administering agency may require a PACE organization to submit 
monthly or quarterly financial statements, or both.



Sec.  460.210  Medical records.

    (a) Maintenance of medical records. (1) A PACE organization must 
maintain a single, comprehensive medical record for each participant, in 
accordance with accepted professional standards.
    (2) The medical record for each participant must meet the following 
requirements:
    (i) Be complete.
    (ii) Accurately documented.
    (iii) Readily accessible.
    (iv) Systematically organized.
    (v) Available to all staff.
    (vi) Maintained and housed at the PACE center where the participant 
receives services.
    (b) Content of medical records. At a minimum, the medical record 
must contain the following:
    (1) Appropriate identifying information.
    (2) Documentation of all services furnished, including the 
following:
    (i) A summary of emergency care and other inpatient or long-term 
care services.
    (ii) Services furnished by employees of the PACE center.
    (iii) Services furnished by contractors and their reports.
    (3) Interdisciplinary assessments, reassessments, plans of care, 
treatment, and progress notes that include the participant's response to 
treatment.
    (4) All recommendations for services made by employees or 
contractors of the PACE organization, including specialists.
    (5) If a service recommended by an employee or contractor of the 
PACE organization, including a specialist, is not approved or provided, 
the reason(s) for not approving or providing that service.
    (6) Original documentation, or an unaltered electronic copy, of any 
written communication the PACE organization receives relating to the 
care, health or safety of a participant, in any format (for example, 
emails, faxes, letters, etc.) and including, but not limited to the 
following:
    (i) Communications from the participant, his or her designated 
representative, a family member, a caregiver, or any other individual 
who provides information pertinent to a participant's health or safety 
or both.
    (ii) Communications from an advocacy or governmental agency such as 
Adult Protective Services.

[[Page 690]]

    (7) Laboratory, radiological and other test reports.
    (8) Medication records.
    (9) Hospital discharge summaries, if applicable.
    (10) Reports of contact with informal support (for example, 
caregiver, legal guardian, or next of kin).
    (11) Enrollment Agreement.
    (12) Physician orders.
    (13) Discharge summary and disenrollment justification, if 
applicable.
    (14) Advance directives, if applicable.
    (15) A signed release permitting disclosure of personal information.
    (c) Transfer of medical records. The organization must promptly 
transfer copies of medical record information between treatment 
facilities.
    (d) Authentication of medical records. (1) All entries must be 
legible, clear, complete, and appropriately authenticated and dated.
    (2) Authentication must include signatures or a secured computer 
entry by a unique identifier of the primary author who has reviewed and 
approved the entry.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71337, Dec. 8, 2006; 86 
FR 6135, Jan. 19, 2021]

[[Page 691]]



             SUBCHAPTER F_QUALITY IMPROVEMENT ORGANIZATIONS





PART 475_QUALITY IMPROVEMENT ORGANIZATIONS--Table of Contents



                      Subpart A_General Provisions

Sec.
475.1 Definitions.

Subpart B [Reserved]

               Subpart C_Quality Improvement Organizations

475.100 Scope and applicability.
475.101 Eligibility requirements for QIO contracts.
475.102 Requirements for performing case reviews.
475.103 Requirements for performing quality improvement initiatives.
475.104 [Reserved]
475.105 Prohibition against contracting with health care facilities, 
          affiliates, and payor organizations.
475.106 [Reserved]
475.107 QIO contract awards.

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



                      Subpart A_General Provisions



Sec.  475.1  Definitions.

    For purposes of this part:
    Case reviews means the different types of reviews that QIOs are 
authorized to perform. Such reviews include, but are not limited to--
    (1) Beneficiary complaint reviews;
    (2) General quality of care reviews;
    (3) Emergency Medical Treatment and Labor Act (EMTALA) reviews;
    (4) Medical necessity reviews, including appeals and DRG validation 
reviews; and
    (5) Admission and discharge reviews.
    Five percent or more owner means a person (including, where 
appropriate, a corporation) who:
    (1) Has an ownership interest of 5 percent or more;
    (2) Has an indirect ownership interest equal to 5 percent or more;
    (3) Has a combination of direct and indirect ownership interests 
(the possession of equity in the capital, the stock, or the profits of 
an entity) equal to 5 percent or more; or
    (4) Is the owner of an interest of 5 percent or more in any 
obligation secured by an entity, if the interest equals at least 5 
percent of the value of the property or assets of the entity.
    Health care facility means an institution that directly provides or 
supplies health care services for which payment may be made in whole or 
in part under Title XVIII of the Act. A health care facility may be a 
hospital, skilled nursing facility, home health agency, free-standing 
ambulatory surgical center, or outpatient facility or any other entity 
which provides or supplies direct care to Medicare beneficiaries.
    Managing employee means a general manager, business manager, 
administrator, director or other individual who exercises operational or 
managerial control over the entity or organization, or who, directly or 
indirectly, conducts the day-to-day operations of the entity or 
organization.
    Payor organization means any organization, other than a self-insured 
employer, which makes payments directly or indirectly to health care 
practitioners or providers whose health care services are reviewed by 
the organization or would be reviewed by the organization if it entered 
into a QIO contract. ``Payor organization'' also means any organization 
which is affiliated with any entity which makes payments as described 
above, by virtue of the organization having two or more governing body 
members who are also either governing body members, officers, partners, 
5 percent or more owners or managing employees in a health maintenance 
organization or competitive medical plan.
    Physician means:
    (1) A doctor of medicine or osteopathy, a doctor of dental surgery 
or dental medicine, a doctor of podiatry, a doctor of optometry, or a 
chiropractor as described in section 1861(r) of the Act;
    (2) An intern, resident, or Federal Government employee authorized 
under State or Federal law to practice as a doctor as described in 
paragraph (1) of this definition; and

[[Page 692]]

    (3) An individual licensed to practice as a doctor as described in 
paragraph (1) of this definition in any Territory or Commonwealth of the 
United States of America.
    Practitioner has the same meaning as provided in Sec.  476.1 of this 
chapter.
    QIO area means the defined geographic area, such as the State(s), 
region(s), or community(ies), in which the CMS contract directs the QIO 
to perform.
    Quality improvement initiative has the same meaning as provided in 
Sec.  476.1 of this chapter.

[43 FR 32085, July 24, 1978, as amended at 49 FR 7206, Feb. 27, 1984. 
Redesignated at 50 FR 15327, Apr. 17, 1985, and amended at 50 FR 15328, 
Apr. 17, 1985; 51 FR 43197, Dec. 1, 1986. Redesignated at 64 FR 66279, 
Nov. 24, 1999, as amended at 78 FR 75198, Dec. 10, 2013]

Subpart B [Reserved]



               Subpart C_Quality Improvement Organizations

    Source: 78 FR 75198, Dec. 10, 2013, unless otherwise noted.



Sec.  475.100  Scope and applicability.

    This subpart implements sections 1152 and 1153(b) and (c) of the 
Social Security Act as amended by section 261 of the Trade Adjustment 
Assistance Extension Act of 2011. This subpart defines the types of 
organizations that are eligible to become Quality Improvement 
Organizations (QIOs) and describes certain steps CMS will take in 
selecting QIOs.



Sec.  475.101  Eligibility requirements for QIO contracts.

    In order to be eligible for a QIO contract, an organization must 
meet the following requirements:
    (a) Have a governing body that includes at least one individual who 
is a representative of health care providers and at least one individual 
who is a representative of consumers.
    (b) Demonstrate the ability to perform the functions of a QIO, 
including--
    (1) The ability to meet the eligibility requirements and perform 
activities as set forth in the QIO Request for Proposal; and
    (2) The ability to--
    (i) Perform case reviews as described in Sec.  475.102; and/or
    (ii) Perform quality improvement initiatives as set forth in Sec.  
475.103.
    (c) Demonstrate the ability to actively engage beneficiaries, 
families, and consumers, as applicable, in case reviews as set forth in 
Sec.  475.102, and/or quality improvement initiatives as set forth in 
Sec.  475.103.
    (d) Demonstrate the ability to perform the functions of a QIO with 
objectivity and impartiality and in a fair and neutral manner.



Sec.  475.102  Requirements for performing case reviews.

    (a) In determining whether or not an organization has demonstrated 
the ability to perform case review, CMS will take into consideration 
factors such as:
    (1) The organization's proposed processes, capabilities, 
quantitative, and/or qualitative performance objectives and methodology 
to perform case reviews;
    (2) The organization's proposed involvement of and access to 
physicians and practitioners in the QIO area with the appropriate 
expertise and specialization in the areas of health care related to case 
reviews;
    (3) The organization's ability to take into consideration urban 
versus rural, local, and regional characteristics in the health care 
setting where the care under review was provided;
    (4) The organization's ability to take into consideration evidence-
based national clinical guidelines and professionally recognized 
standards of care; and
    (5) The organization's access to qualified information technology 
(IT) expertise.
    (b) In making determinations under this section, CMS may consider 
characteristics such as the organization's geographic location and size. 
CMS may also consider prior experience in health care quality 
improvement that CMS considers relevant to performing case reviews; such 
prior experience may include prior similar case review experience.
    (c) A State government that administers a Medicaid program will be 
considered incapable of performing case

[[Page 693]]

review in an effective manner, unless the State demonstrates to the 
satisfaction of CMS that the State agency performing the case review 
will act with complete objectivity and independence from the Medicaid 
program.



Sec.  475.103  Requirements for performing quality improvement initiatives.

    (a) In determining whether or not an organization has demonstrated 
the ability to perform quality improvement initiatives, CMS will take 
into consideration factors such as:
    (1) The organization's proposed processes, capabilities, 
quantitative, and/or qualitative performance objectives, and methodology 
to perform quality improvement initiatives;
    (2) The organization's proposed involvement of and access to 
physicians and practitioners in the QIO area with the appropriate 
expertise and specialization in the areas of health care concerning the 
quality improvement initiatives;
    (3) The organization's access to professionals with appropriate 
knowledge of quality improvement methodologies and practices; and
    (4) The organization's access to qualified information technology 
(IT) expertise.
    (b) In making determinations under this section, CMS may consider 
characteristics such as the organization's geographic location and size. 
CMS may also consider prior experience in health care quality 
improvement that CMS considers relevant to performing quality 
improvement initiatives; such prior experience may include prior similar 
quality improvement initiative experience and whether it achieved 
successful results.
    (c) A State government that administers a Medicaid program will be 
considered incapable of performing quality improvement initiative 
functions in an effective manner, unless the State demonstrates to the 
satisfaction of CMS that the State agency performing the quality 
improvement initiatives will act with complete objectivity and 
independence from the Medicaid program.



Sec.  475.104  [Reserved]



Sec.  475.105  Prohibition against contracting with health care facilities,
affiliates, and payor organizations.

    (a) Basic rule. Except as permitted under paragraph (a)(3) of this 
section, the following are not eligible for QIO contracts:
    (1) A health care facility in the QIO area.
    (2) A health care facility affiliate; that is, an organization in 
which more than 20 percent of the members of the governing body are also 
either a governing body member, officer, partner, five percent or more 
owner, or managing employee in a health care facility in the QIO area.
    (3) A payor organization, unless the Secretary determines that--
    (i) There is no other entity available for an area with which the 
Secretary can enter into a contract under this part; or
    (ii) A payor organization is a more qualified entity to perform one 
or more of the functions of a QIO described in Sec.  475.101(b), meets 
all other requirements and standards of this part, and demonstrates to 
the satisfaction of CMS that, in performing QIO activities, the payor 
organization will act with complete objectivity and independence from 
its payor program.
    (b) [Reserved]
    (c) Subcontracting. A QIO must not subcontract with a health care 
facility to perform any case review activities except for the review of 
the quality of care.



Sec.  475.106  [Reserved]



Sec.  475.107  QIO contract awards.

    Subject to the provisions of Sec.  475.105, CMS will--
    (a) Ensure that all awardees meet the requirements of Sec. Sec.  
475.101 through 475.103, as applicable; and
    (b) Award the contract to the selected organization for a specific 
QIO area for a period of 5 years.

[[Page 694]]



PART 476_QUALITY IMPROVEMENT ORGANIZATION REVIEW--Table of Contents



                      Subpart A_General Provisions

Sec.
476.1 Definitions.

Subpart B [Reserved]

 Subpart C_Review Responsibilities of Quality Improvement Organizations 
                                 (QIOs)

                           General Provisions

476.70 Statutory bases and applicability.
476.71 QIO review requirements.
476.73 Notification of QIO designation and implementation of review.
476.74 General requirements for the assumption of review.
476.76 Cooperation with health care facilities.
476.78 Responsibilities of providers and practitioners.
476.80 Coordination with Medicare administrative contractors, fiscal 
          intermediaries, and carriers.
476.82 Continuation of functions not assumed by QIOs.

                          QIO Review Functions

476.83 Initial denial determinations.
476.84 Changes as a result of DRG validation.
476.85 Conclusive effect of QIO initial denial determinations and 
          changes as a result of DRG validations.
476.86 Correlation of Title XI functions with Title XVIII functions.
476.88 Examination of the operations and records of health care 
          facilities and practitioners.
476.90 Lack of cooperation by a provider or practitioner.
476.93 Opportunity to discuss proposed initial denial determination and 
          changes as a result of a DRG validation.
476.94 Notice of QIO initial denial determination and changes as a 
          result of a DRG validation.
476.96 Review period and reopening of initial denial determinations and 
          changes as a result of DRG validations.
476.98 Reviewer qualifications and participation.
476.100 Use of norms and criteria.
476.102 Involvement of health care practitioners other than physicians.
476.104 Coordination of activities.
476.110 Use of immediate advocacy to resolve oral beneficiary 
          complaints.
476.120 Submission of written beneficiary complaints.
476.130 Beneficiary complaint review procedures.
476.140 Beneficiary complaint reconsideration procedures.
476.150 Abandoned complaints and reopening rights.
476.160 General quality of care review procedures.
476.170 General quality of care reconsideration procedures.

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

    Source: 44 FR 32081, June 4, 1979, unless otherwise noted. 
Redesignated at 64 FR 66279, Nov. 24, 1999.



                      Subpart A_General Provisions



Sec.  476.1  Definitions.

    As used in this part, unless the context indicates otherwise:
    Admission review means a review and determination by a QIO of the 
medical necessity and appropriateness of a patient's admission to a 
specific facility.
    Appointed representative means an individual appointed by a Medicare 
beneficiary to represent the beneficiary in the beneficiary complaint 
review process.
    Authorized representative means an individual authorized, under 
State or other applicable law, to act on behalf of a Medicare 
beneficiary. An authorized representative has all of the rights and 
responsibilities of a Medicare beneficiary throughout the processing of 
a beneficiary complaint.
    Beneficiary complaint means a complaint by a Medicare beneficiary or 
a Medicare beneficiary's representative alleging that the quality of 
Medicare covered services received by the beneficiary did not meet 
professionally recognized standards of care. A complaint may consist of 
one or more quality of care concerns.
    Beneficiary complaint review means a review conducted by a QIO in 
response to the receipt of a written beneficiary complaint to determine 
whether the quality of Medicare covered services provided to the 
beneficiary was consistent with professionally recognized standards of 
health care.
    Beneficiary representative means an individual identified as an 
authorized or appointed representative of a Medicare beneficiary.
    Continued stay review means QIO review that is performed after 
admission

[[Page 695]]

review and during a patient's hospitalization to determine the medical 
necessity and appropriateness of continuing the patient's stay at a 
hospital level of care.
    Criteria means predetermined elements of health care, developed by 
health professionals relying on professional expertise, prior 
experience, and the professional literature, with which aspects of the 
quality, medical necessity, and appropriateness of a health care service 
may be compared.
    Diagnosis related group (DRG) means a system for classifying 
inpatient hospital discharges. DRGs are used for purposes of determining 
payment to hospitals for inpatient hospital services under the Medicare 
prospective payment system.
    DRG validation means a part of the prospective payment system in 
which a QIO validates that DRG assignments are based on the correct 
diagnostic and procedural information.
    Elective, when applied to admission or to a health care service, 
means an admission or a service that can be delayed without substantial 
risk to the health of the individual.
    Five percent or more owner means a person (including, where 
appropriate, a corporation) who:
    (1) Has an ownership interest of 5 percent or more;
    (2) Has an indirect ownership interest equal to 5 percent or more;
    (3) Has a combination of direct and indirect ownership interests 
(the possession of equity in the capital, the stock, or the profits of 
an entity) equal to five percent or more; or
    (4) Is the owner of an interest of five percent or more in any 
obligation secured by an entity, if the interest equals at least five 
percent of the value of the property or assets of the entity.
    General quality of care review means a review conducted by a QIO to 
determine whether the quality of Medicare covered services provided to a 
Medicare beneficiary was consistent with professionally recognized 
standards of health care. A general quality of care review may be 
carried out as a result of a referral to the QIO or a QIO's 
identification of a potential concern during the course of another 
review activity or through the analysis of data.
    Gross and flagrant violation means a violation of an obligation 
resulting from inappropriate or unnecessary services, services that do 
not meet recognized professional standards of care, or services that are 
not supported by evidence of medical necessity or quality as required by 
the QIO. The violation must have occurred in one or more instances that 
present an imminent danger to the health, safety, or well-being of a 
program patient or places the program patient unnecessarily in high-risk 
situations.
    Health care facility or facility means an organization involved in 
the delivery of health care services for which reimbursement may be made 
in whole or in part under Title XVIII of the Act.
    Health care practitioners other than physicians means those health 
professionals who do not hold a doctor of medicine or doctor of 
osteopathy degree, who meet all applicable State or Federal requirements 
for practice of their professions, and who are in active practice.
    Hospital means a health care institution or distinct part of a 
health care institution, as defined in Section 1861(e)-(g) of the Act, 
other than a religious nonmedical institution as defined in Sec.  
440.170(b) of this chapter.
    Immediate advocacy means an informal alternative dispute resolution 
process used to quickly resolve an oral complaint a Medicare beneficiary 
or his or her representation has regarding the quality of Medicare 
covered health care received. This process involves a QIO 
representative's direct contact with the provider and/or practitioner.
    Initial denial determination means an initial negative decision by a 
QIO, regarding the medical necessity, quality, or appropriateness of 
health care services furnished, or proposed to be furnished, to a 
patient.
    Major clinical area means medicine, surgery, pediatrics, obstetrics 
and gynecology, or psychiatry.
    Major procedure means a diagnostic or therapeutic procedure which 
involves a surgical or anesthetic risk or requires highly trained 
personnel or special facilities or equipment.
    Non-facility organization means a corporate entity that (1) is not a 
health care facility; (2) is not a 5 percent or

[[Page 696]]

more owner of a facility; and (3) is not owned by one or more health 
care facilities or association of facilities in the QIO area.
    Norm means a pattern of performance in the delivery of health care 
services that is typical for a specified group.
    Norms means numerical or statistical measures of average observed 
performance in the delivery of health care services.
    Outliers means those cases that have either an extremely long length 
of stay or extraordinarily high costs when compared to most discharges 
classified in the same DRG.
    Peer review means review by health care practitioners of services 
ordered or furnished by other practitioners in the same professional 
field.
    Physician means:
    (1) A doctor or medicine or osteopathy, a doctor of dental surgery 
or dental medicine, a doctor of podiatry, a doctor of optometry, or a 
chiropractor, as described in section 1861(r) of the Act;
    (2) An intern, resident, or Federal Government employee authorized 
under State or Federal law to practice as a doctor as described in 
paragraph (1) of this definition; and
    (3) An individual licensed to practice as a doctor as described in 
paragraph (1) of this definition in any Territory or Commonwealth of the 
United States of America.
    Practitioner means an individual credentialed within a recognized 
health care discipline and involved in providing the services of that 
discipline to patients.
    Preadmission certification means a favorable determination, 
transmitted to the hospital and the fiscal intermediary or the Medicare 
administrative contractor, approving the patient's admission for payment 
purposes.
    Preadmission review means review prior to a patient's admission to a 
hospital to determine, for payment purposes, the reasonableness, medical 
necessity and appropriateness of placement at an acute level of care.
    Preprocedure review means review of a surgical or other invasive 
procedure prior to the conduct of the procedure.
    Provider means a health care facility, institution, or organization, 
including but not limited to a hospital, involved in the delivery of 
health care services for which payment may be made in whole or in part 
under Title XVIII of the Act.
    QIO review means review performed in fulfillment of a contract with 
CMS, either by the QIO or its subcontractors.
    Quality improvement initiative means any formal activity designed to 
serve as a catalyst and support for quality improvement that uses proven 
methodologies to achieve these improvements. The improvements may relate 
to safety, health care, health and value and involve providers, 
practitioners, beneficiaries, and/or communities.
    Quality of care concern means a concern that care provided did not 
meet a professionally recognized standard of health care. A general 
quality of care review or a beneficiary complaint review may cover a 
single or multiple concerns.
    Quality of care review means a review conducted by a QIO to 
determine whether the quality of Medicare covered services provided to 
beneficiaries was consistent with professionally recognized standards of 
health care. A quality of care review can either be a beneficiary 
complaint review or a general quality of care review.
    Profile means aggregated data in formats that display patterns of 
health care services over a defined period of time.
    Profile analysis means review and analysis of profiles to identify 
and consider patterns of health care services.
    Quality review study means an assessment conducted by or for a QIO 
of a patient care problem for the purpose of improving patient care 
through peer analysis, intervention, resolution of the problem and 
follow-up.
    Regional norms, criteria, and standards means norms, criteria, and 
standards that apply to a geographic division which is larger than a QIO 
area.
    Retrospective review means review that is conducted after services 
are provided to a patient. The review is focused on determining the 
appropriateness, necessity, quality, and reasonableness of health care 
services provided.

[[Page 697]]

    Review responsibility means (1) the responsibility of the QIO to 
perform review functions prescribed under Part B of Title XI of the Act 
and the Social Security Amendments of 1983 (Pub. L. No. 98-21) and the 
regulations of this part; (2) the responsibility to fulfill the terms 
and meet the objectives set forth in the negotiated contract between CMS 
and the QIO; and (3) the authority of a QIO to make conclusive initial 
denial determinations regarding the medical necessity and 
appropriateness of health care and changes as a result of DRG 
validations.
    Significant quality of care concern means a determination by the QIO 
that the quality of care provided to a Medicare beneficiary did not meet 
the standard of care and, while not a gross and flagrant or substantial 
violation of the standard, represents a noticeable departure from the 
standard that could reasonably be expected to have a negative impact on 
the health of a beneficiary.
    Skilled nursing facility (SNF) means a health care institution or 
distinct part of an institution that (a) is primarily engaged in 
providing skilled nursing care or rehabilitative services to injured, 
disabled, or sick persons, and (b) has an agreement to participate in 
Medicare or Medicaid or both, and (c) is not a religious nonmedical 
institution as defined in Sec.  440.170(b) of this chapter
    Standards means professionally developed expressions of the range of 
acceptable variation from a norm or criterion.
    Subcontractor means a facility or a non-facility organization under 
contract with a QIO to perform QIO review functions.
    Substantial violation in a substantial number of cases means a 
pattern of providing care that is inappropriate, unnecessary, or does 
not meet recognized professional standards of care, or is not supported 
by the necessary documentation of care as required by the QIO.
    Working day means any one of at least five days of each week 
(excluding, at the option of each QIO, legal holidays) on which the 
necessary personnel are available to perform review.

[44 FR 32081, June 4, 1979, as amended at 45 FR 67545, Oct. 10, 1980; 46 
FR 48569, Oct. 1, 1981. Redesignated and amended at 50 FR 15328, 15329, 
Apr. 17, 1985; 51 FR 43197, Dec. 1, 1986. Redesignated at 64 FR 66279, 
Nov. 24, 1999, as amended at 64 FR 67052, Nov. 30, 1999; 77 FR 53682, 
Aug. 31, 2012; 77 FR 68559, Nov. 15, 2012; 78 FR 75199, Dec. 10, 2013]

Subpart B [Reserved]



 Subpart C_Review Responsibilities of Quality Improvement Organizations 
                                 (QIOs)

    Source: 50 FR 15330, Apr. 17, 1985, unless otherwise noted. 
Redesignated at 64 FR 66279, Nov. 24, 1999.

                           General Provisions



Sec.  476.70  Statutory bases and applicability.

    (a) Statutory bases. Sections 1154, 1866(a)(1)(F), and 1886(f)(2) of 
the Act require that a QIO review those services furnished by 
physicians, other health care professionals, providers and suppliers as 
specified in its contract with the Secretary.
    (b) Applicability. The regulations in this subpart apply to review 
conducted by a QIO and its subcontractors.

[77 FR 68560, Nov. 15, 2012]



Sec.  476.71  QIO review requirements.

    (a) Scope of QIO review. In its review, the QIO must determine (in 
accordance with the terms of its contract)--
    (1) Whether the services are or were reasonable and medically 
necessary for the diagnosis and treatment of illness or injury or to 
improve functioning of a malformed body member, or (with respect to 
pneumococcal vaccine) for prevention of illness or (in the case of 
hospice care) for the palliation and management of terminal illness;
    (2) Whether the quality of the services meets professionally 
recognized standards of health care, as determined through the 
resolution of oral beneficiary complaints as specified in Sec.  476.110, 
written beneficiary complaints as specified in Sec.  476.120, or the 
completion of general quality of care reviews as specified in Sec.  
476.160.

[[Page 698]]

    (3) Whether those services furnished or proposed to be furnished on 
an inpatient basis could, consistent with the provisions of appropriate 
medical care, be effectively furnished more economically on an 
outpatient basis or in an inpatient health care facility of a different 
type;
    (4) Through DRG validation, the validity of diagnostic and 
procedural information supplied by the hospital;
    (5) The completeness, adequacy and quality of hospital care 
provided;
    (6) The medical necessity, reasonableness and appropriateness of 
hospital admissions and discharges;
    (7) 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; and
    (8) Whether a hospital has misrepresented admission or discharge 
information or has taken an action that results in--
    (i) The unnecessary admission of an individual entitled to benefits 
under part A;
    (ii) Unnecessary multiple admissions of an individual; or
    (iii) Other inappropriate medical or other practices with respect to 
beneficiaries or billing for services furnished to beneficiaries.
    (b) Payment determinations. On the basis of the review specified 
under paragraphs (a) (1), (3), (6), (7), and (8) of this section, the 
QIO must determine whether payment may be made for these services. A QIO 
may grant a period of not more than two days (grace days) for the 
purpose of arranging post discharge care when the provider did not know 
or could not reasonably be expected to have known that payment for the 
service(s) would not be made under the Medicare program as specified in 
Sec.  405.330(b).
    (c) Other duties and functions. (1) The QIO must review at least a 
random sample of hospital discharges each quarter and submit new 
diagnostic and procedural information to the Medicare administrative 
contractor, fiscal intermediary, or carrier if it determines that the 
information submitted by the hospital was incorrect.
    (2) As directed by CMS, the QIO must review changes in DRG and LTC-
DRG assignments made by the intermediary under the provisions of 
Sec. Sec.  412.60(d) and 412.513(c) of this chapter that result in the 
assignment of a higher-weighted DRG or a different LTC-DRG. The QIO's 
review must verify that the diagnostic and procedural information 
supplied by the hospital is substantiated by the information in the 
medical record.
    (d) Coordination of sanction activities. The QIO must carry out the 
responsibilities specified in subpart C of part 1004 of this title 
regarding imposition of sanctions on providers and practitioners who 
violate their statutory obligations under section 1156 of the Act.

[52 FR 37457, Oct. 7, 1987; 52 FR 47003, Dec. 11, 1987, as amended at 59 
FR 45402, Sept. 1, 1994. Redesignated at 64 FR 66279, Nov. 24, 1999; 67 
FR 56056, Aug. 30, 2002; 77 FR 68560, Nov. 15, 2012]



Sec.  476.73  Notification of QIO designation and implementation of review.

    (a) Notice of CMS's decision. CMS sends written notification of a 
QIO contract award to the State survey agency and Medicare 
administrative contractors, fiscal intermediaries, and carriers. The 
notification includes the effective dates of the QIO contract and 
specifies the area and types of health care facilities to be reviewed by 
the QIO. The QIO must make a similar notification when review 
responsibilities are subcontracted.
    (b) Notification to health care facilities and the public. As 
specified in its contract with CMS, the QIO must--
    (1) Provide, to each health care facility scheduled to come under 
review, a timely written notice that specifies the date and manner in 
which the QIO proposes to implement review, and the information to be 
furnished by the facility to each Medicare beneficiary upon admission as 
specified in Sec.  476.78(b)(3) of this part.
    (2) Publish, in at least one local newspaper of general circulation 
in the QIO area, a notice that states the date the QIO will assume 
review responsibilities and lists each area health care facility to be 
under review. The QIO

[[Page 699]]

must indicate that its plan for the review of health care services as 
approved in its contract with CMS is available for public inspection in 
the QIO's business office and give the address, telephone number and 
usual hours of business.

[50 FR 15330, Apr. 17, 1985. Redesignated at 52 FR 37457, Oct. 7, 1987, 
and further redesignated at 64 FR 66279, Nov. 24, 1999; 77 FR 68560, 
Nov. 15, 2012]



Sec.  476.74  General requirements for the assumption of review.

    (a) A QIO must assume review responsibility in accordance with the 
schedule, functions and negotiated objectives specified in its contract 
with CMS.
    (b) A QIO must notify the appropriate Medicare administrative 
contractor, fiscal intermediary, or carrier of its assumption of review 
in specific health care facilities no later than five working days after 
the day that review is assumed in the facility.
    (c) A QIO must maintain and make available for public inspection at 
its principal business office--
    (1) A copy of each agreement with Medicare administrative 
contractors, fiscal intermediaries, and carriers;
    (2) A copy of its currently approved review plan that includes the 
QIO's method for implementing review; and
    (3) Copies of all subcontracts for the conduct of review.
    (d) A QIO must not subcontract with a facility to conduct any review 
activities except for the review of the quality of care. The QIO may 
subcontract with a non-facility organization to conduct review in a 
facility.
    (e) If required by CMS, a QIO is responsible for compiling 
statistics based on the criteria contained in Sec.  411.402 of this 
chapter and making limitation of liability determinations on excluded 
coverage of certain services that are made under section 1879 of the 
Act. If required by CMS, QIOs must also notify a provider of these 
determinations. These determinations and further appeals are governed by 
the reconsideration and appeals procedures in part 405, subpart G of 
this chapter for Medicare Part A related determinations and part 405, 
subpart H of this chapter for Medicare Part B related determinations.
    (f) A QIO must make its responsibilities under its contract with 
CMS, primary to all other interests and activities that the QIO 
undertakes.

[50 FR 15330, Apr. 17, 1985, as amended at 77 FR 68560, Nov. 15, 2012]



Sec.  476.76  Cooperation with health care facilities.

    Before implementation of review, a QIO must make a good faith effort 
to discuss the QIO's administrative and review procedures with each 
involved health care facility.



Sec.  476.78  Responsibilities of providers and practitioners.

    (a) Every hospital seeking payment for services furnished to 
Medicare beneficiaries must maintain a written agreement with a QIO 
operating in the area in which the hospital is located. These agreements 
must provide for the QIO review specified in Sec.  476.71.
    (b) Cooperation with QIOs. Health care providers that submit 
Medicare claims must cooperate in the assumption and conduct of QIO 
review.
    (1) Providers must allocate adequate space to the QIO for its 
conduct of review at the times the QIO is conducting review.
    (2) Providers and practitioners must provide patient care data and 
other pertinent data to the QIO at the time the QIO is collecting review 
information that is required for the QIO to make its determinations. 
When the QIO does postadmission, preprocedure review, the provider must 
provide the necessary information before the procedure is performed, 
unless it must be performed on an emergency basis. Providers and 
practitioners must--
    (i) Except as provided under Sec. Sec.  476.130(b) and 476.160(b), 
relating to beneficiary complaint reviews and general quality of care 
reviews, deliver to the QIO all required information within 14 calendar 
days of a request. A QIO is authorized to require the receipt of the 
medical information earlier than the 14-day timeframe if the QIO makes a 
preliminary determination that the review involves a potential gross and 
flagrant or substantial violation as specified in part 1004 of this 
title and

[[Page 700]]

circumstances warrant earlier receipt of the medical information. A 
practitioner's or provider's failure to comply with the request for 
medical information within the established timeframe may result in the 
QIO taking action in accordance with Sec.  476.90.
    (ii) Except if granted a waiver as described in paragraph (d) of 
this section, send secure transmission of an electronic version of each 
requested patient record to the QIO.
    (A) Providers and practitioners must deliver electronic versions of 
patient records within 14 calendar days of the request.
    (B) A QIO is authorized to require the receipt of the patient 
records earlier than the 14-day timeframe if the QIO makes a preliminary 
determination that the review involves a potential gross and flagrant or 
substantial violation as specified in part 1004 of this title and 
circumstances warrant earlier receipt of the patient records.
    (C) A practitioner's or provider's failure to comply with the 
request for patient records within the established timeframe may result 
in the QIO taking action in accordance with Sec.  476.90.
    (3) Providers must inform Medicare beneficiaries at the time of 
admission, in writing, that the care for which Medicare payment is 
sought will be subject to QIO review and indicate the potential outcomes 
of that review. Furnishing this information to the patient does not 
constitute notice, under Sec.  411.402(a) of this chapter, that can 
support a finding that the beneficiary knew the services were not 
covered.
    (4) When the provider has issued a written determination in 
accordance with Sec.  412.42(c)(3) of this chapter that a beneficiary no 
longer requires inpatient hospital care, it must submit a copy of its 
determination to the QIO within 3 working days.
    (5) Providers must assure, in accordance with the provisions of 
their agreements with the QIO, that each case subject to preadmission 
review has been reviewed and approved by the QIO before admission to the 
hospital or a timely request has been made for QIO review.
    (6)(i) Providers must agree to accept financial liability for any 
admission subject to preadmission review that was not reviewed by the 
QIO and is subsequently determined to be inappropriate or not medically 
necessary.
    (ii) The provisions of paragraph (b)(6)(i) of this section do not 
apply if a provider, in accordance with its agreement with a QIO, makes 
a timely request for preadmission review and the QIO does not review the 
case timely. Cases of this type are subject to retrospective prepayment 
review under paragraph (b)(7) of this section.
    (7) Hospitals must agree that, if the hospital admits a case subject 
to preadmission review without certification, the case must receive 
retrospective prepayment review, according to the review priority 
established by the QIO.
    (c) Submission of patient records in electronic format. Except as 
specified in paragraph (d) of this section, a provider or practitioner 
must deliver patient records requested by a QIO for the purpose of 
fulfilling one or more QIO functions, in an electronic format, using the 
mechanism specified by the QIO. In the absence of any mechanism 
specified by the requesting QIO, the requested patient records must be 
submitted using any CMS-approved mechanism.
    (d) Waiver from the requirement to submit patient records in an 
electronic format. (1) A provider or practitioner that lacks the 
capability to submit requested patient records to the requesting QIO in 
an electronic format may request a waiver from the requirements in 
paragraph (c) of this section.
    (i) For providers that are required to execute a written agreement 
with the QIO, a request for a waiver must be made during execution of 
the written agreement with the QIO.
    (ii) Providers that are required to execute a written agreement with 
the QIO must request a waiver by notifying the QIO that they lack the 
capability to submit patient records in electronic format, if their lack 
of capability arises after the written agreement is executed.
    (iii) Upon approval of the waiver, the waiver becomes part of the 
written agreement with the QIO.
    (iv) A provider with an approved waiver may submit patient records 
by

[[Page 701]]

facsimile or by photocopying and mailing to the QIO.
    (v) A provider with an approved waiver may be reimbursed by the QIO 
for patient records submitted by facsimile or by photocopying and 
mailing in accordance with paragraph (e)(2) of this section.
    (vi) A QIO may not reimburse for any patient record submitted to the 
QIO by facsimile or by photocopying and mailing if the provider does not 
have an approved waiver.
    (2) Providers and practitioners that are not required to execute a 
written agreement with the QIO may request a waiver to be exempted from 
submitting patient records in an electronic format.
    (i) Such providers and practitioners may request a waiver by 
notifying the QIO that they lack the capability to submit patient 
records in electronic format.
    (ii) Upon approval of the waiver, a provider or practitioner may 
submit patient records by facsimile or by photocopying and mailing to 
the QIO.
    (iii) Providers and practitioners with approved waivers may be 
reimbursed by the QIO for patient records submitted by facsimile or by 
photocopying and mailing in accordance with paragraph (e)(2) of this 
section.
    (iv) A QIO may not reimburse for any patient records submitted to 
the QIO by facsimile or by photocopying and mailing, if the provider or 
practitioner does not have an approved waiver.
    (e) Reimbursement for submitting patient records to the QIO. (1) For 
purposes of this paragraph (e), a patient record means all patient care 
data and other pertinent data or information relating to care or 
services provided to an individual patient in the possession of the 
provider or practitioner, as requested by a QIO for the purpose of 
performing one or more QIO functions.
    (2) A QIO may reimburse a provider or practitioner for requested 
patient records submitted in an electronic format, at the rate of $3.00 
per patient record.
    (3) For a provider or practitioner that has an approved waiver under 
paragraph (d) of this section, a QIO may reimburse the provider or 
practitioner for requested records submitted by--
    (i) Facsimile at the rate of $0.15 per page; or
    (ii) Photocopying and mailing at the rate of $0.15 per page, plus 
the cost of first class postage.
    (4) A QIO may only reimburse a provider or practitioner once for 
each patient record submitted, per request, even if a patient record is 
submitted using multiple formats, in fragments, or more than once in 
response to a single request by the QIO.
    (f) Appeals. Reimbursement for the costs of submitting requested 
patient records to the QIO in electronic format, by facsimile or by 
photocopying and mailing is an additional payment to providers under the 
prospective payment system, as specified in Sec. Sec.  412.115, 413.355, 
and 484.265 of this chapter. Appeals concerning these costs are subject 
to the review process specified in part 405, subpart R, of this chapter.
    (c) Submission of patient records in electronic format. Except as 
specified in paragraph (d) of this section, a provider or practitioner 
must deliver patient records requested by a QIO for the purpose of 
fulfilling one or more QIO functions, in an electronic format, using the 
mechanism specified by the QIO. In the absence of any mechanism 
specified by the requesting QIO, the requested patient records must be 
submitted using any CMS-approved mechanism.
    (d) Waiver from the requirement to submit patient records in an 
electronic format. (1) A provider or practitioner that lacks the 
capability to submit requested patient records to the requesting QIO in 
an electronic format may request a waiver from the requirements in 
paragraph (c) of this section.
    (i) For providers that are required to execute a written agreement 
with the QIO, a request for a waiver must be made during execution of 
the written agreement with the QIO.
    (ii) Providers that are required to execute a written agreement with 
the QIO must request a waiver by notifying the QIO that they lack the 
capability to submit patient records in electronic format, if their lack 
of capability arises after the written agreement is executed.

[[Page 702]]

    (iii) Upon approval of the waiver, the waiver becomes part of the 
written agreement with the QIO.
    (iv) A provider with an approved waiver may submit patient records 
by facsimile or by photocopying and mailing to the QIO.
    (v) A provider with an approved waiver may be reimbursed by the QIO 
for patient records submitted by facsimile or by photocopying and 
mailing in accordance with paragraph (e)(2) of this section.
    (vi) A QIO may not reimburse for any patient record submitted to the 
QIO by facsimile or by photocopying and mailing if the provider does not 
have an approved waiver.
    (2) Providers and practitioners that are not required to execute a 
written agreement with the QIO may request a waiver to be exempted from 
submitting patient records in an electronic format.
    (i) Such providers and practitioners may request a waiver by 
notifying the QIO that they lack the capability to submit patient 
records in electronic format.
    (ii) Upon approval of the waiver, a provider or practitioner may 
submit patient records by facsimile or by photocopying and mailing to 
the QIO.
    (iii) Providers and practitioners with approved waivers may be 
reimbursed by the QIO for patient records submitted by facsimile or by 
photocopying and mailing in accordance with paragraph (e)(2) of this 
section.
    (iv) A QIO may not reimburse for any patient records submitted to 
the QIO by facsimile or by photocopying and mailing, if the provider or 
practitioner does not have an approved waiver.
    (e) Reimbursement for submitting patient records to the QIO. (1) For 
purposes of this paragraph (e), a patient record means all patient care 
data and other pertinent data or information relating to care or 
services provided to an individual patient in the possession of the 
provider or practitioner, as requested by a QIO for the purpose of 
performing one or more QIO functions.
    (2) A QIO may reimburse a provider or practitioner for requested 
patient records submitted in an electronic format, at the rate of $3.00 
per patient record.
    (3) For a provider or practitioner that has an approved waiver under 
paragraph (d) of this section, a QIO may reimburse the provider or 
practitioner for requested records submitted by--
    (i) Facsimile at the rate of $0.15 per page; or
    (ii) Photocopying and mailing at the rate of $0.15 per page, plus 
the cost of first class postage.
    (4) A QIO may only reimburse a provider or practitioner once for 
each patient record submitted, per request, even if a patient record is 
submitted using multiple formats, in fragments, or more than once in 
response to a single request by the QIO.
    (f) Appeals. Reimbursement for the costs of submitting requested 
patient records to the QIO in electronic format, by facsimile or by 
photocopying and mailing is an additional payment to providers under the 
prospective payment system, as specified in Sec. Sec.  412.115, 413.355, 
and 484.265 of this chapter. Appeals concerning these costs are subject 
to the review process specified in part 405, subpart R, of this chapter.

[50 FR 15330, Apr. 17, 1985, as amended at 57 FR 47787, Oct. 20, 1992; 
59 FR 45402, Sept. 1, 1994. Redesignated at 64 FR 66279, Nov. 24, 1999, 
as amended at 68 FR 67960, Dec. 5, 2003; 76 FR 51784, Aug. 18, 2011; 77 
FR 53682, Aug. 31, 2012; 77 FR 68560, Nov. 15, 2012; 85 FR 59025, Sept. 
18, 2020]



Sec.  476.80  Coordination with Medicare administrative contractors,
fiscal intermediaries, and carriers

    (a) Procedures for agreements. Medicare administrative contractor, 
fiscal intermediary, or carrier must have a written agreement with the 
QIO. The QIO must take the initiative with the fiscal intermediary or 
carrier in developing the agreement. The following steps must be taken 
in developing the agreement.
    (1) The QIO and the Medicare administrative contractor, fiscal 
intermediary, or carrier must negotiate in good faith in an effort to 
reach written agreement. If they cannot reach agreement, CMS will assist 
them in resolving matters in dispute.
    (2) The QIO must incorporate its administrative procedures into an 
agreement with the Medicare administrative

[[Page 703]]

contractor, fiscal intermediary, or carrier and obtain approval from 
CMS, before it makes conclusive determinations for the Medicare program, 
unless CMS finds that the Medicare administrative contractor, fiscal 
intermediary, or carrier has--
    (i) Refused to negotiate in good faith or in a timely manner, or
    (ii) Insisted on including in the agreement, provisions that are 
outside the scope of its authority under the Act.
    (b) Content of agreement. The agreement must include procedures 
for--
    (1) Informing the appropriate Medicare administrative contractors, 
fiscal intermediaries, and carriers of--
    (i) Changes as a result of DRG validations and revisions as a result 
of the review of these changes; and
    (ii) Initial denial determinations and revisions of these 
determinations as a result of reconsideration, or reopening all 
approvals and denials with respect to cases subject to preadmission 
review, and outlier claims in hospitals under a prospective payment 
system for health care services and items;
    (2) Exchanging data or information;
    (3) Modifying the procedures when additional review responsibility 
is authorized by CMS; and
    (4) Any other matters that are necessary for the coordination of 
functions.
    (c) Action by CMS. (1) Within the time specified in its contract, 
the QIO must submit to CMS for approval its agreement with the Medicare 
administrative contractors, fiscal intermediaries, and carriers, or if 
an agreement has not been established, the QIO's proposed administrative 
procedures, including any comments by the Medicare administrative 
contractors, fiscal intermediaries, and carriers.
    (2) If CMS approves the agreement or the administrative procedures 
(after a finding by CMS as specified in paragraph (a)(2) of this 
section), the QIO may begin to make determinations under its contract 
with CMS.
    (3) If CMS disapproves the agreement or procedures, it will--
    (i) Notify the QIO and the appropriate fiscal agents in writing, 
stating the reasons for disapproval; and
    (ii) Require the QIO and Medicare administrative contractor, fiscal 
intermediary, or carrier to revise its agreements or procedures.
    (d) Modification of agreements. Agreements or procedures may be 
modified, with CMS's approval--
    (1) Through a revised agreement with the Medicare administrative 
contractor, fiscal intermediary, or carrier, or
    (2) In the case of procedures, by the QIO, after providing 
opportunity for comment by the Medicare administrative contractor, 
fiscal intermediary, or carrier.
    (e) Role of the Medicare administrative contractor or fiscal 
intermediary. (1) The Medicare administrative contractor or fiscal 
intermediary will not pay any claims for those cases which are subject 
to preadmission review by the QIO, until it receives notice that the QIO 
has approved the admission after preadmission or retrospective review.
    (2) A QIO's determination that an admission is medically necessary 
is not a guarantee of payment by the Medicare administrative contractor 
or fiscal intermediary. Medicare coverage requirements must also be 
applied.

[50 FR 15330, Apr. 17, 1985; 50 FR 41886, Oct. 16, 1985. Redesignated at 
64 FR 66279, Nov. 24, 1999; 77 FR 68560, Nov. 15, 2012]



Sec.  476.82  Continuation of functions not assumed by QIOs.

    Any of the duties and functions under Part B of Title XI of the Act 
for which a QIO has not assumed responsibility under its contract with 
CMS must be performed in the manner and to the extent otherwise provided 
for under the Act or in regulations.

                          QIO Review Functions



Sec.  476.83  Initial denial determinations.

    A determination by a QIO that the health care services furnished or 
proposed to be furnished to a patient are not medically necessary, are 
not reasonable, or are not at the appropriate level of care, is an 
initial denial determination and is appealable under part 473 of this 
chapter.

[[Page 704]]



Sec.  476.84  Changes as a result of DRG validation.

    A provider or practitioner may obtain a review by a QIO under part 
473 of this chapter for changes in diagnostic and procedural coding that 
resulted in a change in DRG assignment as a result of QIO validation 
activities.



Sec.  476.85  Conclusive effect of QIO initial denial determinations
and changes as a result of DRG validations.

    A QIO initial denial determination or change as a result of DRG 
validation is final and binding unless, in accordance with the 
procedures in part 473--
    (a) The initial denial determination is reconsidered and revised; or
    (b) The change as a result of DRG validation is reviewed and 
revised.



Sec.  476.86  Correlation of Title XI functions with Title XVIII functions.

    (a) Payment determinations. (1) QIO initial denial determinations 
under this part with regard to the reasonableness, medical necessity, 
and appropriateness of placement at an acute level of patient care as 
are also conclusive for payment purposes with regard to the following 
medical issues:
    (i) Whether inpatient care furnished in a psychiatric hospital meets 
the requirements of Sec.  424.14 of this chapter.
    (ii) Whether payment for inpatient hospital or SNF care beyond 20 
consecutive days is precluded under Sec.  489.50 of this chapter because 
of failure to perform review of long-stay cases.
    (iii) Whether the care furnished was custodial care or care not 
reasonable and necessary and, as such, excluded under Sec.  411.15(g) or 
Sec.  411.15(k) of this chapter.
    (iv) Whether the care was appropriately furnished in the inpatient 
or outpatient setting.
    (2) Reviews with respect to determinations listed in paragraph 
(a)(1) of this section must not be conducted, for purposes of payment, 
by Medicare administrative contractors, fiscal intermediaries, and 
carriers except as outlined in paragraph (c) of this section.
    (3) QIOs make determinations as to the appropriateness of the 
location in which procedures are performed. A procedure may be medically 
necessary but denied if the QIO determines that it could, consistent 
with the provision of appropriate medical care, be effectively provided 
more economically on an outpatient basis or in an inpatient health care 
facility of a different type.
    (4) QIO determinations as to whether the provider and the 
beneficiary knew or could reasonably be expected to have known that the 
services described in paragraph (a)(1) of this section were excluded are 
also conclusive for payment purposes.
    (b) Utilization review activities. QIO review activities to 
determine whether inpatient hospital or SNF care services are reasonable 
and medically necessary and are furnished at the appropriate level of 
care fulfill the utilization review requirements set forth in Sec. Sec.  
405.1035, 405.1042, and 405.1137 of this chapter.
    (c) Coverage. Nothing in paragraphs (a) (1) and (3) of this section 
will be construed as precluding CMS or a Medicare administrative 
contractor, fiscal intermediary, or carrier, in the proper exercise of 
its duties and functions, from reviewing claims to determine:
    (1) In the case of items or services not reviewed by a QIO, whether 
they meet coverage requirements of Title XVIII relating to medical 
necessity, reasonableness, or appropriateness of placement at an acute 
level of patient care. However, if a coverage determination pertains to 
medical necessity, reasonableness, or appropriateness of placement at an 
acute level of patient care, the Medicare administrative contractor, 
fiscal intermediary, or carrier must use a QIO to make a determination 
on those issues if a QIO is conducting review in the area and must abide 
by the QIO's determination.
    (2) Whether any claim meets coverage requirements of Title XVIII 
relating to issues other than medical necessity, reasonableness or 
appropriateness of placement at an acute level of patient care.
    (d) Payment. Medicare administrative contractors, fiscal 
intermediaries, and carriers are not precluded from making payment 
determinations with regard to coverage determinations made under 
paragraph (c) of this section.

[[Page 705]]

    (e) Survey, compliance and assistance activities. QIO review and 
monitoring activities fulfill the requirements for compliance and 
assistance activities of State survey agencies under section 1864(a) 
with respect to sections 1861(e)(6), 1861(j)(8), 1861(j)(12), and 
1861(k) of the Act, and activities required of Medicare administrative 
contractors, fiscal intermediaries, and carriers under Sec. Sec.  
421.100(d) and 421.200(f) of this chapter.
    (f) Appeals. The requirements and procedures for QIO review of 
changes as a result of DRG validation and the reconsideration, hearing 
and judicial review of QIO initial denial determinations are set forth 
in part 478 of this chapter.

[50 FR 15330, Apr. 17, 1985; 50 FR 41886, Oct. 16, 1985, as amended at 
53 FR 6648, Mar. 2, 1988. Redesignated at 64 FR 66279, Nov. 24, 1999; 77 
FR 68561, Nov. 15, 2012]



Sec.  476.88  Examination of the operations and records of health care
facilities and practitioners.

    (a) Authorization to examine records. A facility claiming Medicare 
payment must permit a QIO or its subcontractor to examine its operation 
and records (including information on charges) that are pertinent to 
health care services furnished to Medicare beneficiaries and are 
necessary for the QIO or its subcontractor to--
    (1) Perform review functions including, but not limited to--
    (i) DRG validation;
    (ii) Outlier review in facilities under a prospective payment 
system; and
    (iii) Implementation of corrective action and fraud and abuse 
prevention activities;
    (2) Evaluate cases that have been identified as deviating from the 
QIO norms and criteria, or standards; and
    (3) Evaluate the capability of the facility to perform quality 
review functions under a subcontract with the QIO.
    (b) Limitations on access to records. A QIO has access to the 
records of non-Medicare patients if--
    (1) The records relate to review performed under a non-Medicare QIO 
contract and if authorized by those patients in accordance with State 
law; or
    (2) The QIO needs the records to perform its quality review 
responsibilities under the Act and receives authorization from the 
facility or practitioner.
    (c) Conditions of examination. When examining a facility's operation 
or records the QIO must--
    (1) Examine only those operations and records (including information 
on charges) required to fulfill the purposes of paragraph (a) of this 
section;
    (2) Cooperate with agencies responsible for other examination 
functions under Federal or Federally assisted programs in order to 
minimize duplication of effort;
    (3) Conduct the examinations during reasonable hours; and
    (4) Maintain in its principal office written records of the results 
of the examination of the facility.



Sec.  476.90  Lack of cooperation by a provider or practitioner.

    (a) If a provider or practitioner refuses to allow a QIO to enter 
and perform the duties and functions required under its contract with 
CMS, the QIO may--
    (1) Determine that the provider or practitioner has failed to comply 
with the requirements of 42 CFR 1004.10(c) and report the matter to the 
HHS Inspector General; or
    (2) Issue initial denial determinations for those claims it is 
unable to review, make the determination that financial liability will 
be assigned to the provider or practitioner, and may report the matter 
to the HHS Inspector General.
    (b) If a QIO gives a provider or practitioner sufficient notice and 
a reasonable amount of time to respond to a request for information 
about a claim, and if the provider or practitioner does not respond in a 
timely manner, the QIO will deny the claim. A provider or practitioner 
may request that the QIO reconsider its decision to deny the claim. No 
further appeal rights are available.

[77 FR 53683, Aug. 31, 2012]

[[Page 706]]



Sec.  476.93  Opportunity to discuss proposed initial denial determination
and changes as a result of a DRG validation.

    Before a QIO reaches an initial denial determination or makes a 
change as a result of a DRG validation, it must--
    (a) Promptly notify the provider or supplier and the patient's 
attending physician (or other attending health care practitioner) of the 
proposed determination or DRG change; and
    (b) Afford an opportunity for the provider or supplier and the 
physician (or other attending health care practitioner) to discuss the 
matter with the QIO physician advisor and to explain the nature of the 
patient's need for health care services, including all factors which 
preclude treatment of the patient as an outpatient or in an alternative 
level of inpatient care.



Sec.  476.94  Notice of QIO initial denial determination and changes as
a result of a DRG validation.

    (a) Notice of initial denial determination--(1) Parties to be 
notified. A QIO must provide written notice of an initial denial 
determination to--
    (i) The patient, or if the patient is expected to be unable to 
comprehend the notice, the patient's next of kin, guardian or other 
representative or sponsor;
    (ii) The attending physician, or other attending health care 
practitioner;
    (iii) The facility; and
    (iv) The Medicare administrative contractor, fiscal intermediary, or 
carrier.
    (2) Timing of the notice. The notice must be delivered to 
beneficiaries in the facility or mailed to those no longer in the 
facility, within the following time periods--
    (i) For admission, on the first working day after the initial denial 
determination;
    (ii) For continued stay (e.g., outliers in facilities under a 
prospective payment system), by the first working day after the initial 
denial determination if the beneficiary is still in the facility, and 
within 3 working days if the beneficiary has been discharged;
    (iii) For preprocedure review, before the procedure is performed;
    (iv) For preadmission review, before admission;
    (v) If identification as a Medicare program patient has been 
delayed, within three working days of identification;
    (vi) For retrospective review, (excluding DRG validation and post 
procedure review), within 3 working days of the initial denial 
determination; and
    (vii) For post-procedure review, within 3 working days of the 
initial denial determination.
    (3) Preadmission review. In the case of preadmission review, the QIO 
must document that the patient and the facility received notice of the 
initial denial determination.
    (b) Notice of changes as a result of a DRG validation. The QIO must 
notify the provider and practitioner of changes to procedural and 
diagnostic information that result in a change of DRG assignment, within 
30 days of the QIO's decision.
    (c) Content of the notice. The notice must be understandable and 
written in plain English and must contain--
    (1) The reason for the initial denial determination or change as a 
result of the DRG validation;
    (2) For day outliers in hospitals, the date on which the stay or 
services in the facility will not be approved as being reasonable and 
medically necessary or appropriate to the patients' health care needs;
    (3) A statement informing each party or his or her representative of 
the right to request in accordance with the provisions of part 478, 
subpart B of this chapter--
    (i) Review of a change resulting from DRG validation; or
    (ii) Reconsideration of the initial denial determination;
    (4) The locations for filing a request for reconsideration or review 
and the time period within which a request must be filed;
    (5) A statement about who is liable for payment of the denied 
services under section 1879 of the Act; and
    (6) A statement concerning the duties and functions of the QIO under 
the Act.
    (d) Notice to payers. The QIO must provide prompt written notice of 
an initial denial determination or changes as a result of a DRG 
validation to the Medicare administrative contractor, fiscal 
intermediary, or carrier within

[[Page 707]]

the same time periods as the notices to the other parties.
    (e) Record of initial denial determination and changes as a result 
of a DRG validation. (1) The QIO must document and preserve a record of 
all initial denial determinations and changes as a result of DRG 
validations for six years from the date the services in question were 
provided.
    (2) The documentary record must include--
    (i) The detailed basis for the initial denial determination or 
changes as a result of a DRG validation; and
    (ii) A copy of the determination or change in DRG notices sent to 
all parties and identification of each party and the date on which the 
notice was mailed or delivered.

[50 FR 15330, Apr. 17, 1985, as amended at 77 FR 68561, Nov. 15, 2012]



Sec.  476.96  Review period and reopening of initial denial determinations
and changes as a result of DRG validations.

    (a) General timeframe. A QIO or its subcontractor--
    (1) Within one year of the date of the claim containing the service 
in question, may review and deny payment; and
    (2) Within one year of the date of its decision, may reopen an 
initial denial determination or a change as a result of a DRG 
validation.
    (b) Extended timeframes. (1) An initial denial determination or 
change as a result of a DRG validation may be made after one year but 
within four years of the date of the claim containing the service in 
question, if CMS approves.
    (2) A reopening of an initial denial determination or change as a 
result of a DRG validation may be made after one year but within four 
years of the date of the QIO's decision if--
    (i) Additional information is received on the patient's condition;
    (ii) Reviewer error occurred in interpretation or application of 
Medicare coverage policy or review criteria;
    (iii) There is an error apparent on the face of the evidence upon 
which the initial denial or DRG validation was based; or
    (iv) There is a clerical error in the statement of the initial 
denial determination or change as a result of a DRG validation.
    (c) Fraud and abuse. (1) A QIO or its subcontractor may review and 
deny payment anytime there is a finding that the claim for service 
involves fraud or a similar abusive practice that does not support a 
finding of fraud.
    (2) An initial denial determination or change as a result of a DRG 
validation may be reopened and revised anytime there is a finding that 
it was obtained through fraud or a similar abusive practice that does 
not support a finding of fraud.



Sec.  476.98  Reviewer qualifications and participation.

    (a) Peer review by physician. (1) Except as provided in paragraph 
(a)(2) of this section, each person who makes an initial denial 
determination about services furnished or proposed to be furnished by a 
licensed doctor of medicine or osteopathy or by a doctor of dentistry 
must be respectively another licensed doctor of medicine or osteopathy 
or of dentistry in the QIO area.
    (2) If a QIO determines that peers are not available to make initial 
denial determinations, a doctor of medicine or osteopathy may make 
denial determinations for services ordered or performed by a doctor in 
any of the three specialties.
    (3) For purposes of paragraph (a)(1) of this section, individuals 
authorized to practice medicine in American Samoa, the Northern Mariana 
Islands, and the Trust Territory of the Pacific Islands as ``medical 
officers'' may make determinations on care ordered or furnished by their 
peers but not on care ordered or furnished by licensed doctors of 
medicine or osteopathy.
    (b) Peer review by health care practitioners other than physicians. 
Health care practitioners other than physicians may review services 
furnished by other practitioners in the same professional field.
    (c) DRG validation review. Decisions about procedural and diagnostic 
information must be made by physicians. Technical coding issues must be 
reviewed by individuals with training and experience in ICD-9-CM coding.
    (d) Persons excluded from review. (1) A person may not review health 
care

[[Page 708]]

services or make initial denial determinations or changes as a result of 
DRG validations if he or she, or a member of his or her family--
    (i) Participated in developing or executing the beneficiary's 
treatment plan;
    (ii) Is a member of the beneficiary's family; or
    (iii) Is a governing body member, officer, partner, 5 percent or 
more owner, or managing employee in the health care facility where the 
services were or are to be furnished.
    (2) A member of a reviewer's family is a spouse (other than a spouse 
who is legally separated under a decree of divorce or separate 
maintenance), child (including a legally adopted child), grandchild, 
parent, or grandparent.

[50 FR 15330, Apr. 17, 1985, as amended at 77 FR 68561, Nov. 15, 2012]



Sec.  476.100  Use of norms and criteria.

    (a) Use of norms. As specified in its contract, a QIO must use 
national, or where appropriate, regional norms in conducting review to 
achieve QIO contract objectives. However, with regard to determining the 
number of procedures selected for preadmission review, a QIO must use 
national admission norms.
    (b) Use of criteria. In assessing the need for and appropriateness 
of an inpatient health care facility stay, a QIO must apply criteria to 
determine--
    (1) The necessity for facility admission and continued stay (in 
cases of day outliers in hospitals under prospective payment);
    (2) The necessity for surgery and other invasive diagnostic and 
therapeutic procedures; or
    (3) The appropriateness of providing services at a particular health 
care facility or at a particular level of care. The QIO must determine 
whether the beneficiary requires the level of care received or whether a 
lower and less costly level of care would be equally effective.
    (c) Establishment of criteria and standards. For the conduct of 
review a QIO must--
    (1) Establish written criteria based upon typical patterns of 
practice in the QIO area, or use national criteria where appropriate; 
and
    (2) Establish written criteria and standards to be used in 
conducting quality review studies.
    (d) Variant criteria and standards. A QIO may establish specific 
criteria and standards to be applied to certain locations and facilities 
in the QIO area if the QIO determines that--
    (1) The patterns of practice in those locations and facilities are 
substantially different from patterns in the remainder of the QIO area; 
and
    (2) There is a reasonable basis for the difference which makes the 
variation appropriate.



Sec.  476.102  Involvement of health care practitioners other than 
physicians.

    (a) Basic requirement. Except as provided in paragraph (b) of this 
section, a QIO must meet the following requirements:
    (1) Consult with the peers of the practitioners who furnish the 
services under review if the QIO reviews care and services delivered by 
health care practitioners other than physicians.
    (2) Assure that in determinations regarding medical necessity of 
services or the quality of the services they furnish, these 
practitioners are involved in--
    (i) Developing QIO criteria and standards;
    (ii) Selecting norms to be used; and
    (iii) Developing review mechanisms for care furnished by their 
peers.
    (3) Ensure that an initial denial determination or a change as a 
result of DRG validation of services provided by a health care 
practitioner other than a physician is made by a physician only after 
consultation with a peer of that practitioner. Initial denial 
determinations and changes as a result of DRG validations must be made 
only by a physician or dentist.
    (b) Exception. The requirements of paragraph (a) of this section do 
not apply if--
    (1) The QIO has been unable to obtain a roster of peer practitioners 
available to perform review; or
    (2) The practitioners are precluded from performing review because 
they participated in the treatment of the patient, the patient is a 
relative, or the practitioners have a financial interest

[[Page 709]]

in the health care facility as described in Sec.  466.98(d).
    (c) Peer involvement in quality review studies. Practitioners must 
be involved in the design of quality review studies, development of 
criteria, and actual conduct of studies involving their peers.
    (d) Consultation with practitioners other than physicians. To the 
extent practicable, a QIO must consult with nurses and other 
professional health care practitioners (other than physicians defined in 
1861(r) (1) and (2) of the Act) and with representatives of 
institutional and noninstitutional providers and suppliers with respect 
to the QIO's responsibility for review.

[50 FR 15330, Apr. 17, 1985; 50 FR 41886, Oct. 16, 1985. Redesignated at 
64 FR 66279, Nov. 24, 1999]



Sec.  476.104  Coordination of activities.

    In order to achieve efficient and economical review, a QIO must 
coordinate its activities (including information exchanges) with the 
activities of--
    (a) Medicare administrative contractors, fiscal intermediaries, and 
carriers.
    (b) Other QIOs; and
    (c) Other public or private review organizations as may be 
appropriate.

[50 FR 15330, Apr. 17, 1985, as amended at 77 FR 68561, Nov. 15, 2012]



Sec.  476.110  Use of immediate advocacy to resolve oral beneficiary
complaints.

    (a) Immediate advocacy. A QIO may offer the option of resolving an 
oral complaint through the use of immediate advocacy if:
    (1) The complaint is received not later than 6 months from the date 
on which the care giving rise to the complaint occurred.
    (2) After initial screening of the complaint, the QIO makes a 
preliminary determination that--
    (i) The complaint is unrelated to the clinical quality of health 
care itself but relates to items or services that accompany or are 
incidental to the medical care and are provided by a practitioner and/or 
provider; or
    (ii) The complaint, while related to the clinical quality of health 
care received by the beneficiary, does not rise to the level of being a 
gross and flagrant, substantial, or significant quality of care concern.
    (3) The beneficiary agrees to the disclosure of his or her name to 
the involved provider and/or practitioner.
    (4) All parties orally consent to the use of immediate advocacy.
    (5) All parties agree to the limitations on redisclosure set forth 
in Sec.  480.107 of this subchapter.
    (b) Discontinuation of immediate advocacy. The QIO or either party 
may discontinue participation in immediate advocacy at any time.
    (1) The QIO must inform the parties that immediate advocacy will be 
discontinued; and
    (2) The beneficiary must be informed of his or her right to submit a 
written complaint in accordance with the procedures in Sec.  476.120.
    (c) Confidentiality requirements. All communications, written and 
oral, exchanged during the immediate advocacy process must not be 
redisclosed without the written consent of all parties.
    (d) Abandoned complaints. If any party fails to participate or 
otherwise comply with the requirements of the immediate advocacy 
process, the QIO may determine that the complaint has been abandoned 
and--
    (1) Inform the parties that immediate advocacy will be discontinued; 
and
    (2) Inform the Medicare beneficiary of his or her right to submit a 
written complaint in accordance with the procedures in Sec.  476.120.

[77 FR 68561, Nov. 15, 2012]



Sec.  476.120  Submission of written beneficiary complaints.

    (a) Timeframe for submission of written complaints. A QIO shall be 
responsible for conducting a review of any written complaint received 
from a Medicare beneficiary or a Medicare beneficiary's representative 
about the quality of health care if the complaint is received not later 
than 3 years from the date on which the care giving rise to the 
complaint occurred.
    (1) A written complaint includes a complaint submitted 
electronically to the QIO.
    (2) In those instances where a Medicare beneficiary contacts the QIO 
regarding a complaint but declines to

[[Page 710]]

submit the complaint in writing and immediate advocacy has not been 
offered, the QIO may complete a general quality of care review in 
accordance with Sec.  476.160 if the QIO makes a preliminary 
determination that the complaint involves a potential gross and 
flagrant, substantial or significant quality of care concern.
    (b) New concerns raised by a Medicare beneficiary. If a Medicare 
beneficiary raises new concerns relating to the same complaint after the 
completion of the interim initial determination in Sec.  476.130(c), the 
concerns will be processed as a new complaint. The QIO may process new 
concerns raised after the receipt of the written complaint as part of 
the same complaint, provided they are received prior to the completion 
of the interim initial determination. Even if a concern is received 
before the interim initial determination, the QIO can address it as a 
separate complaint if the QIO determines that this is warranted by the 
circumstances.

[77 FR 68561, Nov. 15, 2012]



Sec.  476.130  Beneficiary complaint review procedures.

    (a) Scope of the QIO review. In completing its review, the QIO shall 
consider any information and materials submitted by the Medicare 
beneficiary or his or her representative and any information submitted 
by the provider and/or practitioner. All information obtained by the QIO 
that fits within the definition of ``confidential information'' under 
Sec.  480.101, will be held by the QIO as confidential.
    (1) The QIO's review will focus on the episode of care from which 
the complaint arose and address the specific concerns identified by the 
beneficiary and any additional concerns identified by the QIO. The QIO 
may separate concerns into different complaints if the QIO determine 
that the concerns relate to different episodes of care.
    (2) The QIO will use evidence-based standards of care to the maximum 
extent practicable. If no standard of care exists, the QIO will use 
available norms, best practices and established guidelines to establish 
the standard that will be used in completing the review. The QIO's 
determination regarding the standard used is not subject to appeal.
    (b) Medical information requests. (1) Upon request by the QIO, a 
provider or practitioner must deliver all medical information requested 
in response to a Medicare beneficiary complaint within 14 calendar days 
of the request. A QIO is authorized to require the receipt of the 
medical information sooner if the QIO make a preliminary determination 
that the complaint involves a potential gross and flagrant or 
substantial quality of care concern as specified in part 1004 of this 
title and circumstances warrant earlier receipt of the medical 
information. A practitioner's or provider's failure to comply with the 
request for medical information within the established timeframe may 
result in the QIO taking action in accordance with Sec.  476.90.
    (2) In requesting medical information in response to a Medicare 
beneficiary complaint, the QIO must notify the practitioner and/or 
provider that the medical record is being requested in response to a 
beneficiary complaint, explain the practitioner's and/or provider's 
right to discuss the QIO's interim initial determination, and request 
the name of a contact person in order to ensure timely completion of the 
discussion.
    (c) Interim initial determination. The QIO peer reviewer will 
complete the review and the practitioner and/or provider will be 
notified of the interim initial determination within 10 calendar days of 
the receipt of all medical information.
    (1) A practitioner and provider will be notified by telephone of the 
opportunity to discuss the QIO's interim initial determination with the 
QIO in those situations where the peer reviewer determines that the 
quality of services does not meet professionally recognized standards of 
care for any concern in the complaint. The discussion must be held no 
later than 7 calendar days from the date of the initial offer.
    (2) The interim initial determination becomes the final initial 
determination if the discussion is not completed timely as a result of 
the practitioner's and/or provider's failure to respond.

[[Page 711]]

    (3) Written statements in lieu of a discussion must be received no 
later than 7 calendar days from the date of the initial offer.
    (4) In rare circumstances, the QIO may grant additional time to 
complete the discussion or submission of a written statement in lieu of 
a discussion.
    (d) Final initial determination. The QIO must issue written 
notification of its final initial determination in those cases in which 
the QIO has determined that care met professionally recognized 
standards, as well as in those cases in which the QIO determined that 
standards were not met and the opportunity for discussion has been 
completed.
    (1) No later than 3 business days after completion of its review, or 
for cases in which the standard was not met, no later than 3 business 
days after the discussion or receipt of the provider's and/or 
practitioner's written statement, the QIO will notify (by telephone) the 
beneficiary and the provider/practitioner of its final initial 
determination and of the right to request a reconsideration of the QIO's 
final initial determination.
    (2) Written notice of the QIO's final initial determination will be 
forwarded to all parties within 5 calendar days after completion of its 
review, and must include:
    (i) A statement for each concern that care did or did not meet the 
standard of care;
    (ii) The standard identified by the QIO for each of the concerns; 
and
    (iii) A summary of the specific facts that the QIO determines are 
pertinent to its findings, including references to medical information 
and, if held, the discussion with the involved practitioner and/or 
provider.

[77 FR 68561, Nov. 15, 2012]



Sec.  476.140  Beneficiary complaint reconsideration procedures.

    (a) Right to request a reconsideration. Beginning with complaints 
filed after July 31, 2014, a Medicare beneficiary, a provider, or a 
practitioner who is dissatisfied with a QIO's final initial 
determination may request a reconsideration by the QIO.
    (1) The reconsideration request must be received by the QIO, in 
writing or by telephone, no later than 3 calendar days following initial 
notification of the QIO's determination. If the QIO is unable to accept 
a request, the request must be submitted by noon of the next day the QIO 
is available to accept a request.
    (2) The Medicare beneficiary, or his or her representative, and the 
practitioner and/or provider must be available to answer any questions 
or supply any information that the QIO requests in order to conduct its 
reconsideration.
    (3) The QIO must offer the Medicare beneficiary and the practitioner 
and/or provider an opportunity to provide further information. A 
Medicare beneficiary, a practitioner, and a provider may, but are not 
required to, submit evidence to be considered by the QIO in making its 
reconsideration decision.
    (b) Issuance of the QIO's final decision. No later than 5 calendar 
days after receipt of the request for a reconsideration, or, if later, 5 
calendar days after receiving any medical or other records needed for 
such reconsideration, the QIO must complete the review and notify the 
beneficiary and the practitioner/provider of its decision.
    (1) The QIO's initial notification may be done by telephone, 
followed by the mailing of a written notice by noon of the next calendar 
day that includes--
    (i) A statement for each concern that care did or did not meet the 
standard of care;
    (ii) The standard identified by the QIO for each of the concerns;
    (iii) A summary of the specific facts that the QIO determines are 
pertinent to its findings; and
    (iv) A statement that the letter represents the QIO's final 
determination and that there is no right to further appeal.
    (2) The QIO may provide information to the beneficiary, 
practitioner, and provider regarding opportunities for improving the 
care given to patients based on the specific findings of its review and 
the development of quality improvement initiatives.

[77 FR 68561, Nov. 15, 2012]



Sec.  476.150  Abandoned complaints and reopening rights.

    (a) Abandoned complaints. If a Medicare beneficiary fails to 
participate or

[[Page 712]]

otherwise comply with the requirements of the beneficiary complaint 
review process and the QIO does not have sufficient information to 
complete its review, the QIO may determine that the complaint has been 
abandoned and--
    (1) Inform the parties that its complaint review will be 
discontinued; and
    (2) Inform the beneficiary of his or her right to resubmit a written 
complaint in accordance with the procedures in Sec.  476.120.
    (b) Reopening complaint reviews. A QIO may reopen a Medicare 
beneficiary complaint review using the same procedures that the QIO 
would use for reopening initial denial determinations and changes as a 
result of DRG validation, as described in Sec.  476.96.

[77 FR 68561, Nov. 15, 2012]



Sec.  476.160  General quality of care review procedures.

    (a) Scope of the QIO review. A QIO may conduct a general quality of 
care review in accordance with section 1154(a)(1)(B) of the Act.
    (1) A QIO may conduct general quality of care reviews based on--
    (i) Concerns identified during the course of other QIO review 
activities;
    (ii) Referrals from other sources, including but not limited to 
individuals, contractors, other Federal or State agencies; or
    (iii) Analysis of data.
    (2) The QIO's review will focus on all concerns identified by the 
QIO and/or identified by those who have referred or reported the 
concerns, with consideration being given to the episode of care related 
to the concerns.
    (3) The QIO will use evidence-based standards of care to the maximum 
extent practicable. If no standard of care exists, the QIO must use 
available norms, best practices, and established guidelines to establish 
the standard that will be used in completing the review. The QIO's 
determination regarding the standard used is not subject to appeal.
    (b) Medical information requests. Upon request by the QIO, a 
provider or practitioner must deliver all medical information requested 
within 14 calendar days of the request. A QIO is authorized to require 
the receipt of the medical information sooner if the QIO makes a 
preliminary determination that the review involves a potential gross and 
flagrant or substantial quality of care concern and circumstances 
warrant earlier receipt of the medical information. A practitioner's or 
provider's failure to comply with the request for medical information 
within the established timeframe may result in the QIO taking action in 
accordance with Sec.  476.90.
    (c) Initial determination. The QIO peer reviewer will complete the 
review and the practitioner and/or provider will be notified of the 
initial determination in writing within 10 calendar days of the receipt 
of all medical information.

[77 FR 68561, Nov. 15, 2012]



Sec.  476.170  General quality of care reconsideration procedures.

    (a) Right to request a reconsideration. Beginning with reviews 
initiated after July 31, 2014, a provider or practitioner who is 
dissatisfied with a QIO's initial determination may request a 
reconsideration by the QIO.
    (1) The reconsideration request must be received by the QIO, in 
writing or by telephone, by no later than 3 calendar days following 
receipt of the QIO's initial determination. If the QIO is unable to 
accept the request, the request must be submitted by noon of the next 
day the QIO is available to accept a request.
    (2) The practitioner or provider must be available to answer any 
questions or supply any information that the QIO requests in order to 
conduct its reconsideration.
    (3) The QIO must offer the practitioner or provider an opportunity 
to provide further information. A practitioner or provider may, but is 
not required to, submit evidence to be considered by the QIO in making 
its reconsideration decision.
    (b) Issuance of the QIO's final decision. No later than 5 calendar 
days after receipt of the request for a reconsideration, or, if later, 5 
calendar days after receiving any medical or other records needed for 
such reconsideration, the QIO must complete the review and notify the 
practitioner or provider of its decision.

[[Page 713]]

    (1) The QIO's initial notification may be done by telephone, 
followed by the mailing of a written notice by noon the next calendar 
day that includes:
    (i) A statement for each concern that care did or did not meet the 
standard of care;
    (ii) The standard identified by the QIO for each of the concerns;
    (iii) A summary of the specific facts that the QIO determines are 
pertinent to its findings; and
    (iv) A statement that the letter represents the QIO's final 
determination and that there is no right to further appeal.
    (2) The QIO may provide information regarding opportunities for 
improving the care given to patients based on the specific findings of 
its review.

[77 FR 68561, Nov. 15, 2012]



PART 478_RECONSIDERATIONS AND APPEALS--Table of Contents



Subpart A [Reserved]

     Subpart B_Utilization and Quality Control Quality Improvement 
             Organization (QIO) Reconsiderations and Appeals

Sec.
478.10 Scope.
478.12 Statutory basis.
478.14 Applicability.
478.15 QIO review of changes resulting from DRG validation.
478.16 Right to reconsideration.
478.18 Location for submitting requests for reconsideration.
478.20 Time limits for requesting reconsideration.
478.22 Good cause for late filing of a request for a reconsideration or 
          hearing.
478.24 Opportunity for a party to obtain and submit information.
478.26 Delegation of the reconsideration function.
478.28 Qualifications of a reconsideration reviewer.
478.30 Evidence to be considered by the reconsideration reviewer.
478.32 Time limits for issuance of the reconsidered determination.
478.34 Notice of a reconsidered determination.
478.36 Record of reconsideration.
478.38 Effect of a reconsidered determination.
478.40 Beneficiary's right to a hearing.
478.42 Submitting a request for a hearing.
478.44 Determining the amount in controversy for a hearing.
478.46 Medicare Appeals Council and judicial review.
478.48 Reopening and revision of a reconsidered determination or a 
          decision.

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

Subpart A [Reserved]



     Subpart B_Utilization and Quality Control Quality Improvement 
             Organization (QIO) Reconsiderations and Appeals

    Source: 50 FR 15372, Apr. 17, 1985, unless otherwise noted. 
Redesignated at 64 FR 66279, Nov. 24, 1999.



Sec.  478.10  Scope.

    This subpart establishes the requirements and procedures for--
    (a) Reconsiderations conducted by a Utilization and Quality Control 
Quality Improvement Organization (QIO) or its subcontractor of initial 
denial determinations concerning services furnished or proposed to be 
furnished under Medicare;
    (b) Hearings and judicial review of reconsidered determinations; and
    (c) QIO review of a change in diagnostic and procedural coding 
information.

[50 FR 15372, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985. Redesignated at 
64 FR 66279, Nov. 24, 1999]



Sec.  478.12  Statutory basis.

    (a) Under section 1154 of the Act, a QIO may make an initial 
determination that services furnished or proposed to be furnished are 
not reasonable, necessary, or delivered in the most appropriate setting.
    (b) Under section 1155 of the Act, the following rules apply:
    (1) A Medicare beneficiary, a provider, or an attending practitioner 
who is dissatisfied with an initial denial determination under paragraph 
(a) of this section is entitled to a reconsideration by the QIO that 
made that determination.
    (2) The beneficiary is also entitled to the following:

[[Page 714]]

    (i) A hearing by an administrative law judge if $200 or more is 
still in controversy after a reconsidered determination.
    (ii) Judicial review if $2000 or more is still in controversy after 
a final determination by the Department.
    (c) Under section 1866(a)(1)(F) of the Act, a hospital that is 
reimbursed by the Medicare program must maintain an agreement with a QIO 
under which the QIO reviews the validity of diagnostic information 
furnished by the hospital.

[50 FR 15372, Apr. 17, 1985, as amended at 60 FR 50442, Sept. 29, 1995. 
Redesignated at 64 FR 66279, Nov. 24, 1999]



Sec.  478.14  Applicability.

    (a) Basic provision. This subpart applies to reconsiderations and 
hearings of a QIO initial denial determination involving the following 
issues:
    (1) Reasonableness of services.
    (2) Medical necessity of services.
    (3) Appropriateness of the inpatient setting in which services were 
furnished or are proposed to be furnished.
    (b) Concurrent appeal. A reconsideration or hearing provided under 
this subpart fulfills the requirements of any other review, hearing, or 
appeal under the Act to which a party may be entitled with respect to 
the same issues.
    (c) Nonapplicability of rules to related determinations. (1) A QIO 
may not reconsider its decision whether to grant grace days.
    (2) Limitation of liability determinations on excluded coverage of 
certain services are made under section 1879 of the Act. Initial 
determinations under section 1879 and further appeals are governed by 
the reconsideration and appeal procedures in part 405, subpart I of this 
chapter for determinations under Medicare Part A and Part B. References 
in those subparts to initial and reconsidered determinations made by an 
intermediary, carrier or CMS should be read to mean initial and 
reconsidered determinations made by a QIO.

[50 FR 15372, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985. Redesignated at 
64 FR 66279, Nov. 24, 1999; 82 FR 5139, Jan. 17, 2017]



Sec.  478.15  QIO review of changes resulting from DRG validation.

    (a) General rules. (1) A provider or practitioner dissatisfied with 
a change to the diagnostic or procedural coding information made by a 
QIO as a result of DRG validation under section 1866(a)(1)(F) of the Act 
is entitled to a review of that change if--
    (i) The change caused an assignment of a different DRG; and
    (ii) Resulted in a lower payment.
    (2) A beneficiary may obtain a review of a QIO DRG coding change 
only if that change results in noncoverage of a furnished service.
    (3) The individual who reviews changes in DRG procedural or 
diagnostic information must be a physician, and the individual who 
reviews changes in DRG coding must be qualified through training and 
experience with ICD-9-CM coding.
    (b) Procedures. Procedures described in Sec. Sec.  478.18 through 
478.36 and 478.48(a) and (c) for a QIO reconsideration or reopening also 
apply to QIO review of a DRG coding change.
    (c) Finality of review. No additional review or appeal for matters 
governed by paragraph (a) of this section is available.

[50 FR 15372, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985. Redesignated at 
64 FR 66279, Nov. 24, 1999; 77 FR 68563, Nov. 15, 2012]



Sec.  478.16  Right to reconsideration.

    A beneficiary, provider or practitioner who is dissatisfied with a 
QIO initial denial determination on one of the issues specified in Sec.  
478.14 has a right to a reconsideration of that determination by the QIO 
that made the initial denial determination.

[50 FR 15330, Apr. 17, 1985, as amended at 77 FR 68563, Nov. 15, 2012]



Sec.  478.18  Location for submitting requests for reconsideration.

    (a) Beneficiaries. Except as provided in paragraph (c) of this 
section concerning requests for expedited reconsideration, a beneficiary 
who wishes to obtain a reconsideration must submit a written request to 
one of the following:
    (1) The QIO or the QIO subcontractor that made the initial 
determination.
    (2) An SSA District Office.

[[Page 715]]

    (3) A Railroad Retirement Board Office, if the beneficiary is a 
railroad retiree.
    (b) Others. A provider, physician or other practitioner that wishes 
to obtain reconsideration must submit a written request to the QIO or 
QIO subcontractor that made the initial determination.
    (c) Expedited reconsideration. A request for an expedited 
reconsideration of a preadmission denial determination must be submitted 
directly to the QIO.



Sec.  478.20  Time limits for requesting reconsideration.

    (a) Basic rules. (1) Except for a request for expedited 
reconsideration as provided in paragraph (c) of this section, or a late 
request with good cause under Sec.  478.22, a dissatisfied party must 
file a request for reconsideration within 60 days after receipt of the 
notice of an initial determination.
    (2) The date of receipt of the notice of the initial determination 
is presumed to be five days after the date on the notice, unless there 
is a reasonable showing to the contrary.
    (3) A request is considered filed on the date it is postmarked.
    (b) Late filing of request. A QIO will accept a request filed after 
60 days after receipt of the notice of the initial determination if the 
QIO finds under the criteria set forth in Sec.  478.22 that there was 
good cause for the party's failure to file a timely request.
    (c) Request for expedited reconsideration. A request for an 
expedited reconsideration under Sec.  478.18(c) must be submitted within 
three days after receipt of the notice of the initial denial 
determination.

[50 FR 15330, Apr. 17, 1985, as amended at 77 FR 68563, Nov. 15, 2012]



Sec.  478.22  Good cause for late filing of a request for a reconsideration
or hearing.

    (a) General Rule. In determining whether a party has good cause for 
not filing a request for reconsideration or hearing timely, the QIO or 
ALJ, respectively, must consider the following:
    (1) What circumstances kept the party from making the request on 
time.
    (2) Whether an action by the QIO misled the party.
    (3) Whether the party understood the requirements of the Act as 
affected by amendments to the Act, other legislation, or court 
decisions.
    (b) Examples. Examples of circumstances in which good cause may 
exist include, but are not limited to, the following:
    (1) A party was seriously ill and was prevented from requesting a 
reconsideration in person, through another person, or in writing.
    (2) There was a death or serious illness in a party's immediate 
family.
    (3) Important records were accidentally destroyed or damaged by fire 
or other cause.
    (4) A party made a diligent effort but could not find or obtain 
necessary relevent information within the appropriate time period.
    (5) A party requested additional information to further explain the 
determination within the time limit, and requested reconsideration 
within 60 days of receiving the explanation (or within 30 days for a 
Departmental Appeals Board hearing).
    (6) The QIO gave the party incorrect or incomplete information about 
when and how to request a reconsideration or hearing.
    (7) A party sent the request to another Government agency in good 
faith within the time limit, but the request did not reach an office 
authorized to receive the request until after the time period had 
expired.
    (8) Other unusual or unavoidable circumstances exist that--
    (i) Show that a party could not have known of the need to file 
timely; or
    (ii) Prevented a party from filing timely.

[50 FR 15372, Apr. 17, 1985, as amended at 61 FR 32349, June 24, 1996. 
Redesignated at 64 FR 66279, Nov. 24, 1999]



Sec.  478.24  Opportunity for a party to obtain and submit information.

    (a) Subject to the rules concerning disclosure of QIO information in 
section 1160 of the Act, at the request of a provider, practitioner or 
beneficiary, the QIO must provide an opportunity for examination of the 
material upon which the initial denial determination

[[Page 716]]

was based. The QIO may not furnish a provider, practitioner or 
beneficiary with--
    (1) A record of the QIO deliberation; or
    (2) The identity of the QIO review coordinators, physician advisors, 
or consultants who assisted in the initial denial determination without 
their consent.
    (b) The QIO may require the requester to pay a reasonable fee for 
the reproduction of the material requested.
    (c) The QIO must provide a party with an opportunity to submit new 
evidence before the reconsidered determination is made.



Sec.  478.26  Delegation of the reconsideration function.

    A QIO may delegate the authority to reconsider an initial 
determination to a nonfacility subcontractor, including the organization 
that made the initial determination as a QIO subcontractor.



Sec.  478.28  Qualifications of a reconsideration reviewer.

    A reconsideration reviewer must be someone who is--
    (a) Qualified under Sec.  476.98 of this chapter to make an initial 
determination.
    (b) Not the individual who made the initial denial determination.
    (c) A specialist in the type of services under review, except where 
meeting this requirement would compromise the effectiveness or 
efficiency of QIO review.

[50 FR 15330, Apr. 17, 1985, as amended at 77 FR 68563, Nov. 15, 2012]



Sec.  478.30  Evidence to be considered by the reconsideration reviewer.

    A reconsidered determination must be based on--
    (a) The information that led to the initial determination;
    (b) New information found in the medical records; or
    (c) Additional evidence submitted by a party.



Sec.  478.32  Time limits for issuance of the reconsidered determination.

    (a) Beneficiaries. If a beneficiary files a timely request for 
reconsideration of an initial denial determination, the QIO must 
complete its reconsidered determination and send written notice to the 
beneficiary within the following time limits--
    (1) Within three working days after the QIO receives the request for 
reconsideration if--
    (i) The beneficiary is still an inpatient in a hospital for the stay 
in question when the QIO receives the request for reconsideration; or
    (ii) The initial determination relates to institutional services for 
which admission to the institution is sought, the initial determination 
was made before the patient was admitted to the institution; and a 
request was submitted timely for an expedited reconsideration.
    (2) Within 10 working days after the QIO receives the request for 
reconsideration if the beneficiary is still an inpatient in a SNF for 
the stay in question when the QIO receives the request for 
reconsideration.
    (3) Within 30 working days after the QIO receives the request for 
reconsideration if--
    (i) The initial determination concerns ambulatory or 
noninstitutional services;
    (ii) The beneficiary is no longer an inpatient in a hospital or SNF 
for the stay in question; or
    (iii) The beneficiary does not submit a request for expedited 
reconsideration timely.
    (b) Providers or practitioners. If the provider or practitioner 
files a request for reconsideration of an initial determination, the QIO 
must complete its reconsidered determination and send written notice to 
the provider or practitioner within 30 working days.



Sec.  478.34  Notice of a reconsidered determination.

    (a) Notice to parties. A written notice of a QIO reconsidered 
determination must contain the following;
    (1) The basis for the reconsidered determination.
    (2) A detailed rationale for the reconsidered determination.
    (3) A statement explaining the Medicare payment consequences of the 
reconsidered determination.

[[Page 717]]

    (4) A statement informing the parties of their appeal rights, 
including the information concerning what must be included in the 
request for hearing, the amount in controversy, locations for submitting 
a request for an administrative hearing and the time period for filing a 
request.
    (b) Notice to payers. (1) A QIO must provide written notice of its 
reconsidered determination to the appropriate Medicare intermediary or 
carrier within 30 days if the initial determination is modified or 
reversed.
    (2) This notice must contain adequate information to allow the 
intermediary or carrier to locate the claim file. This must include the 
name of the beneficiary, the Health Insurance Claim Number, the name of 
the provider, date of admission, and dates or services for which 
Medicare payment will not be made.



Sec.  478.36  Record of reconsideration.

    (a) QIO requirements. A QIO must maintain the record of its 
reconsideration until the later of the following:
    (1) Four years after the date on the notice of the QIO's 
reconsidered determination.
    (2) Completion of litigation and the passage of the time period for 
filing all appeals.
    (b) Contents of the record. The record of the reconsideration must 
include:
    (1) The initial determination.
    (2) The basis for the initial determination.
    (3) Documentation of the date of the receipt of the request for 
reconsideration.
    (4) The detailed basis for the reconsidered determination.
    (5) Evidence submitted by the parties.
    (6) A copy of the notice of the reconsidered determination that was 
provided to the parties.
    (7) Documentation of the delivery or mailing and, if appropriate, 
the receipt of the notice of the reconsidered determination by the 
parties.
    (c) Confidentiality. The record of a QIO reconsideration is subject 
to prohibitions against disclosure of information as specified in 
section 1160 of the Act.



Sec.  478.38  Effect of a reconsidered determination.

    A QIO reconsidered determination is binding upon all parties to the 
reconsideration unless--
    (a) A hearing is requested in accordance with Sec.  478.40 and a 
final decision rendered; or
    (b) The reconsidered determination is later reopened and revised in 
accordance with Sec.  478.48.

[50 FR 15372, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985, as amended at 
62 FR 25855, May 12, 1997; 62 FR 49938, Sept. 24, 1997. Redesignated at 
64 FR 66279, Nov. 24, 1999; 77 FR 68563, Nov. 15, 2012]



Sec.  478.40  Beneficiary's right to a hearing.

    (a) Amount in controversy. If the amount in controversy is at least 
$200, a beneficiary (but not a provider or practitioner) who is 
dissatisfied with a QIO reconsidered determination may request a hearing 
by an administrative law judge (ALJ) of the Office of Medicare Hearings 
and Appeals (OMHA).
    (b) Subject matter. A beneficiary has a right to a hearing on the 
following issues:
    (1) Reasonableness of the services.
    (2) Medical necessity of the services.
    (3) Appropriateness of the setting in which the services were 
furnished.
    (c) Governing provisions. (1) The provisions of subpart I of part 
405 of this chapter apply to hearings and appeals under this subpart 
unless they are inconsistent with specific provisions in this subpart or 
specified in paragraph (c)(2) of this section. Except as provided in 
paragraph (c)(2) of this section, references in subpart I to initial 
determinations made by a Medicare contractor and reconsiderations made 
by a QIC should be read to mean initial determinations and reconsidered 
determinations made by a QIO.
    (2) The following part 405 regulations, and any references thereto, 
specifically do not apply under this subpart:
    (i) Section 405.950 (time frames for making a redetermination).
    (ii) Section 405.970 (time frames for making a reconsideration 
following a contractor redetermination, including the option to escalate 
an appeal to the OMHA level).

[[Page 718]]

    (iii) Section 405.1016 (time frames for deciding an appeal of a QIC 
reconsideration, or escalated request for a QIC reconsideration, 
including the option to escalate an appeal to the Council).
    (iv) The option to request that an appeal be escalated from the OMHA 
level to the Council as provided in Sec.  405.1100(b), and time frames 
for the Council to decide an appeal of an ALJ's or attorney 
adjudicator's decision or an appeal that is escalated from the OMHA 
level to the Council as provided in Sec.  405.1100(c) and (d).
    (v) Section 405.1132 (request for escalation to Federal court).
    (vi) Sections 405.956(b)(8), 405.966(a)(2), 405.976(b)(5)(ii), 
405.1018(c), 405.1028(a), and 405.1122(c), and any other reference to 
requiring a determination of good cause for the introduction of new 
evidence by a provider, supplier, or a beneficiary represented by a 
provider or supplier.

[50 FR 15372, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985. Redesignated at 
64 FR 66279, Nov. 24, 1999; 82 FR 5139, Jan. 17, 2017]



Sec.  478.42  Submitting a request for a hearing.

    (a) Where to submit the written request. A beneficiary who wants to 
obtain a hearing under Sec.  478.40 must submit a written request to the 
OMHA office identified in the notice of the QIO reconsidered 
determination.
    (b) Time limit for submitting a request for a hearing. (1) The 
request for a hearing must be filed within 60 calendar days of receipt 
of the notice of the QIO reconsidered determination, unless the time is 
extended for good cause as provided in Sec.  478.22.
    (2) The date of receipt of the notice of the reconsidered 
determination is presumed to be 5 calendar days after the date on the 
notice, unless there is evidence to the contrary.
    (3) A request is considered filed on the date it is received by 
OMHA.

[82 FR 5139, Jan. 17, 2017]



Sec.  478.44  Determining the amount in controversy for a hearing.

    (a) After an individual appellant has submitted a request for a 
hearing, the ALJ or attorney adjudicator determines the amount in 
controversy in accordance with Sec.  405.1006(d) and (e) of this 
chapter. When two or more appellants submit a request for hearing, the 
ALJ or attorney adjudicator determines the amount in controversy in 
accordance with Sec.  405.1006(d) and (e) of this chapter.
    (b) If the ALJ or attorney adjudicator determines that the amount in 
controversy is less than $200, the ALJ, without holding a hearing, or 
attorney adjudicator notifies the parties that the parties have 15 
calendar days to submit additional evidence to prove that the amount in 
controversy is at least $200.
    (c) At the end of the 15-day period, if an ALJ determines that the 
amount in controversy is less than $200, the ALJ, without holding a 
hearing dismisses the request for a hearing without ruling on the 
substantive issues involved in the appeal and notifies the parties and 
the QIO that the QIO reconsidered determination is conclusive for 
Medicare payment purposes.

[82 FR 5139, Jan. 17, 2017]



Sec.  478.46  Medicare Appeals Council and judicial review.

    (a) The circumstances under which the Medicare Appeals Council 
(Council) will review an ALJ's or attorney adjudicator's decision or 
dismissal are the same as those set forth at Sec. Sec.  405.1102 
(``Request for Council review when ALJ or attorney adjudicator issues 
decision or dismissal'') and 405.1110 (``Council reviews on its own 
motion'') of this chapter.
    (b) If $2,000 or more is in controversy, a party may obtain judicial 
review of a Council decision, or an ALJ's or attorney adjudicator's 
decision if a request for review by the Council was denied, by filing a 
civil action under the Federal Rules of Civil Procedure within 60 days 
after the date the party received notice of the Council decision or 
denial.

[82 FR 5140, Jan. 17, 2017]



Sec.  478.48  Reopening and revision of a reconsidered determination 
or a decision.

    (a) QIO reopenings--(1) General rule. A QIO or QIO subcontractor 
that made a

[[Page 719]]

reconsidered determination, or conducted a review of a DRG change as 
described in Sec.  478.15, that is otherwise binding, may reopen and 
revise the reconsidered determination or review, either on its own 
motion or at the request of a party, within one year from the date of 
the reconsidered determination or review.
    (2) Extension of time limit. A QIO or QIO subcontractor may reopen 
and revise its reconsidered determination, or its review of a DRG change 
as described in Sec.  478.15, that is otherwise binding, after one year 
but within four years of the date of the determination or review if--
    (i) The QIO receives new material evidence;
    (ii) The QIO erred in interpretation or application of Medicare 
coverage policy;
    (iii) There is an error apparent on the face of the evidence upon 
which the reconsidered determination was based; or
    (iv) There is a clerical error in the statement of the reconsidered 
determination.
    (b) ALJ or attorney adjudicator and Council Reopening--Applicable 
procedures. The ALJ or attorney adjudicator, or the Council, whichever 
made the decision, may reopen and revise the decision in accordance with 
the procedures set forth in Sec.  405.980 of this chapter, which 
concerns reopenings and revised decisions under subpart I of part 405 of 
this chapter.
    (c) Fraud or similar abusive practice. A reconsidered determination, 
a review of a DRG change, or a decision of an ALJ or attorney 
adjudicator, or the Council may be reopened and revised at any time, if 
the reconsidered determination, review, or decision was obtained through 
fraud or a similar abusive practice that does not support a formal 
finding of fraud.

[50 FR 15372, Apr. 17, 1985, as amended at 61 FR 32349, June 24, 1996; 
62 FR 25855, May 12, 1997. Redesignated at 64 FR 66279, Nov. 24, 1999; 
77 FR 68563, Nov. 15, 2012; 82 FR 5140, Jan. 17, 2017]



PART 480_ACQUISITION, PROTECTION, AND DISCLOSURE OF QUALITY IMPROVEMENT
ORGANIZATION INFORMATION--Table of Contents



Subpart A [Reserved]

     Subpart B_Utilization and Quality Control Quality Improvement 
                          Organizations (QIOs)

                           General Provisions

Sec.
480.101 Scope and definitions.
480.102 Statutory bases for acquisition and maintenance of information.
480.103 Statutory bases for disclosure of information.
480.104 Procedures for disclosure by a QIO.
480.105 Notice of disclosures made by a QIO.
480.106 Exceptions to QIO notice requirements.
480.107 Limitations on redisclosure.
480.108 Penalties for unauthorized disclosure.
480.109 Applicability of other statutes and regulations.

                        QIO Access to Information

480.111 QIO access to records and information of institutions and 
          practitioners.
480.112 QIO access to records and information of intermediaries and 
          carriers.
480.113 QIO access to information collected for QIO purposes.
480.114 Limitations on data collection.

                          QIO Responsibilities

480.115 Requirements for maintaining confidentiality.
480.116 Notice to individuals and institutions under review.

                Disclosure of Nonconfidential Information

480.120 Information subject to disclosure.
480.121 Optional disclosure of nonconfidential information.

                 Disclosure of Confidential Information

480.130 Disclosure to the Department.
480.131 Access to medical records for the monitoring of QIOs.
480.132 Disclosure of information about patients.
480.133 Disclosure of information about practitioners, reviewers and 
          institutions.
480.134 Verification and amendment of QIO information.
480.135 Disclosure necessary to perform review responsibilities.
480.136 Disclosure to intermediaries and carriers.
480.137 Disclosure to Federal and State enforcement agencies responsible 
          for the

[[Page 720]]

          investigation or identification of fraud or abuse of the 
          Medicare or Medicaid programs.
480.138 Disclosure for other specified purposes.
480.139 Disclosure of QIO deliberations and decisions.
480.140 Disclosure of quality review study information.
480.141 Disclosure of QIO interpretations on the quality of health care.
480.142 Disclosure of sanction reports.
480.143 QIO involvement in shared health data systems.
480.144 Access to QIO data and information.
480.145 Beneficiary authorization of use of confidential information.

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

Subpart A [Reserved]



     Subpart B_Utilization and Quality Control Quality Improvement 
                          Organizations (QIOs)

    Source: 50 FR 15359, Apr. 17, 1985, unless otherwise noted. 
Redesignated at 64 FR 66279, Nov. 24, 1999.

                           General Provisions



Sec.  480.101  Scope and definitions.

    (a) Scope. This subpart sets forth the policies and procedures 
governing--
    (1) Disclosure of information collected, acquired or generated by a 
Utilization and Quality Control Quality Improvement Organization (QIO) 
(or the review component of a QIO subcontractor) in performance of its 
responsibilities under the Act and these regulations; and
    (2) Acquisition and maintenance of information by a QIO to comply 
with its responsibilities under the Act.
    (b) Definitions. As used in this part:
    Abuse means any unlawful conduct relating to items or services for 
which payment is sought under Title XVIII of the Act.
    Aggregate statistical data means any utilization, admission, 
discharge or diagnostic related group (DRG) data arrayed on a 
geographic, institutional or other basis in which the volume and 
frequency of services are shown without identifying any individual.
    Confidential information means any of the following:
    (1) Information that explicitly or implicitly identifies an 
individual patient, practitioner or reviewer.
    (2) Sanction reports and recommendations.
    (3) Quality review studies which identify patients, practitioners or 
institutions.
    (4) QIO deliberations.
    Health care facility or facility means an organization involved in 
the delivery of health care services or items for which reimbursement 
may be made in whole or in part under Title XVIII of the Act.
    Implicitly identify(ies) means data so unique or numbers so small so 
that identification of an individual patient, practitioners or reviewer 
would be obvious.
    Non-facility organization means a corporate entity that: (1) Is not 
a health care facility; (2) is not a 5 percent or more owner of a 
facility; and (3) is not owned by one or more health care facilities in 
the QIO area.
    Patient representative means--(1) an individual designated by the 
patient, in writing, as authorized to request and receive QIO 
information that would otherwise be disclosable to that patient; or (2) 
an individual identified by the QIO in accordance with Sec.  
480.132(c)(3) when the beneficiary is mentally, physically or legally 
unable to designate a representative.
    Practitioner means an individual credentialed within a recognized 
health care discipline and involved in providing the services of that 
discipline to patients.
    Public information means information which has been disclosed to the 
public.
    QIO deliberations means discussions or communications (within a QIO 
or between a QIO and a QIO subcontractor) including, but not limited to, 
review notes, minutes of meetings and any other records of discussions 
and judgments involving review matters regarding QIO review 
responsibilities and appeals from QIO determinations, in which the 
opinions of, or judgment about, a particular individual or institution 
can be discerned.
    QIO information means any data or information collected, acquired or 
generated by a QIO in the exercise of its

[[Page 721]]

duties and functions under Title XI Part B or Title XVIII of the Act.
    QIO interpretations and generalizations on the quality of health 
care means an assessment of the quality of care furnished by an 
individual provider or group of providers based on the QIO's knowledge 
of the area gained from its medical review experience (e.g., quality 
review studies) and any other information obtained through the QIO's 
review activities.
    QIO review system means the QIO and those organizations and 
individuals who either assist the QIO or are directly responsible for 
providing medical care or for making determinations with respect to the 
medical necessity, appropriate level and quality of health care services 
that may be reimbursed under the Act. The system includes--
    (1) The QIO and its officers, members and employees;
    (2) QIO subcontractors;
    (3) Health care institutions and practitioners whose services are 
reviewed;
    (4) QIO reviewers and supporting staff;
    (5) Data support organizations; and
    (6) CMS.
    Quality review study means an assessment, conducted by or for a QIO, 
of a patient care problem for the purpose of improving patient care 
through peer analysis, intervention, resolution of the problem and 
follow-up.
    Quality review study information means all documentation related to 
the quality review study process.
    Reviewer means review coordinator, physician, or other person 
authorized to perform QIO review functions.
    Sanction report means a report filed pursuant to section 1156 of the 
Act and part 474 of this chapter documenting the QIO's determination 
that a practitioner or institution has failed to meet obligations 
imposed by section 1156 of the Act.
    Shared health data system means an agency or other entity authorized 
by Federal or State law that is used by the QIO review system to provide 
information or to conduct or arrange for the collection, processing, and 
dissemination of information on health care services.
    Subcontractor means a facility or a non-facility organization under 
contract with a QIO to perform QIO review functions.

[50 FR 15359, Apr. 17, 1985; 50 FR 41886, Oct. 16, 1985. Redesignated at 
64 FR 66279, Nov. 24, 1999; 69 FR 49267, Aug. 11, 2004; 76 FR 26546, May 
6, 2011]



Sec.  480.102  Statutory bases for acquisition and maintenance of
information.

    (a) Section 1154(a)(7)(C) of the Act requires QIOs to the extent 
necessary and appropriate to examine the pertinent records of any 
practitioner or provider of health care services for which payment may 
be made under Title XVIII of the Act.
    (b) Section 1154(a)(9) of the Act requires QIOs to collect and 
maintain information necessary to carry out their responsibilities under 
the Act.
    (c) Section 1156(a)(3) of the Act requires health care practitioners 
and providers to maintain evidence of the medical necessity and quality 
of health care services they provide to Medicare patients as required by 
QIOs.



Sec.  480.103  Statutory bases for disclosure of information.

    (a) Section 1154(a)(10) of the Act requires QIOs to exchange 
information with intermediaries and carriers with contracts under 
sections 1816 and 1842 of the Act, other QIOs, and other public or 
private review organizations as appropriate.
    (b) Section 1160 of the Act provides that QIO information must be 
held in confidence and not be disclosed except where--
    (1) Necessary to carry out the purpose of Title XI Part B of the 
Act;
    (2) Specifically permitted or required under this subpart;
    (3) Necessary, and in the manner prescribed under this subpart, to 
assist Federal and State agencies recognized by the Secretary as having 
responsibility for identifying and investigating cases or patterns of 
fraud or abuse;
    (4) Necessary, and in the manner prescribed under the subpart to 
assist Federal or State agencies recognized by the Secretary as having 
responsibility for identifying cases or patterns involving risks to the 
public health;

[[Page 722]]

    (5) Necessary, and in the manner prescribed under this subpart, to 
assist appropriate State agencies having responsibility for licensing or 
certification of providers or practitioners; or
    (6) Necessary, and in the manner prescribed under this subpart to 
assist Federal or State health planning agencies by furnishing them 
aggregate statistical data on a geographical, institutional or other 
basis.

[50 FR 15359, Apr. 17, 1985; 50 FR 41886, Oct. 16, 1985. Redesignated at 
64 FR 66279, Nov. 24, 1999]



Sec.  480.104  Procedures for disclosure by a QIO.

    (a) Notice to accompany disclosure. (1) Any disclosure of 
information under the authority of this subpart is subject to the 
requirements in Sec.  480.105 relating to the providing of a notice of 
the disclosure.
    (2) Disclosure of confidential information made under the authority 
of this subpart, except as provided in Sec.  480.106, must be 
accompanied by a written statement informing the beneficiary that the 
information may not be redisclosed except as provided under Sec.  
480.107 that limits redisclosure.
    (b) QIO interpretations. A QIO may provide a statement of comment, 
analysis, or interpretation to guide the beneficiary in using 
information disclosed under this subpart.
    (c) Fees. A QIO may charge a fee to cover the cost of providing 
information authorized under this subpart. These fees may not exceed the 
amount necessary to recover the cost to the QIO for providing the 
information.
    (d) Format for disclosure of public information. A QIO is required 
to disclose public information (Sec.  480.120(a)(6)) only in the form in 
which it is acquired by the QIO or in the form in which it is maintained 
for QIO use.
    (e) Medicare provider number. A QIO must include the provider 
identification number assigned by the Medicare program on information 
that CMS requests.

[50 FR 15359, Apr. 17, 1985. Redesignated at 64 FR 66279, Nov. 24, 1999, 
as amended at 69 FR 49267, Aug. 11, 2004]



Sec.  480.105  Notice of disclosures made by a QIO.

    (a) Notification of the disclosure of nonconfidential information. 
Except as permitted under Sec.  480.106, at least 30 calendar days 
before disclosure of nonconfidential information, the QIO must notify an 
identified institution of its intent to disclose information about the 
institution (other than reports routinely submitted to CMS or Medicare 
administrative contractors or fiscal intermediaries, or to or from QIO 
subcontractors, or to or from the institution) and provide the 
institution with a copy of the information. The institution may submit 
comments to the QIO that must be attached to the information disclosed 
if received before disclosure, or forwarded separately if received after 
disclosure.
    (b) Notification of the disclosure of confidential information. (1) 
A QIO must notify the practitioner who has treated a patient, of a 
request for disclosure to the patient or patient representative in 
accordance with the requirements and exceptions to the requirements for 
disclosure specified under Sec.  480.132.
    (2) A QIO must notify a practitioner or institution of the QIO's 
intent to disclose information on the practitioner or institution to an 
investigative or licensing agency (Sec. Sec.  480.137 and 480.138) 
except for cases specified in Sec.  480.106 involving fraud or abuse or 
imminent danger to individuals or the public health. The practitioner or 
institution must be notified and provided a copy of the information to 
be disclosed at least 30 calendar days before the QIO discloses the 
identifying information. The QIO must forward with the information any 
comments submitted by the practitioner or institution in response to the 
QIO notice if received before disclosure, or forwarded separately if 
received after disclosure.

[50 FR 15359, Apr. 17, 1985; 50 FR 41886, Oct. 16, 1985. Redesignated at 
64 FR 66279, Nov. 24, 1999, as amended at 69 FR 49267, Aug. 11, 2004; 77 
FR 68563, Nov. 15, 2012]



Sec.  480.106  Exceptions to QIO notice requirements.

    (a) Imminent danger to individuals or public health. When the QIO 
determines that requested information is necessary to protect against an 
imminent

[[Page 723]]

danger to individuals or the public health, the notification required in 
Sec.  480.105 may be sent simultaneously with the disclosure.
    (b) Fraud or Abuse. The notification requirement in Sec.  480.105 
does not apply if--
    (1) The disclosure is made in an investigation of fraud or abuse by 
the Office of the Inspector General or the General Accounting Office; or
    (2) The disclosure is made in an investigation of fraud or abuse by 
any other Federal or State fraud or abuse agency and the investigative 
agency specifies in writing that the information is related to a 
potentially prosecutable criminal offense.
    (c) Other. The notification requirements in Sec.  480.105(a) and 
(b)(2) do not apply if:
    (1) The institution or practitioner has requested, in writing, that 
the QIO make the disclosure;
    (2) The institution or practitioner has provided, in writing, 
consent for the disclosure; or
    (3) The information is public information as defined in Sec.  
480.101(b) and specified under Sec.  480.120.

[50 FR 15359, Apr. 17, 1985. Redesignated at 64 FR 66279, Nov. 24, 1999, 
as amended at 69 FR 49266, 49267, Aug. 11, 2004]



Sec.  480.107  Limitations on redisclosure.

    Persons or organizations that obtain confidential QIO information 
must not further disclose the information to any other person or 
organization except--
    (a) As directed by the QIO to carry out a disclosure permitted or 
required under a particular provision of this part;
    (b) As directed by CMS to carry out specific responsibilities of the 
Secretary under the Act;
    (c) As necessary for CMS to carry out its responsibilities for 
appeals under section 1155 of the Act or for CMS to process sanctions 
under section 1156 of the Act;
    (d) If the health care services furnished to an individual patient 
are reimbursed from more than one source, these sources of reimbursement 
may exchange confidential information as necessary for the payment of 
claims;
    (e) If the information is acquired by the QIO from another source 
and the receiver of the information is authorized under its own 
authorities to acquire the information directly from the source, the 
receiver may disclose the information in accordance with the source's 
redisclosure rules;
    (f) As necessary for the General Accounting Office to carry out its 
statutory responsibilities;
    (g) Information pertaining to a patient or practitioner may be 
disclosed by that individual provided it does not identify any other 
patient or practitioner;
    (h) An institution may disclose information pertaining to itself 
provided it does not identify an individual patient or practitioner;
    (i) Governmental fraud or abuse agencies and State licensing or 
certification agencies recognized by CMS may disclose information as 
necessary in a judicial, administrative or other formal legal proceeding 
resulting from an investigation conducted by the agency;
    (j) State and local public health officials to carry out their 
responsibilities, as necessary, to protect against a substantial risk to 
the public health; or
    (k) As necessary for the Office of the Inspector General to carry 
out its statutory responsibilities.
    (l) Redisclosures of information that is confidential because it 
identifies the parties involved in immediate advocacy may occur if all 
parties have consented to the redisclosure, as provided for under Sec.  
476.110(c) of this chapter.

[50 FR 15359, Apr. 17, 1985; 50 FR 41886, Oct. 16, 1985. Redesignated at 
64 FR 66279, Nov. 24, 1999; 77 FR 68564, Nov. 15, 2012]



Sec.  480.108  Penalties for unauthorized disclosure.

    A person who discloses information not authorized under Title XI 
Part B of the Act or the regulations of this part will, upon conviction, 
be fined no more than $1,000, or be imprisoned for no more than six 
months, or both, and will pay the costs of prosecution.



Sec.  480.109  Applicability of other statutes and regulations.

    The provisions of 42 U.S.C. 290dd-3 and 290ee-3 governing 
confidentiality of alcohol and drug abuse patients'

[[Page 724]]

records, and the implementing regulations at 42 CFR part 2, are 
applicable to QIO information.

[50 FR 15359, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985. Redesignated at 
64 FR 66279, Nov. 24, 1999]

                        QIO Access to Information



Sec.  480.111  QIO access to records and information of institutions 
and practitioners.

    (a) A QIO is authorized to have access to and obtain records and 
information pertinent to the health care services furnished to Medicare 
patients, held by any institution or practitioner in the QIO area. The 
QIO may require the institution or practitioner to provide copies of 
such records or information to the QIO.
    (b) A QIO may obtain non-Medicare patient records relating to review 
performed under a non-Medicare QIO contract if authorized by those 
patients in accordance with State law.
    (c) In accordance with its quality review responsibilities under the 
Act, a QIO may have access to and obtain information from, the records 
of non-Medicare patients if authorized by the institution or 
practitioner.
    (d)(1) When submitting patient records to the QIO under this 
section, the institution or practitioner must do so consistent with the 
requirements in Sec.  476.78(c) and (d) of this chapter.
    (2) Reimbursement to an institution or practitioner for the cost of 
providing patient records is paid in accordance with Sec.  476.78(e) of 
this chapter.

[50 FR 15359, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985. Redesignated at 
64 FR 66279, Nov. 24, 1999, as amended at 65 FR 83154, Dec. 29, 2000; 85 
FR 59026, Sept. 18, 2020]



Sec.  480.112  QIO access to records and information of intermediaries
and carriers.

    A QIO is authorized to have access to and require copies of Medicare 
records or information held by intermediaries or carriers if the QIO 
determines that the records or information are necessary to carry out 
QIO review responsibilities.



Sec.  480.113  QIO access to information collected for QIO purposes.

    (a) Institutions and other entities must disclose to the QIO 
information collected by them for QIO purposes.
    (b) Information collected or generated by institutions or 
practitioners to carry out quality review studies must be disclosed to 
the QIO.



Sec.  480.114  Limitation on data collection.

    A QIO or any agent, organization, or institution acting on its 
behalf, that is collecting information under authority of this part, 
must collect only that information which is necessary to accomplish the 
purposes of Title XI Part B of the Act in accordance with 44 U.S.C. 
Chapter 35, Coordination of Federal Reporting Services Information 
Policy.

                          QIO Responsibilities



Sec.  480.115  Requirements for maintaining confidentiality.

    (a) Responsibilities of QIO officers and employees. The QIO must 
provide reasonable physical security measures to prevent unauthorized 
access to QIO information and to ensure the integrity of the 
information, including those measures needed to secure computer files. 
Each QIO must instruct its officers and employees and health care 
institution employees participating in QIO activities of their 
responsibility to maintain the confidentiality of information and of the 
legal penalties that may be imposed for unauthorized disclosure of QIO 
information.
    (b) Responsible individuals within the QIO. The QIO must assign a 
single individual the responsibility for maintaining the system for 
assuring the confidentiality of information within the QIO review 
system. That individual must notify CMS of any violations of these 
regulations.
    (c) Training requirements. The QIO must train participants of the 
QIO review system in the proper handling of confidential information.
    (d) Authorized access. An individual participating in the QIO review 
system on a routine or ongoing basis must not have authorized access to 
confidential QIO information unless that individual--

[[Page 725]]

    (1) Has completed a training program in the handling of QIO 
information in accordance with paragraph (c) of this section or has 
received comparable training from another source; and
    (2) Has signed a statement indicating that he or she is aware of the 
legal penalties for unauthorized disclosure.
    (e) Purging of personal identifiers. (1) The QIO must purge or 
arrange for purging computerized information, patient records and other 
noncomputerized files of all personal identifiers as soon as it is 
determined by CMS that those identifiers are no longer necessary.
    (2) The QIO must destroy or return to the facility from which it was 
collected confidential information generated from computerized 
information, patient records and other noncomputerized files when the 
QIO determines that the maintenance of hard copy is no longer necessary 
to serve the specific purpose for which it was obtained or generated.
    (f) Data system procedures. The QIO must assure that organizations 
and consultants providing data services to the QIO have established 
procedures for maintaining the confidentiality of QIO information in 
accordance with requirements defined by the QIO and consistent with 
procedures established under this part.



Sec.  480.116  Notice to individuals and institutions under review.

    The QIO must establish and implement procedures to provide patients, 
practitioners, and institutions under review with the following 
information--
    (a) The title and address of the person responsible for maintenance 
of QIO information;
    (b) The types of information that will be collected and maintained;
    (c) The general rules governing disclosure of QIO information; and
    (d) The procedures whereby patients, practitioners, and institutions 
may obtain access to information about themselves.

                Disclosure of Nonconfidential Information



Sec.  480.120  Information subject to disclosure.

    Subject to the procedures for disclosure and notice of disclosure 
specified in Sec. Sec.  480.104 and 480.105, the QIO must disclose--
    (a) Nonconfidential information to any person upon request, 
including--
    (1) The norms, criteria, and standards it uses for initial screening 
of cases, and for other review activities;
    (2) Winning technical proposals for contracts from the Department, 
and winning technical proposals for subcontracts under those contracts 
(except for proprietary or business information);
    (3) Copies of documents describing administrative procedures, agreed 
to between the QIO and institutions or between a QIO and the Medicare 
intermediary or Medicare carrier;
    (4) Routine reports submitted by the QIO to CMS to the extent that 
they do not contain confidential information.
    (5) Summaries of the proceedings of QIO regular and other meetings 
of the governing body and general membership except for those portions 
of the summaries involving QIO deliberations, which are confidential 
information and subject to the provisions of Sec.  480.139;
    (6) Public information in its possession;
    (7) Aggregate statiscal information that does not implicitly or 
explicitly identify individual patients, practitioners or reviewers;
    (8) Quality review study information including summaries and 
conclusions from which the identification of patients, practitioners and 
institutions has been deleted; and
    (9) Information describing the characteristics of a quality review 
study, including a study design and methodology.
    (b) Aggregate statistical information that does not implicitly or 
explicitly identify individual patients, practitioners or reviewers, to 
Federal or State health planning agencies (including Health Systems 
Agencies and State Health Planning and Development

[[Page 726]]

Agencies) in carrying out their health care planning and related 
activities.

[50 FR 15359, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985. Redesignated at 
64 FR 66279, Nov. 24, 1999, as amended at 69 FR 49267, Aug. 11, 2004]



Sec.  480.121  Optional disclosure of nonconfidential information.

    A QIO may, on its own initiative, subject to the notification 
requirements in Sec.  480.105, furnish the information available under 
Sec.  480.120 to any person, agency, or organization.

[50 FR 15359, Apr. 17, 1985. Redesignated at 64 FR 66279, Nov. 24, 1999, 
as amended at 69 FR 49267, Aug. 11, 2004]

                 Disclosure of Confidential Information



Sec.  480.130  Disclosure to the Department.

    Except as limited by Sec.  480.139(a) and Sec.  480.140 of this 
subpart, QIOs must disclose to the Department all information requested 
by the Department in the manner and form requested. The information can 
include confidential and non-confidential information and requests can 
include those made by any component of the Department, such as CMS.

[76 FR 26547, May 6, 2011]



Sec.  480.131  Access to medical records for the monitoring of QIOs.

    CMS or any person, organization or agency authorized by the 
Department or Federal statute to monitor a QIO will have access to 
medical records maintained by institutions or health care practitioners 
on Medicare patients. The monitor can require copies of the records.



Sec.  480.132  Disclosure of information about patients.

    (a) General requirements for disclosure. Except as specified in 
Sec. Sec.  476.130(d) and 476.140(b) of this chapter and paragraph (b) 
of this section, a QIO must--
    (1) Disclose patient identified information in its possession to the 
identified patient or the patient's representative if--
    (i) The patient or the patient's representative requests the 
information in writing;
    (ii) The request by a patient's representative includes the 
designation, by the patient, of the representative; and
    (iii) Except as provided under paragraph (b) of this section, all 
other patient and practitioner identifiers have been removed.
    (2) Make disclosure to the patient or the patient's representative 
within 14 calendar days of receipt of the request.
    (b) Exceptions. (1) If a request for information is in connection 
with an initial denial determination under section 1154(a)(2) of the 
Act, the QIO must provide only the information used to support that 
determination in accordance with the procedures for disclosure of 
information related to determinations under Sec.  478.24, including 
relevant practitioner identifiers.
    (2) A QIO must disclose information regarding QIO deliberations only 
as specified in Sec.  480.139(a).
    (3) A QIO must disclose quality review study information only as 
specified in Sec.  480.140.
    (c) Manner of disclosure. (1) The QIO must disclose the patient 
information directly to the patient or the patient's representative when 
the representative has been authorized or appointed to receive that 
information.
    (2) In identifying a representative, the QIO must follow pertinent 
State law requirements regarding the designation of health care 
representatives and agents. If the patient is unable to designate a 
representative and the identity of the representative is not already 
dictated by State law, the QIO must disclose the information to a person 
whom the QIO determines is responsible for the patient.

[50 FR 15359, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985. Redesignated at 
64 FR 66279, Nov. 24, 1999, as amended at 69 FR 49267, Aug. 11, 2004; 77 
FR 68564, Nov. 15, 2012]



Sec.  480.133  Disclosure of information about practitioners, reviewers
and institutions.

    (a) General requirements for disclosure. Except as specified in 
paragraph (b) of this section, the following provisions are required of 
the QIO.

[[Page 727]]

    (1) Disclosure to the identified individual or institution. A QIO 
must disclose, to particular practitioners, reviewers and institutions, 
information about themselves, upon request, and may disclose it to them 
without a request.
    (2) Disclosure to others. (i) A QIO must disclose to an institution, 
upon request, information on a practitioner to the extent that the 
information displays practice or performance patterns of the 
practitioner in that institution.
    (ii) In accordance with section 1160 of the Act, a QIO must disclose 
information that displays practice or performance patterns of a 
practitioner or institution in accordance with the procedures for 
disclosures specified in Sec. Sec.  480.137 and 480.138 to--
    (A) Federal and State agencies that are responsible for the 
investigation of fraud and abuse of the Medicare or Medicaid programs, 
and
    (B) Federal and State agencies that are responsible for licensing 
and certification of practitioners and providers.
    (iii) A QIO may disclose to any person, agency, or organization 
information on a particular practitioner or reviewer at the written 
request of or with the written consent of that practitioner or reviewer. 
The beneficiary of the information has the same redisclosure rights and 
responsibilities as the requesting or consenting practitioner or 
reviewer as provided under this Subpart B.
    (iv) A QIO is not required to obtain the consent of a practitioner 
or provider prior to the release of information to a beneficiary in 
connection with an initial denial determination or in providing a 
beneficiary with the QIO's findings in response to a beneficiary 
complaint. Information that must be specified in a QIO's final decision 
in a complaint review is specified in Sec. Sec.  476.130(d) and 
476.140(b) of this subchapter.
    (b) Exceptions. (1) If the request is in connection with an initial 
denial determination or a change resulting from a diagnostic related 
group (DRG) coding validation under part 476 of this subchapter, the QIO 
must provide only the information used to support that determination in 
accordance with the procedures for disclosure of information relating to 
determinations under Sec.  478.24 of this subchapter.
    (2) A QIO must disclose information regarding QIO deliberations only 
as specified in Sec.  480.139(a).
    (3) A QIO must disclose quality review study information only as 
specified in Sec.  480.140.

[50 FR 15359, Apr. 17, 1885, as amended at 52 FR 37458, Oct. 7, 1987; 52 
FR 47004, Dec. 11, 1987. Redesignated at 64 FR 66279, Nov. 24, 1999, as 
amended at 69 FR 49266, 29267, Aug. 11, 2004; 77 FR 68564, Nov. 15, 
2012]



Sec.  480.134  Verification and amendment of QIO information.

    (a) A QIO must verify the accuracy of its information concerning 
patients, practitioners, reviewers, and institutions and must permit the 
individual or institution to request an amendment of pertinent 
information that is in the possession of the QIO.
    (b) If the QIO agrees with the request for amendment, the QIO must 
correct the information in its possession. If the information being 
amended has already been disclosed, the QIO must forward the amended 
information to the requester where it may affect decisions about a 
particular provider, practitioner or case under review.
    (c) If the QIO disagrees with the request for amendment, a notation 
of the request, reasons for the request, and the reasons for refusal 
must be included with the information and attached to any disclosure of 
the information.

[50 FR 15358, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985. Redesignated at 
64 FR 66279, Nov. 24, 1999]



Sec.  480.135  Disclosure necessary to perform review responsibilities.

    (a) Disclosure to conduct review. The QIO must disclose or arrange 
for disclosure of information to individuals and institutions within the 
QIO review system as necessary to fulfill their particular duties and 
functions under Title XI Part B of the Act.
    (b) Disclosure to consultants and subcontractors. The QIO must 
disclose to consultants or subcontractors the information they need to 
provide specified services to the QIO.

[[Page 728]]

    (c) Disclosure to other QIO and medical review boards. The QIO must 
disclose--
    (1) To another QIO, information on patients and practitioners who 
are subject to review by the other QIO; and
    (2) To medical review boards established under section 1881 of the 
Act, confidential information on patients, practitioners and 
institutions receiving or furnishing end stage renal disease services.



Sec.  480.136  Disclosure to intermediaries and carriers.

    (a) Required disclosure. Except as specified in Sec. Sec.  
480.139(a) and 480.140 relating to disclosure of QIO deliberations and 
quality review study information, a QIO must disclose to intermediaries 
and carriers QIO information that relates to, or is necessary for, 
payment of claims for Medicare as follows:
    (1) Review determinations and claims forms for health care services, 
furnished in the manner and form agreed to by the QIO and the 
intermediary or carrier.
    (2) Upon request, copies of medical records acquired from 
practitioners or institutions for review purposes.
    (3) QIO information about a particular patient or practitioner if 
the QIO and the intermediary or carrier (or CMS if the QIO and the 
intermediary or carrier cannot agree) determine that the information is 
necessary for the administration of the Medicare program.
    (b) Optional disclosure. The QIO may disclose the information 
specified in paragraph (a) of this section to intermediaries and 
carriers without a request.

[50 FR 15359, Apr. 17, 1985. Redesignated at 64 FR 66279, Nov. 24, 1999, 
as amended at 69 FR 49267, Aug. 11, 2004]



Sec.  480.137  Disclosure to Federal and State enforcement agencies
responsible for the investigation or identification of fraud or abuse
of the Medicare or Medicaid programs.

    (a) Required disclosure. Except as specified in Sec. Sec.  
480.139(a) and 480.140 relating to disclosure of QIO deliberations and 
quality review study information, the QIO must disclose confidential 
information relevant to an investigation of fraud or abuse of the 
Medicare or medicaid programs, including QIO medical necessity 
determinations and other information that includes patterns of the 
practice or performance of a practitioner or institution, when a written 
request is received from a State or Federal enforcement agency 
responsible for the investigation or identification of fraud or abuse of 
the Medicare or Medicaid programs that--
    (1) Identifies the name and title of the individual initiating the 
request,
    (2) Identifies the physician or institution about which information 
is requested, and
    (3) States affirmatively that the institution or practitioner is 
currently under investigation for fraud or abuse of the Medicare or 
Medicaid programs and that the information is needed in furtherance of 
that investigation.
    (b) Optional disclosure. The QIO may provide the information 
specified in paragraph (a) of this section to Federal or State fraud and 
abuse enforcement agencies responsible for the investigation or 
identification of fraud or abuse of the Medicare or Medicaid programs, 
without a request.

[50 FR 15358, Apr. 17, 1985, as amended at 52 FR 37458, Oct. 7, 1987. 
Redesignated at 64 FR 66279, Nov. 24, 1999, as amended at 69 FR 49267, 
Aug. 11, 2004]



Sec.  480.138  Disclosure for other specified purposes.

    (a) General requirements for disclosure. Except as specified in 
paragraph (b) of this section, the following provisions are required of 
the QIO.
    (1) Disclosure to licensing and certification bodies. (i) A QIO must 
disclose confidential information upon request, to State or Federal 
licensing bodies responsible for the professional licensure of a 
practitioner or a particular institution. Confidential information, 
including QIO medical necessity determinations that display the practice 
or performance patterns of that practitioner, must be disclosed by the 
QIO but only to the extent that it is required by the agency to carry 
out a function within the jurisdiction of the agency under Federal or 
State law.
    (ii) A QIO may provide the information specified in paragraph 
(a)(1)(i) of this section to the State or Federal licensing body without 
request.

[[Page 729]]

    (2) Disclosure to State and local public health officials. A QIO 
must disclose QIO information to State and local public health officials 
whenever the QIO determines that the disclosure of the information is 
necessary to protect against a substantial risk to the public health.
    (3) Disclosure to the courts. Patient identified records in the 
possession of a QIO are not subject to subpoena or discovery in a civil 
action, including an administrative, judicial or arbitration proceeding.
    (b) Exceptions. (1) The restriction set forth in paragraph (a)(3) of 
this section does not apply to HHS, including Inspector General, 
administrative subpoenas issued in the course of audits and 
investigations of Department programs, in the course of administrative 
hearings held under the Social Security Act or to disclosures to the 
General Accounting Office as necessary to carry out its statutory 
responsibilities.
    (2) A QIO must disclose information regarding QIO deliberations and 
quality review study information only as specified in Sec. Sec.  
480.139(a) and 480.140.

[50 FR 15359, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985. Redesignated at 
64 FR 66279, Nov. 24, 1999, as amended at 69 FR 49267, Aug. 11, 2004]



Sec.  480.139  Disclosure of QIO deliberations and decisions.

    (a)(1) A QIO must not disclose its deliberations except to--
    (i) CMS; or
    (ii) The Office of the Inspector General, and the Government 
Accountability Office as necessary to carry out statutory 
responsibilities.
    (2) QIO deliberations are not disclosable, either in written form or 
through oral testimony, in connection with the administrative hearing or 
review of a beneficiary's claim.
    (b) Reasons for QIO decisions. (1) A QIO may disclose to those who 
have access to QIO information under other provisions of this subpart, 
the reasons for QIO decisions pertaining to that information provided 
that the opinions or judgements of a particular individual or 
practitioner cannot be identified.
    (2) A QIO must disclose, if requested in connection with the 
administrative hearing or review of a beneficiary's claim, the reasons 
for QIO decisions. The QIO must include the detailed facts, findings and 
conclusions supporting the QIO's determination. The QIO must insure that 
the opinions or judgements of a particular individual or practitioner 
cannot be identified through the materials that are disclosed.

[50 FR 15359, Apr. 17, 1985,, as amended at 76 FR 26547, May 6, 2011; 77 
FR 68564, Nov. 15, 2012]



Sec.  480.140  Disclosure of quality review study information.

    (a) A QIO must disclose quality review study information with 
identifiers of patients, practitioners or institutions to--
    (1) Representatives of authorized licensure, accreditation or 
certification agencies as is required by the agencies in carrying out 
functions which are within the jurisdiction of such agencies under state 
law; to Federal and State agencies responsible for identifying risks to 
the public health when there is substantial risk to the public health; 
or to Federal and State fraud and abuse enforcement agencies;
    (2) An institution or practitioner, if the information is limited to 
health care services furnished by the institution or practitioner; and
    (3) A medical review board established under section 1881 of the Act 
pertaining to end-stage renal disease facilities, if the information is 
limited to health care services subject to its review.
    (b) A QIO must disclose quality review study information with 
identifiers of patients, practitioners or institutions to the Office of 
the Inspector General and the General Accounting Office as necessary to 
carry out statutory responsibilities.
    (c) A QIO may disclose information offsite from a particular quality 
review study to any institution or practitioner involved in that study, 
provided the disclosed information is limited to that institution or 
practitioner.
    (d) A QIO may disclose quality review study information with 
identifiers of particular practitioners or institutions, or both, at the 
written request of, or with the written consent of, the

[[Page 730]]

identified practitioner(s) or institution(s).
    (1) The consent or request must specify the information that is to 
be disclosed and the intended beneficiary of the information.
    (2) The beneficiary of the information has the same redisclosure 
rights and responsibilities as the requesting or consenting practitioner 
or institution as provided under this Subpart B.
    (e) An institution or group of practitioners may redisclose quality 
review study information, if the information is limited to health care 
services they provided.
    (f) Quality review study information with patient identifiers is not 
subject to subpoena or discovery in a civil action, including an 
administrative, judicial or arbitration proceeding. This restriction 
does not apply to HHS, including Inspector General, administrative 
subpoenas issued in the course of audits and investigations of 
Department programs, in the course of administrative hearings held under 
the Social Security Act, or to disclosures to the General Accounting 
Office as necessary to carry out its statutory responsibilities.
    (g) A QIO must disclose quality review study information to CMS with 
identifiers of patients, practitioners or institutions--
    (1) For purposes of quality improvement. Activities include, but are 
not limited to, data validation, measurement, reporting, and evaluation.
    (2) As requested by CMS when CMS deems it necessary for purposes of 
overseeing and planning QIO program activities.

[50 FR 15359, Apr. 17, 1985. Redesignated at 64 FR 66279, Nov. 24, 1999, 
as amended at 69 FR 49266, Aug. 11, 2004; 75 FR 19826, Apr. 15, 2010; 76 
FR 26547, May 6, 2011]



Sec.  480.141  Disclosure of QIO interpretations on the quality of 
health care.

    Subject to the procedures for disclosure and notice of disclosure 
specified in Sec. Sec.  480.104 and 480.105, a QIO may disclose to the 
public QIO interpretations and generalizations on the quality of health 
care that identify a particular institution.

[50 FR 15359, Apr. 17, 1985. Redesignated at 64 FR 66279, Nov. 24, 1999, 
as amended at 69 FR 49267, Aug. 11, 2004]



Sec.  480.142  Disclosure of sanction reports.

    (a) The QIO must disclose sanction reports directly to the Office of 
the Inspector General and, if requested, to CMS.
    (b) The QIO must upon request, and may without a request, disclose 
sanction reports to State and Federal agencies responsible for the 
identification, investigation or prosecution of cases of fraud or abuse 
in accordance with Sec.  480.137.
    (c) CMS will disclose sanction determinations in accordance with 
part 474 of this chapter.

[50 FR 15359, Apr. 17, 1985. Redesignated at 64 FR 66279, Nov. 24, 1999, 
as amended at 69 FR 49267, Aug. 11, 2004]



Sec.  480.143  QIO involvement in shared health data systems.

    (a) Information collected by a QIO. Except as prohibited in 
paragraph (b) of this section, information collected by a QIO may be 
processed and stored by a cooperative health statistics system 
established under the Public Health Service Act (42 U.S.C. 242k) or 
other State or Federally authorized shared data system.
    (b) QIO participation. A QIO may not participate in a cooperative 
health statistics system or other shared health data system if the 
disclosure rules of the system would prevent the QIO from complying with 
the rules of this part.
    (c) Disclosure of QIO information obtained by a shared health data 
system. QIO information must not be disclosed by the shared health data 
system unless--
    (1) The source from which the QIO acquired the information consents 
to or requests disclosure; or
    (2) The QIO requests the disclosure of the information to carry out 
a disclosure permitted under a provision of this part.

[[Page 731]]



Sec.  480.144  Access to QIO data and information.

    CMS may approve the requests of researchers for access to QIO 
confidential information not already authorized by other provisions in 
42 CFR part 480.

[76 FR 26547, May 6, 2011]



Sec.  480.145  Beneficiary authorization of use of confidential information.

    (a) Except as otherwise provided under this part, a QIO may not use 
or disclose a beneficiary's confidential information without an 
authorization from the beneficiary. The QIO's use or disclosure must be 
consistent with the authorization.
    (b) A valid authorization is a document that contains the following:
    (1) A description of the information to be used or disclosed that 
identifies the information in a specific and meaningful fashion.
    (2) The name or other specific identification of the QIO(s) and QIO 
point(s) of contact making the request to use or disclose the 
information.
    (3) The name or other specific identification of the person(s), or 
class of persons, to whom the QIO(s) may disclose the information or 
allow the requested use.
    (4) A description of each purpose of the requested use or 
disclosure. The statement ``at the request of the individual'' is a 
sufficient description of the purpose when an individual initiates the 
authorization and does not, or elects not to, provide a statement of 
purpose.
    (5) An expiration date or an expiration event that relates to the 
beneficiary or the purpose of the use or disclosure. The statement ``end 
of the QIO research study,'' ``none,'' or similar language is sufficient 
if the authorization is for a use or disclosure of confidential 
information for QIO research, including for the creation and maintenance 
of a research database or research repository.
    (6) Signature of the individual and date. If the authorization is 
signed by a beneficiary's representative, a description of such 
representative's authority to act for the beneficiary must also be 
provided.
    (c) In addition to those items contained in paragraph (b) of this 
section, the authorization must contain statements adequate to place the 
individual on notice of all of the following:
    (1) The individual's right to revoke the authorization in writing; 
and
    (2) Any exceptions to the right to revoke and a description of how 
the individual may revoke the authorization;
    (3) The ability or inability of the QIO to condition its review 
activities on the authorization, by stating either:
    (i) That the QIO may not condition the review of complaints, 
appeals, or payment determinations, or any other QIO reviews or other 
tasks within the QIO's responsibility on whether the individual signs 
the authorization;
    (ii) The consequences to the individual of a refusal to sign the 
authorization when the refusal will render the QIO unable to carry out 
an activity.
    (4) The potential for information disclosed pursuant to the 
authorization to be subject to either appropriate or inappropriate 
redisclosure by a beneficiary, after which the information would no 
longer be protected by this subpart.
    (d) The authorization must be written in plain language.
    (e) If a QIO seeks an authorization from a beneficiary for a use or 
disclosure of confidential information, the QIO must provide the 
beneficiary with a copy of the signed authorization.
    (f) A beneficiary may revoke an authorization provided under this 
section at any time, provided the revocation is in writing, except to 
the extent that the QIO has taken action in reliance upon the 
authorization.

[77 FR 68564, Nov. 15, 2012]

                           PART 481 [RESERVED]

[[Page 733]]



                              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 735]]



                    Table of CFR Titles and Chapters




                     (Revised as of October 1, 2022)

                      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 736]]

     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 737]]

    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 738]]

     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 739]]

        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 740]]

         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  (Parts 900--999) [Reserved]
         X  Bureau of Consumer Financial Protection (Parts 1000--
                1099)

[[Page 741]]

        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 742]]

      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 743]]

                     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 744]]

                          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 745]]

        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 746]]

        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 747]]

         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 748]]

                          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 749]]

       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 750]]

       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--Federal Acquisition Supply Chain Security
       201  Federal Acquisition Security Council (Parts 201-1--
                201-99)
            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 751]]

                       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 752]]

                      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 753]]

        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 754]]

        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 755]]





           Alphabetical List of Agencies Appearing in the CFR




                     (Revised as of October 1, 2022)

                                                  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 756]]

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 757]]

  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
  Science and Technology Policy, Office of        32, XXIV; 47, II
  Trade Representative, Office of the United      15, XX
       States
Export-Import Bank of the United States           2, XXXV; 5, LII; 12, IV

[[Page 758]]

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 Acquisition Security Council              41, 201
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 759]]

  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 760]]

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 761]]

  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 762]]

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
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, L
Rural Development Administration                  7, XLII
Rural Housing Service                             7, XVIII, XXXV, L
Rural Utilities Service                           7, XVII, XVIII, XLII, L
Safety and Environmental Enforcement, Bureau of   30, II
Science and Technology Policy, Office of          32, XXIV; 47, II
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
State, Department of                              2, VI; 22, I; 28, XI
  Federal Acquisition Regulation                  48, 6

[[Page 763]]

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 765]]



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, 2017 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.

                                  2017

42 CFR
                                                                   82 FR
                                                                    Page
Chapter IV
431.800 Undesignated center heading and section revised............31182
431.804 Revised....................................................31182
431.806 Revised....................................................31182
431.810 Undesignated center heading removed; section revised.......31183
431.812 Revised....................................................31183
431.814 Revised....................................................31183
431.816 Revised....................................................31183
431.818 Revised....................................................31184
431.820 Revised....................................................31184
431.822 Removed....................................................31184
431.861 Undesignated center heading; section removed...............31184
431.862 Removed....................................................31184
431.863 Removed....................................................31184
431.864 Removed....................................................31184
431.865 Removed....................................................31184
431.950 Revised....................................................31184
431.958 Amended....................................................31184
431.960 Revised....................................................31185
431.970 Revised....................................................31185
431.972 Revised....................................................31186
431.974 Removed....................................................31186
431.978 Removed....................................................31186
431.980 Removed....................................................31186
431.988 Removed....................................................31186
431.992 Revised....................................................31186
431.998 Revised....................................................31187
431.1010 Added.....................................................31187
438.6 (c)(2)(i) correctly amended.....................................39
    (d)(1), (3) and (5) revised.....................................5428
438.8 (e)(1) and (f)(2)(i) correctly amended..........................39
438.10 (g)(2)(xiii) correctly amended.................................39
438.210 (a)(2) correctly amended......................................39
438.350 (d) correctly amended.........................................39
438.358 (a)(2), (c)(3) and (4) correctly amended......................39
    (c)(3) and (4) correctly amended...............................12510
438.604 (a)(2) correctly amended......................................39
440.110 (a)(2) and (b)(2) amended...................................4578
    Regulation at 82 FR 4578 eff. date delayed to 1-13ndash;18.....31729
447.299 (c)(10) revised............................................16122
457.628 (a) revised................................................31187
457.1201 (l) and (n)(2) correctly amended.............................40
457.1203 (a) and (e) correctly amended................................40
457.1210 (c)(2) and (4) correctly amended.............................40
457.1214 Correctly revised............................................40
457.1228 Correctly revised............................................40
457.1230 (c) and (d) correctly revised................................40

[[Page 766]]

457.1233 (b) correctly amended........................................40
457.1240 (e) correctly revised; (f) heading corrected.................40
457.1250 (a) correctly revised........................................40
457.1260 Correctly amended............................................40
460 Technical correction...........................................14639
478.14 (c)(2) amended...............................................5139
478.40 (a) and (c) revised..........................................5139
478.42 Revised......................................................5139
478.44 Revised......................................................5139
478.46 Revised......................................................5140
478.48 Heading, (b) and (c) revised.................................5140

                                  2018

42 CFR
                                                                   83 FR
                                                                    Page
Chapter IV
431.802 Removed....................................................19440
438.214 (c) amended; CFR correction................................18441
455 Waiver.........................................................42037
460.40 (j) revised.................................................16756
460.50 (b)(1)(ii) revised..........................................16756
460.68 (a)(4) removed..............................................16756
460.70 (b)(1)(iv) removed..........................................16756
460.71 (b)(7) removed..............................................16756
460.86 Revised.....................................................16756

                                  2019

42 CFR
                                                                   84 FR
                                                                    Page
Chapter IV
438 Authority citation revised.....................................15843
438.210 (c) and (f) revised; (d)(4) added; eff. 1-1-21.............15843
438.400 (a)(4) added; (c) revised; eff. 1-1-21.....................15844
438.402 (a) revised; eff. 1-1-21...................................15844
441 Authority citation revised; eff. 11-29-19......................51816
441.184 (a) introductory text, (4), (b) introductory text, (c) 
        introductory text, (d) introductory text, (1)(ii), and (2) 
        revised; (d)(1)(v) added; eff. 11-29-19....................51816
447 Authority citation revised.......................12136, 19728, 50332
447.10 (g)(4) removed..............................................19728
447.294 Heading, (a), (d), (e) introductory text, (3)(i), (5)(i), 
        (ii), (iii), and (f) revised; (b) amended; (e)(14)(iv) 
        added; eff. 11-25-19.......................................50332
447.502 Amended; interim...........................................64786
447.509 (a)(4) revised; interim....................................12136
455 Authority citation revised; eff. 11-4-19.......................47856
455.21 (c) added...................................................10713
455.101 Amended; eff. 11-4-19......................................47856
455.103 Revised; eff. 11-4-19......................................47856
455.107 Added; eff. 11-4-19........................................47856
457 Authority citation revised; eff. 11-4-19.......................47857
457.990 (a) and (b) redesignated as (b) and (c); new (a) added; 
        eff. 11-4-19...............................................47857
460 Authority citation revised; eff. 11-29-19...............25671, 51816
460.3 Added........................................................25671
460.10 Revised.....................................................25671
460.12 Revised.....................................................25671
460.18 Introductory text and (b) revised; (c) removed..............25671
460.20 (a)(3) removed; (b), (c), and (d) redesignated as (c), (d), 
        and (e); new (b) added; (a) introductory text, new (c), 
        new (d), and new (e) revised...............................25672
460.22 Removed.....................................................25672
460.26 (a) and (b) introductory text revised.......................25672
460.28 Revised.....................................................25672
460.32 (a)(9) and (12) revised.....................................25672
460.40 Introductory text, (a) through (e), (f) introductory text, 
        (f)(1), (2), and (g) through (j) redesignated as (a) 
        introductory text, (1) through (5), (6) introductory text, 
        (i), (ii), and (7) through (10); new (b) added.............25672
460.46 (a) introductory text revised; (a)(1), (2), and (3) amended
                                                                   25672
460.60 (a) removed; (b), (c), and (d) redesignated as new (a), 
        (b), and (c); new (d) added; new (b) and new (c)(3) 
        revised....................................................25673
460.62 (a)(7) revised..............................................25673
460.63 Added.......................................................25673
460.64 (a) introductory text, (3), and (4) revised.................25673
460.66 (a) amended; (b) and (c) removed............................25673
460.68 (a)(2) amended; (a)(3) revised; (a)(4) and (5) added........25673

[[Page 767]]

460.70 (d)(5)(vi) through (ix) redesignated as (d)(6)(i) through 
        (iv); new (d)(6) introductory text added; (b)(1)(iii), new 
        (d)(6)(i), new (ii), and new (iii) revised; (e) and (2) 
        amended....................................................25673
460.71 (a)(1) and (b)(4) revised; (c) and (d) added................25674
460.82 (c)(1), (e) introductory text, (3), (4), and (5) revised; 
        (f) removed................................................25674
460.84 (a) introductory text, (4), (b) introductory text, (c) 
        introductory text, (d) introductory text, (1)(ii), and (2) 
        revised; (d)(1)(v) added; eff. 11-29-19....................51816
460.98 (c)(1) revised; (d) heading and (3) amended.................25674
460.100 (e)(3)(i) amended..........................................25674
460.102 (a)(1), (b) introductory text, (1), (c) introductory text, 
        (1), and (2) introductory text revised; (d)(3) removed; 
        (e) redesignated as (f); new (e) added.....................25674
460.104 (a)(1), (2) introductory text, (i), (3), (4) introductory 
        text, (b), (c), (d) introductory text, (1), and (2) 
        introductory text revised; (d)(2)(i) through (v) 
        redesignated as (d)(2)(ii) through (vi); new (d)(2)(i) 
        added......................................................25674
460.106 (a) revised; (b)(3), (4), and (5) added....................25675
460.112 (b)(1)(ii) removed; (b)(1)(iii) redesignated as new 
        (b)(1)(ii); (b)(1)(i), (3), and (c)(3) revised.............25675
460.116 (c)(1) and (2) revised.....................................25675
460.120 (f) amended................................................25675
460.122 (c)(1) and (i) revised.....................................25675
460.130--460.140 (Subpart H) Heading revised.......................25675
460.130 (a) revised; (d) added.....................................25676
460.132 Heading, (a), and (c)(3) revised...........................25676
460.134 Heading and (a) introductory text amended..................25676
460.136 Heading, (a) heading, (b) heading, (b), (c) introductory 
        text, (1), and (2) amended.................................25676
460.138 (b) amended................................................25676
460.140 Removed....................................................25676
460.150 (c)(2) revised.............................................25676
460.152 (b)(4) revised.............................................25676
460.154 (i) revised................................................25676
460.156 (a)(2) revised; (a)(4) removed.............................25676
460.162 Revised....................................................25676
460.164 (a) through (e) redesignated as (b) through (f); new 
        (b)(2) through (6) redesignated as (b)(4) through (8); new 
        (a), new (b)(2), and new (3) added; new (b)(4) amended; 
        new (c) and new (d) revised................................25676
460.166 Heading revised............................................25677
460.168 (a) revised................................................25677
460.172 (c) amended................................................25677
460.182 (b) introductory text revised..............................25677
460.190 (b)(1) revised; (b)(2), (3), and (4) redesignated as 
        (b)(3), (4), and (5); new (b)(2) added.....................25677
460.192 (b) revised................................................25677
460.194 (a) revised................................................25677
460.196 (d) revised................................................25677
460.200 (f)(1)(ii) and (iii) revised...............................25677

                                  2020

42 CFR
                                                                   85 FR
                                                                    Page
Chapter IV
431 Authority citation revised.....................................25634
431.60 Added.......................................................25634
431.70 Added.......................................................25635
433 Authority citation revised.....................................87100
433.139 (b)(2) removed; (b)(3)(i) and (ii)(B) revised..............87100
433.400 (Subpart G) Added; interim.................................71197
438 Authority citation revised.....................................25635
438.3 (d)(4) revising..............................................37243
    (t) revised....................................................72837
    (s) introductory text, (4), and (5) revised....................87101
438.4 (b)(1) revised; (c) added....................................72837
438.5 (c)(3)(ii) revised...........................................72838
438.6 (a) amended; (b)(1), (c)(1)(iii), and (2) revised; (c)(3) 
        added......................................................72838
    (d)(6) added...................................................72839
438.7 (c)(3) revised; (e) added....................................72839
438.8 (e)(4) amended; (k)(1)(iii) revised..........................72840
438.9 (b)(2) revised...............................................72840
438.10 (d)(2), (3), (f)(1), (h)(1)(vii), and (h)(3) revised; 
        (d)(6)(iv) removed; (g)(2)(ii)(B) amended..................72840

[[Page 768]]

438.54 (b)(3) added................................................72840
438.56 (d)(5) heading, (i), and (iii) revised......................72840
438.62 (b)(1)(vi) and (vii) added..................................25635
438.68 (b)(1) introductory text, (iv), and (2) revised; 
        (b)(1)(viii) removed.......................................72840
438.206 (c)(2) revising............................................37243
438.236 (b)(3) amended.............................................72841
438.242 (b)(5) and (6) added.......................................25635
438.334 (b), (c)(1), and (3) revised; (c)(4) added.................72841
438.340 (b)(2), (3)(i), (6), and (c)(1)(ii) revised; (b)(8) 
        removed; (b)(9) through (11) redesignated as new (b)(8) 
        through (10); new (b)(9) and (c)(3)(ii) amended............72841
438.358 (b)(1)(iii) revised........................................72841
438.362 (c) added..................................................72842
438.364 (a)(7) added; (d) revised..................................72842
438.400 (b) amended................................................72842
438.402 (c)(3)(ii) revised.........................................72842
438.406 (b)(3) revised.............................................72842
438.408 (f)(2) revised.............................................72842
440 Authority citation revised.....................................19291
440.20 (b) introductory text amended...............................72909
440.30 (d) added; interim..........................................27626
440.70 (a)(2), (b)(1)(ii), (3)(iii), and (iv) revised; interim.....19291
    (a)(2), (b)(1)(ii), (f) introductory text, (3)(i), (4), and 
(g)(1) revised; (a)(3) and (f)(3)(vi) added; (b)(3)(iii), (iv), 
(f)(3)(ii), (iv), and (5) introductory text amended; interim.......27626
440.262 Revised....................................................37243
441.17 (a)(1), (4), and (b) amended................................72909
441.18 (c) introductory text amended...............................72909
447.299 (c) introductory text amended..............................72909
447.502 Amended....................................................87101
447.502 Amended; eff. 1-1-22.......................................87101
447.504 (b)(2) removed; (b)(3) redesignated as new (b)(2)..........87102
447.504 (c)(25) through (29) and (e)(13) through (17) revised; 
        eff. 1-1-23................................................87102
447.505 (a) amended; (d)(3) revised; eff. 1-1-22 in part...........87102
447.505 (c)(8) through (12) revised; eff. 1-1-23...................87102
447.506 (a) amended; (b) revised...................................87103
447.509 (a)(5) revised; (a)(6) introductory text amended; (a)(7), 
        (8), and (9) added.........................................87103
    (a)(4)(ii) introductory text revised; (a)(4)(iii) redesignated 
as (a)(4)(iv); new (a)(4)(iii) added; eff. 1-1-22..................87103
447.510 (b)(1)(vi) added...........................................87103
447.511 (a) introductory text amended; (b) revised; (d) and (e) 
        added; eff. 1-1-22.........................................87103
447.518 (d) redesignated as (d)(1); (d)(2) and (3) added; eff. 1-
        1-22.......................................................87104
456 Authority citation revised.....................................87104
456.703 (h) redesignated as (i); new (h) added.....................87104
456.712 (c) added..................................................87104
457 Authority citation revised.....................................25635
457.700 (a)(1) and (2) redesignated as (a)(2) and (3); new (a)(1) 
        added; (c) revised.........................................25635
457.730 Added......................................................25636
457.760 Added......................................................25637
457.1233 (d) revised...............................................25637
460 Policy statement...................................................7
460.98 (b)(3) revised..............................................37243
460.112 (a) revised................................................37243
476 Authority citation revised.....................................59025
476.78 (d) redesignated as (f); new (d) and (e) added; (b)(2)(i) 
        amended; (b)(2)(ii), (c), and new (f) revised..............59025
480 Authority citation revised.....................................59026
480.111 (d) revised................................................59026

                                  2021

42 CFR
                                                                   86 FR
                                                                    Page
Chapter I
431 Notification...................................................70412
435 Notification...................................................70412
438 Notification...................................................70412
440 Notification...................................................70412
441.151 (c) added; interim.........................................61617
447.502 Amended....................................................64825
447.505 (a) amended................................................64825
447.505 Correction: Instruction 3 removed..........................71583
455 Technical correction...........................................58019
455.2 Amended.......................................................6131
455.410 (d) added..................................................45521
457 Notification...................................................70412
460.6 Amended.......................................................6131
460.56 Added........................................................6132
460.74 (d) added; interim..........................................61618

[[Page 769]]

460.92 Revised......................................................6132
460.96 (a) and (b) removed; (c) through (e) redesignated as (a) 
        through (c).................................................6132
460.98 (a) revised; (b)(1) amended; (b)(4) and (5) added............6132
460.102 (d)(1) and (2)(ii) revised..................................6132
460.104 (d)(2) revised..............................................6132
460.112 (c)(3) redesignated as (c)(5); (b)(4), new (c)(3) and (4) 
        added.......................................................6132
460.121 Added.......................................................6132
460.122 Introductory text, (b), (c)(1), (2), (4), (d), (g), and 
        (h) revised; (c)(5) and (6) redesignated as (c)(6) and 
        (7); new (c)(5) added.......................................6134
460.124 Revised.....................................................6134
460.200 (b)(1) through (4) redesignated as (b)(1)(i) through (iv); 
        new (b)(2) added; (d) revised...............................6134
460.210 (b)(4) through (12) redesignated as (b)(7) through (15); 
        new (b)(4) through (6) added................................6135

                                  2022

  (Regulations published from January 1, 2022, through October 1, 2022)

42 CFR
                                                                   87 FR
                                                                    Page
Chapter I
433 Policy statement...............................................58456
447.10 (a) revised; (i) added......................................29690


                                  [all]